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There is a strong association between total hip bone mineral density (THBMD) changes after 24 mo of treatment and reduced fracture risk. We examined whether changes in THBMD after 12 and 18 mo of treatment are also associated with fracture risk reduction. We used individual patient data (n = 122 235 participants) from 22 randomized, placebo-controlled, double-blind trials of osteoporosis medications. We calculated the difference in mean percent change in THBMD (active-placebo) at 12, 18, and 24 mo using data available for each trial. We determined the treatment-related fracture reductions for the entire follow-up period, using logistic regression for radiologic vertebral fractures and Cox regression for hip, non-vertebral, all (combination of non-vertebral, clinical vertebral, and radiologic vertebral) fractures and all clinical fractures (combination of non-vertebral and clinical vertebral). We performed meta-regression to estimate the study-level association (r2 and 95% confidence interval) between treatment-related differences in THBMD changes for each BMD measurement interval and fracture risk reduction. The meta-regression revealed that for vertebral fractures, the r2 (95% confidence interval) was 0.59 (0.19, 0.75), 0.69 (0.32, 0.82), and 0.73 (0.33, 0.84) for 12, 18, and 24 mo, respectively. Similar patterns were observed for hip: r2 = 0.27 (0.00, 0.54), 0.39 (0.02, 0.63), and 0.41 (0.02, 0.65); non-vertebral: r2 = 0.27 (0.01, 0.52), 0.49 (0.10, 0.69), and 0.53 (0.11, 0.72); all fractures: r2 = 0.44 (0.10, 0.64), 0.63 (0.24, 0.77), and 0.66 (0.25, 0.80); and all clinical fractures: r2 = 0.46 (0.11, 0.65), 0.64 (0.26, 0.78), and 0.71 (0.32, 0.83), for 12-, 18-, and 24-mo changes in THBMD, respectively. These findings demonstrate that treatment-related THBMD changes at 12, 18, and 24 mo are associated with fracture risk reductions across trials. We conclude that BMD measurement intervals as short as 12 mo could be used to assess fracture efficacy, but the association is stronger with longer BMD measurement intervals.

ObjectiveDiabetic foot ulcers (DFUs) present a significant global health challenge, resulting in high morbidity and economic costs. Current available treatments often fail to achieve satisfactory healing rates, highlighting the need for novel therapies. This study evaluated the safety and efficacy of a novel autologous whole blood clot (AWBC)-a blood-based, biodegradable provisional matrix-in conjunction with standard of care (SoC) when compared to SoC alone in the treatment of hard-to-heal DFUs.MethodA multicentre, prospective, blinded assessor, randomised controlled trial was conducted at 16 sites across the US, South Africa and Turkey. A cohort of patients with hard-to-heal DFUs was enrolled and randomised to either the AWBC group or the control group. The primary endpoint was complete wound closure at 12 weeks, while secondary endpoints included time to heal and percentage area reduction (PAR) at four and eight weeks. Data were analysed using both intention-to-treat (ITT) and per-protocol (PP) populations.ResultsThe cohort included 119 patients. AWBC treatment resulted in a significantly higher healing rate compared to the control in both ITT (41% versus 15%, respectively; p=0.002) and PP populations (51% versus 18%, respectively; p=0.0075). AWBC treatment also resulted in a shorter mean time to heal and higher durability of wound closure. Safety analysis showed a similar incidence of adverse events (AEs) between groups, with no device-related AEs.ConclusionThe AWBC system, by modulating the wound microenvironment and providing a functional extracellular matrix, offered a promising new approach to treating hard-to-heal DFUs, demonstrating superior healing outcomes compared to SoC alone in this study.

Background: Breast cancer is the most diagnosed cancer in women worldwide and carries a considerable psychosocial burden. Interventions based on Acceptance and Commitment Therapy (ACT) and compassion-based approaches show promise in improving adjustment and quality of life in people with cancer. The Mind programme is an integrative ACT and compassion-based intervention tailored for women with breast cancer, which aims to prepare women for survivorship by promoting psychological flexibility and self-compassion. A pilot study of the Mind programme has shown acceptability and preliminary efficacy in improving quality of life and psychological health. This paper presents the study protocol of two randomised controlled trials that aim to test the efficacy and cost-effectiveness of an optimised version of the Mind programme in women with breast cancer. Methods: Participants will be women diagnosed with breast cancer randomly assigned to the Mind programme or a support group intervention (active control) in a 1:1 ratio for study 1, while study 2 includes one more arm (treatment as usual; inactive control) and a 2:2:1 ratio. Both interventions will be delivered weekly via an 8-session face-to-face or online group format. Data will be collected at baseline, post-treatment and 6-month follow-up. The efficacy and cost-effectiveness of the two interventions will be assessed. Treatment outcomes will comprise cancer-specific quality of life (primary outcome), anxiety and depressive symptoms, psychological flexibility, self-compassion, health-related quality of life, resource use, and intervention's acceptability and feasibility. Study 1 will also include immunological and epigenetic markers associated with breast cancer prognosis and mental health. Outcome assessors will be blind to group allocation. Statistical analyses will be conducted using an intention-to-treat approach. Analyses of moderators and mediators of change will also be performed. Discussion: These trials examine the efficacy and cost-effectiveness of an integrative ACT and compassion-based intervention tailored for women with breast cancer. Greater improvements in psychosocial, biological and resource use are expected in the Mind group, when compared to the control group(s). Results will likely support the potential benefits of the Mind programme for breast cancer patients and highlight the clinical relevance of integrative and holistic interventions in oncology. Trials registration {2a, 2b}: ClinicalTrials.gov NCT05642897 and NCT06212414. Registered on December 8, 2022, and January 18, 2024. [ABSTRACT FROM AUTHOR]

Background: Smoking rates in the UK have declined steadily over the past decades, masking considerable inequalities, as little change has been observed among people with a mental health condition. This trial sought to assess the feasibility and acceptability of supplying an electronic cigarette (e-cigarette) starter kit for smoking cessation as an adjunct to usual care for smoking cessation, to smokers with a mental health condition treated in the community, to inform a future effectiveness trial. Methods: This randomised controlled feasibility trial, conducted March-December 2022, compared the intervention (e-cigarette starter kit with a corresponding information leaflet and demonstration with Very Brief Advice) with a 'usual care' control at 1-month follow-up. Participants were ≥ 18 years, receiving treatment for any mental health condition in primary or secondary care in three Mental Health Trusts in Yorkshire and one in London, UK. They were also willing to address their smoking through either cessation or reduction of cigarette consumption. The agreed primary outcome measure was feasibility (consent ~ 15% of eligible participants; attrition rate < 30%). Acceptability, validated sustained abstinence and ≥ 50% cigarette consumption reduction at 1-month, were also evaluated and qualitative interviews conducted to further explore acceptability in this population. Results: Feasibility targets were partially met; of 201 eligible participants, 43 (mean age = 45.2, SD = 12.7; 39.5% female) were recruited (21.4%) and randomised (intervention:48.8%, n = 21; control:51.2%, n = 22). Attrition rate was 37.2% at 1-month follow-up and was higher (45.5%) in the control group. At follow-up (n = 27), 93.3% (n = 14) in the intervention group and 25.0% (n = 3) in the control group reported e-cigarette use. The intervention was well received with minimal negative effects. In intention-to-treat analysis, validated sustained abstinence at 1-month was 2/21 (9.5%) and 0/22 (0%) and at least 50% reduction in cigarette consumption 13/21 (61.9%) and 3/22 (13.6%), for the intervention and control group, respectively. Qualitative analysis of participant interviews (N = 5) showed the intervention was broadly acceptable, but they also highlighted areas of improvements for the intervention and trial delivery. Conclusions: Offering an e-cigarette starter kit to smokers with a mental health condition treated in the community was acceptable and largely feasible, with harm reduction outcomes (i.e. switching from cigarette smoking to e-cigarette use and substantial reduction in cigarette consumption) favouring the intervention. The findings of the study will be used to help inform the design of a main trial. Trial Registration: Registry: ISRCTN. Registration number: ISRCTN17691451. Date of registration: 30/09/2021 [ABSTRACT FROM AUTHOR]

