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.

Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial): study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial.

BACKGROUND: The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI. METHODS: SWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use. DISCUSSION: Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres. TRIAL REGISTRATION: ISRCTN 26277546 . Prospectively registered on 25 March 2019.

Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over: the OTIS RCT.

BACKGROUND: Falls and fall-related fractures are highly prevalent among older people and are a major contributor to morbidity and costs to individuals and society. Only one small pilot trial has evaluated the effectiveness of a home hazard assessment and environmental modification in the UK. This trial reported a reduction in falls as a secondary outcome, and no economic evaluation was undertaken. Therefore, the results need to be confirmed and a cost-effectiveness analysis needs to be undertaken. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of a home hazard assessment and environmental modification delivered by occupational therapists for preventing falls among community-dwelling people aged ≥ 65 years who are at risk of falling, relative to usual care. DESIGN: This was a pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and a qualitative study. SETTING: Eight NHS trusts in primary and secondary care in England. PARTICIPANTS: In total, 1331 participants were randomised (intervention group, n = 430; usual-care group, n = 901) via a secure, remote service. Blinding was not possible. INTERVENTIONS: All participants received a falls prevention leaflet and routine care from their general practitioner. The intervention group were additionally offered one home environmental assessment and modifications recommended or provided to identify and manage personal fall-related hazards, delivered by an occupational therapist. MAIN OUTCOME MEASURES: The primary outcome was the number of falls per participant during the 12 months from randomisation. The secondary outcomes were the proportion of fallers and multiple fallers, time to fall, fear of falling, fracture rate, health-related quality of life and cost-effectiveness. RESULTS: The primary analysis included all 1331 randomised participants and indicated weak evidence of a difference in fall rate between the two groups, with an increase in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% confidence interval 0.99 to 1.38; p = 0.07). A similar proportion of participants in the intervention group (57.0%) and the usual-care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the secondary outcomes. The base-case cost-effectiveness analysis from an NHS and Personal Social Services perspective found that, on average per participant, the intervention was associated with additional costs (£18.78, 95% confidence interval £16.33 to £21.24), but was less effective (mean quality-adjusted life-year loss -0.0042, 95% confidence interval -0.0041 to -0.0043). Sensitivity analyses demonstrated uncertainty in these findings. No serious, related adverse events were reported. The intervention was largely delivered as intended, but recommendations were followed to a varying degree. LIMITATIONS: Outcome data were self-reported by participants, which may have led to inaccuracies in the reported falls data. CONCLUSIONS: We found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in this population of community-dwelling participants aged ≥ 65 years deemed at risk of falling. The intervention was more expensive and less effective than usual care, and therefore it does not provide a cost-effective alternative to usual care. FUTURE WORK: An evaluation of falls prevention advice in a higher-risk population, perhaps those previously hospitalised for a fall, or given by other professional staff could be justified. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22202133. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 46. See the NIHR Journals Library website for further project information.

Falling is a common problem among older people. In fact, up to half of people aged over 80 years fall each year, with most falls happening inside the home. Unfortunately, some falls cause serious injuries, such as broken bones. People often think that falls are part of getting older and that little can be done to stop them from falling. However, there are many ways to reduce falls. The Occupational Therapist Intervention Study (OTIS) explored whether or not a home assessment visit by an NHS occupational therapist could reduce falls among older people who are likely to be at risk of falling. In total, 1331 people aged 65 years or older living in England took part in the study. These people were all sent an Age UK leaflet about how to prevent falls, and 430 people were selected at random to receive a visit from an occupational therapist. The occupational therapist assessed their homes for hazards, such as slippery floors or poor lighting, and made suggestions for changes. We collected information from participants using monthly falls calendars and postal questionnaires to ask them about their falls, their quality of life, how often they used NHS services and how often they used paid care workers. We also asked them about whether they had had equipment and adaptations installed as a result of the assessments. We found that the home assessment visits did not reduce the number of falls people had or make any difference to participants' quality of life. However, many of the recommendations made by the occupational therapists were not carried out. The home assessment visits by an occupational therapist were not good value for money.

