Finding What Works in Health Care Standards for Systematic Reviews (2011) / Chapter Skim
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2 Standards for Initiating a Systematic Review
2 Standards for Initiating a Systematic Review
Pages 45-80
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From page 45... ...
However, a process should be in place to reduce the risk of bias and COI from user and stakeholder input and in the SR team. The importance of the review questions and analytic framework in guiding the entire review process demands a rigorous approach to formulating the research questions and analytic framework.
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From page 46... ...
2 On January 14, 2010, the committee held a workshop that included four panels with representatives of organizations engaged in using and/or developing systematic reviews, including SR experts, professional specialty societies, payers, and consumer groups. See Appendix C for the complete workshop agenda.
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From page 47... ...
It should be multidisciplinary, with experts in SR methodology, including risk of bias, study design, and data analysis; librarians or informa tion specialists trained in searching bibliographic databases for SRs; and clinical content experts. Other relevant users and stakeholders should be included as feasible (CRD, 2009; Higgins and Green, 2008; Slutsky et al., 2010)
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For example, review teams that are too dominated by clinical content experts are more likely to hold preconceived opinions related to the topic of the SR,
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. Research examining dynamics in clinical practice guideline (CPG)
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Based on this research, a guideline team considering interventions to prevent hip fracture in the elderly, for example, should include family physicians, internists, orthopedists, social workers, and others likely to work with the patient population at risk. The Team Leader Minimal research and guidance have been done on the leadership of SR teams.
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. The International Committee of Medical Journal Editors (ICMJE)
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. The Cochrane Collaboration, for example, requires that if a member of 4 The Patient Protection and Affordable Care Act, Public Law 111-148, 111th Cong., Subtitle D, § 6301 (March 23, 2010)
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. RECOMMENDED STANDARDS FOR ORGANIZING THE REVIEW TEAM The committee recommends two standards for organizing the review team: Standard 2.1 -- Establish a team with appropriate expertise and experience to conduct the systematic review Required elements: 2.1.1 Include expertise in pertinent clinical content areas 2.1.2 Include expertise in systematic review methods 2.1.3 Include expertise in searching for relevant evidence 2.1.4 Include expertise in quantitative methods 2.1.5 Include other expertise as appropriate Standard 2.2 -- Manage bias and conflict of interest (COI)
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From page 54... ...
Their expertise includes decisions about study design and potential for bias and influence on findings, methods to minimize bias in the SR, qualitative synthesis, quantitative methods, and issues related to data collection and data management. For SRs of comparative effectiveness research (CER)
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. Creating a clear and explicit mechanism for users and stakeholders to provide input into the SR process at multiple levels, beginning with formulating the research questions and analytic framework, is essential to achieving this purpose.
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. Consumer Involvement in Systematic Reviews.
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Key sources for 7 of the 17 organizations (AHRQ, Oregon Evidence-based Practice Center, Johns Hopkins EPC, Campbell Collaboration, Cochrane Collaboration, Cochrane Musculoskeletal Group, and Cochrane Pregnancy and Childbirth Group) reported that their organization has a process in place to involve consumers on a regular basis.
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Some key sources reported that consumers should be involved early in the SR process, such as in topic formulation and refinement and in identification of the research questions and outcomes. Others involve consumers in reviewing the draft protocol.
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The Cochrane Collaboration has conducted a review of its Consumer Network, which included process issues, and its newly hired consumer coordinator may undertake a close review of processes and impacts. The AHRQ Community Forum may also help establish more uniform standards in this area based on the results of methodological research address ing the most effective methods of involving consumers (AHRQ, 2010)
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. Payer Involvement The committee heard from representatives of several payers at its workshop6 and during a series of informal interviews with representatives from Aetna, Kaiser Permanente, Geisinger, Blue Cross and Blue Shield's Technology Evaluation Center, Centers for Medicare & Medicaid Services, and the Veterans Health Administration.
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Separation of the SR and the CPG teams, such as the approach used by NIH Consensus Development Conferences to develop evidence-based consensus statements, may guard against the CPG panel interfering in the SR methods and interpretation, but at the risk of producing an SR that is unresponsive to the guidelines team's questions. By shutting out the CPG panel from the SR process, particularly in the analysis of the evidence and preparation of the final report, this approach reduces the likelihood that the primary audience for the SR will understand the nuances of the existing evidence.
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The AHRQ EPC searches the literature, selects and extracts data from relevant studies, and summarizes the findings in evidence tables. • The evidence tables are delivered to the CPG chapter leaders: o The clinical content editors provide input into preparing, summariz ing, and interpreting the evidence.
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Teams General Models of Interaction Between Developers of SRs and CPGs More Isolatation Moderate Unified Level of • R and CPG teams confer about S • PG and SR teams collaborate at C • PG team members may conduct the C interaction key questions; firewall between various stages; a firewall is created SR; no firewall SR and CPG until a draft SR by giving the methodologists final report is produced say on interpreting the evidence Potential • eters inappropriate CPG D • elps ensure that SR research H • nsures that the SR research protocol E benefits influence over the collection protocol responds to questions and responds to questions and information and interpretation of evidence information needs of the CPG team needs of the CPG team • R team assures that prespecified S • PG team may better understand the C research protocol is followed limitations of the evidence (protecting against bias) Potential • R may not be fully responsive S • R may not be fully responsive to S • ewer protections against bias in the F drawbacks to all CPG concerns all CPG concerns SR • PG team will have only C • PG developers may lack the skills C limited understanding of the and resources needed to produce SRs body of evidence as well as CPGs 63
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From page 64... ...