Background: Little is known about the involvement of gut microbiota in the disease course of diverticulitis and the potential benefits of manipulating the gut milieu. We propose to conduct a randomised placebo-controlled feasibility trial of faecal microbiota transplantation (FMT) given as capsules to patients with acute uncomplicated diverticulitis. Objectives: The objective is primarily to investigate the feasibility of clinical safety, explore efficacy associated with FMT in this patient population, and examine changes in patient-reported quality of life and the composition and function of the gut microbiota. Design: Study protocol for a randomised placebo-controlled trial. Methods and analysis: Participants with acute, uncomplicated diverticulitis, as confirmed by computed tomography (CT) scan, will be recruited from Odense University Hospital (Denmark) and randomly assigned to either the intervention group or the control group. The intervention group will consist of 20 patients who receive encapsulated FMT. The control group will also consist of 20 patients, receiving placebo capsules. Primary safety endpoint : Patient safety is monitored by (a) the number of re-admissions and (b) the number of adverse events within 3 months of FMT/placebo; Primary efficacy endpoint : Reduction in the proportion of patients treated with antibiotics within 3 months following FMT/placebo; Secondary outcome : Change from baseline to 3 months in the GI-QLI questionnaire. Results will be analysed using an intention-to-treat approach. Adverse events or unintended consequences will be reported. Ethics and discussion: This is the first study to investigate the safety and efficacy of FMT in patients with acute uncomplicated diverticulitis. The project has the potential to broaden the knowledge and literature on the role of the intestinal microbiota in diverticulitis, and we believe it will elevate our understanding of cause and effect. Trial registration: Informed consent is obtained from all participants. The study is approved by the regional ethics committee (ref. S-20230023) and the Danish Data Protection Agency (ref. 24/2435). The trial was registered on clinicaltrials.gov (NCT06254625) on 10th February 2024. [ABSTRACT FROM AUTHOR]

Purpose: To summarise the extent and type of evidence in relation to adverse events (AEs) associated with the use of cannabis-based products (CBP) in people living with cancer. Methods: The Joanna Briggs Institute (JBI) methodology for scoping reviews was applied. A search was performed in MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), Scopus, Web of Science Core Collections and AMED (Ovid) from their inception to 7 May 2023. Primary studies reporting AEs associated with any form of natural or synthetic CBP use in any cancer care setting and location were included. Results: One hundred fifty-two studies were included, with the most prevalent being randomised controlled trials (RCTs) (n = 61), followed by non-randomised controlled trials (n = 26) and case reports (n = 23). CBP was mainly used in gastrointestinal, liver, or peritoneal cancer (n = 98) and haematological or lymphoid cancer (n = 92), primarily to manage nausea and vomiting (n = 78) and cancer pain (n = 37). The most common CBP ingredients were combinations of THC and CBD (n = 69), synthetic THC (n = 47), single compounds of THC (n = 42) and CBD (n = 16) with diverse forms, administration routes and doses. The primary methods of administration were oral (n = 94) and inhalation (n = 54). A broad range of AEs were reported; the most common were related to the nervous system (n = 118), psychiatric (n = 101) and gastrointestinal system (n = 81). Diverse patient characteristics, significant under-reporting and low-quality reporting were observed in many studies. Conclusions: More rigorous research designs that prioritise comprehensive, standardised reporting of AEs and CBP use are required to fully elucidate the safety profile of CBP use in cancer care. [ABSTRACT FROM AUTHOR]

Image-guided adaptive radiotherapy allowed bladder tumour radiotherapy dose escalation without a significant increase in toxicity. The use of multiple adaptive plans suggests an on-going need for radiotherapy optimisation with adaptive therapy. Dose escalation achieves promising tumour control with low salvage cystectomy rates. Delivering radiotherapy to the bladder is challenging as it is a mobile, deformable structure. Dose-escalated adaptive image-guided radiotherapy could improve outcomes. RAIDER aimed to demonstrate the safety of such a schedule. RAIDER is an international phase 2 noncomparative randomised controlled trial (ISRCTN26779187). Patients with unifocal T2-T4a urothelial bladder cancer were randomised (1:1:2) to standard whole bladder radiotherapy (WBRT), standard-dose adaptive radiotherapy (SART), or dose-escalated adaptive radiotherapy (DART). Two fractionation (f) schedules recruited independently. WBRT and SART dose was 55 Gy/20f or 64 Gy/32f, and DART dose was 60 Gy/20f or 70 Gy/32f. For SART and DART, a radiotherapy plan (small, medium, or large) was chosen daily. The primary endpoint was the proportion of patients with radiotherapy-related late Common Terminology Criteria for Adverse Events grade ≥3 toxicity; the trial was designed to rule out >20% toxicity with DART. A total of 345 patients were randomised between October 2015 and April 2020: 41/46 WBRT, 41/46 SART, and 81/90 DART patients in the 20f/32f cohorts, respectively. The median age was 72/73 yr; 78%/85% had T2 tumours, 46%/52% had neoadjuvant chemotherapy, and 70%/71% had radiosensitising therapy. The median follow-up was 42.1/38.2 mo. Sixty-six of 77 (86%) 20f and 74 of 82 (90%) 32f participants planned for DART met the mandatory medium plan dose constraints. Radiotherapy-related grade ≥3 toxicity was reported in one of 58 patients (90% confidence interval [CI] 0.1, 7.9) with 20f DART and zero of 56 patients with 32f DART. Two-year overall survival was 77% (95% CI 69, 82) for WBRT + SART and 80% (95% CI 73, 85) for DART (hazard ratio = 0.84, 95% CI 0.59, 1.21, p = 0.4). Thirteen of 345 (3.8%) participants had salvage cystectomy. Grade ≥3 late toxicity was low. DART was safe and feasible to deliver, meeting preset toxicity thresholds. Disease-related outcomes are promising for dose-escalated treatments, with a low salvage cystectomy rate and overall survival similar to that seen in cystectomy cohorts. [ABSTRACT FROM AUTHOR]

Aim: To determine whether a strength‐based home‐visiting program enhances parent–child interaction during the first year at home for children born extremely preterm (gestational age < 28). Methods: A randomised controlled trial of 130 infants born extremely preterm 2018–2021 in Stockholm, allocated to either the Stockholm preterm interaction‐based intervention (SPIBI) (n = 66) or an extended follow‐up program (n = 64). The intervention group received ten home visits during the first year by a trained interventionist following SPIBI guidelines: an interaction‐based intervention supporting sensitive parental responses to infants' signals. The primary outcome of emotional availability was assessed at 12 months corrected age (CA) using the emotional availability scales (EAS). Results: At 1‐year CA, data were collected from 115/130 (89%) of the included children. There were no significant group differences in emotional availability at 12 months CA. A secondary analysis showed an effect modifier in families with mothers self‐rated as depressed at discharge, with the outcome favouring intervention in the EAS dimension of child involvement. Conclusion: The SPIBI had no significant main effect on emotional availability at 12 months CA. Children of self‐reported depressed mothers displayed superior involvement behaviour in the intervention group, prompting further research on risk groups and potential modifications of post‐discharge interventions. [ABSTRACT FROM AUTHOR]

