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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.

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]

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]

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]

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]

Men having postoperative radiotherapy after radical prostatectomy usually have a favourable outcome. The results of RADICALS-HD will help patients and their clinicians decide on the duration of androgen deprivation therapy with postoperative radiotherapy. Future trials should focus on patients at a higher risk of metastases. The use and duration of androgen deprivation therapy (ADT) with postoperative radiotherapy (RT) have been uncertain. RADICALS-HD compared adding no ("None"), 6-months ("Short"), or 24-mo ("Long") ADT to study efficacy in the long term. Participants with prostate cancer were indicated for postoperative RT and agreed randomisation between all durations. ADT was allocated for 0, 6, or 24 mo. The primary outcome measure (OM) was metastasis-free survival (MFS). The secondary OMs included freedom from distant metastasis, overall survival, and initiation of nonprotocol ADT. Sample size was determined by two-way comparisons. Analyses followed standard time-to-event approaches and intention-to-treat principles. Between 2007 and 2015, 492 participants were randomised one of three groups: 166 None, 164 Short, and 162 Long. The median age at randomisation was 66 yr; Gleason scores at surgery were as follows: <7 = 64 (13%), 3+4 = 229 (47%), 4+3 = 127 (26%), and 8+ = 72 (15%); T3b was 112 (23%); and T4 was 5 (1%). The median follow-up was 9.0 yr and, with MFS events reported for 89 participants (32 None, 31 Short, and 26 Long), there was no evidence of difference in MFS overall (logrank p = 0.98), and, for Long versus None, hazard ratio = 0.948 (95% confidence interval 0.54–1.68). After 10 yr, 80% None, 77% Short, and 81% Long patients were alive without metastatic disease. The three-way randomisation was not powered to conventional levels for assessment, yet provides a fair comparison. Long-term outcomes after radical prostatectomy are usually favourable. In those indicated for postoperative RT and considered suitable for no, short-term, or long-term ADT, there was no evidence of improvement with addition of ADT. Future research should focus on patients at a higher risk of metastases in whom improvements are required more urgently. [ABSTRACT FROM AUTHOR]

Objectives: Despite growing interest, the cost-effectiveness of eHealth interventions for supporting quality of life of people with dementia and their caregivers remains unclear. This study evaluated the cost-effectiveness of the FindMyApps intervention, compared to digital care-as-usual. FindMyApps aims to help people with dementia and their caregivers find and learn to use tablet apps that may support social participation and self-management of people with dementia and sense of competence of caregivers. Method: A randomised controlled trial (Netherlands Trial Register NL8157) was conducted, including people with mild cognitive impairment (MCI) or mild dementia and their informal caregivers (FindMyApps n = 76, digital care-as-usual n = 74). Outcomes for people with MCI/dementia were Quality-Adjusted Life-Years (QALYs), calculated from EQ-5D-5L data and the Dutch tariff for utility scores, social participation (Maastricht Social Participation Profile) and quality of life (Adult Social Care Outcomes Toolkit), and for caregivers, QALYs and sense of competence (Short Sense of Competence Questionnaire). Societal costs were calculated using data collected with the RUD-lite instrument and the Dutch costing guideline. Multiple imputation was employed to fill in missing cost and effect data. Bootstrapped multilevel models were used to estimate incremental total societal costs and incremental effects between groups which were then used to calculate Incremental Cost-Effectiveness Ratios (ICERs). Cost-effectiveness acceptability curves were estimated. Results: In the FindMyApps group, caregiver SSCQ scores were significantly higher compared to care-as-usual, n = 150, mean difference = 0.75, 95% CI [0.14, 1.38]. Other outcomes did not significantly differ between groups. Total societal costs for people with dementia were not significantly different, n = 150, mean difference = €-774, 95%CI [–2.643,.,079]. Total societal costs for caregivers were significantly lower in the FindMyApps group compared to care-as-usual, n = 150, mean difference = € −392, 95% CI [−1.254, −26], largely due to lower supportive care costs, mean difference = €−252, 95% CI [−1.009, 42]. For all outcomes, the probability that FindMyApps was cost-effective at a willingness-to-pay threshold of €0 per point of improvement was 0.72 for people with dementia and 0.93 for caregivers. Conclusion: FindMyApps is a cost-effective intervention for supporting caregivers' sense of competence. Further implementation of FindMyApps is warranted. [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials (RCTs) are considered the gold standard for generating clinical evidence. The focus on high internal validity in RCTs challenges the external validity and generalisability of findings, potentially hindering their application in routine care. In neurorehabilitation, limited literature addresses conducting RCTs feasibly and efficiently. We investigated barriers and facilitators to conducting RCTs within routine care of neurorehabilitation centres from the perspective of stakeholders in neurorehabilitation in Germany and Austria. Methods: We conducted semi-structured interviews with stakeholders in neurorehabilitation from four centres in Germany and Austria, informed by the Theoretical Domains Framework (TDF) and the Capability, Opportunity, Motivation and Behaviour model (COM-B). Employing a hybrid approach, the interview analysis integrated both deductive, theory-driven analysis based on the TDF domains and COM-B model and inductive, reflexive thematic analysis. Results: Twelve stakeholders (4 physicians, 4 therapy managers, 4 therapists; 5 females, 7 males; with research experience spanning 0–40 years) were interviewed. Key barriers to conducting RCTs in neurological rehabilitation centres include limited financial, human, and time resources, high clinical workloads, and a lack of interest of some therapists. Ineffective leadership, perceived lack of research expertise, and communication issues were also significant barriers. Social influence factors such as lack of employer support and inadequate training access further contributed to the challenges. Additionally, barriers included insufficient research infrastructure, limited space, internal power struggles, and rigid cost bearer specifications. Key facilitators included physicians' and therapists' motivation to advance the field, contribute to knowledge, and to prioritise patient health. Support from supervisors, joint decision-making, and efficient organisation were crucial facilitators. Flexible therapy planning, mutual support, and interdisciplinary collaboration also played important roles. Conclusion: Our results suggest that increasing professional development and understanding, along with providing adequate financial, human, time, and spatial resources to support research endeavours, implementing effective communication strategies to enhance interdisciplinary collaboration and coordination among team members may contribute to increased motivation and facilitate RCTs within the setting of neurorehabilitation centres. Trial registration: This study was prospectively registered with the German Clinical Trials Register (08.04.2021 DRKSID DRKS00024982). [ABSTRACT FROM AUTHOR]

