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Methods Guide for Effectiveness andComparative Effectiveness ReviewsJanuary 2014

Methods Guide for Effectiveness and ComparativeEffectiveness ReviewsAHRQ Publication No. 10(14)-EHC063-EFJanuary 2014

This document was written with support from the Effective Health Care Program at the Agencyfor Healthcare Research and Quality (AHRQ). None of the authors has a financial interest in anyof the products discussed in this document. The findings and conclusions in this document arethose of the authors, who are responsible for its contents; the findings and conclusions do notnecessarily represent the views of AHRQ, the Veterans Health Administration, or the HealthServices Research and Development Service. Therefore, no statement in this report should beconstrued as an official position of these entities, the U.S. Department of Health and HumanServices, or the U.S. Department of Veterans Affairs.This document is in the public domain and may be used and reprinted without permission exceptthose copyrighted materials noted for which further reproduction is prohibited without thespecific permission of copyright holders.None of the investigators have any affiliations or financial involvement that conflicts with thematerial presented in this report.Suggested citation: Methods Guide for Effectiveness and Comparative Effectiveness Reviews.AHRQ Publication No. 10(14)-EHC063-EF. Rockville, MD: Agency for Healthcare Researchand Quality. January 2014. Chapters available at: www.effectivehealthcare.ahrq.gov.ii

PrefacePrefaceEffectiveness and Comparative Effectiveness Reviews, systematic reviews of existingresearch on the effectiveness, comparative effectiveness, and comparative harms of differenthealth care interventions, are intended to provide relevant evidence to inform real-world healthcare decisions for patients, providers, and policymakers. In an effort to improve the transparency,consistency, and scientific rigor of the work of the Effective Health Care (EHC) Program,through a collaborative effort, the Agency for Healthcare Research and Quality (AHRQ), theScientific Resource Center, and the Evidence-based Practice Centers (EPCs) have developed aMethods Guide for Effectiveness and Comparative Effectiveness Reviews. We intend that thesedocuments will serve as a resource for our EPCs as well as for other investigators interested inconducting Comparative Effectiveness Reviews. This Guide presents issues key to thedevelopment of Effectiveness and Comparative Effectiveness Reviews and describesrecommended approaches for addressing difficult, frequently encountered methodological issues.The Methods Guide for Effectiveness and Comparative Effectiveness Reviews is a livingdocument and will be updated as further empiric evidence develops and our understanding ofbetter methods improves. Comments and suggestions on the Methods Guide for Effectivenessand Comparative Effectiveness Reviews and the Effective Health Care Program can be made atwww.effectivehealthcare.ahrq.gov.Richard Kronick, Ph.D.DirectorAgency for Healthcare Research and QualityJean Slutsky, P.A., M.S.P.H.Director, Center for Outcomes and EvidenceAgency for Healthcare Research and QualityStephanie Chang, M.D., M.P.H.Director, Evidence-based Practice Center ProgramAgency for Healthcare Research and Qualityiii

ContentsContentsForeword. Comparing Medical Interventions: AHRQ and the Effective Health Care Program .1Chapter 1. Principles in Developing and Applying Guidance for Comparing MedicalInterventions .5Chapter 2. Identifying, Selecting, and Refining Topics for Comparative Effectiveness SystematicReviews .15Chapter 3. Developing and Selecting Topic Nominations for Systematic Reviews.32Chapter 4. The Refinement of Topics for Systematic Reviews: Lessons and RecommendationsFrom the Effective Health Care Program .54Chapter 5. Finding Evidence for Comparing Medical Interventions .96Chapter 6. Finding Grey Literature Evidence and Assessing for Outcome and AnalysisReporting Biases When Comparing Medical Interventions: AHRQ and the Effective Health CareProgram .120Chapter 7. Avoiding Bias in Selecting Studies .163Chapter 8. Selecting Observational Studies for Comparing Medical Interventions .180Chapter 9. Assessing the Risk of Bias of Individual Studies in Systematic Reviews of HealthCare Interventions .193Chapter 10. Assessing the Applicability of Studies When Comparing Medical Interventions .222Chapter 11. Assessing Harms When Comparing Medical Interventions .236Chapter 12. Conducting Quantitative Synthesis When Comparing Medical Interventions .254Chapter 13. Expanded Guidance on Selected Quantitative Synthesis Topics .270Chapter 14. Handling Continuous Outcomes in Quantitative Synthesis .285Chapter 15. Grading the Strength of a Body of Evidence When Assessing Health CareInterventions for the Effective Health Care Program of the Agency for Healthcare Research andQuality: An Update .314Chapter 16. Using Existing Systematic Reviews To Replace De Novo Processes in ComparativeEffectiveness Reviews .349Chapter 17. Updating Comparative Effectiveness Reviews: Current Efforts in AHRQ’s EffectiveHealth Care Program.365iv