• Low-grade inflammation is associated with some cases of depression. • Inflamed patients receiving anti-inflammatories had best outcomes of all groups. • Effect not apparent until 29 weeks after stopping the anti-inflammatory. • Anti-inflammatories in patients without inflammation had no additional benefit. • TNF-α was associated with clinical changes and is a potential biomarker in depression. Major depressive disorder (MDD) is a highly prevalent condition with a substantial incidence of relapse or treatment resistance. A subset of patients show evidence of low-grade inflammation, with these patients having a higher likelihood of more severe or difficult to treat courses of illness. Anti-inflammatory treatment of MDD has been investigated with mixed results, and no known studies have included assessments beyond cessation of the anti-inflammatory agent, meaning it remains unknown if any benefit from treatment persists. The objective of the present study was to investigate treatment outcomes up to 29 weeks post-cessation of celecoxib or placebo augmentation of an antidepressant, and how concentrations of selected inflammatory markers change over the same period. The PREDDICT parallel-group, randomised, double-blind, placebo-controlled trial (University of Adelaide, Australia) ran from December 2017 to April 2020. Participants with MDD were stratified into normal range or elevated inflammation strata according to screening concentrations of high sensitivity C-reactive protein (hsCRP). Participants were randomised to treatment with vortioxetine and celecoxib or vortioxetine and placebo for six weeks, and vortioxetine alone for an additional 29 weeks (35 total weeks). Following a previous publication of results from the six-week RCT phase, exploratory analyses were performed on Montgomery–Åsberg Depression Rating Scale (MADRS) scores, response and remission outcomes, and selected peripheral inflammatory markers across the entire study duration up to week 35. Participants retained at each observation were baseline N=119, week 2 N=115, week 4 N=103, week 6 N=104, week 8 N=98, week 22 N=81, and week 35 N=60. Those in the elevated hsCRP celecoxib-augmented group had a statistically significantly greater reduction in MADRS score from baseline to week 35 compared to all other groups, demonstrating the greatest clinical improvement long-term, despite no group or strata differences at preceding time points. Response and remission outcomes did not differ by treatment group or hsCRP strata at any time point. Changes in hsCRP between baseline and week 35 and Tumour Necrosis Factor-α (TNF-α) concentrations between baseline and week 6 and baseline and week 35 were statistically significantly associated with MADRS scores observed at week 6 and week 35 respectively, with reducing TNF-α concentrations associated with reducing MADRS scores and vice versa in each case. A post-hoc stratification of the participant cohort by baseline TNF-α concentrations led to significant prediction by the derived strata on clinical response at weeks 6, 8 and 35, with participants with elevated baseline TNF-α less likely to achieve clinical response. The present analysis suggests for the first time a possible longer-term clinical benefit of celecoxib augmentation of vortioxetine in inflammation-associated MDD treatment. However, further research is needed to confirm the finding and to ascertain the reason for such a delayed effect. Furthermore, the trial suggests that TNF-α may have a stronger relationship with anti-inflammatory MDD treatment outcomes than hsCRP, and should be investigated further for potential predictive utility. Clinical Trials Registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000527369p. Registered on 11 April 2017, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617000527369p. [ABSTRACT FROM AUTHOR]

The aim of this study was to find out how well pomegranate use affects quality of life and PMS symptoms. This randomised controlled trial (Clinical trial number: NCT06201702) was conducted in a city in the western region of Turkey, reaching women with PMS through social media announcements. Data were collected between 2 January 2024 and 15 May 2024. In the study of 60 participants (intervention group: 30, control group: 30), the intervention group was given pomegranate exrat supplementation for 2 cycles, while the control group did not receive any intervention. The research data were collected through a descriptive information, Premenstrual Syndrome Scale and World Health Organisation Quality of Life Scale. IBM SPSS Version 23 software was used for data analysis. Chi-square test, paired sample t -test and independent sample t-test were used. P -value <.05 was considered statistically significant. When the intervention and control groups were compared in terms of premenstrual syndrome scores, a statistically significant difference was found and it was observed that symptoms decreased significantly in the intervention group after the intervention (p <.05). However, no statistically significant change was observed in the control group (p >.05). When the quality of life scores after the intervention were evaluated, it was seen that the social quality of life of the intervention group was higher than the control group (p <.05). This study shows that pomegranate may be a potential natural solution, especially in reducing PMS symptoms, and may also be effective in improving social quality of life. • This study examined the effect of pomegranate use on PMS symptoms and quality of life. • Pomegranate was found to have a statistically significant effect on PMS symptoms. • Pomegranate had no statistically significant effect on quality of life. • Pomegranate may be a suitable natural remedy, especially in reducing PMS symptoms [ABSTRACT FROM AUTHOR]

The physical and psychological health management of nurses is very important not only for individual nurses but also for organizations and patients. However, nurses are exposed to high stress, sleep problems, and high presenteeism. Therefore, this study aimed to examine the effects of auricular acupressure (AA) on nurses' stress, sleep problems, and presenteeism. This randomized controlled trial encompassed 60 nurses divided into an experimental group (n = 30) and a control group (n = 30). Auricular acupressure using AA stickers with small magnets attached was performed in the experimental group, and a placebo AA using simple AA stickers (without the small magnets) was performed in the control group. The treatment lasted 7 weeks. To confirm the results, stress, sleep quality, and presenteeism were measured at pre- and posttest. There was a statistically significant difference in scores for sleep quality (t = −1.98, P = .047), health problems (z = −2.38, P = .017), and work impairment (t = −4.46, P < .001) between the experimental and control groups at posttest. Auricular acupressure increased sleep quality scores and decreased presenteeism. Auricular acupressure using AA stickers with small magnets attached was effective in improving sleep quality and reducing presenteeism in nurses. [ABSTRACT FROM AUTHOR]

Purpose Methods Results Conclusions To investigate 2‐year changes in macular choroidal thickness (ChT) in children receiving 0.01% atropine eyedrops and its relationship with spherical equivalent refraction (SER) progression and axial length (AL) elongation.A total of 250 myopic children aged 6–16 years (167%–0.01% atropine, 83‐placebo) were enrolled in the MOSAIC (ISRCTN36732601) clinical trial. Participants with complete 2‐year ChT (Topcon Triton Swept‐Source OCT), SER, and AL data were included in this study. Changes in macular ChT at 2 years and associations with changes in SER and AL elongation were analysed using linear mixed models.A total of 187 children (126%–0.01% atropine, 61‐placebo) were included in the analysis. Choroidal thickness over 2 years was stable in the 0.01% atropine compared with placebo group, which exhibited consistent thinning in subfoveal (mean ± SE: 0.49 ± 2.22 μm vs. −9.46 ± 2.69 μm; p = 0.034), parafoveal (1.40 ± 1.73 μm vs. −8.11 ± 2.08 μm; p = 0.002), and perifoveal (0.80 ± 1.25 vs. −6.17 ± 1.69; p = 0.002) macular subfields. Choroidal thickening was observed in participants with slower axial eye growth and myopia progression, regardless of their treatment group. Mediation analysis indicated that atropine 0.01% had a significant effect on ChT, with 68.3% of the effect being direct and 31.7% mediated through axial length changes. For SER, the direct effect on ChT was 80%, with the remaining 20% mediated by SER changes.Myopic participants treated with 0.01% atropine exhibited stable ChT over 2 years, whereas the placebo group showed consistent thinning. The effect of atropine 0.01% on ChT was only partially explained by axial length and SER changes, indicating a direct effect of atropine treatment on the choroid. [ABSTRACT FROM AUTHOR]

Background: Around 40% of people with major depressive disorder (MDD) experience moderate remission, with the remainder meeting the criteria for resistant major depression (RMD). It has been shown that exercise has a low-to-moderate effect on MDD, but there is a lack of evidence on exercise interventions in RMD patients. The primary purpose of the proposed study will be to investigate the effect of a 12-week supervised combined exercise program on depressive symptoms in people with RMD compared to a treatment-as-usual (TAU) group. Method: This randomised, single-blind, controlled experimental trial will include 70 adults (≥ 18 years old) with RMD. Participants randomised to an exercise intervention, or a TAU group will be assessed at baseline and after a three-month intervention period. The primary variable will be participants' depressive symptoms measured with the Montgomery-Asberg Depression Rating Scale. Secondary outcome variables will include cardiorespiratory fitness (peak oxygen uptake through peak cardiopulmonary exercise test), body composition (bioimpedance and anthropometric variables), physical activity level (the International Physical Activity Questionnaire), health-related quality of life (the Short Form-36 Health Survey), functional outcome (the Sheehan Disability Scale and Quality of Life in Depression Scale), overall disease severity (the Clinical Global Impression Scale-Severity of Illness), and biochemical variables (a fasting blood sample). Discussion: This study will try to answer whether a supervised co-adjuvant combined (aerobic and resistance training) exercise program will help the prognosis of this population with RMD. Trial registration: ClinicalTrials.gov NCT05136027. Last public release on 12/13/2023. [ABSTRACT FROM AUTHOR]

