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PubMed2003

[The German guideline clearing-project on bronchial asthma-part 1: Methodology and results of formal appraisal].

BACKGROUND: In order to promote quality of asthma management in Germany, a national asthma guidelines clearing project was initiated in 2000 by the German Guidelines Clearinghouse (Sponsors: German Medical Association (GMA), National Association of the Statutory Health Insurance Physicians (NASHIP), German Hospital Federation, Federal Association of the Statutory Sickness Funds. Part 1 of this article shows the methodology and the results of the appraisal, part 2 (to be published) shows the key topics which should be dealt with in a german guideline on bronchial asthma. OBJECTIVES: To identify and compare evidence-based, high-quality German- and English language asthma guidelines as benchmarks for ongoing guideline development and implementation programmes. To disseminate information about asthma guidelines developed in accordance with current methodological know-how. To identify and consent key topics for a national evidence-based guideline for Germany. METHODS: Search procedure, formal appraisal: Systematic search using literature databases (XMED, incl. Medline and Embase) and English-/German-language guideline databases (via www. leitlinien.de), published between January 1990 and March 2000. Abstract screening of the search results according to the inclusion criteria (n = 54 of a total of 502 hits). Methodological guideline evaluation of 16 guidelines using the German checklist for methodological guideline appraisal. Appraisal of guidelines' contents: Peer review of guidelines with the following inclusion criteria: Bronchial Asthma-general, German and English language, based in references published later than 1994, new guideline or actual update. Peer review was performed by a multidisciplinary focus group of EBM experts (clinical and ambulatory settings). No expert was involved in guideline production during the review period. RESULTS: Methodological appraisal: 16 out of guidelines were in accordance with the formal minimal standard with a wide range within the following domains: "description of the development process", "declaration of authors' independence", "explicit link between recommendations and the supporting evidence", "management options", "tools for implementation". The focus group recommended for future national asthma guidelines to rely on the following procedures: (1) to formulate the recommendations using standardized, clearly described consensus methods basing on evidence retrieved and selected in a systematic way (2) to prove links between recommendations and supporting evidence (3) to develop guideline versions for health care professionals as well as for consumer/patients (4) to develop guideline-based education tools (5) to ensure periodical updates of the asthma guideline (6) to consider the methodological recommendations and to give reasons for deviations from the methodological recommendations. APPRAISAL OF GUIDELINES CONTENT: None of the guidelines identified comprised information about all of the following key topics considered to be relevant for a German national guideline by the focus group: (1) intended guideline users/goals, (2) definition (3) cause of disease, (4) form of disease, (5) severity, (6) diagnosis, (7) therapeutic goals, (8) prevention, (9) pharmacotherapy, (10) non-pharmacotherapy, (11) therapy control and compliance, (12) emergency treatment, (13) rehabilitation, (14) comorbidity, (15) special aspects, (16) coordination of care, (17) quality assurance/quality management, (18) implementation. SUMMARY POINTS: For quality promotion of bronchial asthma management in Germany, the development of a national evidence-based guideline, using the internationally accepted quality criteria for clinical practice guidelines, was recommended by an expert group of the German Guideline Clearinghouse. The experts identified and peer-reviewed 16 out of 54 guidelines, which might be useful as benchmarks and examples for a German asthma guideline. From the peer review results, the expert group identified 18 key topics for a national asthma guideline.

Asthma↗
PubMedDate not supplied

An independent AGREE evaluation of the Occupational Medicine Practice Guidelines.

