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

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Torgerson" }, { "@type": "Person", "name": "SSHeW Study Team" } ], "publisher": { "@type": "Organization", "name": "F1000Research", "logo": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 480, "width": 60 } }, "image": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 1200, "width": 150 }, "description": "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." } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/9-577", "name": "Enclosing a pen to improve response rate to postal questionnaire:..." } } ] } Home Browse Enclosing a pen to improve response rate to postal questionnaire:... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Cunningham-Burley R, Roche J, Fairhurst C et al. Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.12688/f1000research.23651.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Research Article Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] Rachel Cunningham-Burley https://orcid.org/0000-0001-8724-8276 1 , Jenny Roche 1 , Caroline Fairhurst https://orcid.org/0000-0003-0547-462X 1 , [...] Sarah Cockayne https://orcid.org/0000-0002-1288-5497 1 , Catherine Hewitt 1 , Heather Iles-Smith 2 , David J. Torgerson https://orcid.org/0000-0002-1667-4275 1 , SSHeW Study Team Rachel Cunningham-Burley https://orcid.org/0000-0001-8724-8276 1 , Jenny Roche 1 , [...] Caroline Fairhurst https://orcid.org/0000-0003-0547-462X 1 , Sarah Cockayne https://orcid.org/0000-0002-1288-5497 1 , Catherine Hewitt 1 , Heather Iles-Smith 2 , David J. Torgerson https://orcid.org/0000-0002-1667-4275 1 , SSHeW Study Team PUBLISHED 09 Jun 2020 Author details Author details 1 York Trials Unit, Department of Health Sciences, University of York, UK, York, YO10 5DD, UK 2 Research and Innovation Department, The Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK Rachel Cunningham-Burley Roles: Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Jenny Roche Roles: Data Curation, Formal Analysis, Methodology, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Caroline Fairhurst Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Software, Validation, Visualization, Writing – Review & Editing Sarah Cockayne Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Visualization, Writing – Review & Editing Catherine Hewitt Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Methodology, Resources, Software, Validation, Visualization, Writing – Review & Editing Heather Iles-Smith Roles: Funding Acquisition, Methodology, Project Administration, Writing – Review & Editing David J. Torgerson Roles: Conceptualization, Funding Acquisition, Methodology, Resources, Supervision, Validation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Studies Within A Trial (SWAT) collection. 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. READ ALL READ LESS Keywords randomised controlled trial, embedded trial, postal questionnaire, response rate, pen Corresponding Author(s) Rachel Cunningham-Burley ( [email protected] ) Close Corresponding author: Rachel Cunningham-Burley 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. Grant information: This work was conducted as part of the SSHeW Trial which was funded by the NIHR Public Health Research Programme (Project reference number 15/05/28) and the Health and Safety Executive (HSE). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, HSE or the Department of Health and Social Care. The University of York is the study sponsor and has legal responsibility for the initiation and management of the study: sponsor representative Mr Michael Barber, Research and Enterprise Directorate, Innovation Office, York Science Park, Heslington, York, YO10 5DG, UK. The embedded trial was supported by the MRC PROMETHEUS programme (grant number MR/R013748/1). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2020 Cunningham-Burley R et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Cunningham-Burley R, Roche J, Fairhurst C et al. Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.12688/f1000research.23651.1 ) First published: 09 Jun 2020, 9 :577 ( https://doi.org/10.12688/f1000research.23651.1 ) Latest published: 09 Jun 2020, 9 :577 ( https://doi.org/10.12688/f1000research.23651.1 ) Introduction Randomised controlled trials (RCTs) are key to evaluating the effectiveness of interventions and often use postal questionnaires to collect outcome data. However, low response rates can limit the validity of the trial findings by reducing the power of the study and introducing bias 1 . Numerous strategies to increase response rates have been studied 2 , 3 including sending a pen with the questionnaire. 