Welcome to the Clinical Center Grand Rounds, a weekly series of educational lectures for physicians and health care professionals broadcast from the Clinical Center at the National Institutes of Health in Bethesda, MD. The NIH Clinical Center is the world's largest hospital totally dedicated to investigational research and leads the global effort in training today's investigators and discovering tomorrow's cures. Learn more by visiting us online https://clinicalcenter.nih.gov >> I'M DAVE WENDLER, DEPARTMENT OF BIOETHICS IN THE CLINICAL CENTER, THE HOST OF ETHICS GRAND ROUNDS. A COUPLE HOUSEKEEPING NOTES, THE LAST ETHICS GRAND ROUNDS FOR THIS SPRING WILL BE THE FIRST WEDNESDAY IN APRIL, SO BASICALLY TWO MONTHS FROM TODAY. DOUG WHITE, AN ETHICIST AT UNIVERSITY OF PITTSBURGH WILL BE HERE TO TALK ABOUT PROSPECTIVE BENEFIT AND WHEN TREATMENT OFFERS SUFFICIENT BENEFIT TO JUSTIFY SIGNIFICANT RISKS, HOW YOU MAKE THAT DETERMINATION, AND HOW WE SHOULD AND HOW WE SHOULDN'T CONVEY THAT TO PATIENTS AND THEIR FAMILIES. SO, I THINK EVERYBODY'S HERE BECAUSE THESE ARE INTERESTING TOPICS AND THEY WANT TO TALK ABOUT INTERESTING THINGS BUT THERE MIGHT BE ONE OR TWO PEOPLE WHO ACTUALLY CARE ABOUT CME CREDITS, SO IMPORTANT NOTICE, THE CODE IS 24521, THAT NUMBER RIGHT THERE FOR ANYBODY CLAIMING C.E. CREDITS, YOU HAVE TO TEXT THAT CODE NUMBER. SO, THESE ARE CASES, PEOPLE HAVE BEEN HERE IN THE PAST KNOW ETHICS GRAND ROUNDS TYPICALLY COMES FROM CASES THAT COME TO OUR CONSULT SERVICE, SO THE DEPARTMENT WITH THE COMMITTEE AND CLINICAL CENTER HAS A 24/7 CONSULTATION SERVICE FOR ANYBODY TO DISCUSS, HAVE SOMEBODY HELP THEM THINK THROUGH AN ETHICAL QUESTION OR DILEMMA. MOST OF OUR PRESENTATIONS AT ETHICS GRAND ROUNDS ARE CASES THAT COME FROM CONSULTATION SERVICE, INCLUDING TODAY'S AND SO WE ALWAYS HAVE TO THANK THE CLINICIANS WHO ARE BRAVE ENOUGH TO CALL CONSULT, HAVE THEM DISCUSSED WITH OTHER PEOPLE, AND THEN IN DR. ZERBE'S CASE HAVE THE EXTRA COURAGE TO PRESENT IN FRONT OF ETHICS GRAND ROUNDS. WE COULDN'T DO THESE WITHOUT CLINICIANS WHO BRING CASES TO US. THESE SESSIONS ARE STREAMED ON THE WEB, 100 OR 150 PEOPLE ARE WATCHING. THEY CAN ONLY HEAR IF THINGS ARE SAID INTO THE MIC. IF YOU HAVE A QUESTION, GET TO AN AISLE MIC BEFORE YOU ASK IT. IF YOU'RE IN THE MIDDLE, SAY IT TO ME AND I'LL REPEAT IT INTO THE MIC BEFORE WE ASK THE RELEVANT PERSON TO ANSWER IT. SO FOR TODAY, WE HAVE CHRISTA ZERBE, WHO WILL PRESENT FOR US. SHE'S GOING TO DESCRIBE A CASE FOR US INVOLVING QUESTIONS ABOUT DECISIONAL CAPACITY. WE FOUND OVER THE YEARS THAT MAYBE A QUARTER TO A THIRD OF THE BIOET ETHICS CONSULTATIONS WE GET INVOLVE EXCESS OF CAPACITY, EITHER TO MAKE DECISIONS ABOUT THEIR CLINICAL CARE, DECISIONS ABOUT THEIR RESEARCH PARTICIPATION, OR IN THIS CASE DECISIONS ABOUT BOTH OF THOSE. SO WELCOME, DR. ZERBE. >> THANK YOU. FOR A MINUTE I WAS WORRIED YOU WERE ABOUT TO SAY A THIRD OF CONSULTS COME FROM OUR SERVICE. IT WOULD NOT BE COMPLETELY UNTRUE. SO, AGAIN, I HAVE NO FINANCIAL DISCLOSURS. HERE ARE THE OBJECTIVES FOR TODAY, WHICH I HOPE BY THE END OF THE GRAND ROUNDS YOU FEEL CONFIDENT HAVE BEEN MET. I'M HERE, YOU KNOW, I JUST WANT TO SAY THAT I'M VERY -- HEY, WE'RE SHARING CLICKING IN THREE EASY STEPS. I WANT TO SAY SINCE WE HAVE A MOMENT WITH THE RANDOM SLIDE THAT I FEEL VERY HONORED AND PRIVILEGED TO COME AND SPEAK TODAY TO HOPEFULLY HELP YOU UNDERSTAND SOME OF THE CASES THAT COME HERE TO THE CLINICAL CENTER. I THINK, YOU KNOW, I KNOW THAT I BELONG TO AN INSTITUTE WHERE -- I'M GOING TO DO THIS. I BELONG TO AN INSTITUTE WHERE WE HAVE NOT LIKE OTHER INSTITUTES FORTUNATE ABILITY TO HAVE STANDARD OF CARE PROTOCOLS, I WOULD ARGUE ABOVE LEVELS OF STANDARD OF CARE, BUT FOR PATIENTS AS WELL AS TRY TO CHANGE THE NATION'S STANDARD OF CARE BY RESEARCH PROTOCOLS. SO I HOPE TODAY'S CASE GIVES YOU AN IDEA OF THE KIND OF CARE WE CAN PROVIDE HERE AT THE NIH, AND HELP YOU UNDERSTAND SOME OF THE CHALLENGES WE FACE WHEN WE EXPAND RECRUITMENT AND EXPAND OUR LOOK IN TERMS OF WHO TO BRING HERE TO THE NIH FOR OUR PROTOCOLS. I'M GOING TO TALK TO YOU, WE'RE GOING TO USE INITIALS, A 30-YEAR-OLD GENTLEMAN, I'M NOT GOING TO TALK ABOUT CGD BUT SUFFICE TO SAY IT IS A PRIMARY IMMUNODEFICIENCY, PATIENTS ARE SUSCEPTIBLE TO CERTAIN TYPES OF INFECTIONS, THESE INFECTIONS CAN SOMETIMES BE FATAL. WHEN WE INITIALLY SAW HIM, WHEN HE WAS A YOUNG CHILD, HE WAS PART OF A LARGER FAMILY WHO WE WERE FOLLOWING HERE AT THE NIH, AND HIS I.Q. TESTING AT THAT POINT SHOWED AN I.Q. OF 61. AS A RESULT OF HIS ONGOING CHRONIC GRANULOMATOUS DISEASE FOR WHICH THERE'S ONLY ONE KNOWN CURE IN TODAY'S MEDICAL AGE, HE EXPERIENCED NUMEROUS INFECTIONS OVER HIS LIFETIME AND SPENT TIME IN AND OUT OF HOSPITALS. AS A RESULT, DID NOT GO THROUGH PAST THE 8th GRADE OF EDUCATION. SO, HE HAS HAD A HISTORY OF MOOD AND ANXIETY DISORDERS FOR WHICH HE SELF MEDICATED WITH SUBSTANCES, LEGAL AND NOT LEGAL. AND HAD BEEN DIAGNOSED WHEN HE WAS IN SCHOOL WITH SOME INTELLECTUAL OR LEARNING DISABILITIES THAT REQUIRED ACCOMMODATIONS, SIGNIFICANT ENOUGH THAT THE PUBLIC SCHOOL SYSTEM IN NEW YORK CITY GRANTED HIM ACCOMMODATIONS. HE REALLY LEFT SCHOOL MIDWAY THROUGH ABOUT HIS 9th GRADE YEAR. AGAIN, I THINK REFLECTIVE OF CHRONIC ILLNESS, HE HAD HOSPITALIZATIONS WHICH INTERFERED WITH ABILITY TO HAVE CONTINUED EDUCATION. HE WAS DIAGNOSED WITH A TYPE OF FUNGUS INFECTION, WHICH ONLY HAPPENS IN THIS POPULATIONS OF PATIENTS, WHICH HAD PROGRESSED DESPITE AGGRESSIVE THERAPY WITH HIS HOME PHYSICIANS. AND REALLY LIKE I SAID THERE'S ONLY ONE KNOWN CURE FOR CGD, AND BOTH THE EUROPEANS AND OUR CENTER HAVE REALLY SHOWN THAT YOU CAN