Can routine assessment of older people's mental health lead to improved outcomes: A regression discontinuity analysis.

OBJECTIVE: To assess whether case finding for depression among people aged 65 and above improves mental health. DESIGN: Opportunistic evaluation using a regression discontinuity analysis with data from a randomised controlled trial. SETTING: The REFORM trial, a falls prevention study that recruited patients from NHS podiatry clinics. PARTICIPANTS: 1010 community-dwelling adults over the age of 65 with at least one risk factor for falling (recent previous fall or fear of falling). INTERVENTION: Letter sent to patient's General Practitioner if they scored 10 points or above on the 15-item Geriatric Depression Scale (GDS-15) informing them of the patient's risk of depression. MAIN OUTCOME MEASURE: GDS-15 score six months after initial completion of GDS-15. RESULTS: 895 (88.6%) of the 1010 participants randomised into REFORM had a valid baseline and six-month GDS-15 score and were included in this study. The mean GDS-15 baseline score was 3.5 (SD 3.0, median 3.0, range 0-15); 639 (71.4%) scored 0-4, 204 (22.8%) scored 5-9 indicating mild depression, and 52 (5.8%) scored 10 or higher indicating severe depression. At six months follow-up, those scoring 10 points or higher at baseline had, on average, a reduction of 1.08 points on the GDS-15 scale (95% confidence interval -1.83 to -0.33, p = 0.005) compared to those scoring less than 10, using the simplest linear regression model. CONCLUSION: Case finding of depression in podiatry patients based on a GDS-15 score of 10 or more followed by a letter to their General Practitioner significantly reduced depression severity. Whether this applies to all older patients in primary care is unknown. Further research is required to confirm these findings. Regression discontinuity analyses could be prespecified and embedded within other existing research studies.

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

Background: Randomised controlled trials ('trials') are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives: PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial. Design: A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously. Setting: Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible. Participants: Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom. Interventions: Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial. Main outcome measures: Number of host trials funded. Results: Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials. Limitations: The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed (n = 2) or prematurely terminated (n = 3). Conclusions: PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial. Future work: Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice. Study registration: All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository. 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.

A Study Within A Trial is a research study nested inside a larger 'host trial', promoting the use of Studies Within A Trial aimed to do Study Within A Trial routine practice in clinical trial units by funding and supporting at least 25 Studies Within A Trial. The best way to test health and social care treatments is to do a randomised controlled trial ('trial'), where some patients get the treatment being tested and some do not. The results of different groups are compared to see if the treatment improves care. Recruiting patients and keeping them involved in trials is often very difficult. Research teams often do not know how best to recruit and keep patients engaged as the methods have not been tested to see if they work. The best way to test these methods is by doing a Study Within A Trial. We test a programme of Studies Within A Trial for recruiting and keeping patients engaged in trials. Trial teams were able to apply for funding of up to £5000 and receive support from Promoting the use of Study Within A Trial team to do Studies Within A Trial. We used our experience of doing Studies Within A Trial to outline lessons learnt for doing Studies Within A Trial. We funded 42 Studies Within A Trial and gave teams necessary advice to do them. We significantly increased the knowledge for both recruitment and retention strategies, and found 'pre-notifying' before sending questionnaires, sending pens and personalised text messages were all effective for increasing responses by participants. We tested Studies Within A Trial across several different trials at the same time to find out more quickly whether their methods worked. We highlight key lessons learnt to guide others doing Studies Within A Trial, including involving patient partners; picking the right strategy to test; getting ethical approvals; how to do and report Studies Within A Trial. Promoting the use of studies within a trial was successful and supported more Studies Within A Trial than planned. We hope our experience will support those doing Studies Within A Trial in the future.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

Introduction: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions. Methods and analysis: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

