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AIMS: The aim of this study was to describe the demographic details of patients who sustain a femoral periprosthetic fracture (PPF), the epidemiology of PPFs, PPF characteristics, and the predictors of PPF types in the UK population. METHODS: This is a multicentre retrospective cohort study including adult patients presenting to hospital with a new PPF between 1 January 2018 and 31 December 2018. Data collected included: patient characteristics, comorbidities, anticoagulant use, social circumstances, level of mobility, fracture characteristics, Unified Classification System (UCS) type, and details of the original implant. Descriptive analysis by fracture location was performed, and predictors of PPF type were assessed using mixed-effects logistic regression models. RESULTS: In total, 720 femoral PPFs from 27 NHS sites were included. PPF patients were typically elderly (mean 79.9 years (SD 10.6)), female (n = 455; 63.2%), had at least one comorbidity (n = 670; 93.1%), and were reliant on walking aids or bed-/chair-bound prior to admission (n = 419; 61.7%). The study population included 539 (74.9%) hip PPFs, 151 (21.0%) knee PPFs, and 30 (4.2%) dividing type PPFs. For hip (n = 407; 75.5%) and knee (n = 88; 58.3%) arthroplasty UCS B type fractures were most common. Overall, 556 (86.2%) were treated in the presenting hospital and 89 (13.8%) required transfer for treatment. Female sex was the only significant predictor of fracture type (A/B1/C type versus B2/B3) for femoral hip PPFs (odds ratio 0.61 (95% confidence interval 0.41 to 0.91); p = 0.014). Sex, residence type, primary versus revision implant PPF, implant fixation, and time between arthroplasty and PPF were not found to predict fracture type for hip PPFs. CONCLUSION: This multicentre analysis describes patient and injury factors for patients presenting with femoral PPFs to centres across the UK. These patients are generally elderly and frail, comparable to those sustaining a hip fracture. These data can be useful in planning future services and clinical trials. Cite this article: Bone Joint J 2022;104-B(8):987-996 .

AIMS: The aim of this study was to describe the management and associated outcomes of patients sustaining a femoral hip periprosthetic fracture (PPF) in the UK population. METHODS: This was a multicentre retrospective cohort study including adult patients who presented to 27 NHS hospitals with 539 new PPFs between 1 January 2018 and 31 December 2018. Data collected included: management strategy (operative and nonoperative), length of stay, discharge destination, and details of post-treatment outcomes (reoperation, readmission, and 30-day and 12-month mortality). Descriptive analysis by fracture type was performed, and predictors of PPF management and outcomes were assessed using mixed-effects logistic regression. RESULTS: In all, 417 fractures (77%) were managed operatively and 122 (23%) conservatively. The median time to surgery was four days (interquartile range (IQR) 2 to 7). Of those undergoing surgery, 246 (59%) underwent revision and/or fixation and 169 (41%) fixation alone. The surgical strategy used differed by Unified Classification System for PPF type, with the highest rate of revision in B2/B3 fractures (both 77%, 176/228 and 24/31, respectively) and the highest rate of fixation alone in B1- (55/78; 71%) and C-type (49/65; 75%) fractures. Cemented stem fixation (odds ratio (OR) 2.66 (95% confidence interval (CI) 1.42 to 4.99); p = 0.002) and B2/B3 fracture type (OR 7.56 (95% CI 4.14 to 13.78); p < 0.001) were predictors of operative management. The median length of stay was 15 days (IQR 9 to 23), 12-month reoperation rate was 5.6% (n = 30), and 30-day readmission rate was 8.4% (n = 45). The 30-day and 12-month mortality rates were 5.2% (n = 28) and 21.0% (n = 113). Nonoperative treatment, older age, male sex, admission from residential or nursing care, and sustaining the PPF around a revision prosthesis were significant predictors of an increased 12-month mortality. CONCLUSION: Femoral hip PPFs have mortality, reoperation, and readmission rates comparable with hip fracture patients. However, they have a longer wait for surgery, and surgical treatment is more complex. There is a need to create a national framework for data collection for this heterogeneous group of patients in order to understand the outcomes of different approaches to treatment. Cite this article: Bone Joint J 2022;104-B(8):997-1008 .

