Giorgi Rossi Paolo
Servizio Interaziendale di Epidemiologia, AUSL Reggio Emilia, Via Amendola 2, Reggio Emilia I42122, Italy.
BMC Med Ethics. 2014 Mar 28;15:28. doi: 10.1186/1472-6939-15-28.
Providing individuals with the information necessary to make informed decisions is now considered an ethical standard for health systems and general practitioners.
Results from intention-to-treat analysis have thus far been used to illustrate screening benefits and harms, but intention-to-treat analysis in most screening trials compares no intervention to invitation to screening. Therefore, the intervention arm includes everyone who was invited, regardless of actual participation. These results may be misleading for individual decision-making. We propose to use a per protocol analysis that includes all subjects who presented to screening and compares them to those in control arm, adjusting for self-selection bias. Such an analysis can give more accurate and useful information for individual decision-making.
Correct information for individual decision to participate in screening or not should consider the efficacy, benefits, and harms observed for subjects who actually participated at least once in screening compared to the control arm, adjusting for self-selection bias. Thus, per protocol analysis, even a very conservative one, should be used, not a full intention-to-treat analysis.
为个人提供做出明智决策所需的信息，如今被视为卫生系统和全科医生的一项道德标准。
迄今为止，意向性分析的结果一直被用于说明筛查的益处和危害，但大多数筛查试验中的意向性分析是将不干预与邀请参加筛查进行比较。因此，干预组包括所有被邀请的人，无论其实际是否参与。这些结果可能会对个体决策产生误导。我们建议采用符合方案分析，该分析纳入所有前来接受筛查的受试者，并将他们与对照组受试者进行比较，同时对自我选择偏倚进行校正。这样的分析可以为个体决策提供更准确、有用的信息。
关于个体是否参与筛查的决策的正确信息，应考虑与对照组相比，实际至少参加过一次筛查的受试者所观察到的疗效、益处和危害，并对自我选择偏倚进行校正。因此，应采用符合方案分析，即使是非常保守的符合方案分析，而不是完全的意向性分析。