Background: Suicide is the leading cause of preventable death in prisons. Deaths from suicide in prison are significantly, and persistently, elevated compared to those living in the community. Psychological therapies have been shown to be a potentially effective means of alleviating suicidal thoughts, plans and behaviours, but patients located in prison often have no access to evidence-based psychological interventions targeting suicide. The objectives of this programme of research are to investigate the clinical and cost effectiveness of a new psychological therapy programme delivered to male prisoners at risk of suicide. Methods: The PROSPECT trial is a two-armed single blind, pragmatic, randomised controlled trial and will recruit a target sample size of 360 male prisoners, identified as at-risk of suicide, across 4 prisons in the North of England. Participants will be randomised to receive a psychological talking therapy (Cognitive Behavioural Suicide Prevention, CBSP) plus treatment as usual, or treatment as usual alone. Co-primary outcomes (Suicide Ideation and Suicide Behaviours), as well as related secondary outcomes, will be assessed at baseline and at 6-months follow-up. An intention to treat analysis will be conducted with primary stratification based on prison site and lifetime history of suicide attempt (yes/no). A nested qualitative process evaluation will investigate the nature and context in which the intervention is delivered, with specific focus upon the facilitators and barriers to the implementation of the therapy within prisons. Discussion: The key outputs from this trial will be to determine whether a psychological therapy for suicidal prisoners is clinically and cost effective; and to generate a project implementation platform that identifies how best to implement the new intervention across the broader prison estate. Trial registration: ISRCTN (reference ISRCTN14056534 https://www.isrctn.com/ISRCTN14056534; 24th September 2021). Registration confirmed prior to participant recruitment commencing. Modifications to protocol are listed on the study website at ISRCTN. [ABSTRACT FROM AUTHOR]

Background: Cognitive impairment is common in haemodialysis patients with no known beneficial interventions. Cooler dialysate slows brain white-matter changes, but its effect on cognition is unknown. This feasibility trial was performed to inform a fully-powered, randomised trial to assess this. Methods: We aimed to randomise (1:1) 90 haemodialysis patients to this double-blinded, randomised controlled feasibility trial to standard care (dialysate-temperature 36.5 °C) or intervention (35 °C). Eligible patients were adult chronic haemodialysis recipients with no established diagnosis of dementia or psychiatric disease. The primary outcome was change in Montreal Cognitive Assessment (MoCA) score at 12-months. Secondary outcomes included recruitment and attrition rates, reasons for non-recruitment, intradialytic hypotension, depression, patient burden, computerised cognition test battery, and quality of life. Findings: Of 334 patients screened, 160 were eligible. 99 declined mainly for the extra non-dialysis day study visits. Sixty-one patients consented, 43 randomised – 20 in standard care, 23 in intervention arms; 13 withdrew for non-dialysis day visits and 5 without reason before randomisation. 27 patients (12 standard care, 15 intervention) completed the trial – 5 died, 1 transplanted, 4 withdrew consent, and 6 could not attend due to the pandemic. Low temperature dialysis was well tolerated. There was no difference in change in MoCA from baseline to 12 months between the standard and intervention arms; 1.0 (-2.8–3.0, p = 0.755) and − 2.0 (-1.0 - -4.0, p = 0.047) respectively. There were no differences between groups on any secondary measures. There were no significant adverse events reported. Discussion: The trial was significantly affected by the COVID-19 pandemic contributing to an attrition rate of 27%. The non-dialysis day research visits were mainly responsible for low recruitment and consent withdrawal. There are several learning points, described in the article, which will inform design of definitive trials in this area in the future. Trial registration: ClinicalTrials.gov Identifier NCT03645733. Registration date 24/08/2018. [ABSTRACT FROM AUTHOR]

AbstractPurposeMethodsResultsConclusions\nIMPLICATIONS FOR REHABILITATIONThe Falls After Stroke Trial (FAST) intervention involves habit-forming functional exercise and mobility practice which may increase physical activity. This substudy of FAST explores physical activity in community-dwelling people after stroke comparing the FAST intervention to usual care.This study used a subset of 49 participants from a randomised trial. Outcome measures were taken at baseline, 6- and 12-months. The primary outcome was physical activity (step count, upright time and sedentary time, activPAL4™ micro).Thirty-nine participants (80%) had valid primary outcome data at 6 months and 36 participants (73%) at 12 months. Compared to baseline, the experimental group completed 485 (95% CI −434 to 1405) more steps/day than the control group at 6 months and 724 (95% CI −239 to 1667) more steps/day at 12 months; and spent 36 (95% CI −46 to 118) fewer min/day in sedentary behaviour than the control group at 6 months and 34 (95% CI −51 to 119) fewer min/day at 12 months, although the differences were not significant.FAST may improve physical activity more than usual care at 6- and 12-months but results are inconclusive. Further research could be conducted to confirm any benefit in a larger sample.Physical activity levels of older community-dwelling people after stroke in the chronic phase are low.Although there is uncertainty, a tailored, multicomponent intervention involving habit-forming functional exercise and mobility practice (FAST) may have a positive impact on physical activity in people after stroke.Rehabilitation clinicians could consider the use of FAST, and in particular habit-forming functional exercise, to support physical activity opportunities in community-dwelling people after stroke.Physical activity levels of older community-dwelling people after stroke in the chronic phase are low.Although there is uncertainty, a tailored, multicomponent intervention involving habit-forming functional exercise and mobility practice (FAST) may have a positive impact on physical activity in people after stroke.Rehabilitation clinicians could consider the use of FAST, and in particular habit-forming functional exercise, to support physical activity opportunities in community-dwelling people after stroke. [ABSTRACT FROM AUTHOR]

The gut microbiome is impacted by certain types of dietary fibre. However, the type, duration and dose needed to elicit gut microbial changes and whether these changes also influence microbial metabolites remain unclear. This study investigated the effects of supplementing healthy participants with two types of non-digestible carbohydrates (resistant starch (RS) and polydextrose (PD)) on the stool microbiota and microbial metabolite concentrations in plasma, stool and urine, as secondary outcomes in the Dietary Intervention Stem Cells and Colorectal Cancer (DISC) Study. The DISC study was a double-blind, randomised controlled trial that supplemented healthy participants with RS and/or PD or placebo for 50 d in a 2 × 2 factorial design. DNA was extracted from stool samples collected pre- and post-intervention, and V4 16S rRNA gene sequencing was used to profile the gut microbiota. Metabolite concentrations were measured in stool, plasma and urine by high-performance liquid chromatography. A total of fifty-eight participants with paired samples available were included. After 50 d, no effects of RS or PD were detected on composition of the gut microbiota diversity (alpha- and beta-diversity), on genus relative abundance or on metabolite concentrations. However, Drichlet's multinomial mixture clustering-based approach suggests that some participants changed microbial enterotype post-intervention. The gut microbiota and fecal, plasma and urinary microbial metabolites were stable in response to a 50-d fibre intervention in middle-aged adults. Larger and longer studies, including those which explore the effects of specific fibre sub-types, may be required to determine the relationships between fibre intake, the gut microbiome and host health. [ABSTRACT FROM AUTHOR]

Background: People with severe mental illness experience physical health inequalities and a 15–20-year premature mortality rate. Forensic inpatients are particularly affected by restrictions on movement, long admissions, and obesogenic/sedative psychotropic medication. We aimed to establish the feasibility and acceptability of Motiv8, a multidisciplinary weight management intervention co-produced with service users for forensic inpatients. Methods: A randomised waitlist-controlled trial of Motiv8(+Treatment-As-Usual) vs.TAU was conducted in medium-secure forensic services in Greater Manchester. Motiv8 is a 9-week programme of exercise sessions, diet/cooking classes, psychology, physical health/sleep education, and peer support. Physical and mental health assessments were conducted at baseline/10-weeks/3-months. A nested qualitative study captured participant experiences. A staff sub-study explored ward environment. Results: We aimed to recruit 32 participants (four cohorts). The trial met recruitment targets (n=29, 90.9%; 4 cohorts, 100%), participants were randomised to Motiv8+TAU (n=12) or waitlist (control) (n=17). Acceptable retention rates were observed (93.1%, 10-weeks; 72.4%, 3-months), and participants engaged well with the intervention. The blind was maintained, and no safety concerns raised. Assessment completion was high suggesting acceptability (>90% for people retained and engaged in the study). Participants reported high levels of satisfaction. Conclusions: The trial was not powered to detect group differences. However, data suggests it is feasible to conduct a rigorous, methodologically robust study of Motiv8 vs.TAU for adults on forensic inpatient units. Motiv8 was acceptable with potential promise providing evidence to proceed to a definitive trial for males. A larger trial is needed to explore potential effectiveness and reduce physical health inequalities for people with SMI. Clinical trial registration: https://doi.org/10.1186/ISRCTN13539285 , identifier ISRCTN13539285. [ABSTRACT FROM AUTHOR]

