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Background During the COVID-19 pandemic, mental health problems increased as access to mental health services reduced. Recovery colleges are recovery-focused adult education initiatives delivered by people with professional and lived mental health expertise. Designed to be collaborative and inclusive, they were uniquely positioned to support people experiencing mental health problems during the pandemic. There is limited research exploring the lasting impacts of the pandemic on recovery college operation and delivery to students. Aims To ascertain how the COVID-19 pandemic changed recovery college operation in England. Method We coproduced a qualitative interview study of recovery college managers across the UK. Academics and co-researchers with lived mental health experience collaborated on conducting interviews and analysing data, using a collaborative thematic framework analysis. Results Thirty-one managers participated. Five themes were identified: complex organisational relationships, changed ways of working, navigating the rapid transition to digital delivery, responding to isolation and changes to accessibility. Two key pandemic-related changes to recovery college operation were highlighted: their use as accessible services that relieve pressure on mental health services through hybrid face-to-face and digital course delivery, and the development of digitally delivered courses for individuals with mental health needs. Conclusions The pandemic either led to or accelerated developments in recovery college operation, leading to a positioning of recovery colleges as a preventative service with wider accessibility to people with mental health problems, people under the care of forensic mental health services and mental healthcare staff. These benefits are strengthened by relationships with partner organisations and autonomy from statutory healthcare infrastructures.

Background Lateral compression type-1 pelvic fractures are a common fragility fracture in older adults. Patients who do not mobilise due to ongoing pain are at greater risk of immobility-related complications. Standard treatment in the United Kingdom is provision of pain relief and early mobilisation, unlike fragility hip fractures, which are usually treated surgically based on evidence that early surgery is associated with better outcomes. Currently there is no evidence on whether patients with lateral compression type-1 fragility fractures would have a better recovery with surgery than non-surgical management. Objectives To assess the clinical and cost effectiveness of surgical fixation with internal fixation device compared to non-surgical management of lateral compression type-1 fragility fractures in older adults. Design Pragmatic, randomised controlled superiority trial, with 12-month internal pilot; target sample size was 600 participants. Participants were randomised between surgical and non-surgical management (1 : 1 allocation ratio). An economic evaluation was planned. Setting UK Major Trauma Centres. Participants Patients aged 60 years or older with a lateral compression type-1 pelvic fracture, arising from a low-energy fall and unable to mobilise independently to a distance of 3 m and back due to pelvic pain 72 hours after injury. Interventions Internal fixation device surgical fixation and non-surgical management. Participants, surgeons and outcome assessors were not blinded to treatment allocation. Main outcome measures Primary outcome – average patient health-related quality of life, over 6 months, assessed by the EuroQol-5 Dimensions, five-level version utility score. Secondary outcomes (over the 6 months following injury) – self-rated health, physical function, mental health, pain, delirium, displacement of pelvis, mortality, complications and adverse events, and resource use data for the economic evaluation. Results The trial closed early, at the end of the internal pilot, due to low recruitment. The internal pilot was undertaken in two separate phases because of a pause in recruitment due to the coronavirus disease 2019 pandemic. The planned statistical and health economic analyses were not conducted. Outcome data were summarised descriptively. Eleven sites opened for recruitment for a combined total of 92 months. Three-hundred and sixteen patients were assessed for eligibility, of whom 43 were eligible (13.6%). The main reason for ineligibility was that the patient was able to mobilise independently to 3 m and back (n = 161). Of the 43 eligible participants, 36 (83.7%) were approached for consent, of whom 11 (30.6%) provided consent. The most common reason for eligible patients not consenting to take part was that they were unwilling to be randomised to a treatment (n = 10). There were 11 participants, 5 randomised to surgical management with internal fixation device and 6 to non-surgical management. The average age of participants was 83.0 years (interquartile range 76.0, 89.0) and the EuroQol-5 Dimensions, five-level version utility score at 6 months post randomisation (n = 8) was 0.32 (standard deviation 0.37). A limitation of the trial was that study objectives were not addressed due to poor recruitment. Conclusions It was not feasible to recruit to this trial in the current context. Further research to understand the treatment and recovery pathways of this group of patients, along with their outcomes, would be needed prior to undertaking a future trial. Future work Exploration of equipoise across different healthcare professional groups. Investigate longer-term patient outcomes. Trial registration This trial is registered as ISRCTN16478561. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/167/57) and is published in full in Health Technology Assessment; Vol. 28, No. 15. See the NIHR Funding and Awards website for further award information. Plain language summary When older adults with weak bones fall onto their side, they can fracture the pelvis in a certain way known as a ‘lateral compression type-1 fracture’; this summary will use ‘pelvic fracture’. Pelvic fractures can heal without surgery; patients are offered pain relief and encouraged to move as much as they can after the injury. Pelvic fractures can be painful, and some people are not able to get up and walk for weeks. These fractures can cause health problems such as chest infections, urinary tract infections, pressure sores and blood clots. To avoid these problems, we are trying to find treatments to help people recover sooner. Pelvic surgeons think patients may benefit from surgery with an internal fixation device (a bar and screws) to stabilise the pelvis; however, there can be risks and complications with any surgery. This study aimed to find out which treatment is better for patients and better value for money for the National Health Service. This required 600 people aged over 60, in hospital with a pelvic fracture and having difficulty walking to take part. Three hundred would receive surgery and 300 would receive non-surgical treatment. Over 6 months, participants would complete questionnaires, a walking assessment and have X-rays to check healing. The trial had a 12-month run-in period to see if enough people would take part. The trial closed early as we were unable to recruit sufficient people into the study. Fewer older patients with pelvic fractures were identified than expected, 51% were able to walk after a few days and therefore were not eligible to be included in the study. Of the patients, 13.6% were eligible and 30.6% of those consented to take part. Restrictions on visitors during the coronavirus disease 2019 pandemic made it difficult to discuss the study with patients’ families and fewer patients were admitted to hospital where the study was taking place. The research question could not be answered by this study at the present time. Scientific summary Background Lateral compression type-1 (LC-1) pelvic fractures are a common fragility fracture in older adults. Older patients who do not get back walking following an LC-1 fracture due to ongoing pain are at greater risk of immobility-related complications. In the UK, standard treatment for LC-1 fragility fracture is to ‘mobilise as pain allows’, involving prescribing pain relief, getting patients up within a few days of injury with physiotherapy input and encouraging them to mobilise with an assistive device until the fracture heals. This is unlike fragility hip fractures (fractures involving the upper end of the femur) where there is evidence that early surgery (within 1–2 days) is associated with reduced risk of death and pressure sores and these fractures are usually treated surgically. Despite LC-1 fractures being similarly disabling for some patients in terms of pain and immobility and occurring in the same patient group as hip fractures, to date, it has not been shown whether elderly patients with LC-1 fractures would have a better recovery with surgery than non-surgical management. Objectives To assess the clinical and cost effectiveness of surgical fixation with internal fixation device (INFIX) compared to non-surgical management of LC-1 fragility fractures in older adults (L1FE trial): undertake a 12-month internal pilot to obtain robust estimates of recruitment and confirm trial feasibility undertake a parallel group multicentre randomised controlled trial (RCT) to assess the effectiveness of surgical fixation with INFIX versus non-surgical management of LC-1 fragility fractures in older adults undertake an economic evaluation to compare the cost effectiveness of surgical fixation compared to non-surgical management, to determine the most efficient provision of future care and to describe the resource impact on the NHS for the two treatment options undertake a long-term review of patient well-being [EuroQol-5 Dimensions, five-level version (EQ-5D-5L) and mortality] 12 months after entering the trial. Design Pragmatic, randomised controlled superiority trial, with 12-month internal pilot to assess recruitment assumptions, and an economic evaluation. Participants were randomised between INFIX surgical fixation and non-surgical management