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Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization.

Despite enormous energies invested in authoring clinical practice guidelines, the quality of individual guidelines varies considerably. The Conference on Guideline Standardization (COGS) was convened in April 2002 to define a standard for guideline reporting that would promote guideline quality and facilitate implementation. Twenty-three people with expertise and experience in guideline development, dissemination, and implementation participated. A list of candidate guideline components was assembled from the Institute of Medicine Provisional Instrument for Assessing Clinical Guidelines, the National Guideline Clearinghouse, the Guideline Elements Model, and other published guideline models. In a 2-stage modified Delphi process, panelists first rated their agreement with the statement that "[Item name] is a necessary component of practice guidelines" on a 9-point scale. An individualized report was prepared for each panelist; the report summarized the panelist's rating for each item and the median and dispersion of rankings of all the panelists. In a second round, panelists separately rated necessity for validity and necessity for practical application. Items achieving a median rank of 7 or higher on either scale, with low disagreement index, were retained as necessary guideline components. Representatives of 22 organizations active in guideline development reviewed the proposed items and commented favorably. Closely related items were consolidated into 18 topics to create the COGS checklist. This checklist provides a framework to support more comprehensive documentation of practice guidelines. Most organizations that are active in guideline development found the component items to be comprehensive and to fit within their existing development methods.

Documentation↗

Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated?

CONTEXT: Practice guidelines need to be up-to-date to be useful to clinicians. No published methods are available for assessing whether existing practice guidelines are still valid, nor does any empirical information exist regarding how often such assessments need to be made. OBJECTIVES: To assess the current validity of 17 clinical practice guidelines published by the US Agency for Healthcare Research and Quality (AHRQ) that are still in circulation, and to use this information to estimate how quickly guidelines become obsolete. DESIGN, SETTING, AND PARTICIPANTS: We developed criteria for defining when a guideline needs updating, mailed surveys to members of the original AHRQ guideline panels (n = 170; response rate, 71%), and searched the literature for evidence through March 2000 (n = 6994 titles yielding 173 articles plus 159 new guidelines on the same topics). MAIN OUTCOME MEASURES: Identification of new evidence calling for a major, minor, or no update of the 17 guidelines; survival analysis of the rate at which guidelines became outdated. RESULTS: For 7 guidelines, new evidence and expert judgment indicated that a major update is required; 6 were found to be in need of a minor update; 3 were judged as still valid; and for 1 guideline, we could reach no conclusion. Survival analysis indicated that about half the guidelines were outdated in 5.8 years (95% confidence interval [CI], 5.0-6.6 years). The point at which no more than 90% of the guidelines were still valid was 3.6 years (95% CI, 2.6-4.6 years). CONCLUSIONS: More than three quarters of the AHRQ guidelines need updating. As a general rule, guidelines should be reassessed for validity every 3 years.

Practice Guidelines as Topic↗

The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation.

PURPOSE: To develop a conceptual tool for the systematic development of cancer treatment practice guidelines. MATERIALS AND METHODS: The guidelines development tool, the Practice Guidelines Development Cycle, was derived from observing an evidence-based practice guidelines initiative at a comprehensive cancer center in Ontario, Canada, and from a literature review that uncovered barriers to guidelines development and implementation. Based on the literature findings and direct observations of how clinicians struggled with evidence-based guidelines development, we evolved a framework to incorporate clinical and administrative factors (eg, costs) into evidence-based guidelines. Use of the Practice Guidelines Development Cycle is illustrated with a clinical example (the use of adjuvant systemic therapy in good-risk, node-negative premenopausal breast cancer patients). RESULTS: The result is the Practice Guidelines Development Cycle, which consists of eight sequential steps, from topic selection to policy formulation. Independent validation of guidelines is included. The cycle products are the evidence-based recommendation, the practice guideline, and the practice policy. The main features of the cycle are emphasis on scientific evidence, acknowledgment of the roles of clinical experience and nonclinical (administrative) factors through consensus, and explicit separation of clinical and cost considerations in guidelines development. Twenty guidelines are currently in development. CONCLUSION: Attention to the barriers of guidelines development and the sociocultural nature of clinical practice, and respect for clinical experience, can lead to improved strategies for guidelines development.

Cancer Care Facilities↗

Are nonspecific practice guidelines potentially harmful? A randomized comparison of the effect of nonspecific versus specific guidelines on physician decision making.

