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Background Young adults represent a third of the United Kingdom prison population and are at risk of poor health outcomes, including drug and alcohol misuse, self-harm and suicide. Court diversion interventions aim to reduce the negative consequences of criminal sanctions and address the root causes of offending. However, evidence of their effectiveness has not yet been established. The Gateway programme, issued as a conditional caution, aimed to improve the life chances of young adults committing low-level offences. Participants agreed not to reoffend during the 16-week caution and, following a needs assessment, received individual support from a Gateway navigator and attended two workshops encouraging analysis of own behaviour and its consequences. Objective To evaluate the effectiveness and cost-effectiveness of Gateway in relation to health and well-being of participants compared to usual process (court summons or a different conditional caution). Design, setting and participants Pragmatic, multisite, parallel-group, superiority randomised controlled trial with two 6-month internal pilots and a target sample size of 334. Randomisation between Gateway and usual process was on a 1 : 1 basis. Four Hampshire Constabulary sites recruited 18- to 24-year-old residents of Hampshire and Isle of Wight who were questioned for an eligible low-level offence. Semistructured interviews were also held with a sample of Gateway programme participants, staff and police study recruiters. Main outcome measures Primary outcome was the Warwick-Edinburgh Mental Wellbeing Scale score at 12 months. Secondary outcomes included health status, alcohol and drug use, recidivism and resource use. Results Recruitment commenced in October 2019 and the trial stopped in April 2021. A total of 191 participants were recruited, with 109 randomised to Gateway and 82 to usual process. Due to an initial overestimation of potentially eligible young people and low retention rates, recruitment targets were adjusted, and a range of mitigating measures introduced. Although recruitment broadly met study progression criteria [35/50 (70%) Pilot 1: 64/74 (86%) Pilot 2], retention was low throughout (overall: data collected at week 4 was 50%: at week 16 it was 50%: 1-year 37%). Low retention was multifactorial, with one of the main barriers being difficulties contacting participants. It was therefore not possible to complete the randomised controlled trial or the health economics analyses. Qualitative interviews held with 58 individuals yielded rare insights into the benefits and limitations of this type of intervention, as well as barriers and facilitators in relation to recruitment in this setting. Limitations Despite close collaboration with the police to address recruitment and consent issues, expansion of the inclusion criteria and recruitment area and introducing other measures, the researchers were unable to collect sufficient data within an acceptable timeframe. Conclusions The Gateway study was a unique endeavour to gather evidence for a potentially life-changing intervention for an underserved population. The experience gained indicates that randomised controlled trials of interventions, with a health-related outcome, are possible in this setting but point towards the need for conservative recruitment and retention estimates in this target population. Other study designs should be considered. The qualitative evaluation provided a range of valuable lessons for those seeking to design similar interventions or conduct research in similar settings. Study registration This study is registered as ISRCTN11888938. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 16/122/20) and is published in full in Public Health Research; Vol. 12, No. 7. See the NIHR Funding and Awards website for further award information. Plain language summary Young adults who commit low-level offences often have many health and social needs, making them vulnerable to physical and mental health problems. The Gateway programme was a conditional caution developed to address the underlying causes of low-level offending in young people aged 18–24 years and hence improve their life chances. In Gateway, a mentor assessed the young person’s needs and supported them, signposting to healthcare, housing or other services as required. The young people also participated in two workshops, analysing the causes and consequences of their behaviour. To find out if Gateway improved health and reoffending rates, a group of those who received a Gateway conditional caution were compared with a group of those receiving a court summons or a different conditional caution. Of the 191 participants recruited to the study, 109 were randomised to Gateway and 82 to the usual process. However, the researchers had significant difficulties getting hold of the study participants on the phone and they were unable to collect enough information from them to be able to say whether Gateway worked. The researchers introduced various changes to overcome this, but in the end had to stop the study early. As part of the study, the researchers interviewed 28 Gateway programme participants, 17 Gateway project staff and 13 police officers and staff who had been recruiting into the study. From the interviews the study discovered the perceived benefits of Gateway, how programmes like this could be improved and which factors helped or got in the way of doing research in the police setting. The Gateway study aimed to provide evidence for a potentially life-changing intervention for vulnerable young adults. Although it proved impossible to complete the study, the lessons learnt from running it should help colleagues design similar programmes or plan research studies with similar populations or in similar settings. Scientific summary Background Young adults represent a third of the United Kingdom (UK) prison population and are at risk of poor health outcomes including drug and alcohol misuse, self-harm and suicide. Those aged between 18 and 24, who have been questioned as suspects in relation to a low-level offence, may need to attend court and, if convicted, face penalties such as imprisonment. However, other means aimed at preventing young adults from reoffending exist. Court diversion interventions aim to reduce the negative consequences of some types of criminal sanctions and focus resources on addressing the root causes of offending. Although diversions are widely used in the UK, evidence of their effectiveness in terms of health outcomes has not yet been established using robust research methods. Hampshire Constabulary (HC), working with local charities, developed the Gateway programme, an out-of-court disposal aimed at improving the life chances of young adults. Objectives The aim of this study was to evaluate the effectiveness and cost-effectiveness of the Gateway programme issued as a conditional caution (intervention) compared to usual process (court appearance or a different conditional caution). The study objectives were to: Examine the effectiveness of the Gateway intervention on: (1) health and well-being including alcohol and substance use, (2) access to and use of health and social services and (3) quality of life, among young adult offenders. Explore the views and experiences of victims. Assess the quantity and quality of the Gateway intervention as delivered in the study and the generalisability of the findings. Identify and measure relevant consequences, both cost and benefits, of the Gateway intervention compared with usual process. Examine the effectiveness of the Gateway intervention on recidivism. Methods Design The study undertook a pragmatic, superiority RCT with two 6-month internal pilot phases and qualitative evaluation: an economic evaluation was planned. Participants were randomised using a 1 : 1 allocation ratio to either the Gateway conditional caution (intervention) or disposal as usual to a court summons or a different conditional caution to Gateway (usual process). The qualitative evaluation aimed to capture the experiences and perceptions of the impact of the intervention on participants, the police, victims and those delivering the intervention. Participants, setting and recruitment Eligible participants were those aged 18–24 who had committed low-level offences and resided within Hampshire and Isle of Wight (IoW) area. Participants were recruited by Police investigators during processing for an offence. Potential participants were offered a chance by the police to receive the Gateway caution, and those interested were invited to take part in the study. Police officers obtained Stage 1 consent and carried out an eligibility check, after which those eligible were automatically randomised to receive either a Gateway caution or follow the usual process, such as court appearance or a different conditional caution. Qualitative interviews were undertaken with trial participants, police officers and those delivering the intervention. Sample size There is no widely accepted and established minimal clinically significant difference for the primary outcome, Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). A change of three or more points is likely to be important to individuals. There is also variation in the standard deviation (SD) of the WEMWBS with estimates ranging from 6 to 10.8 with the pooled estimate of 10 across all studies. Assuming 90% power, 5% 2-sided statistical significance, mean difference of 4 points on WEMWBS and a SD of 10, 266 participants were required. Conservatively, assuming a 20% attrition rate, the study aimed to recruit and randomise 334 participants. Interventions The Gateway programme, issued as a conditional caution, required participants to undertake a health and social care needs assessment, attend workshops encouraging analysis of their behaviour and its consequences, and agree not to reoffend during the 16-week caution. Usual process was disposal to a court summons or an alternative conditional caution. Outcomes The primary outcome measure was the WEMWBS. Participants self-reported WEMWBS at 4-weeks, 16-weeks and 1-year post-randomisation. Secondary outcomes were health status [Short Form 12 questionnaire (SF-12)]; alcohol [Alcohol Use Disorders Identification Test (AUDIT)] and drug [Adolescent Drug Involvement Scale (ADIS)] use; type and frequency of reoffending (police data); and health and social care resource use (self-reported). Statistical methods The original plan, pre-specified in version 1.0 of the SAP, was to carry out a repeated measures, mixed-effects linear regression model with the WEMWBS score at 4-weeks, 16-weeks and 1-year post-randomisation as the dependent variable, adjusting for treatment group, time, group by time interaction, total number of records management system incidents and police national computer convictions 1-year prerandomisation, age at randomisation, Index of Multiple Deprivation quintile at randomisation, pandemic time period and standard of usual process available as fixed effects. Recruiting site was to be adjusted for as a random effect. However, due to the study closing early because of issues with retaining participants, a descriptive analysis was undertaken with no formal hypothesis testing. All outcomes were summarised descriptively by a randomised treatment group. Qualitative evaluation A qualitative evaluation was conducted to assess the implementation of the Gateway programme, including any related issues and observed benefits to the clients. Focusing on implementation, mechanisms and context, the research questions were: How is Gateway being implemented? What are the barriers to the implementation and effects of the Gateway programme? What are the mechanisms through which the intervention brings about change? How do different delivery methods (face-to-face/virtual/telephone) influence the above questions? We conducted qualitative interviews and focus groups with a range of stakeholders across three time periods during the implementation of the Gateway programme. Economic evaluation A formal health economic analysis was not feasible. Health economic data are summarised descriptively with the trial data. Results Randomised controlled trial We recruited 191 participants; 109 were randomised to Gateway and 82 to usual process. Although recruitment rates were within acceptable limits, the number of participants providing data [94 (32%) at week 4; 95 (34%) at week 16; 43 (28%) at 1-year] was insufficient to undertake any formal hypothesis testing and the trial was closed early. The groups were generally well balanced in terms of characteristics and percentage providing data, but more of those providing valid data had a previous conviction than those who did not provide data. Similar percentages from each arm provided data with those attending interviews completing all sections. Telephone interviews were acceptable to those willing to share an active telephone number. Rates for those who were non-contactable were similar between the groups at all three time points. Eighty-one of the 101 allocated to Gateway complied with the intervention. Reasons for non-compliance were reoffending and non-attendance at the LINX workshops. Qualitative evaluation Across 3 time points, 69 in-depth interviews were conducted with: 28 young people, 25 Gateway staff, 13 police recruiters and 3 focus groups with navigators. The researchers were unable to pursue interviews with victims as there were few offences with a victim. Our findings showed that, following engagement with the Gateway programme, young people reported being better able to make decisions after engagement with the LINX workshops, while navigators played a significant role in enabling compliance and change among young people. The role of the navigator was akin to that of the mentor, providing practical support towards improved health including, for example, making and attending doctors’ appointments with clients, as well as offering a listening role. Young people felt that, for them, the wider determinants (or ‘areas’) addressed with navigators, such as access to employment or improved health, were of greater importance than a reduction in reoffending. There was a polarity of needs among young people, which meant that all stakeholders valued the ability to tailor and adapt the programme to individual client’s needs, also giving clients a sense of agency and control over their lives. The independence of the Gateway intervention team, from the police, was highly valued by young people. Factors related to communication were a concern for all, particular at the point of recruitment (by police) and between multiple delivery agencies. Discussion The problems encountered throughout this trial and the researchers’ endeavours to overcome these problems provide valuable insights for colleagues seeking to design similar interventions and/or conduct studies with vulnerable populations in the police setting. Co-production is essential for studies in the police setting. By working in close collaboration with HC, and their two project dedicated officers, the researchers were able to make pragmatic adjustments to the study design as issues arose. However, training an entire police force is fraught with difficulty even when supported by senior officers; competing interests precluded mandatory training for research purposes. The use of a two-stage consent process and a web-based eligibility and randomisation tool facilitate recruitment in the police setting, but frequent, regular need to use is required to maintain the study profile. Young people who have committed an offence are known to be a difficult group to engage with generally, let alone in research. The study identified and tested implementation of different approaches to overcome this problem. Switching to telephone interviews produced a positive response. Persistence and engagement paid off, but the study was unable to solve the problem of inactive mobile telephone numbers; an issue shared by the navigators and police. Independence of those delivering the intervention is important as perceived links with the police caused some disengagement. The collected data provide valuable information on attrition rates for health studies. Interestingly, allocation did not appear to make any difference to participation. The study’s qualitative evaluation highlighted the unmet health needs for this group of 18- to 24-year-olds, and the need to address the wider determinants of reoffending through individualised assessment. The Gateway programme was, however, developed for those with higher needs, which meant that flexibility and adaptability to suit individual needs was essential. It further highlighted the invaluable role of mentors in rehabilitative programmes such as Gateway. The study has demonstrated that it is possible to recruit and randomise to a RCT in the police setting. The data that the study presents should be used to inform the planning of future trials, including anticipated attrition rates, and setting conservative targets for retention as well as recruitment rates. Internal pilots should be long enough to confirm recruitment and data collection rates are achievable over an adequate follow-up period. Given the challenges encountered, alternative study designs should be considered for the evaluation of interventions with a health-related outcome. These include: cluster RCTs where processes at individual cluster sites could be simplified; post hoc cohort studies which may address non-response and attrition bias; and regression discontinuity design (RDD), a quasi-experimental approach at lower risk of bias which has the potential to equate to a RCT. Conclusions This ambitious RCT and qualitative study provides information about an out-of-court intervention aimed at improving life chances, health and well-being and recidivism in young adults. Challenges encountered in participation and retention in this setting and the ways in which these may be addressed are described and will be useful in planning future research. Study registration This study is registered as ISRCTN11888938. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 16/122/20) and is published in full in Public Health Research; Vol. 12, No. 7. See the NIHR Funding and Awards website for further award information.

