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IntroductionYoung people are the most frequent users of social media and smartphones and there has been an increasing speculation about the potential negative impacts of their use on mental health. This has coincided with a sharp increase in the levels of self-harm in young people. To date, studies researching this potential association are predominantly cross-sectional and reliant on self-report data, which precludes the ability to objectively analyse behaviour over time. This study is one of the first attempts to explore temporal patterns of real-world usage prior to self-harm, to identify whether there are usage patterns associated with an increased risk.Methods and analysisTo study the mechanisms by which social media and smartphone use underpin self-harm in a clinical sample of young people, the Social media, Smartphone use and Self-harm in Young People (3S-YP) study uses a prospective, observational study design. Up to 600 young people aged 13–25 years old from secondary mental health services will be recruited and followed for up to 6 months. Primary analysis will compare real-world data in the 7 days leading up to a participant or clinician recorded self-harm episode, to categorise patterns of problematic usage. Secondary analyses will explore potential mediating effects of anxiety, depression, sleep disturbance, loneliness and bullying.Ethics and disseminationThis study was approved by the National Research Ethics Service, London - Riverside, as well as by the Joint Research and Development Office of the Institute of Psychiatry, Psychology and Neuroscience and South London and Maudsley NHS Foundation Trust (SLaM), and the SLaM Clinical Research Interactive Search (CRIS) Oversight Committee. The findings from this study will be disseminated through peer-reviewed scientific journals, conferences, websites, social media and stakeholder engagement activities.Trial registration numberNCT04601220.

Background Individuals with low serum vitamin B-12 and high serum folate have higher plasma concentrations of methylmalonic acid (MMA). Whether folic acid (FA) causes an increase in MMA is not known. Objectives We aimed to determine the impact of FA supplementation on plasma MMA concentration in people with low or marginal serum vitamin B-12. Methods We conducted a multicenter double-blind placebo-controlled randomized trial of oral FA (5 mg/d for 12 wk) in middle-aged patients treated with antidepressant medication participating in the FoLATED (Folate Augmentation of Treatment—Evaluation for Depression) trial. Participants defined as having “low” serum vitamin B-12 (vitamin B-12 ≥150 and

Background Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support. Primary research question In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0–10 scale) compared with care as usual? Methods A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation. We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups. Discussion The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients’ quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals. Trial registration ISRCTN71618461. Registered on 9 September 2019.

AIMS: The aim was to determine if the 17 June 2014 Tracey judgment regarding 'do not attempt cardiopulmonary resuscitation' decisions led to increases in the rate of in-hospital cardiac arrests resulting in a resuscitation attempt (IHCA) and/or proportion of resuscitation attempts deemed futile. METHOD: Using UK National Cardiac Arrest Audit data, the IHCA rate and proportion of resuscitation attempts deemed futile were compared for two periods (pre-judgment (01 July 2012 - 16 June 2014, inclusive) and post-judgment (01 July 2014 - 30 June 2016, inclusive)) using interrupted time series analyses. RESULTS: A total of 43,109 IHCAs (115 hospitals) were analysed. There were fewer IHCAs post- than pre-judgment (21,324 vs 21,785, respectively). The IHCA rate was declining over time before the judgment but there was an abrupt and statistically significant increase in the period immediately following the judgment (p

Aim\ud Cerebral Performance Category (CPC) can be used to categorise neurological outcome after cardiac arrest. There is no consensus on what information sources can be used to derive the CPC. This study describes the information sources used by hospitals participating in the UK National Cardiac Arrest Audit (NCAA) and their impact on the CPC reported for individuals surviving an in-hospital cardiac arrest (IHCA).\ud \ud Methods\ud Data on the CPCs and on the information source used to assess the CPC (either case note review, communication with clinical team or direct patient assessment) were abstracted for individual adult patients who survived to discharge following an IHCA in an acute hospital participating in NCAA between 1 May 2014 and 30 April 2016.\ud \ud Results\ud Data for 33,114 IHCAs (in 31,783 patients) from 195 hospitals were reported to NCAA, of whom 6093 (18.4%) survived to hospital discharge. Of these hospital survivors, 5492 (90.1%) had both the CPC and information source reported: case note review (3989 patients, 72.6%), communication with the clinical team (1053 patients, 19.2%); and direct patient assessment (450 patients, 8.2%). Most (96.6%) survivors were reported to have had a good neurological outcome (CPC 1 or 2). There were small differences in the CPC reported derived from the different information sources but these differences were not clinically important.\ud \ud Conclusion\ud In the UK IHCA audit, the most commonly used information source for CPC assessment is case notes. Most survivors of IHCA are reported as having a CPC score of 1 or a good outcome (CPC scores 1 or 2).

