Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review.

ABSTRACT:

Background

Pragmatic trials evaluating complex health interventions often compare them to usual care. This comparator should resemble care as provided in everyday practice. However, usual care can differ for the same condition, between patients and practitioners, across clinical sites and over time. Heterogeneity within a usual care arm can raise methodological and ethical issues. To address these it may be necessary to standardise what usual care entails, although doing so may compromise a trial's external validity. Currently, there is no guidance detailing how researchers should decide the content of their usual care comparators. We conducted a methodology review to summarise current thinking about what should inform this decision.

Methods

MEDLINE, Embase, CINAHL and PsycI

SUBMITTER: Turner KM 

PROVIDER: S-EPMC10860249 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature