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Evaluating the quality of clinical practice guidelines.

OBJECTIVE: To review and identify established methods for evaluating the quality of practice guidelines and to use a selected assessment tool to assess 2 chiropractic practice guideline documents. METHODS: A search of the medical literature was performed to identify current methods and procedures for practice guideline evaluation. Two chiropractic practice guideline documents, Vertebral Subluxation in Chiropractic Practice (CCP) and Guidelines for Chiropractic Quality Assurance and Practice Parameters (Mercy) were then independently evaluated for validity by 10 appraisers using the identified appraisal tool. The appraisal scores were tabulated, and consensus appraisals were generated for the CCP and Mercy guideline documents. RESULTS: The "Appraisal Instrument for Clinical Guidelines" (Cluzeau instrument) was identified as a reliable and valid method of guideline evaluation. The result of the application of this appraisal tool in the assessment of the CCP and Mercy guideline documents was that the former scored notably lower than the latter. On the basis of the results of the guideline appraisals, the CCP document is not recommended, and its guidelines are not considered suitable for application in chiropractic practice. The Mercy guidelines are recommended for application in chiropractic practice, with the proviso that new scientific data should be considered. CONCLUSIONS: The literature reviewed suggests that professional organizations or groups should undertake a critical review of guidelines using available critical guideline appraisal tools. Guideline validity appraisal should be done before acceptance by the chiropractic profession. To avoid unwarranted utilization of poorly constructed guidelines, it is strongly recommended that all future guidelines be reviewed for validity and scientific accuracy with the findings published in a medically indexed journal before they are adopted by the chiropractic community.

Chiropractic↗

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↗

Application of NKF-K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease: changes of clinical practices and their effects on outcomes and quality standards in three haemodialysis units.

BACKGROUND: The K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease was published in October 2003. The objective of this study was to analyse the effect of the application of those guidelines on clinical practices and on the achievement of bone disease targets and quality standards. METHODS: We included in the study 342 patients dialysed in our three HD units during 2003 and 2004. Starting October 2003, the K-DOQI recommendations were introduced into practice. Parathyroid hormone (PTH) was measured every 3 months and the serum Ca and P levels, monthly. In patients whose medications were modified, PTH was measured monthly and Ca and P levels, weekly or biweekly. RESULTS: The following are the main findings for 2004 (post-K/DOQI): an increased use of dialysates with a Ca concentration of 2.5 mEq/l (27.2-50.9%, P<0.001) and a reduced use of a dialysate calcium of 3.0 mEq/l (44.6-39.6%, P: NS) and 3.5 mEq/l (28-9.4%, P<0.001); a reduced use of calcium-based phosphate binders (891.9-565.5 mg Ca/day, P<0.001) and increased use of sevelamer hydrochloride (800 mg) (from 4.86 to 7.51 mg, tablets/day, P<0.001) lower serum Ca levels (9.7-9.4 mg/dl, P<0.01), and higher intact PTH levels (201.4-311.8 pg/ml, P<0.001), without changes in serum P levels; an increased proportion of patients with serum Ca levels within the K/DOQI target range (38.7-46.6%, P<0.01), resulting mainly from the reduced percentage of patients with hypercalcaemia (55-44.4%, P<0.01); a decreased proportion of patients with PTH<150 pg/ml (53.8-31.4%, P<0.001) but an increased proportion of patients with PTH>300 pg/ml, with no change in the proportion of patients with PTHs within the K/DOQI target range. Phosphorus levels and targets did not show significant differences between 2003 and 2004 (56.9-56.2%, P: NS). CONCLUSIONS: The only way to ensure that K/DOQI guidelines actually improve medical outcomes is to emphasize implementation strategies and also the scientific evaluation of their effectiveness in clinical settings. In spite of the application of the K-DOQI recommendations, a large proportion of our patients stayed outside the proposed targets, which points to the need for more effective therapeutic options.

Aged↗

Reducing lengths of stay in the coronary care unit with a practice guideline for patients with congestive heart failure. Insights from a controlled clinical trial.