TRANSPLANT PATIENTS WITH ACTIVE INFECTION, WHICH IS COMPLETELY CONTRAINDICATED IN THE CANCER SETTING, BUT YOU CAN TRANSPLANT THEM WITH ACTIVE INFECTIONS AND THEY CAN DO QUITE WELL. IT CURES BOTH THE INFECTION AND THEIR UNDERLYING IMMUNE DEFICIENCY. AND SO HE WAS BROUGHT HERE TO EVALUATE HIS ABILITY TO GO THROUGH THIS RESEARCH PROTOCOL. HE WAS BROUGHT HERE ON A STANDARD OF CARE PROTOCOL, AND WE WERE EVALUATING FOR WHETHER OR NOT HE COULD GO FORWARD. I JUST WANT TO GIVE YOU AN INDICATION, AND I HAVE ARROWS, I DON'T NEED TO USE THE POINTER, BUT I WANTED TO GIVE YOU JUST A FLAVOR OF THE EXTENT OF HIS INFECTION BECAUSE YOU MAY NOT UNDERSTAND WHY WE THOUGHT THAT BONE MARROW TRANSPLANT WAS REALLY HIS ONLY OPTION. SO, ON YOUR LEFT, NOW I'M NERVOUS ABOUT USING THE POINTER, SO ON YOUR LEFT IS HIS LEFT LEG, AND THIS IS -- SORRY, HIS RIGHT LEG, THIS IS LEFT LEG. I LABELED IT. PATELLA, OR KNEECAP, AND FEMUR. YOU CAN SEE HYPODENSE AREAS, I POINT THEM OUT IN YELLOW, THAT'S PUS THAT SITS THERE. IT ISN'T JUST IN ONE PLACE. HERE YOU HAVE MORE PUS AND INFLAMMATION OF MUSCLE YOU DON'T SEE ON LEFT LEG, UNIQUELY SYMMETRICAL IN THAT RESPECT, IT TRAVELS OTHER PLACES. HERE THIS IS HIS RIGHT HIP AND LEFT HIP. THE FAT HERE IS THIS DARK GRAY COLOR IS CLEAN. ON THIS SIDE THERE'S A LOT OF LIGHTER GRAY, THAT'S INDICATIVE OF INFECTION AND FLUID ACCUMULATION. SO THAT WOULD -- THE DISCUSSION OF, WELL, WHAT SHOULD WE DO, SO IN ORDER TO CURE A LEG LIKE THIS THAT EXTENDED FROM THE KNEE UP INTO HIS HIP YOU WOULD HAVE TO DO A COMPLETE DISC ARTICULATION, TAKE OUT BOTH HIS FEMUR AND HIS ENTIRE LOWER EXTREMITY, WHICH FOR HIM WAS NOT A CONSIDERATION OR OPTION HE WANTED TO CONSIDER, AND WE WOULDN'T IN FACT CURE THE DISEASE BECAUSE IN HIS LUNGS HAD HE EVIDENCE OF INFECTION AS WELL SO IT'S NOT SOMETHING WHERE YOU COULD EVEN THINK ABOUT SURGICAL AMP INDICATION WOULD BE WORTHWHILE BECAUSE OF EVIDENCE OF DISEASE IN OTHER PLACES. THE PROTOCOL TO WHICH WE BROUGHT HIM IS DR. ELIZABETH KANG'S PROTOCOL, THE NUMBER IS THERE FOR YOU. ESSENTIALLY IT'S USING HIGH PERIPHERAL BLOOD STEM CELL TRANSPLANT. HIS SISTER WAS A 10 OUT OF MATCH, UNAFFECTED AND NOT CARRYING THE GENE. THE EXPERIMENTAL NATURE OF THIS PROTOCOL WAS TO LOOK AT GRAPH-VERSUS-HOST DISEASE AND ENGRAFTMENT, THE PRIMARY ENDPOINT. LIKE I SAID, TRANSPLANTATION, HEMATOPOIETIC STEM CELL TRANSPLANTATION IS THE ONLY KNOWN CURE FOR CGD RIGHT NOW. THIS PROVIDES A CLINICALLY INDICATED TRANSPLANT UNDER RESEARCH PROTOCOL AND RESEARCH PROTOCOL WAS LOOKING AT PRIMARY OUTCOME, RATES OF ENGRAFTMENT AND RATES OF CHRONIC GRAFT-VERSUS-HOST DISEASE, SOMETHING YOU WANT TO AVOID, IN MALIGNANCY IT'S SOMETHING YOU HOPE FOR A LITTLE BIT SO THAT THERE'S SOME GRAFT VERSUS LEUKEMIA EFFECT BUT IN PRIMARY IMMUNODEFICIENCY YOU WANT NOTHING TO DO WITH GRAFT-VERSUS-HOST DISEASE OF ANY TYPE. WE USE A MEDIATOR OF GvHD, THIS DOESN'T ALLOW FOR SECONDARY CONSENT, REQUIRES THE PATIENT CONSENT FOR THEMSELVES. WE HAD CONCERNS GIVEN HIS KNOWN I.Q. AND SOME OF THE INDICATIONS THAT HE MAY NOT HAVE THE ABILITY TO TRULY UNDERSTAND WHAT THE RISKS OF RESEARCH PROTOCOL WOULD BE, AND SO AS A RESULT WE CALLED BIOETHICS. >> THANK YOU, CHRISTA. SO, THESE ARE THE QUESTIONS WE'RE GOING TO ASK OUR DISCUSSANT. THEY WERE THE QUESTIONS WE WERE GOING TO ASK OUR DISCUSSANT, TO HELP US THINK THROUGH. GOING TO STOP FOR A MINUTE AND ASK DOES ANYBODY HAVE ANY QUESTIONS FOR DR. ZERBE BEFORE WE GO ON TO THE ETHICS DISCUSSION OF THESE ISSUES? ANYTHING IN THE BACKGROUND OF THIS CASE THAT WOULD BE HELPFUL TO KNOW IN ORDER TO THINK THROUGH THE ISSUES? EVERYBODY'S FEELING GOOD? OH, OKAY. YES? >> DOES THE PATIENT HAVE A LEGAL GUARDIAN OR SOMEONE WHO MAKES HIS DAY-TO-DAY IMPORTANT DECISIONS FOR HIM AND THEN -- >> COULD YOU COME UP TO THE MIC? SO THE QUESTION IS WHETHER OR NOT THIS PATIENT HAS SOMEBODY ELSE WHO MAKES DECISIONS FOR HIM, A LEGALLY APPOINTED SURROGATE OR GUARDIAN WHO MAKES DECISIONS FOR HIM. >> NO. SOCIALLY HE DOES NOT WORK. LIVES WITH HIS MOTHER, WHO HOUSES HIM AND PAYS FOR HIS LODGING. HIS SISTER WHO WAS THE MATCH WAS REALLY THE PERSON WITH WHOM HE RELIED ON THE MOST TO HELP HIM MAKE DECISIONS, BUT HE HAD NO LEGAL/MEDICAL DECISION MAKER FOR HIM. >> KEVIN? >> WOULD HE BE ABLE TO GET A BONE MARROW TRANSPLANT ANYWHERE, OR IS THAT SOMETHING WE ONLY DO HERE FOR THESE PATIENTS AT NIH? >> SO, THERE ARE OTHER CENTERS IN THE U.S. THAT TRANSPLANT PATIENTS WITH GRANULOMATOUS DISEASE. BECAUSE OF HIS INFECTION, INSURANCE APENIA, HE WASN'T A CANDIDATE FOR TRANSPLANT UP IN NEW YORK CITY, HE DID NOT QUALIFY. A LOT OF TRANSPLANT CENTERS REQUIRE A CERTAIN AMOUNT OF READY AVAILABLE FUNDING FROM PATIENTS AHEAD OF TRANSPLANTATION. BECAUSE IT ISN'T TRULY STANDARD OF CARE, IT'S NOT AUTOMATICALLY APPROVED BY STATE-FUNDED INSURANCE COMPANIES. AND HE HAD A SIGNIFICANT AMOUNT OF TRUST AND HIS SIS SISTER HAD TRUST BECAUSE THEY CAME HERE PREVIOUSLY. >> IS THERE CONCERN FOR ONGOING SUBSTANCE USE ISSUES? >> NOT WHILE HE WAS HERE AT THE NIH. SO WHAT MY SERVICE DOES, BECAUSE I'M NOT A TRANSPLANTER, I OFTEN BRING PATIENTS IN WHO HAVE REFRACTORY INFECTIONS, AND OPTIMIZE THEIR CARE FOR SEVERAL MONTHS AHEAD OF TRANSPLANT. AND THAT PROVIDES US ALSO THE ABILITY IN THIS SITUATION TO HOUSE THEM DURING THAT INTENSIVE MEDICAL THERAPY. >> OKAY. THANK YOU, CHRISTA. FOR PEOPLE STANDING IN THE BACK, IF YOU WANT TO STAND, THAT'S GREAT. IF YOU'RE INTERESTED IN A SEAT WE HAVE A MINUTE OF TRANSITION. THERE ARE SEATS HERE AND IT'S AND -- AND ALSO DOWN HERE IN THE FRONT. WE'VE BEEN DOING ETHICS GRAND ROUNDS FOR ALMOST 20 YEARS, IF MY MATH IS RIGHT. AND ONE OF THE THINGS I'VE SAID MANY