Communication interventions for medically unexplained symptom conditions in general practice: A systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Medically unexplained symptoms (MUS) account for 3-50% of all General Practitioner (GP) consultations and are difficult to diagnose due to their unknown aetiology, symptom overlap between conditions, and lack of effective treatment options. MUS patients' and primary care clinicians frequently face challenges during consultations, with GPs reporting difficulty identifying and classifying MUS, whilst patients report stigma and feeling illegitimised by clinicians. Communication interventions have been proposed as a method to facilitate the doctor-patient relationship and aid the management of MUS. AIM: This systematic review aims to evaluate the effectiveness of primary care based communication interventions at improving MUS patients' and/or clinician outcomes. METHOD: Four electronic databases were searched from inception to November 2021. Two researchers independently undertook screening, data extraction and quality appraisal. Given the heterogeneous nature of the studies identified, narrative syntheses were conducted, along with meta-analyses where possible to pool data. RESULTS: 9 papers from 10 Randomised Controlled Trials were included. The included studies displayed considerable risk of bias and poor reporting. Some limited evidence suggests that communication interventions tailored to MUS and not following a pre-specified model (such as reattribution) could improve pain, mental and physical functioning whilst reattribution training may improve clinician confidence treating MUS. However, methodological limitations mean that these findings should be interpreted with caution. CONCLUSION: A range of interventions for improving communication with MUS patients in primary care have been evaluated. However, the heterogeneous nature of existing evidence and poor study quality mean we cannot conclude whether these interventions are effective. Before considering further randomised controlled trials researchers should focus on developing a new or modified communication intervention for MUS patients and their clinicians. TRAIL REGISTRATION: The systematic review was prospectively registered with PROSPERO (registration record CRD42020206437).

Relationship between age, workplace slips and the effectiveness of slip-resistant footwear among healthcare workers.

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 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<0.001) with those aged 60+ having double the slip rate of those aged <30 years (95% CI 1.40 to 2.87). In the intention-to-treat analysis, the interaction between allocation and age was statistically significant (p=0.002). In addition, for all age groups except those aged <30 years, the slip rate in the intervention group was statistically significantly lower than the control group; the smallest incidence rate ratio (ie, the biggest effect) was 0.39 (95% CI 0.24 to 0.64) in the 60+ age group. CONCLUSION: The provision of appropriate slip-resistant footwear was more effective at reducing workplace slips for older NHS staff.

Scaling up Quality Improvement for Surgical Teams (QIST)-avoiding surgical site infection and anaemia at the time of surgery: a cluster randomised controlled trial of the effectiveness of quality improvement collaboratives to introduce change in the NHS.

BACKGROUND: The aim of this trial was to assess the effectiveness of quality improvement collaboratives to implement large-scale change in the National Health Service (NHS) in the UK, specifically for improving outcomes in patients undergoing primary, elective total hip or knee replacement. METHODS: We undertook a two-arm, cluster randomised controlled trial comparing the roll-out of two preoperative pathways: methicillin-sensitive Staphylococcus aureus (MSSA) decolonisation (infection arm) and anaemia screening and treatment (anaemia arm). NHS Trusts are public sector organisations that provide healthcare within a geographical area. NHS Trusts (n = 41) in England providing primary, elective total hip and knee replacements, but that did not have a preoperative anaemia screening or MSSA decolonisation pathway in place, were randomised to one of the two parallel collaboratives. Collaboratives took place from May 2018 to November 2019. Twenty-seven Trusts completed the trial (11 anaemia, 16 infection). Outcome data were collected for procedures performed between November 2018 and November 2019. Co-primary outcomes were perioperative blood transfusion (within 7 days of surgery) and deep surgical site infection (SSI) caused by MSSA (within 90 days post-surgery) for the anaemia and infection trial arms, respectively. Secondary outcomes were deep and superficial SSIs (any organism), length of hospital stay, critical care admissions and unplanned readmissions. Process measures included the proportion of eligible patients receiving each preoperative initiative. RESULTS: There were 19,254 procedures from 27 NHS Trusts included in the results (6324 from 11 Trusts in the anaemia arm, 12,930 from 16 Trusts in the infection arm). There were no improvements observed for blood transfusion (anaemia arm 183 (2.9%); infection arm 302 (2.3%) transfusions; adjusted odds ratio 1.20, 95% CI 0.52-2.75, p = 0.67) or MSSA deep SSI (anaemia arm 8 (0.13%); infection arm 18 (0.14%); adjusted odds ratio 1.01, 95% CI 0.42-2.46, p = 0.98). There were no significant improvements in any secondary outcome. This is despite process measures showing the preoperative pathways were implemented for 73.7% and 61.1% of eligible procedures in the infection and anaemia arms, respectively. CONCLUSIONS: Quality improvement collaboratives did not result in improved patient outcomes in this trial; however, there was some evidence they may support successful implementation of new preoperative pathways in the NHS. TRIAL REGISTRATION: Prospectively registered on 15 February 2018, ISRCTN11085475.

