皮肤病学随机对照临床试验中生活质量结果的报告不佳。
Poor reporting of quality of life outcomes in dermatology randomized controlled clinical trials.
作者信息
Le Cleach Laurence, Chassany Olivier, Levy Annabelle, Wolkenstein Pierre, Chosidow Olivier
机构信息
Service de Dermatologie, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France.
出版信息
Dermatology. 2008;216(1):46-55. doi: 10.1159/000109358.
BACKGROUND
Because many dermatological diseases are chronic but not life-threatening, consideration of their impact on health-related quality of life (QOL) seems essential.
OBJECTIVE
To analyze the use of QOL as an evaluation endpoint in randomized clinical trials concerning skin diseases.
METHODS
Studies identified by computerized search of 3 bibliographical databases were selected, and their data on QOL as an evaluation endpoint were collected and analyzed.
RESULTS
Among the 67 studies retained, 87% did not adequately describe the questionnaires; 75% did not address handling of missing data; 95% did not calculate the number of subjects needed to obtain the desired statistical power; 95% did not disclose before-and-after results as means of overall scores and each dimension.
CONCLUSION
Our analysis highlighted methodological weaknesses in the use of QOL questionnaire and poor reporting of QOL outcomes in randomized clinical trials.
背景
由于许多皮肤病是慢性的，但不危及生命，因此考虑它们对健康相关生活质量（QOL）的影响似乎至关重要。
目的
分析在关于皮肤病的随机临床试验中使用生活质量作为评估终点的情况。
方法
选择通过计算机检索3个书目数据库确定的研究，并收集和分析其关于生活质量作为评估终点的数据。
结果
在保留的67项研究中，87%未充分描述问卷；75%未涉及缺失数据的处理；95%未计算获得所需统计效能所需的受试者数量；95%未将前后结果作为总体得分和各维度的均值披露。
结论
我们的分析突出了随机临床试验中使用生活质量问卷的方法学弱点以及生活质量结果报告不佳的问题。
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