Gøtzsche P C
The Nordic Cochrane Centre, Rigshospitalet, Department 7112, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.
Ann Rheum Dis. 2001 Apr;60(4):349-52. doi: 10.1136/ard.60.4.349.
To study whether the reporting of clinical outcomes in arthritis trials measured on ordinal and interval scales is adequate in relation to meta-analysis.
Systematic review of randomised trials of non-steroidal anti-inflammatory drugs in patients with rheumatoid arthritis. Optimal reporting was defined as data in the original ordered categories for global evaluation and pain, and as mean and SD for number of tender joints and grip strength, and if a visual analogue scale had been used to measure pain.
A total of 144 trials were included. The median sample size was 60 patients. The quality of the reporting increased over time for three of the four variables. Global evaluation was optimally reported in 52 of the 127 trials (41%) in which it was recorded. Pain was optimally reported in 27 of 98 trials (28%), number of tender joints in 41 of 123 trials (33%), and grip strength in 34 of 124 trials (27%). Even if rather broad criteria are adopted, only about half of the data were reported in a potentially useful way for a meta-analysis.
Arthritis trials have been reported inadequately in relation to meta-analysis. As most trials are underpowered, meta-analysis is indispensable and the deficit therefore needs urgent improvement. Investigators should specify a priori what constitutes an important treatment effect and report numbers of patients improved.
研究在关节炎试验中,以有序和区间量表测量的临床结局报告对于荟萃分析而言是否充分。
对类风湿关节炎患者使用非甾体抗炎药的随机试验进行系统评价。最佳报告定义为:对于整体评估和疼痛,采用原始有序分类中的数据;对于压痛关节数和握力,采用均值和标准差,若使用视觉模拟量表测量疼痛则也采用该量表数据。
共纳入144项试验。样本量中位数为60例患者。四个变量中有三个变量的报告质量随时间有所提高。在记录了整体评估的127项试验中,有52项(41%)报告最佳。在98项试验中,有27项(28%)对疼痛的报告最佳;在123项试验中,有41项(33%)对压痛关节数的报告最佳;在124项试验中,有34项(27%)对握力的报告最佳。即便采用相当宽泛的标准,对于荟萃分析而言,也只有约一半的数据是以可能有用的方式报告的。
关于荟萃分析,关节炎试验的报告并不充分。由于大多数试验的效能不足,荟萃分析不可或缺,因此这一缺陷急需改进。研究者应事先明确什么构成重要的治疗效果,并报告改善的患者数量。