Background There is strong evidence that those recruited into studies are not always representative of the population for whom the research is most relevant. Development of the study design and funding decisions are points in the research process where considerations about inclusion of under-served populations may usefully be made. Current practical guidance focuses on designing and modifying participant recruitment and retention approaches but an area that has not been addressed is recruitment site selection. Methods We present case studies of three NIHR funded trials to demonstrate how publicly available UK population datasets can be used to facilitate the identification of under-served communities for inclusion in trials. The trials have different designs, address different needs and demonstrate recruitment planning across Trauma centres, NHS Trusts and special educational settings. We describe our use of national freely available datasets, such as those provided by NHS Digital and the Office for National Statistics, to identify potential recruitment sites with consideration of health status, socio-economic status and ethnicity as well as clinical and risk factors to support inclusivity. For all three studies, we produced lists of potential recruitment sites in excess of the number anticipated as necessary to meet the recruitment targets. Discussion We reflect on the challenges to our approach and some potential future developments. The datasets used are all free to use but each has their limitations. Agreeing search parameters, acceptable proxies and identifying the appropriate datasets, then cross referencing between datasets takes considerable time and particular expertise. The case studies are trials, but the methods are generalisable for various other study types. Conclusion Through these exemplars, we aim to build on the NIHR INCLUDE project, by providing trialists with a much needed practical approach to embedding EDI into trial design at the grant application stage.

