TY - JOUR

T1 - SCIMITAR+ Trial: A randomised study within a trial (SWAT) of a contingent financial reward to improve trial follow-up

AU - Arundel, Catherine Ellen

AU - Elizabeth, Coleman

AU - Fairhurst, Caroline Marie

AU - Peckham, Emily Jane

AU - Bailey, Della

AU - Gilbody, Simon

PY - 2019/11/20

Y1 - 2019/11/20

N2 - ObjectivesTo evaluate the effectiveness of a contingent financial incentive (£10 note in addition to a routinely provided £10 voucher) versus no contingent financial incentive, on improving the retention rate in a randomised controlled trial (RCT).MethodsA two arm ‘Study within a Trial’ (SWAT) embedded within a host RCT (SCIMITAR+). Participants were randomised to the SWAT using a 2:1 (intervention:control) allocation ratio. The primary outcome measure was the proportion of participants completing a CO breath measurement at the first SCIMITAR+ follow up time point (6 months). Secondary outcomes were withdrawing from follow-up after contact and time from assessment due date to completion. Analyses were conducted using logistic or Cox Proportional Hazards regression as appropriate.ResultsA total of 434 participants were randomised into this SWAT. Completion of the CO breath measurement at 6 months was 88.5% (n=247) in the intervention arm of the SWAT and 85.4% (n=123) in the control arm. The difference (3.1%) was not statistically significant (p=0.36; OR 1.29, 95% CI 0.71-2.33, p=0.41). There was also no evidence of a difference in the proportion of participants withdrawing from follow-up after contact (intervention n=7 (2.5%), control n=5 (3.5%); OR 0.76, 95% CI 0.23-2.44, p=0.64), nor in terms of proximity of 6-month visit completion to due date (HR 1.07, 95% CI 0.86-1.33, p=0.55).ConclusionContingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population. However, the sample size of this SWAT was constrained by the size of the host trial and power was limited. This SWAT adds to the body of evidence for initiatives to increase response rates in trials. Key WordsSWAT, retention; randomized controlled trial

AB - ObjectivesTo evaluate the effectiveness of a contingent financial incentive (£10 note in addition to a routinely provided £10 voucher) versus no contingent financial incentive, on improving the retention rate in a randomised controlled trial (RCT).MethodsA two arm ‘Study within a Trial’ (SWAT) embedded within a host RCT (SCIMITAR+). Participants were randomised to the SWAT using a 2:1 (intervention:control) allocation ratio. The primary outcome measure was the proportion of participants completing a CO breath measurement at the first SCIMITAR+ follow up time point (6 months). Secondary outcomes were withdrawing from follow-up after contact and time from assessment due date to completion. Analyses were conducted using logistic or Cox Proportional Hazards regression as appropriate.ResultsA total of 434 participants were randomised into this SWAT. Completion of the CO breath measurement at 6 months was 88.5% (n=247) in the intervention arm of the SWAT and 85.4% (n=123) in the control arm. The difference (3.1%) was not statistically significant (p=0.36; OR 1.29, 95% CI 0.71-2.33, p=0.41). There was also no evidence of a difference in the proportion of participants withdrawing from follow-up after contact (intervention n=7 (2.5%), control n=5 (3.5%); OR 0.76, 95% CI 0.23-2.44, p=0.64), nor in terms of proximity of 6-month visit completion to due date (HR 1.07, 95% CI 0.86-1.33, p=0.55).ConclusionContingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population. However, the sample size of this SWAT was constrained by the size of the host trial and power was limited. This SWAT adds to the body of evidence for initiatives to increase response rates in trials. Key WordsSWAT, retention; randomized controlled trial

U2 - 10.12688/f1000research.21059.1

DO - 10.12688/f1000research.21059.1

M3 - Article

JO - F1000Research

JF - F1000Research

SN - 2046-1402

ER -