BackgroundAround 60 000 people in England live in mental health supported accommodation. There are three main types: residential care, supported housing and floating outreach. Supported housing and floating outreach aim to support service users in moving on to more independent accommodation within 2 years, but there has been little research investigating their effectiveness.AimsA 30-month prospective cohort study investigating outcomes for users of mental health supported accommodation.MethodWe used random sampling, accounting for relevant geographical variation factors, to recruit 87 services (22 residential care, 35 supported housing and 30 floating outreach) and 619 service users (residential care 159, supported housing 251, floating outreach 209) across England. We contacted services every 3 months to investigate the proportion of service users who successfully moved on to more independent accommodation. Multilevel modelling was used to estimate how much of the outcome and cost variations were due to service type and quality, after accounting for service-user characteristics.ResultsOverall 243/586 participants successfully moved on (residential care 15/146, supported housing 96/244, floating outreach 132/196). This was most likely for floating outreach service users (versus residential care: odds ratio 7.96, 95% CI 2.92–21.69, P < 0.001; versus supported housing: odds ratio 2.74, 95% CI 1.01–7.41, P < 0.001) and was associated with reduced costs of care and two aspects of service quality: promotion of human rights and recovery-based practice.ConclusionsMost people do not move on from supported accommodation within the expected time frame. Greater focus on human rights and recovery-based practice may increase service effectiveness.

Background: Mental health supported accommodation services are implemented across England, usually organised into a ‘step-down’ care pathway that requires the individual to repeatedly move as they gain skills and confidence for more independent living. There have been no trials comparing the effectiveness of different types of supported accommodation, but two widely used models (supported housing and floating outreach) have been found to provide similar support. We aimed to assess the feasibility of conducting a large-scale trial comparing these two models. Methods: Individually randomised, parallel group feasibility trial in three regions of England (North London, East London, and Cheltenham and Gloucestershire). We aimed to recruit 60 participants in 15 months, referred to supported accommodation, randomly allocated on an equal basis to receive either a local supported housing or floating outreach service. We assessed referrals to the trial, participants recruited, attrition, time from recruitment to moving into either type of supported accommodation, and feasibility of masking. We conducted a process evaluation to examine our results further. Results: We screened 1,432 potential participants, of whom 17 consented to participate, with 8 agreeing to randomisation (of whom 1 was lost to attrition) and 9 participating in naturalistic follow-up. Our process evaluation indicated that the main obstacle to recruitment was staff and service user preferences for certain types of supported accommodation or for specific services. Staff also felt that randomisation compromised their professional judgement. Conclusions: Our results do not support investment in a large-scale trial in England at this time. Trial registration: UK CRN Portfolio database, Trial ID: ISRCTN19689576. Trial funding: National Institute of Health Research (RP-PG-0707-10093).

