Fihn S D, Stamm W E
Rev Infect Dis. 1985 Jul-Aug;7(4):468-78. doi: 10.1093/clinids/7.4.468.
Recent treatment trials for uncomplicated urinary tract infection were reviewed to determine most commonly used methodologic approaches and to assess whether methodologic problems often compromise internal validity and comparability of these studies. The 62 studies surveyed fulfilled an average of 56% (standard deviation, 19.2%) of 12 standards necessary for accurate interpretation and comparability. Standards most often met were: reporting the incidence of adverse-effects (90%); recording presence or absence of pretreatment symptoms (81%); and describing clinical response to therapy (71%). Standards least often met were: having adequate statistical power to detect a meaningful difference between therapies (21%); double-blinded assigning of treatment regimens (37%); and clearly defining criteria for diagnosing cure and failure (35%). Two recurring characteristics that impaired both interpretation of individual studies and comparisons between studies were failure to separately randomize or stratify patients with risk factors known to adversely affect therapeutic response and inadequate description of outcome measures. Consideration of these factors and use of a proposed system for classifying therapeutic outcome in future treatment trials would improve the basis for clinical decision making.
对近期关于单纯性尿路感染的治疗试验进行了综述，以确定最常用的方法学途径，并评估方法学问题是否经常损害这些研究的内部有效性和可比性。所调查的62项研究平均满足了准确解释和可比性所需的12项标准中的56%（标准差为19.2%）。最常达到的标准是：报告不良反应的发生率（90%）；记录治疗前症状的有无（81%）；以及描述对治疗的临床反应（71%）。最不常达到的标准是：有足够的统计效力来检测不同治疗方法之间的有意义差异（21%）；治疗方案的双盲分配（37%）；以及明确界定治愈和失败的诊断标准（35%）。妨碍对个体研究进行解释以及研究之间进行比较的两个反复出现的特征是，未能对已知会对治疗反应产生不利影响的危险因素的患者进行单独随机分组或分层，以及对结局指标的描述不充分。在未来的治疗试验中考虑这些因素并使用提议的治疗结局分类系统将改善临床决策的依据。
