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Abstract Objective We aimed to validate the Japanese version of the Patient Health Questionnaire-4 (PHQ-4-J). People in Japan, especially healthcare workers (HCWs) suffer from high rates of mental health symptoms. The PHQ-4 is an established ultra-brief mental health measure used in various settings, populations and languages. The Japanese version of the PHQ-4 has not been validated. Methods Two hundred eighty people in Japan (142 HCWs and 138 from the general public) responded to the PHQ-4-J. Internal consistency, and factorial validity were assessed using confirmatory factor analysis (CFA) and Multiple Indicators Multiple Causes (MIMIC) models. Results Internal consistency was high (α = 0.70–0.86). CFA yielded very good fit indices for a two-factor solution (RMSEA = 0.04, 95% CI 0.00–0.17) and MIMIC models indicated the performance differed between HCWs and the general population. Conclusions The PHQ-4-J is a reliable ultra-brief scale for depression and anxiety in Japanese, which can be used to meet current needs in mental health research and practice in Japan. Disaster research and gerontology research can benefit from this scale, enabling mental health assessment with little participant burden. In practice, early detection and personalised care can be facilitated by using the scale. Future research should target specific populations in Japan during a non-emergency time.

Abstract Recovery Colleges (RCs) are learning-based mental health recovery communities, located globally. However, evidence on RC effectiveness outside Western, educated, industrialised, rich, and democratic (WEIRD) countries is limited. This study aimed to evaluate associations between cultural characteristics and RC fidelity, to understand how culture impacts RC operation. Service managers from 169 RCs spanning 28 WEIRD and non-WEIRD countries assessed the fidelity using the RECOLLECT Fidelity Measure, developed based upon key RC operation components. Hofstede’s cultural dimension scores were entered as predictors in linear mixed-effects regression models, controlling for GDP spent on healthcare and Gini coefficient. Higher Individualism and Indulgence, and lower Uncertainty Avoidance were associated with higher fidelity, while Long-Term Orientation was a borderline negative predictor. RC operations were predominantly aligned with WEIRD cultures, highlighting the need to incorporate non-WEIRD cultural perspectives to enhance RCs’ global impact. Findings can inform the refinement and evaluation of mental health recovery interventions worldwide.

Aims: To assess the cost-effectiveness of a two-layer compression bandage versus a standard wool and crepe bandage following total knee arthroplasty, using patient-level data from the Knee Replacement Bandage Study (KReBS). Methods: A cost-utility analysis was undertaken alongside KReBS, a pragmatic, two-arm, open label, parallel-group, randomized controlled trial, in terms of the cost per quality-adjusted life year (QALY). Overall, 2,330 participants scheduled for total knee arthroplasty (TKA) were randomized to either a two-layer compression bandage or a standard wool and crepe bandage. Costs were estimated over a 12-month period from the UK NHS perspective, and health outcomes were reported as QALYs based on participants’ EuroQol five-dimesion five-level questionnaire responses. Multiple imputation was used to deal with missing data and sensitivity analyses included a complete case analysis and testing of costing assumptions, with a secondary analysis exploring the inclusion of productivity losses. Results: The base case analysis found participants in the compression bandage group accrued marginally fewer QALYs, on average, compared with those in the standard bandage group (reduction of 0.0050 QALYs (95% confidence interval (CI) -0.0051 to -0.0049)), and accumulated additional mean costs (incremental cost of £52.68 per participant (95% CI 50.56 to 54.80)). Findings remained robust to assumptions tested in sensitivity analyses, although considerable uncertainty surrounded the outcome estimates. Conclusion: Use of a two-layer compression bandage is marginally less effective in terms of health-related quality of life, and more expensive when compared with a standard bandage following TKA, so therefore is unlikely to provide a cost-effective option. Cite this article: Bone Jt Open 2024;5(7):550–559.