Background Older adults with multimorbidity experience impaired health-related quality of life and treatment burden. Yoga has the potential to improve several aspects of health and well-being. The British Wheel of Yoga’s Gentle Years Yoga© programme was developed specifically for older adults, including those with chronic conditions. A pilot trial demonstrated feasibility of using Gentle Years Yoga in this population, but there was limited evidence of its effectiveness and cost-effectiveness. Objective To determine the effectiveness and cost-effectiveness of the Gentle Years Yoga programme in addition to usual care versus usual care alone in older adults with multimorbidity. Design Pragmatic, multisite, individually randomised controlled trial with embedded economic and process evaluations. Setting Participants were recruited from 15 general practices in England and Wales from July 2019 with final follow-up in October 2022. Participants Community-dwelling adults aged 65 years and over with multimorbidity, defined as two or more chronic health conditions from a predefined list. Interventions All participants continued with any usual care provided by primary, secondary, community and social services. The intervention group was offered a 12-week programme of Gentle Years Yoga. Main outcome measures The primary outcome and end point were health-related quality of life measured using the EuroQol-5 Dimensions, five-level version utility index score over 12 months. Secondary outcomes were health-related quality of life, depression, anxiety, loneliness, incidence of falls, adverse events and healthcare resource use. Results The mean age of the 454 randomised participants was 73.5 years; 60.6% were female, and participants had a median of three chronic conditions. The primary analysis included 422 participants (intervention, n = 227 of 240, 94.6%; usual care, n = 195 of 214, 91.1%). There was no statistically or clinically significant difference in the EuroQol-5 Dimensions, five-level version utility index score over 12 months: the predicted mean score for the intervention group was 0.729 (95% confidence interval 0.712 to 0.747) and for usual care it was 0.710 [95% confidence interval (CI) 0.691 to 0.729], with an adjusted mean difference of 0.020 favouring intervention (95% CI −0.006 to 0.045, p = 0.14). No statistically significant differences were observed in secondary outcomes, except for the pain items of the Patient-Reported Outcomes Measurement Information System-29. No serious, related adverse events were reported. The intervention cost £80.85 more per participant (95% CI £76.73 to £84.97) than usual care, generated an additional 0.0178 quality-adjusted life-years per participant (95% CI 0.0175 to 0.0180) and had a 79% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. The intervention was acceptable to participants, with seven courses delivered face to face and 12 online. Limitations Self-reported outcome data raise the potential for bias in an unblinded trial. The COVID-19 pandemic affected recruitment, follow-up and the mode of intervention delivery. Conclusions Although the Gentle Years Yoga programme was not associated with any statistically significant benefits in terms of health-related quality of life, mental health, loneliness or falls, the intervention was safe, acceptable to most participants and highly valued by some. The economic evaluation suggests that the intervention could be cost-effective. Future work Longer-term cost-effectiveness modelling and identifying subgroups of people who are most likely to benefit from this type of intervention. Trial registration This trial is registered as ISRCTN13567538. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/94/36) and is published in full in Health Technology Assessment; Vol. 28, No. 53. See the NIHR Funding and Awards website for further award information. Plain language summary It is common for older adults to have two or more long-term health conditions. These conditions affect quality of life differently, with some people feeling well and others needing healthcare support. The Gentle Years Yoga programme was developed to improve quality of life for older adults, including those with long-term health conditions. We wanted to see how well the programme worked and if it offered good value for money for the NHS. We tested whether offering a 12-week course of Gentle Years Yoga improved the quality of life and reduced anxiety, depression, loneliness and falls for people aged 65 years and over who had two or more long-term health conditions. We recruited 454 people through general practices across England and Wales, with 240 people selected at random to be invited to take part in the Gentle Years Yoga programme and the other 214 to continue with their usual care and not be offered Gentle Years Yoga. The average age of participants was 74 years, nearly two-thirds were female and the number of long-term health conditions participants had ranged from two to nine (average was three). They completed four questionnaires over a 12-month period. We also interviewed some of the participants and the yoga teachers to find out how the approach worked in practice. The yoga was delivered either face to face or online. We did not find any significant benefits in terms of quality of life, anxiety, depression, loneliness or falls. At interview, some yoga participants noted no or a modest impact on their health or lifestyle, while others described Gentle Years Yoga as transformative, having substantial impacts and improvements on their physical health and emotional well-being. Because running the yoga classes was relatively inexpensive and some insignificant benefits were seen, the Gentle Years Yoga programme may be good value for money. Scientific summary Background Multimorbidity, having two or more chronic health conditions, is a major challenge for older adults and increases healthcare utilisation and associated costs. Multimorbidity is associated with reduced health-related quality of life (HRQoL), impaired functional status, worse physical and mental health and premature death. In 2015, 54% of people aged 65 years and over in England had multimorbidity. There has been limited exploration of the effectiveness of interventions to improve outcomes for people with multimorbidity. There is some evidence to suggest that yoga may help to prevent and treat various physical and mental illnesses and improve HRQoL. The available data offer support for the beneficial effects of yoga in older adults and for several chronic conditions. However, robust evidence of clinical and cost effectiveness is limited, and little research has specifically focused on older adults with multimorbidity. The Gentle Years Yoga (GYY) programme was developed to cater specifically to the needs of older adults, including those with health conditions common to an older cohort such as osteoarthritis, hypertension and cognitive impairment. A pilot randomised trial of the GYY programme (n = 52 adults, mean age 75 years) demonstrated feasibility, with a potential for a clinically important benefit on health status [EuroQol-5 Dimensions, five-level version (EQ-5D-5L) utility index score] at 3 months after randomisation [mean difference 0.12, 95% confidence interval (CI) 0.03 to 0.21]. Consequently, we conducted this larger trial, as if shown to be clinically and cost-effective, GYY could be widely implemented, leading to improved outcomes for this population. Objectives The primary objective was to establish if the offer of a 12-week GYY programme in addition to usual care is more effective compared with usual care alone in improving HRQoL (EQ-5D-5L utility index score) over 12 months in people aged 65 years or over with multimorbidity. Secondary objectives were to: explore the effect of the GYY programme on HRQoL, depression, anxiety, loneliness and incidence of falls explore the safety of the GYY programme in terms of the occurrence of adverse events assess the cost-effectiveness of the GYY programme undertake a qualitative process evaluation to explore the acceptability of the intervention and the experience of participants and teachers, explain the determinants of delivery and identify the optimal implementation strategies. Methods Design This was a multisite, two-arm, parallel-group, superiority, individually randomised controlled trial comparing an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer of GYY in community-dwelling people aged 65 years or over who had multimorbidity. Both trial arms continued with any usual care provided by primary, secondary, community and social services. The study also included cost-effectiveness and qualitative process evaluations. Setting Participants were recruited from primary care general practices in the UK. General practices interested in taking part in the trial were identified with help from the NHS Clinical Research Networks and the Health and Care Research Wales Support and Delivery Centre. General practices were selected based on their proximity to yoga class venues and local transport routes. The yoga courses were delivered either face-to-face in a yoga studio, community hall or leisure centre or online via video conferencing during periods of social distancing restrictions. The trial’s yoga consultants identified yoga teachers who were eligible and potentially interested in taking part in the trial. Yoga teachers needed to have completed the British Wheel of Yoga (BWY) Qualification Level 4 Teaching GYY and have valid BWY membership and insurance. For online courses, teachers also needed to be proficient in remote teaching. Participant recruitment and consent Patients were eligible to join the study if they were aged 65 years or older, community-dwelling and had two or more of the predefined chronic health conditions derived from the NHS Quality and Outcomes Framework. Exclusion criteria were: inability to attend one of the GYY courses on offer; yoga practice in the previous 6 months; contraindications to yoga participation; severe mental health problem; learning disability; or being unable to provide consent and/or return the baseline questionnaire. For online classes, ineligibility also included no internet access; inability to use the internet; no suitable device; insufficient space at home; and/or no sturdy chair for use during the classes. Potential participants were identified by searching general practitioner (GP) electronic patient databases. Participating practices ran a custom-built search, based on predefined read codes, which identified patients with eligible health conditions. Potentially eligible patients were sent a recruitment pack including an information sheet and, if interested, were invited to sign and return a consent form. After the research team checked their suitability for the trial with their GP, eligible patients were asked to provide baseline data on sociodemographic measures, primary and secondary outcome measures and preferences/beliefs for the treatments on offer in the trial. Participants indicated on the consent form if they also wanted to be considered to take part in the process evaluation interviews. Intervention and comparison Gentle Years Yoga is designed for older adults, including those with chronic conditions. Based on standard Hatha Yoga, it incorporates physical postures and transitions as well as breathing, concentration and relaxation activities. The aims of GYY are to improve muscle strength, flexibility, balance, mobility and mental and social well-being. Chairs are used for seated exercise and support when standing. The yoga practices are modified so individuals with varying medical conditions and functional abilities can participate safely. Props are used to modify some of the postures and concentration activities. The physical challenge of each posture can be progressed throughout the course as participants become more able and confident. Participants randomised to the intervention were invited to take part in a free GYY course. Each course involved 12, 75-minute sessions of group-based yoga, usually delivered 1 week apart, either face to face or online. Each class included: ‘housekeeping’ activities (5 minutes); an introduction to the theme and practices of the class, basic breathing and focusing activities (5 minutes); an extended warmup/mobilisation and preparatory postures (30–35 minutes); focused postures and restorative activities (10–15 minutes); breathing exercises (5–10 minutes); and relaxation and concentration activities (5–10 minutes), followed by optional after-class social time (15–30 minutes). Throughout the trial, both trial arms continued with any usual care provided by primary care, secondary care, community and social services. Sample size We proposed to randomise 586 participants in a 1:1 ratio to be able to detect a difference of 0.06 in EQ-5D-5L utility index score, assuming a standard deviation (SD) of 0.20, with 90% power, a two-sided alpha of 0.05 and 20% attrition. In October 2021, an interim calculation of the correlation between baseline and 12-month EQ-5D-5L utility index score indicated we would be able to detect a clinically important difference with close to or greater than 90% power with 454 participants, since the primary analysis adjusted for baseline score, which affords gains in power. Randomisation Participants were randomised via a central, computer-based randomisation system designed and managed by York Trials Unit (YTU), University of York. Randomisation was stratified by site using varying block sizes and allocation ratios. Blinding of participants or the yoga teachers was not possible. Outcome measures Outcomes were self-reported by the participant and collected using questionnaires at baseline and 3, 6 and 12 months after randomisation. The primary outcome and end point was the EQ-5D-5L utility index score over the 12-month follow-up period. Utility index scores were calculated following current National Institute for Health and Care Excellence guidance. Secondary outcomes were: EQ-5D-5L utility index score at 3, 6 and 12 months after randomisation EQ-5D-5L visual analogue scale (VAS) score at 3, 6 and 12 months and overall HRQoL at 3, 6 and 12 months and overall using PROMIS-29 (v2.1) depression severity at 3, 6 and 12 months and overall using the Patient Health Questionnaire-8 (PHQ-8) anxiety severity at 3, 6 and 12 months and overall using the Generalised Anxiety Disorder-7 (GAD-7) loneliness at 3, 6 and 12 months and overall. Questions used to capture loneliness were taken from the English Longitudinal Study of Ageing (ELSA), based on the University of California, Los Angeles 3-item (UCLA-3) loneliness scale and a direct question about how often the respondent felt lonely the incidence of falls, adverse events and healthcare resource use over 12 months. Analysis All analyses were conducted in Stata version 17 (StataCorp LP, College Station, TX, USA) following the principles of intention-to-treat using two-sided statistical tests at the 5% significance level. The primary outcome was analysed using a linear mixed model, including data at all available follow-up time points, adjusting for baseline EQ-5D-5L utility index score, time point, trial arm and an arm-by-time interaction as fixed effects. Participant (to account for the repeated measures) and site were included as random effects. In sensitivity analyses, age, gender and adapted Bayliss (severity-adjusted count of health conditions) score were added as covariates to the primary analysis model, and the site was substituted for yoga teacher as a random effect. Complier-average causal effect (CACE) analyses, using a two-stage instrumental variable regression approach with randomised group as the instrumental variable, were implemented to assess the impact of receiving GYY on the primary treatment estimate. A subgroup analysis was conducted to assess for differential effects of the intervention based on mode of delivery (face to face or online). The secondary outcomes of EQ-5D VAS, GAD-7, PHQ-8, T-scores from each of the seven subscales of the PROMIS-29 and the physical and mental health component scores and the global item score, UCLA-3 score and ELSA single-item direct loneliness question were analysed using the same methods as for the primary outcome, with baseline EQ-5D-5L utility index score swapped as a covariate for baseline value of the outcome. The incidence of falls during the 12-month follow-up period was analysed using a mixed-effect negative binomial regression model, adjusting for the number of falls in the 3 months prior to baseline and site as a random effect. Adverse events are summarised descriptively. Economic analysis The economic analysis assessed the relative cost-effectiveness of the GYY programme in addition to continued access to usual care compared with usual care alone. Costs and health outcomes were evaluated from the perspective of the NHS and Personal Social Services using a within-trial economic analysis and a cost–consequence analysis, both over a 12-month time horizon; hence, discounting was not required. Health outcomes were assessed in terms of quality-adjusted life-years (QALYs) using EQ-5D-5L data, with costs collected for healthcare resource use, medications and the intervention. Findings were presented in terms of the incremental cost-effectiveness ratio for the intervention versus usual care and net monetary benefit. The base-case analysis was undertaken on an intention-to-treat basis, with multiple imputation used to deal with missing data and sensitivity analyses conducted to explore uncertainty around the cost-effectiveness findings. Process evaluation The process evaluation was informed by qualitative interviews with trial participants, trial decliners, trial yoga teachers and stakeholders, as well as by observations of standardisation training sessions and yoga classes. Intervention fidelity was assessed by class observation and via interviews with teachers as part of the process evaluation. Interviews were audio-recorded, transcribed verbatim and edited to ensure respondent anonymity. Data analysis was iterative throughout the trial and conducted according to standard procedures of qualitative analysis. Results Between July 2019 and August 2021, 13,070 invitation packs were sent to potentially eligible participants, of which 1297 responded. Of these, 454 (35.0%) participants were randomised: 240 to the intervention and 214 to usual care. The mean age of participants was 73.5 years (range 65–99); 60.6% were female, and participants had a median of three chronic conditions. Among the intervention group, the mean number of GYY sessions attended was 8.8 (SD 3.7, median 10, range 0–12). Two hundred and twenty-two (92.5%) participants attended at least one session, and fifty-three (22.1%) attended all twelve. Eighty per cent (n = 192) attended at least three of the first six sessions and at least three other sessions. One participant in the usual care group was invited to attend classes in error; they attended eight sessions, including five of the first six. The primary analysis included 422 participants with valid EQ-5D-5L data at baseline and at least one post-randomisation time point (intervention n = 227 of 240, 94.6%; usual care n = 195 of 214, 91.1%). There was no statistically or clinically significant difference in the EQ-5D-5L utility index score over 12 months: the predicted mean score for the intervention group was 0.729 (95% CI 0.712 to 0.747) and for usual care was 0.710 (95% CI 0.691 to 0.729), with an adjusted mean difference of 0.020 favouring intervention (95% CI −0.006 to 0.045; p = 0.14). The sensitivity analyses produced very similar results. The CACE analyses, which considered compliance as attending (1) ≥1 GYY session and (2) ≥6 including 3 of the first 6, produced slightly greater, but not clinically relevant, treatment estimates (0.025, 95% CI −0.002 to 0.052; p = 0.07; and 0.029, 95% CI −0.002 to 0.059; p = 0.06, respectively). There was no evidence of an interaction between trial arm and intended mode of delivery (interaction effect 0.007, 95% CI −0.042 to 0.057; p = 0.77). No statistically significant differences were observed in secondary outcomes, except in the T-score for the pain interference subscale of the PROMIS-29 at 3 months (−1.44, 95% CI −2.63 to −0.26; p = 0.02) and over the 12 months (−1.14, 95% CI −2.24 to −0.04; p = 0.04), and in the global (pain intensity) PROMIS-29 item at 12 months (−0.45, 95% CI −0.83 to −0.08; p = 0.02) and over the 12 months (−0.32, 95% CI −0.61 to −0.04; p = 0.03), favouring intervention. No serious, related adverse events were reported. Economic evaluation The base-case economic evaluation found that the intervention cost £80.85 more per participant (95% CI £76.73 to £84.97) than usual care, generated an additional 0.0178 QALYs per participant (95% CI 0.0175 to 0.0180) and had a 79% probability of being cost-effective at the willingness-to-pay threshold of £20,000 per QALY gained. Process evaluation Participants found both face-to-face and online courses acceptable. Participants were highly motivated; most viewed their health as good and engaged well with the GYY classes over time. The majority viewed GYY as a form of gentle exercise with mindful breathing. Some participants noted no or only a modest impact of GYY on their health or lifestyle, including physical, psychological and self-management benefits, while others described GYY as transformative, having substantial impacts and improvements on their physical health and emotional well-being. Conclusions The offer of a 12-week GYY programme was not associated with any statistically significant benefits in terms of HRQoL, mental health, loneliness or falls in older adults with multimorbidity. However, the intervention was safe, acceptable to most participants and highly valued by some. The economic evaluation suggests that the intervention could be cost-effective. Trial registration This trial is registered as ISRCTN13567538. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/94/36) and is published in full in Health Technology Assessment; Vol. 28, No. 53. See the NIHR Funding and Awards website for further award information.