, allow both SR methodologists and clinical content experts from the CPG team to have input into preparing the SR report. Bias and COI is prevented because the SR methodologists, not the clinical content experts, have final responsibility for the interpretation and presentation of the evidence (Guyatt et al., 2010)
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RECOMMENDED STANDARDS FOR ENSURING USER AND STAKEHOLDER INPUT The committee recommends two standards for ensuring user and stakeholder input in the SR process: Standard 2.3 -- Ensure user and stakeholder input as the review is designed and conducted Required element: 2.3.1. Protect the independence of the review team to make the final decisions about the design, analy sis, and reporting of the review Standard 2.4 -- Manage bias and COI for individuals providing input into the systematic review Required elements: 2.4.1.
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The type of users and stakeholders important to consult, and the decision on whether to create a formal or informal advisory group, depend on the topic and circumstances of the SR. Getting input from relevant CPG teams (as appropriate)
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FORMULATING THE TOPIC Informative and relevant SRs of CER require user and other stakeholder input as the review's research questions are being developed and designed. CER questions should address diverse populations of study participants, examine interventions that are feasible to implement in a variety of healthcare settings, and measure a broad range of health outcomes (IOM, 2009b)
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. If there is good reason to believe a treatment may work differently in diverse subpopulations, the review protocol should structure the review so that these populations are examined separately.
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. Analytic Framework An analytic framework (also called "logic framework")
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However, the analytic framework diagram may need to evolve to accurately represent SRs of CER that compare alternative treatments and interventions. Figure 2-1 shows an analytic framework for evaluating studies of a new enteral supplement to heal bedsores (Helfand and Balshem, 2010)
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RECOMMENDED STANDARDS FOR FORMULATING THE TOPIC The importance of the research questions and analytic framework in determining the entire review process demands a rigorous approach to topic formulation. The committee recommends the following standard: Standard 2.5 -- Formulate the topic for the systematic review Required elements: 2.5.1 Confirm the need for a new review 2.5.2 Develop an analytic framework that clearly lays out the chain of logic that links the health inter vention to the outcomes of interest and defines the key clinical questions to be addressed by the systematic review 2.5.3 Use a standard format to articulate each clinical question of interest 2.5.4 State the rationale for each clinical question 2.5.5 Refine each question based on user and stake holder input
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. DEVELOPING THE SYSTEMATIC REVIEW PROTOCOL The SR protocol is a detailed description of the objectives and methods of the review (CRD, 2009; Higgins and Green, 2008; Liberati et al., 2009)
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The inclusion of multiple perspectives on the review team and gathering user and stakeholder input helps prevent choices in the protocol that are based on such prior knowledge. The use of protocols in SRs is increasing, but is still not standard practice.
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The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement reflects the growing recognition of the importance of prospective registration of protocols, and requires that published SRs indicate whether a review protocol exists and if and where it can accessed (e.g., web address)
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75 STANDARDS FOR INITIATING A SYSTEMATIC REVIEW Standard 2.6 -- Develop a systematic review protocol Required elements: 2.6.1 Describe the context and rationale for the re view from both a decision-making and research perspective 2.6.2 Describe the study screening and selection criteria (inclusion/exclusion criteria) 2.6.3 Describe precisely which outcome measures, time points, interventions, and comparison groups will be addressed 2.6.4 Describe the search strategy for identifying rel evant evidence 2.6.5 Describe the procedures for study selection 2.6.6 Describe the data extraction strategy 2.6.7 Describe the process for identifying and resolving disagreement between researchers in study selec tion and data extraction decisions 2.6.8 Describe the approach to critically appraising individual studies 2.6.9 Describe the method for evaluating the body of evidence, including the quantitative and qualita tive synthesis strategy 2.6.10 Describe and justify any planned analyses of dif ferential treatment effects according to patient subgroups, how an intervention is delivered, or how an outcome is measured 2.6.11 Describe the proposed timetable for conducting the review Standard 2.7 -- Submit the protocol for peer review Required element: 2.7.1 Provide a public comment period for the protocol and publicly report on disposition of comments Standard 2.8 -- Make the final protocol publicly available, and add any amendments to the protocol in a timely fashion Rationale The majority of these required elements are consistent with leading guidance, and ensure that the protocol provides a detailed description of the objectives and methods of the review (AHRQ,
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.12 All of the leading guidance requires that the final protocol be pub 10 The elements are all discussed in more detail in Chapters 3 through 5. 11 The Patient Protection and Affordable Care Act, Public Law 111-148, 111th Cong., Subtitle D, § 6301(d)
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2010. Register of ongoing systematic reviews.
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2008. Cochrane handbook for systematic reviews of interventions.
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2005. Towards systematic reviews that inform health care management and policy making.
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2010. AHRQ Series Paper 3: Identifying, selecting, and refining topics for comparative effectiveness systematic reviews: AHRQ and the Effective Health-Care Program.
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