Patient - Centered outcomes research - New directions, major challenges, transformative potential

>> GOOD AFTERNOON. I'M GARY GIBBONS HERE AT NIH. IT'S MY PLEASURE TO INTRODUCE TODAY'S WALS LECTURER, DR. CLYDE YANCY, WHO'S OUR GUEST FOR TODAY TODAY. AS PART OF THE WALS TRADITION, HE'S PROFESSOR OF THE DEPARTMENT OF MEDICINE, NORTHWESTERN UNIVERSITY, CHIEF OF CARDIOLOGY THERE. I MUST BY DISCLOSURE SAY THAT I'VE KNOWN DR. YANCY FOR A COUPLE OF DECADES. IT'S GIVEN ME A SENSE OF THE NATURE OF THE MAN. HE GOT HIS M.D. FROM TULANE, DID HIS TRAINING AT UNIVERSITY OF TEXAS SOUTHWESTERN, PARK LAND HOSPITAL, ROSE TO THE RANKS FROM FELLOW TO PROFESSOR AT U.T. SOUTHWESTERN, AND BEFORE HE HAD HIS MOST RECENT POSITION AT NORTHWESTERN. HE'S RECOGNIZED AS A LEADING EXPERT IN PARTICULARLY CLINICAL RESEARCH THAT IS TRANSLATIONAL AND IN BOTH THE T1, T2 ALL THE WAY TO THE END OF IMPLEMENTATION IMPLEMENTATION. WHERE HE'S DISTINGUISHED HIMSELF AS REALLY A LEADER IN THE FIELDS OF HYPERTENSION AND HEART FAILURE AND HEALTH DISPARITIES RESEARCH, AND WITH OVER 300 PUBLICATIONS IN THE HIGHEST IMPACT JOURNALS IN HIS FIELD, THE NEW ENGLAND JOURNAL, AND JAMA. SO HE'S KNOWN THROUGHOUT THE WORLD AS A LEADING EXPERT IN THIS CLINICAL RESEARCH REALM. I COULD GO ON AND ON ABOUT HIS ACHIEVEMENTS, HIS SCIENTIFIC LEADERSHIP, WHETHER IN THE EXTRA MURAL COMMUNITY IN VARIOUS SOCIETIES SUCH AS AMERICAN HEART ASSOCIATION, HEART FAILURE SOCIETY, HIS CONTRIBUTIONS TO THE NIH ON THE ACD OF THE NIH DIRECTOR, STUDY SECTIONS, PCORI, BUT THOSE ARE PARTS OF HIS CV THAT YOU CAN APPRECIATE ON THE WEB. WHAT I JUST BRIEFLY SHARE IS THAT WHEN WE'RE IN OUR QUIET MOMENTS, WE'RE PART OF THE SAME GENERATION, SOME WOULD CALL THE JOSHUA GENERATION, SO WE GREW UP PROFESSIONALLY TOGETHER. WE SHARE COMMONALITIES OF FAMILIES THAT WERE A COUPLE GENERATIONS FROM SHARECROPPERS, AND HIS MOTHER WAS A TEACHER LIKE MINE AND STARTED HIM ON A PATHWAY. WE ALSO SHARE LIVES BECAUSE HE'S GOT TWO DYNAMIC DAUGHTERS THAT HE RAISED AFTER THE PASSING OF HIS WIFE THAT HE'S VERY PROUD OF. THEY ARE BRILLIANT. ONE JUST BECAME A RHODES SCHOLAR AT HARVARD, SO WE HAVE COMPETING DAD WARS THAT HAVE GONE ON FOR A NUMBER OF YEARS. THEY'RE TWO DROP DEAD GORGEOUS YOUNG WOMEN. OBVIOUSLY AS YOU'LL SEE, NO RESEMBLANCE TO CLYDE. [LAUGHTER] WE'RE OLD FRIENDS. BUT GAINS ME AS HIS FRIEND IS HIS PASSION. WE CAN TALK ABOUT DAUGHTERS OR JAZZ OR OUR LATEST READ, AND HE HAS THAT PASSION. HE ALSO IS A MAN OF GREAT COMPASSION. HE'S SOMEONE WHO'S COMMITTED TO MAKING A DIFFERENCE TO SERVICE AND HELPING, AND I THINK THAT THAT COMPASSION MAKES HIM SUCH A GREAT PHYSICIAN, GREAT CLINICIAN, BECAUSE HE WANTS TO BRING THAT SCIENCE TO BEAR TO HELP PATIENTS LIVE BETTER AND LONGER AND MORE FULFILLING LIVES, AND IT'S THAT SENSE OF COMPASSION, LITERALLY COMING ALONGSIDE THOSE WHO SUFFER, THAT I THINK IS REALLY THE SPIRIT OF HIS LECTURE TODAY, BECAUSE IT'S THAT SENSE OF SCIENCE AND THE COMPASSION OF SCIENCE IN HELPING PATIENTS WHICH IS AT THE CORE OF THE NIH MISSION, AND I WOULD BELIEVE THE VERY ESSENCE OF WHAT WALS LECTURES SHOULD BE ABOUT IN DISPLAYING THE FULL DIVERSITY OF OUR PORTFOLIO IS AT THE END OF THE DAY, WE'RE HERE TO TURN DISCOVERY SCIENCE INTO ENHANCEMENTS OF HUMAN HEALTH. AND WHAT HE'LL TALK ABOUT TODAY IS THE IMPORTANCE OF THE PATIENT CENTERED RESEARCH AGENDA. SO WITHOUT ANY FURTHER ADO, WE'RE LOOKING FORWARD TO YOUR TALK ON PATIENT CENTERED OUT COME RESEARCH, NEW DIRECTIONS, MAJOR CHALLENGES, AND TRANSFORMATIVE POTENTIAL. THANK YOU SO MUCH FOR COMING. [APPLAUSE] >> GOOD AFTERNOON. THAT'S NOT GOOD ENOUGH. I AM FROM THE DEEP SOUTH, AND WHEN SOMEONE GREETS YOU CORDIALLY AND THEY DON'T RESPOND, THAT'S A BAD MOMENT. SO GOOD AFTERNOON. >> GOOD AFTERNOON! >> SO MUCH BETTER. IT REALLY IS MY VERY HUMBLE AND SINCERE PRIVILEGE TO BE ON THE CAMPUS TODAY. I HAVE BEEN A FAN OF AND MOST RECENTLY A CONSULTANT AND AN ADVOCATE FOR THE NATIONAL INSTITUTES OF HEALTH, AND I FULLY ENDORSE AND EMBRACE THE WORK DONE ON THIS CAMPUS. I HAVE A NUMBER OF FOOTHOLDS, IF YOU WILL, IN GOVERNMENT SERVICE. THE NIH, THE FDA, AHRQ, AND I'M CONTINUALLY IMPRESSED, EVEN AWESTRUCK, BY THE INCREDIBLE COMMITMENT THAT SOME OF YOU HAVE TO ALMOST SEEMINGLY THANKLESS JOBS, BUT I WANT TO INDICATE TODAY THAT YOUR JOBS ARE TERRIFIC. YOU GET MY GRATITUDE, YOU HAVE MY THANKS, FOR THE WORK YOU DO TO REALLY HELP US DO THE WORK THAT WE DO, AND WE'RE ALL IN THE SAME SPACE. SO I'D LIKE TO EXTEND THE WARMEST GREETING OF THE SEASON TO YOU, WHATEVER THE SEASON MEANS, AND MAKE YOU AWARE THAT MANY PEOPLE LIKE ME REALLY, REALLY APPRECIATE WHO YOU ARE AND WHAT YOU DO, ESPECIALLY UNDER THE CIRCUMSTANCES WITH WHICH YOU'VE HAD TO OPERATE NOT JUST RECENTLY BUT FOR THE LAST SEVERAL YEARS. THIS IS BIGGER THAN A SEQUESTRATION. THIS IS BIGGER THAN A BUDGET ARGUMENT. THIS IS BIGGER THAN PARTISAN POLITICS. YOU'RE FUNDAMENTALLY CHANGING HEALTH. YOU'RE FUNDAMENTALLY INCREASING HOPE. AND THAT HAS ITS OWN THRESHOLD THAT EXCEEDS ANYTHING THAT IS POLITICALLY EXTAUNT RIGHT NOW. MY THANKS ALSO TO GARY FOR AN INCREDIBLY WARM, KIND AND VERY GENEROUS INTRODUCTION. HE'S SPOT-ON. IF I WAS AS HANDSOME AS HIM, YOU'D THINK THAT WE WERE TWINS. [LAUGHTER] >> BUT THE ONE THING THAT WE'VE NEVER TAKEN TO TASK IS THIS LITTLE BASKETBALL THING. I KNOW I CAN TAKE HIM. BUT HE WILL NOT SUBMIT TO A 1 ON 1 COMPETITION. BUT LET'S GET RIGHT TO THE HEART OF THE MATTER. I WANTED TO TALK TO YOU TODAY ABOUT PATIENT CENTERED RESEARCH AND PATIENT ENGAGEMENT. A NUMBER OF YOU IN THE AUDIENCE KNOW ME PROFESSIONALLY AND HAVE KNOWN THE DIFFERENT SPACES IN WHICH I'VE LIVED. HUMAN PHYSIOLOGY, EXERCISE, PERFORMANCE, HEART FAILURE, HEART TRANSPLANTATION, HYPERTENSION, CLINICAL TRIAL STUDY, AND THEN CLINICAL PRACTICE GUIDELINE GENERATION. ALL THOSE TWO DEFINE DIFFERENT EXPERIENCES I'VE HAD AS A CLINICIAN SCIENTIST, BUT TODAY I WANT TO TALK ABOUT PATIENT CENTERED RESEARCH. SO BY A SHOW OF HANDS, HOW MANY PEOPLE IN THE AUDIENCE ARE ENGAGED ACTIVELY IN A RESEARCH INITIATIVE, CLINICAL, TRANSLATIONAL OR BASIC? ALL RIGHT. MOW I WANNOW I WANT YOUR HANDS A LITTLE BIT HIGHER BECAUSE WE'RE GOING TO DO AN EXERCISE. WHILE YOUR HANDS ARE RAISED, HOW MANY OF YOU HAVE SPOKEN WITH A PATIENT AS STEP 1 FOR WHICHEVER RESEARCH