Evaluating 'Enhancing Pragmatic Language skills for Young children with Social communication impairments' (E-PLAYS): a feasibility cluster-randomised controlled trial.

BACKGROUND: This article reports the results from a feasibility study of an intervention ('E-PLAYS') aimed at supporting children who experience difficulties with social communication. E-PLAYS is based around a dyadic computer game, which aims to develop collaborative and communication skills. A pilot study found that when E-PLAYS was delivered by researchers, improvements on communication test scores and on collaborative behaviours were observed. The aim of this study was to ascertain the feasibility of running a full-scale trial to test the effectiveness of E-PLAYS in a National Health Service (NHS) setting with delivery by speech and language therapists and teaching assistants. METHODS: The study was a two-arm feasibility cluster-randomised controlled trial of the E-PLAYS intervention with a treatment as usual control arm. Data relating to recruitment and retention, treatment fidelity, acceptability to participants, suitability of outcomes and feasibility of collecting health economic measures and of determining cost-effectiveness were collected. Speech and language therapists selected suitable children (ages 4-7 years old) from their caseload. E-PLAYS intervention (experimental group) was then delivered by teaching assistants overseen by speech and language therapists. The control group received usual care. Assessments included blinded language measures and observations, non-blinded teacher-reported measures of peer relations and classroom behaviour and non-blinded parent-reported use of health and education resources and quality of life. RESULTS: Planned recruitment was for 70 children, in the event, 50 children were recruited which was sufficient for feasibility purposes. E-PLAYS was very highly rated by children, teaching assistants and speech and language therapists and treatment fidelity did not pose any issues. We were able to collect health economic data which suggests that E-PLAYS would be a low-cost intervention. CONCLUSION: Based on recruitment, retention and adherence rates and our outcome measures, a full-scale randomised controlled trial estimated appears feasible and warranted to assess the effectiveness of E-PLAYS for use by the NHS and schools. TRIAL REGISTRATION: ISRCTN 14818949 (retrospectively registered).

Surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder: the UK FROST three-arm RCT.