Abstract Background There is increasing interest in the capacity of adaptive designs to improve the efficiency of clinical trials. However, relatively little work has investigated how economic considerations – including the costs of the trial – might inform the design and conduct of adaptive clinical trials. Methods We apply a recently published Bayesian model of a value-based sequential clinical trial to data from the ‘Hydroxychloroquine Effectiveness in Reducing symptoms of hand Osteoarthritis’ (HERO) trial. Using parameters estimated from the trial data, including the cost of running the trial, and using multiple imputation to estimate the accumulating cost-effectiveness signal in the presence of missing data, we assess when the trial would have stopped had the value-based model been used. We used re-sampling methods to compare the design’s operating characteristics with those of a conventional fixed length design. Results In contrast to the findings of the only other published retrospective application of this model, the equivocal nature of the cost-effectiveness signal from the HERO trial means that the design would have stopped the trial close to, or at, its maximum planned sample size, with limited additional value delivered via savings in research expenditure. Conclusion Evidence from the two retrospective applications of this design suggests that, when the cost-effectiveness signal in a clinical trial is unambiguous, the Bayesian value-adaptive design can stop the trial before it reaches its maximum sample size, potentially saving research costs when compared with the alternative fixed sample size design. However, when the cost-effectiveness signal is equivocal, the design is expected to run to, or close to, the maximum sample size and deliver limited savings in research costs.

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.

This review focuses on the potential direct physical, chemical, and microbiological contamination from disposable gloves when utilized in food environments, inclusive of the risks posed to food products as well as worker safety. Unrecognized problems endemic to glove manufacturing were magnified during the COVID-19 pandemic due to high demand, increased focus on PPE performance, availability, supply chain instability, and labor shortages. Multiple evidence-based reports of contamination, toxicity, illness, deaths, and related regulatory action linked to contaminated gloves in food and healthcare have highlighted problems indicative of systemic glove industry shortcomings. The glove manufacturing process was diagramed with sources and pathways of contamination identified, indicating weak points with documented occurrences detailed. Numerous unsafe ingredients can introduce chemical contaminants, potentially posing risks to food and to glove users. Microbial hazards present significant challenges to overall glove safety as contaminants appear to be introduced via polluted water sources or flawed glove manufacturing processes, resulting in increased risks within food and healthcare environments. Frank and opportunistic pathogens along with food spoilage organisms can be introduced to foods and wearers. When the sources and pathways of glove−borne contamination were explored, it was found that physical failures play a pivotal role in the release of sweat build-up, liquefaction of chemical residues, and incubation of microbial contaminants from hands and gloves. Thus, with glove physical integrity issues, including punctures in new, unused gloves that can develop into significant rips and tears, not only can direct physical food contamination occur but also chemical and microbiological contamination can find their way into food. Enhanced regulatory requirements for Acceptable Quality Limits of food−grade gloves, and the establishment of appropriate bioburden standards would enhance safety in food applications. Based on the information provided, together with a false sense of security associated with glove use, the unconditional belief in glove chemical and microbiological purity may be unfounded.

Introduction Biological disease-modifying antirheumatic drugs (bDMARDs) have revolutionised the treatment of inflammatory arthritis (IA). However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently, bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to IA flares and loss of disease control. The question of whether to stop or continue bDMARDs in the perioperative period has not been adequately addressed in a randomised controlled trial (RCT).Methods and analysis PERISCOPE is a multicentre, superiority, pragmatic RCT investigating the stoppage or continuation of bDMARDs. Participants will be assigned 1:1 to either stop or continue their bDMARDs during the perioperative period. We aim to recruit 394 adult participants with IA. Potential participants will be identified in secondary care hospitals in the UK, screened by a delegated clinician. If eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported PROMIS-29 (Patient Reported Outcome Measurement Information System) over the first 12 weeks postsurgery. Secondary outcome measures are as follows: PROMIS - Health Assessment Questionnaire (PROMIS-HAQ), EQ-5D-5L, Disease activity: generic global Numeric Rating Scale (patient and clinician), Self-Administered Patient Satisfaction scale, Health care resource use and costs, Medication use, Surgical site infection, delayed wound healing, Adverse events (including systemic infections) and disease-specific outcomes (according to IA diagnosis). The costs associated with stopping and continuing bDMARDs will be assessed. A qualitative study will explore the patients’ and clinicians’ acceptability and experience of continuation/stoppage of bDMARDs in the perioperative period and the impact postoperatively.Ethics and dissemination Ethical approval for this study was received from the West of Scotland Research Ethics Committee on 25 April 2023 (REC Ref: 23/WS/0049). The findings from PERISCOPE will be submitted to peer-reviewed journals and feed directly into practice guidelines for the use of bDMARDs in the perioperative period.Trial registration number ISRCTN17691638.