INITIATIVE YOU DO? I HAVE ABOUT A HALF DOZEN PEOPLE. WHO HAVE THEIR HANDS RAISED AND I'LL TALK TO YOU AT THE RECEPTION BECAUSE I BET YOU'RE WRONG. BUT I WILL GIVE YOU MY OWN MIA CULL PA. I'VCULPA. I'VE BEEN DOING CLINICAL TRIALS SINCE 1989. IN FACT, SINCE 1985 IF I COUNT MY DAYS AS A HYPERTENSION INVESTIGATOR WORKING WITH TOM AT TULANE. NOT A SINGLE TIME AS A COINVESTIGATOR, AS A SITE PARTICIPANT, LATER AS A PRINCIPAL INVESTIGATOR, DID I EVER GO TO THE CONSTITUENCY WE WERE STUDYING AND SAY, WHAT QUESTION IS IMPORTANT TO YOU? WHAT WOULD YOU LIKE TO KNOW THAT YOU DON'T KNOW? WHAT WOULD MAKE A DIFFERENCE FOR YOUR DISEASE PROCESS? WE TAKE AND WE HAVE TAKEN A VERY PA TRERNPATERNAL APPROACH WHEN WE DO CLINICAL RESEARCH. I'VE GOT A P VALUE, THIS MAKES SENSE, YOU SHOULD DO THIS. WELL, IS THAT REALLY THE RIGHT THING TO DO? IS IT REALLY THE WAY IN WHICH WE CAN, AS MANY OF US TALKED ABOUT EARLIER THIS AFTERNOON, EFFECT IMPLEMENTATION SCIENCE? SO WHAT HAS TRANSPIRED OVER SOME PERIOD OF TIME AND WHAT I'VE HAD THE PRIVILEGE OF BEING INVOLVED IN IS PATIENT CENTERED OUTCOMES RESEARCH. I'M SHARING WITH YOU MY DISCLOSURES NOT BECAUSE I WANT YOU TO KNOW THAT I DO A LOT OF THINGS, BUT I WANT YOU TO APPRECIATE UNDER THE THIRD BULLET, FEDERAL APPOINTMENTS, THAT I AM LIKE YOU, AND I UNDERSTAND YOUR SPACE. I DON'T LIVE IN IT EVERY DAY, BUT MANY DAYS I LIVE IN YOUR SPACE AND I DO A NUMBER OF THINGS WITH THE NIH AND OTHER GOVERNMENT ORGANIZATIONS. ALL OF US HAVE A PRISM THAT WE USE INTERPRETIVE INFORMATION. MY PRISM COMES FROM, YES, THE FEDERAL APPOINTMENTS PLUS THE EFFORTS TO ADJUDICATE EVIDENCE AND PE PERFORMANCE MEASURES FROM MY WORK ON EDITORIAL BOARDS, TRYING TO SIMULATE AND DETERMINE WHAT INFORMATION NEEDS TO BE BROUGHT FORWARD TO THE LARGER COMMUNITY, AND THEN AS DR. GIBBONS MENTIONED, THE WORK WE DO WITH VOLUNTEER HEALTH ORGANIZATIONS, PARTICULARLY THE AMERICAN HEART ASSOCIATION. AND THE AMERICAN COLLEGE OF CARDIOLOGY. THIS IS THE THEME THAT WILL BE PREDOMINANT OVER THE NEXT 30 TO 35 MINUTES. AND THAT IS, PATIENT CENTERED OUTCOMES RESEARCH IN THE ITERATION KNOWN AS PCORI IS, IN FACT, AS DR. CRUMHOLZ MENTIONED IN 2012, IT IS RESEARCH DONE DIFFERENTLY. THAT BEARS REPEAT. IT IS RESEARCH DONE DIFFERENTLY. THINK ABOUT HOW WE DO RESEARCH NOW. THEN USE THAT AS THE COMPARATOR FOR WHAT I'M GOING TO SHOW WITH YOU THAT DEFINES A VERY DIFFERENT WAY OF DOING THINGS. LET'S WALK THROUGH A JOURNEY. THIS IS A MATRIX THAT WAS PUBLISHED BY OUR PCORI METHODOLOGY COMMITTEE IN THE NEW ENGLAND JOURNAL OF MEDICINE OVER A YEAR AGO. BUT IT STARTS IN THE 1940s, AND IT CAPTURES MILESTONES IN CLINICAL INVESTIGATION FROM 1940 THROUGH THE 2010s. IF ONE STARTS AT THE VERY BEGINNING, WE'RE TALKING ABOUT THE INTRODUCTION OF ANTIBIOTIC THERAPY, LARGELY DURING THE MAJOR INTERNATIONAL MILITARY CONFLICTS WHERE WE UNDERSTOOD THE BENEFITS OF SULFA. IN THE 1950s, WE BEGAN TO LOOK INTO ORGAN TRANSPLANTATION AND THE POTENTIAL BENEFIT OF CARDIOPULMONARY RESUSCITATION. THIS IS THE FIRST TIME THAT A CASE CONTROLLED METHODOLOGY WAS USED, IF YOU WILL, AN OBSERVATIONAL ANALYSES, AND THE FIRST TIME A KAPLAN MEIER ANALYSIS WAS USED TO PROJECT OUTCOMES IF WE DIDN'T HAVE THOSE OUTCOMES IN HAND. IN THE 1960s, CORONARY ARTERY BYPASS GRAFTING, SOMETHING THAT IS PARCEL TO MY EVERYDAY WORK AS A CLINICAL CARDIOLOGIST, WAS INTRODUCED. THIS IS WHEN WE BEGAN TO DEAL WITH OBSERVATIONAL RESEARCH METHODS, DEALING WITH QUESTIONS ABOUT DATA INTEGRITY AND DATA SAFETY. LOOK AT THE 1970s. CORONARY ANGIOGRAPHY, QUALITY MEASURES IN HEALTHCARE, AMBULATORY SURGERY, LARGE SCALE VACCINATIONS. THIS IS WHEN WE INTRODUCED METAANALYTIC TECHNIQUES, WHEN THERE WAS EVEN MORE SUPPORT FOR RANDOMIZED CONTROL TRIALS, AND WE BEGAN TO HAVE A MORE SOPHISTICATED USE OF STATISTICAL MEASURES. IN THE 1980s, THROMBOLYTICS FOR HEART ATTACKS, I REMEMBER THAT AREA VERY CLEARLY. THE ROBUSTNESS OF THE ARGUMENTS, THE OPPORTUNITY TO MAKE A DIFFERENCE TO CHANGE THE DISEASE, SIMILARLY A PLETHORA OF HYPERTENSION DRUGS WERE INTRODUCED. THIS IS WHEN WE BEGAN TO TALK ABOUT LARGE SCALE CLINICAL TRIALS, PRAGMATIC TRIALS, IF YOU WILL. THIS IS WHEN WE BEGAN TO THINK ABOUT COST-EFFECTIVE ANALYSES MARKOV MODELS. IN THE 1990s, STINTING WAS INTRODUCED WITH CORONARY ARTERY DISEASE. WORK WAS DONE WITH HUMAN IMMUNODEFICIENCY VIRUS, AND THIS IS WHERE THE NOTION OF EVIDENCE BASED MEDICINE STARTED TO CREEP INTO OUR LANGUAGE AND BECAME IMPORTANT. AS YOU KNOW, PRAN CYS FRANCIS COLLINS SPEARHEADED THE CULMINATION OF THE HUMAN GENOME PROJECT WHICH HAS YIELDED SOME NEW DITS COVER RES. DISCOVERIES. CLINICAL TRIALS.GOV BECAME INITIATED, AND THEN IN THE 2010s, GENOMICS, E AND NOW THE METHODOLOGY OF CHOICE IS PATIENT CENTERED OUTCOMES RESEARCH. THE POINT HERE IS THAT THROUGH EACH GENERATION OF OUR EMBRACE OF THE NEEDS FOR HEALTHCARE, WE HAVE HAD TO UTILIZE DEFINED METHODOLOGIES THAT HAVE BEEN EVOLUTIONARY TO HELP US IDENTIFY WHAT HAVE BEEN TRANSCENDENT CHANGES IN HEALTHCARE: SO WHERE WE ARE NOW, THAT THRESHOLD IS LOOKING AT THE POSSIBILITY THAT PATIENT CENTERED OUTCOMES RESEARCH CAN DO THAT. SO PCORI. I JUST WANT TO ANSWER SEVERAL QUESTIONS WITH YOU AS WE GO FOR IT. WHAT IS IT, WHAT'S DIFFERENT ABOUT IT, HOW IT WORKS AND WHAT HAS IT ACTUALLY DONE. I WANT TO START BY MAKING IT VERY CLEAR THAT AFTER A NEARLY THREE-YEAR INVOLVEMENT IN PCORI, IT ABSOLUTELY IS NOT AN ALTERNATIVE TO THE WORK DONE BY THE NATIONAL INSTITUTES OF HEALTH. BY ORDERS OF SCALE, VERY, VERY DIFFERENT. BY ORDERS OF PROCESS, VERY, VERY DIFFERENT. THIS REALLY IS SOMETHING THAT IS SYNERGISTIC WITH WHAT HAS TRADITIONALLY BEEN DONE WITH THE NIH AND SHOULD NOT BE LOOKED AT AS BEING COMPETITIVE OR AS ALTERNATIVE, BUT AS ANOTHER PLATFORM TO CAPTURE VERY UNIQUE MODEL OF RESEARCH. SO AS WE BEGIN TO THINK ABOUT WHY PCORI, IT IS LARGELY BECAUSE OF WHAT I INTRODUCED TO YOU AS MY OWN MIA CULPA. VERY FEW OF US IN CLINICAL INVESTIGATION HAVE ACTUALLY TAKEN THE TIME TO UNDERSTAND WHAT A PATIENT'S NEEDS WERE BEFORE INTRODUCING A STRATEGY THAT WE THOUGHT WAS VAI VERIFIABLE. WHAT WAS ORIGINALLY DISCUSSED AS COMPARATIVE EFFECTIVENESS RESEARCH BUT FOR POLITICAL CONCERNS NEEDED TO BE REINVENTED AS SOMETHING DIFFERENT CREATED AN INCREDIBLE OPPORTUNITY. THAT OPPORTUNITY WAS, IN