OBJECTIVE: To test the ability of two different clinical practice guideline formats to influence physician ordering of electrodiagnostic tests in low back pain. DATA SOURCES/STUDY DESIGN: Randomized controlled trial of the effect of practice guidelines on self-reported physician test ordering behavior in response to a series of 12 clinical vignettes. Data came from a national random sample of 900 U.S. neurologists, physical medicine physicians, and general internists. INTERVENTION: Two different versions of a practice guideline for the use of electrodiagnostic tests (EDT) were developed by the U.S. Agency for Health Care Policy and Research Low Back Problems Panel. The two guidelines were similar in content but varied in the specificity of their recommendations. DATA COLLECTION: The proportion of clinical vignettes for which EDTs were ordered for appropriate and inappropriate clinical indications in each of three physician groups were randomly assigned to receive vignettes alone, vignettes plus the nonspecific version of the guideline, or vignettes plus the specific version of the guideline. PRINCIPAL FINDINGS: The response rate to the survey was 71 percent. The proportion of appropriate vignettes for which EDTs were ordered averaged 77 percent for the no guideline group, 71 percent for the nonspecific guideline group, and 79 percent for the specific guideline group (p = .002). The corresponding values for the number of EDTs ordered for inappropriate vignettes were 32 percent, 32 percent, and 26 percent, respectively (p = .08). Pairwise comparisons showed that physicians receiving the nonspecific guidelines ordered fewer EDTs for appropriate clinical vignettes than did physicians receiving no guidelines (p = .02). Furthermore, compared to physicians receiving nonspecific guidelines, physicians receiving specific guidelines ordered significantly more EDTs for appropriate vignettes (p = .0007) and significantly fewer EDTs for inappropriate vignettes (p = .04). CONCLUSIONS: The clarity and clinical applicability of a guideline may be important attributes that contribute to the effects of practice guidelines.

Decision Making↗

[Guidelines in pain treatment--methodical quality of guidelines for treatment of pain patients].

The committee for quality assurance of the German IASP chapter (DGSS) evaluated all relevant guidelines concerning pain treatment. Quality of guidelines was analysed according to the checklist "Methodical quality of guidelines" by Ollenschläger and the user manual released by the German Medical Centre for Quality Assurance. The guideline for the treatment of back pain released by the German Medical Association was examined as well as the one released by the German Association for physical therapy and rehabilitation, the guideline on cervical and lumbal nerve root compression syndrome of the German Association of Neurosurgeons, the guideline for cancer pain of the Drug Committee of the German Medical Association was compared with the one of the German Interdisciplinary Association for Pain Treatment. The guideline for the treatment of chronic headache and facial pain of the Medical Association was evaluated and the guideline for the treatment of trigeminal neuralgia of the German Association of Neurosurgery and Neurology, also the guideline for the treatment of acute postoperative and posttraumatic pain. All guidelines show deficiencies in different aspects and of different severity. At first there are deficiencies in interdisciplinary formulation of the guidelines and identification and interpretation of evidence of multimodal pain treatment options. The most prominent deficiency is the lack of implementation and application trials or impulses by all author associations. This way all expenditure on releasing guidelines is given away without improving quality of pain treatment. The authors' recommendation is to adjust to guidelines and, if they are working or not, tell the authors and improve interdisciplinary in pain treatment guidelines.

Analgesics↗

Barriers between guidelines and improved patient care: an analysis of AHCPR's Unstable Angina Clinical Practice Guideline. Agency for Health Care Policy and Research.

OBJECTIVES: To describe common barriers that limit the effect of guidelines on patient care, with emphasis on recommendations for triage in the Agency for Health Care Policy and Research (AHCPR) Unstable Angina Clinical Practice Guideline. DATA SOURCES: Previously reported results from a prospective clinical study of 10,785 patients presenting to the emergency department (ED) with symptoms suggestive of acute cardiac ischemia. STUDY DESIGN: Design is an analysis of the AHCPR guideline with regard to recognized barriers in guideline implementation. Presentation of hypothetical scenarios to ED physicians was used to determine interrater reliability in applying the guideline to assess risk and to make triage decisions. PRINCIPAL FINDINGS: The AHCPR guideline's triage recommendations demonstrate (1) poor interobserver reliability in interpretation by ED physicians; (2) limited applicability of recommendations for outpatient management (applies to 6 percent of patients presenting to the ED with unstable angina); (3) incomplete specifications of exceptions that may require deviation from guideline recommendations; (4) unexpected effects on medical care by significantly increasing the demand for limited intensive care beds; and (5) unknown effects on patient outcomes. In addition, analysis of the guideline highlights the need to address organizational barriers, such as administrative policies that conflict with guideline recommendations and the need to adapt the guideline to conform to local systems of care. CONCLUSIONS: Careful analysis of guideline attributes, projected effect on medical care, and organizational factors reveal several barriers to successful guideline implementation that should be addressed in the design of future guideline-based interventions.