Background People with multiple long-term conditions are more likely to have poorer health-related quality of life (HRQOL). Yoga has the potential to improve HRQOL. Gentle Years Yoga© (GYY) is a chair-based yoga programme for older adults. We investigated the effectiveness and cost-effectiveness of the GYY programme in older adults with multiple long-term conditions. Methods In this pragmatic, multi-site, open, randomised controlled trial, we recruited adults aged ≥65 years with ≥2 long-term conditions from 15 primary care practices in England and Wales. Participants were randomly assigned to usual care control or a 12-week, group-based, GYY programme delivered face-to-face or online by qualified yoga teachers. The primary outcome was HRQOL (EQ-5D-5L) over 12 months. Secondary outcomes included anxiety, depression, falls, loneliness, healthcare resource use, and adverse events. Results Between October 2019 and October 2021, 454 participants were randomised between the intervention (n=240) and control (n=214) groups. Seven GYY courses were delivered face-to-face and 12 courses were delivered online. The mean number of classes attended among all intervention participants was nine (SD 4, median 10). In our intention-to-treat analysis (n=422), there was no statistically significant difference between trial groups in the primary outcome of HRQOL (adjusted difference in mean EQ-5D-5L = 0.020 [favouring intervention]; 95% CI -0.006 to 0.045, p=0.14). There were also no statistically significant differences in key secondary outcomes. No serious, related adverse events were reported. The incremental cost-effectiveness ratio was £4,546 per quality-adjusted life-year (QALY) and the intervention had a 79% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY. The intervention was acceptable to most participants and perceived as useful by some. Conclusions The offer of a 12-week chair-based yoga programme in addition to usual care did not improve HRQOL in older adults with multiple long-term conditions. However, the intervention was safe, acceptable, and probably cost-effective.

Abstract Objective: (1) To explore the feasibility of such programmes in Australia, this study examined parents’ views on free school lunch provision. (2) To examine the associations between parents’ demographic and personal characteristics and their support for free universal school lunches. Design: An online cross-sectional survey of parents. Setting: Australia, April 2021. Participants: Seven hundred and eighty-seven parents took the survey. They had a mean age of 40. The respondents were predominantly female (95 %) and had a university degree (72 %). Results: Fifty-three percentage of the respondents agreed that all students should have access to healthy and well-balanced, free school lunches. Parents were concerned about healthiness, catering, allergies and cost of school-provided school lunches. Ethnic background, universalism values and education levels were significantly associated with support for free school lunch provision. Non-native English-speaking parents were almost three times more likely to support free universal lunches in primary schools than their native English-speaking counterparts. Parents with higher universalism-concern values were more likely to endorse free lunches in primary school. However, the level of education was negatively associated with parents’ support for free school lunches. Conclusions: The survey results highlight the complexity of parental views on free school lunch provision. Parents’ concerns regarding lunches should be considered in developing school lunch programmes that meet the needs and preferences of diverse communities. These findings can be used to guide future primary school lunch provision initiatives.

Background There is strong evidence that those recruited into studies are not always representative of the population for whom the research is most relevant. Development of the study design and funding decisions are points in the research process where considerations about inclusion of under-served populations may usefully be made. Current practical guidance focuses on designing and modifying participant recruitment and retention approaches but an area that has not been addressed is recruitment site selection. Methods We present case studies of three NIHR funded trials to demonstrate how publicly available UK population datasets can be used to facilitate the identification of under-served communities for inclusion in trials. The trials have different designs, address different needs and demonstrate recruitment planning across Trauma centres, NHS Trusts and special educational settings. We describe our use of national freely available datasets, such as those provided by NHS Digital and the Office for National Statistics, to identify potential recruitment sites with consideration of health status, socio-economic status and ethnicity as well as clinical and risk factors to support inclusivity. For all three studies, we produced lists of potential recruitment sites in excess of the number anticipated as necessary to meet the recruitment targets. Discussion We reflect on the challenges to our approach and some potential future developments. The datasets used are all free to use but each has their limitations. Agreeing search parameters, acceptable proxies and identifying the appropriate datasets, then cross referencing between datasets takes considerable time and particular expertise. The case studies are trials, but the methods are generalisable for various other study types. Conclusion Through these exemplars, we aim to build on the NIHR INCLUDE project, by providing trialists with a much needed practical approach to embedding EDI into trial design at the grant application stage.

Background Young adults who commit low-level offences commonly have a range of health and social needs and are significantly over-represented in the criminal justice system. These young adults may need to attend court and potentially receive penalties including imprisonment. Alternative routes exist, which can help address the underlying causes of offending. Some feel more should be done to help young adults entering the criminal justice system. The Gateway programme was a type of out-of-court disposal developed by Hampshire Constabulary, which aimed to address the complex needs of young adults who commit low-level crimes. This study aimed to evaluate the effectiveness and cost-effectiveness of the Gateway programme, issued as a conditional caution, compared with usual process.Methods The Gateway study was a pragmatic, parallel-group, superiority randomised controlled trial that recruited young adults who had committed a low-level offence from four sites covering Hampshire and Isle of Wight. The primary outcome was mental health and well-being measured using the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes were quality of life, alcohol and drug use, and recidivism. Outcomes were measured at 4, 16 and 52 weeks postrandomisation.Results Due to issues with retention of participants and low data collection rates, recruitment ended early, with 191 eligible participants randomised (Gateway 109; usual process 82). The primary outcome was obtained for 93 (48.7%) participants at 4 weeks, 93 (48.7%) at 16 weeks and 43 (22.5%) at 1 year. The high attrition rates meant that effectiveness could not be assessed as planned.Conclusions Gateway is the first trial in a UK police setting to have a health-related primary outcome requiring individual data collection, rather than focusing solely on recidivism. We demonstrated that it is possible to recruit and randomise from the study population, however follow-up rates were low. Further work is needed to identify ways to facilitate engagement between researchers and vulnerable populations to collect data.Trial registration number ISRCTN11888938.