Background People with severe mental illness (SMI), such as schizophrenia, have higher rates of physical long-term conditions (LTCs), poorer health outcomes, and shorter life expectancy compared with the general population. Previous research exploring SMI and diabetes highlights that people with SMI experience barriers to self-management, a key component of care in long-term conditions; however, this has not been investigated in the context of other LTCs. The aim of this study was to explore the lived experience of co-existing SMI and LTCs for service users, carers, and healthcare professionals. Methods A qualitative study with people with SMI and LTCs, their carers, and healthcare professionals, using semi-structured interviews, focused observations, and focus groups across the UK. Forty-one interviews and five focus groups were conducted between December 2018 and April 2019. Transcripts were coded by two authors and analysed thematically. Results Three themes were identified, 1) the precarious nature of living with SMI, 2) the circularity of life with SMI and LTCs, and 3) the constellation of support for self-management. People with co-existing SMI and LTCs often experience substantial difficulties with self-management of their health due to the competing demands of their psychiatric symptoms and treatment, social circumstances, and access to support. Multiple long-term conditions add to the burden of self-management. Social support, alongside person-centred professional care, is a key facilitator for managing health. An integrated approach to both mental and physical healthcare was suggested to meet service user and carer needs. Conclusion The demands of living with SMI present a substantial barrier to self-management for multiple co-existing LTCs. It is important that people with SMI can access person-centred, tailored support for their LTCs that takes into consideration individual circumstances and priorities.

Objective To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection. Study design and setting Twelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later. Results Four RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable; no surgeons attended. In the intervention group, there was evidence of increased confidence when pre and post training scores were compared (mean difference in change 1.42; 95% CI 0.56, 2.27; p = 0.002) – there was no effect on recruitment rate. Conclusion It was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations. Trial registration ISRCTN registry: DISC (ISRCTN18254597), registered on 4th April 2017; PROFHER 2 (ISRCTN76296703), registered on 5th April 2018; IntAct (ISRCTN13334746), registered on 10th April 2017; and START:REACTS (ISRCTN17825590), registered on 5th March 2018. The training SWAT has been submitted to the MRC SWAT repository (SWAT111) Keywords: Randomised controlled trial (RCT), Study Within A Trial (SWAT), recruitment, staff training, professional education, feasibility study, surgical trials

Introduction Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negative consequences on the physical and mental wellbeing of older adults. In the Behavioural Activation in Social IsoLation (BASIL+) trial we will test whether a brief psychological intervention (based on Behavioural Activation), delivered remotely, can mitigate depression and loneliness in older adults with long-term conditions during isolation. Methods We will conduct a two-arm, parallel-group, randomised controlled trial across several research sites, to evaluate the clinical and cost-effectiveness of the BASIL+ intervention. Participants will be recruited via participating general practices across England and Wales. Participants must be aged ≥65 with two or more long-term conditions, or a condition that may indicate they are within a ‘clinically extremely vulnerable’ group in relation to COVID-19, and have scored ≥5 on the Patient Health Questionnaire (PHQ9), to be eligible for inclusion. Randomisation will be 1:1, stratified by research site. Intervention participants will receive up to eight intervention sessions delivered remotely by trained BASIL+ Support Workers and supported by a self-help booklet. Control participants will receive usual care, with additional signposting to reputable sources of self-help and information, including advice on keeping mentally and physically well. A qualitative process evaluation will also be undertaken to explore the acceptability of the BASIL+ intervention, as well as barriers and enablers to integrating the intervention into participants’ existing health and care support, and the impact of the intervention on participants’ mood and general wellbeing in the context of the COVID-19 restrictions. Semi-structured interviews will be conducted with intervention participants, participant’s caregivers/supportive others and BASIL+ Support Workers. Outcome data will be collected at one, three, and 12 months post-randomisation. Clinical and cost-effectiveness will be evaluated. The primary outcome is depressive symptoms at the three-month follow up, measured by the PHQ9. Secondary outcomes include loneliness, social isolation, anxiety, quality of life, and a bespoke health services use questionnaire. Discussion This study is the first large-scale trial evaluating a brief Behavioural Activation intervention in this population, and builds upon the results of a successful external pilot trial. Trial registration ClinicalTrials.Gov identifier ISRCTN63034289, registered on 5th February 2021.