Objectives: To explore physiotherapists' experiences and perceived acceptability of delivering a bracing intervention for knee osteoarthritis (OA) in the 'PROvision of braces for Patients with knee OA' (PROP OA) randomised controlled trial. Method: Semi‐structured telephone interviews with consenting physiotherapists who received the PROP OA training programme and delivered the knee bracing intervention (advice, information and exercise instruction plus knee brace matched to patients' clinical and radiographic presentation and with adherence support). Interviews were recorded and transcribed verbatim. Two‐stage analytic framework: inductive thematic analysis preceded mapping to constructs of the Theoretical Framework of Acceptability. Results: Eight physiotherapists were interviewed and six key themes were developed. Perceptions of the training programme were generally positive, but additional formal training and experiential learning consolidated confidence and skills in novel intervention components. Advice, information, and exercise instruction reflected usual physiotherapy care for knee OA. Physiotherapists were confident in delivering the knee brace, but determining the pattern of knee OA to inform brace type selection was challenging. Physiotherapists valued brace adherence enhancing strategies and the follow‐up appointment to facilitate adherence. Perceived impact of the bracing intervention for people with OA was positive. The bracing intervention was perceived as acceptable, although improving self‐efficacy to deliver novel intervention components (e.g., reading x‐rays) would enhance acceptability. Conclusion: The complex knee bracing intervention was broadly perceived as acceptable by physiotherapists. If implemented within clinical practice beyond the trial, physiotherapists might benefit from not only initial training in brace selection but also ongoing support and mentoring to increase self‐efficacy in delivery. [ABSTRACT FROM AUTHOR]

Breast conservation surgery is the standard of care for patients with early breast cancer. Although most surgeons perform oncoplasty for closure of defect, there is no randomised evidence for its favour as compared to simple closure of breast defect. We compared the cosmetic outcomes of patients treated by oncoplasty versus simple closure with 1-cm vs. 2-cm margin of excision. One hundred and four patients with breast cancer were randomised to four groups: excision with 1-cm margin with simple closure or excision with 2-cm margin with simple closure; excision with 1-cm margin and oncoplasty; and excision with 2-cm margin oncoplasty. Fifty-two patients underwent oncoplasty and 52 patients had simple closure of breast defect. There was no significant difference in the cosmetic outcomes in patients undergoing oncoplasty compared to simple closure. Excision with 2-cm margin compared to 1 cm did not worsen the cosmetic outcome. The margin positivity and re-excision rates were higher with 1-cm margin and oncoplastic closure group (p-value 0.018). There was no significant difference in complications between oncoplasty compared to simple closure, and 1-cm vs. 2-cm margin of excision. Simple closure demonstrated similar cosmesis as compared to oncoplasty. [ABSTRACT FROM AUTHOR]

Stereotactic body radiotherapy (SBRT) without androgen deprivation therapy (ADT) has lower rates of incontinence and sexual dysfunction, with a small trade-off in bowel bother, compared with prostatectomy. At 2 yr, 50% of men who underwent prostatectomy reported using urinary pads, compared with 6.5% who underwent SBRT, whilst only a modest reduction in the Expanded Prostate Index Composite (EPIC) bowel domain score was seen for SBRT compared with that for prostatectomy. Prostatectomy participants reported worse sexual function at 2 yr. Randomised data on patient-reported outcomes (PROs) for stereotactic body radiotherapy (SBRT) and prostatectomy in localised prostate cancer are lacking. PACE-A compared patient-reported health-related quality of life after SBRT with that after prostatectomy. PACE is a phase 3 open-label, randomised controlled trial. PACE-A randomised men with low- to intermediate-risk localised prostate cancer to SBRT or prostatectomy (1:1). Androgen deprivation therapy (ADT) was not permitted. The coprimary outcomes were the Expanded Prostate Index Composite (EPIC-26) number of absorbent urinary pads required daily and bowel domain score at 2 yr. The secondary endpoints were clinician-reported toxicity, sexual functioning, and other PROs. In total, 123 men were randomised (60 undergoing prostatectomy and 63 SBRT) from August 2012 to February 2022. The median follow-up time was 60.7 mo. The median age was 65.5 yr and the median prostate-specific antigen (PSA) value 7.9 ng/ml; 92% had National Comprehensive Cancer Network (NCCN) intermediate-risk disease. Fifty participants received prostatectomy and 60 received SBRT. At 2 yr, 16/32 (50%) prostatectomy and three of 46 (6.5%) SBRT participants used one or more urinary pads daily (p < 0.001; 15 and two, respectively, used one pad daily); the estimated difference was 43% (95% confidence interval [CI]: 25%, 62%). At 2 yr, bowel scores were better for prostatectomy (median [interquartile range] 100 [100–100]) than for SBRT (87.5 [79.2–100]; p < 0.001), with an estimated mean difference of 8.9 between these (95% CI: 4.2, 13.7); sexual scores were worse for prostatectomy (18 [13.8–40.3]) than for SBRT (62.5 [32.0–87.5]). The limitations were slow recruitment and incomplete 2-yr PRO response rates. SBRT was associated with less patient-reported urinary incontinence and sexual dysfunction, and slightly more bowel bother than prostatectomy. These randomised data should inform treatment decision-making for patients with localised, intermediate-risk prostate cancer. [ABSTRACT FROM AUTHOR]

Declining prostate-specific antigen levels during [177Lu]Lu-PSMA-617 treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer were strongly associated with prolonged radiographic progression-free survival, overall survival, and time to health-related quality-of-life worsening. These findings demonstrate the prognostic importance of this biomarker in patients receiving PSMA-targeted radioligand therapy. The prognostic value of declining prostate-specific antigen (PSA) levels is under investigation in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) receiving PSMA-targeted radioligand therapy with [177Lu]Lu-PSMA-617 (177Lu-PSMA-617). This post hoc analysis of the phase 3 VISION trial aimed to evaluate associations between PSA decline and clinical and patient-reported outcomes in patients receiving 177Lu-PSMA-617. Of 831 enrolled patients with PSMA-positive progressive mCRPC treated previously with one or more androgen receptor pathway inhibitors and one to two taxanes, 551 were randomised to 177Lu-PSMA-617 plus protocol-permitted standard of care (SoC). Radiographic progression-free survival, overall survival, radiographic objective response rate, and patient-reported health-related quality of life (HRQoL) and pain were analysed in subgroups of patients categorised by the magnitude of unconfirmed PSA decline from baseline. Patients randomised to 177Lu-PSMA-617 with the best PSA declines of ≥0–<50% (96/551 [17%]), ≥50–<90% (152/551 [28%]), and ≥90% (83/551 [15%]) up to and including week 12 had 61%, 72%, and 88% reduced risks of radiographic disease progression or death, and 51%, 70%, and 87% reduced risks of death, respectively, versus those with increased PSA levels (160/551 [29%]), based on hazard ratios in a multivariate Cox proportional hazard model. In patients with greater PSA declines, radiographic responses were more frequent and median time to worsening in HRQoL and pain scores were longer. The magnitude of PSA decline was associated with improvement in clinical and patient-reported outcomes in patients with mCRPC receiving 177Lu-PSMA-617 plus SoC in VISION. PSA decline therefore appears to have a prognostic value during 177Lu-PSMA-617 treatment in this population. [ABSTRACT FROM AUTHOR]

The management of stress has evolved in recent years due to widespread availability of mobile-device applications (apps) and their capacity to deliver psychological interventions. We evaluated the efficacy of mental health apps on stress and sought to identify characteristics associated with effect size estimates. Sixty-nine randomised controlled trials (RCTs) were included. Random effects meta-analyses were performed and putative moderators were examined at univariate and multivariate (combinations and interactions) levels. From 78 comparisons, we observed a small but significant pooled effect of apps over control conditions on perceived stress levels (g = 0.27; 95% CI = 0.20, 0.34; I2 = 68%). This effect weakened after taking into account small-study bias according to the trim-and-fill procedure (g = 0.10; 95% CI = 0.02, 0.19; I2 = 78%). Delivery of apps with stress monitoring features produced smaller efficacy estimates, although this association interacted with other trial features (small sample size and inactive control group) in multivariate analyses, suggesting that this effect may have been explained by features characteristic of low-quality trials. Mental health apps appear to have small, acute effects on reducing perceived stress. Future research should shift focus towards identifying change mechanisms, longitudinal outcomes, features that facilitate sustained app usage, and tangible pathways to integrating apps into real-world clinical settings. [ABSTRACT FROM AUTHOR]