Background: Chronic diseases are a significant and growing problem of our time. They impair the ability to work and increase the risk of early retirement. To support the return to work, rehabilitation services can be applied for in Germany. Currently, the application system for rehabilitation allows only a limited degree of individualisation of the treatment and is associated with a lack of multidisciplinary communication. To facilitate rehabilitation care planning, we developed a complex intervention. A digital, platform-based case management approach (intervention) will ensure multidisciplinary communication and the tailored selection of medical treatments and/or non-medical support measures. The overall objective is to assess the effectiveness of the intervention compared to treatment as usual (control condition). The German Federal Ministry of Labour and Social Affairs (BMAS) funds the RehaPro-SERVE study (grant number: 661R0053K1). Methods: This is the protocol for an investigator-initiated, pragmatic, multicentre, randomised and controlled two-arm parallel-group superiority trial with embedded qualitative process evaluation. The study will be conducted in Hesse state, Germany. N = 59 primary care physicians will be recruited and tasked with the recruitment of six eligible patients each. Eligibility criteria: age 40–60; minimum of 4-week work disability due to musculoskeletal, oncologic or psychological conditions or the post-COVID-19 syndrome within the last 6 months; at high risk for early retirement. In total, n = 352 patients will be randomised with a 1:1 allocation to intervention or control group and stratified by primary care practice using permuted blocks. The primary outcome is the number of days of sick leave during a 12-month period after the assumed completion of treatments (t1 to t2). Secondary outcomes include the number of days of sick leave (self-report), work ability, and health-related quality of life, as well as data from the qualitative process evaluation. Discussion: The results of the study will inform the design of future care services and provide valuable information on multidisciplinary case management in the context of rehabilitation care planning. The results of the qualitative process evaluation will further contribute to the understanding of facilitating and hindering factors. Trial registration: DRKS-German Clinical Trials Register, DRKS0 00242 07. Registered on 22 March 2021. [ABSTRACT FROM AUTHOR]

