Abstract
Background: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded ‘studies within a trial’ (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. Methods: Seven ‘host’ trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. Results: Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I2 = 0%). Conclusions: Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. Trial registration: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).
| Original language | English |
|---|---|
| Article number | 218 |
| Journal | BMC medicine |
| Volume | 19 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 23 Sept 2021 |
Bibliographical note
Funding Information:The authors wish to acknowledge the MRC Methodology Research Programme which funds this research (MRC grant reference: G1002325). The MRC has no role in the study design; collection, management, analysis and interpretation of data; writing of the report; or the decision to submit the report for publication.
Funding Information:
As part of the START programme, chief investigators on trials recently funded by the National Institute of Health Research (NIHR) Health Technology Assessment Programme or on the Primary Care Research Network portfolio were invited to participate in START. Interested trials were selected on the basis of sample size (at least 800 participants to be approached) and design (using a recruitment method amenable to the START recruitment strategies). Although a variety of recruitment methods could be adopted for studies included in the programme (such as postal or face-to-face recruitment), all studies that participated used postal recruitment methods. The minimum sample size of 800 participants to be approached in each trial was based on an indicative sample size calculation, although the expectation was always that the primary analysis would involve pooling of results across trials in a meta-analysis []. Host trials were offered access to one of two strategies (participant information sheets optimised through user-testing or multimedia information), both intended to improve communication of trial information to potential participants, which has been shown to have potential to increase research participation rates []. We aimed to recruit 6 ‘host’ trials to each strategy. This was based on practical considerations and a desire to test the strategy in a reasonable range of contexts rather than a formal sample size calculation.
Funding Information:
The ‘systematic techniques for assisting recruitment to trials’ (START) research programme funded by the UK Medical Research Council (MRC) responds to these limitations. The START programme was designed to develop the conceptual, methodological and logistical framework to make SWATs a routine part of the delivery of trials, and to assess the feasibility of this approach by developing a small number of recruitment strategies and testing them across multiple host trials in SWATs [].
Keywords
- Information
- Randomised controlled trial
- Recruitment
- Research methodology
- SWATs
- User-testing
ASJC Scopus subject areas
- General Medicine
