Commentary: On the levels of patient selection in registry-based randomized controlled trials

Trials

Florian Lasch¹  Kristina Weber¹  Armin Koch¹ 

[1] Department of Biostatistics, Hannover Medical School;

关键词: Registry;    Registry-based RCT;    Patient selection;    Pragmatic trials;    Generalizability;    External validity;   

DOI  :  10.1186/s13063-019-3214-x

来源: DOAJ

【 摘 要 】

Abstract Registry-based randomized controlled trials (RCTs) are presumed to include a less-selected patient population and thus to have enhanced generalizability compared to conventional RCTs. However, this view disregards the levels of patient selection in registry-based RCTs: the registry selection level and the trial selection level. At both levels, systematic selection can occur and generalizability can be diminished. Nevertheless, using a registry as a basis for recruitment, randomization, and data collection results in an advantage: the trial selection takes place within the registry framework, where baseline characteristics of non-enrolled patients are automatically documented as well. By comparing the baseline variables of the enrolled and non-enrolled patients, the trial selection can always be investigated, which gives a sound basis for discussing the generalizability to the registry population.

【 授权许可】

Unknown