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Atle Fretheim

Publications and source records attributed to Atle Fretheim.

At least 19 recordsLinked to original sources
PubMed2006

Improving the use of research evidence in guideline development: 13. Applicability, transferability and adaptation.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the thirteenth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on applicability, transferability, and adaptation of guidelines. METHODS: We searched five databases for existing systematic reviews and relevant primary methodological research. We reviewed the titles of all citations and retrieved abstracts and full text articles if the citations appeared relevant to the topic. We checked the reference lists of articles relevant to the questions and used snowballing as a technique to obtain additional information. We used the definition "coming from, concerning or belonging to at least two or all nations" for the term international. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We did not identify systematic reviews addressing the key questions. We found individual studies and projects published in the peer reviewed literature and on the Internet. Should WHO develop international recommendations? Resources for developing high quality recommendations are limited. Internationally developed recommendations can facilitate access to and pooling of resources, reduce unnecessary duplication, and involve international scientists. Priority should be given to international health problems and problems that are important in low and middle-income countries, where these advantages are likely to be greatest. Factors that influence the transferability of recommendations across different settings should be considered systematically and flagged, including modifying factors, important variation in needs, values, costs and the availability of resources. What should be done centrally and locally? The preparation of systematic reviews and evidence profiles should be coordinated centrally, in collaboration with organizations that produce systematic reviews. Centrally developed evidence profiles should be adaptable to specific local circumstances. Consideration should be given to models that involve central coordination with work being undertaken by centres located throughout the world. While needs, availability of resources, costs, the presence of modifying factors and values need to be assessed locally, support for undertaking these assessments may be needed to make guidelines applicable. WHO should provide local support for adapting and implementing recommendations by developing tools, building capacity, learning from international experience, and through international networks that support evidence-informed health policies, such as the Evidence-informed Policy Network (EVIPNet). How should recommendations be adapted? WHO should provide detailed guidance for adaptation of international recommendations. Local adaptation processes should be systematic and transparent, they should involve stakeholders, and they should report the key factors that influence decisions, including those flagged in international guidelines, and the reasons for any modifications that are made.

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PubMed2006

Improving the use of research evidence in guideline development: 14. Reporting guidelines.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the 14th of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on reporting guidelines and recommendations. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: There is little empirical evidence that addresses these questions. Our answers are based on logical arguments and standards put forward by other groups. What standard types of recommendations or reports should WHO use? WHO should develop standard formats for reporting recommendations to facilitate recognition and use by decision makers for whom the recommendations are intended, and to ensure that all the information needed to judge the quality of a guideline, determine its applicability and, if needed, adapt it, is reported. WHO should develop standard formats for full systematically developed guidelines that are sponsored by WHO, rapid assessments, and guidelines that are endorsed by WHO. All three formats should include the same information as full guidelines, indicating explicitly what the group preparing the guideline did not do, as well as the methods that were used. These formats should be used across clinical, public health and health systems recommendations. How should recommendations be formulated and reported? Reports should be structured, using headings that correspond to those suggested by the Conference on Guideline Standardization or similar headings. The quality of evidence and strength of recommendations should be reported explicitly using a standard approach. The way in which recommendations are formulated should be adapted to the specific characteristics of a specific guideline. Urgent attention should be given to developing a template that provides decision makers with the relevant global evidence that is needed to inform a decision and offers practical methods for incorporating the context specific evidence and judgements that are needed.

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PubMed2006

Improving the use of research evidence in guideline development: 15. Disseminating and implementing guidelines.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the 15th of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: In this review we address strategies for the implementation of recommendations in health care. METHODS: We examined overviews of systematic reviews of interventions to improve health care delivery and health care systems prepared by the Cochrane Effective Practice and Organisation of Care (EPOC) group. We also conducted searches using PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: What should WHO do to disseminate and facilitate the uptake of recommendations? WHO should choose strategies to implement their guidelines from among those which have been evaluated positively in the published literature on implementation research Because the evidence base is weak and modest to moderate effects, at best, can be anticipated, WHO should promote rigorous evaluations of implementation strategies. What should be done at headquarters, by regional offices and in countries? Adaptation and implementation of WHO guidelines should be done locally, at the national or sub-national level. WHO headquarters and regional offices should support the development and evaluation of implementation strategies by local authorities.

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PubMed2006

Improving the use of research evidence in guideline development: 16. Evaluation.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised 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 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on evaluating guidelines and recommendations, including their quality, whether they are likely to be up-to-date, and their implementation. We also considered the role of guideline developers in undertaking evaluations that are needed to inform recommendations. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: Our answers to these questions were informed by a review of instruments for evaluating guidelines, several studies of the need for updating guidelines, discussions of the pros and cons of different research designs for evaluating the implementation of guidelines, and consideration of the use of uncertainties identified in systematic reviews to set research priorities. How should the quality of guidelines or recommendations be appraised? WHO should put into place processes to ensure that both internal and external review of guidelines is undertaken routinely. A checklist, such as the AGREE instrument, should be used. The checklist should be adapted and tested to ensure that it is suitable to the broad range of recommendations that WHO produces, including public health and health policy recommendations, and that it includes questions about equity and other items that are particularly important for WHO guidelines. When should guidelines or recommendations be updated? Processes should be put into place to ensure that guidelines are monitored routinely to determine if they are in need of updating. People who are familiar with the topic, such as Cochrane review groups, should do focused, routine searches for new research that would require revision of the guideline. Periodic review of guidelines by experts not involved in developing the guidelines should also be considered. Consideration should be given to establishing guideline panels that are ongoing, to facilitate routine updating, with members serving fixed periods with a rotating membership. How should the impact of guidelines or recommendations be evaluated? WHO headquarters and regional offices should support member states and those responsible for policy decisions and implementation to evaluate the impact of their decisions and actions by providing advice regarding impact assessment, practical support and coordination of efforts. Before-after evaluations should be used cautiously and when there are important uncertainties regarding the effects of a policy or its implementation, randomised evaluations should be used when possible. What responsibility should WHO take for ensuring that important uncertainties are addressed by future research when the evidence needed to inform recommendations is lacking? Guideline panels should routinely identify important uncertainties and research priorities. This source of potential priorities for research should be used systematically to inform priority-setting processes for global research.

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PubMed2006

Improving the use of research evidence in guideline development: 8. Synthesis and presentation of evidence.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the eighth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on the synthesis and presentation of research evidence, focusing on four key questions. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We found two reviews of instruments for critically appraising systematic reviews, several studies of the importance of using extensive searches for reviews and determining when it is important to update reviews, and consensus statements about the reporting of reviews that informed our answers to the following questions. How should existing systematic reviews be critically appraised? Because preparing systematic reviews can take over a year and require capacity and resources, existing reviews should be used when possible and updated, if needed. Standard criteria, such as A MeaSurement Tool to Assess Reviews (AMSTAR), should be used to critically appraise existing systematic reviews, together with an assessment of the relevance of the review to the questions being asked. When and how should WHO undertake or commission new reviews? Consideration should be given to undertaking or commissioning a new review whenever a relevant, up-to-date review of good quality is not available. When time or resources are limited it may be necessary to undertake rapid assessments. The methods that are used to do these assessments should be reported, including important limitations and uncertainties and explicit consideration of the need and urgency of undertaking a full systematic review. Because WHO has limited capacity for undertaking systematic reviews, reviews will often need to be commissioned when a new review is needed. Consideration should be given to establishing collaborating centres to undertake or support this work, similar to what some national organisations have done. How should the findings of systematic reviews be summarised and presented to committees responsible for making recommendations? Concise summaries (evidence tables) of the best available evidence for each important outcome, including benefits, harms and costs, should be presented to the groups responsible for making recommendations. These should include an assessment of the quality of the evidence and a summary of the findings for each outcome. The full systematic reviews, on which the summaries are based, should also be available to both those making recommendations and users of the recommendations. What additional information is needed to inform recommendations and how should this information be synthesised with information about effects and presented to committees? Additional information that is needed to inform recommendations includes factors that might modify the expected effects, need (prevalence, baseline risk or status), values (the relative importance of key outcomes), costs and the availability of resources. Any assumptions that are made about values or other factors that may vary from setting to setting should be made explicit. For global guidelines that are intended to inform decisions in different settings, consideration should be given to using a template to assist the synthesis of information specific to a setting with the global evidence of the effects of the relevant interventions.

