international Centre for Allied Health Evidence, University of South Australia, Australia.
BMC Med Res Methodol. 2011 Feb 28;11:23. doi: 10.1186/1471-2288-11-23.
Clinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology and associated processes to assist Australian guideline developers in considering a body of evidence and grading the resulting guideline recommendations.
In recognition of the complexities of clinical guidelines and the multiple factors that influence choice in health care, a working group of experienced guideline consultants was formed under the auspices of the Australian National Health and Medical Research Council (NHMRC) to produce and pilot a framework to formulate and grade guideline recommendations. Consultation with national and international experts and extensive piloting informed the process.
The FORM framework consists of five components (evidence base, consistency, clinical impact, generalisability and applicability) which are used by guideline developers to structure their decisions on how to convey the strength of a recommendation through wording and grading via a considered judgement form. In parallel (but separate from the grading process) guideline developers are asked to consider implementation implications for each recommendation.
The framework has now been widely adopted by Australian guideline developers who find it to be a logical and intuitive way to formulate and grade recommendations in clinical practice guidelines.
临床实践指南是循证实践的重要组成部分。考虑到证据通常很复杂,这对指南制定者来说可能是一个问题,他们过去可能会使用单个研究的证据水平作为推荐强度的准指标。本文报告了一种方法和相关流程的制定和试用情况,以帮助澳大利亚的指南制定者考虑证据体系并对得出的指南建议进行分级。
为了认识到临床指南的复杂性以及影响医疗保健选择的多种因素,在澳大利亚国家卫生和医学研究委员会(NHMRC)的支持下,由经验丰富的指南顾问组成了一个工作组,制定并试行一个框架,以制定和分级指南建议。与国内外专家进行了磋商,并进行了广泛的试点,为该过程提供了信息。
FORM 框架由五个部分(证据基础、一致性、临床影响、普遍性和适用性)组成,指南制定者使用这些部分来构建他们的决策,以通过措辞和通过深思熟虑的判断表来分级来传达推荐强度。同时(与分级过程分开),指南制定者被要求考虑每个建议的实施影响。
该框架现已被澳大利亚的指南制定者广泛采用,他们发现这是一种在临床实践指南中制定和分级建议的逻辑和直观方法。