Stewart William C, Jackson Angi L, Jenkins Jessica N
Pharaceutical Research Network, and Carolina Eye Institute, University of South Carolina School of Medicine, Columbia, South Carolina 29412-2464, USA.
Am J Ophthalmol. 2004 Apr;137(4):639-45. doi: 10.1016/j.ajo.2003.11.028.
To describe dropout rates for the intent-to-treat and per protocol analyses from prospective clinical trials.
Review of prospective multi-center parallel studies of 100 patients or more from 1996 onwards.
We identified 33 articles (70 treatment arms) that fit the criteria for this study. No statistical differences in dropout rates were observed among drug classes for either the intent-to-treat (P =.075) or per protocol analyses (P =.40). A difference was observed in the percent dropout rate for the intent-to-treat analyses decreasing with the length of the study (P <.0001). This finding was not observed by the number of study visits (P =.44). However, a statistically greater percent dropout rate was observed for the per protocol analyses increasing with the length of the study (P =.034) and number of study visits (P =.01). No statistical differences were observed or with increasing sample size of the study for either the intent-to-treat or per protocol analyses (P >.05).
Known discontinuation rates for per protocol and intent-to-treat analyses may help in planning sample sizes for future clinical trials.
描述前瞻性临床试验中意向性分析和符合方案分析的失访率。
回顾1996年起的100例及以上患者的前瞻性多中心平行研究。
我们确定了33篇文章（70个治疗组）符合本研究标准。在意向性分析（P = 0.075）或符合方案分析中，各药物类别间失访率无统计学差异（P = 0.40）。在意向性分析中，观察到失访率百分比随研究时长降低（P < 0.0001）。在研究访视次数方面未观察到此现象（P = 0.44）。然而，在符合方案分析中，观察到失访率百分比随研究时长增加有统计学显著差异（P = 0.034）以及随研究访视次数增加有统计学显著差异（P = 0.01）。在意向性分析或符合方案分析中，未观察到失访率随研究样本量增加有统计学差异（P > 0.05）。
已知的符合方案分析和意向性分析的停药率可能有助于规划未来临床试验的样本量。
