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QI vs Research: Where do we draw the line?

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  • Margaret Bourke-White, a great American photographer who established herself as an industrial photographer at a very young age. She also photographed other, non-industrial scenes, such as the one on the left of a bombed Nuremberg in 1945.
  • The Doctors Trial considered the fate of twenty-three German physicians who either participated in the Nazi program to euthanize persons deemed "unworthy of life" (the mentally ill, mentally retarded, or physically disabled) or who conducted experiments on concentration camp prisoners without their consent. The Doctors Trial lasted 140 days. Eighty-five witnesses testified and almost 1,500 documents were introduced. Sixteen of the doctors charged were found guilty. Seven were executed.
  • Brigadier General Telford Taylor offers the opening statement for the prosecution.
  • Brigadier General Telford Taylor offers the opening statement for the prosecution.
  • Brigadier General Telford Taylor offers the opening statement for the prosecution.
  • The heavily-favored Cleveland Indians--whose .721 winning percentage (111-43) still stands as the American League record--were locked in a 2-2 tie with the New York Giants. The game was played at New York's Polo Grounds, where the wall in dead center field was listed at 483 feet from home plate (in other years, the distance was listed at anywhere from 475 to 505 feet, with no explanation for the changes). In the top of the eighth inning, Cleveland's first two batters, Larry Doby and Al Rosen, reached base, bringing up the hot-hitting Wertz. The Indians' first baseman would finish the day 4-for-5, including a double and a triple. The three-bagger had hit the right field wall and brought home both of Cleveland's runs in the first inning.
    This time, Wertz blasted a ball toward deep center field, threatening to break the game wide open. But Mays, the 23-year-old phenom, was off with the crack of the bat. After a long run, Mays hauled the ball in with a spectacular over-the-shoulder catch in front of the fence, then spun and threw the ball back to the infield. Doby tagged and advanced to third (a forgotten fact), but Rosen held at first, and they were stranded there. The Giants went on to win the game in extra innings, then complete a stunning upset by sweeping the demoralized Indians in four games.
  • Brigadier General Telford Taylor offers the opening statement for the prosecution.
  • BACKGROUND: Prompt reperfusion treatment is essential for patients who have myocardial infarction with ST-segment elevation. Guidelines recommend that the interval between arrival at the hospital and intracoronary balloon inflation (door-to-balloon time) during primary percutaneous coronary intervention should be 90 minutes or less. However, few hospitals meet this objective. We sought to identify hospital strategies that were significantly associated with a faster door-to-balloon time. METHODS: We surveyed 365 hospitals to determine whether each of 28 specific strategies was in use. We used hierarchical generalized linear models and data on patients from the Centers for Medicare and Medicaid Services to determine the association between hospital strategies and the door-to-balloon time. RESULTS: In multivariate analysis, six strategies were significantly associated with a faster door-to-balloon time. These strategies included having emergency medicine physicians activate the catheterization laboratory (mean reduction in door-to-balloon time, 8.2 minutes), having a single call to a central page operator activate the laboratory (13.8 minutes), having the emergency department activate the catheterization laboratory while the patient is en route to the hospital (15.4 minutes), expecting staff to arrive in the catheterization laboratory within 20 minutes after being paged (vs. >30 minutes) (19.3 minutes), having an attending cardiologist always on site (14.6 minutes), and having staff in the emergency department and the catheterization laboratory use real-time data feedback (8.6 minutes). Despite the effectiveness of these strategies, only a minority of hospitals surveyed were using them. CONCLUSIONS: Several specific hospital strategies are associated with a significant reduction in the door-to-balloon time in the management of myocardial infarction with ST-segment elevation.
    N Engl J Med. 2006 Nov 30;355(22):2308-20. Epub 2006 Nov 13.