BACKGROUND AND CONTEXT: A large number of practice guidelines are being produced by numerous organizations. Health-care professionals need to critically evaluate these practice guidelines to understand whether they are well constructed and representative of the preponderance of evidence. The guideline development process should be precise and rigorous to ensure that the results are reproducible and not vague. PURPOSE: To evaluate the quality of the second edition of the practice guidelines published by the American College of Occupational and Environmental Medicine (ACOEM Guidelines). STUDY DESIGN/SETTING: Four appraisers used the AGREE (Appraisal of Guidelines Research and Evaluation) guideline evaluation instrument to evaluate the ACOEM Guidelines. METHODS: The Guidelines were evaluated with the AGREE guideline evaluation instrument. The AGREE instrument has been widely adopted around the world, and the authors recommended that it be adopted as the standard of guideline construction process evaluation in the United States. The instrument standardizes the quantitative assessment of quality for a guideline's development process across six domains that include: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, application, and editorial independence. Scores from four assessors were collected and interpreted. Additionally, each evaluator selected one of four global assessment choices: "strongly recommended for use in practice," "recommended for use with some modification or proviso," "not recommended as suitable for use in practice," or "unsure". RESULTS: The ACOEM Guidelines scored highest in the dimensions that evaluated reporting of the guideline's scope and purpose (79.63) as well as clarity and presentation (86.81). The guideline scored much lower in the remaining areas that included stakeholder involvement (46.06), rigor of development (26.59), application (31.48), and editorial independence (19.17). The global assessment was unanimous with all four evaluators assessing the guideline as recommend with proviso. CONCLUSIONS: Many of the Guidelines recommendations were consistent with current literature and guidelines; however, the AGREE assessment instrument evaluates the guideline development process and not the content. All the evaluators thought the content of the guidelines was substantially better than the documentation of the guideline construction process. The ACOEM Guidelines appear to have content consistent with their stated objectives, but the reporting of the guidelines construction process, particularly the rigor of recommendation development, is flawed, and the recommendations may not be valid owing to possible evidence selection deficiencies. The reader should consider these flaws and limitations when using the guideline. The reader should consider utilizing guidelines of higher quality when possible. Future guidelines should incorporate better reporting and give closer attention to guideline construction.

Attitude of Health Personnel↗
PubMed2001

How to develop cost-conscious guidelines.

BACKGROUND: Clinical guidelines, defined as 'systematically developed statements to assist both practitioner and patient decisions in specific circumstances', have become an increasingly familiar part of clinical care. Guidelines are viewed as useful tools for making care more consistent and efficient and for closing the gap between what clinicians do and what scientific evidence supports. Interest in clinical guidelines is international and has its origin in issues faced by most healthcare systems: rising healthcare costs; variations in service delivery with the presumption that at least some of this variation stems from inappropriate care; the intrinsic desire of healthcare professionals to offer, and patients to receive, the best care possible. Within the UK, there is ongoing interest in the development of guidelines and a fast-developing clinical-effectiveness agenda within which guidelines figure prominently. Over the last decade, the methods of developing guidelines have steadily improved, moving from solely consensus methods to methods that take explicit account of relevant evidence. However, UK guidelines have tended to focus on issues of effectiveness and have not explicitly considered broader issues, particularly cost. This report describes the methods developed to handle benefit, harm and cost concepts in clinical guidelines. It reports a series of case studies, each describing the development of a clinical guideline; each case study illustrates different issues in incorporating these different types of evidence. HEALTH ECONOMICS AND CLINICAL GUIDELINES: There has been no widely accepted successful way of incorporating economic considerations into guidelines. Unlike other areas of guideline development, there is little practical or theoretical experience to direct the incorporation of cost issues within clinical guidelines. However, the reasons for considering costs are clearly stated: "health interventions are not free, people are not infinitely rich, and the budgets of [health care] programmes are limited. For every dollar's worth of health care that is consumed, a dollar will be paid. While these payments can be laundered, disguised or hidden, they will not go away" (Eddy DM. A manual for assessing health practices and designing practice policies: the explicit approach. Philadelphia: American College of Physicians; 1992). Such opportunity costs are a universal phenomenon. In the USA it has been recommended that every set of clinical guidelines should include information on the cost implications of the alternative preventive, diagnostic, and management strategies for each clinical situation. The stated rationale was that this information would help potential users to evaluate better the potential consequences of different practices. However, it was acknowledged that "the reality is that this recommendation poses major methodological and practical challenges" (Institute of Medicine. Guidelines for clinical practice: from development to use. Washington: National Academy Press; 1992). METHODS OF DEVELOPING CLINICAL GUIDELINES: A guideline development process summarises the technical information about the value of treatments in a manner that makes them accessible and ready for use in clinical practice, alongside information on contextual issues. The requirement is that the presentation of costs and benefits of treatments is methodologically sound, robust and accessible. This report includes a summary of the current best practice in evidence-based guideline development, including recent methodological advances. The manner in which cost and cost-effectiveness concepts have been successfully incorporated into the guideline process is introduced. GUIDELINE DEVELOPMENT CASE STUDIES: The 'cost-effectiveness' sections of 11 guidelines are reported to illustrate both the range of methods used and the nature of the recommendations reached by the guideline development groups when considering the profile of consequences of treatments including costs. These guidelines are broadly grouped as: (1) those using qualitative evidence summary methods; (2) those using quantitative evidence summary methods and addressing relatively narrow clinical questions; (3) those using quantitative evidence summary methods and addressing a broad clinical area; (4) a guideline based upon a decision analysis model. CONCLUSIONS: The focus of this project was to explore the methods of incorporating cost issues within clinical guidelines. However, the process of reviewing evidence in guideline development groups is becoming increasingly sophisticated, not only in considerations of cost but also in review techniques and group process. At the outset of the project it was unclear how narrowly or broadly the concept of 'cost' could be considered. (ABSTRACT TRUNCATED)

