Recruitment and retention interventions in surgical and wound care trials: A systematic review

Background Recruitment and retention to surgical trials has previously been reported to be problematic, resulting in research waste. Surgery often results in wounds, meaning these trials are likely to have similar populations. There is currently no systematic assessment of effective strategies for these populations and hence, systematic assessment of these was deemed to be of importance. Methods A systematic review was conducted. Studies were eligible if they were randomised controlled trials undertaken to test an intervention to improve recruitment or retention within a surgical or wound based host randomised controlled trial. MEDLINE, EMBASE, Cochrane Library, ORRCA Database and the Northern Ireland Hub for Trials Methodology Research SWAT Repository Store were searched. Two independent reviewers screened the search results and extracted data for eligible studies using a piloted extraction form. A narrative synthesis was used due to a lack of heterogeneity between strategies which prevented meta-analysis. Results A total of 2133 records were identified which resulted in 13 ultimately being included in the review; seven on recruitment and six on retention. All included studies were based within surgical host trials. Four of the seven recruitment studies focussed on the provision of consent information to participants, one focussed on study set up and one on staff training, with only one relating to consent information finding any significant effect. A range of retention strategies were assessed by the included studies, however only two found (pen vs no pen, mailing strategies) found any significant effect. Conclusion The included studies within a trial were all conducted within surgical trials. There was significant variation in strategies used, and limited replications and therefore further assessment may be warranted. Given the lack of studies embedded within wound care trials, further studies in this area are recommended. Trial registration PROSPERO (CRD42020205475)

Exploring feedback from research nurses in relation to the design and conduct of a randomised controlled trial of wound care treatments: a sequential, dependent, mixed-methods study

Background Research nurse involvement in trials is crucial to successful conduct, however their feedback on trial design and conduct is not necessarily always collected and shared. This study was designed to explore research nurse feedback in relation to study and protocol design and implementation in the National Institute for Health Research Programme Grants for Applied Research funded Surgical Wounds Healing by Secondary Intention pilot and feasibility trial (SWHSI). The primary aim of this study was to inform the design and conduct of a proposed future, larger study in this area. Given the evidence gap, it was deemed prudent to share these findings for the benefit of others. Methods A sequential, dependent mixed methods study, comprising a Likert scale questionnaire and semi-structured interviews, explored the experiences, in relation to study design and conduct, of research nurses involved in the trial. Of the 10 research nurses involved in the trial, eight nurses completed a questionnaire and were interviewed. Questionnaire data was analysed using descriptive statistics and interview data using thematic analysis. Results A range of questionnaire responses were provided, however at least 50% (n=4) of respondents indicated that they were happy with both the study design and conduct. Interview data identified key themes to consider when involving research nurses in the design, delivery and conduct of RCTs; removing barriers to recruitment, time management, engagement strategies and resource provision. ConclusionEngagement of research nurses is important to enable effective trial conduct. Research teams should therefore consider how best to obtain and include input from all members of the research team from the outset. Furthermore, the sharing of feedback on research design and conduct, from the perspective of research nurses delivering trial recruitment and retention, remains crucial to effective and efficient trial conduct

Challenges and solutions to nicotine replacement therapy access: observations from SCIMITAR+

Background Given, smoking results in poor physical and mental health, reducing tobacco harm is of high importance. Recommendations published by National Institute for Health and Care Excellence to reduce smoking harms included provision of support, use of nicotine containing products and commissioning of smoking cessation services. Aims This report explores the difficulties in obtaining such support, as observed in a recently conducted randomised controlled trial in patients with severe mental ill health, and outlines suggestions to improve facilitation of provision. Methods Data collected during the Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR+) trial, was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of NRT. Actions taken to facilitate access and provision of NRT were collated to outline how provision could be better facilitated. Results Access to nicotine replacements therapy (NRT) varied across study settings and in some instances proved impossible for patients to access. Difficulty in access was irrespective of a diagnosis of severe mental ill health. Where NRT was provided, this was not always provided in accordance with NICE guidelines. Conclusions Availability of smoking cessation support, and NRT provision would benefit from being made clearer, simpler and more easily accessible so as to enhance smoking cessation rates

Study within a trial 119 : The effectiveness of a thank you card to improve trial follow up; a randomised study within a trial

Background With attrition common in randomised trials, strategies are needed to minimise this. Many retention strategies include ‘thanks’ elements however there is currently no evidence of the effectiveness of a ‘thank you’ intervention separate to other trial activity or information. This Study Within A Trial (SWAT) sought to assess if a thank you card increases completion of the host trial primary outcome. Methods A two arm SWAT, using a 1:1 (intervention:control) allocation ratio, embedded within the DISC trial. The primary outcome was the difference in retention rate at 1 year post-treatment. Secondary outcomes were outcome data completeness, cost, and retention at 2 years post-treatment. Analyses were conducted using logistic regression adjusting for SWAT and host trial allocation. Results A total of 358 participants were randomised and included in the SWAT analyses. Completion of the 1-year outcome visit was 89.7% (n = 157) in the intervention group and 90.2% (165) in the control group (adjusted odds ratio (OR) 0.95, 95% CI 0.48 to 1.90, p = .89). There was no evidence of a difference in completeness of key outcome data (adjusted OR 1.84, 95% CI 0.71 to 4.73, p = .20) or retention at 2 years post treatment (adjusted OR 1.13, 95% CI 0.59 to 2.17, p = .72). Conclusion It remains unclear if thank you cards increased the rate of primary outcome follow-up completion within the DISC trial. However, as the first evaluation of a distinct ‘thank you’ intervention for improving retention rates, further replications are required to determine effectiveness, ideally in populations other than older, male, Caucasians