  • Transcript

    • 1. QI vs Research: WhereQI vs Research: Where do we draw the line?do we draw the line? Sandra L. Alfano, Pharm.D. FASHPSandra L. Alfano, Pharm.D. FASHP Chair, Human Investigation Committee-IChair, Human Investigation Committee-I Yale University School of MedicineYale University School of Medicine October 23, 2008October 23, 2008
    • 2. Session ObjectivesSession Objectives  Provide guidance on when a project meetsProvide guidance on when a project meets criteria as QI or researchcriteria as QI or research  Present a bioethical perspective examining issuesPresent a bioethical perspective examining issues involved with QI and researchinvolved with QI and research  Provide a researcher’s perspective on bothProvide a researcher’s perspective on both conducting QI and researchconducting QI and research
    • 3. SpeakersSpeakers  Sandra L. Alfano, Pharm.D., FASHPSandra L. Alfano, Pharm.D., FASHP Chair, Human Investigation CommitteeChair, Human Investigation Committee Yale University School of MedicineYale University School of Medicine  Nancy Neveloff Dubler, LL.B.Nancy Neveloff Dubler, LL.B. Professor of Bioethics, Albert Einstein College of MedicineProfessor of Bioethics, Albert Einstein College of Medicine Director, Division of Bioethics, Montefiore Medical CenterDirector, Division of Bioethics, Montefiore Medical Center  Harlan Krumholz, MD, SMHarlan Krumholz, MD, SM Professor of Medicine and Epidemiology and Public HealthProfessor of Medicine and Epidemiology and Public Health Yale UniversityYale University
    • 4. AudienceAudience  Researchers and research personnelResearchers and research personnel  Quality improvement personnelQuality improvement personnel  IRB staff, regulatory perspectiveIRB staff, regulatory perspective  Some that do a little of bothSome that do a little of both
    • 5. ContinuumContinuum
    • 6. Pronovost/OHRP/JHU CasePronovost/OHRP/JHU Case TimelineTimeline  NEJM PublicationNEJM Publication  Dramatic effective results to decreaseDramatic effective results to decrease infection rateinfection rate  Letter of complaint to OHRPLetter of complaint to OHRP  Allegations of lack of prior IRB review,Allegations of lack of prior IRB review, and lack of informed consent on theand lack of informed consent on the part of the patientspart of the patients  JHU responds to OHRPJHU responds to OHRP  Insists study was exemptInsists study was exempt  OHRP responds to JHUOHRP responds to JHU  Asks for corrective actionsAsks for corrective actions  JHU responds that PI has suspendedJHU responds that PI has suspended all activitiesall activities  December 28, 2006December 28, 2006  Prompts OHRP compliance investigationPrompts OHRP compliance investigation  March 30, 2007March 30, 2007  July 19, 2007July 19, 2007  September 25, 2007September 25, 2007
    • 7. Timeline continuedTimeline continued  OHRP to JHUOHRP to JHU  Atul Gawande, NYAtul Gawande, NY TimesTimes  ““A Lifesaving Checklist”A Lifesaving Checklist”  OHRP listserve responseOHRP listserve response  Clarifies that JHUClarifies that JHU suspended study, notsuspended study, not OHRPOHRP  November 6, 2007November 6, 2007  December 30, 2007December 30, 2007  January 15, 2008January 15, 2008
    • 8. Timeline continuedTimeline continued  OHRP response to JHU: 2-14-08OHRP response to JHU: 2-14-08  Now refers to the ‘Initiative activities’Now refers to the ‘Initiative activities’  Notes the intervention was done for clinical purposesNotes the intervention was done for clinical purposes  The only data released are de-identified, so therefore project has evolvedThe only data released are de-identified, so therefore project has evolved to be no longer engaged in human subjects researchto be no longer engaged in human subjects research 2 NEJM editorials: 2-21-082 NEJM editorials: 2-21-08  Miller and Emanuel:Miller and Emanuel:  Not exempt, as it was a prospective studyNot exempt, as it was a prospective study  Should have been reviewed by IRB via full or expedited reviewShould have been reviewed by IRB via full or expedited review  Baily:Baily:  Sophisticated IRB had difficulty with interpretation of regulations is a badSophisticated IRB had difficulty with interpretation of regulations is a bad sign in itselfsign in itself  Project was a combo of QI and research on organizationsProject was a combo of QI and research on organizations
    • 9. Timeline continuedTimeline continued  QI Panel presentation to SACHRP: March 27,QI Panel presentation to SACHRP: March 27, 20082008  OHRP letter to Pronovost: July 30, 2008OHRP letter to Pronovost: July 30, 2008  Posted prominently on OHRP websitePosted prominently on OHRP website http://www.hhs.gov/ohrp/policy/correspond/Pronovost20080730.htmlhttp://www.hhs.gov/ohrp/policy/correspond/Pronovost20080730.html
    • 10. Regulatory research definitionsRegulatory research definitions  ResearchResearch: a systematic investigation designed to: a systematic investigation designed to develop or contribute to generalizabledevelop or contribute to generalizable knowledgeknowledge  Human SubjectHuman Subject: a: a livingliving individual about whomindividual about whom an investigator conducting research obtainsan investigator conducting research obtains  data through interaction or intervention with thedata through interaction or intervention with the individual, orindividual, or  identifiable private informationidentifiable private information
