Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Implement Sci. 2013 Jul 10;8:78. doi: 10.1186/1748-5908-8-78.
A variety of systems have been developed to grade evidence and develop recommendations based on the available evidence. However, development of guidelines for medical tests is especially challenging given the typical indirectness of the evidence; direct evidence of the effects of testing on patient important outcomes is usually absent. We compared grading systems for medical tests on how they use evidence in guideline development.
We used a systematic strategy to look for grading systems specific to medical tests in PubMed, professional guideline websites, via personal correspondence, and handsearching back references of key articles. Using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument as a starting point, we defined two sets of characteristics to describe these systems: methodological and process ones. Methodological characteristics are features relating to how evidence is gathered, appraised, and used in recommendations. Process characteristics are those relating to the guideline development process. Data were extracted in duplicate and differences resolved through discussion.
Twelve grading systems could be included. All varied in the degree to which methodological and process characteristics were addressed. Having a clinical scenario, identifying the care pathway and/or developing an analytical framework, having explicit criteria for appraising and linking indirect evidence, and having explicit methodologies for translating evidence into recommendations were least frequently addressed. Five systems at most addressed these, to varying degrees of explicitness and completeness. Process wise, features most frequently addressed included involvement of relevant professional groups (8/12), external peer review of completed guidelines (9/12), and recommendations on methods for dissemination (8/12). Characteristics least often addressed were whether the system was piloted (3/12) and funder information (3/12).
Five systems for grading evidence about medical tests in guideline development addressed to differing degrees of explicitness the need for and appraisal of different bodies of evidence, the linking of such evidence, and its translation into recommendations. At present, no one system addressed the full complexity of gathering, assessing and linking different bodies of evidence.
已经开发了各种系统来对证据进行分级，并根据现有证据制定建议。然而，由于证据的典型间接性，制定医疗测试指南尤其具有挑战性；通常缺乏关于测试对患者重要结局影响的直接证据。我们比较了不同的分级系统，以了解它们在指南制定中如何使用证据。
我们使用系统策略在 PubMed、专业指南网站、个人通信以及关键文章的回溯参考文献中查找特定于医疗测试的分级系统。我们以评估研究和评估指南（AGREE）工具为起点，定义了两组描述这些系统的特征：方法学和过程特征。方法学特征是与如何收集、评估证据以及在建议中使用证据相关的特征。过程特征是与指南制定过程相关的特征。数据由两人重复提取，通过讨论解决差异。
可以纳入 12 个分级系统。所有系统在方法学和过程特征的处理程度上都存在差异。具有临床情况、确定护理途径和/或制定分析框架、具有明确的评估间接证据的标准、以及具有明确的将证据转化为建议的方法，这些特征的处理最少。最多有 5 个系统在不同程度上明确和完整地处理了这些特征。在过程方面，最常涉及的特征包括涉及相关专业团体（12/12）、外部同行审查已完成指南（12/12）以及建议传播方法（12/12）。最少涉及的特征是系统是否经过试点（12/12）和资金来源信息（12/12）。
在指南制定中评估医疗测试证据的 5 个分级系统在不同程度上明确了需要和评估不同类型证据、将这些证据联系起来以及将其转化为建议的需求。目前，没有一个系统完全解决了收集、评估和联系不同类型证据的全部复杂性。
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