I'M KATHERINE LONG, DIRECTOR OF COMMUNICATIONS FOR NATIONAL CENTER FOR COMPLIMENTARY INTEGRATIVE HEALTH FOR NIH ON BEHALF OF THE PARTNERS AND TRANS-NIH HEALTH WORKING GROUP MEMBERS, THE FOUNDATION FOR THE NIH I WANT TO WELCOME YOU TO DEFINING THE BLOCKS OF MUSIC BASED INTERVENTIONS. THIS IS THE FIRST IN SERIES OF THREE MEETINGS THAT ARE GOING TO BE HELD IN DISCUSSION PANEL FASHION. BEFORE WE BEGIN, I WOULD LIKE TO SHARE A FEW LOGISTICS. NEXT SLIDE,. PLEASE MUTE YOURSELF WHEN NOT SPEAKING. PLEASE RAISE YOUR DIGITAL HANDS FOR COMMENTS AND KEEP YOUR VIDEO ON SO YOU CAN SEE WHEN SPEAKING DURING THE MEETING. SECOND FOR OUR VIDEOCAST VIEWERS, YOU ARE WELCOME TO SUBMIT A QUESTION AT ANY TIME USING THE VIDEOCAST FEEDBACK FORM. THE LINKS SHOULD BE DIRECTLY BELOW THE SCREEN WHICH YOU ARE VIEWING TODAY'S LIVE STREAM. THAT LINK IN GENERATE AN EMAIL THAT WILL COME TO US HERE AT NCCIH. WE WILL TRY TO GET TO AT LEAST A FEW OF THE QUESTIONS FROM THE AUDIENCE DURING THE BROAD Q&A SESSION WHICH IS AT THE END OF TODAY'S AGENDA. IF WE DON'T GET TO YOUR QUESTIONS TODAY WHICH WE WILL PROBABLY NOT BE POSSIBLE DO REST ASSURED THAT ALL QUESTIONS WILL BE COLLECTED AND SHARED WITH THE PLANNING TEAM. SO THEY CAN TAKE THEM INTO ACCOUNT FOR NEUROPLANNING. FINALLY, THIS MEETING IS BEING RECORDED. AND WILL BE ARCHIVED ON THE NIH VIDEOCAST WEBSITE FOR FUTURE VIEWING. WITH THOSE REMINDERS COVERED, I AM NOW PLEASED TO INVITE TWO PEOPLE WHO TRULY NEED NO INTRODUCTION. DR. FRANCIS COLLINS, DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH, DAILY GUIDES THE SCIENCE OF NIH'S 27 INSTITUTES AND CENTERS. AND MS. RENEE FLEMING. RENOWNED SOPRANO, INTERNATIONAL OPERA STAR AND PASSIONATE ARTS AND HEALTH ADVOCATE TO OFFER SOME OPENING REMARKS. DR. COLLINS. PLEASE TAKE IT AWAY. >> THANK YOU VERY MUCH M SEVERAL MEETINGS IN THIS INSANS TO USHER IN THE NEXT PHASE OF O OUR SOUND HEALTH INITIATIVE. I NOTICE THE VISUAL THAT'S PARTS OF THE OPEN OPENING SLIDE UP A MINNESOTA AGO BUT IF YOU HAVE SEWN YOUR PROGRAM YOU KNOW WHAT IT IS ON THE LEFT YOU HAVE WHAT APPEARS TO BE A SIGN WAVE DEPICTION OF MUSICAL TONE WITH AMPLY AMPLITUDE AND FREQUENCY AND THEN IT MORPHS INTO AN EKG PATTERN THAT LOOKS LIKE HEALTHY HEART IN NORMAL SINUS RHYTHM YOU CAN ALSO LOOK AT AT THAT AS A DIFFERENT METAPHOR BUT IT MIGHT LOOK LIKE VENTRICULAR FIBRILLATION THEN BROUGHT TO SMOOTH HAPPY HEART RHYTHM BY EXPERIENCE OF LISTENING TO WONDERFUL MUSIC AT LEAST I'M GOING TO TAKE IT THAT WAY. WE ARE HERE TO TALK ABOUT HOW MUSIC INTERACTING WITH HUMAN BEINGS THROUGH THE MECHANISM WE ARE TRYING TO UNDERSTAND IN AND ARE INCREASINGLY TURNING OUT TO REVEAL SOME OF THEIR SECRETS CAN PROVIDE A HEALING INFLUENCE TO PEOPLE, IN MANY DIFFERENT PHASES OF LIFE AND HERE WE ARE PARTICULARLY GOING TO BE TALKING ABOUT THE BRAIN KISS DISORDERS OF AGING AND HOW IT IS THAT MUSICAL THERAPY UNDERGIRDD BY THE MOST RIGOROUS NEUROSCIENCE AND STATISTICAL AND CLINICAL TRIAL DESIGN, CAN TEACH US HOW WE CAN PROVIDE GREATER OPPORTUNITIES FOR BENEFIT. TO PEOPLE WITH THESE INCREASINGLY COMMON DISORDERS. SOUND HEALTH IS A PARTNERSHIP BETWEEN THE NATIONAL INSTITUTES OF HEALTH, RENEE FLEMING, THE KENNEDY CENTER, AND THE NATIONAL ENDOWMENT FOR THE ARTS. WE HAVE BECOME ALL VERY GOOD FRIENDS OVER THE COURSE OF THESE THREE OR FOUR YEARS AS WE FIGURED OUT WHAT A SHARED SENSE OF VISION WE HAVE TOGETHER. AND WHAT MIGHT BE ACCOMPLISHD BY BRINGING TOGETHER THESE PERSPECTIVES AND THESE DISCIPLINES. SINCE WE ARE TALKING ABOUT THIS BEING FOUNDATIONAL I HAVE TO OF COURSE MAKE A BRIEF ILLUSION TO THE NOW FAMOUS DINNER WHERE RENEE FLEMING AND I MET EACH OTHER FIVE YEARS AGO AT A DINNER INTENDED TO SOOTHE SOME RATHER FRAYED NERVES IN THE FORM OF THREE SUPREME COURT JUSTICES, JUST AFTER THEIR DECISION ABOUT GAY MARRIAGE WHICH HAS NOT GONE THE WAY THAT AT LEAST ONE OF THEM WANTED IT TO. AND SO IN THE COURSE OF THAT EVENING, THROUGH MUSIC, WE WERE ABLE I THINK TO BRING TOGETHER A GROUP OF INDIVIDUALS WHO WERE ON DIFFERENT SIDES OF CRITICAL SOCIAL ISSUES, AND RECOGNIZE THROUGH MUSIC WE CAN ALL SHARE AN EXPERIENCE AND BE BROUGHT TOGETHER. THAT'S WHAT MUSIC HAS DONE FOR US DOWN THROUGH THE IONS DOWN THROUGH THE MILLENNIAL AND WE ARE ALL BENEFITED AS A RESULT OF THAT. SO THE COVID PANDEMIC HAS OF COURSE KEPT US FROM HAVING THE OPPORTUNITY TO BE PRESENT IN PERSON FOR MEETINGS LIKE THIS BUT IT DOES PROVIDE US AN OPPORTUNITY TO GATHER VIRTUALLY THAT MAY BE POSSIBLE TO INCLUDE MORE PEOPLE SO I'M GRATEFUL FOR THAT PART. WHATs HAPPENED AT NIH IN THE COURSE OF THESE LAST FIVE YEARS, WE CRITICALLY FORMED THE TRANS-NIH MUSIC AND HEALTH WORKING GROUP. I KNEW WHEN WE STARTED THAT THAT THERE WERE MANY SCIENTISTS AN RESEARCHERS WHO ARE MUSICIANS OR WHO ARE DEEPLY INTERESTED IN MUSIC BUT THE TURN OUT OF ENTHUSIASM WHEN WE ANNOUNCED THE POSSIBILITY OF FORMING THE WORKING GROUP WAS TRULY GRATIFYING AND HAS BEEN SUSTAINABLE. IT WASN'T JUST ONE OF THESE OKAY I'LL TRY THIS OUT. THE GROUP REPRESENTING ALMOST ALL OF OUR INSTITUTES AND CENTERS HAS CONTINUED TO BE A VIBRANT PASSIONATE PLACE FOR ENTHUSIASTIC VISION TO BE GENERATED IN TERMS OF WHERE WE MIGHT GO WITH BRINGING TOGETHER WHAT WE KNOW ABOUT MUSIC AND WHAT WE KNOW ABOUT THE HUMAN BODY THAT WORKING GROUP DEVELOP AND IMPLEMENTED A RESERGE AGENDA FOR MUSIC AND HEALTH AND RIGHT NOW I WANT TO SHOUT OUT TO THE CO-CHAIRS THAT HAVE LED THAT EFFORT EMILY EDWARDS, BOB FINK FINKSTEEN AND TOM AND OUT OF THAT CAME A FUNDING INITIATIVE WHICH FORMED 15 INVESTIGATIVE TEAMS SPANNING THE RESEARCH SPECTRUM FROM BASIC TO CLINICAL, WE HAD THE FIRST INVESTIGATOR MEETING EARLIER THIS MONO, A REMARKABLE OPPORTUNITY -- MONTH, A REMARKABLE OPPORTUNITY TO SEE THE BREADTH AND DEPTH OF THE KIND OF SCIENTIFIC INVESTIGATION THESE GROUPS WERE PURSUING. WHAT WE HOPE TO DO IN THE COURSE OF THIS MEETING, THE FIRST OF THREE, IS TO REALLY WORK HARD ON HOW WE THINK DEVELOP RIGOROUS REPRODUCIBLE WELL POWERED CLINICAL RESEARCH STUDIES TO BUILD AN EVIDENCE BASE FOR INTEGRATION OF MUSIC BASED INTERVENTIONS AND HEALTHCARE TO INCREASE THE LIKELIHOOD OF SUCCESSFUL INTERVENTIONS AND TO PROVIDE THE KIND OF EVIDENCE TO SUGGEST THESE KINDS OF INTERVENTIONS OUGHT TO BE PAID FOR BY THIRD PARTIES WHICH IS GOING TO BE RATHER IMPORTANT FOR A LOT OF OUR COLLEAGUES MANY THE MUSIC THERAPY ARENA. SO AS LAYING THE FOUNDATION NECESSARY FOR SUCH STUDIES, WE ARE LAUNCHING NOW THIS NEXT PHASE IN PARTNERSHIP VERY IMPORTANT PARTNERSHIP WITH THE RENEE FLEMING FOUNDATION, AND WITH THE FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH, FNIH. THE GOAL HERE IS TO DEVELOP AND VALUE DADE AND THEN DIS-- VALIDATE AND DISSEMINATE AN NIH TOOL KIT, YOU WILL BE HEARING THAT WORD QUITE A BIT, FOR MUSIC BASED PROTOCOLS THAT RESEARCHERS WILL BE ENCOURAGED TO USE AND NIH FUNDED INTERVENTIONAL STUDIES OF MUSIC AND HEALTH, FOCUSING FIRST ON MUSIC BASED INTERVENTIONS FOR DISORDERS OF AGING. WHAT WE WANT TO TRY TO DO IN THE COURSE OF TODAY IS TO BEGIN TO FLESH OUT WHAT OUGHT TO BE THE THAT WOULD ENABLE THIS NEXTIT- GENERATION OF RESEARCH PROJECTS TO PRODUCE THE KIND OF OUTCOMES THAT WILL TAKE US TO THE NEXT LEVEL OF EVIDENCE BASED INTERVENTIONS THAT WE KNOW CAN HELP PEOPLE AND CAN BE REPRODUCED. SO I WANT TO THANK ALL OF YOU FOR AGREEING TO SPEND YOUR TIME WITH US. MANY THANKS O THE ORGANIZERS WHO PUT THIS WORK TOGETHER, A LOT OF WORK HAS GONE INTO THIS AND APPRECIATE VERY MUCH THE CHANCE FOR THESE OPENING COMMENTS AND NOW WANT TO WITH GREAT PLEASURE TURN THE MICROPHONE VIRTUALLY AS IT IS OVER TO MY WONDERFUL FRIND AND COLLEAGUE AND PARTNER IN ALL OF THESE SOUND HEALTH EFFORTS, THE REMARKABLE INCREDIBLE HUMAN BEING AND THE BEST KNOWN SOPRANO OF OTHER ERA, PLEASE WELCOME RENEE FLEMING. >> THANK YOU FRANCIS. TO THINK THIS START WITH A JAM SESSION AND HERE WE ARE DOING THE SAME THING IN A LARGER GROUP. I LOVE IT. THANK YOU FOR JOININGUS HERE THIS AFTERNOON. I HAVE BEEN SO INSPIRED BY YOUR WORK THESE PAST FIVE YEARS AT THE INTERSECTION OF ARTS AND HEALTH AND IT IS CREATING THIS GROUND SWELL OF PUBLIC INTEREST AS WELL. THE FIELD HAS INCREDIBLE POTENTIAL TO PROVIDE NEW INSIGHT AND HOW HOUR BRAIN HOW OUR BRAIN WORKS WITH NON-INVASIVE COST EFFECTIVE TREATMENT USING CRY YEAHTIVE ART THERAPIES. THE U.S. POPULATION IS AGING. BY THE YEAR 2030 ONE IN FIVE AMERICANS IS PROJECTED TO BE 65 YEARS OLD AND OVER. MUSIC BASED INTERVENTIONS SHOW GREAT PROMISE FOR MANAGING SYMPTOMS OF BRAIN DISORDERS OF AGING WITH THE POTENTIAL TO BENEFIT PATIENTS WITH STROKE, PARKINSON'S AND ALWAYS HIGH ALZHEIMER'S DISEASE AMONG OTHERS. THESE THERAPIES COULD POSITIVELY IMPACT SCORES OF PATIENTS INCLUDING THOSE AT LOWER SOCIOECONOMIC LEVELS. MANY MUSIC THERAPY INTERVENTIONS COULD BE ESPECIALLY SUITED TO TELEHEALTH REACHING PATIENTS WHOM TRAVEL IS PHYSICAL OR ECONOMIC BURDEN. AS NON-PHARMACOLOGICAL TREATMENTS CREATIVE ARTS THERAPIES PRODUCE FEW NEGATIVE SIDE EFFECTS AND THEY EVEN BE USED TO MITIGATE SIDE EFFECTS FOR MEDICATION. OF SPECIAL CONCERN FOR OLDER POPULATIONS. THESE THERAPIES HAVE POTENTIAL TO SUPPLEMENT THE EFFICACY OF STANDARD DRUG TREATMENTS. NOVARTIS FOR EXAMPLE IS LOOKING AT BENEFITS OF MUSIC THERAPY OFFERED IN CONJUNCTION WITH THEIR MS MEDICATION. PATIENT BUY IN IS WORTH CONSIDERING. CREATIVE ARTS THERAPIES ARE FAVORABLY ACCEPTED BY PATIENTS ACROSS THE BOARD AND EASILY SCALABLE FROM SMALL COMMUNITY GROUPS TO LARGE HEALTHCARE SYSTEMS. THE UK EVEN HAS A SOCIAL PRESCRIPTION INITIATIVE IN DEVELOPMENT, BY 2023 DOCTORS WILL BE EMPOWERED TO PRESCRIBE ARTS THERAPIES TO ANYONE IN THE UK PERSONALIZED PLAY LISTS DANCE CLASSES OR EVEN SINGING LESSONS WILL BE TARGETED TO TREAT A WIDE RANGE OF PHYSICAL AND MENTAL CONDITIONS. THIS DEVELOPMENT IS PART OF A FURTHER IN THE DIRECTION OF PREVENTATIVE HEALTH. THIS IS A MODEL WHAT WE CAN DO DO HERE IN THE U.S. BUT A MAJOR BARRIER FOR A WIDER APPLICATION OF MUSIC INTERVENTIONS IS THE QUALITY OF AVAILABLE DATA. THERE IS A NEED FOR CONTROLLED CLINICAL TRIALS THAT ARE RIGOROUS, WELL POWERED AND RANDOMIZED. MUCH OF THE RESEARCH IN PREVIOUS DECADES HAS NOT MET THE STANDARDS OF THE NIH. MANY STUDIES HAVE PROVIDED ENCOURAGING RESULTS ABOUT THE POSITIVE HEALTH IMPACT OF MUSICAL THERAPY BUT OFTEN THE TRIALS WERE TOO SMALL OR HAD STATISTICAL BIASES THAT LIMIT THE ABILITY TO DRAW WIDER CONCLUSIONS. I HAVE COME TO APPRECIATE THAT SCIENTIFIC RESEARCH IS AN INCREDIBLY GRANULAR PROCESS AS YOU KNOW. MUSICIANS AND CREATIVE ARTS THERAPISTS HAVE THROUGH PERSONAL EXPERIENCE ALWAYS BEEN AWARE OF THE HOLISTIC VALUE OF MUSIC FOR HEALING. BUT IN ORDER TO IMPROVE AND EXPAND INDIVIDUAL'SED CARE AND ENGAGE THE SUPPORT OF POLICY MAKERS INSURERS AND HEALTHCARE INSTITUTIONS, WE NEED THIS INCREMENTAL PROCESS OF RESEARCH TO SOLIDIFY KNOWLEDGE OF THE CONCRETE IMPACTS OF MUSIC ON HEALTH. SO I'M THRILLED THAT THE RENEE FLEMING FOUNDATION CAN JOIN IN THIS EXCITING PARTNERSHIP WITH THE NIH AND F NIH TO DEVELOP A TOOL KIT FOR FOR MUSIC BASED INTERVENTIONS FOR DISORDERS OF AGING. THE TOOL KIT WILL DEVELOP COMMON GUIDELINES FOR MUSIC AND HEALTH RESEARCH, HELPING INVESTIGATORS BUILD ON EACH OTHER'S DATA AND MAKING THAT DATA ACCEPTABLE TO MORE INSTITUTIONS. ESPECIALLY THE NIH. WHICH COULD LEAD TO CONTINUED FUNDING AND INVESTIGATION. THE BODY OF RESEARCH DEVELOPED WITH THE AID OF THIS INITIATIVE WILL CONTRIBUTE IMMENSELY TO OUR UNDERSTANDING OF HOW THE ARTS AND HEALTH CAN INTERTWINE. SO IN CREATING THIS TOOL KIT FOR BRAIN DISORDERS OF AGING WE HOPE TO IMPROVE THE LIVES OF MILLIONS OF PEOPLE WHO SUFFER FROM ALZHEIMER'S AND PAR PARKINSON'S DISEASE, STROKE AND SIMILAR CONDITIONS, I'M SO DEEPLY GRATEFUL TO FRANCIS COLLINS, EMMELINE EDWARDS, BOB FINKELSTEIN TO BE CHEEVER AND ALL OF YOU RESEARCHERS AT THE NIH AND AROUND THE COUNTRY FOR YOUR COLLECTIVE VISION IN FURTHERING THIS FIELD. EMMELINE, I HAVE BEEN INSPIRED BY YOUR WORK IN SPEARHEADING RESEARCH FOR INTEGRATED MEDICINE AND YOUR DEDICATION TO MAKING THIS TOOL KIT AND THESE CONVENINGS PUBLIC. I'M SOP HONORED THE RENEE FLEMING FOUNDATION CAN SUPPORT THE WORK OF THE F NIH AND THE NIH BEACONS OF MEDICAL RESEARCH FOR THE WORLD. AND I HOPE TO KEEP SINGING THIS TO THE RAFTERS IN THE COMING YEARS BECAUSE I AM YOUR FAN. THANK YOU. >> THANK YOU. MS. FLEMING, AND THANK YOU DR. COLLINS. THOSE WERE WONDERFUL COMMENTS AND I KNOW VERY INSPIRING TO EVERYBODY GATHERED HERE AND EVERYBODY WANTING ON VIDEOCAST -- WATCHING ON VIDEOCAST TODAY. SO NOW I WANT TO TURN TO THE DIRECTORS OF THE SPONSORING INSTITUTES AND CENTER FOR TODAY'S MEETING. SO THAT THEY CAN SHARE A FEW BRIEF THOUGHTS ON THE IMPORTANCE OF MUSIC AND HEALTH TO OUR SPECIFIC INSTITUTES AND CENTERS. WE'RE GOING TO HEAR FROM DR. HELENE LANGEVIN, DIRECTOR NATIONAL CERTAINTY FOR COMPLIMENTARY AND INTEGRATIVE HEALTH, DR. RICHARD HODES, DIRECTOR OF THE NATIONAL INSTITUTES OF AGING, AND DR. NINA SCHOR DEPUTY DIRECTOR NEUROLOGICAL DISORDERS AND STROKE. DR. LANGEVIN, PLEASE TAKE IT AWAY. >> THANK YOU VERY MUCH, KATHERINE. THE NATIONAL CENTER FOR COMPLIMENTARY AND INTEGRATIVE HEALTH IS DELIGHTED TO BE COLLABORATING WITH THE NATIONAL INSTITUTES OF AGING AND THE NATIONAL INSTITUTE ON NEUROLOGICAL DISORDERS AND STROKE. IN THIS PARTNERSHIP WITH FOUNDATION FOR NIH AND RENEE FLEMING FOUNDATION ON BUILDING METHODOLOGY FOR RESEARCH ON MUSIC BASED INTERVENTIONS. MUSIC IS VERY WELL SITUATED WITHIN IN HCCIH MISSION AND SO -- NCCIH MISSION AND DEVELOPMENT OF STRONG RESEARCH METHODS FOR STUDYING COMPLIMENTARY AND INTEGRATIVE INTERVENTIONS. OVER THE PAST 20 YEARS COMPLIMENTARY THERAPIES AND PRACTICES HAVE GRADUALLY BECOME MORE AND MORE INTEGRATED. INTO MAINSTREAM HEALTHCARE. AND THE DEVELOPMENT OF RIGOROUS RESEARCH ON THEIR EFFICACY AND MECHANISMS OF ACTION HAS BEEN KEY TO THIS PROCESS. NOW, AS PART OF NCCIH NEW STRATEGIC PLAN, WE HAVE CREATED A DIAGRAM WHICH I WILL SHARE WITH YOU. WHICH ILLUSTRATES THIS INTEGRATION BY MAPPING COMPLIMENTARY INTERVENTIONS INTO CATEGORIES BASED ON PRIMARY THERAPEUTIC INPUT. NUTRITIONAL -- >> I'M SORRY WE SEEM TO HAVE HAD TECHNICAL ISSUE. IT LOOKS LIKE DR. LANGEVIN'S FEED MAY HAVE DROPPED OFF. I'M GOING TO GO AHEAD WHILE DR. LANGEVIN AND CHECK IN WITH HER. HOPEFULLY SHE CAN RETURN IN A MOMENT. BUT IN THE MEANTIME, DR. HODES, WOULD YOU LIKE TO TAKE IT AWAY? AND SHARE A FEW THOUGHTS FROM THE NIH PERSPECTIVE WHILE WE CHECK IN WITH DR. LANGEVIN. >> BE HAPPY TO DO THAT. IT IS A PRIVILEGE TO BE PART OF THESE WELCOMING REMARKS AND I WANT TO ACKNOWLEDGE THE PROFOUND INSPIRATIONAL INTRODUCTIONS BY BOTH FRANCIS AND RENEE EMPHASIZING POTENTIAL FOR MUSIC THERAPY AND FOR FOCUS ON AGING. NATIONAL INSTITUTE ON AGING IS PRIMARY RESPONSIBILITY AND INTEREST IN MAXIMIZING THE QUALITY OF LIFE WITH AGE, UNDERSTANDING BY SICK PROCESSES AND CHANGE THAT OKAY WITH AGING. IMPORTANT ARE SUBJECTIVE OUTCOMES QUALITY OF LIFE AND UNDERSTANDING THE UNDERPINNINGS AND MOLECULAR CELLULAR AND NEUROPHYSIOLOGIC THAT ARE MANIFEST IN QUALITY OF LIFE. SO WE ARE EXCITED TO BE PART OF THIS ENTERPRISE, WE ACKNOWLEDGE AND REINFORCE THE CRITICAL IMPORTANCE OF BEING AS RIGOROUS AS WE CAN IN OUR SCIENTIFIC AGENDA SO WE MAXIMIZE THE OPPORTUNITIES PACE AND PROBABILITY OF BEING SUCCESSFUL AT IDENTIFYING EFFECTIVE INTERVENTION AND APPRECIATE THE CHANCE FOR NIA AND FOCUS ON AGING TO BE IMPORTANT PART OF THIS INITIATIVE. I HOPE HELENE IS BACK WITH US. >> HERE SHE IS. WE SEE YOU HAVE REJOINED US. IF YOU WANT TO TAKE OVER AGAIN HELENE. >> YES. MY APOLOGY, MY COMPUTER JUST WENT BLANK. SO I'M GOING TO SHARE MY SCREEN AGAIN. SORRY ABOUT THAT. >> NO WORRIES, THESE THINGS DO INDEED HAPPEN IN THE VIRTUAL WORLD. NOTHING TO STRESS ABOUT. DID YOU WANT TO PUT THIS IN TO SLIDE SHOW PLEASE? >> YES. VOILA. OKAY. ARE WE -- >> YOU ARE GREAT. MY VIDEO IS NOT ON. >> IT IS MOST IMPORTANT THAT WE SEE YOUR SLIDE AND HEAR YOU. >> VERY GOOD. SO I WAS TALKING ABOUT THE INTEGRATION AND MAPPING OF THE COMPLIMENTARY INTERVENTIONS INTO CATEGORIES BASED ON PRIMARY THERAPEUTIC INPUT. SO ONE OF THE EXAMPLE OF THIS WOULD BE NUTRITIONAL, BOTANICAL, PROBIOTICS. ANOTHER ONE WOULD BE PSYCHOLOGICAL WITH MEDITATION FOR EXAMPLE MINDFULNESS PRACTICES. AND FINALLY PHYSICAL WITH MANUAL THERAPIES FOR EXAMPLE. THESE CATEGORIES PARTIALLY OVERLAP WITH SOME MORE CONVENTIONAL CATEGORIES LIKE PHARMACOLOGICAL DRUGS OR DEVICES THERE IS OVERLAP BETWEEN CONVENTIONAL AND COMP MEN TAR CATEGORIES WITHIN THE CATEGORIES THEMSELVES. FOR EXAMPLE, CONVENTIONAL PSYCHOTHERAPY METHODS SUCH AS COGNITIVE BEHAVIORAL THERAPY, INCREASEKLY USE ELEMENTS OF MINDFULNESS AND RELAXATION TECHNIQUES AND CONVENTIONAL PHYSICAL THERAPY IS GRADUALLY INCORPORATING TECHNIQUES SUCH AS SPINAL MANIPULATION FOR EXAMPLE, AND OTHER MANUAL TECHNIQUES BORROWED FROM MASSAGE. THERE ARE ALSO AREAS WHERE THE NUTRITIONAL PSYCHOLOGICAL AND PHYSICAL CATEGORIES OVERLAP WITH ONE ANOTHER. ONE EXAMPLE WOULD BE MINDFUL EATING FOR EXAMPLE. STRADDLES THE NUTRITIONAL AND PSYCHOLOGICAL CATEGORIES. A PROMINENT FEATURE OF THIS DIAGRAM IS THE CONSIDERABLE OVERLAP BETWEEN THE PSYCHOLOGICAL AND PHYSICAL CATEGORIES, THIS IS WHERE WE FIND YOGA AND TAI CHI AS WELL AS ART, MUSIC AND DANCE. SINGING AND PLAYING A MUSICAL INSTRUMENT CLEARLY INVOLVES BOTH THE MIND AND THE BODY. AND LISTENING TO MUSIC WHILE PRIMARILY AN ACTIVITY OF THE MIND CAN INVOLVE THE BODY AS WELL. IN THE PERCEPTION AND RESPONSE TO RHYTHM FOR EXAMPLE. IN FACT, THE MIND AND BODY CONNECTION IS A RICH AREA THAT MUSIC CAN HELP US BETTER UNDERSTAND. WE ARE VERY PLEASED TO HAVE THE OPPORTUNITY IN THIS SERIES OF MEETINGS TO EXPLORE THE METHODS NEEDED TO BETTER UNDERSTAND THE IMPACT OF MUSIC. IN THE AREAS OF BRAIN DISORDERS OF AGING. IT IS NOW MY PLEASURE TO HAND THE VIRTUAL PODIUM OVER TO THE DIRECTOR OF THE NATIONAL INSTITUTE ON AGING DR. RICHARD HODES. >> THANK YOU, HELENE. DR. HODES ACTUALLY WAS A WONDERFUL STAND IN AND HE HOPPED IN WHILE YOU WERE COMING BACK ONLINE WITH US SO I THINK WE CAN TRANSITION NOW TO DR. SCHOR FROM NINDS. NINA, TAKE IT AWAY, DR. SCHOR APPRECIATE YOUR TIME. >> THANK YOU SO MUCH, KATHERINE. THANKS TO EVERYONE FOR BEING HERE WITH US TODAY AND FOR GIVING ME THE PRIVILEGE TO HELP WELCOME YOU. THOSE VERY FEW OF YOU WHO KNOW ME FROM OTHER ARENAS MAYBE WONDERING ABOUT NOW WHY IT IS A CHILD NEUROLOGIST IS WELCOMING A BUNCH OF PEOPLE TO A CONFERENCE ON AGING. THE GLIB ANSWER IS THERE CAN BE NO AGING WITHOUT CHILDHOOD BUT THE MORE SERIOUS ANSWER I THINK AND THE MORE IMPORTANT ANSWER IS THAT MANY OF US AT NINDS HAVE BEEN WONDERING AND MAYBE EVEN HYPOTHESIZING THAT THE STUDY OF MUSIC THE INVOLVEMENT IN MUSIC, THE ENGAGEMENT WITH MUSIC DURING EARLY LIFE MAY IN FACT BUILD THE RESILIENCE THAT ALLOWS ONE TO THWART THE FORCES THAT WOULD LEAD TO NEURODEGENERATION IN AGING. AND I THINK THAT IT IS ONLY THREE THE KIND OF RESEARCH THAT WILL ALL OF YOU HAVE BEEN DOING AND THAT THIS INITIATIVE HAS BEEN FOSTERING THAT WE WILL EVER KNOW THE ANSWER TO THAT QUESTION. AND THAT WE WILL EVER BE ABLE TO EMPLOY MUSIC TO ITS FULLEST NOT JUST TO TREAT NEURODEGENERATIVE DISORDERS OF AGING BUT IN FACT TO PREVENT IT IN THE FIRST PLACE. SO AGAIN ON BEHALF OF NINDS AND ALL OF MY COLLEAGUES, THANK YOU SO MUCH FOR BEING WITH US TODAY. AND I'M VERY, VERY MUCH LOOKING FORWARD TO THIS PROGRAM. THANKS. >> THANK YOU, DR. SCHOR AND THANK YOU TO DR.S LANGEVIN AND HODES AS WELL FOR SHARING THOSE THOUGHTS WITH OUR PANELISTS AND VIEWERS. WE ARE NOW GOING TO TURN TO DR. ROBERT FINKELSTEIN, DIRECTOR OF DIVISION OF EXTRAMURAL ACTIVITIES AT THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE, TO INTRODUCE OUR KEY SPEAKER FOR TODAY DR. SHAI SILBERBERG, DR. FINKELSTEIN. >> THANKS, KATHERINE, IT IS A REAL PLEASURE TO INTRODUCE MY GOOD FRIEND AND COLLEAGUE SHAI SILBERBERG FROM NINDS. WE ARE THE NEUROLOGY INSTITUTE AT NIH. SHAI WAS ORIGINALLY PERHAPS NOT ORIGINALLY BUT HE WAS A PROFESSOR AT A UNIVERSITY IN ISRAEL WHO CAME TO NIH INTRAMURAL WHERE HUH STUDIED ION CHANNELS AND DID RIGOROUS WORK. HE GRADUALLY TRANSITIONED TO A PROGRAM EFFICIENT IN EXTRAMURAL PROGRAM AND I REMEMBER ABOUT 11 OR 12 YEARS AGO SHAI CORRECT ME IF I HAVE A TIME OFF, SHAI TOLD ME HE WAS INTERESTED IN INCREASING THE RIGOR OF THE RESEARCH THAT HUNDRED DOLLARS FUNDS AND ALSO THE TRANSPARENCY AND ADEQUACY WHICH IT IS RECORDED. SO HE DECIDED TO FOCUS ON THIS AND I CAN PERSONALLY TESTIFY THAT WHEN SHAI FOCUSES ON SOMETHING HE IS A TRUE FORCE OF NATURE. HE BROUGHT RIGOR TO THE FOREFRONT AT NIH, BIOMEDICAL RESEARCH COMMUNITY. HE'S ORGANIZED LAND MARK WORKSHOPS GIVEN MANY TALKS BOTH WITHIN AND OUTSIDE NIH AND HE'S WRITTEN MANY, MANY ARTICLES ON THIS SUBJECT AND VERY HIGH PROFILE JOURNALS. HE'S ALMOST SINGLE HANDEDLY CHANGED THE EDITORIAL POLICIES OF NATURE AND OTHER LEADING JOURNALS WITH RESPECT TO RIGOR AND HE'S WORKED WITH MANY OTHERS ACROSS NIH TO MAKE SURE THAT RIGOR AND TRANSPARENT -- TRANSPARENT REPORTING IS HIGHLIGHTED WHEN REVIEWING GRANT APPLICATION AND DECIDE WHICH TO FUND. HE IS WORKING TO DEVELOP STAT STATE OF THE ART EDUCATIONAL MATERIALS ON EXPERIMENTAL DESIGNND TO ESTABLISH A NATIONAL NETWORK OF RIGOR CHAMPIONED TO PROMOTE QUALITY SCIENCE. FINALLY HE FOUNDED AND LEADS THE NINDS OFFICE OF RESEARCH QUALITY. I CAN GO ON, I'M A BIG FAN OF SHAI SILBERBERG BUT I WILL STOP THERE AND WELCOME HIM TO OUR MEETING. >> THANK YOU, BOB P. I'LL PAY YOU LATER FOR THIS VERY GENEROUS INTRODUCTION. >> IN CASH PLEASE. >> YEAH. I WANT TO SAY HELLO TO EVERYONE. AND I'M GRATEFUL TO BE HERE. MENT I MUST SAY THAT I'M VERY SURPRISED -- I WON'T SAY SURPRISE BUT I WAS REALLY TAKEN BY DR. COLLINS INTRODUCTION AND IN MY BOOKS THE HONOR LAYER DR. FLEMING ON THE ISSUES OF RIGOR AND BIAS AND WHAT IS NEEDED. HALF OF MY INTRODUCTION IS GONE. I HAVE A DISCLAIMER TO MAKE AND THEN APOLOGY. MY DISCLAIMER IS THAT OPINIONS I WILL VOICE ARE NOT OFFICIAL OPINIONS OF NIH AND AS YOU WILL FIND OUT I HAVE MANY OPINIONS. MY APOLOGY IS THAT KNOWING THIS IS GOING TO BE A DIVERSE AUDIENCE, I SIMPLIFY THINGS AS MUCH AS I COULD SO THE AFICIONADOS PLEASE DON'T TAKE OFFENSE. SO I THINK IT WOULD BE FAIR TO SAY THAT MUSIC HAS BEEN PART OF SOCIETIES ACROSS THE GLOBE FOR MULLENIA AND THEREFORE MUSIC IS GOOD FOR YOU. SO IN THAT CASE WHY DO WE NEED THIS WORKSHOP? AND THAT IS EXACTLY WHAT THERE COLLINS HIGHLIGHTED IS THAT WHEN WE ARE LOOKING FOR IS EVIDENCE BASED THERAPIES. IF ONE TAKES THAT INTO CONSIDERATION, IT'S INTERESTING TO MAKE COMPARISONS BETWEEN THE DEVELOPMENT OF MUSIC BASED INTERVENTIONS AND THOSE OF PHARMACO THERAPIES. SO WHEN YOU DO SUCH A TRIAL, OBVIOUSLY YOU HAVE AN OBJECTIVE, THERE IS A TARGET POPULATION YOU TRY TO REACH. THERE IS A PRIMARY OUTCOME YOU ARE TRYING TO ACHIEVE. AND YOU HAVE TO CONSIDER EFFECT SIZE BECAUSE IT HAS TO BE SIGNIFICANT ENOUGH THAT IT WILL BE WORTHWHILE TO PURSUE. I WOULD LIKE THE DRAW ATTENTION TO THE NUTS AND BOLTS IN THE MIDDLE WHICH I FIND VERY INTERESTING AND THAT IS WHEN YOU THINK ABOUT THE INTERVENTION YOU HAVE TO PAY ATTENTION WHAT IS IT GOING TO BE, LISTENING, PLAYING, SINGING, ALL THOSE HAVE TO BE DEFINED. FORMULATION. WHAT ELEMENT OF MUSIC IS IMPORTANT. WHEN YOU THINK ABOUT THOSE, IT IS NOT ONLY HOW OFTEN AND FOR HOW LONG, BUT MAYBE WE NEED TO AD JUST TO HEARING ABILITY. IF WE TAKE THE EXTREME IF ONE IS TONE DEAF THE MUSIC IS NOT MUCH HELP BUT IF THEY ARE HARD OF HEARING, ONE HAS TO ADJUST THE DOSING SO TO SPEAK. SO WITH THIS KIND OF THOUGHT IN MIND, I ASKED MYSELF WHAT WILL WE PUT IN A TOOL KIT IN THE BRIEF TIME I HAVE TO TALK. SO THIS IS WHAT I CAME UP WITH. I PUT A MIRROR, A BALANCE, DICE, BLINDFOLDS AND A STATISTICIAN. SO LET'S START WITH A MUR WHICH IS FOR US TO LOOK AT OURSELVES OR HUMAN NATURE. 