The James Lind Initiative: books, websites and databases to promote critical thinking about treatment claims, 2003 to 2018.

BACKGROUND: The James Lind Initiative (JLI) was a work programme inaugurated by Iain Chalmers and Patricia Atkinson to press for better research for better health care. It ran between 2003 and 2018, when Iain Chalmers retired. During the 15 years of its existence, the JLI developed three strands of work in collaboration with the authors of this paper, and with others. WORK THEMES: The first work strand involved developing a process for use by patients, carers and clinicians to identify shared priorities for research - the James Lind Alliance. The second strand was a series of articles, meetings, prizes and other developments to raise awareness of the massive amounts of avoidable waste in research, and of ways of reducing it. The third strand involved using a variety of approaches to promote better public and professional understanding of the importance of research in clinical practice and public health. JLI work on the first two themes has been addressed in previously published reports. This paper summarises JLI involvement during the 15 years of its existence in giving talks, convening workshops, writing books, and creating websites and databases to promote critical thinking about treatment claims. CONCLUSION: During its 15-year life, the James Lind Initiative worked collaboratively with others to create free teaching and learning resources to help children and adults learn how to recognise untrustworthy claims about the effects of treatments. These resources have been translated in more than twenty languages, but much more could be done to support their uptake and wider use.

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.

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.

Moving from evidence to developing recommendations in guidelines: article 11 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

INTRODUCTION: 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. METHODS: 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. RESULTS AND DISCUSSION: 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.

Tailored Implementation For Chronic Diseases (TICD): a project protocol.

BACKGROUND: The assumption underlying tailoring is that implementation interventions are most helpful if these effectively address the most important determinants of practice for improvement in the targeted setting. The aim of the Tailored Implementation For Chronic Diseases (TICD) project is to develop valid and efficient methods of tailoring implementation interventions to determinants of practice for knowledge implementation in chronic illness care. METHODS: The TICD project has organized the planned empirical research in three work packages that follow the three main steps of tailoring: identification of determinants of healthcare practice, matching implementation interventions to identified determinants of practice, and applying and assessing the tailored implementation interventions. These three key steps of tailored implementation will be applied to targeted chronic conditions in five different healthcare systems: cardiovascular disease in the Netherlands, obesity in England, depression in Norway, chronic obstructive pulmonary disease in Poland, and multimorbidity in Germany. The design and interpretation of empirical research will be informed by systematic reviews of previous research on tailoring implementation interventions. DISCUSSION: The TICD project will provide much needed evidence on the advantages and disadvantages of different methods of identifying important determinants of practice and selecting implementation strategies that take account of those. It will also provide five rigorous evaluations of tailored implementation interventions for five different chronic conditions.

Towards systematic reviews that inform health care management and policy-making.

OBJECTIVES: To identify ways to improve the usefulness of systematic reviews for health care managers and policy-makers that could then be evaluated prospectively. METHODS: We systematically reviewed studies of decision-making by health care managers and policy-makers, conducted interviews with a purposive sample of them in Canada and the United Kingdom (n = 29), and reviewed the websites of research funders, producers/purveyors of research, and journals that include them among their target audiences (n = 45). RESULTS: Our systematic review identified that factors such as interactions between researchers and health care policy-makers and timing/timeliness appear to increase the prospects for research use among policy-makers. Our interviews with health care managers and policy-makers suggest that they would benefit from having information that is relevant for decisions highlighted for them (e.g. contextual factors that affect a review's local applicability and information about the benefits, harms/risks and costs of interventions) and having reviews presented in a way that allows for rapid scanning for relevance and then graded entry (such as one page of take-home messages, a three-page executive summary and a 25-page report). Managers and policy-makers have mixed views about the helpfulness of recommendations. Our analysis of websites found that contextual factors were rarely highlighted, recommendations were often provided and graded entry formats were rarely used. CONCLUSIONS: Researchers could help to ensure that the future flow of systematic reviews will better inform health care management and policy-making by involving health care managers and policy-makers in their production and better highlighting information that is relevant for decisions. Research funders could help to ensure that the global stock of systematic reviews will better inform health care management and policy-making by supporting and evaluating local adaptation processes such as developing and making available online more user-friendly 'front ends' for potentially relevant systematic reviews.

[Guidelines in general practice--are they read and are they used?]. / Retningslinjer for allmennpraksis--blir de lest og blir de brukt?

BACKGROUND: Many guidelines are not developed from systematic models and are not based on high-quality evidence. The existence of a guideline does not in itself lead to changes in practice and many guidelines are not used once they have been issued. MATERIAL AND METHODS: A questionnaire on continuing education and the use of guidelines was sent to 1500 general practitioners (GP) and GP assistants in 1321 general practices in Norway. 857 GPs and 948 GP assistants returned the questionnaire. RESULTS: There was a large variation in the extent to which guidelines were known and used. Many GPs and GP assistants had little knowledge of guidelines published in the Journal of the Norwegian Medical Association or by the Norwegian Medicines Agency, the Norwegian Board of Health or the Norwegian Centre for Health Technology Assessment. There were exceptions: 52% of GPs used the Norwegian College of General Practitioners' treatment programme for diabetes and 77% of GP assistants used the Norwegian quality assurance programme for laboratory services in primary care. INTERPRETATION: Guidelines should be based on the best available evidence but this in itself is not enough to ensure that they are adhered to. Effective strategies for implementation are also important.

[What do general practitioners do to keep themselves up to date?]. / Hva gjør fastleger for å holde seg faglig oppdatert?

BACKGROUND: Continuing education should ensure that a doctor provides effective care based on the best available evidence. But not all continuing education is equally effective. MATERIAL AND METHODS: A questionnaire on continuing education was sent to 1500 general practitioners (GPs) in Norway. The response rate was 58%. RESULTS: GPs spent on average 2.3 hours per week on continuing education. Discharge reports were used daily for continuing education by 75% of GPs and represented 10% of the total time spent on continuing education in a 30-day period. Courses were not used so often but took up a lot of time when attended. Traditional lectures accounted for 80% of course instruction. Learning something new and improving practice were the two most important objectives for participating in continuing education. Around every second GP participated in a small group of colleagues. INTERPRETATION: GPs spend a lot of time on continuing education activities that research has shown to have little or no effect on practice. It is essential that the activities used are evaluated to a much greater extent than what they are now.

[How do general practice assistants keep themselves up to date?]. / Hva gjør fastlegenes medarbeidere for å holde seg faglig oppdatert?

BACKGROUND: The opportunities for continuing education among general practice (GP) assistants vary because of their dependence on their employers' attitudes and interests. Not all available continuing education activities are equally effective. The purpose of this study was to describe GP assistants' use of a range of quality improvement and continuing education activities, especially with regard to how much time was spent on each activity and how often the activities were used. MATERIAL AND METHODS: A questionnaire was sent to GP assistants in 1321 general practices. RESULTS: 948 GP assistants returned the questionnaires. They spent on average one hour per week on continuing education. The primary activities were discussions with colleagues (daily), and meetings with pharmaceutical industry representatives (weekly). The use of courses was relatively modest; more than half of them were organised by pharmaceutical companies. Learning something new, improving practice and personal development were the most important motives for participating in continuing education. INTERPRETATION: The opportunities for continuing education available to GP assistants vary a great deal and are to a large extent left to the pharmaceutical industry. Many if not most of the opportunities available cannot be expected to lead to changes in practice. Those responsible for general practice - GPs as well as the health authorities--should ensure that GP assistants have a wider and better range of options for continuing education.