Abstract Background Gardening and horticultural therapy (HT) has been widely recognised as a multicomponent approach that has affected a broad range of health and well-being outcomes. The aim of this umbrella review and meta-analysis was to compare the findings of previous reviews on the impact of multiple gardening interventions and gardening attributes on different well-being constructs. Methods Electronic databases including PubMed, Web of Science, Science Direct, the Cochrane Library, and Google Scholar were searched from inception to December 2022. Interventional and observational reviews were eligible for inclusion in this umbrella review. Outcome measures included mental well-being, health status and quality of life. The key exposure variables were gardening and horticultural therapy. Narrative synthesis was used to evaluate the overall impact of gardening and HT on study outcomes. For a subsample of studies with available quantitative data, a random effect meta-analysis was conducted. Results This umbrella review included 40 studies (10 interventional studies, 2 observational studies, and 28 mixed interventional and observational studies). The reviewed studies reported an overall positive impact of gardening activities on several measures of mental well-being, quality of life, and health status. Meta-analysis showed a significant and positive effect of gardening and HT activities on well-being (effect size (ES) 0.55, 95% confidence interval (CI) 0.23, 0.87, p

Abstract The worldwide pooled prevalence of psychiatric disorders in children is 13.4%. Studying the prevalence of childhood psychiatric disorders across radically different economic systems and social structures could indicate universal factors leading to their development. The prevalence of childhood psychiatric disorders in a mixed-subsistence foraging society has not been studied. The Strengths and Difficulties Questionnaire and the Development and Well-Being Assessment were used to compare the prevalence of behavioural symptoms and psychiatric disorders in Hadza children aged 5–16 years (n = 113) to a nationally representative sample from England (n = 18,029) using a cross-sectional study design. Emotional problems, conduct problems and hyperactivity were lower in the Hadza children. Prosocial behaviour and peer problems were higher in Hadza children. 3.6% of Hadza children met the criteria for a psychiatric disorder compared to 11.8% of English children. All psychiatric disorders in Hadza children were co-morbid with autism spectrum disorder. No child from the Hadza group met the criteria for an emotional, behaviour or eating disorder. Further work should study the factors which lead to the different prevalence of psychiatric disorders in Hadza children.

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

BackgroundCertain occupational characteristics have been linked with poor health and reduced longevity. However, the association between occupational characteristics and survival free of disability in a post-retirement age group has not been investigated.MethodsWe investigated outcomes in 12,215 healthy older Australian adults in the Aspirin in Reducing Events in the Elderly (ASPREE) and ASPREE Longitudinal Study of Older Persons (ALSOP) sub-study. The ISCO-88 major occupational groups, settings, and activity levels were assigned based on free-text job descriptions. The Finnish Job Exposure Matrix was used to assign occupational characteristics to the three longest-held jobs. The primary endpoint, disability-free survival, was defined as a composite measure of death, dementia, or persistent physical disability. The endpoint of all-cause mortality was analyzed separately. Because of multiple exploratory analyses, only those associations with a two-sided value of p less than 0.005 were considered statistically significant. Cox proportional hazard models were used to calculate adjusted hazard ratios.ResultsHaving worked in an ‘elementary’ occupation was associated with a reduction in disability-free survival. A specific impact on disability-free survival was observed among those whose work had involved high accident risk and adverse social climate. No significant relationship was identified with those previously exposed to sedentary work, vigorous physical activity, work primarily outdoors, or a range of other occupational characteristics. All-cause mortality was not increased among any of the occupational groups.ConclusionThis exploratory study found a reduction in disability-free survival among people who worked in ‘elementary’ occupations, with specific risks associated with occupations involving high accident risks and adverse social climate.

Monitoring of the mental health status of the population and assessment of its determinants are 2 of the most relevant pillars of public mental health, and data from population health surveys could be instrumental to support them. Although these surveys could be an important and suitable resource for these purposes, due to different limitations and challenges, they are often relegated to the background behind other data sources, such as electronic health records. These limitations and challenges include those related to measurement properties and cross-cultural validity of the tools used for the assessment of mental disorders, their degree of representativeness, and possible difficulties in the linkage with other data sources. Successfully addressing these limitations could significantly increase the potential of health surveys in the monitoring of mental disorders and ultimately maximize the impact of the relevant policies to reduce their burden at the population level. The widespread use of data from population health surveys, ideally linked to electronic health records data, would enhance the quality of the information available for research, public mental health decision-making, and ultimately addressing the growing burden of mental disorders.