BACKGROUND: Frozen shoulder causes pain and stiffness. It affects around 10% of people in their fifties and is slightly more common in women. Costly and invasive surgical interventions are used, without high-quality evidence that these are effective. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of three treatments in secondary care for adults with frozen shoulder; to qualitatively explore the acceptability of these treatments to patients and health-care professionals; and to update a systematic review to explore the trial findings in the context of existing evidence for the three treatments. DESIGN: This was a pragmatic, parallel-group, multicentre, open-label, three-arm, randomised superiority trial with unequal allocation (2 : 2 : 1). An economic evaluation and a nested qualitative study were also carried out. SETTING: The orthopaedic departments of 35 hospitals across the UK were recruited from April 2015, with final follow-up in December 2018. PARTICIPANTS: Participants were adults (aged ≥ 18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation in the affected shoulder to < 50% of the opposite shoulder, and with plain radiographs excluding other pathology. INTERVENTIONS: The inventions were early structured physiotherapy with a steroid injection, manipulation under anaesthesia with a steroid injection and arthroscopic capsular release followed by manipulation. Both of the surgical interventions were followed with post-procedural physiotherapy. MAIN OUTCOME MEASURES: The primary outcome and end point was the Oxford Shoulder Score at 12 months post randomisation. A difference of 5 points between early structured physiotherapy and manipulation under anaesthesia or arthroscopic capsular release or of 4 points between manipulation under anaesthesia and arthroscopic capsular release was judged clinically important. RESULTS: The mean age of the 503 participants was 54 years; 319 were female (63%) and 150 had diabetes (30%). The primary analyses comprised 473 participants (94%). At the primary end point of 12 months, participants randomised to arthroscopic capsular release had, on average, a statistically significantly higher (better) Oxford Shoulder Score than those randomised to manipulation under anaesthesia (2.01 points, 95% confidence interval 0.10 to 3.91 points; p = 0.04) or early structured physiotherapy (3.06 points, 95% confidence interval 0.71 to 5.41 points; p = 0.01). Manipulation under anaesthesia did not result in statistically significantly better Oxford Shoulder Score than early structured physiotherapy (1.05 points, 95% confidence interval -1.28 to 3.39 points; p = 0.38). No differences were deemed of clinical importance. Serious adverse events were rare but occurred in participants randomised to surgery (arthroscopic capsular release,n = 8; manipulation under anaesthesia,n = 2). There was, however, one serious adverse event in a participant who received non-trial physiotherapy. The base-case economic analysis showed that manipulation under anaesthesia was more expensive than early structured physiotherapy, with slightly better utilities. The incremental cost-effectiveness ratio for manipulation under anaesthesia was £6984 per additional quality-adjusted life-year, and this intervention was probably 86% cost-effective at the threshold of £20,000 per quality-adjusted life-year. Arthroscopic capsular release was more costly than early structured physiotherapy and manipulation under anaesthesia, with no statistically significant benefit in utilities. Participants in the qualitative study wanted early medical help and a quicker pathway to resolve their shoulder problem. Nine studies were identified from the updated systematic review, including UK FROST, of which only two could be pooled, and found that arthroscopic capsular release was more effective than physiotherapy in the long-term shoulder functioning of patients, but not to the clinically important magnitude used in UK FROST. LIMITATIONS: Implementing physiotherapy to the trial standard in clinical practice might prove challenging but could avoid theatre use and post-procedural physiotherapy. There are potential confounding effects of waiting times in the trial. CONCLUSIONS: None of the three interventions was clearly superior. Early structured physiotherapy with a steroid injection is an accessible and low-cost option. Manipulation under anaesthesia is the most cost-effective option. Arthroscopic capsular release carries higher risks and higher costs. FUTURE WORK: Evaluation in a randomised controlled trial is recommended to address the increasing popularity of hydrodilatation despite the paucity of high-quality evidence. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48804508. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 71. See the NIHR Journals Library website for further project information.

Frozen shoulder occurs when the soft tissue envelope around the shoulder joint becomes inflamed, scarred and contracted, making movement painful and stiff. It affects around 1 in 10 people and is more common in women. Most patients are treated in the community. Those who do not improve are offered treatments in hospital. This includes costly and invasive surgical options. It is unclear which treatment provides the best patient outcomes and is cost-effective. UK FROST (UK FROzen Shoulder Trial) comprised 503 patients (from 35 UK hospitals) who randomly received one of three commonly offered treatments for frozen shoulder: early physiotherapy to restore movement, including a steroid injection for pain reliefmanipulation under anaesthesia, to stretch and tear the tight capsule to restore movement, and a steroid injection followed by physiotherapyarthroscopic capsular release, which uses keyhole surgery, including manipulation, to restore movement, followed by physiotherapy with pain medication. No important differences were found between the three treatments in shoulder function or pain at 12 months. Fewer patients who received arthroscopic capsular release required further treatment, and patients who received arthroscopic capsular release had slightly better shoulder function and pain outcomes than those who received the manipulation procedure or early physiotherapy. This improvement, however, was unlikely to be of clinical benefit to patients. Arthroscopic capsular release had slightly higher risks and substantially higher costs. Six serious complications were reported in patients who received arthroscopic capsular release (mostly owing to co-existing health problems) and two were reported in patients who received manipulation under anaesthesia. Physiotherapy was the least expensive treatment, but patients who received manipulation under anaesthesia had slightly better general health than those who received physiotherapy. Early physiotherapy with steroid injection could be accessed quicker than the surgical alternatives. Manipulation under anaesthesia cost more than physiotherapy but provided the best value for money. Patients in the study wanted early access to medical help to improve their shoulder problems.

Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial.

BACKGROUND: Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection. METHODS: In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0-48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508. FINDINGS: Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (-1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release). INTERPRETATION: All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention.

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-to-face 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.

Including a pen and/or cover letter, containing social incentive text, had no effect on questionnaire response rate: a factorial randomised controlled Study within a Trial.

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. Trial registration: ISRCTN22202133 (21st June 2020).

Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial.

Background: Randomised controlled trials (RCTs) often fail to recruit to target, resulting in a lack of generalisability of findings. A wide range of strategies for potentially increasing recruitment have been identified; however, their effectiveness has not been established. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT. Methods: A pragmatic, two-armed RCT was conducted, embedded within an existing falls prevention trial (OTIS) in men and women aged 65 years and over living in the community. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). The primary outcome was randomisation into the host trial.  Secondary outcomes related to trial eligibility and retention.  Analyses were via logistic regression and Cox Proportional Hazards regression. Results: Of the 317 SWAT participants, 12 (3.8%) were randomised into the OTIS trial: 3 (handwritten: 3/159 [1.9%]; printed: 9/158 [5.7%]; difference -3.8%, 95% CI -8.0% to 0.4%). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). There were no statistically significant differences between the intervention and control groups on any of the secondary outcomes. Conclusions: There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial. However, due to the small sample size, the results should be interpreted with caution. These findings need to be replicated across larger studies and wider populations. Registration: ISRCTN22202133.

Evaluating 'enhancing pragmatic language skills for young children with social communication impairments' (E-PLAYS): protocol for a feasibility randomised controlled trial study.

BACKGROUND: A number of children experience difficulties with social communication and this has long-term deleterious effects on their mental health, social development and education. The proposal presented in this article describes a feasibility study for a trial to test an intervention ('E-PLAYS') aimed at supporting children with social communication impairments. E-PLAYS harnesses technology in the form of a novel computer game in order to develop collaborative and communication skills. Preliminary studies by the authors show that when E-PLAYS was administered by the research team, children with social communication impairments showed improvements on communication test scores and on observed collaborative behaviours. The study described here is a pragmatic trial to test the application of E-PLAYS delivered by NHS speech and language therapists together with schools. METHODS: This protocol outlines a two-arm feasibility cluster-randomised controlled trial of the E-PLAYS intervention with treatment as usual control arm, with randomisation at the level of the speech and language therapist. The aim of this study is to ascertain whether it will be feasible to progress to running a full-scale definitive trial to test the effectiveness of E-PLAYS in an NHS setting. Data relating to recruitment and retention, the appropriateness of outcomes and the acceptability of E-PLAYS to participants will be collected.Speech and language therapists will select suitable children (ages 4-7 years old) from their caseloads and deliver either the E-PLAYS intervention (experimental group) or treatment as usual (control group). Assessments will include blinded language measures and observations, non-blinded teacher-reported measures of peer relations and classroom behaviour and parent-reported use of resources and quality of life. There will also be a qualitative process evaluation. DISCUSSION: The findings of this study will inform the decision as to whether to progress to a full-scale definitive randomised controlled trial to test the effectiveness of E-PLAYS when delivered by speech and language therapists and teaching assistants within schools. The use of technology in game form is a novel approach in an area where there are currently few available interventions. TRIAL REGISTRATION: ISRCTN 14818949 (retrospectively registered).

Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial.

Background: Meeting recruitment targets for randomised controlled trials is challenging.  This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial. Methods: This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial.  Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio.  The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial.  To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar.  Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months. Results: The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67; p = 0.86).  There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. Conclusion: Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required. Registration: ISRCTN22202133; SWAT 37.

Can occupational therapist-led home environmental assessment prevent falls in older people? A modified cohort randomised controlled trial protocol.

