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Deciding What Type of Evidence and Outcomes to Include in Guidelines: Article 5 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Deciding What Type of Evidence and Outcomes to Include in Guidelines: Article 5 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Proc Am Thorac Soc. 2012 Dec;9(5):243-250

Authors: Wilt TJ, Guyatt G, Kunz R, Macnee W, Puhan MA, Viegi G, Woodhead M, Akl EA, Schünemann HJ, on behalf of the ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development

Abstract
Introduction: Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fifth of a series of 14 articles that were prepared by an international panel to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on what type of evidence and outcomes to include in guidelines. Methods: In this review we addressed the following topics and questions. (1) What methods should be used to select important outcomes? (2) What types of outcomes should be considered? (3) What sources of evidence should be considered? (4) How should the importance of outcomes be ranked? (5) How to deal with surrogate outcomes. (6) What issues related to outcomes should be considered in the evidence review? (7) What quality of evidence should be used? (8) How to interpret the effect on outcomes. (9) How to incorporate outcomes related to harm. We based our responses on a PubMed literature review, prior reviews, relevant methodological research, and workshop discussions. Results and Discussion: Guideline panels should use transparent and systematic methods to select both the evidence and important outcomes, with input from groups that represent a wide range of expertise and constituencies. Outcomes should address both benefits and downsides, with consideration of the definitions, severity, and time course of the outcomes. Guideline panels should use a transparent approach to rank outcome importance recognizing that stakeholder and patient values and preferences may vary. Intermediate and surrogate outcomes are frequently reported, but their correlation with patient important outcomes may be low. A guideline panel should determine a priori the magnitude of effect judged clinically significant, factors that may influence outcome reporting, and whether different ways of measuring the outcomes permit the outcomes to be combined. Comprehensive identification of the evidence includes the use of multiple data sources. While randomized controlled trials (RCTs) provide the highest quality evidence, reviewers of evidence also need to consider nonrandomized studies such as case series, registries, and case-control studies if randomized trials are not available. This is particularly true for harms. The outcomes reported from RCTs may not always directly apply to clinical practice settings (i.e., they may not be generalizable).

PMID: 23256166 [PubMed - as supplied by publisher]

Synthesis, Grading, and Presentation of Evidence in Guidelines: Article 7 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Synthesis, Grading, and Presentation of Evidence in Guidelines: Article 7 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Proc Am Thorac Soc. 2012 Dec;9(5):256-261

Authors: Guyatt G, Akl EA, Oxman A, Wilson K, Puhan MA, Wilt T, Gutterman D, Woodhead M, Antman EM, Schünemann HJ, on behalf of the ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development

Abstract
Introduction: Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the seventh of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on synthesizing, rating, and presenting evidence in guidelines. Methods: In this review we addressed the following questions. (1) What evidence should guideline panels use to inform their recommendations? (2) How should they rate the quality of the evidence they use? (3) How should they grade evidence regarding diagnostic tests? (4) What should they do when quality of evidence differs across outcomes? (5) How should they present the evidence in a guideline? We did not conduct systematic reviews ourselves. We relied on prior evaluations of electronic databases and systematic reviews suggesting that the Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) approach includes the desired features of a system for grading quality of evidence, including provision of models for presenting evidence for guideline panels, and for the consumers of practice guidelines. This article describes the GRADE approach to grading the quality of evidence and presenting evidence. Available evidence, the practice of leading guideline developers, and workshop discussions provide the basis for our conclusions. Results and Discussion: GRADE rates the quality of evidence for each outcome across studies rather than for each study. In the GRADE approach randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down or up. Five factors may lead to rating down the quality of evidence: study limitations or risk of bias, inconsistency of results, indirectness of evidence, imprecision, and publication bias. Three factors may lead to rating up the quality of evidence from observational studies: large magnitude of effect, dose-response gradient, and situations in which all plausible confounders would decrease an apparent treatment effect, or would create a spurious effect when results suggest no effect. GRADE suggests use of evidence profiles that provide a comprehensive way to display the key evidence relevant to a clinical question. Guideline developers who follow this structure will find the transparency of their recommendations markedly enhanced.

PMID: 23256168 [PubMed - as supplied by publisher]

How to Integrate Multiple Comorbidities in Guideline Development: Article 10 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

How to Integrate Multiple Comorbidities in Guideline Development: Article 10 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Proc Am Thorac Soc. 2012 Dec;9(5):274-281

Authors: Fabbri LM, Boyd C, Boschetto P, Rabe KF, Buist AS, Yawn B, Leff B, Kent DM, Schünemann HJ, on behalf of the ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development

