Comparative Effectiveness Review Methods
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Comparative Effectiveness Review Methods
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Author : U. S. Department of Health and Human Services
language : en
Publisher: Createspace Independent Pub
Release Date : 2013-05-17
Comparative Effectiveness Review Methods written by U. S. Department of Health and Human Services and has been published by Createspace Independent Pub this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-17 with Medical categories.
The Agency for Healthcare Research and Quality (AHRQ) commissioned the RTI International–University of North Carolina at Chapel Hill (RTI-UNC) Evidence-based Practice Center (EPC) to explore how systematic review groups have dealt with clinical heterogeneity and to seek out best practices for addressing clinical heterogeneity in systematic reviews (SRs) and comparative effectiveness reviews (CERs). Such best practices, to the extent they exist, may enable AHRQ's EPCs to address critiques from patients, clinicians, policymakers, and other proponents of health care about the extent to which “average” estimates of the benefits and harms of health care interventions apply to individual patients or to small groups of patients sharing similar characteristics. Such users of reviews often assert that EPC reviews typically focus on broad populations and, as a result, often lack information relevant to patient subgroups that are of particular concern to them. More important, even when EPCs evaluate literature on homogeneous groups, there may be varying individual treatment for no apparent reason, indicating that average treatment effect does not point to the best treatment for any given individual. Thus, the health care community is looking for better ways to develop information that may foster better medical care at a “personal” or “individual” level. To address our charge for this methods project, the EPC set out to answer six key questions (KQ). Key questions for methods report on clinical heterogeneity include: 1. What is clinical heterogeneity? a. How has it been defined by various groups? b. How is it distinct from statistical heterogeneity? c. How does it fit with other issues that have been addressed by the AHRQ Methods Manual for CERs? 2. How have systematic reviews dealt with clinical heterogeneity in the key questions? a. What questions have been asked? b. How have they pre-identified population subgroups with common clinical characteristics that modify their intervention-outcome association? c. What are best practices in key questions and how these subgroups have been identified? 3. How have systematic reviews dealt with clinical heterogeneity in the review process? a. What do guidance documents of various systematic review groups recommend? b. How have EPCs handled clinical heterogeneity in their reviews? c. What are best practices in searching for and interpreting results for particular subgroups with common clinical characteristics that may modify their intervention-outcome association? 4. What are critiques in how systematic reviews handle clinical heterogeneity? a. What are critiques from specific reviews (peer and public) on how EPCs handled clinical heterogeneity? b. What general critiques (in the literature) have been made against how systematic reviews handle clinical heterogeneity? 5. What evidence is there to support how to best address clinical heterogeneity in a systematic review? 6. What questions should an EPC work group on clinical heterogeneity address? Heterogeneity (of any type) in EPC reviews is important because its appearance suggests that included studies differed on one or more dimensions such as patient demographics, study designs, coexisting conditions, or other factors. EPCs then need to clarify for clinical and other audiences, collectively referred to as stakeholders, what are the potential causes of the heterogeneity in their results. This will allow the stakeholders to understand whether and to what degree they can apply this information to their own patients or constituents. Of greatest importance for this project was clinical heterogeneity, which we define as the variation in study population characteristics, coexisting conditions, cointerventions, and outcomes evaluated across studies included in an SR or CER that may influence or modify the magnitude of the intervention measure of effect (e.g., odds ratio, risk ratio, risk difference).
Comparative Effectiveness Review Methods
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Author :
language : en
Publisher:
Release Date : 2010
Comparative Effectiveness Review Methods written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with categories.
OBJECTIVES: The Agency for Healthcare Research and Quality (AHRQ) funded the RTI International--University of North Carolina at Chapel Hill Evidence-based Practice Center to determine best practices for addressing clinical heterogeneity in systematic reviews (SRs) and comparative effectiveness reviews (CERs). These best practices address critiques from patients, clinicians, policymakers, and others who assert that SRs typically focus on broad populations and, as a result, often lack information relevant to individual patients or patient subgroups. DATA SOURCES AND METHODS: We used numerous data sources. We abstracted information from guidance documents prepared by U.S. and international organizations engaged in preparing reviews. We searched MEDLINE(r) to identify studies on how to handle clinical heterogeneity and subgroup analyses. We reviewed more than 120 SRs conducted by AHRQ's Evidence-based Practice Centers (EPCs), the Cochrane Collaboration, the Drug Effectiveness Review Project, the United Kingdom's National Institute for Health and Clinical Excellence and others that we identified from the Centre for Reviews and Dissemination Database of Abstracts of Reviews of Effects and Health Technology Assessment. We reviewed peer and public review comments from AHRQ's Scientific Review Center for three CERs, and we conducted key informant interviews with authors of six SRs prepared by AHRQ's EPCs or international organizations. RESULTS: Clinical heterogeneity has been defined as the variation in study population characteristics, coexisting conditions, cointerventions, and outcomes evaluated across studies included in an SR or CER that may influence or modify the magnitude of the intervention measure of effect (e.g., odds ratio, risk ratio, risk difference). Statistical heterogeneity is defined as variability in the observed treatment effects beyond what would be expected by random error. The review organizations we studied varied in their inclusion of factors, in terms of the key questions and analysis that may modify the treatment-outcome association. They tended to give more consideration to demographic factors than to disease factors (e.g., disease severity, risk factors, coexisting disease, or cointerventions). Individual systematic reviewers whom we interviewed preferred a priori identification of effect modifiers to post hoc determination because of the latter's data-dredging nature and the possibility of type 1 error when many subgroups are evaluated. Many publications that we identified through our literature searches did indicate that analysis of individual patient-level data in meta-analyses does allow better assessment of clinical heterogeneity, but the time, cost, and difficulty in obtaining these data are often prohibitive. CONCLUSIONS: Identifying factors that may influence the treatment-outcome association is important to clinicians and patients because it helps them understand which patients will benefit most, who is least likely to benefit, and who is at greatest risk of experiencing adverse outcomes. Clear evidence-based guidance on addressing clinical heterogeneity in SRs and CERs is not available currently but would be valuable to AHRQ's EPCs and to others conducting SRs internationally.