Angina, Unstable↗

Subfertility guidelines in Europe: the quantity and quality of intrauterine insemination guidelines.

BACKGROUND: International collaboration could facilitate systematic development of guidelines to regulate and improve clinical practice. To promote European collaboration in guideline development in reproductive medicine, insight into existing subfertility guidelines in Europe is essential. The study aim was to explore the number and quality of clinical practice guidelines on homologous intrauterine insemination (IUI) in Europe. METHODS: To identify IUI guidelines in Europe, electronic databases and Internet were systematically searched and key experts on assisted reproduction in 25 European countries were questioned. The quality of IUI guidelines was systematically assessed with the internationally validated Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument. Qualitative methods were used to appraise IUI guideline recommendations and references. RESULTS: National guidelines on IUI are available in four of 25 European countries. The quality of IUI guidelines in Europe is moderate to high, but the recommendations and references differ considerably. CONCLUSIONS: The number of IUI guidelines in Europe is surprisingly small, and differences in their recommendations and references are considerable. To overcome these deficiencies in clinical guidance on IUI care in Europe, a central body with expertise in up-to-date guideline development methodology and sufficient resources could be established in Europe for central selection and international exchange of evidence to support guideline recommendations.

Europe↗

Effect of local standards on the implementation of national guidelines for asthma: primary care agreement with national asthma guidelines.

OBJECTIVE: To assess the level of modification by local primary care doctors of key aspects of the National Asthma Education Program (NAEP) Guidelines for the Diagnosis and Management of Asthma. DESIGN: A random sample of primary care physicians participating in local asthma guideline development. SETTING: Two hospital systems, one based in an urban environment, and a second in a community and rural environment. PARTICIPANTS: Primary care physicians. INTERVENTION: Design of consensus-based local asthma guidelines using a modified Delphi approach. MEASUREMENTS AND MAIN RESULTS: A total of 42 physicians participated in the local guideline development. With few exceptions, the primary care physicians modified in major ways the NAEP Guidelines regarding the role of pulmonary function testing and spirometry. Specifically, the local guidelines did not require peak flow and spirometry measurements as the basis for initiating inhaled steroids as did the national guidelines. All 42 physicians emphasized a clinical diagnosis versus one based on a pulmonary function. Peak flow monitoring was recommended by 35 (83%) of physicians in selected patients only, in contrast to the national guidelines, which emphasized monitoring for all patients routinely and during exacerbations. There was strong agreement with the national guidelines on the role and importance of patient education, and on the indications for the use of inhaled steroids. CONCLUSIONS: Disagreement by primary care doctors with parts of the NAEP guideline is a potential cause for poor compliance and lack of influence on patient care. Recognizing the need to modify or customize guidelines through field testing with local primary care physicians will improve acceptance of national guidelines.

Administration, Inhalation↗

The epic project: developing national evidence-based guidelines for preventing healthcare associated infections. Phase I: Guidelines for preventing hospital-acquired infections. Department of Health (England).

In 1998, the Department of Health (England) commissioned the first phase of national evidence-based guidelines for preventing healthcare associated infections. These focused on developing a set of standard principles for preventing infections in hospitals together with guidelines for preventing hospital-acquired infections (HAI) associated with the use of short-term indwelling ureteral catheters in acute care and with central venous catheters in acute care. These guidelines are systematically developed broad statements (principles) of good practice that all practitioners can use and which can be incorporated into local protocols. A nurse-led, multi-professional team composed of infection prevention practitioners, clinical microbiologists/retrovirologist, epidemiologists, and researchers developed the guidelines. A rigorous guideline development process was used to inform the systematic reviews, the clinical and critical appraisal of relevant evidence, and linking that evidence to evolving guidelines. Both general and specialist clinical practitioners were involved in all stages of developing these guidelines, as were representatives from relevant Royal Colleges, learned societies, other professional organisations and key stakeholders. The introduction to these guidelines describes a robust and validated guideline development model that can be used by others to develop future guidelines. This model is described in more detail in the associated technical reports that can be found on the project web site http://www.epic.tvu.ac.uk. Locating and appropriately using good quality evidence to inform guideline development in this field is challenging. Evidence from rigorously conducted experimental studies was frequently limited and consequently a range of other types of evidence were systematically retrieved and carefully appraised. The concluding discussion on implementation highlights potential issues for clinical governance and areas for future research and suggests issues that need to be addressed to allow practitioners to successfully incorporate these guidelines into routine clinical practice.