The effectiveness of behaviour change interventions delivered by non-dental health workers in promoting children's oral health: A systematic review and meta-analysis.

OBJECTIVES: Dental caries is the most common preventable childhood condition. Non-dental professionals and health workers are often well placed to support parents in adopting positive oral health behaviours for their children. The aim of this study was to determine the effectiveness of behaviour change interventions and their individual component behaviour change techniques (BCTs), that were delivered by non-dental professionals and health workers. METHODS: A systematic search of Ovid MEDLINE, PubMed, CINAHL, Cochrane Library, Web of Science, TRoPHI and PROQUEST from inception until March 2021 was conducted. Randomised controlled trials and quasi-experimental studies for improving oral health outcomes in children were included. Quality assessment was carried out using Cochrane Risk of Bias tool and ROBINS-I tool. Publication bias was assessed using funnel plots and Egger's regression intercept. Effect sizes were estimated as standardised mean difference (SMD) and odds ratio/risk ratio for proportions. Meta-analyses were performed for studies reporting mean decayed, missing, filled surfaces (dmfs) and mean decayed, missing, filled, teeth (dmft) indices. Behaviour change technique coding was performed using behaviour change technique taxonomy v1 (BCTTv1). RESULTS: Out of the 9,101 records retrieved, 36 studies were included with 28 showing a significant effect either in clinical and/or behavioural/knowledge outcomes. Most studies (n = 21) were of poor methodological quality. The pooled SMD for caries experience showed statistically significant result for caries prevention at surface level -0.15 (95% CI -0.25, -0.04) and at the tooth level -0.24 (95% CI -0.42, -0.07). In 28 effective interventions, 27 individual BCTs were identified and the most frequently used were: "Instructions on how to perform the behaviour" and "Information about health consequences". CONCLUSION: There is low quality of evidence suggesting non-dental professionals and health workers may help improve oral health outcomes for children. To confirm these findings, further high-quality studies incorporating a variety of BCTs in their interventions for adoption of good oral health behaviours are needed.

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.

A review found small variable blocking schemes may not protect against selection bias in randomized controlled trials.

OBJECTIVE: Blocking is associated with prediction of the allocation sequence and subversion. This paper explores if blocking strategies lead to an increase in baseline age heterogeneity (a marker for potential subversion) and, whether the use of blocking is changing over time. STUDY DESIGN AND SETTINGS: The British Medical Journal, Journal of the American Medical Association, The Lancet and the New England Journal of Medicine were hand searched to identify open RCTs published in January between 2001 and 2020. To explore heterogeneity of baseline age meta-analyses were performed on trials implementing blocking, minimization, and simple randomization. RESULTS: One hundred seventy-nine open RCTs were identified: nine (5.0%) undertook simple randomization, 104 (58.1%) blocking, 25 (13.9%) minimization, and one (0.6%) both. Baseline age heterogeneity of 24% (P= 0.02) was observed in all trials implementing blocking, 62% (P = 0.001) in trials implementing a fixed block of four, 40% (P = 0.07) implementing variable blocks including a 2 and 0% for both simple randomization and minimization. Small block sizes are implemented in modern trials. CONCLUSION: Variable block sizes including two are associated with subversion and should not be implemented. If center only stratification is necessary, it should be used alongside larger blocking schemes. Authors should consider alternative methods to restrict randomization.

Cost-effectiveness of hydroxychloroquine versus placebo for hand osteoarthritis: economic evaluation of the HERO trial.