    • 11. Regulatory research definitionsRegulatory research definitions  Engagement in ResearchEngagement in Research: An institution: An institution becomes “engaged’ in human subjects researchbecomes “engaged’ in human subjects research when its employees or agents intervene orwhen its employees or agents intervene or interact with living individuals for researchinteract with living individuals for research purposes, or obtain individually identifiablepurposes, or obtain individually identifiable private information for research purposesprivate information for research purposes  If engaged in federally funded research, must fileIf engaged in federally funded research, must file a Federalwide Assurance (FWA) with HHSa Federalwide Assurance (FWA) with HHS
    • 12. Regulatory research definitionsRegulatory research definitions  Exempt: Research activities in which the onlyExempt: Research activities in which the only involvement of human subjects will be in one or moreinvolvement of human subjects will be in one or more of theof the stipulated categoriesstipulated categories are exempt from this policyare exempt from this policy (Common Rule, 45CFR46)(Common Rule, 45CFR46)  Expedited review procedures are allowed for certainExpedited review procedures are allowed for certain kinds of research involving no more than minimal risk,kinds of research involving no more than minimal risk, and for minor changes in approved research. In suchand for minor changes in approved research. In such cases, the review is conducted by the IRB Chair, or bycases, the review is conducted by the IRB Chair, or by one or more experienced reviewers designated by theone or more experienced reviewers designated by the Chair from among IRB membersChair from among IRB members
    • 13. A complicating wrinkleA complicating wrinkle  HIPAAHIPAA: Health Insurance Portability and: Health Insurance Portability and Accountability ActAccountability Act  Establishes security and privacy standards for theEstablishes security and privacy standards for the use and disclosure of ‘protected health information’use and disclosure of ‘protected health information’ (PHI)(PHI)  Not well designed to deal with research issuesNot well designed to deal with research issues  Uses different definitions regarding personalUses different definitions regarding personal information (PHI versus identifiable privateinformation (PHI versus identifiable private information)information)
    • 14. Belmont PrinciplesBelmont Principles  Respect for PersonsRespect for Persons  Autonomy, therefore voluntariness requirementAutonomy, therefore voluntariness requirement  Informed consent for research participationInformed consent for research participation  BeneficenceBeneficence  Risk:Benefit analysisRisk:Benefit analysis  JusticeJustice  Fair distribution of burdens and benefitsFair distribution of burdens and benefits
    • 15. Lessons learnedLessons learned  Was it research? If so, ‘Exempt’ versusWas it research? If so, ‘Exempt’ versus ‘Expedited’ review?‘Expedited’ review?  Funding source and FWA engagement issuesFunding source and FWA engagement issues  Informed consent? If so, from whom?Informed consent? If so, from whom?  Publication/dissemination of resultsPublication/dissemination of results
    • 16. Pronovost publicationPronovost publication  The studyThe study  Our studyOur study  Study interventionStudy intervention  ResearchersResearchers  Study hypothesisStudy hypothesis  Study periodStudy period  Objective of the studyObjective of the study  Study designStudy design 1414 11 1414 22 11 55 11 33
    • 17. Was it research? If so, ‘Exempt’Was it research? If so, ‘Exempt’ versus ‘Expedited’ review?versus ‘Expedited’ review?  Researchers seemed to think it was researchResearchers seemed to think it was research  Be careful of terminologyBe careful of terminology  Baily (NEJM 2008) argues that it was QI,Baily (NEJM 2008) argues that it was QI, coupled with organizational research, not humancoupled with organizational research, not human subjects researchsubjects research  If not human subjects research, Common RuleIf not human subjects research, Common Rule does not applydoes not apply
    • 18. Trouble with the exempt versusTrouble with the exempt versus expedited review questionexpedited review question  Miller and Emanuel (NEJM 2008) argue forMiller and Emanuel (NEJM 2008) argue for expedited reviewexpedited review  This assumes the project is ‘human subjectsThis assumes the project is ‘human subjects research’, and the Common Rule appliesresearch’, and the Common Rule applies  Exemption determination requires fitting one ofExemption determination requires fitting one of the stipulated categoriesthe stipulated categories
    • 19. Lessons learnedLessons learned  Was it research? If so, ‘Exempt’ versusWas it research? If so, ‘Exempt’ versus ‘Expedited’ review?‘Expedited’ review?  Funding source and FWA engagement issuesFunding source and FWA engagement issues  Informed consent? If so, from whom?Informed consent? If so, from whom?  Publication/dissemination of resultsPublication/dissemination of results
    • 20. Funding source and FWAFunding source and FWA engagement issuesengagement issues  When federally funded, must follow CommonWhen federally funded, must follow Common Rule regulationsRule regulations  Pronovost study funded by AHRQPronovost study funded by AHRQ  OHRP guidance about engagement in researchOHRP guidance about engagement in research would require an FWA and IRB of record forwould require an FWA and IRB of record for each institution involvedeach institution involved
    • 21. Lessons learnedLessons learned  Was it research? If so, ‘Exempt’ versusWas it research? If so, ‘Exempt’ versus ‘Expedited’ review?‘Expedited’ review?  Funding source and FWA engagement issuesFunding source and FWA engagement issues  Informed consent? If so, from whom?Informed consent? If so, from whom?  Publication/dissemination of resultsPublication/dissemination of results
