Systematic review showed that stepped-wedge cluster randomized trials often did not reach their planned sample size.

OBJECTIVE

To determine how often stepped-wedge cluster randomized controlled trials reach their planned sample size, and what reasons are reported for choosing a stepped-wedge trial design.

STUDY DESIGN AND SETTING

We conducted a PubMed literature search (period 2012 to 2017) and included articles describing the results of a stepped-wedge cluster randomized trial. We calculated the percentage of studies reaching their prespecified number of participants and clusters, and we summarized the reasons for choosing the stepped-wedge trial design as well as difficulties during enrollment.

RESULTS

Forty-six individual stepped-wedge studies from a total of 53 articles were included in our review. Of the 35 studies, for which recruitment rate could be calculated, 69% recruited their planned number of participants, with 80% having recruited the planned number of clusters. Ethical reasons were the most common motivation for choosing the stepped-wedge trial design. Most important difficulties during study conduct were dropout of clusters and delayed implementation of the intervention.

CONCLUSION

About half of recently published stepped-wedge trials reached their planned sample size indicating that recruitment is also a major problem in these trials. Still, the stepped-wedge trial design can yield practical, ethical, and methodological advantages.