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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.

Journal Article↗

[The German Guideline Clearinghouse on Breast Cancer: the need for frequent updating of breast cancer guidelines requires effective guideline updating procedures].

In order to promote the quality of health care and guidelines in Germany the German Guideline Clearinghouse (Sponsors: German Medical Association, National Association of the Statutory Health Insurance Physicians, German Hospital Federation, Associations of the Sickness Funds and the Statutory Pension Insurance) was established at the Agency for Quality in Medicine (AQuMed) in 1999. The results of the 10th Guideline Clearing Project, the Guideline Clearing Report "Breast Cancer", were published in December 2003. In a systematic search using English/German language guideline databases and literature databases (Medline, Healthstar, Embase), 16 national guidelines were identified which were in accordance to the inclusion criteria (breast cancer treatment; German or English language; published after 1992; new guideline or genuine update (no adaptation); recommended for country-wide implementation). The methodological quality of these 16 guidelines was evaluated using the appraisal instrument of the German Guideline Clearinghouse, the checklist "Methodological Quality of Clinical Practice Guidelines". A peer review of the guidelines was performed by a multidisciplinary focus group of experts (intended guideline users from clinical and ambulatory settings as well as patients). This group consented comments and recommendations for actions of health care policy makers in Germany for a German breast cancer guideline based on examples from the appraised guidelines. None of the identified guidelines contained information about all of the 24 key topics that the focus group considered to be relevant for a German national guideline. The selected exemplary text extracts from the evaluated guidelines can be used as benchmarks and example sources for the development of a national German breast cancer guideline. From the beginning, patients should be involved in the development process within a multidisciplinary team. Due to the rapid emergence of new evidence, oncology guidelines need an effective procedure for updating in order to ensure that they are able to promote health care quality by giving current recommendations based on best available evidence. International networks such as the Guidelines International Network (G-I-N) will be helpful to collect and appraise the evidence for the national guideline development groups in an effective way.

Breast Neoplasms↗

[A guideline for guidelines--methodological report and use of the guideline women's information].

UNLABELLED: Information and education is needed to empower autonomy and self-determination of patients (informed consent). Furthermore reliable and accurate medical information is necessary for patients who want to take an active part in medical decision-making. The aim of this work is to define the requirements helping to assure the development of good qualified information material relevant for women and female patients as "a guideline on women information". An example of its use is given by embeding this guideline in the guideline for early detection of breast cancer in Germany by defining the specific elements required for developing qualified information on this issue for women. METHODS: A systematic, stepwise methodological process according to a level two guideline of the German Association of the Scientific Medical Societies (AWMF) and the Agency for Quality in Medicine (AZQ) was performed with the following elements: 1. Establishing an expert panel, 2. Generating the guideline statements by a formal, consensus based nominal group process, 3. External review process and finding supportive partners for the guideline on women information, 4. Using the guideline for guidelines: implementing the concept in the guideline of early detection of breast cancer in Germany. RESULTS: The "guideline women information" comprises nine elements of quality assuring requirements for the development of gender-specific information material and eleven specific elements which directly relate to the guideline statements on early detection of breast cancer. After external review 30 organisations gave their written support for future implementation of the guideline. The "guideline women information" was integrated as a tool for quality assurance of lay information into the "guideline for early detection of breast cancer in Germany". CONCLUSION: The "guideline women information" is a systematically developed, consensus-based recommendation to improve the development of qualified lay information at the point of its process by defining gender-specific aspects required for good lay information and its evaluation. As a guideline for guidelines its use is demonstrated by integrating this guideline into the "guideline for early detection of breast cancer in Germany" to ensure the development of qualified guideline compliant information.

Breast Neoplasms↗

Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature.

CONTEXT: Practice guidelines play an important role in medicine. Methodological principles have been formulated to guide their development. OBJECTIVE: To determine whether practice guidelines in peer-reviewed medical literature adhered to established methodological standards for practice guidelines. DESIGN: Structured review of guidelines published from 1985 through June 1997 identified by a MEDLINE search. MAIN OUTCOME MEASURES: Mean number of standards met based on a 25-item instrument and frequency of adherence. RESULTS: We evaluated 279 guidelines, published from 1985 through June 1997, produced by 69 different developers. Mean overall adherence to standards by each guideline was 43.1% (10.77/25). Mean (SD) adherence to methodological standards on guideline development and format was 51.1% (25.3%); on identification and summary of evidence, 33.6% (29.9%); and on the formulation of recommendations, 46% (45%). Mean adherence to standards by each guideline improved from 36.9% (9.2/25) in 1985 to 50.4% (12.6/25) in 1997 (P<.001). However, there was little improvement over time in adherence to standards on identification and summary of evidence from 34.6% prior to 1990 to 36.1 % after 1995 (P = .11). There was no difference in the mean number of standards satisfied by guidelines produced by subspecialty medical societies, general medical societies, or government agencies (P = .55). Guideline length was positively correlated with adherence to methodological standards (P = .001). CONCLUSION: Guidelines published in the peer-reviewed medical literature during the past decade do not adhere well to established methodological standards. While all areas of guideline development need improvement, greatest improvement is needed in the identification, evaluation, and synthesis of the scientific evidence.

