Sequential multiple assignment randomized trial studies should report all key components: a systematic review.

OBJECTIVE

Sequential Multiple Assignment Randomized Trial (SMART) designs allow multiple randomizations of participants; this allows assessment of stage-specific questions (individual randomizations) and adaptive interventions (i.e. treatment strategies). We assessed the quality of reporting of the information required to design SMART studies.

STUDY DESIGN AND SETTING

We systematically searched four databases (PubMed, Ovid, Web of Science and Scopus) for all trial reports, protocols, reviews, and methodological papers which mentioned SMART designs up to June 15, 2020.

RESULTS

Of the 157 selected records, 12 (7.64%) were trial reports, 24 (15.29%) were study protocols, 91 (58%) were methodological papers, and 30 (19.1%) were review papers. All these trials were powered using stage-specific aims. Only four (33.33%) of these trials reported parameters required for sample size calculations. A small number of the trials (16.67 %) were interested in determining the best embedded adaptive interventions. Most of the trials did not report information about multiple testing adjustment. Furthermore, most of records reported designs that were mainly focused on stage-specific aims.

CONCLUSIONS

Some features of SMART designs are seldomly reported and/or used. Furthermore, studies using this design tend to not adequately report information about all the design parameters, limiting their transparency and interpretability.