Although clinical practice guidelines have been considered an essential part of quality medical practice for decades, most developed for primary care are not up to the task, a study has shown.
Of more than 400 clinical practice guidelines for drug treatment of common noncommunicable diseases (NCDs) such as heart disease, lung disease, and diabetes included in a systematic review, fewer than 100 can be characterized as high-quality on the basis of a widely used standard for assessing practice guidelines, the researchers explain.
The findings of Caroline de Godoi Rezende Costa Molino, MS, of the University of São Paulo in Brazil and colleagues were published online February 18 in JAMA Internal Medicine.
Overall, clinical practice guidelines were more likely to be high quality if they were developed by government institutions (51.5%), had more than 20 authors (40.2%), were revisions of existing documents (35.2%), reported funding sources (41.6%), involved a formal consensus process for recommendations (59.5%), and defined a time schedule for an update (56.1%).
Factors associated with lower-quality guidelines were insufficient rigor of development, lack of applicability, and under-representation of all relevant stakeholders in the development process.
“Currently, thousands of clinical practice guidelines can be freely accessed; however, studies have routinely found that clinical practice guidelines are often based on low-quality, scant, and heterogeneous data,” the authors write. “In addition, methods used by experts to create clinical practice guidelines are widely variable, including protocols for handling of discrepancies between reviewers, searching relevant literature, selecting panel members, and relying on expert opinion where evidence is insufficient.”
Because low-quality guidelines can negatively influence healthcare outcomes, the investigators undertook this study to address a pervasive information deficit around the factors associated with the quality of existing clinical practice guidelines for managing NCDs in primary care. “To date, information about factors associated with quality of clinical practice guidelines for managing NCDs in primary care is limited,” they explain. “Previous studies that estimated factors associated with quality of clinical practice guidelines were limited in scope or did not focus on guidelines for the management of NCDs.”
Using the validated Appraisal of Guidelines for Research and Evaluation Instrument, version II (AGREE-II) tool, the authors systematically assessed the quality of 421 clinical practice guidelines that included pharmacologic interventions for common NCDs in primary care and estimated the factors associated with high quality, defined as a rigor of development score of 60% or higher. Guidelines published between January 1, 2011, and August 30, 2017, and that were written in English, Portuguese, or Spanish were considered for inclusion.
Of the 421 guidelines, 213 (50.6%) were produced by specialty societies, 239 (56.8%) were first-version guidelines, and only 214 (50.8%) reported funding. Only 152 (36.1%) of the guidelines were developed using a systematic review, and only 74 (17.6%) reported a formal method for achieving consensus, the authors report. The fact that only slightly more than one third of the documents were produced as a result of a systematic review is notable given that, in 2011, the Institute of Medicine removed all clinical practice guidelines that were not developed using this methodology from the National Clearinghouse.
On the basis of the AGREE-II assessment, 99 (23.5%) of the 421 clinical practice guidelines met the standard for high quality, whereas 322 (76.5%) were rated as low quality. Mean scores were lower than 60% for rigor of development (38.0%), applicability (27.9%), stakeholder involvement (36.8%), and editorial independence (41.7%). The highest mean scores were observed in the clarity of presentation (68.8%) and scope and purpose (62.1%) domains.
In a multivariable analysis further examining associations with high-quality clinical practice guidelines, clear trends were observed for guidelines that had more authors (odds ratio [OR] for over 20 authors, 9.08; 95% CI, 3.35 – 24.62), came from governmental institutions (OR, 10.38; 95% CI, 2.72 – 39.60), and reported funding (OR, 10.34; 95% CI, 4.77 – 22.39).
“These findings are important to practicing clinicians and policymakers because half of clinical practice guidelines’ recommendations for primary care are based on the opinions of experts rather than on high-quality randomized clinical trials,” the authors write. “Therefore, there is considerable room for biased recommendations, as they can be influenced by financial conflict of interests and potential benefits of increased demand for some specialty group.”
With respect to the multiple authorship association, this finding is consistent with a previous report by the Guideline International Network, which determined that guidelines developed by small groups may not include all relevant stakeholders. “By this measure, a large group may increase the chances of having a multidisciplinary team developing the guidelines,” the authors hypothesize. “Because of the relatively small number of drug trials with external validity for primary care patients, a multidisciplinary team is essential to formulate evidence-based recommendations by including individuals with different expertise, preventing groupthink, and balancing conflicts of interest.”
No associations between geographic region and high-quality guidelines were observed in the current analysis, which is an unexpected finding, according to the authors. “Previous studies showed that clinical practice guidelines from low- and middle-income countries are less likely to be of high quality,” they write, highlighting the need for additional research to investigate this difference.
The findings of this study and those of another investigation reported in the same issue of JAMA Internal Medicine, which indicates fewer than 20% of strong recommendations in American Thoracic Society guidelines were derived from high-quality evidence, are “sobering,” according to the authors of an accompanying editorial.
According to Michael Incze, MD, of the University of California San Francisco (a JAMA Internal Medicine editorial fellow) and Joseph S. Ross, MD, of Yale University School of Medicine, New Haven, Connecticut (a JAMA Internal Medicine associate editor), the reports “suggest that development of high-quality clinical practice guidelines appears to be beyond the capacity of the small groups of content experts who have historically created many widely used guidelines.” In addition, the findings “question the utility of guidelines developed by professional societies, particularly those with financial relationships with industry,” they write.
“Clinicians appear to be best served when government organizations take on the development of clinical practice guidelines and should be tasked with ensuring and updating high-quality guidelines to meet [Institute of Medicine] standards, retiring low-quality guidelines, and resolving conflicts between discordant existing guidelines,” the editorial authors suggest. They also call for the development of fewer clinical practice guidelines going forward and note that when guidelines are developed, they should be done so with appropriate engagement, support, and resources to meet quality standards.
“As a profession, we rely on rigorous and transparent methods to answer scientific questions; our approach to summarizing research into clinical practice guidelines should be no less thorough,” the editorialists conclude.
The study authors have disclosed no relevant financial relationships. Ross has reported financial relationships with Johnson & Johnson, Medtronic, the US Food and Drug Administration, Blue Cross Blue Shield Association, Centers for Medicare & Medicaid Services, Agency for Healthcare Research and Quality, National Heart, Lung, and Blood Institute of the National Institutes of Health, and Laura and John Arnold Foundation. Incze has disclosed no relevant financial relationships.
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