Purgato Marianna, Barbui Corrado, Cipriani Andrea
Department of Public Health and Community Medicine, Section of Psychiatry and Clinical Psychology, University of Verona, Italy.
Epidemiol Psichiatr Soc. 2010 Oct-Dec;19(4):296-7.
Even though randomised controlled trials are the design of choice for evaluating the efficacy of health care interventions, they are not immune to bias that may affect research process and validity of results. In the present paper we discussed how trial quality may be appraised considering both whether a clinical trial is reported in a comprehensive and complete way (consistently with what had been declared in the study protocol), and whether the characteristics of the trial itself are associated with risk of bias.
尽管随机对照试验是评估医疗保健干预措施疗效的首选设计,但它们也无法避免可能影响研究过程和结果有效性的偏差。在本文中,我们讨论了如何评估试验质量,既要考虑临床试验是否以全面和完整的方式报告(与研究方案中所声明的一致),也要考虑试验本身的特征是否与偏差风险相关。