INTRODUCTION: Falls and fall-related injuries are a serious cause of morbidity and cost to society. Environmental hazards are implicated as a major contributor to falls among older people. A recent Cochrane review found an environmental assessment, undertaken by an occupational therapist, to be an effective approach to reducing falls. However, none of the trials included a cost-effectiveness evaluation in the UK setting. This protocol describes a large multicentre trial investigating the clinical and cost-effectiveness of environmental assessment and modification within the home with the aim of preventing falls in older people. METHODS AND ANALYSIS: A two-arm, modified cohort randomised controlled trial, conducted within England, with 1299 community-dwelling participants aged 65 years and above, who are at an increased risk of falls. Participants will be randomised 2:1 to receive either usual care or home assessment and modification. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by monthly patient self-report falls calendars. Secondary self-reported outcome measures include: the proportion of single and multiple fallers, time to first fall over a 12-month period, quality of life (EuroQoL EQ-5D-5L) and health service utilisation at 4, 8 and 12 months. A nested qualitative study will examine the feasibility of providing the intervention and explore barriers, facilitators, workload implications and readiness to employ these interventions into routine practice. An economic evaluation will assess value for money in terms of cost per fall averted. ETHICS AND DISSEMINATION: This study protocol (including the original application and subsequent amendments) received a favourable ethical opinion from National Health Service West of Scotland REC 3. The trial results will be published in peer-reviewed journals and at conference presentations. A summary of the findings will be sent to participants. TRIAL REGISTRATION NUMBER: ISRCTN22202133; Pre-results.

Cost-Effectiveness of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People: The REducing Falls with Orthoses and a Multifaceted Podiatry Intervention Trial Findings.

BACKGROUND: Falls are a major cause of morbidity among older people. Multifaceted interventions may be effective in preventing falls and related fractures. OBJECTIVE: To evaluate the cost-effectiveness alongside the REducing Falls with Orthoses and a Multifaceted podiatry intervention (REFORM) trial. METHODS: REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland; 1,010 participants (> 65 years) were randomised to receive either a podiatry intervention (n = 493), including foot and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or usual podiatry treatment plus a falls prevention leaflet (n = 517). PRIMARY OUTCOME: incidence of falls per participant in the 12 months following randomisation. SECONDARY OUTCOMES: proportion of fallers and quality of life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and Clinical Excellence reference case standards, using a regression-based approach with costs expressed in GBP (2015 price). The base case analysis used an intention-to-treat approach on the imputed data set using multiple imputation. RESULTS: There was a small, non-statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73-1.05, p = 0.16). Participants allocated to the intervention group accumulated on average marginally higher QALYs than the usual care participants (mean difference 0.0129, 95% CI -0.0050 to 0.0314). The intervention costs were on average GBP 252 more per participant compared to the usual care participants (95% CI GBP -69 to GBP 589). Incremental cost-effectiveness ratios ranged between GBP 19,494 and GBP 20,593 per QALY gained, below the conventional National Health Service cost-effectiveness thresholds of GBP 20,000 to GBP 30,000 per additional QALY. The probability that the podiatry intervention is cost-effective at a threshold of GBP 30,000 per QALY gained was 0.65. The results were robust to sensitivity analyses. CONCLUSION: The benefits of the intervention justified the moderate cost. The intervention could be a cost-effective option for falls prevention when compared with usual care in the UK.

A study update newsletter or Post-it® note did not increase postal questionnaire response rates in a falls prevention trial: an embedded randomised factorial trial.