Although more than 1,000 medical practice guidelines have been developed, there have been few evaluations of their use in clinical practice or information to judge whether practice guidelines can be used to reduce health care costs. For this reason, the authors conducted a prospective controlled clinical trial with an alternating-month design at a large teaching community hospital to study the use of a practice guideline to promote early transfer of patients admitted to a hospital with congestive heart failure (CHF) from the coronary care unit (CCU) and intermediate care unit to unmonitored beds. The practice guideline was supported by locally derived risk information and recommended consideration of early "step-down" transfer of low-risk patients with CHF 24 hours after hospital admission. Physicians caring for patients identified as "low risk" received concurrent personalized written and verbal reminders concerning the guideline recommendation. Study subjects were patients admitted to a hospital CCU and intermediate care unit between November 1, 1991 and April 30, 1993 with a diagnosis of CHF or pulmonary edema. Ninety patients with CHF were identified as low risk according to the guideline during the study period. Feedback of the practice guideline recommendation was not associated with a significant increase in physician adoption of the guideline or shorter lengths of stay in the CCU or intermediate care unit. Physicians may have compensated for statistically insignificant reductions in monitored lengths of stay by increasing the length of stay in unmonitored beds (1.80 +/- 2.32 to 4.02 +/- 4.09 days, P = .002) and the total length of stay (4.73 +/- 2.43 to 6.71 +/- 5.44 days, P = .03). Quality of patient care, patient outcomes, and patient satisfaction were not affected by the guideline. Our study results suggest that implementation of a locally derived practice guideline for patients with CHF did not result in adoption of the guideline by physicians. The complexity of implementing the guideline, changes in physician practice before the study, and the failure of the guideline to address the continuum of patient care across monitored and unmonitored beds may have accounted for rejection of the guideline. Our experience demonstrates that practice guidelines, whenever possible, should be evaluated in prospective trials before they should be disseminated for widespread use.

Adult↗

Clinical practice guidelines; legal aspects.

In many countries, practice guidelines are considered an important means to make medical decisions more effective and rational. The growing use of such standards raises a number of legal questions: What is the legal status of practice guidelines? What are the responsibilities of the makers? To what extent do guidelines allow for clinical discretion or for patient preferences? How are they applied by the courts? This paper briefly discusses these questions in the context of Dutch law and medicine. It also addresses the issue, to what extent cost-benefit considerations may be taken into account in developing clinical guidelines.

Cost-Benefit Analysis↗

Neoadjuvant or adjuvant therapy for resectable esophageal cancer: a clinical practice guideline.

BACKGROUND: Carcinoma of the esophagus is an aggressive malignancy with an increasing incidence. Its virulence, in terms of symptoms and mortality, justifies a continued search for optimal therapy. A clinical practice guideline was developed based on a systematic review investigating neoadjuvant or adjuvant therapy on resectable thoracic esophageal cancer. METHODS: A systematic review with meta-analysis was developed and clinical recommendations were drafted. External review of the practice guideline report by practitioners in Ontario, Canada was obtained through a mailed survey, and incorporated. Final approval of the practice guideline was obtained from the Practice Guidelines Coordinating Committee. RESULTS: The systematic review was developed and recommendations were drafted, and the report was mailed to Ontario practitioners for external review. Ninety percent of respondents agreed with both the evidence summary and the draft recommendations, while only 69% approved of the draft recommendations as a practice guideline. Based on the external review, a revised document was created. The revised practice guideline was submitted to the Practice Guidelines Coordinating Committee for review. All 11 members of the PGCC returned ballots. Eight PGCC members approved the practice guideline report as written and three members approved the guideline conditional on specific concerns being addressed. After these recommended changes were made, the final practice guideline report was approved. CONCLUSION: In consideration of the systematic review, external review, and subsequent Practice Guidelines Coordinating Committee revision suggestions, and final approval, the Gastrointestinal Cancer Disease Site Group recommends the following:For adult patients with resectable thoracic esophageal cancer for whom surgery is considered appropriate, surgery alone (i.e., without neoadjuvant or adjuvant therapy) is recommended as the standard practice.

Adenocarcinoma↗

Practice guidelines: pedantic pontification or pragmatic progress? 2003 Ryley-Jeffs Memorial Lecture.