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 – 7 whilst others failed to show a positive impact 4 , 8 . These studies displayed considerable heterogeneity and only two were embedded in RCTs 6 , 7 . 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 . Methods Design This two-armed RCT was embedded in the SSHeW trial, a trial evaluating the effectiveness of slip-resistant footwear to reduce slips in NHS staff 10 . The SSHeW trial was registered (ISRCTN 33051393) and the trial protocol has been published 10 . Participants The SWAT was conducted in seven NHS Trusts in England and included all eligible participants in the SSHeW trial who were due to be sent their 14-week postal questionnaire between 04.07.2018 and 12.02.2019. Intervention The intervention group were sent a York Trials Unit, University of York branded pen with their questionnaire. The control group did not receive a pen. Outcomes The SWAT outcomes are outlined in Table 1 . Table 1. SWAT outcomes. Outcome Type Definition Proportion of participants who return questionnaire (Primary Outcome) Binary (returned/not returned) Proportion of 14-week questionnaires returned to York Trials Unit. (Returns were censored at 11.06.2019) Time to response Time to event (days) Number of days between the date the 14-week questionnaire was sent and the date the returned questionnaire was received by York Trials Unit. Completeness of response Continuous (0–5) Number of completed responses to 5 key questions on the 14-week questionnaire. Reminder notice sent Binary (sent/not sent) Proportion of participants sent a reminder questionnaire (sent three weeks after the initial questionnaire if no response had been received, no additional pens were sent with reminders). Cost Continuous Consideration of cost effectiveness of pen inclusion Sample size As is usual with an embedded trial, a formal sample size calculation was not undertaken as the sample size was determined by the number of participants due to receive their 14-week questionnaire. We anticipated that randomising 2,000 participants into the SWAT would provide 80% power to detect an absolute difference of 6% (two-sided α=0.05) in response rates between the two groups, assuming a control rate of 60%. Randomisation Participants were allocated to either the intervention (pen) or control (no pen) group using simple randomisation in a 1:1 ratio. The allocation sequence was generated by the SSHeW trial statistician, who was not involved in sending out the questionnaires. Blinding Participants were not aware of their involvement in this SWAT but due to the nature of the intervention participants and study team members could not be blinded to group allocation. Approvals This SWAT was approved by the Department of Health Sciences Research Ethics Committee at the University of York and the Health Research Authority (HSRGC/2016/187/A). Statistical analysis Data were analysed using Stata version 15 11 on an intention-to-treat basis, using two-sided tests at the 5% significance level. The models used for each outcome are given in Table 2 , the values associated with the pen allocation from each model is presented with its 95% confidence interval and p-value. All models were adjusted for main trial group allocation (slip-resistant footwear or wait-list control) and pen sub-study allocation (pen or no pen). Table 2. Analysis models. Outcome Analysis model Value presented Proportion of participants who return questionnaire Logistic regression Odds ratio (OR) Time to response Cox proportional hazards regression Hazard ratio Completeness of response Linear regression Adjusted mean difference Reminder notice sent Logistic regression OR Costing The total cost of a standard SSHeW questionnaire pack was £2.42 (envelope and postage: £0.86; questionnaire and cover letter: £0.65; pre-paid envelope and postage: £0.91). The additional cost of including a pen was £0.32. The cost analysis incorporates the changes in number of questionnaires returned and reminders required. Results A total of 1466 participants were included in the SWAT (pen, n=733; no pen, n=733). In total, 13 participants withdrew from the main SSHeW trial after they had been randomised into the SWAT but before being sent their follow-up questionnaire, leaving 1453 participants ( Figure 1 ). Baseline characteristics are summarised descriptively in Table 3 . Table 3. Baseline characteristics of participants included in the analysis. Pen (n = 728) No pen (n = 725) Overall (n = 1453) Main trial allocation, n (%) Usual Care Intervention 355 (48.8) 373 (51.2) 376 (51.9) 349 (48.1) 731 (50.3) 722 (49.7) Age (years), mean (SD) 43.0 (11.1) 42.9 (11.5) 43.0 (11.3) Gender, n (%) Male Female Prefer not to say 111 (15.3) 