Objectives To determine the effectiveness of sending Christmas cards to participants in randomised controlled trials to increase retention rate at follow-ups, and to explore the feasibility of doing a study within a trial (SWAT) across multiple host trials simultaneously. Design Randomised SWAT conducted simultaneously across eight host trials. Setting Eight randomised controlled trials researching various areas including surgery and smoking cessation. Participants 3223 trial participants who were still due at least one follow-up from their host randomised controlled trial. Intervention Participants were randomised (1:1, separately by each host trial) to either received a Christmas card in mid-December 2019 or to not receive a card. Main outcome measure Proportion of participants completing their next follow-up (retention rate) within their host randomised controlled trial. Results 1469 participants (age 16-94 years; 70% (n=1033) female; 96% (813/847) white ethnicity) across the eight host randomised controlled trials were involved in the analysis (cut short owing to covid-19). No evidence was found of a difference in retention rate between the two arms for any of the host trials when analysed separately or when the results were combined (85.3% (639/749) for cards versus 85.4% (615/720) for no card; odds ratio 0.96, 95% confidence interval 0.71 to 1.29; P=0.77). No difference was observed when comparing just participants who were due a follow-up in the 30 days after receiving the card (odds ratio 0.96, 0.42 to 2.21). No evidence of a difference in time to complete the questionnaire was found (hazard ratio 1.01, 95% confidence interval 0.91 to 1.13; P=0.80). These results were robust to post hoc sensitivity analyses. The cost of this intervention was £0.76 (€0.91; $1.02) per participant, and it will have a carbon footprint of approximately 140 g CO 2 equivalent per card. One benefit of this approach was the need to only submit one ethics application. Conclusions Sending Christmas cards to participants in randomised controlled trials does not increase retention. Undertaking a SWAT within multiple randomised controlled trials at the same time is, however, possible. This approach should be used more often to build an evidence base to support selection of recruitment and retention strategies. Although no evidence of a boost to retention was found, embedding a SWAT in multiple host trials simultaneously has been shown to be possible. Study registration SWAT repository https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,846275,en.pdf#search=SWAT%2082 .

Background Approximately 60,000 people in England have coexisting type 2 diabetes mellitus (T2DM) and severe mental illness (SMI). They are more likely to have poorer health outcomes and require more complex care pathways compared to those with T2DM alone. Despite increasing prevalence, little is known about the healthcare resource use and costs for people with both conditions. Aims To assess the impact of SMI on healthcare resource use and service costs for adults with T2DM, and explore the predictors of healthcare costs and lifetime costs for people with both conditions. Method Matched cohort study using data from Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) for 1,620 people with comorbid SMI and T2DM and 4,763 people with T2DM alone. Generalised linear models (GLMs) and the Bang and Tsiatis method were used to explore cost predictors and mean lifetime costs respectively. Results People with T2DM and SMI had higher average annual costs (£1,930) than people with T2DM alone, driven primarily by mental health and non-mental health-related hospitalisations. Key predictors of higher total costs were older age, comorbid hypertension, use of antidepressants and first-generation antipsychotics, and increased duration of living with both conditions. Expected lifetime costs were approximately £35,000 per person with both SMI and T2DM. Extrapolating nationally, this would generate total annual costs to the NHS of around £250m per year. Conclusions Our estimates of resource use and costs for people with both T2DM and SMI will aid policy makers and commissioners in service planning and resource allocation.

Aims To systematically review and synthesise qualitative evidence about determinants of self-management in adults with SMI. The goal is to use findings from this review to inform the design of effective self-management strategies for people with SMI and LTCs. Background People living with serious mental illness (SMI) have a reduced life expectancy by around 15–20 years, mainly due to the high prevalence of long-term physical conditions such as diabetes and heart disease. People with SMI face many challenges when trying to manage their physical health. Little is known about the determinants of self-management – managing the emotional and practical issues – of long-term conditions (LTCs) for people with SMI. Method Six databases, including CINAHL and MEDLINE, were searched to identify qualitative studies that explored people's perceptions about determinants of self-management in adults with SMI (with or without comorbid LTCs). Self-management was defined according to the American Association of Diabetes Educator's self-care behaviours (AADE7). Determinants were defined according to the Capabilities, Opportunity, Motivations and Behaviours (COM-B) framework. Eligible studies were purposively sampled for synthesis according to the richness of the data (assessed using Ames et al (2017)'s data richness scale), and thematically synthesised. Result Twenty-six articles were included in the synthesis. Seven studies focused on self-management of LTCs, with the remaining articles exploring self-management of SMI. Six analytic themes and 28 sub-themes were identified from the synthesis. The themes included: the additional burden of SMI; living with comorbidities; beliefs and attitudes about self-management; support from others for self-management; social and environmental factors; routine, structure and planning. Capabilities for self-management were linked to people's perceptions about the support they received for their SMI and LTC from healthcare professionals, family and friends. Opportunities for self-management were more commonly expressed in the context of social and environmental factors. Motivation for self-management was influenced by beliefs and attitudes, whilst being closely related to the burden of SMI. Conclusion The themes identified from the synthesis suggest that capabilities, opportunities and motivations for self-management can be negatively influenced by the experience of SMI, whilst social and professional support, improved access to resources, and increased involvement in care, could promote self-management. Support programmes for people with SMI and LTCs need to account for these experiences and adapt to meet the unique needs of this population.

