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>> GOOD MORNING WELCOME
BACK TO 

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THE NIDDK WORKSHOP LEVERAGING 

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EVIDENCE TO ASSESS BENEFITS AND 

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GLP-1-BASED THERAPIES.  THIS 

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MORNING BEGINS WITH SESSION 4 ON

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BEST PRACTICES FOR STUDIES GLP-1

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THERAPIES.  WE WILL BREAK FOR 

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LUNCH AT 12:35 UNTIL 1:15 P.M. 

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EASTERN TIME AND AFTER THE LUNCH

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WORKSHOP WILL CONTINUE AND 

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SUMMARIZE RESEARCH GAPS AND 

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OPPORTUNITIES AND LEAD A 

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DISCUSSION WITH WORKSHOP 

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ATTENDEES LAND ADJOURN AT 2 

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O'CLOCK PM EASTERN TIME.  BEFORE

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WE GET STARTED I WOULD LIKE TO 

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REVIEW SOME HOUSEKEEPING ITEMS. 

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THE MEETING IS BEING RECORDED 

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AND WILL BE POSTED TO NIH 

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WEBSITE AND JOHN FROM SCIENTIFIC

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CONSULTING GROUP OR SCG IS THE 

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MEETING HOST.  E-MAIL HER AT 

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DJONIGAN WITH ANY TECHNICAL 

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ISSUES AND USE THE Q & A 

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FUNCTION TO ASK QUESTIONS OF 

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SPEAKERS AT ANY TIME.  ATTENDEES

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CAN UPVOTE QUESTIONS IN THE Q
& 

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A.  

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THE CHAT IS DISABLED FOR THE 

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WORKSHOP AND RAISED HAND FEATURE

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WILL NOT BE USED.  PLEASE USE 

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THE Q & A FUNCTION INSTEAD. 
I 

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WOULD LIKE TO WELCOME KATHLEEN 

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MCTEEING MODERATOR FOR SESSION 

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4, BEST PRACTICES FOR STUDYING 

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GLP-1-BASED THERAPIES DEFINING 

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EXPOSURE AND OUTCOMES. 

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DR. MATIG?  

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>> THANK SO YOU MUCH.  I'M

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DELIGHTED TO INTRODUCE OUR FIRST

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SPEAKER THIS MORNING.  A. 

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RESEARCH FOCUSES ON IDENTIFYING 

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SCALEABLE AND TRANSLATABLE 

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METHODS PREVENTING AND TREATING 

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OBESITY WITH EMPHASIS LEVERAGING

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REAL WORLD DATA SETS 

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PARTICULARLY HEALTH CARE 

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PATTERNS. 

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DR. LOUIS WILL DISCUSS DEFINING 

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EXPOSURES TO GLP-1-BASED 

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THERAPIES AND COMPARISON GROUPS 

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USING REAL WORLD DATA AND 

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REMINDER TO PUT Q & A
QUESTIONS 

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IN THE PANEL AND WE WILL 

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DISCUSSION THEM AFTER THE 

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PRESENTATION.  DR. LOUIS. 

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>> ALL RIGHT.  LET ME GET
MY 

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SCREENS PULLED UP FOR YOU GUYS. 

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HOPEFULLY YOU ARE SEEING AND 

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HEARING.  

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GOOD MORNING, EVERYBODY.  AND 

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THANK YOU FOR COMING BACK FOR 

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ROUND 2.  SO MANY GREAT TALKS 

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YESTERDAY.  I'M EXCITED TO 

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HOPEFULLY BUILD ON SOME OF THE 

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CONCEPTS AND MAYBE PRESENT THEM 

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IN A SLIGHTLY DIFFERENT LIGHT 

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THINKING ABOUT METHODS WE WANT 

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TO USE WHEN WE ARE USING 

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REAL-WORLD DATA SETS TO COMPARE 

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OUTCOMES AFTER GLP-1 THERAPIES 

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AND HOPING IN PARTICULAR YOU ARE

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ABLE TO CATCH BEFORE RENANS TALK

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YESTERDAY ON TRIALS.  LOTS OF 

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CONKROEPTS I WILL COVER WILL 

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REFLECT STEPS OR DESIGN CHOICES 

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A RESEARCH MIGHT MAKE IN THAT 

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PROCESS.  AS A DISCLAIMER, I 

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WOMAN TO THE AREA OF RESEARCH IN

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BACKGROUND IN CLINICAL OBESITY 

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MANY ED CIN AND HEALTH RESEARCH 

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AND NOT A 

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PHARMACOEPIDEMIOLOGISTS BY 

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TRAINING AND MY HOPE IS FOR 

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THOSE IN THE AUDIENCE WITH A 

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CLINICAL BACKGROUND, THIS 

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LECTURE CAN HELP TO WALK YOU 

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THROUGH VERY BASIC CONCEPTS IN 

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PHARMACOEPITHAT WILL IMPROVE 

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INTERNAL VALIDITY OF YOUR 

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REAL-WORLD STUDIES OF GLP-1 

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MEDICATIONS. 

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THESE ARE MY DISCLOSURES. 

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I GUESS, FIRST, YOU KNOW, WE SAW

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LOTS OF DATA PRESENTED YESTERDAY

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THAT SHOWS US THE ENORMOUS 

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UPTAKE AND INTEREST IN THESE 

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MEDICATIONS IN THE UNITED STATES

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AND AROUND THE WORLD ARE 

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MILLIONS OF PEOPLE THAT HAVE 

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BEEN EXPOSED TO GLP-1 

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MEDICATIONS AND THINK IT IS 

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IMPORTANT AS WE THINK ABOUT THE 

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NUMBER OF PEOPLE THAT CAN 

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POTENTIALLY COME INTO OUR 

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STUDIES THAT WE ARE VERY 

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THOUGHTFUL ABOUT WHO MAKES IT 

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INTO OUR STUDY COHORTS USING 

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REAL WORLD DATA SETS. 

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FOR MANY RESEARCH QUESTIONS 

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SEEKING TO ESTABLISH A CAUSAL 

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LINK BETWEEN STARTING A GLP-1 

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AND A POSITIVE HEALTH OUTCOME OR

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ADVERSE HEALTH OUTCOME IT WILL 

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BE OPTIMAL IN MOST CASES TO 

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SELECT PEOPLE TAKING A MANY 

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EDUCATION FOR A FIRST TIME 

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INCIDENT OR NEW USERS AND WHY DO

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WE WANT TO DO THIS?  SELECTING 

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FIRST-TIME USERS WILL GIVE US 

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MORE CONFIDENCE THAT OUR 

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BASELINE AND PRE-TREATMENT 

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CHARACTERISTICS ARE BEING 

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MEASURED IN ADVANCE TO EXPOSURE 

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OF THING WE ARE TRYING TO STUDY 

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GLP-1 AND SOMEONE BEING ON A 

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GLP-1 IN PAST YEAR MIGHT HAVE A 

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CURRENT BMI OF 30 BUT COULD BE 

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DOWN FROM BMI OF 35 AND IS 

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PHYSIOLOGICALLY A DIFFERENT 

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PATIENT THAN PERSON STARTING OUT

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IN BMI OF 30 AND INITIATING 

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GLP-1 AND INITIALLY PREVALENT 

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USERS OF MEDICATION ARE INCLUDED

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ALONGSIDE BRAND NEW USERS IT 

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WILL RISK US NOT GETTING A REAL 

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TRUE SENSE OF THE TOLLRABILITY 

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OF THESE MEDICATIONS. 

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PREVALENT USERS ARE PEOPLE 

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PROBABLY THAT DIDN'T HAVE SUPER 

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HORRIBLE OR REACTIONS OR SERIOUS

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ADVERSE REACTION AND CAN RESTART

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THE MEDICATION OR RESTART IT 

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SAFELY AFTER A BREAK AND 

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OPERATIONALIZING THIS IDEA 

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IMAGINE WE HAVE AN E HAD.  R 

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DATA SET AND WANT TO LOOK AT 

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WEIGHTELOUS OUTCOMES FOR 

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PATIENTS ON SEW MAKING LA TIED 

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AND -- .25 MILLIGRAMS IN FIRST 

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MONTH DATA SAYING THESE ARE 

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PEOPLE STARTING OUT AND PLAN TO 

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FOLLOW INDIVIDUALS FOR 12 MONTHS

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WE WOULD PROBABLY CAPTURE NEW 

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USERS OF MEDICATION WITH THIS 

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APPROACH BUT WOULD ALSO MIX IN A

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LOT OF PEOPLE WHO HAD BEEN 

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TAKING THE MEDICINE PREVIOUSLY 

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AND CONTINUED BECAUSE IT WAS 

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WORKING WELL FOR THEM OR 

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RESUMING AFTER A PAUSE TAKEN FOR

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SOME OTHER REASON. 

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HOW DO WE GO ABOUT FINDING 

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INCIDENT USERS OF GLP-1 

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MEDICATIONS?  IN REAL-WORLD 

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DATASETS WE WILL HAVE ACCESS TO 

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CALENDAR TIME PERIOD WORTH OF 

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DATA AND IMAGINE 2020 TO 2024 

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AND LOOKING AT PEOPLE WITH FIRST

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PRESCRIPTION OFSOME AGO LA TIED 

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IN DATA WE WON'T BE SURE WHETHER

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THAT IS FIRST TIME WE ARE 

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GETTING MEDICINE OR FIRST TIME 

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WE CAN SEE IT IN OUR DATA SET.  

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WE DON'T HAVE INFORMATION PRIOR 

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TO 20 TWENTD AND FOR THIS REASON

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WE NEED A LOOK-BACK PERIOD OR 

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WASH OUT AND SOME TIME BEFORE WE

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CALL START DATE OFSOME AGO LA 

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TIED FOR EACH PERSON SCANNING 

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BACK OVER TIME AND DOUBLE 

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CHECKING THEY WEREN'T PREVIOUSLY

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PRESCRIBED THIS MED KRAGS.  

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APPLYING A WASHOUT ADDS ANOTHER 

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LAYER FOR INCLUSION FOR STUDY.  

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NOT ONLY DOES PERSON HAVE TO 

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HAVE FIRST PRESCRIPTION FORSOME 

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AGO LOW TIDE. 

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>> SEM AGO LA AGLUTIDE --
LIMIT 

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A SMALLER POOL OF PEOPLE WITH 

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THAT MUCH PREPRESCRIPTION DATA 

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AVAILABLE TO LOOK AT.  CONVERSE 

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OF THESE THINGS WILL BE TRUE 

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WITH A LONGER WASHOUT.  HOW LONG

195
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IS IDEAL OR ADEQUATE FOR A 

196
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WASHOUT?  THERE HAVE BEEN REALLY

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NICE STUDIES LOOKING AT THIS 

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WITH OTHER MEDICATIONS FOR 

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CHRONIC CONDITIONS THAT SUGGESTS

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THAT SORT OF STANDARD SIX MONTHS

201
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WE USE IN MANY STUDIES IS 

202
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PROBABLY THE BEAR MINIMUM AROUND

203
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AT RISK FOR LOTS OF 

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MISCLASSIFICATION AND IDEALLY IF

205
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SAMPLE SIZE AND DATA CAN SUPPORT

206
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IT LOOKING BACK 12 TO 24 MONTHS 

207
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MAKES MORE SENSE AND MAKES SENSE

208
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TO DO IT IN A FEW DIFFERENT WAYS

209
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AND USING LESS STRINGENT 

210
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12-MONTH WASHOUT FOR MAIN 

211
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ANALYSIS ON LARGEST SAMPLE AND 

212
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DOG SENSITIVITY ANALYSIS TO SEE 

213
00:08:54,734 --> 00:08:56,436
HOW RESULTS CHANGE IF YOU 

214
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RESTRICT TO PEOPLE WITH TRUE 

215
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INCIDENT USE USING A 24-MONTH 

216
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WASHOUT AND MAKING IT EASIER FOR

217
00:09:05,178 --> 00:09:09,182
GLP-1S COMPARED TO OLDER OAMS 

218
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AND MANY DRUGS IS MOST CAME TO 

219
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MARKET AND DATA EXPANDING BEFORE

220
00:09:14,120 --> 00:09:16,356
TIME OF FDA APPROVAL YOU CAN BE 

221
00:09:16,356 --> 00:09:18,591
PRETTY CONFIDENT YOU ARE NOT 

222
00:09:18,591 --> 00:09:20,360
MISSING ANY PREVALENT USERS 

223
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BEFORE THAT DATE. 

224
00:09:21,728 --> 00:09:22,595
ANOTHER IMPORTANT CONSIDERATION 

225
00:09:22,595 --> 00:09:25,198
WHEN WE ARE CONDUCTING RESEARCH 

226
00:09:25,198 --> 00:09:28,001
ON GLP-1S IS TRYING TO TEASE OUT

227
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THE REASON THAT SOMEBODY IS 

228
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USING THE MEDICATION THAT CAN 

229
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HAVE REALLY IMPORTANT 

230
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IMPLICATIONS FOR INTERPRETING 

231
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EFFECTIVENESS AT SAFETY SIGNALS.

232
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THIS WAS DISCUSSED A LOT 

233
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YESTERDAY.  I THINK ONE OF THE 

234
00:09:40,146 --> 00:09:41,981
REASONS THIS CLASS OF MEDICINES 

235
00:09:41,981 --> 00:09:44,751
IS SO EXCITING IS THAT UNLIKE 

236
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OTHER MEDICINES USED FOR OBESITY

237
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OR DIABETES, GLP-1S HAVE 

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MULTIPLE LABELED AND EMERGING 

239
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OFF-LABEL USES FOR WHICH DOCTORS

240
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ARE PRESCRIBING THEM AND AS WE 

241
00:09:57,163 --> 00:09:59,232
USE CLINICAL DATA TO STUDY MEDS 

242
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THOUGH, IT IS IMPORTANT FOR US 

243
00:10:00,433 --> 00:10:01,734
TO TRY TO UNDERSTAND THE REASON 

244
00:10:01,734 --> 00:10:04,604
WHY SOMEONE IS TAKING A GLP-1 

245
00:10:04,604 --> 00:10:07,841
BECAUSE OF THE RISK OF 

246
00:10:07,841 --> 00:10:11,244
CONFOUNDING BY INDICATION OR 

247
00:10:11,244 --> 00:10:11,878
CONTRAINDICATION. 

248
00:10:11,878 --> 00:10:13,746
OUTCOMES OF INTEREST SUCH AS 

249
00:10:13,746 --> 00:10:15,682
WEIGHT LOSS TALKING ABOUT 

250
00:10:15,682 --> 00:10:17,016
OBESITY COULD BE DIFFERENT 

251
00:10:17,016 --> 00:10:18,585
DEPENDING ON POPULATIONS OF 

252
00:10:18,585 --> 00:10:20,753
PATIENTS DEPENDING WHY THEY ARE 

253
00:10:20,753 --> 00:10:22,722
TAKING THE MEDICINE AND FOR 

254
00:10:22,722 --> 00:10:24,591
EXAMPLE IF YOU WANT TO COMPARE 

255
00:10:24,591 --> 00:10:30,363
WEIGHT LOSS FOR PATIENTS TAKING 

256
00:10:30,363 --> 00:10:31,998
SEMAGLUTIDE IT IS IMPORTANT THAT

257
00:10:31,998 --> 00:10:36,102
YOU KNOW THAT 100% OF SAMPLE OF 

258
00:10:36,102 --> 00:10:37,637
USERS WILL TAKE THAT MEDICATION 

259
00:10:37,637 --> 00:10:39,739
FOR WEIGHT LOSS AND IS THE ONLY 

260
00:10:39,739 --> 00:10:43,643
INDICATION FOR THAT DRUG.  WHILE

261
00:10:43,643 --> 00:10:47,280
IF NOT CAREFUL -- DIABETES 

262
00:10:47,280 --> 00:10:49,182
TREATMENT NOT WEIGHT LOSS AND 

263
00:10:49,182 --> 00:10:50,783
PATIENTS WITH DIABETES HAVE 

264
00:10:50,783 --> 00:10:53,152
DIFFERENT BEHAVIOR AND CARE 

265
00:10:53,152 --> 00:10:54,187
PATTERNS AND DIFFERENT 

266
00:10:54,187 --> 00:10:56,823
PHYSIOLOGY THAT IMPACT 

267
00:10:56,823 --> 00:10:58,525
EFFECTIVENESS OF SEMAGLUTIDE FOR

268
00:10:58,525 --> 00:11:00,860
WEIGHT LOSS YOU HAVE COMPARISON 

269
00:11:00,860 --> 00:11:03,563
WITH UNMEASURED CONFOUNDING BY 

270
00:11:03,563 --> 00:11:05,031
MEDICATION AND HOW DOES IT PLAY 

271
00:11:05,031 --> 00:11:07,834
INTO THE REAL-WORLD DATA AND 

272
00:11:07,834 --> 00:11:09,168
THIS STUDY WAS CITED SOME 

273
00:11:09,168 --> 00:11:10,436
YESTERDAY AND IS A GROUP THAT 

274
00:11:10,436 --> 00:11:12,171
HAS DONE PUBLISHING LOOKING AT 

275
00:11:12,171 --> 00:11:16,676
EARLY OUTCOMES WITH GLP-1S AND 

276
00:11:16,676 --> 00:11:18,845
REAL WORLD DATA SETS AND THIS 

277
00:11:18,845 --> 00:11:20,613
TABLE SHOWS WHERE WHEN THEY LOOK

278
00:11:20,613 --> 00:11:23,016
AT WEIGHT LOSS ACROSS 

279
00:11:23,016 --> 00:11:23,850
INDICATIONS ACCORDING TO BRAND 

280
00:11:23,850 --> 00:11:26,786
NAME THE PRESENCE OF TYPE 2 

281
00:11:26,786 --> 00:11:28,087
DIABETES DIAGNOSIS, YOU CAN SEE 

282
00:11:28,087 --> 00:11:30,056
HERE THE PROPORTION OF PATIENTS 

283
00:11:30,056 --> 00:11:32,358
IN THIS STUDY WHO WERE ABLE TO 

284
00:11:32,358 --> 00:11:35,061
ACHIEVE 10% WEIGHT LOSS BY ONE 

285
00:11:35,061 --> 00:11:37,330
YEAR AFTER TREATMENT INITIATION 

286
00:11:37,330 --> 00:11:39,332
WAS NEARLY DOUBLED AMONG THOSE 

287
00:11:39,332 --> 00:11:46,773
APPEARING TO TAKE MEDICATION FOR

288
00:11:46,773 --> 00:11:47,473
BEAU BE

289
00:11:47,473 --> 00:11:48,942
-- OBESITY AND TYPE 2 DIABETES 

290
00:11:48,942 --> 00:11:51,811
IS LOWER THAN WHAT WE WOULD SEE 

291
00:11:51,811 --> 00:11:53,980
IN A CLINICAL TRIAL AND SAMPLE 

292
00:11:53,980 --> 00:11:56,215
SIZES HERE YOU CAN SEE FAR FEWER

293
00:11:56,215 --> 00:11:57,750
PATIENTS MAKING IT INTO GROUPS 

294
00:11:57,750 --> 00:12:02,221
OF TAKING THIS MEDICINE FOR 

295
00:12:02,221 --> 00:12:04,357
OBESITY.  

296
00:12:04,357 --> 00:12:07,126
HOW DO WE GO ABOUT FIGURING OUT 

297
00:12:07,126 --> 00:12:08,761
THE INDICATION WHEN WE DON'T 

298
00:12:08,761 --> 00:12:09,929
NECESSARILY WE WEREN'T THERE IN 

299
00:12:09,929 --> 00:12:12,198
THE ROOM AND DON'T KNOW 

300
00:12:12,198 --> 00:12:13,199
CONVERSATION BETWEEN CLINICIAN 

301
00:12:13,199 --> 00:12:14,601
AND PATIENT AND A COUPLE 

302
00:12:14,601 --> 00:12:15,668
DIFFERENT WAYS TO THINK ABOUT 

303
00:12:15,668 --> 00:12:17,370
DOING THIS IF YOU ARE REALLY 

304
00:12:17,370 --> 00:12:21,140
WANTING TO UNDERSTAND GLP-1 AS 

305
00:12:21,140 --> 00:12:23,243
TREATMENT FOR OBESITY A STRICT 

306
00:12:23,243 --> 00:12:24,811
WAY TO IDENTIFY PATIENTS MIGHT 

307
00:12:24,811 --> 00:12:26,145
BE TO RESTRICT TO PEOPLE THAT 

308
00:12:26,145 --> 00:12:28,514
DON'T HAVE EVIDENCE OF TYPE 2 

309
00:12:28,514 --> 00:12:30,149
DIABETES IN ENTIRE TREATMENT 

310
00:12:30,149 --> 00:12:31,150
BASELINE PERIOD AND ONLY REALLY 

311
00:12:31,150 --> 00:12:32,752
LOOK AT PEOPLE TAKING THE 

312
00:12:32,752 --> 00:12:35,355
VERSION OF THE MEDICINE LABELED 

313
00:12:35,355 --> 00:12:42,128
FOR OBESITY AND FOR SEMAGLUTIDE 

314
00:12:42,128 --> 00:12:43,796
USING [INDISCERNIBLE] AND OSDEM 

315
00:12:43,796 --> 00:12:45,632
PICK AND MAKING SURE PATIENT 

316
00:12:45,632 --> 00:12:48,468
MEETS CRITERIA AND PATIENT IS 

317
00:12:48,468 --> 00:12:50,570
ELIGIBLE FOR OBESITY TREATMENT 

318
00:12:50,570 --> 00:12:53,940
AT BASELINE BMI MEASURE OR 

319
00:12:53,940 --> 00:12:56,509
OBESITY DIAGNOSIS AND UPSIDE OF 

320
00:12:56,509 --> 00:12:58,845
TAKING STRICTER APPROACH TO 

321
00:12:58,845 --> 00:13:00,113
DEFINING INDICATION WOULD 

322
00:13:00,113 --> 00:13:01,214
INCLUDE REDUCING RISK OF 

323
00:13:01,214 --> 00:13:02,582
CONFOUNDING AND PROBABLY 

324
00:13:02,582 --> 00:13:04,617
PRODUCING A MORE ACCURATE 

325
00:13:04,617 --> 00:13:05,752
ESTIMATE OF TREATMENT EFFECTS 

326
00:13:05,752 --> 00:13:06,986
FOR POPULATION YOU ARE 

327
00:13:06,986 --> 00:13:11,057
INTERESTED IN GENERALIZING TO. 

328
00:13:11,057 --> 00:13:13,026
DOWNSIDES YOU WILL END UP WITH 

329
00:13:13,026 --> 00:13:14,727
SMALLER SAMPLE SIZE FOR BEING 

330
00:13:14,727 --> 00:13:17,196
STRICT AND OBESITY TREATMENT IN 

331
00:13:17,196 --> 00:13:18,798
PARTICULAR SHORTER FOLLOW UP 

332
00:13:18,798 --> 00:13:22,068
TIME NOW GIVEN RELATIVELY RECENT

333
00:13:22,068 --> 00:13:25,104
FDA APPROVAL OF VERSIONS OF MEDS

334
00:13:25,104 --> 00:13:26,973
RELATIVE TO DIABETES VERSIONS. 

335
00:13:26,973 --> 00:13:30,677
BECAUSE OF THE DIFFICULTIES 

336
00:13:30,677 --> 00:13:31,944
INHERIENT IN STRICTLY 

337
00:13:31,944 --> 00:13:34,347
IDENTIFYING PATIENTS USING 

338
00:13:34,347 --> 00:13:35,915
GLP-1S AND OBESITY AND BECAUSE 

339
00:13:35,915 --> 00:13:38,384
OF LARGE AMOUNT OF OFF LABEL USE

340
00:13:38,384 --> 00:13:40,453
OF DIABETES MEDICINES FOR 

341
00:13:40,453 --> 00:13:42,622
PURPOSE IT MIGHT MAKE MORE SENSE

342
00:13:42,622 --> 00:13:45,191
FOR CURRENT DATASETS TO TAKE A 

343
00:13:45,191 --> 00:13:46,826
LITTLE LESS STRICT APPROACH TO 

344
00:13:46,826 --> 00:13:49,195
CREATE LARGER AND MORE 

345
00:13:49,195 --> 00:13:50,263
GENERALIZABLE COHORTS AND HERE 

346
00:13:50,263 --> 00:13:52,031
YOU CAN THINK OF LIMITING 

347
00:13:52,031 --> 00:13:54,500
COHORTS TO PEOPLE TAKING ONE OF 

348
00:13:54,500 --> 00:13:55,935
GLP-1 MEDICATIONS WHO DON'T 

349
00:13:55,935 --> 00:13:57,937
APPEAR TO HAVE EVIDENCE OF 

350
00:13:57,937 --> 00:13:59,405
DIABETES IN PRETROO EMENT 

351
00:13:59,405 --> 00:14:00,807
BASELINE PERIOD LAND ALLOW YOU 

352
00:14:00,807 --> 00:14:03,276
TO CAPTURE MORE FOLKS EXPOSED TO

353
00:14:03,276 --> 00:14:05,178
MEDICATION SOONER AND MAKING 

354
00:14:05,178 --> 00:14:07,213
SENSE GIVEN TREATMENT 

355
00:14:07,213 --> 00:14:08,715
ENVIRONMENT OF THE LAST FEW 

356
00:14:08,715 --> 00:14:08,948
YEARS. 

357
00:14:08,948 --> 00:14:11,384
WHEN WE ARE TRYING TO UNDERSTAND

358
00:14:11,384 --> 00:14:13,419
THE HEALTH AND SAFETY 

359
00:14:13,419 --> 00:14:14,721
IMPLICATIONS OF THESE 

360
00:14:14,721 --> 00:14:17,056
MEDICATIONS, IT IS ALSO REALLY, 

361
00:14:17,056 --> 00:14:18,524
REALLY IMPORTANT AS WE DESIGN 

362
00:14:18,524 --> 00:14:20,293
THESE STUDIES TO THINK CAREFULLY

363
00:14:20,293 --> 00:14:23,162
ABOUT THE CHOICE OF COMPARISON 

364
00:14:23,162 --> 00:14:23,396
GROUP. 

365
00:14:23,396 --> 00:14:25,098
ONE OPTION THAT IS PRETTY 

366
00:14:25,098 --> 00:14:27,533
APPEALING IS TO TAKE PATIENTS 

367
00:14:27,533 --> 00:14:31,571
WHO ARE GIVEN A GLP-1 MEDICINE 

368
00:14:31,571 --> 00:14:33,106
COMPARING TO GROUP OF PATIENTS 

369
00:14:33,106 --> 00:14:34,607
WITH MEDICATION WHETHER OBOO 

370
00:14:34,607 --> 00:14:36,509
ESTY AND DIABETES AND THOSE THAT

371
00:14:36,509 --> 00:14:39,479
ARE NOT TREATED WITH 

372
00:14:39,479 --> 00:14:40,480
PHARMACOTHERAPY AT ALL THIS 

373
00:14:40,480 --> 00:14:43,850
COULD BE A NEW USER OF GLP-1 

374
00:14:43,850 --> 00:14:46,285
VERSUS A NONUSER DESIGN.  IN 

375
00:14:46,285 --> 00:14:48,688
THEORY THIS DESIGN IS APPEALING 

376
00:14:48,688 --> 00:14:51,758
SIMILAR TO PHASE 3 PLACEBO 

377
00:14:51,758 --> 00:14:53,426
CONTROL TRIAL AND NONCARE IS 

378
00:14:53,426 --> 00:14:57,096
PHARMACOLOGICAL INTERVENTION AND

379
00:14:57,096 --> 00:14:58,564
OBESITY ASSUME CARE OF LIFESTYLE

380
00:14:58,564 --> 00:15:00,199
ADVICE AND IN THIS DESIGN WE 

381
00:15:00,199 --> 00:15:01,634
SEEK TO ANSWER QUESTION IS IT 

382
00:15:01,634 --> 00:15:03,636
BETTER TO TREAT WITH THIS DRUG 

383
00:15:03,636 --> 00:15:06,038
OR NOT TREAT AT ALL WITH A DRUG?

384
00:15:06,038 --> 00:15:07,807
IN THIS DESIGN WE IDENTIFY A 

385
00:15:07,807 --> 00:15:13,045
GROUP OF INCIDENT USERS WITH 

386
00:15:13,045 --> 00:15:14,046
SEMAGLUTIDE AND COMPARE THEM TO 

387
00:15:14,046 --> 00:15:17,183
GROUP OF PEOPLE NOT TAKING 

388
00:15:17,183 --> 00:15:21,020
MEDICINE FOR OBESITY AND ARE 

389
00:15:21,020 --> 00:15:29,428
SIMILAR -- ALTHOUGH THIS IS 

390
00:15:29,428 --> 00:15:31,564
APPEALING IN A NUMBER OF 

391
00:15:31,564 --> 00:15:32,532
SETTINGS THAT IS IMPORTANT TO 

392
00:15:32,532 --> 00:15:34,934
THINK ABOUT HOW THIS APPROACH 

393
00:15:34,934 --> 00:15:37,970
MIGHT LEAD TO INACCURATE 

394
00:15:37,970 --> 00:15:41,374
ESTIMATES OF DRUG SAFETY AND 

395
00:15:41,374 --> 00:15:51,117
EFFECTIVENESS AND -- AS HE NOTED

396
00:15:51,117 --> 00:15:55,054
A NUMBER OF OBSERVATIONAL 

397
00:15:55,054 --> 00:15:57,190
STUDIES AND IDENTIFIED SIZABLE 

398
00:15:57,190 --> 00:16:00,560
AND RELATIVELY RAPID IMPACTS OF 

399
00:16:00,560 --> 00:16:04,664
BERI AT TRICK SURGERY ON 

400
00:16:04,664 --> 00:16:06,532
CARDIOVASCULAR ENDPOINTS WITH 

401
00:16:06,532 --> 00:16:09,168
50% REDUCTION IN MACE RISK AND 

402
00:16:09,168 --> 00:16:11,204
THAT WAS A NICE PAPER PUBLISHED 

403
00:16:11,204 --> 00:16:13,306
A COUPLE YEARS AGO AND 

404
00:16:13,306 --> 00:16:15,241
HYPOTHESIZED THAT USE OF 

405
00:16:15,241 --> 00:16:17,844
UNTREATED CONTROLS WAS 

406
00:16:17,844 --> 00:16:19,278
CONFOUNDED IN SURGERY STUDIES 

407
00:16:19,278 --> 00:16:22,782
AND TYPE OF PATIENT SELECTED 

408
00:16:22,782 --> 00:16:27,220
BERI AT TRICK SURGERY AND 

409
00:16:27,220 --> 00:16:38,097
UNDERGOES IT -- BARI AT TRATRIC 

410
00:16:47,006 --> 00:16:49,876
ASSOCIATED WITH ABILITY TO 

411
00:16:49,876 --> 00:16:52,712
UNDERGO ELECTRICAL SURGERY LIKE 

412
00:16:52,712 --> 00:16:54,480
BERI AT TRICK SURGERY AROUND 

413
00:16:54,480 --> 00:16:56,449
COMPARISON GROUP OF PATIENTS 

414
00:16:56,449 --> 00:16:59,418
WITH OBESITY UNDERGOING ELECTIVE

415
00:16:59,418 --> 00:17:01,187
JOINT REPLACEMENT SURGERY AND 

416
00:17:01,187 --> 00:17:03,723
NOT AN OBESITY TREATMENT AND 

417
00:17:03,723 --> 00:17:05,191
NONETHELESS ELECTIVE PROCEDURE 

418
00:17:05,191 --> 00:17:07,493
THAT PEOPLE WITH OBESITY HAVE 

419
00:17:07,493 --> 00:17:11,264
AND SHOULDN'T HAVE DIRECT IMPACT

420
00:17:11,264 --> 00:17:15,167
ON OUTCOME OF CVD. 

421
00:17:15,167 --> 00:17:17,503
YET THE WEIGHT LOSS AND DIABETES

422
00:17:17,503 --> 00:17:19,071
BENEFITS OF BERI AT TRICK 

423
00:17:19,071 --> 00:17:21,040
SURGERY WERE MAINTAINED IN 

424
00:17:21,040 --> 00:17:22,708
ANALYSIS AND I KNOW THERE HAVE 

425
00:17:22,708 --> 00:17:24,710
BEEN CRITIQUES OF THE PAPER IN 

426
00:17:24,710 --> 00:17:26,979
TERMS OF SELECTION OF JOINT 

427
00:17:26,979 --> 00:17:28,281
REPLACED SURGERY INAPPROPRIATE 

428
00:17:28,281 --> 00:17:29,916
COMPARISON GROUP AND THINK IT IS

429
00:17:29,916 --> 00:17:32,118
AN IMPORTANT DEMONSTRATION OF 

430
00:17:32,118 --> 00:17:33,653
THE IMPACT THAT OUR COMPARATOR 

431
00:17:33,653 --> 00:17:35,888
GROUP HAS ON OUTCOMES LIKELY 

432
00:17:35,888 --> 00:17:38,124
HIGHLY CORRELATED WITH FACTORS 

433
00:17:38,124 --> 00:17:39,992
THAT RELATE TO TREATMENT 

434
00:17:39,992 --> 00:17:40,293
ENGAGEMENT. 

435
00:17:40,293 --> 00:17:44,030
ANOTHER ISSUE FOR RESEARCHERS TO

436
00:17:44,030 --> 00:17:46,098
BE CAREFUL ABOUT WITH UNTREATED 

437
00:17:46,098 --> 00:17:51,203
CONTROL WAS THAT OF IMMORTAL 

438
00:17:51,203 --> 00:17:54,907
TIME BIAS AND IMAGINE A STUDY WE

439
00:17:54,907 --> 00:17:56,042
WANT TO UNDERSTAND ALL CAUSE 

440
00:17:56,042 --> 00:17:59,578
MORTALITY WITH ADULTS WITH KNOWN

441
00:17:59,578 --> 00:18:00,846
CARDIOVASCULAR DISEASE AND FOR 

442
00:18:00,846 --> 00:18:02,315
THIS STUDY WE WOULD PROBABLY 

443
00:18:02,315 --> 00:18:05,685
IDENTIFY PEOPLE WITH KNOWN CBD 

444
00:18:05,685 --> 00:18:09,355
WHO ARE STARTED ONSOME AGO LA 

445
00:18:09,355 --> 00:18:11,490
TIED AND WE START TO FOLLOW THEM

446
00:18:11,490 --> 00:18:13,359
FORWARD LOOKING FOR OUTCOME OF 

447
00:18:13,359 --> 00:18:15,628
DEATH AND UNTREATED COMPARISON 

448
00:18:15,628 --> 00:18:19,598
GROUP HERE WE IDENTIFY PEOPLE 

449
00:18:19,598 --> 00:18:20,733
WITH CARDIOVASCULAR DISEASE AND 

450
00:18:20,733 --> 00:18:22,935
CLAIMS AND EHR FOLLOWING FIRST 

451
00:18:22,935 --> 00:18:27,039
TIME WE SEE CEB EVENT FOLLOWING 

452
00:18:27,039 --> 00:18:29,342
CLAIMS IN FOLLOW UP GROUP AND 

453
00:18:29,342 --> 00:18:32,678
FOLLOWING THEM FORWARD LOOKING 

454
00:18:32,678 --> 00:18:35,481
AT OUTCOME TIME OF DEATH AND 

455
00:18:35,481 --> 00:18:39,352
GIVEN THIS APPROACH WE GIVE 

456
00:18:39,352 --> 00:18:40,319
SEMAGLUTIDE GROUP AN AHEAD HERE 

457
00:18:40,319 --> 00:18:43,022
AND IN THE PAST THEY HAD CVD 

458
00:18:43,022 --> 00:18:45,758
EVENT AND SURVIVED IT LONG 

459
00:18:45,758 --> 00:18:47,493
ENOUGH AND DID WELL ENOUGH 

460
00:18:47,493 --> 00:18:49,161
SOMEONE THOUGHT THEY SHOULD BE 

461
00:18:49,161 --> 00:18:53,466
STARTED ON SEMAGLUTIDE AND 

462
00:18:53,466 --> 00:18:57,036
STARTING SEMAGLUTIDE IS EXCLUDED

463
00:18:57,036 --> 00:18:58,170
FROM ANALYSIS APPROACH AND 

464
00:18:58,170 --> 00:19:02,341
WITHIN IT IS DEATHS OF PEOPLE 

465
00:19:02,341 --> 00:19:04,176
THAT DIDN'T MAKE IT OR WEREN'T 

466
00:19:04,176 --> 00:19:06,278
WELL ENOUGH AND WILL BE CAPTURED

467
00:19:06,278 --> 00:19:08,014
IN UNTREATED CONTROLS. 

468
00:19:08,014 --> 00:19:11,150
SO OUR SEMAGLUTIDE USERS ARE IN 

469
00:19:11,150 --> 00:19:13,185
A SENSE SOMEWHAT IMMORTAL 

470
00:19:13,185 --> 00:19:16,389
COMPARED TO NONUSER CVD CONTROLS

471
00:19:16,389 --> 00:19:21,193
LEADING TO OVERESTIMATE OF 

472
00:19:21,193 --> 00:19:23,496
SEMAGLUTIDE FOR ALL CAUSE IN 

473
00:19:23,496 --> 00:19:28,868
THIS GROUP AND NUMBER OF COOL 

474
00:19:28,868 --> 00:19:30,369
DESIGN -- I WON'T COVER THEM 

475
00:19:30,369 --> 00:19:32,171
TODAY.  I WILL PROVIDE YOU 

476
00:19:32,171 --> 00:19:33,506
REFERENCES AT THE END OF THIS IF

477
00:19:33,506 --> 00:19:37,043
YOU WANT TO GO BACK AND DO MORE 

478
00:19:37,043 --> 00:19:38,744
READING AND LEARN MORE. 

479
00:19:38,744 --> 00:19:41,247
RATHER THAN COMPARING GLP-1 

480
00:19:41,247 --> 00:19:44,050
TREATED PATIENTS TO UNTREATED 

481
00:19:44,050 --> 00:19:46,252
CONTROLS BETTER STRATEGY IN MOST

482
00:19:46,252 --> 00:19:47,920
CASES IS SELECTING ACTIVE 

483
00:19:47,920 --> 00:19:49,255
COMPARATORS AND PEOPLE GETTING 

484
00:19:49,255 --> 00:19:50,823
SOME OTHER KIND OF TREATMENT FOR

485
00:19:50,823 --> 00:19:52,591
CONDITION UNDER STUDY AND IN 

486
00:19:52,591 --> 00:19:53,959
THIS CASE BECAUSE BOTH GROUPS 

487
00:19:53,959 --> 00:19:56,796
ARE PEOPLE WHO ARE PRESUMABLY 

488
00:19:56,796 --> 00:19:59,031
BOTH SEEKING AND RECEIVING 

489
00:19:59,031 --> 00:20:00,633
TREATMENT THAT I THINK RECEIVING

490
00:20:00,633 --> 00:20:02,802
TREATMENT PIECE IS CRITICAL HERE

491
00:20:02,802 --> 00:20:03,936
FOR OBESITY AND THEY ARE MORE 

492
00:20:03,936 --> 00:20:06,705
LIKELY TO BE SIMILAR ON A NUMBER

493
00:20:06,705 --> 00:20:07,840
OF IMPORTANT CHARACTERISTICS AND

494
00:20:07,840 --> 00:20:09,608
SOME OF THE CHARACTERISTICS ARE 

495
00:20:09,608 --> 00:20:11,510
THINGS EASY TO MEASURE AND MATCH

496
00:20:11,510 --> 00:20:13,846
AND ADJUST FOR ANYWAY. 

497
00:20:13,846 --> 00:20:16,515
OTHER OF THE CHARACTERISTICS 

498
00:20:16,515 --> 00:20:18,717
MIGHT NOT BE EASILY MEASURABLE 

499
00:20:18,717 --> 00:20:20,953
IN REAL-WORLD DATA SETS AND IS 

500
00:20:20,953 --> 00:20:23,489
NICE TO HAVE THIS INTANGIBLES 

501
00:20:23,489 --> 00:20:25,357
AND BACKINTANGIBLES THAT ARE 

502
00:20:25,357 --> 00:20:27,626
LIKELY BALANCED AS WELL IN THESE

503
00:20:27,626 --> 00:20:28,994
GROUPS AND ANOTHER CLEAR BENEFIT

504
00:20:28,994 --> 00:20:31,530
HERE IS IF YOU HAVE TWO ACTIVELY

505
00:20:31,530 --> 00:20:33,332
TREATED GROUPS CAN YOU ASSIGN A 

506
00:20:33,332 --> 00:20:35,167
CLEAR TIME 0 FOR START DATA 

507
00:20:35,167 --> 00:20:37,002
TREATMENT TO BOTH GROUPS 

508
00:20:37,002 --> 00:20:39,238
REDUCING RISK OF IMMORTAL TIME 

509
00:20:39,238 --> 00:20:41,574
BIAS AND IT IS IMPORTANT TO 

510
00:20:41,574 --> 00:20:44,310
CHOOSE YOUR COMPARISON GROUP 

511
00:20:44,310 --> 00:20:45,478
CAREFULLY TO CONSIDER HOW YOU 

512
00:20:45,478 --> 00:20:49,615
CAN BALANCE GROUPS ON MEASURES 

513
00:20:49,615 --> 00:20:50,916
INTRODUCING INDICATION AND 

514
00:20:50,916 --> 00:20:52,218
CONTRAINDICATION AND DR. HER AND

515
00:20:52,218 --> 00:20:53,786
INS TALK YESTERDAY AS A 

516
00:20:53,786 --> 00:20:55,521
CLINICIAN ASK YOURSELF IS IT 

517
00:20:55,521 --> 00:20:57,022
GOING TO ANSWER AN IMPORTANT 

518
00:20:57,022 --> 00:20:59,225
CLINICAL OR POLICY QUESTION TO 

519
00:20:59,225 --> 00:21:00,493
RANDOMIZE THIS GROUP OF PATIENTS

520
00:21:00,493 --> 00:21:02,394
TO EACH OF THE TWO TREATMENTS 

521
00:21:02,394 --> 00:21:04,130
AND IS IT SOMETHING THAT MAKES 

522
00:21:04,130 --> 00:21:08,400
SENSE TO DO AND IF NOT DON'T 

523
00:21:08,400 --> 00:21:12,571
PURSUE THE QUESTION MAYBE. 

524
00:21:12,571 --> 00:21:14,640
WHAT TYPE OF ACTIVE COMPARATOR 

525
00:21:14,640 --> 00:21:19,211
WOULD WE PICK IN STUDIES OF 

526
00:21:19,211 --> 00:21:23,149
GLP-1S AND REALLY NICE ONE THAT 

527
00:21:23,149 --> 00:21:24,350
ANSWERS A PERTINENT QUESTION IF 

528
00:21:24,350 --> 00:21:26,552
YOU HAVE A PATIENT CONSIDERING 

529
00:21:26,552 --> 00:21:28,621
GLP1 WHICH SHOULD YOU PUT THEM 

530
00:21:28,621 --> 00:21:31,824
ON?  IS THERE ONE BETTER THAN 

531
00:21:31,824 --> 00:21:42,268
THE OTHER?  FOR EXAMPLE. 

532
00:21:58,417 --> 00:22:00,119
COMPARING WHAT HAPPENS TO 

533
00:22:00,119 --> 00:22:02,655
PATIENTS WHO ARE PLACED ON GLP-1

534
00:22:02,655 --> 00:22:04,290
VERSUS MEDICATIONS FROM A 

535
00:22:04,290 --> 00:22:05,591
DIFFERENT CLASS; RIGHT?  

536
00:22:05,591 --> 00:22:08,761
THIS IS A DECISION WE MAKE A LOT

537
00:22:08,761 --> 00:22:11,163
IN CLINICAL PRACTICE AND IN THE 

538
00:22:11,163 --> 00:22:14,366
TYPES OF COMPARISONS YOU HAVE TO

539
00:22:14,366 --> 00:22:16,502
BE CAREFUL FOR CONFOUNDING BY 

540
00:22:16,502 --> 00:22:17,837
INDICATION AND CONTRAINDICATION 

541
00:22:17,837 --> 00:22:20,673
AND IMAGINE LOOKING AT 

542
00:22:20,673 --> 00:22:23,609
CARDIOVASCULAR OUTCOMES AND 

543
00:22:23,609 --> 00:22:26,512
PATIENTS PRESCRIBED FENTER MEAN 

544
00:22:26,512 --> 00:22:28,314
VERSUS GLP-1 FENTER MEAN IS THIN

545
00:22:28,314 --> 00:22:30,316
ON THOSE PEOPLE WITH 

546
00:22:30,316 --> 00:22:32,117
CARDIOVASCULAR RISK PEOPLE WON'T

547
00:22:32,117 --> 00:22:34,186
BE PRESCRIBED THAT MEDICATION IF

548
00:22:34,186 --> 00:22:36,255
THEY HAVE CARDIOVASCULAR RISK 

549
00:22:36,255 --> 00:22:38,324
AND PAYING ATTENTION TO THAT.  

550
00:22:38,324 --> 00:22:42,528
MOST NONGLP-1 OBESITY MEDICINES 

551
00:22:42,528 --> 00:22:47,066
ARE A FEW YEARS OLDER OR BEEN ON

552
00:22:47,066 --> 00:22:49,034
MARKET OLDER AND -- OLDER DRUG 

553
00:22:49,034 --> 00:22:53,606
USERS MAY ACTUALLY BE PREVALENT 

554
00:22:53,606 --> 00:23:03,716
USE

555
00:23:22,201 --> 00:23:23,602
USERS. 

556
00:23:23,602 --> 00:23:31,310
ONE THING I LIKE ABOUT THIS FOR 

557
00:23:31,310 --> 00:23:36,382
NEWER POTENT DRUGS AND YOU WANT 

558
00:23:36,382 --> 00:23:41,320
A COMPARISON GROUP WITH 

559
00:23:41,320 --> 00:23:41,954
COMPAR

560
00:23:41,954 --> 00:23:43,289
COMPARABLE WEIGHT LOSS THIS IS 

561
00:23:43,289 --> 00:23:46,058
APPEALING AND IS IMPORTANT TO 

562
00:23:46,058 --> 00:23:46,992
REMEMBER AND BROUGHT UP 

563
00:23:46,992 --> 00:23:49,128
YESTERDAY BARIATRIC PATIENTS 

564
00:23:49,128 --> 00:23:51,063
HAVE TO GO THROUGH ENORMOUS 

565
00:23:51,063 --> 00:23:52,831
PRESCREENING PROCESS AND FOLKS 

566
00:23:52,831 --> 00:23:55,501
MAKING IT TO BARIATRIC SURGERY 

567
00:23:55,501 --> 00:23:57,236
ARE LESS LIKELY TO HAVE 

568
00:23:57,236 --> 00:23:58,370
PRE-EXISTING CANCER AT TIME THEY

569
00:23:58,370 --> 00:24:00,406
HAVE SURGERY AND ARE LESS LIKELY

570
00:24:00,406 --> 00:24:03,042
TO HAVE ACTIVE SEVERE MENTAL 

571
00:24:03,042 --> 00:24:04,610
ILLNESS AND CARDIOVASCULAR 

572
00:24:04,610 --> 00:24:06,545
DISEASE AND LOOKING FOR OUTCOMES

573
00:24:06,545 --> 00:24:09,214
IN FIRST FEW YEARS AFTER SURGERY

574
00:24:09,214 --> 00:24:11,650
VERSUS STARTING IN AOM BARAT 

575
00:24:11,650 --> 00:24:13,419
TRICK PATIENTS WILL BE LESS 

576
00:24:13,419 --> 00:24:15,287
LIKELY TO HAVE THEM BASED ON 

577
00:24:15,287 --> 00:24:17,523
VIRTUE OF PRESCREENING AND ONCE 

578
00:24:17,523 --> 00:24:19,525
YOU HAVE IDENTIFIED YOUR TREATED

579
00:24:19,525 --> 00:24:20,926
POPULATION AND COMPARISON GROUP 

580
00:24:20,926 --> 00:24:23,429
AND HAVE A STARTING POINT FOR 

581
00:24:23,429 --> 00:24:25,597
EVERY PATIENT IN YOUR STUDY 

582
00:24:25,597 --> 00:24:26,665
ANOTHER IMPORTANT CONSIDERATION 

583
00:24:26,665 --> 00:24:27,933
FOR YOU WITH REAL WORLD DATA 

584
00:24:27,933 --> 00:24:30,836
WILL BE HOW DO YOU FOLLOW PEOPLE

585
00:24:30,836 --> 00:24:35,674
FORWARD AND ANALYZE THEIR DATA 

586
00:24:35,674 --> 00:24:37,476
OVER OBSERVABLE FOLLOW UP TIME 

587
00:24:37,476 --> 00:24:39,111
AND THIS DIRECTION IS LINKED TO 

588
00:24:39,111 --> 00:24:42,881
YOUR PLANS FOR ANALYSIS OF THAT 

589
00:24:42,881 --> 00:24:50,022
OUTCOME DATA CONSIDERING TARGET 

590
00:24:50,022 --> 00:24:52,291
TRIAL -- INTENTION TO TREAT 

591
00:24:52,291 --> 00:24:55,427
ANALYSIS IN MIND AND APPLYING 

592
00:24:55,427 --> 00:24:56,662
THIS LOGIC TO AN OBSERVATIONAL 

593
00:24:56,662 --> 00:24:59,665
STUDY OF GLP-1 AND USING 

594
00:24:59,665 --> 00:25:01,166
INSURANCE CLAIMS DATA THAT I 

595
00:25:01,166 --> 00:25:05,037
WORK WITH A LOT WE MIGHT HAVE A 

596
00:25:05,037 --> 00:25:10,976
PATIENT IDENTIFIED WITH INCIDENT

597
00:25:10,976 --> 00:25:11,710
USERS OF SEMAGLUTIDE AND IN 

598
00:25:11,710 --> 00:25:14,513
APRIL OF 2021 AND REMAINS 

599
00:25:14,513 --> 00:25:16,715
OBSERVABLE AND ENROLLED IN 

600
00:25:16,715 --> 00:25:18,951
DATASET IN DECEMBER OF 2024 

601
00:25:18,951 --> 00:25:21,186
UNDER THE INTENT TO TREAT 

602
00:25:21,186 --> 00:25:22,588
ANALYSIS FRAMEWORK, WE WOULD 

603
00:25:22,588 --> 00:25:24,890
TING TO FOLLOW THIS PATIENT FOR 

604
00:25:24,890 --> 00:25:27,426
OUTCOMES OF INTEREST IN OUR 

605
00:25:27,426 --> 00:25:29,361
STUDY POTENTIALLY WELL AFTER THE

606
00:25:29,361 --> 00:25:31,163
DRUG WAS DISCONTINUED. 

607
00:25:31,163 --> 00:25:32,898
I WOULD LIKE TO THINK OF THIS 

608
00:25:32,898 --> 00:25:34,633
TYPE OF ANALYSIS AS BEING A 

609
00:25:34,633 --> 00:25:37,169
LITTLE BIT MORE OF A REALISTIC 

610
00:25:37,169 --> 00:25:40,539
SNAPSHOT OF THE WORLD AS IT IS 

611
00:25:40,539 --> 00:25:42,608
BAKING ALL OF THE POSSIBLE 

612
00:25:42,608 --> 00:25:44,243
OUTCOMES INTO THE CAKE FOR A 

613
00:25:44,243 --> 00:25:45,778
PERFECT CONSIDERING INITIATING A

614
00:25:45,778 --> 00:25:47,880
NEW TREATMENT AND PROS OF THIS 

615
00:25:47,880 --> 00:25:49,181
APPROACH INCLUDE BY CONTINUING 

616
00:25:49,181 --> 00:25:51,383
TO FOLLOW SOMEONE FOR MONTHS OR 

617
00:25:51,383 --> 00:25:52,885
YEARS AFTER THEY TAKE A 

618
00:25:52,885 --> 00:25:54,553
MEDICATION WE MIGHT BE ABLE TO 

619
00:25:54,553 --> 00:25:57,189
BETTER DETECT DELAYED SAFETY 

620
00:25:57,189 --> 00:25:58,624
SIGNALS RELATING TO EARLIER 

621
00:25:58,624 --> 00:26:00,225
EXPOSURE INCLUDING THINGS LIKE 

622
00:26:00,225 --> 00:26:04,496
BIRTH DEFECTS AND ADVERSE 

623
00:26:04,496 --> 00:26:07,065
PREGNANCY OUTCOMES BEING DELAYED

624
00:26:07,065 --> 00:26:10,002
SOME MONTHS FOLLOWING DRUG 

625
00:26:10,002 --> 00:26:16,375
DISCONTINUED -- STROKE OR 

626
00:26:16,375 --> 00:26:18,444
MYOCARDIAL INFARCTION. 

627
00:26:18,444 --> 00:26:20,612
ANOTHER UPSIDE TO ITT ANALYSIS, 

628
00:26:20,612 --> 00:26:23,348
IT IS SORT OF FROM A POPULATION 

629
00:26:23,348 --> 00:26:24,883
HEALTH STANDPOINT IT PROVIDES A 

630
00:26:24,883 --> 00:26:26,819
MORE REALISTIC PRAGMATIC VIEW OF

631
00:26:26,819 --> 00:26:31,490
THE BENEFITS AND RISKS OF 

632
00:26:31,490 --> 00:26:32,858
STREEMENT INITIATION AND 

633
00:26:32,858 --> 00:26:35,027
PREDESCRIBING DRUGS IN CURRENT 

634
00:26:35,027 --> 00:26:38,831
CLIMATE OF SHORT ACCESS AND 

635
00:26:38,831 --> 00:26:40,098
COVERING SEMAGLUTIDE AND I DON'T

636
00:26:40,098 --> 00:26:41,266
WANT TO ONLY KNOW WHAT HAPPENS 

637
00:26:41,266 --> 00:26:43,936
TO PATIENTS THAT REMAIN ADHERENT

638
00:26:43,936 --> 00:26:46,738
FOR THE NEXT TWO YEARS AND WANT 

639
00:26:46,738 --> 00:26:47,806
TO UNDERSTAND FULL RANGE OF 

640
00:26:47,806 --> 00:26:49,274
POSSIBLE OUTCOMES FOR PERSON 

641
00:26:49,274 --> 00:26:51,076
INCLUDING WHAT HAPPENS IF THEY 

642
00:26:51,076 --> 00:26:52,911
CAN'T TOLERATE THE MEDICATION OR

643
00:26:52,911 --> 00:26:54,680
STOP TAKING IT AND DOWNSIDES OF 

644
00:26:54,680 --> 00:26:57,182
THE APPROACH INCLUDE THAT WE 

645
00:26:57,182 --> 00:26:59,551
MIGHT INCORRECTLY ATTRIBUTE A 

646
00:26:59,551 --> 00:27:00,886
DISTAL OUTCOME TO TAKING 

647
00:27:00,886 --> 00:27:03,856
MEDICINE WHEN IN FACT IT IS 

648
00:27:03,856 --> 00:27:06,091
RELATED TO INTERCURRENT EXPOSURE

649
00:27:06,091 --> 00:27:07,659
COMING TO PERSON TAKING GLP-1 

650
00:27:07,659 --> 00:27:10,629
AND THIS ANALYSIS WILL BE 

651
00:27:10,629 --> 00:27:12,464
IMPACTED BY PREMATURE 

652
00:27:12,464 --> 00:27:13,365
DISCONTINUATIONS AND TREATMENT 

653
00:27:13,365 --> 00:27:16,034
SWITCHING THAT ARE COMMON NOW 

654
00:27:16,034 --> 00:27:18,136
WITH GLP-1 AND WILL DILUTE THE 

655
00:27:18,136 --> 00:27:21,173
EFFECTIVENESS MEASURE OF 

656
00:27:21,173 --> 00:27:22,307
MEDICATIONS AND MAKE ABILITY 

657
00:27:22,307 --> 00:27:23,742
POTENTIALLY TO DETECT SAFETY 

658
00:27:23,742 --> 00:27:25,611
SIGNALS IN A SENSE THAT IS ALSO 

659
00:27:25,611 --> 00:27:29,181
A LITTLE BIT DILUTED. 

660
00:27:29,181 --> 00:27:32,885
ONE OTHER ALTERNATIVE ANALYTIC 

661
00:27:32,885 --> 00:27:34,520
APPROACH WITH A DIFFERENT FOLLOW

662
00:27:34,520 --> 00:27:35,754
UP COULD BE ON TREATMENT 

663
00:27:35,754 --> 00:27:37,189
ANALYSIS AND SHOWN HERE IS HOW 

664
00:27:37,189 --> 00:27:40,158
WE MIGHT APPLY THIS IDEA IN AN 

665
00:27:40,158 --> 00:27:41,727
OBSERVATIONAL STUDY WHERE IF A 

666
00:27:41,727 --> 00:27:45,063
PATIENT STOPS THEIR ASSIGNED 

667
00:27:45,063 --> 00:27:46,365
TREATMENT BEFORE THE END OF THE 

668
00:27:46,365 --> 00:27:48,267
STUDY THEY ARE NOT FOLLOWED FOR 

669
00:27:48,267 --> 00:27:49,501
OUTCOMES OF INTEREST EVEN IF 

670
00:27:49,501 --> 00:27:54,373
THEY ARE STILL TECHNICALLY 

671
00:27:54,373 --> 00:27:56,408
OBSERVABLE OR ENROLLED OR AT 

672
00:27:56,408 --> 00:27:58,510
RISK AND IN THIS OPTION 

673
00:27:58,510 --> 00:27:59,177
CONSIDERING PATIENT BEFORE 

674
00:27:59,177 --> 00:28:01,179
STOPPED FOLLOWING PERSON OR 

675
00:28:01,179 --> 00:28:03,849
ANALYZING DATA AFTER FOLLOWING 

676
00:28:03,849 --> 00:28:06,752
DISPENSING OF SEMAGLUTIDE 

677
00:28:06,752 --> 00:28:07,953
TRUNCATING TIME SHE CONTRIBUTES 

678
00:28:07,953 --> 00:28:10,822
TO THE STUDY A LOT AND ITT 

679
00:28:10,822 --> 00:28:12,791
ANALYSIS MIGHT GIVE A SNAPSHOT 

680
00:28:12,791 --> 00:28:14,526
OF THE WORLD AS IT IS WE CAN 

681
00:28:14,526 --> 00:28:16,128
THINK OF ON TREATMENT ANALYSIS 

682
00:28:16,128 --> 00:28:17,563
AS THE WORLD AS WE WOULD LIKE IT

683
00:28:17,563 --> 00:28:20,465
TO BE AND GETS CLOSER TO THAT 

684
00:28:20,465 --> 00:28:22,200
IDEAL CLINICAL TRIAL SCENARIO 

685
00:28:22,200 --> 00:28:24,937
WHAT HAPPENS IF 100% PATIENTS 

686
00:28:24,937 --> 00:28:27,272
STAY ON MEDICATION AND PROS OF 

687
00:28:27,272 --> 00:28:29,174
THIS APPROACH IT WILL GIVE MORE 

688
00:28:29,174 --> 00:28:31,109
ACCESS ASSESSMENT OF DIRECT 

689
00:28:31,109 --> 00:28:32,444
EFFECT OF BEING ON MEDICATION 

690
00:28:32,444 --> 00:28:35,714
AND LOOKING AT REAL-TIME 

691
00:28:35,714 --> 00:28:37,983
CONSEQUENCE WE WANT TO LOOK AT 

692
00:28:37,983 --> 00:28:39,551
THAT WHILE SOMEONE IS TAKING 

693
00:28:39,551 --> 00:28:41,720
MEDICINE NOT 6 MONTHS AFTER THEY

694
00:28:41,720 --> 00:28:44,156
STOP IT AND AFTER THIS APPROACH 

695
00:28:44,156 --> 00:28:45,557
WILL PRODUCE EFFECTIVENESS 

696
00:28:45,557 --> 00:28:47,492
ESTIMATES THAT CLOSELY ALIGN 

697
00:28:47,492 --> 00:28:50,796
WITH CLINICAL TRIALS AND 

698
00:28:50,796 --> 00:28:51,430
ADHERENCE RATES WITH R HIGH DUE 

699
00:28:51,430 --> 00:28:54,266
TO ONGOING SUPPORT AND DOWNSIDES

700
00:28:54,266 --> 00:28:56,034
OF APPROACH ARE CENSORING 

701
00:28:56,034 --> 00:28:58,303
PATIENTS WHEN THEY STOP TAKING 

702
00:28:58,303 --> 00:29:00,539
MEDICINE MIGHT CAUSE YOU TO MISS

703
00:29:00,539 --> 00:29:01,773
DELAYED QUALITIES OF EXPOSURE 

704
00:29:01,773 --> 00:29:03,709
AND GIVEN CURRENT DIFFICULTIES 

705
00:29:03,709 --> 00:29:05,177
THAT PATIENTS HAVE WITH 

706
00:29:05,177 --> 00:29:07,813
CONSISTENTLY STAYING ON 

707
00:29:07,813 --> 00:29:09,181
MEDICATIONS LONG TERM IN REAL 

708
00:29:09,181 --> 00:29:11,950
WORLD COHORTS SUBSET OF FOLKS 

709
00:29:11,950 --> 00:29:13,819
YOU WILL HAVE WITH CONTINUOUS 

710
00:29:13,819 --> 00:29:16,521
USE OF GLP-1S WILL BE SMALL AND 

711
00:29:16,521 --> 00:29:18,790
NOT GENERALIZABLE AND ULTIMATELY

712
00:29:18,790 --> 00:29:19,791
WILL BE RESEARCH QUESTION 

713
00:29:19,791 --> 00:29:21,727
WHERE'S ITT ANALYSIS IS 

714
00:29:21,727 --> 00:29:24,663
APPROPRIATE AND OTHERS WHERE 

715
00:29:24,663 --> 00:29:26,264
ONTREATMENT OR [INDISCERNIBLE] 

716
00:29:26,264 --> 00:29:27,099
ANALYSIS MAKES SENSE AND OFTEN 

717
00:29:27,099 --> 00:29:30,369
BOTH TYPES OF ANALYSIS CAN BE 

718
00:29:30,369 --> 00:29:32,170
USED TO LOOK AT SAME QUESTION 

719
00:29:32,170 --> 00:29:33,772
FROM DIFFERENT PERSPECTIVES AND 

720
00:29:33,772 --> 00:29:35,507
WILL BE COVERED MORE IN 

721
00:29:35,507 --> 00:29:36,708
SUBSEQUENT TALKS AND I WILL END 

722
00:29:36,708 --> 00:29:39,344
WITH MENTIONING A COUPLE AREAS 

723
00:29:39,344 --> 00:29:40,912
WHERE I THINK CURRENT REAL WORLD

724
00:29:40,912 --> 00:29:43,315
DATA FALLS SHORT WHEN COMING TO 

725
00:29:43,315 --> 00:29:45,784
STUDYING GLP-1 MEDICATIONS AND 

726
00:29:45,784 --> 00:29:46,818
MENTIONED YESTERDAY AND I WON'T 

727
00:29:46,818 --> 00:29:48,854
SPEND A TON OF TIME HERE AS YOU 

728
00:29:48,854 --> 00:29:51,289
ARE LIKELY AWARE OF A NUMBER OF 

729
00:29:51,289 --> 00:29:52,924
COMPANIES AND HEALTHCARE 

730
00:29:52,924 --> 00:29:55,093
PROVIDERS TURNED TO COMPOUNDING 

731
00:29:55,093 --> 00:29:56,061
PHARMACIES TO PROVIDE ANOTHER 

732
00:29:56,061 --> 00:29:58,930
SOURCE OF GLP-1 MEDS FOR 

733
00:29:58,930 --> 00:30:01,166
PATIENTS AND WILL BE I HAVE HARD

734
00:30:01,166 --> 00:30:02,768
TO CAPTURE IN TRADITIONAL REAL 

735
00:30:02,768 --> 00:30:05,704
WORLD DATA SOURCES FROM CLAIM 

736
00:30:05,704 --> 00:30:06,738
STANDPOINT THESE ARE CASH PAY 

737
00:30:06,738 --> 00:30:08,507
AND WE WOULD BE COMPLETELY 

738
00:30:08,507 --> 00:30:10,509
UNAWARE OF THEM AND WITHIN A 

739
00:30:10,509 --> 00:30:11,710
HEALTHCARE SYSTEM MOST OF THE 

740
00:30:11,710 --> 00:30:13,478
TIME THEY ARE NOT NECESSARILY 

741
00:30:13,478 --> 00:30:15,747
GETTING THESE COMPOUNDED 

742
00:30:15,747 --> 00:30:17,015
MEDICATIONS FROM A DOCTOR WITHIN

743
00:30:17,015 --> 00:30:18,884
THEIR HEALTH CARE SYSTEM GOING 

744
00:30:18,884 --> 00:30:22,854
OUT TO A TELEHEALTH COMPANY OR 

745
00:30:22,854 --> 00:30:23,488
OUT SOMEWHERE ELSE AND MIGHT 

746
00:30:23,488 --> 00:30:25,157
MISS IT THERE AS WELL AND 

747
00:30:25,157 --> 00:30:27,492
SOMETHING TO THINK ABOUT IN 

748
00:30:27,492 --> 00:30:31,663
TERMS OF A BLINDSPOT AND ANOTHER

749
00:30:31,663 --> 00:30:32,497
RELATIVE BLINDSPOT IS 

750
00:30:32,497 --> 00:30:34,299
INFORMATION OF LIFESTYLE CHANGES

751
00:30:34,299 --> 00:30:36,768
HABITS EXERCISE AND BEHAVIORS 

752
00:30:36,768 --> 00:30:38,537
THAT PATIENTS MIGHT ENGAGE IN 

753
00:30:38,537 --> 00:30:40,338
DURING TREATMENT FOR OBESITY AND

754
00:30:40,338 --> 00:30:41,740
DIABETES AND GET CONCERN FROM 

755
00:30:41,740 --> 00:30:43,475
REVIEWERS OF PAPERS TO WHAT 

756
00:30:43,475 --> 00:30:47,279
EXTENT ARE BEHAVIORS UNMEASURED 

757
00:30:47,279 --> 00:30:49,815
CONFOUNDERS WHEN COMPARING GLP-1

758
00:30:49,815 --> 00:30:52,250
TO PATIENTS USING EXAMPLE OF 

759
00:30:52,250 --> 00:30:53,652
OBESITY AND WHAT WE THINK IS 

760
00:30:53,652 --> 00:30:56,154
HAPPENING HERE IS IF A PATIENT 

761
00:30:56,154 --> 00:30:57,089
TAKING A MEDICATION LEADS THEM 

762
00:30:57,089 --> 00:30:58,924
TO BE ABLE TO CHANGE THE WAY 

763
00:30:58,924 --> 00:31:01,059
THEY EAT AND LEADS THEM TO BE 

764
00:31:01,059 --> 00:31:05,163
ABLE TO BE MORE COMFORTABLE 

765
00:31:05,163 --> 00:31:05,831
BEING PHYSICALLY ACTIVE 

766
00:31:05,831 --> 00:31:08,266
LIFESTYLE CHANGES ARE ON CAUSAL 

767
00:31:08,266 --> 00:31:09,434
PATHWAY TAKING MEDICATION AND 

768
00:31:09,434 --> 00:31:11,403
INTEREST AND THUS NOT 

769
00:31:11,403 --> 00:31:13,171
CONFOUNDERS AND SIMILARLY IF 

770
00:31:13,171 --> 00:31:14,406
FOLLOWING CLINICAL GUIDELINES 

771
00:31:14,406 --> 00:31:16,808
AND MANY EDUCATIONS ARE BEING 

772
00:31:16,808 --> 00:31:19,978
PRESCRIBED ALONGSIDE LIFESTYLE 

773
00:31:19,978 --> 00:31:21,713
BEHAVIORAL ADVICE AND CHANGES 

774
00:31:21,713 --> 00:31:24,349
START WITH AOM PRESCRIPTION AND 

775
00:31:24,349 --> 00:31:26,384
BOTH GROUPS COMPARING LIKELY TO 

776
00:31:26,384 --> 00:31:29,221
GET LIFESTYLE BEHAVIORAL THERAPY

777
00:31:29,221 --> 00:31:31,590
LIFESTYLE CHANGES SHOULDN'T BE 

778
00:31:31,590 --> 00:31:32,524
UNMEASURED CONFOUNDERS AND IN 

779
00:31:32,524 --> 00:31:34,192
THEORY IF ONE GROUP YOU ARE 

780
00:31:34,192 --> 00:31:35,827
COMPARING IS MORE LIKELY TO HAVE

781
00:31:35,827 --> 00:31:37,863
A CERTAIN SET OF LIFESTYLE 

782
00:31:37,863 --> 00:31:40,232
BEHAVIORS BEFORE INITIATING 

783
00:31:40,232 --> 00:31:41,800
TREATMENT COMPARED TO CONTROL 

784
00:31:41,800 --> 00:31:43,201
GROUP AND LIFESTYLE BEHAVIORS 

785
00:31:43,201 --> 00:31:44,970
ARE WHAT IS CAUSING OUTCOME OF 

786
00:31:44,970 --> 00:31:46,505
INTEREST THIS IS WHERE THINGS 

787
00:31:46,505 --> 00:31:48,406
CAN GET PROBLEMATIC AND TO THE 

788
00:31:48,406 --> 00:31:49,508
EXTENT POSSIBLE WE WANT TO TRY 

789
00:31:49,508 --> 00:31:52,677
TO MATCH OR ADJUST FOR BASELINE 

790
00:31:52,677 --> 00:31:53,545
CHARACTERISTICS HIGHLY 

791
00:31:53,545 --> 00:31:57,182
REFLECTIVE OF PRE-EXISTING 

792
00:31:57,182 --> 00:32:07,526
LIFESTYLE FACTORS. 