Development and use of practice guidelines is one strategy to assist health professionals in translating research into practice. There has been a significant growth in the number of practice guidelines developed, with the increased focus on justifying health care costs and demonstrating outcomes. Quality and influence on established practice, however, has sometimes been lacking. Recognizing both the importance of practice guidelines and some of the controversies surrounding their quality and use, Dietitians of Canada convened a task group to make recommendations on future development. They reviewed the practice guideline programs of others and identified the key elements needed to ensure any dietetics-produced guidelines would be credible, feasible and applicable to clinical counselling, administration and community health promotion. In this memorial lecture, the chair of that task group briefly reviews the history of dietetic practice guidelines, new innovations in systematic review and consensus development methods, and specifically the Delphi process used to develop a new Dietetic Practice Guidelines Framework. The 34 elements of the framework direct overall management of the guideline development process, including topic nomination, systematic literature review, group judgment, and pilot testing.

Canada↗

A template-based approach to support utilization of clinical practice guidelines within an electronic health record.

Practice guidelines are an integral part of evidence-based health care delivery. When the authors decided to install the clinical documentation component of an electronic health record in a nurse practitioner faculty practice, however, they found that they lacked the resources to integrate it immediately with other systems and components that would support the processing of clinical rules. They were thus challenged to devise an initial approach for decision support related to clinical practice guidelines that did not include interfacing with an inference engine and set of decision rules. The authors developed a prototypic application within the WAVE electronic health record that demonstrates the feasibility of representing a guideline as structured encoded text organized into an online patient-encounter template. Although this approach may be more broadly applicable, it is described within the context of the management of diabetes mellitus by nurse practitioners. The advantages of the approach relate primarily to the integration of the guideline recommendations with the encounter form, the online interaction of the clinician with the system, and the ease of creation and modification of the guideline-based encounter form. However, there are several limitations of the current approach as a result of the inability to do inference and the lack of integration with patient-specific data to trigger specific rules.

Decision Support Systems, Clinical↗

An approach to the development of practice guidelines for community health interventions.

The Community Health Practice Guidelines (CHPG) project was initiated to develop a systematic approach to the critical evaluation of evidence on the effectiveness and efficiency of community health interventions and to the formulation of evidence-based practice recommendations. Three community health interventions--immunization delivery methods, partner notification for sexually transmitted diseases and the combination of restaurant inspection and education of food handlers--were used as prototypes to develop a standardized approach. The CHPG process consists of three components: a review of scientific evidence, a practice survey and formulation of practice guidelines. Imperatives for further development of the CHPG and define research priorities process include creating a coalition of public health organizations to sponsor the process and refining the consensus process so that the practice guidelines accurately reflect both the scientific basis of public health practice and the values of those affected.

Canada↗

Practice guidelines and malpractice litigation: a two-way street.

OBJECTIVE: To understand how practice guidelines are used in malpractice litigation. DESIGN: Review of the open and closed malpractice claims of two medical malpractice insurance companies, and a mailed survey of attorneys who litigate malpractice claims. SETTING: United States. PARTICIPANTS: Two insurance companies and 960 randomly selected malpractice attorneys. MEASUREMENTS: Frequency and nature of the use of practice guidelines in litigation; understanding and frequency of the use of practice guidelines by attorneys in malpractice cases. RESULTS: 259 claims opened in 1990-1992 at two insurance companies, including all obstetrics and anesthesia claims and a random sample of other claims, were reviewed. Seventeen of these claims involved practice guidelines, which were used as exculpatory evidence (exonerating the defendant physician) in 4 cases and as inculpatory evidence (implicating the defendant physician) in 12 cases. The only physician or patient factors associated with use of a guideline was a longer physician-patient relationship (P = 0.021). Nine hundred and sixty surveys were mailed and 578 were returned (response rate, 60.1%). Attorneys reported that once a suit is initiated, practice guidelines are likely to be used for inculpatory purposes (inculpatory in 54% of cases; exculpatory in 22.7% of cases). However, guidelines that seem to offer exculpatory value induce attorneys not to bring suits. The only attorney factor associated with increased use of guidelines was a practice in which more than 50% of business was in medical malpractice. CONCLUSIONS: Guidelines are used both by plaintiffs' and defendants' attorneys in malpractice cases. The emphasis in health reform proposals on guidelines as exculpatory evidence should be carefully considered.

Humans↗

Consensus methods in practice guideline development: a review and description of a new method.

Practice guidelines are an increasingly important means of conveying to practitioners and administrators the most appropriate methods of treating patients. Although the development of practice guidelines relies on scientific evidence, the consensus of expert opinion is an important ingredient, particularly in many key areas of clinical decision making that are insufficiently informed by experimental data. The authors review current methods in the assessment of expert opinion for practice guideline development and the problem of the lack of quantification. A new method is presented for quantification of expert opinion on surveys, and the development of expert consensus practice guidelines from the resulting data.

