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Randomized Controlled Trial
. 2020 Jun 9:9:577.
doi: 10.12688/f1000research.23651.1. eCollection 2020.

Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial

Rachel Cunningham-Burley  1 , Jenny Roche  1 , Caroline Fairhurst  1 , Sarah Cockayne  1 , Catherine Hewitt  1 , Heather Iles-Smith  2 , David J Torgerson  1 ; SSHeW Study Team
Affiliations
Randomized Controlled Trial

Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial

Rachel Cunningham-Burley et al. F1000Res. .

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.

Keywords: embedded trial; pen; postal questionnaire; randomised controlled trial; response rate.

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Conflict of interest statement

Competing interests: David Torgerson declares previous membership of NIHR HTA Commissioning Board and is Director of York Trials Unit which receives CTU funding from NIHR. Catherine Hewitt declares membership of NIHR HTA Commissioning Committee 2015-2020 David Torgerson is Chief Investigator of the Prometheus project. Catherine Hewitt is co-applicant on the Prometheus grant.

Figures

Figure 1.
Figure 1.. CONSORT flow diagram of participants in the embedded trial.
Figure 2.
Figure 2.. Kaplan-Meier curve for time to questionnaire return.
See this image and copyright information in PMC

References

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