TIMES IS WE'RE LUCKY BEING AT THE NIH, WE'RE ABLE TO ATTRACT EXPERTS, THE VERY WELL-QUALIFIED PEOPLE TO DISCUSS THESE ISSUES WITH US. I COUNTED AT LEAST TEN TIMES IN THE PAST WHERE I CLAIM, I THINK RIGHTLY, THAT WE HAD ONE OF THE NATIONAL OR WORLD'S EXPERTS ON THE PARTICULAR ISSUE THAT'S GOING TO DISCUSS IT WITH US. THE FIRST TIME WE HAVE I THINK ARGUABLY THE WORLD'S EXPERT ON THIS ISSUE TO DISCUSS DECISIONAL CAPACITY WITH US. PAUL APPLEBAUM IS ELIZABETH DOLLARD PROFESSOR, PAST PRESIDENT OF THE AMERICAN PSYCHIATRIC ASSOCIATION, HE IS INDUCTED INTO THE NATIONAL ACADEMY OF SCIENCES, FOR OUR PURPOSES HE IS ONE OF THE FOUNDERS FOR PEOPLE WHO KNOW INSTRUMENTS FOR DOING CAPACITY, PAUL IS ONE OF THE MAIN DRIVERS OF THE MACAT TOOL FOR CAPACITY ASSESSMENT. PAUL HAS BEEN INVOLVED IN WORKING ON CAPACITY ASSESSMENTS, HOW TO DO THEM, HOW TO DO THEM RIGHT FOR A LONG TIME. WELCOME, PAUL. >> THANK YOU, DAVE. [APPLAUSE] THANKS, EVERYBODY. IT'S A PLEASURE TO BE HERE. IT'S BEEN A FEW YEARS SINCE I'VE SPOKEN AT NIH. IT'S NICE TO BE BACK. SO, LET ME -- OOPS. THE SLIDES ARE ADVANCING ON MY SCREEN BUT NOT UP THERE. THERE WE GO. SO JUST IN KEEPING WITH WHAT YOU'VE JUST HEARD, I RECEIVE ROYALTIES ON THE SALES OF THESE TWO INSTRUMENTS THAT WE DEVELOPED. I'M NOT OTHERWISE GOING TO BE TALKING ABOUT THEM HERE TODAY. AND THE GOALS, WHAT MY GOAL IS IN THE NEXT 20 MINUTES OR SO IS TO GIVE YOU A QUICK OVERVIEW OF HOW WE THINK ABOUT DECISIONAL CAPACITY. I USE THE TERMS COMPETENCE AND CAPACITY INTERCHANGEABLY. I'M HAPPY TO TALK WITH YOU ABOUT WHY THAT IS. YOU'LL HEAR ME USE THEM BOTH UP HERE TODAY, TO IDENTIFY SORTS OF ISSUES THAT CAN COMPARE CAPACITY, SOME AT STAKE IN THE CASE WE JUST HEARD ABOUT, AND THEN TO GIVE YOU SORT OF A BRIEF INTRODUCTION TO DOING COMPETENCE ASSESSMENTS. WHAT I'M NOT GOING TO DO, AT LEAST IN THIS CORE PRESENTATION, IS TRY TO TELL YOU WHETHER THIS PATIENT WE JUST HEARD ABOUT HAS THE CAPACITY OR DOESN'T HAVE THE CAPACITY TO CONSENT TO THE SORT OF PROCEDURE THAT IS AT ISSUE IN THIS CASE. I THINK THERE ARE COMPLEXITIES THERE THAT YOU MAY WANT TO ASK ABOUT, WE MAY WANT TO TALK ABOUT, AS WELL. SO, WHY DO WE WORRY ABOUT DECISIONAL COMPETENCE? WHY IS THIS AUDITORIUM AS FULL AS IT IS TODAY? I WANT TO SUGGEST THERE ARE TWO SETS OF ISSUES THAT ARE REALLY AT CONCERN WHEN WE TALK ABOUT PATIENTS HAVING OR LACKING CAPACITY TO CONSENT TO TREATMENT OR RESEARCH, FOR THAT MATTER. WE ARE CONCERNED WITH THE PROTECTION OF MEANINGFUL CHOICE. WE BELIEVE THAT WHEN PATIENTS ARE ABLE TO CHOOSE FOR THEMSELVES, IT PROTECTS THEIR WELL-BEING, THAT IN MANY RESPECTS ALL OF US ARE ABLE TO DECIDE FOR OURSELVES, WHAT IS IN OUR INTEREST, BETTER THAN ANYONE ELSE IS. AND IT PROMOTES OUR AUTONOMY AS WELL. THAT IS, IT IS GOOD IN ITSELF FOR PEOPLE TO BE ABLE TO MAKE CHOICES THAT ARE THEIRS AND DON'T MERELY REFLECT DECISIONS MADE FOR THEM BY OTHER PEOPLE. BUT OF COURSE, WE LIVE IN THE REAL WORLD, AS WELL. WE'RE NOT ONLY DEALING WITH ETHICAL ISSUES HERE, WE'RE DEALING WITH LEGAL IMPERATIVES AS WELL. LEGALLY, A DECISION MADE BY AN INCOMPETENT PERSON IS NOT A VALID DECISION. AND THAT APPLIES NOT JUST IN THE MEDICAL SETTING WHERE WE'RE TALKING ABOUT TREATMENT OR RESEARCH; IT APPLIES IN THE REST OF THE WORLD AS WELL. PEOPLE WHO ARE INCOMPETENT TO DO SO CANNOT SIGN CONTRACTS, GIVE GIFTS, MAKE DECISIONS ABOUT DISPOSING OF THEIR PROPERTY AFTER THEIR DEATH, OR DEPENDING ON THE STATE, VOTE, OR DECIDE TO MARRY OR DIVORCE. SO THIS TURNS OUT TO BE A KEYSTONE IN THE STRUCTURE OF LEGAL RIGHTS THAT WE ALL ORDINARILY POSSESS AND WE POSSESS THOSE RIGHTS ONLY UNTIL THE POINT WHERE WE LOSE THE ABILITY TO MAKE OUR CHOICES IN A COMPETENT WAY. IN THE MEDICAL SETTING, IF PATIENTS MAKE INCOMPETENT CHOICES, MAKE CHOICES WHILE THEY ARE INCOMPETENT TO DO SO, THE PHYSICIANS INVOLVED IN THEIR CARE, RISK BEING LIABLE FOR ADVERSE OUTCOMES THAT MAY RESULT, AND OTHER DECISIONS AS WE'VE SAID MAY SIMPLY BE VOIDED. AN INCOMPETENT PERSON WHO WRITES A WILL IS IT AT RISK OF HAVING THAT WILL VOIDED AND SOME OTHER SYSTEM, SOME OTHER STRUCTURE FOR DISPOSING OF THEIR ASSETS TO BE IMPOSED INSTEAD. I WANT TO SUGGEST THAT AS WE THINK ABOUT ASSESSING COMPETENCE, AND WHAT COMPETENCE IS, THAT THERE ARE THREE PRELIMINARY ISSUES THAT WE NEED TO KEEP IN MIND. THE FIRST IS THAT ALTHOUGH FOR CENTURIES, LITERALLY CENTURIES, DATING BACK TO MEDIEVAL TIMES IN ENGLAND, WE THOUGHT ABOUT COMPETENCE IN THE ANGLO-AMERICAN LEGAL TRADITION AS AN ALL-OR-NOTHING PHENOMENON. YOU WERE COMPETENT OR NOT, COMPETENT TO DO EVERYTHING OR COMPETENT TO DO NOTHING WHICH WE CALL GENERAL COMPETENCE, OR GENERAL INCOMPETENCE. THAT HAS NOW CHANGED. BEGINNING IN THE MIDDLE OF THE 20th CENTURY, AND DRIVEN LARGELY BY ADVOCATES FOR PEOPLE WITH INTELLECTUAL DISABILITIES, WHAT WAS THEN CALLED MENTAL RETARDATION, A VERY INFLUENTIAL REPORT BY PRESIDENT KENNEDY'S PRESIDENTIAL COMMISSION ON MENTAL RETARDATION, THAT POINTED OUT THAT PEOPLE OF INTELLECTUAL DISABILITIES HAD SOME CAPACITIES AND LACKED OTHERS, AND THAT IT WAS UNFAIR TO DEPRIVE THEM OF ALL THEIR DECISION-MAKING RIGHTS WHEN A MUCH MORE FOCAL APPROACH COULD ADEQUATELY PROTECT THEIR INTERESTS. AND SO THESE DAYS WE RECOGNIZE THAT. AND WE ASK COURTS, FOR EXAMPLE, TO TAILOR THEIR DECLARATIONS OF INCAPACITY NARROWLY, SO THAT IF A GUARDIAN IS APPOINTED OR A SIMILAR PERSON, IN SOME STATES THEY ARE CALLED CONSERVEATORS, FOR SOME PURPOSES, THAT DECISION MAKER, THAT SUBSTITUTE DECISION MAKER, HAS ONLY THE POWERS TO MAKE DECISIONS ABOUT THOSE AREAS IN WHICH ACTUAL IMPAIRMENT IS PRESENT AND HERE WE'RE TALK BECOME THE CAPACITY TO CONSENT TO CLINICAL RESEARCH IN AN AMBIGUOUS