外科试验中的方法学标准。
Methodologic standards in surgical trials.
作者信息
Hall J C, Mills B, Nguyen H, Hall J L
机构信息
University Department of Surgery, Royal Perth Hospital, PerthWA, Australia.
出版信息
Surgery. 1996 Apr;119(4):466-72. doi: 10.1016/s0039-6060(96)80149-8.
BACKGROUND
Concerns have been raised that flaws in the design and analysis of trials will hinder the interpretation of their relevance to clinical practice. The objective of this study was to review the nature and methodologic standards of surgical trails published in 10 prestigious journals between January 1988 and December 1994.
METHODS
We evaluated the demography and methodologic standards of 364 trials. Each article was independently scrutinized by two assessors with documentation of the interassessor variation.
RESULTS
Less than 50% of the trials made comment about an unbiased assessment of outcome, gave an adequate description of the randomization technique, or provided a prospective estimate of the sample size. Economic factors were declared in 6.5% of the trials. Only 2% of the trials attempted to measure the effect of an intervention on the quality of life patients.
CONCLUSIONS
Readers should be cautious when interpreting the results of surgical trials.
背景
有人担心试验设计和分析中的缺陷会妨碍对其与临床实践相关性的解读。本研究的目的是回顾1988年1月至1994年12月期间在10种著名期刊上发表的外科试验的性质和方法学标准。
方法
我们评估了364项试验的人口统计学和方法学标准。每篇文章由两名评估者独立审查，并记录评估者间的差异。
结果
不到50%的试验对结果的无偏评估进行了评论，对随机化技术进行了充分描述，或对样本量进行了前瞻性估计。6.5%的试验声明了经济因素。只有2%的试验试图测量干预对患者生活质量的影响。
结论
读者在解读外科试验结果时应谨慎。
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