Background: Exposure to second-hand smoke from tobacco is a major contributor to global morbidity and mortality. We aimed to evaluate the efficacy and cost-effectiveness of a community-based smoke-free-home intervention, with or without indoor-air-quality feedback, in reducing second-hand-smoke exposure in homes in Bangladesh.Methods: We did a three-arm, cluster-randomised, controlled trial in Dhaka, Bangladesh, and randomly assigned (1:1:1) mosques and consenting households from their congregations to a smoke-free-home intervention plus indoor-air quality feedback, smoke-free-home intervention only, or usual services. Households were eligible if they had at least one resident attending one of the participating mosques, at least one adult resident (age 18 years or older) who smoked cigarettes or other forms of smoked tobacco (eg, bidi, waterpipe) regularly (on at least 25 days per month), and at least one non-smoking resident of any age. The smoke-free-home intervention consisted of weekly health messages delivered within an Islamic discourse by religious leaders at mosques over 12 weeks. Indoor-air-quality feedback comprised providing households with feedback on their indoor air quality measured over 24 h. Households in the usual services group received no intervention. Masking of participants and mosque leaders was not possible. The primary outcome was the 24-h mean household airborne fine particulate matter (

Objective: To establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality-of-life through improving communication and hearing aid use in the UK National Health Service. Design: Randomised controlled, open feasibility trial with embedded economic and process evaluations. Setting: Audiology Departments in two hospitals in two UK cities. Participants: Twelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid. Interventions: Consenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to Active Communication Education (ACE) plus treatment-as-usual (intervention group) or treatment-as-usual only (control group). Primary outcome measures: The primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants, and fidelity of treatment delivery. Secondary outcome measures: International Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible. Results: Twelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3,500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size. Conclusions: Whilst ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month post-hearing aid fitting point. Trial registration: ISRCTN28090877

Background: People with severe mental illnesses (SMI) have reduced life expectancy compared with the general population. Diabetes is a major contributor to this disparity with higher prevalence and poorer outcomes in people with SMI. Aim: To determine the impact of SMI on healthcare processes and outcomes for diabetes. Design and setting: Retrospective observational matched nested case-control study using patient records from the Clinical Practice Research Datalink linked to Hospital Episode Statistics. Methods: We compared a range of healthcare processes (primary care consultations, physical health checks, metabolic measurements) and outcomes (prevalence and hospitalisation for cardiovascular disease (CVD), and mortality risk) for 2,192 people with SMI and type 2 diabetes (cases) with 7,773 people with diabetes alone (controls). Socio-demographics, comorbidity and medication prescription were covariates in regression models. Results: SMI was associated with increased risk of all-cause mortality (Hazard Ratio [HR]: 1.92; 95% CI: 1.60 to 2.30) and CVD-specific mortality (HR: 2.24; 1.55 to 3.25); higher physician consultation rates (Incidence Rate Ratio [IRR]: 1.15; 1.11 to 1.19); more frequent checks of blood pressure (IRR: 1.02; 1.00 to 1.05) and cholesterol (IRR: 1.04; 1.02 to 1.06); lower prevalence of angina (Odds Ratio [OR]: 0.67; 0.45 to 1.00); higher emergency admissions for angina (IRR: 1.53; 1.07 to 2.20) and lower elective admissions for ischaemic heart disease (IRR: 0.68; 0.51 to 0.92). Conclusion: Monitoring of metabolic measurements was comparable for people with diabetes with and without SMI. Increased mortality rates observed in SMI may be attributable to under-diagnosis of CVD and delays in treatment.

Background: Reviews have consistently shown that allocation concealment is frequently implemented and reported suboptimally in randomised controlled trials (RCTs). This research aims to pilot engaging with authors of RCTs to explore their knowledge and understanding of allocation concealment implementation and reporting to ascertain areas and mechanisms for their improvement. Methods: Authors that published RCTs in core clinical journals in one month in 2019 were identified. Authors were invited to complete questionnaires to elicit their views and experiences on the implementation and reporting quality focussing on allocation concealment. Methodological quality of allocation concealment was evaluated in this sample by assessing adherence to the Consolidated Standards of Reporting Trials (CONSORT). Results: Reporting was suboptimal, with only 57% of allocation concealment methods reported to be implemented which were judged as adequate, with 18% using sealed envelopes and more than 40% not adequately reporting allocation methods. When exploring allocation concealment, implementation and reporting questionnaires were found to elicit a low response rate amongst authors of RCTs. Discussion: Following analysis of the themes that emerged from the questionnaires, the main recommendations to improve reporting quality are: journals need to endorse, adhere and promote reporting guidelines, a methodologist could review methodological details of publications simultaneously to peer review, envelopes as a form of allocation concealment are poorly implemented and reported, so careful review of these is required, funders need to insist on more robust allocation concealment methods are employed if the RCT setting allows, and authors need to acknowledge their responsibility for transparent reporting of RCTs.

