Bergmann J F
Clinique Thérapeutique, Hôpital Lariboisière, Paris.
Prog Urol. 1996 Apr;6(2):199-204.
To define the principles of the methodology applied to therapeutic trials in medicine and surgery. To define methodological aspects related to therapeutic trials in urology. To exhaustively study three urology journals in order to analyse the methodological quality of the articles published.
The basic principles of therapeutic trials are described: the randomized double-blind placebo-controlled trial is the most valid trial to demonstrate the efficacy of a treatment. In surgery, and especially in urology, these therapeutic trials comparing two surgical techniques must be conducted by teams accepting the ambivalence of comparison after randomization. Ideally, treatment is evaluated by observers blinded to the technique used. The assessment criteria must be as clinical as possible and must be based on universally accepted standardized measurements. The quality of a therapeutic trial is assessed in terms of its protocol, but also on the quality of practical conduct of the trial, the precision and accuracy of its statistical analysis and the presentation of the results. The first 1995 issue of the "Journal of Urology", the "British Journal of Urology" and "Progrès en Urologie" were studied exhaustively, looking for articles dealing with a therapeutic evaluation. The comparative or non-comparative nature of the study, the presence or absence of randomization, double-blind, and a predetermined sample size were noted for each study.
Ten non-comparative retrospective studies, one non-comparative prospective study and five trials with a control group, including two open randomized trials were reported in the "Journal of Urology". Nine retrospective non-controlled studies were reported in the "British Journal of Urology". Seven retrospective studies, including one open, non-randomized study with a control group, were reported in "Progrès en Urologie".
The principles of the methodology of therapeutic trials can be applied to the evaluation of a treatment or a surgical technique, especially in urology. Compliance with the rules of methodology impose additional constraints, sometimes difficult to implement, but essential to ensure the quality of the results obtained. Randomized trials are rare in urological publications, which still largely consist of retrospective non-comparative series.
明确应用于医学和外科治疗试验的方法学原则。明确与泌尿外科治疗试验相关的方法学方面。详尽研究三种泌尿外科期刊，以分析所发表文章的方法学质量。
描述治疗试验的基本原则：随机双盲安慰剂对照试验是证明治疗效果最有效的试验。在外科手术中，尤其是泌尿外科，比较两种手术技术的这些治疗试验必须由在随机分组后接受比较矛盾性的团队进行。理想情况下，治疗由对所用技术不知情的观察者进行评估。评估标准必须尽可能具有临床相关性，且必须基于普遍接受的标准化测量。治疗试验的质量根据其方案进行评估，同时也根据试验实际开展的质量、统计分析的精确性和准确性以及结果的呈现来评估。对《泌尿外科杂志》《英国泌尿外科杂志》和《泌尿外科进展》1995年的第一期进行了详尽研究，查找涉及治疗评估的文章。记录每项研究的研究比较性或非比较性、是否存在随机分组、双盲以及预定样本量。
《泌尿外科杂志》报道了10项非比较性回顾性研究、1项非比较性前瞻性研究和5项有对照组的试验，其中包括2项开放随机试验。《英国泌尿外科杂志》报道了9项回顾性非对照研究。《泌尿外科进展》报道了7项回顾性研究，其中包括1项有对照组的开放非随机研究。
治疗试验的方法学原则可应用于治疗或手术技术的评估，尤其是在泌尿外科。遵循方法学规则会带来额外限制，有时难以实施，但对于确保所获结果的质量至关重要。随机试验在泌尿外科出版物中很少见，这些出版物在很大程度上仍由回顾性非比较系列组成。
