Proceedings of the American Thoracic Society
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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. Different clinical practice guidelines addressing the management of the same disease may vary widely in the evidence used and the format of the recommendations, with the result that not all are appropriate for all audiences. This is the first of a series of 14 articles that clinicians, methodologists, and researchers from around the world prepared to advise those developing guidelines in respiratory and other diseases about the potential impact of identifying the target audiences for their clinical practice guidelines. ⋯ Clinicians desire COPD and other guidelines that are concise, use evidence from practices similar to theirs, and whose authors have expertise in providing care in similar settings and with similar patients. In the case of COPD, barriers to generalists' use of guidelines include lack of awareness of the guidelines, failure to embrace the diagnostic methods as capable of providing definitive confirmation of COPD, and, most importantly, failure of previous guidelines to address the treatment of COPD in the context of the broad range of multiple morbidities that affect most people with COPD. COPD specialists may require guidelines with more details regarding complex COPD management. The purpose of the guidelines may determine the appropriate audience. Guidelines developed to improve care by enhancing education may have a very different audience than guidelines designed to improve care by limiting the scope of practice, punishing noncompliance, or saving money. The purpose will drive dissemination and implementation strategies, but should not influence the methods used to develop a guideline. Clinicians desire guidelines, but data suggest that the current development systems, content, format, and dissemination strategies may need to be altered to fit these audiences. After the purpose and audience are determined, the guideline committee must decide how to fairly address these audiences, which will usually require seeking their input.
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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. ⋯ 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.
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Both the Institute of Medicine and the Guidelines International Network have recently published standards for trustworthy guidelines. The standards address multiple aspects of guideline development, including being transparent about funding and methodology, minimizing bias related to conflicts of interest, assembling writing committees with broad stakeholder representation, using rigorous and systematic methods to synthesize evidence and formulate recommendations, and periodically assessing guidelines for currency and updating them as required. In this article, we present the perspective of the Documents Development and Implementation Committee of the American Thoracic Society (ATS) on these and other guideline-related topics of relevance to ATS members. In addition, we summarize the many important take-home messages from a workshop that was jointly sponsored by the ATS and the European Respiratory Society, and attempt to place these messages in the context of a methodology that is rapidly evolving and a landscape in which clinical practice guidelines are subjected to ever-increasing scrutiny by clinicians, patients, and other third-party stakeholders.
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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. ⋯ 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).
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Professional societies, like many other organizations, 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 last of a series of 14 articles that methodologists and researchers from around the world have prepared to advise guideline developers in respiratory and other diseases on how to achieve this. We updated a review of the literature on guideline adaptation, evaluation, and updating, focusing on four key questions. ⋯ Guideline adaptation can be seen as an alternative to de novo development and as part of an implementation process, taking into consideration the user's own context. A systematic approach should be followed to ensure high quality of the resulting guidance. On the topic of COPD, many guidelines are available. Guidelines of the Global Initiative for Chronic Obstructive Lung Disease and of the American Thoracic Society and European Respiratory Society are particularly well-suited for adaptation. The adaptation process includes (1) definition of specific questions that need to be answered by the guideline; (2) assessment of guideline quality; (3) assessment of the clinical content, validity, acceptability, applicability, and transferability of the recommendations; and (4) decisions about adoption or adaptation of the recommendations. The use of the guidelines in practice can be measured with performance indicators. Adverse effects of strict adherence to guideline recommendations should be prevented, in particular when the improvement of patient outcomes is unclear. COPD guidelines should be updated at least every 2 years. Collaboration between COPD guideline developers is recommended to prevent duplication of effort.