Abstract Objective: To explore what Australian primary school parents want to learn about food and nutrition to improve their children’s eating behaviours, as well as the associations between parents’ personal and demographic characteristics and their views regarding their food and nutrition knowledge needs. Design: An online nationwide cross-sectional survey was conducted in 2021 using a mixed-methods approach. Logistic regression analysis was utilised to examine the relationship between parents’ demographics, personal values and their views. Content analysis was performed using Leximancer. Setting: Australia. Participants: Seven hundred and eighty-seven parents. Results: Fifty-one per cent wanted to learn more about food and nutrition to improve their children's healthy eating habits, and 77% of those preferred schools to provide that information. Online/printed newsletters and YouTube were the most preferred methods for receiving food and nutrition related information. Higher universalism-concern value (concern for the welfare of those in the larger society and world) scores were positively associated parents’ preference for schools to provide food and nutrition-related information. Parents with non-English-speaking backgrounds and younger parents were more likely to want to learn about food and nutrition. Parents wanted to learn more about encouraging healthy eating, ideas for the lunchbox, food labels and age-specific portion sizes and recommendations. Conclusions: Findings can inform public health educators and assist them in designing future food and nutrition education programmes and resources targeting primary school parents.

BackgroundThe treatment of non–small cell lung cancer (NSCLC) has evolved dramatically with the approval of immuno-oncology (IO) and targeted therapies (TTs). Insights on the patient experience with these therapies and their impacts are lacking. Health-related social media has been increasingly used by patients to share their disease and treatment experiences, thus representing a valuable source of real-world data to understand the patient’s voice and uncover potential unmet needs. ObjectiveThis study aimed to describe the experiences of patients with NSCLC as reported in discussions posted on lung cancer–specific social media with respect to their disease symptoms and associated impacts. MethodsPublicly available posts (2010-2019) were extracted from selected lung cancer– or NSCLC-specific websites. Social media users (patients and caregivers posting on these websites) were stratified by metastatic- and adjuvant-eligible subgroups and treatment received using natural language processing (NLP) and machine learning methods. Automated identification of symptoms was conducted using NLP. Qualitative data analysis (QDA) was conducted on random samples of posts mentioning pain-related, fatigue-related, respiratory-related, or infection-related symptoms to capture the patient experience with these and associated impacts. ResultsOverall, 1724 users (50,390 posts) and 574 users (4531 posts) were included in the metastatic group and adjuvant group, respectively. Among users in the metastatic group, pain, discomfort, and fatigue were the most commonly mentioned symptoms (49.7% and 39.6%, respectively), and in the QDA (258 posts from 134 users), the most frequent impacts related to physical impairments, sleep, and eating habits. Among users in the adjuvant group, pain, discomfort, and respiratory symptoms were the most commonly mentioned (44.8% and 23.9%, respectively), and impacts identified in the QDA (154 posts from 92 users) were mostly related to physical functioning. ConclusionsFindings from this exploratory observational analysis of social media among patients and caregivers informed the lived experience of NSCLC in the era of novel therapies, shedding light on most reported symptoms and their impacts. These findings can be used to inform future research on NSCLC treatment development and patient management.

Background: Poor response rates to follow-up questionnaires can adversely affect the progress of a randomised controlled trial and the validity of its results. This embedded ‘study within a trial’ aimed to investigate the impact of including a pen with the postal 3-month questionnaire completed by the trial participants on the response rates to this questionnaire. Methods: This study was a two-armed randomised controlled trial nested in the Gentle Years Yoga (GYY) trial. Participants in the intervention group of the GYY trial were allocated 1:1 using simple randomisation to either receive a pen (intervention) or no pen with their 3-month questionnaire (control). The primary outcome was the proportion of participants sent a 3-month questionnaire who returned it. Secondary outcomes were time taken to return the questionnaire, proportion of participants sent a reminder to return the questionnaire, and completeness of the questionnaire. Binary outcomes were analysed using logistic regression, time to return by Cox Proportional hazards regression and number of items completed by linear regression. Results: There were 111 participants randomised to the pen group and 118 to the no pen group who were sent a 3-month questionnaire. There was no evidence of a difference in return rates between the two groups (pen 107 (96.4%), no pen 117 (99.2%); OR 0.23, 95% CI 0.02 to 2.19, p=0.20). Furthermore, there was no evidence of a difference between the two groups in terms of time to return the questionnaire (HR 0.90, 95% CI 0.69 to 1.18, p=0.47), the proportion of participants sent a reminder (OR 0.85, 95% CI 0.48 to 1.53, p=0.60) nor the number of items completed (mean difference 0.51, 95% CI -0.04 to 1.06, p=0.07). Conclusion: The inclusion of a pen with the postal 3-month follow-up questionnaire did not have a statistically significant effect on response rate.

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

Abstract Background Primary schools have long been identified as appropriate settings for improving the healthy eating behaviours of children and helping them develop food skills. This qualitative study explored the views of Australian primary school parents and teachers about schools’ strengths and weaknesses in promoting healthy eating and equipping children with food skills. Methods Nineteen parents and 17 teachers from Victoria participated in semi-structured interviews. Audio recordings were transcribed and underwent thematic analysis using Nvivo. Results This study demonstrated that parents and teachers believed that several facilitators helped promote children’s healthy eating. These included food and nutrition education (FNE) programs, the community-based nature of schools, and teacher role modelling and the authority schools possess over children. Time scarcity, lack of teacher expertise, lack of leadership and funding were reported as barriers. School food environments such as canteens, lunch orders, fundraising events and school fairs were identified as both weaknesses and strengths by parents and teachers, which indicated inconsistent implementation of school nutrition policies across schools. Conclusions Australian primary schools demonstrate some useful efforts to promote healthy eating among children. However, there are numerous facilitators and barriers which impact on the promotion of healthy eating. These factors need to be addressed in order to develop healthy eating habits further among elementary students. These results provide directions for policymakers and school managers, as they point to the areas that need to be improved to assist the design of schools that better promote healthy eating among children.

Background: Poor response rates to follow-up questionnaires can adversely affect the progress of a randomised controlled trial and the validity of its results. This embedded ‘study within a trial’ aimed to investigate the impact of including a pen with the postal 3-month questionnaire completed by the trial participants on the response rates to this questionnaire. Methods: This study was a two-armed randomised controlled trial nested in the Gentle Years Yoga (GYY) trial. Participants in the intervention group of the GYY trial were allocated 1:1 using simple randomisation to either receive a pen (intervention) or no pen with their 3-month questionnaire (control). The primary outcome was the proportion of participants sent a 3-month questionnaire who returned it. Secondary outcomes were time taken to return the questionnaire, proportion of participants sent a reminder to return the questionnaire, and completeness of the questionnaire. Binary outcomes were analysed using logistic regression, time to return by Cox Proportional hazards regression and number of items completed by linear regression. Results: There were 111 participants randomised to the pen group and 118 to the no pen group who were sent a 3-month questionnaire. There was no evidence of a difference in return rates between the two groups (pen 107 (96.4%), no pen 117 (99.2%); OR 0.23, 95% CI 0.02 to 2.19, p=0.20). Furthermore, there was no evidence of a difference between the two groups in terms of time to return the questionnaire (HR 0.90, 95% CI 0.69 to 1.18, p=0.47), the proportion of participants sent a reminder (OR 0.85, 95% CI 0.48 to 1.53, p=0.60) nor the number of items completed (mean difference 0.51, 95% CI -0.04 to 1.06, p=0.07). Conclusion: The inclusion of a pen with the postal 3-month follow-up questionnaire did not have a statistically significant effect on response rate.

Abstract There is limited information about the initiation of triple therapy (TT) in patients with chronic obstructive pulmonary disease (COPD) in primary care. This was an observational, population-based study in patients identified from a primary care electronic medical records database in Catalonia from 2011 to 2015 aimed to identify the use of TT in patients with newly diagnosed COPD. A total of 69,668 newly diagnosed patients were identified of whom 11,524 (16.5%) initiated TT, of whom 8626 initiated TT at or immediately after COPD diagnosis. Among them, 72.3% were GOLD A/B, 14.6% were frequent exacerbators, and 7.1% had asthma–COPD overlap (ACO). Variables associated with TT initiation were: male sex, older age, previous exacerbations, ACO, a previous treatment regimen containing an inhaled corticosteroid, previous pneumonia, and history of lung cancer. A significant number of COPD patients in Primary Care initiated TT shortly after or even before an established COPD diagnosis.

BackgroundImmunotherapy and targeted therapy treatments are novel treatments available for patients with metastatic and adjuvant melanoma. As recently approved treatments, information surrounding the patients’ and caregivers’ experience with these therapies, perceptions of treatments, and the effect the treatments have on their day-to-day life are lacking. Such insights would be valuable for any future decision-making with regard to treatment options. ObjectiveThis study aims to use health-related social media data to understand the experience of patients with adjuvant and metastatic melanoma who are receiving either immunotherapy or targeted therapies. This study also included caregivers’ perspectives. MethodsPublicly available social media forum posts by patients with self-reported adjuvant or metastatic melanoma (and their caregivers) between January 2014 to October 2019 were programmatically extracted, deidentified, cleaned, and analyzed using a combination of natural language processing and qualitative data analyses. This study identified spontaneously reported symptoms and their impacts, symptom duration, and the impact of treatment for both treatment groups. ResultsOverall, 1037 users (9023 posts) and 114 users (442 posts) were included in the metastatic group and adjuvant group, respectively. The most identified symptoms in both groups were fatigue, pain, or exanthema (identified in 5%-43% of patients dependent on the treatment group). Symptom impacts reported by both groups were physical impacts, impacts on family, and impacts on work. Positive treatment impacts were reported in both groups and covered the areas of work, social and family life, and general health and quality of life. ConclusionsThis study explored health-related social media to better understand the experience and perspectives of patients with melanoma receiving immunotherapy or targeted therapy treatments as well as the experience of their caregivers. This exploratory work uncovered the most discussed concerns among patients and caregivers on the forums including symptoms and their impacts, thus contributing to a deeper understanding of the patient/caregiver experience.