    • 22. Informed consent? If so, fromInformed consent? If so, from whom?whom?  If it is human subjects research, strongIf it is human subjects research, strong requirement to get voluntary participation fromrequirement to get voluntary participation from subjects of the research, via informed consentsubjects of the research, via informed consent  Remember there were two groups involved:Remember there were two groups involved: staff and patientsstaff and patients  If viewed as QI and organizational research, noIf viewed as QI and organizational research, no requirement for informed consent from eitherrequirement for informed consent from either patients or staffpatients or staff
    • 23. Lessons learnedLessons learned  Was it research? If so, ‘Exempt’ versusWas it research? If so, ‘Exempt’ versus ‘Expedited’ review?‘Expedited’ review?  Funding source and FWA engagement issuesFunding source and FWA engagement issues  Informed consent? If so, from whom?Informed consent? If so, from whom?  Publication/dissemination of resultsPublication/dissemination of results
    • 24. Publication/dissemination of resultsPublication/dissemination of results  Research is designed to develop or contribute toResearch is designed to develop or contribute to generalizable knowledgegeneralizable knowledge  Many consider publication as a threshold for meetingMany consider publication as a threshold for meeting the ‘generalizable’ definition of researchthe ‘generalizable’ definition of research  But it certainly seems counterproductive to say it is OKBut it certainly seems counterproductive to say it is OK to improve care (via QI) as long as you don’t tellto improve care (via QI) as long as you don’t tell anyone about it!anyone about it!  Most now agree publication does not make a projectMost now agree publication does not make a project ‘research’‘research’ per seper se (OHRP even recognizes this fact in its(OHRP even recognizes this fact in its new guidance on Engagement in Research)new guidance on Engagement in Research)
    • 25. ConclusionsConclusions  Organizations wishing to conduct QualityOrganizations wishing to conduct Quality Improvement activities need to do so withoutImprovement activities need to do so without inappropriate regulatory burdeninappropriate regulatory burden  Project design, and terminology used, must beProject design, and terminology used, must be carefully examinedcarefully examined  QI and research components should be carefullyQI and research components should be carefully defineddefined  Publication of results is not a determinant ofPublication of results is not a determinant of researchresearch
    • 26. WorkgroupWorkgroup  EmailEmail ysmhic@yale.eduysmhic@yale.edu  Or sandra.alfano@yale.eduOr sandra.alfano@yale.edu
    • 27. A Process of Quality Improvement:A Process of Quality Improvement: Informed Participation andInformed Participation and Institutional ProcessInstitutional Process Yale UniversityYale University October 23, 2008October 23, 2008 Nancy Neveloff DublerNancy Neveloff Dubler Senior AssociateSenior Associate Montefiore-Einstein Center for BioethicsMontefiore-Einstein Center for Bioethics Montefiore Medical CenterMontefiore Medical Center Professor EmeritaProfessor Emerita The Albert Einstein College of MedicineThe Albert Einstein College of Medicine
    • 28. Quality Improvement and Research:Quality Improvement and Research: The permeable barrierThe permeable barrier Bellin E, Dubler NN, The Quality Improvement–Bellin E, Dubler NN, The Quality Improvement– Research Divide and the Need for ExternalResearch Divide and the Need for External Oversight,Oversight, American Journal of Public HealthAmerican Journal of Public Health, 2001,, 2001, 91(9): 1512-1517.91(9): 1512-1517.  Use of large data setsUse of large data sets  RandomizationRandomization  Eschew IRB reviewEschew IRB review  Need for Oversight not for IRB ReviewNeed for Oversight not for IRB Review  IntentIntent  Ability/authority to implement resultsAbility/authority to implement results 
    • 29. ResearchResearch 45 CFR 46.102 (d):45 CFR 46.102 (d): Research means a systematic investigation,Research means a systematic investigation, including research development, testing andincluding research development, testing and evaluation, designed to develop or contribute toevaluation, designed to develop or contribute to generalizable knowledge. Activities which meetgeneralizable knowledge. Activities which meet this definition constitute research for purposesthis definition constitute research for purposes of this policy, whether or not they are conductedof this policy, whether or not they are conducted or supported under a program which isor supported under a program which is considered research for other purposes. Forconsidered research for other purposes. For example, some demonstration and serviceexample, some demonstration and service
    • 30. Quality ImprovementQuality Improvement  ““The group defined QI as the systematic, data-The group defined QI as the systematic, data- guided activities designed to bring aboutguided activities designed to bring about immediate improvements in health care deliveryimmediate improvements in health care delivery in a particular setting”.in a particular setting”.  [The Ethics of Using Quality Improvement[The Ethics of Using Quality Improvement Methods in Health Care, Lynn et al, Annals, MayMethods in Health Care, Lynn et al, Annals, May 2007, Vol.146, No.9, 666-674]2007, Vol.146, No.9, 666-674]