of LC-1 pelvic fracture with a 1 : 1 allocation ratio. The target sample size was 600 participants. For the internal pilot the target was to set up a minimum of 19 recruitment sites and randomise 148 participants in order to meet the target sample size in the main trial. To progress to the main trial, an average recruitment rate of one participant per centre per month was required. Setting and participants Participants were recruited from Major Trauma Centres (MTCs) in the UK. Adults aged 60 years or older with an LC-1 pelvic fracture, arising from a low-energy fall from standing height or less, and unable to mobilise independently to a distance of around 3 m and back due to pelvic pain 72 hours after injury were eligible for inclusion. Interventions Internal fixation device surgical fixation and non-surgical management (both groups received pain relief and were seen by a physiotherapy team who worked to mobilise the patients as pain allowed). Internal fixation device surgery uses an INFIX to stabilise the pelvis. INFIX devices have screws that are secured into the pelvic bone, and these are connected by a metal bar across the front of the patient. The INFIX device sits entirely under the patient’s skin. Main outcome measures Primary outcome – average patient health-related quality of life, over 6 months, assessed by the patient-reported outcome measure, EQ-5D-5L utility score. Collected at baseline, 2 weeks, 6 weeks, 12 weeks and 6 months post-randomisation time points. Secondary outcomes – health-related quality of life using the EQ-5D-5L visual analogue scale (VAS); physical function using the eight-item Patient-Reported Outcome Measures Information System (PROMIS) lower extremity function (LEF) (mobility) – Short Form and Timed Up and Go (TUG) test; mental health using the PROMIS Scale v1.2 – Global Health Mental 2a subscale; pelvic pain using a VAS; delirium using the Abbreviated Mental Test Score (AMTS) and 4AT Rapid Assessment Test for Delirium; displacement of the pelvis based on a radiological assessment at the 12-week visit; mortality; complications and adverse events including lateral cutaneous nerve injury which was an adverse event of special interest (AESI); resource use; long-term review of patient well-being using the EQ-5D-5L and mortality at 12 months (optional follow-up for those recruited early in the trial). Information on resource use such as length of hospital stay, medication use, surgery details and details of rehabilitation therapy received was collected throughout the follow-up period to assess the impact on the NHS as part of the economic evaluation. Sample size Sample size was calculated based on the primary outcome, EQ-5D-5L. To be conservative, we took the lowest published estimate of the minimal clinically important differences (MCID) (0.074) with an estimated standard deviation (SD) of 0.25 (estimated from the 0.30 reported for the 3L version and adjusted down to account for the 5L version’s greater sensitivity). Based on these assumptions we would have needed to analyse 480 participants (240 per group) and, after accounting for loss to follow-up of 20%, we would have needed to recruit and randomise 600 participants for a study with 90% power (2p = 0.05). Randomisation Intervention allocation was assigned using an online data management system developed for the L1FE study by the software team at York Trials Unit (YTU). There was independent and concealed random allocation (1 : 1 ratio), using computer-generated random permuted blocks of random sizes (4, 6 and 8), stratified by centre, following confirmation of eligibility and written consent. Analysis The originally planned primary analysis was a mixed-effects linear regression model, with EQ-5D-5L scores at 2, 6 and 12 weeks and 6 months follow-up as the dependent variable, adjusting for baseline EQ-5D-5L, randomised group and other pertinent baseline characteristics as fixed effects. The plan was to control for potential clustering at hospital site level by including it in the model as a random effect and to account for the correlation of scores within patients over time by means of an appropriate covariance structure. Due to the small sample size and stopping at the end of the internal pilot, a descriptive analysis was undertaken with no formal hypothesis testing. All reported summary statistics are given at both a treatment group and overall level. The planned economic analysis was to examine the overall difference in EQ-5D-5L index scores between the two groups using regression methods, consistent with the model selected in the statistical analysis. The EQ-5D-5L health states were to be valued in accordance with National Institute for Health and Care Excellence (NICE) guidance. Quality-adjusted life-years (QALYs) were to be calculated by plotting the utility scores at each of the four time points and estimating the area under the curve and regression methods used to express the incremental cost per QALYs gained. Results were to be presented using incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves (CEACs). Results