616 (84.6) 1 (0.1) 90 (12.4) 635 (87.6) 0 (0.0) 201 (13.8) 1251 (86.1) 1 (0.1) Job role, n (%) Admin and IT Facilities Direct patient care Other 44 (6.0) 50 (6.9) 610 (83.8) 24 (3.3) 51 (7.0) 38 (5.2) 614 (84.7) 22 (3.0) 95 (6.5) 88 (6.1) 1224 (84.2) 46 (3.2) Average working hours, mean (SD) 35.0 (5.2) 35.1 (4.9) 35.0 (5.0) Injury resulting from a slip or fall (in previous 12 months), n (%) 43 (5.9) 30 (4.1) 73 (5.0) Figure 1. CONSORT flow diagram of participants in the embedded trial. Results are presented in Table 4 . Overall, 962 (66.2%) questionnaires were returned (pen, 67.7%; no pen, 64.7%) and an average of 4.9/5 items were completed. There was no evidence of a difference in return rate between the groups (OR 1.15, 95% CI 0.92 to 1.43, p=0.22), nor number of items completed (AMD -0.01, 95% CI 0.06 to 0.05, p=0.77). Table 4. Summary of results. OD, odds ratio; HR, hazards ratio; AMD, adjusted mean difference Results Returns, n/total (%) OR 95% CI p-value Pen No pen Overall 493/728 (67.7) 469/725 (64.7) 962/1453 (66.2) 1.15 0.92, 1.43 0.22 Time to response (days), median (IQR) HR 95% CI p-value Pen No pen Overall 15 (9-33) 18 (9-37) 16 (9-35) 1.12 0.98, 1.27 0.09 Completeness of response, mean (SD) AMD 95% CI p-value Pen No pen Overall 4.9 (0.4) 4.9 (0.4) 4.9 (0.4) -0.01 -0.06, 0.05 0.77 Reminder sent, n/total (%) OR 95% CI p-value Pen No pen Overall 339/728 (46.6) 369/725 (50.9) 708/1453 (48.7) 0.83 0.68, 1.02 0.08 There was weak evidence of a difference, in favour of the pen group, in both time to return (median time to return 15 vs 18 days; HR 1.12, 95% CI 0.98 to 1.27, p=0.09) ( Figure 2 ), and in the proportion of participants requiring a reminder (OR 0.83, 95% CI 0.68 to 1.02, p=0.08). Figure 2. Kaplan-Meier curve for time to questionnaire return. Costing A 3% difference in questionnaire response rate and an absolute difference in the percentage of participants who required a reminder of 1.1% were found. Considering these to be true effects, in order to receive one additional questionnaire, 33 participants would have to be sent a pen, at a cost of approximately 33x32p=£10.56. Approximately 91 participants would need to be sent a pen to prevent one reminder mailing and therefore to save £2.42. Hence, roughly one reminder is required per three retained participants, and the cost per retained participant is approximately £10. Discussion Whilst the results of all outcomes in this SWAT favoured the pen group, we found that the addition of a pen did not statistically significantly increase the response rate to, or completeness of, a follow-up questionnaire sent at 14 weeks post-randomisation among participants of the SSHeW trial. There was some evidence of a reduction in time to response and the number of reminders required. It may be that, in this group of participants, the pen failed to act as a facilitator or was not a sufficient incentive to return the questionnaire, given the fact that participants in the trial already received a free pair of shoes (although offer of shoes was not conditional on returning the questionnaire). However, the trial ultimately only had about 40% power to detect a difference of 3% in response rates (from 64.7 to 67.7%) and is therefore at risk of a type II error. Another potential weakness is that, due to the select population of healthcare workers, the results may not be generalisable to other populations or contexts. The strength of this study is that it was a randomised trial. Conclusion This SWAT suggests that enclosing a pen in a questionnaire mail out may be an effective method to increase response rates but was likely underpowered to detect a statistically significant difference of the 3% observed. Since pens are inexpensive, even a small difference is likely to be cost-effective. The results contribute to the body of evidence regarding this intervention and may be included in future meta-analyses to improve power. Data availability Underlying data Open Science Framework: SSHeW Trial Pen SWAT, https://doi.org/10.17605/OSF.IO/YQ76U 12 . Reporting guidelines Open Science Framework: CONSORT checklist for ‘Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial’, https://doi.org/10.17605/OSF.IO/YQ76U 12 . Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication). Acknowledgements The authors would like to thank the embedded trial participants who returned their trial documentation and the data administration staff at the YTU who worked to support the study. The paper was written by the authors on behalf of the SSHeW Trial team, which is made up of the following individuals: Emily Bain (Health and Safety Executive); Sarah Cockayne (University of York); Rachel Cunningham-Burley (University of York); Caroline Fairhurst (University of York); Gillian Frost (Health and Safety Executive); Catherine Hewitt (University of York); Heather Iles-Smith (Leeds Teaching Hospital NHS Trust); Mark Liddle (Health and Safety Executive), Misbah Mogradia (Health and Safety Executive); David Torgerson (University of York), Michael Zand (Health and Safety Executive) and others. With the exception of Emily Bain and Misbah Morgradia, who supported Health Economic Evaluation for the host SSHeW Trial, all members of the SSHeW study team were involved in the designing this SWAT. We would also like to acknowledge the support of individuals from the PROMETHEUS programme. Faculty Opinions recommended References 1. Edwards P, Roberts I, Clarke M, et al. : Increasing response rates to postal questionnaires: systematic review. BMJ. 2002; 324 (7347): 1183. PubMed Abstract | Publisher Full Text | Free Full Text 2. Edwards PJ, Roberts I, Clarke MJ, et al. : Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009; (3): MR000008. PubMed Abstract | Publisher Full Text 3. Brueton VC, Tierney JF, Stenning S, et al. : Strategies to improve retention in randomised trials: a Cochrane systematic review and meta-analysis. BMJ Open. 2014; 4 (2): e003821. PubMed Abstract | Publisher Full Text | Free Full Text 4. Clark T, Khan K, Gupta J: Provision of pen along with questionnaire does not increase the response rate to a postal survey: a randomised controlled trial. J Epidemiol Community Health. 2001; 55 (8): 595–6. PubMed Abstract | Publisher Full Text | Free Full Text 5. White E, Carney PA, Kolar AS: Increasing response to mailed questionnaires by including a pencil/pen. Am J Epidemiol. 2005; 162 (3): 261–6. PubMed Abstract | Publisher Full Text 6. Sharp L, Cochran C, Cotton SC, et al. : Enclosing a pen with a postal questionnaire can significantly increase the response rate. J Clin Epidemiol. 2006; 59 (7): 747–54. PubMed Abstract | Publisher Full Text 7. Bell K, Clark L, Fairhurst C, et al. : Enclosing a pen reduced time to response to questionnaire mailings. J Clin Epidemiol. 2016; 74 : 144–50. PubMed Abstract | Publisher Full Text 8. Aveyard P, Manaseki S, Griffin C: The cost effectiveness of including pencils and erasers with self-completion epidemiological questionnaires. Public Health. 2001; 115 (1): 80–1. PubMed Abstract | Publisher Full Text 9. Treweek S, Bevan S, Bower P, et al. : Trial forge guidance 1: what is a study within a trial (SWAT)? Trials. 2018; 19 (1): 139. PubMed Abstract | Publisher Full Text | Free Full Text 10. Cockayne S, Fairhurst C, Frost G, et al. : SSHeW study protocol: does slip resistant footwear reduce slips among healthcare workers? A randomised controlled trial. BMJ Open. 2018; 8 (11): e026023. PubMed Abstract | Publisher Full Text | Free Full Text 11. StataCorp: Stata Statistical Software: Release 15. In: College Station, TX:StataCorp LLC; 2017. Reference Source 12. Cunningham-Burley R, Roche J, Fairhurst C, et al. : SSHeW Trial Pen SWAT. 2020. http://www.doi.org/10.17605/OSF.IO/YQ76U Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 09 Jun 2020 ADD YOUR COMMENT Comment Author details Author details 1 York Trials Unit, Department of Health Sciences, University of York, UK, York, YO10 5DD, UK 2 Research and Innovation Department, The Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK Rachel Cunningham-Burley Roles: Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Jenny Roche Roles: Data Curation, Formal Analysis, Methodology, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Caroline Fairhurst Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Software, Validation, Visualization, Writing – Review & Editing Sarah Cockayne Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Visualization, Writing – Review & Editing Catherine Hewitt Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Methodology, Resources, Software, Validation, Visualization, Writing – Review & Editing Heather Iles-Smith Roles: Funding Acquisition, Methodology, Project Administration, Writing – Review & Editing David J. Torgerson Roles: Conceptualization, Funding Acquisition, Methodology, Resources, Supervision, Validation, Writing – Review & Editing 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. Grant information This work was conducted as part of the SSHeW Trial which was funded by the NIHR Public Health Research Programme (Project reference number 15/05/28) and the Health and Safety Executive (HSE). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, HSE or the Department of Health and Social Care. The University of York is the study sponsor and has legal responsibility for the initiation and management of the study: sponsor representative Mr Michael Barber, Research and Enterprise Directorate, Innovation Office, York Science Park, Heslington, York, YO10 5DG, UK. The embedded trial was supported by the MRC PROMETHEUS programme (grant number MR/R013748/1). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 09 Jun 2020, 9:577 https://doi.org/10.12688/f1000research.23651.1 Copyright © 2020 Cunningham-Burley R et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Cunningham-Burley R, Roche J, Fairhurst C et al. Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.12688/f1000research.23651.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 09 Jun 2020 Views 0 Cite How to cite this report: Bracken K. Reviewer Report For: Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.5256/f1000research.26098.r80788 ) The direct URL for this report is: https://f1000research.com/articles/9-577/v1#referee-response-80788 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 08 Mar 2021 Karen Bracken , NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia Approved VIEWS 0 https://doi.org/10.5256/f1000research.26098.r80788 This paper describes the result of a SWAT embedded within the SSHeW trial. The SWAT aimed to evaluate whether including a pen with a follow-up postal questionnaire would impact questionnaire response rate. The authors indicate that previous studies have yielded mixed ... Continue reading READ ALL This paper describes the result of a SWAT embedded within the SSHeW trial. The SWAT aimed to evaluate whether including a pen with a follow-up postal questionnaire would impact questionnaire response rate. The authors indicate that previous studies have yielded mixed results. The results of this SWAT add to the body of existing evidence. The paper is clear and concise and addresses a common problem faced by trials; low response rates to questionnaires. The paper provides adequate detail for other trialists to replicate the intervention within their own trial. The inclusion of cost analyses is particularly useful. I was interested to see that the cost of including the pen was very low and would have liked an explanation of the components of the cost (cost of pen, additional cost of postage and posting materials). Like many SWATs, this SWAT was unavoidably constrained in sample size by the host trial, making conclusions difficult due to lack of power. It is unclear from the paper whether the authors expected that the sample size of 1466 was sufficient to detect an operationally important difference between groups. If not, then I suggest the conclusion be updated to make this clear, rather than stating that a statistically significant increase was not found. Would the authors suggest that further SWATs are needed in this area based on the Trial Forge guidance? (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3980-5 1 ) Also, I suggest removing the observed power calculation from the discussion (https://lesslikely.com/statistics/observed-power-magic/ provides an explanation as to why observed power calculations should be avoided). Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Partly References 1. Treweek S, Bevan S, Bower P, Briel M, et al.: Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed. Trials . 2020; 21 (1): 33 PubMed Abstract | Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: Trial operations and recruitment I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Bracken K. Reviewer Report For: Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.5256/f1000research.26098.r80788 ) The direct URL for this report is: https://f1000research.com/articles/9-577/v1#referee-response-80788 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Duncan A, Aceves-Martins M and Bruhn H. Reviewer Report For: Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.5256/f1000research.26098.r68921 ) The direct URL for this report is: https://f1000research.com/articles/9-577/v1#referee-response-68921 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 02 Sep 2020 Anna Duncan , CHaRT, University of Aberdeen, Aberdeen, UK Magaly Aceves-Martins , HSRU, University of Aberdeen, Aberdeen, UK Hanne Bruhn , Health Services Research Unit, University of Aberdeen, Aberdeen, UK Approved VIEWS 0 https://doi.org/10.5256/f1000research.26098.r68921 The current study is a SWAT – a Study Within A Trial. A SWAT is a methodological study aiming to add to the evidence base for randomised controlled rial design and conduct. In a SWAT an intervention to improve the ... Continue reading READ ALL The current study is a SWAT – a Study Within A Trial. A SWAT is a methodological study aiming to add to the evidence base for randomised controlled rial design and conduct. In a SWAT an intervention to improve the conduct of