Understanding factors that promote student engagement with online learning environments is important for benchmarking and improving the quality of teaching in a digital era. This study aimed to describe the online interactive content created for delivery of an undergraduate nutrition course and to evaluate student engagement with the online interactive content. We collected online questionnaire data in 2018 and 2019 from two cohorts of students enrolled in a Deakin University undergraduate nutrition unit. Two-sample unpaired t-tests were used to examine differences in participant engagement with online topic guides between static text-based and interactive content. A total of 89 participants (19–56 years) were included. Sixty four of students reported always/usually reading static text-based topic guides most weeks and 64% perceived them as moderately/highly effective. While 60% of participants reported reading the online interactive topic guides most weeks and 93% perceived them as moderate/highly effective. Most participants indicated the interactive topic guides were more effective than static text-based topic guides they experienced in other courses (76%). Hours dedicated to the online interactive topic guide were higher (6.4 SD 2.9 vs. 1.7 SD 1.7 h; P < 0.001) as was the rating of how engaging the topic guides were (7.2 SD 1.6 vs. 6.7 SD 2.5; P = 0.008). These findings suggest that interactive content is more engaging. However, this content may not be accessible to all students, and so familiarization and training prior to engaging in an interactive online unit may be needed.

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

Abstract Background Measures shown to improve outcomes for patients often fail to be adopted into routine practice in the NHS. The Institute for Health Improvement Breakthrough Series Collaborative (BSC) model is designed to support implementation at scale. This trial aims to assess the effectiveness and cost-effectiveness of quality improvement collaboratives (QICs) based on the BSC method for introducing service improvements at scale in the NHS. Methods Forty Trusts will be randomised (1:1) to introduce one of two protocols already shown to improve outcomes in patients undergoing elective total hip and knee replacement surgery. The intervention is improvement collaboratives based on the BSC model, a learning system that brings together a large number of teams to seek improvement focussed on a proven intervention. Collaboratives aim to deliver at scale, maximise local engagement and leadership and are designed to build capacity, enable learning and prepare for sustainability. Collaboratives involve Learning Sessions, Action Periods, and a summative congress. Trusts will be supported to introduce either: decolonisation for Methicillin Sensitive Staphylococcus aureus (MSSA) to reduce post-operative infection (QIST: Infection), or an anaemia optimisation programme to reduce peri-operative blood transfusions (QIST: Anaemia). Trusts will continue with their usual practice for whichever protocol they are not introducing. Anonymised data related to both infection and anaemia outcomes for patients undergoing hip or knee arthroplasty at all sites will mean that the two groups act as controls for each other. The primary outcome for the QIST: Infection collaborative is deep MSSA surgical site infection within 90 days of surgery, and for the QIST: Anaemia collaborative is blood transfusion within 7 days of surgery. Patient-level secondary outcomes include length of hospital stay and readmission, which will also inform the economic costings. Qualitative interviews will evaluate the support provided to teams. Discussion The scale of this trial brings considerable challenges and potential barriers to delivery. Anticipated challenges relate to recruiting and sustaining up to 40 organisations, each with its own culture and context. This complex project with multiple stakeholders across a large geographical area will be managed by experienced senior-level project leaders with a proven track record in advanced project management. The team should ensure effective project governance and communications. Trial registration ISRCTN, ISRCTN11085475. Prospectively registered on 15 February 2018.

Background: There is informal consensus that simple compression fractures of the body of the thoracolumbar vertebrae between the 10th thoracic vertebra and the second lumbar vertebra without neurological complications can be managed conservatively and that obvious unstable fractures require surgical fixation. However, there is a zone of uncertainty about whether surgical or conservative management is best for stable fractures. Objectives: To assess the feasibility of a definitive randomised controlled trial comparing surgical fixation with initial conservative management of stable thoracolumbar fractures without spinal cord injury. Design: External randomised feasibility study, qualitative study and national survey. Setting: Three NHS hospitals. Methods: A feasibility randomised controlled trial using block randomisation, stratified by centre and type of injury (high- or low-energy trauma) to allocate participants 1 : 1 to surgery or conservative treatment; a costing analysis; a national survey of spine surgeons; and a qualitative study with clinicians, recruiting staff and patients. Participants: Adults aged ≥ 16 years with a high- or low-energy fracture of the body of a thoracolumbar vertebra between the 10th thoracic vertebra and the second lumbar vertebra, confirmed by radiography, computerised tomography or magnetic resonance imaging, with at least one of the following: kyphotic angle > 20° on weight-bearing radiographs or > 15° on a supine radiograph or on computerised tomography; reduction in vertebral body height of 25%; a fracture line propagating through the posterior wall of the vertebra; involvement of two contiguous vertebrae; or injury to the posterior longitudinal ligament or annulus in addition to the body fracture. Interventions: Surgical fixation: open spinal surgery (with or without spinal fusion) or minimally invasive stabilisation surgery. Conservative management: mobilisation with or without a brace. Main outcome measure: Recruitment rate (proportion of eligible participants randomised). Results: Twelve patients were randomised (surgery, n = 8; conservative, n = 4). The proportion of eligible patients recruited was 0.43 (95% confidence interval 0.24 to 0.63) over a combined total of 30.7 recruitment months. Of 211 patients screened, 28 (13.3%) fulfilled the eligibility criteria. Patients in the qualitative study (n = 5) expressed strong preferences for surgical treatment, and identified provision of information about treatment and recovery and when and how they are approached for consent as important. Nineteen surgeons and site staff participated in the qualitative study. Key themes were the lack of clinical consensus regarding the implementation of the eligibility criteria in practice and what constitutes a stable fracture, alongside lack of equipoise regarding treatment. Based on the feasibility study eligibility criteria, 77% (50/65) and 70% (46/66) of surgeons participating in the survey were willing to randomise for high- and low-energy fractures, respectively. Limitations: Owing to the small number of participants, there is substantial uncertainty around the recruitment rate. Conclusions: A definitive trial is unlikely to be feasible currently, mainly because of the small number of patients meeting the eligibility criteria. The recruitment and follow-up rates were slightly lower than anticipated; however, there is room to increase these based on information gathered and the support within the surgical community for a future trial. Future work: Development of consensus regarding the population of interest for a trial. Trial registration: Current Controlled Trials ISRCTN12094890. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 62. See the NIHR Journals Library website for further project information.

Objectives The prevalence of diabetes has reportedly increased among adolescents in low-income and middle-income countries of the Middle East and may be linked to social, demographic and economic contextual factors. This study aimed: (1) to estimate the prevalence of self-reported diagnosis of diabetes in the adolescent population of the United Arab Emirates (UAE); (2) to assess differences in the prevalence based on gender and (3) to identify other characteristics of those with diabetes including parental marital status, smoking/illegal drug use, quality of life and nationality.Design A secondary data analysis was performed on data from the National Study of Population Health in the UAE, conducted between 2007 and 2009.Setting Large cross-sectional population-based survey study.Participants Survey was administered to a stratified random sample of 151 public and private schools from the UAE, across 7 emirates. 6365 school-attending adolescents (12–22 years; mean=16 years) participated.Outcomes Multivariable logistic regression analysis was used to examine the relationships between diabetes diagnosis and characteristics of participants after adjusting for confounding from other predictors.Results The overall prevalence of self-reported diabetes was 0.9% (95% CI 0.7% to 1.2%) and was higher in males 1.5% (95% CI 1.0% to 2.1%) than females 0.5% (95% CI 0.3% to 0.8%), (p

Parents and teachers have a major influence in the formation of primary school children’s eating behaviours. Although the cooperation of parents and teachers has frequently been recommended in the promotion of healthy eating habits among primary school children, little is known about the communication between these two groups regarding food- and nutrition-related issues. This paper reports findings from semi-structured interviews with primary school parents (n = 19) and primary teachers (n = 17), as well as findings from a survey of 787 parents in Australia. Audio-recorded interviews were analysed using NVivo and descriptive statistics were calculated for the survey questions. The results indicated that their communications involved various topics, including allergies, lunchbox content, and supervision requests, through diverse communication channels. The risk of offending each other and time scarcity were reported as communication barriers. Parents mainly expected teachers to ensure that their children were given enough time to eat their lunch, teach healthy eating, and be good role models of healthy eating. This study highlights the need to overcome communication barriers between parents and teachers and support teachers in their multifaceted professional roles.