Introduction Lower limb conditions requiring reconstructive surgery can be either congenital or acquired from trauma, infection or other medical conditions. Patient reported outcome measures (PROMS) are often used by healthcare professionals to assess the impact of a patient’s condition (and treatment) on quality of life. However, we are not aware of any measures developed specifically for people requiring lower limb reconstructive surgery. Consequently, it is not clear the extent to which current PROMs accurately and specifically measure the outcomes that are important to these patients. Methods and analysis The ‘PROLLIT’ (Patient Reported Outcome Measure for Lower Limb Reconstruction) involves three phases: to explore what is important to patients with regards to quality of life (phase 1), ascertain whether current measures adequately capture these experiences (phase 2) and if not begin the development of a new patient reported outcome measure (phase 3). The population of interest is people requiring, undergoing or after undergoing reconstructive surgery for a lower limb condition. In this paper we describe Phase 1, which aims to develop a conceptual framework to identify and map what is important to this group with regards to social interactions, employment, perceived health and quality of life after condition onset/injury and throughout recovery. The conceptual framework will be developed through three steps: (Step A) a qualitative evidence synthesis, (Step B) a qualitative study with patients and staff to explore patient’s views and experiences of lower limb reconstructive surgery and (Step C) a roundtable discussion with key stakeholders where findings from Step A and Step B will be brought together and used to finalise the conceptual framework. Ethics consideration and dissemination Ethical approval has been granted for the qualitative data collection (Step B) from South Central Berkshire Research Ethics committee (REF:20/SC/0114). Findings from Steps A and B will be submitted for peer-reviewed publication in academic journals, and presented at academic conferences. PROSPERO registration number: CRD42019139587 ISRCTN Registration number: ISRCTN75201623

Introduction People with severe mental illness (SMI) die on average 10–20 years earlier than the general population. Most of these deaths are due to physical health conditions. The aim of this cross-sectional study is to determine the prevalence of physical health conditions and their associations with health-risk behaviours, health-related quality of life and various demographic, behavioural, cognitive, psychological and social variables in people with SMI attending specialist mental health facilities in South Asia. Methods and analysis We will conduct a survey of patients with SMI attending specialist mental health facilities in Bangladesh, India and Pakistan (n=4500). Diagnosis of SMI will be confirmed using the Mini-international neuropsychiatric interview V.6.0. We will collect information about physical health and related health-risk behaviours (WHO STEPwise approach to Surveillance (STEPS)); severity of common mental disorders (Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder scale (GAD-7)) and health-related quality of life (EQ-5D-5L). We will measure blood pressure, height, weight and waist circumference according to WHO guidelines. We will also measure glycated haemoglobin, lipid profile, thyroid function, liver function, creatinine and haemoglobin. Prevalence rates of physical health conditions and health-risk behaviours will be presented and compared with the WHO STEPS survey findings in the general population. Regression analyses will explore the association between health-risk behaviours, mental and physical health conditions. Ethics and dissemination The study has been approved by the ethics committees of the Department of Health Sciences University of York (UK), Centre for Injury Prevention and Rehabilitation (Bangladesh), Health Ministry Screening Committee and Indian Council of Medical Research (India) and National Bioethics Committee (Pakistan). Findings will be disseminated in peer-reviewed articles, in local and international conferences and as reports for policymakers and stakeholders in the countries involved.

Background: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased.\ud \ud Objective: To compare clinical and cost-effectiveness of surgical fixation with cast treatment and early fixation of those that fail to unite for scaphoid waist fractures in adults.\ud \ud Design: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and nested qualitative study.\ud \ud Setting: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013 with final follow-up in September 2017.\ud \ud Participants: Adults (aged ≥ 16 years), presenting within two weeks of injury with a clear bicortical fracture of the scaphoid waist on plain radiographs.\ud \ud Interventions: Early surgical fixation using CE marked headless compression screws. Below elbow cast immobilisation for six to ten weeks, and urgent fixation of confirmed non-union.\ud \ud Main outcome measures: The primary outcome and end-point was the Patient Rated Wrist Evaluation (PRWE) total score at 52 weeks, with a clinically relevant difference of six points. Secondary outcomes included PRWE pain and function subscales, Short Form 12-item questionnaire (SF-12), bone union, range of movement, grip strength, complications and return to work.\ud \ud Results: The mean age of 439 participants was 33 years, 363 were male (83%) and 269 had an undisplaced fracture (61%). The primary analysis was on 408 participants providing valid PRWE outcome data for at least one post-randomisation time-point (surgery n=203 of 219; cast n=205 of 220). There was no clinically relevant difference in the total PRWE at 52 weeks: cast group mean 14.0 [95% confidence interval (CI) 11.3 to 16.6] and surgery group mean 11.9 (95% CI 9.2 to 14.5); adjusted mean difference of -2.1 in favour of surgery (95% CI -5.8 to 1.6, p=0.27). Non-union rate was low (surgery group n=1; cast group n=4). Eight participants in the surgery group had 11 re-operations, and one participant in the cast group required a re-operation for non-union. The base-case economic analysis at 52 weeks found the cost of surgery was £1,295 more per patient (95% CI £1,084 to £1,504) than cast treatment. The base-case analysis of a lifetime extrapolated model confirmed that the cast treatment pathway was the most cost-effective option. The nested qualitative study identified patients desire to have a “sense of recovering” which surgeons should address at the outset.\ud \ud Limitation: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, 14 within six months from randomisation and three after six months. Three of four participants in the cast group, who had a non-union at 52 weeks, were not offered surgery.\ud \ud Conclusions: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed.\ud \ud Future work: Patients will be followed-up at five years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life.