Clinical Medicine↗

[The Dutch College of General Practitioners' practice guidelines, "Examination of the neonate": response from the perspective of general practice medicine].

With the publication of the Dutch College of General Practitioners' practice guideline 'Examination of the neonate', a discussion which has lasted several decades has been brought to an end. Up to now a second neonatal examination by the general practitioner on the third, fourth or fifth day after a midwife-assisted birth was recommended. The arguments in support of this recommendation were based on the following: (a) the limited expertise of midwives in the past, (b) the experience that general practitioners had in examining children, although this experience was not specifically related to the defects for which neonates should be checked, and (c) the government bodies' wish to restrict the number of hospital deliveries by giving greater structure to the organisation of midwife care, which in practice, did not lead to large changes. Based on three studies, the practice guideline recommends that a second examination is of no added value.

Clinical Competence↗

Clinical practice guidelines. The Agency for Health Care Policy and Research fosters the development of evidence-based guidelines.

As medical technology increases rapidly and becomes more complex, clinical practice guidelines can help healthcare providers assess current practices and integrate technological advances. Through the Agency for Health Care Policy and Research (AHCPR), the federal government has begun to facilitate the development of clinical practice guidelines. Expert or contract panels, authorized by the AHCPR, develop guidelines on specific clinical conditions. The AHCPR guideline methodology is designed to produce evidence-based guidelines that are valid, clinically applicable, and clinically flexible. Each panel spends a year or more developing the guideline, beginning with an extensive literature search and review. The panel prepares evidence tables, statistically analyzes aggregate data (where appropriate), conducts harm and benefit analyses, and prepares health policy analyses (or cost-impact studies). During this process, the panel holds an open forum to solicit comments on the guideline topic. After this public discussion, the panel prepares a final draft of the guideline. Several hundred individuals review the guideline. Some policymakers believe clinical practice guidelines can lead to better healthcare outcomes. Guidelines can provide information in a useful format for clinicians to use at the bedside or the point of decision making in patient care. Guidelines also provide information that can be used in continuing education and professional education programs.

Decision Making↗

Clinical practice guidelines in complementary and alternative medicine. An analysis of opportunities and obstacles. Practice and Policy Guidelines Panel, National Institutes of Health Office of Alternative Medicine.

An estimated 1 of 3 Americans uses some form of complementary and alternative medicine (CAM), such as acupuncture, homeopathy, or herbal medicine. In 1995, the National Institutes of Health Office of Alternative Medicine convened an expert panel to examine the role of clinical practice guidelines in CAM. The panel concluded that CAM practices currently are unsuitable for the development of evidence-based practice guidelines, in part because of the lack of relevant outcomes data from well-designed clinical trials. Moreover, the notions of standardization and appropriateness, inherent in guideline development, face challenging methodologic problems when applied to CAM, which considers many different treatment practices appropriate and encourages highly individualized care. Due to different belief systems and divergent theories about the nature of health and illness, CAM disciplines have fundamental differences in how they define target conditions, causes of disease, interventions, and outcome measures of effectiveness. These differences are even more striking when compared with those used by Western medicine. The panel made a series of recommendations on strategies to strengthen the evidence base for future guideline development in CAM and to meet better the current information needs of clinicians, patients, and guideline developers who seek information about CAM treatments.

Complementary Therapies↗

The rural health care workforce implications of practice guideline implementation.

BACKGROUND: Rural health care workforce forecasting has not included adjustments for predictable changes in practice patterns, such as the introduction of practice guidelines. PURPOSE: To estimate the impact of a practice guideline for a single health condition on the needs of a rural health professional workforce. METHODS: The current care of a cohort of rural Medicare recipients with diabetes mellitus was compared with the care recommended by a diabetes practice guideline. The additional tests and visits that were needed to comply with the guideline were translated into additional hours of physician services and total physician full-time equivalents. RESULTS: The implementation of a practice guideline for Medicare recipients with diabetes in rural Minnesota would require over 30,000 additional hours of primary care physician services and over 5,000 additional hours of eye care professionals' time per year. This additional need represents a 1.3% to 2.4% increase in the number of primary care physicians and a 1.0% to 6.6% increase in the number of eye-care clinicians in a state in which the rural medical provider to population ratios already meet some recommended workforce projections. CONCLUSIONS: The implementation of practice guidelines could result in an increased need for rural health care physicians or other providers. That increase, caused by guideline implementation, should be accounted for in future rural health care workforce predictions.