AbstractPurposeMaterials and methodsResults\nIMPLICATIONS FOR REHABILITATIONCognitive functional therapy (CFT) is an individualised person-centred biopsychosocial intervention that demonstrated large and sustained clinically important improvements in people with chronic, disabling low back pain (LBP) in the RESTORE randomised controlled trial. This study aimed to explore physiotherapists’ experiences of delivering CFT in the RESTORE trial.Cross-sectional qualitative design using reflexive thematic analysis with interviews of 15 treating physiotherapists (3–25 years experience) across Perth and Sydney.The overarching theme was “Driving on P(probationary)-plates.” The probationary driver analogy encompassed feelings of being newly competent, gaining experience, and refining competencies. Four themes were developed: “Sharing the journey of transformational change,” “Refining new competencies,” “Navigating patient complexity,” and “Balancing patient care with trial-related processes.” Physiotherapists described the life-changing improvements and re-engagement with valued activities of their patients under the theme of “Sharing the journey of transformational change.” “Refining new competencies” described the continued enhancement of physiotherapists’ new competencies towards an individualised and collaborative approach.The experiences of physiotherapists trained to deliver individualised, person-centred biopsychosocial care within an RCT can be likened to being a probationary driver. Experiential learning, ongoing support, and opportunities to navigate challenges with complex patients were important aspects of the journey towards mastery.Physiotherapists have traditionally reported challenges addressing psychosocial barriers in people with chronic low back pain.People with disabling CLBP should be offered high-value person-centred biopsychosocial interventions, such as CFT, with a therapist who shares the journey with them.Ongoing peer and mentor support is a valuable extension to high-quality competency based training for physiotherapists delivering expanded scope biopsychosocial treatments like CFT.When treating patients with complex presentations, physiotherapists and their patients may benefit from integrated interdisciplinary input (e.g., from physicians, psychologists, and social workers).Physiotherapists have traditionally reported challenges addressing psychosocial barriers in people with chronic low back pain.People with disabling CLBP should be offered high-value person-centred biopsychosocial interventions, such as CFT, with a therapist who shares the journey with them.Ongoing peer and mentor support is a valuable extension to high-quality competency based training for physiotherapists delivering expanded scope biopsychosocial treatments like CFT.When treating patients with complex presentations, physiotherapists and their patients may benefit from integrated interdisciplinary input (e.g., from physicians, psychologists, and social workers). [ABSTRACT FROM AUTHOR]

Background: Chronic kidney disease (CKD) prevalence is steadily increasing, in part due to increased multimorbidity in our aging global population. When progression to kidney failure cannot be avoided, people need unbiased information to inform decisions about whether to start dialysis, if or when indicated, or continue with holistic person-centred care without dialysis (conservative kidney management). Comparisons suggest that while there may be some survival benefit from dialysis over conservative kidney management, in people aged 80 years and over, or with multiple health problems or frailty, this may be at the expense of quality of life, hospitalisations, symptom burden and preferred place of death. Prepare for Kidney Care aims to compare preparation for a renal dialysis pathway with preparation for a conservative kidney management pathway, in relation to quantity and quality of life in multimorbid, frail, older people with advanced CKD. Methods: This is a two-arm, superiority, parallel group, non-blinded, individual-level, multi-centre, pragmatic trial, set in United Kingdom National Health Service (NHS) kidney units. Patients with advanced CKD (estimated glomerular filtration rate < 15 mL/min/1.73 m2, not due to acute kidney injury) who are (a) 80 years of age and over regardless of frailty or multimorbidity, or (b) 65–79 years of age if they are frail or multimorbid, are randomised 1:1 to 'prepare for responsive management', a protocolised form of conservative kidney management, or 'prepare for renal dialysis'. An integrated QuinteT Recruitment Intervention is included. The primary outcome is mean total number of quality-adjusted life years during an average follow-up of 3 years. The primary analysis is a modified intention-to-treat including all participants contributing at least one quality of life measurement. Secondary outcomes include survival, patient-reported outcomes, physical functioning, relative/carer reported outcomes and qualitative assessments of treatment arm acceptability. Cost-effectiveness is estimated from (i) NHS and personal social services and (ii) societal perspectives. Discussion: This randomised study is designed to provide high-quality evidence for frail, multimorbid, older patients with advanced CKD choosing between preparing for dialysis or conservative kidney management, and healthcare professionals and policy makers planning the related services. Trial registration: ISRCTN, ISRCTN17133653 (https://doi.org/10.1186/ISRCTN17133653). Registered 31 May 2017. [ABSTRACT FROM AUTHOR]