Arthritis↗
PubMed2003

Assessment of the scope and quality of clinical practice guidelines in lung cancer.

STUDY OBJECTIVES: To provide an evidence-based background for developing the American College of Chest Physicians (ACCP) lung cancer guidelines, a systematic review of the literature was performed to identify published lung cancer guidelines and evaluate their quality. DESIGN, SETTING, AND PARTICIPANTS: A systematic search was performed for relevant literature from MEDLINE, Cancerlit, CINAHL, HealthStar, the Cochrane Library, and the National Guidelines Clearinghouse published from January 1989 to July 2001. MEASUREMENT AND RESULTS: From 369 citations, 51 relevant guidelines were identified. Each guideline was evaluated by at least four reviewers using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument and was coded for clinical topics covered. The recommendations included in each guideline also were abstracted. Of the 51 guidelines evaluated, 27 (53%) were evidence-based. Clinical topics identified by the ACCP for their guideline effort each were represented by at least one existing guideline. Of the 880 clinical recommendations abstracted from the guidelines, only 253 (29%) were evidence-based. The AGREE instrument rates guidelines along six domains. As a group, the guidelines performed well in the scope and purpose domain, with only six guidelines (12%) scoring < 50%. For the remaining domains, however, the guidelines did not perform as well, as follows: for stakeholder involvement, 41 guidelines (80%) scored < 50%; for rigor of development, 29 guidelines (57%) scored < 50%; for clarity and presentation, 17 guidelines (33%) scored < 50%; for applicability, 46 guidelines (90%) scored < 50%; and for editorial independence, 47 guidelines (92%) scored < 50%. After considering the domain scores, the reviewers recommended only 19 of the guidelines (37%). CONCLUSIONS: All major clinical lung cancer topics are covered by at least one guideline, but no single guideline addresses all areas. Furthermore, although existing guidelines may accurately reflect clinical practice, most performed poorly when evaluated for quality. Future guideline efforts that address each item of the AGREE instrument would add substantially to the literature.

Consensus↗
PubMed2002

Quality and methods of developing practice guidelines.

BACKGROUND: It is not known whether there are differences in the quality and recommendations between evidence-based (EB) and consensus-based (CB) guidelines. We used breast cancer guidelines as a case study to assess for these differences. METHODS: Five different instruments to evaluate the quality of guidelines were identified by a literature search. We also searched MEDLINE and the Internet to locate 8 breast cancer guidelines. These guidelines were classified in three categories: evidence based, consensus based and consensus based with no explicit consideration of evidence (CB-EB). Each guideline was evaluated by three of the authors using each of the instruments. For each guideline we assessed the agreement among 14 decision points which were selected from the NCCN (National Cancer Comprehensive Network) guidelines algorithm. For each decision point we recorded the level of the quality of the information used to support it. A regression analysis was performed to assess if the percentage of high quality evidence used in the guidelines development was related to the overall quality of the guidelines. RESULTS: Three guidelines were classified as EB, three as CB-EB and two as CB. The EB guidelines scored better than CB, with the CB-EB scoring in the middle among all instruments for guidelines quality assessment. No major disagreement in recommendations was detected among the guidelines regardless of the method used for development, but the EB guidelines had a better agreement with the benchmark guideline for any decision point. When the source of evidence used to support decision were of high quality, we found a higher level of full agreement among the guidelines' recommendations. Up to 94% of variation in the quality score among guidelines could be explained by the quality of evidence used for guidelines development. CONCLUSION: EB guidelines have a better quality than CB guidelines and CB-EB guidelines. Explicit use of high quality evidence can lead to a better agreement among recommendations. However, no major disagreement among guidelines was noted regardless of the method for their development.