trials is tested in an ongoing ‘host’ trial. The current host trial was Stopping Slips among Healthcare Workers (SSHeW), a trial testing slip-resistant footwear with NHS Staff to reduce slips at work. The SWAT intervention was to include a pen with the follow-up questionnaire to test whether participants who received a pen were more likely to return their questionnaire than those participants who did not receive a pen. The authors also looked at whether inclusion of a pen with the questionnaire affected the time taken to send back the questionnaire; how complete they questionnaire was answered and; whether a reminder had to be sent for return of the questionnaire. The SWAT was run on the 14 week post randomisation follow-up questionnaire. All SSHEW participants were randomised into the SWAT (n=1466). There were no significant difference in return rates between the two groups but weak evidence that including a pen might make participants return the questionnaire sooner and less will need a reminder. This study reports findings contributing to the evidence base for how trial teams can increase questionnaire response rates in their trials, using the gold standard randomised comparison. This is a hugely important area as low response rates affect the conclusions that can be drawn from trial findings. Unfortunately, low questionnaire response rates are something which continues to affect a lot of trials. We have a few comments which should be addressed: ABSTRACT No comments. INTRODUCTION It would be interesting to know if the authors expected there to be an issue with the questionnaire return rate in the host trial and what was the basis of this expectation (e.g. low response rate to previous questionnaires)? Please consider adding what the expected response rate for the host trial was. This could be added in the introduction or methods according to the authors preference. Commonly, SWATs are reactive so some background information to the approach in this SWAT would provide a helpful context. The authors mention that the pen would act as facilitator and incentive, it would be helpful to have any reference to this use as a behavioural motivator or barrier. METHODS It would be interesting to know if the investigators found any issues with posting a pack including a pen, eg additional bulk causing any issues with standard franking machines. Did any changes have to be made to the process of posting out to include the pen? RESULTS No comments. DISCUSSION Please include some consideration as to whether the timing of the incentive to return questionnaires might have affected the findings. In many trials participants are followed-up for two years or longer and that is the point when it gets really tough to keep the response rate high (reviewers’ personal experiences). It would be really valuable to have the authors thoughts on this for trial teams looking for help. Paragraph 3 -The authors list a lack of power as a limitation. We’d suggest highlighting that many SWATs will be underpowered because they are generally unable to change the size of the host trial; they are made for meta-analysis really. CONCLUSION This is a very well conducted and clearly written article on a SWAT that investigated including a pen to improve response rates to a questionnaire, and importantly addressed the cost effectiveness of the intervention as one of the outcomes. The results of the SWAT did not provide strong evidence in itself of the effectiveness of including a pen to improve response rates but the results add to the body of evidence and will be important to include in meta-analysis to examine the effectiveness of a pen as an incentive/facilitator in retention rates. While the pen itself is inexpensive, when it is multiplied up over the issue of thousands of questionnaires is an additional cost any trials unit would have to justify to funder. The cost for a 3% gain is £10 per retained participant according to statement in Results (Costings) so not an insubstantial amount for weak evidence of an effect. Replication of this SWAT is needed to include other settings, different timepoints etc before concluding that including a pen may be effective and cost-effective way of improving response rates. The authors should expand on this in the concluding paragraph and consider revising sentence 2 of the concluding paragraph. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? I cannot comment. A qualified statistician is required. Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Partly Competing Interests: Hanne Bruhn: None. Anne Duncan: None. Magaly Aceves Martins: I am participating in the Cochrane Review Update on Strategies to improve retention in randomised trials. Reviewer Expertise: Hanne Bruhn: Health Services Research and Trial Methodology. Anne Duncan: Trial Management and conduct and Trial Methodology. Magaly Aceves Martins: Nutrition and systematic reviewing. We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Duncan A, Aceves-Martins M and Bruhn H. Reviewer Report For: Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.5256/f1000research.26098.r68921 ) The direct URL for this report is: https://f1000research.com/articles/9-577/v1#referee-response-68921 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 09 Jun 2020 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 1 09 Jun 20 read read Anna Duncan , University of Aberdeen, Aberdeen, UK Magaly Aceves-Martins , University of Aberdeen, Aberdeen, UK Hanne Bruhn , University of Aberdeen, Aberdeen, UK Karen Bracken , The University of Sydney, Sydney, Australia Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2021 Bracken K. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 08 Mar 2021 | for Version 1 Karen Bracken , NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia 0 Views copyright © 2021 Bracken K. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This paper describes the result of a SWAT embedded within the SSHeW trial. The SWAT aimed to evaluate whether including a pen with a follow-up postal questionnaire would impact questionnaire response rate. The authors indicate that previous studies have yielded mixed results. The results of this SWAT add to the body of existing evidence. The paper is clear and concise and addresses a common problem faced by trials; low response rates to questionnaires. The paper provides adequate detail for other trialists to replicate the intervention within their own trial. The inclusion of cost analyses is particularly useful. I was interested to see that the cost of including the pen was very low and would have liked an explanation of the components of the cost (cost of pen, additional cost of postage and posting materials). Like many SWATs, this SWAT was unavoidably constrained in sample size by the host trial, making conclusions difficult due to lack of power. It is unclear from the paper whether the authors expected that the sample size of 1466 was sufficient to detect an operationally important difference between groups. If not, then I suggest the conclusion be updated to make this clear, rather than stating that a statistically significant increase was not found. Would the authors suggest that further SWATs are needed in this area based on the Trial Forge guidance? (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3980-5 1 ) Also, I suggest removing the observed power calculation from the discussion (https://lesslikely.com/statistics/observed-power-magic/ provides an explanation as to why observed power calculations should be avoided). Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Partly References 1. Treweek S, Bevan S, Bower P, Briel M, et al.: Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed. Trials . 2020; 21 (1): 33 PubMed Abstract | Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise Trial operations and recruitment I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Bracken K. Peer Review Report For: Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.5256/f1000research.26098.r80788) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/9-577/v1#referee-response-80788 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2020 Bruhn H et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 02 Sep 2020 | for Version 1 Anna Duncan , CHaRT, University of Aberdeen, Aberdeen, UK Magaly Aceves-Martins , HSRU, University of Aberdeen, Aberdeen, UK Hanne Bruhn , Health Services Research Unit, University of Aberdeen, Aberdeen, UK 0 Views copyright © 2020 Bruhn H et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The current study is a SWAT – a Study Within A Trial. A SWAT is a methodological study aiming to add to the evidence base for randomised controlled rial design and conduct. In a SWAT an intervention to improve the conduct of trials is tested in an ongoing ‘host’ trial. The current host trial was Stopping Slips among Healthcare Workers (SSHeW), a trial testing slip-resistant footwear with NHS Staff to reduce slips at work. The SWAT intervention was to include a pen with the follow-up questionnaire to test whether participants who received a pen were more likely to return their questionnaire than those participants who did not receive a pen. The authors also looked at whether inclusion of a pen with the questionnaire affected the time taken to send back the questionnaire; how complete they questionnaire was answered and; whether a reminder had to be sent for return