Nobre Moacyr Roberto Cuce, da Costa Frnanda Marques
Unidade de Epidemiologia Clínica - InCor, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo Brazil.
Evid Based Med. 2012 Feb;17(1):3-7. doi: 10.1136/ebm-2011-100058. Epub 2011 Oct 12.
Surrogate endpoints may be used as substitutes for, but often do not predict clinically relevant events. Objective To assess the methodological quality of articles that present their conclusions based on clinically relevant or surrogate outcomes in a systematic review of randomised trials and cohort studies of patients with rheumatoid arthritis treated with antitumour necrosis factor (TNF) agents.
PubMed, Embase and Cochrane databases were searched. The Jadad score, the percentage of Consolidated Standards Of Reporting Trials (CONSORT) statement items adequately reported and levels-of-evidence (Center for Evidence-based Medicine, Oxford) were used in a descriptive synthesis.
Among 88 articles appraised, 27 had surrogate endpoints, mainly radiographic, and 44 were duplicate publications; 74% of articles with surrogate and 39% of articles with clinical endpoints (p=0.006). Fewer articles with surrogate endpoints represented a high level of evidence (Level 1b, 33% vs 62%, p=0.037) and the mean percentage of CONSORT statement items met was also lower for articles with surrogate endpoints (62.5 vs 70.7, p=0.026). Although fewer articles with surrogate endpoints were randomised trials (63% vs 74%, p=0.307) and articles with surrogate endpoints had lower Jadad scores (3.0 vs 3.2, p=0.538), these differences were not statistically significant.
Studies of anti-TNF agents that report surrogate outcomes are of lesser methodological quality. As such, inclusion of such studies in evidence syntheses may bias results.
替代终点可作为临床相关事件的替代指标，但通常无法预测临床相关事件。目的：在一项关于使用抗肿瘤坏死因子（TNF）药物治疗类风湿关节炎患者的随机试验和队列研究的系统评价中，评估基于临床相关结局或替代结局得出结论的文章的方法学质量。
检索PubMed、Embase和Cochrane数据库。采用Jadad评分、充分报告的《报告试验的统一标准》（CONSORT）声明项目百分比以及证据水平（牛津循证医学中心）进行描述性综合分析。
在评估的88篇文章中，27篇有替代终点，主要是影像学终点，44篇为重复发表；有替代终点的文章占74%，有临床终点的文章占39%（p = 0.006）。有替代终点的文章中代表高证据水平的较少（1b级，33%对62%，p = 0.037），有替代终点的文章满足CONSORT声明项目的平均百分比也较低（62.5对70.7，p = 0.026）。尽管有替代终点的文章作为随机试验的较少（63%对74%，p = 0.307），且有替代终点的文章Jadad评分较低（3.0对3.2，p = 0.538），但这些差异无统计学意义。
报告替代结局的抗TNF药物研究方法学质量较低。因此，将此类研究纳入证据综合分析可能会使结果产生偏差。