FACT, TO ARTICULATE THE NECESSITY AND THEN THE ORGANIZATIONAL NECESSITY FOR A PATIENT CENTERED OUTCOMES RESEARCH INITIATIVE TO BE SOMETHING MORE THAN JUST COMPARATIVE EFFECTIVENESS RESEARCH. SO AS AFFORDED US BY THE LANGUAGE IN THE ACA OR THE AFFORDABLE CARE ACT AS A MATTER OF LAW, THERE, IN FACT, WAS THE GENESIS OF THE PATIENT CENTERED OUTCOMES RESEARCH INSTITUTE TO BE CONSTITUTED BY ONE GROUPS. ONE WAS A BOARD OF GOVERNORS AND THE OTHER WAS A METHODOLOGY COMMITTEE. FRANCIS COLLINS SITS ON THE BOARD OF GOVERNORS, I SIT ON THE METHODOLOGY COMMITTEE ALONG WITH MIKE LAWYER AND LAUER AND OTHERS I WILL SHARE WITH YOU IN A FEW MOMENTS. THIS IS THE LIST OF THE BOARD OF GOVERNORS. THE PREVIOUS CHAIR WAS GENE WASHINGTON, DEAN OF THE UCLA SCHOOL OF MEDICINE, IT'S NOW GREG NORQUIST, CHAIR OF THE DEPARTMENT OF PSYCHIATRY AT THE UNIVERSITY OF MISS PI SEE. YOU CAMISSISSIPPI. YOU CAN SEE THE OTHER PEOPLE THAT HAVE THE PRIVILEGE OF SITTING ON THE COMMITTEE INCLUDING FRANCIS COLLINS, AND YOU CAN SEE THE DEPTH AND BREADTH OF THE MEMBERSHIP OF THOSE THAT SIT ON THE BOARD OF GOVERNORS. THEY'RE NOT ALL PHYSICIANS, BY STATUTE, THERE ARE CONSUMER-ORIENTED INDIVIDUALS, THERE ARE INDIVIDUALS FROM INDUSTRY AND THERE ARE DIFFERENT DISCIPLINES. FOR EXAMPLE, A CHIROPRACTOR SITS ON THE PCORI BOARD OF GOVERNORS. IT'S MEANT TO BE AN INCLUSIVE INITIATIVE. THIS IS THE INTENTION FOR THE CONSTRUCT OF THE METHODOLOGY COMMITTEE MADE UP OF INDIVIDUALS THAT HAVE EXPERTISE IN HEALTH SERVICES RESEARCH, MEMBERSHIP THAT COMES FROM PUBLIC AND PRIVATE INS TUESDAYS INSTITUTIONS, THOSE T HAT ARE DEFINED AS BIOSTATISTICIANS, OTHERS THAT REPRESENT A NUMBER OF ENTITIES LIKE I MEDICAL CENTERS, THE VETERANS AFFAIRS CENTERS, THE NATIONAL INSTITUTES OF HEALTH, AHRQ, ALL OF THOSE COME TOGETHER TO FORMULATE THIS METHODOLOGY COMMITTEE NOW UNDER THE CHAIRMAN SHIP OF ROBIN NEWHOUSE, PREVIOUSLY UNDER THE CHAIRMANSHIP OF DEAN OF THE SCHOOL OF THE MEDICINE AT MAYO. THE OTHER MEMBERS ARE AS YOU SEE HERE, AND AGAIN YOU SEE A DEPTH AND BREADTH OF EXPERIENCES AND EXPERTISE THAT BRING UNIQUE SKILLS TO THIS METHODOLOGY GROUP GROUP. SO WHAT IS THE MISSION STATEMENT? I WANT THIS TO STAY UP FOR A FEW SECONDS SO YOU CAN DWELL ON IT, BECAUSE I THINK THERE'S SOME IMPORTANT STATEMENTS HERE THAT BEAR EMPHASIS. SO THE MISSION IS TO HELP PEOPLE MAKE INFORMED HEALTHCARE DECISIONS, IMPROVE HEALTHCARE DELIVERY AND OUTCOMES, USING EVIDENCE-BASED INFORMATION THAT COMES FROM RESEARCH THAT IS -- AND THIS IS A KEY CONSIDERATION -- GUIDED BY, NOT ON BEHALF OF BUT GUIDED BY PATIENTS, CAREGIVERS, AND THE BROADER HEALTHCARE COMMUNITY. IMPORTANTLY, SOMETHING VERY SMART WAS DONE WHEN PCORI WAS SET UP. IT WAS GIVEN A FIREWALL, IF YOU WILL, FROM SOME OF THE POLITICAL MASMASHNATIONS OF THE DAY. SO IT'S AN IND PENDED NON-PROFIT CORPORATION EMBEDDED WITHIN THE AFFORDABLE CARE ACT. FOR THE FORESEEABLE FUTURE ME MEASURED IN THE NEXT SEVERAL YEARS, PCORI APPEARS TO BE LARGELY INTACT BUT NO ONE EVER KNOWS HOW THE POLITICAL PERSUASIONS WILL GO FORWARD, BUT FOR THE TIME BEING, IT IS UNIQUELY INDEPENDENT, NOT ALIGNED WITH ANY OTHER GOVERNMENT ENTITY. IT IS SEPARATELY FUNDED, AND IT'S A NON-PROFIT ORGANIZATION. THIS IS WHERE PCORI BECOMES REALLY VERY RELEVANT. THIS GRAPHIC THAT WE REPLICATE IN EVERY PRESENTATION ABOUT PCORI REALLY DOES SAY IT ALL. IT STARTS WITH PATIENT ENGAGEMENT. WHAT IS IT THAT THE PATIENT WOULD LIKE TO HAVE DONE. IT THEN GOES TO PATIENT-DRIVEN RESEARCH, A VERY NOVEL CONCEPT ALIGNING RESEARCH QUESTIONS AND METHODS WITH PATIENT NEEDS, AND THEN DISSEMINATION, A PIECE THAT WE'RE STILL TRYING TO ARCHITECT, THAT IS TO SAY HOW DO WE GET THE INFORMATION TO PATIENTS AND THEIR PROVIDERS SO BETTER DECISIONS CAN BE MADE? THIS MAY BE MY FAVORITE PIECE OF PCORI, BECAUSE WE WENT THROUGH A VERY DELIBERATE PROCESS OF LISTENING TO TESTIMONY FROM PATIENT GROUPS, FROM STAKEHOLDERS, FROM DISEASE ADVOCACY GROUPS, AND IN SO DOING, WE SMOOTHED ALL THEIR COMMENTARY AND CAME UP WITH THESE FOUR QUESTIONS THAT REALLY DEFINE A VERY DIFFERENT TAKE ON DOING RESEARCH. EXPECTATIONS. GIVEN MY PERSONAL CHARACTERISTICS, CONDITIONS AND PREFERENCES, WHAT SHOULD I EXPECT WILL HAPPEN TO ME? OPTIONS. WHAT ARE MY OPTIONS AND WHAT ARE THE POTENTIAL BENEFITS AND HARMS OF THOSE OPTIONS? OUTCOMES. WHAT CAN I DO TO IMPROVE THE OUTCOMES THAT ARE MOST IMPORTANT TO ME? DECISIONS. HOW CAN CLINICIANS NND CARE AND DELIVERY SYSTEMS HELP ME MAKE THE BEST A DECISIONS ABOUT MY HEALTH AND HEALTHCARE? SO AGAIN, I'LL TAKE A VERY PERSONAL VIEW. MY FAMILY HISTORY IS UNFORTUNATELY LITTERED WITH CARDIOVASCULAR DISEASE. THERE ARE NO LONG TERM SURVIVORS IN MY EXTENDED FAMILY, EVERYBODY HAS SUCCUMB TO SOME ITERATION OF HYPERTENSION AND ITS COMPLICATIONS, EITHER HEART FAILURE, STROKE, RENAL DISEASE, MYOCARDIAL INFARCTION. AND SO DESPITE ALL OF MY EFFORTS AT LIVING A HEART HEALTHY LIFESTYLE, I TOO HAVE HYPERTENSION. SO LET'S WALK THROUGH THIS. SO WHEN MY HYPERTENSION WAS DISCOVERED, WHAT WERE MY EXPECTATIONS, MY PERSONAL CHARACTERISTICS, HOW DO WE MAKE THE DECISION ABOUT SOMEONE LIKE ME IN THIS SPACE TO KNOW WHAT I SHOULD DO? IS IT TRUE THAT EVERYBODY WITH HYPERTENSION IS THE SAME, IS PREHYPERTENSION A NON-ISSUE OR IS IT A CONCERN? THESE WERE THE QUESTIONS THAT HAD TO BE ANSWERED WHEN I DEALT WITH THE EXPECTATIONS OF CARE FOR MY OWN HYPERTENSION. WHAT ABOUT THE OPTIONS? WHAT ARE MY OPTIONS? WHAT ARE THE POTENTIAL HARMS AND BENEFITS OF THOSE OPTIONS? SO IN MY SCENARIO, I ENDED UP UNDERGOING SOME CARDIOVASCULAR TESTING TO BE SURE, TO UNDERSTAND WHAT MY OPTIONS WERE. THEN WHEN MY OPTIONS WERE CONSIDERED, WHICH DRUGS WERE APPROPRIATE FOR ME AND WHAT I DO? WHAT I DO HOPEFULLY IS HIGHLY COGNITIVE. SO MAYBE BETA-BLOCKERS WEREN'T A GOOD CHOICE FOR ME. WITBUT I CERTAINLY DIDN'T WANT TO VOID ALL DAY LONG SO DIURETICS WEREN'T VERY ATTRACTIVE. SO I WORK WITH MY PHYSICIAN TO TRY TO UNDERSTAND WHAT OPTIONS WERE BEST FOR ME. AND THEN OUTCOMES. I ONLY HAVE ONE SHOT AT THIS. IF I DO IT WRONG, TOO BAD. SO WHAT AM I REALLY HOPING FOR? THAT DIALOGUE HAD TO GO FORWARD AND FINALLY WHAT DECISION DID WE MAKE AND UPON WHAT DATA DID WE MAKE THAT DECISION? FOR THOSE THAT KNOW THE HYPERTENSION LITERATURE, I REFERRED TO THE TROPHY TRIAL WHICH LOOKED AT PATIENTS