Abstract
Background: Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the 10th of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases. This article deals with how multiple comorbidities (co-existing chronic conditions) may be more effectively integrated into guidelines. Methods: In this review we addressed the following topics and questions using chronic obstructive pulmonary disease (COPD) as an example. (1) How important are multiple comorbidities for guidelines? (2) How have other organizations involved in the development of guidelines for single chronic disease approached the problem of multiple comorbidities? (3) What are the implications of multiple comorbidities for pharmacological treatment? (4) What are the potential changes induced by multiple comorbidities in guidelines? (5) What are the implications of considering a population of older patients with multiple comorbidities in designing clinical trials? Our conclusions are based on available evidence from the published literature, experience from guideline developers, and workshop discussions. We did not attempt to examine all Clinical Practice Guidelines (CPGs) and relevant literature. Instead, we selected CPGs generated by prominent professional organizations and relevant literature published in widely read journals, which are likely to have a high impact on clinical practice. Results and Conclusions: A widening gap exists between the reality of the care of patients with multiple chronic conditions and the practical clinical recommendations driven by CPGs focused on a single disease, such as COPD. Guideline development panels should aim for multidisciplinary representation, especially when contemplating recommendations for individuals aged 65 years or older (who often have multiple comorbidities), and should evaluate the quality of evidence and the strength of recommendations targeted at this population. A priority area for research should be to assess the effect of multiple concomitant medications and assess how their combined effects are altered by genetic, physiological, disease-related, and other factors. One step that should be implemented immediately would be for existing COPD guidelines to add new sections to address the impact of multiple comorbidities on screening, diagnosis, prevention, and management recommendations. Research should focus on the possible interaction of multiple medications. Furthermore, genetic, physiological, disease-related, and other factors that may influence the directness (applicability) of the evidence for the target population in clinical practice guidelines should be examined.

PMID: 23256171 [PubMed - as supplied by publisher]

Reporting and Publishing Guidelines: Article 12 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Reporting and Publishing Guidelines: Article 12 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Proc Am Thorac Soc. 2012 Dec;9(5):293-297

Authors: Wilson KC, Irwin RS, File TM, Schünemann HJ, Guyatt GH, Rabe KF, on behalf of the ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development

Abstract
Introduction: Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the twelfth of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases. This article discusses the reporting and publishing of guidelines. Methods: The authors formulated and discussed the following questions on the reporting and publishing of guidelines. (1) What should be reported in guidelines? (2) How should guidelines be written? (3) How should the bottom-line message be conveyed? (4) How should guidelines be packaged? (5) Where should guidelines be published? (6) Who benefits from the publication of guidelines? (7) What information should be vetted by the editor(s)? (8) How should guidelines be peer reviewed? We conducted a review of the literature, looking for systematic reviews and methodological research that addressed these questions, but we did not conduct a full systematic review. Our conclusions are based on the available evidence from the published literature and logical arguments from experienced guideline developers. Results and Discussion: There is little empirical evidence that addresses the reporting and publishing of guidelines. A standard format for reporting guidelines is desirable to ensure that guidelines are comprehensive and that all of the information necessary to judge their quality is presented. In addition, guidelines should contain concise evidence-based recommendations. To facilitate the use of guidelines by consumers, it is preferable to publish them in journals that serve the target audience and to package them in multiple ways. Editors and peer reviewers should ensure that reporting standards have been met, potential conflicts of interest have been adequately addressed and made public, and that the recommendations address important clinical questions.

PMID: 23256173 [PubMed - as supplied by publisher]

Disseminating and Implementing Guidelines: Article 13 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Disseminating and Implementing Guidelines: Article 13 in Integrating and Coordinating Efforts in COPD Guideline Development. An Official ATS/ERS Workshop Report.

Proc Am Thorac Soc. 2012 Dec;9(5):298-303

Authors: Grimshaw JM, Schünemann HJ, Burgers J, Cruz AA, Heffner J, Metersky M, Cook D, on behalf of the ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development

Abstract
Background: Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the thirteenth of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases. This article focuses on current concepts and research evidence about how to disseminate and implement guidelines optimally on a national and international level to improve quality of care. Methods: In this article we address the following questions: What frameworks can aid guideline dissemination and implementation; what are the effects of different guideline dissemination and implementation strategies; and, what is the role of guideline developers in guideline dissemination and implementation? We identified existing systematic reviews and relevant methodological research. Our conclusions are based on evidence from published literature, experience from guideline developers, and workshop discussions. Results and Conclusions: The Knowledge to Action cycle proposed by Graham and colleagues (J Contin Educ Health Prof 2006;26:13-24) provides a useful framework for planning dissemination and implementation activities that emphasize the need for tailored approaches based on an assessment of local barriers. There are a broad range of interventions that are generally effective at improving the uptake of evidence. The best intervention depends on likely barriers, available resources, and other practical considerations. Financial interventions (such as pay for performance) appear to be as effective as other interventions that aim to change professional behavior. Guideline developers who do not have responsibility for guideline implementation in their jurisdiction should support those with responsibility for implementation by considering the "implementability" of their guidelines.

PMID: 23256174 [PubMed - as supplied by publisher]

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