Smoking cessation in severe mental illness: : combined long-term quit rates from the UK SCIMITAR trials programme

Simon Gilbody, Emily Peckham, Della Bailey, Catherine Arundel, Paul Heron, , , , and members of the SCIMITAR+ collaborative

SWATted away : the challenging experience of setting up a programme of SWATs in paediatric trials

The authors wish to acknowledge the National Institute of Health Research (NIHR) Health Services and Delivery Research funding for the TRECA study (NIHR Health Services and Delivery Research Project: 14/21/21). The NIHR did not have a role in the design of the study or the writing of this manuscript. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.Peer reviewedPublisher PD

Trial Forge Guidance 4 : A guideline for reporting the results of randomised Studies Within A Trial (SWATs)

Acknowledgements We would like to thank those members of the PROMETHEUS programme who are not explicitly named as authors of this publication, but who provided valuable input to the delivery and conduct of the programme within which the guideline development sat. PROMETHEUS programme members include co-authors CA, LK, AP, DB, CC, DD, SG, KG, CH, CS, DT, and ST and P Bower (University of Manchester), L Culliford (University of Bristol), L Doherty (University of York), and R Emsley (Kings College London). We would like to thank public contributors who provided input and comment on earlier versions of this work. We would also like to thank the authors of the previous guidelines for reporting of embedded recruitment trials for their advice and input in the early stages of guideline development and to the independent reviewers and trialists who offered comments and piloting of the draft guideline. Funding Development of the SWAT reporting guideline was initiated as part of The PROMoting THE Use of SWATs (PROMETHEUS) programme, funded by the Medical Research Council (MRC) [grant number MR/R013748/1].Peer reviewe

Patient-reported quality of life factors in vascular surgical wounds healing by secondary intention (SWHSI) : a qualitative patient and public involvement (PPI) exploration

Background: Surgical wounds healing by secondary intention (SWHSI) represent a significant burden to patients and services. An understanding of quality of life factors affecting this population is essential to recognise the impact of this wound entity on patients. Understanding of the patient experience is necessary to building effective services and designing high-quality research studies to improve care in this population. Methods: Twelve individuals with lived experience of living with a SWHSI or caring for a person with a SWHSI were recruited to one of two focus groups. Participants were identified from those who had previously been recruited into the NIHR-funded SWHSI-2 trial (NIHR17/42/94; a study assessing healing of surgical wound healing by secondary intention). All participants in this cohort had lower limb SWHSIs and a history of peripheral vascular disease. Sessions followed a general topic guide and were guided by the research team. Sessions were audio-recorded, transcribed and analysed using thematic analysis methods. Results: Four main areas of impact on quality of life were identified: mental health, physical symptoms, lifestyle symptoms and service-based impacts. There was a clear heterogeneity of experience seen within the group, with some reporting a more significant impact than others. This was ascribed to the loss of social and professional functioning, and the subsequent impact on mental health. There was a differential impact of this on younger participants (who tended to be employed and hold caring roles for children or family members) compared to older participants who did not have these social roles to fulfil, and were less affected in these areas. The need for improved preoperative counselling was highlighted, as many participants reported feeling unprepared for the postoperative course. Conclusions: This study considered the experiences of patients with a SWHSI and identified the main areas of impact on quality of life. This work will help to underpin future research into treatments and services for the SWHSI population. It may also form the basis for identifying an appropriate patient-reported outcome measure (PROM) related to quality of life in SWHSI for use in the research setting. Limitations of the study included the number and diversity of participants, and the impact of the SARS-CoV-2 (COVID-19) pandemic on the experiences of participants. Further exploration of the area through formal qualitative study is warranted to understand the breadth, generalisability and possible future applications of the work

SCIMITAR+ Trial: A randomised study within a trial (SWAT) of a contingent financial reward to improve trial follow-up

Objectives To evaluate the effectiveness of a contingent financial incentive (£10 note in addition to a routinely provided £10 voucher) versus no contingent financial incentive, on improving the retention rate in a randomised controlled trial (RCT). Methods A two arm ‘Study within a Trial’ (SWAT) embedded within a host RCT (SCIMITAR+). Participants were randomised to the SWAT using a 2:1 (intervention:control) allocation ratio. The primary outcome measure was the proportion of participants completing a CO breath measurement at the first SCIMITAR+ follow up time point (6 months). Secondary outcomes were withdrawing from follow-up after contact and time from assessment due date to completion. Analyses were conducted using logistic or Cox Proportional Hazards regression as appropriate. Results A total of 434 participants were randomised into this SWAT. Completion of the CO breath measurement at 6 months was 88.5% (n=247) in the intervention arm of the SWAT and 85.4% (n=123) in the control arm. The difference (3.1%) was not statistically significant (p=0.36; OR 1.29, 95% CI 0.71-2.33, p=0.41). There was also no evidence of a difference in the proportion of participants withdrawing from follow-up after contact (intervention n=7 (2.5%), control n=5 (3.5%); OR 0.76, 95% CI 0.23-2.44, p=0.64), nor in terms of proximity of 6-month visit completion to due date (HR 1.07, 95% CI 0.86-1.33, p=0.55). Conclusion Contingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population. However, the sample size of this SWAT was constrained by the size of the host trial and power was limited. This SWAT adds to the body of evidence for initiatives to increase response rates in trials. Key Words SWAT, retention; randomized controlled tria

Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials : lessons learnt from the PROMETHEUS research programme

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.Peer reviewedPublisher PD