Background Little is known about the role of air pollution in how people with dementia use mental health services.Objective We examined longitudinal associations between air pollution exposure and mental health service use in people with dementia.Methods In 5024 people aged 65 years or older with dementia in South London, high resolution estimates of nitrogen dioxide (NO2) and particulate matter (PM2.5 and PM10) levels in ambient air were linked to residential addresses. Associations between air pollution and Community Mental Health Team (CMHT) events (recorded over 9 years) were examined using negative binomial regression models. Cognitive function was measured using the Mini Mental State Examination (MMSE) and health and social functioning was measured using the Health of the Nation Outcomes Scale (HoNOS65+). Associations between air pollution and both MMSE and HoNOS65+ scores were assessed using linear regression models.Findings In the first year of follow-up, increased exposure to all air pollutants was associated with an increase in the use of CMHTs in a dose-response manner. These associations were strongest when we compared the highest air pollution quartile (quartile 4: Q4) with the lowest quartile (Q1) (eg, NO2: adjusted incidence rate ratio (aIRR) 1.27, 95% CI 1.11 to 1.45, p

Abstract Background Globally, around 13% of children experience dental anxiety (DA). This group of patients frequently miss dental appointments, have greater reliance on treatment under general anaesthesia (GA) and have poorer oral health-related quality of life (OHRQoL) than their non-dentally anxious peers. Recently, a low-intensity cognitive behavioural therapy (CBT)-based, self-help approach has been recommended for management of childhood anxiety disorders. A feasibility study conducted in secondary care found this guided self-help CBT resource reduced DA and a randomised controlled trial was recommended. The present study aims to establish the clinical and cost-effectiveness of a guided self-help CBT intervention to reduce DA in children attending primary dental care sites compared to usual care. Methods This 4-year randomised controlled trial will involve 600 children (aged 9–16 years) and their parent/carers in 30 UK primary dental care sites. At least two dental professionals will participate in each site. They will be assigned, using random allocation, to receive the CBT training and deliver the intervention or to deliver usual care. Children with DA attending these sites, in need of treatment, will be randomly allocated to be treated either by the intervention (CBT) or control (usual care) dental professional. Children will complete questionnaires relating to DA, OHRQoL and HRQoL before treatment, immediately after treatment completion and 12 months post-randomisation. Attendance, need for sedation/GA and costs of the two different approaches will be compared. The primary outcome, DA, will be measured using the Modified Child Dental Anxiety Scale. Scores will be compared between groups using a linear mixed model. Discussion Treating dentally anxious patients can be challenging and costly. Consequently, these children are frequently referred to specialist services for pharmacological interventions. Longer waiting times and greater travel distances may then compound existing healthcare inequalities. This research will investigate whether the intervention has the potential to reduce DA and improve oral health outcomes in children over their life-course, as well as upskilling primary dental healthcare professionals to better manage this patient group. Trial registration This clinical trial has been registered with an international registry and has been allocated an International Standard Randomised Controlled Trial Number (ISRCTN27579420).

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

Summary: Background: The 8-item version of the Patient Health Questionnaire (PHQ-8) is one of the self-reported questionnaires most frequently used worldwide for the screening and severity assessment of depression. However, in some European countries its reliability is unknown, and it is unclear whether its psychometric properties vary between European countries. Therefore, the aim of this study was to assess the internal structure, reliability and cross-country equivalence of the PHQ-8 in Europe. Methods: All participants from the 27 countries included in the second wave of the European Health Interview Survey (EHIS-2) between 2014 and 2015 with complete information on the PHQ-8 were included (n = 258,888). The internal structure of the PHQ-8 was assessed using confirmatory factor analyses (CFA) for categorical items. Additionally, the reliability of the questionnaire was assessed based on the internal consistency, Item Response Theory information functions, and item-discrimination (using Graded Response Models), and the cross-country equivalence based on multi-group CFA. Findings: The PHQ-8 shows high internal consistency for all countries. The countries in which the PHQ-8 was more reliable were Romania, Bulgaria and Cyprus and less reliable were Iceland, Norway and Austria. The PHQ-8 item with highest discrimination was item 2 (feeling down, depressed, or hopeless) in 24 of the 27 countries. Measurement invariance between countries in Europe was observed from multigroup CFA at the configural, metric and scalar levels. Interpretation: The results from our study, likely the largest study to the date assessing the internal structure, reliability and cross-country comparability of a self-reported mental health assessment measure, shows that the PHQ-8 has an adequate reliability and cross-country equivalence across the 27 European countries included. These results highlight the suitability of the comparisons of the PHQ-8 scores in Europe. They could be helpful to improve the screening and severity assessment of depressive symptoms at the European level. Funding: This work was partially funded by CIBER Epidemiology and Public Health (CIBERESP) as part of the Intramural call of 2021 (ESP21PI05).