The trial closed early, at the end of the internal pilot due to low recruitment. The internal pilot took place in two separate phases (August 2019 to March 2020 and March 2021 to September 2021) because of a 1-year recruitment pause due to the coronavirus disease 2019 (COVID-19) pandemic. Site set-up Eleven sites in England and Wales were opened during the first phase of the internal pilot. Ten of these re-opened following the study recruitment pause. A further 10 sites, including 3 in Scotland, were interested in participating and were in various stages of set-up prior to study closure. The 11 sites were open for a combined total of 92 months. Patient screening During the internal pilot, 316 patients were assessed for eligibility, of whom 43 were eligible (13.6%). The main reasons for ineligibility were: patient able to mobilise independently 3 m and back (n = 161), concomitant injury that impedes mobilisation (n = 57), surgery contraindicated (n = 40), patient did not have a low-energy LC-1 pelvic fracture (n = 38), unable to schedule surgery within 10 days of injury (n = 34), patient was under 60 years of age (n = 23) and/or the patient was non-ambulatory or required assistance prior to injury (n = 22). Recruitment, withdrawals and follow-up Of the 43 eligible participants, 36 (83.7%) were approached for consent, of whom 11 (30.6%) provided consent. Eleven (100%) of the consenting patients were randomised into the study. The most common reason for eligible patients not consenting to take part was that they were unwilling to be randomised to a treatment (n = 10). The average recruitment rate per site per month was 0.175, well below the target rate of one patient per site per month. Eleven patients were randomised, five to INFIX surgical fixation and six to non-surgical management. Three participants in the non-surgical management group were withdrawn from the study. One participant died, one participant lost capacity and their family member no longer wanted them to take part in the study and one participant had sight problems and considered themselves too frail to continue. Of the five participants randomised to surgical fixation, all received surgery and no one in the non-surgical management group received surgery. All participants in the surgical fixation group completed the 6-month questionnaires and the remaining participants in the non-surgical management group provided data at 6 months (3/6). The average age of participants was 83.0 years (interquartile range 76.0–89.0) and the EQ-5D-5L utility score at 6 months post randomisation (n = 8) was 0.32 (SD 0.37). Barriers to recruitment and actions taken There were multiple barriers to recruitment, which, combined with the impact of COVID-19 on the NHS, resulted in a very low recruitment rate. These included: Fewer patients than anticipated were screened and screening activity was variable across sites. Patients had multiple entry points to hospital for treatment with onward admissions to several possible departments (Geriatric ward, Orthopaedic ward, Medical ward or an Admissions unit). This made screening resource-intensive for the research teams at sites. This became particularly challenging following the recruitment pause, as recruiting staff at sites were not all back to full capacity. A substantial proportion of patients were able to mobilise by 72 hours post injury and therefore did not meet the eligibility criteria for the trial. There was also variation across sites in how the assessment of mobility was undertaken and the extent of assistance provided to patients. The COVID-19 pandemic led to a concerted focus on avoidance of hospital admissions where possible, thereby minimising hospital stays. Because the pre-trial standard care for LC-1 pelvic fragility fractures was non-surgical management, there were challenges in the delivery of the L1FE trial. Patients were increasingly being discharged before the 72-hour assessment to nursing homes, residences with care packages or rehabilitation hospitals and could not be screened for the trial. There was evidence of a lack of equipoise amongst both surgical and non-surgical healthcare professionals, with a preference for non-surgical management in some centres. For example, some surgeons felt that INFIX was not a good treatment for this patient cohort, or they felt that most patients could mobilise fairly quickly. The recruiting window was relatively small. There were 3 days before the initial approach was permitted, with the surgery required to take place before day 10 (but in reality, this was often shorter due to 1 day per week operating lists or no operating at weekends at some sites). Making a decision about participating in a trial where the interventions are very different in intensity and risks is potentially a daunting one for patients and their consultees (where patients lacked capacity). From the perspective of recruiting staff, the resulting consent process was experienced as time consuming, involving difficult conversations and a lot of back-and-forth, waiting for patients to discuss