How do trial teams plan for retention during the design stage of the trial? A scoping review

Abstract

Background Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require “plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols” be included in trial protocols. The evidence for inclusion of this retention information in protocols is absent. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial. Methods A scoping review with searches in key databases (MEDLINE/PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014-2019 inclusive) to identify randomised controlled trial protocols. Quantitative and qualitative methods were used to synthesise results. Results Eight-hundred and twenty-four protocols met our inclusion criteria. Definitive RCTs (n=722) and pilot and feasibility trial protocols (n=102) reported using the SPIRIT guidelines during protocol development 35% and 34.3% of the time respectively. Of these protocols, only 9.5% and 11.4% respectively reported all aspects of SPIRIT item 18b “plans to promote participant retention and to complete follow-up, including list of any outcome data for participants who discontinue or deviate from intervention protocols”. Of the definitive RCT protocols, 36.8% included proactive “plans to promote participant retention”. Most protocols planned ‘combined strategies’ (48.1%). Of these, the joint most commonly reported were “reminders and data collection location and method” and “reminders and monetary incentives”. The most popular individual retention strategy was “reminders” (14.7%) followed by “monetary incentives- conditional” (10.2%). Of the pilot and feasibility protocols, 40.2% included proactive “plans to promote participant retention” with the use of ‘combined strategies’ being most frequent (46.3%). The use of “monetary incentives – conditional” (22%) was the most popular individual reported retention strategy. Conclusion There is a lack of communication of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct.

Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol; an analysis of patient information leaflets and their corresponding protocols.

“…We recommend that when choosing a retention strategy, the suitability of the strategy to the target population should also be considered. Similar to ndings of our recent scoping review (37), among the PILs most retention strategies were generic retention strategies that did not speci cally target groups more 'at risk' of dropping out. This may need to be considered by trial teams going forward as there may be cultural and generational differences in preferences in terms of what would be deemed suitable strategies to use to promote participant retention.…”