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Integrating Health Outcomes Integrating Health Outcomes into the Publication Plan into the Publication Plan Frank J. Rodino, PA, MHS Frank J. Rodino, PA, MHS Churchill Communications Churchill Communications Ch hill Cli i l R h Ch hill Cli i l R h Churchill Clinical Research Churchill Clinical Research December 9, 2009 December 9, 2009

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Page 1: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Integrating Health Outcomes Integrating Health Outcomes into the Publication Planinto the Publication Plan

Frank J. Rodino, PA, MHSFrank J. Rodino, PA, MHSChurchill CommunicationsChurchill CommunicationsCh hill Cli i l R hCh hill Cli i l R hChurchill Clinical ResearchChurchill Clinical Research

December 9, 2009December 9, 2009

Page 2: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Lecture ObjectivesLecture ObjectivesLecture ObjectivesLecture Objectives

P id b i i f h l h i h P id b i i f h l h i h •• Provide basic overview of health outcomes, with an Provide basic overview of health outcomes, with an emphasis on “Real World” research emphasis on “Real World” research

•• Explore key differences between RCT and health Explore key differences between RCT and health Explore key differences between RCT and health Explore key differences between RCT and health outcomes reportingoutcomes reporting

•• Highlight some helpful resources for health outcomes Highlight some helpful resources for health outcomes bli hibli hipublishingpublishing

Page 3: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Glossary of AbbreviationsGlossary of AbbreviationsGlossary of AbbreviationsGlossary of Abbreviations

ARRA A i R d R i t t A tARRA A i R d R i t t A t•• ARRA: American Recovery and Reinvestment ActARRA: American Recovery and Reinvestment Act•• CER: Comparative Effectiveness ResearchCER: Comparative Effectiveness Research•• HIPAA: Health Information Portability and Accountability ActHIPAA: Health Information Portability and Accountability ActHIPAA: Health Information Portability and Accountability ActHIPAA: Health Information Portability and Accountability Act•• IOM: Institutes of MedicineIOM: Institutes of Medicine•• OR: Outcomes ResearchOR: Outcomes Research•• PE: PharmacoeconomicsPE: Pharmacoeconomics•• QOL: Quality of LifeQOL: Quality of Life•• QUOROM: Quality of Reporting of MetaQUOROM: Quality of Reporting of Meta--analysisanalysis•• QUOROM: Quality of Reporting of MetaQUOROM: Quality of Reporting of Meta--analysisanalysis•• RCT: Randomized Clinical TrialRCT: Randomized Clinical Trial•• RW: Real WorldRW: Real World•• STROBE: Strengthening the Reporting of Observational Studies STROBE: Strengthening the Reporting of Observational Studies

in Epidemiologyin Epidemiology

Page 4: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Health Outcomes ResearchHealth Outcomes ResearchOverview Overview

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Page 5: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

ISPORISPORISPORISPOR

I i l S i f Ph i d I i l S i f Ph i d •• International Society of Pharmacoeconomics and International Society of Pharmacoeconomics and Outcomes ResearchOutcomes Research

•• Global organization focusing on PE and ORGlobal organization focusing on PE and ORGlobal organization focusing on PE and ORGlobal organization focusing on PE and OR•• Excellent resources on all aspects of PE and ORExcellent resources on all aspects of PE and OR•• Numerous policy statements on designing, interpreting, Numerous policy statements on designing, interpreting,

and publishing outcomes researchand publishing outcomes research•• Value in HealthValue in Health, official, indexed, peer, official, indexed, peer--reviewed journal reviewed journal

of ISPORof ISPORof ISPORof ISPOR•• www.ispor.orgwww.ispor.org

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Page 6: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

ISPOR Definition of h

ISPOR Definition of hOutcomes ResearchOutcomes Research

Th i f h i (h l h i ) d The science of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of healthcare interventions on patient well-being, p g,including clinical, economic, and patient-reported outcomes) that facilitates the translation of this research into useful information for healthcare decision-makers to into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely, fairly, and efficiently.