the trial with their relatives and/or surgeon, or for next of kin to do so. This was exacerbated by the COVID-19 pandemic. Where patients lacked capacity, discussions with consultees had to take place remotely and recruitment staff felt that it was more difficult to build rapport and trust. There was a perception amongst staff that patients’ next of kin were also reluctant to consent on behalf of the patient whom they were unable to see due to COVID-19 visiting restrictions, in order to have a better idea of how they were doing, or get a better sense of the study. We used multiple strategies to mitigate against the barriers identified. We used cross-site meetings with the aim of bringing together research staff at recruiting sites to discuss the challenges with recruitment experienced at each site, share knowledge and provide support from the central trial team. We obtained approval for changes to the protocol clarifying how the 72-hour mobility inclusion criterion was implemented. During the recruitment pause we developed new resources to support recruitment staff: a short video introduction to the trial that sites could share across departments; a narrated animation on identifying patients across departments; a video resource on how to undertake the 72-hour mobility assessment for the trial; a patient-facing consent video; and updated consent guidance. We obtained approval for the associate principal investigator (API) scheme to be extended to orthogeriatricians to increase their engagement with the study. The trial team including the chief investigator (CI), physiotherapist, orthogeriatrician and trial co-ordinators provided support to address issues at individual sites. With the input of our patient and public involvement (PPI) group, the patient information sheet (PIS) was also revised. Despite the efforts of the central trial team and recruiting teams at sites, the strategies did not sufficiently mitigate against the barriers. Conclusions It is not feasible to recruit to this trial in the current context. Further research to understand the treatment and recovery pathways of this group of patients, along with their outcomes, would be needed prior to undertaking a future trial. Trial registration This trial is registered as ISRCTN16478561. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/167/57) and is published in full in Health Technology Assessment; Vol. 28, No. 15. See the NIHR Funding and Awards website for further award information.

Abstract Background Lateral compression type1 (LC-1) fragility fractures are a common, painful injury in older adults resulting in reduced mobility. The incidence of these fractures is increasing with the growing older adult population. The current standard of care is non-surgical management; however, patients with this injury are at risk of long-term immobility and related complications. INFIX is a pelvic fixation device used in younger patients with high-energy fractures. The device is fitted via a percutaneous technique with no external pin sites and has good purchase even in osteoporotic bone. It therefore has the potential to be well tolerated in patients with LC-1 fragility fractures. INFIX could improve patients’ ability to mobilise and reduce the risk of immobility-related complications. However, there is a risk of complications related to surgery, and robust evidence is required on patient outcomes. This study will investigate the clinical and cost-effectiveness of surgical fixation with INFIX compared to non-surgical management of LC-1 fragility fractures in older adults. Methods A multi-centre randomised controlled trial of 600 patients allocated 1:1 to non-surgical management or INFIX surgery. The study will have a 12-month internal pilot to assess recruitment and trial feasibility. The primary outcome will be the patient quality of life over 6 months, measured by the patient-reported EQ-5D-5L. The secondary outcomes will include physical function, mental health, pain, delirium, imaging assessment, resource use, and complications. Discussion The L1FE study aims to compare the clinical and cost-effectiveness of surgical and non-surgical management of people aged 60 years and older with LC-1 fragility fractures. The trial is sufficiently powered and rigorously designed to inform future clinical and patient decision-making and allocation of NHS resources. Trial registration International Standard Randomised Controlled Trial Number Registry ISRCTN16478561. Registered on 8 April 2019