793
00:32:13,698 --> 00:32:15,600
BIG TAKE-HOME POINTS FOCUSING 

794
00:32:15,600 --> 00:32:17,169
ON INCIDENT USERS PEOPLE WILL 

795
00:32:17,169 --> 00:32:19,171
GIVE YOU A GOOD IDEA OF SAFETY 

796
00:32:19,171 --> 00:32:22,007
AND EFFECTIVENESS OF MEDS IN THE

797
00:32:22,007 --> 00:32:23,742
REAL WORLD AND WATCHING OUT WHEN

798
00:32:23,742 --> 00:32:25,777
BUILDING STUDIES FOR CONFOUNDING

799
00:32:25,777 --> 00:32:27,445
BY INDICATION AND BY 

800
00:32:27,445 --> 00:32:29,214
CONTRAINDICATION AND CHOOSING 

801
00:32:29,214 --> 00:32:33,151
ACTIVELY TREATED CONTROL GROUP 

802
00:32:33,151 --> 00:32:35,821
TO PREVENT RISK OF TIME BIAS AND

803
00:32:35,821 --> 00:32:37,155
CONSIDERING TYPES OF ANALYSIS 

804
00:32:37,155 --> 00:32:38,924
DEPENDING ON QUESTIONS YOU ARE 

805
00:32:38,924 --> 00:32:40,625
LOOKING AT AND QUICKLY RESEARCH 

806
00:32:40,625 --> 00:32:42,794
GAPS AND OPPORTUNITIES I SEE 

807
00:32:42,794 --> 00:32:44,930
OBVIOUSLY RIGHT NOW AS FUN AS IT

808
00:32:44,930 --> 00:32:47,566
WOULD BE TO USE REAL-WORLD DATA 

809
00:32:47,566 --> 00:32:49,167
TO STUDY LONG-TERM TREATMENT 

810
00:32:49,167 --> 00:32:51,069
WITH MEDICINES WE DON'T HAVE 

811
00:32:51,069 --> 00:32:52,437
PATIENTS AND ABLE TO DO LONG 

812
00:32:52,437 --> 00:32:54,072
TERM TREATMENT TO USE DATA FOR 

813
00:32:54,072 --> 00:32:55,440
THAT.  THAT IS SOMETHING THAT WE

814
00:32:55,440 --> 00:32:57,609
SHOULD LOOK FOR GOING FORWARD. 

815
00:32:57,609 --> 00:32:59,845
AND THEN KEEPING IN MIND THERE 

816
00:32:59,845 --> 00:33:01,980
ARE CERTAIN BIG BLIND SPOTS IN 

817
00:33:01,980 --> 00:33:04,983
USING REAL WORLD DATA TO STUDY 

818
00:33:04,983 --> 00:33:05,917
LIFESTYLE CHANGE AND COMPOUNDED 

819
00:33:05,917 --> 00:33:08,553
DRUGS THIS IS NOT WHERE TO DO IT

820
00:33:08,553 --> 00:33:10,956
AND WE DESPERATELY DESPERATELY 

821
00:33:10,956 --> 00:33:13,225
NEED STUDIES TO USE REAL WORLD 

822
00:33:13,225 --> 00:33:17,462
DATA TO STUDY HETEROGENEITY OF 

823
00:33:17,462 --> 00:33:19,030
OBESITY RESPONSE AND ANSWER 

824
00:33:19,030 --> 00:33:20,465
QUESTIONS AROUND STEP AND 

825
00:33:20,465 --> 00:33:21,433
MAINTENANCE THERAPY AND 

826
00:33:21,433 --> 00:33:22,367
SWITCHING THERAPIES AND THANK 

827
00:33:22,367 --> 00:33:25,036
YOU TO DR. HALES AND ALL OF THE 

828
00:33:25,036 --> 00:33:26,404
OTHER ORGANIZERS OF THE 

829
00:33:26,404 --> 00:33:27,839
CONFERENCE FOR THE INVITATION 

830
00:33:27,839 --> 00:33:29,541
AND THANK YOU TO MY RESEARCH 

831
00:33:29,541 --> 00:33:31,743
TEAM IN BOSTON AND ELSEWHERE WHO

832
00:33:31,743 --> 00:33:36,548
ARE WORKING HARD ON KWIS USING 

833
00:33:36,548 --> 00:33:43,021
CLAIMS DATA.  

834
00:33:43,021 --> 00:33:47,559
>> KRISTINA, THANKS SO
MUCH.  IT

835
00:33:47,559 --> 00:33:49,194
WAS QUITE AN AMAZING 

836
00:33:49,194 --> 00:33:50,462
PRESENTATION AND REMINDING THE 

837
00:33:50,462 --> 00:33:52,597
GROUP TO PUT QUESTIONS INTO THE 

838
00:33:52,597 --> 00:33:54,699
Q & A GROUP OR BOX ON THE
RIGHT 

839
00:33:54,699 --> 00:33:55,967
OF YOUR SCREEN.  

840
00:33:55,967 --> 00:33:59,004
SO I WANT TO START OUT WITH ONE 

841
00:33:59,004 --> 00:34:01,039
QUESTION THAT CAME IN EARLIER.  

842
00:34:01,039 --> 00:34:03,842
IT WAS RELATED TO DOKES. 

843
00:34:03,842 --> 00:34:06,611
WOULD YOU SAY IT IS IMPORTANT TO

844
00:34:06,611 --> 00:34:10,081
BE CONSIDERING DOSE OF GLP-1 IN 

845
00:34:10,081 --> 00:34:12,317
CRE STUDIES ESPECIALLY IF 

846
00:34:12,317 --> 00:34:13,785
LUMPING TOGETHER ON LABEL AND 

847
00:34:13,785 --> 00:34:16,755
OFF LABEL PATIENTS INTO A SINGLE

848
00:34:16,755 --> 00:34:21,192
GROUP TAKING A GIVEN DRUG ATHEN 

849
00:34:21,192 --> 00:34:22,260
RELATED TO THAT WHAT CHALLENGE 

850
00:34:22,260 --> 00:34:24,029
DO YOU SEE RELATED TO THIS. 

851
00:34:24,029 --> 00:34:25,163
>> GREAT, GREAT QUESTION
AND 

852
00:34:25,163 --> 00:34:30,535
SOMETHING THAT IS ONGOING 

853
00:34:30,535 --> 00:34:31,503
DISCUSSIONS IN ANY GROUP ON 

854
00:34:31,503 --> 00:34:32,904
THIS.  DOSE IS REALLY 

855
00:34:32,904 --> 00:34:34,439
INTERESTING.  IN CLINICAL TRIALS

856
00:34:34,439 --> 00:34:36,741
WHAT WE SAW WAS, YOU KNOW, AT 

857
00:34:36,741 --> 00:34:40,045
LEAST IN THE INITIAL CLINICAL 

858
00:34:40,045 --> 00:34:42,347
TRIALS FOR SEMAGLUTIDE AND 

859
00:34:42,347 --> 00:34:44,416
[INDISCERNIBLE] RIGID UP 

860
00:34:44,416 --> 00:34:46,685
TITRATION OF EVERYBODY IN TRIALS

861
00:34:46,685 --> 00:34:48,887
TO MAXIMUM DOSE AND LOOKING AT 

862
00:34:48,887 --> 00:34:50,455
PACKAGE INSERT FOR DRUGS IS WHAT

863
00:34:50,455 --> 00:34:51,523
WE ARE SUPPOSED TO DO AND 

864
00:34:51,523 --> 00:34:54,492
LOOKING AT WHAT IS HAPPENING IN 

865
00:34:54,492 --> 00:34:55,594
CLINICAL PRACTICE HARDLY ANYBODY

866
00:34:55,594 --> 00:34:57,729
IS DOING THAT AND FOR LOTS OF 

867
00:34:57,729 --> 00:35:00,298
REASONS AND CLINICAL PROVIDERS 

868
00:35:00,298 --> 00:35:01,533
ARE NOT UPTIGHT TRAITING PEOPLE 

869
00:35:01,533 --> 00:35:05,070
AND WHAT THEY ARE DOING IS TIGHT

870
00:35:05,070 --> 00:35:07,005
TRAITING PEOPLE BASED ON 

871
00:35:07,005 --> 00:35:08,707
TOLLRABILITY AND EFFECTIVENESS 

872
00:35:08,707 --> 00:35:10,742
AND WHAT PATIENTS ARE 

873
00:35:10,742 --> 00:35:12,410
COMFORTABLE WITH AND THEY ARE IN

874
00:35:12,410 --> 00:35:14,346
ESSENCE TREATING TO TARGET SORT 

875
00:35:14,346 --> 00:35:15,513
OF; RIGHT?  

876
00:35:15,513 --> 00:35:17,849
AND I THINK USING CLINICAL 

877
00:35:17,849 --> 00:35:19,250
JUDGMENT TO FIND DOSE THAT IS 

878
00:35:19,250 --> 00:35:20,852
RIGHT FOR THAT PATIENT AND I 

879
00:35:20,852 --> 00:35:22,721
WOULD ARGUE SORT OF THAT IF 

880
00:35:22,721 --> 00:35:23,989
SOMEONE IS ON A PARTICULAR DOSE 

881
00:35:23,989 --> 00:35:25,423
OF MEDICATION AND STAYING ON 

882
00:35:25,423 --> 00:35:26,791
THAT DOSE, IT IS PROBABLY 

883
00:35:26,791 --> 00:35:30,695
BECAUSE IT IS WORKING FOR THEM 

884
00:35:30,695 --> 00:35:33,865
AND TOLERATED AND SHOULDN'T 

885
00:35:33,865 --> 00:35:44,309
WORRY TOO MUCH ABOUT IT. 

886
00:35:48,847 --> 00:35:50,615
INTERESTING TO LOOK AT PATTERNS 

887
00:35:50,615 --> 00:35:52,217
AND ONE THING WE TALKED ABOUT IS

888
00:35:52,217 --> 00:35:55,253
IT POSSIBLE TO LOOK AT PATTERN 

889
00:35:55,253 --> 00:35:57,188
OF UPTITRATION AND DOES IT 

890
00:35:57,188 --> 00:35:58,023
PREDICT PEOPLE COMING OFF OR 

891
00:35:58,023 --> 00:35:59,891
STAYING ON MEDICATIONS IF 

892
00:35:59,891 --> 00:36:01,159
CLINICIANS ARE TRYING TOO HARD 

893
00:36:01,159 --> 00:36:04,062
TO FOLLOW WHAT WAS DONE IN 

894
00:36:04,062 --> 00:36:05,163
CLINICAL TRIALS AND FORCE PEOPLE

895
00:36:05,163 --> 00:36:07,732
UP BEFORE THEY ARE READY ARE WE 

896
00:36:07,732 --> 00:36:09,167
GOING TO SORT OF BACKFIRE AND 

897
00:36:09,167 --> 00:36:10,902
GET PEOPLE STOPPING MEDS THEY 

898
00:36:10,902 --> 00:36:13,605
SAY I CAN'T TOLERATE THIS?  

899
00:36:13,605 --> 00:36:16,274
SO I THINK IT IS INTERESTING 

900
00:36:16,274 --> 00:36:19,377
DATA TO POTENTIALLY LOOK AT AND 

901
00:36:19,377 --> 00:36:23,114
DON'T THINK IT NECESSARILY MEANS

902
00:36:23,114 --> 00:36:24,315
SOMEONE IS NOT BEING TREATED 

903
00:36:24,315 --> 00:36:26,985
CORRECTLY IF ON A LOWER DOSE OR 

904
00:36:26,985 --> 00:36:28,520
USING IT IN OFF-LABEL WAY. 

905
00:36:28,520 --> 00:36:30,522
>> WE REALLY CUT DOWN YOUR

906
00:36:30,522 --> 00:36:33,024
SAMPLE IF YOU DEMANDED IT.  

907
00:36:33,024 --> 00:36:34,959
THERE IS A FOLLOW-UP QUESTION ON

908
00:36:34,959 --> 00:36:36,961
TOPIC OF PATIENTS GOING ON AND 

909
00:36:36,961 --> 00:36:37,962
OFF MEDICATIONS. 

910
00:36:37,962 --> 00:36:38,229
>> YEAH. 

911
00:36:38,229 --> 00:36:41,166
>> IF USING A PROTOCOL
APPROACH.

912
00:36:41,166 --> 00:36:44,536
CAN YOU REINTRODUCE PATIENTS IF 

913
00:36:44,536 --> 00:36:45,937
THEY STOPPED IT AND RESTARTED IT

914
00:36:45,937 --> 00:36:48,039
AND HOW WOULD YOU DEAL WITH IT 

915
00:36:48,039 --> 00:36:48,406
ANALYTICALLY?  

916
00:36:48,406 --> 00:36:49,607
>> YEAH.  THERE IS A
COUPLE 

917
00:36:49,607 --> 00:36:51,342
DIFFERENT WAYS TO DO THIS AND 

918
00:36:51,342 --> 00:36:53,511
ONE WAY THAT OUR GROUP TALKED 

919
00:36:53,511 --> 00:36:57,182
ABOUT IS YOU KNOW AFTER -- AFTER

920
00:36:57,182 --> 00:36:59,617
SOMEBODY'S LAST FILL OF A 

921
00:36:59,617 --> 00:37:01,152
MEDICATION WITHIN A GIVEN 

922
00:37:01,152 --> 00:37:02,654
TREATMENT EPISODE THERE IS SOME 

923
00:37:02,654 --> 00:37:03,855
AMOUNT OF TIME AFTER THAT WHERE 

924
00:37:03,855 --> 00:37:06,624
WE SORT OF SAY OKAY YOUR LAST 

925
00:37:06,624 --> 00:37:08,893
FILL OF MEDICINE YOU HAD 30 DAYS

926
00:37:08,893 --> 00:37:11,963
ON HAND AND LET'S SAY YOU TOOK 

927
00:37:11,963 --> 00:37:14,432
IT MOST DAYS, SOME DAYS YOU 

928
00:37:14,432 --> 00:37:17,535
DIDN'T.  WE WILL GIVE YOU SOME 

929
00:37:17,535 --> 00:37:25,810
EXTRA BUFFER PERIOD.  

930
00:37:25,810 --> 00:37:27,912
PEOPLE GOING ON AND OFF 

931
00:37:27,912 --> 00:37:28,680
MEDICINES NOT BECAUSE THEY 

932
00:37:28,680 --> 00:37:30,381
WANTED TO BUT FOLKS COULDN'T 

933
00:37:30,381 --> 00:37:33,151
FIND IT AT ANY PHARMACIES FOR A 

934
00:37:33,151 --> 00:37:38,523
MONTH OR 2 AND WANT TO BUILD IN 

935
00:37:38,523 --> 00:37:40,825
A GRACE PERIOD MODIFIED ANALYSIS

936
00:37:40,825 --> 00:37:44,662
YOU ALLOW UP TO 90 DAY GAP OR 

937
00:37:44,662 --> 00:37:47,365
SOMETHING AFTER THAT AFTER THE 

938
00:37:47,365 --> 00:37:49,834
LAST FILL AS LONG AS SOMEONE 

939
00:37:49,834 --> 00:37:51,202
REINITIATES TREATMENT AND CALLS 

940
00:37:51,202 --> 00:37:52,871
IT PART OF THE SAME TREATMENT 

941
00:37:52,871 --> 00:37:54,973
EPISODE AND RATHER THAN SAYING 

942
00:37:54,973 --> 00:37:58,476
YOU MISSED OUT ON FILLING 

943
00:37:58,476 --> 00:37:59,978
MEDICINE EXACTLY FOR DATE WE 

944
00:37:59,978 --> 00:38:02,847
LOOKED FOR IT SEEMS CENSORED AND

945
00:38:02,847 --> 00:38:05,016
DOESN'T SEEM FAIR GIVEN SUPPLY 

946
00:38:05,016 --> 00:38:06,718
CHAIN CONSTRAINTS OF 

947
00:38:06,718 --> 00:38:07,051
ENVIRONMENT. 

948
00:38:07,051 --> 00:38:09,420
>> GREAT.  THAT IS REALLY 

949
00:38:09,420 --> 00:38:11,523
HELPFUL.  YOU KNOW, YESTERDAY, 

950
00:38:11,523 --> 00:38:13,158
THERE WAS DISCUSSION AROUND 

951
00:38:13,158 --> 00:38:14,926
PATIENTS FINDING INTENTION TO 

952
00:38:14,926 --> 00:38:17,162
TREAT ANALYSIS TO NOT BE VERY 

953
00:38:17,162 --> 00:38:18,263
HELPFUL AND SAY I WANT TO KNOW 

954
00:38:18,263 --> 00:38:20,231
WHAT HAPPENS IF I TAKE THIS 

955
00:38:20,231 --> 00:38:23,001
MEDICATION AND WE SAW THIS 

956
00:38:23,001 --> 00:38:24,769
APPROACH OFTEN PREFERRED AND 

957
00:38:24,769 --> 00:38:26,504
DEVELOPMENT OF EVIDENCE SIN THES

958
00:38:26,504 --> 00:38:29,908
HE'S AND WHAT DO YOU THINK DO 

959
00:38:29,908 --> 00:38:31,176
ITT ANALYSIS MAKE SENSE IN 

960
00:38:31,176 --> 00:38:32,944
CURRENT AREA A LOT OF PEOPLE 

961
00:38:32,944 --> 00:38:35,313
WITH OBESITY STAY ON MEDICINES 

962
00:38:35,313 --> 00:38:36,881
FOR A FEW MONTHS RATHER THAN 

963
00:38:36,881 --> 00:38:38,483
TAKING THEM FOR THE LONG TERM AS

964
00:38:38,483 --> 00:38:39,817
THE LABEL WOULD SUGGEST?  

965
00:38:39,817 --> 00:38:43,188
>> I THINK IT IS.  IT IS
REALLY 

966
00:38:43,188 --> 00:38:44,889
IMPORTANT TO CONSIDER THAT.  I 

967
00:38:44,889 --> 00:38:46,691
-- I STILL THINK THERE IS A 

968
00:38:46,691 --> 00:38:48,760
PLACE FOR BOTH.  I DON'T THINK 

969
00:38:48,760 --> 00:38:51,996
WE SHOULD JUST FOCUS ON ITT AND 

970
00:38:51,996 --> 00:38:53,565
DON'T THINK WE SHOULD JUST FOCUS

971
00:38:53,565 --> 00:38:54,933
ON ON TREATMENT.  

972
00:38:54,933 --> 00:38:56,734
I -- I THINK IT IS HARDER TO 

973
00:38:56,734 --> 00:38:59,137
MAKE A CASE, YOU KNOW, IF DOING 

974
00:38:59,137 --> 00:39:02,941
AN ITT ANALYSIS AND YOU WANT TO 

975
00:39:02,941 --> 00:39:05,476
LOOK AT 5-YEAR RISK OF 

976
00:39:05,476 --> 00:39:07,512
CARDIOVASCULAR OUTCOMES AND 

977
00:39:07,512 --> 00:39:08,846
TREATED GROUP ON AVERAGE IS 

978
00:39:08,846 --> 00:39:10,348
TAKING MEDICINE FOR ONLY THREE 

979
00:39:10,348 --> 00:39:11,816
MONTHS IT DOESN'T REALLY MEAN 

980
00:39:11,816 --> 00:39:13,184
ANYTHING AND IS PROBABLY NOT IN 

981
00:39:13,184 --> 00:39:15,019
THAT CASE IT IS NOT SO MUCH A 

982
00:39:15,019 --> 00:39:20,959
PROBLEM OF ITT AND PRO PROTOCOL 

983
00:39:20,959 --> 00:39:22,293
ANALYSIS IS NOT HELPFUL THERE 

984
00:39:22,293 --> 00:39:24,162
AND THERE IS A MISMATCH BETWEEN 

985
00:39:24,162 --> 00:39:25,563
QUESTION YOU ARE TRYING TO 

986
00:39:25,563 --> 00:39:27,465
ANSWER AND ABILITY OF DATASET 

987
00:39:27,465 --> 00:39:28,633
RIGHT NOW TO ANSWER THAT 

988
00:39:28,633 --> 00:39:30,868
QUESTION.  I THINK IF YOU ARE 

989
00:39:30,868 --> 00:39:34,772
INTERESTED IN YOU KNOW LET'S SAY

990
00:39:34,772 --> 00:39:39,577
PREGNANCY OUTCOMES OR SOMETHING 

991
00:39:39,577 --> 00:39:41,412
LIKE THAT IT MAKES SENSE FOR 

992
00:39:41,412 --> 00:39:43,414
ANALYSIS AND PROVIDERS MAKING 

993
00:39:43,414 --> 00:39:46,551
DECISION FOR PATIENT PANELS AND 

994
00:39:46,551 --> 00:39:49,520
POPULATIONS WANT THOSE ITT 

995
00:39:49,520 --> 00:39:49,787
ANALYSIS. 

996
00:39:49,787 --> 00:39:53,625
>> HOW ABOUT CAN YOU
COMMENT ON 

997
00:39:53,625 --> 00:39:56,761
DEALING WITH PRESCRIPTION DATA 

998
00:39:56,761 --> 00:39:58,196
VERSUS FILL DATA?  

999
00:39:58,196 --> 00:40:00,331
HOW DO YOU MANAGE DATA WILL 

1000
00:40:00,331 --> 00:40:00,665
IMITATIONS?  

1001
00:40:00,665 --> 00:40:07,772
>> YEAH.  THIS IS A REALLY
-- 

1002
00:40:07,772 --> 00:40:09,173
MASHI ELUDED TO THIS YESTERDAY 

1003
00:40:09,173 --> 00:40:11,209
IN HIS TALK.  THE GRASS IS 

1004
00:40:11,209 --> 00:40:12,176
ALWAYS GREENER AND WHENEVER I 

1005
00:40:12,176 --> 00:40:14,679
WORK WITH CLAIMS DATA I THINK, 

1006
00:40:14,679 --> 00:40:17,282
MAN.  I WISH I HAD ELECTRONIC 

1007
00:40:17,282 --> 00:40:20,318
HEALTH RECORD DATA WITH ACTUAL 

1008
00:40:20,318 --> 00:40:22,186
BMI MEASURES AND BLOOD PRESSURES

1009
00:40:22,186 --> 00:40:23,688
AND STUFF AND ONE NICE THING 

1010
00:40:23,688 --> 00:40:25,156
ABOUT INSURANCE CLAIMS PROVIDED 

1011
00:40:25,156 --> 00:40:27,025
YOU HAVE PEOPLE WITH PHARMACY 

1012
00:40:27,025 --> 00:40:28,860
BENEFIT COVERAGE IN YOUR DATASET

1013
00:40:28,860 --> 00:40:30,595
IS WE ARE ABLE TO ACTUALLY SEE 

1014
00:40:30,595 --> 00:40:33,598
WHAT PEOPLE IF ILL AT THE 

1015
00:40:33,598 --> 00:40:33,865
PHARMACY. 

1016
00:40:33,865 --> 00:40:36,868
AND WITH ALL MEDICATIONS BUT 

1017
00:40:36,868 --> 00:40:37,769
ESPECIALLY WITH THESE 

1018
00:40:37,769 --> 00:40:40,104
MEDICATIONS WHERE THERE IS 

1019
00:40:40,104 --> 00:40:41,406
STICKER SHOCK AND LOTS OF 

1020
00:40:41,406 --> 00:40:43,041
NONCOVERAGE OF MEDICATIONS, 

1021
00:40:43,041 --> 00:40:45,443
THERE IS PROBLEM OF PRIMARY 

1022
00:40:45,443 --> 00:40:47,645
ADHERENCE IS ENORMOUS; RIGHT?  

1023
00:40:47,645 --> 00:40:49,914
LOTS OF TIMES DOCTORS WRITE 

1024
00:40:49,914 --> 00:40:51,349
PRESCRIPTION AND PATIENTS 

1025
00:40:51,349 --> 00:40:53,051
EXCITED LEAVING OFFICE AND SHOW 

1026
00:40:53,051 --> 00:40:57,188
UP AT CVS WHO SAYS THAT WILL BE 

1027
00:40:57,188 --> 00:40:59,457
$1,000 FOR A MONTH SUPPLY AND NO

1028
00:40:59,457 --> 00:41:01,492
THANK YOU AND ELECTRONIC HEALTH 

1029
00:41:01,492 --> 00:41:05,029
RECORD DATA AND LINKED PHARMACY 

1030
00:41:05,029 --> 00:41:06,664
DATASET YOU ONLY KNOW WHERE 

1031
00:41:06,664 --> 00:41:10,068
THING WAS PRESCRIBED AND DON'T 

1032
00:41:10,068 --> 00:41:11,202
KNOW WHAT HAPPENED AND IS AN 

1033
00:41:11,202 --> 00:41:12,036
IMPORTANT LIMITATION TO KEEP IN 

1034
00:41:12,036 --> 00:41:14,038
MIND AND RESEARCH EVERIES WILL 

1035
00:41:14,038 --> 00:41:17,175
DO SOMETHING WHERE THEY REQUIRE 

1036
00:41:17,175 --> 00:41:19,510
AT LEAST ONE REFILL UP TO BE 

1037
00:41:19,510 --> 00:41:22,280
ORDERED IN E HR DATA FOR SOMEONE

1038
00:41:22,280 --> 00:41:23,982
TO QUALIFY.  I THINK YOU START 

1039
00:41:23,982 --> 00:41:25,950
TO GET INTO A SITUATION THERE 

1040
00:41:25,950 --> 00:41:27,452
WHERE YOU ARE CONDITIONING 

1041
00:41:27,452 --> 00:41:29,654
COHORT ENTRY ON A FUTURE EVENT 

1042
00:41:29,654 --> 00:41:31,022
AND MAYBE PROBLEMS THERE AND 

1043
00:41:31,022 --> 00:41:33,124
MAYBE YOU START FOLLOW UP AT THE

1044
00:41:33,124 --> 00:41:34,826
POINT OF THE FIRST REFILL AND 

1045
00:41:34,826 --> 00:41:36,127
THEN AGAIN YOU WILL MISS ALL OF 

1046
00:41:36,127 --> 00:41:38,329
THE PEOPLE WHO MAYBE COULDN'T 

1047
00:41:38,329 --> 00:41:39,864
TOLERATE EVEN THAT FIRST MONTH 

1048
00:41:39,864 --> 00:41:41,966
AND EARLY ADVERSE EVENTS YOU 

1049
00:41:41,966 --> 00:41:43,968
MISSED THERE AND TRADEOFFS AND I

1050
00:41:43,968 --> 00:41:45,837
DON'T KNOW.  DOES IT ANSWER THE 

1051
00:41:45,837 --> 00:41:47,772
QUESTION?  

1052
00:41:47,772 --> 00:41:49,774
>> I THINK IT DOES.  ALSO,
I 

1053
00:41:49,774 --> 00:41:51,876
MEAN, PARTICULARLY FOR A LOT OF 

1054
00:41:51,876 --> 00:41:53,478
TIMES PEOPLE HAVE ONLY USED EHR 

1055
00:41:53,478 --> 00:41:55,413
AND THINKING OF WORKING WITH 

1056
00:41:55,413 --> 00:41:56,881
CLAIMS OR ONLY USE CLAIMS AND 

1057
00:41:56,881 --> 00:41:59,984
THINKING OF WORKING WITH EHR AND

1058
00:41:59,984 --> 00:42:02,186
IS HELPFUL TO THINK OF WHAT 

1059
00:42:02,186 --> 00:42:04,722
TRADEOFFS ACTUALLY ARE AND SORT 

1060
00:42:04,722 --> 00:42:07,258
OF SIMILARLY WHAT WOULD BE 

1061
00:42:07,258 --> 00:42:08,593
IMPLICATIONS FOR CLAIMS VERSUS E

1062
00:42:08,593 --> 00:42:11,062
HAD.  R DATA THINKING OF 

1063
00:42:11,062 --> 00:42:11,696
GROUPING PATIENTS BASED ON 

1064
00:42:11,696 --> 00:42:13,598
INDICATION AND IF YOU WANT TO 

1065
00:42:13,598 --> 00:42:16,033
KNOW WHETHER THEY TAKE IT FOR 

1066
00:42:16,033 --> 00:42:17,969
OBESITY OR DIABETES OR FOR 

1067
00:42:17,969 --> 00:42:18,369
WHATEVER REASON. 

1068
00:42:18,369 --> 00:42:20,004
>> I THINK IT IS PROBABLY
WAY 

1069
00:42:20,004 --> 00:42:22,507
EASIER TO DO THAT WITH 

1070
00:42:22,507 --> 00:42:23,975
ELECTRONIC HEALTH RECORD DATA 

1071
00:42:23,975 --> 00:42:25,710
ESPECIALLY IF YOU CAN ACCESS 

1072
00:42:25,710 --> 00:42:29,080
SOME OF THE UNSTRUCTURED DATA 

1073
00:42:29,080 --> 00:42:31,416
THAT DR. MENTIONED YESTERDAY AND

1074
00:42:31,416 --> 00:42:32,283
CLINICIAN PROGRESS NOTES WHERE 

1075
00:42:32,283 --> 00:42:34,519
THEY ARE REALLY TALKING ABOUT 

1076
00:42:34,519 --> 00:42:35,787
THINKING AND DECISION MAKING 

1077
00:42:35,787 --> 00:42:36,254
PROCESS. 

1078
00:42:36,254 --> 00:42:39,323
IT WOULD BE ENORMOUSLY HELPFUL 

1079
00:42:39,323 --> 00:42:41,159
AND OBVIOUSLY IN BIG DATA 

1080
00:42:41,159 --> 00:42:43,494
SETTING YOU NEED TO USE NATURAL 

1081
00:42:43,494 --> 00:42:44,462
LANGUAGE PROCESSING OR SOMETHING

1082
00:42:44,462 --> 00:42:45,797
TO DO THAT AND KNOW THOSE TYPES 

1083
00:42:45,797 --> 00:42:47,999
OF TECHNOLOGIES ARE CONSTANTLY 

1084
00:42:47,999 --> 00:42:49,067
EVOLVING AND PROBABLY WILL 

1085
00:42:49,067 --> 00:42:50,401
CONTINUE TO GET BETTER BY THE 

1086
00:42:50,401 --> 00:42:54,439
END OF THE DAY.  SO THAT IS 

1087
00:42:54,439 --> 00:42:57,175
GREAT.  I THINK, YOU KNOW, BEING

1088
00:42:57,175 --> 00:42:59,844
ABLE TO IDENTIFY WHAT SOMEONE'S,

1089
00:42:59,844 --> 00:43:01,846
YOU KNOW, ACTUAL BMI IS AROUND 

1090
00:43:01,846 --> 00:43:03,848
THE TIME WHEN THEY ARE STARTING 

1091
00:43:03,848 --> 00:43:06,017
THE MEDICATION IS REALLY HELPFUL

1092
00:43:06,017 --> 00:43:08,252
AND TRAJECTORY OF BMI IS LEADING

1093
00:43:08,252 --> 00:43:09,353
UP TO STARTING MEDICATION CAN 

1094
00:43:09,353 --> 00:43:11,522
YOU DO THAT WITH ELECTRONIC 

1095
00:43:11,522 --> 00:43:13,157
HEALTH RECORD DATA AND CLAIMS 

1096
00:43:13,157 --> 00:43:16,594
DATA WE MIGHT BE LUCKY AND HAVE 

1097
00:43:16,594 --> 00:43:17,895
OBESITY DIAGNOSIS THAT IS MORE 

1098
00:43:17,895 --> 00:43:20,965
COMMON WHEN DOING BARIATRIC 

1099
00:43:20,965 --> 00:43:23,401
SURGERY RESEARCH INSURANCE 

1100
00:43:23,401 --> 00:43:24,869
COMPANIES REQUIRE CERTAIN VERY 

1101
00:43:24,869 --> 00:43:27,405
SPECIFIC BMI CODE TO BE ABLE TO 

1102
00:43:27,405 --> 00:43:29,474
QUALIFY FOR BARIATRIC SURGERY 

1103
00:43:29,474 --> 00:43:31,275
AND SEE WELL-POPULATED AND 

1104
00:43:31,275 --> 00:43:33,644
PROBABLY FAIRLY ACCURATE BMI 

1105
00:43:33,644 --> 00:43:35,780
CODES AROUND TIME OF BARIATRIC 

1106
00:43:35,780 --> 00:43:38,983
SURGERY AND THERE IS MISSING BMI

1107
00:43:38,983 --> 00:43:42,019
DATA WITH OBESITY MEDICINES AND 

1108
00:43:42,019 --> 00:43:44,589
OLDER MEDICINES CHEAP OUT OF 

1109
00:43:44,589 --> 00:43:46,991
POCKET $5 FENTER MEAN I WON'T 

1110
00:43:46,991 --> 00:43:48,159
TRY TO NECESSARILY FIGHT 

1111
00:43:48,159 --> 00:43:49,727
INSURANCE COMPANIES ON THAT ONE.

1112
00:43:49,727 --> 00:43:53,498
I MIGHT NOT PUT IN SPECIFIC BMI 

1113
00:43:53,498 --> 00:43:53,798
DIAGNOSIS. 

1114
00:43:53,798 --> 00:43:54,899
>> MAKES SENSE. 

1115
00:43:54,899 --> 00:43:56,501
THERE IS A FOLLOW UP THAT IS 

1116
00:43:56,501 --> 00:43:58,436
GOING BACK TO A POINT FROM A 

1117
00:43:58,436 --> 00:44:00,071
COUPLE TURNS BACK IN THE 

1118
00:44:00,071 --> 00:44:02,840
CONVERSATION AND PEDIATRIC 

1119
00:44:02,840 --> 00:44:04,675
OBESITY MEDICINE DOCTOR WHO GOT 

1120
00:44:04,675 --> 00:44:06,777
A LOT OF PUSH FROM INSURANCE 

1121
00:44:06,777 --> 00:44:09,147
PLANS TO FOLLOW EXACT PROTOCOL 

1122
00:44:09,147 --> 00:44:10,581
AND WONDER HAS THERE BEEN 

1123
00:44:10,581 --> 00:44:11,816
PUBLISHING AND WE HEARD A COUPLE

1124
00:44:11,816 --> 00:44:14,118
TIMES HOW THAT IS NO THE WHAT IS

1125
00:44:14,118 --> 00:44:15,786
BEING DONE IN FACT AND IS THERE 

1126
00:44:15,786 --> 00:44:19,090
PUBLISHED DATA THIS PERSON COULD

1127
00:44:19,090 --> 00:44:20,424
PERHAPS LEAN ON A LITTLE BIT AND

1128
00:44:20,424 --> 00:44:21,993
LEAD CONVERSATIONS WITH 

1129
00:44:21,993 --> 00:44:22,326
INSURERS?  

1130
00:44:22,326 --> 00:44:24,195
>> I FEEL FOR YOU AND
SPEND A 

1131
00:44:24,195 --> 00:44:26,764
LOT OF TIME DEALING WITH PRIOR 

1132
00:44:26,764 --> 00:44:28,633
AUTHORIZATIONS AND DEALING WITH 

1133
00:44:28,633 --> 00:44:30,034
PEOPLE GETTING THEIR COVERAGE 

1134
00:44:30,034 --> 00:44:32,603
REVOKED AND I AM NOT AWARE OF 

1135
00:44:32,603 --> 00:44:33,838
ANYTHING THAT WOULD SPEAK TO 

1136
00:44:33,838 --> 00:44:36,774
THAT AND THINK IF IT IS AN 

1137
00:44:36,774 --> 00:44:37,742
IDENTIFIED NEED FOR RESEARCH 

1138
00:44:37,742 --> 00:44:39,343
MAYBE THAT IS SOMETHING THAT OUR

1139
00:44:39,343 --> 00:44:42,013
CONFERENCE ORGANIZERS COULD JOT 

1140
00:44:42,013 --> 00:44:44,181
DOWN AS A GAP OR OPPORTUNITY AND

1141
00:44:44,181 --> 00:44:47,084
OTHER THING I HEARD IS INSURANCE

1142
00:44:47,084 --> 00:44:49,086
COMPANIES REVOKING COVERAGE FOR 

1143
00:44:49,086 --> 00:44:50,388
PATIENTS WHO ARE NON-COMPLIANT 

1144
00:44:50,388 --> 00:44:51,822
AND BECAUSE DOCTORS ARE GETTING 

1145
00:44:51,822 --> 00:44:54,091
SMART AND FIGURING OUT THEY CAN 

1146
00:44:54,091 --> 00:45:04,135
WRITE, YOU KNOW, A 30-DAY SUPPLY

1147
00:45:04,135 --> 00:45:06,037
-- IT LOOKS INSURANCE STANDPOINT

1148
00:45:06,037 --> 00:45:07,638
LIKE THIS PERSON HASN'T FILLED 

1149
00:45:07,638 --> 00:45:11,175
MEDICINE IN THREE MONTHS. 

1150
00:45:11,175 --> 00:45:12,577
>> NOT LONG TERM. 

1151
00:45:12,577 --> 00:45:14,579
>> WE WILL CUT THEM OFF
AND 

1152
00:45:14,579 --> 00:45:16,147
AGAIN SOMEONE PUT THIS COMMENT 

1153
00:45:16,147 --> 00:45:17,181
YESTERDAY AND THOUGHT WAS RIGHT 

1154
00:45:17,181 --> 00:45:18,783
AND ALL THIS COMES BACK TO HIGH 

1155
00:45:18,783 --> 00:45:20,051
COST OF MEDICATIONS. 

1156
00:45:20,051 --> 00:45:21,886
IF WE COULD ADDRESS THAT, I 

1157
00:45:21,886 --> 00:45:23,754
THINK LOTS OF THESE -- LOTS OF 

1158
00:45:23,754 --> 00:45:26,057
THESE MESSINESS THAT WE ARE 

1159
00:45:26,057 --> 00:45:29,160
SEEING IN THE REAL-WORLD DATA 

1160
00:45:29,160 --> 00:45:31,629
WOULD START TO GET -- GO AWAY. 

1161
00:45:31,629 --> 00:45:33,598
>> I NOTICE A REALLY
INTERESTING

1162
00:45:33,598 --> 00:45:37,168
POINT THERE IS A LOT OF 

1163
00:45:37,168 --> 00:45:39,303
PURPOSEFUL OB FUSS INDICATION OF

1164
00:45:39,303 --> 00:45:41,205
DATA BECAUSE OF INCREDIBLY HIGH 

1165
00:45:41,205 --> 00:45:41,439
COSTS. 

1166
00:45:41,439 --> 00:45:41,973
>> YEAH. 

1167
00:45:41,973 --> 00:45:43,207
>> WE HAVE ANOTHER
QUESTION 

1168
00:45:43,207 --> 00:45:45,042
HERE.  COULD YOU SHARE 

1169
00:45:45,042 --> 00:45:46,243
PERSPECTIVE ON TRIAL EMULATION 

1170
00:45:46,243 --> 00:45:49,013
APPROACH AND POTENTIAL TO OVERIN

1171
00:45:49,013 --> 00:45:50,815
HERRIENT CHALLENGES IN 

1172
00:45:50,815 --> 00:45:53,150
OBSERVATIONAL DATA?  

1173
00:45:53,150 --> 00:45:58,489
DO YOU SEE THIS TO BE A LIMITING

1174
00:45:58,489 --> 00:45:58,990
FACTOR?  

1175
00:45:58,990 --> 00:46:01,125
>> I THINK -- I MEAN, YOU
KNOW, 

1176
00:46:01,125 --> 00:46:02,827
I THINK WE HAD THE WORLD'S 

1177
00:46:02,827 --> 00:46:04,862
EXPERT IN THIS TALK ABOUT IT 

1178
00:46:04,862 --> 00:46:05,162
YESTERDAY. 

1179
00:46:05,162 --> 00:46:06,931
I DON'T, YOU KNOW, HAVE TOO MUCH

1180
00:46:06,931 --> 00:46:08,432
TO ADD ON TOP OF WHAT HE SAID. 

1181
00:46:08,432 --> 00:46:10,935
I THINK IT IS A REALLY HELPFUL 

1182
00:46:10,935 --> 00:46:13,638
WAY TO THINK ABOUT THIS.  IT IS 

1183
00:46:13,638 --> 00:46:16,507
JUST NICE TO KIND OF ORGANIZE 

1184
00:46:16,507 --> 00:46:18,943
AND STRUCTURE YOUR THINKING. 

1185
00:46:18,943 --> 00:46:20,778
AND -- AND, YOU KNOW, THE 

1186
00:46:20,778 --> 00:46:24,582
DOWNSIDE IS YOU MIGHT SORT OF 

1187
00:46:24,582 --> 00:46:25,750
GET THROUGH THAT APPROACH AND 

1188
00:46:25,750 --> 00:46:28,853
REALIZE THAT I WOULDN'T DO THIS 

1189
00:46:28,853 --> 00:46:30,621
TRIAL.  I SHOULDN'T DO THIS 

1190
00:46:30,621 --> 00:46:31,889
STUDY.  YOU KNOW?  

1191
00:46:31,889 --> 00:46:35,393
BUT -- BUT IN SOME WAYS THAT IS 

1192
00:46:35,393 --> 00:46:37,061
A HELPFUL EXERCISE; RIGHT?  

1193
00:46:37,061 --> 00:46:38,262
TO GET TO THAT. 

1194
00:46:38,262 --> 00:46:40,197
I DO THINK IT IS HELPFUL.  I 

1195
00:46:40,197 --> 00:46:43,100
THINK, YOU KNOW, AND I -- AND I 

1196
00:46:43,100 --> 00:46:44,301
KNOW THAT DR. HERNANDEZ 

1197
00:46:44,301 --> 00:46:45,770
MENTIONED THIS.  ONE THING THAT 

1198
00:46:45,770 --> 00:46:47,972
IS NICE ABOUT IT IS THAT THERE 

1199
00:46:47,972 --> 00:46:49,473
ARE CERTAIN CLINICAL TRIALS THAT

1200
00:46:49,473 --> 00:46:51,442
WE WOULD ALL LOVE TO SEE DONE 

1201
00:46:51,442 --> 00:46:53,444
BUT ARE NEVER GOING TO BE 

1202
00:46:53,444 --> 00:46:54,879
FUNDED; RIGHT?  

1203
00:46:54,879 --> 00:46:56,447
THEY ARE NOT IN ANYBODY'S 

1204
00:46:56,447 --> 00:46:57,948
FINANCIAL INTEREST IN THE 

1205
00:46:57,948 --> 00:47:01,052
PRIVATE SECTOR AND ARE TOO LARGE

1206
00:47:01,052 --> 00:47:02,920
AND UNWIELDY PROBABLY FOR NIH. 

1207
00:47:02,920 --> 00:47:05,156
THAT IS WHERE I THINK IT IS 

1208
00:47:05,156 --> 00:47:07,091
INCREDIBLY HELPFUL AND THINK IT 

1209
00:47:07,091 --> 00:47:09,160
IS HELPFUL FOR ANSWERING 

1210
00:47:09,160 --> 00:47:10,761
QUESTIONS THAT FRANKLY WOULD BE 

1211
00:47:10,761 --> 00:47:13,631
UNETHICAL TO ANSWER WITH A 

1212
00:47:13,631 --> 00:47:14,265
CLINICAL TRIAL AROUND HARM AND 

1213
00:47:14,265 --> 00:47:15,700
THAT ARE REALLY IMPORTANT TO GET

1214
00:47:15,700 --> 00:47:18,402
RIGHT FROM A, YOU KNOW, DESIGN 

1215
00:47:18,402 --> 00:47:20,571
STANDPOINT AND INTERNAL VALIDITY

1216
00:47:20,571 --> 00:47:21,672
STANDPOINT AND THINK THERE IS A 

1217
00:47:21,672 --> 00:47:24,041
PLACE FOR BOTH AND I'M A BIG 

1218
00:47:24,041 --> 00:47:26,277
PROPONENT OF DOING MORE 

1219
00:47:26,277 --> 00:47:27,611
PRAGMATIC TRIALS AS DISCUSSED 

1220
00:47:27,611 --> 00:47:31,649
YESTERDAY TO GET ANSWERS FASTER 

1221
00:47:31,649 --> 00:47:34,151
IN MULTIPLE WAYS. 

1222
00:47:34,151 --> 00:47:37,188
>> GREAT.  WE HAVE ANOTHER

1223
00:47:37,188 --> 00:47:39,190
QUESTION HERE ABOUT DO YOU THINK

1224
00:47:39,190 --> 00:47:41,592
-- DO YOU HAVE ANY INSIGHTS 

1225
00:47:41,592 --> 00:47:44,862
ABOUT HOW REAL WORLD DATA COULD 

1226
00:47:44,862 --> 00:47:45,296
BE USED TO INCREASE 

1227
00:47:45,296 --> 00:47:47,732
UNDERSTANDING ABOUT 

1228
00:47:47,732 --> 00:47:50,701
HETEROGENEITY WITHIN GROUP OF 

1229
00:47:50,701 --> 00:47:52,103
PEOPLE BROADLY LEFT TOGETHER AS 

1230
00:47:52,103 --> 00:47:52,970
BEING OBESE?  

1231
00:47:52,970 --> 00:47:54,805
>> YEAH.  THIS IS ONE OF
-- I 

1232
00:47:54,805 --> 00:48:00,111
THINK POTENTIAL REALLY UNTAPPED 

1233
00:48:00,111 --> 00:48:02,346
STRENGTHS OF REAL-WORLD DATA AND

1234
00:48:02,346 --> 00:48:04,615
TURNED TO FIELD IN FIRST PLACE 

1235
00:48:04,615 --> 00:48:07,485
AS CLINICIAN I WOULD GET DARN 

1236
00:48:07,485 --> 00:48:09,787
FRUSTRATED WHEN I OPEN MEDICINE 

1237
00:48:09,787 --> 00:48:11,922
AND JAMMA AND TRIAL CAME OUT 

1238
00:48:11,922 --> 00:48:14,158
LOOKING AT TABLE 1 AND THESE ARE

1239
00:48:14,158 --> 00:48:17,161
NOT MY PATIENTS AND TRIALS ARE 

1240
00:48:17,161 --> 00:48:19,430
RECRUITING PATIENTS THAT ARE NOT

1241
00:48:19,430 --> 00:48:20,064
GENERALIZABLE. 

1242
00:48:20,064 --> 00:48:22,233
I THINK THAT IS WHERE REAL-WORLD

1243
00:48:22,233 --> 00:48:24,368
DATA IS SO WONDERFUL IS THAT YOU

1244
00:48:24,368 --> 00:48:29,140
KNOW THE PATIENTS ARE INCREDIBLY

1245
00:48:29,140 --> 00:48:30,441
HETEROGENOUS IN BASELINE 

1246
00:48:30,441 --> 00:48:32,009
CHARACTERISTICS AND HOW THEY 

1247
00:48:32,009 --> 00:48:32,977
RESPOND TO TREATMENT AND SO 

1248
00:48:32,977 --> 00:48:35,079
THINK USING THAT AND TRYING TO 

1249
00:48:35,079 --> 00:48:37,248
WORK WITH METHODOLOGISTS OR 

1250
00:48:37,248 --> 00:48:39,917
TAKING PAIRING A CLINICIAN WHO 

1251
00:48:39,917 --> 00:48:41,185
UNDERSTANDS WHAT IT LOOKS LIKE 

1252
00:48:41,185 --> 00:48:43,654
AND WHAT PHENOTYPE LOOKS LIKE ON

1253
00:48:43,654 --> 00:48:46,190
THE GROUND AND WORKING WITH 

1254
00:48:46,190 --> 00:48:47,625
PHARMACOEPIPERSON OR SOME OTHER 

1255
00:48:47,625 --> 00:48:50,127
TYPE OF METHODOLOGIST WHO CAN 

1256
00:48:50,127 --> 00:48:51,729
HELP YOU CREATE A DESIGN FOR 

1257
00:48:51,729 --> 00:48:56,700
YOUR STUDY THAT IS GOING TO 

1258
00:48:56,700 --> 00:48:58,435
LEVERAGE THAT RATHER THAN, YOU 

1259
00:48:58,435 --> 00:49:00,504
KNOW, SOMETIMES I THINK THE 

1260
00:49:00,504 --> 00:49:03,240
TARGET TRIAL PIECE ONE, ONE 

1261
00:49:03,240 --> 00:49:04,542
MAYBE DOWNFALL IS IF IT LOOKS 

1262
00:49:04,542 --> 00:49:07,545
LIKE A NARROW CLINICAL TRIAL YOU

1263
00:49:07,545 --> 00:49:09,580
END UP EXCLUDING A LOT OF PEOPLE

1264
00:49:09,580 --> 00:49:11,215
THAT DON'T AND STUDY DESIGNS WE 

1265
00:49:11,215 --> 00:49:13,150
MIGHT CONSIDER TO MAYBE THERE IS

1266
00:49:13,150 --> 00:49:15,386
A PRAGMATIC TARGET CLINICAL 

1267
00:49:15,386 --> 00:49:17,955
TRIAL OR SOMETHING THAT WOULD 

1268
00:49:17,955 --> 00:49:19,957
ALLOW A LITTLE MORE FLEXIBILITY 

1269
00:49:19,957 --> 00:49:20,191
THERE. 

1270
00:49:20,191 --> 00:49:21,892
>> TAKE ADVANTAGE OF 

1271
00:49:21,892 --> 00:49:23,260
GENERALIZABLE POPULATION. 

1272
00:49:23,260 --> 00:49:23,828
>> EXACTLY. 

1273
00:49:23,828 --> 00:49:25,296
>> AND MORE RIGOROUS
APPROACHES 

1274
00:49:25,296 --> 00:49:27,198
AND IT IS A GREAT POINT. 

1275
00:49:27,198 --> 00:49:28,466
SOMEBODY ASKED IF YOU COULD 

1276
00:49:28,466 --> 00:49:29,934
SPEAK TO FORMING A REGISTRY AND 

1277
00:49:29,934 --> 00:49:32,937
NOT SURE WHAT ASPECTS OF 

1278
00:49:32,937 --> 00:49:33,871
REGISTRY THEY ARE CONSIDERING 

1279
00:49:33,871 --> 00:49:36,140
AND PUT THAT IN IF YOU WANT TO 

1280
00:49:36,140 --> 00:49:38,576
ADD DETAILS IT MIGHT BE HELPFUL 

1281
00:49:38,576 --> 00:49:40,377
AND YESTERDAY WE TALKED ABOUT 

1282
00:49:40,377 --> 00:49:41,912
HOW REGISTRIES COULD BE USEFUL 

1283
00:49:41,912 --> 00:49:43,814
AND SOMETIMES ARE NOT REAL-WORLD

1284
00:49:43,814 --> 00:49:45,482
DATA BUT CERTAINLY IS A LIKENESS

1285
00:49:45,482 --> 00:49:47,451
AND WHAT ARE THOUGHTS FOR 

1286
00:49:47,451 --> 00:49:49,153
REGISTRIES AND RESEARCH RELATED 

1287
00:49:49,153 --> 00:49:50,554
TO GLP-1S?  

1288
00:49:50,554 --> 00:49:53,157
>> THEY ARE WONDERFUL TO
HAVE 

1289
00:49:53,157 --> 00:49:55,659
AND POTENTIALLY A REALLY NICE 

1290
00:49:55,659 --> 00:49:58,462
IDEA WITH ALL THESE TELEMEDICINE

1291
00:49:58,462 --> 00:50:00,064
COMPANIES THAT ARE COMING OUT 

1292
00:50:00,064 --> 00:50:02,800
AND -- AND WHERE, YOU KNOW, ALL 

1293
00:50:02,800 --> 00:50:05,536
OF THESE PATIENTS ARE NOW BEING 

1294
00:50:05,536 --> 00:50:06,937
TREATED IN A SPACE WHERE WE 

1295
00:50:06,937 --> 00:50:09,173
DON'T HAVE EYES ON THEM.  RIGHT?

1296
00:50:09,173 --> 00:50:12,776
THAT DATA IS NOT SHOWING UP IN 

1297
00:50:12,776 --> 00:50:14,912
ELECTRONIC HEALTH RECORD AND 

1298
00:50:14,912 --> 00:50:16,513
INSURANCE CLAIMS AND IS ONE 

1299
00:50:16,513 --> 00:50:17,448
PLACE IN PARTICULAR WHERE 

1300
00:50:17,448 --> 00:50:18,983
EITHER, YOU KNOW, I DON'T KNOW 

1301
00:50:18,983 --> 00:50:21,752
IF WILL IS A POLICY GUIDELINE OR

1302
00:50:21,752 --> 00:50:23,954
SOMETHING THAT WOULD REQUIRE IT 

1303
00:50:23,954 --> 00:50:25,856
OR IF SOMEBODY WANTS TO TAKE IT 

1304
00:50:25,856 --> 00:50:29,159
ON AND CREATE A REGISTRY OF 

1305
00:50:29,159 --> 00:50:31,061
PATIENTS THAT ARE TREATED AND 

1306
00:50:31,061 --> 00:50:32,930
SYSTEMATIC WAY OF COLLECTING 

1307
00:50:32,930 --> 00:50:36,400
SIMILAR SAFETY AND EFFICACY 

1308
00:50:36,400 --> 00:50:39,670
MEASURES ACROSS THESE DIFFERENT 

1309
00:50:39,670 --> 00:50:41,438
COMPANIES WOULD BE REALLY 

1310
00:50:41,438 --> 00:50:44,208
WONDERFUL AND THINK THAT IS A 

1311
00:50:44,208 --> 00:50:45,743
DEFINITE NEED AND WITH 

1312
00:50:45,743 --> 00:50:49,146
BLINDSPOTS IN OUR DATA SETS, YOU

1313
00:50:49,146 --> 00:50:51,916
KNOW, DOCTORS AND HEALTH SYSTEMS

1314
00:50:51,916 --> 00:50:54,118
WON'T DOCUMENT THINGS THAT ARE 

1315
00:50:54,118 --> 00:50:55,586
NOT NECESSARILY THAT IMPORTANT 

1316
00:50:55,586 --> 00:50:57,521
FOR BILLING.  THINGS WE MIGHT 

1317
00:50:57,521 --> 00:51:00,224
REALLY CARE ABOUT AS OBESITY 

1318
00:51:00,224 --> 00:51:01,325
RESEARCHERS LIKE LIFESTYLE AND 

1319
00:51:01,325 --> 00:51:03,160
QUALITY OF LIFE AND THOSE THINGS

1320
00:51:03,160 --> 00:51:05,396
ARE NOT GENERALLY CAPTURED 

1321
00:51:05,396 --> 00:51:06,764
SYSTEMATICALLY AND IS ANOTHER 

1322
00:51:06,764 --> 00:51:09,967
PLACE WHERE LIKE YOU ENVISION A 

1323
00:51:09,967 --> 00:51:11,635
NICE REGISTRY WHERE PATIENTS ARE

1324
00:51:11,635 --> 00:51:12,770
ABLE TO REPORT EXPERIENCES AND 

1325
00:51:12,770 --> 00:51:15,539
WHAT IS HAPPENING IN THEIR LIVES

1326
00:51:15,539 --> 00:51:17,207
AGAIN ON A SYSTEMATIC WAY TO 

1327
00:51:17,207 --> 00:51:19,610
PAIR IT UP WITH EXISTING 

1328
00:51:19,610 --> 00:51:21,478
HEALTHCARE AND HEALTH SERVICES 

1329
00:51:21,478 --> 00:51:22,079
OUTCOMES THAT WE HAVE. 

1330
00:51:22,079 --> 00:51:24,114
>> YEAH.  THAT WOULD BE
GREAT.  

1331
00:51:24,114 --> 00:51:26,116
AND THE IDEAIN CORPORATING 

1332
00:51:26,116 --> 00:51:27,952
PATIENT REPORTED OUTCOMES THAT 

1333
00:51:27,952 --> 00:51:31,889
WOULD ADD REALLY GREAT VALUE. 

1334
00:51:31,889 --> 00:51:32,423
QUESTION.  ADDING MORE 

1335
00:51:32,423 --> 00:51:33,757
INFORMATION ABOUT THEIR THINKING

1336
00:51:33,757 --> 00:51:36,393
OF REGISTRY OR PROVIDER INPUTS 

1337
00:51:36,393 --> 00:51:37,761
DATA FROM PATIENT VISITS. 

1338
00:51:37,761 --> 00:51:38,796
>> OH, YEAH. 

1339
00:51:38,796 --> 00:51:41,198
>> TO AVOID THAT CHART AND
STEP 

1340
00:51:41,198 --> 00:51:44,101
THAT IS DOABLE AND TAKES A LOT 

1341
00:51:44,101 --> 00:51:45,169
OF EXTRA WORK. 

1342
00:51:45,169 --> 00:51:47,805
>> PUTTING IT IN
STRUCTURED DATA

1343
00:51:47,805 --> 00:51:48,205
FIELD.  YEAH. 

1344
00:51:48,205 --> 00:51:50,374
>> SO SIMILARLY GOING BACK
TO 

1345
00:51:50,374 --> 00:51:52,242
ONE THING THAT YOU RAISED AS A 

1346
00:51:52,242 --> 00:51:55,079
-- AS A -- AS A REAL CHALLENGE 

1347
00:51:55,079 --> 00:51:56,747
WITH A COMPOUNDING MEDICATIONS 

1348
00:51:56,747 --> 00:51:58,182
THAT, YOU KNOW, WE JUST DON'T 

1349
00:51:58,182 --> 00:52:00,217
HAVE GOOD DATA IN E HR AND MAYBE

1350
00:52:00,217 --> 00:52:03,287
THERE IS DATA IN THE NOTES AND 

1351
00:52:03,287 --> 00:52:04,621
YOU KNOW NOT NECESSARILY MAYBE 

1352
00:52:04,621 --> 00:52:05,990
PEOPLE DON'T TELL CLINICIANS 

1353
00:52:05,990 --> 00:52:07,725
ABOUT IT AND YOU RAISE A POINT 

1354
00:52:07,725 --> 00:52:09,326
THERE ARE TELEHEALTH COMPANIES 

1355
00:52:09,326 --> 00:52:11,595
OUT THERE PROVIDING MEDICATIONS.

1356
00:52:11,595 --> 00:52:12,596
HAVE YOU SEEN WORK WHERE PEOPLE 

1357
00:52:12,596 --> 00:52:14,598
HAVE BEEN ABLE TO ACCESS THEIR 

1358
00:52:14,598 --> 00:52:17,534
DATA AND LINK IT IN WITH EHR 

1359
00:52:17,534 --> 00:52:17,768
DATA?  

1360
00:52:17,768 --> 00:52:18,969
>> I IMAGINE THERE ARE
PEOPLE 

1361
00:52:18,969 --> 00:52:21,171
DOING THAT AND KNOW LOTS OF 

1362
00:52:21,171 --> 00:52:22,439
TELEHEALTH COMPANIES ARE 

1363
00:52:22,439 --> 00:52:24,475
AFFILIATED WITH, YOU KNOW, 

1364
00:52:24,475 --> 00:52:26,110
RESEARCHERS AND HAVE PEOPLE 

1365
00:52:26,110 --> 00:52:28,278
SITTING ON THEIR BOARDS THAT ARE

1366
00:52:28,278 --> 00:52:29,847
IN THIS FIELD AND WOULD IMAGINE 

1367
00:52:29,847 --> 00:52:31,949
THAT IS HAPPENING.  

1368
00:52:31,949 --> 00:52:34,385
I DON'T KNOW.  YOU KNOW, I THINK

1369
00:52:34,385 --> 00:52:36,253
SIMILAR TO ANY KIND OF FOR 

1370
00:52:36,253 --> 00:52:38,188
PROFIT COMPANY, I THINK, YOU 

1371
00:52:38,188 --> 00:52:40,357
KNOW, YOU JUST HAVE TO VIEW ANY 

1372
00:52:40,357 --> 00:52:41,859
RESULTING PUBLICATIONS THROUGH 

1373
00:52:41,859 --> 00:52:43,394
LENS OF LIKE WOULD THEY PUBLISH 

1374
00:52:43,394 --> 00:52:45,396
THIS IF IT WAS TERRIBLE. 

1375
00:52:45,396 --> 00:52:45,796
>> YES. 

1376
00:52:45,796 --> 00:52:47,498
>> PROBABLY NOT.  SO I
THINK 

1377
00:52:47,498 --> 00:52:49,166
THERE IS THAT AND IT WOULD BE 

1378
00:52:49,166 --> 00:52:51,435
REALLY NICE TO HAVIN DEPENDENT 

1379
00:52:51,435 --> 00:52:52,803
LOOK AT THAT DATA. 

1380
00:52:52,803 --> 00:52:54,271
>> YEAH.  EXCELLENT
POINTS. 

1381
00:52:54,271 --> 00:52:55,873
SOMEONE NOTED THAT THEY ARE 

1382
00:52:55,873 --> 00:52:58,342
WORKING ON A REGISTRY THAT WAS 

1383
00:52:58,342 --> 00:53:00,244
JUST SIMILAR TO WHAT WAS JUST 

1384
00:53:00,244 --> 00:53:01,078
DESCRIBED AND IS GREAT. 

1385
00:53:01,078 --> 00:53:03,781
>> THANK YOU.  THANK YOU
FOR 

1386
00:53:03,781 --> 00:53:04,048
THAT. 

1387
00:53:04,048 --> 00:53:05,849
>> ALL RIGHT.  I THINK WE
ARE 

1388
00:53:05,849 --> 00:53:08,585
RUNNING OUT OF QUESTIONS ON MY 

1389
00:53:08,585 --> 00:53:09,987
LIST.  OH, ONE POPPED UP IN THE 

1390
00:53:09,987 --> 00:53:11,688
CHAT AND LET ME SEE WHAT THEY 

1391
00:53:11,688 --> 00:53:13,023
SAY AND DO YOU THINK CURRENT 

1392
00:53:13,023 --> 00:53:16,326
REAL WORLD DATA ON ADHERENCE ARE

1393
00:53:16,326 --> 00:53:19,530
ESSENTIALLY FLAWED AND UNINTERP 

1394
00:53:19,530 --> 00:53:21,765
RECEIPTABLE AND GIVEN ALL 

1395
00:53:21,765 --> 00:53:23,600
CHANGES IN HIGH COVERAGE AND 

1396
00:53:23,600 --> 00:53:23,867
COSTS.

1397
00:53:23,867 --> 00:53:25,202
HOW WOULD YOU -- WHAT IS YOUR 

1398
00:53:25,202 --> 00:53:28,639
ADVICE FOR APPROACHING 

1399
00:53:28,639 --> 00:53:28,939
ADHERENCE?  

1400
00:53:28,939 --> 00:53:32,376
>> I WOULD WORK WITH
CLINICIANS 

1401
00:53:32,376 --> 00:53:33,077
PRESCRIBING MEDICATIONS TO HELP 

1402
00:53:33,077 --> 00:53:34,978
YOU UNDERSTAND PATTERNS YOU ARE 

1403
00:53:34,978 --> 00:53:35,212
SEEING. 

1404
00:53:35,212 --> 00:53:37,181
AND I -- I -- IT IS A LITTLE BIT

1405
00:53:37,181 --> 00:53:40,884
OF A PET PEEVE.  I KIND OF LIKE 

1406
00:53:40,884 --> 00:53:42,986
-- THE WORD ADHERENCE IN THIS 

1407
00:53:42,986 --> 00:53:45,155
CONTEXT IS PUTTING THE ONUS ON 

1408
00:53:45,155 --> 00:53:47,524
THE PATIENT AND SAYING ARE YOU 

1409
00:53:47,524 --> 00:53:48,826
NOT ADHERENT WHEN THAT IS NOT 

1410
00:53:48,826 --> 00:53:52,096
WHAT IS GOING ON IN 95% OF THESE

1411
00:53:52,096 --> 00:53:54,598
CASES.  PEOPLE WANT TO BE ON 

1412
00:53:54,598 --> 00:53:56,633
MEDS AND STAY ON THEM IF WE CAN 

1413
00:53:56,633 --> 00:53:59,770
TOLERATE THEM AND HAVE TO COME 

1414
00:53:59,770 --> 00:54:01,805
UP WITH A BETTER TERM. 

1415
00:54:01,805 --> 00:54:02,906
>> JUST PLAIN CAN'T GET
THEM. 

1416
00:54:02,906 --> 00:54:03,507
>> YEAH. 

1417
00:54:03,507 --> 00:54:05,642
>> GREAT.  THIS BRINGS US
TO END

1418
00:54:05,642 --> 00:54:06,844
OF TIMEFRAME AND THANK YOU 

1419
00:54:06,844 --> 00:54:09,012
AGAIN.  IT WAS REALLY A 

1420
00:54:09,012 --> 00:54:09,913
WONDERFUL PRESENTATION AND GREAT

1421
00:54:09,913 --> 00:54:11,148
RESPONSES TO ALL OF THE 

1422
00:54:11,148 --> 00:54:11,882
QUESTIONS AND. 

1423
00:54:11,882 --> 00:54:14,351
>> AWESOME.  THANK SO YOU
MUCH. 

1424
00:54:14,351 --> 00:54:17,221
>> HAVE A GOOD DAY. 

1425
00:54:17,221 --> 00:54:20,290
>> OKAY. 

1426
00:54:20,290 --> 00:54:22,493
>> NOW WE WILL MOVE ON TO
A 

1427
00:54:22,493 --> 00:54:25,162
SERIES OF FOUR TALKS THAT ARE 

1428
00:54:25,162 --> 00:54:27,464
ALL ADDRESSING REAL WORLD 

1429
00:54:27,464 --> 00:54:31,735
EFFECTIVENESS AND SAFETY OF 

1430
00:54:31,735 --> 00:54:32,703
GLP-1-BASED THERAPIES. 

1431
00:54:32,703 --> 00:54:37,474
AND DR. MCCOY, DR. ROZALINA 

1432
00:54:37,474 --> 00:54:38,775
MCCOY IS THE FIRST SPEAKER 

1433
00:54:38,775 --> 00:54:41,445
TODAY.  SHE IS AN ASSOCIATE 

1434
00:54:41,445 --> 00:54:43,580
PROFESSOR OF MEDICINE AND 

1435
00:54:43,580 --> 00:54:45,048
POPULATION HEALTH AT UNIVERSITY 

1436
00:54:45,048 --> 00:54:48,118
OF MARYLAND SCHOOL OF MEDICINE 

1437
00:54:48,118 --> 00:54:50,320
AND RESEARCH LEVERAGES REAL 

1438
00:54:50,320 --> 00:54:52,890
WORMED DATA -- DIABETES CARE ON 

1439
00:54:52,890 --> 00:54:54,224
BOTH INDIVIDUAL AND POPULATION 

1440
00:54:54,224 --> 00:54:57,528
HEALTH BASIS AND IN THIS SESSION

1441
00:54:57,528 --> 00:55:00,063
SHE WILL BE ADDRESSING 

1442
00:55:00,063 --> 00:55:01,665
CARDIOVASCULAR AND METABOLIC 

1443
00:55:01,665 --> 00:55:04,101
DISEASE AND AS A REMINDER, 

1444
00:55:04,101 --> 00:55:06,370
PLEASE PUT QUESTIONS IN Q &
A.  

1445
00:55:06,370 --> 00:55:08,172
WE WILL DISCUSS AFTER THIS GROUP

1446
00:55:08,172 --> 00:55:10,307
OF PRESENTATIONS. 

1447
00:55:10,307 --> 00:55:12,643
DR. MCCOY, I WILL TURN THE FLOOR

1448
00:55:12,643 --> 00:55:13,143
OVER TO YOU. 

1449
00:55:13,143 --> 00:55:17,147
>> THANK YOU SO MUCH.  AND
THANK

1450
00:55:17,147 --> 00:55:21,151
YOU TO EVERYBODY WHO IS HERE AND

1451
00:55:21,151 --> 00:55:24,688
CONTINUING TO ENGAGE.  IT IS 

1452
00:55:24,688 --> 00:55:29,259
REALLY AN INCREDIBLE WEBINAR AND

1453
00:55:29,259 --> 00:55:38,202
HOPEFULLY YOU CAN SEE MY SLIDES.

1454
00:55:38,202 --> 00:55:39,102
THEY CHANGED. 

1455
00:55:39,102 --> 00:55:40,103
>> WE CAN SEE THEM. 

1456
00:55:40,103 --> 00:55:43,440
>> PERFECT.  I HAVE NO 

1457
00:55:43,440 --> 00:55:44,608
DISCLOSURES AND WHAT I REFERENCE

1458
00:55:44,608 --> 00:55:47,311
TODAY IS SUPPORTED BY NI DID.  

1459
00:55:47,311 --> 00:55:51,682
DK AND PCORI AND YALE AND 

1460
00:55:51,682 --> 00:55:54,284
UNIVERSITY OF MARYLAND. 