400 YEARS AGO FRANCIS BACON WROTE ONCE A MAN'S UNDERSTAND HAS SETTLED ON SOMETHING IT DRAWS EVERYTHING ELSE ALSO TO SUPPORT AND AGREE WITH IT. HE WENT ON TO SAY IT IS AN INNATE AND CONSTANT MISTAKE IN THE HUMAN UNDERSTANDING TO BE MUCH MORE MOVED AND EXCITED BY AFFIRMATIVES THAN BY NEGATIVES. WE DON'T REALLY KNOW WHAT HE MEANT BY HUMAN UNDERSTANDING OR WHERE HE THOUGHT IT RESIDES BUT WE KNOW THAT IT IS IN THE BRAIN. THAT'S WHY I LIKE THE WAY IT WAS CRYSTALIZED BY THE COMEDIAN PHILLIPS. HE SAID I USED TO THINK THE BRAIN WAS THE MOST WONDERFUL ORGAN IN MY BODY THEN I REALIZED HE WAS TELLING ME THIS. SO IT IS INTERESTING TO THINK ABOUT THIS FOR A MOMENT BECAUSE HE SEPARATES ME FROM THE BRAIN. TWO SEPARATE THINGS. BASICALLY FRANCIS BACON AND MANY OTHERS IN BETWEEN HAVE SAID SIMILAR THINGS. WHAT THEY WERE REFERRING TO IS DISTORTIONS IN THINKING OR ANOTHER WAY OF PUTTING IT IS UNCONSCIOUS BIAS. LET'S LOOK AT AN EXAMPLE. YOU SEE A DRAWING OF TWO TABLES, I HAVE LABELED ONE SIDE OF EACH TABLE WITH A W TO INDICATE THAT'S THE WIDTH OF THE TABLE AND WHEN I LOOK AT THESE TWO IT IS OBVIOUS TO ME THAT THE TABLE ON THE LIGHT IS WIDER THAN THE TABLE ON THE LEFT. SO LET'S PUT THIS TO THE TEST, I COVERED THE TABLE ON THE LEFT AND GRADUALLY MOVE THIS OVER AND YOU CAN SEE THEY ARE EXACTLY THE SAME SIZE. NO MATTER HOW MANY TIMES I DO THIS MY BRAIN IS TELLING ME THAT TABLE ON THE LIGHT IS STILL WIDER AND I'M SURE THE SAME IS TRUE FOR MOST OF YOU. SO WHY AM I GIVEK THIS EXAMPLE, NOT BECAUSE WE CARE ABOUT TABLES, WE HAVE TO THINK ABOUT -- WE HAVE TO THINK ABOUT TWO THINGS. FIRST WHAT WE SEE IS NOT NECESSARILY WHAT WE GET. THE OTHER IS THAT WHEN THERE'S SO MANY THINGS WE DO IN SCIENCE DEPEND ON VISUAL SYSTEM, IF WE ARE EVALUATING FUNCTIONAL MRI RESULTS OR TRYING TO ASSESS BEHAVIOR OF PATIENTS, WE A LOT OF TIMES USING NON-OBJECTIVE PARAMETERS BASED ON OUR VISION. SO WE HAVE TO BE VERY CAREFUL. SO MANY DIFFERENT KINDS OF BIASES BY THE WAY, SO HOW DO WE ADDRESS THAT. I LIKE THE APPROACH THAT WAS TAKEN BY DAVID RANSIHOFF. HE SAID THE RELIABILITY OF STUDY WAS DETERMINED BY INVESTIGATORS CHOICES CRITICAL DETAILS OF RESEARCH DESIGN AND CONDUCT. IN OTHER WORDS HE PLACES THE ONUS OF MAKING SURE THE STUDIES ARE RIGOROUS AND CAREFULLY DONE ARE EVIDENCE BASED ON THE INVESTIGATOR. BUT HE GOES ON TO SAY, BIAS IS UNINTENTIONAL AND UNCONSCIOUS SO HOW CAN WE RECONCILE THESE? HOW CAN WE BE RESPONSIBLE FOR SOMETHING WE ARE UNAWARE OF AND UNINTENTIONAL? WHAT HE SAYS IS REALLY IMPORTANT. HE SAYS PROCESS OF ADDRESSING BIAS INVOLVES MAKING EVERYTHING EQUAL DURING THE DESIGN CONDUCT AND INTERPRETATION OF THE STUDY, AND REPORTING THESE STEPS IN EXPLICIT AND TRANSPARENT WAY. I CAN'T EMPHASIZE ENOUGH THE IMPORTANCE OF THE REPORTING THINGS IN TRANSPARENT WAY. SO WE HAVE TO MAKE EVERYTHING EQUAL BETWEEN COMPARISON GROUPS EXCEPT FOR THAT ONE PARAMETER THAT WE ARE STUDYING. LET'S LOOK AT AN EXAMPLE. THIS IS A PILOT STUDY ON YOUR LOGICAL MUSIC THERAPY FOR PARKINSON'S DISEASE. US INVOLVED 55 SUBJECTS THEY HAD SIMILAR SYMPTOMS, INVESTIGATORS RANDOMIZE THEM INTO TWO GROUPS. CONTROL GROUP AND TEST GROUP. THIS IS INCREDIBLY IMPORTANT TO TRY TO MINIMIZE THE POSSIBILITY THAT THE GROUPS WILL BE BIASED IN SOME WAY. UNCONSCIOUSLY THAT WE WILL BIAS WHICH SUBJECTS GO INTO WHICH GROUPS. AND RANDOMIZATION IS ALSO IMPORTANT AS IS FOUNDATION FOR MANY STATISTICAL TESTS WE USE, THEREFORE WHEN POSSIBLE WE RANDOMIZE SUBJECTS INTO COMPARISON GROUPS. INDEED WHEN THEY COMPARE THE AVERAGE AGE OF THE PATIENTS IN THE TWO GROUPS THEY WERE ESSENTIALLY IDENTICAL. IN THIS STUDY, THE MUSIC THERAPY GROUP RECEIVED 45 MINUTE SESSIONS FOUR TIME AS WEEK FOR FOUR WEEKS. THEY PRACTICE DAILY LIFE ACTIVITIES BALANCE PRE-GATE AND GATE PATTERN AND THERE WAS MUSIC TO ACCOMPANY THE TREATMENT. THE CONTROL GROUP WERE ASKED TO STAY ACTIVE AND PERFORM DAILY LIFE ACTIVITIES. THIS IS HARDLY MAKING EVERYTHING EQUAL BETWEEN COMPARISON GROUPS EXCEPT FOR THE ONE INTERVENTION WHICH IS MUSIC. SO WHAT IF THE ACTUAL TRIP TO THE FACILITY WHERE THIS THERAPY TOOK PLACE IS BENEFICIAL, WHAT IF SEEING OTHER PEOPLE AROUND YOU IS BENEFICIAL? WHAT IF BEING FORCED TO PRACTICE DAILY LIFE ACTIVITIES IS BENEFICIAL? DO WE CONCLUDE FROM SUCH A STUDY MUSIC IS BENEFICIAL? WE HAVE A PROBLEM HERE. THESE THINGS I MENTION MANY OTHERS ARE CALLED CONFOUNDING VARIABLES BECAUSE THEY -- WE ARE NOT TAKING THEM INTO CONSIDERATION. BUT THEY MAY HAVE IMPACT. ANOTHER EXAMPLE THIS TIME IT'S MUSIC THERAPY, FOR DEPRESSION, HERE YOU CAN SEE MUSIC THERAPY GROUP THEY RECEIVE TREATMENT AS USUAL FOR DEPRESSION AN 20 BIWEEKLY MUSIC THERAPY SESSIONS EACH ONE 60 MINUTES LONG. IT WAS ACTIVE MUSIC THERAPY WITH INDIVIDUAL AN INDIVIDUAL SETTING SO THERAPIST AND CLIENT VARIOUS MUSICAL INSTRUMENT, BOTH THERAPIST AND CLIENT USE THE SAME INSTRUMENTATION. THE CONTROL GROUP WERE TREATED AS USUAL. THE SAME ISSUE. LET'S LOOK AT ONE MORE EXAMPLE, THIS IS AN INTERESTING EXAMPLE USING ANIMALS, IT WAS CONDUCTED MORE THAN 50 YEARS AGO. IT INCLUDED 14 RODENTS IN THE FORM OF RATS AND 39 HOMOSAPIENS IN THE FORM OF STUDENTS AND THIS RATIO MIGHT LOOK A LITTLE ODD BUT UNTIL YOU REALIZE THE EXPERIMENTAL SUBJECTS HERE WERE ACTUALLY STUDENTS AND NOT THE RATS. THIS WAS PART OF A COURSE OF AN EXPERIMENTAL PSYCHOLOGY AND THE STUDENTS WERE ASKED TO -- THROUGHOUT THE SEMESTER TO TRAIN RATS TO DO DIFFERENT TASKS AND TO MONITOR HOW FAST THEY LEARN. THEY WERE TOLD THAT THERE WERE TWO KINDS OF RATS, RATS BRED TO BE BRIGHT, THEY LEARN FAST AND THERE WERE ADULT RATS WHO WERE SLOW LEARNERS. THE 42 EXPERIMENTS THEY WERE TOLD WHICH RAT TO STUDY MANY THAT PARTICULAR STUDY. AT THE END OF THE COURSE, IT WAS FOUND THAT THE BRIGHT RATS YOU CAN SEE HERE IN THE LIGHT BLUE LEARNED FASTER THAN THE DULL RATS. IN FACT THIS EXPERIMENT WAS REPEATED FIVE TIMES. EACH TIME THEY GOT THE SAME RESULT. THERE WAS JUST ONE PROBLEM WITH THIS. THERE WAS NO SUCH THING AS RIGHT AND DULL RATS. THESE WERE RATS RANDOMLY TAKEN FROM THE CAGE. SO WHAT HAPPENED HERE? THERE WAS EXPECTATION BIAS ON THE SIDE OF THE STUDENTS, THEY EXPECTED THE BRIGHT RATS TO LEARN FASTER SO THAT'S WHAT THEY FOUND. IT DOESN'T TAKE A ROCKET SCIENTIST TO SAY WHAT COULD HAVE BEEN DONE TO PREVENT THIS, ALL WE HAVE DO IS NOT TELL THEM WHAT RAT TO STUDY THAT PARTICULAR DAY BUT THAT IS BLINDING. SO IF WE GO BACK TO PREVIOUS STUDY ONE ON DEPRESSION AND MUSIC THERAPY IN DEPRESSION, THEY ACTUALLY WENT TO GREAT LENGTH TO MAKE SURE STUDY WAS BLINDED. THESE ARE QUOTE FROM THE MAN JEW SCRIPT, A MASS CLINICAL EXPERT ASSESS ALL PARTICIPANTS BEFORE RANDOMIZATION, EACH PARTICIPANTS LOCATION WAS CONCEAL FROM THE INVESTIGATORS UNTIL DECISIONS ABOUT INCREASE WAS MADE. A MASS CLINICAL EXPERT CONDUCTED ALL PSYCHIATRIC ASSESSMENTS. KUDOS FOR THEM FOR PAYING GREAT ATTENTION TO BIAS. HOWEVER IT IS A SHAME OTHER ELEMENTS DIDN'T MAKE SURE GROUPS WERE EQUAL. WHEN YOU CONSIDER BLINDING YOU SHOULD REALLY TRY TO BLIND EVERY SINGLE PARTICIPANT IN THE CLINICAL TRIAL AND EVERY STAGE OF THE CLINICAL TRIAL SO THAT PARTICIPANTS, PRACTICERS, DATA COLLECTORS OUTCOME JAY TORRS AN DATA ANALYSTS, BUT THAT IS NOT OFTEN THE -- POSSIBLE P. AND THEREFORE, AS WE SAID BEFORE WE SHOULD DO OUR BEST TO ADJUST THE GROUPS TO BE EQUAL, EXCEPT FOR THE ONE INTERVENTION AND IMPORTANTLY TO TRY TO USE OBJECTIVE RELIABLE OUTCOMES AS OPPOSED TO THE INVESTIGATOR JUST SAYING WELL THIS IS WHAT I THINK IS GOING ON. AND THE LAST ONE I THINK IS INCREDIBLY IMPORTANT IS TO ACKNOWLEDGE LIMITATIONS. THAT'S BEING TRANSPARENT IN THE REPORTING. SO THIS BRINGS ME TO MY LAST TOOL THAT I ADDED TO THE TOOL KIT AND THAT'S STATISTICIAN. AS YOU KNOW WHEN ANY EXPERIMENT WE DO WE TAKE A SAMPLE, WE TRY TO INFER FROM THAT WHAT HAPPENS IN THE ENTIRE POPULATION. THAT'S NOT SIMPLE. WE HAVE TO KNOW WHAT SAMPLE WE SHOULD USE. FOR EXAMPLE, LET'S ASSUME THIS IS OUR POPULATION FOR JUST A MOMENT. IF I RANDOMLY SELECTED THESE TWO INDIVIDUALS, I MIGHT CONCLUDE THAT THE POPULATION OF ALL REDHEADS OR IF I HAPPEN TO SELECT THESE THREE, I WILL CONCLUDE POPULATION ARE FEMALES. EVEN IF WE TAKE THIS ENTIRE COHORT OF 24 PARTICIPANTS AS IF THAT IS OUR SAMPLE, IT WILL BE A BIAS SAMPLE BECAUSE THERE IS MORE MALE THAN FEMALE AND EVERY SINGLE MALE HERE HAS A BEARD. SO HOW DO WE DECIDE WHAT SAMPLE SIZE WE NEED? THAT'S WHAT WE NEED THE STATISTICIAN FOR. BECAUSE IT IS NOT THAT SIMPLE, IT IS NOT SAYING THAT'S WHAT'S CUSTOMARY IN THE FIELD OR I USED IT BEFORE. IF WE TRY TO PUT THIS TOGETHER IT IS INTERESTING TO LOOK AT A SYSTEMATIC REVIEW. AS AN EXAMPLE, I TOOK THIS EXAMPLE OF PIG BARK EXTRACT IN TREATING DISORDERS. IT REVIEWED 27 RANDOMIZED CLINICAL TRIALS THAT INCLUDED TOTAL OF 1,641 PATIENTS, THAT'S APPROXIMATELY 60 PATIENTS PER TRIAL. AND IT COVERED TEN CHRONIC DISORDERS. THE RESULTS OF THIS REVIEW, THIS IS A CHOCK RAN REVIEW, SUMMARIZED HERE IN THIS GRAPHIC. SO GREEN IS LOW RISK OF BIAS, YELLOW IS CLEAR RISK OF BIAS AND RED IS HIGH RISK OF BIAS. TWO THINGS I THINK SHOULD BE TAKEN FROM THIS. ONE IS THAT THERE IS A LOT OF RED IN SELECTIVE REPORTING. SHOWING YOU THE IMPORTANCE OF TRANSPARENCY. ONCE YOU REPORT EVERYTHING THEN WE CAN ASSESS HOW SIGNIFICANT THE RESULTS ARE. BUT JUST LOOK HOW MUCH YELLOW IS WILL. UNCLEAR RISK OF BIAS MEANS THERE IS NOT ENOUGH INFORMATION IN THE PAPER TO DETERMINE WHETHER STUDY WAS DONE CAREFULLY OR NOT. INDEED THEY CONCLUDE HERE SMALL SAMPLE SIZES LIMITED NUMBER OF CLINICAL TRIALS, YA DA, DO NOT MAKE IT POSSIBLE TO REACH ANY KIND OF CONCLUSION ABOUT THE BENEFIT OF PIG BARK EXTRACT. SO JUST THINK ABOUT IT. 27 RANDOMIZE CLINICAL TRIALS MORE THAN 1600 PATIENTS AND WE HAVE NOTHING TO SAY ABOUT IT. THAT SHOWS THE IMPORTANCE OF REALLY DOING THINGS RIGOROUSLY AND REPORTING TRANSPARENTLY. SO WHAT'S THE TAKE HOME MESSAGE? THE TAKE HOME MESSAGE IS WE ARE ALL PRONE TO BIAS AND THEREFORE WE MUST CRITICALLY ASSESS RESULTS AND PUBLICATIONS. NIH GAVE YOU EXAMPLES OF WHERE THERE WERE CLEAR DEFICIENCIES IN THE STUDIES, OR LACK OF INFORMATION AND IF WE FOLLOW WHAT FRANCIS BACON SAID WE MIGHT ENDORSE THESE PUBLICATION BECAUSE THEY FIT OUR HYPOTHESIS AND WE WON'T BE CRITICAL AND WE WERE CRITICAL ABOUT OTHER STUDIES. WE MUST RIGOROUSLY DESIGN AND EXECUTE AND ANALYZE EXPERIMENTS, AND PLAN TO EXPERIMENTS TO DISPROVE THE HYPOTHESIS NOT TO PROVE IT RIGHT. WHICH IS WE SHOULD ALWAYS TRY TO DO OUR BEST NOT TO FALL PRAY TO OUR OWN BIASES. WE SHOULD FAVOR LARGE EFFECTS. I DIDN'T SAY MUCH ABOUT LARGE EFFECTS BECAUSE WE REALLY DON'T HAVE TIME. I JUST WANT TO LEAVE YOU WITH A THOUGHT. THE ODDS OF WINNING THE MEGA MILLION JACK P POT IS ONE IN 302 MILLION AND CHANGE. MANY PEOPLE BELIEVE THEY CAN WIN THE JACKPOT AND SOME PEOPLE DO. THE ODDS OF BEING STRUCK BY LIGHTENING IN A GIVEN YEAR IN THE UNITED STATES IS ONE IN 700,000. YET MANY PEOPLE ARE TERRIFIED OF LIGHTNING AND UNFORTUNATELY THERE ARE PEOPLE WHO GET STRUCK BY IT. YET WE SCIENTISTS THINK THE ODDS OF 1 AND 20 AREN'T LIKELY TO HAPPEN BY CHANCE. GO FIGURE. SO THAT'S WHY WE NEED TO CONSIDER LARGE EFFECT SIZES AS OPPOSED TO STATISTICAL TESTS OF SIGNIFICANCE WHICH MIGHT BE BY CHANCE ALONE. SO WITH THAT I WANT TO THANK YOU FOR YOUR ATTENTION AND I'M GOING TO LEAVE YOU WITH THE WORDS OF ABRAHAM LINCOLN, THAT HE SAID IN THE COOPER UNION ADDRESS BY I WAS INCREDIBLY MOVED BY AND I'M MORE HAPPY TO OPEN THIS TO DISCUSSION. THANK YOU. >> THANKS A LOT SHAI FOR THE USUAL INTERESTING AND PROVOCATIVE TALK. ARE THERE ANY QUESTIONS FOR SHAI? WE HAVE ABOUT SIX OR SEVEN MINUTES FOR QUESTIONS. >> I HAVE ONE WHILE YOU ARE THINKING. I ACTUALLY HAVE TWO LOOKING FOR SHAI ON MY SCREEN. THERE YOU ARE. CAN YOU TALK A LITTLE BIT ABOUT THE DIFFERENCES BETWEEN RIGOR AND REPRODUCIBILITY? WHEN YOU BEGAN THIS CAMPAIGN AT NIH THERE WAS A LOT OF TALK THAT WAS TRIGGERED BY SOME RESULTS THAT WE FUNDED NOT BEING REPRODUCIBLE AND THERE'S ALSO THE PARAMETER OF RIGOR. COULD YOU TALK ABOUT THOSE TWO DIFFERENT TERMS AND THE DIFFERENCES -- >> ABSOLUTELY. AGAIN, I WANT TO REMIND YOU MY DISCLAIMER. BECAUSE WHAT I'M GOING TO SAY HERE IS GOING TO BE OUTSPOKEN. I SHOW YOU THE EXPERIMENTS THAT WERE DONE WITH THE RATS AND THE STUDENTS. THEY REPEATED THAT EXPERIMENT FIVE TIMES AND EACH TIME THEY GOT EXACTLY THE SAME RESULT. SO IF YOU ARE DOING A EXPERIMENT IT DOESN'T MATTER HOW MANY TIMES YOU REPEAT IT AND GET THE SAME RESULT IT DOESN'T MAKE IT RIGHT. SO I PERSONALLY DON'T THINK THAT OUR AIM SHOULD BE REPRODUCIBILITY, OUR AIM SHOULD BE TO DO GOOD SCIENCE. BECAUSE ACTUALLY EVEN IF YOU HAVE A VERY WELL DONE EXPERIMENT AND SAY IT WAS AT A STATISTICAL LEVEL OF .05, EVERYONE LIKES TO SAY, THE CHANCE THAT IT WILL REPRODUCE IS ONLY 50%. SO THERE ARE MANY REASONS RESULTS WON'T BE REPRODUCED AND I REMEMBER VERY CLEARLY DR. COLLINS TALKING ABOUT THIS AT CONGRESS IN A HEARING. THERE CAN BE MANY CONFOUNDING VARIABLES THAT WE ARE NOT A AWARE OF THAT IMPACTED THE OUTCOME, THAT'S PART OF SCIENCE. THAT'S HOW SCIENCE ADVANCES SAY HEY WAIT A MINUTE WE ARE NOT GETTING THE SAME RESULTS WHAT IS GOING ON WHY, THAT'S HOW YOU MAKE NEW DISCOVERIES. PERSONALLY I AM NOT A FAN OF USING THE TERM REPRODUCIBILITY. I LIKE TO TALK ABOUT RIGOR AND TRANSPARENCY. >> THANKS A LOT. I SEE A VIRTUAL HAND UP, DAN, THAT YOUR VIRTUAL HAND UP. >> THANK YOU, SHAI. THAT WAS A WONDERFUL PRESENTATION AND I WISH THAT YOU CAN GIVE IT TO ALL OF OUR GRADUATE STUDENTS BECAUSE IT APPLIES OF COURSE TO THINGS WAY BEYOND STUDY OF MUSIC. I LIKE -- I RESONATE TO THE IDEA THAT WE WANT TO KNOW WHY MUSIC IS WORKING OF COURSE AND QUESTION WHETHER IT IS PICTURE RHYTHM CONTOUR THESE VARIOUS THINGS STRIKES ME AS PROBLEMATIC IN THAT I THINK WHEN MUSIC WORKS, IT WORKS AS A GESTALDT. I'M REMINDED OF ALAN WATTS TRYING TO DESCRIBE EASTERN RELIGIONS SAID THAT YOU CAN'T STUDY THE RIVER BY GOING TO IT TAKING A BUCKET OUT OF IT AND TAKING THE BUCKET OF WATER BACK TO LABORATORY. THAT IS NOT RIVER. I THINK ABOUT WHAT MAKES SHAKES PIERCE SHAKESPEARE IS THE -- IAMBIC PENTAMETER, IS IT SHORTAGE OF WORDS, COINAGE OF WORDS, THE CHARACTERS? I DON'T KNOW THAT IT IS POSSIBLE OR EVEN NECESSARY TO DISTINGUISH THEM BUT I WONDER WHAT YOUR THOUGHTS ARE ABOUT THAT. >> YOU ARE ABSOLUTELY RIGHT. BUT IT IS HARD TO DEFINE THESE THINGS. I WAS THINKING TO MYSELF WHEN THINKING ABOUT HE IS THINGS, FOR EXAMPLE WHAT IF SOMEONE HAS AN INCREDIBLE EAR FOR MUSIC AND WHATEVER THERAPY IT IS IT IS COMING OUT THROUGH AWFUL LOUD SPEAKERS. WOULD THAT DO THEM GOOD OR DO THEM HARM? SO THAT IS ONE ASPECT. THE OTHER IS IF WE WANT TO COMPARE BETWEEN DIFFERENT TRIALS IF WE ARE NOT SOMEHOW STANDARDIZING THEM IT WILL BE HARD TO FIGURE OUT WHAT'S GOING ON, WHAT IF FOR EXAMPLE FOR SOME POPULATIONS LISTENING TO MOZART OR BEETHOVEM DO INCREDIBLY GOOD BUT OTHERS DON'T LIKE CLASSICAL MUSIC. MIGHT FIND IT UNHELPFUL WHATSOEVER. SO I THINK WHAT MOVING FORWARD, I DON'T HAVE THE ANSWER TO THIS, THIS IS JUST MY THOUGHTS I'M FAR FROM EXPERT IN THIS FIELD, THINKING THAT WE NEED TO STANDARDIZE SOME THINGS DURING THESE TRIALS. AND IF THEY DON'T WORK YOU MIGHT CHANGE THE STANDARD CARDIZATION AND TRY SOMETHING DIFFERENCE. BUT IF YOU DON'T DO THAT, NO TWO CLINICAL TRIALS WILL BE THE SAME. AND I DON'T KNOW WHAT WE WOULD LEARN FROM THAT. >> IT SUGGESTIONINGS TO ME ONE MIGHT THREE NOT TO MANIPULATE PITCH PER SE BUT LOOK AT WHAT IS MUSIC DOING, IT IS GRABBING YOUR ATTENTION, OR NOT, IT WAS PUTTING YOU IN GOOD MOOD OR NOT, REMINDING YOU'RE THINGS, PUTTING YOU IN MIND WANDERING MODE, WHAT EVERY COMPARISON CONDITIONS WE HAVE AS OTHER PIECES OF MUSIC OR SPEECHES OR BOOKS ON TAPE, IF WE EQUALIZE ACROSS THOSE HIGHER ORDER EMOTIONAL COGNITIVE PARAMETERS HA MAY SOLVE THE PROBLEM. >> EXACTLY AS YES SHAI? >> THAT IS ABSOLUTELY POSSIBLE. RANDOMIZED CLINICAL TRIALS, MAYBE GETTING TOGETHER PLAYING BINGO WILL HAVE THE SAME EFFECT. SO YOU WOULD HAVE TO DETERMINE THAT THAT'S THE PARAMETER, THE MUSIC OR WHATEVER IT IS THAT IS ACTUALLY DOING THE JOB. >> WE HAVE ABOUT 30 SECONDS SO I WILL JUST QUICKLY END BY SAYING THAT I REMEMBER I WAS HELPING A FRIEND OF MINE FIND THE PSYCHOLOGIST FOR HIS DAUGHTER AND WHEN I CONSULTED ONE OF HIS COLLEAGUE AT NIH HIS ADVICE IF YOU MEET PSYCHOLOGIST IS SUCCESSFUL IT IS THEIR PERSONALITY, THE FORCE -- PERSONALITY, RUN THE OTHER WAY. ANY CASE, I WANT TO THANK SHAI AGAIN, WE ARE RIGHT ON TIME AND THAT WAS A VERY SIMPLIFIED VERSION OF THE MANY TALKS SHAI HAS GIVEN BUT HE'S WRITTEN ARTICLES IF YOU ARE INTERESTED IN LEARNING MORE SO THANKS A LOT AND BACK TO YOU, KATHERINE. >> THANK YOU, ALL. >> THANK YOU. THANK YOU DR. SILBERBERG AND FINKELSTEIN. THOSE ARE SOME WONDERFUL INSIGHTS AND THE FUNDAMENTALS OF CONDUCTING RIGOROUS RESEARCH, I THINK AS DR. FINKELSTEIN SAID IS JUST A WONDERFUL SUMMARY AND SO APPLICABLE FOR SUCH A WIDE RANGING AUDIENCE. THANK YOU SO MUCH. NOW WE WILL TURN TO THE CORE OF TODAY'S MEETING. WHICH IS REALLY KICKING OFF THIS FACILITATED DISCUSSION, GOING TO EXPLORE SEVERAL THEMES, CRUCIAL TO DEVELOPING THE TOOL KIT. IN THIS NEXT SESSION WE WILL BEGIN WITH DR. EMMELINE EDWARDS, DIRECTOR OF DIVISION OF EXTRAMURAL RESEARCH AT NCCIH WHO IS GOING TO CHARGE OUR PANELISTS WITH THEIR GOALS AND THEN WE WILL TURN THINGS OVER TO OUR FACILITATOR, MR. WEIL, EDITOR IN CHIEF OF HEALTH AFFAIRS, WHO WILL TAKE OVER AND REALLY SET THE STAGE FOR THIS DISCUSSION AND GUIDE THIS SHE WANT THROUGH THE REST OF ITS PACES TODAY, SO I WANT TO TURN THINGS OVER TO EMMELINE. AND PLEASE TAKE IT AWAY. >> GOOD AFTERNOON OR GOOD MORNING. IT IS A PLEASURE TO WELCOME EVERYONE HERE, I DON'T THINK WE WELCOME VIDEOCAST AUDIENCE, WE WERE GRATIFY THERE HAD'S A HIGH INTEREST IN THIS MEETING. SO THANK YOU AND I HAVE A COUPLE OF SLIDES THAT I'M GOING TO SHARE. JUST TO RE-EMPHASIZE WHAT WAS PRESENTED BY DR. COLLINS AND MS. FLEMING. ONE THING I WOULD LIKE TO STRESS IS THAT THE THREE SPONSORING ICs, INSTITUTE NCCIH, NATIONAL INSTITUTE OF AGING AND I WOULD LIKE TO CALL OUT OUR COLLEAGUE CORYSE SAINT HILLAIRE CLARK AS WELL AS MY COLLEAGUE BOB FINKELSTEIN FROM NINDS. NEXT SLIDE PLEASE. AS ALREADY MENTIONED, WE HAVE THIS PROJECT THAT'S CO-SPONSORED BY FOUNDATION OF THE NIH AND THE FLEMING FOUNDATION AND I WANT TO TAKE THE OPPORTUNITY TO GIVE A GREAT THANK YOU TO RENEE AND HER FOUNDATION FOR PROVIDING FINANCIAL SUPPORT FOR SERIES OF MEETING THAT WE ARE HAVING STARTING TODAY. THE LEADERSHIP OF OUR PLANNING COMMITTEE INCLUDES MYSELF CORYSE ST. HILLAIRE AND BOB FINKELSTEIN AND OUR GOAL IS TO DEVELOP AND PILOT THAT TOOL KIT OF MUSIC BASED INTERVENTION PROTOCOL. NEXT SLIDE. TODAY'S MEETING REALLY IS PART OF THE FIRST PHASE OF OUR PROJECT. WE WANT TO NOT ONLY DEVELOP THIS TOOL KIT BUT WE WANT TO VALIDATE THIS TOOL KIT FOR MUSIC BASED INTERVENTION STUDIES. AND WE WILL HAVE THREE WORKSHOPS, TODAY IS THE FIRST ONE FOLLOWED BY MEETING IN JUNE WHICH WILL FOCUS ON OUTCOME MEASURES AND LAST ONE OF THE SERIES WOULD BE IN AUGUST FOCUSED ON BIOMARKERS FOR BRAIN DISORDERS OF AGING. IN ORDER TO HELP CARRY OUT THE PROJECT WE ENLISTED THE HELP OF A STELLAR GROUP OF PANELISTS FROM FIVE DIFFERENT AREAS, BEHAVIORAL INTERVENTION DEVELOPMENT, CLINICAL TRIAL METHODOLOGY, MUSIC THERAPY, MUSIC MEDICINE, NEUROSCIENCE, AND PATIENT ADVOCACY AND ARTS ORGANIZATION. AT THE END OF THIS FIRST PHASE WE WILL HAVE A TOOL KIT FOR RESEARCH PROJECTS THAT NOT ONLY WOULD CONTAIN THE DATA ELEMENT THAT SHOULD BE INCLUDED IN MUSIC INTERVENTION STUDY BUT ALSO CORE DATA SET OF OUTCOME MEASURES IN BIOMARKERS. NEXT SLIDE PLEASE. PHASE 2 OF THIS FIVE YEAR PROJECTED WILL BE ACTUALLY TO PILOT TESTS THIS TALK BECAUSE WHAT WE REALLY WANT TO ACCOMPLISH IS LAY FOUNDATION FOR LARGE SCALE EFFICACY AND EFFECTIVENESS TRIAL FOR BRAIN DISORDERS OF AGING. NEXT SLIDE PLEASE. I WOULDN'T BE ABLE TO SIT HERE AND TALK TO YOU WITHOUT THE HELP OF OUR WONDERFUL NIH PLANNING COMMITTEE. WE HAD MEMBERS FROM NCCIH NATIONAL CENTER FOR COMPLIMENTARY AND INTEGRATIVE HEALTH, THE NATIONAL INSTITUTE OF AGING, THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE, THE NATIONAL INSTITUTE OF DEAFNESS AND COMMUNICATIVE DISORDERS, AND THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCE RESEARCH. THANK YOU ALL FOR YOUR DEDICATION AND ALL YOUR WORK THAT YOU PUT IN FOR THIS PROJECT. NEXT. OF COURSE OUR PANELISTS, THEY WERE CHOSEN FOR THE AREAS OF EXPERTISE AND ALSO THEIR DEDICATION TO TRANSPARENCY AND RIGOR AS SHAI EDUCATED US. OUR GROUP WAS REPRESENTED FIVE DIFFERENT DISCIPLINES AND WE WERE CAREFUL TO ACTUALLY PROVIDE A MIX OF INDIVIDUAL THAT WERE NOT ACTUALLY CURRENTLY DOING