Abstract
Background: Several studies have investigated whether personalising trial documentation can aid recruitment and retention. We did a ‘study within a trial’ (SWAT) evaluating the effectiveness of a personalised text message compared to a non-personalised text message, on the retention rate in a large orthopaedic trial. Methods: The SWAT was embedded in the Knee Replacement Bandaging Study (KReBS) trial. The primary outcome was the proportion of 12-month questionnaires returned. Secondary outcomes were the proportion of questionnaires completed and time to questionnaire return. Binary data were analysed using logistic regression and time to return using Cox proportional hazards regression. Odds ratios (OR) and hazard ratios (HR) are presented, with associated 95% confidence intervals (CI) and p-values. Results: In total, 1465 participants were included in the SWAT. In the personalised group, 644/723 (89.1%) of participants returned a questionnaire, compared to 654/742 (88.1%) in the non-personalised group. The absolute difference in return rate was 0.9% (95% CI: -2.3% to 4.2%; p=0.57). There was no evidence of a difference between the groups in the likelihood of returning a questionnaire (OR 1.09; 95% CI: 0.79 to 1.51; p=0.61), the likelihood of returning a complete questionnaire (OR 1.11; 95% CI: 0.82 to 1.51; p=0.50) nor in time to return (HR 1.05; 95% CI: 0.94 to 1.17; p=0.40). Conclusion: This SWAT adds to the growing evidence base for whether personalised text messages are effective. Registration: ISRCTN87127065 (20/02/2017); SWAT 35 (01/12/2015)
Highlights
Clinical trialists have identified the recruitment and retention of participants as key issues for randomised controlled trials (RCT)[1,2].Several studies have investigated whether personalising trial documentation can aid recruitment and retention[3,4]
To further add to the evidence on the effectiveness of personalised text messages, we did a ‘study within a trial’ (SWAT) evaluating the effectiveness of a personalised text message compared to a non-personalised text message on postal questionnaire response rates in a large orthopaedic trial
In total, 2335 participants were recruited into the Knee Replacement Bandaging Study (KReBS) trial and 1470 were randomised to the SWAT (Figure 1)
Summary
Clinical trialists have identified the recruitment and retention of participants as key issues for randomised controlled trials (RCT)[1,2]. Several studies have investigated whether personalising trial documentation can aid recruitment and retention[3,4]. Cochrane et al looked at the effect of personalised text messages compared to standard text messages in improving retention rates[5]. This study was carried out in response to a number of embedded trials evaluating the effectiveness of SMS messages in improving retention rates[6,7,8,9,10,11], alongside a study suggesting personalised messages increased the payment of delinquent fines[12]. To further add to the evidence on the effectiveness of personalised text messages, we did a ‘study within a trial’ (SWAT) evaluating the effectiveness of a personalised text message compared to a non-personalised text message on postal questionnaire response rates in a large orthopaedic trial
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