WHO WERE ABLE TO THWART THE ABILITY OR THE INCLINATION TO BECOME FRANKLY HYPERTENSIVE BY INTRODUCING A STANDARD DOSE OF AN INHIBITOR, SO THAT'S THE WAY THIS PROCESS WORKED THROUGH, BUT THIS WAS A PROCESS THAT WAS WORKED THROUGH BY A VERY INFORMED PATIENT WHO CAN ALMOST NAVIGATE IT HIM OR HERSELF. WHAT HAPPENS WHEN A PATIENT SHOWS UP WHO DOESN'T HAVE THE INSIGHT OR THE EXPERIENCE, HOW CAN WE ENSURE THAT THE PATIENT THAT ORDINARILY COMES TO AN OFFICE HAS THIS EXERCISE DUTIFULLY FULFILLED? SO THERE ARE DIFFERENT WAYS THAT WE GO ABOUT TRYING TO ADDRESS THESE QUESTIONS, BUT THEN THE SPACE OF PATIENT CENTERED OUTCOMES RESEARCH, AND THAT IS TO UNDERSTAND THE TRUE BENEFITS AND HARMS OF DECISION-MAKING, TO UNDERSTAND THE INDIVIDUAL'S PREFERENCES, TO THINK ABOUT A WIDE VARIETY OF SETTINGS AND ENVIRONMENTAL CONSIDERATIONS THAT MIGHT IMPACT THE PATIENT, AND TO INVESTIGATE WAYS TO OPTIMIZE THE OUTCOMES WHILE UNDERSTANDING HOW BEST TO CONVEY INFORMATION TO ALL INVOLVED. SLIGHT SHIFT IN GEARS. ANOTHER REQUIREMENT FOR PCORI AT THE OUTSET WAS TO SET AN AYEN AN AGENDA, BECAUSE IF IT REALLY IS RESEARCH DONE DIFFERENTLY, THEN WE OUGHT BE PURSUING A DIFFERENT SET OF QUESTIONS, WE SHOULD BE DRIVEN BY A DIFFERENT SET OF THEMES. SO THESE ARE THE FIVE THEMES THAT DRIVE PCORI. THE FIRST IS THE ASSESSMENT OF OPTIONS FOR PREVENTION, DIAGNOSIS AND TREATMENT. THE NEXT IS IMPROVING HEALTHCARE SYSTEMS. THE THIRD IS COMMUNICATION DISSEMINATION RESEARCH, THE FOURTH IS ADDRESSING DISPARITIES, AND THE FIFTH IS UNIQUELY UNDERSTANDING HOW ILL PREPARED WE ARE TO DO THIS KIND OF RESEARCH AND HOW IMPORTANT IT IS TO SUPPORT NEW RESEARCH INITIATIVES TO BETTER UNDERSTAND HOW TO ACCOMPLISH PATIENT CENTERED OUTCOMES RESEARCH AND THE METHODOLOGICAL STRATEGIES THAT ARE NECESSARY TO GET THERE. BY LAW, THERE WERE SEVERAL THINGS THAT WERE MUST-DO'S. WE MUST, IN OUR FUNDED RESEARCH, IDENTIFY THE IMPACT ON HEALTH OF THE INDIVIDUALS AND POPULATIONS BEING STUDIED. WE MUST ADDRESS GAPS IN KNOWLEDGE AND VARIATIONS IN CARE. WE ABSOLUTELY MUST BE PATIENT CENTERED. WE MUST ADHERE TO RIGOROUS RESEARCH METHODS. WE MUST IMPACT SYSTEM PERFORMANCE. WE MUST SHOW INCLUSIVENESS OF DIFFERENT POPULATIONS. WE MUST DEMONSTRATE THE POTENTIAL TO INFLUENCE DECISION-MAKING AND EXERCISE EFFICIENT USE OF RESEARCH RESOURCES. THINK ABOUT THIS FOR A MOMENT. IF YOU THINK ABOUT THE CONVENTIONAL BOOK OF BUSINESS THAT QUALIFIES AS CLINICAL RESEARCH, CLINICAL TRIALS, PARTICULARLY CLINICAL TRIALS SUPPORTED BY INDUSTRY, HOW MANY OF THESE REQUIREMENTS DO YOU THINK ARE MET? VERY FEW, IN ANY. SO ANOTHER FUNDAMENTAL WAY IN WHICH PATIENT CENTERED OUTCOMES RESEARCH HAS SUPPORTED BY PCORI IS UNIQUELY DIFFERENT. SO IF WE EXTEND OUR CONVERSATION ABOUT WHAT'S DIFFERENT, THINK THE KEY CONSIDERATION IS THE PATIENT ENGAGEMENT AND ENGAGING THE STAKEHOLDERS. SO ALL OF WHAT YOU SEE BEFORE YOU DEFINE WAYS IN WHICH WE BELIEVE THAT THAT ENGAGEMENT PROCESS GIVES US A CHANCE TO DO SOMETHING VERY DIFFERENT. THE DISSEMINATION PLANS, THE IMPLEMENTATION PLANS, THE METHODOLOGY OF IT WE USE, AND THE WAY IN WHICH WE ENGAGE THE GENERAL COMMUNITY, NOT JUST THE RESEARCH COMMUNITY. THIS IS A PHENOMENAL LIST THAT I THINK REALLY TESTIFIES TO WHAT'S VERY DIFFERENT ABOUT PATIENT CENTERED RESEARCH. IF YOU LOOK AT STAKEHOLDERS, HOW MANY TIMES DO WE TALK ABOUT STAKEHOLDERS EVEN IN A LARGE FORMAT, NHLBI SUPPORTED TRIELTS, I KNOW NHLBI BETTER THAN THE OTHER INSTITUTES. HOW FREQUENTLY DO WE DO THIS? PATIENTS, NON-PROFESSIONAL CAREGIVERS, CLINICIANS OF ALL ITERATIONS, PATIENT ADVOCACY GROUPS, COMMUNITY GROUPS, RESEARCHERS, POLICY MAKERS, INSTITUTIONS, INCLUDING PURCHASERS, PAYORS AND INDUSTRY. THAT'S A VERY DIFFERENT GROUP OF PEOPLE AROUND THE TABLE, INTENDING, AGAIN, TO SUPPORT A VERY DIFFERENT KIND OF RESEARCH. WHAT'S THE ROLE? WELL, ROLE NUMBER ONE IS THAT THE PATIENTS AND THEIR STAKEHOLDERS HAVE PARTICIPATED IN GENERATING THE ACTUAL QUESTION. YOU DON'T GO TO THE PATIENT GROUPS AFTER YOU'VE DESIGNED YOUR PROTOCOL AND SAY, HEY, WOULD YOU LIKE FOR THIS TO BE DONE. IT ACTUALLY IS AN UP FRONT A PRIORI INCLUSION AND WHAT ARE THE QUESTIONS THAT NEED TO BE RAISED. DEFINING THE CENTRAL CHARACTERISTICS OF THE STUDY, YOU MIGHT SAY DO PATIENTS HAVE THE EXPERTISE TO DO THIS, REMARKABLY THE ANSWER IS YES, THEY ARE ABLE TO PARTICIPATE IN DISCUSSIONS ABOUT WHO SHOULD BE STUDIED, WHAT THE COMPARATORS MIGHT BE AND TH THE OUTCOMES, MONITORING THE STUDY OUT COME, CONDUCT AND PROGRESS, AND ESPECIALLY THE RESULTS. SO HOW WILL PCORI ACCOMPLISH ITS WORK? SO THIS VERY SIMPLE DIAGRAM REALLY DISTILLS A LOT OF DISCUSSIONS AND TELLS US WHAT IT IS THAT WILL HAPPEN. IT'S OSTENSIBLY A DESCRIPTION OF HOW WE PLAN TO MEANINGFULLY USE AND HOW WE HAVE BEEN USING ENGAGEMENT AS A MEANS TO DO RIGOROUS RESEARCH. SO IT STARTS WITH NUMBER ONE, WHERE THERE ARE ADVISORY PANELS THAT HELP US IDENTIFY AREAS OF CONCERN, CURIOSITY, ENTRANCE FROM THE GROUND UP COMING FROM THE PAISH STAKEHOLDER COMMUNITY. THESE IDEAS ARE EMBEDDED BY PCORI STAFF. AND WHAT HAPPENS THEN IS THAT A NUMBER OF IDEAS GO FORWARD, BUT IN GOING FORWARD, THEY ARE POPULATED BY EVIDENCE REVIEWS THAT ARE CARRIED OUT BY CONTRACT WITH DIFFERENT PROFESSIONAL ENTITIES. VERY CLEAR HOW BEST TO FORMULATE THESE QUESTIONS, THERE IS A PRIORITIZATION THAT OCCURS, AGAIN, INTERACTING WITH AN ADVISORY PANEL TO SET THE STAGE FOR WHAT'S MOST POSH IMPORTANT, AND THEN THERE IS A PCORI BOARD PROCESS THAT LOOKS AT THE ENTIRETY OF THE PROCESS TO THIS POINT AND MAKES A DECISION ABOUT WHAT GOES FORWARD, AND THEN FINALLY THERE IS A FUNDING ANNOUNCEMENT TO WHICH THERE HAS SO FAR BEEN A ROBUST RESPONSE TO EACH ANNOUNCEMENT THAT WE'VE GENERATED. SO AGAIN, THINK ABOUT THE MODEL THAT USUALLY TAKES PLACE TO COME UP WITH RFAs, THESE ARE PFAs, PCORI FUNDING ANNOUNCEMENTS, YOU CAN SEE THE PATIENT STAKEHOLDER ENGAGEMENT, AND THAT'S THE KEYWORD, FROM THE BEGINNING THROUGHOUT. THESE ADVISORY PANELS ARE VERY INTRIGUING AND I'VE HAD THE OPPORTUNITY TO WORK WITH THE ADDRESSING DISPARITIES PANEL AND IT'S A GREAT COLLECTION OF INDIVIDUALS THAT ARE VERY PASSIONATE ABOUT THE CAUSES THAT WE ALL ARE ADDRESSING. IT ALLOWS A MULTIDISCIPLINARY GROUP TO COME TOGETHER AND BRING THEIR DIFFERENT DOMAINS OF INFORMATION ALL IN ONE SETTING