Purpose: To determine the effectiveness of different types of acupuncture in reducing pain, improving maximum mouth opening and jaw functions in adults with orofacial pain. Methods: Six databases were searched until 15 June 2023. The Cochrane risk of bias tool and GRADE were employed to evaluate bias and overall evidence certainty. Results: Among 52 studies, 86.5% (n = 45) exhibited high risk of bias. Common acupoints, including Hegu LI 4, Jiache ST 6, and Xiaguan ST 7, were used primarily for patients with temporomandibular disorder [TMDs]. Meta-analyses indicated that acupuncture significantly reduced pain intensity in individuals with myogenous TMD (MD = 26.02 mm, I2=89%, p = 0.05), reduced tenderness in the medial pterygoid muscle (standardised mean differences [SMD] = 1.72, I2 = 0%, p < 0.00001) and jaw dysfunction (SMD = 1.62, I2 = 88%, p = 0.010) in mixed TMD when compared to sham/no treatment. However, the overall certainty of the evidence was very low for all outcomes as evaluated by GRADE. Conclusion: The overall results in this review should be interpreted with caution as there was a high risk of bias across the majority of randomized controlled trial (RCTs), and the overall certainty of the evidence was very low. Therefore, future studies with high-quality RCTs are warranted evaluating the use of acupuncture in patients with orofacial pain. IMPLICATIONS FOR REHABILITATION: Acupuncture could potentially reduce subjective pain intensity and sensitivity of masticatory muscles, improve mouth opening, and reduce dysfunction in orofacial pain, specifically in patients with temporomandibular disorder (TMD). Acupuncture points such as LI4, ST6, ST7, GB20, SI19, ST36 were the most commonly used acupuncture points to treat patients with orofacial pain, especially TMDs. Clinicians can use the information in this review with caution to develop an effective and appropriate treatment regimen for the acupuncture treatment of patients with TMDs. [ABSTRACT FROM AUTHOR]

Objective: This study aims to systematically evaluate the efficacy of probiotics in treating minimum hepatic encephalopathy (MHE). Methods: A systematic search was conducted across three major databases: PubMed, China National Knowledge Infrastructure and Wanfang. The search period spanned from the inception of each database to 9 March 2023. The objective was to identify all randomised controlled trials (RCTs) examining the efficacy of probiotic preparations in treating MHE. The search terms included 'probiotics' along with other clinically relevant terms to comprehensively capture all pertinent studies. Results: A total of 18 RCTs were included. The meta‐analysis showed that probiotic treatment outperformed control groups in reducing blood ammonia levels (standard mean difference [MD] = −2.68, 95% confidence interval [CI]: −3.90 to −1.46, p <.0001), improving the remission rate of MHE (risk ratio [RR] = 2.79, 95% CI: 1.23–6.35, p =.01) and lowering alanine aminotransferase levels (MD = −11.10, 95% CI: −16.17 to −6.03, p <.0001). It also significantly reduced the Model for End‐Stage Liver Disease scores (MD = −2.55, 95% CI: −3.56 to −1.54, p <.00001) and the incidence of MHE (RR =.18, 95% CI:.09–.34, p <.00001). Conclusion: Our study demonstrates that probiotics effectively improve blood ammonia levels, liver function and cognitive function in patients with MHE. They significantly enhance the remission rate of MHE and effectively reduce its incidence, providing solid new evidence for treating MHE with probiotics. [ABSTRACT FROM AUTHOR]

Objective: To determine whether completion of an online mental health self-assessment by patients who are waiting in the emergency department can save clinician time taken to complete clinical assessment and documentation. Methods: Patients presenting to a psychiatric emergency department for a period of 6 months were allocated by week of presentation to either the intervention arm (online mental health self-assessment, followed by a clinical interview) or the control arm (usual assessment) arm on a random basis. Time at the beginning and end of the interview was recorded and used to derive interview time. Similarly, time at the beginning and end of the clinical documentation was recorded and used to derive the time to complete clinical documentation. Results: Of 168 patients who presented during the study period, 69 (38.55%) agreed to participate, 33 completed the usual assessment and 30 completed the online mental health self-assessment followed by a clinical interview. Patients receiving usual care had a statistically significant, t (61) = 2.15, p = 0.035, longer interview duration (M = 48.7 minutes, SD = 19.8) compared with those in the online mental health self-assessment arm (M = 38.9 minutes, SD = 15.9). There was no statistically significant difference between groups for documentation time, t (61) = −0.64, p = 0.52. Conclusion: Online mental health self-assessment was associated with a statistically significant reduction in interview time by approximately 10 minutes without increasing documentation time. While online mental health self-assessment is not appropriate for all patients in the emergency department setting, it is likely to yield greater benefits in less acute settings. [ABSTRACT FROM AUTHOR]

Background: In Norway, municipal acute wards (MAWs) were implemented as alternatives to hospitalisation. Evaluations of the quality of MAW services are lacking. The primary objective of this study was to compare patient experiences after admission to a MAW versus to a hospital. The secondary objective was to compare 'readmissions', 'length of stay', 'self-assessed health-related quality of life' as measured by the EuroQol 5 items 5 level (EQ-5D-5L) index, and 'health status' measured by the RAND-12, in patients admitted to a MAW versus a hospital. Methods: A multicentre randomised controlled trial (RCT), randomising patients to either MAW or hospital. Results: In total, 164 patients were enrolled in the study; 115 were randomised to MAW and 49 to hospital. There were no significant differences between the MAW and hospital groups regarding patient experience, which was rated positively in both groups. Patients in the MAW group reported significantly better physical health status as measured by the RAND-12 four to six weeks after admittance than those randomised to hospital (physical component summary score, 31.7 versus 27.1, p = 0.04). The change in EQ-5D index score from baseline to four to six weeks after admittance was significantly greater among patients randomised to MAWs versus hospitals (0.20 versus 0.02, p = 0.03). There were no other significant differences between the MAW and hospital groups. Conclusions: In this study, patient experiences and readmissions were similar, whether patients were admitted to a MAW or a hospital. The significant differences in health status and quality of life favouring the MAWs suggest that these healthcare services may be better for elderly patients. However, unfortunately we did not reach the planned sample size due to challenges in the data collection posed by the Covid-19 pandemic. KEY POINTS: Municipal acute wards have been implemented in Norway as alternatives to hospitalisation. However, the quality of these wards remains unexplored. Results in this study indicates that patient experiences after stays in municipal acute wards are equally positive to experiences after stays in hospital there are no significant differences in length-of-stay, readmission rates or mortality between municipal acute wards and hospital patients have slightly more positive self-rated health and health status 4–6 weeks after staying in a municipal acute ward [ABSTRACT FROM AUTHOR]

This five-year randomised controlled trial explored the impact of the Lifestart home visiting parenting programme, on parent and child development outcomes. The Lifestart Programme is a universal and structured child-centred programme of information and practical activity for parents of children aged from birth to five years of age. In total, 424 parents and children participated, and outcomes were measured at pre-test (child age < 12 months), mid-point (age 3) and post-test (age 5). Compared to the control group, parents who received the Lifestart programme reported reduced parenting related stress, increased knowledge of their child's development and improved confidence in their parenting role. There was no evidence of any change in child development outcomes (i.e. cognitive, behavioural, social or emotional development) and there was no clear evidence of any consistent differential programme effects in relation either to gender, first time motherhood, high pre-test anxiety or low maternal education. The results are commensurate with findings from other evaluations of similar programmes and are aligned to the hypothesised theory of change. The study contributes to the limited knowledge on solely home visiting, universal parenting programmes on parent and child outcomes. [ABSTRACT FROM AUTHOR]

To compare the effect of an illness perception conversation (IPC), relative to a research participation conversation (RPC), on 2-week changes in knee pain in patients with knee osteoarthritis. This was a randomised single-blind trial. Patients were randomised to two matched conversations. An IP conversation concerning the participant's knee pain-related illness perception (IP) or an RPC concerning the participant's motivation for participating in research. Both conversations were followed by an open-label intraarticular saline injection in the most symptomatic knee. The primary outcome was change in knee pain from baseline to 2 weeks follow-up on a 100 mm visual analogue scale (VAS). Key secondary outcomes included the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: Activities of daily living (ADL) and Quality of life (QoL). Main analyses were based on the intention-to-treat population using repeated measures mixed effects linear models. 103 patients were randomised to the IPC group (n = 52) and the RPC group (n = 51). VAS knee pain scores changed statistically significantly from baseline to end of treatment in both groups, −13.7 (standard error [SE]: 3.2) in the IPC group and −13.0 (SE: 3.1) in the RPC group with an adjusted between-group difference of −0.7 (95% CI: −8.3 to 6.9; P = 0.85). Likewise, no group differences were seen in KOOS ADL and KOOS QoL. A conversation concerning knee pain-related IP did not augment the pain-relieving effect of an open-label placebo injection when compared to a similar control conversation concerning motivations for participating in research. NCT05225480. [ABSTRACT FROM AUTHOR]

