Bathing Adaptations in the Homes of Older Adults (BATH-OUT-2): study protocol for a randomised controlled trial, economic evaluation and process evaluation.

BACKGROUND: The onset of disability in bathing is particularly important for older adults as it can be rapidly followed by disability in other daily activities; this may represent a judicious time point for intervention in order to improve health, well-being and associated quality of life. An important environmental and preventative intervention is housing adaptation, but there are often lengthy waiting times for statutory provision. In this randomised controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of bathing adaptations compared to no adaptations and to explore the factors associated with routine and expedited implementation of bathing adaptations. METHODS: BATH-OUT-2 is a multicentre, two-arm, parallel-group RCT. Adults aged 60 and over who are referred to their local authority for an accessible level access shower will be randomised, using pairwise randomisation, 1:1, to receive either an expedited provision of an accessible shower via the local authority or a usual care control waiting list. Participants will be followed up for a maximum of 12 months and will receive up to four follow-ups in this duration. The primary outcome will be the participant's physical well-being, assessed by the Physical Component Summary score of the Short Form-36 (SF-36), 4 weeks after the intervention group receives the accessible shower. The secondary outcomes include the Mental Component Summary score of the SF-36, self-reported falls, health and social care resource use, health-related quality of life (EQ-5D-5L), social care-related quality of life (Adult Social Care Outcomes Toolkit (ASCOT)), fear of falling (Short Falls Efficacy Scale), independence in bathing (Barthel Index bathing question), independence in daily activities (Barthel Index) and perceived difficulty in bathing (0-100 scale). A mixed-methods process evaluation will comprise interviews with stakeholders and a survey of local authorities with social care responsibilities in England. DISCUSSION: The BATH-OUT-2 trial is designed so that the findings will inform future decisions regarding the provision of bathing adaptations for older adults. This trial has the potential to highlight, and then reduce, health inequalities associated with waiting times for bathing adaptations and to influence policies for older adults. TRIAL REGISTRATION: ISRCTN Registry ISRCTN48563324. Prospectively registered on 09/04/2021.

A randomised controlled, feasibility study to establish the acceptability of early outpatient review and early cardiac rehabilitation compared to standard practice after cardiac surgery and viability of a future large-scale trial (FARSTER).

OBJECTIVE: To determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable. METHODS: A randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18-80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention). The primary outcome measures related to trial feasibility including recruitment, retention, CR adherence, and acceptability to participants/staff. Secondary outcome measures included health-rated quality of life using EQ-5D-5L, NHS resource-use, Incremental Shuttle Walk Test (ISWT) distance, 30- and 90-day mortality, surgical site complications and hospital readmission rates. RESULTS: Fifty participants were randomised (25 per group) and 92% declared fit for CR. Participant retention at final follow-up was 74%; completion rates for outcome data time points ranged from 28 to 92% for ISWT and 68 to 94% for follow-up questionnaires. At each time point, the mean ISWT distance walked was greater in the intervention group compared to the control. Mean utility scores increased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1519 for the intervention (£2043 control). Fifteen participants and a research nurse were interviewed. Many control participants felt their outpatient review and CR could have happened sooner; intervention participants felt the timing was right. The research nurse found obtaining consent for willing patients challenging due to discharge timings. CONCLUSION: Recruitment and retention rates showed that it would be feasible to undertake a full-scale trial subject to some modifications to maximise recruitment. Lower than expected recruitment and issues with one of the clinical tests were limitations of the study. Most study procedures proved feasible and acceptable to participants, and professionals delivering early CR. TRIAL REGISTRATION: ISRCTN80441309 (prospectively registered on 24/01/2019).

Recruitment patterns in multicentre randomised trials fit more closely to Price's Law than the Pareto Principle: A review of trials funded and published by the United Kingdom Health Technology Assessment Programme.

OBJECTIVE: This review investigates whether the distribution of recruitment to multicentre randomised controlled trials (RCTs) fits the "Pareto Principle", i.e. 80% of participants are recruited by 20% of sites, or Price's Law, i.e. 50% of participants are recruited by the square root of the total number of sites. METHODS: A review of HTA reports published between 2017 and 2019. RESULTS: 40 RCTs conducted face-to-face recruitment, five recruited via mail-outs and one used both methods. For face-to-face recruitment (n = 41 studies), 80% of participants were recruited by the top recruiting 42.6% of sites; for mail-out methods (n = 6 studies) this was 52.0%. From the square root of sites, 51.3% and 31.8% of participants were recruited for the two recruitment approaches, respectively. Specifically, 3 (7.3%, 95% CI 2.5% to 19.4%) and 20 (48.8%, 95% CI 34.3% to 63.5%) RCTs that recruited face-to-face followed Pareto Principle and Price's Law, respectively. One mail-out recruitment study followed one of these principles, Price's Law. Chief Investigator (CI) sites (n = 24) in face-to-face recruitment studies recruited 18.1% of participants. CONCLUSION: Face-to-face recruitment to HTA-funded RCTs fits more closely to Price's Law than the Pareto Principle, with the CI's site recruiting nearly a fifth of participants. Since we focussed on HTA-funded RCTs with ≥9 recruiting sites and for which the recruitment method and number recruited by site were known, our findings are limited in their generalisability. However, this trend could be used as a guide to aid in estimating how many sites RCTs need. More accurate estimation may prevent the need for recruitment extensions.

Systematic review assessing the evidence for the use of stem cells in fracture healing.