Acute Disease↗

Adherence to practice guidelines: the role of specialty society guidelines.

BACKGROUND: Physician adherence to guidelines is often poor, but the reasons have not been completely studied. We investigated whether physician adherence to guidelines for percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass grafting (CABG) varied by source, development methods, or the extent of their evidence-base. METHODS AND RESULTS: We assessed adherence to guidelines developed by the American College of Cardiology/American Heart Association (ACC/AHA) for PTCA (1988 and 1993) and for CABG (1990) and guidelines developed by RAND for PTCA and CABG in 1990. We randomly sampled patients on Medicare who were undergoing coronary angiography in 5 states in 1991 and 1992, extracting clinical and laboratory data from medical records and using computer programs to classify the appropriateness of each procedure. A total of 543 PTCA and 676 CABG procedures were studied. By use of the 1988 ACC/AHA guidelines, 30% of PTCAs were rated class III (inappropriate), whereas 24% were class III by use of the 1993 guidelines. Only 1.5% of CABG procedures were class III with ACC/AHA guidelines. By use of RAND guidelines, 12% of PTCA and 9% of CABG procedures were classified as inappropriate. CONCLUSIONS: Adherence to guidelines is higher when the recommendations are supported by evidence from randomized clinical trials (CABG). The credibility of the source and familiarity with the guidelines do not ensure compliance. When evidence is lacking, as with PTCA at the time of this study, guideline recommendations may lag behind appropriate changes in clinical practice. More frequent revisions coupled with on-line access have the potential to make guidelines more useful.

Aged↗

Improving the quality of health care: using international collaboration to inform guideline programmes by founding the Guidelines International Network (G-I-N).

Clinical practice guidelines are regarded as powerful tools to achieve effective health care. Although many countries have built up experience in the development, appraisal, and implementation of guidelines, until recently there has been no established forum for collaboration at an international level. As a result, in different countries seeking similar goals and using similar strategies, efforts have been unnecessarily duplicated and opportunities for harmonisation lost because of the lack of a supporting organisational framework. This triggered a proposal in 2001 for an international guidelines network built on existing partnerships. A baseline survey confirmed a strong demand for such an entity. A multinational group of guideline experts initiated the development of a non-profit organisation aimed at promotion of systematic guideline development and implementation. The Guidelines International Network (G-I-N) was founded in November 2002. One year later the Network released the International Guideline Library, a searchable database which now contains more than 2000 guideline resources including published guidelines, guidelines under development, "guidelines for guidelines", training materials, and patient information tools. By June 2004, 52 organisations from 27 countries had joined the network including institutions from Oceania, North America, and Europe, and WHO. This paper describes the process that led to the foundation of the G-I-N, its characteristics, prime activities, and ideas on future projects and collaboration.

Humans↗

The GuideLine Implementability Appraisal (GLIA): development of an instrument to identify obstacles to guideline implementation.

BACKGROUND: Clinical practice guidelines are not uniformly successful in influencing clinicians' behaviour toward best practices. Implementability refers to a set of characteristics that predict ease of (and obstacles to) guideline implementation. Our objective is to develop and validate a tool for appraisal of implementability of clinical guidelines. METHODS: Indicators of implementability were identified from the literature and used to create items and dimensions of the GuideLine Implementability Appraisal (GLIA). GLIA consists of 31 items, arranged into 10 dimensions. Questions from 9 of the 10 dimensions are applied individually to each recommendation of the guideline. Decidability and Executability are critical dimensions. Other dimensions are Global, Presentation and Formatting, Measurable Outcomes, Apparent Validity, Flexibility, Effect on Process of Care, Novelty/Innovation, and Computability. We conducted a series of validation activities, including validation of the construct of implementability, expert review of content for clarity, relevance, and comprehensiveness, and assessment of construct validity of the instrument. Finally, GLIA was applied to a draft guideline under development by national professional societies. RESULTS: Evidence of content validity and preliminary support for construct validity were obtained. The GLIA proved to be useful in identifying barriers to implementation in the draft guideline and the guideline was revised accordingly. CONCLUSION: GLIA may be useful to guideline developers who can apply the results to remedy defects in their guidelines. Likewise, guideline implementers may use GLIA to select implementable recommendations and to devise implementation strategies that address identified barriers. By aiding the design and operationalization of highly implementable guidelines, our goal is that application of GLIA may help to improve health outcomes, but further evaluation will be required to support this potential benefit.

Benchmarking↗