Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets
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 comprehe...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-09-01
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| Series: | BMC Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12916-021-02086-2 |
| _version_ | 1818885699658579968 |
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| author | Vichithranie W. Madurasinghe Peter Bower Sandra Eldridge David Collier Jonathan Graffy Shaun Treweek Peter Knapp Adwoa Parker Jo Rick Chris Salisbury Mei See Man David Torgerson Rebecca Sheridan Frank Sullivan Sarah Cockayne Charlotte Dack |
| author_facet | Vichithranie W. Madurasinghe Peter Bower Sandra Eldridge David Collier Jonathan Graffy Shaun Treweek Peter Knapp Adwoa Parker Jo Rick Chris Salisbury Mei See Man David Torgerson Rebecca Sheridan Frank Sullivan Sarah Cockayne Charlotte Dack |
| author_sort | Vichithranie W. Madurasinghe |
| collection | DOAJ |
| description | 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, I 2 = 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) |
| first_indexed | 2024-12-19T16:09:36Z |
| format | Article |
| id | doaj.art-2e047d3800e3470fb6a432c26c95b669 |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-12-19T16:09:36Z |
| publishDate | 2021-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-2e047d3800e3470fb6a432c26c95b6692022-12-21T20:14:46ZengBMCBMC Medicine1741-70152021-09-011911810.1186/s12916-021-02086-2Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheetsVichithranie W. Madurasinghe0Peter Bower1Sandra Eldridge2David Collier3Jonathan Graffy4Shaun Treweek5Peter Knapp6Adwoa Parker7Jo Rick8Chris Salisbury9Mei See Man10David Torgerson11Rebecca Sheridan12Frank Sullivan13Sarah Cockayne14Charlotte Dack15Nuffield Department of Population Health, University of OxfordNIHR School for Primary Care Research, School of Health Sciences, Manchester Academic Health Science Centre, University of ManchesterCentre for Clinical Trials and Methodology, Institute of Population Health Sciences, Queen Mary University of LondonBarts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of LondonArbury Road Surgery 114Health Services Research Unit, University of AberdeenDepartment of Health Sciences, University of York & the Hull York Medical SchoolYork Trials Unit, Department of Health Sciences, University of YorkNational Institute of Health Research School for Primary Care Research, Manchester Academic Health Science Centre, Centre for Primary Care, University of ManchesterCentre for Academic Primary Care, Department of Population Health Sciences, Bristol Medical School University of BristolNorwich Clinical Trials Unit, Norwich Medical School, University of East AngliaDepartment of Health Sciences, University of YorkDepartment of Health Sciences, University of YorkUniversity of St. Andrews North HaughDepartment of Health Sciences, University of YorkDepartment of Psychology, University of BathAbstract 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, I 2 = 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)https://doi.org/10.1186/s12916-021-02086-2RecruitmentInformationUser-testingResearch methodologyRandomised controlled trialSWATs |
| spellingShingle | Vichithranie W. Madurasinghe Peter Bower Sandra Eldridge David Collier Jonathan Graffy Shaun Treweek Peter Knapp Adwoa Parker Jo Rick Chris Salisbury Mei See Man David Torgerson Rebecca Sheridan Frank Sullivan Sarah Cockayne Charlotte Dack Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets BMC Medicine Recruitment Information User-testing Research methodology Randomised controlled trial SWATs |
| title | Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets |
| title_full | Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets |
| title_fullStr | Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets |
| title_full_unstemmed | Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets |
| title_short | Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets |
| title_sort | can we achieve better recruitment by providing better information meta analysis of studies within a trial swats of optimised participant information sheets |
| topic | Recruitment Information User-testing Research methodology Randomised controlled trial SWATs |
| url | https://doi.org/10.1186/s12916-021-02086-2 |
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