    • 31. Disease ManagementDisease Management  Improve over-all quality of lifeImprove over-all quality of life  Reduce morbidity and mortalityReduce morbidity and mortality  Ensure that patients receive evidence basedEnsure that patients receive evidence based interventions for their particular chronic illnessesinterventions for their particular chronic illnesses  Improve patient and family comprehensionImprove patient and family comprehension  Reduce in-patient admissions and reduce length-of-stayReduce in-patient admissions and reduce length-of-stay  Reduce ER visitsReduce ER visits  Ensure that new evidence-based interventions areEnsure that new evidence-based interventions are incorporated into practice at all levels of careincorporated into practice at all levels of care  Reduce CostsReduce Costs
    • 32. Key components of diseaseKey components of disease managementmanagement  Patient identification, assessment andPatient identification, assessment and stratification;stratification;  Continued physician compliance with newContinued physician compliance with new evidence based interventions;evidence based interventions;  Education and empowerment of patient andEducation and empowerment of patient and family members;family members;  Ongoing monitoring of patient’s health statusOngoing monitoring of patient’s health status
    • 33. Three QI InterventionsThree QI Interventions Design: each patient given a cell phone and called whenDesign: each patient given a cell phone and called when medication is due: vs. Patients not given cell phones vs.medication is due: vs. Patients not given cell phones vs. Patients on DOTPatients on DOT Design: Clinical Looking Glass: Replicate of the clinicalDesign: Clinical Looking Glass: Replicate of the clinical activities: How many patients, which services, whichactivities: How many patients, which services, which physicians, have higher than acceptable viral loads inphysicians, have higher than acceptable viral loads in HIV/AIDS?HIV/AIDS? Smart scale: patient weighs every morning and discussesSmart scale: patient weighs every morning and discusses with nurse.with nurse.
    • 34. Ethical Justification:Ethical Justification: ResearchResearch  Research is not morally mandatory for institutions;Research is not morally mandatory for institutions;  Participation in research is not morally mandatory for humanParticipation in research is not morally mandatory for human subjects; Research is important to advance medical science butsubjects; Research is important to advance medical science but participation is morally gratuitous because most research is notparticipation is morally gratuitous because most research is not necessary for the survival of society;necessary for the survival of society;  The principle of Justice might require the prior beneficiaries ofThe principle of Justice might require the prior beneficiaries of research to repay the benefit that they gained;research to repay the benefit that they gained;  So vital social interest and justice might require participation—So vital social interest and justice might require participation— most conclude do not;most conclude do not;  Therefore, potential human subjects in research are morally freeTherefore, potential human subjects in research are morally free to consent to or to refuse participationto consent to or to refuse participation ..
    • 35. Ethical Justification:Ethical Justification: Quality ImprovementQuality Improvement  Medical professionals are morally required to engage inMedical professionals are morally required to engage in QI in order to revere the basic ethic of medicine [do noQI in order to revere the basic ethic of medicine [do no harm];harm];  Individual health care organizations are morallyIndividual health care organizations are morally required to engage in QI –an obligation derived fromrequired to engage in QI –an obligation derived from organizational ethics and the notion or institutionalorganizational ethics and the notion or institutional moral agency;moral agency;  Patients are morally required to participate in QIPatients are morally required to participate in QI [Responsibilities from possible immediate benefit to[Responsibilities from possible immediate benefit to self and responsibilities from benefits to others]self and responsibilities from benefits to others]
    • 36. Ethical Justifications for DiseaseEthical Justifications for Disease ManagementManagement  Health and wellbeing of chronically illHealth and wellbeing of chronically ill populationspopulations  Quality of care across the continuumQuality of care across the continuum  Lowering or reducing costs of hospitalizationLowering or reducing costs of hospitalization  Helping the health care system to “affordability”Helping the health care system to “affordability”  Assisting patients and families in the communityAssisting patients and families in the community
    • 37. Elements of QIElements of QI  QI: systemic, data-guided and efficientQI: systemic, data-guided and efficient  QI: may inadvertently cause harm, waste scarce resources orQI: may inadvertently cause harm, waste scarce resources or affect some patients unfairlyaffect some patients unfairly  QI: distinguished from research:QI: distinguished from research:  QI: hypothesis, plan, pilot, test, evaluate—repeat—implementQI: hypothesis, plan, pilot, test, evaluate—repeat—implement  [Research: hypothesis, gather data, analyze, discuss][Research: hypothesis, gather data, analyze, discuss]  QI: uses experience to identify promising improvements,QI: uses experience to identify promising improvements, implements change on a small scale and monitors effectsimplements change on a small scale and monitors effects  QI: may review aggregate data impose evidence based methodsQI: may review aggregate data impose evidence based methods  QI: is in intrinsic part of good clinical careQI: is in intrinsic part of good clinical care