Objectives Preoperative anaemia is associated with increased risks of postoperative complications, blood transfusion and mortality. This meta-analysis aims to review the best available evidence on the clinical effectiveness of preoperative iron in anaemic patients undergoing elective total hip (THR) or total knee replacement (TKR).Design Electronic databases and handsearching were used to identify randomised and non-randomised studies of interventions (NRSI) reporting perioperative blood transfusion rates for anaemic participants receiving iron before elective THR or TKR. Searches of CENTRAL, MEDLINE, Embase, PubMed and other databases were conducted on 17 April 2019 and updated on 15 July 2020. Two investigators independently reviewed studies for eligibility and evaluated risk of bias using the Cochrane risk of bias tool for randomised controlled trials (RCTs) and a modified Newcastle-Ottawa scale for NRSIs. Data extraction was performed by ABS and checked by AB. Meta-analysis used the Mantel-Haenszel method and random-effects models.Results 807 records were identified: 12 studies met the inclusion criteria, of which 10 were eligible for meta-analyses (one RCT and nine NRSIs). Five of the NRSIs were of high-quality while there were some concerns of bias in the RCT. Meta-analysis of 10 studies (n=2178 participants) showed a 39% reduction in risk of receiving a perioperative blood transfusion with iron compared with no iron (risk ratio 0.61, 95% CI 0.50 to 0.73, p

Background: PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO contained the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Methods: A random sample of 439 single entry PROSPERO records of reviews of health interventions registered in 2018 was identified. Using a piloted list of 19 PRISMA-P items, divided into 63 elements, two researchers independently assessed the registration records. Where the information was present or not applicable to the review, a score of 1 was assigned. Overall scores were calculated and comparisons made by stage of review at registration, whether or not a meta-analysis was planned and whether or not funding/sponsorship was reported. Results: Some key methodological details, such as eligibility criteria, were relatively frequently reported, but much of the information recommended in PRISMA-P was not stated in PROSPERO registrations. Considering the 19 items, the mean score was 4.8 (SD 1.8; median 4; range 2-11) and across all the assessed records only 25% (2081/8227) of the items were scored as reported. Considering the 63 elements, the mean score was 33.4 (SD 5.8; median 33; range 18-47) and overall, 53% (14,469/27,279) of the elements were assessed as reported. Reporting was more frequent for items required in PROSPERO than optional items. The planned comparisons showed no meaningful differences between groups. Conclusions: PROSPERO provides reviewers with the opportunity to be transparent in their planned methods and demonstrate efforts to reduce bias. However, where the PROSPERO record is the only available source of a priori reporting, there is a significant shortfall in the items reported, compared to those recommended. This presents challenges in interpretation for those wishing to assess the validity of the final review.

Background: PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO contained the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Methods: A random sample of 439 single entry PROSPERO records of reviews of health interventions registered in 2018 was identified. Using a piloted list of 19 PRISMA-P items, divided into 63 elements, two researchers independently assessed the registration records. Where the information was present or not applicable to the review, a score of 1 was assigned. Overall scores were calculated and comparisons made by stage of review at registration, whether or not a meta-analysis was planned and whether or not funding/sponsorship was reported. Results: Some key methodological details, such as eligibility criteria, were relatively frequently reported, but much of the information recommended in PRISMA-P was not stated in PROSPERO registrations. Considering the 19 items, the mean score was 4.8 (SD 1.8; median 4; range 2-11) and across all the assessed records only 25% (2081/8227) of the items were scored as reported. Considering the 63 elements, the mean score was 33.4 (SD 5.8; median 33; range 18-47) and overall, 53% (14,469/27,279) of the elements were assessed as reported. Reporting was more frequent for items required in PROSPERO than optional items. The planned comparisons showed no meaningful differences between groups. Conclusions: PROSPERO provides reviewers with the opportunity to be transparent in their planned methods and demonstrate efforts to reduce bias. However, where the PROSPERO record is the only available source of a priori reporting, there is a significant shortfall in the items reported, compared to those recommended. This presents challenges in interpretation for those wishing to assess the validity of the final review.

Abstract Background There has been an increased drive towards Evidence Based Policing in recent years. Unlike in other public sector services, such as health and education, randomised controlled trials in the police setting are relatively rare. This paper discusses some of the methodological and practical challenges of conducting a randomised controlled trial in the police setting in the UK, based on our experience of the Connect trial. This pragmatic, cluster-randomised controlled trial investigated the effectiveness of a face-to-face training intervention for frontline officers in comparison to routine training. The primary outcome was the number of incidents which resulted in a police response reported to North Yorkshire Police control room in a 1-month period up to 6 months after delivery of training. Main text The methodological and practical challenges that we experienced whilst conducting the Connect trial are discussed under six headings: establishing the unit of randomisation; population of interest and sample size; co-production of evidence; time frame; outcomes; and organisational issues. Conclusion Recommendations on the conduct of future randomised controlled trials in the police setting are made. To understand the context in which research is undertaken, collaboration between police and academia is needed and police officers should be embedded within trial management groups. Engagement with police data analysts to understand what data is available and facilitate obtaining trial data is also recommended. Police forces may wish to review their IT systems and recording practices. Pragmatic trials are encouraged and time frames need to allow for trial set-up and obtaining relevant ethical approvals. Trial registration ISRCTN Registry, ID: ISRCTN11685602 . Retrospectively registered on 13 May 2016.

Abstract Background The police and others in occupations where they come into close contact with people experiencing/with mental ill health, often have to manage difficult and complex situations. Training is needed to equip them to recognise and assist when someone has a mental health issue or learning/intellectual disability. We undertook a systematic review of the effectiveness of training programmes aimed at increasing knowledge, changing behaviour and/or attitudes of the trainees with regard to mental ill health, mental vulnerability, and learning disabilities. Methods Databases searched from 1995 onwards included: ASSIA, Cochrane Central Register of Controlled Clinical Trials (CENTRAL), Criminal Justice Abstracts, Embase, ERIC, MEDLINE, PsycINFO, Social Science Citation Index. Courses, training, or learning packages aimed at helping police officers and others who interact with the public in a similar way to deal with people with mental health problems were included. Primary outcomes were change in practice and change in outcomes for the groups of people the trainees come into contact with. Systematic reviews, randomised controlled trials (RCTs) and non- randomised controlled trials (non-RCTs) were included and quality assessed. In addition non-comparative evaluations of training for police in England were included. Results From 8578 search results, 19 studies met the inclusion criteria: one systematic review, 12 RCTs, three prospective non-RCTs, and three non-comparative studies. The training interventions identified included broad mental health awareness training and packages addressing a variety of specific mental health issues or conditions. Trainees included police officers, teachers and other public sector workers. Some short term positive changes in behaviour were identified for trainees, but for the people the trainees came into contact with there was little or no evidence of benefit. Conclusions A variety of training programmes exist for non-mental health professionals who come into contact with people who have mental health issues. There may be some short term change in behaviour for the trainees, but longer term follow up is needed. Research evaluating training for UK police officers is needed in which a number of methodological issues need to be addressed. Trial registration Protocol registration number: PROSPERO: CRD42015015981 .

Reporting guidelines help improve the reporting of specific study designs, and clear guidance on the best approaches for developing guidelines is available. The methodological strength, or validation of guidelines is however unclear. This article explores what validation of reporting guidelines might involve, and whether this has been conducted for key reporting guidelines. Keywords: Reporting guidelines, Validity, Validation

Purpose: Schools have long been perceived as an ideal setting to support the healthy eating behaviours of children. The aim of the study was to examine the views of Australian primary school parents regarding school food and nutrition, including education, practices and policy. Design/methodology/approach: An online survey was conducted among 787 parents in March 2021, which included closed and open-ended questions. Findings: The results indicated the inconsistent implementation of policies and/or varying practices among different schools. Parents' views were slightly associated with some demographic and personal measures including their SES levels, education, age, the main language spoken at home and universalism values. Parents viewed healthy food provision through canteens, policies and informing parents, fruit and vegetable breaks and kitchen and garden programs as the main contributors to the promotion of healthy eating. They believed unhealthy options in canteens, school fairs, events and birthdays are the major contributors to the formation of unhealthy eating habits among children at schools. Results revealed the efforts to establish health promoting school food environments in Australian primary schools; however, inconsistencies and discrepancies among schools should be addressed to ensure equity among all children. Practical implications: The findings may provide directions for policymakers and school managers and can inform future reforms and initiatives in Australian primary schools and elsewhere. Originality/value: This is the first study that has examined Australian parents' views of school food policy, practices and environments using a mixed-methods design.

INTRODUCTION:Given the prevalence of mental health problems globally, there is an increasing need for the police and other non-mental health trained professionals to identify and manage situations involving individuals with mental health problems. The review aimed to identify and explore qualitative evidence on views and experiences of non-mental health professionals receiving mental health training and the barriers and facilitators to training delivery and implementation. METHODS:A meta-synthesis of qualitative evidence on the barriers, facilitators and perceived impact of mental health training programmes for non-mental health trained professionals. Systematic literature searches were undertaken of the following databases: Criminal Justice Abstracts (CJA); MEDLINE; Embase; PsycINFO; ASSIA; CENTRAL; SSCI; ERIC; Campbell Library; Social Care Online and EPOC from 1995 to 2016. Records were independently screened for eligibility by two researchers, data extraction and quality appraisal of studies was also undertaken independently by two researchers. The CASP tool was used to quality appraise included studies. Included studies were synthesised using a meta-ethnographic approach as outlined by Noblit and Hare. RESULTS:10,282 records were identified and eight qualitative studies were included. A range of barriers and facilitators to training were identified and related to the delivery and content of training; the use of additional resources; and staff willingness to engage with training and organisational factors. The perceived impact of training was also discussed in terms of how it affects trainees; perceptions of mental health; self-perception; responses to situations involving mental health and the potential of training to reduce injury or physical harm in situations involving mental health. The value of training and how to measure its impact were also discussed. CONCLUSION:Findings from this review have implications for those designing, implementing and evaluating mental health training programmes. It is recommended that research evaluating mental health training includes a qualitative component to ensure that the barriers and facilitators to training and its impact on trainees' perceptions of mental health are understood. PROTOCOL REGISTRATION NUMBER:PROSPERO: CRD42015015981.