Background/objectives: Around 11,500 artificial eyes are required yearly for new and existing patients. Artificial eyes have been manufactured and hand-painted at the National Artificial Eye Service (NAES) since 1948, in conjunction with approximately 30 local artificial eye services throughout the country. With the current scale of demand, services are under significant pressure. Manufacturing delays as well as necessary repainting to obtain adequate colour matching, may severely impact a patient’s rehabilitation pathway to a normal home, social and work life. However, advances in technology mean alternatives are now possible. The aim of this study is to establish the feasibility of conducting a large-scale study of the effectiveness and cost-effectiveness of digitally printed artificial eyes compared to hand-painted eyes. Methods: A cross-over, randomised feasibility study evaluating a digitally-printed artificial eye with a hand-painted eye, in patients aged ≥18 years with a current artificial eye. Participants will be identified in clinic, via ophthalmology clinic databases and two charity websites. Qualitative interviews will be conducted in the later phases of the study and focus on opinions on trial procedures, the different artificial eyes, delivery times, and patient satisfaction. Discussion: Findings will inform the feasibility, and design, of a larger fully powered randomised controlled trial. The long-term aim is to create a more life-like artificial eye in order to improve patients’ initial rehabilitation pathway, long term quality of life, and service experience. This will allow the transition of research findings into benefit to patients locally in the short term and National Health Service wide in the medium to long term. ISRCTN registration: ISRCTN85921622 (prospectively registered on 17/06/2021)

Rationale Aims and Objectives Methods Results Conclusion Loss to follow‐up of participants can compromise the statistical validity of randomised trials. Moreover, it can have financial consequences for trial teams and funders. This study explores the Occupational Therapist Intervention Study (OTIS) where, despite a withdrawal rate of less than 10%, the trial team incurred opportunity costs related to participants who were initially recruited but subsequently decided to withdraw from the trial.To estimate the cost of participant losses to follow‐up in the OTIS trial and thus introduce a costing framework to research teams on how they could estimate the opportunity costs of participant withdrawal from their randomised trials.The participants lost to follow‐up are differentiated by (1) the time point at which they were lost to follow‐up; (2) the treatment group they were allocated to; (3) their response patters to follow‐up questionnaires; these elements were considered to identify the relevant types of attrition. Protocol‐driven costs of trial materials, including administration, print, and shipping, were gathered. We calculated unit costs for each type of attrition by multiplying protocol‐driven and intervention costs with the relevant number of participants. Summing up unit costs by type of loss to follow‐up yields aggregate figures, enabling the estimation of aggregate and average opportunity costs of attrition.The average cost per participant loss to follow‐up in the OTIS trial is £98.41. The aggregate cost of participant loss to follow‐up is £10,234.90 from the economic perspective of the trial team. Therefore, 1.42% of the allocated funding has been misallocated because of participant loss to follow‐up.Despite the low attrition rate of the OTIS trial, loss to follow‐up has still generated considerable opportunity costs. It is recommended that decision makers focus on identifying strategies which could improve participant retention in randomised trials to optimise their budget. [ABSTRACT FROM AUTHOR]