The present study aimed to compare postoperative pain in teeth with symptomatic and asymptomatic apical periodontitis (AP) following a single‐visit endodontic treatment using BioRoot™ RCS or AH Plus at 8 h, 24 h and 48 h postoperatively. Postgraduate students performed endodontic treatment on 101 teeth with AP, randomised into two obturation groups. A 100‐mm Visual Analog Scale was used to document the intensity of pain at preoperative, 8‐h, 24‐h and 48‐h intervals. The Kolmogorov–Smirnov test was used for normality, and the median and interquartile ranges were compared using the Mann–Whitney U test. Preoperative pain (1.90 ± 3.50) was more frequent in teeth with symptomatic AP (p < 0.05). However, no significant differences were observed in postoperative pain at the 8‐h, 24‐h and 48‐h intervals. Pre and postoperative pain were directly associated (p < 0.05). Single‐visit root canal treatment in teeth with AP using both sealers resulted in similar levels of postoperative pain. [ABSTRACT FROM AUTHOR]

A growing literature in economics has analysed the effects of psychological interventions designed to boost individual aspirations as a strategy to increase households' propensity to make long-term investments and thus reduce poverty. This paper reports on a randomised controlled trial evaluating a short video-based intervention designed to increase aspirations of adults in poor rural Ethiopian households who are beneficiaries of the Productive Safety Net Program, the main government safety net program in Ethiopia. Evidence from a sample of 5,258 adults from 3,220 households is consistent with the hypothesis that there are no significant effects of the intervention on self-reported aspirations for the household, educational investment in children, or savings nine months post-treatment. This suggests that the effect of light-touch aspirations treatments for extremely poor adults may be limited in this context. [ABSTRACT FROM AUTHOR]

Background: Postmenopausal osteoporosis (PMOP) is a serious condition that affects elderly individuals. Our previous study revealed that Yigu decoction (YGD) effectively improved bone mineral density (BMD) in elderly individuals, but the mechanism underlying this effect remains unclear. In this study, we investigated the relationships among YGD, microRNAs (miRNAs), and bone metabolism by assessing the effects of YGD on the miRNA levels in patient plasma to provide a scientific basis for treating PMOP with YGD. Methods: In this clinical trial, 60 patients were randomly assigned to the YGD group or the control group (ratio of 1:1) and treated for 3 months. The primary outcome measure was BMD, and the secondary outcome measures included plasma miRNA levels, visual analogue scale (VAS) scores, alkaline phosphatase (ALP) levels, anti-tartrate acid phosphatase (TRACP-5b) levels and traditional Chinese medicine (TCM) syndrome scores. We assessed the regulatory roles of miRNAs in PMOP patients by analysing publicly available data from the Gene Expression Omnibus (GEO) database. Bioinformatics methods were also used to explore the mechanism by which YGD regulates miRNAs that are involved in bone metabolism. Results: Compared with those before treatment, the BMD, ALP levels, TRACP-5b levels, TCM syndrome scores and VAS scores improved in both groups after 3 months of treatment (P < 0.05). A total of 82 miRNAs differed between the groups. After analysing data from the GEO database, we confirmed that miR-133a-3p is the key molecule that mediates the effects of YGD intervention on PMOP. GO analysis of key genes suggested that gene enrichment was more pronounced in response to hormones, cellular response to growth factor stimulation, and positive regulation of physiological and metabolic processes. KEGG analysis revealed that these genes were enriched mainly in the PI3K-Akt, FOXO, and JAK-STAT pathways and other pathways. The results of the protein‒protein interaction (PPI) network analysis revealed that epidermal growth factor receptor (EGFR), Insulin-like growth factor 1 (IGF-1), Caveolin-1 (Cav-1) and others were core proteins. Conclusion: This study demonstrated that YGD is beneficial in the treatment of PMOP, ameliorating clinical symptoms and bone turnover indices. Moreover, the inhibition of miR-133a-3p expression may be the key mechanisms by which YGD regulates bone metabolism in the treatment of PMOP, although YGD regulates bone metabolism in a multitarget and multipathway manner. [ABSTRACT FROM AUTHOR]

Background: A new model of care enables French physiotherapists (PT) working in collaboration with family physicians (FP) to expand their usual scope of practice for patients with acute low back pain (LBP). The aim of our study is to evaluate the impact of this new first-contact physiotherapy (FCP) advanced practice model compared to usual FP care. Methods: A multicentre pragmatic non-inferiority cluster randomised controlled trial (RCT) has been conducted in six multidisciplinary primary healthcare centres in France. Patients from 20 to 55 years old with acute LBP consulted either the PT or the FP. PT independently assessed and managed patients including medication prescription. The primary outcome measure was disability at six weeks (Roland Morris Disability Questionnaire, range 0–24). Secondary outcomes include pain, risk disability prognosis, satisfaction with care, healthcare resources use and wait times. Data were collected at baseline, six and twelve weeks. Outcomes across arms were compared using mixed models regression analysis. Except for non-inferiority analysis of the primary outcome measure, other analyses were performed with a two-sided significance level of 0.05. Results: Sixty patients were recruited (PT: 32, FP: 28). The adjusted mean difference between groups for disability at 6 weeks was 0.39 in favour of the FP group (95%CI: -2.03; 2.81, p = 0.753). Considering a 5 points minimal clinically important difference, the FCP-led model of care was not inferior to usual FP care for the primary outcome. There was no statistically significant difference between groups in disability at 3 months and pain at 6 weeks and 3 months. PTs prescribed significantly less medications than FPs (p < 0.001). No statistically significant difference was found for other healthcare resource use outcomes, patients’ satisfaction and wait times. Conclusion: This is the first RCT to evaluate the impact of a FCP advanced practice model of care including medical delegated acts in a primary care setting. Our results suggest that the FCP-led model of care is not inferior to usual FP care regarding disability at 6 weeks. The FCP model could result in possible benefits in terms of healthcare resources use. Further adequate powered studies with larger sample size are needed to draw stronger conclusions. Trial registration: The study has been registered in ClinicalTrials.gov (NCT05200533) on the 20th of January 2022. [ABSTRACT FROM AUTHOR]

Background: Open liver surgery remains a primary surgical approach for complex liver resections and liver transplantation. However, the postoperative pain management is still a major challenge. Ultrasound-guided external oblique intercostal (EOI) plane block is a novel approach of regional anaesthesia and has a great potential to relieve postoperative pain after upper abdominal surgeries. This study aims to investigate the efficacy and safety of ultrasound-guided EOI plane block in managing postoperative pain after open liver surgery. Methods: Seventy-four participants scheduled for open liver surgery will be randomly assigned to either the intervention group, receiving an ultrasound-guided EOI plane block with a single dose of 30 ml 0.375% ropivacaine, or the control group, which will not receive this block. All participants will be provided with opioid-based patient-controlled intravenous analgesia (PCIA) postoperatively. The primary outcome is resting pain score at 3 h postoperatively, assessed using numerical rating scale. Secondary outcomes include pain score at 6, 24, 48, and 72 h postoperatively, perioperative opioid consumption, remedial analgesics within 72 h postoperatively, PCIA usage within postoperative 72 h, postoperative recovery, length of hospital stay, postoperative side effects, block-related complications, and ropivacaine plasma concentration of participants receiving the block. Discussion: This study is a randomised controlled trial to evaluate the efficacy and safety of ultrasound-guided EOI plane block for postoperative analgesia after open liver surgery. As regional anaesthesia plays an important role in the multimodal pain management, EOI plane block may prove to be an effective regional technique for enhancing postoperative pain relief and contributing to enhanced recovery after open liver surgery. Trial registration: Chinese Clinical Trial Registry ChiCTR2200065745. Registered on November 14, 2022. [ABSTRACT FROM AUTHOR]