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From the ISPOR Mission Statement; www.ispor.org

Page 7: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Growing Importance of l h h

Growing Importance of l h hHealth Outcomes Research Health Outcomes Research

P i li i l i h h i illP i li i l i h h i ill•• Patients are living longer with chronic illnessesPatients are living longer with chronic illnesses•• Few largeFew large--scale, headscale, head--toto--head studies of therapeutic head studies of therapeutic

interventionsinterventionsinterventionsinterventions•• Scant evidence for offScant evidence for off--label treatmentslabel treatments•• Wide variability in treatment patternsWide variability in treatment patterns•• We spend the most (15% of GDP) but don’t live the We spend the most (15% of GDP) but don’t live the

longest (78 yrs)longest (78 yrs)

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Page 8: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Randomized Clinical TrialsRandomized Clinical TrialsRandomized Clinical TrialsRandomized Clinical Trials

R d i d li i l i l i f d i i R d i d li i l i l i f d i i •• Randomized clinical trials are important for determining Randomized clinical trials are important for determining efficacy and safety, and registrationefficacy and safety, and registration

•• But they areBut they areBut they areBut they are–– ExpensiveExpensive–– Limited, controlled experimentsLimited, controlled experiments

Oft l b i f l ti f th l lOft l b i f l ti f th l l–– Often vs. placebo or a previous formulation of the same moleculeOften vs. placebo or a previous formulation of the same molecule–– Not always generalizable to larger populationsNot always generalizable to larger populations

•• There is a need to follow RCTs with studies of how the There is a need to follow RCTs with studies of how the product is used in the real worldproduct is used in the real world

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Page 9: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Who Benefits from h

Who Benefits from hOutcomes ResearchOutcomes Research

H l h hH l h h•• Health care researchersHealth care researchers•• Health technology assessorsHealth technology assessors•• Government health regulatorsGovernment health regulators•• Government health regulatorsGovernment health regulators•• Payers of health carePayers of health care•• Health care providersHealth care providersHealth care providersHealth care providers•• PatientsPatients•• Producers of therapeutic interventionsProducers of therapeutic interventions

Page 10: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Efficacy vs. EffectivenessEfficacy vs. EffectivenessEfficacy vs. EffectivenessEfficacy vs. Effectiveness

EffiEffi•• EfficacyEfficacy–– What an intervention can or can’t doWhat an intervention can or can’t do

Good for patientGood for patient–– Good for patientGood for patient•• EffectivenessEffectiveness

–– Evaluates interventions in real worldEvaluates interventions in real worldEvaluates interventions in real worldEvaluates interventions in real world–– Good for populationGood for population

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Page 11: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Comparative Effectiveness ResearchComparative Effectiveness ResearchComparative Effectiveness ResearchComparative Effectiveness Research

C i f h id d C i f h id d •• Comparison of 2 or more agents that are considered true Comparison of 2 or more agents that are considered true alternativesalternatives

•• Evaluates outcomes of interventions derived from actual Evaluates outcomes of interventions derived from actual Evaluates outcomes of interventions derived from actual Evaluates outcomes of interventions derived from actual practicepractice

•• American Recovery and Reinvestment Act (ARRA) is American Recovery and Reinvestment Act (ARRA) is i i $i i $investing $1.1B to support CERinvesting $1.1B to support CER

•• Approximately 100 highApproximately 100 high--priority research projectspriority research projects•• Goal is to spark innovation and provide information to Goal is to spark innovation and provide information to •• Goal is to spark innovation and provide information to Goal is to spark innovation and provide information to

assist clinicians in making sound evidenceassist clinicians in making sound evidence--based decisionsbased decisions

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Lee EH, Nash DB, ISMPP 2009Lee EH, Nash DB, ISMPP 2009

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Pharmacoeconomic ModelingPharmacoeconomic ModelingPharmacoeconomic ModelingPharmacoeconomic Modeling

S h i id h l h d S h i id h l h d •• Synthesizes evidence on health consequences and costs Synthesizes evidence on health consequences and costs from many different sources includingfrom many different sources including–– Clinical trialsClinical trialsClinical trialsClinical trials–– Observational studiesObservational studies–– Insurance claims databasesInsurance claims databases–– Case registriesCase registries–– Public health statisticsPublic health statistics–– Preference surveysPreference surveys

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Weinstein MC, Value Health 2003Weinstein MC, Value Health 2003

Page 13: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Pharmacoeconomic EvaluationsPharmacoeconomic EvaluationsPharmacoeconomic EvaluationsPharmacoeconomic Evaluations

T f l iT f l i•• Types of evaluationsTypes of evaluations–– Cost consequenceCost consequence

Cost utilityCost utility–– Cost utilityCost utility–– Cost benefitCost benefit

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Weinstein MC, Value Health 2003Weinstein MC, Value Health 2003

Page 14: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Real World OutcomesReal World OutcomesReal World OutcomesReal World Outcomes

ClinicalOutcomes

Economic Patient Reported EconomicOutcomes Outcomes

Quality of Life

Page 15: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Real World Data BenefitsReal World Data BenefitsReal World Data BenefitsReal World Data Benefits