Peer Review, Research↗

From guideline modeling to guideline execution: defining guideline-based decision-support services.

We describe our task-based approach to defining the guideline-based decision-support services that the EON system provides. We categorize uses of guidelines in patient-specific decision support into a set of generic tasks--making of decisions, specification of work to be performed, interpretation of data, setting of goals, and issuance of alert and reminders--that can be solved using various techniques. Our model includes constructs required for representing the knowledge used by these techniques. These constructs form a toolkit from which developers can select modeling solutions for guideline task. Based on the tasks and the guideline model, we define a guideline-execution architecture and a model of interactions between a decision-support server and clients that invoke services provided by the server. These services use generic interfaces derived from guideline tasks and their associated modeling constructs. We describe two implementations of these decision-support services and discuss how this work can be generalized. We argue that a well-defined specification of guideline-based decision-support services will facilitate sharing of tools that implement computable clinical guidelines.

Asthma↗

Primary prevention of ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council: cosponsored by the Atherosclerotic Peripheral Vascular Disease Interdisciplinary Working Group; Cardiovascular Nursing Council; Clinical Cardiology Council; Nutrition, Physical Activity, and Metabolism Council; and the Quality of Care and Outcomes Research Interdisciplinary Working Group: the American Academy of Neurology affirms the value of this guideline.

BACKGROUND AND PURPOSE: This guideline provides an overview of the evidence on various established and potential stroke risk factors and provides recommendations for the reduction of stroke risk. METHODS: Writing group members were nominated by the committee chair on the basis of each writer's previous work in relevant topic areas and were approved by the American Heart Association Stroke Council's Scientific Statement Oversight Committee. The writers used systematic literature reviews (covering the time period since the last review published in 2001 up to January 2005), reference to previously published guidelines, personal files, and expert opinion to summarize existing evidence, indicate gaps in current knowledge, and when appropriate, formulate recommendations based on standard American Heart Association criteria. All members of the writing group had numerous opportunities to comment in writing on the recommendations and approved the final version of this document. The guideline underwent extensive peer review before consideration and approval by the AHA Science Advisory and Coordinating Committee. RESULTS: Schemes for assessing a person's risk of a first stroke were evaluated. Risk factors or risk markers for a first stroke were classified according to their potential for modification (nonmodifiable, modifiable, or potentially modifiable) and strength of evidence (well documented or less well documented). Nonmodifiable risk factors include age, sex, low birth weight, race/ethnicity, and genetic factors. Well-documented and modifiable risk factors include hypertension, exposure to cigarette smoke, diabetes, atrial fibrillation and certain other cardiac conditions, dyslipidemia, carotid artery stenosis, sickle cell disease, postmenopausal hormone therapy, poor diet, physical inactivity, and obesity and body fat distribution. Less well-documented or potentially modifiable risk factors include the metabolic syndrome, alcohol abuse, drug abuse, oral contraceptive use, sleep-disordered breathing, migraine headache, hyperhomocysteinemia, elevated lipoprotein(a), elevated lipoprotein-associated phospholipase, hypercoagulability, inflammation, and infection. Data on the use of aspirin for primary stroke prevention are reviewed. CONCLUSIONS: Extensive evidence is available identifying a variety of specific factors that increase the risk of a first stroke and providing strategies for reducing that risk.

Brain Ischemia↗

Do guidelines matter? Implementation of the ACG and AGA osteoporosis screening guidelines in inflammatory bowel disease (IBD) patients who meet the guidelines' criteria.

OBJECTIVE: The American College of Gastroenterology (ACG) and American Gastroenterology Association (AGA) have both recently issued guidelines (the "Guidelines") regarding the diagnosis and management of osteoporosis in patients with inflammatory bowel disease (IBD). The objective of this study was to determine the yield of implementing the Guidelines' recommendations in a prospective cohort of IBD patients and identify the prevalence of bone loss, risk factors, and potential influence on management. METHODS: One hundred consecutive IBD patients who fulfilled the Guidelines' criteria underwent dual energy X-ray absorptiometry scanning (DEXA) scanning of the lumbar vertebrae and bilateral hips. Demographic data, risk factor information, and changes in therapy based on screening were collected and analyzed. RESULTS: Indications for screening were history of prolonged past or concurrent steroid use (92%), postmenopausal status (7%), and history of low trauma fracture (7%). Forty-four percent of patients had osteopenia of either the lumbar spine or the hips, 12% had osteoporosis of either the spine or hips, and 44% had normal bone density. In a univariate analysis, factors predicting a greater likelihood of osteoporosis (but not osteopenia) were a diagnosis of Crohn's disease (vs. ulcerative colitis), low body mass index in women, and postmenopausal status. Specific therapies based on DEXA findings were initiated in 69% of patients: oral calcium and vitamin D supplementation in 69% and an oral bisphoshphonate in 20%. CONCLUSIONS: Implementation of the Guidelines led to the detection of osteopenia or osteoporosis and initiation of specific therapies in a majority of patients who met the Guidelines' criteria for DEXA screening.

Absorptiometry, Photon↗