MUSIC INTERVENTION WORK. BUT HAD THE EXPERTISE AND THE KNOWEDGE IN VARIOUS DISCIPLINES. BEHAVIORAL AND SOCIAL SCIENCE INTERVENTION DEVELOPMENTS. CLINICAL TRIAL METHODOLOGY, MUSIC THERAPY AND MUSIC MEDICINE, AND NEUROSCIENCE AND THE LAST GROUP OUR PATIENT ADVOCATES AND OUR ART ORGANIZATION REPRESENTATIVE. WE HAVE BEEN WORKING WITH THIS GROUP OF PANELIST POURS THE PAST TWO MONTHS GETTING THEIR INDIVIDUAL INPUT ON A NUMBER OF QUESTIONS THAT WILL BE DISTILLING AT TODAY'S MEETING. FINALLY I WOULD LIKE TO INTRODUCE OUR FACILITATOR NEXT, MR. ALAN WEIL, ALAN, IT IS A PLEASURE TO WELCOME YOU AND HAVE YOU FACILITATE OUR DISCUSSION THIS AFTERNOON, MR. WEIL IS EDITOR IN CHIEF OF HEALTH AFFAIRS, WHICH IS PREMIER JOURNAL FOR HEALTH SCIENCE POLICY RESEARCH. HE HAS A LAW DEGREE FROM HARVARD MEDICAL SCHOOL, SORRY FOR HARVARD LAW SCHOOL AND I HAVE HAD THE PLEASURE OF LISTENING TO ALAN FACILITATE THE NUMBER OF MEETINGS THROUGH THE NEURAL ARTS BLUEPRINT PROJECT THAT IS SPONSORED BY JOHN HOPKINS AND ASPEN INSTITUTE I CAN TELL YOU FIRSTHAND HE HAS A WONDERFUL ABILITY TO SYNTHESIZE AND FACILITATE CONVERSATIONS. SO WITHOUT FURTHER ADIEU I WILL TURN IT OVER TO ALAN TO KICK OFF THIS AFTERNOON GUIDED CONVERSATION. THANK YOU. >> THANK YOU SO MUCH, DR. EDWARDS, HELENE, PLEASURE WORKING WITH YOU AND I WANT TO SAY I KNOW YOU HAVE A LARGE -- A SMALL TEAM BUT THE TEAM IS MIGHTY AND YOU HAVE PUT TOGETHER A REALLY INCREDIBLY WELL ORGANIZED SESSION. I AM HONORED AND TRULY A BIT HUMBLED BY THE TASK OF LEADING THIS CONVERSATION ON SUCH AN IMPORTANT TOPIC, I AM NOT A SUBJECT MATTER EXPERT. I AM THE GENERALIST WHOSE JOB IT IS TO FACILITATE A CONVERSATION, FOR THOSE WHO ARE ON THE PANEL MY GOAL IS TO HAVE A STRUCTURED CONVERSATION, STRUCTURE IS IMPORTANT, WE HAVE FIVE THEMES AND WE NEED TO MOVE THROUGH THEM BUT STRUCTURE DOES NOT NEED TO BE LINEAR, WE DON'T NEED TO COVER EVERYTHING AND THEN LEAVE IT BEHIND WE CAN CIRCLE BACK BUT WE NEED TO MAKE PROGRESS THROUGH MATERIAL. AND I WANT THIS TO BE A CONVERSATION. WE HAVE FOR EACH OF THE THEMES ASKED THREE PEOPLE FROM THREE OF THE DIFFERENT PANELS, TO MAKE SOME OPENING COMMENTS, I HOPE YOU WILL KEEP THEM TO THE THREE OR FOUR MINUTE RANGE AND I DO KEEP A TIMER SO THAT WE CAN ONLY HAVE TEN MINUTES OF PRESENTATION AND SOMEWHERE BETWEEN 15 AND 20 MINUTES OF TRUE CONVERSATION. AFTER THOSE OPENING REMARKS ARE MADE. I WOULD NOTE THE OPENING COMMENTS REALLY ARE REPRESENTING WORK OF A COMMITTEE BUT ONCE THOSE THREE PRESENTATIONS ARE OVER I HOPE YOU WILL SPEAK FOR YOURSELVES AND NOT RYE TO REPRESENT YOUR COMMITTEES THERE IS NO NEED TO DO ANYTHING OTHER THAN USE YOUR OWN VOICE OTHER THAN THOSE WHO ARE SAYING THIS IS WHAT THE SUMMARY IS FROM THEIR COMMITTEE MEETING. TO THE BROADER AUDIENCE, MUCH OF WHAT YOU WILL HEAR IN THE NEXT FEW HOURS WILL BE THE CONVERSATION THAT I DESCRIBED, BUT WHEN WE ARE DONE WE WILL TURN TO QUESTIONS, WE WOULD ASK YOU AS YOU ARE -- WAS NOTED A T OUTSET, YOU CAN PUT HOSE QUESTIONS IN BELOW THE SCREEN OF THE BROADCAST. I CAN TELL YOU FROM HAVING DONE THESE THE EARLIER YOU GET YOUR QUESTION IN, THE EASIER FOR US TO HAVE A CHANCE THE LOOK AT IT AND RYE TO GET IT IN, BUT I WOULD NOTE THAT WE HAVE A LOT OF PARTICIPANTS AND IT IS UNLIKELY ALL QUESTIONS WILL BE ANSWERED AND IT'S NOT ALWAYS EVEN CLEAR WHO SHOULD BE THE RIGHT PERSON TO ANSWER THEM SO IT MAY JUST BE FOOD NOR THOUGHT AND CONVERSATION AND I HOPE WE CONSIDER THAT TO BE A SUCCESS. MY FINAL NOTE BEFORE WE BEGIN IS THAT WE HAVE A LOT OF PEOPLE ON THIS AND THEY HAVE ALL BEEN INSTRUCTED TO RAISE THEIR VIRTUAL HANDS THROUGH ZOOM. I WOULD NOTE THAT OUR PANELISTS ARE PARTICULARLY CHOSEN FOR THIS ENDEAVOR AND I WOULD HOPE WE CAN GIVE THEM AS MUCH OF SPEAKING TIME AS POSSIBLE. THOSE WHO PLAY OTHER ROLES WILL HAVE OTHER OPPORTUNITIES TO WEIGH IN ON INITIATIVE. DO FEEL FREE TO PARTICIPATE BUT I HOPE WE CAN LEAD WITH THE VOICE OF OUR PANELISTS. WITH THOSE PLEA LIMBNARIES BEHIND US, LET'S MOVE DIRECTLY INTO THE MATERIAL. AS NOTED THERE ARE FIVE THEMES THAT WE ARE GOING TO CENTER THE DISCUSSION AROUND IN THE NEXT -- FOR THE NEXT COUPLE OF HOURS. THE FIRST IS THE IMPORTANCE OF CONCEPTUAL FRAMEWORK, FOUR MUSIC BASED INTERVENTIONS AND I THINK YOU HAVE ALREADY BEEN INTRODUCED SOMEWHAT TO THAT FROM OUR EXCELLENT KEYNOTE PRESENTATION AS NOTED. THREE OF THE GROUPS WILL HAVE BRIEF REMARKS SOME COMING OUT OF CONVERSATIONS THEY HAVE HAD IN ADVANCE OF THIS MEETING. I WILL TURN FIRST TO ROBERT SATORI. >> GOOD AFTERNOON, EVERYONE. THANK YOU, VERY MUCH FOR CALLING ON ME FIRST. I'M GOING TO SUMMARIZE VERY QUICKLY SOME OF THE MAIN THEMES THAT WE CAME UP WITH IN THE NEUROSCIENCE PANEL. AND I THINK ONE OF THE MAIN STARTING POINTS HERE IS THAT WE WERE VERY SUPPORTIVE OF THE IDEA THAT NIH HAS TO TRY TO IMPLEMENT MORE RIGOROUS CLINICAL RESEARCH BUT WE HI THAT HAS TO REST ON EQUALLY RIGOROUS BASIC SCIENCE RESEARCH AND IN THE NEUROSCIENCE THIS IS I THINK PARTICULARLY IMPORTANT BECAUSE OUR GOAL IS TO PROVIDES THE MECHANISTIC UNDERSTANDING OF HOW MUSIC WORKS MANY THE BRAIN FROM WHICH THEN WE THINK CLINICAL TYPES OF APPLICATIONS MAY E MERGE. WE THINK THERE NEEDS TO BE A NICE BALANCE BETWEEN MORE BASIC WORK AND THE MORE CLINICALLY APPLIED WORK AND INDEED THAT THEY VERY MUCH INFORM ONE ANOTHER. SO WE NEED ONE ANOTHER I THINK TO BE ABLE TO MOVE FORWARD. THE OTHER SORT OF IMPORTANT POINT THAT WE WANTED TO EMPHASIZE I THINK HAS COME UP ALREADY A LITTLE BIT IN DR. SILBERBERG'S PRESENTATION BUT IT IS A STUFF THIS IDEA THAT MUSIC IS MULTI-FACETED AND ENGAGES MANY, MANY DIFFERENT COGNITIVE AND NEURAL SYSTEMS, THAT INDEED IS ONE OF ITS GREAT STRENGTHS, PROBABLY REASON IT WORKS AT ALL IN ANY THERAPEUTIC SETTING BUT THE SAME TIME THAT RAISES SOME PROBLEMS FROM THE EXPERIMENTAL POINT OF VIEW WAS IT IS HARD TO KNOW EXACTLY IF THERE IS AN EFFECT WHY IS THERE ONE OR IF THERE ISN'T WHY IS THERE NOT ONE. ONE PROPOSAL WE CAME UP WITH ON THE NEUROSCIENCE PANEL WAS TO THINK IN TERMS OF WHAT NEURAL SYSTEM IS BEING TARGETED BY THE PROPOSED INTERVENTION. SO FOR EXAMPLE, I WILL GIVE A FEW EXAMPLES, YOU MIGHT BE INTERESTED IN THE PER ACCEPT ACTUAL ASPECT OF MUSIC, WHEN YOU PERCEIVE MUSIC THERE IS A COMPLEX COGNITIVE PER ACCEPT ACTUAL -- THAT'S ON, THAT MIGHT BE HIGHLY APPLICABLE TO HEARING LOSS WHICH IS COMMON DISORDER OF AGING, WE KNOW WILL IS EVIDENCE MUSICAL TRAINING IS ASSOCIATED WITH ENHANCED ABILITIES TO PERCEIVE SOUNDS. IF YOU ARE GOING TO LOOK AT THAT POPULATION THE PER ACCEPT ACTUAL SYSTEM MIGHT BE THE TARGET. ON THE OTHER HAND IF YOU ARE LOOKING A AT DISORDERS OF THE MOTOR SYSTEM IN PARKINSON'S OR IN STROKE, THEN YOU ARE PROBABLY TARGETING THE MOTOR SYSTEM. THERE AGAIN WE KNOW THERE ARE STRONG LINKS BETWEEN PER ACCEPT ACTUAL AND MOTOR SYSTEMS AND THE CONTEXT OF MUSIC. ANOTHER VERY IMPORTANT NEURAL SYSTEM ENGAGED BY MUSIC IS THE MEMORY SYSTEM, AND THIS RAISES QUESTIONS ABOUT TYPES OF INTERVENTIONS THAT MIGHT BE RELEVANT, OBVIOUSLY IN DEMENTIA AND OTHER DISORDERS THAT SLOUGH MEMORY, FOR EXAMPLE, AUTOBIOGRAPHICAL MEMORIES MIGHT BE A TARGET. AND FINALLY I THINK THE LEEWARD SYSTEM IS A VERY CRITICAL SYSTEM FOR MUSIC. WE KNOW FROM A LOT OF RESEARCH THAT MUSIC ENGAGES DOPAMINERGIC NEURONS IN THE ME SOW LIMB BIC PARTS OF THE BRAIN SO THIS OPENS UP MANY POSSIBLE APPLICATIONS FOR DISORDERS OF MOTIVATION AROUND HEDONIA. WE EVEN KNOW FROM SOME RESEARCH OUR GROUP HAS DONE IN OTHERS AS WELL THAT DURING THE COVID TIME MUSIC SEEMS TO REALLY BE PARTICULARLY IMPORTANT FOR DEALING WITH DEPRESSION AN ANXIETY. SO DEPENDING ON WHAT RESEARCH YOU ARE TRYING TO DO, WHAT POPULATION YOU HAVE, WHAT DISORDER POPULATION HAS YOU SHOULD BE THINKING OF IT IN TERMS OF WHAT NEURAL SYSTEMS YOUR INTERVENTION IS MEANT TO TARGET AND WE THINK THAT WOULD BE A VERY USEFUL FRAMEWORK FOR GOING FORWARD TRYING TO DESIGN SOME KIND OF CLINICAL TRIAL. >> THANK YOU VERY MUCH FOR KICKING OFF. FOLLOWING MY INSTRUCTION I WILL KEEP FOLKS ON THEIR TOES IN THAT REGARD. NEXT IS (INAUDIBLE). >> THANK YOU DR. SATORI. OUR GROUP, SO I REPRESENT MUSIC THERAPY AND MUSIC BASED INTERVENTION GROUP AND WE TALKED A LOT ABOUT DIFFERENT CONCEPTUAL MODELS AND NEURAL MECHANISTIC CONCEPTUAL MODELS LIKE SEVERAL EXAMPLES OF VERY IMPORTANT IN THIS TYPE OF RESEARCH BUT WE ALSO TALKED ABOUT THE IMPORTANCE OF BEHAVIORAL MODELS SOCIAL MODELS CONCEPTUAL MODEL, THAT CAN BE VALUABLE IN RESEARCH ON MUSIC BASE INTERVENTIONS. FOR EXAMPLE, THERE'S MANY BEHAVIORAL MODELS THAT TALK ABOUT OR OUTLINE OR DETAIL PROTECTIVE AND RISK FACTORS, RELATED TO SPECIFIC DISEASE OR DISORDERS OR HELP OUT-- HEALTH OUTCOMES. THOSE MODELS CAN BE VERY VALUABLE IN THE DEVELOPMENT OF MUSIC BASE INTERVENTIONS AND THEN GENERATION OF HYPOTHESES OF COURSE. WE HAD A GOOD CONVERSATION WHETHER CONCEPTUAL MODELS THAT GUIDE MUSIC BASED INTERVENTION RESEARCH SHOULD BE MUSIC SPECIFIC OR NOT. WE HAD SOME DISAGREEMENT IN OUR GROUP ABOUT THAT, SOME FELT THAT WAS VERY IMPORTANT AND OTHERS FELT THERE IS WIDER BEHAVIORAL MODELS OR PSYCHOSOCIAL MODELS THAT ARE NOT MUSIC SPECIFIC BUT CERTAINLY BE VALUABLE AS A CONCEPTUAL MODEL IN MUSIC BASE INTERVENTION RESEARCH. IN TERMS OF WE ARE ALSO TASKED WITH TALKING ABOUT THE ROLE OF SUPPORTING DATA AS RELATED TO HYPOTHESES AND CONCEPTUAL FRAME WORKS AND WE FELT THAT THE SUPPORTING DATA IN THINKING ABOUT AND DEVELOPING YOUR RESEARCH NEEDS TO COME FROM HOPEFULLY FROM PRIOR RIGOROUS RESEARCH LITERATURE AS WELL AS CLINICAL PRACTICE SO WE CANNOT IGNORE THE WISDOM THAT COMES FROM CLINICAL PRACTICE AS WE CONSIDER DIFFERENT CONCEPTUAL MODELS AND BEGIN TO DEVELOP HYPOTHESES. I'M NOT SURE ABOUT THIS TIME, WHILE WE SHOULD TALK A LITTLE BIT TOO ABOUT THE ROLE OF PRIOR DATA IN THIS FIRST THEME WE ARE DISCUSSING. >> I THINK WE CAN HOLD THAT A LITTLE BIT BUT I DON'T WANT TO HOLD IT TOO LONG. >> THAT'S FINE. I WILL WAIT TO SPEAK ON THAT. >> OKAY. WONDERFUL, THANK YOU SO MUCH. THIRD WE WILL HEAR FROM DON EDMONDSON. >> FASTER WITH MY UNMUTE BUTTON. I -- YES SO I'M HAPPY TO BE HERE. I WAS ASKED TO BE PART OF BEHAVIORAL INTERVENTION TEAM OF EXPERTS AND WE WERE TASKED WITH CONTRIBUTING OUR EXPERTISE TO SCIENTISTS WORKING TO TOGETHER AND VALIDATE FOUNDATIONAL TOOLS FOR CONDUCTING THE SCIENCE OF MUSIC BASED INTERVENTIONS. NOT SPEAKING FOR MY WHOLE TEAM, BECAUSE WE HAVE AMAZING SCIENTIST WHO CAN SPEAK FOR THEMSELVES, BUT ON OUR TEAM GENERALLY OUR HOPE WAS TO HELP MUSIC RESEARCHERS AVOID THE MISTAKES OUR FIELD MAY PARTICULARLY IN ITS EARLY YEARS BUT SOME OF THAT IS STILL LEFT, AT THE MOST BASIC LEVEL WE CONSISTENTLY IMPLORE THE FIELD TO APPLY THE FRAMEWORKS THAT HAVE BEEN OFFERED BY PARTICULARLY NIH FUNDED THINGS BUT OTHER SCIENTISTS OVER THE YEARS, AND THE FRAMEWORKS ADOPTED BY THE MOST SUCCESSFUL BEHAVIORAL SCIENCES SO SOME OF THE LESSONS LEARNED THAT WE WANTED TO BRING TO THE FOREFRONT, I THINK SOME OF THESE WILL HAVE OVERLAP WHAT WE HEAR FROM OTHER GROUPS BUT MAYBE OUR GROUP WILL FOCUS IN ON A COUPLE OF PARTICULARLY RELEVANT FOR INTERVENTION DEVELOPMENT. BUT SORT OF THREE OR FOUR THREE BIG LESSON LEARNED FIRST SYSTEMATIC REVIEW IS CRUCIAL AND WE THINK ABOUT MUSIC INTERVENTION DEVELOPMENT REVIEW OF BASIC AND NEUROSCIENTIFIC FINDINGS SHOULD INFORM THEORETICAL MODELS, TO STUDY COMPONENTS OF INTERVENTIONS THAT WORK. WHICH MECHANISMS ARE INFLUENCED AND IN TURN HOW DOES CHANGES IN THOSE MECHANISMS RESULT IN CHANGE IN SOME CLINICALLY RELEVANT OUTCOME OF INTEREST. THE SECOND BIG LESSONS LEARNED, THE NIH STAGE MODEL HAS BEEN INCREDIBLY USEFUL. TO OUR FIELD WITH RESPECT TO HELPING RESEARCHERS UNDERSTAND DIFFERENT LEVELS OF DEVELOPMENT OF AN INTERVENTION WHAT SHOULD BE THE BIG TASKS RIGHT NOW FOR OUR FIELD WITH RESPECT TO FOCUSING ON THIS INTERVENTION. AND THIRD, THE NIH SCIENCE BEHAVIORAL CHANGE PROGRAM HAS OFFERED A REALLY VALUABLE SET OF INSIGHTS AROUND HOW WE CAN GAIN RIGOR AND REPRODUCIBILITY AS WELL AS FILL OUT OUR CONCEPTUAL MODELS THROUGH A REAL FOCUS ON MECHANISMS OF ACTION. SORT OF THE EXPERIMENTAL MEDICINE APPROACH HAS BECOME THE GOLD STANDARD IN OUR FIELD FOR IDENTIFYING AND TESTING HYPOTHESIZE MECHANISM OF ACTION OF INTERVENTION AT EACH STAGE OF INTERVENTION DEVELOPMENT AND IT ALSO OFFERS A REALLY BEAUTIFUL BRIDGE BETWEEN BASIC TRANSLATIONAL AND CLINICAL TRIALS RESEARCHERS ALL WHOM MAY CONTRIBUTE TO UNIQUELY IDENTIFYING MEASURING INFLUENCING AND DETERMINING THE MAGNITUDE OF MEDIATED EFFECT OF AN INTERVENTION THROUGH A GIVEN MECHANISM. WE ALSO HAVE GREAT RESEARCHERS WHO ARE FOCUSED ON MIND BODY INTERVENTIONS, AND I IMAGINE WE WILL HEAR FROM THEM BECAUSE I THINK THERE'S UNIQUE CONTRIBUTIONS THEY HAVE TO THIS DISCUSSION. I THINK THAT IS GOOD FOR NOW. >> THANK YOU TO THE THREE OF YOU FOR GETTING US STARTED. SO AT A VERY HIGH LEVEL WHAT I'M HEARING IS THERE IS SUPPORT FOR RIGOR BUT IT CAN COME IN A LOT OF DIFFERENT WAYS PARTLY BECAUSE OF THE COMPLEXITY OF THE INTERVENTION YOU CAN MEASURE SOMETHING QUITENARY LOW. OR MEASURE SOMETHING MORE HOLISTIC AS DR. LEVITON MENTIONED IN HIS QUESTION FOR FROM SILBERBERG. SOMETIMES WE HAVE NEUROLOGICAL MECHANISMS THAT ARE WELL -- HAVE A STRONG EVIDENCE BASE ALREADY AND WE CAN BUILD ON THOSE. OTHER TIMES WITH BROADER INTERVENTIONS WE ARE LOOKING AT LESS CLEAR MECHANISTIC PATHWAY BUT THAT STILL VERY IMPORTANT DATA AND WORTH STUDYING WITH RIGOR EVEN IF IT IS MISSING AT THE STAGE OF THE RESEARCH AT THAT POINT IT MAY NOT HAVE AS CLEAR MECHANISM. IN MIND AS LISTENING THAT HAS IS CLEAR MECHANISM HYPOTHESIS CHANGE TOWARD THE END. BUILD ON SOME OF THESE. Y'ALL ARE THE EXPERTS. I DON'T HAVE ANY HANDS UP AND THAT SEEMS VERY SURPRISING TO ME. WHO WOULD LIKE THE TAKE THIS FURTHER? ERIC I SEE YOU. QUESTION. YES. >> THANK YOU. I WANT TO BUILD ON IMPORTANT COMMENT BY DR. EDMONDSON ABOUT EXPERIMENTAL MEDICINE APPROACH. I THINK THIS IS KEY TO THE DEVELOPMENT OF THIS NEW FIELD OF INTERVENTION RESEARCH. I WILL USE THE MINDFULNESS RESEARCH FIELD AS A CASE STUDY TO UNDERSCORE MY POINT HERE. WHICH IS THAT IN MINDFULNESS RESEARCH WE WORK BACKWARDS IN TERMS OF FAIRLY WELL DEVELOPED INTERVENTION PACKAGE, IN THIS CASE MDSR WAS PROTOTYPICAL INTERVENTION. AND THEN TESTED ITS EFFICACY AND WORKED BACKWARDS TO UNDERSTAND MECHANISMS, AND WE ARE STILL IN THE PROCESS OF DOING THAT WITH MINDFULNESS BASED INTERVENTIONS IN GENERAL. THIS APPROACH IS INFORMATIVE BUT MAY NOT BE OPTIMAL IN TERMS OF DESIGNING THE MOST EFFICACIOUS FORM OF INTERVENTION POSSIBLE. RATHER IF WE TAKE EXPERIMENTAL MEDICINE APPROACH, IN DEVELOPMENT OF MUSIC BASED INTERVENTION, YOU MAY WITH A MORE POTENT FORM OF INTERVENTION BY ATTENDING TO THE MECHANISMS OF BEHAVIOR CHANGE INCLUDING NEUROBIOLOGICAL MECHANISMS OF BEHAVIORAL CHANGE IN THE BEGINNING OF THIS PROCESS. SO IF WE ATTEND TO WHAT ARE THE PROXIMAL CHANGE PROCESSES THAT ARE ELICITED BY MUSIC BASED INTERVENTIONS. THIS INCLUDES MODULATING FACTORS THAT MAY HAVE THERAPEUTIC POTENCY WHETHER AUDITORY FREQUENCY, AM PRIA TUESDAY OF AUDITORY SIGNAL OR RANGE OF VARIABLES THAT MUSIC THERAPY COLLEAGUES HERE CAN PROBABLY OAR IT CAN LATE BETTER THAN I CAN. IF WE ATTEND TO THOSE AND HOW THOSE MODULATE, THE PROXIMAL CHANGE FACTORS MAY END UP WITH A MORE POTENT CLINICAL OUTCOME, DISTAL OUTCOME DOWNSTREAM. SO I WANT TO UNDERSCORE DR. EDMONDSON'S POINT, IT IS KEY HERE IN BUILDING THIS FIELD. TAKE THE EXPERIMENTAL MEDICINE APPROACH, WHICH REALLY NCCIH HAS ADOPTED IN TERMS OF ITS INTERVENTION DEVELOPMENT FRAMEWORK AND I I THINK IT SERVES AS A GREAT MODEL FOR THIS FIELD. THANK YOU. >> I WILL TURN TO RA MONA HIX. >> THANK YOU. I JUST WANTED TO REINFORCE A FEW POINTS THAT I HEARD FROM SHAI. ONE IS THIS DESIRE OR WILLINGNESS TO DISPROVE YOUR HYPOTHESIS. SO I DO THINK THAT CLINICIANS AND PEOPLE THAT DO INTERVENTIONS THAT SEEING IS BELIEVING AND WHEN YOU SEE THINGS EVEN ANECDOTAL LEVEL IT IS VERY HARD SOMETIMES TO SHAKE OFF THAT SENSE OF THIS REALLY WORKS. I DO THINK CHANGING CULTURE WHERE THE WHOLE IDEA IS PROVE YOURSELF WRONG, I THINK IS REALLY AN IMPORTANT POINT. ALONG THOSE LINES THEN THIS IDEA OF THE REVIEW AND THE SOURCE OF INFORMATION SO I USED TO TEACH STUDENTS PHYSICAL THERAPY STUDENTS THAT OFTEN HAD SOME INTRIGUING BUT OFF THE WALL IDEAS FOR EFFECTIVE INTERVENTION, WHAT IS THE DATA TO SUPPORT THIS, THEY COME UP WITH SOURCES FROM LIKE THE 18TH CENTURY. THE FRANCIS BACON THING FROM 16TH CENTURY WAS SOLID BUT A LOT OF THESE SOURCES WEREN'T THAT SOLID. I THINK SIMILAR TO WHAT I KNOW NIH IS TRYING TO DO AND SHAI AND OTHERS IS REALLY STILL SCIENCE LITERACY IN ALL CLINICIANS. SO I WANT TO REINFORCE SOME OF THOSE POINTS. >> THANK YOU. SUNIL. >> THANK YOU. SO MONA AND I FROM ADVOCACY AND ARTS FEDERAL GROUP, VERY MUCH AN ARTS ORGANIZATION, I JUST WANTED TO I GUESS I THOUGHT IT WOULD BE BE WORTH REPEATED WHAT OUR GROUP DISCUSSED IN LIGHT OF THIS QUESTION, BECAUSE ONE OF THE THINGS I DIDN'T HEAR MUCH ABOUT AND SOMETHING I THINK THAT CAME UP WITH US IS THIS SORT OF VARIOUS COMPONENTS OF MUSIC PROGRAMMING OR MUSIC THERAPY THAT PROBABLY NEED TO BE UNPACKED. WE ALL ARE THOSE OF US IN THIS MEETING TALKED ABOUT THEM IN VARIOUS CONTEXT BUT FOR THE PURPOSE OF UNDERSTANDING BUILDING BLOCKS UNDERSTANDING DIFFERENCES BETWEEN ACTIVE AND PASSIVE WHETHER WE CALL IT THAT OR NOT BUT WE KNOW CREATING MUSIC OR LISTENING OBSERVING MUSIC UNDERSTANDING DIFFERENCES ACROSS GENRES. MUSICAL GENRES AND HERE MAYBE TO DEFER DR. SILBERBERG UNDERSTANDING MUSICAL PREFERENCES, WHAT ARE THE BIASES OR WHAT DO PEOPLE'S INNATE OR CULTURALLY SPECIFIC KINDS OF INCLINATIONS ARE TOWARD DIFFERENT KINDS OF MUSIC. THAT'S CLEARLY GOING TO HAVE A BEARING ON THE OUTCOME. SO I THINK HAVING THOSE COMPONENTS BAKED INTO SOME CONCEPTUAL FRAMEWORK ARE NECESSARY AND NOT ANCILLARY. I THINK UNDERSTANDING WE TALK ABOUT THIS ALSO, CLEARLY THERE ARE A LOT OF CONTEXTUAL FACTORS WITH THESE MUSIC PROGRAMS AN INTERVENTIONS THAT NEED TO BE CONSIDERED WHETHER -- THE PATIENTS OR SUBJECTS BEING BROUGHT TO BEAR FOR EXAMPLE HOUSEHOLD CHARACTERISTICS, DEMOGRAPHICS AND OTHER MAYBE VARIABLES THAT WE MIGHT NORMALLY RELEGATE TO THE SIDE THAT MAYBE COME TO THE FORE WITH CERTAIN TYPES OF MUSIC PERHAPS. AND SO UNDERSTANDING THOSE RELATIONSHIPS A LITTLE BETTER SOMETHING I THINK WE DISCUSSED AS WELL. ONE OF THE THINGS OUR GROUP REALLY MORE THAN ANYTHING PERHAPS WAS THIS IDEA OF MULTIPLE DOMAINS OF OUTCOMES. WE NEED TO UNDERSTAND BETTER, AND THAT GETS TO WHAT WAS SAID AT THE TOP, DR. SATORI ABOUT SPECIFICALLY FROM A NEUROBIOLOGICAL LENS, LOOKING, UNDERSTANDING, WHAT MECHANISTIC OUTCOMES ASPIRING FOR TO UNDERSTAND BUT MAYBE APPLYING THAT FOR OUTCOMES MORE BROADLY IN TERMS OF SOCIAL EMOTIONAL AND PSYCH LOGIC MECHANISMS. >> DR. JAI THEN DR. SATORI. >> THANK YOU. I WANTED TO MAKE A QUICK COMMENT BASED ON DR. SATORI WAS SAYING EARLIER. THESE THEMES ARE COMING UP IN WHAT OTHER PEOPLE ARE SAYING. IN TERMS OF WHAT -- I'M A BIG FAN OF GROUNDING WORK IN THE CONCEPTUAL MODEL AND BASIC MECHANISMS. BUT I WANTED TO MAKE SURE THAT IF WE DON'T GET STUCK IN PICKING THE ONE SYSTEM THAT I'M TARGETING LIKE COGNITIVE OR MOTOR OR REWARD SYSTEM AND NOT BEING OPEN TO SORT OF THIS POSSIBILITY, THAT ALL THOSE SYSTEMS ARE INTERACTING AND TALKING TO EACH OTHER, VERY MUCH THE INTEGRATIVE MEDICINE APPROACH WE THINK ABOUT THAT SORT OF COMPLEX BODIES WHERE ALL THESE SYSTEMS ARE REALLY INTERTWINED AND INTERRELATED AND SO YES, GROUNDING IN A MODEL EARLY ON TO DEVELOP YOUR INTERVENTION BUT NOT TO BE OPEN TO THAT POSSIBILITY AND THAT EXPLORATION. DR. SATORI. >> I'M GLAD HE BROUGHT THAT UP BECAUSE ONE LINE IN MY TEXT THAT I DIDN'T GET TO WAS REMEMBER THESE SYSTEMS INTERACT. MY TREATMENTS WERE UP SO I STOPPED. BUT THAT'S VERY GOOD POINT. I THINK COMPLEXITY OF MUSIC THAT I ALLUDED TO IN THE BEGINNING IS BOTH STRENGTH AND SORT OF ACHILLIES HEAL IN TRYING TO DO SCIENCE ON IT. AND I THINK ONE IS GO TOO FAR EXTREME. ONE HAND I DON'T THINK ITs THE RIGHT QUESTION TO ASK WHAT EXACT FREQUENCIES DO WE NEED TO USE. THAT'S PROBABLY A LEVEL OF GRANULARITY DOES NOT ACTUALLY RELEVANT. BUT ON THE OTHER HAND, IT IS A BIT OF COP OUT TO SIGH MUSIC IS JUST ONE COMPLEX GESTALDT HOLISTIC THING AND WE CAN'T BREAK APART COMPONENTS I THINK THERE IS A REASONABLE MIDDLE GROUND THERE AND I'LL COME BACK TO WHAT I SAID BEFORE WHICH IS A LOT DEPENDS ON THE NATURE OF THE DISEASE OR DISORDER THAT YOU ARE TARGETING AND WHICH NEURAL SYSTEMS ARE INVOLVED THERE. REALLY IF YOU ARE INTERESTED IN BRAINMENT OF GATE FOR EXAMPLE, THE MUSICAL GENRE MAY NOT MATTER, MAYBE A METRANOME IS SUFFICIENT. IN YOU LOOK AT AUTOBIOGRAPHICAL MEMORY YOU MUST TAKE INTO ACCOUNT MUSICAL PARAMETERS PERTAINING TO THAT PARTICULAR INDIVIDUAL'S PAST EXPERIENCE WITH MUSIC. SO THE SEARCH BASE IS LARGE AND OUR GOAL FOR THIS TOOL KIT IS KIND OF DESCRIBE WHAT THAT SEARCH BASE IS RATHER THAN TO SAY THE RESEARCH OR THE APPLICATION SHOULD ONLY USE THIS OR ONLY TAKE INTO ACCOUNT THAT. >> I KNOW WE ARE ABOUT TO MOVE TO ANOTHER ITEM BUT I JUST TOSS OUT THIS THOUGHT. WE HAVE HAD DISCUSSION OF DIFFERENT COMPONENTS OF INTERVENTION, MUSIC IS COMPLEX AND MULTI-FACETED BUT IT HAS ATTRIBUTES THAT CAN BE MEASURED. WE TALKED COMPONENTS OF MECHANISM, SOME CHANNELS THAT WE ARE AWARE OF BUT ALSO INTERACTION ACROSS THEM. WE HAVEN'T TALKED MUCH ABOUT THE OUTCOME SIDE. IN A WELL FRAMED IN A WELL FRAMED -- FRAMEWORK I GUESS A WELL DESIGNED FRAMEWORK FOR STUDY. I WONDER IF I COULD GET A COMMENT OR TWO ON THAT ASPECT BEFORE WE MOVE TO NEXT TOPIC. JEFF WILLIAMS, YOU RAISED YOUR HND? >> I'M GLAD YOU RAISE THIS, I HAVE BEEN THINKING AS WE HAVE BEEN TALKING. I'M BRINGING IN THE PERSPECTIVE OF A GERIATRICIAN NOW WHO SEE PATIENTS AND SEE PATIENTS IN ADVANCE STAGE OF ILLNESS WHO OFTEN THE OUTCOME THAT I SEE WHEN THEY ARE LISTENING TO MUSIC IS NOT A DISEASE BASED OUTCOME. IT IS A FUNCTIONAL OUTCOME, AN OUTCOME THAT REALLY I HAVE PATIENTS IN NURSING HOMES WHO WALK AWAY FROM MUSIC SESSIONS WITH MORE JOY AND MAYBE MORE FUNCTION FOR SHORT AMOUNT OF TIME. IT DOESN'T CHANGE THE COURSE OF THEIR DISEASE, SO I WANTED TO PLUG IN THERE AS YOU ASKED FOR OUTCOMES IN CLINICAL TRIAL LEVEL HUMAN BASED LEVEL PHYSICAL