A diff i i i A diff i i i A different perspective on interventions, eg, A different perspective on interventions, eg, •• Estimates of effectiveness vs. efficacy in a variety of Estimates of effectiveness vs. efficacy in a variety of

settingssettingssettingssettings•• Comparison of multiple interventions for optimal choicesComparison of multiple interventions for optimal choices•• Evolving riskEvolving risk--benefit profiles of new interventionsbenefit profiles of new interventions•• Clinical outcomes in a diversity of study populationsClinical outcomes in a diversity of study populations•• Results on a broader range of outcomes than those for Results on a broader range of outcomes than those for

RCTRCTRCTRCT•• Data on resource use for cost evaluationsData on resource use for cost evaluations

15Garrison Jr. LP, Value Health 2007Garrison Jr. LP, Value Health 2007

Page 16: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Real World Data Benefits, contd.Real World Data Benefits, contd.Real World Data Benefits, contd.Real World Data Benefits, contd.

D d i d li i li i l iD d i d li i li i l i•• Data on dosing and compliance in clinical practiceData on dosing and compliance in clinical practice•• Useful in situations where RCT is impossibleUseful in situations where RCT is impossible•• Substantiation of RCT dataSubstantiation of RCT data•• Substantiation of RCT dataSubstantiation of RCT data•• Provide data to support reimbursement in urgent Provide data to support reimbursement in urgent

situationssituations•• Source of interim evidence for preliminary decisionsSource of interim evidence for preliminary decisions•• Net clinical and economic impact of payment policiesNet clinical and economic impact of payment policies

Garrison Jr LP Value Health 2007Garrison Jr LP Value Health 2007

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Garrison Jr. LP, Value Health 2007Garrison Jr. LP, Value Health 2007

Page 17: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Real World Data CategoriesReal World Data CategoriesReal World Data CategoriesReal World Data Categories

S l di i l i i RCTS l di i l i i RCT•• Supplements to traditional registration RCTsSupplements to traditional registration RCTs•• Large simple trials (practical clinical trials)Large simple trials (practical clinical trials)•• RegistriesRegistries•• RegistriesRegistries•• Administrative dataAdministrative data•• Health surveysHealth surveysHealth surveysHealth surveys•• Electronic medical records and chart reviewsElectronic medical records and chart reviews

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Garrison Jr. LP, Value Health 2007Garrison Jr. LP, Value Health 2007

Page 18: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Evidence HierarchyEvidence HierarchyEvidence HierarchyEvidence Hierarchy

Page 19: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Magnitude of Net BenefitMagnitude of Net BenefitMagnitude of Net BenefitMagnitude of Net Benefit

Wh i h b fi i f i l Wh i h b fi i f i l •• What is the net benefit in support of a particular What is the net benefit in support of a particular technology?technology?

•• Magnitude of net benefit must be taken into account Magnitude of net benefit must be taken into account Magnitude of net benefit must be taken into account Magnitude of net benefit must be taken into account when assessing real world evidencewhen assessing real world evidence

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Page 20: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Limits of Real World DataLimits of Real World DataLimits of Real World DataLimits of Real World Data

NN d i dd i d•• NonNon--randomizedrandomized•• Potential for bias and confoundingPotential for bias and confounding•• Not likely to meet methodological rigor of an RCTNot likely to meet methodological rigor of an RCT•• Not likely to meet methodological rigor of an RCTNot likely to meet methodological rigor of an RCT•• Good research practices are needed and should be Good research practices are needed and should be

followed from study design through publicationfollowed from study design through publication

Garrison Jr LP Value Health 2007Garrison Jr LP Value Health 2007

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Garrison Jr. LP, Value Health 2007Garrison Jr. LP, Value Health 2007

Page 21: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Health Outcomes and Health Outcomes and Publication PlanningPublication Planning

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Page 22: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Growth of Outcomes PublishingGrowth of Outcomes PublishingGrowth of Outcomes PublishingGrowth of Outcomes Publishing

dli i i

0006000

Medline Citations (Human/Clinical/Meta‐analysis/Guidelines)

2000300040005000

010002000

2000 2001 2002 2003 2004 2005 2006 2007 20082000 2001 2002 2003 2004 2005 2006 2007 2008

Page 23: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Indexed Publications Focusing l h

Indexed Publications Focusing l hon Health Outcomeson Health Outcomes

Journal Circulation ImpactHealth and Quality of Life Outcomes 37,041 3.2Q y ,Pharmacoeconomics 9,980 2.808Value in Health 4,000 3.009

• Other journals have OR sections

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Page 24: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