Background: Participants not returning data collection questionnaires is a problem for many randomised controlled trials. The resultant loss of data leads to a reduction in statistical power and can result in bias. The aim of this study was to assess whether the use of a study update newsletter and/or a handwritten or printed Post-it® note sticker increased postal questionnaire response rates for participants of a randomised controlled trial. Method: This study was a factorial trial embedded within a host trial of a falls-prevention intervention among men and women aged ≥65 years under podiatric care. Participants were randomised into one of six groups: newsletter plus handwritten Post-it®; newsletter plus printed Post-it®; newsletter only; handwritten Post-it® only; printed Post-it® only; or no newsletter or Post-it®. The results were combined with those from previous embedded randomised controlled trials in meta-analyses. Results: The overall 12-month response rate was 803/826 (97.2%) (newsletter 95.1%, no newsletter 99.3%, printed Post-it® 97.5%, handwritten Post-it® 97.1%, no Post-it® 97.1%). The study update newsletter had a detrimental effect on response rates (adjusted odds ratio 0.14, 95% CI 0.04 to 0.48, p<0.01) and time to return the questionnaire (adjusted hazard ratio 0.86, 95% CI 0.75 to 0.99, p=0.04). No other statistically significant differences were observed between the intervention groups on response rates, time to response, and the need for a reminder. Conclusions: Post-it® notes have been shown to be ineffective in three embedded trials, whereas the evidence for newsletter reminders is still uncertain.

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial.

BACKGROUND: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy. METHODS: We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods. DISCUSSION: The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508 . Registered on 25 July 2014.

Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial).

BACKGROUND: Falls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care. DESIGN: A pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study. SETTING: Nine NHS trusts in the UK and one site in Ireland. PARTICIPANTS: In total, 1010 participants aged ≥ 65 years were randomised (intervention, n = 493; usual care, n = 517) via a secure, remote service. Blinding was not possible. INTERVENTIONS: All participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises. MAIN OUTCOME MEASURES: The primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness. RESULTS: The primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05; p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00; p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI -£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants. LIMITATIONS: Owing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care. CONCLUSIONS: The intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective. FUTURE WORK: Further research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68240461. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

Fostering the future of health promotion as seen through the 'Message from Youth Delegates on Health Promotion and Sustainable Development'.

The World Health Organization 9th Global Conference on Health Promotion presented us with the Shanghai Declaration for promoting health in the 2030 Agenda for Sustainable Development. At the same time, the participants of the conference symposium, 'How can youth become future leaders in delivering on the 2030 Agenda for Sustainable Development?' produced the 'Message from Youth Delegates on Health Promotion and Sustainable Development' as its complement. This 'Message from Youth Delegates' outlined pledges of young leaders in health promotion and proposed the necessary steps to ensure the future of health promotion includes more meaningful participation by young people. In order to fulfil the newest promises of the Shanghai Declaration and the past promises of the Ottawa Charter for Health Promotion, we must think to close the divides between generations of health promoters and move forward on actions designed to develop the best possible future leaders for the field of global health. (Global Health Promotion, 2017; 24(1): 62-65).

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.

BACKGROUND: Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. METHODS: A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. RESULTS: Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). CONCLUSIONS: This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.

Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).

BACKGROUND: Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. DESIGN: Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. RESULTS: In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. CONCLUSION: There was a small reduction in falls. The intervention may be cost-effective. TRIAL REGISTRATION: ISRCTN ISRCTN68240461.

A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial.

OBJECTIVES: To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomized controlled trial (RCT). METHODS: A methodological, two-arm, RCT was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomized for the embedded trial, using a 1:2 ratio (intervention : control) before being randomized for REFORM. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2-3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox proportional hazards model and incremental cost-effectiveness ratios. RESULTS: Of the 1436 intervention group participants, 73 (5.1%) were randomized into the REFORM trial compared with 126 (4.4%) of the 2878 control group participants. The associated relative risk (1.16) was not statistically significant [95% confidence interval (CI) 0.88-1.56]. Return rate was not significantly increased (relative risk 1.10, 95% CI 0.92-1.28) nor time to return decreased (hazard ratio: 1.11, 95% CI 0.93-1.33). Incremental cost-effectiveness ratios indicated the intervention may be cost-effective if the true estimate of effect was close to the upper bound of the associated 95% CI. CONCLUSION: Pre-notification for potential trial participants demonstrated a small difference to randomization (0.7% difference) and return rates (1.1% difference) in favour of the intervention. Results should however be interpreted with caution as CIs for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended.