Evaluating the use of SPIRIT on participant retention in randomised trials: Challenges in reporting and implications for practice

Abstract

Objectives To establish whether the use of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) item 18b (retention), evidence of planning for retention, has any effect on participant retention rates in randomised controlled trials. Study design and setting A retrospective study of randomised controlled trials between 2014 and 2019. We reviewed 506 trial protocols, 253 protocols that stated the use of SPIRIT guidelines in the protocol, and 253 protocols that did not. Results The reported use of SPIRIT guideline item 18b in the trial protocol has no significant effect on participant retention rates in the corresponding trials. It does not impact the overall retention rate of participants throughout the trial, nor the retention rate of the primary outcome measure. Conclusion SPIRIT item 18b appeared not to contribute to improved participant retention rates in randomised trials. However, the lack of high-certainty evidence for effectiveness of the intervention strategies cited likely impacts this finding. Additionally, inconsistent reporting of retention strategies in trial protocols is evident and needs to be more complete to facilitate evaluation.