CONSORT, QUOROM, d

CONSORT, QUOROM, dSTROBE, and STARDSTROBE, and STARD

CONSORT (1996 2001)CONSORT (1996 2001)•• CONSORT (1996, 2001)CONSORT (1996, 2001)–– CONCONsolidated solidated SStandards tandards OOf f RReporting eporting TTrialsrials–– Improve the reporting of a randomized clinical trialImprove the reporting of a randomized clinical trial

•• QUOROM (1999)QUOROM (1999)–– QUQUality ality OOf f RReporting eporting OOf f MMetaeta--analysesanalyses–– Improve the quality of reporting metaImprove the quality of reporting meta--analyses of randomized, analyses of randomized,

ll d li i l i lll d li i l i lcontrolled clinical trialscontrolled clinical trials•• STROBE (2007)STROBE (2007)

–– SStrengthening trengthening TThe he RReporting of eporting of OBOBservational Studies in servational Studies in EEpidemiologypidemiology–– Improve the quality of reporting of observational studiesImprove the quality of reporting of observational studies

•• STARD (2003)STARD (2003)–– STASTAndards for the ndards for the RReporting of eporting of DDiagnostic accuracy studiesiagnostic accuracy studies–– Improve reporting of studies of diagnostic accuracyImprove reporting of studies of diagnostic accuracy

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Page 25: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

CONSORT, QUOROM, d

CONSORT, QUOROM, dand STROBEand STROBE

Ch kli t CONSORT QUOROM STROBEChecklist CONSORT QUOROM STROBE

# of Items 22 21 22

Title, Abstract, I t d ti

Similar Similar SimilarIntroduction

Methods RandomizationBlinding

SearchingSelectionValidity assessment

Study type•Cohort•Case-controly

Data abstractionQuantitative data synthesis

•Cross-sectionalPotential for bias

Results Recruitment Quantitative data DescriptiveResults RecruitmentAdverse events

Quantitative data synthesis

Descriptiveanalysis

Discussion Interpretation Describe biases in review process

“Cautious” interpretationLi i iLimitations

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Page 26: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Structural ConsiderationsStructural ConsiderationsStructural ConsiderationsStructural Considerations

S f ffi AND ff iS f ffi AND ff i•• Safety, efficacy AND effectivenessSafety, efficacy AND effectiveness•• Incorporate health outcomes research earlier in the drug Incorporate health outcomes research earlier in the drug

development processdevelopment processdevelopment processdevelopment process–– Protocol designProtocol design–– AnalysisAnalysis

E t i t diE t i t di–– Extension studiesExtension studies

•• Add a health outcomes expert(s) to your publication Add a health outcomes expert(s) to your publication planning teamplanning teamp gp g

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Page 27: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Planning ConsiderationsPlanning ConsiderationsPlanning ConsiderationsPlanning Considerations

H l h h ld b l f H l h h ld b l f •• Health outcomes should be a core element of a Health outcomes should be a core element of a publication planpublication plan–– Most congresses/journals now have sections for outcomes Most congresses/journals now have sections for outcomes g jg j

researchresearch

•• A discussion of OR should be on the agenda of every pub A discussion of OR should be on the agenda of every pub planning meetingplanning meetingplanning meetingplanning meeting

•• OR should be part of every gap analysisOR should be part of every gap analysis•• Timing is keyTiming is keyg yg y

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Page 28: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

Reporting ConsiderationsReporting ConsiderationsReporting ConsiderationsReporting Considerations

OR f li OR f li d i d d d i d d •• OR often relies on nonOR often relies on non--randomized data randomized data –– Not likely to meet methodological rigor of an RCTNot likely to meet methodological rigor of an RCT

•• Detailed reporting is required forDetailed reporting is required forDetailed reporting is required forDetailed reporting is required for–– Study designStudy design–– MethodsMethods–– Treatment effectsTreatment effects–– Bias and confoundingBias and confounding

GeneralizabilityGeneralizability–– GeneralizabilityGeneralizability•• Additional details may be included in appendixAdditional details may be included in appendix

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Page 29: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

HIPAA, IRBs, and h h

HIPAA, IRBs, and h hOther Thorny IssuesOther Thorny Issues

NN i i l b i l i i i l b i l i •• NonNon--interventional, observational, or retrospective interventional, observational, or retrospective studies are not exempt from HIPAA rulesstudies are not exempt from HIPAA rules

•• Was the study reviewed, or exempted from review, by an Was the study reviewed, or exempted from review, by an Was the study reviewed, or exempted from review, by an Was the study reviewed, or exempted from review, by an IRB?IRB?

•• FDAAA currently applies to RCT. Will it apply to OR in FDAAA currently applies to RCT. Will it apply to OR in h fh fthe future?the future?