1461
00:55:54,284 --> 00:55:56,420
WHAT I HOPE TO COVER IN THE NEXT

1462
00:55:56,420 --> 00:56:00,290
20 MINUTES ARE THREE THINGS, 

1463
00:56:00,290 --> 00:56:02,926
FIRST, TALK ABOUT WHAT CARDIO 

1464
00:56:02,926 --> 00:56:06,230
KIDNEY METABOLIC OUTCOMES AND 

1465
00:56:06,230 --> 00:56:11,635
NEEDING REAL WORLD DATA AND 

1466
00:56:11,635 --> 00:56:13,770
CLINICAL TRIALS AND REALLY FOCUS

1467
00:56:13,770 --> 00:56:15,939
MOST TIME ON CHALLENGES AND 

1468
00:56:15,939 --> 00:56:19,009
STRENGTH OF USING REAL WORLD 

1469
00:56:19,009 --> 00:56:28,385
DATA TO EXAMINE THESE OUTCOMES. 

1470
00:56:28,385 --> 00:56:30,320
SWITCHING THESE. 

1471
00:56:30,320 --> 00:56:32,222
>> SYSTEMIC DISORDER THAT
IS 

1472
00:56:32,222 --> 00:56:35,058
CHARACTERIZED BY 

1473
00:56:35,058 --> 00:56:35,726
PATHOPHYSIOLOGICAL INTERACTIONS 

1474
00:56:35,726 --> 00:56:37,894
AMONG MULTIPLE METABOLIC RISK 

1475
00:56:37,894 --> 00:56:42,032
FACTORS DEFINED FUNDAMENTALLY BY

1476
00:56:42,032 --> 00:56:46,670
EFFECTS OF FUNCTIONAL ADIPOSITY 

1477
00:56:46,670 --> 00:56:49,039
IN CARDIOVASCULAR SYSTEM AND 

1478
00:56:49,039 --> 00:56:52,976
HIGH RATE OF ADVERSE OUTCOMES 

1479
00:56:52,976 --> 00:56:55,779
ACROSS A WIDE RANGE OF SYSTEMS 

1480
00:56:55,779 --> 00:56:59,449
AND TALKING ABOUT CKM AS A 

1481
00:56:59,449 --> 00:57:02,619
SYNDROME TOED IS GLP-1-BASED 

1482
00:57:02,619 --> 00:57:04,087
THERAPIES DISRUPT THIS PATHWAY 

1483
00:57:04,087 --> 00:57:07,157
AND RESULTING AND PROFOUND 

1484
00:57:07,157 --> 00:57:09,993
IMPROVEMENTS IN CARDIOVASCULAR 

1485
00:57:09,993 --> 00:57:12,296
AND KIDNEY METABOLIC OUTCOMES 

1486
00:57:12,296 --> 00:57:13,730
FOUND DISCRETELY BEFORE AND 

1487
00:57:13,730 --> 00:57:16,166
LEADING TO RANGE OF RELATED 

1488
00:57:16,166 --> 00:57:17,301
ENDPOINTS YOU WILL HEAR ABOUT 

1489
00:57:17,301 --> 00:57:21,705
DURING THE REST OF THE SESSION 

1490
00:57:21,705 --> 00:57:22,172
TODAY. 

1491
00:57:22,172 --> 00:57:29,146
WHAT IS IMPORTANT IS REALLY NEAR

1492
00:57:30,681 --> 00:57:31,181
LY. 

1493
00:57:31,181 --> 00:57:33,750
CONSEQUENCE OF THE SINCOM AND 

1494
00:57:33,750 --> 00:57:39,656
GREATEST IMPACT OF CKM SYNDROME 

1495
00:57:39,656 --> 00:57:42,726
IS THROUGH DISPROPORTION BURDEN 

1496
00:57:42,726 --> 00:57:45,162
OF CARDIOVASCULAR DISEASE AND 

1497
00:57:45,162 --> 00:57:48,298
OTHER CONDITIONS OCCUR INCLUDING

1498
00:57:48,298 --> 00:57:52,469
KIDNEY FAILURE OBSTRUCTIVE SLEEP

1499
00:57:52,469 --> 00:57:54,871
APNEA AND SLEEP DECLINE AND 

1500
00:57:54,871 --> 00:57:58,008
CANCER AND EACH OF THESE 

1501
00:57:58,008 --> 00:57:59,343
CONDITIONS INDIVIDUALLY IS OVER 

1502
00:57:59,343 --> 00:58:00,944
A 10 YEAR LOSS IN LIFE 

1503
00:58:00,944 --> 00:58:03,513
EXPECTANCY AND WHILE WE DON'T 

1504
00:58:03,513 --> 00:58:06,883
KNOW ALL TOGETHER HOW MUCH 

1505
00:58:06,883 --> 00:58:09,186
MULTI-MORBIDITY BURDEN OF CKM 

1506
00:58:09,186 --> 00:58:12,556
IMPACTS LIFE EXPECTANCY WE 

1507
00:58:12,556 --> 00:58:16,126
EXPECT IT TO BE PROFOUND.  IT IS

1508
00:58:16,126 --> 00:58:18,328
EXPENSIVE AND THIS IS DATA FOR 

1509
00:58:18,328 --> 00:58:21,598
2016 ALMOST 481 BILLION DOLLARS 

1510
00:58:21,598 --> 00:58:23,333
IN DIRECT HEALTH CARE COSTS IN 

1511
00:58:23,333 --> 00:58:26,570
ADDITIONAL 1.24 TRILLION DOLLARS

1512
00:58:26,570 --> 00:58:29,005
IN INDIRECT COSTS WERE 

1513
00:58:29,005 --> 00:58:30,507
ATTRIBUTED TO THE WIDE RANGE OF 

1514
00:58:30,507 --> 00:58:32,876
DISEASES DRIVEN BY OBESITY AND 

1515
00:58:32,876 --> 00:58:33,176
OVERWEIGHT. 

1516
00:58:33,176 --> 00:58:41,151
THAT IS 9.3% OF THE ENTIRE 

1517
00:58:41,151 --> 00:58:44,821
USGDP. 

1518
00:58:44,821 --> 00:58:48,291
WHY DO WE NEED REAL WORLD DATA 

1519
00:58:48,291 --> 00:58:54,898
GIP GLP-1RASE ARE STANDARD OF 

1520
00:58:54,898 --> 00:58:56,366
CARE AND CARDIOVASCULAR DISEASE 

1521
00:58:56,366 --> 00:59:00,303
AND OBESITY AND MULTIPLE DISEASE

1522
00:59:00,303 --> 00:59:02,773
ESTABLISHED GLYCEMIC AND 

1523
00:59:02,773 --> 00:59:03,607
CARDIOVASCULAR AND OTHER 

1524
00:59:03,607 --> 00:59:05,142
BENEFITS OF THE THERAPIES AND 

1525
00:59:05,142 --> 00:59:07,277
ONGOING TRIALS THAT CONTINUE TO 

1526
00:59:07,277 --> 00:59:10,347
FOCUS ON GLYCEMIC AND A1C AND 

1527
00:59:10,347 --> 00:59:13,150
TIME AND RANGE AND WEIGHT AND 

1528
00:59:13,150 --> 00:59:15,252
METABOLIC AND CARDIOVASCULAR 

1529
00:59:15,252 --> 00:59:16,753
OUTCOMES AND WONDERING WHY I'M 

1530
00:59:16,753 --> 00:59:20,490
HERE AND NOT START WITH THE NEXT

1531
00:59:20,490 --> 00:59:22,826
TALK TALKING ABOUT MARGIN TO 

1532
00:59:22,826 --> 00:59:25,095
NOVEL OUTCOMES AND ARGUING WE 

1533
00:59:25,095 --> 00:59:26,530
LEARNED YESTERDAY AND EXCELLENT 

1534
00:59:26,530 --> 00:59:28,665
TALKS ON PRAGMATIC AND 

1535
00:59:28,665 --> 00:59:31,234
INTERVENTIONAL AND EMULATED 

1536
00:59:31,234 --> 00:59:33,336
CLINICAL TRIALS REAL WORLD DATA 

1537
00:59:33,336 --> 00:59:35,605
ALLOW FOR THERAPIES ON CKE 

1538
00:59:35,605 --> 00:59:37,841
OUTCOMES AND INDIVIDUALS WHO ARE

1539
00:59:37,841 --> 00:59:39,543
ACTUALLY TAKING THESE 

1540
00:59:39,543 --> 00:59:40,977
MEDICATIONS NOT THOSE WHO ARE 

1541
00:59:40,977 --> 00:59:43,613
STUDIED IN CLINICAL TRIALS WHO 

1542
00:59:43,613 --> 00:59:46,283
ARE A DISTINCT AND DIFFERENT 

1543
00:59:46,283 --> 00:59:47,551
PATIENT POPULATION. 

1544
00:59:47,551 --> 00:59:51,688
AS WELL AS UNDER USUAL CARE 

1545
00:59:51,688 --> 00:59:53,089
CONDITIONS RATHER THAN 

1546
00:59:53,089 --> 00:59:54,291
AIDEALIZED CONDITIONS OF 

1547
00:59:54,291 --> 00:59:57,160
CLINICAL TRIALS AND SPECIFICALLY

1548
00:59:57,160 --> 01:00:02,799
THIS ALLOWS US TO STUDY EFFECTS 

1549
01:00:02,799 --> 01:00:07,103
OF THESE IN PATIENT COHORTS 

1550
01:00:07,103 --> 01:00:11,508
PAVING WAY FOR US TO UNDERSTAND 

1551
01:00:11,508 --> 01:00:14,411
HIT ROW GENIUS EFFECTS WE CAN 

1552
01:00:14,411 --> 01:00:16,413
STUDY INDIVIDUALS TAKING DRUGS 

1553
01:00:16,413 --> 01:00:18,849
WHO DON'T HAVE CARDIOVASCULAR 

1554
01:00:18,849 --> 01:00:20,517
CKM DISEASE AND INDICATORS OF 

1555
01:00:20,517 --> 01:00:21,852
HIGH RISK AND STUDY WOMEN OF 

1556
01:00:21,852 --> 01:00:24,321
CHILD BEARING POTENTIAL AND 

1557
01:00:24,321 --> 01:00:25,822
PREGNANCY EXCLUDED FROM ALL 

1558
01:00:25,822 --> 01:00:29,059
TRIALS AND SIMILARLY CAN LOOK AT

1559
01:00:29,059 --> 01:00:30,560
YOUTH AND PATIENTS WITH FRAILTY 

1560
01:00:30,560 --> 01:00:33,296
AND MULTI-MORBIDITY AND AT RISK 

1561
01:00:33,296 --> 01:00:36,166
FOR ADVERSE EFFECTS OF THERAPIES

1562
01:00:36,166 --> 01:00:37,601
AND ARE BEING TREATED AND SHOULD

1563
01:00:37,601 --> 01:00:41,171
BE TREATED WITH MEDICATIONS IN 

1564
01:00:41,171 --> 01:00:43,540
THE REAL WORLD DUE TO THEIR 

1565
01:00:43,540 --> 01:00:45,375
BENEFITS AND INDIVIDUALS WITH 

1566
01:00:45,375 --> 01:00:48,278
TYPE 1 DIABETES WHO EXPERIENCE 

1567
01:00:48,278 --> 01:00:53,250
HIGH RATE OF CKM AND SYNDROME 

1568
01:00:53,250 --> 01:00:54,451
COMORBIDITIES AND OFTEN HAVE 

1569
01:00:54,451 --> 01:00:56,253
BEEN EXCLUDED FROM TRIALS AND 

1570
01:00:56,253 --> 01:00:59,155
SIMILARLY IT IS IMPORTANT TO 

1571
01:00:59,155 --> 01:01:01,324
STUDY REAL WORLD CONDITIONS. 

1572
01:01:01,324 --> 01:01:05,161
BOTH WITHOUT UNDERLYING 

1573
01:01:05,161 --> 01:01:07,063
LIFESTYLE OPTIMIZATION.  AND IN 

1574
01:01:07,063 --> 01:01:10,033
PATIENTS FACING ADVERSE EVENTS 

1575
01:01:10,033 --> 01:01:12,135
INTOLLRABILITY COVERAGE BARRIERS

1576
01:01:12,135 --> 01:01:15,906
AND DRUG SHORTAGES ADDING TO 

1577
01:01:15,906 --> 01:01:17,741
PREVIOUS COMMENT ABOUT 

1578
01:01:17,741 --> 01:01:19,943
IMPORTANCE OF INTENTION TO TREAT

1579
01:01:19,943 --> 01:01:21,678
ANALYSIS AND TO ME BIGGEST 

1580
01:01:21,678 --> 01:01:24,548
BENEFIT OF ITT ANALYSIS IS BEING

1581
01:01:24,548 --> 01:01:26,383
ABLE TO TELL MY PATIENT WHAT IS 

1582
01:01:26,383 --> 01:01:28,418
LIKELY TO BE IMPACT OF THEM 

1583
01:01:28,418 --> 01:01:31,488
STARTING THIS MEDICATION IF THEY

1584
01:01:31,488 --> 01:01:34,858
TAKE IT THE SAME WAY THAT 

1585
01:01:34,858 --> 01:01:37,160
REALISTICALLY THEY LIKELY WILL 

1586
01:01:37,160 --> 01:01:39,095
BASED ON DATA FACING 

1587
01:01:39,095 --> 01:01:40,764
SIDE-EFFECTS AND COST CONSTRAINT

1588
01:01:40,764 --> 01:01:43,600
AND FACING DRUG SHORTAGES NOT 

1589
01:01:43,600 --> 01:01:45,635
IDEAL WORLD WITH NO 

1590
01:01:45,635 --> 01:01:47,704
INTOLLRABILITY AND DRUG IS FREE 

1591
01:01:47,704 --> 01:01:49,205
AND ALWAYS THERE WITH NO DELAY 

1592
01:01:49,205 --> 01:01:51,641
AND I DON'T HAVE TO SPEND HOURS 

1593
01:01:51,641 --> 01:01:56,680
EVERY WEEK WRITING IT OFF I 

1594
01:01:56,680 --> 01:01:58,014
THINK UNDERSTANDING WHAT IS 

1595
01:01:58,014 --> 01:01:59,649
LIKELY TO HAPPEN BASED ON REAL 

1596
01:01:59,649 --> 01:02:03,486
WORLD EXPERIENCE CAN BE VERY 

1597
01:02:03,486 --> 01:02:03,820
INFORMATIVE. 

1598
01:02:03,820 --> 01:02:06,656
SO SOME OF -- I WILL GO THROUGH 

1599
01:02:06,656 --> 01:02:10,160
THIS QUICKLY FOCUSING ON CKM AND

1600
01:02:10,160 --> 01:02:13,863
DR. LEWIS FOCUSED ON THIS A LOT 

1601
01:02:13,863 --> 01:02:17,601
ALREADY AND HOW DO WE ASSESS CKM

1602
01:02:17,601 --> 01:02:19,903
OUTCOMES IN REAL WORLD DATA AND 

1603
01:02:19,903 --> 01:02:23,873
FOCUSING ON ELECTRONIC HEALTH 

1604
01:02:23,873 --> 01:02:25,275
RECORDS AND CLAIMS AND 

1605
01:02:25,275 --> 01:02:26,776
REGISTRIES AND OFTEN THEY ARE 

1606
01:02:26,776 --> 01:02:31,615
MIX OF THE TWO TO SOME SXENLT 

1607
01:02:31,615 --> 01:02:34,084
LOOKING AT LABORATORY RESULTS, 

1608
01:02:34,084 --> 01:02:36,586
THOSE ARE LABS AND BIOMETRICS 

1609
01:02:36,586 --> 01:02:39,289
AND HEALTH CARE UTILIZATION 

1610
01:02:39,289 --> 01:02:41,958
EVENTS SUCH AS APPOINTMENTS AND 

1611
01:02:41,958 --> 01:02:43,793
EMERGENCY DEPARTMENT VISITS AND 

1612
01:02:43,793 --> 01:02:45,495
HOSPITALIZATIONS AND THOSE ARE 

1613
01:02:45,495 --> 01:02:48,331
GENERALLY AVAILABLE IN 

1614
01:02:48,331 --> 01:02:49,699
ELECTRONIC HEALTH RECORD IF 

1615
01:02:49,699 --> 01:02:51,334
PERFORMED IN INCLUDED HEALTH 

1616
01:02:51,334 --> 01:02:54,170
SYSTEM AND DEPENDING ON HEALTH 

1617
01:02:54,170 --> 01:02:56,406
SYSTEM WHOSE EHR YOU WANT TO USE

1618
01:02:56,406 --> 01:03:00,010
THAT MAY BE A BIG DEAL OR NOT 

1619
01:03:00,010 --> 01:03:01,745
DEPENDING ON HOW LEAKY THE 

1620
01:03:01,745 --> 01:03:03,146
HEALTH CARE SYSTEM IS.  FOR 

1621
01:03:03,146 --> 01:03:07,050
EXAMPLE I'M IN UNIVERSITY OF 

1622
01:03:07,050 --> 01:03:08,118
MARYLAND AND IN BALTIMORE 

1623
01:03:08,118 --> 01:03:11,655
LOCATION PATIENTS HAVE OPTION OF

1624
01:03:11,655 --> 01:03:12,756
HEALTH SYSTEMS AND PRIVATE 

1625
01:03:12,756 --> 01:03:15,792
PRACTICES TO GO TO FOR THEIR 

1626
01:03:15,792 --> 01:03:18,061
CARE.  THERE IS A LOT OF LEAKAGE

1627
01:03:18,061 --> 01:03:21,164
AND WE MIGHT NOT BE ABLE TO 

1628
01:03:21,164 --> 01:03:22,766
CAPTURE SUBSTANTIAL NUMBER OF 

1629
01:03:22,766 --> 01:03:23,967
THEM. 

1630
01:03:23,967 --> 01:03:26,236
OPPOSED TO NOT UNTIL TWO YEARS 

1631
01:03:26,236 --> 01:03:31,975
AGO I WAS AT MAYO CLINIC IN 

1632
01:03:31,975 --> 01:03:33,576
ROCHESTER MINNESOTA MAYO CLINIC 

1633
01:03:33,576 --> 01:03:35,712
WAS IT AND EXISTING FOR PATIENTS

1634
01:03:35,712 --> 01:03:38,381
IN THE CATCHMENT AREA OPPOSED TO

1635
01:03:38,381 --> 01:03:39,516
THOSE THAT CAME FOR DESTINATION 

1636
01:03:39,516 --> 01:03:40,850
CARE.  YOU HAVE TO ALWAYS THINK 

1637
01:03:40,850 --> 01:03:43,653
ABOUT WHAT IS YOUR POPULATION 

1638
01:03:43,653 --> 01:03:45,689
THAT YOU ARE TARGETING AND WHAT 

1639
01:03:45,689 --> 01:03:48,291
DOES YOUR EHR LOOK LIKE?  

1640
01:03:48,291 --> 01:03:51,061
CLAIMS DATA CAPTURED ALL 

1641
01:03:51,061 --> 01:03:52,629
REIMBURSABLE UTILIZATION. 

1642
01:03:52,629 --> 01:03:55,265
YOU WILL HAVE KIND OF ALL HEALTH

1643
01:03:55,265 --> 01:03:56,566
CARE UTILIZATION EVENTS AS LONG 

1644
01:03:56,566 --> 01:03:58,868
AS THEY ARE BILLED FOR BUT WON'T

1645
01:03:58,868 --> 01:04:01,137
HAVE LAB RESULTS OR BIOMETRICS 

1646
01:04:01,137 --> 01:04:03,707
UNLESS YOU ARE ABLE TO WORK IN A

1647
01:04:03,707 --> 01:04:06,109
SETTING WHERE YOU CAN LINK 

1648
01:04:06,109 --> 01:04:09,512
CLAIMS AND EHR. 

1649
01:04:09,512 --> 01:04:12,382
VERBAL METRIC MEASUREMENTS 

1650
01:04:12,382 --> 01:04:14,651
GENERALLY LIKE WASTE TO HIP 

1651
01:04:14,651 --> 01:04:16,953
CIRCUMFERENCE, ET CETERA, THOSE 

1652
01:04:16,953 --> 01:04:20,090
ARE RARELY AVAILABLE IF DONE IN 

1653
01:04:20,090 --> 01:04:21,858
PRACTICE AND THEY MAY BE 

1654
01:04:21,858 --> 01:04:24,127
DOCUMENTED IN ELECTRONIC HEALTH 

1655
01:04:24,127 --> 01:04:26,596
RECORD AS UNSTRUCTURED DATA AND 

1656
01:04:26,596 --> 01:04:30,800
USING NLPS OFTEN THAT ARE 

1657
01:04:30,800 --> 01:04:32,001
IMFEASIBLE AND IMPRACTICAL TO 

1658
01:04:32,001 --> 01:04:34,571
MANY RESEARCHERS AND DEFINITELY 

1659
01:04:34,571 --> 01:04:36,906
NOT AVAILABLE IN CLAIMS AND 

1660
01:04:36,906 --> 01:04:39,342
PATIENT REPORTED MEASURES ABOUT 

1661
01:04:39,342 --> 01:04:40,276
SIDE EFFECTS AND TOLLRABILITY 

1662
01:04:40,276 --> 01:04:42,412
AND RARELY AVAILABLE AS 

1663
01:04:42,412 --> 01:04:44,581
STRUCTURED DATA NOT AVAILABLE IN

1664
01:04:44,581 --> 01:04:46,049
HR AND CLAIM AND WHEN YOU THINK 

1665
01:04:46,049 --> 01:04:48,451
ABOUT EACH OF THESE AND NOT ONLY

1666
01:04:48,451 --> 01:04:50,754
DO WE THINK ABOUT WHAT IS 

1667
01:04:50,754 --> 01:04:52,822
FEASIBLE TO BE AVAILABLE BUT 

1668
01:04:52,822 --> 01:04:53,690
THINKING ABOUT CONSIDERATIONS 

1669
01:04:53,690 --> 01:04:58,128
AROUND WHAT TYPES OF ENCOUNTERS 

1670
01:04:58,128 --> 01:05:00,430
ARE COUNTED TO VISITS AND 

1671
01:05:00,430 --> 01:05:02,599
HOSPITALIZATIONS AND OUTPATIENT 

1672
01:05:02,599 --> 01:05:05,135
VISITS AND WHAT EXTENT DOES IT 

1673
01:05:05,135 --> 01:05:06,436
REPRESENT ACTIVE VERSUS 

1674
01:05:06,436 --> 01:05:09,139
HISTORICAL PROBLEMS AND DO WE 

1675
01:05:09,139 --> 01:05:11,674
LOOK AT ALL CLAIMS NO THE JUST 

1676
01:05:11,674 --> 01:05:13,276
THOSE FOR EVALUATION AND 

1677
01:05:13,276 --> 01:05:15,345
MANAGEMENT INCLUDING LABS; 

1678
01:05:15,345 --> 01:05:16,780
RIGHT?  

1679
01:05:16,780 --> 01:05:18,281
IMAGING LINKED DIAGNOSIS AND 

1680
01:05:18,281 --> 01:05:20,216
WHAT ARE IMPLICATIONS OF EACH OF

1681
01:05:20,216 --> 01:05:22,652
THE DECISIONS AND WHAT CODES AND

1682
01:05:22,652 --> 01:05:24,921
CODE POSITIONS ARE ACCEPTED TO 

1683
01:05:24,921 --> 01:05:26,623
ESTABLISH WHETHER OUTCOME OR 

1684
01:05:26,623 --> 01:05:29,325
COMORBIDITY AND HOW MUCH CODING 

1685
01:05:29,325 --> 01:05:31,828
VARIATION IS THERE BETWEEN 

1686
01:05:31,828 --> 01:05:34,330
CLINICIAN AND PRACTICES?  AND DO

1687
01:05:34,330 --> 01:05:35,865
WE NEED TO REQUIRE CONFIRMATION 

1688
01:05:35,865 --> 01:05:38,134
OF THAT TO KNOW THAT IT HAPPENED

1689
01:05:38,134 --> 01:05:41,371
OR IS THAT A SINGLE EXTENSIVE 

1690
01:05:41,371 --> 01:05:43,473
DIAGNOSIS THAT IS ENOUGH AND ALL

1691
01:05:43,473 --> 01:05:45,175
THESE ARE IMPORTANT 

1692
01:05:45,175 --> 01:05:48,411
CONSIDERATIONS WHEN WE THINK 

1693
01:05:48,411 --> 01:05:53,950
ABOUT CAPTURE IING CAPTURING CK 

1694
01:05:53,950 --> 01:05:55,919
AND BREAKING IT DOWN 

1695
01:05:55,919 --> 01:05:57,187
SPECIFICALLY WHAT IS THIS THAT 

1696
01:05:57,187 --> 01:05:59,055
WE MIGHT WANT TO MEASURE?  

1697
01:05:59,055 --> 01:06:02,692
OUTCOMES THAT ARE MEASURED IN 

1698
01:06:02,692 --> 01:06:03,760
CLINICAL TRIALS OF 

1699
01:06:03,760 --> 01:06:05,161
CARDIOVASCULAR OUTCOMES LOOKING 

1700
01:06:05,161 --> 01:06:12,068
AT HARD OUTCOMES OF MAJOR 

1701
01:06:12,068 --> 01:06:13,169
CARDIOVASCULAR EVENTS THAT 

1702
01:06:13,169 --> 01:06:16,005
INCLUDES STROKE VARIABILITY 

1703
01:06:16,005 --> 01:06:17,440
BETWEEN ISCHEMIC AND MEM ORAGIC 

1704
01:06:17,440 --> 01:06:20,810
AND THOSE CONSIDERED AND 

1705
01:06:20,810 --> 01:06:22,212
CARDIOVASCULAR MORTALITY AND CV 

1706
01:06:22,212 --> 01:06:24,080
OUTCOMES THAT I VIEW AS BEING 

1707
01:06:24,080 --> 01:06:26,049
IMPACTED BY PATIENTS 

1708
01:06:26,049 --> 01:06:28,651
SELF-MANAGEMENT AND CARE ACCESS 

1709
01:06:28,651 --> 01:06:31,321
LIKE ANJIENA TIA AND HEART 

1710
01:06:31,321 --> 01:06:32,822
FAILURE HOSPITALIZATIONS THAT 

1711
01:06:32,822 --> 01:06:36,492
ARE HARD OUTCOMES BUT IMPACT -- 

1712
01:06:36,492 --> 01:06:39,262
THERE IS SOME VARIABILITY INTO 

1713
01:06:39,262 --> 01:06:40,897
COMPLETENESS TO BE ABLE TO BE 

1714
01:06:40,897 --> 01:06:42,432
SEEN IN REAL WORLD DATA. 

1715
01:06:42,432 --> 01:06:45,068
AND THERE IS OUTCOMES THAT ARE 

1716
01:06:45,068 --> 01:06:47,837
IMPACTED BY LOCAL PRACTICES SUCH

1717
01:06:47,837 --> 01:06:50,807
AS LOEKING AT REVASCULARIZATION 

1718
01:06:50,807 --> 01:06:53,142
PROCEDURES AND TRIALS INCLUDE 

1719
01:06:53,142 --> 01:06:54,944
MECHANISTIC OUTCOMES SUCH AS 

1720
01:06:54,944 --> 01:06:57,213
FUNCTIONAL STUDIES AND MYOCARD 

1721
01:06:57,213 --> 01:07:00,116
YUM THAT IS TRULY MORE 

1722
01:07:00,116 --> 01:07:00,783
RESEARCH-BASED RATHER THAN 

1723
01:07:00,783 --> 01:07:02,752
PRACTICE AND HOW DO THEY 

1724
01:07:02,752 --> 01:07:05,288
TRANSLATE INTO THE ABILITY TO BE

1725
01:07:05,288 --> 01:07:08,291
IMPLEMENTED IN REAL-WORLD DATA? 

1726
01:07:08,291 --> 01:07:10,793
AGAIN, BREAKING THINGS DOWN BY 

1727
01:07:10,793 --> 01:07:12,295
EHR AND CLAIMS. 

1728
01:07:12,295 --> 01:07:14,297
SO THINGS LIKE ACUTE MI AND 

1729
01:07:14,297 --> 01:07:16,132
STROKE, THOSE DO GENERATE A 

1730
01:07:16,132 --> 01:07:17,800
UTILIZATION OF THAT. 

1731
01:07:17,800 --> 01:07:20,603
WE CAN CAPTURE THAT PREVIOUS 

1732
01:07:20,603 --> 01:07:22,906
CAVEATS ABOUT LEAKINESS OF 

1733
01:07:22,906 --> 01:07:27,377
HEALTH SYSTEMS ASIDE. 

1734
01:07:27,377 --> 01:07:28,912
CARDIOVASCULAR DEATH IS MORE 

1735
01:07:28,912 --> 01:07:31,347
CHALLENGING REQUIRING LINKAGE TO

1736
01:07:31,347 --> 01:07:33,850
DEATH DATA AND ALSO TO CAUSES OF

1737
01:07:33,850 --> 01:07:34,217
DEATH. 

1738
01:07:34,217 --> 01:07:36,786
SO NOT ALL ELECTRONIC HEALTH 

1739
01:07:36,786 --> 01:07:42,392
RECORDS THAT HAVE A LINKAGE TO 

1740
01:07:42,392 --> 01:07:44,894
DEATH DATA OR CERTIFICATES THAT 

1741
01:07:44,894 --> 01:07:47,297
IS HIGHLY VARIABLE AND MANY 

1742
01:07:47,297 --> 01:07:51,000
CLAIMS WILL PARTIALLY CAPTURE 

1743
01:07:51,000 --> 01:07:53,036
DEATH BUT NOT ALL PARTICULARLY 

1744
01:07:53,036 --> 01:07:55,405
FOR COMMERCIAL CLAIMS. 

1745
01:07:55,405 --> 01:07:57,173
AND IN CAUSE OF DEATH DATA THAT 

1746
01:07:57,173 --> 01:08:00,510
IS GENERALLY NOT AVAILABLE. 

1747
01:08:00,510 --> 01:08:05,548
THINGS LIKE ANGINA AND TIA AND 

1748
01:08:05,548 --> 01:08:07,617
VARIABLE AND INCONSISTENCIES 

1749
01:08:07,617 --> 01:08:09,152
CODED AND DOCUMENTED 

1750
01:08:09,152 --> 01:08:10,820
PARTICULARLY AND ANOTHER EVENT 

1751
01:08:10,820 --> 01:08:16,559
THAT LED TO ANGINA TIA AND 

1752
01:08:16,559 --> 01:08:17,827
DEPENDING ON WHAT DEFINITIONS 

1753
01:08:17,827 --> 01:08:21,130
YOU REQUIRE OR CODES OR POSITION

1754
01:08:21,130 --> 01:08:23,399
ON THE CLAIM WHETHER YOU REQUIRE

1755
01:08:23,399 --> 01:08:25,101
PERINEAR DIAGNOSIS OR NOT YOU 

1756
01:08:25,101 --> 01:08:29,038
MAY OR MAY NOT SEE IT AND 

1757
01:08:29,038 --> 01:08:30,506
REVASCULARIZATION PROCEDURES ARE

1758
01:08:30,506 --> 01:08:32,375
GENERALLY CAPTURED AND 

1759
01:08:32,375 --> 01:08:34,143
CARDIOVASCULAR FUNCTIONAL 

1760
01:08:34,143 --> 01:08:36,212
STUDIES ARE OFTEN NOT PART OF 

1761
01:08:36,212 --> 01:08:39,415
ROUTINE CARE AND IF ARE IN 

1762
01:08:39,415 --> 01:08:41,117
FREETAX OF ECHO REPORT FOR 

1763
01:08:41,117 --> 01:08:43,186
EXAMPLE OR NOT AND AVAILABLE ON 

1764
01:08:43,186 --> 01:08:44,654
A LARGE SCALE. 

1765
01:08:44,654 --> 01:08:47,490
SO HERE IS AN EXAMPLE USING REAL

1766
01:08:47,490 --> 01:08:50,860
WORLD DATA TO STUDY 

1767
01:08:50,860 --> 01:08:51,527
CARDIOVASCULAR OUTCOMES AND HERE

1768
01:08:51,527 --> 01:08:57,166
WE USE LABS THAT IS A DATA BASE 

1769
01:08:57,166 --> 01:09:00,069
ADVANTAGE BENEFICIARIES, SORRY 

1770
01:09:00,069 --> 01:09:01,738
LINKED TO MEDICARE 

1771
01:09:01,738 --> 01:09:03,106
FEE-FOR-SERVICE CLAIMS AND 

1772
01:09:03,106 --> 01:09:05,141
LOOKING AT CARDIOVASCULAR 

1773
01:09:05,141 --> 01:09:07,910
OUTCOMES SHOWING GLP-1 BASED 

1774
01:09:07,910 --> 01:09:11,280
COMPARISONS WE LOOKED AT FOR 

1775
01:09:11,280 --> 01:09:13,149
CLASSES OF DRUGS IN PAIRWISE 

1776
01:09:13,149 --> 01:09:15,718
COMPARISONS AND LOOKED AT MAJOR 

1777
01:09:15,718 --> 01:09:18,554
CARDIOVASCULAR EVENTS DEFINED AS

1778
01:09:18,554 --> 01:09:20,656
MR STROKE AND MORTALITY AND 

1779
01:09:20,656 --> 01:09:23,526
HEART FAILURE HOSPITALIZATIONS 

1780
01:09:23,526 --> 01:09:26,295
AND REVASCULARIZATION EVENTS. 

1781
01:09:26,295 --> 01:09:32,001
WE WR ABLE TO SHOW THAT AS GLT2S

1782
01:09:32,001 --> 01:09:33,703
AND GLP-1S ARE COMPARABLE TO 

1783
01:09:33,703 --> 01:09:35,872
EACH OTHER WITH EXCEPTION OF 

1784
01:09:35,872 --> 01:09:37,140
HEART FAILURE HOSPITALIZATIONS 

1785
01:09:37,140 --> 01:09:40,376
AND THEY ARE SUPERIOR TO GLP-1S 

1786
01:09:40,376 --> 01:09:45,348
NO SURPRISE THEY ARE GLP-1S THAT

1787
01:09:45,348 --> 01:09:51,120
GENERALLY ARE SUPERIOR TO DGGP 

1788
01:09:51,120 --> 01:09:53,956
-- AND PROFOUND INFERIOR TO 

1789
01:09:53,956 --> 01:09:56,826
GLP-1S AS WELL AS ULTIMATELY ALL

1790
01:09:56,826 --> 01:09:59,228
OTHER CLASSES AS WELL. 

1791
01:09:59,228 --> 01:10:00,730
AND WE CAN MAP IT OUT HERE.  

1792
01:10:00,730 --> 01:10:04,534
REASON I SHOW THIS IS TO 

1793
01:10:04,534 --> 01:10:06,502
UNDERSCORE POWER OF REAL WORLD 

1794
01:10:06,502 --> 01:10:08,471
DATA LOOKING AT NUMBER OF 

1795
01:10:08,471 --> 01:10:12,308
PATIENTS AT RISK FOR THESE 

1796
01:10:12,308 --> 01:10:15,878
EVENTS AND THIS WAS IRN VERSE 

1797
01:10:15,878 --> 01:10:19,615
PROBABILITY OF TREATMENT RATED 

1798
01:10:19,615 --> 01:10:22,585
COHORT AND YOU CAN SEE THESE ARE

1799
01:10:22,585 --> 01:10:24,320
INDIVIDUALS WITH MODERATE RISK 

1800
01:10:24,320 --> 01:10:26,189
OF CARDIOVASCULAR DISEASE AND 

1801
01:10:26,189 --> 01:10:27,657
PEOPLE THAT HAVE NOT BEEN PART 

1802
01:10:27,657 --> 01:10:29,759
OF CARDIOVASCULAR OUTCOMES 

1803
01:10:29,759 --> 01:10:32,562
TRIALS AND HAD OVER 200,000 

1804
01:10:32,562 --> 01:10:35,431
INDIVIDUALS WITH URIAS AND 

1805
01:10:35,431 --> 01:10:40,736
46,000 WITH SGLT2S AND 41,000 

1806
01:10:40,736 --> 01:10:46,075
WITH GLP-1S AND 82,000 WITH 

1807
01:10:46,075 --> 01:10:47,643
GLP4S AND THIS THERAPY AND DROP 

1808
01:10:47,643 --> 01:10:49,145
OFF ALSO OUT OF HEALTH COVERAGE 

1809
01:10:49,145 --> 01:10:50,847
YOU CAN SEE WE HAVE A LARGE 

1810
01:10:50,847 --> 01:10:53,149
NUMBER OF PEOPLE CONTINUING TO 

1811
01:10:53,149 --> 01:10:54,584
HAVE ENROLLMENT AND REALLY 

1812
01:10:54,584 --> 01:10:56,953
THROUGH 84 MONTHS OF OBSERVATION

1813
01:10:56,953 --> 01:11:01,157
PROVIDING POWER TO ASSESS FOR 

1814
01:11:01,157 --> 01:11:02,592
HETEROGENOUS EFFECT AND 

1815
01:11:02,592 --> 01:11:05,661
ANALYSIS, ET CETERA THAT ARE NOT

1816
01:11:05,661 --> 01:11:06,596
GENERALLY POSSIBLE IN CLINICAL 

1817
01:11:06,596 --> 01:11:10,233
TRIALS AND MOVING ON TO K, 

1818
01:11:10,233 --> 01:11:12,068
CLINICAL TRIALS GENERALLY LOOK 

1819
01:11:12,068 --> 01:11:18,875
AT MAJOR ADVERSE KIDNEY EVENTS 

1820
01:11:18,875 --> 01:11:21,777
THAT ARE DEFINED REQUIRING 

1821
01:11:21,777 --> 01:11:23,079
REPLACEMENT THERAPY AND IS 

1822
01:11:23,079 --> 01:11:25,515
VARIATION BETWEEN TRIALS AS TO 

1823
01:11:25,515 --> 01:11:30,086
WHETHER THEY TALK ABOUT DIALYSIS

1824
01:11:30,086 --> 01:11:33,156
INITIATION AND ONE-TIME EPISODE 

1825
01:11:33,156 --> 01:11:36,125
AND CHRONIC DIAGNOSIS AND 

1826
01:11:36,125 --> 01:11:38,494
DEFINING KIDNEY FAILURE OPPOSED 

1827
01:11:38,494 --> 01:11:40,329
TO ACUTE KIDNEY INJURY AND 

1828
01:11:40,329 --> 01:11:42,498
PARALLEL TO MACE LOOKING AT 

1829
01:11:42,498 --> 01:11:44,834
RENAL DEATH AND TRIALS ALSO LOOK

1830
01:11:44,834 --> 01:11:47,570
AT SURROGATE OUTCOMES OF 

1831
01:11:47,570 --> 01:11:53,176
INCIDENT OF PROGRESSIVE ALBUMIN 

1832
01:11:53,176 --> 01:11:56,979
URIA AND LONG RATE OF DECLINE IN

1833
01:11:56,979 --> 01:11:57,180
GFR. 

1834
01:11:57,180 --> 01:11:59,849
SO THINKING ABOUT HOW CAN WE 

1835
01:11:59,849 --> 01:12:01,817
OPERATIONALIZE THESE TYPES OF 

1836
01:12:01,817 --> 01:12:09,992
OUTCOMES AND REAL WORLD DA DATA 

1837
01:12:09,992 --> 01:12:11,661
KIDNEY FAILURE WE HAVE TO THINK 

1838
01:12:11,661 --> 01:12:13,896
OF IMMORTAL TIME BIAS TO 

1839
01:12:13,896 --> 01:12:15,898
ESTABLISH KIDNEY FAILURE AND 

1840
01:12:15,898 --> 01:12:17,133
[INDISCERNIBLE] WHEN IT IS FIRST

1841
01:12:17,133 --> 01:12:18,301
DOCUMENTED AND HOW YOU KNOW 

1842
01:12:18,301 --> 01:12:20,536
WHETHER IT IS TRULY KIDNEY 

1843
01:12:20,536 --> 01:12:22,905
FAILURE OR SINGLE EPISODE 

1844
01:12:22,905 --> 01:12:24,807
WITHOUT REQUIRING THEY SURVIVE 

1845
01:12:24,807 --> 01:12:28,811
LONG ENOUGH AFTER FIRST DIALYSIS

1846
01:12:28,811 --> 01:12:31,113
ENSURE OUTCOME AND DIFFERENT 

1847
01:12:31,113 --> 01:12:33,216
APPLICATION OF TIME BIAS AND 

1848
01:12:33,216 --> 01:12:36,018
OUTCOME AND EXPOSURE BUT IS 

1849
01:12:36,018 --> 01:12:38,221
SIMILAR DEAL AND KIDNEY DEPTH 

1850
01:12:38,221 --> 01:12:40,489
AGAIN REQUIRES LINKAGE TO 

1851
01:12:40,489 --> 01:12:43,926
MORTALITY DATA AS WELL AS CAUSE 

1852
01:12:43,926 --> 01:12:47,797
OF DEATH. 

1853
01:12:47,797 --> 01:12:50,132
ALBUMINURIA, I FLIPPED MY COST 

1854
01:12:50,132 --> 01:12:51,901
ANALYSIS, SORRY IT IS AVAILABLE 

1855
01:12:51,901 --> 01:12:54,870
IN E HR AND NOT IN CLAIMS AND IS

1856
01:12:54,870 --> 01:12:58,174
CONTINGENT TO BEING MEASURED.  

1857
01:12:58,174 --> 01:13:00,276
INCIDENT DISEASE, AS MEASURED BY

1858
01:13:00,276 --> 01:13:03,412
GFR WOULD BE AVAILABLE IN E HR 

1859
01:13:03,412 --> 01:13:05,948
AND NOT -- AND OFTEN NOT IN 

1860
01:13:05,948 --> 01:13:08,050
CLAIMS UNLESS, YOU KNOW, WE ARE 

1861
01:13:08,050 --> 01:13:10,052
GOOD ABOUT RELYING ON A 

1862
01:13:10,052 --> 01:13:12,421
DIAGNOSIS CODES AND WHEN 

1863
01:13:12,421 --> 01:13:15,091
PATIENTS DEVELOP STAGE 3 OR 

1864
01:13:15,091 --> 01:13:19,295
HIGHER CKD WE SEE DIEINGOSIS 

1865
01:13:19,295 --> 01:13:21,364
KOEZED THAT ARE GENERALLY NOT 

1866
01:13:21,364 --> 01:13:24,600
DOCUMENTED AT ALL AND DECLINE IN

1867
01:13:24,600 --> 01:13:25,067
GFR. 

1868
01:13:25,067 --> 01:13:27,937
YES.  CONTINGENT ON THINGS BEING

1869
01:13:27,937 --> 01:13:29,739
MEASURED IN CLINICAL PRACTICE 

1870
01:13:29,739 --> 01:13:30,973
AND SORRY ABOUT THIS MISTAKE AND

1871
01:13:30,973 --> 01:13:34,043
HOW DID WE MEASURE IT?  SIMILAR 

1872
01:13:34,043 --> 01:13:36,612
ANALYSIS OF PATIENTS MODERATE 

1873
01:13:36,612 --> 01:13:39,849
RISK FOR CARDIOVASCULAR DISEASE 

1874
01:13:39,849 --> 01:13:41,417
NOT HAVING EVIDENCE OF STAGE 3 

1875
01:13:41,417 --> 01:13:44,487
OR HIGHER DISEASE AS BASELINE AS

1876
01:13:44,487 --> 01:13:47,223
DOCUMENTED USING DIAGNOSIS CODES

1877
01:13:47,223 --> 01:13:49,792
AND WE COMPARIN KRIDIENTS STAGE 

1878
01:13:49,792 --> 01:13:54,063
3 OR HIGHER CKD AND DEFINED BY 

1879
01:13:54,063 --> 01:13:55,431
DIAGNOSIS CODES AND KIDNEY 

1880
01:13:55,431 --> 01:14:00,002
FAILURE THAT WE DEFINED AS FIRST

1881
01:14:00,002 --> 01:14:03,172
DIALYSIS OR KIDNEY TRANSPLANT.  

1882
01:14:03,172 --> 01:14:06,575
OR, YEAH.  PROGRESSION TO KIDNEY

1883
01:14:06,575 --> 01:14:08,978
REPLACEMENT THERAPIES USING 

1884
01:14:08,978 --> 01:14:11,113
DIAGNOSIS CODES AND KIDNEY 

1885
01:14:11,113 --> 01:14:12,448
REPLACEMENT THERAPY TO DEFINE 

1886
01:14:12,448 --> 01:14:14,383
THIS AND ANOTHER OUTCOME WE 

1887
01:14:14,383 --> 01:14:15,785
LOOKED AT ALL CAUSE MORTALITY 

1888
01:14:15,785 --> 01:14:18,754
AND CAUSE OF DEATH IS NOT 

1889
01:14:18,754 --> 01:14:19,689
AVAILABLE. 

1890
01:14:19,689 --> 01:14:24,694
AND IN THIS STUDY, WE FOUND 

1891
01:14:24,694 --> 01:14:27,563
THAT, AGAIN, GLP-1S ARE SUPERIOR

1892
01:14:27,563 --> 01:14:33,202
TO DPP4S AND TO CELL PHONOURIAS 

1893
01:14:33,202 --> 01:14:39,041
AND SLP2S ARE SUPERIOR TO GLP-1S

1894
01:14:39,041 --> 01:14:43,045
FOR KIND OF OUTCOMES THAT EXCEPT

1895
01:14:43,045 --> 01:14:44,347
FOR THE INDIVIDUAL WHERE WE 

1896
01:14:44,347 --> 01:14:46,882
REALLY HAVE A WIDE CONFERENCE 

1897
01:14:46,882 --> 01:14:48,517
INTERVAL BECAUSE OF LOW NUMBER 

1898
01:14:48,517 --> 01:14:50,853
OF EVENTS AND AGAIN RELYING ON 

1899
01:14:50,853 --> 01:14:52,722
CLAIMS DATA ONLY WITHOUT LINKAGE

1900
01:14:52,722 --> 01:14:56,325
TO EHR LIMITS ABILITY TO EXAMINE

1901
01:14:56,325 --> 01:14:58,494
MANY, YOU KNOW, EARLIER STAGE 

1902
01:14:58,494 --> 01:15:00,496
OUTCOMES THAT ARE IMPORTANT FOR 

1903
01:15:00,496 --> 01:15:02,598
STUDYING KIDNEY DISEASE 

1904
01:15:02,598 --> 01:15:04,066
PROGRESSION. 

1905
01:15:04,066 --> 01:15:06,369
>> CAN YOU GO BACK -- YOU
HAVE 

1906
01:15:06,369 --> 01:15:06,902
TWO MINUTES LEFT. 

1907
01:15:06,902 --> 01:15:09,138
>> I'M GETTING THERE. 

1908
01:15:09,138 --> 01:15:11,774
FINALLY, FOR M, WHAT DO WE 

1909
01:15:11,774 --> 01:15:12,575
MEASURE?  

1910
01:15:12,575 --> 01:15:15,878
WE HAVE GLYCEMIC OUTCOMES AND 

1911
01:15:15,878 --> 01:15:17,146
WEIGHT OUTCOMES AS WELL AS 

1912
01:15:17,146 --> 01:15:18,447
[INDISCERNIBLE] OUTCOMES WITH 

1913
01:15:18,447 --> 01:15:21,717
KIND OF EMERGING AS ESSENTIAL 

1914
01:15:21,717 --> 01:15:23,552
COMPLICATION OF DIABETES 

1915
01:15:23,552 --> 01:15:26,655
MANAGEMENT AND RISK FACTOR FOR 

1916
01:15:26,655 --> 01:15:27,723
CARDIOVASCULAR DISEASE. 

1917
01:15:27,723 --> 01:15:30,593
THESE ARE MUCH HARDER TO FIND 

1918
01:15:30,593 --> 01:15:31,627
AND ELECTRONIC HEALTH RECORD 

1919
01:15:31,627 --> 01:15:35,064
WILL GENERALLY MAKE AVAILABLE 

1920
01:15:35,064 --> 01:15:36,932
A1C AND FASTING GLUCOSE AND 

1921
01:15:36,932 --> 01:15:40,436
WEIGHT AS WELL AS DIAGNOSIS OF 

1922
01:15:40,436 --> 01:15:42,605
LIVER FAILURE AND CIRRHOSIS AND 

1923
01:15:42,605 --> 01:15:45,241
WHAT IS HARDER TO FIND IS CGM 

1924
01:15:45,241 --> 01:15:46,375
MEASURES THAT ARE OFTEN THOSE 

1925
01:15:46,375 --> 01:15:50,112
ARE NOT AVAILABLE AS ANALYZABLE 

1926
01:15:50,112 --> 01:15:52,448
DATA IN E HR BECAUSE THEY ARE 

1927
01:15:52,448 --> 01:15:54,884
KEPT IN EITHER AS A SCANNED IN 

1928
01:15:54,884 --> 01:16:00,823
PDF OR UPLOADED PDF OR LIVE IN 

1929
01:16:00,823 --> 01:16:03,893
REVIEW OR CLARITY PORTALS AND 

1930
01:16:03,893 --> 01:16:05,061
BODY MEASUREMENTS AND 

1931
01:16:05,061 --> 01:16:08,130
COMPOSITIONS ARE GENERALLY NOT 

1932
01:16:08,130 --> 01:16:08,431
AVAILABLE. 

1933
01:16:08,431 --> 01:16:12,034
CLAIMS, THEY REALLY CAN ONLY BE 

1934
01:16:12,034 --> 01:16:15,604
USED FOR DIAGNOSIS AND HEART 

1935
01:16:15,604 --> 01:16:17,540
OUTCOMES AND AVAILABLE FOR LIVER

1936
01:16:17,540 --> 01:16:21,010
FAILURE AND CIRRHOSIS AND A SHOW

1937
01:16:21,010 --> 01:16:25,147
WE DID TRY TO IN LABS IS LINKED 

1938
01:16:25,147 --> 01:16:28,884
TO AMBLATTORY LAB RESULTS DATA 

1939
01:16:28,884 --> 01:16:32,922
AND WE ARE -- OUR TEAM WANTED TO

1940
01:16:32,922 --> 01:16:34,890
EMULATE THE GRADE TRIAL 

1941
01:16:34,890 --> 01:16:36,425
PRAGMATIC COMPARED TO 

1942
01:16:36,425 --> 01:16:39,695
EFFECTIVENESS TRIAL LOOKING AT 

1943
01:16:39,695 --> 01:16:41,297
A1C-BASED OUTCOMES EMULATING IT 

1944
01:16:41,297 --> 01:16:44,333
PRIOR TO GRADES PUBLICATION AS A

1945
01:16:44,333 --> 01:16:46,001
FEASIBILITY PROJECT TO SEE IF IT

1946
01:16:46,001 --> 01:16:47,603
IS POSSIBLE AND HERE WE COMPARED

1947
01:16:47,603 --> 01:16:49,472
GRADES RESULTS TO WHAT WE DID 

1948
01:16:49,472 --> 01:16:54,577
AND HIGHLIGHTED GLP1-BASED 

1949
01:16:54,577 --> 01:16:55,945
COMPARI

1950
01:16:55,945 --> 01:16:56,312
COMPARISONS. 

1951
01:16:56,312 --> 01:16:58,914
YOU CAN SEE WE GOT SAME RESULTS 

1952
01:16:58,914 --> 01:17:02,418
ON SAME DIRECTION AND SAME LEVEL

1953
01:17:02,418 --> 01:17:05,154
OF SIGNIFICANCE AND FOR ONE OF 

1954
01:17:05,154 --> 01:17:08,791
THE COMPARISONS AND OVERLAPPING 

1955
01:17:08,791 --> 01:17:11,060
CONFERENCE INTERVALS EMULATION 

1956
01:17:11,060 --> 01:17:14,630
COMPARED TO GRADE TRIALS AND ONE

1957
01:17:14,630 --> 01:17:16,565
YOU HAVE LINKED LAB MEASURES, 

1958
01:17:16,565 --> 01:17:20,169
THOSE ARE USABLE AS WELL AND 

1959
01:17:20,169 --> 01:17:21,137
VISUALLY THINGS LOOK THE SAME 

1960
01:17:21,137 --> 01:17:23,038
AND BRIEFLY TO END YOU KNOW CAN 

1961
01:17:23,038 --> 01:17:23,939
WE DO THIS?  

1962
01:17:23,939 --> 01:17:26,575
CAN WE KEEP DOING IT FOR OUR 

1963
01:17:26,575 --> 01:17:27,176
TRIALS?  

1964
01:17:27,176 --> 01:17:31,280
I LOOKED THROUGH CLINICAL 

1965
01:17:31,280 --> 01:17:33,115
TRIALS.GOV TO SEE WHAT ONGOING 

1966
01:17:33,115 --> 01:17:35,251
PHASE III OR HIGHER 

1967
01:17:35,251 --> 01:17:37,353
INTERVENTIONAL TRIALS WITH CK 

1968
01:17:37,353 --> 01:17:40,389
OUTCOMES AND OUT OF 32 ACTIVE 

1969
01:17:40,389 --> 01:17:42,658
TRIALS GLP-1S AND 5 OR NOT FOR 

1970
01:17:42,658 --> 01:17:46,462
CKM AND YOU CAN SEE HERE WE CAN 

1971
01:17:46,462 --> 01:17:48,597
IDENTIFY COHORT AND WE CAN 

1972
01:17:48,597 --> 01:17:49,932
EMULATE COHORT FOR MOST OF THESE

1973
01:17:49,932 --> 01:17:51,233
AND WITH THE EXCEPTION THAT WE 

1974
01:17:51,233 --> 01:17:53,702
HAVE TO MAKE SURE TO CLASSIFY 

1975
01:17:53,702 --> 01:17:56,038
TYPE 1 DIABETES CORRECTLY AND 

1976
01:17:56,038 --> 01:17:59,375
PRIMARY OUTCOMES CAN BE ASSESSED

1977
01:17:59,375 --> 01:18:01,143
IN THE HALF AND SECONDARY 

1978
01:18:01,143 --> 01:18:03,512
OUTCOMES GENERALLY CANNOT BE 

1979
01:18:03,512 --> 01:18:05,147
ASSESSED WITH MOST SECONDARY 

1980
01:18:05,147 --> 01:18:09,151
OUTCOMES LOOKING AT REALLY 

1981
01:18:09,151 --> 01:18:12,254
RESEARCH-TYPE OUTCOMES LIKE BODY

1982
01:18:12,254 --> 01:18:14,089
COMPOSITION AND [INDISCERNIBLE] 

1983
01:18:14,089 --> 01:18:16,258
MEASUREMENTS OR MECHANISTIC 

1984
01:18:16,258 --> 01:18:18,627
ENDPOINTS AND THERE IS TRULY A 

1985
01:18:18,627 --> 01:18:19,828
COMPLEMENTARY ROLE FOR ALL OF 

1986
01:18:19,828 --> 01:18:22,565
THE TRIALS. 

1987
01:18:22,565 --> 01:18:24,567
SO THE COMPLEXITY OF ASSESSING 

1988
01:18:24,567 --> 01:18:26,468
CAUSALITY FOR KKE OUTCOMES AND 

1989
01:18:26,468 --> 01:18:28,204
FROM LOTS OF FACTORS DISCUSSED 

1990
01:18:28,204 --> 01:18:30,139
PREVIOUSLY AND THERE IS A LOT OF

1991
01:18:30,139 --> 01:18:35,077
SELECTION BIAS AS DR. LEWIS 

1992
01:18:35,077 --> 01:18:37,146
DISCUSSED EARLIER THEY ARE 

1993
01:18:37,146 --> 01:18:39,915
PREFERENTIALLY COVERED BY THOSE 

1994
01:18:39,915 --> 01:18:41,150
WITH OR ESTABLISHED 

1995
01:18:41,150 --> 01:18:42,451
COMPLICATIONS AND THOSE THAT 

1996
01:18:42,451 --> 01:18:43,485
DESIRE TO LOSE WEIGHT AND THOSE 

1997
01:18:43,485 --> 01:18:45,621
WITH GREATER ACCESS TO HEALTH 

1998
01:18:45,621 --> 01:18:49,124
CARE RESOURTSS AND FUNDS AND 

1999
01:18:49,124 --> 01:18:50,626
IMPORTANTLY PURSUIT OF THERAPY 

2000
01:18:50,626 --> 01:18:53,062
RESULTS IN OVERDOCUMENTATION OF 

2001
01:18:53,062 --> 01:18:54,597
APPROVED INDICATIONS. 

2002
01:18:54,597 --> 01:18:57,833
THERE IS HETEROGENOUS TREATMENT 

2003
01:18:57,833 --> 01:19:00,502
EFFECTS BY BASELINE RISK THAT IS

2004
01:19:00,502 --> 01:19:02,237
DIFFICULT AND RISK IS DIFFICULT 

2005
01:19:02,237 --> 01:19:04,139
TO ASSESS PARTICULARLY USING 

2006
01:19:04,139 --> 01:19:04,440
CLAIMS. 

2007
01:19:04,440 --> 01:19:06,542
THERE IS MEDIATION BY MULTIPLE 

2008
01:19:06,542 --> 01:19:09,545
INTERRELATED OUTCOMES THAT ARE 

2009
01:19:09,545 --> 01:19:12,281
TIME BEARING CO-VARIATES 

2010
01:19:12,281 --> 01:19:14,783
PARTICULARLY WEIGHT LOSS AND 

2011
01:19:14,783 --> 01:19:15,751
GLIESEMIA. 

2012
01:19:15,751 --> 01:19:17,152
SO THERE IS ALSO SPECIAL 

2013
01:19:17,152 --> 01:19:20,222
CIRCUMSTANCES IN POPULATIONS 

2014
01:19:20,222 --> 01:19:21,890
WHERE I THINK THEY ARE REALLY 

2015
01:19:21,890 --> 01:19:24,393
IMPORTANT TO ASSESS THAT ARE 

2016
01:19:24,393 --> 01:19:26,629
CHALLENGING METHODOLOGICALLY AND

2017
01:19:26,629 --> 01:19:28,097
LOOKING AT COMBINATION THERAPY 

2018
01:19:28,097 --> 01:19:30,633
AND DISTILLING EFFECTS OF GLP-1S

2019
01:19:30,633 --> 01:19:33,936
AND SGLT2S LOOKING AT COMPOUNDED

2020
01:19:33,936 --> 01:19:36,305
DRUGS NOT ONLY BECAUSE WE CAN'T 

2021
01:19:36,305 --> 01:19:37,139
CAPTURE THEM AND BECAUSE WE 

2022
01:19:37,139 --> 01:19:38,974
DON'T KNOW WHAT IS IN THE 

2023
01:19:38,974 --> 01:19:40,142
COMPOUNDED PRODUCT THAT MIGHT 

2024
01:19:40,142 --> 01:19:42,611
NOT BE A GLP-1. 

2025
01:19:42,611 --> 01:19:44,880
AND/OR WE DON'T KNOW THE DOSE 

2026
01:19:44,880 --> 01:19:47,616
AND LOOKING AT COMORBID TYPE 1 

2027
01:19:47,616 --> 01:19:49,718
AND TYPE 2 DIABETES TOGETHER 

2028
01:19:49,718 --> 01:19:51,186
KNOWING WITH WHO HAS THAT AND 

2029
01:19:51,186 --> 01:19:53,088
WHO DOESN'T.  

2030
01:19:53,088 --> 01:19:54,923
SO I WILL END WITH KIND OF MY 

2031
01:19:54,923 --> 01:19:56,792
DREAM WORLD OF WHAT I THINK WILL

2032
01:19:56,792 --> 01:19:59,795
MAKE IT POSSIBLE FOR US TO STUDY

2033
01:19:59,795 --> 01:20:03,332
CK OUTCOMES EFFECTIVELY WHEN IT 

2034
01:20:03,332 --> 01:20:06,669
COMES TO GLP-1 THERAPIES AND 

2035
01:20:06,669 --> 01:20:09,004
HAVE STANDARDIZEDONTOLOGY AND 

2036
01:20:09,004 --> 01:20:10,973
CLAIMS TO HELP US KNOW AND 

2037
01:20:10,973 --> 01:20:13,242
REALLY COMPARE APPLES TO APPLES 

2038
01:20:13,242 --> 01:20:15,811
WHEN WE ASSESS STUDIES AND NEED 

2039
01:20:15,811 --> 01:20:18,213
STANDARD DEFINITIONS FOR 

2040
01:20:18,213 --> 01:20:19,348
CARDIOVASCULAR DISEASE RISK 

2041
01:20:19,348 --> 01:20:21,083
ASSESSMENT USING CLAIMS AND EHR 

2042
01:20:21,083 --> 01:20:23,085
DATA AND AMAZING TO HAVE LINKAGE

2043
01:20:23,085 --> 01:20:25,154
TO MORTALITY AND CAUSES OF DEATH

2044
01:20:25,154 --> 01:20:28,090
AND GREATER ACCESS TO AND USE OF

2045
01:20:28,090 --> 01:20:29,958
UNSTRUCTURED DATA HEARING ABOUT 

2046
01:20:29,958 --> 01:20:31,160
BOTH YESTERDAY AND TODAY. 

2047
01:20:31,160 --> 01:20:33,128
AND I'M HOPING WE CAN REALLY 

2048
01:20:33,128 --> 01:20:36,665
WORK TOWARDS GREATER INVESTMENT 

2049
01:20:36,665 --> 01:20:40,035
IN ALL PAIR CLAIMS DATABASES AND

2050
01:20:40,035 --> 01:20:42,404
HEALTH EXCHANGES TO FOLLOW 

2051
01:20:42,404 --> 01:20:44,206
PEOPLE NO MATTER WHERE THEY SEEK

2052
01:20:44,206 --> 01:20:47,343
CARE AND INVEST IN CLAIMS AND 

2053
01:20:47,343 --> 01:20:48,177
EHR LINKAGES TOGETHER TO SEE 

2054
01:20:48,177 --> 01:20:50,579
BOTH SIDES OF THE PUZZLE AND HOW

2055
01:20:50,579 --> 01:20:52,114
EVERYTHING FITS TOGETHER. 

2056
01:20:52,114 --> 01:20:55,718
SO SOME DAY I HOPE THAT THIS 

2057
01:20:55,718 --> 01:20:57,786
DREAM WORLD WILL ENSURE TOWARDS 

2058
01:20:57,786 --> 01:21:01,123
REALITY AND TURNING IT TO 

2059
01:21:01,123 --> 01:21:04,026
COLLEAGUES TO TALK ABOUT OTHER 

2060
01:21:04,026 --> 01:21:08,597
CKM EXTENDED OUTCOMES AND THEIR 

2061
01:21:08,597 --> 01:21:16,405
WORK THERE.  

2062
01:21:16,405 --> 01:21:18,006
>> THANK YOU SO MUCH FOR 

2063
01:21:18,006 --> 01:21:20,008
TERRIFIC OVERVIEW OF REALLY 

2064
01:21:20,008 --> 01:21:21,643
IMPORTANT RESEARCH AREA AND 

2065
01:21:21,643 --> 01:21:24,747
SHIFTING TO DIFFERENT SET OF 

2066
01:21:24,747 --> 01:21:25,013
OUTCOMES. 

2067
01:21:25,013 --> 01:21:26,715
ESTE WILL JOIN US CLINICAL 

2068
01:21:26,715 --> 01:21:28,717
PSYCHOLOGIST AND INVESTIGATOR 

2069
01:21:28,717 --> 01:21:31,954
WITH KAISER PERMANENTE NORTHERN 

2070
01:21:31,954 --> 01:21:33,188
CALIFORNIA DIVISION OF RESEARCH 

2071
01:21:33,188 --> 01:21:36,225
USING QUANTITATIVE AND 

2072
01:21:36,225 --> 01:21:37,059
QUALITATIVE METHODS TO STUDY 

2073
01:21:37,059 --> 01:21:38,761
WAYS TO PERSONALIZE AND 

2074
01:21:38,761 --> 01:21:40,362
INTEGRATE CARE FOR PEOPLE WITH 

2075
01:21:40,362 --> 01:21:43,532
MENTAL ILLNESS WITH GOALS OF 

2076
01:21:43,532 --> 01:21:45,134
IMPROVING MENTAL HEALTH OUTCOMES

2077
01:21:45,134 --> 01:21:47,035
AND CHRONIC DISEASE PREVENTION 

2078
01:21:47,035 --> 01:21:50,405
STATUS AND TODAY WILL DISCUSS 

2079
01:21:50,405 --> 01:21:51,206
REAL-WORLD EFFECTIVENESS AND 

2080
01:21:51,206 --> 01:21:53,776
SAFETY OF GL1 THERAPIES IN 

2081
01:21:53,776 --> 01:21:55,544
REGARD TO PSYCHIATRIC CONDITIONS

2082
01:21:55,544 --> 01:21:56,645
AND THANKS SO MUCH FOR 

2083
01:21:56,645 --> 01:21:58,814
PRESENTING TODAY AND I WILL TURN

2084
01:21:58,814 --> 01:22:00,749
THE FLOOR OVER TO YOU. 

2085
01:22:00,749 --> 01:22:11,226
>> WONDERFUL.  ONE MOMENT.

2086
01:22:14,696 --> 01:22:16,665
GREAT.  CAN YOU SEE MY SLIDES?  

2087
01:22:16,665 --> 01:22:18,801
AM I UNMUTED. 

2088
01:22:18,801 --> 01:22:19,268
>> YES. 

2089
01:22:19,268 --> 01:22:21,370
>> VERY GOOD.  GREAT. 
THANKS SO

2090
01:22:21,370 --> 01:22:22,771
MUCH FOR THIS CHANCE TO TALK 

2091
01:22:22,771 --> 01:22:25,140
ABOUT THIS TOPIC AND I REALLY 

2092
01:22:25,140 --> 01:22:26,775
APPRECIATE SHARING THIS TIME 

2093
01:22:26,775 --> 01:22:28,477
WITH OTHER WONDERFUL SPEAKERS 

2094
01:22:28,477 --> 01:22:34,049
AND I'M GRATEFUL TO DR. LEWIS 

2095
01:22:34,049 --> 01:22:36,051
FOR STANDING UP METHODOLOGICAL 

2096
01:22:36,051 --> 01:22:37,619
DETAILS IN TALKS FOR POPULATION 

2097
01:22:37,619 --> 01:22:41,156
AS WELL AND I HAVE NO CONFLICTS 

2098
01:22:41,156 --> 01:22:41,590
TO REPORT. 

2099
01:22:41,590 --> 01:22:42,291
IN THIS PREEF PRESENTATION I 

2100
01:22:42,291 --> 01:22:44,293
WILL TALK ABOUT POTENTIAL 

2101
01:22:44,293 --> 01:22:46,228
IMPACTS OF GLP1 BASED 

2102
01:22:46,228 --> 01:22:48,330
MEDICATIONS ON BEHAVIORAL HEALTH

2103
01:22:48,330 --> 01:22:49,331
CONDITIONS IN PARTICULAR 

2104
01:22:49,331 --> 01:22:51,767
INCLUDING MENTAL ILLNESS AND 

2105
01:22:51,767 --> 01:22:53,368
SUBSTANCE USE DISORDER AND WILL 

2106
01:22:53,368 --> 01:22:55,504
TALK THROUGH SPECIFIC STUDY 

2107
01:22:55,504 --> 01:22:56,772
DESIGN ISSUES FOCUSING ON 

2108
01:22:56,772 --> 01:22:58,006
PARTICULAR POINTS THAT ARE 

2109
01:22:58,006 --> 01:22:59,541
SPECIAL FOR THIS POPULATION. 

2110
01:22:59,541 --> 01:23:01,844
I WILL FOCUS ESPECIALLY ON 

2111
01:23:01,844 --> 01:23:04,913
TARGET TRIAL EMULATION STUDIES 

2112
01:23:04,913 --> 01:23:06,481
USING ELECTRONIC HEALTH RECORD 

2113
01:23:06,481 --> 01:23:09,151
DATA AND IN SOME WAYS REAL WORLD

2114
01:23:09,151 --> 01:23:10,819
DATA CONTRIBUTE TO UNDERSTANDING

2115
01:23:10,819 --> 01:23:12,154
AND ALSO SHOULD BE COMPLEMENTED 

2116
01:23:12,154 --> 01:23:14,122
AND EXTENDED THROUGH CLINICAL 

2117
01:23:14,122 --> 01:23:14,556
TRIAL EVIDENCE. 

2118
01:23:14,556 --> 01:23:16,558
I WILL PULL EXAMPLES FROM A 

2119
01:23:16,558 --> 01:23:18,727
BUNCH OF DIFFERENT BEHAVIORAL 

2120
01:23:18,727 --> 01:23:21,129
HEALTH CONDITIONS THAT WILL BE A

2121
01:23:21,129 --> 01:23:23,232
JUST KIND OF QUICK SNAPSHOT BUT 

2122
01:23:23,232 --> 01:23:26,101
I WILL TALK ABOUT SUICIDE, 

2123
01:23:26,101 --> 01:23:28,337
DEPRESSION, ADDICTION, AND 

2124
01:23:28,337 --> 01:23:29,371
EATING DISORDERS. 