SETTING, DIFFERENCE BETWEEN RESEARCH AND INDICATED STANDARD OF CARE TREATMENT BECOMES SOMEWHAT BLURRY. THE SECOND GENERAL CONSIDERATION HERE IS THE FACT THAT COMPETENCE IS A CONTEXT-SPECIFIC PROPERTY. FACTS MATTER WHEN WE'RE TALKING ABOUT COMPETENCE. THOSE OF US WHO ARE SOMETIMES CALLED ON TO DO COMPETENCE ASSESSMENTS WILL FREQUENTLY GET CONSULT REQUESTS THAT SAY PLEASE ASSESS THIS PATIENT'S COMPETENCE, AS IF THERE WERE ONLY ONE THING THAT COULD BE ASSESSED, AND REGARDLESS OF THE DECISION AT HAND THE QUESTION AS TO WHETHER THEY WERE COMPETENT OR NOT WOULD HAVE THE SAME ANSWER. IN FACT, THAT'S NOT TRUE. WHETHER SOMEONE IS COMPETENT DEPENDS ON THE ISSUE AT HAND AND THEIR ABILITY TO DEAL WITH THAT SPECIFIC DECISION. AND THAT MAY CHANGE, BOTH FROM DECISION TO DECISION, AND FOR THE SAME DECISION OVER TIME. WHICH BRINGS US TO OUR THIRD CONSIDERATION, WHICH I'VE CALLED TEMPORAL SPECIFICITY. AND THAT IS THE REALITY THAT WE ALL KNOW, THAT MANY OF THE CONDITIONS THAT IMPAIR CAPACITY, SUCH AS SERIOUS PSYCHIATRIC DISORDERS, NEUROLOGICAL CONDITIONS, NEURODEGENERATIVE CONDITIONS SUCH AS ALZHEIMER'S, DEMENTIA, AND RELATED SYNDROMES, OFTEN PRESENT, PARTICULARLY EARLIER IN THEIR COURSE, IN THE CASE OF NEURODEGENERATIVE CONDITIONS, WITH FLUCTUATING DEGREES OF IMPAIRMENT. AT SOME POINT PEOPLE MAY BE ABLE TO MAKE THEIR OWN DECISIONS, EVEN THOUGH AT OTHER POINTS THEY MAY NOT BE. AND SO CHANGE OVER TIME NEEDS TO BE TAKEN INTO ACCOUNT AS WELL. SO, WITH THAT, I WANT TO TURN TO THE QUESTION OF WHAT THIS THING WE'RE TALKING ABOUT, DECISIONAL COMPETENCE, ACTUALLY IS. WE'VE TALKED AROUND IT SO FAR. BUT NOW IT'S TIME TO FOCUS ON THE ESSENTIAL CONCEPT ITSELF. AND OVER TIME, I WOULD SUGGEST TO YOU WE HAVE SETTLED BOTH LEGALLY AND ON THE MEDICAL SIDE OF THE STREET ON AN UNDERSTANDING OF DECISIONAL COMPETENCE THAT ENCOMPASSES FOUR DISTINCT ELEMENTS. LET ME JUST TICK THROUGH THEM WITH YOU BRIEFLY NOW AND THEN WE'LL LOOK AT EACH OF THEM IN A BIT MORE DETAIL. SO, THE FIRST IS UNDERSTANDING. DOES THE PERSON UNDERSTAND THE RELEVANT INFORMATION FOR THE DECISION? THE SECOND IS APPRECIATION. DOES THE PERSON APPRECIATE THE IMPLICATIONS OF THAT INFORMATION FOR THEIR OWN CONDITION? THE THIRD IS REASONING. CAN THEY ENGAGE IN A PROCESS OF WEIGHING RISKS AND BENEFITS? AND FOURTH IS EVIDENCING A CHOICE. DOES THAT PROCESS ACTUALLY RESULT IN AN OUTCOME? NOW, I WANT TO LOOK AT EACH OF THOSE A LITTLE MORE CAREFULLY WITH YOU. SO, UNDERSTANDING. IN THE CONTEXT OF CLINICAL RESEARCH, WHICH IS WHAT I WANT TO FOCUS ON NOW ALTHOUGH I WILL TELL YOU THAT THERE ARE STRONG SIMILARITIES BETWEEN THE ASSESSMENT OF DECISIONAL CAPACITY FOR TREATMENT AND FOR RESEARCH, PEOPLE SHOULD HAVE AN UNDERSTANDING OF THE NATURE OF THE PROPOSED RESEARCH, THAT IS WHAT THIS PROTOCOL IS ALL ABOUT THAT THEY ARE GETTING INTO, WHAT THE GOAL OF THE STUDY IS, AND THE SPECIFIC PROCEDURES THAT WILL BE INVOLVED. THEY SHOULD ALSO UNDERSTAND TO THE EXTENT THAT IT'S RELEVANT IN A GIVEN PROTOCOL THE DIFFERENCES BETWEEN RESEARCH AND TREATMENT. THEY SHOULD UNDERSTAND THAT THE PRIMARY GOAL OF A PARTICULAR STUDY IS TO GENERATE GENERALIZABLE KNOWLEDGE AND NOT SOLELY TO PROVIDE TREATMENT TO THEM AND AS A RESULT THE PROCEDURES THEY UNDERGO MAY DIFFER FROM PROCEDURES THEY WOULD EXPERIENCE IN ORDINARY CLINICAL CARE. THEY SHOULD UNDERSTAND THE POSSIBLE BENEFITS AND RISKS, OR DISCOMFORT, ASSOCIATED WITH PARTICIPATION. THOSE BENEFITS MAY INCLUDE BENEFIT TO THE PERSON, HIM OR HERSELF, BUT IT MAY ALSO INCLUDE BENEFIT TO SUBSEQUENT PEOPLE WHO HAVE SIMILAR CONDITIONS, IF KNOWLEDGE IS GAINED THAT IMPROVES THE DIAGNOSIS OR AND THEY SHOULD UNDERSTAND THAT THEY ARE BEING ASKED TO DO SOMETHING TO WHICH THEY CAN SAY NO. THEY CAN REFUSE, OR WITHDRAW AT A LATER DATE, AND ORDINARY CARE WILL STILL BE AVAILABLE WHEN IN FACT THAT IS THE CASE. UNDERSTANDING OF THIS SORT CAN BE IMPAIRED BY AMONG OTHER FACTORS, I'M NOT TRYING TO BE EXHAUSTIVE HERE, ATTENTIONAL DIFFICULTIES, LIMITED LANGUAGE SKILLS, IF I DON'T UNDERSTAND WHAT YOU'RE SAYING I DON'T THE CONCEPTS YOU'RE TRYING TO CONVEY. IMPAIRED RECALL AND RECENT MEMORY, COGNITIVE IMPAIRMENT MORE GENERALLY AS A SET OF POTENTIAL IMPAIRING FACTORS, BUT BY NO MEANS EXHAUSTING. APPRECIATION. THE SECOND ELEMENT. SO I UNDERSTAND THE INFORMATION. WHAT MORE DO YOU WANT ME TO BE ABLE TO DO WITH IT? WELL, I WOULD LIKE YOU, AND LEGALLY YOU WOULD BE REQUIRED, IN ALMOST EVERY JURISDICTION, TO HAVE A REALISTIC APPRECIATION OF THE NATURE OF YOUR CONDITION AND YOUR PROGNOSIS, AND APPRECIATION DIFFERS FROM UNDERSTANDING IN THAT IN UNDERSTANDING I'M LOOKING FOR DO YOU GRASP THE MEANING OF MY WORDS, DO YOU UNDERSTAND THE WORDS THAT I'M SAYING, WHAT THEY MEAN? IN APPRECIATION, I WANT TO KNOW DO YOU RECOGNIZE THAT I'M TALKING ABOUT YOU, THAT THIS APPLIES TO YOUR SITUATION, THAT IF I SAY THERE'S A 50% CHANCE OF DEATH AS A RESULT OF ENTERING THIS STUDY THAT MEANS YOU'VE GOT A 1 IN 2 CHANCE OF DYING, NOT SOMEONE ELSE MAY DIE, BUT CERTAINLY I'M NOT AT RISK. I WANT YOU TO APPRECIATE THE PURPOSE OF THE STUDY BEING TO GENERATE NEW KNOWLEDGE, THAT THERE ARE METHODS THAT MAY TAKE PRECEDENCE OVER YOUR PERSONAL CARE, YOUR DOCTOR IS NOT IN A RANDOMIZED CONTROLLED TRIAL GOING TO DECIDE WHICH MEDICATION YOU GET. THAT'S GOING TO BE DECIDED BY A COMPUTER PROGRAM. IT'S NOT GOING TO BE ON THE BASIS OF WHAT SOMEBODY THINKS IS IN YOUR BEST INTEREST. AND THAT YOU HAVE AN ACTUAL ABILITY TO DECLINE. NOT, SURE, THEY TOLD ME I COULD SAY NO, BUT I CAN ACTUALLY SAY NO, I CAN WALK AWAY FROM THIS, I HAVE OTHER OPTIONS AVAILABLE TO THE EXTENT THAT THEY ARE. APPRECIATION CAN BE IMPAIRED BY DENIAL. DENIAL