Background Hip and knee replacements are regularly performed for patients who work. There is little evidence about these patients’ needs and the factors influencing their return to work. There is a paucity of guidance to help patients return to work after surgery and a need for structured occupational advice to enable them to return to work safely and effectively. Objective(s) To develop an occupational advice intervention to support early recovery to usual activities including work which is tailored to the requirements of patients undergoing hip and knee replacements. To test the acceptability, practicality and feasibility of this intervention within current care frameworks Design An intervention mapping (IM) approach was used to develop the intervention. The research methods employed were: rapid evidence synthesis; qualitative interviews with patients and stakeholders; prospective cohort study; survey of clinical practice; modified Delphi consensus process. The developed intervention was implemented and assessed during the final feasibility stage of the IM process. Setting Orthopaedic departments within NHS secondary care. Participants Patients in work, and intending to return to work following primary elective hip and knee replacement surgery; healthcare professionals and employers. Interventions Occupational advice intervention. Main outcome measures Development of an occupational advice intervention. Fidelity of the developed intervention when delivered in a clinical setting. Patient and clinician perspectives of the intervention. Preliminary assessments of intervention effectiveness and cost. Results A cohort study (154 patients), 110 stakeholder interviews, survey of practice (152 respondents) and evidence synthesis provided the necessary information to develop the intervention. The intervention included information resources, personalized return to work plan and co-ordination from the healthcare team to support the delivery of 13 patient and 20 staff performance objectives (POs). To support delivery, a range of tools (e.g. occupational checklists, patient workbooks, employer information), roles (e.g. return-to-work coordinator) and training resources were created. Feasibility was assessed in 21 of the 26 patients recruited from 3 NHS trusts. Adherence with the defined performance objectives was 75% for patient POs and 74% for staff POs. The intervention was generally well received although the short timeframe available for implementation and concurrent research evaluation led to some confusion amongst patients and those delivering the intervention regarding its purpose and the roles and responsibilities of key staff. Limitations Implementation and uptake of the intervention was not standardized and was limited by the study timeframe. Evaluation of the intervention involved a small number of patients which limited the ability to assess it. Conclusions The developed occupational advice intervention supports best practice. Evaluation demonstrated good rates of adherence against defined performance objectives. However, a number of operational and implementation issues require further attention Future work The intervention warrants a randomised controlled trial to assess its clinical and cost effectiveness to improve rates and timing of sustained return to work after surgery. This research should include the development of a robust implementation strategy to ensure adoption is sustained. Funding This project was funded by the NIHR Health Technology Assessment programme (project number 15/28/02) Trial Registrations International Standard Randomised Controlled Trials Number Trial ID: ISRCTN27426982 International prospective register of systematic reviews (PROSPERO) Registration: CRD42016045235