TO REALLY HELP PCORI REFINE THE IDEAS AND BETTER ACHIEVE OUR GOALS, AND ONCE AGAIN IT HELPS IN PRIORITIZING THE CONCEPTS IN MONITORING THE RESEARCH AND CONDUCTING THE TRIALS. THERE ARE FOUR PANELS THAT HAVE BEEN PUT TOGETHER TO ADDRESS FOUR OF THE FIVE DOMAINS OF STRATEGIES THAT DEFINE PCORI. SO HOW DO WE REVIEW EACH PROPOSAL? I FIND THIS FASCINATING. EACH PROPOSAL IN RESPONSE TO PCORI FUNDING ANNOUNCEMENT AT STEP ONE IS REVIEWED BY A PATIENT. THINK ABOUT THAT. HAVING A PATIENT REVIEW A RESPONSE TO, IN OUR CASE, A PFA, THAT REALLY DEFINES SOMETHING VERY DIFFERENT. IT GOES THROUGH A TWO-STEP PROCESS, IT ALSO LOOKS AT THE SCIENTIFIC INTEGRITY, SCORES ARE DETERMINED, AND THEN RECOMMENDATIONS ARE MADE BY THE PANELS THAT ADJUDICATE THE APPLICATIONS, AND BY THE BOARD OF GOVERNORS, AGAIN, AND ONE THING THAT IS DIFFERENT THAT WE ARE DEPLOYING IS THAT EVEN AFTER THE AWARD IS MADE, THERE IS WHAT WE ARE CALLING ACTIVE PORTFOLIO MANAGEMENT. WHERE WE ARE WORKING WITH THE INVESTIGATORS TO HELP I'D INERTIA POINTS, FRICTION POINTS, BEST PRACTICES, SO WE CAN OPTIMIZE THE OUTCOME FROM THIS PROCESS. IT'S IMPORTANT TO KNOW THAT THE REVIEWERS COME TO THE TABLE WITH UNIQUELY DIFFERENT SETS OF RESEARCH EXPERTISE, AND AGAIN, PATIENT ENGAGEMENT ACTUALLY IS INVOLVED IN THE REVIEW PROCESS. FOR PRIORITIES ONE THROUGH FOUR, THAT IS ALL EXCEPT THE METHODOLOGY CONSIDERATIONS, THESE ARE THE ISSUES THAT ARE IMPORTANT. IMPACT OF THE CONDITION ON HEALTH, POTENTIAL FOR IMPROVING OUTCOMES, TECHNICAL MERIT, PATIENT CENTEREDNESS, AND PATIENT AND STAKEHOLDER ENGAGEMENT. I MEAN, UNIQUELY DIFFERENT, THIS IS A BIG PART OF THE STRATEGY USED TO ACCOMPLISH THE WORK THAT WE'RE TRYING TO DO. A DIFFERENT SET OF COMPONENTS FOR THE FIFTH PRIORITY THAT IS LARGELY LOOKING AT METHODOLOGY. LET ME GIVE YOU AN EXAMPLE OF THE METHODOLOGY BECAUSE THIS IS WHERE MY INVOLVEMENT HAS BEEN MOST NOTABLE. THIS IS THE FIRST ITERATION OF OUR REPORT WITHIN THE LAST SIX WEEKS, THE FINAL ITERATION OF THE REPORT HAS BEEN RELEASED. I WILL SHARE WITH YOU THAT THERE HAS BEEN GREAT ENTHUSIASM ABOUT THE NOTION OF DEVELOPING GUIDELINES, IF YOU WILL, FOR HOW THIS KIND OF RESEARCH THAT IS THE CANDIDATES OF COMPARATIVE EFFECTIVENESS SHOULD BE DONE AND THESE SEVERAL PUBLICATIONS HAVE ACCEPTED COMMENTARY FROM THE PCORI GROUP, PARTICULARLY THE METHODOLOGY COMMITTEE, TO PROMULGATE THE KINDS OF VIEWPOINTS THAT WE'VE DEVELOPED. THIS IS ONE OF THOSE THAT APPEARED IN THE NEW ENGLAND JOURNAL OF MEDICINE. THIS IS THE OUTLINE OF THE METHODOLOGY MANUAL. WE GO THROUGH A PROCESS THAT LOOKS AT THE METHOD, GOES THROUGH AN INFORMATION GATHERING SCHEMA THAT AGAIN SOMETIMES WILL OUTSOURCE TO OTHERS, THEN TO AN INTERNAL REVIEW WITHIN THE METHODOLOGY COMMITTEE, THE REPORT WAS GENERATED, EDITED, IN SOME CASES REWRITTEN AND HAS SINCE BEEN RELEASED. 17 REPORTS ADDRESSING 15 TOPICS. THESE ARE THE TOPICS THAT APPEAR IN THE REPORT, ALL OF WHICH IDENTIFY QUESTIONS AND OPPORTUNITIES AND REFERENCE POINTS FOR DIFFERENT APPROACHES IN DOING THIS KIND OF RESEARCH. FOR EXAMPLE, THE CONDUCT OF REGISTRY STUDIES, PREVENTION AND HANDLING OF MISSINGNESS AND MISSING DATA, ADDRESSING HETEROGENEITY IS A PROFOUNDLY IMPORTANT CONSIDERATION WHEN ONE IS THINKING ABOUT PATIENT CENTERED RESEARCH. THIS IS THE ONE IN WHICH I WAS INVOLVED IN INVOLVING PATIENTS IN TOPIC GENERATION, AND I'LL DEVELOP THAT FOR YOU SO YOU CAN SEE A GLIMPSE OF WHAT IT IS METHOD LOGICALLY THAT'S INVOLVED IN THIS KIND OF RESEARCH. WE RELIED ON EXPERTISE FROM TWO COCONSULTANTS IN THE U.K. TO BRING TO BEAR STRATEGIES THAT HAVE BEEN BENEFICIAL THERE. SO OUR INTENT WAS TO LOOK AT THE KINDS OF ENGAGEMENT STRATEGIES THAT HAVE BEEN AVAILABLE TO SUMMARIZE QUALITATIVE RESEARCH APPROACHES THAT MIGHT FACILITATE ENGAGEMENT, TO LOOK AT TYPES OF SCIENTIFIC ENGAGEMENT DATA AS A PART OF THE PROCESS AND PROPOSE THE PROCESS OF ENGAGEMENT. THIS, I THINK, IS VERY INFORMATIVE BECAUSE IT IS A SCHEMATIC THAT IDENTIFIES A DYNAMIC THAT STARTS WITH MINIMAL PUBLIC INVOLVEMENT TO PUBLIC CONTROL. MINIMAL PUBLIC INVOLVEMENT ARGUABLY IS HOW WE'VE DONE RESEARCH IN THE PAST. WHERE THE RESEARCH IS THE DRIVER OF THE PROJECT, RESEARCHERS PROVIDE INFORMATION INVITING THE PUBLIC FOR CONSULTATIONS AND COLLABORATIONS BUT IT'S ON THE TERMS OF THE RESEARCHER. YOU GO FROM MINIMAL PUBLIC INVOLVEMENT TO CONSULTATION WHERE THE PUBLIC IS ENCOURAGED TO PARTICIPATE, TO PROVIDE PERCEPTIONS AND IDEAS, TO COLLABORATION WHERE THE PUBLIC IS A PART OF BEING AN ACTIVE PARTNER, AND THEN FINALLY TO CONTROL WHERE THE PUBLIC IS A DRIVER OF THE RESEARCH PROJECTS. THESE ARE FOUR VERY, VERY DIFFERENT THEMES AND UNTIL WE SAW THIS APPROACH, NONE OF US REALLY THOUGHT ABOUT DOING CLINICAL RESEARCH DIFFERENTLY THAN NUMBER ONE. IF YOU THEN THINK ABOUT PUBLIC ENGAGEMENT AS A RESEARCH METHODOLOGY IT ITSELF, IT TURNS OUT THAT THERE ARE QUALITATIVE RESEARCH STRATEGIES TO HELP US, AND HERE THEY ARE. THE FIRST ONE IS IF HE NO, PHENOMENONOLOGY, WHEREAS CULTURAL PHENOMENON THAT HELP POP LACE LATHE THESE THOUGHTS. THERE'S GROUNDED THEORY WHICH IS VERY INTRIGUING BUT IT'S A STUDY OF THEORY THROUGH ANALYSIS OF DATA, LOOKING AT THE FEEDBACK FROM INDIVIDUALS AND COMING UP WITH A SEMI QUANTITATIVE APPROACH TO IDENTIFY WHAT IS MOST IMPORTANT, THEN THERE'S ACTION RESEARCH, WHICH IS A STUDY OF FOCUSED PROBLEM SOLVING AND OF COURSE WE ALL ARE FAMILIAR WITH SURVEYS. SO HAD SOMEONE COME TO YOU AND EMPIRICALLY QUERIED HOW SHOULD YOU ENGAGE PATIENTS, YOU SAY DO A SURVEY, RAISE THE QUESTIONS. BUT IT TURNS OUT THAT THERE ARE MULTIPLE DOMAINS WHERE ONE MIGHT GET VERY DIFFERENT VIEWPOINTS WHEN YOU ENGAGE PATIENTS. THE WHOLE PROCESS GOES FROM THIS CONSULTATIVE PROCESS TO THE COLLABORATIVE PROCESS, WHERE ONE FINALLY GETS TO THE PUBLIC PHYSICIAN PARTNERSHIPS. WITH THAT IN MIND, IT ALLOWS ONE TO GENERATE A DATASET THAT IS QUALITATIVE BUT CAPTURES THE INPUT FROM PATIENTS AND THEN COMPARTMENTALIZES IT INTO THEMES THAT CAN THEN BECOME THE SOURCE FOR INVESTIGATION. SO AGAIN, ANOTHER SCHEMATIC. STARTING HERE, WHERE INDIVIDUALS ARE INVITED TO PARTICIPATE IN A PUBLICLY NICHE PARTNERSHIP, WE HAVE GROUPS THAT GENERATE TOPICS BY CONSULTING WITH THEIR OWN PEER GROUP. EACH GROUP THEN CATEGORIZES EMERGING RESEARCH THEMES, PATIENT-CLINICIAN WORK