2125
01:23:29,371 --> 01:23:31,340
MENTAL HEALTH CONDITIONS ARE 

2126
01:23:31,340 --> 01:23:34,376
VERY COMMON ADDICTIONS AND THEY 

2127
01:23:34,376 --> 01:23:36,178
ARE VERY COMMON AND CONDITIONS 

2128
01:23:36,178 --> 01:23:39,047
THAT CAUSE SUFFERING AND ARE 

2129
01:23:39,047 --> 01:23:41,617
OFTEN ARE UNDERTREATED IN US IN 

2130
01:23:41,617 --> 01:23:44,686
GIVEN YEAR 1 IN 12US ADULTS HAS 

2131
01:23:44,686 --> 01:23:47,022
MAJOR DEPRESSIVE EPISODE AND 1 

2132
01:23:47,022 --> 01:23:49,958
IN 10 AMERICANS AGE 12 HAS 

2133
01:23:49,958 --> 01:23:51,159
ALCOHOL USE DISORDER AND WHEN 

2134
01:23:51,159 --> 01:23:52,628
CONDITIONS ARE SEVERE THEY CAN 

2135
01:23:52,628 --> 01:23:54,463
BE A CAUSE OF GREAT DISABILITY 

2136
01:23:54,463 --> 01:23:56,832
AND CAN BE BURDEN SOME TO OUR 

2137
01:23:56,832 --> 01:23:59,234
SOCIETY AND CAN BE 

2138
01:23:59,234 --> 01:24:00,202
LIFE-THREATENING AND MOST PEOPLE

2139
01:24:00,202 --> 01:24:02,137
ARE NOT TREATED RIGHT AWAY IF AT

2140
01:24:02,137 --> 01:24:02,671
ALL. 

2141
01:24:02,671 --> 01:24:04,873
AND I WANT TO EMPHASIZE THAT 

2142
01:24:04,873 --> 01:24:08,343
THERE HAVE NOT BEEN ADVANCES IN 

2143
01:24:08,343 --> 01:24:10,279
MENTAL HEALTH TREATMENT AND 

2144
01:24:10,279 --> 01:24:11,813
OUTCOMES IN THE SAME WAY YOU 

2145
01:24:11,813 --> 01:24:13,682
HAVE SEEN IN OTHER AREAS AND 

2146
01:24:13,682 --> 01:24:13,949
MEDICINE. 

2147
01:24:13,949 --> 01:24:18,754
FOR EXAMPLE, WE ARE SEEING OVER 

2148
01:24:18,754 --> 01:24:19,254
THE LAST COUPLE DECADE 

2149
01:24:19,254 --> 01:24:20,856
INCREASING RATES OF SUICIDE IN 

2150
01:24:20,856 --> 01:24:22,724
THE US THAT IS ACTUALLY NOT 

2151
01:24:22,724 --> 01:24:25,127
HAPPENING IN OTHER COUNTRIES AND

2152
01:24:25,127 --> 01:24:30,732
SUICIDE IS HIGHLY CORRELATEDED 

2153
01:24:30,732 --> 01:24:32,367
MENTAL ILLNESS AND SUBSTANCE USE

2154
01:24:32,367 --> 01:24:33,769
DISORDER AND ALONG 

2155
01:24:33,769 --> 01:24:36,071
IDIMPROVEMENTS AND AREAS AND 

2156
01:24:36,071 --> 01:24:37,606
REDUCTIONS FROM DEATH IN HEART 

2157
01:24:37,606 --> 01:24:39,308
DISEASE AND CHRONIC ILLNESSES 

2158
01:24:39,308 --> 01:24:40,709
AND MEDICAL CONDITIONS AND ONE 

2159
01:24:40,709 --> 01:24:41,877
THING I THINK ABOUT WITH 

2160
01:24:41,877 --> 01:24:44,980
MEDICATIONS IS POSSIBILITY THEY 

2161
01:24:44,980 --> 01:24:46,982
ARE NEUROPROTECTIVE AND PERHAPS 

2162
01:24:46,982 --> 01:24:50,185
COULD BE ANOTHER SET OF TOOLS WE

2163
01:24:50,185 --> 01:24:52,054
USE FOR A HIGHLY VULNERABLE 

2164
01:24:52,054 --> 01:24:53,422
POPULATION AND ANOTHER THING TO 

2165
01:24:53,422 --> 01:24:54,790
THINK ABOUT IS OTHER KINDS OF 

2166
01:24:54,790 --> 01:24:56,925
MORTALITY IN THIS POPULATION AND

2167
01:24:56,925 --> 01:25:00,128
WE HAVE SEEN LAST COUPLE YEARS 

2168
01:25:00,128 --> 01:25:01,630
NOW NOTWITHSTANDING OVERALL 

2169
01:25:01,630 --> 01:25:04,833
INCREASED LIFE EXPECTANCY IN THE

2170
01:25:04,833 --> 01:25:07,135
US AND PERSISTENT CHALLENGE IS 

2171
01:25:07,135 --> 01:25:08,503
MORTALITY GAP FOR PEOPLE WITH 

2172
01:25:08,503 --> 01:25:10,572
MENTAL ILLNESS AND ADDICTION AND

2173
01:25:10,572 --> 01:25:12,341
SEE PEOPLE WITH CONDITIONS DIE A

2174
01:25:12,341 --> 01:25:14,943
DECADE OR TWO DECADES EARLIER 

2175
01:25:14,943 --> 01:25:16,645
WITH PEERS WITHOUT MENTAL 

2176
01:25:16,645 --> 01:25:20,215
ILLNESS AND LOOK AT GAPS IN OWN 

2177
01:25:20,215 --> 01:25:23,752
HEALTH SYSTEM THINKING KAISER 

2178
01:25:23,752 --> 01:25:24,620
PERMANENTE PATIENTS HAVE 

2179
01:25:24,620 --> 01:25:26,388
INSURANCE AND ACCESS TO MEDICAL 

2180
01:25:26,388 --> 01:25:29,124
CARE AND FOUND SUBSTANTIAL GAP 

2181
01:25:29,124 --> 01:25:32,127
SO PATIENTS WITH SERIOUS MENTAL 

2182
01:25:32,127 --> 01:25:33,495
ILLNESS OR SUBSTANCE USE 

2183
01:25:33,495 --> 01:25:35,163
DISORDER DIED EARLIER THAN WOULD

2184
01:25:35,163 --> 01:25:37,199
BE EXPECTED BASED ON YEAR OF 

2185
01:25:37,199 --> 01:25:39,601
THEIR BIRTH AND TENDED TO DIE 

2186
01:25:39,601 --> 01:25:42,371
NOT OF SUICIDE OR INJURIES OR 

2187
01:25:42,371 --> 01:25:45,707
HOMICIDE BUT TENDED TO DIE OF 

2188
01:25:45,707 --> 01:25:47,576
QUOTE UNQUOTE NATURAL CAUSES 

2189
01:25:47,576 --> 01:25:49,244
THAT ARE DRIVEN BY METABOLIC 

2190
01:25:49,244 --> 01:25:51,913
CONDITIONS SUCH AS OBESITY AND 

2191
01:25:51,913 --> 01:25:54,282
DIABETES AND PATIENTS HAVE A 

2192
01:25:54,282 --> 01:25:56,385
HIGHER RATE OF DEATH FROM THESE 

2193
01:25:56,385 --> 01:25:57,853
CHRONIC CONDITIONS. 

2194
01:25:57,853 --> 01:25:59,755
SO SOMETHING TO CONSIDER WITH 

2195
01:25:59,755 --> 01:26:01,723
GLP-1 BASED MEDICATIONS IN TERMS

2196
01:26:01,723 --> 01:26:05,127
OF IMPACT IS PERHAPS THEY CAN BE

2197
01:26:05,127 --> 01:26:06,862
USED TO TREAT METABOLIC 

2198
01:26:06,862 --> 01:26:07,996
CONDITIONS THAT ARE MORE COMMON 

2199
01:26:07,996 --> 01:26:09,931
IN THIS POPULATION AND IF THEY 

2200
01:26:09,931 --> 01:26:12,501
ALSO HAVE SOME KIND OF 

2201
01:26:12,501 --> 01:26:13,235
NEUROPROTECTIVE EFFECT THAT IS A

2202
01:26:13,235 --> 01:26:15,437
DOUBLE BLESSING FOR THIS 

2203
01:26:15,437 --> 01:26:17,506
POPULATION THAT IS JUST VERY 

2204
01:26:17,506 --> 01:26:20,509
VULNERABLE TO MULTIPLE KINDS OF 

2205
01:26:20,509 --> 01:26:20,876
COMORBIDITIES. 

2206
01:26:20,876 --> 01:26:23,245
HERE I WILL GIVE A VERY QUICK 

2207
01:26:23,245 --> 01:26:24,980
OVERVIEW OF PRELIMINARY DATA ON 

2208
01:26:24,980 --> 01:26:28,950
CONDITIONS AND I HOPE THAT I DO 

2209
01:26:28,950 --> 01:26:30,085
NOT NEGLECT IMPORTANT POINTS BUT

2210
01:26:30,085 --> 01:26:32,587
WILL DO MY BEST IN A LIMITED 

2211
01:26:32,587 --> 01:26:34,089
TIME AND FIRST WITH SUICIDE 

2212
01:26:34,089 --> 01:26:34,423
RISK. 

2213
01:26:34,423 --> 01:26:36,091
SO I HAVE BEEN TALKING SO FAR 

2214
01:26:36,091 --> 01:26:38,427
ABOUT POTENTIAL BENEFITS OF 

2215
01:26:38,427 --> 01:26:39,961
THESE MEDICATION. 

2216
01:26:39,961 --> 01:26:42,164
THERE ARE AS WAS MENTIONED IN A 

2217
01:26:42,164 --> 01:26:43,899
COUPLE OF TALKS YESTERDAY 

2218
01:26:43,899 --> 01:26:45,067
POTENTIAL RISKS AS WELL. 

2219
01:26:45,067 --> 01:26:47,903
ONE HAS EMERGED FROM AEARLY 

2220
01:26:47,903 --> 01:26:49,671
SURVEILLANCE DATA FOR SOME OF 

2221
01:26:49,671 --> 01:26:51,873
THE MEDICATIONS INCREASED 

2222
01:26:51,873 --> 01:26:53,742
SUICIDAL IDEATION OR BEHAVIOR 

2223
01:26:53,742 --> 01:26:55,343
AND THERE HAS BEEN A LOT OF WORK

2224
01:26:55,343 --> 01:26:57,145
IN THE AREA THAT IS ONLY 

2225
01:26:57,145 --> 01:26:58,914
EMERGING NOW AND I THINK THAT WE

2226
01:26:58,914 --> 01:27:00,782
HAVE TO KEEP OUR EYE ON THIS.  

2227
01:27:00,782 --> 01:27:02,684
IT IS STILL UNCLEAR WHAT ANSWERS

2228
01:27:02,684 --> 01:27:03,185
WILL BE. 

2229
01:27:03,185 --> 01:27:04,619
I REMEMBER HEARING YESTERDAY TOO

2230
01:27:04,619 --> 01:27:07,322
THAT FDA IS WORKING ON 

2231
01:27:07,322 --> 01:27:08,223
REAL-WORLD STUDY TO TRY TO 

2232
01:27:08,223 --> 01:27:10,792
UNDERSTAND THIS BETTER AND SOME 

2233
01:27:10,792 --> 01:27:12,828
RECENT ANALYSIS OF OBSERVATIONAL

2234
01:27:12,828 --> 01:27:14,996
DATA AND CLINICAL TRIAL DATA 

2235
01:27:14,996 --> 01:27:16,898
HAVE SUGGESTED THAT MAYBE THERE 

2236
01:27:16,898 --> 01:27:20,569
IS NOT INCREASED RISK OR MAYBE 

2237
01:27:20,569 --> 01:27:22,838
EVEN MEDICATIONS ARE PROTECTIVE 

2238
01:27:22,838 --> 01:27:25,841
AGAINST SUICIDAL BEHAVIOR AND 

2239
01:27:25,841 --> 01:27:26,675
ARE LOTS OF LIMITATIONS IN THE 

2240
01:27:26,675 --> 01:27:29,111
WORK AND OBSERVATIONAL DATA THAT

2241
01:27:29,111 --> 01:27:31,179
HAS METHODOLOGICAL LIMITATIONS 

2242
01:27:31,179 --> 01:27:34,649
MENTIONED EARLIER RELATED TO NOT

2243
01:27:34,649 --> 01:27:36,751
HAVING ACTIVE COMPARATOR AND 

2244
01:27:36,751 --> 01:27:37,786
CLINICAL TRIALS COME FROM 

2245
01:27:37,786 --> 01:27:40,122
STUDIES OF MEDICATIONS IN 

2246
01:27:40,122 --> 01:27:42,457
RELATION TO WEIGHT LOSS OR 

2247
01:27:42,457 --> 01:27:44,226
DIABETES AND STUDIES INCLUDE 

2248
01:27:44,226 --> 01:27:46,061
POPULATIONS THAT DON'T HAVE 

2249
01:27:46,061 --> 01:27:48,663
MENTAL HEALTH HISTORY OR LOW 

2250
01:27:48,663 --> 01:27:50,332
RISK FOR SUICIDE TO BEGIN WITH 

2251
01:27:50,332 --> 01:27:52,367
AND SOMETHING TO KEEP AN EYE ON.

2252
01:27:52,367 --> 01:27:53,568
WITH REGARDS TO ADDICTION, THERE

2253
01:27:53,568 --> 01:27:55,704
HAS BEEN A LOT OF EXCITEMENT 

2254
01:27:55,704 --> 01:27:58,874
ABOUT USING MEDICATIONS TO TREAT

2255
01:27:58,874 --> 01:28:00,108
ALCOHOL USE DISORDER OR 

2256
01:28:00,108 --> 01:28:01,977
SUBSTANCE USE DISORDERS THAT IS 

2257
01:28:01,977 --> 01:28:04,980
BASED ON PRE-LYNNE CAL DATA AND 

2258
01:28:04,980 --> 01:28:07,048
ANECDOTES AND STUFF YOU READ ON 

2259
01:28:07,048 --> 01:28:09,785
REDDIT THAT PEOPLE DESCRIBE A 

2260
01:28:09,785 --> 01:28:11,419
REDUCED DESIRE TO USE SUBSTANCES

2261
01:28:11,419 --> 01:28:13,822
AND THIS TYPE OF EFFECT IS BEING

2262
01:28:13,822 --> 01:28:15,824
BORN OUT IN EMERGING 

2263
01:28:15,824 --> 01:28:17,058
OBSERVATIONAL AND REAL-WORLD 

2264
01:28:17,058 --> 01:28:19,194
DATA RIGHT NOW AS WELL AS 

2265
01:28:19,194 --> 01:28:20,328
CLINICAL TRIAL EVIDENCE THAT 

2266
01:28:20,328 --> 01:28:22,931
THERE IS SOME NEW WORK THAT HAS 

2267
01:28:22,931 --> 01:28:24,332
BEEN DONE IN ALCOHOL USE 

2268
01:28:24,332 --> 01:28:26,268
DISORDER AND SOME WORK IS 

2269
01:28:26,268 --> 01:28:29,004
UNDERWAY IN OPIOID USE DISORDER 

2270
01:28:29,004 --> 01:28:31,006
AND SUBSTANCE USE DISORDERS ARE 

2271
01:28:31,006 --> 01:28:33,308
ALSO BEING STUDIED AND WITH 

2272
01:28:33,308 --> 01:28:34,776
REGARD TO EATING DISORDER THIS 

2273
01:28:34,776 --> 01:28:37,245
IS A NUANCED PICTURE.  WE KNOW 

2274
01:28:37,245 --> 01:28:39,881
FROM ANECDOTAL DATA THAT SOME 

2275
01:28:39,881 --> 01:28:42,584
PATIENTS USE GLP-1 BASED 

2276
01:28:42,584 --> 01:28:43,818
MEDICATIONS IN A WAY THAT 

2277
01:28:43,818 --> 01:28:45,153
WOULDN'T BE RECOMMENDED AND THEY

2278
01:28:45,153 --> 01:28:47,389
ARE RESTRICTING CALORIE INTAKE 

2279
01:28:47,389 --> 01:28:49,624
AND THIS IS PART OF MORE AN 

2280
01:28:49,624 --> 01:28:50,959
EATING DISORDER PRESENTATION. 

2281
01:28:50,959 --> 01:28:52,861
BUT ON THE FLIPSIDE, IT IS 

2282
01:28:52,861 --> 01:28:54,596
POSSIBLE THAT THESE MEDICATIONS 

2283
01:28:54,596 --> 01:28:56,131
COULD BE HELPFUL FOR BINGE 

2284
01:28:56,131 --> 01:28:59,267
EATING THAT IS A BEHAVIOR THAT 

2285
01:28:59,267 --> 01:29:01,369
IS SEEN FOR SUBSTANTIAL MINORITY

2286
01:29:01,369 --> 01:29:04,439
OF PEOPLE THAT HAVE EXCESS 

2287
01:29:04,439 --> 01:29:05,140
WEIGHT. 

2288
01:29:05,140 --> 01:29:08,743
SOME EARLY SMALLER TRIALS AND 

2289
01:29:08,743 --> 01:29:10,078
OBSERVATIONAL DATA SUGGESTED 

2290
01:29:10,078 --> 01:29:11,613
THAT MEDICATIONS CAN HELP 

2291
01:29:11,613 --> 01:29:12,714
CERTAINLY WITH WEIGHT LOSS AND 

2292
01:29:12,714 --> 01:29:15,417
REDUCTION IN EATING AND ALSO MAY

2293
01:29:15,417 --> 01:29:17,953
BE HELPFUL FOR SOME OF THE 

2294
01:29:17,953 --> 01:29:21,189
COGNITIONS AND SPECIFIC BEHAV

2295
01:29:21,189 --> 01:29:22,457
BEHAVIORS THAT YOU SEE WITH 

2296
01:29:22,457 --> 01:29:24,559
BINGE EATING DISORDER AND WE 

2297
01:29:24,559 --> 01:29:25,560
HAVE TO BE CAUTION HERE BECAUSE 

2298
01:29:25,560 --> 01:29:27,462
WE HAVE TO FULLY EVALUATE 

2299
01:29:27,462 --> 01:29:28,597
DIFFERENT OUTCOMES AND 

2300
01:29:28,597 --> 01:29:30,498
MECHANISMS THAT COULD BE RELATED

2301
01:29:30,498 --> 01:29:32,267
HERE AND IS POSSIBLE THAT PEOPLE

2302
01:29:32,267 --> 01:29:35,370
ARE YOU KNOW TAKING MEDICATIONS 

2303
01:29:35,370 --> 01:29:37,172
AND SEEING REDUCED BINGE EATING 

2304
01:29:37,172 --> 01:29:40,275
AND HAVING MALADAPTIVE BEHAVIORS

2305
01:29:40,275 --> 01:29:41,142
AND THOUGHTS THAT ARE A 

2306
01:29:41,142 --> 01:29:42,844
DIFFERENT KIND OF EATING 

2307
01:29:42,844 --> 01:29:43,845
DISORDER AND WITH REAL WORLD 

2308
01:29:43,845 --> 01:29:45,513
DATA THERE IS POTENTIAL TO 

2309
01:29:45,513 --> 01:29:47,916
INCLUDE A LARGE SAMPLE AS BEEN 

2310
01:29:47,916 --> 01:29:49,684
SAID EARLIER WITH INCLUSIVE 

2311
01:29:49,684 --> 01:29:51,720
POPULATION AND TRY TO PICK UP 

2312
01:29:51,720 --> 01:29:53,154
AND DETECT INITIAL EVIDENCE 

2313
01:29:53,154 --> 01:29:55,590
RELATED TO RISKS AND BENEFITS 

2314
01:29:55,590 --> 01:29:57,859
AND DATA CAN BE HELPFUL AND 

2315
01:29:57,859 --> 01:29:58,960
ALREADY HAVE INFORMED LABELING 

2316
01:29:58,960 --> 01:30:00,795
DECISIONS WITH, YOU KNOW, WITH 

2317
01:30:00,795 --> 01:30:05,133
REGARD TO SUICIDE RISK.  

2318
01:30:05,133 --> 01:30:08,270
HERELY TOUCH ON IDEAS AROUND 

2319
01:30:08,270 --> 01:30:09,905
MEASUREMENT AND I REALLY 

2320
01:30:09,905 --> 01:30:10,939
APPRECIATE DR. MCCOY TALKING 

2321
01:30:10,939 --> 01:30:12,841
THROUGH ISSUES EARLIER AND WILL 

2322
01:30:12,841 --> 01:30:15,377
TRY TO FOCUS IN ON ISSUES 

2323
01:30:15,377 --> 01:30:17,178
SPECIFIC TO BEHAVIORAL HEALTH 

2324
01:30:17,178 --> 01:30:20,148
AND LOOKING AT MENTAL HEALTH 

2325
01:30:20,148 --> 01:30:22,450
DIAGNOSIS AND REAL-WORLD STUDIES

2326
01:30:22,450 --> 01:30:24,386
USE DIAGNOSTIC AND ICD CODES TO 

2327
01:30:24,386 --> 01:30:26,821
MEASURE NOT JUST THINGS LIKE 

2328
01:30:26,821 --> 01:30:28,356
DEPRESSION BUT ALSO SELF-HARM 

2329
01:30:28,356 --> 01:30:30,825
BEHAVIOR CODED IN THE HEALTH 

2330
01:30:30,825 --> 01:30:32,360
RECORD AND LIMITATION OF MINE OF

2331
01:30:32,360 --> 01:30:36,197
COURSE IS THEY ARE STIGMATIZED 

2332
01:30:36,197 --> 01:30:37,399
CONDITIONS THAT ARE OFTEN 

2333
01:30:37,399 --> 01:30:38,500
UNDERREPORTED AND MEDICATIONS 

2334
01:30:38,500 --> 01:30:39,901
YOU KNOW OBVIOUSLY IT IS 

2335
01:30:39,901 --> 01:30:42,103
IMPORTANT TO MEASURE USE OF 

2336
01:30:42,103 --> 01:30:44,673
MEDICATIONS AND ACTIVE 

2337
01:30:44,673 --> 01:30:48,576
COMPARATOR AS WELL AS OTHER 

2338
01:30:48,576 --> 01:30:49,144
CONCOMITANT TREATMENTS AND 

2339
01:30:49,144 --> 01:30:50,912
HEALTH CONDITIONS AND IN OUR 

2340
01:30:50,912 --> 01:30:52,580
SYSTEM WE HAVE A ROBUST SET OF 

2341
01:30:52,580 --> 01:30:54,916
DATA RELATED TO DISPENSING IN 

2342
01:30:54,916 --> 01:30:57,285
OUR SYSTEM IT IS CLOSED SYSTEM 

2343
01:30:57,285 --> 01:30:59,321
AND DELIVERY SIFTIN IT EGG 

2344
01:30:59,321 --> 01:31:01,589
GREATED WITH PAYER AND INSURANCE

2345
01:31:01,589 --> 01:31:03,058
COMPANY NOT ALWAYS AVAILABLE IN 

2346
01:31:03,058 --> 01:31:04,959
E HR DATA. 

2347
01:31:04,959 --> 01:31:06,761
WITH OTHER TYPES OF DATA 

2348
01:31:06,761 --> 01:31:08,763
ELEMENTS SUCH AS BMI OR 

2349
01:31:08,763 --> 01:31:10,598
LABORATORY RESULTS, THAT CAN BE 

2350
01:31:10,598 --> 01:31:12,901
AVAILABLE IN ELECTRONIC HEALTH 

2351
01:31:12,901 --> 01:31:14,836
RECORDS AND SOMETIMES IN 

2352
01:31:14,836 --> 01:31:15,770
STRUCTURED FIELDS AND THEY CAN 

2353
01:31:15,770 --> 01:31:17,806
BE HARD TO USE IN STUDIES 

2354
01:31:17,806 --> 01:31:20,508
BECAUSE MAYBE THEY ARE NOT 

2355
01:31:20,508 --> 01:31:22,143
ASCERTAINED VERY REGULARLY 

2356
01:31:22,143 --> 01:31:23,144
ACROSS THE LARGE POPULATION THEY

2357
01:31:23,144 --> 01:31:24,579
ARE INTERESTED IN AND YOU HAVE 

2358
01:31:24,579 --> 01:31:26,848
TO CONSIDER WHAT DATA GENERATION

2359
01:31:26,848 --> 01:31:28,450
MECHANISM IS THAT LED TO 

2360
01:31:28,450 --> 01:31:30,285
PARTICULAR DATA ELEMENTS. 

2361
01:31:30,285 --> 01:31:32,954
WE ARE ABLE TO LINK ELECTRONIC 

2362
01:31:32,954 --> 01:31:35,323
HEALTH RECORD AND CLAIMS DATA TO

2363
01:31:35,323 --> 01:31:37,125
OUTSIDE DATA SOURCES THAT IS 

2364
01:31:37,125 --> 01:31:38,226
IMPORTANT WHEN STUDYING SUICIDE 

2365
01:31:38,226 --> 01:31:40,328
AND YOU ARE ABLE TO EVALUATE 

2366
01:31:40,328 --> 01:31:42,897
CAUSE OF DEATH BY DOING THIS 

2367
01:31:42,897 --> 01:31:43,598
LINKAGE. 

2368
01:31:43,598 --> 01:31:46,101
IN ELECTRONIC HEALTH RECORDS YOU

2369
01:31:46,101 --> 01:31:49,137
ARE SOMETIMES ABLE TO ACCESS 

2370
01:31:49,137 --> 01:31:50,405
PATIENT-REPORTED OUTCOMES. 

2371
01:31:50,405 --> 01:31:52,340
MOST USEFUL ONES ARE THOSE PART 

2372
01:31:52,340 --> 01:31:53,942
OF SCREENING MEASURES THAT ARE 

2373
01:31:53,942 --> 01:31:56,077
QUESTION AIRS THAT ARE 

2374
01:31:56,077 --> 01:31:57,112
ADMINISTERED VERY BROADLY TO 

2375
01:31:57,112 --> 01:31:59,481
LOTS OF PEOPLE TO MEASURE THINGS

2376
01:31:59,481 --> 01:32:01,716
LIKE DEPRESSION OR SUICIDAL 

2377
01:32:01,716 --> 01:32:02,217
IDEATION. 

2378
01:32:02,217 --> 01:32:04,285
WE ALSO HAVE BRIEF SCREENING 

2379
01:32:04,285 --> 01:32:05,954
PROTOCOLS THAT ARE JUST VERBAL 

2380
01:32:05,954 --> 01:32:07,655
WHERE LET'S SAY MEDICAL 

2381
01:32:07,655 --> 01:32:10,692
ASSISTANT RECORDS IN HEALTH 

2382
01:32:10,692 --> 01:32:12,694
RECORD WHEN PATIENT COMES IN 

2383
01:32:12,694 --> 01:32:14,996
WHAT THEIR DRINKING OR SMOKING 

2384
01:32:14,996 --> 01:32:17,098
HISTORY IS LIKE AND ADDING A 

2385
01:32:17,098 --> 01:32:18,466
CAVEAT THAT YOU HAVE TO KNOW 

2386
01:32:18,466 --> 01:32:20,602
MORE ABOUT WHAT IS HAPPENING IN 

2387
01:32:20,602 --> 01:32:21,603
DELIVERY SYSTEM AND DOING 

2388
01:32:21,603 --> 01:32:23,938
RESEARCH AND DATA ELEMENTS ARE 

2389
01:32:23,938 --> 01:32:26,107
NOT STRUCTURED AND NOT EASILY 

2390
01:32:26,107 --> 01:32:28,276
ACCESSIBLE AND IN TERMS OF 

2391
01:32:28,276 --> 01:32:31,212
PATIENT-REPORTED OUTCOMES I WILL

2392
01:32:31,212 --> 01:32:34,115
HIGHLIGHT WORK THAT IS ONGOING 

2393
01:32:34,115 --> 01:32:36,184
FOCUSING ON DRINKING AND MEANS 

2394
01:32:36,184 --> 01:32:38,653
TO STUDY NOW AND COLLEAGUE 

2395
01:32:38,653 --> 01:32:40,855
VANESSA IS WORKING ON ANALYSIS 

2396
01:32:40,855 --> 01:32:43,358
USING SCREENING DATA FOR ALCOHOL

2397
01:32:43,358 --> 01:32:46,094
USE AND ABLE TO USE FEW ITEMS 

2398
01:32:46,094 --> 01:32:48,430
THAT ARE REGULARLY USED 

2399
01:32:48,430 --> 01:32:49,831
CLINICALLY TO CALCULATE AVERAGE 

2400
01:32:49,831 --> 01:32:51,466
DRINKS PER WEEK THAT IS 

2401
01:32:51,466 --> 01:32:53,368
EMULATING A TARGET TRIAL TO 

2402
01:32:53,368 --> 01:32:55,103
UNDERSTAND THE ASSOCIATION 

2403
01:32:55,103 --> 01:32:57,806
BETWEEN GLP-1 BASED MEDICATIONS 

2404
01:32:57,806 --> 01:33:00,308
AND CHANGES IN DRINKING OVER THE

2405
01:33:00,308 --> 01:33:01,743
COURSE OF A YEAR. 

2406
01:33:01,743 --> 01:33:04,212
AND IN A SIMILAR STUDY THAT HAS 

2407
01:33:04,212 --> 01:33:06,748
BEEN PUBLISHED RECENTLY ONLINE 

2408
01:33:06,748 --> 01:33:08,983
COLLEAGUES AT THE VA HAVE 

2409
01:33:08,983 --> 01:33:10,518
SIMILARLY USED ALCOHOL SCREENING

2410
01:33:10,518 --> 01:33:13,521
DATA AND HAVE REPORTED A GREATER

2411
01:33:13,521 --> 01:33:15,056
REDUCTION IN DRINKING BEHAVIOR 

2412
01:33:15,056 --> 01:33:17,992
FOR PATIENTS WHO ARE RECEIVING 

2413
01:33:17,992 --> 01:33:19,661
GLP-1 BASED MEDICATIONS. 

2414
01:33:19,661 --> 01:33:22,931
AND INTERESTINGLY, A STRONGER 

2415
01:33:22,931 --> 01:33:27,836
EFFECT FOR MORE SEVERE LEVELS OF

2416
01:33:27,836 --> 01:33:28,870
DRINKINGCA INDICATED BY ALCOHOL 

2417
01:33:28,870 --> 01:33:30,171
USE DISORDER DIAGNOSIS AND 

2418
01:33:30,171 --> 01:33:32,307
BUILDING ON EARLIER REMARKS FROM

2419
01:33:32,307 --> 01:33:34,309
SPEAKERS ABOUT HOW TO DEFINE 

2420
01:33:34,309 --> 01:33:36,478
POPULATIONS AND COMPARATORS I 

2421
01:33:36,478 --> 01:33:38,046
WILL FOCUS IN ON HOW WE DO THIS 

2422
01:33:38,046 --> 01:33:40,115
WITH REGARD TO BEHAVIORAL HEALTH

2423
01:33:40,115 --> 01:33:41,783
AND SOMETHING THAT IS IMPORTANT 

2424
01:33:41,783 --> 01:33:43,952
TO CONSIDER IS THAT MEDICATIONS 

2425
01:33:43,952 --> 01:33:46,554
ARE NOT REALLY PRESCRIBED FOR 

2426
01:33:46,554 --> 01:33:48,256
BEHAVIORAL HEALTH CONDITIONS AT 

2427
01:33:48,256 --> 01:33:49,958
THE MOMENT AND MIGHT CHANGE AS 

2428
01:33:49,958 --> 01:33:51,893
OFF USE LABEL INCREASES WITH 

2429
01:33:51,893 --> 01:33:53,528
GREATER EVIDENCE AND STUDIES YOU

2430
01:33:53,528 --> 01:33:55,663
HAVE TO REMEMBER THAT PATIENTS 

2431
01:33:55,663 --> 01:33:57,165
INCLUDING FALL INTO OVERLAP 

2432
01:33:57,165 --> 01:33:59,701
BETWEEN INDICATIONS FOR WHICH 

2433
01:33:59,701 --> 01:34:02,737
MEDICATIONS BEING PROVIDED AND 

2434
01:34:02,737 --> 01:34:05,139
SOME KIND OF ELEMENT OF RISK 

2435
01:34:05,139 --> 01:34:06,474
FOFR BEHAVIORAL HEALTH CONDITION

2436
01:34:06,474 --> 01:34:09,444
AND WE CAN EMULATE A STUDY 

2437
01:34:09,444 --> 01:34:11,412
LOOKING AT COLLATERAL EFFECT 

2438
01:34:11,412 --> 01:34:14,148
WITHIN OTHER OVERLAP POPULATION 

2439
01:34:14,148 --> 01:34:16,217
AND SAYING COLLATERAL EFFECT I 

2440
01:34:16,217 --> 01:34:18,419
REFER TO UNINTENDED OR SECONDARY

2441
01:34:18,419 --> 01:34:19,854
OUTCOME OF INTERVENTION THAT IS 

2442
01:34:19,854 --> 01:34:22,423
FOCUSING ON CHANGES IN BEHAVIORS

2443
01:34:22,423 --> 01:34:23,958
AND HEALTH CONDITIONS NOT 

2444
01:34:23,958 --> 01:34:26,461
PRIMARY TARGET OF INTERVENTION 

2445
01:34:26,461 --> 01:34:28,363
AND COLLATERAL EFFECTS ARE IDEA 

2446
01:34:28,363 --> 01:34:30,632
COMING UP MORE IN BEHAVIORAL 

2447
01:34:30,632 --> 01:34:32,834
RESEARCH AND IN A SENSE COMMON 

2448
01:34:32,834 --> 01:34:36,971
SIDE-EFFECTS GI AND SYMPTOMS ARE

2449
01:34:36,971 --> 01:34:38,673
TYPE OF CHICANO/CHICANA 

2450
01:34:38,673 --> 01:34:39,340
LATINO/LATINA EFFECT AND MIGHT 

2451
01:34:39,340 --> 01:34:41,276
BE INTERESTED IN EFFECTS OF 

2452
01:34:41,276 --> 01:34:42,977
MEDICATIONS AND INTERVENTIONS 

2453
01:34:42,977 --> 01:34:44,512
NOT ANTICIPATED AND SOME COULD 

2454
01:34:44,512 --> 01:34:47,148
BE POSITIVED REDUCED DRINKING 

2455
01:34:47,148 --> 01:34:50,218
BEHAVIOR AND IMPROVED MOVE MOOD 

2456
01:34:50,218 --> 01:34:51,719
AND SOME NEGATIVE PERHAPS 

2457
01:34:51,719 --> 01:34:53,154
CHANGES IN MOOD THAT ARE 

2458
01:34:53,154 --> 01:34:56,257
DEPRESSIVE AND INCREASED 

2459
01:34:56,257 --> 01:34:58,059
SUICIDALITY OR EATING DISORDER 

2460
01:34:58,059 --> 01:34:59,994
AND THINKING ABOUT DEVELOPING A 

2461
01:34:59,994 --> 01:35:02,096
TARGET TRIAL EMULATION STUDY YOU

2462
01:35:02,096 --> 01:35:04,399
FOCUS IN ON OVERLAP POPULATION 

2463
01:35:04,399 --> 01:35:06,434
AND SIMILAR TO WORK DESCRIBED 

2464
01:35:06,434 --> 01:35:08,336
EARLIER YOU WANT TO JUST FIGURE 

2465
01:35:08,336 --> 01:35:10,572
OUT WHAT SLICE OF THE POPULATION

2466
01:35:10,572 --> 01:35:13,908
WOULD BE ELIGIBLE FOR BOTH GLP-1

2467
01:35:13,908 --> 01:35:15,677
BASED MEDICATION AND OTHER 

2468
01:35:15,677 --> 01:35:17,145
ACTIVE COMPARATOR GROUP FOCUSING

2469
01:35:17,145 --> 01:35:20,848
IN ON NEW USERS AND CAN LOOK AT 

2470
01:35:20,848 --> 01:35:22,517
COLLATERAL EFFECT AS OUTCOME AND

2471
01:35:22,517 --> 01:35:25,353
ANOTHER CONSIDERATION THAT I 

2472
01:35:25,353 --> 01:35:29,991
THINK IS IMPORTANT TO THINK 

2473
01:35:29,991 --> 01:35:31,993
ABOUT AND VALUABLE FOR FUNDERS 

2474
01:35:31,993 --> 01:35:33,928
FOCUSING ON RESEARCH IS 

2475
01:35:33,928 --> 01:35:35,430
IMBEDDING STUDY OF COLLATERAL 

2476
01:35:35,430 --> 01:35:36,998
EFFECT WITH LARGER PARENT TRIAL 

2477
01:35:36,998 --> 01:35:39,634
THAT MIGHT BE FOCUSED ON 

2478
01:35:39,634 --> 01:35:42,403
ENTIRELY DIFFERENT OUTCOME OF 

2479
01:35:42,403 --> 01:35:43,905
INTEREST AND PERHAPS COLLATERAL 

2480
01:35:43,905 --> 01:35:45,707
EFFECT THAT MIGHT FIT IN WITH 

2481
01:35:45,707 --> 01:35:47,108
ORIGINAL STUDY POPULATION THAT 

2482
01:35:47,108 --> 01:35:51,646
COULD BE ADDITIONAL OUTCOME OF 

2483
01:35:51,646 --> 01:35:52,914
INTEREST TO STUDY. 

2484
01:35:52,914 --> 01:35:55,216
A STUDY I WANT TO HIGHLIGHT THAT

2485
01:35:55,216 --> 01:35:59,087
DOES THIS IS TARGET DM STUDY -- 

2486
01:35:59,087 --> 01:36:00,788
TRIALS USING TARGETED LEARNING 

2487
01:36:00,788 --> 01:36:04,759
AND IS BEING CO-LED BY MY 

2488
01:36:04,759 --> 01:36:07,061
COLLEAGUE AND PAT TRICK O'CONNOR

2489
01:36:07,061 --> 01:36:09,397
AT HEALTH PARTNERS INSTITUTE OF 

2490
01:36:09,397 --> 01:36:12,233
MINNESOTA AND HAVE TAKEN A LARGE

2491
01:36:12,233 --> 01:36:14,235
DATA SET FROM 6 DIFFERENT HEALTH

2492
01:36:14,235 --> 01:36:15,703
CARE SYSTEMS ACROSS THE COUNTRY 

2493
01:36:15,703 --> 01:36:17,905
AND THIS DATA SET INCLUDES MORE 

2494
01:36:17,905 --> 01:36:20,408
THAN 50 MILLION DIABETES DRUG 

2495
01:36:20,408 --> 01:36:23,077
FILLS THAT ARE DOING A -- YOU 

2496
01:36:23,077 --> 01:36:25,980
KNOW, REAL WORLD DATA TARGET 

2497
01:36:25,980 --> 01:36:28,449
TRIAL EMULATION HEAD TO HEAD 

2498
01:36:28,449 --> 01:36:29,651
COMPARISON AMONG DIFFERENT 

2499
01:36:29,651 --> 01:36:31,786
DIABETES MEDICATIONS AND PRIMARY

2500
01:36:31,786 --> 01:36:35,690
OUTCOME OF INTEREST IS MAJOR 

2501
01:36:35,690 --> 01:36:36,658
ADVERSE CARDIOVASCULAR EVENTS 

2502
01:36:36,658 --> 01:36:40,628
AND ALONG WITH THIS AND STUDY IS

2503
01:36:40,628 --> 01:36:42,430
SUPPORTED AND FUNDED BY PCORI 

2504
01:36:42,430 --> 01:36:47,335
AND IT IS INTERESTED IN. 

2505
01:36:47,335 --> 01:36:48,469
>> PARTICIPANT:   PARTNER 

2506
01:36:48,469 --> 01:36:50,972
ENGAGEMENT AND RESEARCH THAT IS 

2507
01:36:50,972 --> 01:36:52,607
PARTICULARLY MEANINGFUL TO 

2508
01:36:52,607 --> 01:36:54,509
PATIENTS IS MOOD AND DEPRESSION 

2509
01:36:54,509 --> 01:36:56,544
AND OUR COLLABORATOR STEPHANIE 

2510
01:36:56,544 --> 01:36:58,713
HOOKER HEALTH PARTNERS LEADS 

2511
01:36:58,713 --> 01:37:01,749
ANALYSIS FOCUSED ON INCIDENT 

2512
01:37:01,749 --> 01:37:06,654
DEPRESSION MEASURED BY ICD CODES

2513
01:37:06,654 --> 01:37:08,890
STUDYING WITHIN HEAD TO HEAD 

2514
01:37:08,890 --> 01:37:10,858
COMPARISONS POTENTIAL EFFECTS ON

2515
01:37:10,858 --> 01:37:12,193
OUTCOME AND MENTIONING COLLEAGUE

2516
01:37:12,193 --> 01:37:14,195
JULIE HAS BEEN LEADING PARTNER 

2517
01:37:14,195 --> 01:37:15,963
ENGAGEMENT WORK THAT IS SO 

2518
01:37:15,963 --> 01:37:18,900
INFLUENTIAL HERE.  STRENGTHS OF 

2519
01:37:18,900 --> 01:37:21,369
THIS APPROACH THAT I MENTIONED 

2520
01:37:21,369 --> 01:37:23,071
THE FIRST COUPLE HERE THAT 

2521
01:37:23,071 --> 01:37:25,106
INCLUDE DISPENSING DATA FROM 

2522
01:37:25,106 --> 01:37:26,708
PHARMACY AND ALL THESE SYSTEMS 

2523
01:37:26,708 --> 01:37:30,178
INVOLVED IN THE STUDY HAVE 

2524
01:37:30,178 --> 01:37:31,245
INTEGRATION BETWEEN DELIVERY 

2525
01:37:31,245 --> 01:37:34,649
SYSTEM AND PAYER AND ARE ABLE TO

2526
01:37:34,649 --> 01:37:35,917
PRESUMABLY MEASURE WHETHER 

2527
01:37:35,917 --> 01:37:37,118
PATIENTS ARE GETTING MEDICATIONS

2528
01:37:37,118 --> 01:37:41,122
AND OF COURSE WITH CAVEATS THAT 

2529
01:37:41,122 --> 01:37:43,057
GLP-1-BASED MEDICATIONS NOW ARE 

2530
01:37:43,057 --> 01:37:44,459
BEING OBTAINED NOW THROUGHOUT 

2531
01:37:44,459 --> 01:37:46,728
THE SYSTEM AND DISCUSSED THAT 

2532
01:37:46,728 --> 01:37:49,664
AND INNOVATIVE METHODS TEAM IS 

2533
01:37:49,664 --> 01:37:52,734
USING TO ADJUST FOR BASELINE 

2534
01:37:52,734 --> 01:37:54,736
CONFOUNDING AND TIME VARYING 

2535
01:37:54,736 --> 01:37:56,471
FACTORS THAT COULD BE DIFFERENT 

2536
01:37:56,471 --> 01:37:58,372
BETWEEN DIFFERENT GROUPS IN EACH

2537
01:37:58,372 --> 01:38:00,508
COMPARISON AND REMAIN HAS BEEN 

2538
01:38:00,508 --> 01:38:03,111
ABLE TO USE SOPHISTICATED 

2539
01:38:03,111 --> 01:38:04,712
TARGETING LEARNING METHODS USING

2540
01:38:04,712 --> 01:38:06,047
COMBINATION OF DIFFERENT 

2541
01:38:06,047 --> 01:38:08,149
APPROACHES INCLUDING PROPENSITY 

2542
01:38:08,149 --> 01:38:09,951
SCORES AND MACHINE LEARNING TO 

2543
01:38:09,951 --> 01:38:11,719
ADJUST FOR SOME POTENTIAL 

2544
01:38:11,719 --> 01:38:14,055
CONFOUNDING AND RECENTLY WHEN I 

2545
01:38:14,055 --> 01:38:14,922
TALKED TO STEPHANIE SHE 

2546
01:38:14,922 --> 01:38:17,892
MENTIONED THAT MODELS ARE 

2547
01:38:17,892 --> 01:38:19,560
COMPUTATION ALLEY INTENSIVE 

2548
01:38:19,560 --> 01:38:22,697
TAKING WEEKS TO RUN AND CAN BE A

2549
01:38:22,697 --> 01:38:24,799
DIFFICULT TASK TO DO THIS AND IS

2550
01:38:24,799 --> 01:38:26,334
A RIGOROUS WAY OF APPROACHING 

2551
01:38:26,334 --> 01:38:28,703
VARIOUS COMPARISONS AND APPROACH

2552
01:38:28,703 --> 01:38:29,604
IS INTERESTING AND WON'T TELL 

2553
01:38:29,604 --> 01:38:31,706
BUT THEM THEY ARE NOT PUBLIC 

2554
01:38:31,706 --> 01:38:32,940
YESTERDAY AND LOOK OUT FOR MORE 

2555
01:38:32,940 --> 01:38:36,210
ON THE STUDY AND IN YOUR FUTURE 

2556
01:38:36,210 --> 01:38:37,745
AND WANT TO MENTION OTHER WORK 

2557
01:38:37,745 --> 01:38:41,415
PUBLISHED IN THE LAST YEAR OR 

2558
01:38:41,415 --> 01:38:41,582
SO. 

2559
01:38:41,582 --> 01:38:45,887
SO WE HAVE SEEN MORE REAL WORLD 

2560
01:38:45,887 --> 01:38:47,789
STUDIES ON SUICIDE DEATH AND 

2561
01:38:47,789 --> 01:38:50,591
BEHAVIOR AND SUICIDAL IDEATION 

2562
01:38:50,591 --> 01:38:54,162
AND STUDY FROM UADA USING EXTAND

2563
01:38:54,162 --> 01:38:57,198
NAVIAN REGISTRY DATA USING NEW 

2564
01:38:57,198 --> 01:39:00,368
ACTIVE USER COMPARATOR TYPE OF 

2565
01:39:00,368 --> 01:39:01,302
APPROACH.  THEY FOUND THERE 

2566
01:39:01,302 --> 01:39:03,337
WASN'T EVIDENCE FOR INCREASED 

2567
01:39:03,337 --> 01:39:04,705
SUICIDE DEATH RISK THAT IS A 

2568
01:39:04,705 --> 01:39:06,641
HARD ONE TO STUDY BECAUSE WHEN 

2569
01:39:06,641 --> 01:39:08,376
YOU ONLY HAVE TWO OR THREE YEARS

2570
01:39:08,376 --> 01:39:11,412
OF FOLLOW UP DATA YOU ARE NOT 

2571
01:39:11,412 --> 01:39:13,080
EXPECTING TO SEE SUICIDE DEATH 

2572
01:39:13,080 --> 01:39:14,715
IN A SHORT TIME PERIOD AND HAVE 

2573
01:39:14,715 --> 01:39:16,450
TO CONTINUE TO BE CAUTION ABOUT 

2574
01:39:16,450 --> 01:39:18,953
THIS AND THEY FOUND A SMALL 

2575
01:39:18,953 --> 01:39:20,755
PROTECTIVE EFFECT FOR ANOTHER 

2576
01:39:20,755 --> 01:39:22,590
SUICIDALITY OUTCOMES THAT IS A 

2577
01:39:22,590 --> 01:39:25,626
COMPOSITE OF FATAL AND NON-FATAL

2578
01:39:25,626 --> 01:39:26,027
ATTEMPTS. 

2579
01:39:26,027 --> 01:39:27,662
ANOTHER EXAMPLE OF REAL WORLD 

2580
01:39:27,662 --> 01:39:31,065
DATA BEING USED WAS IN THE STUDY

2581
01:39:31,065 --> 01:39:34,602
OF OPIOID OVERDOSE AND SO WONG 

2582
01:39:34,602 --> 01:39:36,904
AND COLLEAGUES USED FEDERATED 

2583
01:39:36,904 --> 01:39:39,173
HEALTH CARE DATA AND COMPARED 

2584
01:39:39,173 --> 01:39:40,908
TIED TO A BUNCH OF DIFFERENT 

2585
01:39:40,908 --> 01:39:43,077
KINDS OF DIABETES MEDICATIONS 

2586
01:39:43,077 --> 01:39:47,281
AND GLP-1 RECEPTOR AGONISTS AND 

2587
01:39:47,281 --> 01:39:49,083
FOUND GLUTIDE WAS ASSOCIATED 

2588
01:39:49,083 --> 01:39:51,118
WITH LOWER RISK OVERDOSE IN 1 

2589
01:39:51,118 --> 01:39:53,754
YEAR FOLLOW UP PERIOD AND HAD 

2590
01:39:53,754 --> 01:39:55,089
PRETTY SMALL SAMPLES FOR EEP OF 

2591
01:39:55,089 --> 01:39:59,360
THE COMPARISONS 1 THOUSAND TO 

2592
01:39:59,360 --> 01:40:01,028
2,000 PATIENTS AND PROPENSITY 

2593
01:40:01,028 --> 01:40:03,231
MATCHED TO ADJUST FOR SOME 

2594
01:40:03,231 --> 01:40:04,765
CONFOUNDING AND NOW EATING 

2595
01:40:04,765 --> 01:40:06,434
DISORDER TREATMENT IS NOT MY 

2596
01:40:06,434 --> 01:40:11,572
AREA OF SXEERT TE-- EXPERTISE A 

2597
01:40:11,572 --> 01:40:13,975
LOOKED AT LITERATURE AND 

2598
01:40:13,975 --> 01:40:16,110
APPROACHES THERE AND WELCOME 

2599
01:40:16,110 --> 01:40:18,479
FEEDBACK FROM LISTENERS THAT ARE

2600
01:40:18,479 --> 01:40:20,181
EXPERTS IN THIS AND CONDITION 

2601
01:40:20,181 --> 01:40:23,184
STUDYING REAL WORLD DATA AND YOU

2602
01:40:23,184 --> 01:40:24,352
MIGHT FIND THAT PEOPLE LOSE 

2603
01:40:24,352 --> 01:40:27,655
WEIGHT AND REDUCE RISK OF EATING

2604
01:40:27,655 --> 01:40:30,024
BUT HAVE TO UNDERSTAND BETTER 

2605
01:40:30,024 --> 01:40:31,726
MALADAPTIVE THOUGHTS AND 

2606
01:40:31,726 --> 01:40:33,895
BEHAVIORS THAT COULD UNDERLINE 

2607
01:40:33,895 --> 01:40:35,096
AN EATING DISORDER AND COULD BE 

2608
01:40:35,096 --> 01:40:37,832
SATURDAYS HERBATED DURING COURSE

2609
01:40:37,832 --> 01:40:39,267
OF TREATMENT WITH MEDICATIONS 

2610
01:40:39,267 --> 01:40:40,568
AND PEOPLE THAT ARE DEVELOPING 

2611
01:40:40,568 --> 01:40:43,337
MORE FOCUS ON WEIGHT OR BODY AND

2612
01:40:43,337 --> 01:40:46,741
THIS COULD BECOME A PROBLEMATIC 

2613
01:40:46,741 --> 01:40:47,041
SITUATION. 

2614
01:40:47,041 --> 01:40:48,743
AND OF COURSE THERE COULD BE 

2615
01:40:48,743 --> 01:40:50,478
PATIENTS THAT DON'T HAVE AN 

2616
01:40:50,478 --> 01:40:52,446
EATING DISORDER AT THE BEGINNING

2617
01:40:52,446 --> 01:40:54,015
OF TREATMENT THAT DEVELOP A NEW 

2618
01:40:54,015 --> 01:40:55,816
EATING DISORDER AS PART OF THEIR

2619
01:40:55,816 --> 01:40:56,617
TREATMENT. 

2620
01:40:56,617 --> 01:40:57,818
WE REALLY DO NEED TO UNDERSTAND 

2621
01:40:57,818 --> 01:40:59,186
THIS BETTER AND SOMETHING I HAVE

2622
01:40:59,186 --> 01:41:01,722
BEEN WONDERING ABOUT IS WHAT -- 

2623
01:41:01,722 --> 01:41:05,793
WHETHER INCIDENT EATING DISORDER

2624
01:41:05,793 --> 01:41:07,061
SIMILAR TO EATING INCIDENT 

2625
01:41:07,061 --> 01:41:09,864
DEPRESSION AND SUICIDE BEHAVIOR 

2626
01:41:09,864 --> 01:41:12,600
OUTCOME COULD BE SAFETY OUTCOME 

2627
01:41:12,600 --> 01:41:14,969
IN STUDIES USING REAL WORLD DATA

2628
01:41:14,969 --> 01:41:19,006
PERHAPS MEASURING EATING 

2629
01:41:19,006 --> 01:41:20,341
DISORDER THROUGH CODES AND GIVE 

2630
01:41:20,341 --> 01:41:22,476
INITIAL SENSE WHETHER THERE IS A

2631
01:41:22,476 --> 01:41:23,911
RISK EFFECT THERE. 

2632
01:41:23,911 --> 01:41:26,080
IN SUMMARY, REAL WORLD DATA CAN 

2633
01:41:26,080 --> 01:41:27,448
FILET NEED FOR DISCOVERING 

2634
01:41:27,448 --> 01:41:29,784
POTENTIAL BENEFITS AND RISKS FOR

2635
01:41:29,784 --> 01:41:32,954
BEHAVIORAL HEALTH AND DATA 

2636
01:41:32,954 --> 01:41:34,255
MEANINGFULLY COMPLEMENT RCTS 

2637
01:41:34,255 --> 01:41:36,257
WHEN YOU HAVE ENOUGH DATA YOU 

2638
01:41:36,257 --> 01:41:37,658
ARE ABLE TO INCLUDE LOTS OF 

2639
01:41:37,658 --> 01:41:39,093
DIFFERENT PEOPLE AND RESULTS 

2640
01:41:39,093 --> 01:41:40,628
COULD BE GENERALIZABLE BECAUSE 

2641
01:41:40,628 --> 01:41:41,128
OF THAT. 

2642
01:41:41,128 --> 01:41:43,364
THEY CAN ALSO HELP US TO STUDY 

2643
01:41:43,364 --> 01:41:46,534
LOW FREQUENCY OUTCOMES AND AS 

2644
01:41:46,534 --> 01:41:47,935
MENTIONED EARLIER YOU MIGHT NEED

2645
01:41:47,935 --> 01:41:49,503
MORE DATA THAN CURRENTLY WHAT WE

2646
01:41:49,503 --> 01:41:53,074
HAVE AND SOME OUTCOMES LIKE 

2647
01:41:53,074 --> 01:41:55,009
SUICIDALITY AND ALSO EATINGIN 

2648
01:41:55,009 --> 01:41:59,880
KRIDIENTS CAN BE A VERY LOW RATE

2649
01:41:59,880 --> 01:42:01,082
AND MULTI-SITE STUDIES ARE 

2650
01:42:01,082 --> 01:42:02,984
IMPORTANT AND FUTURE WORK SEEMS 

2651
01:42:02,984 --> 01:42:05,119
IMPORTANT TO MAXIMIZE PATIENT 

2652
01:42:05,119 --> 01:42:07,455
REPORTED MEASURES NATURE OF 

2653
01:42:07,455 --> 01:42:09,323
BEHAVIORAL HEALTH CONDITIONS AND

2654
01:42:09,323 --> 01:42:14,528
THINGS WE NEED TO LEARN ABOUT 

2655
01:42:14,528 --> 01:42:14,862
FR

2656
01:42:14,862 --> 01:42:16,764
PATIENTS REPORT AND MEASURE THAT

2657
01:42:16,764 --> 01:42:18,199
IS ROUTINELY SCREENED WE WON'T 

2658
01:42:18,199 --> 01:42:20,768
BE ABLE TO CAPTURE IT EASILY AND

2659
01:42:20,768 --> 01:42:21,969
STRUCTURE HEALTH RECORD DATA AND

2660
01:42:21,969 --> 01:42:24,138
MIGHT BE SOME OTHER MEASURES OR 

2661
01:42:24,138 --> 01:42:25,706
METHODS WE COULD USE IN THE 

2662
01:42:25,706 --> 01:42:27,675
FUTURE THAT CAPITALIZE ON 

2663
01:42:27,675 --> 01:42:29,610
SEMISTRUCTURE UNSTRUCTURED TEXT 

2664
01:42:29,610 --> 01:42:33,748
FROM NOTES.  SO THIS WOULD BE IN

2665
01:42:33,748 --> 01:42:36,450
AREA OF NATURAL LANGUAGE 

2666
01:42:36,450 --> 01:42:40,087
PROCESSING OR LARGE LANGUAGE 

2667
01:42:40,087 --> 01:42:41,122
MODELING AND HAVEN'T SEEN THIS 

2668
01:42:41,122 --> 01:42:43,324
STUDY AND COULD BE AREA OF 

2669
01:42:43,324 --> 01:42:45,893
FUTURE FOCUS AND ANALYSIS I 

2670
01:42:45,893 --> 01:42:47,495
MENTIONED EARLIER ABOUT TARGETED

2671
01:42:47,495 --> 01:42:49,096
LEARNING IS AN IMPORTANT METHOD 

2672
01:42:49,096 --> 01:42:51,932
TO CONTINUE TO DEVELOP TO TRY TO

2673
01:42:51,932 --> 01:42:54,201
CREATE RIGOROUS COMPARISONS 

2674
01:42:54,201 --> 01:42:55,403
BETWEEN DIFFERENT CONDITIONS AND

2675
01:42:55,403 --> 01:42:56,704
SOMETHING I DIDN'T GET TO TALK 

2676
01:42:56,704 --> 01:42:58,973
ABOUT THAT IS IMPORTANT IS 

2677
01:42:58,973 --> 01:43:02,410
HETEROGENEITY AND ONE TYPE OF 

2678
01:43:02,410 --> 01:43:03,744
HETEROGENEITY THAT HAS BEEN 

2679
01:43:03,744 --> 01:43:04,912
NEGLECTED HAS BEEN PREVIOUS 

2680
01:43:04,912 --> 01:43:07,682
MENTAL HEALTH HISTORY AND SO IT 

2681
01:43:07,682 --> 01:43:10,418
IS A BIT EASIER SO FAR WITH REAL

2682
01:43:10,418 --> 01:43:12,787
WORLD DATA TO STUDY INCIDENT 

2683
01:43:12,787 --> 01:43:15,890
TYPES OF BEHAVIORAL HEALTH 

2684
01:43:15,890 --> 01:43:16,824
OUTCOMES CREATING CLEANER TYPE 

2685
01:43:16,824 --> 01:43:19,560
OF COMPARISON AND CAN YOU HAVE A

2686
01:43:19,560 --> 01:43:20,895
SORT OF WASH OUT PERIOD THAT CAN

2687
01:43:20,895 --> 01:43:23,330
YOU TRY TO FOCUS ON PEOPLE WHO 

2688
01:43:23,330 --> 01:43:25,099
DON'T HAVE PREVIOUS MENTAL 

2689
01:43:25,099 --> 01:43:26,600
HEALTH CONDITIONS AND CLINICALLY

2690
01:43:26,600 --> 01:43:30,738
WOULD BE USEFUL TO KNOW HOW WE 

2691
01:43:30,738 --> 01:43:34,508
ADVISE PATIENTS COMING IN WITH 

2692
01:43:34,508 --> 01:43:35,409
PRE-EXISTING SUICIDALITY AND 

2693
01:43:35,409 --> 01:43:37,111
MOOD DISORDER AND THESE PATIENTS

2694
01:43:37,111 --> 01:43:40,681
I FOCUS ON A LOT IN RESEARCH WHO

2695
01:43:40,681 --> 01:43:42,249
HAVE SERIOUS MENTAL ILLNESS AND 

2696
01:43:42,249 --> 01:43:45,052
HOW THESE MEDICATIONS ARE 

2697
01:43:45,052 --> 01:43:45,920
EFFECTING THEM. 

2698
01:43:45,920 --> 01:43:48,155
THIS IS SOMETHING THAT WE NEED 

2699
01:43:48,155 --> 01:43:50,758
TO TACKLE AND NEED TO HAPPEN IN 

2700
01:43:50,758 --> 01:43:52,560
RANDOMIZED CONTROL TRIALS AND IN

2701
01:43:52,560 --> 01:43:53,894
TERMS OF WHY TRIALS CONTINUE TO 

2702
01:43:53,894 --> 01:43:56,397
BE IMPORTANT.  I MEAN, SAME 

2703
01:43:56,397 --> 01:43:57,798
ISSUES COMING UP IN OTHER TALKS 

2704
01:43:57,798 --> 01:44:02,036
APPLY HERE AND I WANT TO 

2705
01:44:02,036 --> 01:44:03,971
EMPHASIZE THAT YES REAL WORLD 

2706
01:44:03,971 --> 01:44:07,808
DATA DOES OR IS INCLUSIVE WHEN 

2707
01:44:07,808 --> 01:44:11,378
YOU CONSIDER RCTS ARE DONE TO 

2708
01:44:11,378 --> 01:44:13,414
STUDY GLP-1 BASED MEDICATIONS 

2709
01:44:13,414 --> 01:44:15,950
FOR WEIGHT LOSS OR DIABETES AND 

2710
01:44:15,950 --> 01:44:17,551
WILL INCLUDE PEOPLE WITH GREATER

2711
01:44:17,551 --> 01:44:19,587
MENTAL HEALTH RISK IN REAL WORLD

2712
01:44:19,587 --> 01:44:21,122
DATA AND SOMETHING UNIQUE ABOUT 

2713
01:44:21,122 --> 01:44:23,591
PEOPLE WITH BEHAVIORAL HEALTH 

2714
01:44:23,591 --> 01:44:25,059
CONDITIONS WHERE THEY MIGHT NOT 

2715
01:44:25,059 --> 01:44:27,495
GET INTO REAL WORLD DATA EITHER.

2716
01:44:27,495 --> 01:44:29,964
RCTS MIGHT NEED TO BE DESIGNED 

2717
01:44:29,964 --> 01:44:33,000
NOT JUST FOR WEIGHT LOSS BUT FOR

2718
01:44:33,000 --> 01:44:33,601
THIS POPULATION AND REALLY 

2719
01:44:33,601 --> 01:44:35,903
CONSIDER INCLUSIVE ISSUES THERE.

2720
01:44:35,903 --> 01:44:38,038
SO THERE ARE PEOPLE WHO ARE NOT 

2721
01:44:38,038 --> 01:44:40,808
IN REAL WORLD DATA WHO ARE NOT 

2722
01:44:40,808 --> 01:44:42,977
BEING OBSERVED BECAUSE THEY HAVE

2723
01:44:42,977 --> 01:44:44,145
UNDIAGNOSED DEPRESSION AND DON'T

2724
01:44:44,145 --> 01:44:46,213
COME UP IN HEALTH RECORD AS 

2725
01:44:46,213 --> 01:44:47,414
HAVING DIAGNOSIS AND DON'T GET 

2726
01:44:47,414 --> 01:44:50,284
INTO THE STUDY AND MIGHT BE ON 

2727
01:44:50,284 --> 01:44:51,719
THE FRINGES OF ELIGIBILITY FOR 

2728
01:44:51,719 --> 01:44:54,955
THESE MEDICATIONS. 

2729
01:44:54,955 --> 01:44:56,257
AND SO MAYBE THEY COULD BENEFIT 

2730
01:44:56,257 --> 01:44:58,459
FROM IT AND ARE NOT GETTING IT 

2731
01:44:58,459 --> 01:45:00,161
BECAUSE THEY DON'T HAVE A HIGH 

2732
01:45:00,161 --> 01:45:03,130
ENOUGH BMI AND DON'T HAVE TYPE 2

2733
01:45:03,130 --> 01:45:04,765
DIABETES YET AND COULD BENEFIT 

2734
01:45:04,765 --> 01:45:07,101
PRANCE AND ANOTHER ISSUE IS 

2735
01:45:07,101 --> 01:45:10,738
ACCESS CHALLENGES MENTAL ILLNESS

2736
01:45:10,738 --> 01:45:12,840
AND SUBSTANCE USE DISORDER AND 

2737
01:45:12,840 --> 01:45:13,941
ECONOMIC STRUGGLES AND PATIENTS 

2738
01:45:13,941 --> 01:45:15,876
MIGHT NOT BE ABLE TO GET 

2739
01:45:15,876 --> 01:45:17,745
MEDICATIONS AT ALL AND IS 

2740
01:45:17,745 --> 01:45:20,714
GENERALLY LOTS OF STIGMA AND 

2741
01:45:20,714 --> 01:45:21,682
CHALLENGES NAVIGATING HEALTH 

2742
01:45:21,682 --> 01:45:22,917
PERSISTENCE FOR THIS POPULATION 

2743
01:45:22,917 --> 01:45:24,585
AND THEY MIGHT NOT BE ABLE TO 

2744
01:45:24,585 --> 01:45:26,353
GET MEDICATIONS BUT PERHAPS IF 

2745
01:45:26,353 --> 01:45:27,888
WE DESIGN A TRIAL WELL ENOUGH WE

2746
01:45:27,888 --> 01:45:29,757
CAN REACH PATIENTS AND ASSESS 

2747
01:45:29,757 --> 01:45:33,561
HOW THEY DO ON MEDICATIONS. 

2748
01:45:33,561 --> 01:45:35,129
AND THAT IS WHAT I HAVE FOR YOU 

2749
01:45:35,129 --> 01:45:38,666
AND WANT TO SAY THANK YOU TO MY 

2750
01:45:38,666 --> 01:45:40,935
COLLEAGUES AT KAISER AND 

2751
01:45:40,935 --> 01:45:42,403
NORTHERN CALIFORNIA AND 

2752
01:45:42,403 --> 01:45:43,204
COLLABORATORS AND THANKING 

2753
01:45:43,204 --> 01:45:44,805
NATIONAL INSTITUTES OF MENTAL 

2754
01:45:44,805 --> 01:45:47,041
HEALTH FOR SUPPORTING ME AS 

2755
01:45:47,041 --> 01:45:49,009
EARLY STAGE INVESTIGATOR WITH 

2756
01:45:49,009 --> 01:45:51,045
DEVELOPMENT AWARD AND FUNDERS OF

2757
01:45:51,045 --> 01:45:52,913
RESEARCH AND THANKS TO ALL OF 

2758
01:45:52,913 --> 01:45:55,182
YOU FOR BEING HERE AND FOR THE 

2759
01:45:55,182 --> 01:46:05,693
ORGANIZERS OF THE WORKSHOP.  

2760
01:46:09,563 --> 01:46:18,138
>> NOW WE ARE GOING TO
2I7B TO 

2761
01:46:18,138 --> 01:46:21,742
RUN AND PHARMACEUTICAL OUTCOMES 

2762
01:46:21,742 --> 01:46:31,151
AND POLICY PHARMACOINFORMATICS 

2763
01:46:31,151 --> 01:46:32,720
DISCUSSING REAL WORLD 

2764
01:46:32,720 --> 01:46:35,656
EFFECTIVENESS AND GL1 THERAPIES 

2765
01:46:35,656 --> 01:46:37,825
IN REGARDS TO NEURODEGENERATIVE 

2766
01:46:37,825 --> 01:46:39,727
DISEASES AND WITH TALKS PUT 

2767
01:46:39,727 --> 01:46:41,562
QUESTIONS IN Q & A PANEL AND

2768
01:46:41,562 --> 01:46:49,136
DISCUSS THEM AFTER SET OF FOUR 

2769
01:46:49,136 --> 01:46:51,472
PRESENTATIONS WHY DON'T YOU GO 

2770
01:46:51,472 --> 01:46:53,140
AND TAKE THE FLOOR?  

2771
01:46:53,140 --> 01:46:56,977
>> THANKS FOR NICE
INTRODUCTION 

2772
01:46:56,977 --> 01:47:00,614
AND LET ME SHARE MY SCREEN. 

2773
01:47:00,614 --> 01:47:04,818
CAN EVERYONE SEE THE SLIDE?  

2774
01:47:04,818 --> 01:47:05,252
>> YES. 

2775
01:47:05,252 --> 01:47:08,889
>> THANK YOU FOR HAVING ME
FOR 

2776
01:47:08,889 --> 01:47:10,624
THIS WORKSHOP.  IT IS A GREAT 

2777
01:47:10,624 --> 01:47:14,194
HONOR TO BE HERE TODAY GIVING A 

2778
01:47:14,194 --> 01:47:16,597
PRESENTATION ON TOPIC OF JOB 

2779
01:47:16,597 --> 01:47:20,000
RECEPTOR AGONISTS AND 

2780
01:47:20,000 --> 01:47:22,870
NEURODEGENERATIVE CONDITIONS AND

2781
01:47:22,870 --> 01:47:24,838
IN THIS TALK I WILL 

2782
01:47:24,838 --> 01:47:26,373
[INDISCERNIBLE] DEMENTIA AND 

2783
01:47:26,373 --> 01:47:29,710
ALSO BRIEFLY TOUCHING ON 

2784
01:47:29,710 --> 01:47:31,745
EMERGING EVIDENCE RELATED TO 

2785
01:47:31,745 --> 01:47:32,646
[INDISCERNIBLE] DISEASE AND THIS

2786
01:47:32,646 --> 01:47:34,381
IS MY DISCLOSURE AND RESEARCH 

2787
01:47:34,381 --> 01:47:37,117
THAT IS SUPPORTED BY SEVERAL 

2788
01:47:37,117 --> 01:47:42,389
FEDERAL AGENCIES AS WELL AS 

2789
01:47:42,389 --> 01:47:44,091
FORMER FOUNDATION AND PRESENTING

2790
01:47:44,091 --> 01:47:48,963
TODAY IS MY OWN.  IN THE NEXT 18

2791
01:47:48,963 --> 01:47:51,265
MINUTES I WILL START WITH 

2792
01:47:51,265 --> 01:47:53,500
BACKGROUND ON INTERSECTION OF 

2793
01:47:53,500 --> 01:47:56,036
OBESITY AND DIABETES AND 

2794
01:47:56,036 --> 01:47:57,137
[INDISCERNIBLE] RELATED DEMENTIA

2795
01:47:57,137 --> 01:48:00,974
AND WILL BRIEFLY REVIEW CLINICAL

2796
01:48:00,974 --> 01:48:03,944
TRIAL LANDSCAPE FOR TOPIC THAT 

2797
01:48:03,944 --> 01:48:07,081
IS SPECIFICALLY ON GLP-1 AND 

2798
01:48:07,081 --> 01:48:09,683
DEMENTIA OUTCOME AND GOING INTO 

2799
01:48:09,683 --> 01:48:11,719
REAL-WORLD EVIDENCE IN ADDITION 

2800
01:48:11,719 --> 01:48:13,153
TO SHARING EXISTING REAL WORLD 

2801
01:48:13,153 --> 01:48:16,757
STUDIES ON TOPIC AND WILL ALSO 

2802
01:48:16,757 --> 01:48:19,059
DISCUSS METHODOLOGICAL 

2803
01:48:19,059 --> 01:48:19,793
CHALLENGES SPECIFIC TO REAL 

2804
01:48:19,793 --> 01:48:23,464
WORLD STUDIES IN THIS SPACE AND 

2805
01:48:23,464 --> 01:48:25,499
I'M GLAD TO HEAR PREVIOUS 

2806
01:48:25,499 --> 01:48:27,968
SPEAKERS COVERED GENERAL ISSUES 

2807
01:48:27,968 --> 01:48:31,905
IN GLP-1 STUDIES USING REAL 

2808
01:48:31,905 --> 01:48:42,116
WORLD DATA. 