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PubMed2006

Improving the use of research evidence in guideline development: 9. Grading evidence and recommendations.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the ninth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on grading evidence and recommendations in guidelines. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct a full systematic review ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: Should WHO grade the quality of evidence and the strength of recommendations? Users of recommendations need to know how much confidence they can place in the underlying evidence and the recommendations. The degree of confidence depends on a number of factors and requires complex judgments. These judgments should be made explicitly in WHO recommendations. A systematic and explicit approach to making judgments about the quality of evidence and the strength of recommendations can help to prevent errors, facilitate critical appraisal of these judgments, and can help to improve communication of this information. What criteria should be used to grade evidence and recommendations? Both the quality of evidence and the strength of recommendations should be graded. The criteria used to grade the strength of recommendations should include the quality of the underlying evidence, but should not be limited to that. The approach to grading should be one that has wide international support and is suitable for a wide range of different types of recommendations. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which is currently suggested in the Guidelines for WHO Guidelines, is being used by an increasing number of other organizations internationally. It should be used more consistently by WHO. Further developments of this approach should ensure its wide applicability. Should WHO use the same grading system for all of its recommendations? Although there are arguments for and against using the same grading system across a wide range of different types of recommendations, WHO should use a uniform grading system to prevent confusion for developers and users of recommendations.

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PubMed2006

Improving the use of research evidence in guideline development: 10. Integrating values and consumer involvement.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised 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 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on integrating values and consumers in guideline development. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We reviewed the titles of all citations and retrieved abstracts and full text articles if the citations appeared relevant to the topic. We checked the reference lists of articles relevant to the questions and used snowballing as a technique to obtain additional information. We did not conduct a full systematic review ourselves. Our conclusions based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We did not find a systematic review of methods for integrating values in guidelines, but we found several systematic reviews that dealt with related topics. Whose values should WHO use when making recommendations? Values, the relative importance or worth of a state or consequences of a decision (outcomes relating to benefits, harms, burden and costs), play a role in every recommendation. Ethical considerations, concepts that determine what is right, also play a role. The values used in making recommendations should reflect those of the people affected. Judgements should be explicit and should be informed by input from those affected (including citizens, patients, clinicians and policy makers). When differences in values may lead to different decisions or there is uncertainty about values, this should also be explicit. If differences in values are likely to affect a decision, such that people in different setting would likely make different choices about interventions or actions based on differences in their values, global recommendations should be explicit in terms of which values were applied and allow for adaptation after incorporating local values. How should WHO ensure that appropriate values are integrated in recommendations? All WHO guideline groups should uniformly apply explicit, transparent and clearly described methods for integrating values. WHO should consider involving relevant stakeholders if this is feasible and efficient. WHO should develop a checklist for guidelines panels to help them to ensure that ethical considerations relevant to recommendations are addressed explicitly and transparently. How should users and consumers be involved in generating recommendations? Including consumers in groups that are making global recommendations presents major challenges with respect to the impossibility of including a representative spectrum of consumers from a variety of cultures and settings. Nonetheless, consideration should be given to including consumers in groups who are able to challenge assumptions that are made about the values used for making recommendations, rather than represent the values of consumers around the world. WHO should establish a network to facilitate involvement of users. Draft recommendations should be reviewed by consumers, who should be asked explicitly to consider the values that were used. How should values be presented in recommendations? Recommendations should include a description of how decisions were made about the relative importance of the consequences (benefits, harms and costs) of a decision. Values that influence recommendations should be reported along with the research evidence underlying recommendations. When differences in values would lead to different decisions or there is important uncertainty about values that are critical to a decision, this should be flagged and reflected in the strength of the recommendation. Adaptable guideline templates that allow for integration of different values should be developed and used when differences in values are likely to be critical to a decision.