Developing A Protocol For Observational Comparative Effectiveness Research A User S Guide
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Author : Agency for Health Care Research and Quality (U.S.)
language : en
Publisher: Government Printing Office
Release Date : 2013-02-21
Developing A Protocol For Observational Comparative Effectiveness Research A User S Guide written by Agency for Health Care Research and Quality (U.S.) and has been published by Government Printing Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-21 with Medical categories.
This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Methods Guide For Effectiveness And Comparative Effectiveness Reviews
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Author :
language : en
Publisher:
Release Date : 2008
Methods Guide For Effectiveness And Comparative Effectiveness Reviews written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with categories.
Comparative Effectiveness Reviews are systematic reviews of existing research on the effectiveness, comparative effectiveness, and harms of different health care interventions. They provide syntheses of relevant evidence to inform real-world health care decisions for patients, providers, and policymakers. Strong methodologic approaches to systematic review improve the transparency, consistency, and scientific rigor of these reports. Through a collaborative effort of the Effective Health Care (EHC) Program, the Agency for Healthcare Research and Quality (AHRQ), the EHC Program Scientific Resource Center, and the AHRQ Evidence-based Practice Centers have developed a Methods Guide for Comparative Effectiveness Reviews. This Guide presents issues key to the development of Comparative Effectiveness Reviews and describes recommended approaches for addressing difficult, frequently encountered methodological issues. The Methods Guide for 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 Comparative Effectiveness Reviews and the Effective Health Care Program can be made at www.effectivehealthcare.ahrq.gov.
Methods In Comparative Effectiveness Research
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Author : Constantine Gatsonis
language : en
Publisher: CRC Press
Release Date : 2017-02-24
Methods In Comparative Effectiveness Research written by Constantine Gatsonis and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-24 with Mathematics categories.
Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies—experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections—causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.
Methods Guide For Effectiveness And Comparative Effectiveness Reviews
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Author : Agency for Healthcare Research and Quality (US)
language : en
Publisher:
Release Date : 2008
Methods Guide For Effectiveness And Comparative Effectiveness Reviews written by Agency for Healthcare Research and Quality (US) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Evidence-Based Practice categories.
Finding What Works In Health Care
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-07-20
Finding What Works In Health Care written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-07-20 with Medical categories.
Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.
Methods Guide For Effectiveness And Comparative Effectiveness Reviews
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Author : Agency for Healthcare Research and Quality
language : en
Publisher:
Release Date : 2008
Methods Guide For Effectiveness And Comparative Effectiveness Reviews written by Agency for Healthcare Research and Quality and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with categories.
Reporting The Findings Of Updated Systematic Reviews Of Comparative Effectiveness
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Author : Sydne J. Newberry
language : en
Publisher:
Release Date : 2013
Reporting The Findings Of Updated Systematic Reviews Of Comparative Effectiveness written by Sydne J. Newberry and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with categories.
BACKGROUND: To remain useful, comparative effectiveness reviews (CERs) and other systematic reviews require periodic updating. Although several studies have been conducted assessing when and how to update, no research has been conducted on optimal formats for presenting the results to users. The aim of the present study was to gather the input of various users of CERS regarding the usability of a range of formatting methods for showing the changes from the original to the update report. METHODS: Using the executive summaries of a comparative effectiveness review our Evidence-based Practice Center conducted in 2001 and the update review we conducted in 2008, we initially created five different versions of the update summary. Each succeeding version used a different format to show changes from the original to the update report (e.g., new and retired Key Questions, changes in search strategies and inclusion/exclusion criteria) and changes in the findings. To test the five differently formatted summaries, we identified several categories of users of CERs, convened an informal virtual focus group comprising various users, and asked them to evaluate the summaries on several dimensions, first via an email questionnaire and then in a group conference call where we presented the results of the questionnaire. Based on group feedback, we created two additional versions and tested them in a second focus group and among a third small group. The rationales for the selection of formats were two-fold: to imitate, and thus evaluate, the formats used by several organizations whose role is to conduct systematic reviews and updates and to create and test novel formats in response to users' suggestions. RESULTS: Policymakers who rely on CERs and other systematic reviews as the basis for policy (including health insurance companies, health care organizations, research funders, and guideline makers) expressed the need to see changes in review process as well as outcomes clearly marked, (with changes in outcomes and conclusions preferably shown in graphic form), while at the same time having access to the entire set of data and the analyses on which the conclusions were based. The small group of clinicians preferred to see the skeleton of the report (Key Questions, conceptual framework, inclusion/exclusion criteria) as well as the outcomes and conclusions presented entirely in graphic form for ease of reading. CONCLUSIONS: Different users of CERs clearly have different information needs. Yet whereas policymakers need access to the entire data set and analyses that comprise a systematic review (the original and the update), all users benefit from summaries that clearly show what changed in as succinct a format as possible, preferable in graphic form.
Finding What Works In Health Care
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-06-20
Finding What Works In Health Care written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-06-20 with Medical categories.
Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.