Foreword. Comparing Medical Interventions: AHRQ and the Effective Health Care ProgramOriginally Posted: October 5, 2009Foreword. Comparing Medical Interventions: AHRQand the Effective Health Care ProgramJean Slutsky, David Atkins, Stephanie Chang, Beth A. Collins SharpHealth care expenditures are growing faster than incomes for most developed countries,jeopardizing the stability of health care systems globally.1 This trend has led to interest inknowledge about the most effective use of health care worldwide. To increase the value of healthcare services, many countries have established programs or independent agencies that informhealth care decisionmaking through systematic reviews of technologies, pharmaceuticals, andother health care interventions. A few examples include the National Institute for Health andClinical Excellence (NICE) in the United Kingdom, the Institute for Quality and Efficiency inHealth Care (IQWiG) in Germany, the Haute Autorité de Santé (HAS) in France, and theCanadian Agency for Drugs and Technologies in Health (CADTH). Some internationalconsortiums and collaborations are also committed to increasing the use of evidence in healthcare decisionmaking. The Cochrane Collaboration has received international recognition for itssustained efforts at developing and disseminating systematic reviews. Additionally, HealthTechnology Assessment International (HTAi) is an organization with global membership thatpromotes evidence-based technology assessments.By any measure, health care expenditures in the United States are increasing much fasterthan the health of the population and at a faster rate than in any other industrialized nation.Driven by the same goals as other countries and organizations—improving the quality,effectiveness, and efficiency of health care delivery—the U.S. Agency for Healthcare Researchand Quality (AHRQ) created the Effective Health Care (EHC) Program in 2005.A series of articles to be presented here in upcoming months give guidance on themethods to be used in conducting systematic reviews of technologies and interventions under theEHC Program, and together they form the Methods Guide for Effectiveness and ComparativeEffectiveness Reviews. While the various international programs and agencies mentioned here areunited in their goal of providing objective assessments of effective health care interventionsthrough systematic reviews, the varied health care system environments necessitate differencesamong the programs. For example, with the presence of a universal health system, NICEconducts cost-effectiveness studies, which are more difficult in a decentralized health caresystem. It is important to understand the context, principles, and philosophies of each program oragency, since they carry implications for the various approaches, methods, and end products ofsystematic reviews from the various groups.The United States spent an estimated 1.8 trillion in 2005 on health care, including 342billion under its Medicare program, with an annual estimated cost growth of 2.4 percent abovethe Gross Domestic Product.2 Potential solutions for long-term solvency of the Medicareprogram for seniors and the disabled have been the cause of much political debate. This debateled to a series of Medicare reforms passed by Congress in 2003.3 These reforms included a newdrug benefit for seniors as well as new funding of 15 million annually for AHRQ (subsequentlydoubled to 30 million) to conduct and support research with a focus on the outcomes,comparative clinical effectiveness, and appropriateness of pharmaceuticals, devices, and healthcare services. Underlying this effort is a realization that improving value and controllingMedicare costs can be achieved only by understanding the relative effectiveness of the different1

