Design characteristics of sequential multiple assignment randomised trials (SMARTs) for human health: a scoping review of studies between 2009 and 2024.

ABSTRACT:

Objective

To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.

Design

Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.

Background

SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient's response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies.

SUBMITTER: Freeman NLB 

PROVIDER: S-EPMC12766822 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature