Rigorous Development does not Ensure that Guidelines are Acceptable to a Panel of Knowledgeable Providers

Abstract

BACKGROUND: Rigorous guideline development methods are designed to produce recommendations that are relevant to common clinical situations and consistent with evidence and expert understanding, thereby promoting guidelines' acceptability to providers. No studies have examined whether this technical quality consistently leads to acceptability. OBJECTIVE:To examine the clinical acceptability of guidelines having excellent technical quality. DESIGN AND MEASUREMENTS:We selected guidelines covering several musculoskeletal disorders and meeting 5 basic technical quality criteria, then used the widely accepted AGREE Instrument to evaluate technical quality. Adapting an established modified Delphi method, we assembled a multidisciplinary panel of providers recommended by their specialty societies as leaders in the field. Panelists rated acceptability, including "perceived comprehensiveness" (perceived relevance to common clinical situations) and "perceived validity" (consistency with their understanding of existing evidence and opinions), for ten common condition/therapy pairs pertaining to Surgery, physical therapy, and chiropractic manipulation for lumbar spine, shoulder, and carpal tunnel disorders. RESULTS:Five guidelines met selection criteria. Their AGREE scores were generally high indicating excellent technical quality. However, panelists found 4 guidelines to be only moderately comprehensive and valid, and a fifth guideline to be invalid overall. Of the topics covered by each guideline, panelists rated 50% to 69% as "comprehensive" and 6% to 50% as "valid". CONCLUSION:Despite very rigorous development methods compared with guidelines assessed in prior studies, experts felt that these guidelines omitted common clinical situations and contained much content of uncertain validity. Guideline acceptability should be independently and formally evaluated before dissemination.KEY WORDS: practice guidelines; quality assurance; health care; evidence-based medicine; attitude of health personnel; evaluation.

AGREE II: advancing guideline development, reporting and evaluation in health care

“…While rigorous development and explicit reporting are necessary, they do not guarantee optimal and acceptable recommendations or better health outcomes for patients and populations. 9,10 The new item assessing the description of strengths and limitations of the body of evidence (i.e., item 9) can be considered as a precursor for clinical validity or appropriateness of the recommendations. The consortium is targeting this area as its next priority for further study in the AGREE A3 initiative.…”

AGREE II: Advancing guideline development, reporting, and evaluation in health care

“…However, they do not evaluate the clinical appropriateness or validity of the recommendations themselves. While rigorous development and explicit reporting are necessary, they do not guarantee optimal and acceptable recommendations or better health outcomes for patients and populations (Nuckols et al, 2008;Watine et al, 2006). The new item assessing the description of strengths and limitations of the body of evidence (i.e., item 9) can be considered as a precursor for clinical validity or appropriateness of the recommendations.…”

The Global Rating Scale complements the AGREE II in advancing the quality of practice guidelines

“…Thus, for the purposes of informing practice decisions, these data suggest bottom line clinical advice -new information not captured by the AGREE II -are, not surprisingly, of particular relevance to the clinical community. In response and recognizing that guideline quality as measured with the AGREE II tool does not necessarily predict high clinical validity of the recommendations [9,10], continued research exploring the concept of clinical validity or appropriateness is warranted and is under way (see www.agreetrust.org). In contrast to what emerged with the clinician participants, the policy makers and developers/researchers focused on methodological issues.…”