Reporting Disease Activity in Clinical Trials of Patients With Rheumatoid Arthritis: EULAR/ACR Collaborative Recommendations
Reporting Disease Activity in Clinical Trials of Patients With Rheumatoid Arthritis: EULAR/ACR Collaborative Recommendations
复制标题
DOI：
10.1002/art.24123
复制
发表时间：
2008-10-15
期刊：
影响因子：
--
通讯作者：
Felson, D.
中科院分区：
文献类型：
--
作者：
Aletaha, D.;Landewe, R.;Felson, D.
Objective.对欧洲抗风湿联盟（EULAR）和美国风湿病学会（ACR）认可的类风湿关节炎（RA）临床试验中如何报告疾病活动性提出建议。该项目遵循EULAR标准化操作程序，该程序使用三步方法：1）基于专家的相关研究问题定义（2006年11月）; 2）系统性文献检索（2006年11月至2007年5月）; 3）基于文献检索结果的专家建议共识（2007年5月）。此外，由于这是欧洲法律和法规联盟/非洲法律和法规联盟关于建议的第一份联合出版物，因此采取的额外步骤包括与非洲法律和法规联盟小组举行会议，以批准专家组拟订的建议（2007年8月）。确定了11个相关问题用于文献检索。基于文献证据，专家组建议每个试验应报告以下项目：1）疾病活动反应和疾病活动状态; 2）基线、终点和核心集中单个变量变化的适当描述性统计量; 3）基线疾病活动水平（一般情况下）; 4）达到低疾病活动状态和缓解的患者百分比; 5）主要结局发生的时间; 6）主要结局的可持续性; 7）疲乏。EULAR和ACR认可的这些建议将有助于协调临床试验结果的呈现。遵守这些建议将为临床试验的读者提供更多重要结局的细节，而更高水平的同质性可能有助于比较不同试验的结局和汇总试验结果，例如荟萃分析。
Objective. To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods. The project followed the EULAR standardized operating procedures, which use a three-step approach: 1) expert-based definition of relevant research questions (November 2006); 2) systematic literature search (November 2006 to May 2007); and 3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007).Results. Eleven relevant questions were identified for the literature search. Based on the evidence from the literature, the expert panel recommended that each trial should report the following items: 1) disease activity response and disease activity states; 2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; 3) baseline disease activity levels (in general); 4) the percentage of patients achieving a low disease activity state and remission; 5) time to onset of the primary outcome; 6) sustainability of the primary outcome; 7) fatigue.Conclusion. These recommendations endorsed by EULAR and ACR will help harmonize the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.