White Ian R
MRC Biostatistics Unit, Institute of Public Health, Robinson Way, Cambridge CB2 2SR, UK.
Stat Methods Med Res. 2005 Aug;14(4):327-47. doi: 10.1191/0962280205sm406oa.
In randomized trials with departures from allocated treatment, intention-to-treat analysis is important but not always sufficient. The most common supplement to intention-to-treat analysis is per-protocol analysis, whose assumption of comparability between different nonrandomized groups is often implausible. Randomization-based methods avoid making this assumption and are preferable. Situations where intention-to-treat analysis is insufficient and a randomization-based method is useful include provision of patient information, exploration of treatment-covariate and treatment-time interactions, meta-analysis, and equivalence trials.
在偏离分配治疗方案的随机试验中，意向性分析很重要，但并不总是足够的。意向性分析最常见的补充是符合方案分析，其关于不同非随机分组之间具有可比性的假设往往不可信。基于随机化的方法避免了做出这一假设，因而更可取。意向性分析不足而基于随机化的方法有用的情况包括提供患者信息、探索治疗协变量与治疗时间的相互作用、荟萃分析以及等效性试验。
