Atkins David, Briss Peter A, Eccles Martin, Flottorp Signe, Guyatt Gordon H, Harbour Robin T, Hill Suzanne, Jaeschke Roman, Liberati Alessandro, Magrini Nicola, Mason James, O'Connell Dianne, Oxman Andrew D, Phillips Bob, Schünemann Holger, Edejer Tessa Tan-Torres, Vist Gunn E, Williams John W
Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 540 Gaither Rd. Rokville, MD 20852, USA.
BMC Health Serv Res. 2005 Mar 23;5(1):25. doi: 10.1186/1472-6963-5-25.
Systems that are used by different organisations to grade the quality of evidence and the strength of recommendations vary. They have different strengths and weaknesses. The GRADE Working Group has developed an approach that addresses key shortcomings in these systems. The aim of this study was to pilot test and further develop the GRADE approach to grading evidence and recommendations.
A GRADE evidence profile consists of two tables: a quality assessment and a summary of findings. Twelve evidence profiles were used in this pilot study. Each evidence profile was made based on information available in a systematic review. Seventeen people were given instructions and independently graded the level of evidence and strength of recommendation for each of the 12 evidence profiles. For each example judgements were collected, summarised and discussed in the group with the aim of improving the proposed grading system. Kappas were calculated as a measure of chance-corrected agreement for the quality of evidence for each outcome for each of the twelve evidence profiles. The seventeen judges were also asked about the ease of understanding and the sensibility of the approach. All of the judgements were recorded and disagreements discussed.
There was a varied amount of agreement on the quality of evidence for the outcomes relating to each of the twelve questions (kappa coefficients for agreement beyond chance ranged from 0 to 0.82). However, there was fair agreement about the relative importance of each outcome. There was poor agreement about the balance of benefits and harms and recommendations. Most of the disagreements were easily resolved through discussion. In general we found the GRADE approach to be clear, understandable and sensible. Some modifications were made in the approach and it was agreed that more information was needed in the evidence profiles.
Judgements about evidence and recommendations are complex. Some subjectivity, especially regarding recommendations, is unavoidable. We believe our system for guiding these complex judgements appropriately balances the need for simplicity with the need for full and transparent consideration of all important issues.
不同组织用于对证据质量和推荐强度进行分级的系统各不相同。它们各有优缺点。GRADE工作组已开发出一种方法,以解决这些系统中的关键缺陷。本研究的目的是对GRADE证据和推荐分级方法进行试点测试并进一步完善。
一份GRADE证据概要由两张表格组成:质量评估表和结果总结表。本试点研究使用了12份证据概要。每份证据概要均基于系统评价中可得的信息编制而成。17人接受指导并独立对12份证据概要中的每一份的证据水平和推荐强度进行分级。针对每个示例收集判断结果,在小组内进行总结和讨论,目的是改进提议的分级系统。计算卡帕值,作为对12份证据概要中每个结果的证据质量的机会校正一致性的衡量指标。还询问了17位评判者该方法的易理解性和合理性。记录所有判断结果并讨论分歧之处。
对于与12个问题中的每一个相关的结果的证据质量,达成的一致程度各不相同(超出机遇的一致性卡帕系数范围为0至0.82)。然而,对于每个结果的相对重要性存在合理的一致性。对于利弊平衡和推荐意见的一致性较差。大多数分歧通过讨论很容易得到解决。总体而言,我们发现GRADE方法清晰、易懂且合理。对该方法进行了一些修改,并一致认为证据概要中需要更多信息。
对证据和推荐意见的判断很复杂。有些主观性,尤其是关于推荐意见的主观性,是不可避免的。我们认为,我们用于指导这些复杂判断的系统在简单性需求与全面透明考虑所有重要问题的需求之间取得了适当平衡。