    • 38. Similarities Between QI andSimilarities Between QI and ResearchResearch  Involve human participantsInvolve human participants  Are concerned with inquiryAre concerned with inquiry  Are processes in which empirical or systematicAre processes in which empirical or systematic inquiry generates a question that data collectioninquiry generates a question that data collection is designed to answeris designed to answer  Propose a set of outcome measures that willPropose a set of outcome measures that will support proposalsupport proposal  Testing solutionsTesting solutions  Involve critical evaluation of dataInvolve critical evaluation of data
    • 39. Ethical Requirements forEthical Requirements for Protection of Human ParticipantsProtection of Human Participants in QI Activities:in QI Activities: Social or scientific value of the individual QI project;Social or scientific value of the individual QI project;  Scientific validity in design and methodology;Scientific validity in design and methodology;  Fair participant selection that does not overly burden one population norFair participant selection that does not overly burden one population nor stigmatize any population;stigmatize any population;  Favorable risk-benefit ratio: basically minimal risk or less than minimal risk;Favorable risk-benefit ratio: basically minimal risk or less than minimal risk;  Respect for participantsRespect for participants  Informed participation or occasionally in QI efforts that require individualInformed participation or occasionally in QI efforts that require individual actions, informed consent;actions, informed consent;  Independent review by an institutional office authorized to approve orIndependent review by an institutional office authorized to approve or disapprove QI projects, to register these projects, to gather data ondisapprove QI projects, to register these projects, to gather data on completion, to evaluate results and see to the implementation of new systems.completion, to evaluate results and see to the implementation of new systems.
    • 40. Moral Obligation: Research andMoral Obligation: Research and QIQI Participation is morally imperative only if researchParticipation is morally imperative only if research or QI is so characterized;or QI is so characterized; Research is important to advance medical scienceResearch is important to advance medical science but participation isbut participation is morally gratuitousmorally gratuitous because mostbecause most research isresearch is not necessary for the survival ofnot necessary for the survival of society;society; Justice requires prior beneficiaries to repay;Justice requires prior beneficiaries to repay; SoSo vital social interestvital social interest andand justicejustice might requiremight require participation—most conclude do not.participation—most conclude do not.
    • 41. Moral Imperative for Patients,Moral Imperative for Patients, Providers and InstitutionsProviders and Institutions Three moral imperatives:Three moral imperatives: 1.1. Medical professionals mustMedical professionals must conductconduct QI;QI; [do no harm][do no harm] 2.2. Individual health care organizations mustIndividual health care organizations must supportsupport QI;QI; [obligation from moral agency][obligation from moral agency] 3.3. Active patients mustActive patients must participateparticipate in QI.in QI. [Responsibilities from possible immediate benefit to self[Responsibilities from possible immediate benefit to self and responsibilities from benefits to others]and responsibilities from benefits to others]
    • 42. Ethical Protections forEthical Protections for Patient/Participants in QIPatient/Participants in QI  Social or scientific valueSocial or scientific value  Scientific validityScientific validity  Fair participant selectionFair participant selection  Favorable risk-benefit ratio: minimal riskFavorable risk-benefit ratio: minimal risk  Respect for participantsRespect for participants  Informed consent/informed participationInformed consent/informed participation  Independent reviewIndependent review
    • 43. Provisions in research for altering or waivingProvisions in research for altering or waiving the requirement of Informed Consent:the requirement of Informed Consent:  Exceptions to Informed Consent: IRB may alter or waive:Exceptions to Informed Consent: IRB may alter or waive:  (1) The research involves no more than minimal risk to the(1) The research involves no more than minimal risk to the subjects;subjects;  (2) The waiver or alteration will not adversely affect the rights(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;and welfare of the subjects;  (3) The research could not practicably be carried out without the(3) The research could not practicably be carried out without the waiver or alteration; andwaiver or alteration; and  (4) Whenever appropriate the subjects will be provided with(4) Whenever appropriate the subjects will be provided with additional pertinent information after participation.additional pertinent information after participation.  §46.111 (d)§46.111 (d)
    • 44. Informed participation:Informed participation:  Clear statements by the health care institutionClear statements by the health care institution about QI—obligation to participate in minimalabout QI—obligation to participate in minimal risk QI projects for the immediate benefit torisk QI projects for the immediate benefit to some patients and the long-term benefits for all;some patients and the long-term benefits for all;  Oversight structure for QI—review before;Oversight structure for QI—review before;  Structure for accountability—implementation ofStructure for accountability—implementation of positive findings after data are collected andpositive findings after data are collected and analyzed;analyzed;  Feedback and Information forFeedback and Information for patients/participants.patients/participants.
    • 45. Oversight Structure “Investigator” is uncertain QI registration site surveillance IRB concerns or “QI rejections” Institutional referrals Quality Improvement Research Committee Performance Improvement, Bioethics, Legal Affairs, Risk Management, Bioethics, Administration, Interdisciplinary Providers Research Both Research and QI Quality Improvement IRB submission Informed consent QI project registration Informed participation Liability issues Legal Affairs Draft “Investigator” elects to not proceed
    • 46. EXAMPLE: Registration FormEXAMPLE: Registration Form
    • 47. Conclusion:Conclusion: QI is morally mandatory for institutionsQI is morally mandatory for institutions physicians, and patients: It is part of the socialphysicians, and patients: It is part of the social contract of medicine that do no harm impliescontract of medicine that do no harm implies the need to improve as the skills and tools ofthe need to improve as the skills and tools of improvement are developed. QI is not subjectimprovement are developed. QI is not subject to review as research but is open, transparentto review as research but is open, transparent and part of the culture of the medical center.and part of the culture of the medical center.
    • 48. Quality ImprovementQuality Improvement Research: EthicalResearch: Ethical ConsiderationsConsiderations Harlan M. Krumholz MDHarlan M. Krumholz MD Yale School of MedicineYale School of Medicine New Haven, CTNew Haven, CT October 23, 2008
    • 49. Out of the ashes of Nuremberg… Margaret Bourke-White
    • 50. …rose a trial with particular relevance to medical research.
    • 51. …rose a trial with particular relevance to medical research.
    • 52. Nuremberg Code is the articulation of our ethical obligations to study subjects.
    • 53. The voluntary consent of the human subject is absolutely essential.
    • 54. Having principles isn’t enough…
    • 55. There wasThere was this simplethis simple idea…idea… Gawande, The NewGawande, The New Yorker, 12/10/2007Yorker, 12/10/2007
    • 56. InterventionIntervention 1. Wash their hands with soap.1. Wash their hands with soap. 2. Clean the patient’s skin with chlorhexidine.2. Clean the patient’s skin with chlorhexidine. 3. Put sterile drapes over the entire patient.3. Put sterile drapes over the entire patient. 4. Wear a sterile mask, hat, gown and gloves.4. Wear a sterile mask, hat, gown and gloves. 5. Put a sterile dressing over the catheter site.5. Put a sterile dressing over the catheter site.
    • 57. Grant Number:Grant Number: 5UC1HS014246-025UC1HS014246-02 Project Title: Statewide Efforts toProject Title: Statewide Efforts to Improve Care in Intensive Care UnitImprove Care in Intensive Care Unit  We hypothesize that we can improve patientWe hypothesize that we can improve patient safety; improve safety culture; and reduce ICUsafety; improve safety culture; and reduce ICU mortality, blood stream infections, aspirationmortality, blood stream infections, aspiration pneumonia and ICU length of stay.pneumonia and ICU length of stay.
    • 58. Statewide Efforts to Improve CareStatewide Efforts to Improve Care in Intensive Care Unitin Intensive Care Unit  To accomplish this, we will partner with theTo accomplish this, we will partner with the Michigan Hospital Association, whose has overMichigan Hospital Association, whose has over 130 Michigan hospitals, to implement a safety130 Michigan hospitals, to implement a safety program and other interventions in a cohort ofprogram and other interventions in a cohort of hospitals.hospitals.
    • 59. Statewide Efforts to Improve CareStatewide Efforts to Improve Care in Intensive Care Unitin Intensive Care Unit Specific aims are to implement and evaluate:Specific aims are to implement and evaluate:  impact of the Comprehensive Unit-based Safetyimpact of the Comprehensive Unit-based Safety Program that includes the ICU Safety ReportingProgram that includes the ICU Safety Reporting System;System;  effect of an intervention to improveeffect of an intervention to improve communication and staffing in ICUs;communication and staffing in ICUs;
    • 60. Statewide Efforts to Improve CareStatewide Efforts to Improve Care in Intensive Care Unitin Intensive Care Unit  effect of an intervention to reduce/eliminateeffect of an intervention to reduce/eliminate catheter related blood stream infections;catheter related blood stream infections;  effect of an intervention to improve the care ofeffect of an intervention to improve the care of ventilated patients; andventilated patients; and  effect of an intervention to reduce mortality.effect of an intervention to reduce mortality.
    • 61. The results were published inThe results were published in NEJMNEJM
    • 62. And the results were very good.And the results were very good.
