Abstract
BACKGROUND: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed 'Studies Within A Trial' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment.
METHODS: Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part.
RESULTS: Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes.
CONCLUSIONS: Multimedia alongside written information did not improve trial recruitment rates.
TRIAL REGISTRATION: ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.
Original language | English |
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Article number | 425 |
Number of pages | 10 |
Journal | BMC medicine |
Volume | 21 |
Issue number | 1 |
Early online date | 8 Nov 2023 |
DOIs | |
Publication status | Published - 8 Nov 2023 |
Bibliographical note
AcknowledgementsWe would like to acknowledge all those in the trial teams who supported this programme of SWATs, as well as our public contributors (Ailsa Donnelly and Judith Hogg). We also thank Paul Wallace (original MRC START applicant) and Reason Digital for multimedia development. We thank the patients who participated in the GHT2000, PSM COPD, HI-Light, seAFOod and STOP-ACEi trials, the members of the Birmingham and Nottingham Clinical Trials Units, the Research and Development Team at Hull University Teaching Hospitals NHS Trust, and the staff members at all the participating trial centres.
Funding
The authors wish to acknowledge the MRC Methodology Research Programme which funds this research (MRC grant reference: G1002325). The MRC has no role in study design; collection, management, analysis and interpretation of data; writing of the report; or the decision to submit the report for publication.
Keywords
- Recruitment
- Information
- user testing
- Research methodology
- Randomised controlled trial
- SWATS
- Metanalysis