Importance The value of facedown positioning following surgery for large full-thickness macular holes is unknown. Objective To determine whether advice to position facedown postoperatively improves the outcome for large macular holes. Design, Setting, and Participants This randomized, parallel group superiority trial with 1:1 randomization stratified by site with 3 months’ follow-up was conducted at 9 sites across the United Kingdom and included participants with an idiopathic full-thickness macular hole of at least 400 μm minimum linear diameter and a duration of fewer than 12 months. All participants had vitrectomy surgery with peeling of the internal limiting membrane and injection of perfluoropropane (14%) gas, with or without simultaneous surgery for cataract. Interventions Following surgery, participants were randomly advised to position either facedown or face forward for 8 hours daily for 5 days. Main Outcomes and Measures The primary outcome was closure of the macular hole determined 3 months following surgery by masked optical coherence tomography evaluation. Secondary outcome measures at 3 months were visual acuity, participant-reported experience of positioning, and quality of life measured by the National Eye Institute Visual Function Questionnaire 25. Results A total of 185 participants (45 men [24.3%]; 156 white [84.3%]; 9 black [4.9%]; 10 Asian [5.4%]; median age, 69 years [interquartile range, 64-73 years]) were randomized. Macular hole closure was observed in 90 (85.6%) who were advised to position face forward and 88 (95.5%) advised to position facedown (adjusted odds ratio, 3.15; 95% CI, 0.87-11.41;P = .08). The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR (equivalent to 1 Snellen line) in the face-forward group and 0.57 (0.42) logMAR (equivalent to 3 Snellen lines) in the facedown group (adjusted mean difference, 0.22 [95 % CI, 0.05-0.38]; equivalent to 2 Snellen lines); 95% CI, 0.05-0.38;P = .01). The median National Eye Institute Visual Function Questionnaire 25 score was 89 (interquartile range, 76-94) in the facedown group and 87 (interquartile range, 73-93) in the face-forward group (mean [SD] change on a logistic scale, 0.08 [0.26] face forward and 0.11 [0.25] facedown; adjusted mean [SD] difference on a logistic scale, 0.02; 95% CI, −0.03 to 0.07;P = .41). Conclusions and Relevance The results do not prove that facedown positioning following surgery is more likely to close large macular holes compared with facing forward but do support the possibility that visual acuity outcomes may be superior. Trial Registration Isrctn.org Identifier: 12410596

Previous trials in adults with impaired immunity and respiratory failure suggest that early noninvasive ventilation avoids endotracheal intubation and improves survival. No randomized clinical trials have addressed this question in children.We undertook an open, parallel-group randomized trial in three pediatric hospitals.Children with impaired immunity and acute respiratory failure defined as tachypnoea (90th centile); a new requirement for supplemental oxygen; and new chest radiograph infiltrates.Children were randomly assigned to early PICU admission for continuous positive airways pressure (early continuous positive airways pressure) or to standard care. The primary outcome was endotracheal intubation by 30 days.One-hundred fourteen children met inclusion criteria of whom 42 were randomized between January 2013 and January 2016. There was no significant difference in endotracheal intubation by 30 days with early continuous positive airways pressure (10/21; 48%) compared with standard care (5/21; 24%), odds ratio 2.9 (0.8-10.9), p value equals to 0.11. However, 30-day mortality was significantly higher with early continuous positive airways pressure (7/21; 33%) compared with standard care (1/21; 5%), odds ratio 10.0 (1.1-90.6), p value equals to 0.041. Mortality at 90 days was early continuous positive airways pressure (11/21; 52%) versus standard care (4/21; 19%), odds ratio 4.7 (1.2-18.6), p value equals to 0.029, whereas mortality at 1 year was similar early continuous positive airways pressure (13/21; 61.9%) versus standard care (9/21; 42.7%), odds ratio 2.2 (0.6-7.4), p value equals to 0.22. There were two serious adverse events: early continuous positive airways pressure (pneumothorax) and standard care (hemothorax).This study provided no evidence to support early PICU admission for continuous positive airways pressure in children with acute respiratory failure and impaired immunity. There was a trend toward increased endotracheal intubation and a higher early mortality in the early continuous positive airways pressure group.

