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.In this review we addressed the following questions. (1) Which high-quality guidelines on chronic obstructive pulmonary disease (COPD) are available? (2) How should guidelines be adapted to the user's context and culture? (3) How should the use of guidelines be evaluated in clinical practice? and (4) How should guidelines be efficiently kept up-to-date? We did not conduct systematic reviews ourselves. We relied on a literature review published in 2006 and on a manual produced by the ADAPTE Collaboration to inform our judgments, as well as our collective experience and workshop discussions.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.

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.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.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.

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.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.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.

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence. This is the 11th of a series of 14 articles that methodologists and researchers from around the world prepared to advise guideline developers for respiratory and other diseases on how to achieve this goal. For this article, we developed five key questions and updated a review of the literature on moving from evidence to recommendations.We addressed the following specific questions.What is the strength of a recommendation and what determines the strength? What are the implications of strong and weak recommendations for patients, clinicians, and policy makers? Should guideline panels make recommendations in the face of very low-quality evidence? Under which circumstances should guideline panels make research recommendations? How should recommendations be formulated and presented? We searched PubMed and other databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on available evidence, consideration of what guideline developers are doing, and pre- and postworkshop discussions.The strength of a recommendation reflects the extent to which guideline developers can, across the range of patients for whom the recommendations are intended, be confident that the desirable effects of following the recommendation outweigh the undesirable effects. Four factors influence the strength of a recommendation: the quality of evidence supporting the recommendation, the balance between desirable and undesirable effects, the uncertainty or variability of patient values and preferences, and costs. Strong and weak (also called "conditional") recommendations have distinct implications for patients, clinicians, and policy makers. Adherence to strong recommendations or, in the case of weak (conditional) recommendations, documentation of discussion or shared decision making with a patient, might be used as quality measures or performance indicators. Clinicians desire guidance regardless of the quality of the underlying evidence. Very low-quality evidence should ideally result in either appropriately labeled recommendations (i.e., as based on very low-quality evidence) or a statement that the guideline panel did not reach consensus on the recommendation due to the lack of confidence in the effect estimates. However, guideline panels often have more resources, time, and information than practicing clinicians. Therefore, they may be in a position to use their best judgments to make recommendations even when there is very low-quality evidence, although some guideline developers disagree with this approach and prefer a general approach of not making recommendations in the face of very low-quality evidence. Guideline panels should consider making research recommendations when there is important uncertainty about the desirable and undesirable effects of an intervention, further research could reduce that uncertainty, and the potential benefits and savings of reducing the uncertainty outweigh the potential harms of not making the research recommendation. Recommendations for additional research should be as precise and specific as possible.

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.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.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.

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence with input from appropriate stakeholders. This is the ninth 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. We updated a review of the literature on stakeholder involvement, focusing on six key questions.In this review we addressed the following questions. (1) What are "stakeholders"? (2) Why involve stakeholders in guidelines? (3) At what stage should stakeholders contribute to guidelines? (4) What are the potential barriers to integrating stakeholder involvement? (5) How can stakeholders be involved effectively? (6) Should anyone be excluded from the process? We searched PubMed and other databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct our own systematic reviews. Our conclusions are based on available evidence, the experience of guideline developers, and workshop discussions.Stakeholders are all those who have a legitimate interest in a guideline. They include healthcare professionals, patients and caregivers, public and private funding bodies, managers, employers, and manufacturers. Their engagement is justified for several reasons, including limitations of evidence, principles of transparency and democracy, ownership, and potential policy implications. They have a role to play at different points of guideline development, but their involvement can be complex. To be successful, stakeholder engagement needs to be inclusive, equitable, and adequately resourced.

Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence. They are also realizing the need to involve consumers of healthcare (patients, caregivers, and the public) and integrate their values and preferences in clinical guideline development. This is the eighth of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases. It focuses on where to find information about consumer values and preferences, at what points in the guideline development process to integrate their values and preferences, and why.In this review, we addressed the following questions: (1) What do we mean by "consumers"? (2) Why integrate the values and preferences of consumers of healthcare (patients, caregivers, and the public) into clinical practice guidelines? (3) What are the sources of information on consumer values? (4) When and how should consumer values and preferences be integrated into chronic obstructive pulmonary disease guideline recommendations? We defined consumers as patients, caregivers, and members of the public, excluding groups that may also be identified as consumers of guidelines including health professionals, providers, and commissioners of services. We searched PubMed and other databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on available evidence, supplemented by a rapid appraisal of a selection of qualitative studies, experience of what guideline developers are doing, and workshop discussions.A clear distinction needs to be made between the use of information on consumer values and preferences by guideline developers, and the direct involvement of consumers in guideline development processes. Sources of information on consumer values include the research literature and direct elicitation of values both from organizations representing consumer interests and from individuals. To complement the identification of consumer values, there are a range of methods for involving consumers at all stages of guideline development, from consultation to direct membership of guideline development groups.Evidence-based guidelines need to consider explicitly the values and preferences of all relevant stakeholders (including those of consumers) and to provide opportunities for patients, caregivers, and the public to engage in the processes that consider and integrate those values into the development of guideline recommendations.

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.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.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.

Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that health care recommendations are based on the best available research evidence. This is the sixth of a series of 14 articles prepared to advise guideline developers for respiratory and other diseases on how to achieve this goal. In this article, we focused on integrating cost and resource information in guideline development and formulating recommendations focusing on four key questions.We addressed the following specific questions. (1) When is it important to incorporate costs, and/or resource implications, and/or cost-effectiveness, and/or affordability considerations in guidelines? (2) Which costs and which resource use should be considered in guidelines? (3)What sources of evidence should be used to estimate costs, resource use, and cost-effectiveness? (4) How can cost-effectiveness, resource implications, and affordability be taken into account explicitly? Our work was based on a prior review on this topic and our conclusions are based on available evidence, consideration of what guideline developers are doing, and workshop discussions.Many authorities suggest that there is a need to include explicit consideration of costs, resource use, and affordability during guideline development. Where drug use is at issue, "explicit consideration" may need to involve only noting whether the price (easily determined and usually the main component of "acquisition cost") of a drug is high or low. Complex interventions such as rehabilitation services are to a greater degree setting- and system-dependent. Resources used, and the costs of those resources, will vary among systems, and formal identification by a guideline group of the resource requirements of a complex intervention is essential. A clinical guideline usually contains multiple recommendations, and in some cases there are hundreds. Defining costs and resource use for all of them-especially for multiple settings-is unlikely to be feasible. At present, disaggregated resource utilization accompanied by some cost information seems to be the most promising approach. The method for assigning values to costs, including external or indirect cost (such as time off work), can have a significant impact on the outcome of any economic evaluation. The perspective that the guideline assumes should be made explicit. Standards for evidence for clinical data are usually good-quality trials reporting a relevant endpoint that should be summarized in a systematic review. Like others, we are therefore proposing that the ideal sources of evidence for cost and resource utilization data for guideline development are systematic reviews of randomized controlled trials that report resource utilization, with direct comparisons between the interventions of interest.