GROUP AND CREATES A CONSENSUS LIST OF QUESTIONS. THAT IS THEN LEFT FOR OPEN DISCUSSION, REVIEW AND COMMENT IN THE TRANSPARENT PROCESS, AND THEN THAT INFORMS PCORI TO BEGIN THE RESEARCH PRIORITIZATION IN FUNDING PROGRAM AND ONE BEGINS TO LOOK AT THE IMPACT OF THESE STUDIES AND THEN THESE ISSUES ARE CATALYZED BY SYSTEMIC REVIEWS, BY ANALYSES OF HEALTH DISPARITIES AND BY HEALTH EXPERIENCE RESEARCH, AND SO THIS ENDS UP BEING A VERY DIFFERENT MODEL THAN WE'VE EVER TRIED BEFORE TO ACCOMPLISH CLINICAL RESEARCH AND IN LARGE MEASURE, THIS IS WHAT OUR ADVISORY PANEL LOOKS LIKE THAT IS INFORMED BY THIS BACKGROUND EXPERIENCE OF DIVING DEEPLY AND TO UNDERSTANDING HOW OTHERS ARE DOING THIS ENGAGEMENT RESEARCH. HERE IS I THINK THE MOST IMPORTANT THING, WHAT HAS PCORI DONE. IT'S BEEN PRETTY IMPRESSIVE. IF ONE LOOKS AT, AGAIN, THOSE BIG DOMAINS, LESS THE ISSUE OF METHODOLOGY AND STARTS WITH IMPROVING HEALTHCARE SYSTEMS, BY HEALTH TOPIC, YOU CAN SEE CARDIOVASCULAR DISEASE AND INCREMENTAL DISORDERS, CANCER, NERVOUS SYSTEM, BUT THERE HAVE BEEN 32 AWARDS, ALMOST $59 MILLION FOR ISSUES THAT ADDRESS DECISION-MAKING IN HEALTHCARE SYSTEMS. IF ONE LOOKS AT COMMUNICATION AND DISSEMINATION RESEARCH, THERE HAVE BEEN 20 AWARDS OVER $33 MILLION, ALONG THE LINES OF MESSAGING FOR CHILDREN, MESSAGING FOR THE E ELDERLY, MESSAGING FOR DIFFERENT HIGH RISK GROUPS, RACIAL MINORITIES, MESSAGING ACCORDING TO RURAL DOMAINS AND SOCIOECONOMIC DOMAINS. SO AGAIN ACCOMPLISHING ONE OF OUR BIG GOALS, COMMUNICATION DISSEMINATION RESEARCH. WHAT ABOUT ADDRESSING DISPARITY, SOMETHING VERY IMPORTANT TO MANY OF US. 23 AWARDS OVER $38 MILLION, AGAIN, CARDIOVASCULAR AND INCREMENTAL, CANCER, OTHER RELATED DISEASES, AND THEN SUBSTANCE ABUSE ISSUES. AS WE GO FORWARD, THERE'S SOME VERY EXCITING INFORMATION THAT'S RIGHT ON THE THRESHOLD. JUST YESTERDAY, WE ANNOUNCED THE AWARDS FOR THE TREATMENT OF ASTHMA IN AFRICAN-AMERICAN CHILDREN. A SIGNIFICANT INVESTMENT THAT WE BELIEVE WILL ANSWER SOME IMPORTANT QUESTIONS. I WILL TELL YOU ABOUT ANOTHER HUGE OPPORTUNITY THAT WAS ANNOUNCED JUST YESTERDAY. WHAT'S UNDER CONSIDERATION IS AN EFFORT TO ADDRESS UTERINE FIBROIDS, ANOTHER EFFORT TO ADDRESS OBESITY, TRANSITIONS IN CARE, AND TREATMENT OPTIONS FOR BACK PAY. IF YOU THINK ABOUT THIS, THIS IS THE ORDINARY STUFF. THIS IS THE STUFF THAT DISRUPTS EVERYBODY'S DAY. FIBROIDS, BACK PAIN, ASTHMA, TRANSITION OF CARE, OBESITY. THESE ARE THE KINDS OF ISSUES THAT WE'RE USING A PATIENT ENGAGEMENT PROCESS TO IDENTIFY NEW WAYS TO DO THE RESEARCH, NEW WAYS TO ANSWER THE QUESTIONS. THE THINGS THAT PROBABLY IS MOST CENTRAL TO TOPICAL DISCUSSIONS TODAY IS THE DEVELOPMENT OF THIS NATIONAL PATIENT CENTERED CLINICAL RESEARCH NETWORK, AND IT IS KNOWN ON THE WEB AS PCO PCORNET THESE AWARDS WERE ANNOUNCED JUST YESTERDAY. IT IS A REMARKABLE OPPORTUNITY THAT WE'VE NEVER HAD BEEN. WHERE BRINGING TOGETHER MULTIPLE DIFFERENT COMPONENTS OF DATA ACQUISITION INTO A SINGLE TENT TO EQUIP US WITH AN IDEAL INFRASTRUCTURE WHERE PCORI IS THE MOTIVE SO IT LOOKS AT LONGITUDINAL DATA CAPTURE, PATIENT REPORTED OUTCOMES, ACTIVE PATIENT AND CLINICAL ENGAGEMENT AND THE GOVERNANCE OF DATA USE, LINKAGE TO HEALTH SYSTEMS FOR RAPID DISSEMINATION. RANDOMIZATION AT INDIVIDUAL AND CLUSTER LEVELS. ALL OF THESE COMPONENTS ARE BEING BROUGHT UNDER THE SAME TENT BY CREATING THESE NETWORKS. THE CLINICAL DATA RESEARCH NETWORKS ARE IN FACT SYSTEM BASED NETWORKS WHICH WILL TAKE ADVANTAGE OF CURRENT AND CONTEMPORARY ELECTRONIC HEALTH RECORDS TO REALLY HELP US IDENTIFY A RESPONSE TO THE QUESTIONS I RAISED EARLIER, BUT WHAT'S REALLY REMARKABLE IS THIS PPRN OR THE PATIENT POWERED RESEARCH NETWORKS, RESEARCH NETWORKS THAT GERMINATE FROM PATIENT ADVOCACY GROUPS TO DISEASE ADVOCACY GROUPS, SOMETHING WE'VE NEVER DONE BEFORE, AND THEN EXPERIENCE COORDINATING CENTERS, ACTUALLY TWO CENTERS, THAT WILL DO THE WORK NECESSARY TO AMAL GA MATE ANALOGY MAT E THE TWO DIFFERENT INITIATIVES, ACADEMIC INSTITUTIONS, IF YOU WILL, AND THIS VERY NOVEL PATIENT NETWORK. IT LOOKS SOMETHING LIKE THIS, SCIENTIFIC ADVISORY BOARD, STEERING COMMITTEE WITH AWAR DES AND MULTIPLE STAKEHOLDERS THAT OVERSEE DATA, SPECIAL EXPERTS FOR PARTICULAR TOPICS, AND THEN THE CONSTITUTION OF THE PATIENT POWERED NETWORKS AND THE DATA NETWORKS ALL FITTING INTO A COORDINATING CENTER. IF YOU JUST LOOK AT THIS, IF YOU'RE STILL ENGAGED WITH ME, WE'VE NEVER HAD THIS KIND OF CLINICAL RESEARCH INFRASTRUCTURE. THE OPPORTUNITIES WE HAVE NOW TO ANSWER UNIQUE QUESTIONS IS -- THE OPPORTUNITY IS EXTRAORDINARY, AND WE NEED TO TAKE FULL ADVANTAGE OF THIS. THESE ARE THE PEOPLE AND THE ENTITIES THAT CAN PARTICIPATE IN THIS KIND OF EFFORT, AND THIS IS WHERE WE ARE AS OF YESTERDAY. $93.5 MILLION WAS ANNOUNCED TO SUPPORT IT. 18 OF THE AWARDS WERE TO PATIENT-POWERED RESEARCH NETWORKS, 11 WERE TO CLINICAL DATA RESEARCH NETWORKS. BEYOND THIS $92.5 MILLION ANNOUNCED YESTERDAY, THE AGGREGATE ANNOUNCED YESTERDAY WAS $191 MILLION FOR A TOTAL OF 82 PROJECTS, SO SOME ADDITIONAL 50 PROJECTS THAT ARE ANSWERING SPECIFIC QUESTIONS THAT RELATE TO PATIENT CENTERED OUTCOMES RESEARCH. THIS IS A SMALL PIECE COMPARED TO WHAT'S TYPICALLY SUPPORTED BY THE NIH, BUT IT'S A UNIQUE PIECE THAT'S ADDRESSING VERY DIFFERENT, VERY IMPORTANT QUESTIONS. THE NEXT THING UP TO BAT IS DOING MORE WORK ON DISSEMINATION IMPLEMENTATION. I WANT TO BEGIN TO WRAP THIS UP BY GOING FROM THE ABSTRACT AND THE PROCESS ISSUES TO SOMETHING MORE SUBSTANTIVE, TO SHOW YOU THE KINDS OF THINGS THAT HAVE BEEN FUNDED. SO WITHIN THE DOMAIN OF THE ASSESSMENT AND PREVENTION DIAGNOSIS AND TREATMENT OPTIONS, THERE WAS THE CHEST PAIN CHOICE TRIAL. I PULLED THIS BECAUSE I THOUGHT IT WAS VERY NOVEL. IT IN FACT IS A WEB BASED TOOL TO HELP PATIENTS BETTER UNDERSTAND THE TESTS THAT WILL BE REQUIRED TO DETERMINE THE CAUSE OF THEIR CHEST PAIN, AND TO GIVE THEM AN ASSESSMENT ON AN INDIVIDUALIZED BASIS OF THE OUTCOMES THEY CAN EXPECT FOR THEIR OWN PRESENTATION WITH A HEART ATTACK. A VERY DIFFERENT MODEL. THIS IN THE SAME DOMAIN, PREVENTING VENUS THROMBOEMBOLISM, IS A PATIENT-LED HEALTH EDUCATED MODERATED TRAINING SESSION WHERE NURSES WILL ENHANCE THE COMMUNICATION ABOUT VENUS THROMBOEMBOLISM WITH PATIENTS. WE'VE NEVER HAD SOMETHING LIKE THIS BEFORE. THE