Background There has been no randomised controlled trial (RCT) of fluid bolus therapy in paediatric sepsis in the developed world despite evidence that excess fluid may be associated with harm. Objectives To determine the feasibility of the Fluids in Shock (FiSh) trial – a RCT comparing restricted fluid bolus (10 ml/kg) with current practice (20 ml/kg) in children with septic shock in the UK. Design (1) Qualitative feasibility study exploring parents’ views about the pilot RCT. (2) Pilot RCT over a 9-month period, including integrated parental and staff perspectives study. Setting (1) Recruitment took place across four NHS hospitals in England and on social media. (2) Recruitment took place across 13 NHS hospitals in England. Participants (1) Parents of children admitted to a UK hospital with presumed septic shock in the previous 3 years. (2) Children presenting to an emergency department with clinical suspicion of infection and shock after 20 ml/kg of fluid. Exclusion criteria were receipt of > 20 ml/kg of fluid, conditions requiring fluid restriction and the patient not for full active treatment (i.e. palliative care plan in place). Site staff and parents of children in the pilot were recruited to the perspectives study. Interventions (1) None. (2) Children were randomly allocated (1 : 1) to 10- or 20-ml/kg fluid boluses every 15 minutes for 4 hours if in shock. Main outcome measures (1) Acceptability of FiSh trial, proposed consent model and potential outcome measures. (2) Outcomes were based on progression criteria, including recruitment and retention rates, protocol adherence and separation between the groups, and collection and distribution of potential outcome measures. Results (1) Twenty-one parents were interviewed. All would have consented for the pilot study. (2) Seventy-five children were randomised, 40 to the 10-ml/kg fluid bolus group and 35 to the 20-ml/kg fluid bolus group. Two children were withdrawn. Although the anticipated recruitment rate was achieved, there was variability across the sites. Fifty-nine per cent of children in the 10-ml/kg fluid bolus group and 74% in the 20-ml/kg fluid bolus group required only a single trial bolus before shock resolved. The volume of fluid (in ml/kg) was 35% lower in the first hour and 44% lower over the 4-hour period in the 10-ml/kg fluid bolus group. Fluid boluses were delivered per protocol (volume and timing) for 79% of participants in the 10-ml/kg fluid bolus group and for 55% in the 20-ml/kg fluid bolus group, mainly as a result of delivery not being completed within 15 minutes. There were no deaths. Length of hospital stay, paediatric intensive care unit (PICU) transfers, and days alive and PICU free did not differ significantly between the groups. Two adverse events were reported in each group. A questionnaire was completed by 45 parents, 20 families and seven staff were interviewed and 20 staff participated in focus groups. Although a minority of site staff lacked equipoise in favour of more restricted boluses, all supported the trial. Conclusions Even though a successful feasibility and pilot RCT were conducted, participants were not as unwell as expected. A larger trial is not feasible in its current design in the UK. Future work Further observational work is required to determine the epidemiology of severe childhood infection in the UK in the postvaccine era. Trial registration Current Controlled Trials ISRCTN15244462. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 51. See the NIHR Journals Library website for further project information.

Background Compared to men in the general population, men in substance use treatment are more likely to perpetrate intimate partner abuse (IPA). The ADVANCE group intervention for men in substance use treatment is tailored to address substance use and IPA in an integrated way. In a feasibility trial pre-COVID, men who received the ADVANCE intervention via face-to-face group delivery showed reductions in IPA perpetration. Due to COVID-19, ADVANCE was adapted for remote digital delivery. Methods/design This mixed-methods non-randomised feasibility study, with a nested process evaluation, will explore the feasibility and acceptability of delivering the ADVANCE digital intervention to men in substance use treatment who have perpetrated IPA towards a female partner in the past year. Sixty men will be recruited from seven substance use treatment services in Great Britain. The ADVANCE digital intervention comprises a preparatory one-to-one session with a facilitator to set goals, develop a personal safety plan, and increase motivation and a preparatory online group to prepare men for taking part in the intervention. The core intervention comprises six fortnightly online group sessions and 12 weekly self-directed website sessions to recap and practise skills learned in the online group sessions. Each website session is followed by a one-to-one video/phone coaching session with a facilitator. Men will also receive their usual substance use treatment. Men’s female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Outcome measures for men and women will be sought post intervention (approximately 4 months post male baseline interview). Feasibility parameters to be estimated include eligibility, suitability, consent, recruitment, attendance, retention and follow-up rates. In-depth interviews or focus groups will explore the intervention’s acceptability to participants, facilitators and ISS workers. A secondary focus of the study will estimate pre-post-differences in outcome measures covering substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts and quality of life. Discussion Findings will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE digital intervention for reducing IPA. Trial registration The feasibility study was prospectively registered: ISRCTN66619273.