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

## TL;DR

This study found that following SPIRIT guidelines for planning participant retention in clinical trials does not significantly improve retention rates.

## Contribution

The study evaluates the real-world effectiveness of SPIRIT item 18b on participant retention in randomized trials.

## Key findings

- Use of SPIRIT item 18b in trial protocols did not significantly affect participant retention rates.
- Inconsistent and incomplete reporting of retention strategies in trial protocols was observed.
- Lack of high-certainty evidence for retention strategies may explain the lack of impact.

## Abstract

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.

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.

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.

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.