    • 63. TimelineTimeline
    • 64. Pronovost became a celebrity.Pronovost became a celebrity.
    • 65. What wasWhat was the ethicalthe ethical obligation?obligation?
    • 66. QuestionsQuestions werewere raised byraised by OHRP.OHRP.
    • 67. OHRPOHRP sendssends anotheranother letter inletter in July ‘08.July ‘08.
    • 68. They clarified what was being done.
    • 69. What determines what we needWhat determines what we need to do to protect subjects?to do to protect subjects? intent (mens rea)intent (mens rea) intervention?intervention? rigor?rigor? publication?publication? funding?funding? timing?timing? safety?safety? feasibility?feasibility?
    • 70. ExemptionExemption "research involving the collection or study of"research involving the collection or study of existing data, documents, records, pathologicalexisting data, documents, records, pathological specimens, or diagnostic specimens, if these arespecimens, or diagnostic specimens, if these are publicly available or if the information ispublicly available or if the information is recorded by the investigator in such a mannerrecorded by the investigator in such a manner that subjects cannot be identified."that subjects cannot be identified."
    • 71. ExemptionExemption Nevertheless, the research could have been reviewed in anNevertheless, the research could have been reviewed in an expedited fashion by the IRB chair alone, since it posedexpedited fashion by the IRB chair alone, since it posed no more than "minimal risks" and fit within twono more than "minimal risks" and fit within two categories for expedited review specified by the OHRP:categories for expedited review specified by the OHRP: "collection of data through noninvasive procedures"collection of data through noninvasive procedures (not including anesthesia or sedation) routinely(not including anesthesia or sedation) routinely employed in clinical practice" and "research includingemployed in clinical practice" and "research including materials (data, documents, records, or specimens) thatmaterials (data, documents, records, or specimens) that have been collected or will be collected solely forhave been collected or will be collected solely for nonresearch purposes (such as medical treatment ornonresearch purposes (such as medical treatment or diagnosis)."diagnosis)." Miller and Emanuel NEJM
    • 72. Treatment of STEMITreatment of STEMI
    • 73. Primary PCI for STEMI is aPrimary PCI for STEMI is a remarkable intervention.remarkable intervention.
    • 74. The D2B standard in 1999The D2B standard in 1999 was 90was 90 ± 30 minutes± 30 minutes
    • 75. Around the turn of the century,Around the turn of the century, performance was stable.performance was stable. 020406080100120 Door-to-balloontime(minutes) Jan 99 Jul 00 Jan 02 Jul 03 Month 020406080100120 Door-to-balloontime(minutes) Jan 99 Jul 00 Jan 02 Jul 03 Month
    • 76. Several key strategies were identified.Several key strategies were identified.
    • 77. D2B AllianceD2B Alliance is a vehicle to disseminateis a vehicle to disseminate knowledge and promote improvement.knowledge and promote improvement. www.d2balliance.or g
    • 78. More than 1,000 hospitalsMore than 1,000 hospitals joined the effort.joined the effort.
    • 79. 87 The use of strategies changedThe use of strategies changed inin D2B AllianceD2B Alliance hospitalshospitals Recommended Strategy*Recommended Strategy* BaselineBaseline Follow-upFollow-up EM activationEM activation 52%52% 60%60% Single callSingle call 31%31% 37%37% Cath team < 30 minCath team < 30 min 81%81% 89%89% Prompt data feedbackPrompt data feedback 61%61% 79%79% Activate from PH ECGActivate from PH ECG 33%33% 41%41% D2B TeamD2B Team 64%64% 85%85% * All differences are significant P* All differences are significant P<< 0.0010.001
    • 80. NCDR Cath PCI RegistryNCDR Cath PCI Registry % < 90 minutes% < 90 minutes
    • 81. Was shortening LOS for patients after CABGWas shortening LOS for patients after CABG an intervention?an intervention?
    • 82. What isWhat is research?research?
    • 83. What is human research?What is human research?  A systematic investigation designed to developA systematic investigation designed to develop or contribute to generalizable knowledgeor contribute to generalizable knowledge  Data through interaction or intervention with theData through interaction or intervention with the individual, orindividual, or  Identifiable private informationIdentifiable private information
    • 84. What is quality improvement?What is quality improvement?  Systematic, data-guided activities designed toSystematic, data-guided activities designed to bring about immediate improvements in healthbring about immediate improvements in health care delivery in a particular settingcare delivery in a particular setting
    • 85. Is QI withoutIs QI without evaluation (research) ethical?evaluation (research) ethical?
    • 86. Baily: Organizational research notBaily: Organizational research not human subjects researchhuman subjects research
    • 87. Improving theImproving the effectiveness ofeffectiveness of care is part ofcare is part of the researchthe research agenda.agenda.
    • 88. Is it about language?Is it about language?

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