Background: An economic evaluation alongside the Hydroxychloroquine Effectiveness in Reducing symptoms of hand Osteoarthritis (HERO) trial was undertaken to assess the cost-effectiveness of hydroxychloroquine compared with placebo for symptomatic treatment of hand osteoarthritis for patients with at least moderate hand pain and inadequate response to current therapies. Methods: A trial-based cost-utility analysis was undertaken from the perspective of the UK National Health Service and Personal Social Services over a 12-month time horizon, using evidence from 248 participants included in the HERO trial, conducted in England. Patient-level data were collected prospectively over a 12-month period, using participant-completed questionnaires and investigator forms, to collect healthcare utilisation, costs and quality-adjusted life years (QALYs) using the EQ-5D-5L. The base-case analysis was conducted on an intention-to-treat basis and used multiple imputation methods to deal with missing data. Results were presented in terms of incremental cost-effectiveness ratios (incremental cost per QALY) and net health benefit, with uncertainty surrounding the findings explored using cost-effectiveness acceptability curves. Results: The base-case analysis estimated slightly lower costs on average (-£11.80; 95% confidence interval (CI) -£15.60 to -£8.00) and marginally fewer QALYs (-0.0052; 95% CI -0.0057 to -0.0047) for participants in the hydroxychloroquine group versus placebo group at 12 months. The resulting incremental cost-effectiveness ratio of £2,267 per QALY lost indicated that although costs were saved, health-related quality of life was lost. Even assuming symmetrical preferences regarding losses and gains for health benefits, the findings do not fall within the cost-effective region. Similar findings arose for analyses conducted from the societal perspective and using complete cases only. Conclusions: This economic evaluation indicates that hydroxychloroquine is unlikely to provide a cost-effective pain relief option for improving health-related quality of life in adult patients with moderate-to-severe hand osteoarthritis.

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.

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS).

BACKGROUND: Use of a person's name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient's name) versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires. METHODS: Using a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either (1) a personalised text message which included their name or (2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire, and cost. RESULTS: Between March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n = 309) or standard (n = 309) text message and all were included in the analysis. The overall questionnaire response rate was 87% (n = 537/618); 90% (n = 277/309) of participants responded in the personalised text message group compared to 84% (n = 260/309) in the standard text message group (relative risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n = 185/309; 60% vs. n = 160/309; 52%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8%. Post hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message. CONCLUSION: Overall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message. TRIAL REGISTRATION: GRASP Trial ISRCTN16539266 ; SWAT Repository ID 35.

Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial.

BACKGROUND: Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga's Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain. METHODS: This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles. DISCUSSION: This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity. TRIAL REGISTRATION: ISRCTN ISRCTN13567538 . Registered on 18 March 2019.

Slip-resistant footwear reduces slips among National Health Service workers in England: a randomised controlled trial.

OBJECTIVES: Assess the effectiveness of 5* GRIP-rated slip-resistant footwear in preventing slips in the workplace compared to usual footwear (control group). METHODS: A multicentre, randomised controlled trial; 4553 National Health Service (NHS) staff were randomised 1:1 to the intervention group (provided with 5* GRIP-rated slip-resistant footwear) or the control group. The primary outcome of incidence rate of self-reported slips in the workplace over 14 weeks was analysed using a mixed-effects negative binomial model. Secondary outcome measures included incidence rate of falls from a slip, falls not from a slip, proportion of participants reporting a slip, fall or fracture and time to first slip and fall. RESULTS: 6743 slips were reported: 2633 in the intervention group (mean 1.16 per participant, range 0 to 36) and 4110 in the control group (mean 1.80 per participant, range 0 to 83). There was a statistically significant reduction in slip rate in the intervention group relative to the control group (incidence rate ratio (IRR) 0.63, 95% CI 0.57 to 0.70, p<0.001). Statistically significant differences, in favour of the intervention group, were observed in falls from a slip (IRR 0.51, 95% CI 0.28 to 0.92, p=0.03), the proportion of participants who reported a slip (OR 0.58, 95% CI 0.50 to 0.66, p<0.001) or fall (OR 0.73, 95% CI 0.54 to 0.99, p=0.04) and time to first slip (HR 0.73, 95% CI 0.67 to 0.80, p<0.001). CONCLUSIONS: The offer and provision of 5* GRIP-rated footwear reduced slips in NHS staff in the workplace. TRIAL REGISTRATION NUMBER: ISRCTN33051393.

A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment in a randomised controlled trial of yoga for older adults with multimorbidity.

Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: This was a 2x2 factorial 'study within a trial' of including a pen and/or £5 with a postal recruitment pack to improve randomisation rate (primary outcome) into the host Gentle Years Yoga trial in older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant recruited. Binary data were analysed using logistic regression and time to return data using Cox proportional hazards regression.  Results: 818 potential host trial participants included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the likelihood of being randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63-3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75-1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77-1.55). There was evidence of improved screening return rates (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13-2.45) and time to return screening form (HR 1.56, 95% CI 1.09-2.22) but not randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54-2.57) in those sent £5 (n=409) compared with those not sent £5 (n=409). No significant interaction effects between the interventions were observed. The cost per additional participant recruited was £32 for the pen and £1000 for the £5 incentive. Conclusion: Including a small, monetary incentive encouraged increased and faster response to the recruitment invitation but did not result in more participants being randomised into the host trial. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens are cheaper but did not provide evidence of benefit. Further studies may be required.

An evaluation of a personalised text message reminder compared to a standard text message on postal questionnaire response rates: an embedded randomised controlled trial.

Background: Research outcome data is commonly collected using postal questionnaires; however, poor response can introduce bias and reduce statistical power. Text messaging is simple, cost-effective, and can be customised to the individual. Personalised, reminder text messages may improve response rates. Methods: A two-arm, parallel group 'Study within a Trial' (SWAT) was embedded within the Occupational Therapist Intervention Study (OTIS), a randomised controlled trial of a home assessment for falls prevention in older people.  OTIS participants who provided a mobile phone number were randomly allocated (1:1) to receive either a personalised text message (Title, Surname, plus York Trials Unit (YTU) text) or the standard YTU text alone, prior to receiving their four-month post-randomisation follow-up postal questionnaire. The primary outcome measure was the proportion of participants who returned the questionnaire. Secondary outcomes were: time to response, completeness of response, requirement of a reminder letter, and cost-effectiveness. Binary data were compared using logistic regression and time to response by Cox proportional hazards regression. Results: A total of 403 participants were randomised: 201 to the personalised text and 202 to the standard text.  Of the 283 participants included in the final analysis, 278 (98.2%) returned their questionnaire; 136 (97.8%) for the personalised text versus 142 (98.6%) for the standard text (adjusted odds ratio 0.64, 95% CI 0.10 to 3.88, p=0.63).  The median time to response was nine days in both groups.  In total, 271 (97.5%) participants returned a complete questionnaire; 133 (97.8%) in the personalised text versus 138 (97.2%) for the standard text.  In total, 21 reminder letters were sent. The additional cost of personalised text messages was £0.04 per participant retained. Conclusions: Personalised texts were not superior to standard texts in any outcome assessed in our study. Further SWATs are needed to perform a meta-analysis and obtain more evidence. Registration: ISRCTN22202133; SWAT 35.

Pragmatic randomised evaluation of stable thoracolumbar fracture treatment outcomes (PRESTO): study protocol for a randomised controlled feasibility trial combined with a qualitative study and survey.

BACKGROUND: A thoracolumbar fracture is the most common fracture of the spinal column. Where the fracture is not obviously stable or unstable, the optimal management is uncertain. There are variations between surgeons, treating centres and within the evidence base as to whether surgical or non-surgical approaches should be used. In addition, the boundaries of this zone of uncertainty for stability are unclear.This study has been designed in response to an NIHR HTA commissioning brief to assess the feasibility of undertaking a large-scale trial to evaluate the effectiveness of surgical and non-surgical treatments for thoracolumbar fractures without neurological deficit. METHODS: Assessment of feasibility will be addressed through three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study.The external feasibility study is a pragmatic, parallel-group, randomised controlled trial comparing surgical fixation (intervention) versus non-surgical management (control). Recruitment will take place in three secondary care centres in the UK.The primary outcome is recruitment rate, defined as the proportion of eligible participants who are randomised. Further outcomes related to recruitment, randomisation, drop-out, cross-over, loss to follow-up, completeness of outcome data, study processes and details of the interventions delivered will be collected.The survey of surgeons and qualitative study of clinicians, recruiting staff and patients will enhance the feasibility study, enabling a broad overview of current practice in the field in addition to perceived facilitators and barriers to running a full-scale trial. DISCUSSION: PRESTO is a feasibility study which aims to inform methodology for a definitive trial comparing surgical fixation with non-surgical management for patients with stable thoracolumbar fractures. TRIAL REGISTRATION: The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 (http://www.isrctn.com/ISRCTN12094890).

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.

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).

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).