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PubMed2006

Improving the use of research evidence in guideline development: 12. Incorporating considerations of equity.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the 12th of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on incorporating considerations of equity in guidelines and recommendations. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We found few directly relevant empirical methodological studies. These answers are based largely on logical arguments. When and how should inequities be addressed in systematic reviews that are used as background documents for recommendations? The following question should routinely be considered: Are there plausible reasons for anticipating differential relative effects across disadvantaged and advantaged populations? If there are plausible reasons for anticipating differential effects, additional evidence should be included in a review to inform judgments about the likelihood of differential effects. What questions about equity should routinely be addressed by those making recommendations on behalf of WHO? The following additional questions should routinely be considered: How likely is it that the results of available research are applicable to disadvantaged populations and settings? How likely are differences in baseline risk that would result in differential absolute effects across disadvantaged and advantaged populations? How likely is it that there are important differences in trade-offs between the expected benefits and harms across disadvantaged and advantaged populations? Are there different implications for disadvantaged and advantaged populations, or implications for addressing inequities? What context specific information is needed to inform adaptation and decision making in a specific setting with regard to impacts on equity? Those making recommendations on behalf of WHO should routinely consider and offer advice about the importance of the following types of context specific data that might be needed to inform adaptation and decision making in a specific setting: Effect modifiers for disadvantaged populations and for the likelihood of differential effects. Baseline risk in relationship to social and economic status. Utilization and access to care in relationship to social and economic status. Costs in relationship to social and economic status. Ethics and laws that may impact on strategies for addressing inequities. Availability of resources to address inequities. What implementation strategies are likely be needed to ensure that recommendations are implemented equitably? Organisational changes are likely to be important to address inequities. While it may only be possible to consider these in relationship to specific settings, consideration should be given to how best to provide support for identifying and addressing needs for organisational changes. In countries with pervasive inequities institutional, cultural and political changes may first be needed. Appropriate indicators of social and economic status should be used to monitor the effects of implementing recommendations on disadvantaged populations and on changes in social and economic status.

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PubMed2006

Improving the use of research evidence in guideline development: 5. Group processes.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised 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 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVE: In this review we address approaches to facilitate sound processes within groups that develop recommendations for health care. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTION AND ANSWER: What should WHO do to ensure appropriate group processes? Various strategies can be adopted to ensure that the group processes in play when panels are developing recommendations are inclusive, so that all voices can be heard and all arguments given fair weight, including the use of formal consensus development methods, such at the Nominal Group Technique or the Delphi method; the selection of a group leader who is qualified and responsible for facilitating an appropriate group process.

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PubMed2006

Improving the use of research evidence in guideline development: 6. Determining which outcomes are important.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the sixth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on determining which outcomes are important for the development of guidelines. METHODS: We searched five databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct a complete systematic review ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We did not find a systematic review that addresses any of the following key questions and we found limited relevant research evidence. What methods should WHO use to identify important outcomes? Methods of outcome identification should be transparent and explicit. The consultation process should start with identification of all relevant outcomes associated with an intervention. Those affected, including consumers, should be involved in the selection of outcomes. A question driven approach (what is important?) is preferable to a data driven approach (what data are at hand?) to identify important outcomes. What type of outcomes should WHO consider and how should cultural diversity be taken account of in the selection of outcomes? Desirable (benefits, less burden and savings) and undesirable effects should be considered in all guidelines. Undesirable effects include harms (including the possibility of unanticipated adverse effects), greater burden (e.g. having to go to the doctor) and costs (including opportunity costs). Important outcomes (e.g. mortality, morbidity, quality of life) should be preferred over surrogate, indirect outcomes (e.g. cholesterol levels, lung function) that may or may not correlate with patient important outcomes. Ethical considerations should be part of the evaluation of important outcomes (e.g. impacts on autonomy). If the importance of outcomes is likely to vary across cultures, stakeholders from diverse cultures should be consulted and involved in the selection of outcomes. How should the importance of outcomes be ranked? Outcomes should be ranked by relative importance, separated into benefits and downsides. Information from research on values and preferences should inform the ranking of outcomes whenever possible. If the importance of outcomes is likely to vary across cultures, ranking of outcomes should be done in specific settings. If evidence is lacking for an important outcome, this should be acknowledged, rather than ignoring the outcome.

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PubMed2006

Improving the use of research evidence in guideline development: 7. Deciding what evidence to include.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised 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 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on what constitutes "evidence" in guidelines and recommendations. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTION AND ANSWERS: We found several systematic reviews that compared the findings of observational studies with randomised trials, a systematic review of methods for evaluating bias in non-randomised trials and several descriptive studies of methods used in systematic reviews of population interventions and harmful effects. What types of evidence should be used to address different types of questions? The most important type of evidence for informing global recommendations is evidence of the effects of the options (interventions or actions) that are considered in a recommendation. This evidence is essential, but not sufficient for making recommendations about what to do. Other types of required evidence are largely context specific. The study designs to be included in a review should be dictated by the interventions and outcomes being considered. A decision about how broad a range of study designs to consider should be made in relationship to the characteristics of the interventions being considered, what evidence is available, and the time and resources available. There is uncertainty regarding what study designs to include for some specific types of questions, particularly for questions regarding population interventions, harmful effects and interventions where there is only limited human evidence. Decisions about the range of study designs to include should be made explicitly. Great caution should be taken to avoid confusing a lack of evidence with evidence of no effect, and to acknowledge uncertainty. Expert opinion is not a type of study design and should not be used as evidence. The evidence (experience or observations) that is the basis of expert opinions should be identified and appraised in a systematic and transparent way.

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PubMed2006

Improving the use of research evidence in guideline development: 2. Priority setting.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the second of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on priority setting for health care guidelines, recommendations and technology assessments. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: There is little empirical evidence to guide the choice of criteria and processes for establishing priorities, but there are broad similarities in the criteria that are used by various organisations and practical arguments for setting priorities explicitly rather than implicitly, WHAT CRITERIA SHOULD BE USED TO ESTABLISH PRIORITIES?: WHO has limited resources and capacity to develop recommendations. It should use these resources where it has the greatest chance of improving health, equity, and efficient use of healthcare resources. We suggest the following criteria for establishing priorities for developing recommendations based on WHO's aims and strategic advantages: Problems associated with a high burden of illness in low and middle-income countries, or new and emerging diseases. No existing recommendations of good quality. The feasibility of developing recommendations that will improve health outcomes, reduce inequities or reduce unnecessary costs if they are implemented. Implementation is feasible, will not exhaustively use available resources, and barriers to change are not likely to be so high that they cannot be overcome. Additional priorities for WHO include interventions that will likely require system changes and interventions where there might be a conflict in choices between individual and societal perspectives. WHAT PROCESSES SHOULD BE USED TO AGREE ON PRIORITIES?: The allocation of resources to the development of recommendations should be part of the routine budgeting process rather than a separate exercise. Criteria for establishing priorities should be applied using a systematic and transparent process. Because data to inform judgements are often lacking, unmeasured factors should also be considered--explicitly and transparently. The process should include consultation with potential end users and other stakeholders, including the public, using well-constructed questions, and possibly using Delphi-like procedures. Groups that include stakeholders and people with relevant types of expertise should make decisions. Group processes should ensure full participation by all members of the group. The process used to select topics should be documented and open to inspection. SHOULD WHO HAVE A CENTRALISED OR DECENTRALISED PROCESS?: Both centralised and decentralised processes should be used. Decentralised processes can be considered as separate "tracks". Separate tracks should be used for considering issues for specific areas, populations, conditions or concerns. The rationales for designating special tracks should be defined clearly; i.e. why they warrant special consideration. Updating of guidelines could also be considered as a separate "track", taking account of issues such as the need for corrections and the availability of new evidence.

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PubMed2006

Improving the use of research evidence in guideline development: 3. Group composition and consultation process.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the third of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVE: In this review we address the composition of guideline development groups and consultation processes during guideline development. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: What should be the composition of a WHO-panel that is set up to develop recommendations? The existing empirical evidence suggests that panel composition has an impact on the content of the recommendations that are made. There is limited research evidence to guide the exact composition of a panel. Based on logical arguments and the experience of other organisations we recommend the following: Groups that develop guidelines or recommendations should be broadly composed and include important stakeholders such as consumers, health professionals that work within the relevant area, and managers or policy makers. Groups should include or have access to individuals with the necessary technical skills, including information retrieval, systematic reviewing, health economics, group facilitation, project management, writing and editing. Groups should include or have access to content experts. To work well a group needs an effective leader, capable of guiding the group in terms of the task and process, and capable of facilitating collaboration and balanced contribution from all of the group members. Because many group members will not be familiar with the methods and processes that are used in developing recommendations, groups should be offered training and support to help ensure understanding and facilitate active participation.What groups should be consulted when a panel is being set up?We did not identify methodological research that addressed this question, but based on logical arguments and the experience of other organisations we recommend that as many relevant stakeholder groups as practical should be consulted to identify suitable candidates with an appropriate mix of perspectives, technical skills and expertise, as well as to obtain a balanced representation with respect to regions and gender. What methods should WHO use to ensure appropriate consultations? We did not find any references that addressed issues related to this question. Based on logical arguments and the experience of other organisations we believe that consultations may be desirable at several stages in the process of developing guidelines or recommendations, including: Identifying and setting priorities for guidelines and recommendations, commenting on the scope of the guidelines or recommendations, commenting on the evidence that is used to inform guidelines or recommendations, commenting on drafts of the guidelines or recommendations, commenting on plans for disseminating and supporting the adaptation and implementation of the guidelines or recommendations, key stakeholder organisations should be contacted directly whenever possible, consultation processes should be transparent and should encourage feedback from interested parties.

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PubMed2006

Improving the use of research evidence in guideline development: 1. Guidelines for guidelines.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the first of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on guidelines for the development of guidelines. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We found no experimental research that compared different formats of guidelines for guidelines or studies that compared different components of guidelines for guidelines. However, there are many examples, surveys and other observational studies that compared the impact of different guideline development documents on guideline quality. WHAT HAVE OTHER ORGANIZATIONS DONE TO DEVELOP GUIDELINES FOR GUIDELINES FROM WHICH WHO CAN LEARN?: Establish a credible, independent committee that evaluates existing methods for developing guidelines or that updates existing ones. Obtain feedback and approval from various stakeholders during the development process of guidelines for guidelines. Develop a detailed source document (manual) that guideline developers can use as reference material. WHAT SHOULD BE THE KEY COMPONENTS OF WHO GUIDELINES FOR GUIDELINES?: Guidelines for guidelines should include information and instructions about the following components: 1) Priority setting; 2) Group composition and consultations; 3) Declaration and avoidance of conflicts of interest; 4) Group processes; 5) Identification of important outcomes; 6) Explicit definition of the questions and eligibility criteria ; 7) Type of study designs for different questions; 8) Identification of evidence; 9) Synthesis and presentation of evidence; 10) Specification and integration of values; 11) Making judgments about desirable and undesirable effects; 12) Taking account of equity; 13) Grading evidence and recommendations; 14) Taking account of costs; 15) Adaptation, applicability, transferability of guidelines; 16) Structure of reports; 17) Methods of peer review; 18) Planned methods of dissemination & implementation; 19) Evaluation of the guidelines. WHAT HAVE OTHER ORGANIZATIONS DONE TO IMPLEMENT GUIDELINES FOR GUIDELINES FROM WHICH WHO CAN LEARN?: Obtain buy-in from regions and country level representatives for guidelines for guidelines before dissemination of a revised version. Disseminate the guidelines for guidelines widely and make them available (e.g. on the Internet). Develop examples of guidelines that guideline developers can use as models when applying the guidelines for guidelines. Ensure training sessions for those responsible for developing guidelines. Continue to monitor the methodological literature on guideline development.

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PubMed2006

Improving the use of research evidence in guideline development: introduction.

In 2005 the World Health Organisation (WHO) asked its Advisory Committee on Health Research (ACHR) for advice on ways in which WHO can improve the use of research evidence in the development of recommendations, including guidelines and policies. The ACHR established the Subcommittee on the Use of Research Evidence (SURE) to collect background documentation and consult widely among WHO staff, international experts and end users of WHO recommendations to inform its advice to WHO. We have prepared a series of reviews of methods that are used in the development of guidelines as part of this background documentation. We describe here the background and methods of these reviews, which are being published in Health Research Policy and Systems together with this introduction.

