Can we achieve better recruitment by providing better information?: Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets

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

doi:10.1186/s12916-021-02086-2

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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
Pages (from-to)	1-8
Number of pages	8
Journal	BMC Medicine
Volume	19
Issue number	1
DOIs	https://doi.org/10.1186/s12916-021-02086-2
Publication status	Published - 23 Sept 2021

Bibliographical note

Keywords

Humans
Odds Ratio
Patient Selection
Research Design

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s12916-021-02086-2
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Cite this

Madurasinghe, V. W., Bower, P., Eldridge, S., Collier, D., Graffy, J., Treweek, S., Knapp, P., Parker, A., Rick, J., Salisbury, C., Man, M. S., Torgerson, D., Sheridan, R., Sullivan, F., Cockayne, S., & Dack, C. (2021). Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets. BMC Medicine, 19(1), 1-8. https://doi.org/10.1186/s12916-021-02086-2

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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).",

keywords = "Humans, Odds Ratio, Patient Selection, Research Design",

author = "Madurasinghe, {Vichithranie W} and Peter Bower and Sandra Eldridge and David Collier and Jonathan Graffy and Shaun Treweek and Peter Knapp and Adwoa Parker and Jo Rick and Chris Salisbury and Man, {Mei See} and David Torgerson and Rebecca Sheridan and Frank Sullivan and Sarah Cockayne and Charlotte Dack",

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doi = "10.1186/s12916-021-02086-2",

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Madurasinghe, VW, Bower, P, Eldridge, S, Collier, D, Graffy, J, Treweek, S, Knapp, P , Parker, A, Rick, J, Salisbury, C, Man, MS , Torgerson, D , Sheridan, R, Sullivan, F, Cockayne, S & Dack, C 2021, 'Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets', BMC Medicine, vol. 19, no. 1, pp. 1-8. https://doi.org/10.1186/s12916-021-02086-2

TY - JOUR

T1 - Can we achieve better recruitment by providing better information?

T2 - Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets

AU - Madurasinghe, Vichithranie W

AU - Bower, Peter

AU - Eldridge, Sandra

AU - Collier, David

AU - Graffy, Jonathan

AU - Treweek, Shaun

AU - Knapp, Peter

AU - Parker, Adwoa

AU - Rick, Jo

AU - Salisbury, Chris

AU - Man, Mei See

AU - Torgerson, David

AU - Sheridan, Rebecca

AU - Sullivan, Frank

AU - Cockayne, Sarah

AU - Dack, Charlotte

PY - 2021/9/23

Y1 - 2021/9/23

N2 - 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).

AB - 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).

KW - Humans

KW - Odds Ratio

KW - Patient Selection

KW - Research Design

U2 - 10.1186/s12916-021-02086-2

DO - 10.1186/s12916-021-02086-2

M3 - Article

C2 - 34551765

SN - 1741-7015

VL - 19

SP - 1

EP - 8

JO - BMC Medicine

JF - BMC Medicine

IS - 1

ER -