2809
01:48:45,753 --> 01:48:48,889
CURRENTLY MORE THAN 7 MILLION 

2810
01:48:48,889 --> 01:48:53,127
AMERICANS AGE 65 AND OLDER ARE 

2811
01:48:53,127 --> 01:48:59,800
LIVING WITH ALZHEIMER'S DISEASE 

2812
01:48:59,800 --> 01:49:03,704
NUMBER PROJECTED TO DOUBLE TO 14

2813
01:49:03,704 --> 01:49:06,607
MILLION AND ALREADY CURRENTLY IS

2814
01:49:06,607 --> 01:49:09,076
7TH LEADING CAUSE OF DEATH IN 

2815
01:49:09,076 --> 01:49:10,611
UNITED STATES AND MORTALITY RATE

2816
01:49:10,611 --> 01:49:13,580
CONTINUES TO RISE. 

2817
01:49:13,580 --> 01:49:17,551
IT IS STRIKING TO SEE THAT.  

2818
01:49:17,551 --> 01:49:20,387
MANY OTHER CHRONIC DISEASE LIKE 

2819
01:49:20,387 --> 01:49:22,156
STROKE AND HEART DISEASE 

2820
01:49:22,156 --> 01:49:23,757
MORTALITY IS DECREASING IN PAST 

2821
01:49:23,757 --> 01:49:27,461
TWO DECADES AND THE ADRD 

2822
01:49:27,461 --> 01:49:31,932
MORTALITY HAS BEEN RISING A LOT 

2823
01:49:31,932 --> 01:49:36,670
AND DESPITE GLOWING ECONOMIC 

2824
01:49:36,670 --> 01:49:38,138
CONDITION EFFECTIVE TREATMENT 

2825
01:49:38,138 --> 01:49:41,241
OPTION REMAIN OR ARE LIMITED 

2826
01:49:41,241 --> 01:49:43,677
URGING NEEDS PREVENTIVE 

2827
01:49:43,677 --> 01:49:45,913
STRATEGIES AND THERAPEUTIC 

2828
01:49:45,913 --> 01:49:46,246
TARGETS. 

2829
01:49:46,246 --> 01:49:48,615
SO LET'S TALK ABOUT A LITTLE OF 

2830
01:49:48,615 --> 01:49:51,351
GLP-1 AND HAVING TO TALK A LOT 

2831
01:49:51,351 --> 01:49:53,120
ABOUT RECEPTOR AGONISTS 

2832
01:49:53,120 --> 01:49:55,155
YESTERDAY AND TODAY AND WE KNOW 

2833
01:49:55,155 --> 01:49:58,725
IT IS AN ISSUE AND 

2834
01:49:58,725 --> 01:50:01,462
[INDISCERNIBLE] FOR TREATMENT OF

2835
01:50:01,462 --> 01:50:05,466
TYPE 2 DIABETES AND EXPANDED TO 

2836
01:50:05,466 --> 01:50:05,966
MANAGEMENT BECAUSE OF 

2837
01:50:05,966 --> 01:50:07,935
SIGNIFICANT BENEFIT OF LOWER 

2838
01:50:07,935 --> 01:50:11,872
BODY WEIGHT AND SO BASED ON A 

2839
01:50:11,872 --> 01:50:13,106
RESEARCH [INDISCERNIBLE] 

2840
01:50:13,106 --> 01:50:13,807
PUBLISHED IN [INDISCERNIBLE] 

2841
01:50:13,807 --> 01:50:19,179
LAST YEAR CURRENTLY BASED ON 

2842
01:50:19,179 --> 01:50:25,119
EXIST

2843
01:50:25,119 --> 01:50:31,492
EXIST

2844
01:50:31,492 --> 01:50:32,025
EXISTING  236789 /* -- 

2845
01:50:32,025 --> 01:50:33,026
POTENTIALLY ELIGIBLE FOR 

2846
01:50:33,026 --> 01:50:37,998
RECEPTOR AGONISTS AND SOME 

2847
01:50:37,998 --> 01:50:40,767
GROUPS FOR EXAMPLE HAVE BECOME 

2848
01:50:40,767 --> 01:50:43,737
BEST SELLING DRUG IN US IN 2023 

2849
01:50:43,737 --> 01:50:46,507
IN A COUPLE YEARS APPROVED IN 

2850
01:50:46,507 --> 01:50:49,042
MARKET AND OWN WORK USING DATA 

2851
01:50:49,042 --> 01:50:52,179
FROM DATA FLORIDA WE OBSERVED A 

2852
01:50:52,179 --> 01:50:54,915
MORE THAN 10 INCREASE IN JOB 

2853
01:50:54,915 --> 01:50:57,384
HUMOR RECEPTOR AGONISTS USED 

2854
01:50:57,384 --> 01:50:59,820
BETWEEN 2020 AND 2023 IN ALL 

2855
01:50:59,820 --> 01:51:02,589
THESE THREE YEARS REFLECTING 

2856
01:51:02,589 --> 01:51:06,693
RAPID UPTAKE OF THERAPIES IN 

2857
01:51:06,693 --> 01:51:17,137
REAL WORLD SETTINGS TYPE 2 

2858
01:51:17,137 --> 01:51:21,108
DIABETES ALZHEIMER'S DISEASE AND

2859
01:51:37,224 --> 01:51:39,860
RETHEY LOWER BODY WEIGHT AND 

2860
01:51:39,860 --> 01:51:45,132
OBESITY DIABETES POPULATION THEY

2861
01:51:45,132 --> 01:51:47,034
HAVE NEUROPROTECTIVE EFFECT AND 

2862
01:51:47,034 --> 01:51:50,871
PRECLINICAL AND TRANSLATIONAL 

2863
01:51:50,871 --> 01:51:53,473
STUDIES SUGGEST THAT GLP-1 

2864
01:51:53,473 --> 01:51:56,109
RECEPTOR AGONISTS DELAY SEVERAL 

2865
01:51:56,109 --> 01:52:05,619
KEY PATHWAYS INCLUDING REDUCING 

2866
01:52:05,619 --> 01:52:09,323
-- AND MITIGATING OXIDATIVE 

2867
01:52:09,323 --> 01:52:12,593
STRESS AND ALL TOGETHER 

2868
01:52:12,593 --> 01:52:15,329
INTERSECTION FORMS STRONG 

2869
01:52:15,329 --> 01:52:16,997
BIOLOGICAL RATIONAL FOR 

2870
01:52:16,997 --> 01:52:19,299
INVESTIGATING GLP-1 AGONIST FOR 

2871
01:52:19,299 --> 01:52:23,036
POTENTIAL STRATEGY FOR DEMENTIA 

2872
01:52:23,036 --> 01:52:23,437
TREATMENT.  

2873
01:52:23,437 --> 01:52:25,739
CURRENTLY NO RANDOMIZED TRIALS 

2874
01:52:25,739 --> 01:52:29,109
HAVE BEEN PUBLISHED TO 

2875
01:52:29,109 --> 01:52:31,645
SPECIFICALLY ASSESS THE DEMENTIA

2876
01:52:31,645 --> 01:52:35,983
OUTCOMES WITH GLP-1 RECEPTOR 

2877
01:52:35,983 --> 01:52:38,118
AGONISTS AND EVIDENCE-BASE COMES

2878
01:52:38,118 --> 01:52:41,021
FROM MY ANALYSIS OF EXISTING 

2879
01:52:41,021 --> 01:52:43,090
METABOLIC OUTCOME RCTS. 

2880
01:52:43,090 --> 01:52:45,826
THIS IS ONE OF OUR INITIAL 

2881
01:52:45,826 --> 01:52:48,562
METAANALYSIS OF CARDIO METABOLIC

2882
01:52:48,562 --> 01:52:51,698
OUTCOME TRIALS AND WE EVALUATED 

2883
01:52:51,698 --> 01:52:57,871
21 RANDOMIZED TRIALS INCLUDING A

2884
01:52:57,871 --> 01:53:01,041
TOTAL OF 167 PARTICIPANTS 

2885
01:53:01,041 --> 01:53:03,043
OBSERVING THE SIGNAL AND 

2886
01:53:03,043 --> 01:53:05,312
SUGGESTING A PROTECTIVE 

2887
01:53:05,312 --> 01:53:08,582
POTENTIAL BENEFIT OF GLP-1 

2888
01:53:08,582 --> 01:53:14,187
RECEPTORS IN REDUCING RISK OF 

2889
01:53:14,187 --> 01:53:15,355
MUSCULAR DIM ENSHH AND WHILE 

2890
01:53:15,355 --> 01:53:18,525
NUMBER OBSERVED IN ADR ONES ARE 

2891
01:53:18,525 --> 01:53:20,027
VERY, VERY LOW IN THESE TRIALS 

2892
01:53:20,027 --> 01:53:29,136
AND MOST OF THE ASSOCIATION DID 

2893
01:53:29,136 --> 01:53:30,504
NOT REACH STATISTICAL 

2894
01:53:30,504 --> 01:53:32,039
SIGNIFICANCE IN DEMENTIA OUTCOME

2895
01:53:32,039 --> 01:53:37,511
AND CONDUCTED UPDATED NETWORK 

2896
01:53:37,511 --> 01:53:42,315
METAANALYSIS THAT INCLUDE 26RCT 

2897
01:53:42,315 --> 01:53:45,085
THIS TIME AND INVOLVING ALMOST 

2898
01:53:45,085 --> 01:53:48,155
200,000 PARTICIPANTS AND IN THIS

2899
01:53:48,155 --> 01:53:50,857
NETWORK WE EXAMINED A TOTE AFTER

2900
01:53:50,857 --> 01:53:54,528
OF SIX CLINICAL DOMAINS 

2901
01:53:54,528 --> 01:53:57,130
ASSESSING 21 INDIVIDUAL HEALTH 

2902
01:53:57,130 --> 01:54:01,034
OUTCOMES AND WE FOCUS ON 

2903
01:54:01,034 --> 01:54:02,436
NEURODEGENERATIVE DISEASE DOMAIN

2904
01:54:02,436 --> 01:54:06,640
AND MOST FINDINGS RELATED TO 

2905
01:54:06,640 --> 01:54:10,343
DEMENTIA AND PARKINSON'S DISEASE

2906
01:54:10,343 --> 01:54:13,113
REMAIN NONSIGNIFICANT AND 

2907
01:54:13,113 --> 01:54:16,683
FUNDING POINTING OUT DIRECTION 

2908
01:54:16,683 --> 01:54:19,152
AND UNDERSCORE LIMITATIONS OF 

2909
01:54:19,152 --> 01:54:22,422
RELYING ON EXISTING METABOLIC 

2910
01:54:22,422 --> 01:54:25,392
TRIALS RELATING TO DEMENTIA AND 

2911
01:54:25,392 --> 01:54:27,828
OTHER DEGENERATIVE OUTCOMES AND 

2912
01:54:27,828 --> 01:54:34,367
CURRENTLY TWO LARGE RCTS ONGOING

2913
01:54:34,367 --> 01:54:37,604
IN WORK AND IN EVOKE PLUS 

2914
01:54:37,604 --> 01:54:39,339
INVOLVING EARLY ALZHEIMER'S 

2915
01:54:39,339 --> 01:54:43,710
DISEASE PATIENTS AND EACH TRIAL 

2916
01:54:43,710 --> 01:54:46,446
ENROLLED ABOUT 1,800 

2917
01:54:46,446 --> 01:54:47,647
PARTICIPANTS APPLYING TO FOLLOW 

2918
01:54:47,647 --> 01:54:49,216
UP TO THREE YEARS AND MAIN 

2919
01:54:49,216 --> 01:54:53,520
RESULT WOULD BE EVALUATED AT END

2920
01:54:53,520 --> 01:54:55,922
OF THE SECOND YEAR AND EXTENSION

2921
01:54:55,922 --> 01:54:57,624
RESULT WILL BE EVALUATED IN THE 

2922
01:54:57,624 --> 01:55:00,427
END OF 9 THIRD YEAR. 

2923
01:55:00,427 --> 01:55:06,199
WE ARE REALLY LOOKING FORWARD TO

2924
01:55:06,199 --> 01:55:09,536
RESULTS HOPEFULLY COMING OUT IN 

2925
01:55:09,536 --> 01:55:17,110
NEXT FEW MONTHS IN LATE 2025 AND

2926
01:55:17,110 --> 01:55:23,583
2026.  

2927
01:55:23,583 --> 01:55:26,419
IN SUMMARY SO FAR TREATMENT 

2928
01:55:26,419 --> 01:55:28,488
CENTER SEVERAL KEY LIMITATIONS 

2929
01:55:28,488 --> 01:55:30,157
IN THIS CONTEXT THAT IS 

2930
01:55:30,157 --> 01:55:34,361
PERCEIVED IN EVALUATING ADRD 

2931
01:55:34,361 --> 01:55:35,862
OUTCOME.  FIRST DEMENTIA 

2932
01:55:35,862 --> 01:55:38,398
OUTCOMES TYPICALLY REQUIRE VERY 

2933
01:55:38,398 --> 01:55:39,900
LONG-TERM FOLLOW UP THAT IS VERY

2934
01:55:39,900 --> 01:55:42,102
DIFFICULT TO ACCOMMODATE IN MOST

2935
01:55:42,102 --> 01:55:49,109
OF THE CLINICAL TRIAL SETTINGS. 

2936
01:55:49,109 --> 01:55:54,481
ALSO SAMPLE SIZE IN THIS TRIAL 

2937
01:55:54,481 --> 01:55:55,115
[INDISCERNIBLE] TREATMENT ACROSS

2938
01:55:55,115 --> 01:55:58,251
SUBGROUP OF PATIENT POPULATION 

2939
01:55:58,251 --> 01:56:00,187
AND CHALLENGES UNDERSCORE 

2940
01:56:00,187 --> 01:56:02,389
CRITICAL ROLE OF ROBUST 

2941
01:56:02,389 --> 01:56:04,024
REAL-WORLD EVIDENCE IN FIELDING 

2942
01:56:04,024 --> 01:56:07,327
KNOWLEDGE GAP AND PROVIDING 

2943
01:56:07,327 --> 01:56:08,495
COMPLEMENTARY INSIGHTS INTO LONG

2944
01:56:08,495 --> 01:56:11,665
TERM NEUROPROTECTIVE POTENTIAL 

2945
01:56:11,665 --> 01:56:20,240
FOR JOB QR RECEPTOR AGONISTS 

2946
01:56:20,240 --> 01:56:22,275
LET'S LOOK INTO REAL-WORLD 

2947
01:56:22,275 --> 01:56:24,711
EVIDENCE AND CONDUCT ANALYSIS OF

2948
01:56:24,711 --> 01:56:25,545
OBSERVATIONAL STUDIES AND FROM 

2949
01:56:25,545 --> 01:56:29,716
THAT THAT IS ABOUT 2 TO 3 YEARS 

2950
01:56:29,716 --> 01:56:30,116
AGO. 

2951
01:56:30,116 --> 01:56:33,153
WE IDENTIFY STUDIES AND INSPECT 

2952
01:56:33,153 --> 01:56:37,123
THEM AND FROM THAT ALL THREE 

2953
01:56:37,123 --> 01:56:40,327
[INDISCERNIBLE] DRUGS RECEPTOR 

2954
01:56:40,327 --> 01:56:44,531
[INDISCERNIBLE] GL2 INHIBITORS, 

2955
01:56:44,531 --> 01:56:45,999
INHIBITORS ARE SIGNIFICANTLY 

2956
01:56:45,999 --> 01:56:49,102
ASSOCIATED WITH LOWER RISK OF 

2957
01:56:49,102 --> 01:56:50,737
[INDISCERNIBLE] DEMENTIA.  AS 

2958
01:56:50,737 --> 01:56:55,342
YOU CAN SEE THAT THE ANALYSIS 

2959
01:56:55,342 --> 01:56:57,277
REVIEWED SUBSTANTIAL HETERAUTO 

2960
01:56:57,277 --> 01:57:00,280
JENAETY ACROSS STUDIES AND ALSO 

2961
01:57:00,280 --> 01:57:02,749
NONE OF THESE INCLUDED STUDIES 

2962
01:57:02,749 --> 01:57:05,886
ADJUSTED FOR IMPORTANT 

2963
01:57:05,886 --> 01:57:08,955
CONFOUNDERS SUCH AS BMI IN 

2964
01:57:08,955 --> 01:57:12,125
HEMOGLOBIN A1C AND LIMITATIONS 

2965
01:57:12,125 --> 01:57:14,828
POINT TO NEEDS FOR MORE 

2966
01:57:14,828 --> 01:57:16,596
RIGOROUSLY DESIGNED REAL WORLD 

2967
01:57:16,596 --> 01:57:19,065
STUDIES THAT ACCOUNT FOR KEY 

2968
01:57:19,065 --> 01:57:20,567
METABOLIC FACTORS. 

2969
01:57:20,567 --> 01:57:24,704
SO IN OUR OWN STUDY, WE EMULATED

2970
01:57:24,704 --> 01:57:29,109
A TARGETED TRIAL USING REAL 

2971
01:57:29,109 --> 01:57:30,043
WORLD DATA FROM FLAR DAH AND 

2972
01:57:30,043 --> 01:57:33,680
ELECTRONIC HEALTH RECORD AND 

2973
01:57:33,680 --> 01:57:35,916
CONDUCTED THREE EMULATED TRIAL 

2974
01:57:35,916 --> 01:57:40,086
COHORT AND ONE COMPARING GLP-1 

2975
01:57:40,086 --> 01:57:42,689
RECEPTOR AGONISTS TO OTHER LINE 

2976
01:57:42,689 --> 01:57:44,891
GLUCOSE [INDISCERNIBLE] IN OUR 

2977
01:57:44,891 --> 01:57:49,129
PATIENTS AND SECOND COMPARING 

2978
01:57:49,129 --> 01:57:53,133
SGLT2 INHIBITORS VERSUS OTHER 

2979
01:57:53,133 --> 01:57:55,302
GLUCOSE LOWERING DRUG AND THIRD 

2980
01:57:55,302 --> 01:57:57,137
COHORT CONDUCTING DIRECT HEAD TO

2981
01:57:57,137 --> 01:58:05,111
HEAD COMPARISON OF GLT1 -- STUDY

2982
01:58:05,111 --> 01:58:07,314
DESIGNED FOLLOWING AN ALREADY 

2983
01:58:07,314 --> 01:58:08,615
CONVENTIONAL 

2984
01:58:08,615 --> 01:58:09,249
PHARMACO[INDISCERNIBLE] ACTIVE 

2985
01:58:09,249 --> 01:58:13,119
NEW USER ACTIVE COMPARATOR 

2986
01:58:13,119 --> 01:58:14,654
INTEND TO TREAT. 

2987
01:58:14,654 --> 01:58:19,059
SO OUR FINDINGS SHOWED A 

2988
01:58:19,059 --> 01:58:20,393
SIGNIFICANT LOWER RISK OF 

2989
01:58:20,393 --> 01:58:23,363
ALZHEIMER'S DISEASE AND RELATED 

2990
01:58:23,363 --> 01:58:26,533
DEMENTIAS AND ASSOCIATED WITH 

2991
01:58:26,533 --> 01:58:30,103
GLP-1 RECEPTOR AGONISTS IN THIS 

2992
01:58:30,103 --> 01:58:32,939
THE GREEN LINE IS FOR GLP 

2993
01:58:32,939 --> 01:58:34,908
RECEPTOR AND RED LINE FOR OTHER 

2994
01:58:34,908 --> 01:58:37,410
SECOND LINE GLUCOSE LOWERING 

2995
01:58:37,410 --> 01:58:40,547
DRUGS AND RESULTS WERE 

2996
01:58:40,547 --> 01:58:42,849
CONSISTENT ACROSS SUBGROUPS IN 

2997
01:58:42,849 --> 01:58:44,317
GENERAL.  WE CAN SEE SOME 

2998
01:58:44,317 --> 01:58:47,620
SUBGROUPS THAT WE HAD SAMPLES 

2999
01:58:47,620 --> 01:58:49,122
ISSUE OVERALL DIRECTION AND WERE

3000
01:58:49,122 --> 01:58:54,928
VERY CONSISTENT ACROSS THESE 

3001
01:58:54,928 --> 01:58:55,228
SUBGROUPS. 

3002
01:58:55,228 --> 01:58:58,064
SIMILARLY, SGLT2 INHIBITORS 

3003
01:58:58,064 --> 01:59:01,101
ASSOCIATED WITH LOWER RISK ADRD 

3004
01:59:01,101 --> 01:59:02,469
COMPARED TO OTHER GLUCOSE 

3005
01:59:02,469 --> 01:59:05,105
LOWERING DRUGS AND AGAIN IN A 

3006
01:59:05,105 --> 01:59:08,241
COUPLE OF NEAR GRAPH THE GREEN 

3007
01:59:08,241 --> 01:59:12,779
LINES THAT EXTENDS FOR SGLT 

3008
01:59:12,779 --> 01:59:15,048
INHIBITORS AND GLUCOSE LOWERING 

3009
01:59:15,048 --> 01:59:17,717
DRUGS AND PRE-SPECIFIED SUBGROUP

3010
01:59:17,717 --> 01:59:19,352
ANALYSIS WERE CONSISTENT AND 

3011
01:59:19,352 --> 01:59:22,122
WHEN DIRECTLY COMPARING JOB 

3012
01:59:22,122 --> 01:59:26,993
RECEPTOR AGONISTS TO SGL 

3013
01:59:26,993 --> 01:59:28,828
INHIBITORS THERE IS NO REAL 

3014
01:59:28,828 --> 01:59:31,831
SIGNIFICANT DIFFERENCE OBSERVED.

3015
01:59:31,831 --> 01:59:36,036
WE THEN USED THE CAUSAL AM 

3016
01:59:36,036 --> 01:59:39,005
METHOD TO EXPLORE HETEROGENEITY 

3017
01:59:39,005 --> 01:59:40,707
FACTORS THROUGH DATA DRIVEN 

3018
01:59:40,707 --> 01:59:43,009
APPROACH AND MODELS 

3019
01:59:43,009 --> 01:59:45,111
INTERESTINGLY REVIEWED SPECIFIC 

3020
01:59:45,111 --> 01:59:47,113
SUBGROUPS THAT BENEFIT RISK 

3021
01:59:47,113 --> 01:59:50,283
ACTUALLY WERE THOSE WHO HAD 

3022
01:59:50,283 --> 01:59:52,419
HIGHER BASED METABOLIC RISK AND 

3023
01:59:52,419 --> 01:59:55,021
THOSE PEOPLE SEEM TO GET MORE 

3024
01:59:55,021 --> 01:59:57,123
NEUROPROTECTION BENEFIT FROM 

3025
01:59:57,123 --> 02:00:00,393
GLP-1 RECEPTOR AGONISTS AND FOR 

3026
02:00:00,393 --> 02:00:05,398
EXAMPLE FOR BOTH GLP-1 AND SGLT2

3027
02:00:05,398 --> 02:00:11,237
INHIBITOR GROUPS, PEOPLE WITH 

3028
02:00:11,237 --> 02:00:11,938
BOTH CARDIOVASCULAR 

3029
02:00:11,938 --> 02:00:12,906
[INDISCERNIBLE] AND 

3030
02:00:12,906 --> 02:00:15,942
CARDIOVASCULAR CONDITIONS 

3031
02:00:15,942 --> 02:00:20,113
BENEFIT THE MOST FROM LOWER ADRD

3032
02:00:20,113 --> 02:00:25,118
RISK FROM RECEPTOR COMPARED TO 

3033
02:00:25,118 --> 02:00:27,520
OTHER GLUCOSE LOWERING DRUGS AND

3034
02:00:27,520 --> 02:00:30,623
PATTERNS FOUND IN SGLT2 

3035
02:00:30,623 --> 02:00:33,126
INHIBITORS AND EVEN THOUGH IN 

3036
02:00:33,126 --> 02:00:35,228
THE COMPARISON BETWEEN THESE 

3037
02:00:35,228 --> 02:00:38,164
INHIBITORS EVEN THE OVERALL 

3038
02:00:38,164 --> 02:00:40,700
AVERAGE BENEFIT WAS SIMILAR 

3039
02:00:40,700 --> 02:00:42,569
BETWEEN TWO GROUPS AND PATIENTS 

3040
02:00:42,569 --> 02:00:47,640
WE OBSERVED THAT PATIENTS WITH 

3041
02:00:47,640 --> 02:00:49,209
THIS AND THIS MAY BENEFIT MOST 

3042
02:00:49,209 --> 02:00:51,811
FROM GLP RECEPTOR AGONISTS 

3043
02:00:51,811 --> 02:00:55,415
COMPARED TO SGLT2 INHIBITORS AND

3044
02:00:55,415 --> 02:00:58,051
STEP FORWARD WE APPLIED A CAUSAL

3045
02:00:58,051 --> 02:01:01,521
MEDIATION ANALYSIS TO 

3046
02:01:01,521 --> 02:01:04,824
INVESTIGATE WHETHER THE 

3047
02:01:04,824 --> 02:01:07,327
IMPROVEMENT IN HEMOGLOBIN A1C 

3048
02:01:07,327 --> 02:01:13,399
AND BMI TWO WILD KNOWN CARDIO 

3049
02:01:13,399 --> 02:01:16,536
METABOLIC MARKERS MIGHT EXPLAIN 

3050
02:01:16,536 --> 02:01:17,570
OBSERVED NEUROPROTECTIVE IN FACT

3051
02:01:17,570 --> 02:01:21,007
OF GLP-1 RECEPTOR AGONISTS ON 

3052
02:01:21,007 --> 02:01:24,611
ADRD RISKS AND IS A -- YEAH.  WE

3053
02:01:24,611 --> 02:01:28,681
TRY TO QUANTIFY TO WHAT EXTENT 

3054
02:01:28,681 --> 02:01:30,817
THOSE BIOMARKERS PLAY A ROLE AS 

3055
02:01:30,817 --> 02:01:33,753
A CAUSAL MEDIATOR. 

3056
02:01:33,753 --> 02:01:35,555
INTERESTINGLY, OUR RESULTS 

3057
02:01:35,555 --> 02:01:38,124
SHOWED THAT THE REDUCTION OF 

3058
02:01:38,124 --> 02:01:43,396
ADRD RISK ASSOCIATED WITH GLP-1 

3059
02:01:43,396 --> 02:01:46,799
RECEPTOR AGONISTS USED APPEAR TO

3060
02:01:46,799 --> 02:01:50,403
BE LARGELY INDEPENDIENT OF THIS 

3061
02:01:50,403 --> 02:01:55,408
OR BMI AND PROPORTION OF 

3062
02:01:55,408 --> 02:01:58,444
MEDIATED THROUGH EITHER 

3063
02:01:58,444 --> 02:02:05,118
HEMOGLOBIN A1C AND 

3064
02:02:05,118 --> 02:02:06,886
[INDISCERNIBLE] WITHOUT 

3065
02:02:06,886 --> 02:02:08,021
STATISTICAL SIGNIFICANCE AND 

3066
02:02:08,021 --> 02:02:11,124
WORKING WITH REAL WORLD DATA AND

3067
02:02:11,124 --> 02:02:12,392
SPECIFIC TOPIC COMES WITH OWN 

3068
02:02:12,392 --> 02:02:14,060
SIDE OF CHALLENGES AND HAVE 

3069
02:02:14,060 --> 02:02:15,028
THREE OF THEM HERE. 

3070
02:02:15,028 --> 02:02:19,432
FIRST OF ALL ADRD IS OFTEN 

3071
02:02:19,432 --> 02:02:21,801
MISCLASSIFIED WHEN USING ONLY 

3072
02:02:21,801 --> 02:02:25,138
ICD CODES AND APPLYING DATA 

3073
02:02:25,138 --> 02:02:27,640
COMPUTATIONAL PHENOTYPES IS 

3074
02:02:27,640 --> 02:02:30,243
CONSIDERITY CALLING AND ALSO AS 

3075
02:02:30,243 --> 02:02:33,713
WE KNOW THAT NEURODEGENERATIVE 

3076
02:02:33,713 --> 02:02:37,417
DISORDERS INCLUDING ADRD ONSITE 

3077
02:02:37,417 --> 02:02:40,186
AND MAY PROCEED BEFORE THE 

3078
02:02:40,186 --> 02:02:42,055
MEDICATION EXPOSURE BECAUSE OF 

3079
02:02:42,055 --> 02:02:45,892
THE DELAYED DIAGNOSIS AND 

3080
02:02:45,892 --> 02:02:47,093
CAREFUL CONSIDERATIONS ON STUDY 

3081
02:02:47,093 --> 02:02:50,630
DESIGN AND SENSITIVITY ANALYSIS 

3082
02:02:50,630 --> 02:02:52,632
IS VERY IMPORTANT.  

3083
02:02:52,632 --> 02:02:54,100
OUR FIRST SPEAKER COVERED A LOT 

3084
02:02:54,100 --> 02:02:58,204
OF THE CHALLENGES IN SELECTING 

3085
02:02:58,204 --> 02:03:01,474
COMPARATORS AND THERE IS REALLY 

3086
02:03:01,474 --> 02:03:03,610
NO APPROPRIATE ACTIVE COMPARATOR

3087
02:03:03,610 --> 02:03:07,413
DRUG FOR GLP-1 RECEPTOR AGONIST 

3088
02:03:07,413 --> 02:03:08,715
IN WHICH [INDISCERNIBLE] SO FAR 

3089
02:03:08,715 --> 02:03:12,819
AND CHALLENGE FOR US TO HAVE 

3090
02:03:12,819 --> 02:03:14,587
THOSE CONFOUNDING INDICATION. 

3091
02:03:14,587 --> 02:03:19,425
THIS IS A CASE STUDY THAT 

3092
02:03:19,425 --> 02:03:22,895
DESCRIBED DEVELOPMENT 

3093
02:03:22,895 --> 02:03:24,063
COMPUTATIONAL PHENOTYPE AND THIS

3094
02:03:24,063 --> 02:03:27,767
USED FOR EHRE DATA AND THIS 

3095
02:03:27,767 --> 02:03:30,737
PERFORMING CD ALGORITHM BASED ON

3096
02:03:30,737 --> 02:03:34,674
THIS REQUIRED PRESENSE OF TWO AD

3097
02:03:34,674 --> 02:03:37,110
RELATED CODE AND AT LEAST ONE 

3098
02:03:37,110 --> 02:03:39,712
RELEVANT KEY WORD IDENTIFIED IN 

3099
02:03:39,712 --> 02:03:43,483
CLINICAL NODES AND THIS USING 

3100
02:03:43,483 --> 02:03:45,852
DATA FROM [INDISCERNIBLE] AND WE

3101
02:03:45,852 --> 02:03:48,221
EXTERNALLY VALIDATED INTO 

3102
02:03:48,221 --> 02:03:52,425
INDEPENDENT HEALTHCARE NETWORKS.

3103
02:03:52,425 --> 02:03:54,894
OKAY.  BEYOND ALZHEIMER'S 

3104
02:03:54,894 --> 02:03:56,596
DISEASE AND DEMENTIA THIS IS 

3105
02:03:56,596 --> 02:04:01,434
ALSO BEING INVESTIGATED FOR 

3106
02:04:01,434 --> 02:04:02,769
PARKINSON'S DISEASE. 

3107
02:04:02,769 --> 02:04:07,440
THIS PHASE 2 TRIAL WAS PUBLISHED

3108
02:04:07,440 --> 02:04:10,643
LAST YEAR AND SHOWED THAT 

3109
02:04:10,643 --> 02:04:12,245
[INDISCERNIBLE] THERAPY RESULTS 

3110
02:04:12,245 --> 02:04:14,747
IN LESS PROGRESSION OF MOTOR 

3111
02:04:14,747 --> 02:04:16,783
DISABILITY THAN PLACEBO AT 12 

3112
02:04:16,783 --> 02:04:21,120
MONTHS AND IS VERY EXCITING AND 

3113
02:04:21,120 --> 02:04:22,322
[INDISCERNIBLE] DATA.  HOWEVER, 

3114
02:04:22,322 --> 02:04:26,392
IN THIS YEAR, A COUPLE OF MONTHS

3115
02:04:26,392 --> 02:04:29,128
AGO, PHASE 3 TRIAL WITH 

3116
02:04:29,128 --> 02:04:30,330
[INDISCERNIBLE] PUBLISHED DID 

3117
02:04:30,330 --> 02:04:33,132
NOT PUBLISH IN LESS THAN AND DID

3118
02:04:33,132 --> 02:04:37,136
NOT CONFORM DISEASE MODIFYING IN

3119
02:04:37,136 --> 02:04:40,506
FACT FOR PARKINSON'S DISEASE AND

3120
02:04:40,506 --> 02:04:42,542
BOTH CLINICAL TRIALS MORE SAMPLE

3121
02:04:42,542 --> 02:04:46,012
SIZE AND COVERED PEOPLE WITH 

3122
02:04:46,012 --> 02:04:47,647
EARLY PARKINSON'S DISEASE AND 

3123
02:04:47,647 --> 02:04:49,415
OUR INITIAL TARGET TRIAL 

3124
02:04:49,415 --> 02:04:50,817
EMULATION STUDY WAS CONDUCTED 

3125
02:04:50,817 --> 02:04:54,454
ABOUT TWO YEARS AGO. 

3126
02:04:54,454 --> 02:04:58,758
BACK THEN, WE EXAMINED AMONG 

3127
02:04:58,758 --> 02:05:00,960
PATIENTS WITH TYPE 2 DIABETES 

3128
02:05:00,960 --> 02:05:01,427
AND AGONISTS WITH 

3129
02:05:01,427 --> 02:05:03,596
[INDISCERNIBLE] INHIBITORS IN 

3130
02:05:03,596 --> 02:05:05,498
RELATION TO PARKINSON'S DISEASE 

3131
02:05:05,498 --> 02:05:09,435
RISK AND FOUND THAT GLP-1 WAS 

3132
02:05:09,435 --> 02:05:16,042
ASSOCIATED WITH A LOWER RISK OF 

3133
02:05:16,042 --> 02:05:16,909
DEVELOPING PARKINSON'S DISEASE 

3134
02:05:16,909 --> 02:05:19,579
SEEN IN THIS PARAGRAPH BLUE 

3135
02:05:19,579 --> 02:05:23,916
LINES FOR THIS RECEPTOR AGONIST 

3136
02:05:23,916 --> 02:05:26,219
AND THESE INHIBITORS. 

3137
02:05:26,219 --> 02:05:31,924
SO BY FAR, A LOT OF STUDIES ARE 

3138
02:05:31,924 --> 02:05:35,595
LOOKING AT THE HIGH RISK 

3139
02:05:35,595 --> 02:05:39,065
POPULATION OLDER AGE AND 

3140
02:05:39,065 --> 02:05:42,869
DIABETES AND OBESITY METABOLIC 

3141
02:05:42,869 --> 02:05:46,639
PROFILE IN RISK OF CLINICAL 

3142
02:05:46,639 --> 02:05:47,640
ENDPOINT SUCH AS [INDISCERNIBLE]

3143
02:05:47,640 --> 02:05:51,244
IN THIS ONGOING PROJECT WE 

3144
02:05:51,244 --> 02:05:53,913
EXAMINE THE EFFECT OF GLP 

3145
02:05:53,913 --> 02:05:56,015
RECEPTOR AGONIST IN PATIENTS 

3146
02:05:56,015 --> 02:06:01,788
WITH REM SLEEP BEHAVIOR DISORDER

3147
02:06:01,788 --> 02:06:03,022
AND STRONG [INDISCERNIBLE] 

3148
02:06:03,022 --> 02:06:09,896
INDICATOR OF PARKINSON'S DISEASE

3149
02:06:09,896 --> 02:06:12,598
SPECIFICALLY SEEING WHETHER THIS

3150
02:06:12,598 --> 02:06:16,636
IMPACT ON DISEASE PROGRESSION. 

3151
02:06:16,636 --> 02:06:20,973
WE LOOK AT THE IMPACT OF GLP-1 

3152
02:06:20,973 --> 02:06:22,141
ON PHENOCONVERSION RISK AND 

3153
02:06:22,141 --> 02:06:26,813
TIMING FROM RBDE TO PARKINSON'S 

3154
02:06:26,813 --> 02:06:31,284
DISEASE THIS STUDY IS 

3155
02:06:31,284 --> 02:06:32,952
PRELIMINARY FUNDING AND SAMPLE 

3156
02:06:32,952 --> 02:06:33,586
PATIENTS WITH [INDISCERNIBLE] 

3157
02:06:33,586 --> 02:06:36,389
AND THEY ARE PROMISING THIS VERY

3158
02:06:36,389 --> 02:06:38,291
LARGE COMPETENCE INTERVAL THAT 

3159
02:06:38,291 --> 02:06:40,059
IS A SMALL SAMPLE SIZE AND WE 

3160
02:06:40,059 --> 02:06:42,128
ARE NOW EXPANDING ANALYSIS TO 

3161
02:06:42,128 --> 02:06:45,498
INCLUDE A BROADER POPULATION 

3162
02:06:45,498 --> 02:06:48,167
THAT IS [INDISCERNIBLE] TAKE 

3163
02:06:48,167 --> 02:06:50,937
AWAY MESSAGE USE OF THIS 

3164
02:06:50,937 --> 02:06:52,271
RECEPTOR AGONIST EXPANDED 

3165
02:06:52,271 --> 02:06:53,439
SIGNIFICANTLY AND SMALL 

3166
02:06:53,439 --> 02:07:01,047
ITERATION IN ADRPD AND OTHER 

3167
02:07:01,047 --> 02:07:02,281
NEURODEGENERATIVE DISORDER RISKS

3168
02:07:02,281 --> 02:07:04,183
WITH WIDESPREAD IMPLICATIONS AND

3169
02:07:04,183 --> 02:07:06,652
THIS FACE INHERIENT LIMITATIONS 

3170
02:07:06,652 --> 02:07:10,289
OBSERVING LONG TERM OUTCOMES AND

3171
02:07:10,289 --> 02:07:13,059
DIFFICULTIES IN IDENTIFYING 

3172
02:07:13,059 --> 02:07:14,460
HETEROGENEITY AND TREATMENT 

3173
02:07:14,460 --> 02:07:15,795
EFFECT AND ROBUST REAL-WORLD 

3174
02:07:15,795 --> 02:07:18,030
EVIDENCE IS CRITICALLY NEEDED TO

3175
02:07:18,030 --> 02:07:21,467
EVALUATE IMPACT OF CHRONIC GLP-1

3176
02:07:21,467 --> 02:07:25,104
EXPOSURE ON RISK OF THESE 

3177
02:07:25,104 --> 02:07:26,038
NEURODEGENERATIVE CONDITIONS. 

3178
02:07:26,038 --> 02:07:27,673
THAT IS IT.  THANK YOU.  THANK 

3179
02:07:27,673 --> 02:07:29,675
YOU VERY MUCH FOR THE ORGANIZER 

3180
02:07:29,675 --> 02:07:33,412
IN THE AUDIENCE AND OUR PEER 

3181
02:07:33,412 --> 02:07:35,181
SPEAKER IN THE SESSION.  THAT IS

3182
02:07:35,181 --> 02:07:35,481
IT.  

3183
02:07:35,481 --> 02:07:37,483
>> THANK YOU SO MUCH FOR
THIS 

3184
02:07:37,483 --> 02:07:41,120
REALLY WONDERFUL PRESENTATION ON

3185
02:07:41,120 --> 02:07:42,889
SUCH IMPORTANT PROBLEMS. 

3186
02:07:42,889 --> 02:07:47,126
WE WILL COME BACK TO THIS IN THE

3187
02:07:47,126 --> 02:07:50,196
MODERATED DISCUSSION AFTER THE 

3188
02:07:50,196 --> 02:07:50,730
4TH TALK. 

3189
02:07:50,730 --> 02:07:52,765
SHIFTING NO YOU TO ONE MORE AREA

3190
02:07:52,765 --> 02:07:55,902
OF DIFFERENT OUTCOMES WHERE 

3191
02:07:55,902 --> 02:07:58,170
GLP-1S HAVE SIGNIFICANCE AND DR.

3192
02:07:58,170 --> 02:08:00,773
JENNIFER LUND WILL PRESENT AND 

3193
02:08:00,773 --> 02:08:03,209
IS PROFESSOR OF EPIDEMIOLOGY AT 

3194
02:08:03,209 --> 02:08:07,580
UNIVERSITY OF NORTH CAROLINA AT 

3195
02:08:07,580 --> 02:08:09,782
CHAPEL HILL -- APPLICATIONS IN 

3196
02:08:09,782 --> 02:08:12,451
CANCER, AGE THE ENVIRONMENT AND 

3197
02:08:12,451 --> 02:08:13,986
WILL DISCUSS REAL WORLD 

3198
02:08:13,986 --> 02:08:16,489
EFFECTIVENESS IN SAFETY 

3199
02:08:16,489 --> 02:08:17,690
GLP-1-BASED THERAPIES AS THEY 

3200
02:08:17,690 --> 02:08:19,358
RELATE TO CANCER. 

3201
02:08:19,358 --> 02:08:20,726
DR. LUND?  

3202
02:08:20,726 --> 02:08:26,165
>> THANK YOU VERY MUCH. 
SO I 

3203
02:08:26,165 --> 02:08:29,135
WILL DIVE RIGHT ANY HAVE NO 

3204
02:08:29,135 --> 02:08:30,102
RELEVANT DISCLOSURES AND 

3205
02:08:30,102 --> 02:08:32,405
CONFLICTS OF INTEREST RELATED TO

3206
02:08:32,405 --> 02:08:35,942
PRESENTATION AND SEVERAL FUNDING

3207
02:08:35,942 --> 02:08:37,543
SOURCES ARE LISTED HERE.  IN 

3208
02:08:37,543 --> 02:08:39,845
THIS FINAL TALK OF THE SESSION I

3209
02:08:39,845 --> 02:08:41,113
WILL FOCUS ON UNIQUE 

3210
02:08:41,113 --> 02:08:42,748
CONSIDERATIONS AND APPROACHES 

3211
02:08:42,748 --> 02:08:45,284
REQUIRED WHEN WE ARE EVALUATING 

3212
02:08:45,284 --> 02:08:48,054
EFFECTS OF GLP-1S ON RISK OF 

3213
02:08:48,054 --> 02:08:50,590
CANCER AND PARTICULARLY USING 

3214
02:08:50,590 --> 02:08:51,490
REAL WORLD DATA. 

3215
02:08:51,490 --> 02:08:53,059
AS WE GET STARTED IT IS 

3216
02:08:53,059 --> 02:08:54,527
IMPORTANT TO RECOGNIZE THAT 

3217
02:08:54,527 --> 02:08:58,464
CANCER IS NOT A SINGLE 

3218
02:08:58,464 --> 02:09:02,168
MONOLITHIC DISEASE BUT RATHER 

3219
02:09:02,168 --> 02:09:07,506
COLLECTION OF HETEROGENOUS 

3220
02:09:07,506 --> 02:09:16,649
CONDITIONS -- HAVE REALLY 

3221
02:09:16,649 --> 02:09:18,985
GREATLY INCREASED KNOWLEDGE IN 

3222
02:09:18,985 --> 02:09:22,555
UNDERSTANDING OF CANCER 

3223
02:09:22,555 --> 02:09:22,822
ETIOLOGY. 

3224
02:09:22,822 --> 02:09:24,924
SECOND, THERE ARE SEVERAL 

3225
02:09:24,924 --> 02:09:26,492
POTENTIAL MECHANISMS EFFECTING 

3226
02:09:26,492 --> 02:09:29,095
HOW GLP-1 INCREASE OR DECREASE 

3227
02:09:29,095 --> 02:09:31,497
OF RISKS OF CANCER AND FOR 

3228
02:09:31,497 --> 02:09:35,635
EXAMPLE IMPROVE METABOLIC 

3229
02:09:35,635 --> 02:09:37,570
REGULATION AND DIRECT ANTITUMOR 

3230
02:09:37,570 --> 02:09:39,739
EFFECTS CAN DECREASE CANCER RISK

3231
02:09:39,739 --> 02:09:42,475
AND IMMUNE MODULATION AND 

3232
02:09:42,475 --> 02:09:43,976
EPIGENETIC CHANGES COULD 

3233
02:09:43,976 --> 02:09:48,748
INCREASE OR DECREASE CANCER R

3234
02:09:48,748 --> 02:09:49,048
RISK. 

3235
02:09:49,048 --> 02:09:50,549
TAKING THIS ALL TOGETHER THERE 

3236
02:09:50,549 --> 02:09:52,852
IS GROWING EVIDENCE TO SUPPORT 

3237
02:09:52,852 --> 02:09:54,787
GLP-1S MAY HAVE BOTH POTENTIAL 

3238
02:09:54,787 --> 02:09:56,522
BENEFICIAL AND HARMFUL EFFECTS 

3239
02:09:56,522 --> 02:09:59,091
RELATED TO CANCER.  FOR EXAMPLE 

3240
02:09:59,091 --> 02:10:01,060
SEVERAL STUDIES AND METAANALYSIS

3241
02:10:01,060 --> 02:10:04,463
SHOW GLP-1S REDUCE RISK OF 

3242
02:10:04,463 --> 02:10:06,632
SEVERAL OBESITY RELATED CANCERS 

3243
02:10:06,632 --> 02:10:08,167
AND SERIES OF SEPARATE STUDIES 

3244
02:10:08,167 --> 02:10:10,736
SHOW THAT GLP-1S MAY BE 

3245
02:10:10,736 --> 02:10:13,105
ASSOCIATED WITH INCREASED RISK 

3246
02:10:13,105 --> 02:10:15,374
OF THYROID AND PARTICULARLY 

3247
02:10:15,374 --> 02:10:16,676
MEDULLARY CANCER EVIDENCE FROM 

3248
02:10:16,676 --> 02:10:20,680
ANIMAL MODEL SHOWING GLP-1S CAN 

3249
02:10:20,680 --> 02:10:22,081
INCREASE THYROID PROLIFERATION 

3250
02:10:22,081 --> 02:10:23,649
AND HYPERMRASHIA. 

3251
02:10:23,649 --> 02:10:26,886
TO STUDY EFFECTS OF MEDICATIONS 

3252
02:10:26,886 --> 02:10:29,155
LIKE GLP-1S ON RISK OF CANCER 

3253
02:10:29,155 --> 02:10:31,524
RESEARCHERS HAVE TO UNDERSTAND 

3254
02:10:31,524 --> 02:10:33,125
CARCINOGENESIS PROCESS AND HOW 

3255
02:10:33,125 --> 02:10:35,394
MEDICATION EXPOSURES COULD ACT 

3256
02:10:35,394 --> 02:10:36,796
AT VARIOUS POINTS IN THIS 

3257
02:10:36,796 --> 02:10:37,129
PROCESS. 

3258
02:10:37,129 --> 02:10:40,800
THIS KNOWLEDGE IS CRITICAL TO 

3259
02:10:40,800 --> 02:10:42,468
HELP INFORM KEY DECISIONS AROUND

3260
02:10:42,468 --> 02:10:44,136
STUDY DESIGN AND ANALYSIS. 

3261
02:10:44,136 --> 02:10:46,772
IN THIS FIGURE, DRUG A HERE IS 

3262
02:10:46,772 --> 02:10:48,808
CONSIDERED TUMOR INITIALATOR OR 

3263
02:10:48,808 --> 02:10:51,510
CAUSE OF FIRST CLONE OF 

3264
02:10:51,510 --> 02:10:52,545
NEOPLASTIC CELLS AND DRUG B ALSO

3265
02:10:52,545 --> 02:10:54,680
SHOWN HERE IS A TUMOR PROMOTOR 

3266
02:10:54,680 --> 02:10:57,950
OR DRUG THAT CAN ACCELERATE 

3267
02:10:57,950 --> 02:11:00,252
PROGRESSION OR GROWTH OF 

3268
02:11:00,252 --> 02:11:02,521
MALIGNANT OR SUBCLINICAL DISEASE

3269
02:11:02,521 --> 02:11:03,456
AND HYPOTHESIS WHERE DRUG MAY 

3270
02:11:03,456 --> 02:11:06,225
ACT ALONG IT PROCESS HAS 

3271
02:11:06,225 --> 02:11:07,660
IMPLICATIONS FOR POTENTIAL 

3272
02:11:07,660 --> 02:11:09,962
LENGTH OF EXPOSURE REQUIRING FOR

3273
02:11:09,962 --> 02:11:11,697
CLINICALLY RELEVANT EFFECTS ON 

3274
02:11:11,697 --> 02:11:13,599
CANCER RISK AND WHEN WE REFER TO

3275
02:11:13,599 --> 02:11:14,867
AS INDUCTION PERIOD AND FOR 

3276
02:11:14,867 --> 02:11:16,302
DURATION OF FOLLOW UP THAT IS 

3277
02:11:16,302 --> 02:11:18,871
REQUIRED TO BE ABLE TO DETECT 

3278
02:11:18,871 --> 02:11:21,006
CLINICALLY SIGNIFICANT 

3279
02:11:21,006 --> 02:11:23,242
MALIGNANCIES FOR LATENT PERIODS.

3280
02:11:23,242 --> 02:11:24,944
WHILE THERE IS OFTEN NOT ENOUGH 

3281
02:11:24,944 --> 02:11:26,612
KNOWN ABOUT A DRUG'S MECHANISM 

3282
02:11:26,612 --> 02:11:29,415
TO UNDERSTAND WHETHER IT IS AN 

3283
02:11:29,415 --> 02:11:33,119
INITIALATOR OR PROMOTER OR WHAT 

3284
02:11:33,119 --> 02:11:34,720
REVELIANANT INDUCTION PERIODS 

3285
02:11:34,720 --> 02:11:36,789
ARE HAVING LONG TERM DATA ON 

3286
02:11:36,789 --> 02:11:39,391
DRUG EXPOSURES AND FOLLOW UP 

3287
02:11:39,391 --> 02:11:41,127
ALLOW RESEARCHERS TO MAKE 

3288
02:11:41,127 --> 02:11:42,728
DIFFERENT ASSUMPTIONS ABOUT 

3289
02:11:42,728 --> 02:11:44,563
DIFFERENT RELEVANT EXPOSURE 

3290
02:11:44,563 --> 02:11:44,830
PERIODS. 

3291
02:11:44,830 --> 02:11:45,598
SO WITH THESE IMPORTANT 

3292
02:11:45,598 --> 02:11:48,100
CONSIDERATIONS IN MIND, WE CAN 

3293
02:11:48,100 --> 02:11:50,302
NOW REVIEW SOME EVIDENCE ON 

3294
02:11:50,302 --> 02:11:52,738
GLP-1S IN CANCER RISK AND HOW TO

3295
02:11:52,738 --> 02:11:55,708
BEST LEVERAGE REAL WORLD DATA TO

3296
02:11:55,708 --> 02:11:57,710
FURTHER EXPAND ON EVIDENCE BASE.

3297
02:11:57,710 --> 02:11:59,545
SO THERE IS SEVERAL TRIALS THAT 

3298
02:11:59,545 --> 02:12:02,148
HAVE BEEN META-ANALYZED TO 

3299
02:12:02,148 --> 02:12:04,383
EVALUATE EFFECTS OF GLP-1S ON 

3300
02:12:04,383 --> 02:12:06,552
RISK OF SPECIFIC CANCER TYPES 

3301
02:12:06,552 --> 02:12:09,955
AND HERE I HIGHLIGHTED THREE 

3302
02:12:09,955 --> 02:12:12,658
METAANALYSIS IN THYROID AND 

3303
02:12:12,658 --> 02:12:13,592
BREAST CANCER AND LARGEST EFFECT

3304
02:12:13,592 --> 02:12:16,162
SIZE IN MAGNITUDE IS FOR THYROID

3305
02:12:16,162 --> 02:12:17,329
CANCER AND HOWEVER THERE ARE 

3306
02:12:17,329 --> 02:12:19,198
SEVERAL WILL IMITATIONS TO 

3307
02:12:19,198 --> 02:12:21,000
METAANALYSIS FOR TRIALS FOR 

3308
02:12:21,000 --> 02:12:23,302
UNDERSTANDING EFFECTS OF GLP-1S 

3309
02:12:23,302 --> 02:12:24,537
ON CANCER RISK AND FIRST 

3310
02:12:24,537 --> 02:12:27,039
EVIDENCE IS LARGELY DERIVED FROM

3311
02:12:27,039 --> 02:12:28,507
PATIENTS WITH TYPE 2 DIABETES 

3312
02:12:28,507 --> 02:12:31,577
AND LESS CLINICAL EVIDENCE AND 

3313
02:12:31,577 --> 02:12:35,514
CONTEXT FROM  OBESITY SETTING 

3314
02:12:35,514 --> 02:12:39,218
AND TRIALS HAVE SHORT FOLLOW UP 

3315
02:12:39,218 --> 02:12:40,452
AND ESTIMATES CAN'T BE 

3316
02:12:40,452 --> 02:12:41,587
EXTRAPOLATED TO LONGER TERM 

3317
02:12:41,587 --> 02:12:43,255
EFFECTS AND OUTCOMES ARE RARE IN

3318
02:12:43,255 --> 02:12:46,992
TRIALS AND WITH POOLING ACROSS 

3319
02:12:46,992 --> 02:12:49,061
TRIALS, ESTIMATES ARE INPRECISE.

3320
02:12:49,061 --> 02:12:50,529
FINALLY, BECAUSE OF FOCUS OF 

3321
02:12:50,529 --> 02:12:52,765
TRIALS HAS NOT BEEN ON CANCER AS

3322
02:12:52,765 --> 02:12:55,601
AN OUTCOME OF INTEREST THERE IS 

3323
02:12:55,601 --> 02:13:01,106
OFTEN NO SUBDATYPE DATA THAT IS 

3324
02:13:01,106 --> 02:13:01,974
COLLECTED AND OFTEN NECESSARY 

3325
02:13:01,974 --> 02:13:03,342
AND RESULT RESEARCHERS ARE 

3326
02:13:03,342 --> 02:13:05,110
INCREASING WILL I TURNING 

3327
02:13:05,110 --> 02:13:07,446
TOWARDS REAL WORLD DATA STUDYING

3328
02:13:07,446 --> 02:13:09,582
EFFECTS ON GLP-1S RISK AND 

3329
02:13:09,582 --> 02:13:13,118
NUMBER OF STUDIES EVALUATING 

3330
02:13:13,118 --> 02:13:14,253
ASSOCIATIONS EXPONENTIALLY HAS 

3331
02:13:14,253 --> 02:13:15,955
GROWN IN THE PAST FEW YEARS AND 

3332
02:13:15,955 --> 02:13:18,290
OVERALL MOST OF THE STUDIES USE 

3333
02:13:18,290 --> 02:13:20,659
COMMON DATA SOURCES OF REAL 

3334
02:13:20,659 --> 02:13:23,762
WORLD DATE AINCLUDING ELECTRONIC

3335
02:13:23,762 --> 02:13:25,865
HEALTH RECORDS AND 

3336
02:13:25,865 --> 02:13:27,533
ADMINISTRATIVE AND INSURANCE 

3337
02:13:27,533 --> 02:13:30,803
CLAIMS DATA AND OBVIOUSLY DATA 

3338
02:13:30,803 --> 02:13:32,037
SOURCES HAVE THEIR OWN DISTINCT 

3339
02:13:32,037 --> 02:13:33,505
STRENGTHS AND LIMITATIONS MANY 

3340
02:13:33,505 --> 02:13:36,408
OF WHICH HAVE BEEN MENTIONED 

3341
02:13:36,408 --> 02:13:38,510
TODAY AND WILL FOCUS ON THOSE 

3342
02:13:38,510 --> 02:13:41,113
RELATED TO STUDYING GLP-1S AND 

3343
02:13:41,113 --> 02:13:43,582
CANCER RISK AND FIRST 

3344
02:13:43,582 --> 02:13:45,050
ADMINISTRATIVE DATA TEND TO 

3345
02:13:45,050 --> 02:13:49,121
CAPTURE LARGE BROAD POPULATIONS 

3346
02:13:49,121 --> 02:13:52,258
CONTAINING GRANULAR LONGITUDINAL

3347
02:13:52,258 --> 02:13:53,726
DRUG EXPOSURE NEEDED FOR STUDIES

3348
02:13:53,726 --> 02:13:55,594
AND CAPTURE CARE DELIVERED 

3349
02:13:55,594 --> 02:13:57,529
ACROSS HEALTH CARE SYSTEMS.  

3350
02:13:57,529 --> 02:13:59,632
HOWEVER, IN CONTEXT CLAIMS DATA 

3351
02:13:59,632 --> 02:14:01,600
IS OFTEN LIMITED IN INFORMATION 

3352
02:14:01,600 --> 02:14:03,569
IN CLINICAL INDICATION FOR 

3353
02:14:03,569 --> 02:14:05,137
GLP-1S AND ALSO SPECIFIC 

3354
02:14:05,137 --> 02:14:06,739
SUBTYPES OF CANCER THAT WE MAY 

3355
02:14:06,739 --> 02:14:10,242
BE INTERESTED IN STUDYING. 

3356
02:14:10,242 --> 02:14:12,344
ON THE OTHER HAND AS WE HAVE 

3357
02:14:12,344 --> 02:14:14,847
HEARD BEFORE ELECTRONIC HEALTH 

3358
02:14:14,847 --> 02:14:16,448
RECORDS ARE ABLE TO CAPTURE 

3359
02:14:16,448 --> 02:14:18,417
GRANULAR CLINICAL DATA OFTEN ON 

3360
02:14:18,417 --> 02:14:20,519
INDICATION OF TREATMENT AND MORE

3361
02:14:20,519 --> 02:14:21,186
CLINICALLY RELEVANT INFORMATION 

3362
02:14:21,186 --> 02:14:23,689
ON CANCER AND HOWEVER THEY 

3363
02:14:23,689 --> 02:14:26,759
FREQUENTLY LACK LONGITUDINAL 

3364
02:14:26,759 --> 02:14:28,460
DRUG EXPOSURE IN DISPENSING DATA

3365
02:14:28,460 --> 02:14:30,529
AND MIGHT HAVE A HIGH DEGREE OF 

3366
02:14:30,529 --> 02:14:32,898
MISSINGNESS OF KEY VARIABLES AND

3367
02:14:32,898 --> 02:14:34,166
AGAIN IS CONCERN ABOUT 

3368
02:14:34,166 --> 02:14:35,367
OBSERVABILITY WHEN CARE IS 

3369
02:14:35,367 --> 02:14:38,203
DELIVERED OUTSIDE OF CAPTURE OF 

3370
02:14:38,203 --> 02:14:40,239
A GIVEN HEALTH CARE SYSTEM.  

3371
02:14:40,239 --> 02:14:41,941
FINALLY, WHAT WE WILL TOUCH ON 

3372
02:14:41,941 --> 02:14:44,977
IS PATIENT REGISTRIES THAT ARE 

3373
02:14:44,977 --> 02:14:45,911
OFTEN MANDATED TO COLLECT 

3374
02:14:45,911 --> 02:14:47,813
STRUCTURED CANCER DATA INCLUDING

3375
02:14:47,813 --> 02:14:50,582
HISTOLOGY AND HAVE POTENTIAL TO 

3376
02:14:50,582 --> 02:14:53,085
BE LINKED TO SOURCES OF DRUG 

3377
02:14:53,085 --> 02:14:53,986
DISPENSING AND CLINICAL 

3378
02:14:53,986 --> 02:14:55,587
INFORMATION AND HOWEVER DATA IS 

3379
02:14:55,587 --> 02:14:58,724
LIMITED IN SAMPLE SIZE AND 

3380
02:14:58,724 --> 02:15:00,759
INJURE DICTIONS THAT COLLECT 

3381
02:15:00,759 --> 02:15:02,494
INFORMATION MIGHT NOT BE NAMELY 

3382
02:15:02,494 --> 02:15:04,496
LARGED FOR EXAMPLE EXTANDIN 

3383
02:15:04,496 --> 02:15:05,230
AFIAN COUNTRIES HAVE THIS TYPE 

3384
02:15:05,230 --> 02:15:07,633
OF DATA AND BECAUSE OF THAT 

3385
02:15:07,633 --> 02:15:10,736
MIGHT BE DIFFERENCED IN CARE 

3386
02:15:10,736 --> 02:15:14,606
DMRIFRY HAM PPERING POTENTIAL 

3387
02:15:14,606 --> 02:15:16,008
GENERALIZABILITY TO US CONTEXT 

3388
02:15:16,008 --> 02:15:17,710
AND BEYOND THINKING ABOUT 

3389
02:15:17,710 --> 02:15:19,578
FITNESS OF DATA STUDYING EFFECTS

3390
02:15:19,578 --> 02:15:23,415
OF GLP-1S AND CANCER RISK WE CAN

3391
02:15:23,415 --> 02:15:24,683
THINK CLEARLY ABOUT HOW TO 

3392
02:15:24,683 --> 02:15:27,386
DESIGN AN OBSERVATIONAL STUDY TO

3393
02:15:27,386 --> 02:15:29,355
AVOID COMMON PITFALLS IMMORTAL 

3394
02:15:29,355 --> 02:15:31,156
TIME BIAS AND SELECTION BIAS 

3395
02:15:31,156 --> 02:15:35,394
THAT SPEAKERS REITERATED AND SAW

3396
02:15:35,394 --> 02:15:40,165
IN WORKSHOP USEFUL IN HELPING 

3397
02:15:40,165 --> 02:15:43,602
RESEARCHERS SPECIFY PROTOCOL OF 

3398
02:15:43,602 --> 02:15:45,104
RANDOMIZED PRAGMATIC TRIAL TO 

3399
02:15:45,104 --> 02:15:46,672
ANSWER CALLS OF QUESTION OF 

3400
02:15:46,672 --> 02:15:48,440
INTEREST AND WHEN WE CALL TARGET

3401
02:15:48,440 --> 02:15:50,576
TRIAL AND SECOND IT HELPS 

3402
02:15:50,576 --> 02:15:53,112
RESEARCHERS USE OBSERVATIONAL 

3403
02:15:53,112 --> 02:15:54,580
DATA TO ATTEMPT TO EMULATE THIS 

3404
02:15:54,580 --> 02:15:57,483
TRIAL AND COMPONENTS OF TARGET 

3405
02:15:57,483 --> 02:15:58,951
TRIAL INCLUDE ELIGIBILITY 

3406
02:15:58,951 --> 02:16:00,953
CRITERIA TREATMENT STRATEGIES 

3407
02:16:00,953 --> 02:16:02,855
ASSIGNMENT PROCEDURES FOLLOW UP 

3408
02:16:02,855 --> 02:16:04,990
OUTCOMES AND CAUSAL CONTRAST AND

3409
02:16:04,990 --> 02:16:08,794
DATA ANALYSIS AND FOR PURPOSES 

3410
02:16:08,794 --> 02:16:10,229
OF DURATION OF THIS PRESENTATION

3411
02:16:10,229 --> 02:16:12,765
I WILL WALK THROUGH A SPECIFIC 

3412
02:16:12,765 --> 02:16:13,799
STUDY FROM THESE AND DISCUSS 

3413
02:16:13,799 --> 02:16:16,368
EACH OF THE COMPONENTS WITH 

3414
02:16:16,368 --> 02:16:16,935
SPECIFIC CONSIDERATION OF 

3415
02:16:16,935 --> 02:16:20,806
STUDYING CANCER AS AN OUTCOME OF

3416
02:16:20,806 --> 02:16:22,508
PRIMARY INTEREST. 

3417
02:16:22,508 --> 02:16:25,110
STUD YAY THAT I WILL FOCUS ON IS

3418
02:16:25,110 --> 02:16:28,814
A RECENT PUBLICATION BY PASTOR 

3419
02:16:28,814 --> 02:16:30,716
KNACKIN AND COLLEAGUES PUBLISHED

3420
02:16:30,716 --> 02:16:33,118
IN DECEMBER OF 2024 

3421
02:16:33,118 --> 02:16:35,687
MULTI-COUNTRY DATA BASE STUDY 

3422
02:16:35,687 --> 02:16:38,490
USING PATIENT REGISTRIES FROM 

3423
02:16:38,490 --> 02:16:40,926
DENMARK NORWAY AND SWEDEN 

3424
02:16:40,926 --> 02:16:44,463
INCLUDING INITIATORS WITH GLP-1S

3425
02:16:44,463 --> 02:16:46,865
AND DPP INHIBITORS IN DIABETES 

3426
02:16:46,865 --> 02:16:48,667
CONTEXT AND OUTCOME OF INTEREST 

3427
02:16:48,667 --> 02:16:50,002
IS THYROID CANCER AND 

3428
02:16:50,002 --> 02:16:52,337
INDIVIDUALED FOLLOWED IN 

3429
02:16:52,337 --> 02:16:54,740
DATABASES AVERAGE OF FOUR YEARS 

3430
02:16:54,740 --> 02:16:58,343
IN GLP-1 GROUP AND 5.1 YEARS IN 

3431
02:16:58,343 --> 02:17:00,479
DPP4 INHIBITOR GROUP AND OVERALL

3432
02:17:00,479 --> 02:17:03,115
AUTHORS REPORTED THAT INITIATION

3433
02:17:03,115 --> 02:17:05,350
OF GLP-1S VERSUS DPP4 INHIBITOR 

3434
02:17:05,350 --> 02:17:07,619
NOZ THE ASSOCIATED WITH 

3435
02:17:07,619 --> 02:17:10,289
INCREASED RISK OF THYROID CANCER

3436
02:17:10,289 --> 02:17:11,990
OR MEDULLARY THYROID CANCER AND 

3437
02:17:11,990 --> 02:17:13,959
WAS A WELL-DONE STUDY AND CAN 

3438
02:17:13,959 --> 02:17:16,261
USE IT TO HIGHLIGHT SPECIFIC 

3439
02:17:16,261 --> 02:17:18,097
COMPONENTS OF TARGET TRIAL MORE 

3440
02:17:18,097 --> 02:17:19,364
BROADLY AND TALK ABOUT 

3441
02:17:19,364 --> 02:17:23,168
EXTENSIONS TO OTHER FORMS OF 

3442
02:17:23,168 --> 02:17:26,438
REAL-WORLD DATA. 

3443
02:17:26,438 --> 02:17:28,807
SO THE FIRST COMPONENT IS 

3444
02:17:28,807 --> 02:17:29,141
ELIGIBILITY.  

3445
02:17:29,141 --> 02:17:30,976
SO WHAT WE ARE TRYING TO DO IS 

3446
02:17:30,976 --> 02:17:32,911
FIGURE OUT WHO WILL BE IN THE 

3447
02:17:32,911 --> 02:17:33,178
STUDY. 