Objective: Eating disorders are complex illnesses with high morbidity and mortality. Yet, there is promising evidence to support the effects of nutrition on the brain and behaviour. One proposed example is the use of tyrosine as an adjunct treatment in anorexia nervosa (AN). However, recruitment and retention in eating disorder clinical trials has posed difficulties for researchers. The aim of this study was to pilot test a parallel randomised controlled trial (RCT) of tyrosine supplementation to explore the feasibility of recruitment and retention, intervention adherence and data collection methods from the perspective of participants and researchers. Method: Feasibility was assessed using numbers participating, questionnaire completion in patients and parent/carers completing and declining participation, a researcher implementation record and clinical measures. Subjects included adolescents aged 12–17 years with AN. The study was conducted over a 12-week period, with the intervention group receiving 5 mg of L-tyrosine supplement and the control group receiving a placebo. Results: Recruitment targets were not met and recruitment to a full RCT based on the current study protocol and recruitment sites did not prove feasible. Of the 39 approached for RCT participation, seven were recruited to the RCT (18% response rate) despite extending recruitment periods, with 100% retained and analysed. Patients or parents/carers identified barriers to study participation including burden, the need to consume tyrosine as tablets, and the use of blood, urine and psychological testing. Blood tyrosine rose markedly for subjects in the intervention group. No side effects were reported or measured. Conclusions: This study offers a unique exploration of the feasibility of a tyrosine trial in anorexia nervosa and is of relevance to assist the success of future nutrition trials. Exploring the suitability of future study designs for nutrition intervention research is warranted. Plain English Summary: Eating disorders are serious mental illnesses and exploration of effective treatments are required as a priority. This study explored whether using of a dietary protein (tyrosine) in supplement form added to usual treatment appeared feasible and acceptable to study participants. Study components perceived as potential barriers included use of tyrosine capsules as well as physical and psychological testing. Exploring suitable future study designs for nutrition intervention research with people with an eating disorder and parents/carers is required. [ABSTRACT FROM AUTHOR]

Summary The study aims to test the efficacy of a family‐centred healthy lifestyle program in primary care health centres among children with overweight or obesity, evaluating the results at 3, 6, and 9 months post‐intervention. A single‐blind, randomised controlled cluster study where participants will be blinded to group assignment to reduce bias will be followed. The intervention comprises a 6‐month program with intensive and maintenance behavioural therapies, including dietary modifications and guidelines for physical activity, administered by a multidisciplinary team. Participants will be assigned to an intervention group or a treatment‐as‐usual control group. Primary health centres in Seeb Wilayat, serving densely populated areas and willing to participate, will be included. Randomisation will be conducted at the cluster level to improve recruitment efficiency. A sample size calculation will ensure adequate power to detect significant differences. Ethical approval is granted and informed consent/assent will be obtained from all participants. The proposed study focusses on testing the efficacy of a family‐centred healthy lifestyle program in primary care centres through a controlled, randomised study. Successful outcomes could lead to informed interventions, improvements in the health system, policy recommendations, positive community impacts, information on behavioural therapies, and improved long‐term health outcomes for affected children and their families. This study will contribute to the literature by providing a culturally sensitive and evidence‐based solution to a pressing public health issue, which can be adapted to similar contexts in Oman and beyond. [ABSTRACT FROM AUTHOR]

Introduction: Hypertensive intracerebral hemorrhage (HICH) is a condition associated with significant morbidity, mortality, and disability, particularly among the elderly population. The management of moderate thalamic-basal ganglia cerebral hemorrhage primarily relies on conservative approaches. Nevertheless, the rate of long-term disability remains high. In recent years, there has been significant advancement in minimally invasive surgery and diffusion tensor imaging techniques. Consequently, the utilization of Diffusion Tensor Imaging (DTI) technology in patients with cerebral haemorrhage allows for the identification of the haematoma's location in relation to the Corticospinal Tract (CST). This enables the development of precise puncture pathways that can be visualized, thereby avoiding any potential damage to the CST. Methods and analysis: Diffusion Tensor Imaging (DTI) is a method used to assess the structural and physiological characteristics of biological tissue by examining the diffusion behavior of water molecules.In the central nervous system, limb paralysis will be inevitable if the corticospinal tract is damaged. By employing DTI imaging techniques on individuals, it becomes possible to visualize the spatial relationship between the hematoma and the CST. This approach allows avoidance of the CST during preoperative planning of the puncture path, thus reducing secondary injuries caused by the procedure. The primary objective of this study was to assess the ability of patients in the minimally invasive surgery group and the conservative group to perform activities of daily living after 6 months of treatment. In addition, secondary outcomes included assessment of hematoma resorption/clearance ratios, cytokine levels, complication rates, and therapeutic indexes at different treatment durations, as well as long-term safety and efficacy at 2–3 years of follow-up. Furthermore, subgroup analysis, and sensitivity analysis were conducted to further analyze the data. Logistic single-variate and multivariate regression analyses were applied to understand the adverse factors affecting prognosis. Ethics and dissemination: The clinical study was reviewed and approved by the Ethics Committee of the First People's Hospital of Yibin. The ethical number is: 2023 Review (64). Registration number: This protocol is registered in the Prospective Registry of Chinese Clinical Trial Registries (PROCCTR). The full date of first registration is 28/12/2023. The registration number for PROCCTR is ChiCTR2300079252. [ABSTRACT FROM AUTHOR]

Background: The increasing prevalence of mental health disorders in the United Kingdom necessitates the exploration of novel treatment modalities. This study aimed to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) evaluating the efficacy of four osteopathic interventions on psychophysiological and mental health outcomes. Methods: A mixed-methods feasibility study with an explanatory sequential design was implemented. The quantitative phase involved randomising 42 participants into four intervention groups: (1) high-velocity and articulation techniques (HVAT), (2) soft-tissue massage (STM), (3) craniosacral therapy (CST), and (4) a combination approach. Primary outcome measures encompassed recruitment rate, assessment duration, questionnaire completion, intervention attrition, and adverse events. Secondary outcomes included validated assessments of depression, anxiety, stress, psychological flexibility, heart rate variability (HRV), and interoception, administered pre- and post-intervention. Analysis of variance (ANOVA) was employed to evaluate pre-post intervention changes. The qualitative phase comprised semi-structured interviews analysed using thematic analysis. Results: The study achieved a recruitment rate of 21 eligible participants per month, with 54.8% of respondents meeting eligibility criteria. All 33 participants who completed the study underwent interventions and assessments within the allocated one-hour timeframe, with full questionnaire completion. The attrition rate was 21%. No adverse events were reported. Qualitative analysis revealed positive participant experiences, with themes highlighting good practitioner communication, intervention accessibility, and increased bodily awareness. Some participants found the questionnaire battery burdensome. Exploratory quantitative analyses showed variations in effects across interventions for heart rate variability, interoceptive accuracy, and mental health measures, but these results should be interpreted cautiously due to the small sample size. Conclusions: This study provides evidence supporting the feasibility and acceptability of a larger-scale RCT investigating osteopathic interventions for individuals presenting with mild psychological symptoms. The preliminary findings suggest potential efficacy in improving mental health outcomes, warranting further investigation. Trial registration NCT05674071, registered 06/01/2023. [ABSTRACT FROM AUTHOR]

The primary aim of this study was to establish the feasibility of implementing a larger RCT designed to evaluate the effect of financial incentives on HCV treatment initiation among persons receiving opioid agonist therapy and/or who have injected drugs in the prior six months. ETHOS Engage is an observational cohort of participants recruited from drug treatment and needle and syringe programs in Australia. Among 11 drug and alcohol clinics, participants who were HCV RNA-positive were randomized (1:1) to receive standard of care or a AUD $60 gift card at treatment initiation. Regarding feasibility, 100% (57/57) of eligible participants enrolled to take part. Twenty-eight participants were randomised to the financial incentive arm (AUD $60 gift card) plus standard of care and 29 participants to the standard of care arm. In this pilot RCT (n = 57), median age was 42 years (IQR 37–49), 63% were male (n = 36), 35% Indigenous (n = 20) and 36% (n = 21) reported injecting drugs daily in the past month. Twelve weeks post-study enrolment, 11 (39%) participants in the financial incentive arm and 17 (59%) participants in the standard of care arm initiated HCV treatment. Findings indicate high feasibility among people who inject drugs to be randomised to receive financial incentives to initiate HCV treatment. [ABSTRACT FROM AUTHOR]