Abstract Background Recovery Colleges are a relatively recent initiative within mental health services. The first opened in 2009 in London and since then numbers have grown. They are based on principles of personal recovery in mental health, co-production between people with lived experience of mental health problems and professionals, and adult learning. Student eligibility criteria vary, but all serve people who use mental health services, with empirical evidence of benefit. Previously we developed a Recovery College fidelity measure and a preliminary change model identifying the mechanisms of action and outcomes for this group, which we refer to as service user students. The Recovery Colleges Characterisation and Testing (RECOLLECT) study is a five-year (2020–2025) programme of research in England. The aim of RECOLLECT is to determine Recovery Colleges’ effectiveness and cost-effectiveness, and identify organisational influences on fidelity and improvements in mental health outcomes. Methods RECOLLECT comprises i) a national survey of Recovery Colleges, ii) a prospective cohort study to establish the relationship between fidelity, mechanisms of action and psychosocial outcomes, iii) a prospective cohort study to investigate effectiveness and cost-effectiveness, iv) a retrospective cohort study to determine the relationship between Recovery College use and outcomes and mental health service use, and v) organisational case studies to establish the contextual and organisational factors influencing fidelity and outcomes. The programme has been developed with input from individuals who have lived experience of mental health problems. A Lived Experience Advisory Panel will provide input into all stages of the research. Discussion RECOLLECT will provide the first rigorous evidence on the effectiveness and cost effectiveness of Recovery Colleges in England, to inform their prioritising, commissioning, and running. The validated RECOLLECT multilevel change model will confirm the active components of Recovery Colleges. The fidelity measure and evidence about the fidelity-outcome relationship will provide an empirically-based approach to develop Recovery Colleges, to maximise benefits for students. Findings will be disseminated through the study website (researchintorecovery.com/recollect) and via national and international Recovery College networks to maximise impact, and will shape policy on how Recovery Colleges can help those with mental health problems lead empowered, meaningful and fulfilling lives.

Aims: As the world continues to fight successive waves of COVID-19 variants, we have seen worldwide infections surpass 100 million. London, UK, has been severely affected throughout the pandemic, and the resulting impact on the NHS has been profound. The aim of this study is to evaluate the impact of COVID-19 on theatre productivity across London’s four major trauma centres (MTCs), and to assess how the changes to normal protocols and working patterns impacted trauma theatre efficiency. Methods: This was a collaborative study across London’s MTCs. A two-month period was selected from 5 March to 5 May 2020. The same two-month period in 2019 was used to provide baseline data for comparison. Demographic information was collected, as well as surgical speciality, procedure, time to surgery, type of anaesthesia, and various time points throughout the patient journey to theatre. Results: In total, 1,243 theatre visits were analyzed as part of the study. Of these, 834 patients presented in 2019 and 409 in 2020. Fewer open reduction and internal fixations were performed in 2020 (33.5% vs 38.2%), and there was an increase in the number of orthoplastic cases in 2020 (8.3% vs 2.2%), both statistically significant results (p < 0.000). There was a statistically significant increase in median time from 2019 to 2020, between sending for a patient and their arrival to the anaesthetic room (29 vs 35 minutes; p = 0.000). Median time between arrival in the anaesthetic room and commencement of anaesthetic increased (7 to 9 minutes; p = 0.104). Conclusion: Changes in working practices necessitated by COVID-19 led to modest delays to all aspects of theatre use, and consequently theatre efficiency. However, the reality is that the major concerns of impact of service did not occur to the levels that were expected.

Introduction Patients with rib fractures commonly experience significant acute pain and are at risk of hypoxia, retained secretions, respiratory failure and death. Effective analgesia improves these outcomes. There is widespread variation in analgesic treatments given to patients including oral, intravenous and epidural routes of administration. Erector spinae plane (ESP) blockade, a novel regional analgesic technique, may be effective, but high-quality evidence is lacking.Methods and analysis To determine if a definitive trial of ESP blockade in rib fractures is possible, we are conducting a multicentre, randomised controlled pilot study with feasibility and qualitative assessment. Fifty adult patients with rib fractures will be randomised in a 1:1 ratio to ESP blockade with multimodal analgesia or placebo ESP blockade with multimodal analgesia. Participants and outcome assessors will be blinded. The primary feasibility outcomes are recruitment rate, retention rate and trial acceptability assessed by interview.Ethics and dissemination The study was approved by the Oxford B Research Ethics Committee on 22 February 2022 (REC reference: 22/SC/0005). All participants will provide written consent. Trial results will be reported via peer review and to grant funders.Trial registration number ISRCTN49307616.