3448
02:17:33,178 --> 02:17:35,447
WHEN FOCUSED ON STUDYING 

3449
02:17:35,447 --> 02:17:37,649
HIGHROID CANCERS AND OUTCOME WE 

3450
02:17:37,649 --> 02:17:39,485
HAVE TO FIRST ENSURE THAT PEOPLE

3451
02:17:39,485 --> 02:17:42,521
IN THE TRIAL HAVE NOT PREVIOUSLY

3452
02:17:42,521 --> 02:17:44,456
HAD THYROID CANCER AND MAY 

3453
02:17:44,456 --> 02:17:45,657
CONSIDER EXCLUDING INDIVIDUALS 

3454
02:17:45,657 --> 02:17:48,293
RECENTLY DIAGNOSED WITH ANOTHER 

3455
02:17:48,293 --> 02:17:50,395
CANCER THAT MAY UNDERGO ACTIVE 

3456
02:17:50,395 --> 02:17:52,331
CANCER AND TREATMENT AND THIRD 

3457
02:17:52,331 --> 02:17:54,399
MAY CONSIDER ALSO EXCLUDING 

3458
02:17:54,399 --> 02:17:56,468
INDIVIDUALS WITH CERTAIN 

3459
02:17:56,468 --> 02:17:58,904
HERITABLE SYNDROMES VASTLY 

3460
02:17:58,904 --> 02:17:59,872
INCREASING RISK OF THYROID 

3461
02:17:59,872 --> 02:18:03,275
CANCER AND IN TERMS OF EMULATING

3462
02:18:03,275 --> 02:18:04,643
CRITERIA USING PATIENT ARE 

3463
02:18:04,643 --> 02:18:06,612
EDGETRY DATA PASTER KNACK STUDY 

3464
02:18:06,612 --> 02:18:08,947
WAS ABLE TO LEVERAGE CANCER 

3465
02:18:08,947 --> 02:18:11,784
REGISTRY DATA TO EXCLUDE THOSE 

3466
02:18:11,784 --> 02:18:13,886
WITH PRIOR HISTORY OF THYROID 

3467
02:18:13,886 --> 02:18:15,821
CANCER AND THOSE DIAGNOSED IN 

3468
02:18:15,821 --> 02:18:16,955
THE PAST YEAR AND FURTHERMORE 

3469
02:18:16,955 --> 02:18:21,126
USED MEDICAL ARE EDGE STRERS TO 

3470
02:18:21,126 --> 02:18:23,428
EXCLUDE INDIVIDUALS WITH 

3471
02:18:23,428 --> 02:18:24,029
SPECIFIC -- ASSOCIATED WITH 

3472
02:18:24,029 --> 02:18:26,665
THOIROID CANCER AND THINKING OF 

3473
02:18:26,665 --> 02:18:29,368
SOURCES OF REAL WORLD DATA LIKE 

3474
02:18:29,368 --> 02:18:31,036
EHRS AND CLAIMS WE MIGHT 

3475
02:18:31,036 --> 02:18:33,238
CONSIDER WHETHER IT IS FEASIBLE 

3476
02:18:33,238 --> 02:18:36,341
TO LINK CANCER TO SAME EXCLUSION

3477
02:18:36,341 --> 02:18:37,576
CRITERIA AND IF NOT POSSIBLE 

3478
02:18:37,576 --> 02:18:39,344
VALIDATION STUDIES FOR 

3479
02:18:39,344 --> 02:18:40,512
ALGORITHMS APPLIED WITHIN 

3480
02:18:40,512 --> 02:18:43,782
RESOURCES ARE NEEDED AND WE NEED

3481
02:18:43,782 --> 02:18:47,052
TO ATHAT THOSE ALGORITHMS ARE 

3482
02:18:47,052 --> 02:18:48,353
APPLICABLE TO TARGET POPULATION 

3483
02:18:48,353 --> 02:18:49,721
OF INTEREST.  

3484
02:18:49,721 --> 02:18:51,957
SO THE SECOND COMPONENT ARE 

3485
02:18:51,957 --> 02:18:53,358
TREATMENT STRATEGIES AND 

3486
02:18:53,358 --> 02:18:57,563
EMULATION AND SOLET PASTER KNACK

3487
02:18:57,563 --> 02:19:07,673
STU

3488
02:19:42,574 --> 02:19:43,208
STUDY. 

3489
02:19:43,208 --> 02:19:45,110
ALSO CAPTURE INFORMATION ON BUY 

3490
02:19:45,110 --> 02:19:46,812
DEETIES MEDICATIONS AND 

3491
02:19:46,812 --> 02:19:49,715
COMPLICATIONS AND RELEVANT 

3492
02:19:49,715 --> 02:19:52,718
MORBID CONDITIONS CONSIDERING 

3493
02:19:52,718 --> 02:19:57,122
REAL WORLD DATA SOURCES WE HAVE 

3494
02:19:57,122 --> 02:20:01,093
TO THINK OF COMPLETENESS AND 

3495
02:20:01,093 --> 02:20:03,729
ACCUR

3496
02:20:03,729 --> 02:20:05,097
ACCURACY. 

3497
02:20:05,097 --> 02:20:07,566
SCREENING PATTERNS THAT MAY LEAD

3498
02:20:07,566 --> 02:20:11,436
TO EARLIER DETECTION IN ONE 

3499
02:20:11,436 --> 02:20:16,408
GROUP VERSUS ANOTHER. 

3500
02:20:16,408 --> 02:20:19,244
FINALLY 4TH COMPONENT OF FOLLOW 

3501
02:20:19,244 --> 02:20:21,880
UP STARTING IT AT DRUG 

3502
02:20:21,880 --> 02:20:22,781
INITIATION AND CONTINUE AND 

3503
02:20:22,781 --> 02:20:25,717
EARLIER OF FOLLOWING EVENTS AND 

3504
02:20:25,717 --> 02:20:27,719
THYROID CANCER AND DEATH OR 10 

3505
02:20:27,719 --> 02:20:29,321
YEARS OF FOLLOW UP AND PASTER 

3506
02:20:29,321 --> 02:20:32,891
KNACK STUDY FOLLOWED A SIMILAR 

3507
02:20:32,891 --> 02:20:34,092
STRATEGY?  EMULATION AND 

3508
02:20:34,092 --> 02:20:34,593
CONSIDERED EMMI [GROUP 

3509
02:20:34,593 --> 02:20:35,694
PRESENTATION] FROM COUNTRIES OF 

3510
02:20:35,694 --> 02:20:37,896
INTEREST AS A CENSORING EVENT. 

3511
02:20:37,896 --> 02:20:39,965
WHEN WE THINK ABOUT FOLLOW UP 

3512
02:20:39,965 --> 02:20:42,267
AND REAL WORLD DATA SOURCES 

3513
02:20:42,267 --> 02:20:44,503
THERE IS LOTS OF VARIATION IN 

3514
02:20:44,503 --> 02:20:46,104
DURATION OF FOLLOW UP BY PAYER 

3515
02:20:46,104 --> 02:20:48,607
WITH TYPICALLY LONGER PERIODS OF

3516
02:20:48,607 --> 02:20:50,509
CONTINUOUS ENROLLMENT OF 

3517
02:20:50,509 --> 02:20:51,910
MEDICARE ELIGIBLE POPULATIONS 

3518
02:20:51,910 --> 02:20:53,779
COMPARED WITH COMMERCIALLY 

3519
02:20:53,779 --> 02:20:54,880
ENSURED POPULATIONS AND E HAD.  

3520
02:20:54,880 --> 02:20:58,750
R WE ARE CONCERNED ABOUT 

3521
02:20:58,750 --> 02:21:01,553
OBSERVABILITY ISSUES AND NEED TO

3522
02:21:01,553 --> 02:21:02,888
CENSOR INDIVIDUALS WHEN 

3523
02:21:02,888 --> 02:21:04,323
FOLLOWING UP AND BECAUSE OF 

3524
02:21:04,323 --> 02:21:07,326
CONCERNS, AGAIN, AROUND RELEVANT

3525
02:21:07,326 --> 02:21:09,094
INDUCTION PERIODS RESEARCHERS 

3526
02:21:09,094 --> 02:21:10,929
INCLUDING PASTER KNACK AND 

3527
02:21:10,929 --> 02:21:12,864
COLLEAGUES FREQUENTLY EXAMINED 

3528
02:21:12,864 --> 02:21:15,033
RISK OF CANCER EARLY IN THE 

3529
02:21:15,033 --> 02:21:16,568
FOLLOW UP PERIOD AND UNLIKELY 

3530
02:21:16,568 --> 02:21:18,537
THAT EARLY CANCERS ARE DUE TO 

3531
02:21:18,537 --> 02:21:20,005
EFFECT OF THE DRUG AND IN 

3532
02:21:20,005 --> 02:21:21,907
ADDITION AUTHORS WILL WANT 

3533
02:21:21,907 --> 02:21:24,743
IMPLEMENT A SERIES OF 

3534
02:21:24,743 --> 02:21:25,677
SENSITIVITY ANALYSIS THAT USE 

3535
02:21:25,677 --> 02:21:26,745
DIFFERENT LAG TIMES WHERE PRIOR 

3536
02:21:26,745 --> 02:21:29,114
TO THE END OF THE LAG TIME 

3537
02:21:29,114 --> 02:21:30,816
CANCERS ARE ACTUALLY NOT 

3538
02:21:30,816 --> 02:21:32,517
ATTRIBUTED TO THE EXPOSURE GROUP

3539
02:21:32,517 --> 02:21:35,854
AND THIS CAN HELP PROVIDE SOME 

3540
02:21:35,854 --> 02:21:37,622
BOUNDS OF AROUND HOW DIFFERENT 

3541
02:21:37,622 --> 02:21:39,491
ASUCTIONS OF INDUCTION AND 

3542
02:21:39,491 --> 02:21:42,561
LATENT PERIODS CAN ACTUALLY 

3543
02:21:42,561 --> 02:21:44,296
EFFECT TREATMENT ESTIMATES. 

3544
02:21:44,296 --> 02:21:46,631
SO IN TERMS OF IDENTIFYING THE 

3545
02:21:46,631 --> 02:21:48,400
OUTCOME TARGET TRIAL TYPICALLY 

3546
02:21:48,400 --> 02:21:51,269
IN A PRAGMATIC SETTING MAY 

3547
02:21:51,269 --> 02:21:55,474
REQUIRE SELF-PURPORTED CANCER 

3548
02:21:55,474 --> 02:21:56,641
DOOIGNOSIS WITH SUBSEQUENT 

3549
02:21:56,641 --> 02:21:58,043
DOCUMENTATION AND IN PASTER 

3550
02:21:58,043 --> 02:22:00,312
KNACK STUDY THEY WERE ABLE TO 

3551
02:22:00,312 --> 02:22:02,647
IDENTIFY THYROID CANCER USING 

3552
02:22:02,647 --> 02:22:04,282
NATIONWIDE CANCER ARE EDGETRIES 

3553
02:22:04,282 --> 02:22:06,651
THAT INCLUDE DETAILED TUMOR 

3554
02:22:06,651 --> 02:22:08,653
INFORMATION.  SIMILAR AS IN 

3555
02:22:08,653 --> 02:22:11,223
PRIOR COMPONENTS IF STUDIES RELY

3556
02:22:11,223 --> 02:22:13,058
ON REAL WORLD DATA ON ALGORITHMS

3557
02:22:13,058 --> 02:22:14,893
THEY HAVE TO BE VALIDATED IN 

3558
02:22:14,893 --> 02:22:17,295
TARGET POPULATION OF INTEREST 

3559
02:22:17,295 --> 02:22:19,731
AND POTENTIALLY NEED TO CONSIDER

3560
02:22:19,731 --> 02:22:21,633
DOING SOME BIAS ANALYSIS WHERE 

3561
02:22:21,633 --> 02:22:24,870
IT MIGHT BE WARRANTED. 

3562
02:22:24,870 --> 02:22:25,504
AGAIN, BROAD CONSIDERATIONS 

3563
02:22:25,504 --> 02:22:33,512
AROUND LINKAGIN INCIDENT CANCER 

3564
02:22:33,512 --> 02:22:36,415
TO REGISTRIES IS IMPORTANT TO 

3565
02:22:36,415 --> 02:22:37,516
CONSIDER AND SECOND THING IS 

3566
02:22:37,516 --> 02:22:39,117
CAUSAL CONTRAST AND THERE HAS 

3567
02:22:39,117 --> 02:22:41,119
BEEN DISCUSSION AROUND 

3568
02:22:41,119 --> 02:22:43,155
ESTIMATING INTENTION TO TREAT 

3569
02:22:43,155 --> 02:22:46,024
AND PRO PROTOCOL EFFECTS AND 

3570
02:22:46,024 --> 02:22:49,127
PASTER KNACK STUDY AND EMULATION

3571
02:22:49,127 --> 02:22:51,329
THEY EVALUATED OBSERVATIONAL 

3572
02:22:51,329 --> 02:22:52,531
ANALOGUE IN ATTENTION TO TREAT 

3573
02:22:52,531 --> 02:22:55,033
EFFECT AND TREATED ANALYSIS THEY

3574
02:22:55,033 --> 02:22:57,135
CENSORED AND WEIGHTED 

3575
02:22:57,135 --> 02:22:58,637
INDIVIDUALS THAT DISCONTINUED OR

3576
02:22:58,637 --> 02:23:00,472
SWITCHED AND THINKING OF OTHER 

3577
02:23:00,472 --> 02:23:02,707
SOURCES OF REAL WORLD DATA EHRS 

3578
02:23:02,707 --> 02:23:04,142
DON'T HAVE ACCESS TO 

3579
02:23:04,142 --> 02:23:06,244
LONGITUDINAL DATA AND THUS MAY 

3580
02:23:06,244 --> 02:23:09,114
NOT BE USED FOR AS TREATED OR 

3581
02:23:09,114 --> 02:23:11,049
PROPROPOE COLANALYSIS AND 

3582
02:23:11,049 --> 02:23:12,350
IMPORTANT CONSIDERATION IS REAL 

3583
02:23:12,350 --> 02:23:14,152
WORLD DATA MAY NOT CONTAIN ALL 

3584
02:23:14,152 --> 02:23:16,655
INFORMATION ON TIME VARYING 

3585
02:23:16,655 --> 02:23:17,556
CONFOUNDERS NEEDED TO ESTIMATE 

3586
02:23:17,556 --> 02:23:21,660
APPROPRIATE CENSORING LINKS. 

3587
02:23:21,660 --> 02:23:25,430
AS WAS DISCUSSED FOR SWITCHING 

3588
02:23:25,430 --> 02:23:32,604
IS COMMON IN SETTING OF TYPE 2 

3589
02:23:32,604 --> 02:23:43,115
DIABETES -- GLP-1S ONG CANCER 

3590
02:23:43,815 --> 02:23:49,254
AND DONG BY PASTER KNACK AND 

3591
02:23:49,254 --> 02:23:51,289
COLLEAGUES IT IS IMPORTANT TO 

3592
02:23:51,289 --> 02:23:53,158
PLOT CUMULATIVE RISK CURVES FOR 

3593
02:23:53,158 --> 02:23:54,826
CANCER OVER TIME AND CONSIDER 

3594
02:23:54,826 --> 02:23:56,795
ACCOUNTING FOR OTHER COMPETING 

3595
02:23:56,795 --> 02:23:59,464
EVENTS LIKE DEATH USING 

3596
02:23:59,464 --> 02:24:02,868
APPROPRIATE ESTIMATORS. 

3597
02:24:02,868 --> 02:24:06,471
SO I THINK TO WRAP UP IN SUMMARY

3598
02:24:06,471 --> 02:24:08,607
USING REAL WORLD DATA EVALUATING

3599
02:24:08,607 --> 02:24:10,842
EFFECTS OF GLP-1S ON CANCER WE 

3600
02:24:10,842 --> 02:24:16,481
HAVE TO RECOGNIZE THAT CANCER IS

3601
02:24:16,481 --> 02:24:19,451
HETEROGENOUS DISEASE STUDYING 

3602
02:24:19,451 --> 02:24:22,354
MEANINGFUL SUBTYPES AND FOLLOW 

3603
02:24:22,354 --> 02:24:25,490
UP FOR STUDIES WITH SHORT TERM 

3604
02:24:25,490 --> 02:24:26,725
FOLLOW UP AND NEED ENSURE THAT 

3605
02:24:26,725 --> 02:24:29,394
OUR STUDIES ARE USING VALIDATED 

3606
02:24:29,394 --> 02:24:30,996
ALGORITHMS FOR KEY VARIABLES AND

3607
02:24:30,996 --> 02:24:33,064
THEY ARE RELEVANT TO TARGET 

3608
02:24:33,064 --> 02:24:34,266
POPULATIONS OF INTEREST AND WE 

3609
02:24:34,266 --> 02:24:37,769
NEED TO BE VERY CLEAR ABOUT 

3610
02:24:37,769 --> 02:24:38,837
TRADEOFFS ESTIMATING DIFFERENT 

3611
02:24:38,837 --> 02:24:41,339
CAUSAL CONTRASTS AND BEGIN IS 

3612
02:24:41,339 --> 02:24:44,709
NICELY DISCUSSED EARLIER IN THE 

3613
02:24:44,709 --> 02:24:46,778
SESSION.  FINALLY, SPECIFIC TO 

3614
02:24:46,778 --> 02:24:50,348
CANCER IT IS A RARE OUTCOME OF 

3615
02:24:50,348 --> 02:24:53,785
THIS ESTIMATING ADVERSE RISKS 

3616
02:24:53,785 --> 02:24:56,955
AND PUTTING RISK IN CONTEXT OF 

3617
02:24:56,955 --> 02:24:57,956
BENEFITS OF THERAPY.  

3618
02:24:57,956 --> 02:25:00,058
SO IN THINKING ABOUT WHETHER 

3619
02:25:00,058 --> 02:25:02,160
PRAGMATIC TRIALS ARE NEEDED, 

3620
02:25:02,160 --> 02:25:03,562
FIRST THING WE NEED TO THINK 

3621
02:25:03,562 --> 02:25:05,664
ABOUT IS WHO WOULD BE ELIGIBLE 

3622
02:25:05,664 --> 02:25:07,332
FOR A TRIAL LOOKING AT A CANCER 

3623
02:25:07,332 --> 02:25:09,668
OUTCOME AND HAS TO BE IN A VERY 

3624
02:25:09,668 --> 02:25:10,936
LARGE TRIAL WITH LONG TERM 

3625
02:25:10,936 --> 02:25:13,038
FOLLOW UP POTENTIALLY IN 

3626
02:25:13,038 --> 02:25:14,839
ENROLLING HIGH RISK POPULATIONS 

3627
02:25:14,839 --> 02:25:17,108
IN OLDER ADULTS AND NEED TO 

3628
02:25:17,108 --> 02:25:18,977
THINK ABOUT AGAIN ABOUT WHAT 

3629
02:25:18,977 --> 02:25:19,844
IMPORTANT TREATMENT STRATEGIES 

3630
02:25:19,844 --> 02:25:22,280
IN COMPARATORS WOULD BE AND THEN

3631
02:25:22,280 --> 02:25:23,648
I THINK THIS IS AN IMPORTANT 

3632
02:25:23,648 --> 02:25:26,918
POINT IF WE WANT TO CONDUCT A 

3633
02:25:26,918 --> 02:25:30,789
LARGE LONG TERM PRAGMATIC TRIAL 

3634
02:25:30,789 --> 02:25:32,057
LINKING DATA TO CANCER 

3635
02:25:32,057 --> 02:25:34,059
REGISTRIES POTENTIALLY THROUGH 

3636
02:25:34,059 --> 02:25:36,428
THE VIRTUAL POOLED ARE EDGETRY 

3637
02:25:36,428 --> 02:25:38,263
OR CANCER LINKAGE SYSTEM THAT 

3638
02:25:38,263 --> 02:25:40,699
WOULD BE A RELEVANT WAY TO DO 

3639
02:25:40,699 --> 02:25:43,802
THIS AT A MORE PRAGMATIC SCALE 

3640
02:25:43,802 --> 02:25:47,105
AND TO NOTE, BRITISH DOCTORS 

3641
02:25:47,105 --> 02:25:48,273
ASPIRIN TRIAL AND ANOTHER TRIAL 

3642
02:25:48,273 --> 02:25:50,909
IN UK HAVE DONE THIS AND THEY 

3643
02:25:50,909 --> 02:25:52,043
WERE STUDYING CARDIOVASCULAR 

3644
02:25:52,043 --> 02:25:54,646
OUTCOMES AND WERE ATOIBL LINK 

3645
02:25:54,646 --> 02:25:56,147
AND FOLLOW PEOPLE OVER 20 YEARS 

3646
02:25:56,147 --> 02:26:00,285
TO LOOK AT COLORECTAL CANCER 

3647
02:26:00,285 --> 02:26:02,988
INCIDENTS AS AN OUTCOME AND IN 

3648
02:26:02,988 --> 02:26:04,889
THE FINAL KIND OF PIECE HERE, 

3649
02:26:04,889 --> 02:26:07,125
THERE ARE SEVERAL GAPS IN AREAS 

3650
02:26:07,125 --> 02:26:10,428
FOR FUTURE RESEARCH AND FIRST 

3651
02:26:10,428 --> 02:26:11,896
RESEARCHERS ARE LARGELY 

3652
02:26:11,896 --> 02:26:13,331
CONDUCTING CASE CONTROL AND 

3653
02:26:13,331 --> 02:26:15,100
COHORT STUDIES EVALUATING 

3654
02:26:15,100 --> 02:26:17,836
EFFECTS OF GLP-1S ON CANCER 

3655
02:26:17,836 --> 02:26:21,106
RISKS AND OTHER DESIGNS SHOULD 

3656
02:26:21,106 --> 02:26:22,574
BE REQUIRED REQUIRING DIFFERENT 

3657
02:26:22,574 --> 02:26:25,110
ASSUMPTIONS RELYING RESEARCH 

3658
02:26:25,110 --> 02:26:27,846
COMMUNITY TO TRIANGULATE 

3659
02:26:27,846 --> 02:26:29,981
EVIDENCE AND GENERATE OBSERVED 

3660
02:26:29,981 --> 02:26:31,616
SUPPORT FOR FINDINGS AND SECOND 

3661
02:26:31,616 --> 02:26:34,152
DONE BY PASTER KNACK SHOULD 

3662
02:26:34,152 --> 02:26:35,020
CONSIDER POSSIBILITY OF 

3663
02:26:35,020 --> 02:26:37,155
CONDUCTING MULTINATIONAL DATA 

3664
02:26:37,155 --> 02:26:39,357
BASE STUDIES THAT ARE 

3665
02:26:39,357 --> 02:26:40,458
INCREASINGLY POSSIBLE WITH 

3666
02:26:40,458 --> 02:26:42,727
ADOPTION OF COMMON DATA MODELS 

3667
02:26:42,727 --> 02:26:44,663
AND POWERFUL TOOL TO STUDY RARE 

3668
02:26:44,663 --> 02:26:46,731
OUTCOMES LIKE CANCER AND THIRD 

3669
02:26:46,731 --> 02:26:49,000
THE RESEARCH COMMUNITY NEEDS TO 

3670
02:26:49,000 --> 02:26:52,270
INVEST IN SUPPORT LARGE SCALE 

3671
02:26:52,270 --> 02:26:53,104
LINKAGE EFFORTS BETWEEN REAL 

3672
02:26:53,104 --> 02:26:56,875
WORLD DATA LINKING EHRS AND 

3673
02:26:56,875 --> 02:27:00,078
CENTRAL ARE EDGETRY DATA AND 

3674
02:27:00,078 --> 02:27:02,247
ONGOING EFFORTS N3C AND CANCER 

3675
02:27:02,247 --> 02:27:03,982
REGISTRIES AND LINKAGE WITH 

3676
02:27:03,982 --> 02:27:05,917
MEDICARE AND MEDICAID CLAIMS 

3677
02:27:05,917 --> 02:27:08,486
DATA AND FINALLY, BECAUSE CANCER

3678
02:27:08,486 --> 02:27:11,389
IS SUCH A RARE OUTCOME THERE IS 

3679
02:27:11,389 --> 02:27:15,093
AN URGENT NEED TO CONTEXTUALIZE 

3680
02:27:15,093 --> 02:27:15,694
EVIDENCE GENERATED FROM REAL 

3681
02:27:15,694 --> 02:27:17,495
WORLD DATA INTO CONTEXT OF 

3682
02:27:17,495 --> 02:27:19,731
BENEFITS OF MEDICATIONS AND 

3683
02:27:19,731 --> 02:27:21,499
IMPROVED APPROACHES FOR PATIENT 

3684
02:27:21,499 --> 02:27:24,836
PROVIDER COMMUNICATION AROUND 

3685
02:27:24,836 --> 02:27:26,004
TRADEOFFS ARE NEEDED. 

3686
02:27:26,004 --> 02:27:28,106
I THINK THAT IS IT FOR ME AND 

3687
02:27:28,106 --> 02:27:30,041
WOULD LIKE TO THANK COLLEAGUES 

3688
02:27:30,041 --> 02:27:33,912
AT UNC AND NORTH CAROLINA 

3689
02:27:33,912 --> 02:27:35,313
DIABETES RESEARCH CENTER AND DR.

3690
02:27:35,313 --> 02:27:37,382
HILL AND OTHER ORGANIZERS AND 

3691
02:27:37,382 --> 02:27:40,919
LOOKING FORWARD TO OUR UPCOMING 

3692
02:27:40,919 --> 02:27:50,929
DISCUSSION.  THANK YOU.  

3693
02:27:50,929 --> 02:27:53,098
>> THANK YOU FOR THE GREAT
TOUR 

3694
02:27:53,098 --> 02:27:56,434
IN GLP-1 AND CANCER SITUATION. 

3695
02:27:56,434 --> 02:27:59,237
SO IT IS NOW 1228 AND I WILL 

3696
02:27:59,237 --> 02:28:00,739
JUST INVITE THE PANELISTS TO ALL

3697
02:28:00,739 --> 02:28:11,249
TURN THEIR CAMERAS BACK ON.  

3698
02:28:15,120 --> 02:28:17,088
I WILL DOUBLE CHECK WE HAVE 

3699
02:28:17,088 --> 02:28:19,858
UNTIL 12:45 FOR THE DISCUSSION 

3700
02:28:19,858 --> 02:28:23,094
AND WILL ADJUST THE TIME LINE A 

3701
02:28:23,094 --> 02:28:25,063
BIT AND IF YOU ARE HERE AND CAN 

3702
02:28:25,063 --> 02:28:26,664
TURN THE CAMERA BACK ON THAT 

3703
02:28:26,664 --> 02:28:27,799
WOULD BE GREAT. 

3704
02:28:27,799 --> 02:28:29,534
WE CAN GO AHEAD AND START TO 

3705
02:28:29,534 --> 02:28:31,669
TALK THROUGH QUESTIONS THAT CAME

3706
02:28:31,669 --> 02:28:31,870
UP. 

3707
02:28:31,870 --> 02:28:34,072
DR. MCCOY, I WILL GO TO YOU 

3708
02:28:34,072 --> 02:28:35,440
FIRST WITH A QUESTION THAT CAME 

3709
02:28:35,440 --> 02:28:37,108
IN THROUGH THE CHAT.  

3710
02:28:37,108 --> 02:28:40,812
DO YOU HAVE ANY THOUGHTS HOW TO 

3711
02:28:40,812 --> 02:28:44,616
APPLY CKM REAL-WORLD DATA 

3712
02:28:44,616 --> 02:28:47,051
OUTCOMES MEASURES IN PEDIATRICS 

3713
02:28:47,051 --> 02:28:48,219
AND IN PARTICULAR I BELIEVE THAT

3714
02:28:48,219 --> 02:28:50,021
THE QUESTION IS FOCUSED ON THE 

3715
02:28:50,021 --> 02:28:51,656
IDEA THAT YOU HAVE CHILDREN AND 

3716
02:28:51,656 --> 02:28:53,658
YOU DON'T ACTUALLY GET HARD 

3717
02:28:53,658 --> 02:28:55,427
OUTCOMES OR DON'T GET THEM AS 

3718
02:28:55,427 --> 02:28:57,128
OFTEN AND THERE COULD BE 

3719
02:28:57,128 --> 02:28:58,696
INTERMEDIATE MEASURES AND, YOU 

3720
02:28:58,696 --> 02:28:59,964
KNOW, HOW -- WHAT SORT OF ADVICE

3721
02:28:59,964 --> 02:29:01,399
AND THOUGHTS WOULD YOU HAVE TO 

3722
02:29:01,399 --> 02:29:04,068
SHARE ABOUT HOW TO THINK ABOUT 

3723
02:29:04,068 --> 02:29:05,770
THESE ISSUES IN THE PEDIATRIC 

3724
02:29:05,770 --> 02:29:06,070
SETTING?  

3725
02:29:06,070 --> 02:29:07,872
>> I THINK THAT IS A
REALLY 

3726
02:29:07,872 --> 02:29:09,707
IMPORTANT POINT. 

3727
02:29:09,707 --> 02:29:11,843
I THINK IT ALSO UNDERSCORES 

3728
02:29:11,843 --> 02:29:15,747
IMPORTANCE OF REAL WORLD DATA TO

3729
02:29:15,747 --> 02:29:17,816
STUDY MEDICATION USE IN YOUTH. 

3730
02:29:17,816 --> 02:29:21,319
THEY ARE OFTEN MAYBE USED OFF 

3731
02:29:21,319 --> 02:29:23,121
LABEL AND SCARCITY OF CLINICAL 

3732
02:29:23,121 --> 02:29:26,291
TRIAL DATA IN THIS POPULATION. 

3733
02:29:26,291 --> 02:29:28,993
SO I THINK, YOU KNOW, THE 

3734
02:29:28,993 --> 02:29:30,628
BIGGEST QUESTION THAT CAME UP 

3735
02:29:30,628 --> 02:29:34,199
THROUGHOUT THE TALKS IS LATE NRC

3736
02:29:34,199 --> 02:29:36,568
PERIOD BETWEEN HARD OUTCOME AND 

3737
02:29:36,568 --> 02:29:38,136
TREATMENT EXPOSURE AND DEPENDING

3738
02:29:38,136 --> 02:29:39,637
ON SPECIFIC OUTCOME YOU ARE 

3739
02:29:39,637 --> 02:29:42,707
INTERESTED IN YOU MAY SEE HARD 

3740
02:29:42,707 --> 02:29:45,109
OUTCOMES IN YOUTH.  YOU KNOW?  

3741
02:29:45,109 --> 02:29:47,111
THE OTHER IS LOOKING FOR DATA 

3742
02:29:47,111 --> 02:29:48,913
ASSETS THAT ARE GOING TO HAVE 

3743
02:29:48,913 --> 02:29:50,915
VARIABLES THAT YOU NEED TO 

3744
02:29:50,915 --> 02:29:53,084
ASCERTAIN THE SPECIFIC QUESTION 

3745
02:29:53,084 --> 02:29:57,589
WHETHER YOU ARE LOOKING AT 

3746
02:29:57,589 --> 02:30:01,159
WEIGHT, GLIESEMIA, YOU KNOW, 

3747
02:30:01,159 --> 02:30:02,861
PROGRESSION OF KIDNEY DISEASE, 

3748
02:30:02,861 --> 02:30:05,063
ET CETERA. 

3749
02:30:05,063 --> 02:30:06,331
THINK ELECTRONIC HEALTH RECORD 

3750
02:30:06,331 --> 02:30:08,566
DATA AND EHR THAT IS LINKED TO 

3751
02:30:08,566 --> 02:30:10,401
CLAIMS THAT ARE DEFINITELY 

3752
02:30:10,401 --> 02:30:12,871
ADEQUATE FOR THIS.  I THINK THE 

3753
02:30:12,871 --> 02:30:13,771
BIGGEST CHALLENGE COMING TO 

3754
02:30:13,771 --> 02:30:16,007
YOUTH AND MEDICATIONS THAT IS 

3755
02:30:16,007 --> 02:30:19,310
APPROPRIATELY CLASSIFYING 

3756
02:30:19,310 --> 02:30:21,112
DIABETES TYPE. 

3757
02:30:21,112 --> 02:30:22,947
ESPECIALLY THERE IS YOUTH WITH 

3758
02:30:22,947 --> 02:30:25,250
OBESITY BY ITSELF AND COMING TO 

3759
02:30:25,250 --> 02:30:26,985
DIABETES, I THINK THAT BECOMES A

3760
02:30:26,985 --> 02:30:29,687
LITTLE MORE CHALLENGING TO FULLY

3761
02:30:29,687 --> 02:30:34,058
KIND OF PHENOTYPE THE DIABETES 

3762
02:30:34,058 --> 02:30:35,994
TYPE ESPECIALLY WHEN BOTH TYPE 1

3763
02:30:35,994 --> 02:30:40,064
AND 2 PRESENT AT SAME TIME AND 

3764
02:30:40,064 --> 02:30:42,567
HAS TO BE CONSIDERATIONS DONE TO

3765
02:30:42,567 --> 02:30:44,602
KNOW EXACTLY THE POPULATION YOU 

3766
02:30:44,602 --> 02:30:45,503
ARE STUDYING. 

3767
02:30:45,503 --> 02:30:48,106
I DON'T THINK FOR YOUTH THE 

3768
02:30:48,106 --> 02:30:49,107
CONSIDERATIONS ARE ANY DIFFERENT

3769
02:30:49,107 --> 02:30:51,943
THAN FOR ADULTS OTHER THAN WE 

3770
02:30:51,943 --> 02:30:54,145
NEED REAL WORLD DATA EVEN MORE 

3771
02:30:54,145 --> 02:31:04,689
FOR THAT POPULATION I THINK. 

3772
02:31:04,689 --> 02:31:06,357
>> REALLY EXCELLENT POINTS
AND 

3773
02:31:06,357 --> 02:31:08,660
LOVE HOW THE TALKS PICKED UP ON 

3774
02:31:08,660 --> 02:31:10,528
LOTS OF THEMES BROUGHT UP IN THE

3775
02:31:10,528 --> 02:31:12,163
PLENARY AND UNPACK THEM IN 

3776
02:31:12,163 --> 02:31:13,965
SPECIALIZED SETTINGS AND IS A 

3777
02:31:13,965 --> 02:31:17,101
COUPLE ISSUES YOU ALSO ALL 

3778
02:31:17,101 --> 02:31:18,870
TOUCHED ON AND DID -- I WOULD 

3779
02:31:18,870 --> 02:31:20,371
LOVE IT IF YOU COULD UNPACK THEM

3780
02:31:20,371 --> 02:31:23,541
A LITTLE MORE AND ONE IS A 

3781
02:31:23,541 --> 02:31:25,109
QUESTION OF DATA LINKAGE AND 

3782
02:31:25,109 --> 02:31:26,978
THERE WERE A COUPLE OF EXAMPLES 

3783
02:31:26,978 --> 02:31:30,448
WHERE EHR AND CLAIMS DATA WERE 

3784
02:31:30,448 --> 02:31:31,950
LINKED SORT OF THAT WE SAW 

3785
02:31:31,950 --> 02:31:33,418
FLYING BY.  I WANTED TO EACH 

3786
02:31:33,418 --> 02:31:36,888
GIVE YOU AN OPPORTUNITY TO 

3787
02:31:36,888 --> 02:31:37,956
ADDRESS THAT QUESTION 

3788
02:31:37,956 --> 02:31:39,357
SPECIFICALLY.  DO YOU -- DO YOU 

3789
02:31:39,357 --> 02:31:42,060
-- WHAT DO YOU -- WHAT DO YOU 

3790
02:31:42,060 --> 02:31:45,029
THINK ABOUT THE LINKAGE OF EHR 

3791
02:31:45,029 --> 02:31:46,864
CLAIMS DATA OR REGISTRY DATA AND

3792
02:31:46,864 --> 02:31:49,067
ARE THERE KEY EXAMPLES AND/OR DO

3793
02:31:49,067 --> 02:31:50,668
YOU HAVE KEY RESOURCES THAT YOU 

3794
02:31:50,668 --> 02:31:53,705
THINK THAT THE AUDIENCE SHOULD 

3795
02:31:53,705 --> 02:31:57,075
BE AWARE OF?  

3796
02:31:57,075 --> 02:31:59,677
>> I'M HAPPY TO START
SINCE I 

3797
02:31:59,677 --> 02:32:02,547
KIND OF WAS THE LAST ONE TO 

3798
02:32:02,547 --> 02:32:03,548
MENTION LINKAGE. 

3799
02:32:03,548 --> 02:32:05,717
I THINK IN THE CONTEXT OF 

3800
02:32:05,717 --> 02:32:07,819
CANCER, PROBABLY MOST VALUABLE 

3801
02:32:07,819 --> 02:32:09,921
LINKAGE TO GET TO THE CANCER 

3802
02:32:09,921 --> 02:32:11,656
REGISTRY IS WHERE THE MOST 

3803
02:32:11,656 --> 02:32:12,790
DETAILED GRANULAR INFORMATION 

3804
02:32:12,790 --> 02:32:15,893
ABOUT THE CANCER IS AND WHEN WE 

3805
02:32:15,893 --> 02:32:17,996
REALLY WANT TO UNDERSTAND KIND 

3806
02:32:17,996 --> 02:32:19,964
OF THESE SPECIFIC EFFECTS, I 

3807
02:32:19,964 --> 02:32:21,933
THINK THAT IS THE LEVEL OF 

3808
02:32:21,933 --> 02:32:24,068
GRANULARITY WE ARE TRYING TO GET

3809
02:32:24,068 --> 02:32:26,004
TO AND GOOD NEWS IS I THINK 

3810
02:32:26,004 --> 02:32:28,573
THERE ARE REALLY MORE EFFORTS 

3811
02:32:28,573 --> 02:32:30,675
PUSHING TOWARDS TRYING TO LINK 

3812
02:32:30,675 --> 02:32:33,878
SOME OF THE LARGE-SCALE EHR 

3813
02:32:33,878 --> 02:32:36,981
SYSTEMS AND ONE I MENTIONED WAS 

3814
02:32:36,981 --> 02:32:39,384
N3C COLLABORATIVE THAT IS SET UP

3815
02:32:39,384 --> 02:32:40,585
BECAUSE OF COVID. 

3816
02:32:40,585 --> 02:32:42,353
NOW THEY ARE TRYING TO KEEP 

3817
02:32:42,353 --> 02:32:43,855
INFRASTRUCTURE AND USE IT TO 

3818
02:32:43,855 --> 02:32:45,089
BRING IN OTHER USE CASES. 

3819
02:32:45,089 --> 02:32:47,592
I KNOW THERE IS A BIG PUSH RIGHT

3820
02:32:47,592 --> 02:32:49,761
NOW ONGOING AND UNC IS INVOLVED 

3821
02:32:49,761 --> 02:32:52,330
WITH THIS IN TERMS OF LINKING 

3822
02:32:52,330 --> 02:32:54,399
DATA TO CR REGISTRY DATA AND 

3823
02:32:54,399 --> 02:32:56,300
CLAIMS DATA LIKE MEDICARE. 

3824
02:32:56,300 --> 02:33:00,905
I THINK THAT IS THE TYPE OF RESO

3825
02:33:00,905 --> 02:33:02,940
URS TH -- RESOURCE I THINK WOUL 

3826
02:33:02,940 --> 02:33:04,375
REALLY HELP MOVE THIS LINE OF 

3827
02:33:04,375 --> 02:33:05,109
WORK FORD. 

3828
02:33:05,109 --> 02:33:07,879
>> IT IS SO IMPORTANT. 
SORRY GO

3829
02:33:07,879 --> 02:33:09,113
AHEAD, DR. MCCOY. 

3830
02:33:09,113 --> 02:33:11,249
>> SO SORRY AND COMPLETELY
AGREE

3831
02:33:11,249 --> 02:33:13,084
AND ONE THING TO NOTE IN 

3832
02:33:13,084 --> 02:33:14,752
RELATION TO PREVIOUS QUESTION 

3833
02:33:14,752 --> 02:33:17,255
RAISED IN PEDIATRICS THAT I 

3834
02:33:17,255 --> 02:33:19,557
THINK LINKAGES ARE ESPECIALLY 

3835
02:33:19,557 --> 02:33:20,958
FOR POPULATION AND COMMONLY WHEN

3836
02:33:20,958 --> 02:33:22,794
YOU LOOK AT CLAIMS PEOPLE USE 

3837
02:33:22,794 --> 02:33:25,096
MEDICARE AND THAT IS WHAT IS 

3838
02:33:25,096 --> 02:33:26,931
AVAILABLE NATIONALLY AND FOCUSES

3839
02:33:26,931 --> 02:33:30,835
ON OLDER ADULTS AND WE HAVE VERY

3840
02:33:30,835 --> 02:33:33,137
LITTLE LINKABLE INFORMATION FOR 

3841
02:33:33,137 --> 02:33:37,108
YOUTH AND YOUNG ADULTS AND 

3842
02:33:37,108 --> 02:33:39,677
MEDICATIVE DATA IS VERY 

3843
02:33:39,677 --> 02:33:40,645
CHALLENGING TO ACCESS AND LINK 

3844
02:33:40,645 --> 02:33:42,513
TO OTHER SOURCES AND REGULATORY 

3845
02:33:42,513 --> 02:33:45,716
ISSUES SURROUNDING MEDICAID AND 

3846
02:33:45,716 --> 02:33:47,118
OTHER CONSIDERATION OF BUILDING 

3847
02:33:47,118 --> 02:33:50,922
AGAIN ON THAT, IT IS 

3848
02:33:50,922 --> 02:33:52,123
SELF-ENSURED ORGANIZATIONS AND 

3849
02:33:52,123 --> 02:33:55,193
HMOS AND KAISER IS VERY -- AND 

3850
02:33:55,193 --> 02:33:59,664
VA AND THOSE ARE POWERFUL LINKED

3851
02:33:59,664 --> 02:34:02,200
DATA ASSETS BUT FOR KIND OF 

3852
02:34:02,200 --> 02:34:04,502
SPECIFIC PATIENT POPULATION.  

3853
02:34:04,502 --> 02:34:08,539
AGAIN, VA WON'T HAVE MUCH OR 

3854
02:34:08,539 --> 02:34:09,774
ANYTHING FOR YOUTH. 

3855
02:34:09,774 --> 02:34:12,510
OR FOR YOUNGER ADULTS WITH 

3856
02:34:12,510 --> 02:34:13,711
CHRONIC HEALTH CONDITIONS AND 

3857
02:34:13,711 --> 02:34:17,548
HAVE TO WAIT FOR VETERANS TO AID

3858
02:34:17,548 --> 02:34:18,916
AND DEVELOP THOSE AND SPEAKING 

3859
02:34:18,916 --> 02:34:21,085
TO, ONE, IMPORTANCE OF INVESTING

3860
02:34:21,085 --> 02:34:23,020
IN DATA RESOURCES AND DREAM 

3861
02:34:23,020 --> 02:34:25,056
WORLD AND INTO DOING THE STUDIES

3862
02:34:25,056 --> 02:34:26,357
IN DIFFERENT POPULATIONS. 

3863
02:34:26,357 --> 02:34:29,093
I THINK IT IS ESPECIALLY, YOU 

3864
02:34:29,093 --> 02:34:33,698
KNOW, CALL HERE TO NIDDK THAT 

3865
02:34:33,698 --> 02:34:35,333
FUNDERS THAT SOMETIMES 

3866
02:34:35,333 --> 02:34:36,968
DUPLICATION AND REPLICATION 

3867
02:34:36,968 --> 02:34:38,636
EFFORTS IF DONE IN DIFFERENT 

3868
02:34:38,636 --> 02:34:41,105
POPULATIONS AND USING DATA 

3869
02:34:41,105 --> 02:34:43,508
ASSETS ARE CRITICAL MAY NOT BE 

3870
02:34:43,508 --> 02:34:46,410
AS INNOVATIVE AND THINK THEY ARE

3871
02:34:46,410 --> 02:34:47,845
CRITICALLY IMPORTANT TO GET 

3872
02:34:47,845 --> 02:34:50,281
ANSWERS FOR, YOU KNOW, DIFFERENT

3873
02:34:50,281 --> 02:34:53,084
POPULATIONS THAT WE CARE FOR. 

3874
02:34:53,084 --> 02:34:54,852
AND ENDING WITH ANOTHER PLUG FOR

3875
02:34:54,852 --> 02:34:57,054
WHY -- FOR OUR FUNDERS AND LOTS 

3876
02:34:57,054 --> 02:34:59,357
OF DATA ASSETS ARE VERY 

3877
02:34:59,357 --> 02:35:00,291
EXPENSIVE ALSO. 

3878
02:35:00,291 --> 02:35:02,760
THAT I THINK LIMITS ABILITY TO 

3879
02:35:02,760 --> 02:35:04,762
DO THIS WORK AND WITH DATA I 

3880
02:35:04,762 --> 02:35:07,698
WORK WITH OPTUM LABS THAT 

3881
02:35:07,698 --> 02:35:08,566
INCLUDED ELECTRONIC HEALTH 

3882
02:35:08,566 --> 02:35:11,669
RECORDS LABS AND CLAIMS.  IT IS 

3883
02:35:11,669 --> 02:35:15,106
ALSO LINKED TO CR REGISTRIES AND

3884
02:35:15,106 --> 02:35:18,810
OTHER REGISTRIES AND IS VERY 

3885
02:35:18,810 --> 02:35:20,111
EXPENSIVE AND OFTEN IS AN 

3886
02:35:20,111 --> 02:35:22,246
ASSUMPTION THAT REAL WORLD DATA 

3887
02:35:22,246 --> 02:35:24,615
STUDIES ARE ACHIEVED AND CAN BE 

3888
02:35:24,615 --> 02:35:26,117
DONE WITH LITTLE RESOURCES THAT 

3889
02:35:26,117 --> 02:35:28,719
I THINK I WISH IT WAS THE CASE 

3890
02:35:28,719 --> 02:35:30,288
AND THINK JUST COST AND TIME 

3891
02:35:30,288 --> 02:35:34,058
REQUIRED TO DO LINKAGES OR BUY 

3892
02:35:34,058 --> 02:35:36,861
THEM AS SUBSTANTIAL. 

3893
02:35:36,861 --> 02:35:39,197
>> YEAH.  WELL STATED. 

3894
02:35:39,197 --> 02:35:40,998
>> THAT REALLY GREAT
POINTS AND 

3895
02:35:40,998 --> 02:35:43,935
I JUST WANTED TO ADD BECAUSE OF 

3896
02:35:43,935 --> 02:35:45,837
MENTION OF INTEGRATED HEALTH 

3897
02:35:45,837 --> 02:35:49,006
CARE SYSTEMS AND IN KAISER 

3898
02:35:49,006 --> 02:35:50,308
PERMANENTE, WE ARE ABLE TO PULL 

3899
02:35:50,308 --> 02:35:53,878
IN CLAIMS DATA AND LINK IT 

3900
02:35:53,878 --> 02:35:56,047
SEAMLESSLY IN OUR ANALYSIS. 

3901
02:35:56,047 --> 02:36:01,085
IN KAISER PERMANENTE AND IN OUR 

3902
02:36:01,085 --> 02:36:03,054
PARTICULAR RE REGION OR CALLE W 

3903
02:36:03,054 --> 02:36:05,890
HAVE TO LINK UP PARTNERS AND 

3904
02:36:05,890 --> 02:36:08,159
BRING DATA TOGETHER AND AGREE IT

3905
02:36:08,159 --> 02:36:09,994
IS DISPENSESIVE REQUIRING 

3906
02:36:09,994 --> 02:36:11,996
SUPPORTS AND ILLUSTRATING AN 

3907
02:36:11,996 --> 02:36:13,464
EXAMPLE WE -- COLLEAGUES AND I 

3908
02:36:13,464 --> 02:36:15,633
HAVE BEEN PARTICIPANTS IN MENTAL

3909
02:36:15,633 --> 02:36:19,070
HEALTH RESEARCH NETWORK 

3910
02:36:19,070 --> 02:36:20,738
CONSORTIUM FUNDED FOR SEVERAL 

3911
02:36:20,738 --> 02:36:23,641
CYCLES BY NIMH AND HAS BEEN AN 

3912
02:36:23,641 --> 02:36:24,709
EXTREMELY PRODUCTIVE GROUP OF 

3913
02:36:24,709 --> 02:36:27,845
PEOPLE THAT ALLOWED US TO DO 

3914
02:36:27,845 --> 02:36:29,080
FEDERATED ANALYSIS WHERE 

3915
02:36:29,080 --> 02:36:30,848
ANALYSIS HAVE BEEN DISTRIBUTED 

3916
02:36:30,848 --> 02:36:32,183
ACROSS THE DIFFERENT HEALTH 

3917
02:36:32,183 --> 02:36:33,851
SYSTEMS AND WE HAVE ALSO BEEN 

3918
02:36:33,851 --> 02:36:36,420
ABLE IN LOTS OF PROJECTS TO POOL

3919
02:36:36,420 --> 02:36:38,489
DATA TOGETHER AND DO HIGHER 

3920
02:36:38,489 --> 02:36:41,092
IMPACT WORK.  BUT THAT, YOU 

3921
02:36:41,092 --> 02:36:43,160
KNOW, MECHANISM AND WONDERFULLY 

3922
02:36:43,160 --> 02:36:44,695
SUPPORTED NETWORK HAS BEEN 

3923
02:36:44,695 --> 02:36:46,797
PHASED OUT AND NOW, YOU KNOW, WE

3924
02:36:46,797 --> 02:36:48,199
ARE KEEPING THINGS GOING THROUGH

3925
02:36:48,199 --> 02:36:53,571
OUR SORT OF VOLUNTEER AND, YOU 

3926
02:36:53,571 --> 02:36:55,506
KNOW, FOR AMICABLE RELATIONSHIPS

3927
02:36:55,506 --> 02:36:56,874
WITH EACH OTHER AND FOR REAL 

3928
02:36:56,874 --> 02:36:59,877
WORLD DATA WE NEED TO SUPPORT 

3929
02:36:59,877 --> 02:37:01,445
CONSORTIA.  SOME OUTCOMES ARE 

3930
02:37:01,445 --> 02:37:02,713
VERY RARE AND REQUIRE A LOT OF 

3931
02:37:02,713 --> 02:37:04,849
DATA AND WE WANT TO BE ABLE TO 

3932
02:37:04,849 --> 02:37:09,086
REPLICATE AND BE GENERALIZABLE 

3933
02:37:09,086 --> 02:37:10,354
ACROSS THE WHOLE POPULATION. 

3934
02:37:10,354 --> 02:37:12,256
>> RIGHT.  RIGHT.  YEAH. 
SO 

3935
02:37:12,256 --> 02:37:13,958
REAL WORLD DATA SEEMS LIKE SO 

3936
02:37:13,958 --> 02:37:15,459
MUCH DATA. 

3937
02:37:15,459 --> 02:37:16,627
SOMETIMES YOU KNOW MORE THAN ONE

3938
02:37:16,627 --> 02:37:19,063
HEALTH SYSTEM IS REALLY 

3939
02:37:19,063 --> 02:37:19,363
IMPORTANT. 

3940
02:37:19,363 --> 02:37:22,099
YOU ARE -- YOU CITED ANALYSIS 

3941
02:37:22,099 --> 02:37:24,502
WHICH HAD DATA FROM MULTIPLE 

3942
02:37:24,502 --> 02:37:26,771
INTEGRATED HEALTH SYSTEMS AS ONE

3943
02:37:26,771 --> 02:37:27,038
APPROACH. 

3944
02:37:27,038 --> 02:37:27,571
>> RIGHT. 

3945
02:37:27,571 --> 02:37:29,640
>> SOMEBODY PUT IN CHAT
MORE 

3946
02:37:29,640 --> 02:37:33,144
ABOUT N3C LINKAGES AND KNOW 

3947
02:37:33,144 --> 02:37:36,514
THERE ARE SITES IN PCORI THAT 

3948
02:37:36,514 --> 02:37:38,182
ARE TRYING TO IMPROVE ACCESS TO 

3949
02:37:38,182 --> 02:37:40,451
CLAIMS DATA AND AREA THAT COULD 

3950
02:37:40,451 --> 02:37:44,255
USE MORE FOCUS DEFINITELY. 

3951
02:37:44,255 --> 02:37:46,791
SO A SECOND METHODS ISSUE 

3952
02:37:46,791 --> 02:37:49,427
TOUCHED ON IN MULTIPLE TALKS IS 

3953
02:37:49,427 --> 02:37:51,295
IDEA OF HOW YOU ACCURATELY 

3954
02:37:51,295 --> 02:37:52,730
IDENTIFY YOUR COHORT AND HOW 

3955
02:37:52,730 --> 02:37:54,198
IMPORTANT IT IS.  IT WAS 

3956
02:37:54,198 --> 02:37:56,200
SOMETHING THAT WAS SORT OF JUST 

3957
02:37:56,200 --> 02:37:58,769
SORT OF AN ASIDE AND THINK THAT 

3958
02:37:58,769 --> 02:38:00,538
ALL FOUR PRESENTATIONS AND KNOW 

3959
02:38:00,538 --> 02:38:03,841
WE HAVE SOME PEOPLE ON THE CALL 

3960
02:38:03,841 --> 02:38:06,977
HERE WHO HAVE NOT WORKED MUCH 

3961
02:38:06,977 --> 02:38:09,080
WITH REAL WORLD DATA IN THE PAST

3962
02:38:09,080 --> 02:38:11,248
AND WONDER IF THEY CAN ESTIMATE 

3963
02:38:11,248 --> 02:38:13,117
HOW -- WHAT A TASK THAT IS TO 

3964
02:38:13,117 --> 02:38:14,852
BUILD INTO PROJECT AND WONDER IF

3965
02:38:14,852 --> 02:38:16,587
YOU CAN SHARE A LITTLE ABOUT 

3966
02:38:16,587 --> 02:38:20,057
YOUR APPROACH FOR MAKING SURE 

3967
02:38:20,057 --> 02:38:25,796
THAT YOU USE BEST APPROACH TO 

3968
02:38:25,796 --> 02:38:28,366
IDENTIFY YOUR COHORT. 

3969
02:38:28,366 --> 02:38:32,970
>> SO I THINK I CAN START.
IN 

3970
02:38:32,970 --> 02:38:35,573
OUR DOCUMENT STUDIES WE HAVE TWO

3971
02:38:35,573 --> 02:38:39,643
COHORTS GENERALLY ONE IS TYPE 2 

3972
02:38:39,643 --> 02:38:42,246
DIABETES COHORTS AND GLP-1 

3973
02:38:42,246 --> 02:38:45,349
ACTIVE COMPARATORS WOULD BE THE 

3974
02:38:45,349 --> 02:38:47,551
SECOND LINE AND OTHER SECOND 

3975
02:38:47,551 --> 02:38:50,087
LINE INTERACTS SOMETIMES 

3976
02:38:50,087 --> 02:38:54,358
INDIVIDUAL DRUG LIKE TPP4 AND 

3977
02:38:54,358 --> 02:38:59,296
SDL2 CLUSTERED DRUGS AND IN THIS

3978
02:38:59,296 --> 02:39:09,840
COHORT WE -- WE ALWAYS DO DOUBLE

3979
02:39:27,858 --> 02:39:31,362
-- IN THAT COHORT COMPLETELY 

3980
02:39:31,362 --> 02:39:33,097
OVERWEIGHT OBESITY COHORT AND 

3981
02:39:33,097 --> 02:39:35,433
SOMETIMES WE STRUGGLE WHETHER 

3982
02:39:35,433 --> 02:39:36,567
COHORT WE SHOULD INCLUDE 

3983
02:39:36,567 --> 02:39:40,571
PATIENTS WITH DIABETES AND 

3984
02:39:40,571 --> 02:39:44,074
INCLUDE PATIENTS WITH DIABETES 

3985
02:39:44,074 --> 02:39:46,077
ANYWAY FOR ISSUES AND LOTS OF 

3986
02:39:46,077 --> 02:39:48,412
PEOPLE REALLY YOU CANNOT 

3987
02:39:48,412 --> 02:39:53,083
SEPARATE PATIENTS WITH 

3988
02:39:53,083 --> 02:39:55,786
SUBOPTIMAL METABOLIC PROFILE AND

3989
02:39:55,786 --> 02:39:59,723
IN THAT COHORT WE USE GLP-1 AS 

3990
02:39:59,723 --> 02:40:01,859
TREATMENT AND COMPARATOR ALWAYS 

3991
02:40:01,859 --> 02:40:08,098
NOW USERS IN -- SO IT WAS MORE 

3992
02:40:08,098 --> 02:40:13,304
LIKE RIGOROUS FOR PROPENSITY 

3993
02:40:13,304 --> 02:40:15,673
SCORE APPROACH TO TRY TO 

3994
02:40:15,673 --> 02:40:19,143
MITIGATE CONFOUNDING BY 

3995
02:40:19,143 --> 02:40:29,653
INDICATION.  YEAH A QUESTION 

3996
02:40:31,088 --> 02:40:34,792
CALLED OUT TO YOU IF DOG REAL 

3997
02:40:34,792 --> 02:40:37,728
WORLD DATA STUDY AND BEST 

3998
02:40:37,728 --> 02:40:38,562
PRACTICES YOU MIGHT SUGGEST 

3999
02:40:38,562 --> 02:40:45,936
USING CANCER CODES AND OTHER 

4000
02:40:45,936 --> 02:40:46,203
AVENUES. 

4001
02:40:46,203 --> 02:40:48,772
>> GREAT ONE AND EVERYONE
USING 

4002
02:40:48,772 --> 02:40:50,941
CLAIMS WRESTLES WITH TWO PIECES 

4003
02:40:50,941 --> 02:40:53,077
OF IT, PIECE THAT YOU WANT TO --

4004
02:40:53,077 --> 02:40:55,579
ONCE YOU IDENTIFY INITIATORS OF 

4005
02:40:55,579 --> 02:40:57,114
DRUGS OF INTEREST YOU NEED TO 

4006
02:40:57,114 --> 02:40:58,349
LOOK BACK AND MAKE SURE PEOPLE 

4007
02:40:58,349 --> 02:41:00,551
DON'T HAVE CANCER YOU WILL STUDY

4008
02:41:00,551 --> 02:41:03,521
AND YOU NEED TO LOOK BACK AND WE

4009
02:41:03,521 --> 02:41:05,723
TEND TO USE DIFFERENT ALGORITHMS

4010
02:41:05,723 --> 02:41:08,058
THAT ARE -- YOU KNOW, WE 

4011
02:41:08,058 --> 02:41:09,960
BASICALLY HAVE A VERY HIGH PPV 

4012
02:41:09,960 --> 02:41:12,363
AND LIKE YOU ARE NOT GOING TO 

4013
02:41:12,363 --> 02:41:14,798
GET A LOT OF FALSE POSITIVES AND

4014
02:41:14,798 --> 02:41:16,066
PEOPLE IN THERE TRULY HAVE 

4015
02:41:16,066 --> 02:41:18,168
CANCER AND YOU TRY TO GET RID OF

4016
02:41:18,168 --> 02:41:19,803
PEOPLE AT BASELINE TO MAKE SURE 

4017
02:41:19,803 --> 02:41:22,006
YOU ARE TRULY LOOKING AT 

4018
02:41:22,006 --> 02:41:23,541
INCIDENT DISEASE GOING FORWARD 

4019
02:41:23,541 --> 02:41:25,009
AND THINK THAT IS THE IMPORTANT 

4020
02:41:25,009 --> 02:41:27,378
POINT TO WASH OUT YOU USE A 

4021
02:41:27,378 --> 02:41:28,012
DIFFERENT ALGORITHM THAN YOU 

4022
02:41:28,012 --> 02:41:30,581
MIGHT USE WHEN LOOKING AT 

4023
02:41:30,581 --> 02:41:31,382
INCIDENT CANCER.  

4024
02:41:31,382 --> 02:41:33,584
SO THERE IS A LOT OF ALGORITHMS 

4025
02:41:33,584 --> 02:41:37,087
THAT HAVE BEEN VALIDATED THAT 

4026
02:41:37,087 --> 02:41:39,256
USE 2 PLUS DIAGNOSIS WITHIN 60 

4027
02:41:39,256 --> 02:41:42,426
DAYS AND TRICK ABOUT SOME OF 

4028
02:41:42,426 --> 02:41:43,894
THESE WHEN YOU ACTUALLY 

4029
02:41:43,894 --> 02:41:44,695
IMPLEMENT THEM IS THEY REQUIRE 

4030
02:41:44,695 --> 02:41:46,764
YOU TO LOOK FORWARD IN TIME AND 

4031
02:41:46,764 --> 02:41:48,732
COME UP AND WE GET INTO TRICKY 

4032
02:41:48,732 --> 02:41:50,301
THINGS AROUND LOOKING FORWARD TO

4033
02:41:50,301 --> 02:41:51,602
DEFINING SOMETHING AND WHERE YOU

4034
02:41:51,602 --> 02:41:54,271
ACTUALLY CALL A CANCER A CANCER.

4035
02:41:54,271 --> 02:41:56,507
SO I THINK THAT EVERYONE, YEAH, 

4036
02:41:56,507 --> 02:41:58,976
WE NEED TO BE MINDFUL.  THERE IS

4037
02:41:58,976 --> 02:42:01,078
STILL ROOM HERE FOR IMPROVING 

4038
02:42:01,078 --> 02:42:03,747
SOME ALGORITHMS FOR DEFINING 

4039
02:42:03,747 --> 02:42:08,218
THESE OUTCOMES USING ICD CODES 

4040
02:42:08,218 --> 02:42:10,754
AND OTHER RELATED INFORMATION 

4041
02:42:10,754 --> 02:42:14,191
LIKE TREATMENTS AND LAB DATA IF 

4042
02:42:14,191 --> 02:42:16,827
POSSIBLE AS WELL.  

4043
02:42:16,827 --> 02:42:19,096
>> GREAT.  THANK YOU. 
DR., 

4044
02:42:19,096 --> 02:42:21,632
THERE IS A QUESTION RELATED TO 

4045
02:42:21,632 --> 02:42:23,934
CLASSIFYING AS WELL FOR YOU HOW 

4046
02:42:23,934 --> 02:42:26,237
ACCURATE REAL WORLD DATA SOURCES

4047
02:42:26,237 --> 02:42:27,871
IN CLASSIFYING ADDICTION EATING 

4048
02:42:27,871 --> 02:42:29,873
DISORDERS AND SUICIDALITY AND 

4049
02:42:29,873 --> 02:42:31,875
HOW DO YOU DEAL WITH THIS?  

4050
02:42:31,875 --> 02:42:35,879
>> YEAH.  I MEAN, I THINK 

4051
02:42:35,879 --> 02:42:37,414
SIMILAR CONSIDERATIONS DR. LUND 

4052
02:42:37,414 --> 02:42:39,817
OUTLINED APPLY HERE AND WILL 

4053
02:42:39,817 --> 02:42:41,218
GIVE EXAMPLES AND SIMILARLY 

4054
02:42:41,218 --> 02:42:43,420
THINK OF DIAGNOSIS AS BEING NOT 

4055
02:42:43,420 --> 02:42:45,889
SO SENSITIVE BUT VERY SPECIFIC. 

4056
02:42:45,889 --> 02:42:50,060
IT TAKES AN EXPERIENCE WITH THE 

4057
02:42:50,060 --> 02:42:53,097
DATA TO KNOW WHAT TO EXPECT AND 

4058
02:42:53,097 --> 02:42:55,165
WHAT KINDS OF PREVALENCE YOU 

4059
02:42:55,165 --> 02:42:57,935
EXPECT TO SEE FOR GIVEN SET OF 

4060
02:42:57,935 --> 02:43:01,105
ICD CODES AND USE ALGORITHMS 

4061
02:43:01,105 --> 02:43:04,208
WHERE WE LOOK FOR ONE IN-PATIENT

4062
02:43:04,208 --> 02:43:06,577
OR TWO OUTPATIENT DIAGNOSIS 

4063
02:43:06,577 --> 02:43:08,212
DEPENDING ON CONDITION AND WE 

4064
02:43:08,212 --> 02:43:10,214
HAVE REGISTRY AND WE HAVE AN 

4065
02:43:10,214 --> 02:43:11,949
ALCOHOL REGISTRY IN OUR SIFT 

4066
02:43:11,949 --> 02:43:15,185
THEME IS GENERATIVE OF DIFFERENT

4067
02:43:15,185 --> 02:43:15,452
RESEARCH. 

4068
02:43:15,452 --> 02:43:17,054
I'M NOT FAMILIAR WITH ARE 

4069
02:43:17,054 --> 02:43:19,490
EDGETRY APPROACHES IN MENTAL 

4070
02:43:19,490 --> 02:43:21,191
HEALTH AND WE CERTAINLY HAVE 

4071
02:43:21,191 --> 02:43:22,860
REGISTRIES FOR OTHER CONDITIONS 

4072
02:43:22,860 --> 02:43:27,064
AND WE HAVE A GREAT DIABETES 

4073
02:43:27,064 --> 02:43:27,598
REGISTRY. 

4074
02:43:27,598 --> 02:43:30,467
IT IS WELL VALIDATED AND BRINGS 

4075
02:43:30,467 --> 02:43:31,669
TOGETHER MEDICATIONS AND LABS 

4076
02:43:31,669 --> 02:43:33,604
AND NATURE OF MENTAL HEALTH IS 

4077
02:43:33,604 --> 02:43:36,740
CHALLENGING AND HOW ARE YOU 

4078
02:43:36,740 --> 02:43:39,476
GOING TO VALIDATE DIFFERENT 

4079
02:43:39,476 --> 02:43:41,078
ALGORITHMS AND IS DIFFICULT TO 

4080
02:43:41,078 --> 02:43:44,214
DO A COMPREHENSIVE DIAGNOSTIC 

4081
02:43:44,214 --> 02:43:48,419
INTERVIEW WITH PATIENTS THAT IS 

4082
02:43:48,419 --> 02:43:49,653
COMMON.  WE TRY TO TAKE IT INTO 

4083
02:43:49,653 --> 02:43:51,321
CONSIDERATION DESIGNING 

4084
02:43:51,321 --> 02:43:51,755
ANALYSIS. 

4085
02:43:51,755 --> 02:43:54,858
FOR EXAMPLE, YOU KNOW, IF WE ARE

4086
02:43:54,858 --> 02:43:57,194
INTERESTED IN, YOU KNOW, ONE 

4087
02:43:57,194 --> 02:43:59,430
DIAGNOSIS, WE MIGHT TRY TO FOCUS

4088
02:43:59,430 --> 02:44:00,798
IN -- MIGHT FOCUS THE QUESTION 

4089
02:44:00,798 --> 02:44:03,067
ON A TREATED POPULATION AND 

4090
02:44:03,067 --> 02:44:04,601
UNDERSTANDING THAT THERE ARE ALL

4091
02:44:04,601 --> 02:44:06,570
THESE OTHER PEOPLE THAT ARE NOT 

4092
02:44:06,570 --> 02:44:07,771
DIAGNOSED AND STILL COULD HAVE 

4093
02:44:07,771 --> 02:44:09,673
THE CONDITION THAT ARE NOT BEING

4094
02:44:09,673 --> 02:44:10,374
OBSERVED THAT WAY. 

4095
02:44:10,374 --> 02:44:12,076
SO -- AND THAT HAS LIMITATIONS 

4096
02:44:12,076 --> 02:44:14,211
AND WE MAY WANT TO HAVE A REALLY

4097
02:44:14,211 --> 02:44:15,512
BROAD POPULATION IN OUR STUDY 

4098
02:44:15,512 --> 02:44:17,047
AND THERE ARE SO MANY 

4099
02:44:17,047 --> 02:44:18,415
LIMITATIONS TO USING DIAGNOSIS 

4100
02:44:18,415 --> 02:44:20,784
AND MIGHT BE BETTER TO FOCUS IN 

4101
02:44:20,784 --> 02:44:22,786
AND EXCLUDE PEOPLE TO TRY TO 

4102
02:44:22,786 --> 02:44:24,621
INCREASE INTERNAL VALIDITY OF 

4103
02:44:24,621 --> 02:44:24,955
THE ANALYSIS. 

4104
02:44:24,955 --> 02:44:27,324
>> GREAT.  REALLY GOOD
POINTS. 

4105
02:44:27,324 --> 02:44:29,093
WE DON'T HAVE MUCH TIME LEFT.  

4106
02:44:29,093 --> 02:44:30,655
THERE IS A QUESTION FOR ALL OF 

4107
02:44:30,655 --> 02:44:32,820
THE SPEAKERS AND PERHAPS 

4108
02:44:32,820 --> 02:44:33,721
SOMEBODY COULD COMMENT ON THIS. 

4109
02:44:33,721 --> 02:44:35,156
COULD YOU SAY MORE ABOUT THE 

4110
02:44:35,156 --> 02:44:37,858
IMPORTANCE OF INVESTIGATING 

4111
02:44:37,858 --> 02:44:43,230
WHETHER OUTCOMES OF GLP-1S ARE 

4112
02:44:43,230 --> 02:44:46,167
BY WEIGHT LO S OR OTHER ADVERSE 

4113
02:44:46,167 --> 02:44:48,936
EFFECTS AND IN REAL WORLD DATA 

4114
02:44:48,936 --> 02:44:53,774
IN THOSE ANALYSIS. 

4115
02:44:53,774 --> 02:44:56,344
>> >> YES.  SO SORRY
AND 

4116
02:44:56,344 --> 02:44:57,812
REPORTED COST MEDIATED ANALYSIS 

4117
02:44:57,812 --> 02:45:00,681
AND I WILL ADDRESS THIS 

4118
02:45:00,681 --> 02:45:01,782
QUESTION. 

4119
02:45:01,782 --> 02:45:04,051
SO THEORETICALLY I STILL BELIEVE

4120
02:45:04,051 --> 02:45:05,786
THAT LOWERING BODY WEIGHT IS 

4121
02:45:05,786 --> 02:45:09,590
IMPORTANT CAUSAL PATHWAY THAT IS

4122
02:45:09,590 --> 02:45:12,193
LEADING TO THE BENEFICIAL 

4123
02:45:12,193 --> 02:45:13,794
OUTCOMES FOR MANY CONDITIONS 

4124
02:45:13,794 --> 02:45:16,731
INCLUDING OBESITY ASSOCIATED TO 

4125
02:45:16,731 --> 02:45:19,266
CANCER AND METABOLIC ENDPOINTS 

4126
02:45:19,266 --> 02:45:23,804
AND NEURODEGENERATIVE AND OUR 

4127
02:45:23,804 --> 02:45:26,273
STUDY DIDN'T REALLY SEE MOST 

4128
02:45:26,273 --> 02:45:29,677
INDEPENDENT EFFECT.  I THINK 

4129
02:45:29,677 --> 02:45:31,946
THERE IS SEVERAL KEY 

4130
02:45:31,946 --> 02:45:33,214
CONSIDERATIONS AND SPECIFICALLY 

4131
02:45:33,214 --> 02:45:36,751
FOR ADRD. 