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Page 30: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

SummarySummarySummarySummary

OR i hOR i h•• OR is researchOR is research–– Requires sound methodologies, privacy protection, unbiased data Requires sound methodologies, privacy protection, unbiased data

sources, and thorough analysissources, and thorough analysisOR fill OR fill •• OR fills gapsOR fills gaps–– Helps to address questions and concerns that go beyond the scope of Helps to address questions and concerns that go beyond the scope of

registration studiesregistration studiesOR id tifi OR id tifi •• OR identifies gapsOR identifies gaps–– Helps to identify newer, more effective approaches and interventionsHelps to identify newer, more effective approaches and interventions

•• OR is publishableOR is publishable–– Growing number of guidelines and journals/venues dedicated to ORGrowing number of guidelines and journals/venues dedicated to OR

•• OR is the futureOR is the future–– CER will require continuing followCER will require continuing follow--up to remain relevantup to remain relevant

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Page 31: Integrating Health Outcomes into the Publication Plan€¦ · into useful information for healthcare decision-makers to ensure that society allocates scarce healthcare resources wisely,

BibliographyBibliographyBibliographyBibliography

•• Begg C Cho M Eastwood S Horton R Moher D Olkin I et al Improving the quality of reporting of randomized Begg C Cho M Eastwood S Horton R Moher D Olkin I et al Improving the quality of reporting of randomized •• Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. controlled trials. The CONSORT statement. JAMA.JAMA. 1996;276:6371996;276:637--99

•• Berger ML, Berger ML, MamdaniMamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: The defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: The ISPOR good research practices for retrospective database analysis task force reportISPOR good research practices for retrospective database analysis task force report——Part I. Part I. Value HealthValue Health 2009;122009;12

•• Cox E Martin BC Van Cox E Martin BC Van StaaStaa T Garbe E T Garbe E SiebertSiebert U Johnson ML Good research practices for comparative U Johnson ML Good research practices for comparative •• Cox E, Martin BC, Van Cox E, Martin BC, Van StaaStaa T, Garbe E, T, Garbe E, SiebertSiebert U, Johnson ML, Good research practices for comparative U, Johnson ML, Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of noneffectiveness research: approaches to mitigate bias and confounding in the design of non--randomized studies of randomized studies of treatment effects using secondary data sources: The ISPOR good research practices for retrospective database treatment effects using secondary data sources: The ISPOR good research practices for retrospective database analysis task forceanalysis task force––Part II. Part II. Value HealthValue Health 2009;122009;12

•• Evidence Report/Technology Assessment No. 47. Systems to rate the strength of scientific evidence. (AHRQ Evidence Report/Technology Assessment No. 47. Systems to rate the strength of scientific evidence. (AHRQ Publication No 02Publication No 02--E016)E016)Publication No. 02Publication No. 02--E016)E016)

•• Garrison Jr. LP, Neumann PJ, Erickson P, et al. Using realGarrison Jr. LP, Neumann PJ, Erickson P, et al. Using real--world data for coverage and payment decisions: The world data for coverage and payment decisions: The ISPOR realISPOR real--world data task force report. world data task force report. Value Health Value Health 2007;10:3262007;10:326--3535

•• McGhan WF, Al M, McGhan WF, Al M, DoshiDoshi JA, et al. The ISPOR good practices for quality improvement of costJA, et al. The ISPOR good practices for quality improvement of cost--effectiveness effectiveness research task force report. research task force report. Value Health.Value Health. 2009;122009;12M h D C k DJ E t d S Olki I M h D C k DJ E t d S Olki I R iR i D D StSt DF I i th lit f t f tDF I i th lit f t f t l f l f •• Moher D, Cook DJ, Eastwood S, Olkin I, Moher D, Cook DJ, Eastwood S, Olkin I, RennieRennie D, D, StroupStroup DF. Improving the quality of reports of metaDF. Improving the quality of reports of meta--analyses of analyses of randomisedrandomised controlled trials: the QUOROM statement. Quality of Reporting of Metacontrolled trials: the QUOROM statement. Quality of Reporting of Meta--analyses. analyses. Lancet.Lancet. 1999; 1999; 354:1896354:1896--900.900.

•• Moher D, Moher D, SchulzSchulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallelreports of parallel--group group randomisedrandomised trials. trials. Lancet.Lancet. 2001;357:11912001;357:1191--44

El E Alt DG E M t l Th St th i th R ti f Ob ti l St di i E id i l El E Alt DG E M t l Th St th i th R ti f Ob ti l St di i E id i l

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•• von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med.Ann Intern Med. 2007;147:5732007;147:573––77

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Thank YouThank YouThank YouThank You

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