Objectives:Methods:Results:Discussion:In experimental models, the prenatal diet influences gut microbiota composition in mothers and offspring; however, it is unclear whether this occurs in humans. We investigated the effects of a gut-focused perinatal dietary intervention on maternal and infant gut microbiota composition four weeks after birth.This randomised controlled trial randomised pregnant women to receive dietary advice as part of standard care, or additionally receive a dietary intervention focused on the Australian Dietary Guidelines and increasing prebiotic and probiotic/fermented food intakes (ACTRN12616000936426). Study assessments occurred from gestation week 26 (baseline) to four weeks postpartum (follow-up). Faecal samples, collected at baseline for mothers, and follow-up for mothers and infants, underwent 16SrRNA sequencing. The primary outcome was a between-group mean difference in infant faecal Shannon index. Secondary outcomes included between-group differences in other microbiota measures, including maternal change from baseline CLR-transformed Prevotella abundance.Forty-four women and 45 infants completed the study. The mean Shannon index of infants in the intervention group was −0.35 (95% CI: −0.64, −0.06, SD: 0.52) units lower than control group infants, corresponding to a medium effect size (Cohen’s D: −0.74, 95% CI: −1.34, −0.13). The findings were similar using other metrics of α-diversity. There were no between-group differences in β-diversity, nor any differentially abundant taxa in infants. The intervention increased abundances of the genus Prevotella in mothers compared to controls.This gut-focused perinatal dietary intervention was associated with differences in the maternal and infant gut microbiota composition. Larger studies are required to replicate and extend these findings. [ABSTRACT FROM AUTHOR]

Background: Suicide has become a first-order public health concern, especially following the negative impact of COVID-19 on the mental health of the general population. Few studies have analysed the effects of early psychotherapeutic interventions on subjects who have attempted suicide, and even fewer have focused on those hospitalized in non-psychiatric units after a Medically Serious Suicide Attempt (MSSA). The main aim of this study is to describe the protocol designed to evaluate the effectiveness of individual psychological treatment for patients hospitalized after an MSSA. The secondary objectives of the study are: (1) to evaluate the impact on quality of life and other psychosocial variables of patients with a recent MSSA who receive early psychological intervention; (2) to analyse the biological, psychological, and clinical impact of early psychotherapeutic treatment on subjects hospitalized after an MSSA. Methods: A longitudinal randomised controlled trial will be conducted with patients over 16 years of age admitted to two general hospitals. The case intervention group will enrol for 8-sessions of individual psychotherapy, Suicide Attempts Multi-component Intervention Treatment (SAMIT), combining Dialectical Behaviour Therapy (DBT), Mentalization-Based Therapy (MBT), and Narrative approaches, while the control group will receive a treatment-as-usual intervention (TAU). Longitudinal assessment will be conducted at baseline (before treatment), post-treatment, and 3, 6, and 12 months after. The main outcome variable will be re-attempting suicide during follow-up. Discussion: Some psychotherapeutic interventions, usually implemented in outpatient, have proven to be effective in preventing suicidal behaviours. The combination of some of these may be a powerful treatment for preventing future SA in patients hospitalised after an MSSA, which is the most severely suicidal subgroup. Moreover, assessment of the biological, clinical and psychometric impact of this new intervention on patients during the first year after the attempt may help understand some of the multi-level factors associated with the effectiveness of psychotherapeutic interventions in MSSAs. The prevalence of high suicide rates requires the design of effective psychological interventions for their prevention, and also in order to design new pharmacological and psychological treatments. Trial registration: ClinicalTrials.gov ID: NCT06238414. Date of registration: 1st February 2024, final update is protocol version 3.0, 19th March 2024. [ABSTRACT FROM AUTHOR]