Introduction The BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression.Methods and analysis The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring >16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.Ethics and dissemination Ethical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action.Trial registration number ISRCTN19674644

Abstract Background Patient and Public Involvement (PPI) in mental health research is increasing, especially in early (pre-funding) stages. PPI is less consistent in later stages, including in analysing qualitative data. The aims of this study were to develop a methodology for involving PPI co-researchers in collaboratively analysing qualitative mental health research data with academic researchers, to pilot and refine this methodology, and to create a best practice framework for collaborative data analysis (CDA) of qualitative mental health research. Methods In the context of the RECOLLECT Study of Recovery Colleges, a critical literature review of collaborative data analysis studies was conducted, to identify approaches and recommendations for successful CDA. A CDA methodology was developed and then piloted in RECOLLECT, followed by refinement and development of a best practice framework. Results From 10 included publications, four CDA approaches were identified: (1) consultation, (2) development, (3) application and (4) development and application of coding framework. Four characteristics of successful CDA were found: CDA process is co-produced; CDA process is realistic regarding time and resources; demands of the CDA process are manageable for PPI co-researchers; and group expectations and dynamics are effectively managed. A four-meeting CDA process was piloted to co-produce a coding framework based on qualitative data collected in RECOLLECT and to create a mental health service user-defined change model relevant to Recovery Colleges. Formal and informal feedback demonstrated active involvement. The CDA process involved an extra 80 person-days of time (40 from PPI co-researchers, 40 from academic researchers). The process was refined into a best practice framework comprising Preparation, CDA and Application phases. Conclusions This study has developed a typology of approaches to collaborative analysis of qualitative data in mental health research, identified from available evidence the characteristics of successful involvement, and developed, piloted and refined the first best practice framework for collaborative analysis of qualitative data. This framework has the potential to support meaningful PPI in data analysis in the context of qualitative mental health research studies, a previously neglected yet central part of the research cycle.

Purpose: Flail chest (FC) injuries represent a significant burden on trauma services because of its high morbidity and mortality. Current gold standard conservative management strategies for FC, are now being challenged by renewed interest in surgical rib fixation. This retrospective epidemiological study sets out to evaluate FC patients, and quantify the natural history of this injury by studying the injury patterns, epidemiology and mortality of patients sustaining FC injuries admitted to a major trauma centre (MTC). Methods: A retrospective cohort analysis has been conducted at an MTC with full trauma service. All patients (age > 16 years) sustaining FC were included. Patient demographics, injury characteristics and inpatient stay information were extracted. Results: Two hundred and ninety-three patients were identified, with a mean injury severity score (ISS) of 28.9 (range 9â75), average age of 56.1 years (range of 16â100), and a male predominance (78%). Road traffic accidents accounted for 45% (n = 132) of injuries, whilst 44% were fall or jump from height (n = 129).Associated lung contusion was present in 133 patients (45%) while 76% of patients were found to have 5 or more ribs involved in the flail segment (n = 223) with 96% (n = 281) having a unilateral FC. Inpatient treatment was required 19.9 days (range 0â150 days) with 59% of patients (n = 173) requiring intensive care unit (ICU) level care for 8.4 days (range 1â63) with 61.8% requiring mechanical ventilation (n = 107) for 10.5 days (range 1â54), and 7.8% underwent rib fixation with rib plates (n = 23).The mortality rate was found to be 14% (n = 42). A non-significant trend towards improved outcomes in the conservative group was found when compared with the fixation group; ventilation days (6.94 vs 10.06, p = 0.18) intensive treatment unit (ITU) length of stay (LOS) (12.56 vs 15.53, p = 0.28) and hospital LOS (32.62 vs 35.24, p = 0.69). Conclusion: This study has successfully described the natural history of flail chest injuries, and has found a nonsignificant trend towards better outcomes with conservative management. With the cohort and management challenges now defined, work on outcome improvement can be targeted. In addition the comparability of results to other studies makes collaboration with other MTCs a realistic proposal. Keywords: Flail chest, Natural history, Epidemiology, Rib plates