OF THE PRESENCE OF ILLNESS, DENIAL OF THE LIKELY RESPONSE TO TREATMENT, IN EITHER DIRECTION. I'M SO DEPRESSED NOTHING'S GOING TO HELP ME. OR, I KNOW THAT THESE ARE THE BEST DOCTORS IN THE WORLD AND THERE'S 100% CHANCE THAT THIS IS GOING TO WORK FOR ME. DELUSIONAL BELIEFS, MY DOCTOR IS TRYING TO POISON ME, OR OTHER PSYCHOTIC SYMPTOMS. EXTREME EMOTIONS, ANXIETY, ANGER, FEAR, AND, AGAIN, OF COURSE COGNITIVE IMPAIRMENT. SO NOW YOU UNDERSTAND AND YOU APPRECIATE, AND YOU'VE GOT THIS INFORMATION, AND YOU GET IT THAT IT APPLIES TO YOU, WHAT MORE ARE WE LOOKING FOR? WE'RE LOOKING FOR YOU TO BE ABLE TO WEIGH THE RISKS AND BENEFITS THAT YOU UNDERSTAND AND APPRECIATE APPLY TO YOU. AND IN DOING SO, WE ARE INTERESTED IN YOUR BEING ABLE TO TELL US HOW YOU'VE TAKEN THOSE RISKS AND BENEFITS, THE TWO SETS OF CONSEQUENCES, INTO ACCOUNT. HOW YOU WEIGHED ONE AGAINST THE OTHER, AND WHY ONE SIDE CAME OUT ON TOP. AND IN FACT, GIVEN THE WEIGHTING THAT YOU HAVE ASSIGNED, TO BOTH THE RISKS AND THE CONSEQUENCES THAT YOU'VE COME OUT WITH A CHOICE THAT'S CONSISTENT WITH THE VALUES THAT WENT INTO THAT WEIGHTING PROCESS. REASONING AGAIN CAN BE IMPAIRED BY PSYCHOTIC SYMPTOMATOLOGY INCLUDING THOUGHT DISORDER, COGNITIVE IMPAIRMENT, WHICH COULD BE ON THE BASIS OF DEMENTIA OR DELIRIUM, EXTREME EMOTIONS, PEOPLE WHO ARE TOO ANXIOUS, SOMETIMES YOU'LL HEAR SOMEBODY SAY, I'M JUST TOO ANXIOUS TO THINK ABOUT IT. AND YOU CAN TAKE THAT LITERALLY, IN MANY CASES. ANXIETY CAN JUST BE SO OVERWHELMING THAT IT PREEMPTS A RATIONAL THOUGHT PROCESS. OR EXCESSIVE DEPENDENCY AND PASSIVITY. IT'S FRIGHTENING TO MAKE MY OWN CHOICE, I'M GOING TO RELY ON SOMEONE ELSE TO DO IT. AND FINALLY, SO NOW YOU UNDERSTAND, YOU APPRECIATE, YOU'VE SHOWN YOU CAN REASON WITH THE INFORMATION. I NEED YOU TO TELL ME WHAT YOUR CHOICE IS. NOW, THAT MAY SEEM SELF-EVIDENT, OF COURSE THERE'S SOME PEOPLE THAT CAN'T MAKE CHOICES, PEOPLE WHO ARE IN COMAS, SOMEBODY ELSE HAS TO MAKE A CHOICE FOR THEM. BUT THERE ARE ALSO LESS CLEAR-CUT SITUATIONS. PEOPLE WHO CANNOT ONLY MAKE CHOICES, THEY MAKE TOO MANY CHOICES. IN THE MORNING THEY SAY YES, IN THE AFTERNOON THEY SAY NO, BY DINNER TIME IT'S YES AGAIN. AND THE STABILITY OF THEIR CHOICE IS SO LACKING THAT NEITHER OPTION CAN BE FULLY IMPLEMENTED. WE CAN'T SEND YOU HOME BECAUSE YOU REFUSED, AND WE CAN'T TREAT YOU BECAUSE YOU'VE SAID YES. I DON'T KNOW WHERE WE ARE HERE. IT MAY BE THAT IN THAT CIRCUMSTANCE AT THE EXTREME SOMEONE ELSE REALLY NEEDS TO MAKE THE CHOICE FOR YOU. AND CHOICE CAN BE IMPAIRED BY CONFUSIONAL STATES, PSYCHOSIS, CATATONIA OR OTHER CAUSES OF MUTISM, ANXIETY, AMBIVALENCE, PEOPLE WITH OCD ARE SORT OF THE CLASSIC CASE, BAD OCD, IN UNDERSTANDING PERFECTLY AND BEING PARALYZED WHEN IT COMES TO MAKING A CHOICE. SO, I JUST WANT TO NOTE THERE IS SOME VARIATION IN THE LAW AS TO WHICH OF THESE FOUR ELEMENTS APPLY, AND HOW THEY ARE FRAMED. THE LANGUAGE MAY DIFFER A BIT ACROSS JURISDICTIONS, AND DEPENDING ON THE TASK THE STANDARD IS A LITTLE DIFFERENT FOR SIGNING A CONTRACT THAN IT IS FOR MAKING A MEDICAL DECISION. BUT I ALSO WANT TO SAY THAT I THINK THEY ARE MORE SIMILAR THAN THEY ARE DIFFERENT, WHILE ACKNOWLEDGING THOSE DIFFERENCES, AND MOST JURISDICTIONS IN THIS COUNTRY EITHER BY STATUTE OR BY COURT DECISION ESSENTIALLY EMBRACE ALL FOUR OF THE ELEMENTS THAT I HAVE LAID OUT FOR YOU. THERE ARE VERY FEW EXCEPTIONS. WISCONSIN IS ONE. IN WISCONSIN BY STATUTE IF YOU MAKE A CHOICE AND YOU UNDERSTAND, THAT'S ENOUGH. WE DON'T -- THE PEOPLE IN WISCONSIN DON'T HAVE TO INQUIRE ABOUT APPRECIATION AND REASONING. WISCONSIN LEGISLATURE IN ITS WISDOM DECIDED THEY DIDN'T WANT TO GO THERE. IF YOU UNDERSTOOD, YOU HAD THE RIGHT TO MAKE YOUR OWN CHOICES. WHICH ELEMENTS ARE SELECTED BY STATUTE OR COURT DECISION MAY VARY ACCORDING TO THE DEGREE OF RISK, BUT THE THRESHOLD THAT WE REQUIRE PEOPLE TO REACH IN ANY OF -- ACROSS ANY OF THOSE ELEMENTS MAY ALSO VARY BY THE DEGREE OF RISK. LET ME JUST SAY SOMETHING MORE BRIEFLY ABOUT THAT. THIS IS WHAT'S OFTEN CALLED THE SLIDING SCALE APPROACH HERE. IF YOU'RE MAKING A LOW-RISK DECISION, A DECISION TO GET A FLU SHOT, YOU'RE OLDER, YOU'VE GOT SOME DEGREE OF COGNITIVE IMPAIRMENT, PROBABLY AS A RESULT OF AN EARLY DEMENTIA, BUT YOU'VE HAD FLU SHOTS BEFORE IN YOUR LIFE, AND YOU'VE HAD THE FLU BEFORE IN YOUR LIFE, AND YOU'RE STILL CAPABLE OF RECOGNIZING ONE SEEMS TO YOU TO BE PREFERABLE TO THE OTHER WE'RE NOT GOING TO BE VERY DEMANDING IN TERMS OF WHAT WE'RE ASKING FOR WITH REGARD TO YOUR CAPACITY TO MAKE THAT CHOICE. ON THE OTHER HAND, AND THIS MAY BE CLOSER TO THE SITUATION THAT THIS PATIENT THAT WE'RE TALKING ABOUT TODAY IN SOME RESPECTS PRESENTS, HIGH-RISK DECISIONS INVOLVE MUCH GREATER STAKES. YOU HAVE A BONE MARROW TRANSPLANT AND IT DOESN'T WORK, THAT'S NOT A VERY GOOD SITUATION TO BE IN. YOU COULD DIE. THIS WAS A PATIENT WHO WAS FACING DEATH AS A RESULT OF AN ONGOING INFECTIOUS PROCESS, AS WELL, WHICH CREATES COMPLEXITIES WE CAN TALK ABOUT, BUT IN A HIGH RISK SITUATION I WANT TO BE MORE CERTAIN THAT YOU ACTUALLY HAVE CAPACITY. I'M GOING REQUIRE A HIGHER LEVEL OF UNDERSTANDING, GREATER EVIDENCE OF APPRECIATION, BETTER REASONING ABILITIES, WEIGHING THOSE RISKS AND BENEFITS, AND A CLEARER EXPRESSION OF CHOICE THAN I WOULD FOR THAT FLU SHOT. AND ALTHOUGH THERE'S A POTENTIAL DOWN SIDE TO THE SLIDING SCALE APPROACH, WHICH IS THE DANGER THAT A PHYSICIAN SAYS, WELL, THE PATIENT DISAGREES WITH ME, THAT'S A HIGH RISK DECISION, THEY NEED A LOT OF CAPACITY AND THEY DON'T HAVE IT, SO SOMEBODY ELSE HAS TO MAKE THE DECISION TO AGREE WITH ME, WHICH IS NOT THE WAY THE SLIDING SCALE SHOULD BE APPLIED, DESPITE THAT