Background: This paper reports the results from a feasibility trial of an early parent-delivered social communication intervention for young children with Down syndrome ('ASCEND'). The intervention focuses on developing children's early social communication skills, in particular responding to shared attention. The aim was to inform the feasibility of running a full-scale trial through National Health Service (NHS) Speech and Language Therapy (SaLT) services, to assess whether the intervention is effective in improving language skills before children with Down syndrome start school. Methods: This was a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site, comparing the intervention plus standard NHS SaLT provision with standard NHS SaLT alone. We recruited 20 children with Down syndrome aged between 11 and 36 months through 3 NHS SaLT services, 19 of whom were randomised (10 — intervention group, 9 —control group). Pre- and post-intervention and 6-month follow-up assessments included language, social communication skills, adaptive behaviour, quality of life (parents and children), parental anxiety and depression. The intervention was parent delivered with parents having access to SaLT services and the research team during the intervention. Data were collected on recruitment and retention, standard care, treatment fidelity, acceptability of the intervention by the parents and speech and language therapists, feasibility of collecting health economic measures and suitability of the primary outcome measure. Results: The sample was sufficient for a feasibility study. The intervention (manual, support, materials) was positively received by the participating parents. Speech and language therapists also evaluated the acceptability of the intervention positively. Treatment fidelity which was measured by completion of weekly parent diaries and two adherence phone call was acceptable as 100% of the parent diaries were returned, over 90% of the parental diaries were completed correctly and 100% of adherence phone calls were completed. Retention was acceptable at 84% overall. The preliminary health economic data suggest that this intervention will be low cost. The sample size calculation suggests that 290 participants would need to be recruited, with 228 having a complete data set, for a full RCT. Conclusion: Based on recruitment, retention and treatment fidelity, as well as the acceptability of the intervention to parents and speech and language therapists, a full-scale trial would be feasible in order to assess the effectiveness of the intervention. Trial registration: ISRCTN13902755, registered on 25th August 2020, http://www.isrctn.com/ISRCTN13902755 [ABSTRACT FROM AUTHOR]

Background: Loneliness is common among older adults in institutional settings. It leads to adverse effects on health and wellbeing, for which nature contact with peers in turn may have positive impact. However, the effects of nature engagement among older adults have not been studied in randomised controlled trials (RCT). The "Friends in Nature" (FIN) group intervention RCT for lonely older adults in Helsinki assisted living facilities (ALFs) aims to explore the effects of peer-related nature experiences on loneliness and health-related quality of life (HRQoL). In this study we aim describe the participants' baseline characteristics of the RCT, feasibility of FIN intervention and intervention participants' feedback on the FIN. Methods: Lonely participants were recruited from 22 ALFs in Helsinki area, Finland, and randomised into two groups: 1) nature-based social intervention once a week for nine weeks (n = 162) and 2) usual care (n = 157). Demographics, diagnoses and medication use were retrieved from medical records, and baseline cognition, functioning, HRQoL, loneliness and psychological wellbeing were assessed. Primary trial outcomes will be participants' loneliness (De Jong Giervald Loneliness Scale) and HRQoL (15D). Results: The mean age of participants was 83 years, 73% were female and mean Minimental State Examination of 21 points. The participants were living with multiple co-morbidities and/or disabilities. The intervention and control groups were comparable at baseline. The adherence with intervention was moderate, with a mean attendance of 6.8 out of the nine sessions. Of the participants, 14% refused, fell ill or were deceased, and therefore, participated three sessions or less. General subjective alleviation of loneliness was achieved in 57% of the intervention participants. Of the respondents, 96% would have recommended a respective group intervention to other older adults. Intervention participants appreciated their nature excursions and experiences. Conclusions: We have successfully randomised 319 lonely residents in assisted living facilities into a trial about the effects of nature experiences in a group-format. The feedback from participants was favourable. The trial will provide important information about possibilities of alleviating loneliness with peer-related nature-based experiences in frail residents. Trial registration: ClinicalTrials.gov, ID: NCT05507684. Registration 19/08/2022. [ABSTRACT FROM AUTHOR]

Objective This study investigated the effectiveness of supramaximal high-intensity interval training (supramaximal HIT) on muscle capacities and physical function compared to moderate-intensity training (MIT) for older adults. Methods Sixty-eight older adults (66–79 years, 56% women), not engaged in regular exercise, were randomised to 3 months of twice-weekly supramaximal HIT (20 minutes including 10 × 6-second intervals) or MIT (40 minutes including 3 × 8-minute intervals). Both groups performed the training on stationary bicycles in a group setting. Target intensity was watt-controlled, with standardised cadence and individualised resistance. Outcomes analysed with linear-mixed models included leg power (Nottingham Power Rig), hand grip strength (Jamar dynamometer), static and dynamic balance (One leg stance, 30-second step test), chair stand (30-second chair stand), and anaerobic cycling performance (modified Borg Cycle Strength Test). Results Baseline values were (supramaximal HIT/MIT, mean ± SD) leg power 198 ± 60/189 ± 53 W, hand grip strength 4.2 ± 1.0/4.3 ± 1.1 N/kg, static balance 64 ± 41/62 ± 41 s, dynamic balance 39 ± 7/38 ± 5 steps, chair stands 22 ± 6/22 ± 6 and anaerobic cycling performance 224 ± 60/217 ± 55 W. At 3-month follow-up, a between-group difference in favour of supramaximal HIT [95% CI] was observed in anaerobic cycling performance of 19[3;35] W. Within-group mean changes for supramaximal HIT/MIT were for leg power 8.4[0.9;15.8]/6.0[−1.3;13.3] W, hand grip strength 0.14[0.00;0.27]/0.13[−0.01;0.26] N/kg, static balance 11[3;20]/10[1;18] s, dynamic balance 1.6[0.3;2.8]/2.3[1.1;3.6] steps, 2.1[1.1;3.1]/1.4[0.4;2.3] chair stands and anaerobic cycling performance 31.3[19.6;43.0]/12.0[0.4;23.5] W. Conclusion Supramaximal HIT showed superior effect on anaerobic cycling performance when compared to MIT. Additionally, the results indicate that supramaximal HIT is comparably beneficial as MIT in terms of effects on muscle capacity and physical function for older adults. [ABSTRACT FROM AUTHOR]