Algorithms↗
PubMedDate not supplied

Use of the World Wide Web to implement clinical practice guidelines: a feasibility study.

BACKGROUND: Important efforts have been invested in the past few years in the development of quality clinical guidelines. However, the means for the effective dissemination of guidelines to practicing physicians have not been determined. Several studies have examined the possibilities offered by the World Wide Web (the Web), but studies examining the implementation of clinical guidelines in actual practice are clearly lacking. OBJECTIVE: This study assessed the potential of the Web to implement clinical practice guidelines in actual clinical settings. It also documents the obstacles perceived by the physicians in their use of guidelines on the Internet to determine the role that the Web can play in the implementation of guidelines in practice. METHODS: Two guidelines were developed using a standardized panel method and made available via the Web. One concerned indications for low-back surgery and the other dealt with indications for upper and lower digestive endoscopies. To identify obstacles to their use in clinical practice, 20 physicians were asked to consult the guidelines during consultations with patients. Answers were collected using 3 different questionnaires. RESULTS: Questionnaires were completed for consultations involving 213 patients. Less than 50% of the physicians have direct access to the Internet in their examination room. For 75%, the use of the guidelines was easy and the time required to consult them acceptable (3.4 minutes on average, or 12% of the time spent with the patient). The fear that use of such guidelines might interfere with the physician-patient relationship was mentioned as a reason for not consulting the guidelines for 27 consultations. Taking into account their experience with the Web, 75% of the physicians considered that the Web has a great or very-great potential for the dissemination of guidelines and 78% indicated that they would use such guidelines if they became generally available for clinical questions that concerned them. Only 3 physicians had consulted guidelines on the Web prior to this study. CONCLUSIONS: The acceptance of use of clinical practice guidelines via the Web is high. The main limits to further use of such Web-based guidelines seem to be the lack of a computer connection in the physician's office or examining room and the fear that use of such guidelines might interfere with the physician-patient relationship. Though most participants appreciate the considerable potential of the Web for disseminating guidelines, only a small handful regularly use guidelines available on the Web. There are still numerous obstacles to the regular use of guidelines in clinical practice, some related to the physicians, others to the guidelines themselves.

Decision Support Systems, Clinical↗
PubMed2006

[Critical appraisal of stroke guidelines].

BACKGROUND: Despite the increasing burden of disease and known deficiencies of actual stroke care there is a lack of evidence-based stroke guidelines in Germany. For future guideline development and implementation in Germany, critically appraising internationally available guidelines might be useful. OBJECTIVES: To identify and evaluate published evidence-based German and English language stroke/cerebrovascular disorder guidelines using the established "German Guideline Appraisal Instrument". METHODS: Systematic literature search (published in 1992-2002) using Medline and English-/German language guideline databases. A total of 626 hits resulted in 54 guideline articles. 13 articles (from Australia, Germany, the United Kingdom, Singapore and the USA) fulfilled specific inclusion criteria (recommended for countrywide implementation, complete guidelines for prevention and/or diagnostic/treatment and/or rehabilitation). The systematic guideline appraisal consisted of a) the assessment of the methodological quality using the established "German Guideline Appraisal Instrument" attributing scores and ranking the guidelines according to their overall quality; b) the systematic documentation of appraisal using structured abstracts. RESULTS: The methodological quality of "content and form" (10-17 of a total of 17 points) of the 13 guidelines was comparable. Regarding the domains of the "quality of the development process" (the guidelines achieved 4-15 of 17 points) and "guideline applicability" (0-3 of 6 points), though, the appraised guidelines varied impressively. The 6 best guidelines (> or = 25 of a total of 40 points) were characterized by explicitly linking recommendations and supporting evidence, by expert reviews of the guidelines prior to publication, and the provision of instructions for guideline implementation. CONCLUSION: None of the 13 appraised guidelines covered all key methodological quality criteria. The analysis shows, however, that it should be possible to compile a methodologically sound stroke guideline by using those parts of the different appraised guidelines that fitted the quality criteria best.

Evidence-Based Medicine↗
PubMed1997

What are hospitals doing about clinical guidelines?