4132
02:45:36,751 --> 02:45:38,919
WE CONSIDER THE METABOLIC RISK 

4133
02:45:38,919 --> 02:45:42,223
FACTORS GLUCOSE AND BMI THAT IS 

4134
02:45:42,223 --> 02:45:45,793
MORE LIKE RISK FACTORS OF MID 

4135
02:45:45,793 --> 02:45:48,429
LIFE THAT HAVE REALLY NOT 

4136
02:45:48,429 --> 02:45:50,965
OPTIMAL METABOLIC PROFILE IN 

4137
02:45:50,965 --> 02:45:55,703
THEIR AGE AND IMPACT ON LONG 

4138
02:45:55,703 --> 02:46:00,641
TERM RISK OF ADRD RISK AND 

4139
02:46:00,641 --> 02:46:02,643
DEMENTIA RISK AND ONE REASON AND

4140
02:46:02,643 --> 02:46:05,780
COHORT IS IN LATER YEARS IN LIFE

4141
02:46:05,780 --> 02:46:09,049
AND OVER 65 YEARS OLDER. 

4142
02:46:09,049 --> 02:46:11,552
AND SO THEY PROBABLY PLAY 

4143
02:46:11,552 --> 02:46:15,923
MINIMAL ROLE ON CAUSAL PATHWAYS 

4144
02:46:15,923 --> 02:46:21,395
AND ALSO ACTUALLY IN DEBATE AND 

4145
02:46:21,395 --> 02:46:22,830
NEW [INDISCERNIBLE] REGARDING 

4146
02:46:22,830 --> 02:46:25,766
BMI IN OLDER POPULATION AND IN 

4147
02:46:25,766 --> 02:46:27,802
THE OVER ALL WELLBEING AS WELL 

4148
02:46:27,802 --> 02:46:32,606
AS THE DEMENTIA OUTCOMES 

4149
02:46:32,606 --> 02:46:33,040
PRIORITY. 

4150
02:46:33,040 --> 02:46:37,311
SO YEAH.  THAT IS I THINK ONE 

4151
02:46:37,311 --> 02:46:39,914
OTHER REASON THAT BODY WEIGHT IN

4152
02:46:39,914 --> 02:46:43,217
OLDER POPULATION I THINK YEAH.  

4153
02:46:43,217 --> 02:46:45,786
REALLY WHETHER OLDER POPULATION 

4154
02:46:45,786 --> 02:46:50,257
THINKS THAT THE INTENSIVE WEIGHT

4155
02:46:50,257 --> 02:46:54,395
LOSS IS INTENSIVE EFFECT OF 

4156
02:46:54,395 --> 02:46:56,597
GLP-1S ARE NOT.  

4157
02:46:56,597 --> 02:46:56,797
YEAH. 

4158
02:46:56,797 --> 02:46:58,299
>> ONE OF THE CHALLENGES
TO 

4159
02:46:58,299 --> 02:47:00,034
BRING IT BACK TO WHERE WE 

4160
02:47:00,034 --> 02:47:02,503
STARTED IS I THINK THAT LOTS OF 

4161
02:47:02,503 --> 02:47:04,505
CHALLENGES ARE MECHANISTIC 

4162
02:47:04,505 --> 02:47:06,540
PATHWAYS IS WE, ONE, DON'T FULLY

4163
02:47:06,540 --> 02:47:09,510
UNDERSTAND HOW GLP-1-BASED 

4164
02:47:09,510 --> 02:47:11,412
THERAPIES WORK ACROSS ALL 

4165
02:47:11,412 --> 02:47:12,913
SYSTEMS AND IT IS SO WELL -- 

4166
02:47:12,913 --> 02:47:15,683
THAT IS HOW WE STARTED 

4167
02:47:15,683 --> 02:47:17,017
YESTERDAY.  IT WAS AN EXCELLENT 

4168
02:47:17,017 --> 02:47:18,252
DEMONSTRATION OF THAT AND FACT 

4169
02:47:18,252 --> 02:47:19,954
THAT, YOU KNOW, LOTS OF THE 

4170
02:47:19,954 --> 02:47:21,188
OUTCOMES WE WERE TALKING ABOUT 

4171
02:47:21,188 --> 02:47:25,759
TODAY ARE ALL RELATED AND CKM 

4172
02:47:25,759 --> 02:47:28,162
OUTCOMES BECAUSE OF UNDERLYING 

4173
02:47:28,162 --> 02:47:30,798
METABOLIC DISFUNCTION OCCURRING 

4174
02:47:30,798 --> 02:47:33,033
AS RESULT OF DYSFUNCTIONAL 

4175
02:47:33,033 --> 02:47:36,270
ADIPOSE TISSUE IS NOT ABOUT HOW 

4176
02:47:36,270 --> 02:47:36,937
DRIVING EVERYTHING. 

4177
02:47:36,937 --> 02:47:39,240
I THINK IT IS VERY CHALLENGING 

4178
02:47:39,240 --> 02:47:42,376
TO LOOK AT SINGULAR OUTCOMES 

4179
02:47:42,376 --> 02:47:45,045
AND, YES.  WE DO A GOOD JOB AT 

4180
02:47:45,045 --> 02:47:46,614
ADDRESSING CONFOUNDING -- YOU 

4181
02:47:46,614 --> 02:47:49,183
KNOW, CONFOUNDERS AND BASELINE 

4182
02:47:49,183 --> 02:47:52,987
RISK FACTORS AT BASELINE AND CAN

4183
02:47:52,987 --> 02:47:57,825
DO TIME VARYING CONSIDERATIONS 

4184
02:47:57,825 --> 02:47:59,593
DURING TREATMENT AND WHAT DO WE 

4185
02:47:59,593 --> 02:48:01,562
DO WHEN OUTCOMES ARE AS WELL AND

4186
02:48:01,562 --> 02:48:03,564
THEY ARE DEPENDENT AND THEY ARE 

4187
02:48:03,564 --> 02:48:08,802
NOT AND IS CHALLENGE THAT DRIVES

4188
02:48:08,802 --> 02:48:11,005
NOT IMPACTS REAL WORLD STUDIES 

4189
02:48:11,005 --> 02:48:12,973
AND CLINICAL TRIALS AS WELL AND 

4190
02:48:12,973 --> 02:48:16,043
SAW IN COBTS AND TARGET TRIALS 

4191
02:48:16,043 --> 02:48:19,880
AND DIABETES AND THINK IT COMES 

4192
02:48:19,880 --> 02:48:22,883
TO THE FACT THAT THIS DIRECT 

4193
02:48:22,883 --> 02:48:26,487
LINES AND SOMETIMES I MEAN IT IS

4194
02:48:26,487 --> 02:48:28,155
AMAZING AND WE CAN TARGET 

4195
02:48:28,155 --> 02:48:30,090
UNDERLYING PATHWAY IF WE DON'T 

4196
02:48:30,090 --> 02:48:33,027
FULLY UNDERSTAND WHAT IT IS WITH

4197
02:48:33,027 --> 02:48:34,361
THAT IT COMES WITH RISK AND WE 

4198
02:48:34,361 --> 02:48:36,096
DON'T KNOW WHAT OTHER PATHWAYS 

4199
02:48:36,096 --> 02:48:37,698
MIGHT BE TRIGGERED AT SAME TIME 

4200
02:48:37,698 --> 02:48:39,600
AND WHAT ARE WE MISSING AND WHAT

4201
02:48:39,600 --> 02:48:44,638
HAVEN'T WE LOOKED AT AND WITH 

4202
02:48:44,638 --> 02:48:46,740
MEDICATIONS WITH PLEAOTROPIC 

4203
02:48:46,740 --> 02:48:50,044
EFFECT WE ARE DISCOVERING HOW 

4204
02:48:50,044 --> 02:48:52,413
YOU KNOW WHAT EFFECT VERSUS 

4205
02:48:52,413 --> 02:48:54,515
OUTCOME OF DATA AND RUN INTO OUR

4206
02:48:54,515 --> 02:48:56,450
STUDIES LOOKING AT WHAT I CALL 

4207
02:48:56,450 --> 02:48:58,619
FALSE FICTION ENDPOINT OF 

4208
02:48:58,619 --> 02:49:01,755
PNEUMONIA FIRST PROPOSING GRANTS

4209
02:49:01,755 --> 02:49:04,158
AND TURNS OUT NOT FALSE FICTION 

4210
02:49:04,158 --> 02:49:05,459
ENDPOINTS BUT OUTCOME AND WHAT 

4211
02:49:05,459 --> 02:49:06,994
DO YOU DO WITH THAT AND KNOW 

4212
02:49:06,994 --> 02:49:11,165
WHICH IS WHICH AND THINK GLPS 

4213
02:49:11,165 --> 02:49:14,168
ARE UNIQUELY DIFFICULT TO STUDY 

4214
02:49:14,168 --> 02:49:17,304
BECAUSE OF INTERDEPENDENCIES OF 

4215
02:49:17,304 --> 02:49:18,372
UNDERLYING PATHOLOGY AND US NOT 

4216
02:49:18,372 --> 02:49:20,174
KNOWING WHERE THEY TRULY ACT. 

4217
02:49:20,174 --> 02:49:21,775
>> RIGHT.  GREAT POINT.  I
LOVE 

4218
02:49:21,775 --> 02:49:23,644
THAT YOU LINKED IT RIGHT BACK 

4219
02:49:23,644 --> 02:49:26,847
INTO THE VERY FIRST TALK OF THE 

4220
02:49:26,847 --> 02:49:28,215
WORKSHOP.  I THINK WITH THAT WE 

4221
02:49:28,215 --> 02:49:31,885
WILL GO AHEAD AND WRAP UP THE 

4222
02:49:31,885 --> 02:49:32,152
SESSION. 

4223
02:49:32,152 --> 02:49:34,822
DOES ONE OF THE ORGANIZERS WANT 

4224
02:49:34,822 --> 02:49:36,824
TO COMMENT ON -- THANK YOU.  ON 

4225
02:49:36,824 --> 02:49:37,725
THE NEXT PLANS?  

4226
02:49:37,725 --> 02:49:39,994
>> YEAH.  JUMPING IN AND
SAYING 

4227
02:49:39,994 --> 02:49:41,295
THANK YOU, EVERYBODY. 

4228
02:49:41,295 --> 02:49:42,596
EXCELLENT PRESENTATIONS TODAY.  

4229
02:49:42,596 --> 02:49:45,532
THANK YOU FOR WONDERFUL 

4230
02:49:45,532 --> 02:49:45,833
MODERATION. 

4231
02:49:45,833 --> 02:49:47,801
IT WAS SCHAKTLY WHAT WE WERE 

4232
02:49:47,801 --> 02:49:49,603
LOOKING FOR OUT OF THE SESSION 

4233
02:49:49,603 --> 02:49:49,837
TODAY. 

4234
02:49:49,837 --> 02:49:51,705
AS WE MOVE INTO LUNGE BREAK WE 

4235
02:49:51,705 --> 02:49:57,044
WILL JUST TAKE A 25 MINUTE -- 26

4236
02:49:57,044 --> 02:49:58,212
MINUTE LUNCH BREAK AT THE MOMENT

4237
02:49:58,212 --> 02:50:00,514
AND RECONVENE AT TIME WE 

4238
02:50:00,514 --> 02:50:01,782
PREVIOUSLY ALLOTTED TO COME BACK

4239
02:50:01,782 --> 02:50:05,786
AT 1:15 FOR A SUMMARY. 

4240
02:50:05,786 --> 02:50:07,955
AS YOU MOVE INTO THE SESSION WE 

4241
02:50:07,955 --> 02:50:10,257
WOULD LIKE TO HAVE EVERYONE PUT 

4242
02:50:10,257 --> 02:50:12,593
INTO THE CHAT WHAT YOU WERE 

4243
02:50:12,593 --> 02:50:14,895
TAKING AWAY AS KEY MAJOR GAPS OR

4244
02:50:14,895 --> 02:50:15,729
OPPORTUNITIES FOR RESEARCH IN 

4245
02:50:15,729 --> 02:50:17,765
THE FIELD AND SIMILAR TO WHAT WE

4246
02:50:17,765 --> 02:50:20,701
DID AT THE OUTSET AND WANT YOU 

4247
02:50:20,701 --> 02:50:22,269
TO REREFLECT ON EVERYTHING YOU 

4248
02:50:22,269 --> 02:50:24,605
LEARNED AND ADD INTO THE CHAT 

4249
02:50:24,605 --> 02:50:27,608
THOSE REFLECTIONS ON MAJOR GAPS 

4250
02:50:27,608 --> 02:50:29,376
AND UPVOTE PEOPLES GAPS THEY PUT

4251
02:50:29,376 --> 02:50:30,878
IN THERE TO SAY THAT THIS IS 

4252
02:50:30,878 --> 02:50:32,780
SOMETHING THAT I AGREE IS REALLY

4253
02:50:32,780 --> 02:50:34,248
IMPORTANT FOR US TO ADDRESS AS 

4254
02:50:34,248 --> 02:50:36,016
WE MOVE FORWARD IN THE FIELD. 

4255
02:50:36,016 --> 02:50:40,120
AND IF YOU CAN, WE HAVE -- THE 

4256
02:50:40,120 --> 02:50:40,721
ORGANIZERS HAVE IDENTIFIED 

4257
02:50:40,721 --> 02:50:42,389
SEVERAL KEY THEMES I'M PUTTING 

4258
02:50:42,389 --> 02:50:43,257
IN THE CHAT NOW. 

4259
02:50:43,257 --> 02:50:46,226
IF YOU THINK ANY MAJOR GAPS FIT 

4260
02:50:46,226 --> 02:50:48,228
WITH VARIOUS THEMES WE ARE 

4261
02:50:48,228 --> 02:50:49,797
FOCUSING ON YOU CAN CALL THAT 

4262
02:50:49,797 --> 02:50:53,367
OUT AS A THEME OR ECONOMIC THEME

4263
02:50:53,367 --> 02:50:55,335
OR SOME OTHER THEME.  IT DOESN'T

4264
02:50:55,335 --> 02:50:57,204
FIT INTO THE THEMES THAT IS FINE

4265
02:50:57,204 --> 02:50:58,605
AND PUT IT IN THE CHAT AND WE 

4266
02:50:58,605 --> 02:51:01,275
WOULD LOVE TO HEAR ABOUT WHAT 

4267
02:51:01,275 --> 02:51:02,876
MAJOR GAPS ARE THAT YOU THINK.  

4268
02:51:02,876 --> 02:51:04,812
WE ARE COLLATING THEM AND WILL 

4269
02:51:04,812 --> 02:51:07,681
TALK MORE ABOUT THEM WHEN WE
COME BACK AT 1:15 AFTER LUNCH. 
THANK YOU.  

4270
02:51:09,750 --> 02:51:18,158
>> WELCOME BACK, EVERYONE.

4271
02:51:18,158 --> 02:51:19,393
I KNOW THAT WAS A SHORT BREAK

4272
02:51:19,393 --> 02:51:23,163
FOR LUNCH, BUT WE ARE ATTEMPTING

4273
02:51:23,163 --> 02:51:28,702
TO COME BACK TOGETHER AND TO

4274
02:51:28,702 --> 02:51:31,672
SYNTHESIZE EVERYTHING THAT WE'VE

4275
02:51:31,672 --> 02:51:33,507
LEARNED AND ALL THE IDEAS THAT

4276
02:51:33,507 --> 02:51:34,942
HAVE BEEN GENERATED OVER THE

4277
02:51:34,942 --> 02:51:37,878
LAST COUPLE DAYS TO HELP US MOVE

4278
02:51:37,878 --> 02:51:40,948
THE FIELD FORWARD AND FIGURE OUT

4279
02:51:40,948 --> 02:51:43,050
WHAT ARE THE MAJOR GAPS AND

4280
02:51:43,050 --> 02:51:45,018
OPPORTUNITIES FOR RESEARCH

4281
02:51:45,018 --> 02:51:46,720
TOGETHER COLLABORATIVELY.

4282
02:51:46,720 --> 02:51:49,156
AND SO THE CO-CHAIRS AND I HAVE

4283
02:51:49,156 --> 02:51:52,659
BEEN THINKING ABOUT THIS AS

4284
02:51:52,659 --> 02:51:53,761
WE'VE BEEN PREPARING THIS

4285
02:51:53,761 --> 02:51:56,163
WORKSHOP, BUT ALSO INTEGRATING,

4286
02:51:56,163 --> 02:51:57,131
SYNTHESIZING ALL THE SUGGESTIONS

4287
02:51:57,131 --> 02:51:58,265
THAT HAVE BEEN COMING THROUGH

4288
02:51:58,265 --> 02:52:01,602
OVER THE LAST TWO DAYS.

4289
02:52:01,602 --> 02:52:09,243
SO WE WANTED -- I JUST REALIZED

4290
02:52:09,243 --> 02:52:10,644
MY MICROPHONE WAS MUTED.

4291
02:52:10,644 --> 02:52:11,745
HI, EVERYBODY.

4292
02:52:11,745 --> 02:52:13,280
AND WELCOME BACK TO THIS

4293
02:52:13,280 --> 02:52:15,382
SESSION, WHERE WE'RE GOING TO BE

4294
02:52:15,382 --> 02:52:17,551
SYNTHESIZING MAJOR GAPS AND

4295
02:52:17,551 --> 02:52:22,156
OPPORTUNITIES FOR RESEARCH IN

4296
02:52:22,156 --> 02:52:23,223
THIS -- IN THIS AREA TO HELP

4297
02:52:23,223 --> 02:52:27,194
MOVE THE NEEDLE FORWARD AND

4298
02:52:27,194 --> 02:52:29,797
ESTABLISH THE NEXT PHASE OF

4299
02:52:29,797 --> 02:52:30,798
RESEARCH AND CLOSE SOME OF THESE

4300
02:52:30,798 --> 02:52:34,067
GAPS IN THE COMING DECADE.

4301
02:52:34,067 --> 02:52:35,702
AS THE CO-CHAIRS AND I WERE

4302
02:52:35,702 --> 02:52:36,703
WORKING TOGETHER OVER THE PAST

4303
02:52:36,703 --> 02:52:39,873
YEAR BUT ALSO IN THE LAST TWO

4304
02:52:39,873 --> 02:52:40,841
DAYS, IN PARTICULAR WE'VE BEEN

4305
02:52:40,841 --> 02:52:43,577
TRYING TO SYNTHESIZE KEY THEMES

4306
02:52:43,577 --> 02:52:44,678
AROUND WHAT THE MOST IMPORTANT

4307
02:52:44,678 --> 02:52:46,513
AREAS ARE FOR US TO BE

4308
02:52:46,513 --> 02:52:50,918
ADDRESSING IN THE COMING DECADE,

4309
02:52:50,918 --> 02:52:52,219
AND SOME OF THESE THEMES ARE

4310
02:52:52,219 --> 02:52:53,453
LISTED HERE, AND MAYBE THERE'S

4311
02:52:53,453 --> 02:52:55,923
OTHER THEMES THAT WE DIDN'T

4312
02:52:55,923 --> 02:52:57,791
CAPTURE THAT WE WOULD LOVE TO

4313
02:52:57,791 --> 02:52:59,993
HEAR FROM PEOPLE IF WE'VE MISSED

4314
02:52:59,993 --> 02:53:01,195
ANYTHING, AND SO WE'RE GOING TO

4315
02:53:01,195 --> 02:53:03,063
TAKE SOME TIME TO BREAK DOWN

4316
02:53:03,063 --> 02:53:06,767
EACH OF THESE THEMES IN THE NEXT

4317
02:53:06,767 --> 02:53:07,868
45 MINUTES, UNDERSTAND WHAT

4318
02:53:07,868 --> 02:53:09,403
AREAS HAVE BEEN IDENTIFIED AS

4319
02:53:09,403 --> 02:53:12,806
MAJOR GAPS AND OPPORTUNITIES,

4320
02:53:12,806 --> 02:53:14,641
AND THEN COME BACK AROUND AFTER

4321
02:53:14,641 --> 02:53:19,580
WE'VE GONE THROUGH THESE SLIDES.

4322
02:53:19,580 --> 02:53:21,315
WE HAVE ONE SLIDE OR TWO FOR

4323
02:53:21,315 --> 02:53:22,516
EACH OF THESE DIFFERENT TOPICS.

4324
02:53:22,516 --> 02:53:23,851
WE'RE GOING TO COME BACK AROUND

4325
02:53:23,851 --> 02:53:26,386
AND TRY TO FILL IN THE GAPS AND

4326
02:53:26,386 --> 02:53:27,654
WE'LL BE ALSO MONITORING THE

4327
02:53:27,654 --> 02:53:28,222
CHAT.

4328
02:53:28,222 --> 02:53:29,423
IF SOMETHING COMES TO MIND AS

4329
02:53:29,423 --> 02:53:31,358
WE'RE GOING THROUGH THIS AREA,

4330
02:53:31,358 --> 02:53:35,095
ONE OF THESE AREAS ABOUT -- THIS

4331
02:53:35,095 --> 02:53:36,530
WOULD BE A REALLY IMPORTANT GAP,

4332
02:53:36,530 --> 02:53:40,234
IT DOESN'T SEEM TO BE LISTED,

4333
02:53:40,234 --> 02:53:41,869
PLEASE DO PUT IT RIGHT INTO THE

4334
02:53:41,869 --> 02:53:42,269
CHAT.

4335
02:53:42,269 --> 02:53:43,537
WE'LL BE TRYING TO PULL THOSE IN

4336
02:53:43,537 --> 02:53:44,271
AS WE'RE GOING ALONG.

4337
02:53:44,271 --> 02:53:45,806
SO I'M GOING TO KICK US OFF WITH

4338
02:53:45,806 --> 02:53:49,610
JUST A QUICK SUMMARY.

4339
02:53:53,680 --> 02:53:55,048
MY MICROPHONE KEEPS MUTING.

4340
02:53:55,048 --> 02:53:56,683
I'M GOING TO BE KICKING US OFF

4341
02:53:56,683 --> 02:53:58,318
WITH THE -- TAKE A LOOK AT THE

4342
02:53:58,318 --> 02:54:00,621
LONG-TERM OUTCOMES GAP.

4343
02:54:00,621 --> 02:54:02,322
SO FIRST WHAT WE HEARD PRETTY

4344
02:54:02,322 --> 02:54:04,124
CLEARLY IS THAT OBSERVATIONAL

4345
02:54:04,124 --> 02:54:05,525
TARGET TRIAL STUDY DESIGNS SEEM

4346
02:54:05,525 --> 02:54:08,262
TO BE PARTICULARLY SUITABLE FOR

4347
02:54:08,262 --> 02:54:12,566
INVESTIGATIONS OF LONG TERM

4348
02:54:12,566 --> 02:54:13,967
OUTCOMES, AND WE DO NEED LONG

4349
02:54:13,967 --> 02:54:16,603
TERM DATA ON THE METABOLIC BODY

4350
02:54:16,603 --> 02:54:19,139
COMPOSITION, BEHAVIORAL IMPACTS

4351
02:54:19,139 --> 02:54:20,407
OF COMING OFF OF THESE

4352
02:54:20,407 --> 02:54:21,842
MEDICATIONS, BUT ALSO THE LONG

4353
02:54:21,842 --> 02:54:26,113
TERM IMPACTS OF BEING ON THEM.

4354
02:54:26,113 --> 02:54:29,149
DO BENEFITS WANE OVER TIME AND

4355
02:54:29,149 --> 02:54:30,417
ARE THERE SUBSETS OF PATIENTS

4356
02:54:30,417 --> 02:54:31,551
THAT HAVE THE MOST BENEFIT.

4357
02:54:31,551 --> 02:54:33,420
ARE THERE PARTICULAR BMI RANGES

4358
02:54:33,420 --> 02:54:36,390
OR COMORBIDITIES, AND ARE THERE

4359
02:54:36,390 --> 02:54:40,961
FACTORS THAT GO INTO DETERMINING

4360
02:54:40,961 --> 02:54:42,396
THE HETEROGENEITY IN LONG-TERM

4361
02:54:42,396 --> 02:54:43,931
RESPONSE TO TREATMENT.

4362
02:54:43,931 --> 02:54:46,099
WHAT MORE CAN WE LEARN FROM REAL

4363
02:54:46,099 --> 02:54:47,968
WORLD DATA TO HELP IMPROVE

4364
02:54:47,968 --> 02:54:50,804
RESPONSE OR MAYBE PATIENT

4365
02:54:50,804 --> 02:54:51,805
SELECTION FOR PARTICULAR

4366
02:54:51,805 --> 02:54:54,541
MEDICATIONS.

4367
02:54:54,541 --> 02:54:56,710
IN PARTICULAR, MAYBE EHR

4368
02:54:56,710 --> 02:55:00,213
INTEGRATED TOOLS CAN HELP US

4369
02:55:00,213 --> 02:55:01,982
PREDICT OUTCOMES USING REAL

4370
02:55:01,982 --> 02:55:05,585
WORLD DATA.

4371
02:55:05,585 --> 02:55:07,321
AND ONE OTHER IDEA WAS TO BEGIN

4372
02:55:07,321 --> 02:55:09,022
TO UNDERSTAND OR UNPACK SOCIAL

4373
02:55:09,022 --> 02:55:10,390
DETERMINANTS OF HEALTH, AND

4374
02:55:10,390 --> 02:55:11,758
THEIR INFLUENCE ON LONG TERM

4375
02:55:11,758 --> 02:55:16,196
RESULTS IN THIS POPULATION.

4376
02:55:16,196 --> 02:55:17,197
AN IMPORTANT TOPIC THAT WAS

4377
02:55:17,197 --> 02:55:19,132
RAISED WAS EVALUATING OFF LABEL

4378
02:55:19,132 --> 02:55:21,668
USE OF GLP-1s AND THE FACT

4379
02:55:21,668 --> 02:55:23,203
THAT TARGET TRIALS MAY BE

4380
02:55:23,203 --> 02:55:25,605
SPECIFICALLY WELL SUITED FOR

4381
02:55:25,605 --> 02:55:28,208
EVALUATING OFF LABEL USE.

4382
02:55:28,208 --> 02:55:29,242
THERE WERE SEVERAL QUESTIONS

4383
02:55:29,242 --> 02:55:31,845
ABOUT THE TYPES OF THERAPY OR

4384
02:55:31,845 --> 02:55:34,147
THE COMBINATIONS OF THERAPY.

4385
02:55:34,147 --> 02:55:35,349
SO IS STEP THERAPY MORE

4386
02:55:35,349 --> 02:55:36,883
EFFECTIVE OR COST-EFFECTIVE THAN

4387
02:55:36,883 --> 02:55:41,021
STRAIGHT TO GLP-1 THERAPY FOR

4388
02:55:41,021 --> 02:55:42,456
ANTIOBESITY MEDICATION CARE OR

4389
02:55:42,456 --> 02:55:44,091
FOR OTHER DISEASES?

4390
02:55:44,091 --> 02:55:46,293
IS IT BENEFICIAL TO COMBINE

4391
02:55:46,293 --> 02:55:47,694
DIFFERENT MEDICATIONS TOGETHER

4392
02:55:47,694 --> 02:55:50,230
TO ACHIEVE GREATER OUTCOMES?

4393
02:55:50,230 --> 02:55:52,833
ARE THE NEWER MEDICATIONS MORE

4394
02:55:52,833 --> 02:55:56,103
EFFECTIVE OR SAFER THAN

4395
02:55:56,103 --> 02:55:57,537
METABOLIC SURGERY FOR TREATING

4396
02:55:57,537 --> 02:56:01,608
PATIENTS WITH SEVERE OBESITY?

4397
02:56:01,608 --> 02:56:05,645
SO A NUMBER OF COMPARATIVE

4398
02:56:05,645 --> 02:56:06,513
EFFECTIVENESS QUESTIONS THAT

4399
02:56:06,513 --> 02:56:08,048
MAYBE REAL WORLD DATA CAN SHARE

4400
02:56:08,048 --> 02:56:08,582
SOME LIGHT ON.

4401
02:56:08,582 --> 02:56:09,883
THEN A QUESTION ABOUT THIS

4402
02:56:09,883 --> 02:56:12,519
LEGACY EFFECT IDEA FOR DIABETES,

4403
02:56:12,519 --> 02:56:15,155
WHICH IS AFTER A DEFINED PERIOD

4404
02:56:15,155 --> 02:56:17,657
OF TREATMENT WITH A GLP-1, EVEN

4405
02:56:17,657 --> 02:56:18,959
AFTER YOU STOP TAKING IT, MAYBE

4406
02:56:18,959 --> 02:56:20,827
THERE'S A LEGACY EFFECT OF

4407
02:56:20,827 --> 02:56:23,130
CONTINUED IMPROVEMENTS IN HEALTH

4408
02:56:23,130 --> 02:56:24,865
LIKE HAS BEEN DESCRIBED IN

4409
02:56:24,865 --> 02:56:26,867
PATIENTS WITH GLUCOSE LOWERING

4410
02:56:26,867 --> 02:56:29,803
AGENTS IN TYPE 2 DIABETES.

4411
02:56:29,803 --> 02:56:31,571
SO EVEN WHERE THERE IS WEIGHT

4412
02:56:31,571 --> 02:56:34,608
REGAIN OR WORSENING OF

4413
02:56:34,608 --> 02:56:35,375
COMORBIDITIES, IS THERE STILL

4414
02:56:35,375 --> 02:56:37,010
SOME PERSISTENT BENEFICIAL

4415
02:56:37,010 --> 02:56:37,911
EFFECT OF HAVING HAD A PERIOD OF

4416
02:56:37,911 --> 02:56:41,615
TIME ON THESE MEDICATIONS?

4417
02:56:41,615 --> 02:56:43,083
ADDITIONAL LONG TERM QUESTIONS

4418
02:56:43,083 --> 02:56:44,918
EMERGE SORT OF OUT OF OUR

4419
02:56:44,918 --> 02:56:46,119
CONVERSATIONS ABOUT SPECIFIC

4420
02:56:46,119 --> 02:56:47,621
DISEASES AND I POINT AGAIN TO

4421
02:56:47,621 --> 02:56:50,590
THIS FIGURE BY DANIEL DRUCKER

4422
02:56:50,590 --> 02:56:52,559
ESTABLISHED INDICATIONS FOR

4423
02:56:52,559 --> 02:56:54,094
OBESITY BEING ON THIS LEFT-HAND

4424
02:56:54,094 --> 02:56:56,396
SIDE, AND THERE WERE A LOT OF

4425
02:56:56,396 --> 02:56:57,064
ESTABLISHED INDICATIONS THAT

4426
02:56:57,064 --> 02:57:01,635
WERE COVERED IN OUR TALKS, AND

4427
02:57:01,635 --> 02:57:02,936
IMPORTANT TO THINK ABOUT FOR

4428
02:57:02,936 --> 02:57:05,839
REAL WORLD DATA ANALYSES THAT

4429
02:57:05,839 --> 02:57:07,207
MANY OF THOSE ESTABLISHED

4430
02:57:07,207 --> 02:57:08,975
INDICATIONS ARE COVERED BETTER

4431
02:57:08,975 --> 02:57:11,478
THAN OBESITY, SO DIABETES,

4432
02:57:11,478 --> 02:57:12,579
CARDIOVASCULAR DISEASE, SLEEP

4433
02:57:12,579 --> 02:57:14,114
APNEA MAY BE COVERED, AND SO THE

4434
02:57:14,114 --> 02:57:16,283
PATIENTS MAY HAVE BETTER ACCESS

4435
02:57:16,283 --> 02:57:18,485
AND ADHERENCE TO MEDICATIONS IN

4436
02:57:18,485 --> 02:57:21,421
THOSE PARTICULAR SUBGROUPS, AND,

4437
02:57:21,421 --> 02:57:23,190
THEREFORE, MIGHT BE ABLE TO

4438
02:57:23,190 --> 02:57:23,790
EVALUATE LONG-TERM EFFECTS

4439
02:57:23,790 --> 02:57:26,593
BETTER.

4440
02:57:26,593 --> 02:57:27,894
AND BUT THERE'S ALSO SPECIFIC

4441
02:57:27,894 --> 02:57:28,995
QUESTIONS THAT WERE ARISING WITH

4442
02:57:28,995 --> 02:57:30,831
SOME OF OUR SPEAKERS AROUND

4443
02:57:30,831 --> 02:57:32,165
DIFFERENT ESTABLISHED

4444
02:57:32,165 --> 02:57:33,667
INDICATIONS, ONE THAT CAME TO

4445
02:57:33,667 --> 02:57:36,103
MIND WAS HOW DO GLP-1s IMPACT

4446
02:57:36,103 --> 02:57:37,404
OTHER TREATMENTS FOR THOSE

4447
02:57:37,404 --> 02:57:41,441
DISEASES OR HOW IS THE

4448
02:57:41,441 --> 02:57:43,176
BENEFIT -- COST-BENEFIT RATIO OF

4449
02:57:43,176 --> 02:57:47,481
HAVING MULTIPLE TREATMENTS LIKE

4450
02:57:47,481 --> 02:57:47,714
THAT.

4451
02:57:47,714 --> 02:57:48,982
FOR EXAMPLE, WHAT WAS THE ADDED

4452
02:57:48,982 --> 02:57:54,354
VALUE OF GLP-1 ADDED TO

4453
02:57:54,354 --> 02:57:55,222
SGL-2 ADDED TO PATIENTS WITH

4454
02:57:55,222 --> 02:57:56,756
DIABETES, SO THINKING ABOUT

4455
02:57:56,756 --> 02:57:58,291
COMBINATION THERAPIES OF

4456
02:57:58,291 --> 02:58:00,360
ESTABLISHED TREATMENTS AND

4457
02:58:00,360 --> 02:58:01,795
GLP-1s IN THESE VARIOUS

4458
02:58:01,795 --> 02:58:02,129
INDICATIONS.

4459
02:58:02,129 --> 02:58:04,197
AND AS WE HEARD IN THE LAST

4460
02:58:04,197 --> 02:58:07,501
SESSION, OUR DISE ARE DISEASE OS

4461
02:58:07,501 --> 02:58:09,669
MEDIATE BID WEIGHT LOSS OR A1C

4462
02:58:09,669 --> 02:58:12,072
IMPROVEMENT OR ARE THERE OTHER

4463
02:58:12,072 --> 02:58:13,773
DIRECT GLP-1 ACTIONS AS AT THE

4464
02:58:13,773 --> 02:58:18,211
TOP OF THIS FIGURE THAT MAY BE

4465
02:58:18,211 --> 02:58:19,672
HAVING THE EFFECT ON THOSE
OUTCOMES.

4466
02:58:19,672 --> 02:58:21,941
 THEREWERE SEVERAL
QUESTIONS ABOUT TYPES OF THERAPY
OR 

4467
02:58:21,941 --> 02:58:23,976
COMBINATION OF THERAPY IS IT 

4468
02:58:23,976 --> 02:58:26,746
COST EFFECTIVE THAN STRAIGHT GL1

4469
02:58:26,746 --> 02:58:28,981
THERAPY FOR ANTI-OBESITY 

4470
02:58:28,981 --> 02:58:30,850
MEDICATION CARE OR OTHER 

4471
02:58:30,850 --> 02:58:33,252
DISEASES AND IS IT BENEFICIAL TO

4472
02:58:33,252 --> 02:58:34,487
COMBINE DIFFERENT MEDICATIONS 

4473
02:58:34,487 --> 02:58:36,589
TOGETHER TO ACHIEVE GREATER 

4474
02:58:36,589 --> 02:58:38,991
OUTCOMES AND ARE THERE NEWER 

4475
02:58:38,991 --> 02:58:42,295
MEDICATIONS MORE EFFECTIVE OR 

4476
02:58:42,295 --> 02:58:45,364
SAFER THAN METABOLIC SURGERY FOR

4477
02:58:45,364 --> 02:58:48,267
TREATING PATIENTS WITH SEVERE 

4478
02:58:48,267 --> 02:58:50,136
OBESITY AND NUMBER OF DIFFERENT 

4479
02:58:50,136 --> 02:58:52,672
COMPARATIVE EFFECTIVENESS 

4480
02:58:52,672 --> 02:58:54,674
RELATED QUESTIONS WITH VARIABLE 

4481
02:58:54,674 --> 02:58:56,075
DATA CAN SHED LIGHT ON AND 

4482
02:58:56,075 --> 02:58:59,945
QUESTION ABOUT LEGACY EFFECT 

4483
02:58:59,945 --> 02:59:03,416
IDEA OF DIABETES THAT AFTER 

4484
02:59:03,416 --> 02:59:04,817
DEFINED THERAPY TREATMENT AFTER 

4485
02:59:04,817 --> 02:59:07,186
YOU STOP TAKING IT LEGACY EFFECT

4486
02:59:07,186 --> 02:59:10,856
OF CONTINUED IMPROVEMENTS HEALTH

4487
02:59:10,856 --> 02:59:11,924
THAT IS DESCRIBED IN PATIENTS 

4488
02:59:11,924 --> 02:59:15,828
WITH GLUCOSE LOWERING IN TYPE 2 

4489
02:59:15,828 --> 02:59:17,396
DIABETES AND WHERE THERE IS 

4490
02:59:17,396 --> 02:59:20,533
WEIGHT GAIN FOR WORSENING OF 

4491
02:59:20,533 --> 02:59:21,967
COMORBIDITIES IS THERE 

4492
02:59:21,967 --> 02:59:23,169
PERSISTENT BENEFICIAL EFFECT OF 

4493
02:59:23,169 --> 02:59:25,971
HAVING HAD A PERIOD OF TIME ON 

4494
02:59:25,971 --> 02:59:27,373
MEDICATIONS?  

4495
02:59:27,373 --> 02:59:28,841
ADDITIONAL LONG-TERM QUESTIONS 

4496
02:59:28,841 --> 02:59:31,944
EMERGE SORT OF OUT OF OUR 

4497
02:59:31,944 --> 02:59:34,013
CONVERSATIONS ABOUT SPECIFIC 

4498
02:59:34,013 --> 02:59:36,716
DISEASES POINTING AGAIN TO 

4499
02:59:36,716 --> 02:59:39,385
FIGURE BY DANIEL ESTABLISHING 

4500
02:59:39,385 --> 02:59:42,188
INDICATIONS OF OBESITY BEING ON 

4501
02:59:42,188 --> 02:59:43,389
LEFT-HAND SIDE AND ESTABLISHED 

4502
02:59:43,389 --> 02:59:47,093
INDICATIONS THAT WERE COVERED IN

4503
02:59:47,093 --> 02:59:49,595
OUR TALKS AND IMPORTANT TO THINK

4504
02:59:49,595 --> 02:59:51,864
ABOUT FOR REAL WORLD DATA 

4505
02:59:51,864 --> 02:59:53,332
ANALYSIS THAT MANY ESTABLISHED 

4506
02:59:53,332 --> 02:59:54,600
INDICATIONS ARE COVERED BETTER 

4507
02:59:54,600 --> 02:59:58,971
THAN OBESITY AND SO DIABETES AND

4508
02:59:58,971 --> 03:00:00,206
CARDIOVASCULAR DISEASE AND SLEEP

4509
03:00:00,206 --> 03:00:03,142
APNEA MAY BE COVERED AND 

4510
03:00:03,142 --> 03:00:04,744
PATIENTS MIGHT HAVE BETTER 

4511
03:00:04,744 --> 03:00:06,812
ACCESS AND TO MEDICATIONS IN 

4512
03:00:06,812 --> 03:00:07,380
PARTICULAR SUBGROUPS AND 

4513
03:00:07,380 --> 03:00:09,849
THEREFORE MIGHT BE ABLE TO 

4514
03:00:09,849 --> 03:00:12,218
EVALUATE LONG-TERM EFFECTS 

4515
03:00:12,218 --> 03:00:13,352
BETTER AND THERE IS ALSO 

4516
03:00:13,352 --> 03:00:14,920
SPECIFIC QUESTIONS THAT WERE 

4517
03:00:14,920 --> 03:00:17,089
ARISING WITH SOME SPEAKERS 

4518
03:00:17,089 --> 03:00:18,257
AROUND DIFFERENT ESTABLISHED 

4519
03:00:18,257 --> 03:00:19,992
INDICATIONS AND ONE THAT CAME TO

4520
03:00:19,992 --> 03:00:22,395
MIND IS HOW DO GLP-1 IMPACT 

4521
03:00:22,395 --> 03:00:24,130
OTHER TREATMENTS FOR DISEASES 

4522
03:00:24,130 --> 03:00:28,234
AND WHAT -- YOU KNOW, HOW IS THE

4523
03:00:28,234 --> 03:00:30,803
BENEFIT COST BENEFIT RATIO 

4524
03:00:30,803 --> 03:00:32,138
HAVING MULTIPLE TREATMENTS LIKE 

4525
03:00:32,138 --> 03:00:34,173
THAT AND FOR EXAMPLE WHAT IS 

4526
03:00:34,173 --> 03:00:37,343
ADDED VALUE OF GLP-1 ADDED TO 

4527
03:00:37,343 --> 03:00:39,645
SGLT2 IN PATIENTS WITH TYPE 2 

4528
03:00:39,645 --> 03:00:41,947
DIABETES AND THINKING IN 

4529
03:00:41,947 --> 03:00:43,149
COMBINATION THERAPIES IN 

4530
03:00:43,149 --> 03:00:46,919
ESTABLISHED TREATMENTS IN GLP-1S

4531
03:00:46,919 --> 03:00:48,521
IN VARIOUS INDICATIONS AND AS WE

4532
03:00:48,521 --> 03:00:51,991
HEARD IN THE LAST SESSION, ARE 

4533
03:00:51,991 --> 03:00:54,026
DISEASE OUTCOMES MEDIATED BY 

4534
03:00:54,026 --> 03:00:56,962
WEIGHT LOSS FOR A1C IMPROVEMENT 

4535
03:00:56,962 --> 03:01:00,533
AND ARE THERE OTHER DIRECT GLP-1

4536
03:01:00,533 --> 03:01:03,969
ACTIONS AT TOP OF FIGURE THAT 

4537
03:01:03,969 --> 03:01:07,840
MAY BE HAVING EFFECT ON 

4538
03:01:07,840 --> 03:01:08,607
OUTCOMES?  

4539
03:01:08,607 --> 03:01:10,276
SHIFTING TO INVESTIGATIONAL 

4540
03:01:10,276 --> 03:01:12,678
OUTCOME SIDE OF THINGS, WE HEARD

4541
03:01:12,678 --> 03:01:14,380
ABOUT QUITE A FEW OF THESE TODAY

4542
03:01:14,380 --> 03:01:16,949
AND NOT ALL OF THEM.  ADDITIONAL

4543
03:01:16,949 --> 03:01:18,384
AREAS ARE NOT LISTED ON THE 

4544
03:01:18,384 --> 03:01:20,319
SLIDE TALKING ABOUT TODAY 

4545
03:01:20,319 --> 03:01:21,687
DEPRESSION AND SUICIDALITY AND 

4546
03:01:21,687 --> 03:01:23,122
EATING DISORDERS AND CANCER AND 

4547
03:01:23,122 --> 03:01:25,858
LOTS OF POTENTIAL OUTCOMES THAT 

4548
03:01:25,858 --> 03:01:29,795
COULD BE ADDRESSED HERE. 

4549
03:01:29,795 --> 03:01:32,598
WHERE WOULD BE USING -- USING 

4550
03:01:32,598 --> 03:01:34,700
REAL-WORLD DATA TO LOOK AT 

4551
03:01:34,700 --> 03:01:36,502
LONG-TERM OUTCOMES AND THERE ARE

4552
03:01:36,502 --> 03:01:38,404
CONCERNS THERE FOR A LOT OF 

4553
03:01:38,404 --> 03:01:39,738
THESE CONDITIONS BOTH ON 

4554
03:01:39,738 --> 03:01:41,373
ESTABLISHED AND ON 

4555
03:01:41,373 --> 03:01:43,409
INVESTIGATIONAL SIDE AND HOW WE 

4556
03:01:43,409 --> 03:01:44,276
ACCURATELY IDENTIFY THESE AND 

4557
03:01:44,276 --> 03:01:46,078
SOME QUESTIONS WERE WRESTLED 

4558
03:01:46,078 --> 03:01:49,415
WITH IN SPEAKERS TODAY AND HOW 

4559
03:01:49,415 --> 03:01:53,919
DO WE USE ICD CODES AND EHR OR 

4560
03:01:53,919 --> 03:02:00,526
LAB DATA AND IS NATURAL LANGUAGE

4561
03:02:00,526 --> 03:02:02,461
PROCESSING OR OTHER LINKAGES TO 

4562
03:02:02,461 --> 03:02:05,831
EVALUATE OUTCOMES ARE REALLY 

4563
03:02:05,831 --> 03:02:07,399
IMPORTANT CONSIDERATIONS. 

4564
03:02:07,399 --> 03:02:10,469
SO THE NEXT AREA OF OUR KEY 

4565
03:02:10,469 --> 03:02:12,037
THEME THAT EMERGED IS CLEARLY 

4566
03:02:12,037 --> 03:02:14,206
AROUND ECONOMICS AND COVERAGE 

4567
03:02:14,206 --> 03:02:16,675
AND SO MANY QUESTIONS AROUND 

4568
03:02:16,675 --> 03:02:17,343
THIS.  ARE THERE SIGNIFICANT 

4569
03:02:17,343 --> 03:02:20,246
COST OFFSETS AND SAVINGS FROM 

4570
03:02:20,246 --> 03:02:23,249
GLP-1 USES AND IN OTHER WORDS DO

4571
03:02:23,249 --> 03:02:24,717
CHRONIC CONDITIONS IMPROVE 

4572
03:02:24,717 --> 03:02:27,019
SIGNIFICANTLY SO OTHER HEALTH 

4573
03:02:27,019 --> 03:02:28,954
OUTCOMES BECOME MUCH LESS 

4574
03:02:28,954 --> 03:02:31,290
EXPENSIVE AS RESULT OF USING 

4575
03:02:31,290 --> 03:02:33,092
GLP-1S AND EXPENSIVE THEMSELVES 

4576
03:02:33,092 --> 03:02:34,827
AND SHOULD OLDER LESS EXPENSIVE 

4577
03:02:34,827 --> 03:02:36,562
MEDICATIONS BE CONSIDERED IN 

4578
03:02:36,562 --> 03:02:39,798
CERTAIN PATIENT GROUPS AND IF SO

4579
03:02:39,798 --> 03:02:41,200
WHICH CRITERIA DID WE USE TO 

4580
03:02:41,200 --> 03:02:43,402
GUIDE THIS SELECTION AND HOW DO 

4581
03:02:43,402 --> 03:02:46,539
WE RECONCILE UPFRONT COST OF 

4582
03:02:46,539 --> 03:02:48,073
GLP-1S WITH LONG TERM COST 

4583
03:02:48,073 --> 03:02:51,176
SAVINGS AND IDEA THAT COMMERCIAL

4584
03:02:51,176 --> 03:02:54,480
PAYERS ARE TAKING THE BRUNT 

4585
03:02:54,480 --> 03:02:56,649
PERHAPS CMS AND MEDICARE WOULD 

4586
03:02:56,649 --> 03:03:00,686
REALIZE COST BENEFITS AND 

4587
03:03:00,686 --> 03:03:02,187
UNDERSTANDING HOW THOSE EARLY 

4588
03:03:02,187 --> 03:03:04,857
COST OF GLP-1S MIGHT TRANSLATE 

4589
03:03:04,857 --> 03:03:07,259
INTO BENEFITS FOR CNS AND WHAT 

4590
03:03:07,259 --> 03:03:11,530
PRICE OF GLP-1S WOULD BE NEEDED 

4591
03:03:11,530 --> 03:03:13,365
IN ORDER TO SAVE MONEY ON HEALTH

4592
03:03:13,365 --> 03:03:15,568
CARE COSTS?  

4593
03:03:15,568 --> 03:03:18,170
IS THERE A THRESHOLD OF WHICH 

4594
03:03:18,170 --> 03:03:21,640
GLP-1 TREATMENT IS ACTUALLY COST

4595
03:03:21,640 --> 03:03:23,409
SAVING?  DO DIFFERENT LEVELS OF 

4596
03:03:23,409 --> 03:03:26,245
COST SHARING AND OUT OF POCKET 

4597
03:03:26,245 --> 03:03:27,846
COPAYMENTS AND FILL HAVE 

4598
03:03:27,846 --> 03:03:30,416
SIGNIFICANT IMPACT ON ADHERENCE 

4599
03:03:30,416 --> 03:03:32,284
AND WEIGHT LOSS OUTCOMES AND 

4600
03:03:32,284 --> 03:03:34,053
DIFFERENT SYSTEM LEVEL AND 

4601
03:03:34,053 --> 03:03:37,222
NATURAL EXPERIMENTS THAT CAN BE 

4602
03:03:37,222 --> 03:03:39,892
DONE TO EVALUATE THESE -- THERE 

4603
03:03:39,892 --> 03:03:41,360
IS POLICY CHANGES AND 

4604
03:03:41,360 --> 03:03:42,561
IMPLEMENTATION APPROACHES TO 

4605
03:03:42,561 --> 03:03:45,297
USING GLP-1S TO SEE IF THEY 

4606
03:03:45,297 --> 03:03:47,499
REDUCE GAPS IN HEALTH CARE 

4607
03:03:47,499 --> 03:03:49,234
QUALITY OR HEALTH OUTCOMES AND 

4608
03:03:49,234 --> 03:03:51,637
THERE IS A POINT TO 

4609
03:03:51,637 --> 03:03:53,539
MICROSIMULATION RESEARCH AND 

4610
03:03:53,539 --> 03:03:59,578
10-YEAR FOLLOW-UP WINDOW 

4611
03:03:59,578 --> 03:04:01,080
EVALUATING SUBPOPULATIONS AND 

4612
03:04:01,080 --> 03:04:03,549
DISABILITY AND EMPLOYMENT 

4613
03:04:03,549 --> 03:04:05,117
OUTCOMES TO HELP UNDERSTAND THE 

4614
03:04:05,117 --> 03:04:08,087
SOCIETAL IMPACT OF USE OF THESE 

4615
03:04:08,087 --> 03:04:09,521
MEDICATIONS AND THERE WAS A 

4616
03:04:09,521 --> 03:04:12,157
QUESTION ABOUT COMPREHENSIVE 

4617
03:04:12,157 --> 03:04:13,993
LIFESTYLE PROGRAM COSTS AND IS 

4618
03:04:13,993 --> 03:04:16,762
THERE A NET COST BENEFIT OF 

4619
03:04:16,762 --> 03:04:18,530
COMBINING THESE THINGS TOGETHER?

4620
03:04:18,530 --> 03:04:20,265
CAN WE DEMONSTRATE A COST 

4621
03:04:20,265 --> 03:04:22,201
BENEFIT OF COMBINING THEM 

4622
03:04:22,201 --> 03:04:26,005
INSTEAD OF USING AOMS WITH VERY 

4623
03:04:26,005 --> 03:04:28,707
LIGHT TOUCH OF LIFESTYLE 

4624
03:04:28,707 --> 03:04:28,974
SUPPORT. 

4625
03:04:28,974 --> 03:04:31,243
THEN I WOULD RECALL FROM 

4626
03:04:31,243 --> 03:04:32,311
COLLEAGUES AT PRINT 

4627
03:04:32,311 --> 03:04:35,047
CONGRESSIONAL BUDGET OFFICE TO 

4628
03:04:35,047 --> 03:04:36,815
SAY CAN YOU COMPARE A -- THESE 

4629
03:04:36,815 --> 03:04:37,650
MEDICATIONS AGAINST PEOPLE WHO 

4630
03:04:37,650 --> 03:04:39,151
DON'T TAKE THEM?  

4631
03:04:39,151 --> 03:04:40,419
EVEN THOUGH THERE IS CHALLENGES 

4632
03:04:40,419 --> 03:04:42,721
THERE WE HAVE HEARD ABOUT 

4633
03:04:42,721 --> 03:04:48,127
CHALLENGES TODAY FROM KRISTINA 

4634
03:04:48,127 --> 03:04:49,128
AROUND COMPARING AGAINST 

4635
03:04:49,128 --> 03:04:51,397
UNTREATED GROUPS AND HOW TO BEST

4636
03:04:51,397 --> 03:04:53,399
DO THAT INFORMING PAYERS AROUND 

4637
03:04:53,399 --> 03:04:55,200
VARIOUS COMPLEX ISSUES AND WILL 

4638
03:04:55,200 --> 03:04:57,136
TURN IT TO LESLEY WHO WILL TALK 

4639
03:04:57,136 --> 03:05:00,072
A BIT ABOUT OTHER TOPICS OR KEY 

4640
03:05:00,072 --> 03:05:00,572
THEMES. 

4641
03:05:00,572 --> 03:05:02,808
>> GREAT.  THANK YOU,
DAVID. 

4642
03:05:02,808 --> 03:05:04,810
SO ESPECIALLY YESTERDAY, WE 

4643
03:05:04,810 --> 03:05:05,044
HEARD. 

4644
03:05:05,044 --> 03:05:07,579
>> YOU ARE MUTED ON MY
END, 

4645
03:05:07,579 --> 03:05:07,813
LESLEY. 

4646
03:05:07,813 --> 03:05:11,116
>> LET'S SEE.  I'M UNMUTED
HERE.

4647
03:05:11,116 --> 03:05:11,784
CAN YOU HEAR ME NOW?  

4648
03:05:11,784 --> 03:05:13,218
>> I CAN HEAR YOU. 

4649
03:05:13,218 --> 03:05:13,552
>> YES. 

4650
03:05:13,552 --> 03:05:14,987
>> I CAN HEAR YOU. 

4651
03:05:14,987 --> 03:05:19,058
>> OKAY.  GREAT.  THANK
YOU.  SO

4652
03:05:19,058 --> 03:05:20,459
YESTERDAY IN PARTICULAR, WE 

4653
03:05:20,459 --> 03:05:22,528
HEARD SEVERAL QUESTIONS RELATED 

4654
03:05:22,528 --> 03:05:25,097
TO OR MAJOR GAPS RELATED TO 

4655
03:05:25,097 --> 03:05:27,700
MAINTENANCE ADHERENCE AND DOSING

4656
03:05:27,700 --> 03:05:29,868
AND EARLIER QUESTION THAT CAME 

4657
03:05:29,868 --> 03:05:31,403
UP WAS WHAT ARE BEST PRACTICES 

4658
03:05:31,403 --> 03:05:36,442
FOR TAPERING OFF OF GLP-1S IN 

4659
03:05:36,442 --> 03:05:37,076
COMBINATION POTENTIALLY WITH 

4660
03:05:37,076 --> 03:05:40,345
LIFESTYLE INTERVENTIONS SO WE 

4661
03:05:40,345 --> 03:05:41,580
REDUCE INCIDENCE OF WEIGHT 

4662
03:05:41,580 --> 03:05:41,847
REGAIN. 

4663
03:05:41,847 --> 03:05:45,050
KIND OF RELATED TO THAT AND 

4664
03:05:45,050 --> 03:05:46,819
NEEDING TO UNDERSTAND 

4665
03:05:46,819 --> 03:05:50,889
OFF-RAMPING OR DEPRESCRIBING 

4666
03:05:50,889 --> 03:05:53,358
REGIMENTS AND WHAT MAINTENANCE 

4667
03:05:53,358 --> 03:05:55,127
DOSE REGIMENTS MIGHT LOOK LIKE 

4668
03:05:55,127 --> 03:05:56,729
AFTER DESIRED WEIGHT LOSS HAS 

4669
03:05:56,729 --> 03:05:58,530
BEEN ACHIEVED. 

4670
03:05:58,530 --> 03:06:00,599
RELATED TO I THINK AN ISSUE OR 

4671
03:06:00,599 --> 03:06:02,434
GAP THAT DAVID IDENTIFIED IS A 

4672
03:06:02,434 --> 03:06:04,369
NEED TO IDENTIFY WHICH PATIENTS 

4673
03:06:04,369 --> 03:06:07,506
WILL DO BEST WITH GLP ONES 

4674
03:06:07,506 --> 03:06:08,373
INDEFINITELY VERSUS THOSE WHO 

4675
03:06:08,373 --> 03:06:11,076
WILL BE ABLE TO SUCCESSFULLY 

4676
03:06:11,076 --> 03:06:13,445
TAPER OR SWITCH TO SOME KIND OF 

4677
03:06:13,445 --> 03:06:14,046
MAINTENANCE THERAPY. 

4678
03:06:14,046 --> 03:06:17,249
AND THE ISSUE OF MICRODOSING 

4679
03:06:17,249 --> 03:06:20,419
ALSO CAME UP AND NEED FOR 

4680
03:06:20,419 --> 03:06:21,353
EVIDENCE-BASED RECOMMENDATIONS 

4681
03:06:21,353 --> 03:06:23,222
FOR MICRODOSING. 

4682
03:06:23,222 --> 03:06:24,723
THE OTHER ISSUE WE HEARD WAS 

4683
03:06:24,723 --> 03:06:28,393
JUST ABOUT THE BARRIERS FOR 

4684
03:06:28,393 --> 03:06:29,294
PATIENTS RECEIVING AND 

4685
03:06:29,294 --> 03:06:31,497
CONTINUING GLP-1 PRESCRIPTIONS 

4686
03:06:31,497 --> 03:06:34,166
IN THE LONG TERM AND TO THE 

4687
03:06:34,166 --> 03:06:36,101
EXTENT TO WHICH SIDE-EFFECTS 

4688
03:06:36,101 --> 03:06:39,571
LEAD TO DISCONTINUATION RATES 

4689
03:06:39,571 --> 03:06:42,641
VERSUS ECONOMIC OR COVERAGE 

4690
03:06:42,641 --> 03:06:43,308
ISSUES. 

4691
03:06:43,308 --> 03:06:46,278
AND THEN ON THE NEXT SLIDE, WE 

4692
03:06:46,278 --> 03:06:49,314
-- NOT SURE WHO IS ADVANCING.  

4693
03:06:49,314 --> 03:06:52,818
MAYBE DAVID?  

4694
03:06:52,818 --> 03:06:56,622
WE ALSO IDENTIFIED SEVERAL 

4695
03:06:56,622 --> 03:06:58,357
QUESTIONS.  DAVID, ARE YOU ABLE 

4696
03:06:58,357 --> 03:07:01,360
TO ADVANCE THE SLIDES?  

4697
03:07:01,360 --> 03:07:11,036
NOT SURE THAT I AM. 

4698
03:07:11,036 --> 03:07:12,304
I WILL TALK FROM MY 

4699
03:07:12,304 --> 03:07:13,839
RECOLLECTION.  THERE WE GO. 

4700
03:07:13,839 --> 03:07:16,441
BACK ONE MAYBE TO THE PRAGMATIC 

4701
03:07:16,441 --> 03:07:16,675
TRIALS. 

4702
03:07:16,675 --> 03:07:19,478
THERE WE GO.  GREAT.  

4703
03:07:19,478 --> 03:07:20,879
THANK YOU.  

4704
03:07:20,879 --> 03:07:23,882
WE -- AFTER THE PRAGMATIC TRIALS

4705
03:07:23,882 --> 03:07:24,516
DISCUSSION, WE IDENTIFIED 

4706
03:07:24,516 --> 03:07:27,753
SEVERAL QUESTIONS THAT MIGHT BE 

4707
03:07:27,753 --> 03:07:29,955
PARTICULARLY JER MAIN FOR 

4708
03:07:29,955 --> 03:07:31,890
PRAGMATIC TRIALS AND CERTAINLY 

4709
03:07:31,890 --> 03:07:34,293
HEAD TO HEAD COMPARISONS OF 

4710
03:07:34,293 --> 03:07:36,161
ALTERNATE AND ANTI-OBESITY 

4711
03:07:36,161 --> 03:07:38,964
MEDICINES ESPECIALLY IN DIVERSE 

4712
03:07:38,964 --> 03:07:40,299
HEALTHCARE SETTINGS. 

4713
03:07:40,299 --> 03:07:42,568
WE ALSO TALKED ABOUT PRAGMATIC 

4714
03:07:42,568 --> 03:07:44,169
TRIALS BEING THE APPROPRIATE WAY

4715
03:07:44,169 --> 03:07:46,705
TO REALLY TEST STRATEGIES FOR 

4716
03:07:46,705 --> 03:07:47,840
TAPERING MEDICATIONS IN 

4717
03:07:47,840 --> 03:07:52,611
COMBINATION WITH LIFESTYLE 

4718
03:07:52,611 --> 03:07:52,978
INTERVENTIONS. 

4719
03:07:52,978 --> 03:07:54,780
THE COMPARATIVE EFFECTIVENESS 

4720
03:07:54,780 --> 03:07:57,382
ISSUE IN GENERAL WAS RAISED 

4721
03:07:57,382 --> 03:08:01,353
INCLUDING NOT JUST GLP-1S BUT 

4722
03:08:01,353 --> 03:08:04,223
OTHER ALTERNATIVES FOR WEIGHT 

4723
03:08:04,223 --> 03:08:04,423
LOSS. 

4724
03:08:04,423 --> 03:08:07,159
AND THEN THE QUESTION OF WHETHER

4725
03:08:07,159 --> 03:08:10,128
STEPPED CARE THERAPY IS MORE 

4726
03:08:10,128 --> 03:08:11,630
EFFECTIVE AND LESS EXPENSIVE 

4727
03:08:11,630 --> 03:08:18,670
THAN GOING STRAIGHT TO 

4728
03:08:18,670 --> 03:08:20,439
TREZEPIDIDEO TRANCE GLUM ATIED 

4729
03:08:20,439 --> 03:08:22,307
AND THERE IS SWITCHING AND 

4730
03:08:22,307 --> 03:08:23,442
SUGGESTED THAT PRAGMATIC TRIAL 

4731
03:08:23,442 --> 03:08:25,911
MIGHT BE THE BEST WAY FOR US TO 

4732
03:08:25,911 --> 03:08:29,281
LOOK AT THAT -- THAT SORT OF -- 

4733
03:08:29,281 --> 03:08:31,850
THOSE SWITCHING OPTIONS WHEN 

4734
03:08:31,850 --> 03:08:33,352
PATIENTS FAIL ONE MEDICATION. 

4735
03:08:33,352 --> 03:08:36,221
IN RELATED TO AN ISSUE THAT 

4736
03:08:36,221 --> 03:08:38,190
DAVID BROUGHT UP IN HIS SLIDES. 

4737
03:08:38,190 --> 03:08:41,360
AGAIN, WHAT -- HOW INTENSIVE 

4738
03:08:41,360 --> 03:08:44,396
DOES THE THERAPY NEED TO BE?  

4739
03:08:44,396 --> 03:08:45,197
LIFESTYLE INTERVENTION NEED TO 

4740
03:08:45,197 --> 03:08:48,200
BE TO SUPPORT GLP-1S FOR WEIGHT 

4741
03:08:48,200 --> 03:08:50,636
LOSS AND ACTUALLY DOING THAT -- 

4742
03:08:50,636 --> 03:08:52,204
DOING THOSE COMPARISONS AND 

4743
03:08:52,204 --> 03:08:55,007
MAYBE EVEN USING AN AT-BASED 

4744
03:08:55,007 --> 03:08:57,109
APPROACH VERSUS INTENSIVE GROUP 

4745
03:08:57,109 --> 03:08:59,144
OR INDIVIDUAL COUNSELING 

4746
03:08:59,144 --> 03:09:01,346
APPROACH TO LIFESTYLE 

4747
03:09:01,346 --> 03:09:02,714
INTERVENTIONS. 

4748
03:09:02,714 --> 03:09:05,350
WE ALSO TALKED ABOUT IMPORTANT 

4749
03:09:05,350 --> 03:09:07,519
QUESTIONS RELATED TO OFF-RAMPS 

4750
03:09:07,519 --> 03:09:08,921
FOR MEDICATIONS. 

4751
03:09:08,921 --> 03:09:12,257
AGAIN, DO WE -- WE IS THERE A 

4752
03:09:12,257 --> 03:09:14,393
POTENTIAL FOR INTERMITTENT GL1 

4753
03:09:14,393 --> 03:09:17,629
THERAPY OR SWITCHING TO ORAL 

4754
03:09:17,629 --> 03:09:20,766
ANTI-OBESITY MEDICATIONS OR 

4755
03:09:20,766 --> 03:09:21,466
INTENSIVE LIFESTYLE INTERVENTION

4756
03:09:21,466 --> 03:09:25,337
THAT MIGHT BE REALLY WELL-SUITED

4757
03:09:25,337 --> 03:09:27,439
FOR A PRAGMATIC TRIAL. 

4758
03:09:27,439 --> 03:09:29,241
ALSO, USING A TRIAL TO COMPARE 

4759
03:09:29,241 --> 03:09:31,576
DIFFERENT TITRATION SCHEDULES TO

4760
03:09:31,576 --> 03:09:34,446
LOOK AT THE EFFECT OF THOSE 

4761
03:09:34,446 --> 03:09:37,215
TITRATION SCHEDULES ON OUTCOMES 

4762
03:09:37,215 --> 03:09:40,519
LIKE ADHERENCE, WEIGHT LOSS, AND

4763
03:09:40,519 --> 03:09:41,353
CLINICAL OUTCOMES. 

4764
03:09:41,353 --> 03:09:43,522
DARREN, MAYBE TO YOU FOR THE 

4765
03:09:43,522 --> 03:09:44,289
NEXT ONES. 

4766
03:09:44,289 --> 03:09:47,693
>> THANK YOU, LESLEY.  

4767
03:09:47,693 --> 03:09:51,830
SO WE ALSO SPOKE A LOT ABOUT 

4768
03:09:51,830 --> 03:09:55,534
SUBGROUPS AND ONE OF THEM WAS 

4769
03:09:55,534 --> 03:09:59,571
THAT OBESITY WAS NOT A 

4770
03:09:59,571 --> 03:10:00,839
HOMOGENEOUS CONDITION AND IT 

4771
03:10:00,839 --> 03:10:07,279
WILL BE GOOD TO STUDY EFFECTS OF

4772
03:10:07,279 --> 03:10:07,913
GLP-1-BASED THERAPIES WITHIN 

4773
03:10:07,913 --> 03:10:09,181
THIS LARGE GROUP THAT WE 

4774
03:10:09,181 --> 03:10:12,751
COLLECTIVELY CALL OBESITY. 

4775
03:10:12,751 --> 03:10:14,987
SPENDING A LOT OF TIME FOCUSING 

4776
03:10:14,987 --> 03:10:16,722
ON PEDIATRIC POPULATION AND 

4777
03:10:16,722 --> 03:10:18,323
THERE IS A NUMBER OF QUESTIONS 

4778
03:10:18,323 --> 03:10:19,891
THAT WERE RAISED. 

4779
03:10:19,891 --> 03:10:23,829
ONE WAS ABOUT ACCESS OF THE 

4780
03:10:23,829 --> 03:10:27,366
MEDICATION AND BY -- BY 

4781
03:10:27,366 --> 03:10:28,934
PEDIATRIC POPULATION AND YOUNG 

4782
03:10:28,934 --> 03:10:32,938
ADULT WITH COMORBID CONDITIONS. 

4783
03:10:32,938 --> 03:10:38,276
WE ALSO TALKED ABOUT BENEFIT AND

4784
03:10:38,276 --> 03:10:39,678
HARMS OF THIS PARTICULAR 

4785
03:10:39,678 --> 03:10:41,380
POPULATION AND THERE WAS AN 

4786
03:10:41,380 --> 03:10:42,614
EXCELLENT COMMENT FROM A 

4787
03:10:42,614 --> 03:10:45,283
PARTICIPANT ABOUT TAKING MORE OF

4788
03:10:45,283 --> 03:10:49,388
A LIFE COURSE LENS TO THIS 

4789
03:10:49,388 --> 03:10:51,523
POPULATION FOLLOWING PEDIATRIC 

4790
03:10:51,523 --> 03:10:55,327
POPULATION INTO ADULTHOOD AND SO

4791
03:10:55,327 --> 03:10:55,494
ON. 

4792
03:10:55,494 --> 03:10:59,431
SO THAT WAS SOMETHING THAT STUCK

4793
03:10:59,431 --> 03:11:01,199
WITH ME. 

4794
03:11:01,199 --> 03:11:05,337
THERE WAS SOME DISCUSSION ABOUT 

4795
03:11:05,337 --> 03:11:08,173
PREGNANT INDIVIDUALS AND BENEFIT

4796
03:11:08,173 --> 03:11:10,008
AND RISK OF THIS MEDICATION ON 

4797
03:11:10,008 --> 03:11:13,345
THE MOMS AND THE BABY. 

4798
03:11:13,345 --> 03:11:16,848
SO THAT WAS SOMETHING THAT WE 

4799
03:11:16,848 --> 03:11:18,350
DISCUSSED TODAY. 

4800
03:11:18,350 --> 03:11:19,684
WE KNOW THAT PREGNANT 

4801
03:11:19,684 --> 03:11:20,986
INDIVIDUALS WERE USUALLY 

4802
03:11:20,986 --> 03:11:24,856
EXCLUDED FROM CLINICAL TRIALS. 