Objective: To assess the added value of caregiver-mediated exercises combined with telerehabilitation in addition to usual care compared to usual care alone on the self-reported mobility outcome after subacute stroke. Design: Multicentre, observer-blinded, parallel randomised controlled trial. An off-site researcher allocated treatments using minimisation. Setting: Four rehabilitation centres in the Netherlands. Participants: Forty-one patient–caregiver dyads within 3 months poststroke. Intervention: Eight-week blended care program with caregiver-mediated mobility exercises for 2.5 h per week supported by telerehabilitation and four face-to-face sessions in addition to usual care. Main measures: Self-reported mobility domain of the Stroke Impact Scale postintervention. Secondary outcomes were functional outcome, dyads' psychosocial wellbeing, care transition to the community postintervention and after 6 months. Results: Forty-one dyads (21 intervention, 20 control) were randomised, and 37 (N = 18; N = 19) were analysed following intention-to-treat. The Stroke Impact Scale mobility was not significantly different between groups postintervention (B 0.8, 95% CI –6.8–8.5, p = 0.826). The secondary outcomes, namely, (a) caregivers' quality of life postintervention (p = 0.013), (b) caregivers' symptoms of depression postintervention (p = 0.025), and (c) independence in leisurely activities at 6 months (p = 0.024), showed significant benefits in favour of caregiver-mediated exercises with telerehabilitation. A significant difference favouring controls was found in self-reported muscle strength at 6 months (p = 0.002). Conclusions: Caregiver-mediated exercises combined with telerehabilitation yielded no differential effect on our primary outcome self-reported mobility. Although the trial is underpowered, current findings are in line with previous trials. Future studies should further explore beneficial effects of caregiver involvement in stroke rehabilitation targeting psychosocial wellbeing. [ABSTRACT FROM AUTHOR]

Introduction: Affecting up to 67% of stroke patients, PSCI is a complication that predicts poor quality of life, decreased independence, and substantial economic burden. PSCI remains a major post-stroke complication with limited therapeutic options. Based on current understanding of PSCI's pathogenesis, Trigona honey makes an attractive therapeutic option, as it can act on numerous neuropathological substrates implicated in PSCI's pathogenesis via the action of multiple polyphenols. Materials and methods: The study was conducted following a unicentral, randomised, concurrent active treatment controlled, superiority trial with two parallel groups model. The interventional group included participants who were administered supplemental honey in addition to standard treatment regiments, while those in the control group solely continued the standard therapeutic protocol. Two honey sachets were administered for daily oral consumption for three months, with a total daily dose of 20 g. Demographic and clinical characteristics questionnaire, MoCA, and NIHSS were used to for data collection. Data collected was analysed using SPSS. Results: Difference in mean MoCA score gain between the two groups after three months was statistically significant (p<0.05), with the interventional group having greater gain by 3 points. No statistically significant relationship between demographic characteristics, clinical factors, stroke parameters, and the 3-month progression of PSCI was detected. The only exception was improved cognitive function in current smokers in the interventional group. Conclusion: Trigona honey supplements could be effective in halting progression of PSCI, and smoking can affect 3-month progression of PSCI. No association was detected between stroke severity, TOAST and OCSP classifications, and 3-month progression of PSCI. [ABSTRACT FROM AUTHOR]