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

Background People with hearing loss, particularly those who lose their hearing in adulthood, are at increased risk of social isolation, mental health difficulties, unemployment, loss of independence, risk of accidents, and impaired quality of life. In the United Kingdom (UK), a single third sector organisation provides hearing dogs, a specific type of assistance dog trained to provide sound support to people with hearing loss. These dogs may also deliver numerous psychosocial benefits to recipients. This has not previously been fully investigated. Objective To evaluate the impact of a hearing dog partnership on the lives of individuals with severe or profound hearing loss. Methods and Analysis A two-arm, randomised controlled trial conducted within the UK, with 162 hearing dog applicants, aged 18 years and over. Participants will be randomised 1:1 using a matched-pairs design to receive a hearing dog sooner than usual (intervention arm – Arm B) or to receive a hearing dog within the usual timeframe (comparator arm – Arm A). In the effectiveness analysis, the primary outcome is a comparison of mental wellbeing six-months after Arm B have received a hearing dog (Arm A: not yet received hearing dog), measured using the Short Warwick Edinburgh Mental Wellbeing Scale. Secondary outcome measures include the PHQ-9, GAD-7 and WSAS. An economic evaluation will assess cost-effectiveness including health-related quality-adjusted life years using the EQ-5D-5L and social-care-related-quality-adjusted life-years. Participants will be followed up for up to two years. A nested qualitative study will investigate the impacts of having a hearing dog and how these impacts come about. Results The study was funded by the National Institute for Health Research’s School for Social Care Research. Recruitment commenced in March 2017 and is now complete. 165 participants were randomised. Data collection will continue until January 2020. Results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants. Ethical approval was received from the University of York’s Department of Social Policy and Social Work Research Ethics Committee (reference SPSW/S/17/1). Conclusions The findings from this study will provide, for the first time, strong and reliable evidence on the impact of having a hearing dog on people’s lives in terms of their quality of life, well-being and mental health. Trial registration The trial has been retrospectively registered International Standard Randomised Controlled Trial Number (ISRCTN) 36452009; https://doi.org/10.1186/ISRCTN36452009. Trial status: Ongoing.

This study explored the lived experience of people with inflammatory bowel disease (IBD) and anxiety/depression. It utilised a deductive biopsychosocial framework. Overall, 24 patients and 20 healthcare professionals from two countries participated. In the UK, the main themes included: 1) Bidirectional relationship between IBD and mental health, 2) The need for health care integration, 3) Lack of awareness about the disease. In Australia: 1) The “vicious cycle” of IBD and psychosocial health; 2) The need for biopsychosocial healthcare integration; and 3) The stigma of a hidden disease. Better communication around mental illness is essential in improving IBD healthcare.

Kumar KM,

Objective To describe the roles that pairwise randomisation has to prevent selection bias and allow a common outcome measurement point when timing of treatment is uncertain. Study design and setting A theoretical paper discussing situations where pairwise randomisation might be an appropriate method of allocation. Results When recruitment of participants allows two or more randomisations to occur simultaneously then pairwise randomisation allows site stratification but prevents site predictability. For evaluations of treatments where timing of treatment is uncertain (e.g., elective surgery) pairwise randomisation allows a common post treatment evaluation time point. In waiting list designs where length of treatment varies by patient, pairwise randomisation allows differential follow-up across pairs. Conclusion Since pairwise randomisation was described in 2004, to allow unpredictable site stratification, it has been rarely used. However, it can address other methodological issues and should be considered more widely.

BACKGROUND: The average life expectancy for people with a severe mental illness (SMI) such as schizophrenia or bipolar disorder is 15 to 20 years less than that for the population as a whole. Diabetes contributes significantly to this inequality, being 2 to 3 times more prevalent in people with SMI. Various risk factors have been implicated, including side effects of antipsychotic medication and unhealthy lifestyles, which often occur in the context of socioeconomic disadvantage and health care inequality. However, little is known about how these factors may interact to influence the risk of developing diabetes and poor diabetic outcomes, or how the organization and provision of health care may contribute. OBJECTIVE: This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with SMI. METHODS: This study will employ a concurrent mixed methods design combining the interrogation of electronic primary care health records from the Clinical Practice Research Datalink (CPRD GOLD) with qualitative interviews with adults with SMI and diabetes, their relatives and friends, and health care staff. The study has been funded for 2 years, from September 2017 to September 2019, and data collection has recently ended. RESULTS: CPRD and linked health data will be used to explore the association of sociodemographics, illness, and health care-related factors with both the development and outcomes of type 2 diabetes in people with SMI. Experiences of managing the comorbidity and accessing health care will be explored through qualitative interviews using topic guides informed by evidence synthesis and expert consultation. Findings from both datasets will be merged to develop a more comprehensive understanding of diabetes risks, interventions, and outcomes for people with SMI. Findings will be translated into recommendations for interventions and services using co-design workshops. CONCLUSIONS: Improving diabetes outcomes for people with SMI is a high-priority area nationally and globally. Understanding how risk factors combine to generate high prevalence of diabetes and poor diabetic outcomes for this population is a necessary first step in developing health care interventions to improve outcomes for people with diabetes and SMI. TRIAL REGISTRATION: ClinicalTrials.gov NCT03534921; https://clinicaltrials.gov/ct2/show/NCT03534921.