OUTCOMES, EMOTIONAL OUTCOMES. THAT ARE INTEGRATED AND NOT NECESSARILY IN THE COURSE OF DISEASE. I'M THINKING ABOUT THE NE PARKS, PART OF PEPPER CENTER BUT PEPPER CENTERS WERE DESIGNED BY CONGRESS TO MEASURE FUNCTIONAL OUTCOMES SO FRAMEWORK WHICH STUDIES COULD BUILT SOME POINT TO TAKE TAKE INTO ACCOUNT THESE TYPES OF OUTCOMES ON A MACRO LEVEL. I WILL STOP THERE. >> GREAT. SO I WILL TAKE SHERRY ROBINS TOM IVERSON AND TRY NOT TO LET US GET BEHIND. TO ADD TO WHAT DR. WILLIAMSON WAS SPEAKING TO, THE CLINICAL OUTCOMES ARE IMPORTANT DRIVER JUST AS RESEARCH QUESTIONS HOW TO APPLY MUSIC AND WE ARE TALKING THREE LETCAL FRAME WORKS TO GUIDE SELECTION AND APPLICATION OF MUSIC BUT EQUALLY IMPORTANT IS UNDERSTANDING ETIOLOGY OF CONDITION AND THE OUTCOMES OF INTEREST. SO I THINK IT IS IMPORTANT. I SEE THE WHOLE RESEARCH DESIGN PROCESS AS BEING CYCLICAL IN NATURE VERSUS BOTTOM UP OR TOP DOWN TYPE OF PROCESS. >> DR. AYERSON. >> THANKS SO MUCH, THIS WILL COME UP AGAIN BUT JUST BRIEFLY SAY THE OUTCOME MEASUREMENTS CAN SOLVE SOME OF THE PROBLEMS ABOUT NOT BEING SURE WHICH ASPECT OF MUSIC ARE ACTING IN A GIVEN INTERVENTION. WE TALK SOMETIMES ABOUT THIS DOWNSTREAM OUTCOMES BUT ALSO THE UPSTREAM OUTCOMES THE PROXIMAL OUTCOMES, I WILL ADD A PLUG IT IS IMPORTANT TO MEASURE OUTCOMES ACROSS THE SPECTRUM. AND PARTICULARLY IN MUSIC INTERVENTIONS, TO HAVE SOME OUTCOMES CLOSE TO THE INTERVENTION SO WE CAN ACTUALLY GET A READ OUT OF HOW EFFECTIVE THE MYMUSICAL ASPECT OF THE INTERVENTION WAS. >> I'M GOING TO LET DR. ELIVALI JUMP IN HERE, BECAUSE WE HAVEN'T HAD A TURN BUT I WANT TO KEEP MOVING SO WE'LL MOVE ON AFTER YOU. >> I WAS GOING TO MENTION ALONG THE SAME LINES THAT THINKING ABOUT THESE OUTCOMES AND REALLY DOING THIS IN AN EVIDENCE BASE OR RIGOROUS MANNER, IT IS IMPORTANT TO ALSO KEEP IN MIND WHAT CONTROLS WERE INVOLVED IN THE DESIGN OF THIS STUDY. SO BOTH IN TERMS OF TIMING BUT ALSO IN TERMS OF PARAMETERS OF THIS STUDY, IN ORDER TO BE ABLE TO GET SOME KIND OF CORRELATIONAL LINK BETWEEN THE INTERVENTION AND SOME OF THESE OUTCOMES IS VERY IMPORTANT. SO I'LL STOP THERE. WE'LL CARRY ON LATER. >> THANK YOU SO MUCH. ALL THESE TOPICS ARE INTERRELATED BUT I WANT TO TRY TO MOVE US INTO THE SECOND THEME WHICH HAS TO DO WITH WHO SHOULD BE ON THE INVESTIGATIVE TEAM WHICH SOME LEVEL THE ANSWER IS OBVIOUS THAT IT DEPENDS ON HYPOTHESIS. BUT WE HAVE HAD SOME GROUPS THAT SPENT SOME TIME DIGGING DEEPER INTO THIS QUESTION. I WILL BEGIN WITH YOKA (PHONETIC) FOR THIS DISCUSSION. >> CERTAINLY RIGOROUS RESEARCH REQUIRES A TEAM SCIENCE APPROACH WHERE WE HAVE STRONG INTERDISCIPLINARY TEAM THAT SITS AROUND TABLE TO DESIGN THE STUDY. SO WE THOUGHT OF THE FOLLOWING EXPERTS PEOPLE THAT SHOULD BE PRESENT ON SUCH A TEAM. DEPENDING ON YOUR CONCEPTUAL FRAMEWORK AND THE OUTCOMES AN MECHANISMS THAT YOU HAVE INCLUDED AND THE TYPE OF INTERVENTION, YOU PLAN TO INCLUDE YOU WOULD NEED EXPERTISE OF COURSE IN THE MUSIC INTERVENTION, THE HEALTH PROBLEM OF THE DISEASE OR DISORDER, AND TARGET OUTCOME. TARGET OUTCOME THINKING ABOUT PARTICULAR OUTCOME MEASURES YOU USE TO MEASURE THE OUTCOME SO IF YOU PLAN TO USE BIOMARKERS IT WOULD BE IMPORTANT TO HAVE BIOMARKERS EXPERTISE ON THAT BIOMARKER ON YOUR TEAM. WE ALSO FELT IMPORTANT TO INCLUDE NEEDED METHOD LOGICAL EXPERTISE. QUANTITATIVE RESEARCH EXPERTISE, QUALITATIVE RESEARCH EXPERTISE IF YOU ARE GOING TO USE QUALITATIVE DATA MIXED METHODS RESEARCH EXPERT DEES A STATISTICIAN INVOLVED FROM THE BEGINNING AND NOT JUST AT THE END TO ANALYZE YOUR DATA. BUT REALLY SHOULD BE INVOLVED AT THE DESIGN STUDY. COMPETENT CLINICIAN TO DELIVER INTERVENTION, WE TALKED ABOUT INVOLVING STAKEHOLDERS, SUCH AS PATIENT, CAREGIVERS, DEPENDING WHO THE TARGET POPULATION IS, AND FOR THEM TO INCLUDE THEM FROM THE BEGINNING, NOT JUST DOWN THE ROAD IN STUDY. WE ALSO THOUGHT IMPORTANT TO THE TEAM TO HAVE SENIOR INVESTIGATOR ON TEAM WHO HAS EXPERIENCE CONDUCTING AND MANAGING NIH GRANTS AND ALSO SKILLED STUDY COORDINATOR BECAUSE MANY MANAGING RECRUITMENT STUDY ADHERENCE TO STUDY PROTOCOL, DATA MANAGEMENT BECAUSE TALKING ABOUT RIGOROUS AND TRANSPARENT RESEARCH YOU CAN ONLY BE AS RIGOROUS AND AS TRANSPARENT OR THE RESEARCH CAN ONLY END UP BEING AS RIGOROUS AND AS TRANSPARENT AS YOUR SKILL STUDY COORDINATOR IF YOU DON'T HAVE A GOOD SKILLED STUDY COORDINATOR EVERYTHING MAY FALL APART. FINALLY, WE WANTED TO MENTION THE IMPORTANCE OF PRIOR COLLABORATION AMONG KEY PERSONNEL BECAUSE YOUR NIH REVIEWERS WILL LOOK FOR THAT. SO IF YOU IF THE INDIVIDUAL TEAM MEMBERS HAVE NEVER WORKED TOGETHER, THAT IS NOT GOING TO SCORE WELL AS YOU SUBMIT YOUR APPLICATION TO NIH. IT DOESN'T MEAN EVERYBODY NEEDS WORK TOGETHER BUT AT LEAST SOME OF YOUR KEY PERSONNEL NEEDS TO HAVE PRIOR COLLABORATION TOGETHER AND IDEALLY THAT'S -- YOU HAVE EVIDENCE OF THAT. PRIOR GRANT APPLICATIONS OR PUBLICATIONS THAT YOU HAVE PUT OUT COLLABORATIVELY. THAT'S IT FOR ME. >> WONDERFUL THANK YOU FOR KICKING OFF. SHERRY. >> DR. BROAD DID AN EXCELLENT JOB OF PRETTY MUCH SUMMARIZING A LOT OF WHAT THE CLINICAL TRIALS METHODOLOGY TEAM HIGHLIGHTED. TWO THINGS INTENDING TO HIGHLIGHT ONE ON MEASUREMENT EXPERTISE, BUT DR. WILLIAMSSON ALREADY SPOKE TO ONE OF THE THINGS WE WERE GOING TO HIGHLIGHT WHICH IS THAT YOU NEED MEASUREMENT EXPERTISE IN FUNCTIONAL AND NON-DISEASE OUTCOMES. AS WELL AS BIOLOGICAL AND DISEASE OUTCOMES. SO HE ALREADY SPOKE TO THAT PARTICULAR POINT. THE OTHER ITEMS THAT WE REALLY TALKED ABOUT HAD TO DO WITH THE IMPORTANCE OF INTERDISCIPLINARY AND TEAM SCIENCE WHICH YOKA ALSO SPOKE TO. PART INVOLVING MAYBE HIGHLIGHT FURTHER IS INVOLVEMENT OF CLINICAL CARE TEAM, PROVIDERS, SO WHETHER THAT'S PHYSICIANS B NURSES, INTERVENTIONISTS SUCH AS MUSIC THERAPISTS COMMUNITY MUSIC ARTIST, PEOPLE THAT ULTIMATELY WILL BE INVOLVED IN RECEIPT OR INVOLVED IN THE SPACE WHERE INTERVENTION IS DELIVERED IS IMPORTANT TO WORK COLLABORATIVE LY. BECAUSE WE CAN COME UP WITH GREAT INTERVENTION IDEAS IN OUR OFFICES AND IN OUR LABS BUT IF WE ARE NOT INCLUDING PEOPLE WHO ARE INTERFACING WITH PATIENTS AND FAMILIES, OR OUT IN THE COMMUNITY SPACES WHERE WE EXPECT THESE INTERVENTIONS TO WORK, WE RUN RISK THESE WILL NOT BE VIABLE OR APPLICABLE IN THAT SPACE WHEN IT COMES TIME TO TEST THEM FOR FEASIBILITY. THE ONLY OTHER ITEM I WILL MENTION THAT WE CAN OPEN FOR ACCORDANCE, WORK FORCE DEVELOPMENT IS A TOPIC WE WANTED TO TALK ABOUT AS WELL SO WHAT WILL THE WAYS THAT WE CAN BE BRIDGING DIFFERENT INVESTIGATORS FROM THESE DIFFERENT AREAS OF RESEARCH ALONG WITH CLINICIANS, HOW DO WE GROW TRAINING OPPORTUNITIES FOR PEOPLE WHO ARE -- WANTING TO DO RESEARCH IN THE MUSIC INTERVENTION SPACE AND HOW WE'LL OFFERED A VANCEED TRAINING OPPORTUNITIES PERHAPS THROUGH CAREER DEVELOPMENT AWARDS. I WILL STOP THERE. THANK YOU THEN TURN TO SUNIL AND WE EACH OPEN UP. >> THANK YOU SO I THINK DR. BROAD AND DR. REPRODUCIBILITY HIT IT ON THE HEAD. WE THINK ABOUT THIS AND I THINK THIS ISSUE OF INCENTIVIZING THESE COLLABORATIONS IS CRUCIAL, HOW DO YOU GET -- ENSURE DR.S ARE'S WORDS HOW TO BRIDGE THE GROUPS TOGETHER, I WOULD OFFER THAT WE TALK ABOUT CLINICAL CARE TEAM AND HOW IMPORTANT THAT IS TO INCORPORATE IN -- I THINK THE PARALLEL TO THAT TO ME IS THE MUSIC PROVIDER. THE MUSIC -- NOT JUST MUSIC THERAPIES OF COURSE BUT IT COULD BE THE MUSIC BASED -- COMMUNITY BASED ORGANIZATION PROVIDING MUSIC. AND PARTICULARLY TO ENSURE FIDELITY AND TO UNDERSTAND THE RELATIONSHIP WITH THE SUBJECT BEING WHO ARE RECEIVING THAT INTERVENTION, IT IS REALLY IMPORTANT TO BRING THEM ON BOARD EARLY ON IN DESIGN OF THE STUDY. SO I WOULD OFFER THAT AS PARALLEL TO CLINICAL PROVIDER TEAM. WE TALK ABOUT MANY SAME GROUPS I WON'T REPEAT ALL OF THEM, ONE COUPLE OF GROUPS I WOULD MENTION MAYBE HAVEN'T BEEN MENTIONED PERHAPS PSYCHOLOGISTS AND COULD BE COGNITIVE BEHAVIORAL THERAPIST, COULD BE OTHER PEOPLE WHO ARE PROVIDING THE CONSTRUCTS OF OUTCOME MEASURES TO UNDERSTAND WHAT IS HAPPENING. THAT MAY NOT BE MECHANISTIC ORIENTED AS THE BIOMARKERS OR PEOPLE ON THE CLINIC ON THE OTHER MEMBERS OF THE RESEARCH TEAM. I THINK WE HAVE BEEN TALKING HEALTH ECONOMIST, WE HAVE THE OPPORTUNITY TO BRING SOMEONE WHO UNDERSTANDS QUALITY OF LIFE MEASURES AND OTHER WAYS OF UNDERSTANDING QUALITY OF LIFE ADJUSTED YEARS AND OTHER WAYS UNDERSTANDING THE TRADE OFFS AND THE COST BENEFITS OF MUSIC INTERVENTIONS AS WELL TO OTHER INTERVENTIONS. THIS IS APPLY TONIC TEAM, IT IS YOUR ASPIRATIONAL DREAM TEAM OF FOLKS, SO IT'S IMPORTANT TO ALSO SAY OF COURSE THAT -- IT IS IMPORTANT TO SAY THAT JUST AS WE HAVE SAID THE RESEARCH METHOD SHOULD FOLLOW THE QUESTION WHEN YOU NEED TO COST TEAM ACCORDING TO STUDY. THE ONLY OTHER THING I WILL BE QUIET, PERHAPS ROOM FOR MORE -- THIS IS MENTIONED BY DR. BLOOD MORE QUALITATIVE RESEARCH IN THIS SPACE, PARTICULARLY IN CLARIFYING THESE MODELS AND GETTING BACK TO CONCEPT CONCEPTUAL FRAMEWORK IDEA. ENSURING YOU DO HAVE SOMEONE PERHAPS TO DO SOME MORE DIGGING ON THE QUALITATIVE SIDE THROUGH INTERVIEWS AND SO FORTH, THAT WOULD TELL YOU MORE ABOUT THE MECHANISM ADJACENT TO AGAIN BIOMARKERS AND MORE HARD MEASURES OF WHAT'S HAPPENING IN THE BRAIN OR ELSEWHERE. SO THOSE ARE GROUPS AND ACTUALLY ONE LAST THING OUR GROUP ALLUDED ON COUPLE OF PARALLEL OR GROUPS THAT MAYBE WORTH LOOKING INTO AS KIND OF EXAMPLES OF THIS WORK AND OTHER SPACES SO PHYSICAL THERAPY RESEARCH WAS BROUGHT UP AND THAT WHOLE FIELD OF RESEARCH HAS TAKEN OFF AND BARELY INTERDISCIPLINARY, I UNDERSTAND, TRAUMATIC BRAIN INJURY IS ANOTHER DOMAIN THERE'S BEEN FROM WHAT I UNDERSTAND SUCCESSFUL INTEGRATION OF DIFFERENT COMPETENCIES TO THE TEAM. THOE ARE SOME IDEAS. THANKS. >> I HAVE A FEW PEOPLE QUEUED UP. I WANT TO MAKE SURE SOMEONE HELPS US UNDERSTAND HOW TO BRING THE VOICE OF THE PATIENT INTO THE RESEARCH TEAM AS WELL. BUT AT THIS POINT I HAVE IN THIS ORDER I WILL TAKE ALLISON HARVEY, BILLY SHANI AND SEAN IVERSON AND LOOKS LIKE I HAVE A FEW MORE, LET'S START WITH THOSE THREE AND WE WILL GET THE REST. >> THANK YOU. I WANT TO EXPAND A LITTLE BIT ON DR. BRAD'S HELPFUL COMMENT. PARTICULARLY THINKING ABOUT WHAT CONSTITUTES COMPETENT CLINICIAN. I THINK THERE ARE PROBABLY TWO CHOICES, MAYBE MORE, BUT ONE IS TO START WITH FULLY QUALIFIED CARD CARRYING MUSIC CLINICIANS. ANOTHER CHOICE IS TO START DEPLOYMENT FOCUSED VIEWPOINT. IN OTHER WORDS LOOKING ON THE TRACK AND SAYING ONCE WE HAVE GOT SOMETHING SUCCESSFUL HOW ARE WE GOING TO ROLE IT OUT NATIONALLY AND INTERNATIONALLY. IF WE ONLY STICK WITH THE CARD CARRYING BEST PEOPLE, WE ARE NOT GOING TO BE ABLE TO ROLE THAT OUT. SO I THINK THAT IS A CHOICE POINT. BRIEFLY EXAMPLE Ph.D.s AND CLINICAL PSYCHOLOGY WHEN I WAS TRAINING WITH PEOPLE WHO DID CBT. THAT'S JUST NOT GOING TO BE ABLE TO BE IMPLEMENTED IN THE FIELD WHEN THERE ARE NOT ENOUGH OF US. SO NOW WE ARE TEACHING CBT TO LOTS OF PEOPLE, TO MASTERS TRAIN PEOPLE TO BACHELOR'S TRAIN PEOPLE TO PEER PROVIDERS, PEOPLE WITH LIVED EXPERIENCE. THAT ROLL OUT IS GOING EXCEPTIONALLY WELL. SO THAT'S MAYBE A CHOICE POINT TO THINK ABOUT FULLY AND I THINK THE BUZZ WORD IS DEPLOYMENT FOCUSED. ROLL OUT AND DEVELOPMENT. THANK YOU. >> THANK YOU. BILLY. >> I WANT TO TALK ABOUT THE IMPORTANCE OF HAVING EXPERTISE IN DATA CURATION ON THE TEAM. THIS LETS TO SHAI'S PRESENTATION ABOUT TALK ABOUT TRANSPARENCY. I THINK THAT MANY CLINICAL TRIALS DO PHENOMENAL JOB DESCRIBING THE PROTOCOL FOR THE STUDY AND FOR THE INTERVENTION BUT MANY CASES PROCESS PROCONTROL FOR DATA CURATION IS NOT CLEAR, IT IS NOT CLEAR HOW DATA WAS HANDLED, WAS MANAGED, INTEGRATED, HOW MISSING DATA WAS HANDLED SO ON, THE INTERESTING THING ABOUT IT IS THESE ASSUMPTIONS THAT WE ARE MAKING AND INTEGRATING AND CURATING THE DATA THEY HAVE IMPLICATIONS ON THE RESULTS THAT WE GET. SO I THINK IT IS TIME FOR US TO THINK ABOUT HOW TO OPERATIONALIZE THIS ROLE OF DATA CURATION AND FORMALIZE THIS PART OF THE TEAM. >> THANK YOU. >> SO THE NEUROSCIENCE GROUP WE DELEGATED DIFFERENT PERSON FOR EACH THEME SO THOUGHT I WOULD BRING UP WHAT IS DISCUSSED WE ALL AGREE ON THE BASIC OUTLINES, THE ASPIRATIONS OF HAVING DIVERSE TEAMS BUT IT IS IMPORTANT TO RECOGNIZE THAT THAT'S ALL A LOT EASIER SAID THAN DONE IN CASE, YOKA BROUGHT UP AN OBVIOUS BOTTLE NECK WHICH IS HOW DO YOU BOOT STRAP THESE TEAMS IF YOU HAVEN'T WORKED TOGETHER BEFORE. AND PARTICULARLY IN BRINGING THE CLINICAL, DEEP CLINICAL EXPERT EXPERTISE TOGETHER WITH SOME OF THE MORE MECHANISTIC EXPERTISE. I WOULD LOVE TO TALK MORE THINK ABOUT HOW THEY CAN FACILITATE THAT. AND THESE THINGS TAKE A LOT OF TIME. ND A LOT OF INVESTMENT OF TIME AHEAD -- BEFORE YOU CAN GET TO THE EXPERIMENTAL DESIGN SO I WOULD LIKE TO THINK ABOUT WAYS TO FACILITATE THAT. >> GREAT. I'M GOING TO BRING IN BARBARA ELLS ELIZABETH ANDREA MONA HIC CONTAINERBOARDS. THEN WE WILL SEE WHERE WE ARE ON TIME. >> I WAS THINKING ABOUT DR. HARVEY'S COMMENT ALSO IN TALKING ABOUT THE VOICE OF THE PATIENT. SO BEING ON THE PATIENT ADVOCACY AND ARTS ORGANIZATION SUBGROUP AND REPRESENTED AMERICAN MUSIC THERAPY ASSOCIATESIATION AS PROFESSIONAL ASSOCIATION WE THINK ABOUT THE IMPORTANCE OF THE PATIENT EARLY ON AS PARTS OF THE TEAM AND THE PLANNING OF THE RESEARCH, ONE VERY IMPORTANT REASON TO DO THAT IS THAT IT IS COMMON PLACE FOR POLICY MAKERS AND DECISION MAKERS WHETHER WE ARE GOING TO ALLOW MUSIC THERAPY OR MUSIC BASED INTERVENTION INTO THAT NURSING HOME OR INTO THAT FACILITY OR HOSPITAL IS THEY FOCUS ON OUTCOMES, THEY TEND TO FOCUS ON CLINICAL OUTCOMES, BUT ALSO THINKING ALLISON'S REMARK WE WANT THAT PATIENT VOICE THERE TO REPRESENT THE IMPORTANCE OF DESIGN OF THIS STUDY WAY UPSTREAM BECAUSE THERE IS IMPLICATIONS DOWNSTREAM FROM A POLICY MAKING POINT OF VIEW. AND WE WANT TO HIT ON THAT EARLY. AND DOWNSTREAM FROM PRACTICALITY THAT DR. HARVEY WAS TALKING ABOUT, AND THE IMPLEMENTATION THE PATIENT INVOLVEMENT THEMSELVES COULD BE IMPLIED IN THE DELIVERY OF THE IMPLEMENTATION. SO JUST BECAUSE I'M A CARD CARRYING BOARD CERTIFIED MUSIC THERAPIST, I WANT TO BE SURE THAT WE HAVE A PRACTICAL PROTOCOL. FOR EXAMPLE, TO PUT THIS IN REAL LIFE TERMS WE THINK ABOUT EARLY STAGE DEMENTIAS IN THE COMMUNITY AND WORKING WITH THE CAREGIVER WHO COULD BE SPOUSE OR FAMILY MEMBER, AND THE DELIVERY OF THAT IMPLEMENTATION THEMSELVES IN THE HOME. THANK YOU. >> THANK YOU. >> I WANTED TO TALK MORE ON TRAINING ASPECT THINGS AND NEWER INVESTIGATORS WANTING TO GET INVOLVED TWO POINTS. ONE POINT IS TO BRING THOSE CLINICS I WANT THE STRESS EARLY ON, PRACTICING MUSIC THERAPISTS WHAT YOU MIGHT DO MANY PRACTICE MAYBE DIFFERENT THAN WHAT YOU ARE ASKED TO DO IN AN INTERVENTION BECAUSE OF THE RIGOR OF THE SCIENCE. AND SO YOU WANT TO MAKE SURE THAT YOUR INTERVENTIONISTS REALLY ARE ON BOARD WITH YOU FROM THE BEGINNING TO MAKE SURE THEY ARE FOLLOWING THE RIGOR NEEDED FOR THE RESEARCH STUDY. THE SECOND POINT IS WHEN WE TALK COLLABORATIVE WORK I KNOW AS A YOUNGER INVESTIGATOR, I MAY HAVE NEVER PUBLISHED WITH SOMEONE THAT I'M PUTTING IN A GRANT IN, MAY NOT HAVE GOTTEN A GRANT WITH THAT PERSON BEFORE BUT WE DEVELOPED A RELATIONSHIP OVER THE LAST SEVERAL YEARS THAT MAYBE INVOLVES ADVISING A GRADUATE STUDENT TOGETHER OR OTHER WAYS. SO I WANT TO BRING A POSITIVE LIGHT THAT THERE ARE OTHER WAYS YOU CAN HIGHLIGHT YOUR COLLABORATION WITHIN THESE DIFFERENT AREAS EVEN IF THEY HAVEN'T ACTUALLY COME FORTH AS PUBLICATION OR A GRANT. ESPECIALLY FOR YOUNG INVESTIGATORS. >> THANK YOU. RA MONA. >> SO I WANT TO MENTION THE PERSONS WITH LIVED EXPERIENCE ARE OF COURSE CRITICAL AND BRING SURPRISING INSIGHT, AS I SAID WE DID HAVE A THINK TANK AROUND THIS TOPIC AND ONE OFTHE MOST CRITICAL PEOPLE WAS A YOUNG WOMAN WHO HAS BEEN TRAINED AS PROFESSIONAL MUSICIAN AND THEN HAD A BEHAVIORAL HEALTH PROBLEM SHE NEEDED THERAPY AND SHE WAS PUT INTO A GROUP MUSIC PROGRAM AND SHE JUST HATED IT SO REALLY IMPORTANT TO BRING THEM IN. THEY OFTEN CAN'T BE BROUGHT IN WITHOUT SUPPORT SO A CRITICAL THING IS TO FIGURE OUT WAY TO BRING THEM IN IN AS CONSULTANTS OR GIVEN THEM STIPENDS BECAUSE THEY AREN'T IN FIELD WHERE THEY CAN ABSORB THIS AS PART OF THEIR JOB. IN TERMS OF THE INTERSECTION OF FIELDS IN THE CROSS TALK NEEDED, THAT'S I THINK A GREAT PLACE FOR THE NON-PROFITS. WE HAVE BROUGHT -- CONVENED MANY THINK TANKS AND ALWAYS TRY TO BRING PERSONS WITH LIVED EXPERIENCES, BUT OTHERS ON BOARD AND SO I THINK THAT'S SOMETHING TO CONSIDER TRYING TO LEVERAGE SOME OF THE NON-PROFITS INTERESTED IN THIS SPACE. WE ALSO REALLY ADVOCATE FOR FAMILIES ESPECIALLY PARENTS, THIS IS AN OLDER GROUP SO BUT WITH YOUNGER PEOPLE. I FOUND THE ROLE OF THE FAMILY IS SO IMPORTANT AND THEY ARE OFTEN REALLY NOT BROUGHT IN SO I WOULD ADD THEM TO THE LIST. AND LASTLY, I THINK THAT THIS IDEA OF A PROCESS FOR DATA CURATION IS ON TARGET. WE ACTUALLY WITH -- DID A CONSENSUS MEETING. WE HAVE A CONSENSUS REPORT WITH A TOOL FOR THIS. I'M NOT SAYING IT IS THE THE ONLY ONE BUT I WANT TO SAY I ALSO THINK IT IS REALLY IMPORTANT ACKNOWLEDGE ESPECIALLY FOR LARGER STUDIES, THE IMPORTANCE OF ALSO HAVING A WAY TO GO BACK AND FIND OUT ABOUT THE DATA BEHIND THE STUDY. >> SO I'M GOING TORY TO MOVE FAIRLY QUICKRY THROUGH BELGRAVE ROBERT SATORI AND JEFF AND AT THAT POINT WE'LL NEED TO MOVE TO THE NEXT THEME. >> HI, EVERYBODY. I JUST HAD A QUICK THOUGHT WHEN TALKING ABOUT BRINGING IN PATIENTS. TO THE TABLE. AND THINKING ABOUT THAT SAMPLE WE TALKED ABOUT EARLIER AND DIVERSITY ON AGING AND REALIZING AGING POPULATION IS DIVERSE ON VARIOUS SOCIAL IDENTITIES AND HOW THOSE IDENTIFIES AFFECT PERSONS WILLINGNESS FOR THERAPY. WILLINGNESS FOR HOW THEY APPROACH HEALTH AND MAKING SURE THAT'S PART OF THE PROCESS AS WELL. KNOWING THE DIFFERENT PEOPLE WILL ACCESS MUSIC IN VARIOUS DIFFERENT WAYS RELATED TO HOW HAY SEE THEMSELVES. >> THANK YOU, DR. SATORI. >> I WANTED TO MAKE A QUICK COMMENT WHICH IS THAT IN THE COLLABORATION OF THE TEAM MEMBERSHIP WE SHOULD KEEP AN OPEN MIND ABOUT WHAT KIND OF PEOPLE MIGHT BE NEEDED BECAUSE VERY MUCH DEPENDS ON THE MODEL YOU ARE PROPOSING OF INTERVENTION SOUNDS TO ME LIKE DISCUSSION SO FAR HAS FOCUSED VERY MUCH ON TRADITION TRADITIONAL MODEL WHERE WILL IS A THERAPIST, A PATIENT, FAMILY, CLINICIANS TREATING THE PATIENT. THAT'S ALL GREAT. BUT WE MIGHT WANT TO BROADEN THE DISCUSSION TO THINK ABOUT SITUATIONS WHERE MAYBE THE INTERVENTION IS DELIVERED ON AN APP ON YOUR PHONE. THAT IS A GOOD MODEL AND THERE MIGHT BE GOOD OPPORTUNITIES THERE, DR. HARVEY WAS MENTIONING HOW DIFFICULT IT IS TO SCALE SOME OF THESE THINGS DEPENDING ON NATURE OF THE INTERVENTION, YOU MIGHT BE ABLE THE DO SOMETHING MAYBE INTERNET BASED THAT MAY NOT WORK AT ALL IF YOU NEED TO BE AT THE PATIENT BEDSIDE AND DELIVER SOME KIND OF VERY DIRECT PERSONAL MOTIVE THING BUT P YOU ARE TRYING TO SOLVE A PATIENT MOTOR PROBLEMS, MAYBE THAT DOESN'T LIAR THE SAME TEAM. THAT IS ONE COMMENT TO BE SURE WE CONSIDER OTHER APPROACH BESIDES THE CONVENTIONAL ONE. >> >> VERY QUICKLY. I HAVE SEEN SOME SIGNS LATELY THAT INCORP RAYEDED EXPERTS USER CENTER DESIGN THAT HAVE DONE A GOOD JOB OF INCORPORATING PATIENT CAREGIVER FAMILY VOICE, LASTLY I HAVE BEEN IN NUMBERS OF CLINICAL TRIALS WHERE I WISH WE INVOLVE BASIC SCIENTIST MECHANISTIC SCIENTIST FROM THE BEGINNING TO STUDY WHAT WE ARE SEEING IN THE MACRO LEVEL. SHOULD BE PART OF THESE TEAMS. >> THIS SHOULD HAVE COME UNDER THE BELIEVEIOUS HEADING BUT I WILL THROW IT OUT THERE ANYWAY. WHEN WE TALK ABOUT PATIENT CENTERED CARYOCAR AND THINKING ABOUT THE QUALITATIVE ASPECT OF RESEARCH WE HAVE BEEN TALKING ABOUT, MAYBE UNDERSTANDING SOMEONE'S MUSICAL HISTORY, AS WE UNDERSTAND CLINICAL HISTORY WOULD BE USEFUL AND MAYBE THIS DOESN'T COME UNDER INVESTIGATIVE TEAM BUT IT COMES TO MIND WHEN YOU THINK ABOUT FACTORS THAT MAY BE IMPORTANT TO HAVE -- WHAT KNOWLEDGE YOU IMMEDIATE TO HAVE PERHAPS AT TABLE. >> I LIKE THE NOTION THAT WE HAVE DESIGNED THE PLATONIC TEAM AND PLATONIC TEAM PROBABLY WON'T EXIST FOR EVERY PROJECT BUT WE HAVE IDENTIFIED QUITE A ROBUST LIST AND SET OF CONSIDERATIONS FOR ANY ONE TRYING TO PUT TOGETHER A STUDY TO MAKE SURE THEY THOUGHT THROUGH THE POTENTIAL ROLE OF THESE DIFFERENT PARTIES AND WE HAVE TALKED ABOUT DYNAMICS BOTH HAVING WORKED TOGETHER, HAVING GOOD MANAGEMENT, BRINGING IN WORK FORCE DEVELOPMENT FOR THE NEXT GENERATION, I THINK THIS IS -- WE COVERED ACTUALLY A LOT OF GROUND IN THAT SHORT SEGMENT. OUR LAST THEME BEFORE WE TAKE A SHORT BREAK WITH EMPHASIS ON SHORT, IS THAT WE ARE GOING TO TALK ABOUT THE BUILDING BLOCKS FOR RIGOROUS AND REPRODUCIBILITY MUSIC BASED INTERVENTIONS. THIS STARTS TO HARMONIZE TOPICS WE HAVE BEEN DISCUSSING AND SO IT SHOWS THIS IS NOT A LINEAR CONVERSATION, BUT WE'LL MOVE SIGNIFICANTLY FORWARD. I WILL START BY ASKING SHERRY FROM YOUR GROUP. >> SO I'M GOING TO NOT BE ABLE THE GIVE A COMPREHENSIVE OVERVIEW OF ALL THE ITEMS THAT ARE SUB -- OUR SUBGROUP DISCUSSED BUT I'M CONFIDENT THEY WILL CHIME IN TO SPEAK TO SOME OF THE TOPICS THAT I DIDN'T ADDRESS. I'M GOING TO FOCUS ON TWO PARTICULAR TOPICS ONE BEING TREATMENT FIDELITY AND ONE BEING CONTROL GROUPS. SO ALSO A RECENT REVIEW THAT LOOKED AT REPORTING QUALITY OF MUSIC BASED INTERVENTIONS AND HEALTHCARE. IT SHOWED LESS THAN 50% OF THOSE TRIALS REPORTED STRATEGIES FOR REPORTING OR ADDRESSING TREATMENT FIDELITY. WE KNOW TREATMENT FIDELITY BEGINS WITH STUDY DESIGN AND BUILDS UPON PRIOR CONVERSATIONS ABOUT THE USE OF THREE LETCAL AND SCIENTIFIC FRAME WORKS. BUT IT ALSO INCLUDES METHOD LOGICAL STRATEGIES THAT HELP ENSURE THAT THE INTERVENTIONS THAT ARE BEING DELIVERED OVER THE COURSE OF CLINICAL TRIAL ARE ACTUALLY DELIVERED CONSISTENTLY. ACROSS DIFFERENT INTERVENTIONISTS, DIFFERENT SITES, AND OVER TIME. SO WHAT THAT DOES IS STRENGTHENS OUR ABILITY TO TO ATTRIBUTE ANY OBSERVED BENEFIT WE HAD WAS DUE TO THE INTERVENTION UNDER INVESTIGATION AND NOT SOMETHING ELSE. SO GIVEN THE COMPLEXITY OF MUSIC INTERVENTIONS, ESPECIALLY MULTI-COMPONENT INTERVENTIONS, IT IS ESSENTIAL THAT INVESTIGATORS SPECIFY WHAT ARE THE ESSENTIAL ELEMENTS OF THE INTERVENTION, THEY CREATE STANDARDIZED PROTOCOLS THAT THEY STANDARDIZE TRAINING FOR THOSE PROVIDERS, AND THEN THEY HAVE RIGOROUS STRATEGIES FOR BOTH SELF AND EXTERNAL QUALITY ASSURANCE MONITORING THAT'S DONE OVER TIME. THE REALLY IMPORTANT PART OF TREATMENT FIDELITY IS THAT IT ACTUALLY DOES REDUCE RANDOM AND UNINTENDED INTERVENTION VARIABILITY. WHICH ALSO MEANS ULTIMATELY WE ARE IMPROVING OUR STABILITYCAL POWER TO DETECT DIFFERENCES. SO ONE OF THE RESOURCES THAT WE PROVIDE IN OUR REPORT, IS THE NIH BEHAVIOR CHANGE CONSORTIUM RECOMMENDATIONS FOR TREATMENT FIDELITY WHICH CUTS ACROSS FIVE AREAS AND THERE ARE ALSO ADDITIONAL PUBLICATIONS FROM BORELLI AND COLLEAGUES FOR ASSESSMENT TOOL AND WE ARE STARTING TO SEE SEVERAL PUBLICATIONS ON MUSIC INTERVENTION TRIALS TALKING ABOUT TREATMENT FIDELITY STRATEGIES. SO BRIEFLY THE SECOND TOPIC IS CONTROL GROUPS. WHICH WE HAVE BEEN TALKING ABOUT SO FAR TODAY. ALTHOUGH COMPARATOR GROUP IS NOT ALWAYS NECESSARY, FOR EARLY PHASE TRIALS WHICH I THINK SOMETHING TOO IMPORTANT TO REMEMBER, IT IS A CRITICAL DESIGN FEATURE FOR RANDOMIZE CONTROL TRIALS. SO THERE IS A 2019 NIH EXPERT PANEL RECOMMENDATION PUBLICATION. THAT TALKS ABOUT THIS SELECTION OF COMPARATOR GROUPS OR RCTs AND IN THEIR SUMMARY THE PANEL NOTED THAT COMPARATORS ARE THE LIGHTNING ROD OF HEALTH RELATED BEHAVIORAL INTERVENTION RESEARCH, THEY ATTRACT THUNDER BOLTS OF CONTROVERSY DIVERTING US FROM SCRUTINIZING THE PURPOSE AND GOALS OF OUR TRIALS. AND I THINK THIS IS REALLY IMPORTANT, THEY PUBLISHED THIS NOT JUST TO INFORM SELECTION OF COMPARATORS BY INVESTIGATORS BUT ALSO BY REVIEWERS AN CONSUMERS OF RESEARCH. IT IS THE GOALS, THE PURPOSE, RESEARCH QUESTIONS THAT DRIVE SELECTION OF THE COMPARATOR GROUP. AS MENTIONED BEFORE IN EARLY PHASE TRIALS YOU MAY BE WORKING TO DETECT THE SIGNAL. IN THOSE CASES YOU MAY NOT HAVE A COMPARISON GROUP, IT MAY BE THAT YOU ARE -- HAVE NO COMPARISON GROUP OR MAYBE IT IS USUAL CARE. OR WAIT LIST CONTROL GROUP. AS YOU GO THROUGH DIFFERENT PHASES OF THE INTERVENTION TRIAL, THE OTHER QUESTIONS ASKED THAT ARE RELEVANT TO THAT ARE WHETHER EFFICACY TRIAL, IN THAT CASE YOU NEED MORE RIGOROUS COMPARE TON. BUT IF WE ASK QUESTIONS HOW AND WHY INTERVENTION WORKS, IT MAY BE MORE IMPORTANT THE ISOLATE ACTIVE OR NON-SPECIFIC COMPONENTS OF THE INTERVENTION AND USE THOSE TO DRIVE DESIGN OF THE COMPARATOR GROUP. IT IS NOT ALWAYS THEY HAVE TO BE EQUAL IN EVERY WAY. OFTEN TIMES IT IS THE QUESTIONS THAT WE ARE ASKING THAT SHOULD INFORM THE SELECTION OF WHAT THAT CONTROL CONDITION IS GOING TO LOOK LIKE. SO IT LOOKS QUITE DIFFERENT DEPEND ON PHASE OF THE TRIAL AND THE TYPES OF QUESTIONS THAT ARE BEING ASKED. >> GREAT. SUFFICIENT AN EXCELLENT START TO THIS CONVERSATION. I WILL TURN NOW TO DON EDMONDSON. >> I'M GOING TO SPEAK BRIEFLY BECAUSE DR. GLORIA YE IS GOING THE TALK FOR OUR GROUP BUT WHEN WE ARE THINKING ABOUT BUILDING BLOCKS OF INTERVENTION, IN BEHAVIORAL SCIENCE THERE WAS A SCIENCE SMALL GROUP SCIENTIST IN THE UK WHO MADE A HERCULEAN EFFORT TO GO SYSTEMATIZE THE SMALLEST ACTIVE UNIT OF BEHAVIORAL INTERVENTION, BEHAVIOR CHANGE TECHNIQUES OR BCTs, DR. SUSAN MICY HUMAN BEHAVIOR CHANGE PROJECT. IT IS A NICE FRAMEWORK FOR THINKING ABOUT PARTICULARLY EARLY ON I IMAGINE MUSIC INTERVENTIONS WILL SHARE SIMILARITIES WITH BEHAVIORAL INTERVENTIONS AND THAT IT IS VERY RARE TO HAVE AN INTERVENTION THAT IS NOT ACTUALLY A BUNCH OF INTERVENTIONS OR POTENTIALLY ACTIVE COMPONENTS OF THINGS. WE ARE WORKING WITH THEM FROM THIS BEHAVIOR CHANGE PROGRAM TO LEARN ABOUT THE MECHANISMS ASSOCIATED WITH EACH OF THOSE SMALL UNITS OF BCTs. NOW I WILL SHUT UP AND TURN OVER TO DR. GLORIA. >> THANKS, DON. SO I THINK MUCH OF OUR DISCUSSION IN THE BEHAVIORAL INTERVENTION GROUP A LOT IS ALREADY COME UP BUT WE TALKED ABOUT STRATEGIES FOR DEVELOPMENT AND DELIVERY AND TWO MAJOR BINS OF CONSIDERATION, ONE WAS REALLY JUST BEING VERY THOUGHTFUL IN Q4 DESIGN AND DEVELOPMENT AND A SECOND WAS BEING THOUGHTFUL AND YOUR MEASUREMENT AND REPORTING. SO WHEN THAT FIRST BIN WE TALKED ABOUT BEFORE THERE WAS EMPHASIS IN OUR GROUP ON GROUNDING THE DESIGN AND KNOWLEDGE OF BASIC MECHANISMS WHETHER THAT'S NEUROSCIENCE OR PSYCHOLOGY OR BEHAVIORAL SCIENCE, PARTICULARLY DEVELOPING A NEW INTERVENTION. AT THE SAME TIME WE RECOGNIZED THE VALUE AND THE O IN A MORE PRAGMATIC APPROACH STARTING WITH WHAT IS BEING USED AND PERHAPS HELPFUL IN PRACTICE THAN IF THAT WAS SEEN AS HELPFUL AS A WHOLE MOVING TO DISMANTLE ACTIVE INGREDIENTS AND OPTIMIZING USING THINGS LIKE DR. COLLINS MULTI-PHASE OPTIMIZATION STRATEGY. THE SECOND BIG TOPIC IN THIS HAS BEEN WAS BEING VERY CLEARLY ARTICULATING THE RATIONALE OF ANY SPECIFIC INTERVENTIONS WHY AND HOW THAT PARTICULAR INTERVENTION FOR THAT PARTICULAR TARGET AUDIENCE. AND LEARNING FROM THE MIND BODY RESEARCH SPACE WHERE THERE IS A LOT OF HETEROGENEITY IN PARTICULAR INTERVENTIONS, OFTEN NOT SO CLEAR WHY A PARTICULAR STYLE OR FORM OR SOMETHING LIKE THAT IS CHOSEN. SO IN THIS DISCUSSION WE TALKED ABOUT SPECIFICITY AND GRANULARITY BEING IMPORTANT AND HELPING TO ELEVATE THE RIGOR MUSIC BASE RESEARCH. SO THE SECOND BIN WAS ABOUT THOUGHTFUL MEASUREMENT AND REPORTING AND I THINK THIS GOES TO THAT TRANSPARENCY THAT MANY TALKED ABOUT, DR. SILBERBERG TALKED ABOUT. SO THE FIRST WAS THAT CONSIDERING HOW YOU ARE GOING TO MEASURE THE BEST MEASUREMENT AND THEN REPORTING, REPORTING BEING VERY IMPORTANT THERE. THAT APPLIES TO INTERVENTION COMPONENTS THEMSELVES LIKE MUSIC RHYTHM, TEMPO, VOLUME, BUT ALSO THE TIMING, THE FREQUENCY, BUT THEN ALSO THINGS LIKE HOME PRACTICE IF RELEVANT, ALSO CONSIDERING MEASUREMENT AND REPORTING OF THAT HUMAN INTERACTION COMPONENT WHETHER IT IS A PATIENT THERAPIST, VERSUS SIMPLE MUSIC RECORDING. AND HOW MIGHT YOU ACTUALLY CAPTURE SOMETHING LIKE THAT. THAT INTERACTION AND REPORT THAT. THEN THE OTHER PART OF THAT WAS DOSE, WE TALKED ABOUT THE DOSE, YOU CAN IMAGINE THAT UNDERSTANDING DOSE IN MUSIC INTERVENTIONS MAYBE SIMILARLY CHALLENGING TO MIND BODY THERAPIES, IS IT ENOUGH YOU LOG CLOCK TIME IN LISTENING TO A CERTAIN TYPE OF MUSIC. OR IS THERE A WAY THAT YOU ARE INTERACTING WITH THE MUSIC THAT'S IMPORTANT TO ACHIEVE A CERTAIN DOSE. SO LIKE IN MIND BODY MOVEMENTS LIKE TAI CHI IS MINDFUL MOVEMENT IMPORTANT BEYOND PHYSICAL MOTIONS. WITH YOUR ATTENTION ELSEWHERE. SO REALLY CONSIDERING THINGS LIKE THAT. THE OTHER -- LAST THING I THINK WAS THERE ALREADY SPOKEN ABOUT IS BEING EXPLICIT AND BUILDING INTERVENTION FIDELITY MONITORING INTO THIS STUDIES. USING FIDELITY CHECKLISTS ARE RANDOM OBSERVATION SESSIONS, SINCE THE MUSIC INTERVENTION MAYBE MORE LIKELY TO BE THESE HETEROGENOUS MULTI-MODAL AS WE SAID BEHAVIORAL INTERVENTIONS THAT ARE OFTEN TIMES VERY DIFFICULT TO STANDARDIZE. >> THANK YOU. OUR THIRD OPENER ON THIS IS YOKA (INAUDIBLE). >> THANK YOU. EXCELLENT POINTS HAVE BEEN MADE. I WILL BRING FORWARD A COUPLE OF THINGS WE ALSO MENTION IN OUR GROUP DISCUSSION. THAT MAY NOT HAVE BEEN MENTIONED YET OR SOMETHING ADDITIONAL TO ADD. GLORIA SAID ABOUT THE IMPORTANCE OF HAVING GOOD RATIONALE AND REASONING FOR WHY SPECIFIC INTERVENTION WITH THAT POPULATION. SO WHEN WE WERE YOU CANNING ACTUAL INTERVENTION WE THOUGHT WOULD NEED TO BREAK THE DISCUSSION BETWEEN CONTENT TYPE OF INTERVENTION AND STRUCTURAL COMPONENTS OF THE INTERVENTION SUCH AS DELIVERY FORMAT FREQUENCY DOSE AND SO ON. WHEN WE WERE TALKING ABOUT SPECIFIC INTERVENTION WE FELL THAT WAS OF COURSE SHOULD BE DRIVEN SIGNIFICANTLY BY CONCEPTUAL FRAMEWORK OR DETERMINED BY CONCEPTUAL FRAMEWORK AND ALSO PRIOR CLINICAL PRACTICE. WHEN WE TALKED ABOUT DECISIONS AROUND THE ACTUAL STRUCTURAL COMPONENT SUCH AS DELIVERY FORMAT FREQUENCY AND SO ON, THAT SHOULD BE INFORMED BY SYSTEMATIC BUILDING OF RESEARCH. THAT RESEARCH STUDIES THAT REALLY ADDRESS THESE DOSING -- DOSAGE AND FREQUENCY QUESTIONS, AS WELL AS CONSIDERATIONS AROUND UPTAKE SO REALITY OF THE CLINICAL PRACTICE, MAYBE THAT WE THINK 20 SESSIONS ONE A GREAT IDEA BUT YOUR CLINICAL STUDY MAY SAY THAT WILL NEVER BE REALITY, NEVER BE POSSIBLE, INSURACE REIMBURSEMENT PRACTICES, SO THERE'S MANY FACTORS THAT NEED TO BE TAKEN INTO ACCOUNT EARLY ON. ONE THING SO IMPORTANT IS THAT WE ARE VERY CARFUL BUILDING SYSTEMATIC RESEARCH. ALL TOO OFTEN I SEE ANOTHER RESEARCH STUDY PUBLISHED ON GIVE AN EXAMPLE BECAUSE I WAS IN THE MIDST OF THIS I UPDATED A COCHRAN REVIEW ON MUSIC INTERVENTION WITH CANCER PATIENTS. WE HAVE SO MANY STUDIES ON LISTENING TO MUSIC FOR ANXIETY REDUCTION AND CANCER RESERVATIONS. IT IS OFTEN SAME STUDIES OVER AND OVER AGAIN, LISTENING TO 30 MINUTES OF MUSIC AND YOU MEASURED THE ANXIETY OUTCOME. WE KNOW THAT THAT WORKS. IT IS TIME TO MOVE RESEARCH FORWARD TO SYSTEMATICALLY BUILD AND BEBIN TO REFINE THIS INTERVENTION SO THAT WE CAN OPTIMIZE THAT INTERVENTION AS MUCH AS POSSIBLE. THAT IS ONE EXAMPLE BUT ALSO IN MUSIC THERAPY RESEARCH WHERE MUSIC DELIVERS INTERVENTION, THE IMPORTANCE OF THE TREATMENT FIDELITY IS CRUCIAL IN HAVING MUSIC THERAPY TREATMENT PROTOCOL. EQUALLY CRUCIAL IS TO CONSIDER INVOLVING AGAIN THE STAKEHOLDER VOICE EARLY ON IN TERMS OF WHAT EXAMPLE THROUGH MIX METHODS RESEARCH SO YOU ALSO LEARN FROM THEM IS AN INTERVENTION IS DELIVERED WITH GREAT TREATMENT FIDELITY. WE STILL NEED TO KNOW HOW DO THEY PERCEIVE THE INTERVENTION. WOULD YOU EVER SIGN UP FOR INTERVENTION IF THEY WERE TO GET TO REFER TO MUSIC INTERVENTION LIKE THIS, TO GO FOR IT, TO PLAY FOR IT. WHAT WAS THEIR EXPERIENCE OF PERCEIVED BENEFIT, MAYBE THEY GOT ADDITIONAL BENEFIT OUT OF IT, THAT WE DIDN'T MEASURE THAT WE DIDN'T THINK ABOUT MAYBE THEY HAVE IDEAS PREFER WE FINDING INTERVENTION SO AGAIN BY EARLY ON INVOLVING YOUR STAKEHOLDER IT HELPS YOU TO FURTHER REFINE THAT ENTERSECTION NEXT STUDY TEST WE DEFINE INTERVENTION ADAPTIVE TREATMENT PROTOCOL AND TREATMENT FIDELITY PROCEDURES. I THINK THAT USE INVOLVEMENT AGAIN KEEPS ON COMING BACK BUT SO IMPORTANT IN THIS KIND OF RESEARCH. >> I WILL BRING IN ERIC GARLAND THEN MICHAEL. >> >> I APPRECIATE THE GREAT COMMENTS THAT WERE RAISED: I THINK GIVEN THE JUNCTURE WE ARE AT IN TERMS OF HELPING TO FURTHER DEVELOPMENT OF THIS FIELD, CONSIDERATIONS OF INTERVENTION PARAMETERS LIKE DOSE FREQUENCY, ET CETERA REALLY AT THIS STAGE WOULD BE FRUITFUL TO TREAT THEM NOT AS OBSERVED VARIABLES SO DON'T APPROACH THIS FROM OBSERVATIONAL RESEARCH STANDPOINT BUT RATHER APPROACH IT FROM AN EXPERIMENTAL STANDPOINT IN TERMS OF THESE ARE VARIABLES THAT RESEARCH DESIGNS SHOULD BE MANIPULATED IN ORDER TO TEST THE IMPACT OF VARIOUS INTERVENTION PACKAGES. SO GLOVER RA RAISED LINDA COLLINS MOST DESIGN THINK IT WOULD BE USEFUL UNDER THESE CIRCUMSTANCES MULTI-PHASE OPTIMIZATION STRATEGY USING A FACTORIAL APPROACH TO TEST THE INDEPENDENT INTERACTIVE EFFECTS OF MODULATING DIFFERENT PARAMETERS. SO TWO SESSIONS VERSUS FOUR SESSIONS. A RHYTHM OF I DON'T KNOW X NUMBER OF BEATS PER MINUTE VERSUS ANOTHER BEATS PER MINUTE. TAKING EXPERIMENTAL APPROACH TO MODULATE THESE FACTORS TO GET AT THE CAUSAL EFFECT OF DIFFERENT INTERVENTION COMPONENTS, DESIGN THE MOST EFFICACIOUS INTERVENTION POSSIBLE FROM THE BEGINNING, RATHER THAN WORKING BACKWARDS AND OBSERVING THESE VARIABLES THAT CORRELATIONAL WAY WITH AN EXISTING MUSIC INTERVENTION. >> MICHAEL, GO AHEAD. >> I WANT TO OFFER FOUR POINTS, NOT NECESSARILY NEW. SOME HAVE BEEN MENTIONED IN THE LAST FEW MINUTES. BUT BUT I WILL GIVE YOU THOSE FROM MY PERSPECTIVE, I REVIEW QUITE A BIT OF MUSIC BASED CLINICAL RESEARCH. AND MAYBE THIS IS A PRACTICAL IDEA WHAT I LOOK FOR AND IN TERMS WHAT WOULD BE FOR ME IN RIGOROUS CLINICAL TRIAL. NUMBER ONE, INTERVENTION HAS TO BE REPRODUCIBLE, A LOT OF MUSIC THERAPY, INTERVENTION RESEARCH INTERVENTION IS NOT WELL DEFINED OR SO INDIVIDUALISTIC THAT IT CANNOT BE REPRODUCED IN FIDELITY. IDEALLY YOU WANT TO HAVE AN EQUALIZED COMPARATOR GROUP, I AGREE THAT IS NOT ALWAYS POSSIBLE ESPECIALLY SINCE WE SOMETIMES FORGET THAT THE RCTs RESEARCH, DOING A LOT CLINICAL COHORT RESEARCH THAT DOESN'T LEND ITSELF HOW ARE YOU GOING TO DO LARGE SCALE RCT WITH TRAUMATIC BRAIN INJURY IS EXTREMELY DIFFICULT. SO THAT WOULD BE NUMBER TWO, THERE ARE I THINK AREA CLINICAL DESIGNS THAT ARE STILL RIGOROUS THAT MAY NOT END UP BEING CONSIDERED TECHNICALLY IN RCT BUT MAY CONTRIBUTE KNOWLEDGE, THE NUMBER -- THE THIRD POINT I'M LOOKING FOR IS TRY TO CREATE A DESIGN TO GIVE SOME EXPLANATORY POWER SO THAT YOU ARE NOT JUST STUCK AT THE END OF PROBABILITY. .5 IS A RANDOM TERM, IT COULD BE .06.03. SOMEBODY CAME UP WITH .05 BECAUSE MAYBE WE LIKE ROUND NUMBERS. TRY TO CREATE SOMETHING TREE CREATIVELY IN DESIGN SOME EXPLANATORY POWER WHY THIS GROUP BETTER AND WHAT ELEMENT IN THAT PARTICULAR INTERVENTION DROVE THE CHANGE. THE LAST POINT THAT I OFTEN HAVE ISSUE WITH IS ALSO ALREADY MENTION IS ISSUE OF DOSAGE. LOT OF TIMES THAT IS VERY RANDOMLY DEFINED, WE GOT TWO WEEKS AND WE WILL HAVE FIVE SESSIONS. THREE WEEKS AN 20 SESSIONS. AND SESSION -- EACH SESSION IS 30 MINKS, IS 45 MINUTES. VERY NOT OFTEN IS SOME EXPLANATORY SYSTEM BEHIND FRAMEWORK THAT SAYS THIS IS WHY WE ARE GOING FOR THREE WEEKS DAILY OR TWO WEEKS IN THESE KIND OF DISTANCES SO SPEND SOME TIME THINKING ABOUT -- DOES NOT JUST BECOME A CONVENIENCE -- THIS WE CAN'T AFFORD OR THIS SHOULD WORK. SO INTERVENTION REPRODUCIBLE CREATIVE DESIGNS NOT NECESSARY ALL BIG RCTs BUT THERE CAN BE RIGOROUS DESIGNS WITH EXPLANATORY POWER. JUSTIFY DOSAGE. THOSE ARE THE FOUR POINTS, I ALWAYS -- WHEN YOU LOOK AT REVIEWING. RESEARCH OF GRANT APPLICATION THAT COME OUT FROM MY EXPERIENCE. >> THANK YOU. I HAVE CARL AND BILLY. CARL. >> THANKS, IT MAY SOUND A LITTLE OR THOUGHT NOL TO EVERYTHING WE HAVE BEEN TALKING ABOUT IN TERMS OF BUILDING BLOCKS BUT IF WE THINK ABOUT CLINICAL TRIALS AND EXPERIMENTAL DESIGN AT LEAST FROM MY SIDE WE HAVEN'T TALKED ABOUT THE VERY IMPORTANT SIDE OF RISK AND THOUGH WE THINK INTERVENTIONS CARRY LOW RISK, WOULD BE VERY ADVANTAGEOUS FOR THE FIELD TO HAVE STANDARDIZED METHODS OF ASSESSING TOXICITY RISK SIDE EFFECTS, ADVERSE EVENTS HOWEVER YOU WANT TO NAME THEM BECAUSE ALTHOUGH OUR EFFICACY OUTCOMES MAYBE QUITE DIVERSE, IT WILL BE USEFUL TO HAVE A COMMON METRIC FOR THE RISK SIDE OF THE BENEFIT. THEN THEY DIFFER BY POPULATION BUT IT IS SOMETHING THAT WE HAVE THE PAY ATTENTION TO AND RISKS ASSOCIATED WITH, MUSIC BASED INTERVENTIONS MAYBE QUITE A BIT DIFFERENT THAN WHAT WE THINK OF FOR PHARMACO THERAPY. SO WE HAVEN'T TALKED A LOT HERE BUT IT IS SOMETHING THAT WE WILL AID US WHEN WE LOOK AT RISK BENEFIT RATIOS ABOUT DIFFERENT STRATEGIES HAVING A COMMON LEXICON AROUND RISK. EVEN THOUGH IT MIGHT BE SMALL. THANKS. >> GREAT. THANK YOU. BILLY. >> SO I WANT TO MAKE TWO POINTS. ONE IS ABOUT EXPERIMENTAL DESIGN, ONE IS ABOUT THE INTERVENTION DESIGN. SO THESE ARE TWO DIFFERENT THINGS. ABOUT THE EXPERIMENTAL DESIGN I KNOW SHERRY SAID THAT BUT THIS IS SOMETHING IMPORTANT TO EMPHASIZE, THERE IS A WIDE VARIETY OF EXPERIMENTAL APPROACH STUDY DESIGN APPROACH WE CAN USE TO ANSWER ALL KINDS OF SCIENTIFIC QUESTIONS ABOUT DEVELOPING BEHAVIORAL INTERVENTIONS, AT END OF THE DAY WHAT DESIGN WE CHOOSE HAS TO BE MOTIVATED WITH THE SCIENTIFIC QUESTIONS THAT WE HAVE, AND THE TYPE OF INTERVENTION THAT WE ARE TRYING TO DEVELOP. FOR EXAMPLE THERE'S DISCUSSION ABOT MULTI-COMPONENT INTERVENTIONS. YES MANY BEHAVIORAL INTERVENTION AND MUSIC BASED INTERVENTIONS MANY INCLUDE MULTIPLE COMPONENTS BUT SOME INTERVENTIONS INCLUDE SINGLE COMPONENT AND THAT'S OKAY. SO THE QUESTIONS THAT WOULD -- SO THAT SUCH AN INTERVENTION WOULD MOTIVATE WOULD BE DIFFERENT COMPARED TO A MULTI-COMPONENT INTERVENTION. SOMETIMES WE HAVE AN INTERVENTION THAT IS A PACKAGE THAT INCLUDES MULTIPLE ELEMENTS BUT WE CANNOT DISENTANGLE THEM FOR INVESTIGATION. THAT IS OKAY. THEN THE SCIENTIFIC QUESTIONS CAN BE AROUND IS THIS PACKAGE BETTER THAN CONTROL, WHAT ERIC SAID EARLIER SITUATION WHERE YOU HAVEN'T ESTABLISHED PACKAGE BUT YOU WANT TO IMPROVE IT. SO I THINK IT HAS TO DO WITH FIRST SPECIFYING TYPE OF INTERVENTION WE WANT TO DEVELOP AND THEN LAYING OUT CLEARLY THE SCIENTIFIC QUESTION WE WANT TO ASK. THAT IS ABOUT THE STUDY DESIGN, ABOUT THE INTERVENTION DESIGN, THIS CAME UP IN VARIOUS DISCUSSION ISSUE OF PATIENT SLOUGHMENT, PATIENT PARTICIPATION, I WOULD LIKE THE CALL PATIENT ENGAGEMENT. THIS IS CRITICAL BECAUSE WE CAN DEVELOP REALLY SOPHISTICATED AND POWERFUL INTERVENTIONS BUT AT THE END OF THE DAY, IF PATIENTS ARE NOT GOING TO USE THEM, AND THEY ARE NOT GOING TO ENGAGE IN THEM, AND BY ENGAGE I DON'T MEAN JUST SHOWING UP FOR THE FOUR SESSIONS IT IS ALSO BEING IMMERSED IN THE INTERVENTION AND EMOTIONALLY AND COGNITIVELY. I DON'T THINK THESE INTERVENTIONS WILL BE ABLE TO ACHIEVE THE ULTIMATE GOALS. NOW I'M GOING TO SWITCH TO TALKING ABOUT THE STUDY DESIGNS AGAIN, I THINK THAT WE NEED TO THINK ABOUT SCIENTIFIC QUESTIONS SURROUNDING PATIENT ENGAGEMENT. HOW DO WE GET PATIENTS TO ENGAGE IN THE INTERVENTION, WHAT ELEMENTS OF THE INTERVENTION CAN BE CAN WE INCORPORATE TO DO THAT. TO MAKE THIS PART OF THE INVESTIGATION. PART OF THE PROCESS OF OPTIMIZE INTERVENTION. >> JEFF WILLIAMSON. SPEAKER5: SOMEWHAT SECONDING WHAT BILLY JUST SAID, THERE ARE MODELS IN DRUG AND CHRONIC DISEASE TRIALS WHERE IT IS ACTUALLY A STRATEGY AND NOT A PARTICULAR AGENT TO -- THAT'S THE INTERVENTION, FOR EXAMPLE IN DIABETES WE HAVE HAD MANY STUDIES THAT HAVE -- MANY ANTI-BLOOD SUGAR LOWERING AGENTS AND THE GOAL WAS TO GET TO A HEMOGLOBIN A 1C OF X. AND THE PHYSICIAN AND THEIR PATIENT CAN DECIDE WHICH THEY WANT TO START WITH AND THEN ADD TWO OR THREE. SAME FOR HYPERTENSION, HYPE TENSION AT MANY DIFFERENT THERAPEUTIC REGIMENS SO THE PATIENT AND PHYSICIAN DECIDE WHERE WE WANT START BUT WE WANT THE GET TO THIS BLOOD PRESSURE. SO THERE ARE MODELS THAT CAN HELP THIS TYPE OF ENDEAVOR AS WELL. I THINK I'M SECONDING WHAT BILLY SAID, A LITTLE LESS ELOQUENTLY PROBABLY. THANK YOU. >> DR. SILBERBERG. >> THANKS. I WANT TO -- I THINK IT WAS CARL WHO TALKED ABOUT THE POTENTIAL DANGERS OF MUSIC, THE HARMFULNESS, THE POTENTIAL HARMFULNESS AND I GAVE THIS A LOT OF THOUGHT WHEN I WAS THINKING ABOUT THE PRESENTATION. DISEASE NOT SOMETHING TO TALK ABOUT BUT MUSIC IS USED AS A TORTURE INSTRUMENT AND OF COURSE THE LEVEL OF HARM MUSIC CAN DO AS AN INDIVIDUAL AND YOU CAN IMAGINE ACTUALLY HAD A SIDE CONVERSATION HERE WITH A COLLEAGUE ABOUT SENSITIVITY TO THAT PERFECT HEARING AND SENSITIVITY TO WHEN THE MUSIC IS OFF SO THIS NOTION THAT MUSIC IS NOT JUST A GREAT THING THAT WE WILL ALWAYS DO JUST GOOD AND THE MORE WE GIVE THE BETTER, THAT IS AN IMPORTANT POINT TO KEEP IN MIND. >> I WONDER IF I COULD ADD A DIFFERENT COMMENT ABOUT THAT. MENT WITH DR. SILBERBERG. I JUST WOULD WANT TO WARN THAT WE DONE -- AS NIH OR DSMBs PUSH RESEARCHERS INTO SPINNING SO MUCH TIME EXAMINING HARMS OF A STUDY, THAT THESE CLINICAL TRIALS WHAT ARE LIKELY RATHER BENIGN INTERVENTIONS SPEND A GOOD 50% OF THEIR EFFORT DOING ADVERSE EVENTS MONITORING. WHICH IS SOMETHING I SEE TIME AND TIME AGAIN IN BEHAVIORAL CLINICAL TRIALS. >> SO WE HAVE THIS WONDERFUL CONVERSATION, I'M STRUCK BY THIS NOTION OF ENGAGEMENT AS BOTH DESIGN FEATURE OF INTERVENTION BUT ALSO AS AN OUTCOME OF AN INTERVENTION OR INTERMEDIARY OUTCOME THAT DETERMINE IT IS EFFECTIVENESS OF AN INTERVENTION. THAT PUZZLES ME TO HAVE SOMETHING SO FUNDAMENTAL TO THE ENTERPRISE THAT YOU CAN'T SQUARELY PUT ON EITHER LEFT OR THE RIGHT SIDE. I DON'T KNOW THIS HAS BEEN GREAT BUT SOMEHOW THAT POPPED OUT TO ME AS A COMPLEX PROBLEM THAT I HOPE PEOPLE SMARTER THAN I AM CAN TAKE THE NEXT STEP. YOU ARE THE ONE WHO BROUGHT IT UP YOUR HAND IS UP, I'LL LET YOU TAKE THE NEXT. >> UP ALREADY. I TOTALLY A AGREE WITH YOU AND THIS IS SOMETHING THAT I GO BACK AND FORTH ABOUT. I THINK THAT ENGAGEMENT IS MOST OFTEN BEING VIEWED AS A MECHANISM FOR WHICH AN INTERVENTION CAN EXERT ITS EFFECT AND THAT MAKES PERFECT SENSE BUT I KNOW THAT OUR GROUP IS GRADUALLY TRANSISING INTO THINKING ENGAGEMENT AS A CLINICAL OUTCOME IN AND OF ITSELF BECAUSE ENGAGEMENT IN AND OF ITSELF CAN HELP THERAPEUTIC IMPLICATIONS FOR PEOPLE, BUT I THINK THAT WE NEED MORE OPENNESS AND SCIENTIFIC COMMUNITY FOR TREATING ENGAGEMENT AS A PRIMARY CLINICAL OUTCOME OPPOSED TO MECHANISM BECAUSE USUALLY WHEN I SEE STUDIES FOCUSING ON ENGAGEMENT THERE IS AN EXPECTATION THERE WILL BE A CLINICAL OUTCOME AT THE END OF IT. RIGHT? BUT I THINK THIS IS A GOOD TIME FOR US TO RETHINK THESE ASSUMPTIONS AND THINK OUTSIDE THE BOX. >> I'M GOING TO TO PUSH TO SAY I THINK THERE'S THREE BECAUSE AT THE VERY BEGINNING THERE IS A QUESTION WHETHER THE INTERVENTION INVOLVES ACTIVE OR PASSIVE PARTICIPATION. YOU HAVE DISCUSSED IT AS AN OUTCOME BUT IT IS PART OF THE MECHANISM -- PART OF THE MECHANISM. SO IT IS EVEN MORE COMPLICATED. I LOVE COMPLICATED STUFF. GLAD THAT AS I SAID PEOPLE WHO UNDERSTAND THIS BETTER THAN I DO CAN TAKE IT THE NEXT STEP. DR. SILBERBERG I DON'T KNOW IF YOUR HAND IS UP AGAIN OR IF THAT IS A -- >> IT IS, PLEASE GO AHEAD. >> I WANT TO COMMENT ON WHAT ERIC SAID WHICH IS ABSOLUTELY RIGHT. IF WE FOCUS ON TOO MUCH ON POTENTIAL DANGERS, WE DON'T MAKE ANY PROGRESS. THAT CEASE NOT WHY I MADE THAT POINT. THE REASON I MADE THAT POINT IS NO MATTER WHAT THESE STUDIES ARE GOING TO BE SMALL. ARE ALWAYS GOING TO BE SMALL. AND IF THEY ARE SMALL YOU WANT TO REDUCE VARIABILITY SO YOU WILL INCREASE YOUR POWER. IN ORDER TO REDUCE VARIABILITY AN IMPORTANT THING TO TAKE INTO CONSIDERATION IS WHAT IS AN EFFECTIVE DOSE PER INDIVIDUAL. THAT'S WHY I BROUGHT THAT UP. IF WE DON'T TAKE INTO CONSIDERATION THAT THIS IS NOT OKAY EVERYONE GETS -- WHY 20 SESSIONS OR WHY 60 MINUTES AND WHY THIS MUSIC. THIS HAS MORE THOUGHT HAS TO BE PUT INTO HOW TO REDUCE THE VARIABILITY BETWEEN INDIVIDUALS SO WE CAN GET HIGHER POWER. >> JUST RIPPLING A BIT ON THE COMMENT I MADE IN THE CHAT, IN TURN BASED ON ANOTHER COMMENT THAT WAS MADE, I GUESS I AM STRUGGLING TO THINK ABOUT THIS IS A QUESTION HOW WE CAN THINK ABOUT BUILDING BLOCKS IS DISTINCTIVE FOR STAND ALONE SAY MUSIC INTERVENTIONS OR PROGRAMS WHICH ARE HARD ENOUGH TO ACHIEVE LEK IN ADDITION OF STANDARDS OR IN TERMS OF DESIGN ELEMENTS. VERSUS PROGRAMS THAT ARE WHERE MUSIC IS OFFERED ALONGSIDE ANOTHER THERAPY OR ADJUNCT TO THERAPY OR CONDITION. SORRY THERAPY. AND PARTICULARLY THE