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Methodological study to assess the extent to which the contents of PROSPERO records meet the systematic review protocol reporting items in PRISMA-P

Underlying data and CONSORT checklist for the following paper: Whiteside K, Flett L, Mitchell A et al. Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial [version 1; peer review: awaiting peer review]. F1000Research 2019, 8:315 (https://doi.org/10.12688/f1000research.18300.1) The dataset has been deposited as a .csv file and as a .sav file, that can be opened with IBM SPSS Statistics 25.0.

Data and Supplementary Files repository for "Does Handwriting the Name of a Potential Trial Participant on an Invitation Letter Improve Recruitment Rates? A randomised control trial within a trial."

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

Occupational therapist intervention for falls prevention

Clinical Trial Managers play a vital role in the design and conduct of clinical trials in the UK. There is a current recruitment and retention crisis for this specialist role due to a complex set of factors, most likely to have come to a head due to the Covid-19 pandemic. Academic clinical trials units and departments are struggling to recruit trial managers to vacant positions, and multiple influences are affecting the retention of this highly skilled workforce. Without tackling this issue, we face major challenges in delivery on the Department of Health and Social Care’s Future of UK Clinical Research Delivery implementation plan. This article, led by a leading network of and for UK Trial Managers, presents some of the issues and ways in which national stakeholders may be able to address this.

Objectives. To explore any age-related trend in workplace slip rate and assess the effectiveness of appropriate slip-resistant footwear in preventing workplace slips by age. Methods. Secondary data analysis of the Stopping Slips among Healthcare Workers (SSHeW) trial, a two-arm randomised controlled trial conducted between March 2017 and May 2019. 4553 National Health Service (NHS) staff across seven sites in England were randomised 1:1 to the intervention group (provision of 5* GRIP-rated slip-resistant footwear) or the control group (usual work footwear). The primary outcome was self-reported workplace slips, ascertained primarily through weekly text messages throughout the 14-week trial follow-up and analysed using mixed effects negative binomial regression. This paper reports a control-group only analysis of the association between age and slip rate, and a full intention-to-treat analysis of the effectiveness of slip-resistant footwear by age. Results. The mean age of participants was 43 years (range 18-74). In the control-group only analysis, slip rate differed by age (p

Additional file 3: Supplementary file 3: Completion rates. Table 1: Data completeness of outcome measures collected at baseline. Table 2: Summary of data completeness for measures included in the T1 assessment for those who have completed a T1 questionnaire.Table 3: Summary of data completeness for measures included in the T2 assessment for those who have completed a T2 questionnaire.Table 4: Summary of data completeness for measures included in the T3 assessment for those who have completed a T3 questionnaire.

Additional file 2: Supplementary file 2: Summary of ward level baseline data over the previous 12 month period

Additional file 1: Supplementary file 1. CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial.

Additional file 1.

Introduction PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO contained the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P). Methods A random sample of 439 single entry PROSPERO records of reviews of health interventions registered in 2018 was identified. Using a piloted list of 19 PRISMA-P items, divided into 63 elements, two researchers independently assessed the registration records. Where the information was present or not applicable to the review a score of 1 was assigned. Overall scores were calculated and comparisons made by stage of review at registration, whether or not a meta-analysis was planned and whether or not funding/sponsorship was reported. Results Some key methodological details such as eligibility criteria, were relatively frequently reported, but much of the information recommended in PRISMA-P was not stated in PROSPERO registrations. Considering the 19 items, the mean score was 4.8 (SD 1.8; median 4; range 2-11) and across all the assessed records only 25% (2081/8227) of the items were scored as reported. Considering the 63 elements, the mean score was 33.4 (SD 5.8; median 33; range 18-47) and overall, 53% (14,469/27,279) of the elements were assessed as reported. Reporting was more frequent for items required in PROSPERO than optional items. The planned comparisons showed no meaningful differences between groups. Conclusions PROSPERO provides reviewers with the opportunity to be transparent in their planned methods and demonstrate efforts to reduce bias. However, where the PROSPERO record is the only available source of a priori reporting, there is a significant shortfall in the items reported, compared to those recommended. This presents challenges in interpretation for those wishing to assess the validity of the final review.

Background: Postal questionnaires are frequently used in randomised controlled trials to collect outcome data on participants; however, poor response can introduce bias, affect generalisability and validity, and reduce statistical power. The objective of this study was to assess whether a pen and/or social incentive text cover letter sent with a postal follow-up questionnaire increased response rates in a trial. Method: A two-by-two factorial randomised controlled trial was embedded within the OTIS host trial. Participants due their 12-month (final) follow-up questionnaire were randomised to be sent: a pen; a social incentive text cover letter; both; or neither. The primary outcome measure was the proportion of participants in each group who returned the questionnaire. Secondary outcomes were: time to return, completeness of the questionnaire, necessity of a reminder letter, and the cost effectiveness. Results: The overall 12-month questionnaire response rate was 721 out of 755 (95.5%). Neither the pen nor social incentive cover letter had a statistically significant effect on response rate: pen 95.2% vs. no pen 95.8%, adjusted OR 0.90 (95% CI 0.45 to 1.80; p=0.77); social incentive cover letter 95.2% vs. no social incentive cover letter 95.8%, adjusted OR 0.84 (95% CI 0.42 to 1.69, p=0.63). No statistically significant differences were observed between either of the intervention groups on time to response, need for a reminder or completeness. Therefore, neither intervention was cost-effective. Conclusions: We found no evidence of a difference in response rates associated with the inclusion of a pen and/or social incentive cover letter with the final follow-up postal questionnaire of the host trial. However, when these results are combined with previous SWATs, the meta-analysis evidence remains that including a pen increases response rates. The social incentive cover letter warrants further investigation to determine effectiveness.

Background: Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multicentre, two-arm cohort randomised controlled trial: the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project-specific fidelity can be assessed using a truly mixed-methods approach when informed by qualitative insights. Design: Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. Setting: Seven NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-toface or over the telephone. Participants: Twenty-one REFORM trial participants and 14 podiatrists who delivered the REFORM intervention. Results: Factors affecting fidelity included: how similar the intervention was to routine practice; the challenges of delivering a multifaceted intervention to a heterogeneous older population; and practical issues with delivery such as time and training. Trial participants’ views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial and individual factors such as medical conditions may also have affected intervention fidelity. Conclusions: Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project-specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed-methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. Trial registration: ISRCTN Registry: ISRCTN68240461. Registered on 01/07/2011. Keywords: Process evaluation, Randomised controlled trials, Fidelity, Mixed methods, Falls, Elderly, Ageing, Qualitative

Additional file 2. Topic guide for use with trial participants. Topic guide used for semi-structured interviews with trial participants.

Additional file 1. Topic guide for use with podiatrists. Topic guide used for semi-structured interviews with podiatrists.

Additional file 2. Partners At Care Transitions (PACT): improving patient experience and safety at transitions of care.

Additional file 1. Improving patient experience and safety at transitions of care through the Partners at Care Transitions (PACT) intervention: a study protocol for a cluster randomised controlled feasibility trial.