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

Background: Almost one-half of 12–15 year olds living in deprived areas of the UK have dental caries (tooth decay)with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions such as short messaging service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention—classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS—to reduce the prevalence of dental caries in young people from deprived areas. Objectives:To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas. Methods/design:This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5040 11–13 year olds in 42 schools with a 3-year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at 3 years. Secondary outcomes are: number of carious teeth,frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted. Discussion:The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations. Trial registration: ISRCTN registry, ISRCTN12139369. Registered on 10 May 2017. Keywords: Dental caries, Caries prevention, Prevention, Behaviour change, Randomised controlled trial, Child dental health, mHealth, Short messaging service.

Objectives: To assess whether a core outcome set is required for studies evaluating the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities. Design: Survey of outcome measures used in primary studies identified by a systematic review. Data sources: ASSIA; CENTRAL; Cochrane Database of Systematic Reviews; Conference Proceedings Citation Index; CINAHL; DARE; Embase; HMIC; MEDLINE; MEDLINE In-Process; PsycINFO; Science Citation Index; Social Care Online; Social Policy & Practice; ClinicalTrials.gov; WHO International Clinical Trials Registry Platform (ICTRP); and the UK Clinical Trials Gateway were searched up to February 2017. Eligibility criteria: Studies evaluating pharmacological or non-pharmacological interventions for children (≤ 18 years old) with a neurodisability and experiencing non-respiratory sleep disturbance. Data extraction and synthesis: Outcomes related to child and parent sleep-related outcomes; measures of perceived parenting confidence, efficacy or understanding of sleep management; child-related quality of life, daytime behaviour and cognition; parent/carer outcomes; and adverse events were listed from each study and categorised into domains. Results: Thirty-nine studies (13 melatonin and 26 non-pharmacological) assessed five core outcome areas: child sleep, other child outcomes, parent outcomes, adverse events and process measures. There were 54 different measures of child related sleep across five domains: global measures; sleep initiation; maintenance; scheduling; and other outcomes. The most commonly reported measure in melatonin studies was total sleep time (n=12; 92%); and for non-pharmacological studies was the parent-reported Child Sleep Habits Questionnaire (CSHQ; 58%), both classified as global measures. Fifteen non-pharmacological (58%) and four pharmacological studies (31%) reported child outcomes other than sleep. The domains assessed (using 29 different measures) were child behaviour, quality of life, ADHD symptoms, cognition, school-related, and other. One pharmacological and 14 non-pharmacological (54%) studies reported parent outcomes (17 different measures). Eleven melatonin studies (85%) recorded adverse events, with variation in how data were collected and reported. One non-pharmacological study reported an explicit method of collecting on adverse events. Several process measures were reported, related to adherence, feasibility of delivery, acceptability and experiences of receiving the intervention. Conclusions: There is a lack of consistency between studies in the outcome measures used to assess the effectiveness of interventions for non-respiratory sleep disturbances in children with neurodisabilities. A minimum core outcome set, with international consensus, should be developed in consultation with parents, children and young people, and those involved in supporting families. Registration number systematic review PROSPERO (CRD42016034067)

Summary (abstract) Background: As skin cancer incidence rises, there is a need to evaluate early detection interventions by the public using skin self-examination (SSE), however, the literature focuses on primary prevention. No systematic reviews have evaluated the effectiveness of such SSE-interventions. Objective: To systematically examine, map, appraise and synthesise, qualitatively and quantitatively, studies evaluating the early-detection of skin cancer, using SSE-interventions. Methods: Systematic review (narrative synthesis and meta-analysis) examining randomised controlled trials (RCTs), quasi-experimental, observational, qualitative studies, published in English, using PRISMA and NICE 1 guidance. Electronic databases: MEDLINE, EMBASE and PsycINFO, through to April 2015 (updated April 2018 using MEDLINE). Risk-of-bias assessment was conducted. Results: Included studies (n=18), totalling 6836 participants, were derived from 22 papers; these used 12 RCTs and 5 quasi-experiments (and 1 complex-intervention development). More studies (n=10) focused on those targeting high-risk groups (surveillance) compared to those at no higher risk (screening) (n=8). Ten (45%) study interventions were theoretically underpinned. All the study outcomes were self-reported, behaviour-related and non-clinical in nature. Meta-analysis demonstrated intervention impact on the degree of SSE activity from five studies, especially short-term (up to 4-months) (OR 2.31, 95% CI 1.90 to 2.82), but with small effect sizes. Limitation: Risk-of-bias assessment indicated that 61% (n=11) were of weak quality. Conclusions: Four RCTs and a quasi-experimental study indicate that some interventions can enhance SSE activity and so are more likely to aid early detection of skin cancer, however, the actual clinical impact remains unclear and this is based on overall weak study (evidence) quality.