RISK IT IS CLEAR THAT IF YOU LOOK AT HOW THE COURTS APPLY THESE STANDARDS THEY VERY MUCH EMBRACE THE SLIDING SCALE APPROACH. HIGH RISK DECISIONS REQUIRE HIGHER LEVELS OF CAPACITY. SO, I JUST WANT TO, AS WE COME TO THE END OF MY PRESENTATION HERE, TAKE YOU VERY QUICKLY THROUGH THE APPLICATION OF THE STANDARDS BECAUSE ALTHOUGH IT CAN SOUND COMPLEX, THEORETICALLY IN ACTUAL APPLICATION AT THE BEDSIDE, I THINK THESE CAN BE APPLIED IN FAIRLY STRAIGHTFORWARD WAYS FOR MOST CASES. SO WHEN WE ASSESS UNDERSTANDING, WE SAY TO THE PATIENT, PLEASE TELL ME IN YOUR OWN WORDS WHAT YOUR DOCTOR TOLD YOU ABOUT WHAT'S WRONG, WHAT'S THE NATURE OF YOUR CONDITION, AND WHAT DID YOUR DOCTOR SAY THE RECOMMENDED TREATMENT WAS? DID HE OR SHE TELL YOU ABOUT THE BENEFITS THAT WOULD HAPPEN IF YOU HAD THE TREATMENT? WHAT ABOUT THE RISKS THAT MIGHT OCCUR? AND WHAT ELSE DID YOUR DOCTOR SAY ABOUT WHAT OTHER THINGS YOU COULD DO IF YOU DON'T HAVE THAT TREATMENT? YOU GET THE ANSWERS TO THAT, YOU'VE ASSESSED UNDERSTANDING. APPRECIATION, I'M INTERESTED FIRST IN WHETHER THE PERSON REALLY RECOGNIZES THE NATURE OF THEIR CONDITION. TELL ME WHAT YOU REALLY BELIEVE IS WRONG WITH YOUR HEALTH NOW? THAT QUESTION SOMETIMES GETS AMAZING RESPONSES FROM PATIENTS, WHICH HAVE NOTHING TO DO WITH WHAT YOU THINK THEY ARE THERE IN THE HOSPITAL FOR. DO YOU BELIEVE YOU NEED SOME KIND OF TREATMENT? WHAT'S THE TREATMENT LIKELY TO DO FOR YOU? AND WHY? AND WHAT WILL YOU -- WHAT DO YOU BELIEVE WILL HAPPEN IF YOU'RE NOT TREATED? CHOICE, HAVE YOU DECIDED WHETHER TO GO ALONG WITH YOUR DOCTOR'S SUGGESTIONS FOR TREATMENT, AND CAN YOU TELL ME WHAT THAT DECISION IS? WE USUALLY ASSESS CHOICE BEFORE REASONING. AND NOW REASONING. OKAY. SO NOW TELL ME HOW YOU REACHED THAT DECISION TO ACCEPT OR NOT TO ACCEPT THE RECOMMENDED TREATMENT. WHAT WERE THE FACTORS THAT WERE IMPORTANT TO YOU? HOW DID YOU BALANCE THOSE FACTORS? I'LL OFTEN SAY TO A PATIENT AT THIS POINT, JUST THINK ALOUD FOR ME. TELL ME WHAT YOUR THOUGHTS WERE AS YOU DECIDED THAT THIS WAS SOMETHING THAT YOU WANTED TO DO OR DIDN'T WANT TO DO. OUR GOAL HERE AS YOU'LL SEE WHEN THE NEXT SLIDE HITS THE SCREEN IS TO HELP PATIENTS RETAIN THEIR DECISION-MAKING POWER, IF AT ALL POSSIBLE. OKAY? THIS IS NOT AN EFFORT TO STRIP PEOPLE OF THE RIGHT TO MAKE DECISIONS FOR THEMSELVES. IN THE VAST MAJORITY OF CASES YOU'LL DECIDE PEOPLE IN FACT HAVE CAPACITY TO MAKE DECISIONS, AND WHEN THEY DON'T, RATHER THAN SAYING, OKAY, SOMEBODY ELSE HAS TO MAKE THE DECISION FOR THEM, YOU, WE, SHOULD ALL BE THINKING HOW CAN WE HELP THIS PERSON GET TO THE POINT WHERE THEY CAN MAKE THESE DECISIONS. ANXIETY, MAYBE THEY NEED SOME TREATMENT FOR THEIR ANXIETY WHILE WE POSTPONE THE DECISION, IF IT'S POSSIBLE TO POSTPONE. PSYCHOSIS, MAYBE THE PSYCHOSIS NEEDS TO BE TREATED. SUNDOWNING, SOMEBODY WITH ALZHEIMER'S, MAYBE THEY NEED TO MAKE THE DECISION IN THE MORNING RATHER THAN BEING APPROACHED LATE IN THE DAY. TO THE EXTENT THAT IMPAIRMENT CAN BE AMELIORATED, AMELORIATION I THINK IS A MORAL IMPERATIVE HERE, AND NOT JUST A NICETY THAT YOU COULD CHOOSE TO ENGAGE WITH. SO, THAT'S THE QUICK OVERVIEW. LET ME STOP HERE AND HOPEFULLY WE'LL BE ABLE TO DIVE INTO THE CASE A BIT MORE. [APPLAUSE] >> AGAIN, IF YOU HAVE QUESTIONS, COULD YOU COME TO THE MICS PLEASE. PAUL, I HAD A QUICK QUESTION FOR YOU TO START OFF. SO, A CHALLENGE WE OFTEN FACE HERE HAS TO DO WITH DISTINGUISHING PROBLEMS OF APPRECIATION FROM SOMETHING LIKE OPTIMISM. SO THE PEOPLE WHO END UP HERE ARE OFTEN PEOPLE WHO HAD FIRST-LINE, SECOND-LINE, THIRD-LINE TREATMENTS THOSE HAVEN'T WORKED OR HAVEN'T WORKED WELL ENOUGH. SOME PEOPLE SAY THAT'S ENOUGH, I TRIED. AND THEY GO ON TO SOMETHING ELSE, PALLIATIVE CARE OR GO HOME. SOME PEOPLE KEEP GOING, OFTEN THE PEOPLE WHO END UP HERE. AND I'LL DO A CAPACITY ASSESSMENT ON THEM, AND I'LL SAY, YOU UNDERSTAND THIS IS RESEARCH, IT MIGHT HELP YOU, IT MIGHT NOT, THIS IS UNCERTAIN, THERE'S SERIOUS RISKS, AND THEY ARE PERFECT ON UNDERSTANDING, THEY COULD GIVE YOU THE ODDS, SPIT BACK THE OBJECTIVE PROBABILITIES, AND THEN I SAY SO WHAT DO YOU THINK IS GOING TO HAPPEN, THEY ARE LIKE, IT'S GOING TO WORK FOR ME, I'M GOING TO BE CURED, IT'S GOING TO BE FINE. I KNOW IT'S GOING TO WORK FOR ME. GOD IS LOOKING OUT FOR ME. I'M A LUCKY PERSON, ALL SORTS OF DIFFERENT EXPLANATIONS FOR IT. BUT THEY ARE JUST CONFIDENT IN THEIR CASE, IT'S GOING TO BE FINE. AND THEN I STRUGGLE WITH HOW DO I TELL WHETHER THIS PERSON IS JUST -- HAS A STRONG BELIEF, IS OPTIMISTIC OR REALLY DOESN'T GET THOSE ODDS APPLY TO THEM. YOU SAID THERE'S A 1 IN 2 CHANCE YOU WILL HAVE A BAD OUTCOME. ANY TRICKS OR THOUGHTS WE COULD USE? >> SO, YOU KNOW, YOU CAN'T DENY THAT THAT'S A DIFFICULT SITUATION, AND A TOUGH DISTINCTION OFTEN TO MAKE. WHAT I'M LOOKING FOR IS THE DIFFERENCE BETWEEN HOPE AND DENIAL BASICALLY. OKAY? HOPE IS A GOOD THING. WE WANT OUR PATIENTS TO HAVE HOPE. I WANT A PATIENT TO BE ABLE TO SAY, LOOK, I UNDERSTAND THAT THE ODDS HERE ARE AGAINST ME. THERE'S A 10% CHANCE OF REMISSION, OR 25% CHANCE OF CURE. BUT I'M REALLY HOPEFUL GOING INTO THIS. I WOULD LIKE TO THINK I'M GOING TO BE IN THAT 25%. AND ON THAT BASIS I WANT TO MOVE FORWARD, WHICH IS DIFFERENT FROM SAYING, YOU KNOW, I KNOW I'M GOING TO BENEFIT FROM THIS. THAT WORRIES ME. I THINK AT THAT POINT YOU NEED TO PAUSE AND HOPEFULLY, HOPEFULLY WITHOUT STRIPPING PEOPLE OF THEIR OPTIMISM ALTOGETHER, BE ABLE TO GET THEM TO A MORE REALISTIC PLACE. >> THANKS. YES? >> YES, AS THE POPULATION AGES, A PROBLEM IS ARISING IN TERMS OF TESTAMENTARY COMPETENCE WHICH CAN INVOLVE A CAREGIVER OF PEOPLE THAT NO LONGER HAVE FAMILY MEMBERS, ET CETERA. AND YOU'VE