INTEGRATION OF MUSIC WITH PHARMACOLOGICAL INTERVENTIONS BUT WITH OTHER BEHAVIORAL INTERVENTIONS. THIS IN GENERAL IS A BLANKET COMMENT ONE OF THE THINGS SO CHALLENGING I THINK IS ALSO EXTRACTING OR ISOLATING THE BENEFIT OF MUSIC PER SE OR MUSIC PROGRAM HOWEVER WE ULTIMATELY ANONYMIZE IT. VERSUS SOCIALIZATION THAT OCCURS DURING A LOT OF THESE EXPERIENCES. THIS HAS COME UP BEFORE. BUT REALLY TRYING TO UNDERSTAND THE DEGREE TO WHICH ENGAGEMENT IS THE OUTCOME, THE -- THROUGH MUSIC THERAPISTS COMING IN HAVING ONE THE ONE CONTACT WITH SOMEBODY TO DELIVER TO CREATE MUSIC OR SOMETHING TO TREAT A CERTAIN CONDITION, THAT SOCIALIZATION IS TO WHAT EXTENT IS SOCIAL ELEMENT A FACTOR. MUSIC THERAPISTS HAVE GREAT MODELS TO STUDY THAT AND THAT MAYBE BE MADE MORE CLEAR TO PEOPLE THERE ARE WAYS TO THIS GETS BACK TO ESSENTIAL FLAME WORKS AND UNDERSTAND HOW SOCIALIZATION PLAY AS ROLE. TWO COMMENTS ONE WITH INTEGRATION OF MUSIC WITH OTHER INTERVENTIONS, THE OTHER INHERENT SOCIALIZATION OF SO MUCH MUSIC. >> WE'LL TAKE DR.S LEVITON AN ROBIN THEN A BREAK. >> I WANTED TO BOUNCE BACK A COUPLE OF TOPICS, TO THE ISSUE I WONDER IF PERHAPS IT IS NOT SUCH A DICHOTOMY THAT YOU ARE EITHER JUST SITTING THERE LISTENING LIKE A BLOB OR THAT YOU ARE ACTIVELY MAKING MUSIC. AND IN TERMS OF CONTINUUM ALL OF US KNOW MUSICIANS WHO PLAYING BUT THEY SEEM TO BE PHONING IT IN. SO THAT SEEMS LESS ACTIVE. THEN AS A LISTENER, IT IS IF RENEE FLEMING IS LISTENING TO A NEW MUSICAL WORK, AND SHE'S NOT SINGING ALONG, IS SHE -- I MEAN SHE'S NO DOUBT ACTIVELY PROCESSING IT IN A WAY THAT I CAN'T. I'M THINKING OF TIMES I HAVE BEEN SICK IN BED AND MEDICATED AND MUSIC COMES ON AND I FEEL RESTORED BY IT BUT I DON'T KNOW THAT I'M ATTENDING TO IT IN THE CONVENTIONAL SENSE AND NOT WORKING OUT. SO THOUGH I AGREE THE DISTINCTION IS IMPORTANT I'M PROPOSING IT IS NOT DICHOTOMOUS. >> VERY INTERESTING. DR. ROD LAST WORD BEFORE THE BREAK. >> SORRY, MY BOX MOVED ON THE SCREEN. LAST THING ONE THING I WANTED TO BRING UP WAS TAILORED INTERVENTIONS, OR INDIVIDUALIZING INTERVENTIONS BASED ON PATIENT SPECIFIC FACTORS OR THE WAYS IN WHICH THEY PRESENT IN THE MOMENT. THIS IS CRITICAL TO MUSIC INTERVENTION, WHETHER MUSIC LISTENING, OR ACTIVE MUSIC MAKING OFTENTIMES THE CLINICIAN IS IN THE MOMENT TAILORING THAT MUSIC EXPERIENCE BASED ON BEHAVIORS THAT THE PATIENT MAY BE DEMONSTRATING, IN ORDER TO INCREASE ENGAGEMENT IN THE INTERVENTION WHICH WAS ALREADY HIGHLIGHTED AND I THINK THAT THE NOTION OF PRECISION MEDICINE TAILORED INTERVENTION SOMETIMES INTERVENTIONS ARE TAILORED ON PATIENT SPECIFIC FACTORS AS WE FIGURE OUT WHAT POTENTIAL MODULATORS THAT MAY INFORM WHAT TYPE OF INTERVENTION WORKS FOR DIFFERENT TYPES OF PEOPLE. SO THAT IS ANOTHER PIECE OF EQUATION IN TERMS OF FIDELITY AND RESEARCH DESIGN TAKING INTO ACCOUNT WHETHER OR NOT IT IS TAILORED INTERVENTION. >> GREAT, THANK YOU. KATHERINE I WILL HAND IT BACK TO YOU TO TAKE THIS TO THE BREAK. >> SURE. THANK YOU. ALAN, APPRECIATE THAT. ACTUALLY WE HAVE A FIVE MINUTE BREAK NOW. WE WILL MOVE INTO THE LAST TWO THEMES OF THE DISCUSSION. THEME 4 WHICH IS WHETHER BEST METRICS TO TRACK CLINICAL OUTCOMES AND THEME 5, ADDITIONAL METHOD LOGICAL RESEARCH AND RILE DESIGN ISSUES TO BE CONSIDERED. SO I'M GOING TO TURN THINGS BACK OVER TO MR. WEIL. ALAN. >> THANK YOU, YOU TEED UP OUR FOURTH THEME. SO TO INTRODUCE SUBJECT AROUND METRICS FOR MECHANISTIC AND CLINICAL OUTCOMES I WILL TURN TO DON EDMONDSON. >> I WILL QUICKLY SAY THAT WITH RESPECT TO MEASUREMENT FOR MECHANISMS AND OUTCOMES WHAT IS A MECHANISM AND WHAT IS OUTCOME FOR A GIVEN SCIENTIST IS A QUESTION FOR THAT INDIVIDUAL SCIENTIST. BASED ON AREA OF FOCUS. IN MY RESEARCH CENTER WE HAVE CARDIOLOGISTS ON PHYSICAL ACTIVITY BECAUSE IT IS A MECHANISM OF PSYCHOLOGICAL VARIABLES INFLUENCE ON CARDIOVASCULAR EVENTS. WE ALSO HAVE KINESIOLOGY GISTS INTERESTED IN CHANGING PHYSICAL ACTIVITY WITH BEHAVIORAL INTERVENTIONS. SO WHAT IS A MECHANISM, WHAT IS AN OUTCOME. BUT I WILL SAY THAT AND ALSO I'M NOT A MUSIC EXPERT. THERE ARE LOTS OF GREAT MEASURES OF MECHANISMS THAT WE CAN IMAGINE LISTEN PROPOSED. IN THE DEVELOPMENT OF MUSIC INTERVENTIONS. AND OUTCOMES WHETHER ENGAGEMENT QUALITY OF LIFE, THEY ARE PRETTY SPECIFIC BUT I WILL SAY THAT WITH A STRONG CONCEPTUAL MODEL AND AS BEST AS THE FIELD UNDERSTANDS IT A WELL MEASURED MECHANISM OF ACTION YOU GET RIGOR AND REPRODUCIBILITY WITHOUT AS DR. SILBERBERG MENTIONED RELYING TOO HEAVILY ON HAVING LARGE EFFECT SIZE. WOVEN INTO EVERY STAGE OF THE NIH STAGE MODEL INTERVENTION DEVELOPMENT, BY THE WAY DR. LISA IS HERE, IF UP TO HEAR MORE ABOUT STAGE MODEL. WILL EXIST AS TRANS FORMATIVE INSIGHT THAT EXISTS NEUROLOGY TO IMPLEMENTATION SCIENCE CONTRIBUTES TO THE ADVANCEMENT OF MUSIC INTERVENTION SCIENCE AND IN EVERY SINGLE STUDY THEY CONDUCT. AND THAT INSIGHT IS THAT CONTRARY TO INSTINCT THE MOST VALUABLE STUDIES PARTICULARLY IN THE EARLY DEVELOPMENT OF THE FIELD, ARE NOT RANDOMIZE CONTROL TRIALS, TO SIMPLY SHOW MUSIC INTERVENTION IMPROVES CLINICAL OUTCOME. MOST VALUABLE ARE THOSE THAT STUDY CONCEPTUAL MODEL THAT OFFERS EVIDENCE HOW AND WHOM INTERVENTION MAYBE RELIABLY EFFECTIVE FOR IMPROVING WHATEVER CLINICAL OR BEHAVIORAL OUTCOME OF INTEREST. WE HAVE SEEN IT OVER AND OVER, AN INTERVENTION MAY WORK IN SOME SMALL SAMPLE ONCE GET A LOT OF ATTENTION FROM THE OTHER SCIENTISTS AND PUBLIC BUT OTHER SCIENTISTS OR PRACTITIONERS DEPLOY INTERVENTION, IT DOESN'T WORK AGAIN NET FINDING MAY NEVER BE REPLICATED THE FAILURE TO REPLICATE MAY NEVER BE POLISHED NOT CLEAR WHY IT FAILED MAYBE I'M A BAD SCIENTIST BECAUSE I WASN'T ABLE TO MAKE INTERVENTION, MY INTERVENTION IS NOT GOOD. BUT WITH THAT A STRONG CONCEPTUAL MODEL WITH MEASURABLE MECHANISM OF ACTION OTHER SCIENTISTS CAN'T BUILD ON SUCCESS OR FAILURE TO DEEPEN OUR UNDERSTANDING OF HOW THESE INTERVENTIONS WORK OR WHO MIGHT BENEFIT THEM. BENEFIT FROM THEM. MECHANISM BY SCIENCE HYPOTHESIS TEST TO CONFINE CONCEPTUAL MODELS ARE ACTUALLY IT GIVES A WAY TO MOVE FORWARD WITHOUT PARTICULARLY VIRGINIA SCIENTISTS, WITHOUT HAVING TO TO WONDER WHETHER THEY ARE CONTRIBUTING WHAT IS THE ROUTE TO IMPACT. SO WE ACTUAL WILL I HAVE NIH SCIENCE BEHAVIOR CHANGE PROGRAM IF YOU GO TO WEBSITE SCIENCEBEHAVIORCHANGE.ORG THERE IS A MEASURE OF GOOD NUMBERS THAT MAYBE OPERATIVE HERE, NUMBER OF MEASURES OF POTENTIAL OUTCOME VARIABLES YOU CAN DOWNLOAD THEM, YOU CAN USE THEM FOR FREE. THERE'S NO STAMP OF APPROVAL ON ANY MEASURES, PROBABLY WILL RIGOROUS DISAGREEMENT BUT IT IS A GREAT MEASURES REPOSITORY SO GO AND LOOK AT THOSE. >> THANK YOU. NEXT WE WILL TURN TO YURIK. >> THANK YOU. THIS SEGUES NICELY FROM DR. EDMONDSON'S COMMENTS. OUR CLINICAL TRIAL TEAM SPENT TIME TALKING ABOUT LIKELY SOURCES OF FAILURES IN THIS RESEARCH AS TRUE CLINICAL TRIALISTS I GUESS, WE CAN DO PRE-MORE THEM, AND I WANT TO HIGHLIGHT THE IMPORTANCE OF RELIABILITY OF OUTCOMES AND BIOBEHAVIOR MARKERS IN THESE IT IS EXPECTED THAT MANY OF THESE STUDIES WILL USE AN EXPERIMENTAL MEDICINE APPROACH, SO THEY WILL TRY TO EXAMINE THE RELATIONSHIP BETWEEN A MECHANISM IE A CHANGE IN A BIOBEHAVIORAL MARKER Z AS A RESULT OF THE INTERVENTION AND A CLINICAL OUTCOME. FOR EXAMPLE, AN OLDER ADULT SUFFERING FROM ANXIETY, STUDY MIGHT EXAMINE WHETHER MUSIC INTERVENTION HAS PSYCHOPHYSIOLOGIC EFFECTS SUCH AS REDUCING ELEVATED COURT SOLVE LEVELS OR EXAGGERATED STARTLE RESPONSE WITH RESULTING EFFECTS ON FUNCTIONAL OUTCOMES SUCH AS ANXIETY RELATED DISTRESS OR QUALITY OF LIFE. REFERRED TO AS TARGET ENGAGEMENT, WITH TEST OF MEDIATION. STUDIES MIGHT ALSO AS PREVIOUSLY ALLUDED EXAMINE INDIVIDUAL DIFFERENCES FOR EXAMPLE AMONG ANXIOUS OLDER ADULT, BIOLOGICAL SEX OR LEVEL OF COGNITIVE IMPAIRMENT, MIGHT PREDICT WHO BENEFITS MOST FROM A MUSIC INTERVENTION. AND THIS IS THE TYPICAL PATH OF PRECISION MEDICINE RESEARCH OFTEN FORMALLY TESTED FOR EXAMPLE, WITH A TEST OF MODERATION. HOWEVER FOR THIS TO SUCCEED ALL THE MEASURES THE MECHANISMS, THE PREDICTIVE CHARACTERISTICS AND THE CLINICAL OUTCOMES MUST POSSESS HIGH RELIABILITY. LOWER LIABILITY IS A THREAT TO ANY KIND OF EXPERIMENT AT ANY CLINICAL TRIAL CERTAINLY BUT THE KINDS OF MECHANISTIC OR INDIVIDUAL DIFFERENCES STUDIES, WHICH WE EXPECT WILL BE COMMON IN THE GRANT APPLICATIONS, ARE PARTICULARLY VULNERABLE TO THREATS FROM LOW OR EVEN MODERATE RELIABILITY THEREFORE OUR ADVICE IS THAT RESEARCHERS TEST AND REPORT RELIABILITY OF ALL MEASURES PREFERABLY PROVIDING DATA IN GRANT APPLICATION AND INCLUDING DISCUSSION OF RELIABILITY IN THEIR STATISTICAL A ANALYSIS AND POWER CALCULATION. >> GREAT. NOW WE WILL HEAR FROM (INDISCERNIBLE) >> I THROUGH PIGGY BACK BACKEN O THAT, IN ADDITION TO QUANTIFIABLE RATHER THAN ANECDOTAL METRICS ARE CRITICAL. ONE THOUGHT WE FOCUS ON IN THE NEUROSCIENCE GROUP IS IN ADDITION TO RANGE OF PER ACCEPT ACTUAL COGNITIVE NEUROPSYCHIATRIC EMOTIONAL BEHAVIORAL EFFECT, IT MIGHT BE USEFUL TO ADD TO THE TOOL KIT SOME NEURAL MARKERS THAT CAN BE USED AS TEST BED FOR MECHANISTIC OUTCOME, PHYSIOLOGICAL UNDERPINNINGS OF THE ROLE THAT MUSIC PLAYS TO HELP US BETTER UNDERSTAND WHAT IS MUSIC DOING IN TERMS OF MAKING THESE OUTCOMES THESE INTERVENTIONS SUCCESSFUL SO WHILE THAT MAY NOT APPLY ACROSS ALL THE STUDIES, THERE ARE NUMBER OF MARKERS THAT ONE CAN LOOK FOR IN TERMS OF GRAY MATTER VOLUME, FUNCTIONAL FUNCTION OF TEMPORAL BRAIN REGIONS, THINGS THAT MAY REQUIRE ADDITIONAL TECHNIQUES THAT MAY NOT BE FEASIBLE I WILL EMPHASIZE THAT BUT WE ARE DISCUSSING TOOL KITS IN TERMS OF THINKING WHAT ENCOURAGE IN TERMS OF INVESTIGATORS AND INVESTIGATIVE TEAMS TO THINK ABOUT TO HELP IMPROVE THE FIELD AND SO THERE ARE A NUMBER OF QUANTIFIABLE METRICS OR MARKERS OF EARLY SENSORY MEMORY THAT CAN BE VALUE WAITED BEFORE AND AFTER THE INTERVENTION, THINGS LIKE EVOKE RESPONSES AND SO RESULT MANY ITALY I GUESS THE SPECIFIC METRICS WILL BE DETERMINED BY CONDITION AND EVALUATION AS LONG AS THEY ARE MEASURABLE QUANTITATIVELY OR QUALITATIVELY. THE SECOND POINT I WANT TO BRING UP, BEING TOUCHED UPON IS THIS IDEA OF APPROPRIATE CONTROLS I THINK ONE OF THE BIGGEST CHALLENGES I FEEL IS ESTABLISHING CORRELATIONAL EFFECT BETWEEN INTERVENTION AND OUTCOMES, IDEALLY WE WANT CAUSAL RELATIONSHIPS BUT CORRELATIONAL SOMETIMES CAN BE TRICKY BECAUSE YOU HAVE THIS MULTI-FACETED ASPECT OF MUSIC THAT IS HARD TO DESIGN APPROPRIATE CONTROLS FOR. SO IT IS I THINK IMPORTANT THESE CONTROLS NEED TO INCLUDE CONTROLS OF THE INTERVENTION ITSELF, THERE ARE DISCUSSIONS ABOUT PASSIVE VERSUS ACTIVE, COUPLED THERAPIES, MUSIC SUPPORTED THERAPY, RHYTHMIC STIMULATION, SO WHAT IS THE RIGHT CONTROL FOR THESE KIND OF THINGS, STANDARD OF CARE, ENOUGH, THERE IS A RANGE OF THINGS ONE HAS TO CONSIDER AND SO OBVIOUSLY THERE IS ALSO PARAMETERS THAT NEED TO BE CALIBRATED, THE CHOICE OF MUSIC, FAMILIARITY INDIVIDUALIZED OR NOT, ALL THESE CONTROLS NEED TO BE PUT FORWARD AND THOUGHT ABOUT, OBVIOUSLY WITH THE ADDED CAVEAT THAT WITHIN ONE SPECIFIC INTERVENTION AND STUDY DESIGN IS CHOSEN THERE'S ALL INHERENT PARAMETERS IN THE MUSIC EXPERIENCE AND THE MUSIC SIGNAL ITSELF THAT ARE SOMETIMES HARD TO BREAK DOWN, IT MISTY, PITCH, MELODY, SO YOU DON'T WANT TO DEFINITELY MAKE THE TAKE AWAY FROM THE ARTISTIC EXPERIENCE OR THE MUSICAL EXPERIENCE OF THE SIGNAL BUT AT THE SAME TIME YOU WANT TO TRY TO UNDERSTAND WHAT IS THE RIGHT CHOICE OF PARAMETERS THAT HAVE LED TO CERTAIN OUTCOMES. THE OTHER TWO POINTS I WILL BRING UP IN TERMS OF IMPORTANT METRICS THAT ONE HAS TO CONSIDER THINKING ABOUT THESE TOOL KIT IS ONE IS TIME MARKERS. THROUGHOUT THE DURATION OF THE INTERVENTION WHERE ONE HAS TO EVALUATE CHANGES IN OUTCOMES AS WELL AS ASSESS CORRELTIONAL RELATIONSHIPS WITH TREATMENT CONDITIONS. TO GET A SENSE OF THE TIME COURSE AND EFFICACY AND THEN THE OTHER ONE IS FOLLOW-UP ASSESSMENT AFTER THE INTERVENTION COMPLETION WITHIN A REASONABLE TIME FRAME AND THAT OBVIOUSLY WILL DEPEND ON SPECIFIC CONDITIONS, THESE FOLLOW-UPS I THINK ARE VERY IMPORTANT, THEY MAY NOT BE FEASIBLE IN ALL STUDIES, SHOULDN'T BE A REQUIREMENT SO THERE HAS SOME FLEXIBILITY BUT I THINK THEY ARE IMPORTANT FOR US TO GET A BETTER UNDERSTANDING OF THE EFFICACY AFTER INTERVENTION. THEN THE LAST POINT I BRING UP IS I THINK SOMEBODY BROUGHT THIS UP EARLIER IS WILL HAS BEEN A LOT OF DISCUSSION THROUGHOUT ALL THE POINTS RAISED BEFORE ABOUT MORE TRADITIONAL MODEL AND WE HAVE TO ALSO START THINKING FORWARD IN TERMS OF MORE NOVEL TECHNOLOGIES USE OF INTERNET OR VIRTUAL REALITY WHICH WAS NOT BROUGHT UP AND THERE IS SORT OF POSSIBILITIES IN THAT SPACE THAT COULD BE VALUABLE AND WE SHOULD BE OPEN TO EXPLORING THOSE IN TERMS OF THE POSSIBILITIES OF TOOL KITS AS WE THINK ABOUT THIS FIELD AND WHERE IT IS GOING. OBVIOUSLY THAT COMES WITH A WHOLE SET OF OTHER CHALLENGES BUT IT IS IMPORTANT TO EMBRACE TECHNOLOGY AND ACCESSIBILITY THAT CAN COME WITH THAT WHILE THINKING OBVIOUSLY ABOUT WAYS TO CONTROL FOR THESE CHALLENGES. THANK YOU. >> THIS IS A GREAT OPENING. I HAVE A FEW PEOPLE'S HANDS UP, BEFORE I CALL ON ANYONE, I WANT TO NOTE WHEN WE WERE IN THEME ONE, THINKING ABOUT MODELS WE DID HAVE BEHAVIORAL MOLAL MODELS AND SOCIAL MODELS. I THINK WHAT I HEARD DIDN'T PROVIDE AS MUCH GUIDANCE ON THOSE AS SOME OF THE OTHERS AND HOPE WE CAN BRING INTO THE CONVERSATION. YOKA AND GLORIA NEXT UP. >> MAYBE ACTUALLY MY COMMENT IS A BIT RELATED TO YOUR REQUEST, ALAN. I WAS GOING TO BRING UP A COMMENT IN TERMS OF BEST METRICS OR OUTCOMES OR HOW TO MEASURE CLINICAL OUTCOMES. TO MAKE SURE TO ALSO TAKE INTO ACCOUNT BESIDES OF COURSE ROBUSTNESS OF MEASURE AND RELIABILITY IS SENSITIVITY TO CHANGE AND TO MAKE SURE TO CONNECT THAT TO THE YOUR INTERVENTION SO IF YOUR INTERVENTION IS JUST ONE SESSION, IT DOESN'T MAKE SENSE TO MEASURE QUALITY OF LIFE BEFORE AND AFTER THE INTERVENTION. YET IF YOUR INTERVENTION IS SIX WEEKS LONG OR TEN WEEKS LONG MAYBE YOU HAVE THE POSSIBILITY I WOULD HOPE TO BE ABLE TO IMPACT QUALITY OF LIFE. SO I THINK THAT IS ISSUE WE CAN SEE IN THE LITERATURE OR A PROBLEM THAT SOMETIMES MEASURES ARE CHOSEN OR OUTCOMES ARE CHOSEN AND PARTICULARLY SPECIFIC OUTCOME MEASURES TO MEASURE CLINICAL OUTCOME, DOESN'T MAKE SENSITIVE DURATION OF THE INTERVENTION. TO REALLY I GUESS IN A TOOL KIT MAKE SURE TO PUT A IMPORTANT WARNING FOR THAT TO REALLY PAY ATTENTION TO THAT. I THOUGHT THAT AS WE ARE TALKING ABOUT OUTCOMES I WANTED TO FORMALLY PUT OUT CONCEPT OF MIXED METHOD, DEFINITELY TALKED ABOUT QUANTITATIVE OUTCOMES AS WELL AS QUALITATIVE HAS COME UP BUT THINKING HOW THOSE TWO CAN BE USED TOGETHER AND INFORM ONE ANOTHER IN A VERY DELIBERATE WAY, SO I THINK CERTAINLY FOR INTERVENTION DEVELOPMENT OFTEN TIMES THERE IS STUFF THAT GOES ON BEFOREHAND AND FOCUS GROUPS THAT MAY INFORM THE ACTUAL INTERVENTION DEVELOPMENT AND OFTEN TIMES THERE IS A QUALITATIVE COMPONENT TO EXIT INTERVIEWS AFTER THE INTERVENTION. BUT OFTEN TIMES PEOPLE WILL ANALYZE THE QUANTITATIVE AND QUALITATIVE SEPARATELY AND THERE'S SEPARATE PAPERS BUT MISSING THAT OPPORTUNITY FOR THE TWO TO INFORM EACH OTHER. AND THEN THE SECOND COMMENT NOW, SO IT WAS REGARDING THE TECHNOLOGY AND POTENTIALLY THINKING ABOUT AS WE THINK ABOUT REMOTE DELIVERY WE ALSO CAN THINK ABOUT REMOTE ASSESSMENT AS WELL, THERE ARE A LOT OF OPPORTUNITIES ON THAT END IN TERMS OF THINKING ABOUT WHERABLES AN PICKING OUT PHYSIOLOGICAL SIGNAL THAT CAN BE VERY EASILY DONE REMOTELY. I KNOW OF COURSE THAT COMES WITH MANY DIFFERENT CHALLENGES AND QUESTIONS ON HOW TO DO THAT RELIABLYBLY AND RIGOROUSLY BUT THERE IS OPPORTUNITY THERE. >> ELIZABETH THEN BARBARA. >> I WAS GOING TO MAKE TWO POINTS. FIRST BEING WHEN WE TALK ABOUT RIGOROUS OUTCOME MEASURES, IT IS ALSO IMPORTANT IN THIS FIELD THAT WE THINK ABOUT I DON'T KNOW IF THEY ARE DEVELOPED YET I HAVE HAD TROUBLE WITH THESE BUT HOW DO YOU QUANTIFY CHARACTERISTICS OF YOUR PARTICIPANTS AND HAIR PREVIOUS MUSIC EXPERIENCE? WHAT ARE THE BEST WAYS QUANTIFY THEIR MUSIC PREFERENCE? I DON'T KNOW WE HAVE GREAT RELIABLE MEASURES FOR THOSE BUT WE MOW THAT CAN BE A CONFOUND WHEN DOING THESE INTERVENTIONS, IS THEIR MUSIC PREFERENCE, PREVIOUS MYSICK EXPERIENCE, WHAT CONSTITUTES THEM AS A PROFESSIONAL VERSUS I JUST PLAY AN INSTRUMENT DAILY. WHAT LEVEL OF EXPERTISE AS WELL. IT IS IMPORTANT TO CONSIDER THAT THINKING ABOUT USING THOSE DEVELOPING RIGOROUS O WAYS TO EVALUATE THAT, IT WILL HELP US MOVE FORWARD IN OUR RESEARCH. THE SECOND POINT IS I WOULD JUST LIKE TO MAKE NOTE THAT FROM A PROFESSIONAL STANDPOINT IN THE MUSIC THERAPY FIELD OR MUSIC IS MEDICINE IF WE CAN REMEMBER WHAT CLINICAL OUTCOMES ARE IMPORTANT IN DEMONSTRATING THAT I GUESS YOU WANT TO THINK ABOUT REIMBURSEMENT PURPOSES, POLICY PURPOSES, WHAT OUTCOME MEASURES, IT MAY BE -- YOU MAY NEED TO INCLUDE ONE. BUT IF WE GET BOGGED DOWN IN THOSE BIG -- THOSE LITTLE SMALL DETAILS OF THE KINEMATICS OR KINETICS OR NEUROPHYSIOLOGY BUT MAYBE JUST PUT IN THE FOR EXAMPLE PARKINSON'S DISEASE, THE CLINICAL MEASURE OF THE UPRS. ALONG WITH YOUR KINEMATIC EXAMINATION OF GATE WHAT NOT THAT YOU CAN ALSO HELP TRANSLATE YOUR RESULTS INTO OUR CLINICAL PROFESSIONS THAT MAY ALSO HELP MOVE MUSIC AS MEDICINE, MUSIC THERAPY TO BE MORE ACCEPTABLE MANY THE HEALTHCARE. >> SPEAKING FROM THE PERSPECTIVE OF THE VOICE OF THE PATIENT BRIEFLY, OFTEN TIMES PARTICULARLY WITH ISCHEMIC EVENTS AND AGING AND ACQUIRED BRAIN INJURIES, HAY DO NOT HAVE A VOICE LITERALLY. I WANT TO REMIND EVERYONE THAT THE ADVANTAGE OF MUSIC BASED INTERVENTIONS IS IT DOESN'T HAVE TO BE VERBAL BASED, SOME OF THE METRICS RELY ON THAT, IN PROCESSING THAT MAYBE IMPAIRED. THERE MAYBE A FEW BUT FEW TOOLS OUT THERE IN THE MUSIC THERAPY RESEARCH LITERATURE, THE -- DR. MCGHEE AN COLLEAGUES IN PHILADELPHIA COMES TO MIND, MUSIC BASED METRIC TO TAKE A LOOK AT ALTERED STATES OF CONSCIOUSNESS AND DETECT THOSE LIKE DENTIST DETECT EARLY CONDITION IN MY DENTAL HEALTH MY PHYSICIAN HASN'T PICKED UP ON. WE HAVE VERY BASICALLY ANECDOTAL EVIDENCE AT THIS POINT WE CAN EARLY ON PICK UP ON SOME OF THESE THINGS. THANK YOU. >> BRING IN MICHAEL TOUT AND CARL. >> JUST ABOUT THE RELATIONSHIP BETWEEN THE MECHANISTIC AND CLINICAL OUTCOME MEASURES, JUST A WORD OF CAUTION, THAT BEFORE WE LOOK AT BRAIN MEASURES, I THINK OF CRITICAL THAT WE HAVE GOOD BEHAVIOR TESTABLE HIGH BOTH SEIZE, OTHERWISE IT WILL BE A BIT OF A IF I RECOLLECTING EXPEDITION IN THE BRAIN AND SO EVEN CLINICAL OUTCOME MEASURES ON THE BEHAVIORAL LEVEL HAVE TO PRECEDE ANY MECHANISTIC OR MECHANICAL NEUROMECHANICAL INVESTIGATION IN TERMS OF BRAIN JUST WORD OF CAUTION ABOUT THESE MEASURES SHOULD BE LOOKED AT IN SOME KIND OF INTEGRATED WAY. >> I WAS GOING TO SAY SOMETHING VERY SIMILAR TO WHAT MICHAEL JUST SAID IS THAT AND WE TALK ABOUT IN OUR GROUP THAT IF THERE WERE LARGE MEANINGFUL CLINICAL EFFECTS, EVEN IF WE WERE TO FAIL TO UNDERSTAND HOW THEY MECHANISTICALLY ACHIEVE THOSE ARE IMPORTANT TO IDENTIFY. OF COURSE IF WE UNDERSTAND HOW MEMBERNIST IICALLY ACHIEVED WE CAN OPTIMIZE THEM BUT CAREFUL ABOUT MAKING THE PERFECT ENEMY OF THE GOOD SO IF WE CAN SEE A LARGE CLINICAL EFFECT IT IS NOT AS SATISFYING WHEN WE UNDERSTAND THE MECHANISM BUT IT IS IMPORTANT TO IDENTIFY THAT PARTICULARLY IF THAT MEASURE IS RELEVANT TO PATIENTS AND FAMILIES ON A CLINICAL AND FUNCTIONAL LEVEL RATHER THAN ONLY MECHANISTIC LEVEL. >> I THINK THAT BRINGS US NICELY TO OUR LAST THEME WHICH IS THE EVERYTHING ELSE THEME. ADDITIONAL RESEARCH IN TRIAL DESIGN ISSUES TO BE CONSIDERED METHOD LOGICAL ISSUE TO BE CONSIDERED, ALL YOUR GROUPS HAVE THIS AS AN AREA OF FOCUS BUT I'M GOING TO START BY CALLING ON A FEW OF YOU SUNIL YOU ARE UP FIRST. >> GREAT. THANK YOU. WELL, I'M GOING TO BE HOPEFULLY FAIRLY BRIEF HERE BECAUSE I WOULD LOVE TO HEAR FROM MY -- OTHERS IN OUR TEAM PERHAPS DISCUSSION PART MUCH MORE KNOWLEDGEABLE ABOUT ACTUAL INTERVENTION TYPES OF STUDIES, DESIGNS BUT I CAN TELL YOU SOME OF THE THINGS WE TALKED ABOUT WAS -- I'M GOING TO ECHO WHAT DR. TAUGT WAS SAYING ABOUT RCTs ARE OBVIOUSLY BE THE WAY TO GO ULTIMATELY BUT I THINK A LOT OF WORK TO BE DONE PERHAPS CONDITIONS WHICH IT IS NOT POSSIBLE TO DO THOSE. WAIT LIST CONTROL TRIALS FOR PROGRAMS THAT MAY INVOLVE MUSIC -- MUSIC INTERVENTION PERHAPS AFTER SCHOOLS PROGRAM OR CLINICAL INTERVENTION THAT CAN BE OFFERED WHERE YOU ROTATE THE INTERVENTION OR PATIENT SO THAT EVERYBODY GETS IT EVENTUALLY BUT WILL IS A WAIT LIST SO YOU HAVE A CONTROL GROUP COMPARISON. WE TALK ABOUT WITHIN SUBJECT INTERVENTIONS WITHIN SUBJECT STUDIES MAYBE MORE APPROPRIATE FOR SOME NEUROLOGICAL MAPPING WORK TO UNDERSTAND WITHIN ONE SUBJECT EVEN MECHANISTIC THINGS BETTER. WE TALKED ABOUT ADAPTIVE TRIAL DESIGNS NOT EXPERT ON THAT. BUT I DID RESEARCH ON IT AND SEEMS PROMISING FOR SOMEONE WHO IS NOT CLINICAL RESEARCHER. ANOTHER THING WE HAVE SEEN DONE INCREASINGLY AND I THINK DR. IVERSON IS A GREAT EXAMPLE OF THIS, EMBEDDING STUDIES WITHIN LARGER TRIALS. AND EMBEDDING THIS COULD BE OBSERVATIONAL BUT ALSO EVEN LOOKING AT INCLUDING AN ACTUAL MUSIC BASED INTERVENTION WITHIN A LARGER CLINICAL TRIAL. AND -- BECAUSE YOU WOULD HAVE THE INFRASTRUCTURE TO POTENTIALLY STUDY THAT. IN THAT CONTEXT. AND MIXED METHODS WAS RAISED AS ANOTHER KIND OF DESIGN THAT METHOD LOGICAL -- THAT'S REALLY IMPORTANT. I DON'T MEAN TO COVER THE WATER FRONT BUT TO SAY THESE ARE THINGS WE TRY TO PULL UP OR ELEVATE IN LIGHT OF THE ULTIMATE GOAL ACHIEVING LARGE SCALE RANDOMIZE CONTROL STUDIES. OF COURSE SYSTEMIC -- SYSTEMATIC REVIEWS ARE CENTRAL TO THIS TO UNDERSTANDING WHICH ROUTES TO TAKE. >> THANK YOU. NEXT GO TO CARRIE REED. >> RIGHT SO IN TERMS OF PARTICIPANT BURDEN SUBSTANTIAL IN BRACE DISORDER OF AGING I THINK OUR GROUP RECOGNIZE HOW IMPORTANT SUBSTANTIAL BURDEN CAN BE IN DECREASING ENGAGEMENT AND RETENTION IN STUDIES. AND CAN DROP OUT CAUSE SIGNIFICANT DROP OUT AND THREATEN THE DATA QUALITY, SO I THINK WE VERY MUCH ADVOCATE FOR INCLUDING RECOMMENDATIONS IN THE TOOL KIT SUCH AS USING ALTERATIVE DATA SOURCES WHEN POSSIBLE SUCH AS MEDICAL RECORDS. PILOT TESTING ALL ASSESSMENT TOOLS TO GAUGE THE TIME REQUIRED TO COMPLETE BUILDING BREAKS INTO ASSESS BUT IN OTHER KINDS OF TECHNIQUES TO MITIGATE BURDEN. WITH RESPECT