Foreword. Comparing Medical Interventions: AHRQ and the Effective Health Care ProgramOriginally Posted: October 5, 2009health care interventions at our disposal—both old and new. The EHC Program is guided by 14priority conditions that are important to beneficiaries of the Medicare, Medicaid, and StateChildren’s Health Insurance Program but would resonate with health care programs throughoutthe world.The EHC Program involves the collaborative efforts of three major activities: systematicreview, new research, and translation of findings for different audiences. Like the majority of theprograms throughout the world, the EHC Program relies on systematic review methods toprovide guidance on the effectiveness of therapeutics. The EHC program commissions 14Evidence-based Practice Centers to perform the systematic reviews that provide an essentialfoundation from which to understand what we know from existing research and what criticalresearch gaps remain. The Evidence-based Practice Centers undertake a broad variety of reviewsthat assess the effectiveness, comparative effectiveness, and comparative harms of differenthealth care interventions. Some of these reviews are especially challenging in breadth and depthbecause the questions of most interest to decisionmakers often require complex comparisons.The EHC Program is supported by a Scientific Resource Center, which provides scientific andtechnical support to maintain consistency in the methods used across the different centers.The EHC Program reflects in many ways the decentralized nature of the U.S. health caresystem. The audience includes not only policymakers in government and private health plans butalso clinicians, patients, and members of industry, all of whom play a major role in health caredecisionmaking. All of these stakeholders provide input and guidance to the program, all maycontribute suggestions of new topics for assessment, and all have provided comments on draftsof the guidance given in this series. The EHC Program is meant to provide understandable andactionable information for patients, clinicians, and policymakers.In order to provide useful information on effective health care interventions, the EHCProgram follows three key principles that guide the EHC Program and, thus, the conduct ofsystematic reviews by the Evidence-based Practice Centers. First, reviews must be relevant andtimely in order to meet the needs of decisionmakers. The questions being addressed in reviewsmust answer emerging and complex health care questions at the time when decisionmakers needthe information. This means identifying the most important issues under the priority conditionsand the optimal time to initiate a review. It also requires a conscientious effort to complete thereview as quickly as possible without sacrificing the quality of the product.Second, reviews must be objective and scientifically rigorous. To maintain the objectivityof a review, lead authors on the reports are barred from having any significant competinginterests. In addition, although Evidence-based Practice Center staff, consultants, subcontractors,and other technical experts may not be disqualified from providing comments, they must discloseany financial, business, and professional interests that are related to the subject matter of areview or other product or that could be affected by the findings of the review. With respect tothe types of financial interests to be disclosed, AHRQ is guided by the U.S. Department ofHealth and Human Services Regulations 45 CFR Part 94. Directors of the Evidence-basedPractice Centers are responsible for the scientific integrity of all members of the review team byensuring that they comply with AHRQ policy and by providing opportunities for training inrigorous scientific methods. There are a variety of sources for training in systematic reviewscientific methods in the United States and elsewhere. In addition to having the Methods Guidefor Effectiveness and Comparative Effectiveness Reviews as a resource, AHRQ and the ScientificResource Center have regularly scheduled conference calls with Evidence-based Practice Centersand face-to-face meetings biannually to discuss scientific methods and other aspects of2