OBJECTIVES: To assess the attitudes of senior hospital staff towards clinical guidelines, and to ascertain the perceived extent and benefits of their local use; to identify those hospitals with current or planned future written strategies for the systematic development of clinical guidelines, and the staff responsible for leading them; and to establish the essential elements of existing strategies, and the methods used to ensure the proper development, dissemination, implementation, and evaluation of local guidelines. DESIGN: Cross sectional survey. PARTICIPANTS: Senior staff of 270 acute hospitals in the United Kingdom (response rate 202/270 (75%)) in 1995. RESULTS: 197/199 (99%) of respondents thought that clinical guidelines were a good idea, and 176/196 (90%) were aware of some guideline activity occurring within their hospitals. The most important benefits of local guideline activity were increased healthcare efficiency and effectiveness, greater consistency of treatment, and team building. 174/194 (90%) of respondents were in favour of the development of a readily accessible national repository of evidence-based clinical guidelines. 38/201 (19%) of respondents had a clinical guidelines strategy and a further 91/201 (45%) said that they had plans to develop one in the near future. The need to improve clinical outcomes was most often reported as the reason for developing a strategy. Medical directors most commonly had formal responsibility to lead the strategy, but someone without formal responsibility ran the operation in half the hospitals. Only 18/36 (50%) of strategies gave advice on the development of guidelines; and only a few strategies made explicit statements on which clinical services to target for guideline development, or the methods to be used for their validation and promotion. Some strategies lacked explicit statements on methods to monitor adherence, routine review, and update of guidelines. Internal literature searches (29/31 (94%)), the use of national guidelines (29/32 (91%)), local consensus conferences (28/32 (88%)), and peer group review (21/24 (88%)) were the most popular methods of validation used in hospitals with a strategy. Methods used to promote the dissemination, implementation, and evaluation of clinical guidelines included clinical audit (31/32 (97%)), peer review (25/30 (83%)), continuing education (23/29 (79%)), targeting of opinion leaders (17/26 (65%)), use of structured case notes (14/31 (45%)), patient mediated interventions (9/26 (35%)), and patient specific reminders (8/26 (31%)). CONCLUSIONS: Most senior hospital staff have a favourable attitude towards clinical guidelines. Most hospitals are undertaking some guideline activity, but few seem to be doing so within a locally agreed hospital wide strategy in which guideline development, dissemination, implementation, and evaluation are systematically considered. Many of the current methods used to validate guidelines locally are inadequate. Evidence-based clinical guidelines should be developed nationally, leaving hospitals to focus their energies on the local adaptation, dissemination, implementation, and evaluation of such guidelines. Only in this way will local guidelines achieve their full potential to improve clinical care and patient outcomes.

Attitude of Health Personnel↗
PubMed1995

Clinical guidelines and the law: advice, guidance or regulation?

Proliferation of clinical guidelines has given rise to a number of concerns about the status of clinical advisory statements. Are guidelines advisory or mandatory? What regulatory functions do guidelines serve; do they allow clinical discretion a large enough role? Relationships between legislation and guidelines, and the way courts go about determining the legal status of guidelines, are explained. The following questions in the context of the law of negligence are addressed. Do doctors who deviate from guidelines place themselves at increased risk of being found liable in negligence if patients suffer injury as a result? Could compliance with guidelines protect health care workers from liability in such circumstances? What legal responsibility do the developers and issuers of guidelines have if their guidance is found to be faulty? Common law cases featuring clinical guidelines or protocols have been identified from the database Lexis, which searches the full text of the transcripts and reports of court cases in UK, Commonwealth and United States jurisdictions. Secondary literature, identified from the bibliography of clinical guidelines maintained by the Department of Health Services Research at the University of Aberdeen (assembled from DHSS-DATA, Embase, Grateful Med, Medline and SIGLE) has also been consulted. The legal status of a guideline turns on whether its development and application have statutory backing, and whether the guideline embodies clinical practices accepted as proper by a responsible body of doctors. The mandatory effects of guidelines can be gauged, to some extent, by the sanctions that apply in the event of non-compliance. US courts have ruled that guideline developers can be held liable for faulty guidelines, and that doctors cannot pass off their liability by claiming that adherence to guidelines has corrupted clinical judgement. Protocols and guidelines provide the courts with examples of clinical standards across a wide range of medical practice. As guidelines proliferate, so they will increasingly be used in court. However, adherence to guidelines has not automatically been equated with reasonable practice, and the courts seem unlikely to follow the standards enunciated in clinical guidelines without critically evaluating their authority, flexibility and scope of application.

Clinical Competence↗