David Axelrod|Jesse D. Schold
Measuring What Matters
Vidant Medical Center|East Carolina University|Cleveland Clinic
current system assess transplant center performances needs refinement ensure reduced access transplantation unintended consequence quality measurement see article kasiske et al page 3371 current system assess transplant center performances needs refinement ensure reduced access transplantation unintended consequence quality measurement see article kasiske et al page 3371 modern medical care irreversibly embraced outcomes monitoring public reporting transparency patients payers regulators 1fisher es shortell sm savitz la implementation science potential catalyst delivery system reformjama 2016 315 339340crossref pubmed scopus 74 google scholar 2nelson ec dixonwoods batalden pb patient focused registries improve health care sciencebmj 2016 354 et al i3319crossref pubmed scopus 106 google scholar 3shahian dm public reporting cardiac surgery outcomeswhat know expectj card surg 2010 25 710712crossref pubmed scopus 2 google scholar 4minami ca dahlke bilimoria ky public reporting surgery emerging opportunity improve care inform patientsann surg 2015 261 241242crossref pubmed scopus 15 google scholar patients come expect accurate assessment potential risks likely outcome medical procedures similarly medical professionals rely outcomes data drive health care innovation improvement critical evaluation care processes 5pronovost pj toward eliminating harmsqual manag health care 2016 25 185186crossref pubmed scopus 2 google scholar 6pronovost pj cleeman ji wright srinivasan fifteen years err human success story learn frombmj qual saf 2016 25 396399crossref pubmed scopus 44 google scholar however laudable goals accomplished underlying data must accurate risk adjusted importantly focused meaningful outcomes genuinely reflect effectiveness care delivery issue ajt dr kasiske et al scientific registry transplant recipients srtr evaluated impact two potential changes existing system transplant center performance assessment 7kasiske bl salkowski n wey et al potential implications recent proposed changes regulatory oversight solid organ transplantation united states j transplant 2016 doi 101111ajt13955google scholar currently routine program evaluation based primarily 1year posttransplant graft patient outcomes reported semiannually srtr data used organ procurement transplantation network optn determine compliance membership criteria centers medicare medicaid services cms assess compliance medicare condition participation cop requirements 8snyder jj salkowski n kim sj developing statistical models assess transplant outcomes using national registries process united statestransplantation 2016 100 et al 288294crossref pubmed scopus 38 google scholar optn proposed cms recently adopted new flagging thresholds programs identified programmatic review 9united network organ sharingorgan procurement transplantation network executive summary optnunos board directors meeting december 12 2015 cited 2016 sept 27 available httpsoptntransplanthrsagovmedia1220executivesummary122015pdfgoogle scholar case optn membership professional standards committee mpsc proposed system graded probabilities random programmatic review based 1year outcomes assessment system programs observed expected oe ratio 10 would potential evaluated however likelihood review increase greater degrees deviation benchmark values new cop criteria programs face medicare condition level violation oe graft failure death 1 year exceeds 185 rather prior threshold 15 10center clinical standards qualitysurvey certification group solid transplant programsoutcome thresholdsrevised guidelines may 13 2016 cited 2016 may 13 available httpswwwcmsgovmedicareproviderenrollmentandcertificationsurveycertificationgeninfodownloadssurveyandcertletter1624pdfgoogle scholar changes promoted means increase organ utilization decreasing threat regulatory citation poor outcomes dr kasiske et al present analysis potential impact changes transplant center performance assessment overall conclude changes weaken system regulatory oversight allowing centers higherthanexpected riskadjusted rates graft loss death 1 year avoid potential citation case proposed optn changes however system actually increase rate review relatively wellperforming programs limit review centers elevated oe ratios randomly selected indepth assessment authors argue compellingly new proposals improve patient safety authors suggest changes unlikely increase organ utilization evidence transplantation organs increases risk regulatory citation current thresholds 11snyder jj salkowski n wey effects highrisk kidneys scientific registry transplant recipients program quality reportsam j transplant 2016 16 et al 26462653abstract full text full text pdf pubmed scopus 39 google scholar thus srtr leadership concludes although regulatory changes unlikely decrease organ discard reduce opportunities improve outcomes poorly performing centers authors evaluation flagging proposals provides statistical evidence tweaking regulatory citation levels unlikely improve safety substantially increase organ utilization however pointed authors appropriate level scrutiny ie many centers flag balancing act one hand oversight likely plays important role protecting patient safety fostering quality improvement hand patients may denied access transplant owing centers concerns accuracy risk adjustment models risk regulatory censure decision accept higher risk donor recipient rational may reduce access care organ utilization action potentially harms patients lack resources health care literacy insurance options transfer different center changes recently implemented cms may reassure transplant centers encourage transplantation vulnerable populations new thresholds also important sign transplant community concerns overregulation heard thus although authors may present statistically valid argument cms changes net effect system reduces number lowperformance evaluations may nonetheless contribute improving access transplantation conversely agree authors changes optn flagging system appear increase complexity may add confusion overall system program regulation rather align cms optn regulations new system appears add uncertainty already anxietyproducing process future even centers apparently average results risk review transplant programs demonstrably poor performance avoid opportunity proactive assistance optn random selection proposal although optn tried recast proposal means foster global process improvement system still relies predominantly early posttransplant outcomes identify atrisk centers citation prior approving proposed changes optn could examine methods work cms diminish overregulation centers acceptable performance providing oversight monitoring limited number truly lowperforming centers foster quality improvements collaborative fashion importantly transplant community cms optn leadership need address fundamental concerns choice metrics employed transplant regulation current goals optn include increasing number organ transplants promoting equity access improving outcomes waitlisted patients table 1 unfortunately neither existing flagging thresholds proposed revisions focus measures holistically address improved longterm outcomes example accountability listing practices organ acceptance perspective patients payers highquality transplant centers need appropriately evaluate potential recipients collaboratively manage care prior transplant select beneficial organs achieve prolonged graft survival assist transplant centers focus regulation issues health resources services administration charged collaborative improvement innovation network commonly referred coiin project developing novel strategies evaluation broader score cards diverse metrics including process metrics functional outcomes 12department health human services healthcare systems bureau division transplantation coiin project studying effective practices model hospitals opos 2016 cited 2016 sept 25 available httpsoptntransplanthrsagovnewscoiinprojectstudyingeffectivepracticesatmodelhospitalsoposgoogle scholar vital initiative may move regulation toward meaningful measures matter patients families represents effective change incremental proposals evaluated dr kasiske et altable 1current optnunos goalsincrease number transplantsprovide equity access transplantsimprove waitlisted patient living donor transplant recipient outcomespromote living donor transplant recipient safetypromote efficient management optn open table new tab conclusion measurement effectiveness transplant center performance complex organ specific fraught risk unintended consequences whereas 1year outcomes easy measure provide narrow focus quality improvement regulatory reform needed however moving forward focus achieving greatest overall benefit patients endstage organ failure given potential supply donated organs kasiske et al raise valid concerns recent potential changes regulatory authorities assess transplant care however increasing transplantation expanding acceptance marginal donors achieving superior longterm results ensuring equitable access care much impactful means honoring gift life improving 1year posttransplant outcomes alone authors manuscript conflicts interest disclose described american journal transplantation dr axelrod owner xynmanagement firm produces software assists transplant centers quality assessment outcomes improvement activities author conflicts interest disclose