OVARIAN CANCER PATIENT CENTER AID, THIS IS YET ANOTHER OPPORTUNITY TO ENGAGE PATIENTS IN DECISIONS ABOUT SOMETHING INCREDIBLY IMPORTANT. WHAT ARE THE TRADEOFFS AND THE KINDS OF THERAPY FOR YOUR VARYING CANCER AS A FUNCTION OF QUALITY OF LIFE? EACH OF US HAS A DIFFERENT VALUE ON DURATION OF LIFE VERSUS QUALITY OF LIFE. THIS RESEARCH IS INTENDED TO DEVELOP A TOOL TO HELP PATIENTS NAVIGATE THESE TRADEOFFS, INCREDIBLY IMPORTANT, AND THERE'S NO OTHER CIRCUMSTANCE WHERE THAT KIND OF O RESEARCH WOULD BE DONE. THIS MAY BE MY FAVORITE PCORI-FUNDED PROJECT FROM THE FIRST WAVE. THIS IS IMPROVING HEALTHCARE SYSTEMS, THE FAMILY VOICE STUDY. A RANDOMIZED TRIAL OF FAMILY NAVIGATORS VERSUS USUAL CARE FOR YOUNG CHILDREN TREA TREATED WITH ANTIPSYCHOTIC MEDICATION. THOSE OF YOU THAT KEEP UP WITH NEWSY ITEMS IN MEDICINE KNOW THIS HAS BEEN A VERY PRICKLY AREA BECAUSE WE REALLY HAVE NO EVIDENCE BASE, BUT WE'VE HAD COMPANIES AND THOUGHT LEADERS WHO HAVE ADVOCATED THE USE OF THESE COMPOUNDS AT CONSIDERABLE PERSONAL GAIN AND FOR THE COMPANY'S CONSIDERABLE COMMERCIAL ADVANTAGE TO TREAT CHILDREN THAT HAVE THESE DISEASES. SO WHAT THIS STUDY DOES IS TO PARTNER WITH PARENTS AND FAMILY ADVOCATES CHILD SERVING ORGANIZATIONS WITH THIS FAMILY NAVIGATOR, BUT WHAT'S UNIQUE IS THAT THE NAVIGATOR IS A PERSON WHO HAS CARED FOR THEIR OWN CHILD WITH MENTAL ILLNESS. IMAGINE THE IMPACT THAT NAVIGATOR CAN HAVE ON FAMILIES NEW TO THIS EQUATION. I THINK IT'S VERY NOVEL RESEARCH AND A KIND OF EXEMPLARY KIND OF PATIENT CENTERED RESEARCH THAT'S BEING DONE. YET ANOTHER OPPORTUNITY HERE IS THROUGH THE TRANSITION OF CARE EXPERIENCE, TO SPECIFICALLY ADDRESS 30-DAY RIYADH MISSION RATES. IT'S VERY TOPICAL. AND THEN LOOKING AT COMMUNICATION DISSEMINATION RESEARCH, THIS IS ANOTHER ENTITY THAT IS ORGANIZING THE MESSAGING ACCORDING TO ZIP CODE, SO YOU CAN DEVELOP UNIQUE MESSAGING THAT IS APPROPRIATE FOR THE CHARACTERISTICS OF PATIENTS THAT LIVE IN A PARTICULAR GEOCODE, WHICH I THINK IS QUITE IMPORTANT. AND HERE IS PROBABLY MY SECOND FAVORITE ONE. THIS IS AN APPALACHIAN RISK STUDY, WHERE CULTURALLY APPROPRIATE MESSAGING IS NOT ONLY BEING DEVELOPED FOR THE AP APPALACHIAN COMMUNITY BUT IS BEING DISSEMINATED BY THOSE IN THE COMMUNITY AFTER UNDERGOING THEIR REQUISITE TRAINING. WE'VE NEVER DONE ANYTHING LIKE THIS BEFORE, AND IF THIS IS SUCCESSFUL, THIS IS A SMALL PRICE TO PAY FOR A COMMUNITY THAT BEARS THE ABSOLUTE HIGHEST RISK OF CARDIOVASCULAR DISEASE IN THE COUNTRY. SO IN RESPONSE TO WHAT HAS PCORI DONE, THIS IS WHAT WE'VE DONE. SINCE INCEPTION, 279 PROJECTS, $464 MILLION. IF YOU THINK ABOUT THIS, WE WEPT WENT FROM ZERO TO THIS POINT IN THREE YEARS. QUICKLY I'LL TELL YOU A SMALL VIGNETTE, I WAS ON A TRAIN IN DECEMBER OF 2010 TRAVELING FROM D.C. TO NEW YORK, TO A CME FUNCTION DURING MY TENURE AS PRESIDENT. SO I WAS GOING DAY TO DAY DOING DIFFERENT THINGS FOR THE AMERICAN HEART ASSOCIATION. MY OFFICE CALLED ME, I ANSWERED ON THE TRAIN AND MY ASSISTANT SAID, THE GENERAL ACCOUNTING OFFICE IS ON THE PHONE. I SAID WHO? THE GENERAL ACCOUNTING OFFICE FROM THE WHITE HOUSE. AND FOR A MOMENT, YOU'D THINK, I HAVE EITHER DONE SOMETHING PRETTY EXTRAORDINARY OR I'M IN THE DEEPEST DOODOO I HAVE EVER BEEN IN IN MY ENTIRE LIFE. SO I GET ON THE PHONE AND IT WAS AN INVITATION TO JOIN PCORI. AND I MEAN, I WAS NUMB FOR THE REST OF THE TRAIN TRIP, BUT I BRING THAT STORY UP BECAUSE THAT WAS DECEMBER 2010. THIS IS DECEMBER 2013, IN 3 YEARS, WE BUILT AN INFRASTRUCTURE, WE'VE ENGAGED PATIENT GROUPS, WE SET A METHODOLOGY, WE DEFINED ADMISSION AND AWARDED NEARLY A HALF BILLION DOLLARS ON ALMOST 300 PROJECTS THAT ARE IN EVOLUTION. THINK ABOUT THIS. IF ONLY 10% OF THESE PROJECTS YIELD AN ACTIONABLE ITEM THAT IMPACTS HUMAN HEALTH, WE WILL ALREADY HAVE HAD A HUGE IMPACT. AND IF WE REALIZE THE ADVANTAGE OF HAVING BUILT THESE RESEARCH NETWORKS THAT WERE ANNOUNCED YESTERDAY, WE CAN ANSWER QUESTION, WE CAN EXPLORE CONCEPTS, WE CAN CONTRIBUTE TO THE BENEFIT OF HEALTH LIKE WE'VE NEVER CONSIDERED BEFORE. AND SO FOR ALL OF THOSE WHO SAY WHAT IS PCORI, WHAT I TRIED TO DO IS TO TELL YOU THAT IT'S VERY DIFFERENT. IT'S RESEARCH DONE DIFFERENTLY, AND IT'S ALL ABOUT PATIENT ENGAGEMENT, AND WE HAVE SOME VERY UNIQUE STRATEGIES TO ACCOMPLISH OUR WORK AND WE'RE WELL ON OUR WAY TO MAKING A DIFFERENCE IN HUMAN HEALTH AND DISEASE. THE ADMINISTRATIVE LEADERSHIP A IS AS YOU SEE, JOE SELBY BEING THE EXECUTIVE DIRECTOR, THIS IS THE COMMITTEE ON WHICH I SERVE, THE METHODOLOGY COMMITTEE. YOU CAN GO ONLINE AND YOU CAN SEE A SIMILAR PROFILE OF THE BOARD OF GOVERNORS. THIS IS OUR WEBSITE. YOU CAN FIND US ONLINE. WE'RE ALL OVER THE PLACE. THANK YOU FOR THE OPPORTUNITY TO VISIT WITH YOU TODAY. IT'S BEEN A TERRIFIC DAY. I'VE BEEN ABLE TO ENGAGE WITH FRIENDS, HAVE GREAT CONVERSATIONS WITH MANY OF YOU, SEE THE YOUNGER PEOPLE, MIKE, IT'S GOOD TO SEE YOU HERE, AND SPUR THEM, HOPEFULLY INSPIRE THEM TO DO SOME UNIQUE THINGS, AND BEING AMONGST FRIENDS AND TO TALK ABOUT SOMETHING THAT'S IMPORTANT TO ME HAS BEEN A REALLY GREAT PRIVILEGE AND SO THANK YOU FOR YOUR TIME AND ATTENTION. [APPLAUSE] >> THANK YOU, CLYDE, FOR THAT TERRIFIC AND PROVOCATIVE TALK, INVITE THOSE IN THE AUDIENCE TO COME TO THE MICROPHONE AND IDENTIFY YOURSELF IF YOU HAVE ANY QUESTIONS, WE HAVE TIME TO ENTERTAIN A FEW BEFORE THE RECEPTION. IF I MIGHT SORT OF KICK THINGS OFF, YOU DESCRIBED THE FACT THAT HAD THIS WAS RESEARCH DONE DIFFERENTLY, AND THE NOTION THAT MIGHT ACTUALLY BE AN OPPORTUNITY FOR SYNERGY, AND COMPLIMENTARY SORT OF SPACE. GIVEN THAT YOU'VE BEEN ON ACD, YOU'RE VERY MUCH FAMILIAR WITH THE NIH PORTFOLIO, THE NIH APPROACH, AND NOW PCORI. WHERE DO YOU SEE THE INTERSECTIONS? >> I'LL GIVE YOU ONE VERY BRIEF ANSWER. BIG DATA. TO THE EXTENT THAT THIS IS MORE THAN RHETORIC, WE HAVE CREATED A UNIQUE INFRASTRUCTURE TO ACCOMPLISH RESEARCH USING BIG DATABASES, CONTEMPORARY DATABASES, NEWLY AMACED DATABASES, AND I CAN EXTEND IT ONE STEP FURTHER, THIS CONCEPT OF LARGE PRAGUE NATICK CLINICAL PRAGMATIC CLINICAL TRIALS, THIS WAS THE TOPIC OF CONVERSATION. MIKE WROTE ONE OF THE MOST BRILLIANT EDITORIALS WE'VE EVER READ ABOUT A DISRUPTIVE NEW APPROACH TO DOING RESEARCH WHERE WE CAN USE ALREADY EXTAUNT REGISTRIES THAT CAPTURE THE SIMPLE QUESTIONS QUICKLY