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PubMed2006

Rational Prescribing in Primary care (RaPP): process evaluation of an intervention to improve prescribing of antihypertensive and cholesterol-lowering drugs.

BACKGROUND: A randomised trial of a multifaceted intervention for improving adherence to clinical practice guidelines for the pharmacological management of hypertension and hypercholesterolemia increased prescribing of thiazides, but detected no impact on the use of cardiovascular risk assessment tools or achievement of treatment targets. We carried out a predominantly quantitative process evaluation to help explain and interpret the trial-findings. METHODS: Several data-sources were used including: questionnaires completed by pharmacists immediately after educational outreach visits, semi-structured interviews with physicians subjected to the intervention, and data extracted from their electronic medical records. Multivariate regression analyses were conducted to explore the association between possible explanatory variables and the observed variation across practices for the three main outcomes. RESULTS: The attendance rate during the educational sessions in each practice was high; few problems were reported, and the physicians were perceived as being largely supportive of the recommendations we promoted, except for some scepticism regarding the use of thiazides as first-line antihypertensive medication. Multivariate regression models could explain only a small part of the observed variation across practices and across trial-outcomes, and key factors that might explain the observed variation in adherence to the recommendations across practices were not identified. CONCLUSION: This study did not provide compelling explanations for the trial results. Possible reasons for this include a lack of statistical power and failure to include potential explanatory variables in our analyses, particularly organisational factors. More use of qualitative research methods in the course of the trial could have improved our understanding.

Journal Article↗
PubMed2006

Rational prescribing in primary care (RaPP): a cluster randomized trial of a tailored intervention.

BACKGROUND: A gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease. METHODS AND FINDINGS: We conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1) first-time prescriptions for hypertension where thiazides were prescribed, (2) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals. The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95% confidence interval 1.49-2.49, adjusted for baseline differences and clustering effect). Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals. CONCLUSIONS: Our tailored intervention had a significant impact on prescribing of antihypertensive drugs, but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care.

Anticholesteremic Agents↗
PubMed2006

Rational prescribing in primary care (RaPP): economic evaluation of an intervention to improve professional practice.

BACKGROUND: Interventions designed to narrow the gap between research findings and clinical practice may be effective, but also costly. Economic evaluations are necessary to judge whether such interventions are worth the effort. We have evaluated the economic effects of a tailored intervention to support the implementation of guidelines for the use of antihypertensive and cholesterol-lowering drugs. The tailored intervention was evaluated in a randomized trial, and was shown to significantly increase the use of thiazides for patients started on antihypertensive medication, but had little or no impact on other outcomes. The increased use of thiazides was not expected to have an impact on health outcomes. METHODS AND FINDINGS: We performed cost-minimization and cost-effectiveness analyses on data from a randomized trial involving 146 general practices from two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Only patients that were being started on antihypertensive medication were included in the analyses. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders. Pharmacists conducted the visits. A cost-minimization framework was adopted, where the costs of intervention were set against the reduced treatment costs (principally due to increased use of thiazides rather than more expensive medication). The cost-effectiveness of the intervention was estimated as the cost per additional patient being started on thiazides. The net annual cost (cost minimization) in our study population was 53,395 US dollars, corresponding to 763 US dollars per practice. The cost per additional patient started on thiazides (cost-effectiveness) was 454 US dollars. The net annual savings in a national program was modeled to be 761,998 US dollars, or 540 US dollars per practice after 2 y. In this scenario the savings exceeded the costs in all but two of the sensitivity analyses we conducted, and the cost-effectiveness was estimated to be 183 US dollars. CONCLUSIONS: We found a significant shift in prescribing of antihypertensive drugs towards the use of thiazides in our trial. A major reason to promote the use of thiazides is their lower price compared to other drugs. The cost of the intervention was more than twice the savings within the time frame of our study. However, we predict modest savings over a 2-y period.

Anticholesteremic Agents↗