Foreword. Comparing Medical Interventions: AHRQ and the Effective Health Care ProgramOriginally Posted: October 5, 2009producing scientifically sound and credible systematic reviews. The Evidence-based PracticeCenters participate in many scientific forums, and the work they do in methods informs theprocess and helps in collaborating with the work of similar groups in other countries.Finally, public participation and transparency increase public confidence in the scientificintegrity and credibility of reviews and provide further accountability to the Evidence-basedPractice Centers. Reviews commissioned under the EHC Program are posted publicly at differentstages of the review process, including the stage of proposed Key Questions and the draft reportstage. Public posting of the processes and methodological approaches used in developingsystematic reviews ensures that the reports are accessible, clear, and credible. The publication ofthis series of methods articles in the Journal of Clinical Epidemiology and the posting of theMethods Guide for Effectiveness and Comparative Effectiveness Reviews on the EHC Web site(www.effectivehealthcare.ahrq.gov) are fundamental ways of clearly laying out the EHCapproach to conducting systematic reviews of comparative effectiveness.The Evidence-based Practice Centers’ work on Comparative Effectiveness Reviewsbuilds on nearly 10 years of experience doing systematic reviews of diverse topics, includingdrugs and devices, diagnostic tests, and health care system interventions.4 Unlike many otherprograms or agencies producing systematic reviews, which focus on evaluating individualinterventions, the AHRQ EHC Program focuses on health care questions that requirecomparisons of alternative interventions for a given clinical condition.In addition to the familiar issues raised in a systematic review or meta-analysis of a singleintervention, there are specific challenges encountered in conducting Comparative EffectivenessReviews. The methods papers in this series were written in response to these specific challenges.The aim of a Comparative Effectiveness Review is to depict how the relative benefits andharms of a range of options compare, rather than to answer a narrow question of whether a singletherapy is safe and effective. This requires a clear understanding of the clinical context to ensurethat the review focuses on the appropriate population and interventions among which cliniciansare currently choosing. As an example, our review of coronary artery bypass surgery vs.percutaneous coronary intervention for stable coronary disease focused on patients who havestable angina and two-vessel disease and on other subgroups for which clinicians might currentlyconsider either option. It did not address patients at either clinical extreme, for whom the benefitsof one option might be clear cut.There is rarely a sufficient body of head-to-head trials to support easy conclusions aboutcomparative benefits and harms. Providing useful information requires examining a broaderarray of literature, including placebo-controlled trials and observational studies; the latter areespecially useful for looking more completely at harms, adherence, and persistence. In addition,reviews may examine whether, in the absence of head-to-head trials, indirect comparisons maybe useful (e.g., comparing results of placebo-controlled trials of A and placebo-controlled trialsof B).Carefully examining the applicability of evidence is especially important. A usefulreview compares the tradeoffs of multiple alternatives, each of which may vary with theunderlying population and setting. For example, the results of trials comparing the abilities ofdifferent oral diabetes drugs to control blood glucose may depend in important ways on thepopulations being studied. Evidence on harms is often hard to determine from tightly controlledrandomized trials. Observational studies provide another check on whether results observed intrials appear to hold up under more representative settings and populations.3

Foreword. Comparing Medical Interventions: AHRQ and the Effective Health Care ProgramOriginally Posted: October 5, 2009Finally, the interpretation of the evidence and the limits of interpretation are important.Equivalence of different treatments for a group of patients on average does not necessarily implythey are equivalent for all individuals. Attempts to explore subgroups for which benefits orharms of specific interventions vary may be needed. Often, however, there is limited evidence tosupport strong conclusions about the specific benefits of a particular intervention for subgroups.The articles in this series reflect the final individual chapters of the EHC Methods Guidefor Effectiveness and Comparative Effectiveness Reviews. Written by AHRQ Evidence-basedPractice Center investigators with the intention of improving both consistency and transparencyin the EHC Program, they were initially posted as one draft document for public comment on theEHC Web site in late 2007 and have been revised in response to public comment. Where there isan inadequate empiric evidence base, the articles review the existing guidance produced bydifferent organizations and collaborations and build on these activities, focusing on issuesspecific to conducting Comparative Effectiveness Reviews. As the research methodologiesdevelop, the EHC Program will continue to assess the need to update the current Methods Guidefor Effectiveness and Comparative Effectiveness Reviews.Building a stronger empiric base for methods will i

The Methods Guide for Effectiveness and Comparative Effectiveness Reviews is a living document and will be updated as further empiric evidence develops and our understanding of better methods improves. Comments and suggestions on the Methods Guide for Effectiveness

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