Background: The Health and Social Care Act 2012 (Great Britain. Health and Social Care Act 2012. London: The Stationery Office; 2012) has mandated research use as a core consideration of health service commissioning arrangements. We evaluated whether or not access to a demand-led evidence briefing service improved the use of research evidence by commissioners, compared with less intensive and less targeted alternatives. Design: Controlled before-and-after study. Setting: Clinical Commissioning Groups (CCGs) in the north of England. Main outcome measures: Change at 12 months from baseline of a CCG’s ability to acquire, assess, adapt and apply research evidence to support decision-making. Secondary outcomes measured individual clinical leads’ and managers’ intentions to use research evidence in decision-making. Methods: Nine CCGs received one of three interventions: (1) access to an evidence briefing service; (2) contact plus an unsolicited push of non-tailored evidence; or (3) an unsolicited push of non-tailored evidence. Data for the primary outcome measure were collected at baseline and 12 months post intervention, using a survey instrument devised to assess an organisation’s ability to acquire, assess, adapt and apply research evidence to support decision-making. In addition, documentary and observational evidence of the use of the outputs of the service was sought and interviews with CCG participants were undertaken. Results: Most of the requests were conceptual; they were not directly linked to discrete decisions or actions but were intended to provide knowledge about possible options for future actions. Symbolic use to justify existing decisions and actions were less frequent and included a decision to close a walk-in centre and to lend weight to a major initiative to promote self-care already under way. The opportunity to impact directly on decision-making processes was limited to work to establish disinvestment policies. In terms of impact overall, the evidence briefing service was not associated with increases in CCGs’ capacity to acquire, assess, adapt and apply research evidence to support decision-making, individual intentions to use research findings or perceptions of CCGs’ relationships with researchers. Regardless of the intervention received, at baseline participating CCGs indicated that they felt that they were inconsistent in their research-seeking behaviours and their capacity to acquire research remained so at follow-up. The informal nature of decision-making processes meant that there was little or no traceability of the use of evidence. Limitations: Low baseline and follow-up response rates (of 68% and 44%, respectively) and missing data limit the reliability of these findings. Conclusions: Access to a demand-led evidence briefing service did not improve the uptake and use of research evidence by NHS commissioners compared with less intensive and less targeted alternatives. Commissioners appear to be well intentioned but ad hoc users of research. Future work: Further research is required on the effects of interventions and strategies to build individual and organisational capacity to use research. Resource-intensive approaches to providing evidence may best be employed to support instrumental decision-making. Comparative evaluation of the impact of less intensive but targeted strategies on the uptake and use of research by commissioners is warranted. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Police officers frequently come into contact with individuals with mental health problems. Specialist training in this area for police officers may improve how they respond to individuals with mental health problems; however, evidence to support this is sparse. This study evaluated the effectiveness of one bespoke mental health training package for frontline police officers relative to routine training.Pragmatic, two-armed cluster randomised controlled trial in one police force in England. Police stations in North Yorkshire were randomised with frontline police officers receiving either a bespoke mental health training package or routine training. The primary outcome was the number of incidents which resulted in a police response reported to the North Yorkshire Police control room up to six months after delivery of training. Secondary outcomes included: likelihood of incidents using Section 136 of the Mental Health Act; likelihood of incidents having a mental health tag applied; and number of individuals with a mental health warning marker involved in incidents. The appropriateness of mental health tags applied to a random sample of incidents was checked by an independent mental health professional. Routinely collected data were used.Twelve police stations were recruited and randomised (Intervention group n = 6; Control group n = 6), and 249 officers received the bespoke mental health training intervention. At follow-up, a median of 397 incidents were assigned to trial stations in the intervention group, and 498 in the control group. There was no evidence of a difference in the number of incidents with a police response (adjusted incidence rate ratio (IRR) 0.92, 95% CI 0.61 to 1.38, p = 0.69), or in the number of people with mental health warning markers involved in incidents (adjusted IRR 1.39, 95% CI 0.91 to 2.10, p = 0.13) between the intervention and control groups up to six months following the intervention; however, incidents assigned to stations in the intervention group were more likely to have a mental health tag applied to them than incidents assigned to control stations (adjusted odds ratio 1.41, 95% CI 1.16 to 1.71, p = 0.001). The review of 100 incidents suggests that there may be incidents involving individuals with mental health issues that are not being recorded as such (Kappa coefficient 0.65). There was no statistically significant difference in the likelihood of Section 136 of the Mental Health Act being applied to an incident.The bespoke one day mental health training delivered to frontline officers by mental health professionals did not reduce the number of incidents reported to the police control room up to six months after its delivery; however training may have a positive effect on how the police record incidents involving individuals with mental health problems. Our trial has shown that conducting pragmatic trials within the police setting is feasible and acceptable. There is a wealth of routinely collected police data that can be utilised for research and further collaboration between police forces and academia is encouraged.ISRCTN (ISRCTN11685602). The authors confirm that all ongoing and related trials for this drug/intervention are registered.

Background: Patients who have knee instability that is associated with neuromuscular disease (NMD) and central nervous system (CNS) conditions can be treated using orthoses, such as knee–ankle–foot orthoses (KAFOs). Objectives: To assess existing evidence on the effectiveness of orthoses; patient perspectives; types of orthotic devices prescribed in the UK NHS; and associated costs. Methods: Qualitative study of views of orthoses users – a qualitative in-depth interview study was undertaken. Data were analysed for thematic content. A coding scheme was developed and an inductive approach was used to identify themes. Systematic review – 18 databases were searched up to November 2014: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health, EMBASE, PASCAL, Scopus, Science Citation Index, BIOSIS Previews, Physiotherapy Evidence Database, Recal Legacy, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment database, Cochrane Central Register of Controlled Trials, Conference Proceedings Citation Index: Science, Health Management Consortium, ClinicalTrials.gov, International Clinical Trials Registry Platform and National Technical Information Service. Studies of adults using an orthosis for instability of the knee related to NMD or a CNS disorder were included. Data were extracted and quality was assessed by two researchers. Narrative synthesis was undertaken. Survey and costing analysis – a web survey of orthotists, physiotherapists and rehabilitation medicine physicians was undertaken. Telephone interviews with orthotists informed a costing analysis. Results: Qualitative study – a total of 24 people participated. Potential for engagement in daily activities was of vital importance to patients; the extent to which their device enabled this was the yardstick by which it was measured. Patients’ prime desired outcome was a reduction in pain, falls or trips, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses. Many expressed frustration with perceived deficiencies in service provision relating to appointment and administrative systems and referral pathways. Systematic review – a total of 21 studies (478 participants) were included of people who had post-polio syndrome, inclusion body myositis, were post stroke or had spinal cord injury. The studies evaluated KAFOs (mainly carbon fibre), stance control KAFO and hip KAFOs. All of the studies were at risk of bias and, in general, were poorly reported. Survey and costing analysis – in total, 238 health-care professionals responded. A range of orthoses is prescribed for knee instability that is related to NMD or CNS conditions, approximately half being custom-made. At least 50% of respondents thought that comfort and confidence in mobility were extremely important treatment outcomes. The cost of individual KAFOs was highly variable, ranging from £73 to £3553. Conclusions: Various types of orthoses are used in the NHS to manage patients with NMD/CNS conditions and knee instability, both custom-made and prefabricated, of variable cost. Evidence on the effectiveness of the orthoses is limited, especially in relation to the outcomes that are important to orthoses users. Limitations: The population included was broad, limiting any in-depth consideration of specific conditions. The response rate to the survey was low, and the costing analysis was based on some assumptions that may not reflect the true costs of providing KAFOs. Future work: Future work should include high-quality research on the effectiveness and cost-effectiveness of orthoses; development of a core set of outcome measures; further exploration of the views and experiences of patients; and the best models of service delivery. Study registration: This study is registered as PROSPERO CRD42014010180. The qualitative study is registered as Current Controlled Trials ISRCTN65240228. Funding: The National Institute for Health Research Health Technology Assessment programme.

BackgroundIn response to growing recognition of the value of prospective registration of systematic review protocols, we planned to develop a web-based open access international register. In order for the register to fulfil its aims of reducing unplanned duplication, reducing publication bias, and providing greater transparency, it was important to ensure the appropriate data were collected. We therefore undertook a consultation process with experts in the field to identify a minimum dataset for registration.Methods and findingsA two-round electronic modified Delphi survey design was used. The international panel surveyed included experts from areas relevant to systematic review including commissioners, clinical and academic researchers, methodologists, statisticians, information specialists, journal editors and users of systematic reviews. Direct invitations to participate were sent out to 315 people in the first round and 322 in the second round. Responses to an open invitation to participate were collected separately. There were 194 (143 invited and 51 open) respondents with a 100% completion rate in the first round and 209 (169 invited and 40 open) respondents with a 91% completion rate in the second round. In the second round, 113 (54%) of the participants reported having previously taken part in the first round. Participants were asked to indicate whether a series of potential items should be designated as optional or required registration items, or should not be included in the register. After the second round, a 70% or greater agreement was reached on the designation of 30 of 36 items.ConclusionsThe results of the Delphi exercise have established a dataset of 22 required items for the prospective registration of systematic reviews, and 18 optional items. The dataset captures the key attributes of review design as well as the administrative details necessary for registration.