4803
03:11:24,856 --> 03:11:26,591
REAL WORLD DATA STUDIES ARE 

4804
03:11:26,591 --> 03:11:29,194
STILL THE PRIMARY SOURCE FOR 

4805
03:11:29,194 --> 03:11:30,829
SAFETY AND EFFECTIVENESS 

4806
03:11:30,829 --> 03:11:35,300
INFORMATION FOR PREGNANT 

4807
03:11:35,300 --> 03:11:35,934
INDIVIDUALS. 

4808
03:11:35,934 --> 03:11:38,036
NEXT SLIDE, PLEASE. 

4809
03:11:38,036 --> 03:11:41,339
SO IN ADDITION TO THE BENEFITS 

4810
03:11:41,339 --> 03:11:45,343
OF GLP-1S BASED THERAPY WE SPOKE

4811
03:11:45,343 --> 03:11:47,579
ABOUT POTENTIAL HARMS AND THE 

4812
03:11:47,579 --> 03:11:50,949
SESSIONS EARLIER THIS MORNING 

4813
03:11:50,949 --> 03:11:53,785
FOCUS ON THE NUMBER OF 

4814
03:11:53,785 --> 03:11:57,022
CONDITIONS AND SOME OF THEM WERE

4815
03:11:57,022 --> 03:11:58,690
ABOUT POTENTIAL ADVERSE EFFECTS 

4816
03:11:58,690 --> 03:12:02,360
OF GLP-1 BASED THERAPY AND 

4817
03:12:02,360 --> 03:12:03,895
TALKING ABOUT SUICIDALITY AND 

4818
03:12:03,895 --> 03:12:05,664
MENTAL HEALTH CONDITIONS AND 

4819
03:12:05,664 --> 03:12:08,266
CERTAIN EATING DISORDERS. 

4820
03:12:08,266 --> 03:12:12,370
CERTAIN CANCERS. 

4821
03:12:12,370 --> 03:12:16,808
AND SOCIETAL DEVELOPMENT IN 

4822
03:12:16,808 --> 03:12:19,911
IMMEDIATAT TRICK POPULATION AND 

4823
03:12:19,911 --> 03:12:22,147
AS MENTIONED THERE IS QUITE A 

4824
03:12:22,147 --> 03:12:25,383
BIT OF STUDIES ON SUICIDAL 

4825
03:12:25,383 --> 03:12:28,453
THOUGHTS ON GLP-1 THERAPY AND 

4826
03:12:28,453 --> 03:12:30,021
FINISHING STUDY AND HOPEFULLY WE

4827
03:12:30,021 --> 03:12:32,124
WILL SEE RESULTS SOON. 

4828
03:12:32,124 --> 03:12:34,493
NEXT SLIDE, PLEASE. 

4829
03:12:34,493 --> 03:12:38,530
SO THERE WAS A -- QUITE A BIT OF

4830
03:12:38,530 --> 03:12:41,666
DISCUSSION OF LIFESTYLE 

4831
03:12:41,666 --> 03:12:44,069
INTERVENTIONS ON SEVERAL FRONTS.

4832
03:12:44,069 --> 03:12:47,572
ONE IS ONE BEST PRACTICE FOR 

4833
03:12:47,572 --> 03:12:49,307
BEHAVIORAL LIFESTYLE INNOVATION 

4834
03:12:49,307 --> 03:12:53,278
THAT COULD ACCOMPANY USE OF 

4835
03:12:53,278 --> 03:12:54,112
GLP-1-BASED THERAPIES AND 

4836
03:12:54,112 --> 03:12:55,247
COMMENT ABOUT WHETHER WE SHOULD 

4837
03:12:55,247 --> 03:12:57,816
FOLLOW WHAT WE ARE DOING FOR 

4838
03:12:57,816 --> 03:12:59,317
BARIATRIC SURGERY AND FOLLOWING 

4839
03:12:59,317 --> 03:13:04,189
THE SAME PROCESS FOR GLP-1-BASED

4840
03:13:04,189 --> 03:13:04,456
THERAPY. 

4841
03:13:04,456 --> 03:13:06,758
ANOTHER QUESTION IS HOW MUCH OF 

4842
03:13:06,758 --> 03:13:09,361
THIS INTERVENTION IS NEEDED?  

4843
03:13:09,361 --> 03:13:13,198
TALKING MORE ABOUT THIS COST AND

4844
03:13:13,198 --> 03:13:15,600
SOCIETAL IMPACT OF THIS 

4845
03:13:15,600 --> 03:13:18,503
CO-INTERVENTION AND DR. LEWIS 

4846
03:13:18,503 --> 03:13:20,972
EARLIER TODAY SPOKE ABOUT 

4847
03:13:20,972 --> 03:13:22,040
METHODOLOGICAL ISSUES WHEN DOING

4848
03:13:22,040 --> 03:13:27,245
REAL WORLD STUDIES ON GLP-1S AND

4849
03:13:27,245 --> 03:13:29,247
HOW TO THINK ABOUT THESE 

4850
03:13:29,247 --> 03:13:31,550
BEHAVIORAL INTERVENTION EITHER 

4851
03:13:31,550 --> 03:13:33,351
BEING CONFOUNDERS OR 

4852
03:13:33,351 --> 03:13:34,386
INTERMEDIATE VARIABLES FOR 

4853
03:13:34,386 --> 03:13:36,354
THINGS WE WANT TO LOOK AT AND 

4854
03:13:36,354 --> 03:13:39,191
ARE METHOD LOGICAL ISSUES 

4855
03:13:39,191 --> 03:13:40,625
ASSOCIATED WITH LIFESTYLE 

4856
03:13:40,625 --> 03:13:43,161
INTERVENTION AS WELL. 

4857
03:13:43,161 --> 03:13:45,630
NEXT SLIDE, PLEASE.  

4858
03:13:45,630 --> 03:13:50,902
CAN YOU GO UP ONE SLIDE?  FOR 

4859
03:13:50,902 --> 03:13:56,308
THE -- SO METHODOLOGICAL ISSUES 

4860
03:13:56,308 --> 03:13:59,344
-- THIS IS AN INTERESTING TOPIC.

4861
03:13:59,344 --> 03:14:02,447
WE SPOKE A LOT ABOUT BIASES THAT

4862
03:14:02,447 --> 03:14:04,449
COULD ARISE FROM REAL WORLD DATA

4863
03:14:04,449 --> 03:14:08,887
STUDIES AND DR. HERNON SPOKE 

4864
03:14:08,887 --> 03:14:13,091
ABOUT [INDISCERNIBLE] BIAS AND 

4865
03:14:13,091 --> 03:14:15,727
THINGS THAT ARE SPECIFIC TO REAL

4866
03:14:15,727 --> 03:14:19,664
WORLD DATAS AND SOME 

4867
03:14:19,664 --> 03:14:21,132
METHODOLOGICAL ISSUES SPECIFIC 

4868
03:14:21,132 --> 03:14:25,337
TO GLP-1-BASED THERAPIES THAT 

4869
03:14:25,337 --> 03:14:26,871
ARE MOSTLY ABOUT PEDIATRIC 

4870
03:14:26,871 --> 03:14:28,673
EFFECT OF DRUGS AND DRUGS WORK 

4871
03:14:28,673 --> 03:14:31,443
ON SO MANY SYSTEMS IN THE BODY 

4872
03:14:31,443 --> 03:14:33,345
AND WORK ON SO MANY OUTCOMES WE 

4873
03:14:33,345 --> 03:14:35,747
ARE INTERESTED IN AND THERE WAS 

4874
03:14:35,747 --> 03:14:37,716
SOME DISCUSSION ABOUT MANY OF 

4875
03:14:37,716 --> 03:14:39,684
THE OUTCOMES BEING 

4876
03:14:39,684 --> 03:14:41,720
INTERCONNECTED AND IT IS HARD TO

4877
03:14:41,720 --> 03:14:45,357
STUDY GIVEN OUTCOME IN 

4878
03:14:45,357 --> 03:14:45,690
ISOLATION. 

4879
03:14:45,690 --> 03:14:48,994
WHEN WE TRY TO GET DEEPER INTO 

4880
03:14:48,994 --> 03:14:53,365
THE SPECIFIC MECHANISM FOR HOW 

4881
03:14:53,365 --> 03:14:56,968
GLP-1S INFLUENCE CERTAIN 

4882
03:14:56,968 --> 03:14:58,670
OUTCOME, THIS GETS INTO WHETHER 

4883
03:14:58,670 --> 03:15:01,673
WE NEED TO DO SOME SORT OF 

4884
03:15:01,673 --> 03:15:02,974
MEDIATION ANALYSIS. 

4885
03:15:02,974 --> 03:15:04,976
THE QUESTION IS WE ARE STILL 

4886
03:15:04,976 --> 03:15:08,513
TRYING TO FIGURE OUT HOW THESE 

4887
03:15:08,513 --> 03:15:11,182
DRUGS WORK IN OUR BODY. 

4888
03:15:11,182 --> 03:15:13,218
SO WHETHER IT IS PREMATURE OR 

4889
03:15:13,218 --> 03:15:15,854
WHETHER WE HAVE DATA TO MAKE 

4890
03:15:15,854 --> 03:15:17,722
SURE THAT T-CELL SPECIFIC 

4891
03:15:17,722 --> 03:15:18,823
MECHANISM, I THINK THERE WAS -- 

4892
03:15:18,823 --> 03:15:20,325
THERE IS INTERESTING 

4893
03:15:20,325 --> 03:15:22,093
METHODOLOGICAL ISSUES THAT COULD

4894
03:15:22,093 --> 03:15:24,596
BE EXPLORED THERE. 

4895
03:15:24,596 --> 03:15:25,964
NEXT SLIDE, PLEASE. 

4896
03:15:25,964 --> 03:15:29,534
MAYBE GO UP ONE SLIDE TO THE 

4897
03:15:29,534 --> 03:15:34,105
DATA ENGAGED DISCUSSION. 

4898
03:15:34,105 --> 03:15:36,007
SO ONE THEME THAT EMERGED DURING

4899
03:15:36,007 --> 03:15:38,276
DISCUSSION EARLIER TODAY IS THE 

4900
03:15:38,276 --> 03:15:41,346
NEED FOR DATA LINKAGES. 

4901
03:15:41,346 --> 03:15:43,348
WE STARTED TO TALK ABOUT THE 

4902
03:15:43,348 --> 03:15:46,251
STRENGTHS AND WILL IMITATIONS OF

4903
03:15:46,251 --> 03:15:47,585
SPECIFIC TYPES OF REAL WORLD 

4904
03:15:47,585 --> 03:15:49,521
DATA SOURCES THAT ARE GOOD FOR 

4905
03:15:49,521 --> 03:15:51,489
CERTAIN THINGS AND LACK OTHER 

4906
03:15:51,489 --> 03:15:53,358
INFORMATION THAT WE NEED TO 

4907
03:15:53,358 --> 03:15:57,362
STUDY GLP-1-BASED THERAPIES AND 

4908
03:15:57,362 --> 03:16:00,131
ONE IDEA IS TRYING TO LINK 

4909
03:16:00,131 --> 03:16:02,634
DIFFERENT COMPLEMENTARY DATA 

4910
03:16:02,634 --> 03:16:04,803
SOURCES TO GET A MORE 

4911
03:16:04,803 --> 03:16:05,603
COMPREHENSIVE PICTURE OF 

4912
03:16:05,603 --> 03:16:07,272
PATIENTS AND WHAT HAPPENS TO 

4913
03:16:07,272 --> 03:16:09,441
WHEN THEY TAKE MEDICATIONS. 

4914
03:16:09,441 --> 03:16:11,609
SO LINKING BETWEEN CLAIMS DATA 

4915
03:16:11,609 --> 03:16:17,182
AND EHR OR LINKING BETWEEN 

4916
03:16:17,182 --> 03:16:17,849
OEC EHR 

4917
03:16:17,849 --> 03:16:19,984
REGISTRY AND CLAIMS THAT EMERGE 

4918
03:16:19,984 --> 03:16:23,655
AS A COMMON THEME EARLIER TODAY 

4919
03:16:23,655 --> 03:16:28,593
AND ALSO WAS DISCUSSION ABOUT 

4920
03:16:28,593 --> 03:16:29,561
CONTINUED FOLLOW UP OF 

4921
03:16:29,561 --> 03:16:31,329
INDIVIDUALS PARTICIPATING IN 

4922
03:16:31,329 --> 03:16:33,365
PRAGMATIC TRIAL FOR EXAMPLE AND 

4923
03:16:33,365 --> 03:16:35,133
SOME SPEAKERS SHOW REAL-WORLD 

4924
03:16:35,133 --> 03:16:38,470
EXAMPLE TO SHOW IT IS FEASIBLE 

4925
03:16:38,470 --> 03:16:40,205
EVEN THOUGH TRIAL ENDED AND IT 

4926
03:16:40,205 --> 03:16:43,808
IS POSSIBLE TO LINK TRIAL DATA 

4927
03:16:43,808 --> 03:16:45,744
WITH OTHER REAL WORLD DATA 

4928
03:16:45,744 --> 03:16:47,746
SOURCES TO FOLLOW PATIENTS FOR 

4929
03:16:47,746 --> 03:16:51,349
LONG TERM OUTCOMES AND ARE ALSO 

4930
03:16:51,349 --> 03:16:54,886
DISCUSSIONS ABOUT SOME OF THE 

4931
03:16:54,886 --> 03:16:56,921
EMERGING MULTI-SITE OR 

4932
03:16:56,921 --> 03:16:59,991
MULTI-NATION STUDIES TO ALLOW US

4933
03:16:59,991 --> 03:17:02,861
TO LOOK FOR RARE OUTCOMES AND 

4934
03:17:02,861 --> 03:17:04,729
EXAMPLES THAT SPEAKERS PROVIDED.

4935
03:17:04,729 --> 03:17:07,966
I THINK THAT THOSE ARE THE 

4936
03:17:07,966 --> 03:17:09,367
THEMES THAT WE IDENTIFIED. 

4937
03:17:09,367 --> 03:17:11,736
MAYBE NOW IS A TIME TO GO BACK 

4938
03:17:11,736 --> 03:17:13,271
TO INDIVIDUAL SLIDES TO SEE 

4939
03:17:13,271 --> 03:17:15,173
WHETHER WE MISSED ANYTHING. 

4940
03:17:15,173 --> 03:17:18,543
I SAW DAVID COMING BACK ONLINE. 

4941
03:17:18,543 --> 03:17:21,646
>> GREAT.  THANK YOU FOR
THAT, 

4942
03:17:21,646 --> 03:17:25,350
DARREN.  CAN YOU HEAR ME OKAY?  

4943
03:17:25,350 --> 03:17:25,583
>> YUP. 

4944
03:17:25,583 --> 03:17:29,454
>> GREAT.  I HAD TECH
ISSUES ON 

4945
03:17:29,454 --> 03:17:32,357
MY SIDE AND HAD TO REJOIN AND 

4946
03:17:32,357 --> 03:17:34,392
GLAD YOU COULD HEAR ME BEFORE 

4947
03:17:34,392 --> 03:17:35,727
ANYBODY ELSE AND CRAIG IF YOU 

4948
03:17:35,727 --> 03:17:38,730
WOULDN'T MIND TAKING US BACK TO 

4949
03:17:38,730 --> 03:17:39,931
LONG-TERM OUTCOME SLIDE ON WHICH

4950
03:17:39,931 --> 03:17:41,332
-- THERE WE GO. 

4951
03:17:41,332 --> 03:17:43,435
I THINK WHAT WE WOULD LOVE TO 

4952
03:17:43,435 --> 03:17:45,437
HEAR IS ARE THERE ANY ADDITIONAL

4953
03:17:45,437 --> 03:17:47,605
POINTS WE MISSED AS WE GO 

4954
03:17:47,605 --> 03:17:49,073
FORWARD?  

4955
03:17:49,073 --> 03:17:51,843
YOU KNOW, I -- I THINK THAT, YOU

4956
03:17:51,843 --> 03:17:54,012
KNOW, WE COVER A BIT OF GROUND 

4957
03:17:54,012 --> 03:17:56,281
HERE IN LONG-TERM OUTCOME SLIDE 

4958
03:17:56,281 --> 03:17:57,682
AND NEXT ONE AND THINK THAT 

4959
03:17:57,682 --> 03:17:59,284
THERE MAY NOT BE ADDITIONAL 

4960
03:17:59,284 --> 03:18:01,252
POINTS THAT NEED TO BE ADDED. 

4961
03:18:01,252 --> 03:18:03,221
IF ANYBODY HAS IDEAS THAT CAME 

4962
03:18:03,221 --> 03:18:04,889
TO MIND, YOU KNOW, I WOULD LOVE 

4963
03:18:04,889 --> 03:18:08,326
TO HEAR FROM PEOPLE IN THE CHAT 

4964
03:18:08,326 --> 03:18:10,662
ABOUT OTHER LONG-TERM OUTCOMES 

4965
03:18:10,662 --> 03:18:13,531
WE NEED TO ASSESS OR ANY 

4966
03:18:13,531 --> 03:18:17,202
CHALLENGES OR ISSUES THAT YOU 

4967
03:18:17,202 --> 03:18:20,238
ANTICIPATE BEING AN IMPORTANT 

4968
03:18:20,238 --> 03:18:30,782
THING TO ADDRESS IN THIS SPACE. 

4969
03:18:37,322 --> 03:18:39,924
ANY COMMENTS COMING IN?  

4970
03:18:39,924 --> 03:18:42,193
DARREN, I KNOW THIS IS OUR BEST 

4971
03:18:42,193 --> 03:18:44,262
THINKING COMING TOGETHER THERE. 

4972
03:18:44,262 --> 03:18:47,799
WE COULD MAYBE MOVE ON TO THE 

4973
03:18:47,799 --> 03:18:56,174
ECONOMIC PIECE THAT WAS ROBUSTLY

4974
03:18:56,174 --> 03:18:58,910
TALKED ABOUT IN COMING TWO DAYS 

4975
03:18:58,910 --> 03:18:59,944
AND ENDORSEMENT AND ECONOMIC 

4976
03:18:59,944 --> 03:19:01,946
PIECE OF THIS AND OBVIOUSLY 

4977
03:19:01,946 --> 03:19:04,682
THERE IS BIG GAPS TO FILL HERE 

4978
03:19:04,682 --> 03:19:07,218
WE I THINK ARE HEARING FROM A 

4979
03:19:07,218 --> 03:19:09,120
LOT OF DIFFERENT PEOPLE IN THIS 

4980
03:19:09,120 --> 03:19:10,822
SLIDE AS WELL IN TERMS OF WHAT 

4981
03:19:10,822 --> 03:19:14,492
DIFFERENT GAPS MIGHT BE AND HAD 

4982
03:19:14,492 --> 03:19:15,727
A ROBUST DISCUSSION ABOUT IT 

4983
03:19:15,727 --> 03:19:19,030
YESTERDAY AND DOES ANYBODY HAVE 

4984
03:19:19,030 --> 03:19:21,132
ECONOMIC RELATED ADDITIONAL GAPS

4985
03:19:21,132 --> 03:19:25,336
THEY WOULD LIKE TO ADD TO THE 

4986
03:19:25,336 --> 03:19:35,480
LIST?  

4987
03:19:40,985 --> 03:19:44,522
YOU NEED IT COMING IN THERE AS 

4988
03:19:44,522 --> 03:19:48,226
WELL SHOULD WE MOVE INTO 

4989
03:19:48,226 --> 03:19:49,794
ADHERENCE AND MAINTENANCE DOSING

4990
03:19:49,794 --> 03:19:53,064
OR RELATED QUESTIONS AND HEARD 

4991
03:19:53,064 --> 03:19:55,800
FROM LESLEY ABOUT THOSE. 

4992
03:19:55,800 --> 03:19:57,969
ANY OTHER ISSUES AROUND 

4993
03:19:57,969 --> 03:19:58,970
ADHERENCE OR MAINTENANCE THAT 

4994
03:19:58,970 --> 03:20:03,641
PEOPLE ARE CONCERNED ABOUT?  

4995
03:20:03,641 --> 03:20:05,376
THERE IS A COMMENT FROM 

4996
03:20:05,376 --> 03:20:08,479
ORGANIZERS ABOUT VALUE-BASED 

4997
03:20:08,479 --> 03:20:10,448
ADHERENCE DESIGN PRINCIPLES.  

4998
03:20:10,448 --> 03:20:13,785
GREAT ONE AROUND ECONOMIC PIECE.

4999
03:20:13,785 --> 03:20:15,453
YEAH.  NEW INNOVATIVE DESIGNS 

5000
03:20:15,453 --> 03:20:20,358
AROUND HOW WE MIGHT PAY FOR AND 

5001
03:20:20,358 --> 03:20:24,529
IMPROVE GOOD QUALITY FOR USE OF 

5002
03:20:24,529 --> 03:20:26,698
GLP-1S.  THAT IS GREAT WE CAN 

5003
03:20:26,698 --> 03:20:28,266
CONTINUE THAT SUGGESTION. 

5004
03:20:28,266 --> 03:20:30,401
OTHER QUESTIONS OR CONCERNS 

5005
03:20:30,401 --> 03:20:32,503
ABOUT MAINTENANCE, ADHERENCE OR 

5006
03:20:32,503 --> 03:20:36,140
DOSING OF MEDICATIONS?  

5007
03:20:36,140 --> 03:20:38,743
I WILL ADD I THINK IT CAME UP IN

5008
03:20:38,743 --> 03:20:40,011
OUR SESSION TODAY AND IS JUST 

5009
03:20:40,011 --> 03:20:42,213
OCCURRING TO ME NOW THAT I DON'T

5010
03:20:42,213 --> 03:20:44,449
THINK -- I DON'T THINK WE 

5011
03:20:44,449 --> 03:20:48,386
ADEQUATELY TOUCHED ON THE DOSE 

5012
03:20:48,386 --> 03:20:51,789
OF GLP-1 RELATED ISSUES IN OUR 

5013
03:20:51,789 --> 03:20:52,056
DATA. 

5014
03:20:52,056 --> 03:20:54,525
THIS IDEA THAT, YOU KNOW, WE HAD

5015
03:20:54,525 --> 03:20:55,727
BEEN TALKING ABOUT IDENTIFYING 

5016
03:20:55,727 --> 03:20:58,963
WHO IS TAKING VARIOUS DRUGS AND 

5017
03:20:58,963 --> 03:21:00,765
WHICH DOSE ARE THEY ON AND OVER 

5018
03:21:00,765 --> 03:21:03,568
WHAT PERIOD OF TIME?  

5019
03:21:03,568 --> 03:21:06,704
THAT TIME VARYING PIECE ON WHAT 

5020
03:21:06,704 --> 03:21:09,774
HAPPENS TO YOUR OUTCOMES AS YOU 

5021
03:21:09,774 --> 03:21:11,709
GET TO DIFFERENT DOSES AND 

5022
03:21:11,709 --> 03:21:13,344
WHETHER THERE IS CLEAR DOSE 

5023
03:21:13,344 --> 03:21:16,080
RESPONSE AS YOU SEE IN CLINICAL 

5024
03:21:16,080 --> 03:21:18,950
TRIALS.  YOU KNOW, NOT JUST 

5025
03:21:18,950 --> 03:21:21,352
THINKING ABOUT SOMEONE ON SEM 

5026
03:21:21,352 --> 03:21:23,054
AGO LEWDIDE OR NOT AND WHAT DOSE

5027
03:21:23,054 --> 03:21:25,356
ARE THEY ON ON THAT MEDICATION 

5028
03:21:25,356 --> 03:21:28,493
AND THAT DERIVING SOME 

5029
03:21:28,493 --> 03:21:29,293
HETEROGENEITY AND RESPONSE WE 

5030
03:21:29,293 --> 03:21:31,796
MIGHT SEE.  YOU KNOW, THAT MIGHT

5031
03:21:31,796 --> 03:21:34,265
BE DRIVEN BY TOLLRABILITY OR 

5032
03:21:34,265 --> 03:21:37,468
MAYBE IT IS DRIVEN BY COST OR 

5033
03:21:37,468 --> 03:21:41,873
MAYBE JUST ORDER EXECUTION OF 

5034
03:21:41,873 --> 03:21:42,974
IMPLEMENTATION ON THE CARE 

5035
03:21:42,974 --> 03:21:45,843
DELIVERY SIDE AND IN TERMS OF 

5036
03:21:45,843 --> 03:21:47,612
TITRATION IN TERMS OF OPTIMAL 

5037
03:21:47,612 --> 03:21:50,415
THERAPY AS WE SEE IN MANY MANY 

5038
03:21:50,415 --> 03:21:52,450
HEALTH CONDITIONS AND WHAT ARE 

5039
03:21:52,450 --> 03:21:56,721
VARIOUS FACTORS THAT ARE DRIVING

5040
03:21:56,721 --> 03:21:58,690
DOSING OVER TIME?  WHAT IMPACT 

5041
03:21:58,690 --> 03:22:00,324
DOES IT HAVE ON HEALTH OUTCOMES 

5042
03:22:00,324 --> 03:22:03,261
THAT IS SOMETHING THAT IS COMING

5043
03:22:03,261 --> 03:22:03,895
TO MIND?  

5044
03:22:03,895 --> 03:22:06,698
>> DAVID, ANOTHER POINT
THAT 

5045
03:22:06,698 --> 03:22:08,533
CAME TO MIND AS I'M REMEMBERING 

5046
03:22:08,533 --> 03:22:10,768
IS COMMENT ABOUT USING THE TERM 

5047
03:22:10,768 --> 03:22:13,037
ADHERENCE AS WE TYPICALLY USE IT

5048
03:22:13,037 --> 03:22:16,841
GIVEN THAT IN THIS -- WITH 

5049
03:22:16,841 --> 03:22:18,509
DRUGS, GIVEN COST AND CHALLENGES

5050
03:22:18,509 --> 03:22:21,079
RELATED TO ACCESS, FRAMING OF 

5051
03:22:21,079 --> 03:22:23,281
ADHERENCE MIGHT PUT MORE I WOULD

5052
03:22:23,281 --> 03:22:25,349
SAY MAY ATTRIBUTE MORE TO THE 

5053
03:22:25,349 --> 03:22:27,318
PATIENT THAN IS TRULY IN THEIR 

5054
03:22:27,318 --> 03:22:28,653
CONTROL. 

5055
03:22:28,653 --> 03:22:30,354
IT IS NOT REALLY A GAP AS MUCH 

5056
03:22:30,354 --> 03:22:32,757
AS IT IS NOTING THAT THE WORDS 

5057
03:22:32,757 --> 03:22:35,326
THAT WE USE WE MAY WANT TO BE 

5058
03:22:35,326 --> 03:22:37,161
CAREFUL ABOUT HOW WE -- WE MIGHT

5059
03:22:37,161 --> 03:22:39,764
WANT TO CAREFULLY DEFINE THEM.  

5060
03:22:39,764 --> 03:22:40,865
MAKE SENSE?  

5061
03:22:40,865 --> 03:22:45,336
>> IT DOES.  THANK YOU FOR
THAT 

5062
03:22:45,336 --> 03:22:49,307
CLARIFICATION.  

5063
03:22:49,307 --> 03:22:50,708
THERE IS ALSO A POINT IN THE 

5064
03:22:50,708 --> 03:22:53,344
CHAT THAT IS I THINK RELATED TO 

5065
03:22:53,344 --> 03:22:55,246
THE COST THINKING ABOUT HOW 

5066
03:22:55,246 --> 03:22:57,348
COSTS INFLUENCE THE CHOICE OF 

5067
03:22:57,348 --> 03:22:57,949
THE COMPARATOR. 

5068
03:22:57,949 --> 03:23:02,253
AND THE -- THE POTENTIAL KIND OF

5069
03:23:02,253 --> 03:23:04,188
SELECTION ISSUES BIAS ISSUES 

5070
03:23:04,188 --> 03:23:08,726
THAT MIGHT OCCUR DUE TO COST 

5071
03:23:08,726 --> 03:23:10,128
DIFFERENCES.  

5072
03:23:10,128 --> 03:23:12,463
>> GREAT ONE.  

5073
03:23:12,463 --> 03:23:15,466
>> ALONG LINES OF
ADHERENCE AND 

5074
03:23:15,466 --> 03:23:17,335
DISCUSSION, ONE THING WE DID NOT

5075
03:23:17,335 --> 03:23:19,070
GET A CHANCE TO DISCUSS BUT 

5076
03:23:19,070 --> 03:23:21,205
SOMEONE BROUGHT IT UP IS A 

5077
03:23:21,205 --> 03:23:23,808
QUESTION WAS IMPACT OF 

5078
03:23:23,808 --> 03:23:26,811
COMPOUNDED PRODUCTS. 

5079
03:23:26,811 --> 03:23:29,547
BECAUSE IT IS POSSIBLE THAT SOME

5080
03:23:29,547 --> 03:23:31,682
PATIENTS MIGHT SWITCH TO 

5081
03:23:31,682 --> 03:23:32,617
COMBINED PRODUCTS AND IN THE 

5082
03:23:32,617 --> 03:23:35,019
REAL DATA SOURCES THAT WE HAVE 

5083
03:23:35,019 --> 03:23:36,788
ACCESS TO, WE MIGHT JUST SEE 

5084
03:23:36,788 --> 03:23:39,757
THEM AS STOPPING THE TREATMENT. 

5085
03:23:39,757 --> 03:23:41,926
BUT THAT MIGHT NOT BE THE CASE 

5086
03:23:41,926 --> 03:23:44,595
BECAUSE THEY MIGHT JUST BE 

5087
03:23:44,595 --> 03:23:45,797
GETTING THE DRUG FROM OTHER 

5088
03:23:45,797 --> 03:23:49,901
PLACES AND ARE METHODOLOGICAL 

5089
03:23:49,901 --> 03:23:53,337
ISSUES WITH THAT. 

5090
03:23:57,041 --> 03:23:57,475
>>. 

5091
03:23:57,475 --> 03:24:00,578
AGREE WITH YOU, DARREN. 

5092
03:24:00,578 --> 03:24:02,713
HOPEFULLY IN MAY OF THIS MONTH 

5093
03:24:02,713 --> 03:24:05,683
IT IS SUPPOSED TO BE END OF 

5094
03:24:05,683 --> 03:24:09,921
COMPOUNDING AROUND GLP-1S AND 

5095
03:24:09,921 --> 03:24:11,389
WILL BE INTERESTING TO SEE HOW 

5096
03:24:11,389 --> 03:24:13,357
IT PLAYS OUT THIS IS A REAL 

5097
03:24:13,357 --> 03:24:17,361
IMPORTANT POTENTIAL GAP WITHIN 

5098
03:24:17,361 --> 03:24:19,964
REAL WORLD DATA TO UNDERSTAND 

5099
03:24:19,964 --> 03:24:23,367
WHAT INFLUENCE THIS MIGHT BE AND

5100
03:24:23,367 --> 03:24:26,404
PEOPLE COULD INVESTIGATE HOW 

5101
03:24:26,404 --> 03:24:29,607
COMMON IT IS PEOPLE ARE GOING 

5102
03:24:29,607 --> 03:24:35,613
AND GETTING A COMPOUND DRUG TO 

5103
03:24:35,613 --> 03:24:36,447
ANNOUNCE PHARMACY AND 

5104
03:24:36,447 --> 03:24:38,749
INTERESTING TIMES TO ACCESS 

5105
03:24:38,749 --> 03:24:43,654
MEDICATIONS AND WONDER HOW MUCH 

5106
03:24:43,654 --> 03:24:48,092
DISCONTINUATION IS OBSERVED IN 

5107
03:24:48,092 --> 03:24:55,233
DATABASES MIGHT BE FALSE THAT --

5108
03:24:55,233 --> 03:24:58,269
>> IN ADDITION TO DIETARY 

5109
03:24:58,269 --> 03:25:00,171
CONCERNS THERE IS COMMENT ABOUT 

5110
03:25:00,171 --> 03:25:03,474
ENGAGEMENT WITH PHYSICAL 

5111
03:25:03,474 --> 03:25:09,480
ACTIVITY OVER TIME OFTEN BEING 

5112
03:25:09,480 --> 03:25:13,284
POORLY MEASURED HELPING CAPTURE 

5113
03:25:13,284 --> 03:25:15,920
THAT AND IDEA TO CAPTURE REAL 

5114
03:25:15,920 --> 03:25:19,223
TIME DATA ON LIFESTYLE FACTORS 

5115
03:25:19,223 --> 03:25:20,691
THAT COULD INFLUENCE OUTCOMES 

5116
03:25:20,691 --> 03:25:25,329
WITH PATIENTS GETTING GLP-1S IS 

5117
03:25:25,329 --> 03:25:28,466
A GREAT POINT. 

5118
03:25:28,466 --> 03:25:36,641
THANK YOU.  

5119
03:25:36,641 --> 03:25:39,343
ANY OTHER COMMENTS ABOUT 

5120
03:25:39,343 --> 03:25:40,778
MAINTENANCE ADHERENCE DOSING AND

5121
03:25:40,778 --> 03:25:42,346
PRAGMATIC TRIALS AND ANYBODY 

5122
03:25:42,346 --> 03:25:44,715
ELSE HAVE IDEAS FOR PRAGMATIC 

5123
03:25:44,715 --> 03:25:46,951
TRIALS AND IDEAS HOW THEY COULD 

5124
03:25:46,951 --> 03:25:51,122
BE BEST USED TO MOVE THE FIELD 

5125
03:25:51,122 --> 03:25:54,825
FORWARD DISTINCTLY FROM TARGET 

5126
03:25:54,825 --> 03:26:05,002
TRIALS?  

5127
03:26:19,984 --> 03:26:24,021
WE CAN MOVE ON TO PEDIATRIC 

5128
03:26:24,021 --> 03:26:25,356
TOPICS THAT MIGHT BE NEXT. 

5129
03:26:25,356 --> 03:26:27,758
I DON'T KNOW IF THERE IS ANY 

5130
03:26:27,758 --> 03:26:29,160
OTHER FEEDBACK THAT PEOPLE HAD 

5131
03:26:29,160 --> 03:26:30,661
AROUND VARIOUS TOPICS AND THERE 

5132
03:26:30,661 --> 03:26:34,532
IS A LOT TO COVER IN THAT SPACE 

5133
03:26:34,532 --> 03:26:39,136
AND ARE SUCH GOOD GAPS AND 

5134
03:26:39,136 --> 03:26:42,173
OBVIOUSLY REAL WORLD DATA MIGHT 

5135
03:26:42,173 --> 03:26:47,044
BE AN IMPORTANT COMPONENT OF 

5136
03:26:47,044 --> 03:26:50,314
THAT.  BACK ON PRAGMATIC TRIAL 

5137
03:26:50,314 --> 03:26:52,950
PIECE COMMENT ABOUT STEP THERAPY

5138
03:26:52,950 --> 03:26:54,518
BEING A HIGH PRIORITY TO 

5139
03:26:54,518 --> 03:26:56,387
CONSIDER FACTORIAL DESIGNS I 

5140
03:26:56,387 --> 03:26:59,457
WILL ENDORSE THAT KAISER 

5141
03:26:59,457 --> 03:27:01,192
PERMANENTE'S FIRMLY ADOPTING A 

5142
03:27:01,192 --> 03:27:05,262
STEP THERAPY APPROACH IN AREA OF

5143
03:27:05,262 --> 03:27:06,998
OBESITY WE HAVE ALWAYS HAD THAT 

5144
03:27:06,998 --> 03:27:09,266
IN PLACE OF IN CASE OF DIABETES 

5145
03:27:09,266 --> 03:27:10,901
AND QUESTION REALLY BECOMES HOW 

5146
03:27:10,901 --> 03:27:14,005
DOES A GLP-1 ON TOP OF OTHER 

5147
03:27:14,005 --> 03:27:14,972
TREATMENTS THAT HAVE ALREADY 

5148
03:27:14,972 --> 03:27:18,042
BEEN TRIED COMPARED TO OTHER 

5149
03:27:18,042 --> 03:27:20,478
APPROACHES YOU KNOW SHOULD WE BE

5150
03:27:20,478 --> 03:27:23,214
JUMPING STRAIGHT TO GLP-1S AND 

5151
03:27:23,214 --> 03:27:24,515
DIABETES GUIDELINES SHIFTING IN 

5152
03:27:24,515 --> 03:27:25,950
THAT WAY AND IS INTERESTING TO 

5153
03:27:25,950 --> 03:27:31,122
THINK ABOUT THAT IN OBESITY 

5154
03:27:31,122 --> 03:27:41,232
SPA

5155
03:27:48,039 --> 03:27:48,606
SPACE. 

5156
03:27:48,606 --> 03:27:50,574
NOT SEEING PEDIATRIC SPECIFIC 

5157
03:27:50,574 --> 03:27:53,344
TOPICS COMING IN AND POSSIBLE 

5158
03:27:53,344 --> 03:27:55,546
HARMS IS NEXT.  SO WE HEARD 

5159
03:27:55,546 --> 03:27:59,517
ABOUT MENTAL HEALTH AND SUICIDE 

5160
03:27:59,517 --> 03:28:04,722
RELATED HARMS AND OTHER 

5161
03:28:04,722 --> 03:28:05,056
POPULATIONS. 

5162
03:28:05,056 --> 03:28:11,595
I THINK THIS IS -- YOU KNOW, 

5163
03:28:11,595 --> 03:28:15,099
WEIGHT GAIN WAS ANOTHER TOPIC 

5164
03:28:15,099 --> 03:28:17,535
THAT IS, YOU KNOW, COULD BE PUT 

5165
03:28:17,535 --> 03:28:20,938
IN HARMS SECTION AND THINK WHAT 

5166
03:28:20,938 --> 03:28:22,073
HAPPENS WHEN PATIENTS 

5167
03:28:22,073 --> 03:28:24,642
DISCONTINUE MEDICATION IS A 

5168
03:28:24,642 --> 03:28:25,943
REALLY IMPORTANT POTENTIAL HARM 

5169
03:28:25,943 --> 03:28:30,347
THAT WE, YOU KNOW, NEED TO BE 

5170
03:28:30,347 --> 03:28:30,981
CONSIDERING.  

5171
03:28:30,981 --> 03:28:33,784
NOT ALL PATIENTS WILL TOLERATE 

5172
03:28:33,784 --> 03:28:35,119
GLP-1S AND MAY TAKE THEM FOR A 

5173
03:28:35,119 --> 03:28:36,787
PERIOD OF TIME AND IF THEY 

5174
03:28:36,787 --> 03:28:39,090
TOLERATE WHERE THEY WANT TO STAY

5175
03:28:39,090 --> 03:28:41,625
ON THEM FOR THE REST OF THEIR 

5176
03:28:41,625 --> 03:28:43,327
LIVES AS WELL AND QUESTION 

5177
03:28:43,327 --> 03:28:45,062
BECOMES SORT OF, WELL, WHAT IS 

5178
03:28:45,062 --> 03:28:47,164
THE IMPACT ON HEALTH IF YOU TAKE

5179
03:28:47,164 --> 03:28:48,532
IT FOR A PERIOD OF TIME AND 

5180
03:28:48,532 --> 03:28:51,502
QUESTION ABOUT LEGACY EFFECT.  

5181
03:28:51,502 --> 03:28:53,170
IS THAT LEGACY EFFECT PRESENT?  

5182
03:28:53,170 --> 03:28:55,773
IS THERE STILL BENEFIT HAVING 

5183
03:28:55,773 --> 03:28:57,508
TAKEN IT FOR A SHORT PERIOD OF 

5184
03:28:57,508 --> 03:28:59,310
TIME OR YOU KNOW I HAVE BEEN 

5185
03:28:59,310 --> 03:29:01,879
CONCERNED ABOUT THE POTENTIAL 

5186
03:29:01,879 --> 03:29:03,547
INFLUENCE ON APPETITE, ET 

5187
03:29:03,547 --> 03:29:05,583
CETERA, AFTER STOPPING A GLP-1 

5188
03:29:05,583 --> 03:29:08,319
AND WONDERING WHETHER THE 

5189
03:29:08,319 --> 03:29:10,354
REBOUND BEHAVIORAL EFFECTS OF 

5190
03:29:10,354 --> 03:29:14,291
COMING OFF GLP-1S COULD LEAD TO 

5191
03:29:14,291 --> 03:29:16,060
A SORT OF OVERCORRECTION OF 

5192
03:29:16,060 --> 03:29:18,129
WEIGHT WHERE YOU END UP GAINING 

5193
03:29:18,129 --> 03:29:21,332
WEIGHT BEYOND WHERE YOU WERE 

5194
03:29:21,332 --> 03:29:23,334
INITIALLY AS A RESULT OF 

5195
03:29:23,334 --> 03:29:25,302
CHALLENGE OF DEALING WITH 

5196
03:29:25,302 --> 03:29:28,105
WITHDRAWAL FROM BEING ON A 

5197
03:29:28,105 --> 03:29:30,441
GLP-1.  IT WOULD BE INTERESTING 

5198
03:29:30,441 --> 03:29:32,009
TO SEE WHETHER REAL WORLD DATA 

5199
03:29:32,009 --> 03:29:34,712
CAN SHOW THAT AND THIS KIND OF 

5200
03:29:34,712 --> 03:29:37,348
INFLUENCE OF WEIGHT CYCLING AND 

5201
03:29:37,348 --> 03:29:40,151
REPEATED EPISODES OF BEING 

5202
03:29:40,151 --> 03:29:42,386
EXPOSED TO MEDICATIONS AND NOT 

5203
03:29:42,386 --> 03:29:44,021
BEING ON THEM.  

5204
03:29:44,021 --> 03:29:48,359
THERE HAS BEEN SOME EVIDENCE 

5205
03:29:48,359 --> 03:29:49,960
ABOUT WEIGHT CYCLING RELATED 

5206
03:29:49,960 --> 03:29:52,663
HARMS IN LITERATURE AND THINK 

5207
03:29:52,663 --> 03:29:54,298
MAYBE THERE IS SOME MORE WEIGHT 

5208
03:29:54,298 --> 03:29:55,900
CYCLING RELATED HARMS THAT COULD

5209
03:29:55,900 --> 03:29:58,569
BE INTRODUCED BY MEDICATIONS AND

5210
03:29:58,569 --> 03:30:02,006
MEDICATION CHANGES THAT ARE 

5211
03:30:02,006 --> 03:30:08,145
HAPPENING.  

5212
03:30:08,145 --> 03:30:10,814
ANYTHING ELSE IN THE CHAT COMING

5213
03:30:10,814 --> 03:30:12,816
IN THAT -- OH, GREAT COMMENT 

5214
03:30:12,816 --> 03:30:15,819
HERE FROM CAROLINE ABOUT LOSS OF

5215
03:30:15,819 --> 03:30:18,189
LEAN MASS THAT IS AN INCREDIBLY 

5216
03:30:18,189 --> 03:30:20,057
IMPORTANT ONE AND THANK YOU FOR 

5217
03:30:20,057 --> 03:30:25,095
CALLING IT OUT AND LONG INTERM 

5218
03:30:25,095 --> 03:30:27,565
IMPACT ON FRAILTY FRACTURES, 

5219
03:30:27,565 --> 03:30:29,066
THANK YOU.  GREAT AND VERY 

5220
03:30:29,066 --> 03:30:32,403
IMPORTANT TO BRING THAT IN AS 

5221
03:30:32,403 --> 03:30:42,479
WE

5222
03:30:45,716 --> 03:30:48,485
WELL. 

5223
03:30:48,485 --> 03:30:54,558
JUMPING TO THE NEXT SECTION DR. 

5224
03:30:54,558 --> 03:30:57,361
KING THANK YOU FOR YOUR COMMENT 

5225
03:30:57,361 --> 03:30:59,530
ON FRAILTY AS WELL AND LIFESTYLE

5226
03:30:59,530 --> 03:31:02,466
WE HEARD ABOUT THAT FROM KATIE 

5227
03:31:02,466 --> 03:31:04,168
ROBINSON EARLIER ABOUT LOOKING 

5228
03:31:04,168 --> 03:31:05,769
AT PHYSICAL ACTIVITY IN THIS 

5229
03:31:05,769 --> 03:31:08,205
SPACE IN ADDITION TO DIET 

5230
03:31:08,205 --> 03:31:11,909
NUTRITIONAL COMPONENTS AND 

5231
03:31:11,909 --> 03:31:15,346
INFLUENCE ON OUTCOMES AND OTHER 

5232
03:31:15,346 --> 03:31:18,816
QUESTIONS OR CONCERNS ABOUT 

5233
03:31:18,816 --> 03:31:29,260
LIFESTYLE INTERVENTIONS?  

5234
03:31:30,227 --> 03:31:33,530
OLDER ADULT POPULATIONS THAT 

5235
03:31:33,530 --> 03:31:35,933
VIRGINIA AND RAY PUT IN THE CHAT

5236
03:31:35,933 --> 03:31:38,636
ABOUT THAT AND CROSS-CUTTING 

5237
03:31:38,636 --> 03:31:40,371
CONCERN THAT MAYBE WE COULD 

5238
03:31:40,371 --> 03:31:43,941
INCORPORATE THAT IN SAME SLIDE 

5239
03:31:43,941 --> 03:31:46,543
AS PEDIATRIC PREGNANCY IN OLDER 

5240
03:31:46,543 --> 03:31:49,346
ADULTS OF SPECIAL POPULATION AND

5241
03:31:49,346 --> 03:31:52,383
CONCERN AND FRAILTY ISSUES BEING

5242
03:31:52,383 --> 03:31:54,618
DISCUSSED AND MUSCLE MASS ISSUES

5243
03:31:54,618 --> 03:31:58,289
THAT MAY BE MORE IMPORTANT 

5244
03:31:58,289 --> 03:32:06,664
THERE.  SO LOOKING INTO RISK OF 

5245
03:32:06,664 --> 03:32:10,100
FRACTURES AND RELATED INJURIES 

5246
03:32:10,100 --> 03:32:13,337
OF FRAILTY AND LOSS OF MUSCLE 

5247
03:32:13,337 --> 03:32:15,239
MASS IN EARLY ADULT POPULATION 

5248
03:32:15,239 --> 03:32:24,014
IS A GOOD IDEA.  THAT IS A 

5249
03:32:24,014 --> 03:32:33,090
SEPARATE SUBGROUP.  FOLLOWING 

5250
03:32:33,090 --> 03:32:36,760
HEALTH, YEAH.  THANK YOU, 

5251
03:32:36,760 --> 03:32:39,330
CAROLINE.  THAT IS ANOTHER 

5252
03:32:39,330 --> 03:32:41,799
IMPORTANT POTENTIAL HARM ISSUE 

5253
03:32:41,799 --> 03:32:45,936
AND WHETHER WE CAN BEGIN TO 

5254
03:32:45,936 --> 03:32:47,504
TRACK THAT. 

5255
03:32:47,504 --> 03:32:48,772
UNDER NUTRITION, KATIE, THANK 

5256
03:32:48,772 --> 03:32:50,808
YOU FOR THAT ONE AS WELL.  

5257
03:32:50,808 --> 03:32:54,178
THINKING ABOUT MICRONUTRIENT 

5258
03:32:54,178 --> 03:32:56,880
DEFICIENCIES AND SIMILAR TO 

5259
03:32:56,880 --> 03:32:58,382
BARIATRIC PATIENTS AND THINK 

5260
03:32:58,382 --> 03:33:01,885
WHAT IS OFTEN FOUND IS PATIENTS 

5261
03:33:01,885 --> 03:33:04,655
COME IN MICRONUTRIENT DEFICIENT 

5262
03:33:04,655 --> 03:33:06,790
AND THINK IT MAY BE, AGAIN, IF 

5263
03:33:06,790 --> 03:33:09,893
YOU GO INTO AN INTENSIVE WEIGHT 

5264
03:33:09,893 --> 03:33:12,329
LOSS PROGRAM YOU ARE CONSUMING 

5265
03:33:12,329 --> 03:33:12,930
MUCH LESS. 

5266
03:33:12,930 --> 03:33:14,898
IT MAY INFLUENCE YOUR HEALTH 

5267
03:33:14,898 --> 03:33:19,236
RISK BY INDUCING OR WORSENING 

5268
03:33:19,236 --> 03:33:21,338
AGGREGATING POTENTIAL 

5269
03:33:21,338 --> 03:33:23,574
MICRONUTRIENT DEFICIENCIES THAT 

5270
03:33:23,574 --> 03:33:26,009
IS IMPORTANT FOR A SAFETY 

5271
03:33:26,009 --> 03:33:28,779
EVALUATION HERE AS WELL.  

5272
03:33:28,779 --> 03:33:32,549
IT MAY BE THAT YOU KNOW WHILE 

5273
03:33:32,549 --> 03:33:34,618
BARIATRIC SURGERY HAS 

5274
03:33:34,618 --> 03:33:36,286
MALABSORBTIVE COMPONENTS TO IT, 

5275
03:33:36,286 --> 03:33:37,855
NOT ALL OF THEM DO. 

5276
03:33:37,855 --> 03:33:42,092
SO IT MAY BE THAT THERE IS 

5277
03:33:42,092 --> 03:33:44,027
CERTAINLY JUST IMPORTANCE OF 

5278
03:33:44,027 --> 03:33:45,329
SUPPLEMENTS TO HELP IMPROVE 

5279
03:33:45,329 --> 03:33:49,566
HEALTH OUTCOMES FOR THIS 

5280
03:33:49,566 --> 03:33:52,302
POPULATION.  VIRGINIA POINTS OUT

5281
03:33:52,302 --> 03:33:53,370
MANY MEDICATION ABSORPTION 

5282
03:33:53,370 --> 03:33:55,072
CHANGES AS POTENTIAL HEALTH 

5283
03:33:55,072 --> 03:33:57,074
EFFECTS AND INTERESTING.  I 

5284
03:33:57,074 --> 03:33:59,009
THINK AS YOUR BODY COMPOSITION 

5285
03:33:59,009 --> 03:34:01,478
IS CHANGING AND BODY WEIGHT IS 

5286
03:34:01,478 --> 03:34:04,681
CHANGING, IT COULD INFLUENCE 

5287
03:34:04,681 --> 03:34:07,918
CERTAIN MEDICATIONS.  

5288
03:34:07,918 --> 03:34:09,153
[INDISCERNIBLE] IS A GOOD 

5289
03:34:09,153 --> 03:34:11,054
EXAMPLE AND MENTAL HEALTH 

5290
03:34:11,054 --> 03:34:12,189
MEDICATIONS, YES. 

5291
03:34:12,189 --> 03:34:14,725
SO THINKING ABOUT SAFETY RELATED

5292
03:34:14,725 --> 03:34:16,460
TO DOSING OF OTHER MEDICATIONS 

5293
03:34:16,460 --> 03:34:17,795
AND IF YOU HAVE SIGNIFICANT 

5294
03:34:17,795 --> 03:34:22,699
WEIGHT LOSS.  THANK YOU FOR THAT

5295
03:34:22,699 --> 03:34:33,243
PARTICULARLY.  NEXT SECTION TO 

5296
03:34:39,983 --> 03:34:41,585
DATA LINKAGE LOSS AND 

5297
03:34:41,585 --> 03:34:42,820
INTERESTING OPPORTUNITY AND 

5298
03:34:42,820 --> 03:34:47,090
ANYBODY HAVE IDEAS ON DATA 

5299
03:34:47,090 --> 03:34:52,396
LINKAGE FRONT?  

5300
03:34:52,396 --> 03:34:55,432
>> SOME COMMENTS BY DR. WI
AND 

5301
03:34:55,432 --> 03:34:58,335
WILKINS ABOUT CHALLENGES OF 

5302
03:34:58,335 --> 03:35:01,572
DOING MULTINATIONAL DATABASED 

5303
03:35:01,572 --> 03:35:03,874
STUDIES BECAUSE OF 

5304
03:35:03,874 --> 03:35:04,241
HETEROGENEITY. 

5305
03:35:04,241 --> 03:35:04,508
>> YES. 

5306
03:35:04,508 --> 03:35:08,078
>> HAVING MORE DATA IS
BETTER 

5307
03:35:08,078 --> 03:35:10,914
BUT COMPLICATES THINGS THERE IS 

5308
03:35:10,914 --> 03:35:13,350
ISSUES AND DATA ISSUES WE HAVE 

5309
03:35:13,350 --> 03:35:16,353
TO PAY ATTENTION TO.  

5310
03:35:16,353 --> 03:35:16,920
>> YEAH.  

5311
03:35:16,920 --> 03:35:18,755
>> CAN I EXPAND ON THAT A
BIT IF

5312
03:35:18,755 --> 03:35:20,991
THAT IS ALL RIGHT?  

5313
03:35:20,991 --> 03:35:21,725
>> YEAH.  

5314
03:35:21,725 --> 03:35:23,360
>> YEAH.  SO I THINK THAT
THE 

5315
03:35:23,360 --> 03:35:25,896
REASON WHY I THINK IT IS A 

5316
03:35:25,896 --> 03:35:27,531
BIGGER ISSUE THAT INITIALLY 

5317
03:35:27,531 --> 03:35:30,300
MEETS THE EYE IS THAT WE KNOW 

5318
03:35:30,300 --> 03:35:33,303
THAT CERTAIN COUNTRIES MAYBE 

5319
03:35:33,303 --> 03:35:35,072
HAVE CERTAIN PREFERENCES FOR ONE

5320
03:35:35,072 --> 03:35:37,040
TREATMENT VERSUS THE OTHER. 

5321
03:35:37,040 --> 03:35:38,408
AND FOR PARTICULARLY FOR 

5322
03:35:38,408 --> 03:35:41,545
OUTCOMES THAT WHAT I WOULD CALL 

5323
03:35:41,545 --> 03:35:44,181
SOFTER LIKE DEMENTIA OR 

5324
03:35:44,181 --> 03:35:45,883
PSYCHOLOGICAL FUNCTIONING WHERE 

5325
03:35:45,883 --> 03:35:47,217
IT IS VERY DISCRETIONARY AND 

5326
03:35:47,217 --> 03:35:50,521
WHETHER OR NOT YOU SORT OF DO A 

5327
03:35:50,521 --> 03:35:52,322
SCREENING OR ASSESSMENT THAT 

5328
03:35:52,322 --> 03:35:54,691
THAT IS A HUGE CONFOUNDER.  

5329
03:35:54,691 --> 03:35:56,660
SOMETIMES WHEN YOU SEE A 

5330
03:35:56,660 --> 03:35:57,294
DIFFERENCE TRACKING WITH ONE 

5331
03:35:57,294 --> 03:35:59,696
TREATMENT OR ANOTHER, IT MIGHT 

5332
03:35:59,696 --> 03:36:01,965
JUST BE BECAUSE THE INITIATION 

5333
03:36:01,965 --> 03:36:03,834
OF THAT ONE TREATMENT IS 

5334
03:36:03,834 --> 03:36:05,302
PREFERENTIAL IN ONE COUNTRY THAT

5335
03:36:05,302 --> 03:36:08,105
ALSO HAS A SORT OF DIFFERENTIAL 

5336
03:36:08,105 --> 03:36:09,339
ASSESSMENT OF WHATEVER OUTCOME 

5337
03:36:09,339 --> 03:36:11,074
AND IS A POINT THAT I'M TRYING 

5338
03:36:11,074 --> 03:36:13,176
TO MAKE.  IT IS NOT TRIVIAL. 

5339
03:36:13,176 --> 03:36:17,347
WE HAVE REJECTED LOTS OF PAPERS 

5340
03:36:17,347 --> 03:36:19,116
WHERE THERE ARE SOME DATA SETS 

5341
03:36:19,116 --> 03:36:20,150
WHERE THAT IS A COMPLETE BLACK 

5342
03:36:20,150 --> 03:36:22,719
BOX IN TERMS OF WHAT COUNTRIES 

5343
03:36:22,719 --> 03:36:24,755
ARE CONTRIBUTING AND WHERE DATA 

5344
03:36:24,755 --> 03:36:25,522
IS COMING FROM. 

5345
03:36:25,522 --> 03:36:27,024
ANYWAY, THANK YOU FOR THE 

5346
03:36:27,024 --> 03:36:28,492
OPPORTUNITY FOR ME TO MAKE THAT 

5347
03:36:28,492 --> 03:36:29,326
POINT. 

5348
03:36:29,326 --> 03:36:32,796
>> GREAT.  THANK YOU,
KRISTINA. 

5349
03:36:32,796 --> 03:36:34,865
YEAH.  THERE IS CLEARLY SOME 

5350
03:36:34,865 --> 03:36:36,433
DATA SETS THAT MIGHT BE SUPERIOR

5351
03:36:36,433 --> 03:36:39,870
FOR TRYING TO TRACK SOME ISSUES 

5352
03:36:39,870 --> 03:36:43,307
OVER OTHERS AND SO IF THOSE ARE 

5353
03:36:43,307 --> 03:36:45,409
OF MAJOR CONCERN, IT IS -- IT IS

5354
03:36:45,409 --> 03:36:48,078
DEFINITELY PART OF THE TARGET 

5355
03:36:48,078 --> 03:36:49,346
TRIAL THINKING ABOUT INITIATION 

5356
03:36:49,346 --> 03:36:55,619
AND THOSE KINDS OF ELIGIBILITY 

5357
03:36:55,619 --> 03:36:56,119
PARAMETERS. 

5358
03:36:56,119 --> 03:36:58,655
YOU KNOW?  

5359
03:36:58,655 --> 03:37:00,791
GREAT.  

5360
03:37:00,791 --> 03:37:03,060
I THINK ONE LAST SLIDE THERE 

5361
03:37:03,060 --> 03:37:06,830
AROUND METHOD LOGIC ISSUES THAT 

5362
03:37:06,830 --> 03:37:11,835
WE TOUCHED ON A BIT ABOUT -- WE 

5363
03:37:11,835 --> 03:37:14,104
ARE COMING TO THE TOP OF THE 

5364
03:37:14,104 --> 03:37:16,239
HOUR AND WANT TO CLOSE MYSELF BY

5365
03:37:16,239 --> 03:37:17,741
SAYING THIS WAS FANTASTIC AND 

5366
03:37:17,741 --> 03:37:18,976
THINK THAT THE PRESENTATIONS 

5367
03:37:18,976 --> 03:37:21,945
OVER THE LAST TWO DAYS WERE 

5368
03:37:21,945 --> 03:37:24,948
OUTSTANDING.  

5369
03:37:24,948 --> 03:37:25,716
SPEAKERS, MODERATORS, 

5370
03:37:25,716 --> 03:37:29,186
DISCUSSIONS AS WELL. 

5371
03:37:29,186 --> 03:37:32,656
IT JUST HAS CREATED A RICH SORT 

5372
03:37:32,656 --> 03:37:35,692
OF DATABASE, ESSENTIALLY OF GAPS

5373
03:37:35,692 --> 03:37:37,361
AND OPPORTUNITIES FOR US TO 

5374
03:37:37,361 --> 03:37:38,695
ADDRESS GOING FORWARD. 

5375
03:37:38,695 --> 03:37:40,497
I PERSONALLY LOOK FORWARD TO 

5376
03:37:40,497 --> 03:37:41,832
SEEING THE KINDS OF RESEARCH 

5377
03:37:41,832 --> 03:37:43,667
THAT WILL COME OUT AS A RESULT 

5378
03:37:43,667 --> 03:37:46,036
OF THIS AND THINK THAT SHARING 

5379
03:37:46,036 --> 03:37:48,205
OF ALL THESE BEST PRACTICES WILL

5380
03:37:48,205 --> 03:37:49,840
LEAD TO STRONGER STUDIES AND 

5381
03:37:49,840 --> 03:37:52,876
MORE RIGOROUS PEER REVIEW, ET 

5382
03:37:52,876 --> 03:37:54,811
CETERA, THAT REALLY HELPS TO 

5383
03:37:54,811 --> 03:37:56,113
PUSH THE FIELD FORWARD. 

5384
03:37:56,113 --> 03:37:58,048
THERE IS MAJOR GAPS THAT REAL 

5385
03:37:58,048 --> 03:38:01,084
WORLD DATA WILL BE ABLE TO 

5386
03:38:01,084 --> 03:38:02,686
ADDRESS SEPARATE FROM CLINICAL 

5387
03:38:02,686 --> 03:38:04,221
TRIALS AND LET'S -- I'M EXCITED 

5388
03:38:04,221 --> 03:38:06,890
TO SEE WHAT IT LOOKS LIKE AND 

5389
03:38:06,890 --> 03:38:09,226
WHAT OTHER CLOSING REMARKS WOULD

5390
03:38:09,226 --> 03:38:10,927
YOU HAVE?  

5391
03:38:10,927 --> 03:38:13,230
>> I WILL ECHO YOUR THANKS
TO 

5392
03:38:13,230 --> 03:38:15,098
EVERYONE FOR JOINING US AND THAT

5393
03:38:15,098 --> 03:38:17,734
Q & A AND QUESTIONS
THROUGHOUT 

5394
03:38:17,734 --> 03:38:20,137
WERE SUPERB AND HELPS US TO 

5395
03:38:20,137 --> 03:38:22,939
REALLY GET TO EVEN DEEPER ISSUES

5396
03:38:22,939 --> 03:38:24,307
THAN RAISED IN THE EXCELLENT 

5397
03:38:24,307 --> 03:38:26,143
PRESENTATIONS AND THANKS FOR 

5398
03:38:26,143 --> 03:38:27,110
YOUR ENGAGEMENT. 

5399
03:38:27,110 --> 03:38:27,377
DARREN?  

5400
03:38:27,377 --> 03:38:30,080
>> YEAH.  I WANT TO THANK 

5401
03:38:30,080 --> 03:38:31,281
PARTICIPANTS AND THE DISCUSSION 

5402
03:38:31,281 --> 03:38:33,350
WAS GREAT AND ORGANIZERS AND ALL

5403
03:38:33,350 --> 03:38:36,787
OF THE SPEAKERS AND MODERATORS 

5404
03:38:36,787 --> 03:38:39,222
THIS IS ONE OF THE BEST VIRTUAL 

5405
03:38:39,222 --> 03:38:44,127
MEETINGS I HAVE BEEN PART OF AND

5406
03:38:44,127 --> 03:38:47,698
LOGISTICS HAVE BEEN GREAT.  LOTS

5407
03:38:47,698 --> 03:38:51,401
OF PEOPLE MAKE IT HAPPEN BEHIND 

5408
03:38:51,401 --> 03:38:52,969
THE SCENES.  THANK YOU. 

5409
03:38:52,969 --> 03:38:55,138
>> COORDINATING IT FROM
BEHIND 

5410
03:38:55,138 --> 03:38:56,707
THE SCENES AND DIDN'T RUN 

5411
03:38:56,707 --> 03:38:59,209
SEAMLESSLY THANK YOU AND TURNING

5412
03:38:59,209 --> 03:39:02,846
TO CRAIG TO HELP US CLOSE IT 

5413
03:39:02,846 --> 03:39:03,046
OUT. 

5414
03:39:03,046 --> 03:39:05,949
>> THANK YOU.  THANK YOU
TO 

5415
03:39:05,949 --> 03:39:07,784
EVERYONE FOR THE WORKSHOP WITH 

5416
03:39:07,784 --> 03:39:08,518
SUCH AN IMPORTANT 

5417
03:39:08,518 --> 03:39:11,054
[INDISCERNIBLE] OF GAPS AND 

5418
03:39:11,054 --> 03:39:11,421
OPPORTUNITIES. 

5419
03:39:11,421 --> 03:39:14,057
AND THERE IS A LOT OF THEM.  

5420
03:39:14,057 --> 03:39:15,792
HIGHLIGHTING ALL OF THESE 

5421
03:39:15,792 --> 03:39:18,028
IMPORTANT TOPICS, LIKE YOU SAID 

5422
03:39:18,028 --> 03:39:19,196
THEY WILL HELP MOVE THE FIELD 

5423
03:39:19,196 --> 03:39:21,331
FORWARD IMPROVING UNDERSTANDING 

5424
03:39:21,331 --> 03:39:25,335
OF GLP-1 BASED MEDICATIONS AND 

5425
03:39:25,335 --> 03:39:26,670
PREVENTING AND TREATING SEVERAL 

5426
03:39:26,670 --> 03:39:28,171
CHRONIC DISEASES AND OVER THE 

5427
03:39:28,171 --> 03:39:29,973
LAST FEW DAYS CO-CHAIRS AND 

5428
03:39:29,973 --> 03:39:31,541
SPEAKERS AND MODERATORS HAVE 

5429
03:39:31,541 --> 03:39:33,643
REALLY DONE A FANTASTIC JOB OF 

5430
03:39:33,643 --> 03:39:35,746
MEETING THE OVERALL GOAL OF THE 

5431
03:39:35,746 --> 03:39:38,482
WORKSHOP THAT IS TO IDENTIFY HOW

5432
03:39:38,482 --> 03:39:39,416
REAL-WORLD EVIDENCE CAN HELP 

5433
03:39:39,416 --> 03:39:42,486
FILL KNOWLEDGE GAPS ABOUT USING 

5434
03:39:42,486 --> 03:39:44,454
GLP-1 BASED MEDICATIONS CLINICAL

5435
03:39:44,454 --> 03:39:47,824
PRACTICE CLINICAL GUIDELINES AND

5436
03:39:47,824 --> 03:39:52,562
HEALTHCARE POLICY AND SHINED ON 

5437
03:39:52,562 --> 03:39:54,064
TOUGH METHODOLOGICAL CHALLENGES 

5438
03:39:54,064 --> 03:39:55,699
AND OFFER EFFECTIVE STRATEGIES 

5439
03:39:55,699 --> 03:39:57,334
HOW TO DEAL WITH CHALLENGES. 

5440
03:39:57,334 --> 03:39:59,436
I JUST WANTED TO MAKE SURE THAT 

5441
03:39:59,436 --> 03:40:02,038
EVERYONE KNOWS THAT VIDEO OF THE

5442
03:40:02,038 --> 03:40:03,306
WORKSHOP AND EXECUTIVE SUMMARY 

5443
03:40:03,306 --> 03:40:06,376
WILL BE POSTED TO THE WORKSHOP 

5444
03:40:06,376 --> 03:40:06,643
WEBSITE. 

5445
03:40:06,643 --> 03:40:08,178
AND AS WE GET READY TO ADJOURN 

5446
03:40:08,178 --> 03:40:10,514
THE WORKSHOP I ALSO WOULD LIKE 

5447
03:40:10,514 --> 03:40:12,182
TO THANK EVERYONE WHO MADE THE 

5448
03:40:12,182 --> 03:40:14,184
WORKSHOP A SUCCESS AND STARTING 

5449
03:40:14,184 --> 03:40:20,590
WITH NIDDK CO-ORGANIZERS DR. 

5450
03:40:20,590 --> 03:40:21,591
ZABULA AND [INDISCERNIBLE]. 

5451
03:40:21,591 --> 03:40:23,093
AND FEDERAL PLANNING COMMITTEE 

5452
03:40:23,093 --> 03:40:26,196
FROM ACROSS NIH AND HHS AND TO 

5453
03:40:26,196 --> 03:40:29,366
THE WORKSHOP CO-CHAIRS SUCH AS 

5454
03:40:29,366 --> 03:40:31,701
DAVID AND KURTIS AND DARREN AND 

5455
03:40:31,701 --> 03:40:34,070
HUGE THANK YOU FOR SHARING YOUR 

5456
03:40:34,070 --> 03:40:35,372
VALUABLE TIME AND EXPERTISE TO 

5457
03:40:35,372 --> 03:40:37,374
DEVELOPING THIS WORKSHOP IN THE 

5458
03:40:37,374 --> 03:40:38,642
PAST SEVERAL MONTHS AND THANK 

5459
03:40:38,642 --> 03:40:40,644
YOU TO THE SPEAKERS AND 

5460
03:40:40,644 --> 03:40:42,679
MODERATORS FOR INCREDIBLY 

5461
03:40:42,679 --> 03:40:44,714
INSIGHTFUL PRESENTATIONS AND 

5462
03:40:44,714 --> 03:40:45,749
ENGAGING DISCUSSION ON 

5463
03:40:45,749 --> 03:40:48,518
INTERSECTION OF GLP-1-BASED 

5464
03:40:48,518 --> 03:40:49,386
THERAPIES AND REAL-WORLD 

5465
03:40:49,386 --> 03:40:51,955
EVIDENCE AND THANK YOU TO DANIEL

5466
03:40:51,955 --> 03:40:53,757
OF SCIENTIFIC CONSULTING GROUP 

5467
03:40:53,757 --> 03:40:56,660
FOR MAKING THE WORKSHOP RUN SO 

5468
03:40:56,660 --> 03:40:59,529
SMOOTHLY AND ATTENDEES FOR 

5469
03:40:59,529 --> 03:41:00,697
CONTRIBUTING HELPFUL QUESTIONS 

5470
03:41:00,697 --> 03:41:02,165
AND COMMENTS ON THE IMPORTANT 

5471
03:41:02,165 --> 03:41:04,534
TOPIC AND WITH THAT I WILL CLOSE

5472
03:41:04,534 --> 03:41:06,703
THE MEETING AND HAVE A GOOD 

5473
03:41:06,703 --> 03:41:09,739
MEETING, EVERYONE.  

5474
03:41:09,739 --> 03:41:19,950
TAKE CARE.