WITHOUT THE TIME FOR RECRUITMENT. SO I THINK IT IS UPON US NOW TO SAY WE HAVE BUILT, AND IF WE CAN JUST DRILL DOWN TO THE RIGHT QUESTION, WE SHOULD BE ABLE TO GET ANSWERS QUICKER, WITH LESS MONEY, THAT ARE MORE RELEVANT THAN WE'VE EVER BEEN ABLE TO DO BEFORE. YES, SIR. >> CONGRATULATIONS FOR -- THE PRACTICE OF MEDICINE AND PARTICIPATION OF THE PATIENTS ACTIVELY, YOU NEED REASONABLE HEALTHCARE LITERACY, AND THIS IS WHAT IS MISSING, I THINK, IN SOME OF THE IDEAS WHERE SOME OF THE CONCERNS HAVE BEEN RAISED, AND SO I DID NOT SEE MUCH IN THE WAY OF CONVEYING THE MESSAGE TO THE PAR NER SHIP AN PATIENTS TO BE A BETTER ADVOCATE AND BETTER PRACTITIONER IN COLLABORATION WITH THE PHYSICIANS THEY ARE INTERACTING WITH. >> SO AS I UNDERSTAND YOUR QUESTION, I THINK YOU HAVE CORRECTLY IDENTIFIED THAT THE MISSING COMPONENT IN THIS PATIENT CENTEREDNESS APPROACH IS TO HAVE A CHAMPION, A LEADER, SOMEONE THAT CAN ALIGN THE HEALTHCARE COMMUNITY AND THE PATIENTS TO START THINKING ABOUT THE DIFFERENTNESS OF WHAT WE'RE TRYING TO DO. YES AND NO. I THINK THAT A NATURAL -- WILL EMERGE AS THE DATABASE BECOMES MORE MATURE AND AS WE IDENTIFY THE SIGNIFICANT FINDINGS, BUT I ALSO THINK THAT THOSE THAT ARE ALREADY IN HEALTHCARE LEADERSHIP, ONCE THEY BECOME FAMILIAR WITH SOME OF THE THINGS WE'LL DO, WILL ESSENTIALLY ADOPT A LEADERSHIP BY COMMITTEE APPROACH AND WILL RECOGNIZE THAT THIS IS A NEW STRATEGY THAT WILL ANSWER SOME DEFINED QUESTIONS. WE'RE STILL BUILDING OUT THE INFRASTRUCTURE, STILL GETTING THE INFORMATION, BUT I WILL TELL YOU THAT THE SUBSCRIPTION WE'VE HAD FROM PATIENTS AND ADVOCACY GROUPS ALREADY DEMONSTRATES TO US THAT THIS WAS SOMETHING READY TO HAPPEN, AND IT WAS JUST A MATTER OF PUTTING IT OUT THERE AND PEOPLE COMING TO US. >> SECOND QUESTION. ONE OF THE MAJOR -- IT IS A HUGE ABUSE OF THE FUNDING IN CERTAIN WAYS, SO IT IS A PRACTICE, I GUESS, THAT WILL AFFECT 5% OF THE PATIENTS WITH CHRONIC DISEASE, THEY USE 50% OF THE RESOURCES AVAILABLE IN THE PATIENT CARE. SO I THINK WHEN YOU THINK OF THE LIMITED RESOURCE, AND THESE ARE SOME OF THE CHALLENGES, THIS HAS TO BE -- IN SOME WAY TO MAKE SOME MEANINGFUL USE OF OUR NATIONAL HEALTHCARE RESULTS. >> SO THAT'S A BRIL YABT QUESTION, AND I WANT TO TAKE THAT ON DIRECTLY. I THINK THIS MAY BE ONE OF THE BEST APPLICATIONS OF OUR LIMITED FUNDS FOR THE PURPOSES OF IMPROVING HEALTH, IN PART BECAUSE WE'RE DEALING WITH RELEVANT QUESTIONS. EVEN TODAY, AT LESS THAN $500 MILLION, GENERATED INDEPENDENTLY THROUGH A TAX THAT WAS EMPOWERED BY THE AFFORDABLE CARE ACT, WE REALLY ARE NOT TAKING MONEY AWAY FROM ALREADY ESTABLISHED RESEARCH INITIATIVES, BUTTED AING FUNDS TO THAT. SO I THINK THAT WHEN YOU PARTNER THE UNIQUENESS OF WHAT WE'RE TRYING TO DO WITH THE AMAZING OBSERVATION THAT THESE ARE NEW DOLLARS COMING INTO THE SYSTEM, THEN I HAVE NO ANXIETIES THAT WE ARE TAKING FROM, RATHER I BELIEVE WE'RE ADDING TO. MIKE. >> MIKE LAUER. TERRIFIC TALK, CLYDE, AND IT IS INDEED AMAZING, WHAT HAS HAPPENED OVER THE PAST YEARS. NOT ONLY THE IMPACT THAT PCORI IS HAVING BY ITSELF BUT THE IMPACT THAT IT'S HAVING ON THE ENTIRE RESEARCH ENTERPRISE. ACTUALLY TO TAKE OFF ON YOUR LAST POINT, JUST A QUICK COMMENT COMMENT, WE HAD A MEETING AT THE PCORI THE OTHER DAY THINKING ABOUT EVALUATION, HOW WE'RE GOING TO DETERMINE HOW EFFECTIVE PCORI IS, AND WE GOT TO THE SUBJECT OF PATIENT ENGAGEMENT AND NOTED THAT RIGHT NOW, VERY, VERY FEW PATIENTS PARTICIPATE IN CLINICAL RESEARCH. THERE HAVE BEEN STUDIES ON THIS, IT'S WELL UNDER 10% OF PATIENTS WHO PARTICIPATE IN CLINICAL RESEARCH. THERE IS AN ENORMOUS POTENTIAL OUT THERE, NOT A QUESTION OF TAKING AWAY FROM ANYTHING, THERE'S A HUGE RESERVOIR TO BE TAPPED, AND ONE OF THE THINGS THAT WE'LL BE LOOKING FOR AS PCORI MATURES, IF WE CAN'T EVEN GET IT FROM 5% TO 10%, THAT WOULD BE HUGE, BUT THINK ABOUT WHAT WE COULD DO IF WE COULD GET IT FROM 5% TO 25%, THAT WOULD TOTALLY CHANGE THE ENTIRE STAGE UPON WHICH WE DO RESEARCH. >> SO LET ME PUT WHAT MIKE JUST SAID IN REAL TERMS. LAST WYCHE I WAS IN WASHINGTON, D.C. TWICE, ON ONE OCCASION IT WAS TO CHAIR THE CARDIOVASCULAR DEVICES PANEL FOR THE FDA. WE VETTED, VOTED AND AGREED TO ENDORSE THE RELEASE OF A DEVICE TO PREVENT THE RISK OF STROKE IN THE SETTING OF AGE DEFIBRILLATION ABSENT FO FROM THE NEED OF ORAL ANTICOAGULATION. WE MADE THAT DECISION BASED ON A DENOMINATOR OF FEWER THAN 2,000 PATIENTS. TWO SEPARATE CLINICAL TRIALS WITH ABOUT 7 TO 800 PATIENTS PER, FOR A DISEASE THAT AFFECTS ONE IN FOUR AMERICANS BEFORE THEY DIE. THAT IN ANY ONE POINT IN TIME HAS MORE THAN 5 MILLION PEOPLE WALKING AROUND IMPACTED OR INFLUENCED BY ATRIAL DEFIBRILLATION. REALLY, SHOULD -- THAT'S EXPORTED TO FIVE TO 7 MILLION AND THAT 25% OF US ARE LIKELY TO RECEIVE? THAT'S IDIOCY. SO COMING UP WITH THESE MODELS TO GET THE EXPERIENCES AMALGAMATED FROM A LARGER NUMBER OF PATIENTS TO REALLY UNDERSTAND RISK, BENEFIT, GAIN, ET CETERA, COULDN'T BE MORE IMPORTANT. SO THANK YOU, MIKE, BUT IT REALLY DOES HIGHLIGHT WHAT'S SO IMPORTANT ABOUT THESE NETWORKS. >> HI. WHICH HAVE YOU FOUND TO BE A GREATER CHALLENGE? EDUCATING THE LAY PUBLIC IN HOW TO DEAL WITH CLINICAL RESEARCH PROFESSIONALS, OR TEACHING CLINICAL RESEARCH PROFESSIONALS HOW TO DEAL WITH THE LAY PUBLIC? [LAUGHTER] >> THAT'S GREAT. >> WHAT I WILL TELL YOU IS THAT WHAT I'VE FOUND MOST EFFECTIVE IS LISTENING TO THE LAY PUBLIC TO UNDERSTAND HOW BEST THEY WANT TO INTERFACE. IT WAS ALMOST RIVETTING TO LISTEN TO THE TESTIMONY FROM ONE PATIENT ADVOCATE WHO SAID EVERYTHING YOU GUYS SAY SHOULD BE DISSEMINATED IN TWO LANGUAGES. WHATEVER THAT LANGUAGE IS YOU GUYS SPEAK, AND THEN IN A VERNACULAR THAT YOUR BEST FRIEND COULD UNDERSTAND. BECAUSE YOU HAVE NO IDEA HOW MUCH DIFFICULTY WE HAVE IN THE PHYSICIAN'S OFFICE. WHEN YOU SPEAK AS IF WE ARE PHYSICIANS. SO THAT'S BEEN THE MOST IMPORTANT MESSAGE. IT'S NOT EDUCATING PROVIDERS OR EDUCATING THE LAY PEOPLE. IT'S ACTUALLY LISTENING AND DROPPING OUR PATERNAL URGES TO UNDERSTAND HOW BEST TO COMMUNICATE WITH PATIENTS. IT MAKES A LOT OF TRADITIONAL SCIENTISTS SQUIRM. BUT IT REALLY REFLECTS THE GOING FORWARD STRATEGY. >> AGAIN, THANK YOU SO MUCH FOR THIS PROVOCATIVE TALK. WE PRIESHT YOU BEING A WALS LECTURER, HOPE EVERYONE WILL JOIN US FOR THE RECEPTION. [APPLAUSE]