of the questionnaire. The SWAT was run on the 14 week post randomisation follow-up questionnaire. All SSHEW participants were randomised into the SWAT (n=1466). There were no significant difference in return rates between the two groups but weak evidence that including a pen might make participants return the questionnaire sooner and less will need a reminder. This study reports findings contributing to the evidence base for how trial teams can increase questionnaire response rates in their trials, using the gold standard randomised comparison. This is a hugely important area as low response rates affect the conclusions that can be drawn from trial findings. Unfortunately, low questionnaire response rates are something which continues to affect a lot of trials. We have a few comments which should be addressed: ABSTRACT No comments. INTRODUCTION It would be interesting to know if the authors expected there to be an issue with the questionnaire return rate in the host trial and what was the basis of this expectation (e.g. low response rate to previous questionnaires)? Please consider adding what the expected response rate for the host trial was. This could be added in the introduction or methods according to the authors preference. Commonly, SWATs are reactive so some background information to the approach in this SWAT would provide a helpful context. The authors mention that the pen would act as facilitator and incentive, it would be helpful to have any reference to this use as a behavioural motivator or barrier. METHODS It would be interesting to know if the investigators found any issues with posting a pack including a pen, eg additional bulk causing any issues with standard franking machines. Did any changes have to be made to the process of posting out to include the pen? RESULTS No comments. DISCUSSION Please include some consideration as to whether the timing of the incentive to return questionnaires might have affected the findings. In many trials participants are followed-up for two years or longer and that is the point when it gets really tough to keep the response rate high (reviewers’ personal experiences). It would be really valuable to have the authors thoughts on this for trial teams looking for help. Paragraph 3 -The authors list a lack of power as a limitation. We’d suggest highlighting that many SWATs will be underpowered because they are generally unable to change the size of the host trial; they are made for meta-analysis really. CONCLUSION This is a very well conducted and clearly written article on a SWAT that investigated including a pen to improve response rates to a questionnaire, and importantly addressed the cost effectiveness of the intervention as one of the outcomes. The results of the SWAT did not provide strong evidence in itself of the effectiveness of including a pen to improve response rates but the results add to the body of evidence and will be important to include in meta-analysis to examine the effectiveness of a pen as an incentive/facilitator in retention rates. While the pen itself is inexpensive, when it is multiplied up over the issue of thousands of questionnaires is an additional cost any trials unit would have to justify to funder. The cost for a 3% gain is £10 per retained participant according to statement in Results (Costings) so not an insubstantial amount for weak evidence of an effect. Replication of this SWAT is needed to include other settings, different timepoints etc before concluding that including a pen may be effective and cost-effective way of improving response rates. The authors should expand on this in the concluding paragraph and consider revising sentence 2 of the concluding paragraph. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? I cannot comment. A qualified statistician is required. Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Partly Competing Interests Hanne Bruhn: None. Anne Duncan: None. Magaly Aceves Martins: I am participating in the Cochrane Review Update on Strategies to improve retention in randomised trials. Reviewer Expertise Hanne Bruhn: Health Services Research and Trial Methodology. Anne Duncan: Trial Management and conduct and Trial Methodology. Magaly Aceves Martins: Nutrition and systematic reviewing. We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Duncan A, Aceves-Martins M and Bruhn H. Peer Review Report For: Enclosing a pen to improve response rate to postal questionnaire: an embedded randomised controlled trial [version 1; peer review: 2 approved] . F1000Research 2020, 9 :577 ( https://doi.org/10.5256/f1000research.26098.r68921) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. 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