AIMS: Bone demonstrates good healing capacity, with a variety of strategies being utilized to enhance this healing. One potential strategy that has been suggested is the use of stem cells to accelerate healing. METHODS: The following databases were searched: MEDLINE, CENTRAL, EMBASE, Cochrane Database of Systematic Reviews, WHO-ICTRP, ClinicalTrials.gov, as well as reference checking of included studies. The inclusion criteria for the study were: population (any adults who have sustained a fracture, not including those with pre-existing bone defects); intervention (use of stem cells from any source in the fracture site by any mechanism); and control (fracture healing without the use of stem cells). Studies without a comparator were also included. The outcome was any reported outcomes. The study design was randomized controlled trials, non-randomized or observational studies, and case series. RESULTS: In all, 94 eligible studies were identified. The clinical and methodological aspects of the studies were too heterogeneous for a meta-analysis to be undertaken. A narrative synthesis examined study characteristics, stem cell methods (source, aspiration, concentration, and application) and outcomes. CONCLUSION: Insufficient high-quality evidence is available to determine the efficacy of stem cells for fracture healing. The studies were heterogeneous in population, methods, and outcomes. Work to address these issues and establish standards for future research should be undertaken.Cite this article: Bone Joint Open 2020;1-10:628-638.

Children and young people's concerns and needs relating to their use of health technology to self-manage long-term conditions: a scoping review.

BACKGROUND: The use of patient-facing health technologies to manage long-term conditions is increasing; however, children and young people may have particular concerns or needs before deciding to use different health technologies. AIMS: To identify children and young people's reported concerns or needs in relation to using health technologies to self-manage long-term conditions. METHODS: A scoping review was conducted. We searched MEDLINE, PsycINFO and CINAHL in February 2019. Searches were limited to papers published between January 2008 and February 2019. We included any health technology used to manage long-term conditions. A thematic synthesis of the data from the included studies was undertaken. We engaged children with long-term conditions (and parents) to support review design, interpretation of findings and development of recommendations. RESULTS: Thirty-eight journal articles were included, describing concerns or needs expressed by n=970 children and/or young people aged 5-18 years. Most included studies were undertaken in high-income countries with children aged 11 years and older. Studies examined concerns with mobile applications (n=14), internet (n=9), social media (n=3), interactive online treatment programmes (n=3), telehealth (n=1), devices (n=3) or a combination (n=5). Children and young people's main concerns were labelling and identity; accessibility; privacy and reliability; and trustworthiness of information. DISCUSSION: This review highlights important concerns that children and young people may have before using technology to self-manage their long-term condition. In future, research should involve children and young people throughout the development of technology, from identifying their unmet needs through to design and evaluation of interventions.

An embedded randomised controlled retention trial of personalised text messages compared to non-personalised text messages in an orthopaedic setting.

Background: Several studies have investigated whether personalising trial documentation can aid recruitment and retention. We did a 'study within a trial' (SWAT) evaluating the effectiveness of a personalised text message compared to a non-personalised text message, on the retention rate in a large orthopaedic trial. Methods: The SWAT was embedded in the Knee Replacement Bandaging Study (KReBS) trial. The primary outcome was the proportion of 12-month questionnaires returned. Secondary outcomes were the proportion of questionnaires completed and time to questionnaire return. Binary data were analysed using logistic regression and time to return using Cox proportional hazards regression.  Odds ratios (OR) and hazard ratios (HR) are presented, with associated 95% confidence intervals (CI) and p-values. Results: In total, 1465 participants were included in the SWAT. In the personalised group, 644/723 (89.1%) of participants returned a questionnaire, compared to 654/742 (88.1%) in the non-personalised group. The absolute difference in return rate was 0.9% (95% CI: -2.3% to 4.2%; p=0.57). There was no evidence of a difference between the groups in the likelihood of returning a questionnaire (OR 1.09; 95% CI: 0.79 to 1.51; p=0.61), the likelihood of returning a complete questionnaire (OR 1.11; 95% CI: 0.82 to 1.51; p=0.50) nor in time to return (HR 1.05; 95% CI: 0.94 to 1.17; p=0.40). Conclusion: This SWAT adds to the growing evidence base for whether personalised text messages are effective. Registration: ISRCTN87127065 (20/02/2017); SWAT 35 (01/12/2015).

Poor allocation concealment methods are associated with heterogeneity in age and statistical significance of the primary outcome: Review of recent trials published in four general medical journals.

OBJECTIVE: To assess the association of the quality of allocation concealment with heterogeneity in age, the P value of the primary outcome and statistical significance of the primary outcome. STUDY DESIGN AND SETTING: We extracted data from articles published in four major medical journals in 2017 and 2018 that reported the results of randomized controlled trials. The outcome measures were the quality of allocation concealment used in the trial, the P value of the primary outcome, whether the P value of the primary outcome was statistically significant and the level of heterogeneity in age between the treatment groups (measured using the I2 statistic). The association between the quality of allocation concealment and the P value of the primary outcome was assessed using a kernel density plot, while the association between the quality of allocation concealment and whether the P value was statistically significant was assessed using logistic regression. RESULTS: Trials that used inadequate concealment methods were more likely to report statistically significant findings than trials that used good or adequate methods (OR 1.90; 95% CI: 0.91 to 3.95; P = .09). The values of I2 for trials that used good, adequate, inadequate and unclear concealment methods were 0%, 1.0%, 32.6%, and 93.8%, respectively. CONCLUSION: There is evidence of an association between poor allocation concealment methods and statistical significance of the primary outcome. Trials that use inadequate allocation concealment methods are more likely to have statistically significant P values compared with trials using good or adequate allocation concealment methods.

Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

INTRODUCTION: Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier. METHODS AND ANALYSES: This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial. ETHICS AND DISSEMINATION: Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN80441309.