Abstract
Background: Poor response to questionnaires collecting outcome data in randomised controlled trials (RCTs) can affect the validity of trial results. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of including a pen with a follow-up postal questionnaire on response rate. Methods: A two-armed RCT was embedded within SSHeW (Stopping Slips among Healthcare Workers), a trial of slip-resistant footwear to reduce slips in NHS staff. Participants were randomised 1:1 to receive a pen or no pen with their follow-up questionnaire. The primary outcome was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, and whether a postal reminder notice was required. Data were analysed using logistic regression, linear regression and Cox proportional hazards regression. Results: Overall, 1466 SSHEW trial participants were randomised into the SWAT. In total, 13 withdrew from the host trial before they were due to be sent their follow-up questionnaire, 728 participants received a pen with their questionnaire, and 725 did not receive a pen. A questionnaire was returned from 67.7% of the pen group and 64.7% of the group who did not receive a pen. There was no significant difference in return rates between the two groups (OR 1.15, 95% CI 0.92 to 1.43, p=0.22), nor level of completeness of the questionnaires (AMD -0.01, 95% CI 0.06 to 0.05, p=0.77). There was weak evidence of a reduction in the proportion of participants requiring a reminder and in time to response in the pen group. Conclusion: Inclusion of a pen with the follow-up postal questionnaire sent to participants in the SSHeW trial did not statistically significantly increase the response rate. These results add to the body of evidence around improving response rates in trials. Trial registration: ISRCTN 33051393 (for SSHEW). Registered on 14/03/2017.
Highlights
Randomised controlled trials (RCTs) are key to evaluating the effectiveness of interventions and often use postal questionnaires to collect outcome data
Design This two-armed randomised controlled trials (RCTs) was embedded in the SSHeW trial, a trial evaluating the effectiveness of slip-resistant footwear to reduce slips in NHS staff[10]
13 participants withdrew from the main SSHeW trial after they had been randomised into the study within a trial (SWAT) but before being sent their follow-up questionnaire, leaving 1453 participants (Figure 1)
Summary
Randomised controlled trials (RCTs) are key to evaluating the effectiveness of interventions and often use postal questionnaires to collect outcome data. The pen acts both as a facilitator to aid completion of the questionnaire, and an incentive to return it[4,5] The effectiveness of this intervention is equivocal with some studies reporting an increase in response rate[5,6,7] whilst others failed to show a positive impact[4,8]. A Study within a Trial (SWAT) is a self-contained study embedded within a host trial that can be used to evaluate strategies designed to improve trial efficiency[9] This SWAT evaluated the effectiveness of enclosing a pen with a follow-up postal questionnaire on response rates in the SSHeW trial[10]. Conclusion: Inclusion of a pen with the follow-up postal questionnaire sent to participants in the SSHeW trial did not statistically significantly increase the response rate These results add to the body of evidence
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