Aged↗

National kidney foundation K/DOQI clinical practice guidelines for nutrition in chronic renal failure.

The National Kidney Foundation Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Nutrition in Chronic Renal Failure was recently published in the American Journal of Kidney Diseases. This publication provides 27 clinical practice guidelines for adults and 10 clinical practice guidelines for children. The adult guidelines focus primarily on patients undergoing maintenance dialysis therapy, although there are several clinical practice guidelines on nutritional issues for patients with advanced chronic renal failure (CRF) not undergoing dialysis therapy. The pediatric guidelines focus entirely on children undergoing maintenance dialysis treatment. The present article discusses a number of the more prominent clinical practice guidelines for the adults. Among these is the recommendation that the protein-energy nutritional status in these patients should be assessed by a panel of measures rather than by any single measure. Also, non-dialyzed patients with advanced CRF (ie, glomerular filtration rate <25 mL/min) and those undergoing maintenance hemodialysis or chronic peritoneal dialysis should be prescribed a dietary energy intake of 35 kcal/kg/day for patients who are <60 years of age and 30 kcal/kg for patients >/=60 years of age. Maintenance hemodialysis patients should be prescribed 1.2 g protein/kg/d; chronic peritoneal dialysis patients should be prescribed 1.2 to 1.3 g protein/kg/d. For non-dialyzed patients with CRF (glomerular filtration rate <25 mL/min), 0.60 g protein/kg/d should be prescribed. For patients who will not accept such a diet or are unable to maintain an adequate energy intake on that diet, a protein intake of up to 0.75 g protein/kg/d may be prescribed. At least 50% of the protein intake for all of these patients should be of high biologic value. A guideline concerning indications for inaugurating maintenance dialysis treatment or renal transplantation on the basis of deteriorating nutritional status is also given.

Humans↗

A prospective, multicenter study of a pneumonia practice guideline.

OBJECTIVE: To study the effect of a length of stay practice guideline on patient outcomes. DESIGN: A prospective, nonrandomized, interventional trial. SETTING: Six geographically distributed hospitals. PATIENTS: Two hundred forty-two consecutively hospitalized "low-risk" patients with pneumonia. MEASUREMENTS AND RESULTS: One hundred fifty-two patients (63%) completed the mailed postdischarge survey and were included in the analysis. Data were prospectively collected for 85 patients from the baseline observation period (B) and 67 patients from the intervention period (I). During the I, case managers provided physicians with patient risk information based on guideline recommendations. There was no significant change in guideline compliance (B vs I: 76.5% vs 83.6%; p=0.32) or length of stay (B vs I: 3.5 days [95% confidence interval, 3.2 to 3.8] vs 3.6 days [95% confidence interval, 3.3 to 4.0]). Also, there were no statistically significant effects of the intervention on patient outcomes, care following hospital discharge, and patient satisfaction scores. CONCLUSION: Patients in this study often had shorter lengths of stay than recommended by the practice guideline. This suggests that the external environment may have had a greater effect on physician behavior and length of stay than the practice guideline itself. Moreover, it demonstrates the importance of continuous assessment of physician practices immediately prior to, during, and after application of the clinical practice guideline.

Activities of Daily Living↗

The logic behind a multimethod intervention to improve adherence to clinical practice guidelines in a nationwide network of primary care practices.

The gap between evidence-based guidelines for clinical care and their application in medical settings is well established and widely discussed. Effective interventions are needed to help health care providers reduce this gap. Whereas the development of clinical practice guidelines from biomedical and clinical research is an example of Type 1 translation, Type 2 translation involves successful implementation of guidelines in clinical practice. This article describes a multimethod intervention that is part of a Type 2 translation project aimed at increasing adherence to clinical practice guidelines in a nationwide network of primary care practices that use a common electronic medical record (EMR). Practice performance reports, site visits, and network meetings are intervention methods designed to stimulate improvement in practices by addressing personal and organizational factors. Theories and evidence supporting these interventions are described and could prove useful to others trying to translate medical research into practice. Additional theory development is needed to support translation in medical offices.

Biomedical Research↗