Blockade of Angiotensin type 1 receptor (AT1R) has potential therapeutic utility in the treatment of numerous detrimental consequences of epileptogenesis, including oxidative stress, neuroinflammation, and blood–brain barrier (BBB) dysfunction. We have recently shown that many of these pathological processes play a critical role in seizure onset and propagation in the Scn8a-N1768D mouse model. Here we investigate the efficacy and potential mechanism(s) of action of candesartan (CND), an FDA-approved angiotensin receptor blocker (ARB) indicated for hypertension, in improving outcomes in this model of pediatric epilepsy. We compared length of lifespan, seizure frequency, and BBB permeability in juvenile (D/D) and adult (D/+) mice treated with CND at times after seizure onset. We performed RNAseq on hippocampal tissue to quantify differences in genome-wide patterns of transcript abundance and inferred beneficial and detrimental effects of canonical pathways identified by enrichment methods in untreated and treated mice. Our results demonstrate that treatment with CND gives rise to increased survival, longer periods of seizure freedom, and diminished BBB permeability. CND treatment also partially reversed or ‘normalized’ disease-induced genome-wide gene expression profiles associated with inhibition of NF-κB, TNFα, IL-6, and TGF-β signaling in juvenile and adult mice. Pathway analyses reveal that efficacy of CND is due to its known dual mechanism of action as both an AT1R antagonist and a PPARγ agonist. The robust effectiveness of CND across ages, sexes and mouse strains is a positive indication for its translation to humans and its suitability of use for clinical trials in children with SCN8A epilepsy [ABSTRACT FROM AUTHOR]

In this randomized, double-blind, placebo-controlled trial, 207 participants with knee osteoarthritis with inadequate response to current medications were randomly assigned to receive methotrexate or placebo. Average knee pain at 6 months measured using a numerical rating scale decreased from 6.4 to 5.1 in the methotrexate group versus 6.8 to 6.2 in the placebo group. Findings suggest that oral methotrexate added to usual medications can reduce knee pain in patients with osteoarthritis. Visual Abstract. Pain Reduction With Oral Methotrexate in Knee Osteoarthritis: In this randomized, double-blind, placebo-controlled trial, 207 participants with knee osteoarthritis with inadequate response to current medications were randomly assigned to receive methotrexate or placebo. Average knee pain at 6 months measured using a numerical rating scale decreased from 6.4 to 5.1 in the methotrexate group versus 6.8 to 6.2 in the placebo group. Findings suggest that oral methotrexate added to usual medications can reduce knee pain in patients with osteoarthritis. Background: Treatments for osteoarthritis (OA) are limited. Previous small studies suggest that the antirheumatic drug methotrexate may be a potential treatment for OA pain. Objective: To assess symptomatic benefits of methotrexate in knee OA (KOA). Design: A multicenter, randomized, double-blind, placebo-controlled trial done between 13 June 2014 and 13 October 2017. (ISRCTN77854383; EudraCT: 2013-001689-41) Setting: 15 secondary care musculoskeletal clinics in the United Kingdom. Participants: A total of 207 participants with symptomatic, radiographic KOA and knee pain (severity ≥4 out of 10) on most days in the past 3 months with inadequate response to current medication were approached for inclusion. Intervention: Participants were randomly assigned 1:1 to oral methotrexate once weekly (6-week escalation 10 to 25 mg) or matched placebo over 12 months and continued usual analgesia. Measurements: The primary end point was average knee pain (numerical rating scale [NRS] 0 to 10) at 6 months, with 12-month follow-up to assess longer-term response. Secondary end points included knee stiffness and function outcomes and adverse events (AEs). Results: A total of 155 participants (64% women; mean age, 60.9 years; 50% Kellgren–Lawrence grade 3 to 4) were randomly assigned to methotrexate (n  = 77) or placebo (n  = 78). Follow-up was 86% (n  = 134; methotrexate: 66, placebo: 68) at 6 months. Mean knee pain decreased from 6.4 (SD, 1.80) at baseline to 5.1 (SD, 2.32) at 6 months in the methotrexate group and from 6.8 (SD, 1.62) to 6.2 (SD, 2.30) in the placebo group. The primary intention-to-treat analysis showed a statistically significant pain reduction of 0.79 NRS points in favor of methotrexate (95% CI, 0.08 to 1.51; P  = 0.030). There were also statistically significant treatment group differences in favor of methotrexate at 6 months for Western Ontario and McMaster Universities Osteoarthritis Index stiffness (0.60 points [CI, 0.01 to 1.18]; P  = 0.045) and function (5.01 points [CI, 1.29 to 8.74]; P  = 0.008). Treatment adherence analysis supported a dose-response effect. Four unrelated serious AEs were reported (methotrexate: 2, placebo: 2). Limitation: Not permitting oral methotrexate to be changed to subcutaneous delivery for intolerance. Conclusion: Oral methotrexate added to usual medications demonstrated statistically significant reduction in KOA pain, stiffness, and function at 6 months. Primary Funding Source: Versus Arthritis. [ABSTRACT FROM AUTHOR]