KIND OF PUT THAT AS -- YOU TALKED ABOUT HIGH RISK DECISIONS AND LOW RISK DECISIONS. THE LAW TENDS TO PUT THAT AS A LOW-RISK DECISION. IN OTHER WORDS, IF YOU HAVE A NEURODEGENERATIVE DISEASE, SUCH AS ALZHEIMER'S OR LEWY BODIES OR FRONTAL WHATEVER, THE LAW WILL STATE THAT YOUR EXECUTIVE FUNCTIONS DO NOT HAVE TO BE AS HIGH AS THEY WOULD BE IN SIGNING A CONTRACT. NOW, AS TIME GOES ON, AS THE BABY BOOMER GENERATION KIND OF STARTS TO DIE OFF, WITH HIGH ASSETS, THIS SEEMS TO BE IT'S GOING TO BE A BIG PROBLEM, EVEN THIS WILL APPLY TO THE MEDICAL -- YOUR POPULATION BECAUSE PEOPLE ARE GOING TO BE SICK AND DIE, AND THE QUESTION WILL BE DOES THE CAREGIVER GET THE MONEY OR ARE THEY GOING TO DO SOMETHING DEVIOUS, HAVE YOU RUN INTO THIS PROBLEM? YOU GIVE CONSULTS ON THIS PROBLEM? IS THERE ANY LARGE STUDIES DONE ON THIS? DO YOU THINK IT'S IMPORTANT AND WHAT'S YOUR EXPERIENCE? >> THERE ARE NOT LARGE STUDIES. THERE IS NO STANDARDIZED INSTRUMENT THAT'S BEEN DEVELOPED FOR TESTAMENTARY CAPACITY. IT IS A GROWING ISSUE, AND THERE ARE CERTAINLY HIGH PROFILE CASES THAT HIT THE NEWS PERIODICALLY AND MANY OTHERS THAT ARE SETTLED QUIETLY THAT EVOKE EXACTLY THE SITUATION THAT YOU WERE DESCRIBING. I WILL SAY THAT ALTHOUGH THE LAW SAYS THAT THE STANDARD FOR TESTAMENTARY CAPACITY IS LOWER THAN FOR EXAMPLE FOR CONTRACTUAL CAPACITY BECAUSE WE FAVOR THE NOTION OF LETTING PEOPLE DISPOSE OF THEIR ASSETS AFTER DEATH AT A POINT WHICH THEY CAN'T BE HARMED BY IT AND THEIR CHOICES SHOULD IN GENERAL BE RESPECTED. IN REALITY, I'M NOT SURE THAT THAT'S THE WAY IT PLAYS OUT. I THINK THE COURTS ACTUALLY LOOK VERY CLOSELY AT THE DETAILS OF THEIR DECISION-MAKING CAPACITY WHEN A CHOICE IS CHALLENGED, AT LEAST AS CLOSELY AS THEY DO IN CONTRACTUAL CIRCUMSTANCES. BUT YOU'RE ABSOLUTELY RIGHT. WE SHOULD BE -- WE WILL BE, WHETHER WE SHOULD OR NOT, WE WILL BE SEEING A GROWING NUMBER OF THESE CASES, AND RESEARCH ON THE CAPACITIES INVOLVED AND HOW BEST TO ASSESS THEM WOULD BE A BIG STEP FORWARD. IT HASN'T YET HAPPENED. >> THANK YOU VERY MUCH. >> THANK YOU. >> ALEX? >> THANKS FOR YOUR TALK. YOU TALKED ABOUT A SLIDING SCALE APPROACH TO CAPACITY, THAT COULD BE ABUSED IN A WAY BY DOCTORS SAYING IF YOU DISAGREE WITH ME THEN YOU'RE MAKING A HIGHER RISK DECISION, YOU MIGHT NOT HAVE CAPACITY. I WAS WONDERING IF YOU THINK THAT DISAGREEING WITH YOUR DOCTOR'S JUDGMENT COULD BE CONSTRUED AS A HIGH RISK DECISION? >> THAT'S ART OF WHAT'S TRICKY. IN SOME CASES, AT LEAST, IT IS TRUE THAT IF THERE'S STRONGLY INDICATED TREATMENT AND YOU'RE DECLINING THAT TREATMENT, YOU ARE MAKING A HIGHER RISK DECISION THAN THE DECISION TO ACCEPT THAT TREATMENT. THERE'S NOT AN EASY SOLUTION TO THIS, OTHER THAN THE INTEGRITY OF THE TREATING AND EVALUATING PHYSICIANS OR OTHER HEALTH CARE PROFESSIONALS WHO ARE TRYING AS BEST THEY CAN TO APPLY A STANDARD IN A FAIR WAY. BUT I POINT OUT, BECAUSE I THINK IT'S JUST IMPORTANT FOR ALL OF US TO KEEP IN MIND, THERE'S A WAY YOU CAN TWIST THAT, THAT IS UNDERCUTTING OF THE INDIVIDUAL DECISIONAL RIGHTS THAT PEOPLE SHOULD HAVE. >> I THINK RELATED TO ALEX'S QUESTION, THE PATIENTS THAT I WORK WITH TEND TO BE STROKE PATIENTS WHO ARE LIMITED IN CAPACITY FOR SOME AMOUNT OF TIME AND THEY ARE FACING TIME-LIMITED DECISION ABOUT SOMETHING LIKE FEEDING TUBE, AND SO I WAS WONDERING IF YOU HAD THOUGHTS ABOUT THE ABILITY TO REFUSE SOMETHING THAT'S STANDARD OF CARE, AND HOW WE DECIDE WHETHER SOMEONE HAS THAT DECISION-MAKING CAPACITY? >> MOST TREATMENTS HOPEFULLY THAT WE'RE OFFERING PATIENTS ARE STANDARD OF CARE TREATMENTS. IT'S DIFFERENT IN CLINICAL RESEARCH PROTOCOLS WHERE OFTEN BY DEFINITION THEY ARE NOT. TO THE EXTENT THAT DECISIONS CAN BE POSTPONED, IF CAPACITY -- INCAPACITY LOOKS AS THOSE IT WILL BE TEMPORARY, THEY SHOULD BE POSTPONED. BUT OF COURSE IN SOME CIRCUMSTANCES, THAT'S NOT POSSIBLE. EVERY STATE NOW HAS TWO MECHANISMS THAT CAN BE HELPFUL IN THESE CIRCUMSTANCES. ONE IS THE ABILITY OF A PERSON TO DESIGNATE A HEALTH CARE DECISION MAKER IN ADVANCE, THAT PERSON IS SOMETIMES CALLED A HEALTH CARE PROXY, WHO CAN MAKE DECISIONS FOR THE PERSON IN THE EVENT THAT THEY BECOME INCOMPETENT. AND AS YOU KNOW, WE'RE REQUIRED BY FEDERAL LAW TO ASK EVERY PATIENT ON ADMISSION WHETHER THEY HAVE SUCH AN INSTRUMENT, WHETHER THEY HAVE DESIGNATED A PROXY DECISION MAKER OR OTHERWISE MADE THEIR ADVANCED WISHES KNOWN. BECAUSE ONLY A SMALL PERCENTAGE OF THE POPULATION OVER THE LAST 30 YEARS, WHICH IS AS LONG AS THE PATIENT'S SELF DETERMINATION ACT, FEDERAL LAW, BEEN IF FORCE IT'S STILL PROBABLY UNDER 20% OF PATIENTS ACCORDING TO MOST SURVEYS WHO HAVE SUCH A DOCUMENT. STATES HAVE INCREASINGLY PASSED WHAT ARE SOMETIMES CALLED FAMILY MEDICAL DECISION MAKING ACTS, WHICH PROVIDE A HIERARCHY OF DECISION-MAKERS IN THE EVENT OF INCAPACITY. SO PHYSICIANS AND HOSPITALS NO LONGER HAVE TO GO TO COURT TO GET A GUARDIAN APPOINTED UNDER URGENT CIRCUMSTANCES. THEY ARE IN ALMOST ALL STATES, AT THIS POINT, LEGALLY ENTITLED TO GO DOWN THAT LIST OF NEXT OF KIN TO ASCERTAIN WHAT THE WISHES OF A COMPETENT DECISION MAKER IN THE BEST INTEREST OF THE PATIENT ACTUALLY ARE. IF YOU'VE DECIDED THAT YOUR PATIENT LACKS CAPACITY TO SAY NO TO A FEEDING TUBE, THOSE ARE THE ALTERNATIVES THAT YOU HAVE AT THAT POINT. >> SOMETIMES IN THE OLDER GENERATION, PART OF THEIR LIFESTYLE, PEOPLE JUST DON'T MAKE DECISIONS. THEY RELY ON OTHER PEOPLE TO MAKE. MY HUSBAND MAKES THE DECISIONS. I DON'T. AND NOW IT SEEMS LIKE YOU'RE COMING TO THEM AND SAYING, YOU MUST MAKE A DECISION, EVEN THOUGH YOUR WHOLE LIFE YOU'VE RELIED ON SOMEBODY ELSE. >> SO, IT IS CERTAINLY TRUE THAT PEOPLE DEFER DECISIONS TO OTHERS. IT'S TRUE, AND