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 apen 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. Copyright:
RCT Entities:
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. Copyright:
Authors: Philip James Edwards; Ian Roberts; Mike J Clarke; Carolyn Diguiseppi; Reinhard Wentz; Irene Kwan; Rachel Cooper; Lambert M Felix; Sarah Pratap Journal: Cochrane Database Syst Rev Date: 2009-07-08
Authors: Shaun Treweek; Simon Bevan; Peter Bower; Marion Campbell; Jacquie Christie; Mike Clarke; Clive Collett; Seonaidh Cotton; Declan Devane; Adel El Feky; Ella Flemyng; Sandra Galvin; Heidi Gardner; Katie Gillies; Jan Jansen; Roberta Littleford; Adwoa Parker; Craig Ramsay; Lynne Restrup; Frank Sullivan; David Torgerson; Liz Tremain; Matthew Westmore; Paula R Williamson Journal: Trials Date: 2018-02-23 Impact factor: 2.279
Authors: Emily McBride; Hiromi Mase; Robert S Kerrison; Laura A V Marlow; Jo Waller Journal: BMC Med Res Methodol Date: 2021-12-18 Impact factor: 4.615
Authors: Katie Gillies; Anna Kearney; Ciara Keenan; Shaun Treweek; Jemma Hudson; Valerie C Brueton; Thomas Conway; Andrew Hunter; Louise Murphy; Peter J Carr; Greta Rait; Paul Manson; Magaly Aceves-Martins Journal: Cochrane Database Syst Rev Date: 2021-03-06
Authors: Sophie James; Adwoa Parker; Sarah Cockayne; Sara Rodgers; Caroline Fairhurst; David J Torgerson; Sarah Rhodes; Sarah Cotterill Journal: F1000Res Date: 2020-06-17