Objective: To examine the feasibility of conducting a fully powered randomized controlled trial (RCT) of Individual Placement and Support (IPS). IPS is a form of supported employment which aims to put people into open employment quickly and in accordance with their preferences. It is delivered by employment specialists collocated within clinical teams, and provides time unlimited support for the individual and their employer, along with welfare benefits counselling.Method: A feasibility cluster RCT of treatment as usual (TAU) plus IPS versus TAU alone was conducted over 12 months among patients with offending histories in a community forensic setting in the UK. The feasibility criteria were to achieve 50% recruitment rate; 50% completion rate for IPS; 50% completion rate of all outcome measures; and 80% acceptability rating for IPS. The primary efficacy outcome was the proportion of people in open employment at 12 months. The secondary outcomes were other vocational and educational activities; Brief Psychiatric Rating Scale; Rosenberg’s Self-esteem Scale; Client Service Receipt Inventory; quality of life using the SF12-v2 and EQ5-D3; Social Functioning Questionnaire; Work Limitation Questionnaire; and reoffending.Results: Participants’ mean age was 39.2 years. The majority were male (88.9), White British (72.2), and single (72.2%). Over 72% had no higher qualification beyond secondary education; mean years in education was 10.4. Over one third had schizophrenia, one fifth had depression, and the rest had personality disorder as their primary diagnosis. Participants had a lifetime average of 7.5 convictions for 15.5 offences. The recruitment rate of all referrals was 38.3% (IPS n = 11; TAU n = 7). Completion rate for IPS was 54.5, with 45.5% acceptability rating. Completion rates for outcome measures for the groups at baseline and 12 months ranged from 22.2 to 100%. The proportion of people in open employment at 12 months were 9.1 and 0% for IPS and TAU respectively.Conclusion: It is not feasible to conduct a full RCT of IPS in community forensic settings in the UK owing to recruitment and retention difficulties. Conducting a trial of this kind requires a large pool of patients from multiple sites and longer IPS implementation and recruitment periods than those of this study.Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT02442193.

Introduction: Open tibial fractures are complex injuries with variable outcomes that significantly impact patients’ lives. Surgical debridement is paramount in preventing detrimental complications such as infection and non-union; however, the exact timing of debridement remains a topic of great controversy. The aim of this study is to evaluate the association between timing of surgical debridement and outcomes such as infection and non-union in open tibial fractures. Materials and Methods: We performed a systematic review and meta-analysis of the literature to capture studies evaluating the association between timing of initial surgical debridement and infection or non-union, or other reported outcomes. We searched the MEDLINE, PubMed Central, EMBASE, SCOPUS, Cochrane Central and Web of Science electronic databases. Our methodology was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Cochrane handbook for systematic reviews of interventions. Results: The systematic review included 20 studies with 10,032 open tibial fractures. The overall infection rate was 14.3% (314 out of 2193) and the overall non-union rate 14.2% (116 out of 817). We did not find any statistically significant association between delayed debridement and infection rate (OR = 0.87; 95% CI, 0.68 to 1.11; p = 0.23) or non-union rate (OR = 0.70; 95% CI, 0.42 to 1.15; p = 0.13). These findings did not change when we accounted for the effect of different time thresholds used for defining early and late debridement, nor with the Gustilo–Anderson classification or varying study characteristics. Conclusion: The findings of this meta-analysis support that delayed surgical debridement does not increase the infection or non-union rates in open tibial fracture injuries. Consequently, we propose that a reasonable delay in the initial debridement is acceptable to ensure that optimal management conditions are in place, such that the availability of surgical expertise, skilled staff and equipment are prioritised over getting to surgery rapidly. We recommend changing the standard guidance around timing for performing surgical debridement to ‘as soon as reasonably possible, once appropriate personnel and equipment are available; ideally within 24-h’.

In this paper, we study the system governing flows in the magnetic field within the earth. The system is similar to the magnetohydrodynamic (MHD) equations. By establishing a new priori estimates and following Calderón's procedure for the Navier Stokes equations [1], we obtained, for initial data in space Lp, the global in time existence and uniqueness of weak solution of the system subject to appropriate conditions.