NOBODY RAISED THIS YET, THERE ARE CULTURES IN WHICH DECISIONS ARE NOT INDIVIDUAL DECISIONS, THEY ARE FAMILIAL DECISIONS. AND PEOPLE WILL DECLINE TO MAKE SUCH CHOICES. THERE ARE ALSO CULTURES IN WHICH WIVES DON'T MAKE DECISIONS ON THEIR OWN; THEY ARE COMPELLED CULTURALLY, IT'S NOT IN OTHER WAYS, TO DEFER TO THE DECISIONS OF THEIR HUSBANDS. PEOPLE HAVE THE RIGHT TO WAIVE TWO ASPECTS OF INFORMED CONSENT. AND SOMETIMES WE ARE NOT AWARE OF THIS. AT LEAST IN THE CLINICAL SETTING, THEY HAVE THE RIGHT TO WAIVE DISCLOSURE. THEY CAN SAY, DOC, I DON'T WANT TO HEAR ALL THAT STUFF. I JUST WANT TO GO AHEAD. AND THEY HAVE THE RIGHT TO WAIVE CHOICE. WHICH IS TO SAY, DOC, I HEARD IT ALL, I DON'T KNOW WHAT TO MAKE OF IT, YOU DO WHAT YOU THINK IS BEST FOR ME. AND ALTHOUGH SOMETIMES YOU WILL HEAR PEOPLE AT THE BEDSIDE SAY, NO, MRS. JONES, THE LAW SAYS I HAVE TO TELL YOU THIS INFORMATION, IN FACT THE LAW DOESN'T SAY THAT. MRS.JONES HAS THE RIGHT TO WAIVE EITHER OF THOSE TWO ELEMENTS OF THE PROCESS. THEN THE QUESTION IS, IS IT A COMPETENT WAIVER? SOMEBODY WHO, YOU KNOW, IS PSYCHOTIC, DISORIENTED, UNAWARE OF WHAT THEY ARE DOING MAY NOT HAVE THE CAPACITY TO UNDERSTAND WHAT IT MEANS TO TURN THIS DECISION OVER TO SOMEONE ELSE. SOMEONE WHO IS COMPETENT TO DO SO CAN SAY, YOU KNOW, MY WIFE IS -- I'M AN ACCOUNTANT, MY WIFE IS A PHYSICIAN, SHE'S MUCH BETTER ABLE TO MAKE THIS DECISION THAN I AM. WHATEVER SHE SAYS, I'LL GO ALONG WITH. YOU KNOW, MAY WELL BE MAKING A COMPETENT CHOICE THERE. >> THANK YOU, PAUL. I WONDER IF YOU COULD SAY MORE ABOUT INTERACTION BETWEEN CAPACITY AND COGNITIVE IMPAIRMENT, BECAUSE IN THIS PARTICULAR CASE AND IN OTHER CASES THERE'S A QUESTION I THINK, AND YOU NOTED THE COGNITIVE IMPAIRMENT CAN INTERFERE WITH UNDERSTANDING AND APPRECIATION, AND REASONING AND CHOICE, AND THERE'S A SORT OF -- I DON'T KNOW IF CONFUSION, BUT QUESTION THAT PEOPLE ASK, IF SOMEBODY HAS REALLY LOW I.Q. OR COGNITIVE IMPAIRMENT ON PSYCHOLOGICAL TESTING DO WE DO CAPACITY ASSESSMENT? SAME QUESTION ARISES SOMETIMES WITH CERTAIN KINDS OF MENTAL DIAGNOSES, WHICH I KNOW YOU'VE DONE A LOT OF WORK ON. COULD YOU SAY SOMETHING ABOUT THAT INTERACTION BETWEEN THOSE TWO THINGS? >> YEAH. I THINK THAT'S AN IMPORTANT QUESTION. THERE'S A DIFFERENCE BETWEEN HAVING A DIAGNOSIS AND BEING INCAPABLE OF MAKING DECISIONS. AND THAT'S TRUE FOR ALMOST EVERY DIAGNOSIS. SO THERE'S NO -- ALMOST NO DIAGNOSIS THAT'S PATHOGNOMONIC OF LACK OF CAPACITY, INCLUDING SCHIZOPHRENIA, INCLUDES MAJOR NEUROCOGNITIVE SYNDROMES, AT LEAST EARLY IN THEIR COURSE. IT INCLUDES INTELLECTUAL DISABILITY. OF COURSE, IN ALL THOSE CASES THERE ARE PEOPLE WHO ARE SO SEVERELY IMPAIRED THAT IT'S CLEAR THEY LACK CAPACITIES TO MAKE ALMOST ANY CHOICES, BUT THAT SHOULD BE ASCERTAINABLE FAIRLY QUICKLY ON THE KIND OF EXAMINATION THAT WE'RE TALKING ABOUT. BUT TO FOCUS ON INTELLECTUAL DISABILITY FOR A MOMENT, BECAUSE THAT'S THE CASE AT HAND, SO THIS PATIENT YEARS AGO WAS TESTED, I. Q. OF 61. THE HISTORIC CUTOFF FOR INTELLECTUAL DISABILITY IS I.Q. OF 70. SO THIS IS SOMEBODY WHO WOULD BE CONSIDERED TO HAVE A MILD INTELLECTUAL DISABILITY, WHO WOULD BE CAPABLE OF DOING MANY THINGS FOR HIMSELF AND MAKING MANY CHOICES FOR HIMSELF AND IN FACT THAT SEEMS TO BE HOW HE'S BEEN LIVING HIS LIFE TO THIS POINT, AND I THINK IT WOULD BE EXTREMELY IMPORTANT NOT TO GET THE LABEL CONFUSED WITH THE DEGREE OF FUNCTIONAL CAPACITY, PARTICULARLY IN A CASE LIKE THIS. YES, HE HAS SOME MILD INTELLECTUAL DISABILITY, NOW LET'S SEE WHAT THAT REALLY MEANS. LET'S SEE HOW THAT AFFECTS HIS ABILITY TO MAKE A DECISION IN THIS PARTICULAR SITUATION. >> THANK YOU FOR A GREAT TALK. I ALSO WANTED TO RETURN TO THE CASE, WANTED TO ASK SUPPOSE THAT YOU FIND THE PATIENT LACKS CAPACITY TO MAKE THE DECISION FOR HIMSELF. THEN THE NEXT QUESTION IS GOING TO BE DOES HE HAVE CAPACITY TO SIGN A SURROGATE, INSOFAR AS THERE HASN'T BEEN A SURROGATE ALREADY ASSIGNED. TO YOU SPEAK MORE TO WHAT EXACTLY IN TERMS OF UNDERSTANDING AND APPRECIATION NEEDS TO BE DEMONSTRATED FOR THAT DECISION? HOW THAT COMPARES TO THE FULL DECISION CAPACITY FOR THE DECISION AT HAND? IS IT ENOUGH TO UNDERSTAND SOMEONE ELSE IS GOING TO MAKE THE DECISION FOR ME AND THEY WILL DO SO WITH MY BEST INTEREST AT HEART OR HOW MUCH OF SUBSTANTIVE DECISION AT HAND TO YOU ACTUALLY NEED TO UNDERSTAND, AND YOU DON'T WANT TO HAVE THE SAME REQUIREMENTS IN TERMS OF UNDERSTANDING AND APPRECIATION AS FOR THE ACTUAL DECISION, BUT, YOU KNOW, CAN YOU SPEAK TO THAT DIFFERENCE? >> LET ME -- I'M AWARE THERE'S JUST A MINUTE LEFT. YOU HAVE HERE, HE'S OUT OF TOWN TODAY, ONE OF THE PEOPLE WHO HAS DONE THE BEST WORK ON EXACTLY THAT QUESTION. THE DISTINCTION BETWEEN CAPACITY TO MAKE A DECISION AND CAPACITY TO APPOINT A SURROGATE TO MAKE A DECISION. THAT'S SCOTT KIM, IN THE DEPARTMENT OF BIOETHICS HERE. I WOULD ENCOURAGE YOU TO FOLLOW UP WITH HIM OR GOOGLE HIS WORK TO TAKE A LOOK AT THAT. THE ANSWER, JUST, YOU KNOW, ON ONE LEG HERE, IS THAT YOU NEED TO NOT ONLY KNOW WHAT THE EFFECT OF APPOINTING A SURROGATE DECISION MAKER IS BUT MORE OR LESS WHAT YOU'RE APPOINTING THEM FOR. YOU DON'T NEED THE SAME DEGREE OF DETAILED UNDERSTANDING OF RISK/BENEFITS PROCEDURES, ET CETERA, THAT'S WHAT YOU'RE LETTING SOMEBODY ELSE DECIDE FOR YOU. BUT IN GENERAL WHAT THE NATURE OF THAT DECISION IS IS SOMETHING THAT YOU SHOULD BE AWARE OF, BEFORE YOU TURN THAT CHOICE OVER TO ANOTHER PERSON. BUT SCOTT CAN ELUCIDATE THIS IN MUCH GREATER DETAIL. >> WE'LL GET YOU GUYS LATER. IN THE MEANTIME, FOR PEOPLE HERE, THE FIRST WEDNESDAY IN APRIL, WE HOPE TO SEE YOU HERE AGAIN. IN THE MEANTIME, THANKS VERY MUCH, PAUL. [APPLAUSE]