TO MEASURING ACCEPTABILITY OUR GROUP RECOGNIZES THE IMPORTANCE OF INCORPORATING MEASURES OF ACCEPTANCE THROUGHOUT ALL STAGES OF THE INTERVENTION DEVELOPMENT PROCESS. THERE'S NO GOLD STANDARD MEASURE WE ARE AWARE OF AND I SUSPECT WE USE DIFFERENT ACCEPTANCE MEASURES BUT SURELY ENCOURAGING THEIR USE ROUTINELY IS A GOOD IDEA. WITH RESPECT TO NEW TECHNOLOGIES WE HEARD ABOUT THE POTENTIAL BENEFITS OF VIRTUAL REALITY AND WEARABLES I WOULD INCLUDE THAT LIST SOCIAL MEDIA, VOICE ASSISTANCE, AROUND IMPORTANT ROLE CAN PLAY FROM ACTIVE SENSING BUT PASSIVE SENSING, ANOTHER WAY TO MITIGATE BURDEN BY LOWERING THE AMOUNT OF DATA COLLECTION WE DO. AND THINKING ABOUT THESE TOOLS NOT ONLY TO MONITOR SYMPTOMS AN TRACK THEM OVER TIME, THE TOOLS THEMSELVES CAN BE VEHICLES FOR DELIVERING INTERVENTIONS AND PROVIDING REMINDER PROMPTS. I WOULD POINT OUT TO THIS GROUP AGAIN FROM THE AGING PERSPECTIVE THERE ARE CONCERNS RAISED ABOUT THE DIGITAL DIVIDE. BUT THE OLDER ADULTS ARE THE FASTEST GROWING GROUP IN TERMS OF UP TANK OF THESE DIGITAL TOOLS SO THAT IS LESS A CONCERN. THE LAST POINT I WOULD MAKE IS ABOUT CAREGIVER PARTICIPATION, IT IS IMPORTANT FOR THIS GROUP TO RECOGNIZE THAT ACCORDING TO RICHARD SCHULTZ, TEN MILLION PEOPLE WHO ARE OLDER REQUIRE ININFORMAL CAREGIVERRING. MANY REQUIRE IT BECAUSE BRAIN DISORDERS OF AGING SO WE SHOULD BE THINKING ABOUT ENCOURAGING CAREGIVER PARTICIPATION IN OUR STUDIES. CAREGIVERS CAN HELP REINFORCE ELEMENTS OF INTERVENTION AN SERVE MANY WAYS THERAPY EXTENDERS. THEY CAN ASSIST WITH RETENTION BY GETTING COGNITIVELY IMPAIRED PARTICIPANTS INTO ASSESSMENTS AND CAREGIVERS THEMSELVES ARE LIKELY TO BENEFIT FROM THE INTERVENTIONS THAT WE SHOULD BE ENCOURAGING POSSIBLE DIATIC STUDIES WHEN WE EVALUATE INTERVENTIONS. THOSE ARE MY COMMENTS. >> TERRIFIC. WE WILL NOW HEAR FROM ERIC >> AGAIN, THIS COMES FROM OUR CLINICAL TRIAL GROUP DISCUSSION ABOUT LIKELY SOURCES OF FAILURE OF THE LINE OF RESEARCH AND MY OVERARCHING POINT IS THAT RESEARCHERS SHOULD CONSIDER IMPLEMENTATION OF THE INTERVENTION AT A VERY EARLY STAGE OF RESEARCH, IMPLEMENTATION IS A BROAD CONCEPT REFERRING TO THE CONTEXT WHICH THE INTERVENTION IS DELIVERED. SO THE PATIENTS FAMILIES CLINICIANS AND HEALTHCARE SETTINGS AND OTHER SYSTEMS THAT ENCOMPASSES A NUMBER OF THINGS FIDELITY OF THE INTERVENTION DELIVERY, PARTICIPANT ADHERENCE AND ENGAGEMENT AND ACCEPTABILITY OF THE INTERVENTION AS WELL AS TECHNOLOGY THAT PROVIDES ITS, DR. HARVEY AND DR. BRAD ALLUDED TO THIS IN THEIR COMMENTS ABOUT DEPLOYMENT FOCUSED APPROACH GETTING STAKEHOLDER INPUT, DR. WILLIAMSSON AND HIS COMMENTS ABOUT USER CENTER DESIGN AND DR. REEDE ABOUT ACCEPTABILITY. IMPLEMENTATION IS IMPORTANT OF MUSIC INTERVENTIONS BECAUSE IT REQUIRES A CERTAIN DOSE AND DELIVERY OF MUSIC INTERVENTION AN INTERACTION WITH THE PARTICIPANT LISTENING OR DANCING IN ORDER TO HAVE INTENDED THERAPEUTIC EFFECT. EFFICACY STUDIES, OFTEN CONSIDER IMPLEMENTATION MORE DISSAL ISSUE, SOMETHING TO DO AFTER EFFICACY IS ALREADY DEMONSTRATED, AND THEN WE WANT TO MOVE AN EVIDENCE BASE INTERVENTION OUT INTO THE REAL WORLD BUT WE HAVE SEEN TIME AND AGAIN THAT LACK OF ATTENTION TO IMPLEMENTATION IS A COMMON SOURCE OF FAILURE IN CLINICAL TRIALS. TEST IT CAN EFFICACY OF BEHAVIORAL AND EVEN BIOLOGICAL ENTERSECTION. SO OUR ADVICE, GRANTEES NEED TO REPORT ON IMPLEMENTATION STRATEGIES. SUCH AS METHODSES TO ENSURE AND MEASURE PARTICIPANT ADHERENCE AND TESTING THE INTERVENTION WITH STAKEHOLDER INPUT AS DR. BRAD DESCRIBED BEFORE THE BREAK. IMPORTANTLY SUCH TESTING OF IMPLEMENTATION STRATEGIES SHOULD BE DONE PRIOR TO MOVING TO EFFICACY TESTING TRIALS. IMPLEMENTATION SCIENCE PROVIDES FRAME WORKS AND APPROACH FOR DOING THIS AND FINALLY INCLUSION OF IMPLEMENTATION SCIENCE EXPERTISE SHOULD BE AN EARLY AND NOT A LATE STEP IN THE RESEARCH. THANK YOU. >> WE COVERED TREMENDOUS AMOUNT OF GROUND MANY THOSE THREE PRESENTATIONS. I WONDER IF OTHERS HAVE THOUGHTS TO ADD. IF NOT I GUESS I WANT TO ASK A LITTLE BIT ON THIS REFERENCE CAREGIVER PARTICIPATION AGAIN THIS FEEL AS LITTLE LIKE BOTH POTENTIAL CONFOUNDER AND A POTENTIAL ELEMENT OF THE INTERVENTION BECAUSE YOU CAN IMAGINE ALL FOCUS WE HAVE HAD ON FIDELITY, AS DIFFICULT AS IT CAN BE ONCE YOU ADD A CAREGIVER SEEMS LIKE THAT COMPLICATES, MEASUREMENT OF FIDELITY. IT SEEMS LIKE IT COULD HAVE A BIG EFFECT ON INTERVENTION HOW IT -- I WANT TO SAY EFFECTS BUT ON HOW INTERVENTION ACTUALLY OCCURS. I WONDER IF THERE'S SAMPLES OR IDEAS WE CAN GET FROM OTHER FIELDS THAT HELP US THINK ABOUT THAT CLEARLY. >> I WOULD LIKE TO SAY I THINK THE CONSTRUCT IS THAT WE ARE THINKING ABOUT THE COGNITIVELY INTACT ADULT. BUT MANY INTERVENTIONS WILL TARGET PEOPLE WHO ARE IMPAIRED SO IT IS A DIFFERENT POPULATION. WE SHOULD KEEP THAT IN MIND. >> DR. EDMONDSON. >> I DON'T KNOW HOW MUCH -- ASIDE FROM ON THE CAREGIVER PART I THINK DR. REEDE'S POINT ABOUT DIATIC MODELS AVAILABLE STATISTICAL AND CONCEPTUAL THEY CAN ADDRESS THOSE CONCERNS ABOUT INTERNAL VALIDITY OF THE FINDINGS. ONE OF THE THINGS THAT I WANTED TO MENTION BECAUSE I KNOW WE ARE GETTING DOWN TO THE END OF THE RESEARCH DESIGN AND I HAVEN'T HEARD MUCH ABOUT IT AND I DIDN'T SAY MUCH ABOUT IT. BUT I'M FROM PSYCHOLOGY AND BEHAVIORAL MEDICINE, BOTH HERE FROM NEUROIMAGING, WE HAVE FOLKS HERE FROM COMPLIMENTARY ALTERNATIVE MEDICINE, WE GOT FOLKS HERE FROM MIND BODY INTERVENTIONS, AND ALL OF US ARE COMING FROM FIELDS WHO HAD AT LEAST SOME CONSEQUENCES. OF THE OPEN SCIENCE REVOLUTION. FAILURES EARLY ON PRE-REGISTRATION, COUPLE OF PEOPLE MENTION ISSUES AROUND PATIENT AND THINGS LIKE THAT, WHEN I SAY ALL MY CLOSE COLLEAGUES WHO ARE PARTICULARLY IN MIND BODY AREAS THAT ARE FURTHER DOWN THE LINE FROM THE BEHAVIORAL STUFF THAT I DO WITH RESPECT TO SOME OF THE COMPLIMENTARY ALTERNATIVE IS THAT THERE'S GOING TO BE MORE SKEPTICISM ABOUT ANY PARTICULARLY BIG FINDINGS, TALK ABOUT BIG EFFECT SIZE, THERE'S MORE SKEPTICISM THAT YOU WILL FACE THAN ANYBODY WHO IS DOING PHARMACEUTICAL OR ANYBODY WHO IS DOING MORE ESTABLISHED THINGS. THE ANSWER IS NOT BIGGER EFFECTS, THE ANSWER IS MORE OPEN SCIENCE. EVEN IF IT'S EARLY PART OF THE FIELD. BUT IF YOU ARE OPEN ABOUT IT THEN LET PEOPLE DIG THROUGH IT AND THEY WILL SEE IT FOR WHAT IT IS. AND THERE ARE WELL DOCUMENTED STEP BY STEP, THE YOUNGER YOUR COLLEAGUES ARE THE BETTER THEY WILL BE AT THIS. BUT IT IS SOMETHING THAT SHOULD BE ALSO THINKING ABOUT PEOPLE ON OUR TEAMS TO WHO ARE IT IS THEIR JOB TO MAKE SURE WE ARE OPEN, OPEN, OPEN. >> VERY HELPFUL. OTHER THOUGHTS. >> SPECIFIC ADVICE THERE ABOUT GRANTEES SHOULD BE EXPECTED TO PUBLISH A PROTOCOL AND SHOULD HAVE AN SAP AVAILABLE IN SOME PUBLIC WAY BY X TIME IN THE RESEARCH. OF COURSE THERE IS DATA SHARING AND RESOURCE SHARING THAT'S REQUIRED NOW. >> WE INCLUDE OSF OPEN SCIENCE FOUNDATION, WHERE YOU CAN GO TO SEE PRECISELY WHAT WE ARE GOING TO COLLECT, PRECISELY HOW TO ANALYZE THE DATA EVEN THOUGH RIGHT NOW IT IS THE DREAM THAT HOPEFULLY WILL GET FUNDED FOR IT BUT YOU HAVE TO BE EXPLICIT AND YOU CAN FOLLOW FIVE TO TEN YEARS FROM NOW. >> SUSAN, YOU HAVE A COMMENT. >> SO THIS JUST MADE THEE THINK THIS IS SUCH AN INTERESTING CONVERSATION, I HAVE 35 THOUGHTS AT THE SAME TIME. BUT ONE THOUGHT IS THAT WHEN YOU ARE LOOKING AT STUDY GROUPS AND REVIEWING RESEARCH HERE BECAUSE THESE FIELDS ARE SO BIFURCATED, I WONDER HOW EVALUATING RESEARCH AND THE VALUE OF RESEARCH BASED ON THIS CONVERSATION CAN BE INFORMED. I THINK EASY TO SEE WHERE NEUROSCIENCE REVIEWING THIS, SAYING THIS IS NOT RIGOROUS ENOUGH, ANOTHER FIELD IS SOMETHING COMING FORWARD WITH PUBLIC HEALTH, IT MIGHT BE HAVE A DIFFERENT SET OF QUALITY ASSETS SO JUST THINKING ABOUT OPEN SCIENCE, BUT ALSO THE WAY THAT GRANTS GET RENEWED. I LOVE TO THINK MORE DEEPLY ABOUT HOW WE CAN EDUCATE A VERY SEGMENTED RE-- GROUP OF FOLKS TO MAKE SURE THAT WE ARE ADVANCING AND BEING INNOVATIVE AT THE SAME TIME BEING RIGOROUS AND THINKING ABOUT ALL OF THESE ISSUES THAT WE ARE TALKING ABOUT BECAUSE A LOT OF THINGS STOP AT THAT DOOR, THERE IS NOT A LOT OF FUNDING TO BEGIN WITH, ALL THINGS CONSIDERED. >> I THINK IN THEME 2 TALKED PLOW TONIC INVESTIGATIVE TEAM NOW PLATONIC REVIEW TEAM WHICH DOESN'T REVIEW IN SILOS MORE THAN THE INVESTIGATIVE TEAM, CREATES THE APPLICATION IN SILOS. THAT'S WHERE I TOOK THAT COMMENT AND -- BUT I MEAN IT SERIOUSLY, YOU CAN EASILY DECONSTRUCT ALL THE INTERDISCIPLINARY ASPECTS OF THIS IF THOSE REVIEWING THE WORK ARE UNABLE TO SEE THE VALUE OF THAT MODEL. CARL KEIBURTS AND DAN. CARL. >> I'M GOING DOWN A ROAD FROM MY TEAM BECAUSE WE NEITHER DISCUSS THIS IN ADVANCE NOR ASSURED ANYTHING MY WORLD OF PHARMACO THERAPY DEVELOPMENT IN NEURODEGENERATIVE DISEASE, EVERY SO OFTEN LARGE FINDING ARRIVES, THIS WAS TRUE FOR LITHIUM AND ALS FOR MALOTNIB AND PARKINSON DISEASE LARGELY FROM SINGLE CENTER STUDIES, OFTEN RANDOMIZE STUDIES STOPS EVERYONE IN OUR TRACKS. AS TO WHETHER THIS -- WHAT DOES THIS MEAN. BOTH FIELDS ALS AN PARKINSON DISEASE FORTUNATE TO HAVE MECHANISMS AND ABILITIES TO MOUNT QUICKLY FOLLOW ON STUDIES, MULTI-CENTER ET CETERA. TO SEE WHETHER THERE WAS THERE, THERE SO TO SPEAK. BOTH CASES THERE WASN'T. PROBABLY JUST HAS TO DO WITH STOCHASTIC NATURE OF RESEARCH, BUT HERE IT WOULD BE IMPORTANT FOR THIS NIH INITIATIVE TO HAVE SOME THOUGHT TO THIS ABLE TO RESPOND TO NOVEL FINDINGS PARTICULARLY ONES OF MEANINGFUL BENEFIT ESPECIALLY CIRCUMSTANCE MECHANISM ISN'T UNDERSTAND TO REPLICATE THAT THAT WOULD ACCELERATE THE FIELD BECAUSE YOU AE STUCK WITH NON-EXPECTED AND WHAT DOES THAT MEAN, HAVING A PATHWAY FOR DOING THAT, SOME PEOPLE ALREADY SPOKEN TO SOME OF THESE THINGS ABOUT HOW TO DO THAT AND THERE'S ALSO BEEN PUBLISHED CRITERIA FOR EXAMPLE IN SOMETHING CALLED STROKE ACADEMIC INDUSTRIAL ROUND TABLE WHERE THINGS HAD TO BE FROM TWO SITES, THIS WAS MORE BASIC SCIENCE BUT AGED AND YOUNG MODELS AND INCLUSION AND OTHER MODELS WHAT EVIDENCE IS NECESSARY TO MOVE SOMETHING FORWARD FOR THE NEXT STAGE. SO BOTH THOSE IDEAS HOW YOU CAN ADVANCE A NOVEL FINDING, WHAT THE DATA NEEDS TO UNDERPIN SOMETHING THAT MAKES IT WORTH ADVANCING FOR FURTHER -- THIS IS SOMETHING THAT THIS WHOLE NIH PROGRAM CAN HELP FIELD BY SETTING SOME THOSE GUIDE POSTS, NOT REQUIREMENTS BECAUSE THAT BECOMES PROBLEMATIC. GUIDE POST FOR HOW TO MOVE THINGS FORWARD. >> DR. L EXVITON. >> I WANTED TO RUN A BIT WITH WHAT SUSAN SAID, AND TO ADDRESS THE PLATONIC IDEA OF REVIEW AND DISSEMINATION. SOME OF US IN MY QUARTER OF THE WORLD PUBLISH IN SPECIALTY JOURNALS FOR THE OCCASIONAL BIG NAME JOURNAL BUT THE ADVANTAGE OF US AS A WORKING GROUP ENCOURAGING ONE ANOTHER TO PUBLISH BROADLY, MEANS OF COURSE WIDER RANGE OF REVIEWER EXPERTISE. MORE LIKELY TO REACH PEOPLE WHO COULDN'T OTHERWISE READ ABOUT THE WORK. SO IN ADDITION TO OBVIOUS PLACES ONE WOULD PUBLISH THIS WORK, THERE'S SO MANY GOOD INTERESTING JOURNALS THAT ARE ON THE PERIPHERY, WHO WOULD BE HAPPY TO HAVE SOMETHING LIKE THIS, AGAIN YOU GET BETTER FEEDBACK. IF YOU CAN EXPLAIN WHAT YOU DOING AND CONVINCE SOMEBODY FROM OUTSIDE THE FIELD, THAT IS A DIFFERENT METRIC. >> GREAT. DR. FINKELSTEIN. >> I WANT TO QUICKLY FOLLOW-UP ON COUPLE OF THINGS, WHAT CARL WAS TALKING ABOUT IS WHEN YOU HAVE THE SORT OF INCREDIBLE STUNNING DISCOVERIES AND NO ONE KNOWS IF THEY ARE REPRODUCIBLE SO I HAVE BEEN INVOLVED IN THAT A LOT AT HUNDRED DOLLARS FOR EXAMPLE THE ALS LITHIUM FORKS ALS DISCOVERY STOPPED US IN OUR TRACKS AND WITH A QUICK TURN AROUND WE GAVE A MILLION DOLLARS TO SEE IF THEY CAN REPRODUCE WHICH THEY COULDN'T. SIMILARLY THERE WAS A FINDING THAT YOU WILL ARE SOUND MIGHT SCREW UP SELL MYOPERATION IN THE DEVELOPING FETUS. AND AGAIN, WE JUST GAVE HIM A BOLUS OF MONEY TO SEE IF HE CAN REPRODUCE THAT WHICH HE COULDN'T. IN ANY CASE, AT THE NIH LEVEL WE DO HAVE FAST TURN AROUND SUPPLEMENTS BUT THE BAR FOR GETTING ONE OF THESE IS PRETTY HIGH. IT HAS TO BE SOMETHING THAT IS ESPECIALLY A LOT OF MONEY CRITICAL TO PUBLIC HEALTH. IN TERMS OF SOME OF THE STUFF IN THE CHAT I WON'T GO INTO IT NOW BUT NIH DOES HAVE DATA SHARING, REQUIREMENTS FOR THINGS THAT WE FUND AND WE ALSO HAVE RULES ABOUT SHARING REAGENTS, SOMETHING LIKE THIS, THAT IS AN EXTREMELY IMPORTANT DISCUSSION WE CAN HAVE RIGHT NOW BUT SOMETIME IN ONE OF THE FUTURE WORKSHOPS. >> I'M PRIVY TO SOME OF THE QUESTIONS THAT HAVE COME IN FROM THE AUDIENCE, THEY ARE GREAT. I'M INCLINED TO PIVOT TO THAT SEGMENT. WE ARE ARE NOT GOING TO GET THROUGH ALL OF THEM. AND I WANT TO TO RE-EMPHASIZE THAT THESE ARE QUESTIONS NOT REALLY WITH AN ANSWER, THERE IS NOT A PERSON DESIGNATED TO ANSWER THEM, THEY ARE REALLY TO BRING UP ISSUES, EXTEND ISSUES THAT AROSE EARLIER IN THE CONVERSATION. SO I'M GOING TO BASICALLY READ THEM OR INTERPRET THEM AND THE FLOOR WILL BE OPEN TO ANYONE WHO WANTS TO HELP OUR AUDIENCE UNDERSTAND THESE TOPICS. I THINK THIS IS GOING TO BE A GREAT ADDITION TO THE CONVERSATION WHICH HAS ALREADY BEEN SO GOOD. THERE ARE A NUMBER OF QUESTIONS ABOUT BLINDING, WE HAVE TALKED IN RANDOMIZE CONTROL TRIALS ABOUT THE IMPORTANCE OF CONTROL AND THE IMPORTANCE OF RANDOMIZATION BUT BLINDING CAN BE PARTICULARLY COMPLEX IN THIS TYPE OF THERAPY. SO WONDER IF PEOPLE CAN TALK ABOUT HOW BEST PRACTICES HOW IT'S DONE, WHETHER THERE ARE AL ALTERNATIVE APPROACH NOT RELIANT UPON FULL BLINDING. LOOKS LIKE YOUR HAND IS UP. >> SO ONE OF THE THINGS WE TALKED ABOUT IN OUR SUBGROUP ABOUT BLINDING, MANY TIMES TRIALS THAT ARE LOOKING AT EFFICACY PER SE FOR MUSIC INTERVENTION, PERSON WILL KNOW WHETHER OR NOT THEY HAVE BEEN RANDOMIZED TO MUSIC OR ANOTHER CONDITION. IT REALLY IS IMPORTANT TO BLIND YOUR ASSESSORS OR EVALUATORS, BUT IN ADDITION, ANOTHER STRATEGY FOR ADDRESSING THAT WHICH I BELIEVE ALSO CAN HELP ACCOUNT FOR EXPECT EXPECTED SAY OF BENEFIT FROM INTERVENTION, FOR EXAMPLE IN OUR TRIAL OUR ATTENTION CONTROL CONDITION IS PRESENTED AS AN EQUAL CONDITION, IT IS NOT OUR INTERVENTION OF INTEREST, IN FACT IT IS AN ATTENTION CONTROL CONDITION BUT IT'S BEEN DESIGNED AS SUCH TO BE LOOKING AT PLAY CONDITION SO WE CAN REPRESENT THEM AS EQUAL CONDITIONS THAT INFORM OUR QUESTIONS OF INTEREST. ESSENTIALLY OUR FAMILIES ARE NOT GIVEN THE IMPRESSION THAT MUSIC IS THE INTERVENTION OF INTEREST SO ESSENTIALLY YOU ARE KEEPING THEM BLINDED TO THE FACT THAT THAT'S THE INTERVENTION OF INTEREST IS THAT IS ONE PARTICULAR APPROACH BUT SURE MORE PEOPLE HE CAN SHARE. >> >> OTHER THOUGHTS ON THIS. WE HAVE OTHER QUESTIONS BUT I DON'T WANT TO CUT ANYBODY OFF. I WILL BRING UP -- >> QUICKLY ANOTHER WAY TO THINK ABOUT IT, IT DEPENDS WHAT THE INTERVENTION IS, RIGHT? IF IT'S MUSIC WITHOUT INTERVENTION THE SOLUTION IS A POSSIBLE SOLUTION FOR THE BLINDING, IF IT IS LISTENING TO PRE-RECORDED MUSIC WHICH IS USED IN MUSIC MEDICINE STUDIES YOUR CONTROL CONDITION COULD BE LISTENING TO SOMETHING ELSE. WHETHER WHITE NOISE OR SORRY OR WHATEVER IT MIGHT BE AND THE PARTICIPANT HERE IS NOT TOLD WHICH IS THE ACTUAL INTERVENTION OF INTEREST. MUSIC THERAPY STUDIES AND OTHER CONSIDERATION IS TO LOOK AT WITHIN MUSIC THERAPY LOOKING AT COMPARATIVE STUDIES SO ONCE YOU KNOW THAT A PARTICULAR MUSIC THERAPY INTERVENTION IS EFFECTIVE FOR ENHANCING CERTAIN HEALTH OUTCOME TO COMPARE WITH ANOTHER VERSION OF MUSIC THERAPY INTERVENTION IT EITHER COULD BE SOMETHING YOU THINK WOULD NOT BE QUITE AS POTENT OR COULD BE YOU DO TRUE COMPARATIVE TRIAL AND HAVE ANOTHER MUSIC THERAPY INTERVENTION, SO YOU CAN COMPARE ONE ACTIVE MUSIC THERAPY INTERVENTION, WHERE PATIENT IS ACTIVELY ENGAGE IN MUSIC MAKING WITH ANOTHER TYPE OF MUSIC THERAPY INTERVENTION WHERE THE PATIENT IS ACTIVELY ENGAGE SO AGAIN, PATIENT WOULD BE BLINDED TO THE HYPOTHESIS. I THINK IN MANY CASE CASES INDEED IT IS EXTREMELY CHALLENGING TO DO THIS. BECAUSE THE PATIENT ESPECIALLY IF YOU USE ACTIVE MUSIC THERAPY INTERVENTIONS WHERE PATIENT ACTIVELY MAKES MUSIC WITH THE THERAPIST, IT IS CHALLENGING TO DO SO. ONE OF OUR STUDIES WERE ACTUALLY IT IS A PAIN MANAGEMENT STUDY, WE ARE TELLING PATIENTS THAT THEY MIGHT BE RANDOMIZED TO PAIN -- TWO DIFFERENT TYPES OF PAIN MANAGEMENT SUPPORT PROGRAMS, ONE THAT USES MUSIC OR INCORPORATES MUSIC. AND ANOTHER ONE THAT IS MEETING WITH A VERBAL THERAPIST. SO THE PATIENT AGAIN DOES NOT KNOW WHICH OF THE INTERVENTION OF INTEREST. HOWEVER, I ALWAYS -- I DON'T THINK WE CAN UNDERESTIMATE OUR PARTICIPANTS RIGHT? SO PARTICIPANT WITH LOOK ME UP AS PRIMARY INVESTIGATOR AND SEE MUSIC THERAPIST AT DREXELL UNIVERSITY. THEY WILL FIGURE OUT WHAT MY HYPOTHESIS IS. SO SOMETIMES I THINK WE PUT BLINDERS ON OURSELVES AS RESEARCHERS AND WE GO BY THE BOOKS AND WE TRY TO MAKE A BLINDED INTERVENTION AND FIND A GOOD COMPARATOR AS IF THESE PARTICIPANTS DON'T HAVE ACCESS TO THE INTERNET AND CAN'T LOOK YOU UP AND FIGURE OUT YOU ARE THE MUSIC THERAPIST OR ALL YOUR RESEARCH ALL DOCTOR'S RESEARCH IS RELATED TO MUSIC. THEY WILL FIGURE OUT WHAT THE INTERVENTION OF INTEREST IS. >> GREAT COMMENT. SO THAT YOU ACTUALLY I THINK STARTED TO ANSWER MAYBE COMPLETELY ANSWER THE MENTION SET OF QUESTIONS WHICH ARE AROUND CONTROLS AND WHAT ARE GOOD EXAMPLES OF CONTROLS YOU MENTION WHITE NOISE AND PARTICULAR BUT WONDER IF OTHERS HAVE THOUGHTS IN THEIR WORK AROUND EFFECTIVE EXAMPLE OF CONTROLS. IF WE SHOULD CONSIDER THIS I THINK YOU DID TAKE THAT ON AT THE SAME TIME AS THE BLINDING QUESTION. I WILL KEEP GOING AND LET Y'ALL JUMP IN AS YOU WANT TO. WE ARE A FAIR AMOUNT OF DISCUSSION ABOUT THE DIFFERENT SPECIFIC NEUROLOGICAL SYSTEMS AND THE VALUE IN IDENTIFYING THE HYPOTHESIZED SYSTEM, BASED ON EVIDENCE. BUT THE ACKNOWLEDGMENT THAT THESE SYSTEMS INTERRELATE AND INTERACT AND A GIVEN INTERVENTION IS LIKELY TO AFFECT MULTIPLE SYSTEMS, SO HOW DO YOU THINK ABOUT THE BALANCE FROM A STUDY DESIGN BETWEEN TARGETING SPECIFIC SYSTEMS, AS OPPOSED TO THINKING ABOUT HOW THEY INTERACT. >> PERHAPS I CAN TAKE A SHOT AT THAT SO I THINK THE IDEA IS THAT IN A GIVEN DISORDER, THERE ARE -- THERE IS PROBABLY ONE MAJOR GOAL, ONE MAJOR DISTURBANCE AND YOU THEN WANT TO TAILOR YOUR INTERVENTION SO AS TO AMELIORATE WHATEVER THAT DISTURBANCE IS. IN THAT CONTEXT SAYING THERE'S THE DISTURBANCE OF SAY MEMORY AND DEMENTIA SO THAT IS WHAT WE ARE GOING TO GO AFTER. THEN YOU ARE TALKING ABOUT MEMORY SYSTEM AND THE NATURE OF THE INTERVENTION SHOULD BE SOMETHING THAT BASED ON EVIDENCE IS KNOWN TO ENGAGE THAT PARTICULAR SYSTEM. THE FACT THAT MEMORY SYSTEM COULD INTERACT FOR INSTANCE WITH WITH EMOTION AND REWARD SYSTEM THAT MAKES IT MORE COMPLEX. BUT AT LEAST YOU ARE STARTING OFF WITH A WAY TO FOCUS YOUR BOTH RESEARCH QUESTION AND TYPE OF APPROACH THAT YOU WOULD TAKE WHICH IS BETTER THAN NOT THINKING ABOUT IT AT ALL THAN JUST SAYING WE HAVE PATIENT WHO HAS SOME DISORDER SO WE ARE JUST GOING TO ARBITRARILY ATTEMPT WHATEVER INTERVENTION WE HAVE AT HAND. I THINK THAT WAS THE IDEA. WHILE I HAVE THE FLOOR BRIEFLY, I WANT TO MAKE ONE OTHER POINT WHICH HASN'T BEEN MADE I DON'T THINK, WHICH IS THAT WE HAVE BEEN TALKING ABOUT CLINICAL TRIALS, BUT THERE IS ALSO VERY IMPORTANT COMPONENT OF PRE-CLINICAL RESEARCH THAT MAY NOT INVOLVE PATIENT POPULATIONS AT ALL. BUT MAYBE HAVER VERY NECESSARY TO ORDER EVENTUAL APPLICATIONS TOWARDS REAL CLINICAL POPULATIONS. TO GIVE YOU A QUICK EXAMPLE SOME STUFF WE ARE DOING IN OUR LAB, WE ARE DEVELOPING FEEDBACK TECHNIQUES. BEFORE WE REALLY ARE GOING TO BE READY IN ANY WAY SHAPE OR FORM TO APPLY IT TO ANY KIND OF PATIENT POPULATION, WE NEED TO UNDERSTAND EXACTLY HOW IT WORKS EXACTLY HOW IT DOESN'T WORK, WHAT ARE THE CONSEQUENCES OF USING IT, WHAT ARE THE PARAMETERS, AND WHAT THE BRAIN SIGNALS THAT WE CAN MEASURE WITHOUT DOING THAT FIRST STEP WE CAN'T EVER POSSIBLY APPLY TO CLINICAL POPULATION. AND I THINK THAT IS RELEVANT TO THIS QUESTION OF HOW DO WE GO ABOUT TRYING TO IDENTIFY BRAIN NETWORK THAT MIGHT BE RELEVANT, YOU COULD DO THAT IN A PURELY EXPERIMENTAL PRE-CLINICAL PHASE, WHERE YOU USE BRAIN IMAGING OR NEUROPHYSIOLOGY OR PSYCHOPHYSIOLOGY OR MOVEMENT INDICES OR WHATEVER TO TRY TO UNDERSTAND WHAT IS GOING ON IN A HEALTHY BRAIN AND THEN TAKE THE NEXT STEP. >> WE'LL GO TO DR. TOUT AND EDWARDS. >> THIS IS WHERE A SYSTEMATIC APPROACH COMES IN. MY EXPERIENCE TAKING FIRST OBSERVING THE BEHAVIOR CHANGE AND THEN KIND OF SAYING HERE IS WHAT I KNOW ABOUT THE UNDERLYING MECHANISMS FOR THAT BEHAVIOR AND FOR MY POPULATION OF INTEREST. HERE IS WHAT I KNOW KIND OF ABOUT HOW MUSIC WORKS. BUT THEN FINALLY TAKING THE NEXT PIECE OF WHAT THE PARTICIPANT TELLING ME, PUTTING THAT TOGETHER AND DESIGNING A VERY RIGOROUS RESEARCH STUDY, AND IT STILL DIDN'T TURN OUT LIKE WHAT YOU WOULD THINK BUT I THINK SUPPOSED TO BE OPEN TO THAT. I THINK BEING OPEN TO THE THING THAT IT MAY NOT WORK OUT AS YOU HYPOTHESIZE BUT LOOKING AT THAT DATA WILL DIRECT YOU TO THAT NEXT STEP. AND TO BE OPEN TO UNDERSTANDING HOW ALL THE SYSTEMS INTERPLAY WITH YOU, AND THAT WITH YOUR OUTCOME MEASURE AND THAT MAYBE THE ONE SPECIFIC THING YOU ARE LOOKING AT DIDN'T WORK LIKE YOU THOUGHT BUT POINT YOU TO THE NEXT SYSTEMATIC STEP TRYING TO UNDERSTAND HOW EVERYTHING IS WORKING. I WOULD SAY IT IS KIND OF I WOULD TAKE ALL THE INFORMATION YOU CAN TO DESIGN THE MOST RIGOROUS AND SYSTEMATIC STUDY THAT YOU CAN AND BE OPEN TO READY TO MAYBE LOOK AT WHAT THAT NEXT STEP WOULD BE IF THE RESULTS DON'T SHOW WHAT YOU ARE GOING -- WHAT YOU WOULD EXPECT TO SHOW. >> THANKS. I STRONGLY AGREE WHAT WAS SAID, I RYE TO SORT OF HINT EARLIER ALSO, DON'T PUT PEOPLE IN BRAIN SCANNER UNLESS OF A TESTABLE BEHAVIORAL HYPOTHESIS. CLINICAL OR PURELY BEHAVIORAL. THAT COULD ALSO INCLUDE A HYPOTHESIS ON PRE-CLINICAL STAGE. HOW DO I -- THIS IS TRIVIAL, BUT NOT SINGLE SYSTEM OF THE BRAIN THAT WORKS ON ITS OWN. SUPER CONNECTION THAT WE ARE JUST BEGINNING TO UNRAVEL IMAGING ABILITIES WHERE WE LOOK AT CONNECTIVITY ISSUES (INAUDIBLE) IT IS EXTREMELY IMPORTANT, TO REMEMBER THAT AS YOU HAVE TO HAVE A CLINICAL BEHAVIORAL IDEA WHAT YOU ARE LOOKING AT, OTHERWISE YOU ARE LOOKING AT A TRILLION NEURONS BASICALLY. >> WAS GOING TO SAY FOLLOWING UP ON WHAT SANTORI WAS TALKING ABOUT PARKINSON DISEASE OFFERS AN INTERESTING MODEL FOR MULTI-SYSTEMS BECAUSE WHILE MOST OF US THINK OF PARKINSON AS MOTOR DISEASE, NON-MOTOR SYMPTOMS ARE JUST AS IMPORTANT OR ACTUALLY COULD CAUSE MORE PROBLEMS SO DESIGNING MUSIC INTERVENTION COULD ACTUALLY OFFER OPPORTUNITIES TO LOOK AT THE INTERACTION WEAN THESE MOTOR SYSTEMS AND REWARD SYSTEMS, OTHER COMPONENTS. I DON'T KNOW IF ANYBODY THAT ACTUALLY DOES WORK IN PARKINSON'S WANTS TO COMMENT ON THAT. BUT FOUND THAT THE NON-MOTOR SYSTEMS WERE ACTUALLY QUITE RELEVANT. ALMOST PREDICTIVE ON PROGRESSION OF DISEASE. >> DR. YE THAN THEN A FEW MORE QUESTIONS. >> I WANT TO SAY BRIEFLY, THERE IS -- THERE ARE ANALYTIC TECHNIQUES TO ACTUALLY LOOK AT HOW SYSTEMS MAY BE INTERACTING WITH EACH OTHER SIMULTANEOUSLY THINKING ABOUT COMPLEXITY MEASURES OR NON-LINEAR DYNAMICS, SYSTEMS BASED COMPLEXITY MEASURES ARE EVEN -- OR EVEN NETWORK ANALYSES. SO THERE'S -- THERE MAYBE CUTTING EDGE NEW TOOLS OUT THERE THAT CAN HELP US THINK ABOUT HOW A PARTICULAR INTERVENTION COULD BE AFFECTING BOTH GATE VARIABILITY AS WELL AS HEART RATE VARIABILITY AS WELL AS EEG DYNAMICS FROM ONE TO THE OTHER. >> I WILL BRING IN A FEW MORE QUESTIONS NOW, ONE HAS TO DO WITH TEAM MEMBERS AN REHABILITATION SCIENTISTS AS A QUESTION MYING IS EDUCATORS WHO HAVE THEIR OWN EXPERIENCE TEACHING MUSIC. I DON'T THINK ANYONE MEANT THE LIST WE DISCUSSED TO BE EXCLUSIVE BUT I WONDER IF PEOPLE HAVE REACTIONS TO THOSE OR EXPERIENCE WITH THOSE AS TEAM MEMBERS. >> SORRY. >> NO PROBLEM. >> I MEAN, I THINK YOU ARE RIGHT, WE DIDN'T WANT EVERYBODY WHO COMMENTED ON THIS WAS AWARE THAT IT WOULD BE TO BE TAILOREDDED TO THE STUDY AND RESEARCH QUESTION BUT I THINK IN GENERAL, THE THENESS WAS VERY INCLUSIVE. I DO THINK THOUGH IT IS INTERESTING THE QUESTIONER BROUGHT UP MUSIC EDUCATORS BECAUSE I THINK THAT'S A KINDRED AREA OF RESEARCH EVEN IN EDUCATION PSYCHOLOGY AND UNDERSTANDING SOME OF THE IMPLEMENTATION SCIENCE ISSUES OF MUSIC EDUCATION PERHAPS VERY RELEVANT TO MUSIC AN HEALTH. SO I WANT -- I'M GLAD I CAME UP, I DON'T KNOW WHETHER EVERY SINGLE, I DON'T THINK BUILDING BLOCK YOU SAY EVERY MUSIC BASED INTERVENTION HAS TO HAVE MUSIC EDUCATION EXPERT ON IT, BUT I HI THIS SPEAKS TO PERHAPS PROBABLY NEED TO CONVERGE THE FIELDS A LITTLE CLOSER SOMEHOW. THROUGH SOME OF THE WORK WE DO TOGETHER. SO I WANTED TO CALL THAT OUT. >> I WOULD ADD WE TALKED ABOUT PREVENTION AND EARLY INTERVENTION FOR YOUTH SO THERE'S SOMETHING THERE IN TERMS OF THINKING ABOUT THE ROLE OF THE ARTS IN THE EARLY YEARS AND DEVELOPMENTAL PERIODS AND ALSO I THINK THAT SOCIAL EMOTIONAL HEALTH IS IMPORTANT ACROSS THE LIFE SPAN SO THE MORE EDUCATION ACROSS THE LIFE SPAN THERE IS ALSO SOMETHING THERE. CAREGIVERS OR WITH DIFFERENT POPULATIONS WHO ARE EXPERIENCING LOOKING AT HEALTHY AGE HEALTHY BRAIN AGING, THERE IS SOMETHING TO BE TALKED ABOUT AS WELL. IN TERMS OF EDUCATION. >> I WOULD JUST SAY I DO THINK THE REHAB SCIENCE FIELD WOULD ALSO BE ABLE TO TO REALLY CONTRIBUTE BECAUSE SCIENCE EVOLVED OVER TIME AND MANY LESSONS LEARNED COULD BE BROUGHT TO BEAR. >> THERE WAS A QUESTION I'M GOING TO HAVE TO READ BECAUSE IT USES A PHRASE THAT I HOPE HAS MEANING; SPECIFIC MEANING TO SOME OF YOU IN A WAY THAT IT DOESN'T TO ME SO THE QUESTION IS ABOUT EXPECTATION BIAS. AND IT'S ABOUT ASKING YOU TO TALK ABOUT HOW THE EXPERIMENTAL MEDICINE APPROACH FOR BEHAVIORAL INTERVENTION HAS BEEN EVALUATESSED. HOW IT MIGHT APPLY TO MUSIC AND HEALTH RESEARCH METHODS. SO I CAN'T PROVIDE CONTEXT ON EXPERIMENTAL MEDICINE APPROACH FOR BEHAVIORAL INTERVENTION BUT MAYBE ONE OF YOU CAN ANSWER THE QUESTION. >> GREAT. I'M GLAD MY HAND IS UP. SO MY NAME IS DON EDMONDSON, PRINCIPLE INVESTIGATOR OF THE RESOURCE AND COORDINATING CENTER FOR SCIENCE BEHAVIOR CHANGE PROGRAM, IT IS ALL THE ENTIRE PROGRAM TEN YEARS IS ABOUT APPLYING THE EXPERIMENTAL MEDICINE APPROACH TO BEHAVIORAL SCIENCE I THINK THEY SENT OUT THE WEB LINK EARLIER SCIENCE BEHAVIOR CHANGE ONE WORD.ORG GO THERE AND YOU CAN WALK THROUGH THE ENTIRE PROGRAM, APPLICATION EXPERIMENTAL MEDICINE APPROACH TO BEHAVIOR CHANGE SCIENCE BUT IT IS -- I CAN'T IMAGINE IT BEING NOT PRETTY EASILY TRANSFERABLE TO MOST ASPECT OF WHETHER MUSIC THERAPY OR MUSIC AS MADISON, REALLY JUST ASKING YOURSELF, I DON'T KNOW IF YOU HAVE DONE THIS STATISTICS PROGRAMS, WHERE HOW MUCH STATISTICAL TRAINING RECEIVED BUT WHEN YOU THINK ABOUT INTERVENTION MEDIATOR, OUTCOME, IT IS REALLY ABOUT HOW DO WE SYSTEMATICALLY THINK ABOUT THE MEDIATORS OR THE MECHANISMS WHICH IS OUR INTERVENTIONS WORK MEASURE THEM WELL, ENGAGE THEM EARLY ON SO WE ARE BUILDING CAUSAL CONCEPTUAL MODELS, THAT OTHER PEOPLE CAN BENEFIT FROM OUR RESEARCH WHETHER OR NOT WE GET A WHOPPING CLINICAL EFFECT FROM THIS PARTICULAR STUDY. WHERE ALLOWING OUR FIELD TO ACCUMULATE EVIDENCE FOR WHAT PATHWAYS WORK, WHAT PATHWAYS DON'T, FOR WHOM, INTERVENTIONS MAY WORK, AND FOR WHOM LIKELY NOT TO. GO GO GO TO THAT WEBSITE, THAT'S PRETTY FUN. THERE'S MEASURES THERE TOO. >> THANK YOU, I'M SORRY I WAS UNABLE TO INTERPRET THE QUESTION I'M GLAD YOU ARE ABLE TO. LET'S -- THIS MAY BE MORE TO NIH FOLKS THAN SOME OF THE PANELISTS BUT THERE IS A QUESTION ABOUT LONG TERM PLANS LOOKING AT INTERVENTIONS IN OTHER POPULATIONS PEOPLE WITH OTHER SOCIAL COMMUNICATIVE CHALLENGES. ANYONE ABLE TO ANSWER HA QUESTION? >> REPEAT THAT ALAN. >> WHAT ARE THE LONG LONG TERM PLANS FOR LOOKING AT INTERVENTIONS INNER O POPULATIONS SUCH AS CHILD DEVELOPMENT CHILDREN WITH AUTISM OTHER PEOPLE WITH SOCIAL COMMUNICATIVE DEFICITS, IN ADDITION TO THE POPULATION WE FOCUSED ON IN OUR DISCUSSION TODAY. >> DR. EDWARDS GOOD PLACE TO START YOUR HAND IS UP. >> SO WHAT I WOULD SAY IS THAT THE FIRST PORTION OF THIS PROJECT DEVELOPING THE TOOL KIT IS MEANT TO BE AGNOSTIC OF DISEASE, ESSENTIALLY HOW TO DO MUSIC INTERVENTION THAT COULD BE GENERALIZED TO OTHER POPULATION. WHEN WE GET TO THE OUTCOME MEASURES AND THE BIOMARKERS, WE'RE GOING TO FOCUS ON THE BRAIN DISORDERS OF AGING PER SE WHICH IS OUR FIRST POPULATION THAT WE ARE LOOKING AT. BUT THE HOW TO, THE WHAT ARE THE CRITICAL ELEMENT THAT SHOULD BE INCLUDED IN TO THE MUSIC BASED INTERVENTION PROTOCOL, THE IDEA IS IT SHOULD BE -- YOU SHOULD BE ABLE TO GENERALIZE THAT TO OTHER GROUPS. OF COURSE FOR IN A PEDIATRIC POPULATION YOU HAVE TO TAKE INTO ACCOUNT THE NEURAL DEVELOPMENTAL STAGE OF THAT GROUP. BUT IN GENERAL THE GOAL IS TO HAVE TOOL KIT THAT COULD BE TRANSFERABLE TO OTHER POPULATIONS. >> EXCELLENT. THERE IS A QUESTION ABOUT THE RELATIVE ROLE OF DIFFERENT PROVIDERS OF SERVICES, MUSIC THERAPIST, MUSIC EDUCATORS, WE TALKED ABOUT MUSICIANS THEMSELVES. WE HAVE TALKED ABOUT INTERMEDIATING ROLE OF CAREGIVERS COMMUNITY BASED ORGANIZATIONS HAVE COME UP. HOW DO WE THINK ABOUT WHERE THE START WHICH GROUPS THERE IS STRONGER EVIDENCE BASE FOR, ANY COMMENTS ABOUT THE PARTY DELIVERING THE INTERVENTION? NOT GETTING ANY TAKERS. >> I WAS GOING TO OFFER -- I DIDN'T SEE IT. >> >> I DIDN'T RAISE MY HAND. >> GO AHEAD. >> MUSIC -- I KNOW MUSIC THERAPISTS HAVE THERE'S SOME ADVANTAGE IN THEY HAVE A COHESIVE FIELD OF PRACTICE THAT'S HASPED DEGREE IN TERMS OF HISTORY OF RESEARCH AND PRACTICE KIND OF COINCIDE A LOT OF TIMES. I DO FEEL MAYBE SOME OF THE LIFT HERE IS GOING TO BE TO FIGURE OUT HOW TO INTEGRATE MUSICIANS AS THE INTERVENTION DELIVER, WHAT INTERVENTIONS IS SUITABLE FOR MUSIC NON-MUSIC THERAPIST, TO BE PART OF THIS STUDY, AND TO BE PART OF INTERVENTION. BEYOND EVALUATING SORT OF PROGRAMS THAT ARE ALREADY IN EXISTENCE THAT INVOLVE COMMUNITY BASED MUSIC PROGRAMS I WAS TALKING ABOUT OR MUSICIANS, IS THERE A WAY TO INCLUDE THEM EARLY ON IN THE DEVELOPMENT OF THESE KINDS OF BUILDING BLOCKS. WE UNDERSTAND WHAT IS THE APPROPRIATE LEVEL OF RIGOR FOR DIFFERENT IN DEFINING CERTAIN ELEMENTS OF PRACTICE. IT IS MORE A ADD ON QUESTION QUESTION THAT WAS RAISED SOLUTION BUT COMPLY CASE MATTERS THERE'S NO UNIFIED FEEL HERE. >> ALAN, I WILL ADD TO THAT BUT IN SOME WAYS THINKING ABOUT A CONTINUUM OF CARE AND THERE IS AN ARMY OF ARTISTS AND THERE ARE SO MANY ARTS AND HEALTHND ART THERAPISTS, THAT I THINK CAN BE PART OF A SOLUTION. SO I AGREE WITH SUNIL THE MORE WE CAN CREATE AN ASSET MAP TO LOOK AT WHERE THOSE PRACTITIONERS ARE AND THEY COULD BE SOCIAL WORKERS AND COULD BE PSYCHOLOGISTS AND COULD BE COMING FROM MULTIPLE PHYSICAL THERAPY. THINKING MORE INNOVATIVELY MORE BROADLY ABOUT HOW PRACTICE MEETS NEED AND WHERE NEED IS AND WHERE THE LEVEL OF INTERVENTION IS. THERE'S A LOT MORE CONVERSATION WITH PRACTICERS ACROSS MULTIPLE FIELDS THAT NEEDS TO HAPPEN TO REALLY ADEQUATELY ADDRESS WHAT IS A CONSIDERABLE NEED. >> I WILL TURN TO DR. SATORI AND DR. ROB. >> ONE OTHER THOUGHT THAT WE HAVE BEEN TALKING A LOT ABOUT A PATIENT IN THE INTERVENTION THERAPIST, BUT THERE ARE OTHER MODELS THAT MIGHT INVOLVE MUSICIANS, WE KNOW MUSICAL TRAINING AND MUSICAL PRACTICE ITSELF MIGHT HAVE SOME GREAT VALUE, I'M THINKING FOR EXAMPLE, SITUATIONS THAT DON'T REQUIRE QUOTE UNQUOTE THERAPEUTIC INTERVENTION AT ALL. LIKE COMMUNITY SINGING AND IN CHOIRS WHICH SOMETHING TRIED A LOT IN SOME EUROPEAN COUNTRIES WITH ELDERLY PEOPLE HAS MANY, MANY BENEFITS AND THEY MAY NOT END UP SINGING LIKE RENEE BUT IT CAN BE EXTREMELY ENJOYABLE AND THERE IS A SOCIAL COMPONENT THAT MIGHT BE A WAY ALSO TO ENGAGE MUSICIANS, WHO COULD TRAIN THOSE PEOPLE OR HELP THEM TO ACTUALLY ENGAGE DIRECTLY WITH MUSIC, THAT COULD BE A WAY ALSO TO MAINTAIN ACTIVITY RATHER THAN SOMEONE WHO IS ILL AND NEEDS INTERVENTION, COULD BE PREVENTIVE IN OTHER WORDS. >> >> DR. ROBIN THEN DR. SCHOR. >> SO I WAS JUST GOING TO ELABORATE ON THE PRIOR COMMENT THAT WAS ABOUT REALLY LOOKING AT MUSIC AND MUSIC INTERVENTIONS MUSIC FOR HEALTH, REALLY AS A CONTINUUM OF CARE. AND THAT RIGHT NOW BOARD CERTIFIED MUSIC THERAPIES OFTENTIMES ARE WORKING WITH MORE VULNERABLE POPULATIONS, THEY HAVE A VERY DETAILED SKILL SET, THEY HAVE DEGREES IN TRAINING THAT'S QUITE EXTENSIVE IN TERMS OF HOW TO MANIPULATE MUSIC FOR CLINICAL OUTCOME. THAT SAID, THERE IS A WIDE AREA OF NEED AND AS I THINK PART OF THE ROLE OF RESEARCH IN ANY AREA IS TO AS WE DEVELOP FIGURE OUT HOW MUSIC CAN WORK TO BENEFIT PUBLIC HEALTH IS PART OF THAT IS REALLY DISENTANGLING WHAT IS THE SKILL SET THAT IS REQUIRED TO DELIVER THAT INTERVENTION. MANY MUSIC THERAPISTS ARE ENGAGED IN PROJECTS THAT ARE DISENTANGLING WHAT DOES THE MUSIC THERAPIST DO AND ARE THERE WAYS WE CAN SKILL SHARE OR DEVELOP PROGRAMS TAUGHT AND LED BY OTHER PROFESSIONALS. WHAT WE WILL SEE OVER TIME AS WE BEGIN TO GROW THE BODY OF RESEARCH EVIDENCE IS IT WILL INFORM THE USES OF MUSIC VERY BROADLY. MUCH LIKE DR. SATORI SPOKE OF NOT EVERYBODY REQUIRES THERAPY OR NEEDS INTENSIVE TAILORED USES OF MUSIC BUT THERE MAY BE BROADER APPLICATIONS OF MUSIC LIKE COMMUNITY MUSIC SINGING THAT CAN BE QUITE ADVANTAGEOUS FOR HEALTH OR THINGS WON'T REQUIRE A PERSON. SO SIMILAR TO OTHER TYPES OF THERAPIES, WHERE WE HAVE SELF-HELP. ON THE ONE END I CAN READ A BOOK USE AN APP THAT MOVES ALL WAY TO YOUR SPECIALTY PHYSICIANS AND I THINK WE WILL START TO SEE EMERGENCE OF DIFFERENT PEOPLE WHO WILL BE COME EQUIPPED TO TO USE MUSIC. >> I WOULD ECHO THAT AND MAYBE EVEN TAKE IT ONE FURTHER, I WOULD THINK THAT WHEN YOU ARE FIRST DEVELOPING THE EVIDENCE BASE YOU MIGHT MAKE A FIRST PASS AT CHOOSING THE QUOTE UNQUOTE EXPERT INDIVIDUAL TO PROVIDE THE THERAPY SO THAT YOU WOULD AT LEAST STANDARDIZE THE WAY IN WHICH YOU PROVIDED FOR THE TRIAL. AS TIME GOES ON YOU WANT TO DO MUCH MORE PRAGMATIC STUDIES WHERE YOU SAY IS THIS TRANSLATABLE TO REGIONS IN WHICH THERE ARE REALLY NOT HUGE NUMBERS OF EXPERTS AVAILABLE AND YOU MIGHT EVEN TAKE IT IN THE DIRECTION MANY AUTISM STUDIES ARE GOING WHERE YOU SAY CAN I TRAIN THE FAMILY MEMBERS AND THE TEACHERS IN THE NURSERY SCHOOL AND THE KIDS ON THE PLAYGROUND TO INTERACT WITH THIS CHILD IN THAT PARTICULAR WAY. YOU MIGHT DO THE SAME THING TO SAY FIRST CAN I PROVIDE VERY STANDARDIZED EVIDENCE BASE FOR THIS, IF THE ANSWER IS YES, THEN YOU WOULD ASK CAN I TRANSLATE IT TO MUCH MORE PRACTICAL SETTINGS. >> THE LAST QUESTION WE COULD SPEND AS MUCH TIME AS ALL OTHERS COMBINED BUT I WILL TOSS OUT FOR A FEW REACTS. IT IS A REFERENCE TO PERSONALIZED MEDICINE WHICH CAME UP IN SOME OF THE EARLIER DISCUSSIONS. AND I WILL PHRASE THE QUESTION THIS WAY. THE EVOLUTION TOWARD THINKING PERSONALIZED MEDICINE REQUIRES EARLY RESEARCH AND THEN LARGE DATA SETS THAT ENABLE YOU TO TAILOR, WE WERE TALKENING THIS CONVERSATION ABOUT INDIVIDUALIZING TREATMENT BUT THAT CAN GET -- THAT CAN BOTH BE IMPORTANT TO STUDY BUT ALSO GET IN THE WAY OF STUDYING. BECAUSE I RAISES ISSUES OF FIDELITY AND SAMPLE SIZE. HOW DO WE NAVIGATE OUR WAY TAKING BEST FROM APPLICATION OR PERSONALIZED MEDICINE GIVEN THIS STAGE OF RESEARCH NOW IN MUSIC. >> A GOOD PLACE TO START IS HOW WE INDIVIDUALIZE OR TAYLOR THE TREATMENTS IN A WHICH THAT IS SYSTEMATIC AND WHAT WE LEAVE. FOR CAREGIVERS IN TERMS OF DOING WHAT THEY THINK MAKES SENSE MANY THE CONTEXT OF PROVIDING CLINICAL CARE. FOR EXAMPLE, WE CAN BASE DECISIONS LIKE WHO SHOULD GET AN INTENSIFIED INTERVENTION AND UNDER WHAT CONDITIONS. FOR EXAMPLE IDENTIFYING OUR RESPONDERS AND PROVIDING MORE TREATMENT FOR NON-RESPONDERS. THIS CAN BE SYSTEMATIZED BASED ON EMPIRICAL EVIDENCE SO WE CAN CONDUCT TRIALS TO GET THE KIND OF INFORMATION, THAT I DON'T NECESSARILY NEED TO INVOLVE LARGE SAMPLE. NOT MORE THAN STANDARDIZED RCTs SO WE CAN DO THAT BASED ON EMPIRICAL EVIDENCE AND SOME DECISIONS THESE EXAMPLES WHEN CLINICIAN SITS WITH PATIENT AND BASED ON HIS OR HER RESPONSE MODIFY THE TREATMENT. THESE DECISIONS CAN BE LEFT TO CLINICAL CARE. AS LONG AS WE PROTOCOLIZE THIS, AS LONG AS IT'S CLEAR, WHAT DECISIONS CAN BE MADE BY THE CLINICIAN IN REAL TIME AND WHAT DECISIONS ARE PROTOCOLIZED BASED ON EMPIRICAL EVIDENCE, THIS IS A GOOD PLACE TO START. YES. RONA. >> I THINK THAT BY LOOKING AT NUMBERS OF SMALLER STUDIES, THAT ARE LOOKING AT DIFFERENT THINGS. WE CAN YIELD SOME OVERLAPPING OR CORE PRINCIPLES. SO WHEN YOU THINK OF LIKE HEART HEALTH OR SOMETHING, IT IS NOT THE SAME FOR EVERYBODY BUT THERE ARE SOME BASIC PRINCIPLES THAT EMERGED AND THING WITH HEALTHY DIET, SO THAT IS WHAT I WOULD KIND OF AIM FOR HERE KNOWING THAT THERE IS BILLIONS OF COMBINATIONS AND DIFFERENT DISORDERS BUT IF WE CAN GET A FEW THINGS TO HANG OUR HAT ON, THAT WOULD UNTIL BE A HUGE ADVANCE, THAT WOULD BE WHAT I WOULD -- I THINK COULD COME OUT EVEN IN THE SHORTER RUN EVEN WITH SMALLER STUDIES. CAN LOOK FOR THINGS THAT SAME TO HANG TOGETHER. I DON'T KNOW IF THAT MAKES SENSE. BUT I HAVE SEEN THAT ONCE AGAIN IN PHYSICAL THERAPY WHERE SO MANY DIFFERENT DISORDERS, LIKE ATHLETIC INJURIES AND YOU HAVE PEOPLE WITH STROKE AND YOU HAVE PEOPLE WITH CARDIAC CONDITIONS YET THERE'S SORT OF FUNDAMENTAL PRINCIPLES WITHIN THERE IN TERMS OF HOW YOU APPROACH THIS, YOU NEED FLEXIBILITY FOR EXAMPLE OR YOU NEED SOME STRENGTH. SO THOSE THINGS THEN BECOME BUILDING BLOCKS FOR TAILORED APPROACH TO THE INDIVIDUAL. >> I WANT TO THANK Y'ALL FOR YOUR FULL ENGAGEMENT IN PRESENTING WHAT YOU HAD WORKED ON IN SMALL GROUPS STILLING TO MY TIGHT TIME SCHEDULE AND HAVING WILLINGNESS TO JUMP IN AND ANSWER SOME QUESTIONS THAT WE CERTAINLY DIDN'T PREPARE FOR BUT THEY WERE VERY HELPFUL TO THE AUDIENCE. SO I WILL TURN IT BACK NOW TO KATHERINE. >> THANK YOU, ALAN. APPRECIATE THAT. AND AGAIN, THANK YOU TO OUR PANELISTS AND OUR SPEAKERS AND EVERYBODY WHO JOINED IN, THIS REALLY WONDERFUL DISCUSSION AND I THINK REALLY RICH Q&A SESSION. SO JUST REMINDER TO OUR VIDEOCAST VIEWERS, ANY QUESTIONS NOT ADDRESSED TODAY WILL BE SHARED WITH OUR PLANNING TEAMS AND THEY CAN CONSIDER THEM. AS THEY PREPARE FOR THE NEXT TWO MEETINGS IN THE SERIES OF THREE. SO WITH THIS IT IS NOW TIME TO WRAP UP OUR MEETING. AND PLAN FOR NEXT STEPS SO I WANT TO WELCOME DR. CORYSE ST. HILLAIRE CLARK, SENSORY DISORDER AND AGING PROGRAM MANY THE DIVISION OF NEUROSCIENCE AT NATIONAL INSTITUTES ON AGING AND I WANT TO WELCOME BACK DR. ROBERT FINKELSTEIN IN NINDS TO OFFER FINAL COMMENTS AND THOUGHTS ABOUT MENTION STEPS. SO DR. ST. MILLARD CLARK, PLEASE. >> THANKS, KATHERINE. THANKS TO AGAIN TO ALL OF OUR PARTICIPANTS AND ALAN FOR EXTREMELY PRODUCTIVE AND THOUGHT PROVOKING DISCUSSION THIS AFTERNOON. SO WHAT IS THE NEXT STEP? THE IMMEDIATE NEXT STEP IS TO PUBLISH A REQUEST FOR INFORMATION, RFI. FOR THOSE THAT ARE NOT FAMILIAR WITH THIS, THIS IS A MECHANISM THAT NIH USES TO SOLICIT FEEDBACK AND INPUT FROM THE PUBLIC. ON ACTIVITIES THAT HAVE SIGNIFICANT BROAD IMPACT. THIS IS DEFINITELY ONE OF THOSE TYPES OF ACTIVITIES. WE THINK IT IS ABSOLUTELY CRITICAL TO GATHER AS MANY PERSPECTIVES AND IDEAS FROM ALL OF YOU, WHAT YOU CONSIDER TO BE THE NECESSARY COMPONENTS OF THIS TOOL KIT INTERVENTIONS. THE RESPONSES ARE VOLUNTARY AND ANONYMOUS SO BE AS HONEST AS YOU WANT TO, ENCOURAGE YOU YOU TO SHARE THOUGHT AND IDEAS AND ALL THE TOPICS THAT WERE DISCUSSED HERE TODAY BY RESPONDING TO THAT RFI. WE HOPE TO GET IT PUBLISHED BY MID APRIL WHICH IS ONLY TWO WEEKS AWAY. SO WE HAVE A LOT OF WORK TO DO BUT WE LOOK FORWARD TO PARTICIPATION ON THIS. ALL THE DETAILS WILL BE POSTED ON THE SOUND HEALTH WEBSITE AS WELL AS SOUND HEALTH NET WORK WEBSITE SO PLEASE BE ON THE LOOK OUT FOR THAT. TODAY'S DISCUSSION TOGETHER WITH THOSE RESPONSES THAT WE RECEIVED FROM THE RFI, WILL INFORM THE NEXT TWO MEETINGS IN THE SERIES AND THE ULTIMATELY THE DEVELOPMENT OF THE TOOL KIT. THE SECOND MEETING ON JUNE 18 WILL FOCUS ON ASSESSING AND MEASURING TARGET ENGAGEMENT MECHANISTIC AND CLINICAL OUTCOME MEASURES TO BRAIN DISORDERS OF AGING. THAT MEETING WE WILL DELVE DEEPER INTO THE SPECIFIC MEASURES AND READ OUTS THAT CAN BE USED TO ASSESS THE FACT OF THE MUSIC BASED INTERVENTION. WE HEARD A LITTLE BIT ABOUT THAT HERE TODAY. SO I CAN ONLY IMAGINE WHAT'S IN STORE FOR US AT THAT SECOND MEETING. THE THIRD MEETING AUGUST 25 IS TITLED RELATING TARGET ENGAGEMENT TO CLINICAL BENEFIT BIOMARKERS WITH BRAIN DISORDERS OF AGING. AT THAT MEETING YOU WILL FOCUS ON THE INDICATORS THAT ONE MIGHT USE TO MEASURE OR MONITOR HOW THE BRAIN AND BODY ARE RESPONDING TO A PARTICULAR MUSIC BASED INTERVENTION. SO LOTS OF EXCITING THINGS TO COME AND I HOPE YOU DON'T MISS OUT, STAY TUNED FOR MORE INFORMATION ON THE SOUND WEALTH WEBSITE. NIH.GOV SOUND HEALTH EVENTS. AND I WILL NOW HAND IT OVER TO DR. FINKELSTEIN WHO WILL PROVIDE FINAL ACKNOWLEDGMENTS AND CLOSING REMARKS. >> THANKS A LOT, CORYSE. AN AWESOME RESPONSIBILITY TO PROVIDE FINAL ACKNOWLEDGMENTS. I THOUGHT THIS WAS A FANTASTIC MEETING. I REALLY ENJOYED IT. OUR GOAL AT NIH WAS TO JUST BEGIN BY GETTING AN OVERVIEW OF THE COMPONENTS OF A WELL DESIGNED RESEARCH PROJECT AND I THINK WE DEFINITELY SUCCEEDED IN THAT. THE GOOD NEWS IS THAT THERE'S AS CORYSE SAID TWO MORE WORKSHOPS WE CAN DELVE MORE DEEPLY INTO SOME OF THESE CON POINTS WHICH IS REALLY IMPORTANT. I'M NOT GOING TO TO ATTEMPT TO SUMMARIZE WHAT WENT ON TODAY, SORT OF LIKE DON'T TALK ABOUT WHAT HAPPENS IN FIGHT CLUB OUTSIDE OF FIGHT CLUB. I WANT TO ATTEMPT -- WON'T ATTEMPT TO SUMMARIZE BUT I WILL SAY WHAT I WAS STRUCK BY AND REALLY ENJOYED WAS KIND OF THE AMOUNT OF AGREEMENT AND POSITIVITY AT THE WORKSHOP, IT REMINDED ME OF COMEDY IMPROVE WHERE WHEN ONE PERSON SAYS SOMETHING SOMEONE ELSE SAYS YES AND, AND PROCEEDS TO COME UP WITH A RELATED IDEA. SO I THOUGHT THAT WAS REALLY TERRIFIC. IT IS ALSO CLEAR WE WE ARE WALKING A FINE LINE. AS DANIEL SAID AT THE BEGINNING OF THE WORKSHOP, MUSIC IS A COMPLEX GESTALDT AN WHOLE IS RICHER THAN THE SOME OF ITS PARTS. AT THE SAME TIME AT NIH WHERE WE FUND RESEARCH IT IS IMPORTANT TO TEASE OUT THOSE PARTS AND SOME CASES WHEN POSSIBLE STANDARDIZE THE COMPONENTS. SO IN ANY CASE I THINK THAT'S BEEN TERRIFIC. CATHY ARE YOU GOING TO THANK EVERYBODY OR IS THAT -- >> I CAN'T THANK HERB BUT IF YOU HAVE SPECIFIC THANK YOUS. >> I WILL QUICKLY MAKE A QUICK ATTEMPT TO DO THIS. FIRST I WOULD LIKE TO THANK -- BY WAY, THE THING I FORGOT TO SAY IS THERE HAVE BEEN A STREAM OF TERRIFIC COMMENTS IN THE CHAT. THAT WE DIDN'T REALLY HAVE A TIME TO ADDRESS. AND I WAS STRUCK BY ONE AT THE END BY RENEE WHICH IS THAT WE BARELY TOUCHED ON THE ROLE OF CAREGIVERS IN THIS WHOLE PROCESS. AND THE IMPORTANCE OF RESEARCH RESEARCHING THAT AND THINKING ABOUT HOW WE CAN HELP CAREGIVERS AS WELL AS THE PEOPLE INVOLVED WITH THESE DISEASES OF AGING. SO I WOULD LIKE TO THANK FRANCIS AND RENEE MAKING THIS POSSIBLE IS INSTITUTE DIRECTORS AND DEPUTY DIRECTORS WHO ATTENDED. OBVIOUSLY SHAI SILBERBERG TERRIFIC INSPIRING TALK, ALAN WEIL FOR HELPING TO STEER US, I WROTE -- TRIED TO WRITE THE NAMES I COULD THINK OF, CATHY, LORD MODERATING SHE DID A GREAT JOB. EMILY IN PARTICULAR FOR SPEARHEADING THIS THING. ENORMOUS WORK INTO IT AND WAS INOPERATION TO US. ALL THE NIH STAFF INVOLVED, NOT GOING TO SAY YOUR NAMES BUT PEOPLE PUT WORK INTO THIS. AND MOST OF ALL, ALL THE PANELISTS I THOUGHT THIS WAS A TERRIFIC DISCUSSION. I THANK YOU FOR ALL THE WORK YOU DID BEFORE TODAY WHICH IS I THINK ONE OF THE THINGS MADE A DECISION REALLY GOOD. BUT LOOKING FORWARD TO MORE CONVERSATIONS AND MORE RESEARCH PROJECTS AND MORE OF ALL THE ABOVE. SO THANK YOU VERY MUCH FOR COMING. WE APPRECIATE IT. >> THANK YOU, DR. FINKELSTEIN, WONDERFUL JOB. JUST ACKNOWLEDGING THE MANY, MANY PEOPLE BEHIND A GREAT MEETING. SO I WANT TO THANK YOU AND DR. ST. MILLARD CLARK FOR BRINGING US TO A CLOSE. I WANT TO THANK EVERYBODY ON THE NIH VIDEOCAST STICKING WITH US AND WATCHING. WE HAD OVER 300 PEOPLE AT ONE POINT WATCHING. A BRIEF REMINDER THE MEETING WAS RECORD AND WILL BE ARCHIVED ON THE NIH VIDEOCAST WEBSITE FOR REVIEWING. SO WE HOPE YOU WILL JOIN US ON FRIDAY JUNE 18TH, 2021, 1 P.M. AS WE GATHER VIRTUALLY AGAIN FOR OUR SECOND MEETING IN THIS SERIES. RIGHT NOW YOU CAN FIND MORE DETAILS ABOUT THAT ON THE NCCIH WEBSITE. IN THE NEWS AND EVENTS SECTION NCCIH.NIH.GOV. REGISTRATION WILL BE OPENING SOON FOR THAT EVENT. SO WITH THAT, THANK YOU TO EVERYBODY TODAY FOR A WONDERFUL MEETING, THANK YOU IN PARTICULARLY TO EMMELINE ALWAYS A WONDERFUL PERSON TO WORK WITH ON THESE PROJECTS AND MR. WEIL. WITH THAT, I'M GOING TO BRING OUR MEETING TO A CLOSE. AND I'M GOING TO END OUR ZOOM MEETING AND I WISH OUR VIEWERS A LOVELY EVENING.