Background: The ComEx3 community‐based extended maintenance pulmonary rehabilitation (PR) randomised controlled trial (RCT) aimed to determine the optimal strategy for maintaining the benefits of exercise for people with chronic obstructive pulmonary disease (COPD). We conducted a process evaluation of this RCT to determine if the trial was implemented per protocol, and to explore the barriers and facilitators of the trial, and mechanisms of impact. Methods: This was a mixed methods study consisting of analysis of PR class records, study diaries and interviews of those involved in the trial. We developed a reporting framework from available literature and performed a content analysis. Results: Eleven of the 12 participants in the intervention group attended ≥70% of available classes before the trial was terminated due to the COVID‐19 pandemic. Analysis of the study diaries found that adherence to the home exercise program was higher in the intervention than the control group. Analyses of interviews (n = 21) highlighted the complexity of standardising the processes across multiple sites, but revealed behaviour change amongst class physiotherapists who were able to conform with the required processes. Facilitators of participation included the desire to improve function and quality of life, while barriers included illnesses and lack of motivation. Mechanisms of impact included confidence in exercising and benefits from the education sessions. Conclusions: The ComEx3 RCT was implemented as planned largely due to commitment by the research team and the desire by patients to improve their quality of life by attending a PR program that they are familiar with. Successful implementation of PR RCTs requires good organisational skills, clear and consistent trial documentation, broad understanding of participant needs while being conscious of challenges experienced by people with COPD, and dedication by everyone involved in the RCT. So What?: This article shows the importance of running a process evaluation alongside an RCT. Although this RCT did not progress to completion, this process evaluation which was guided by a robust framework, will provide guidance for future interventions in this area. [ABSTRACT FROM AUTHOR]

Background: Tobacco smoking rates are higher in rural, regional, and remote (RRR) areas in Australia, and strategies to improve access to quit supports are required. This pilot study examined the feasibility of a smoking cessation intervention for people in RRR areas who smoke with the intention of using this data to design a powered effectiveness trial. Methods: A randomised controlled trial (RCT) of the feasibility of a 12‐week 'Outback Quit Pack' intervention consisting of mailout combination nicotine replacement therapy (NRT) and a proactive referral to Quitline, compared with a minimal support control (1‐page smoking cessation support information mailout) was conducted between January and October 2021. Participants recruited via mailed invitation or Facebook advertising, were adults who smoked tobacco (≥10 cigarettes/day) and resided in RRR areas of New South Wales, Australia. Participants completed baseline and 12‐week follow‐up telephone surveys. Outcomes were feasibility of trial procedures (recruitment method; retention; biochemical verification) and acceptability of intervention (engagement with Quitline; uptake and use of NRT). Results: Facebook advertising accounted for 97% of participant expressions of interest in the study (N = 100). Retention was similarly high among intervention (39/51) and control (36/49) participants. The intervention was highly acceptable: 80% of the intervention group had ≥1 completed call with Quitline, whilst Quitline made 3.7 outbound calls/participant (mean 14:05 mins duration). Most of the intervention group requested NRT refills (78%). No differences between groups in self‐reported cessation outcomes. Biochemical verification using expired air breath testing was not feasible in this study. Conclusion: The Outback Quit Pack intervention was feasible and acceptable. Alternative methods for remote biochemical verification need further study. So What?: A powered RCT to test the effectiveness of the intervention to improve access to evidence‐based smoking cessation support to people residing in RRR areas is warranted. [ABSTRACT FROM AUTHOR]

Summary: Insomnia is an emerging risk factor for the onset of mild cognitive impairment (MCI) and its progression to dementia. Impaired cognition and neuropsychiatric symptoms create challenges for persons with MCI to participate actively in non‐pharmacological interventions. This study examined the feasibility and preliminary effects of empowerment‐based cognitive‐behavioural therapy for insomnia (CBT‐I) on sleep, cognitive function, and health‐related quality of life (HRQoL) in persons with MCI and sleep problems. Sixty participants were randomly allocated to the intervention or control group to receive empowerment‐based CBT‐I or usual care, respectively. The 12 week intervention comprised all core CBT‐I techniques delivered through a group and individualised face‐to‐face approach. An empowerment approach with interactive teaching methods, goal setting, and action planning was used to deliver the intervention. Outcome measures included subjective and objective sleep quality and pattern, and a battery of neuropsychological tests and the 12‐item Short Form Survey were administered 3 months (T1) and 6 months post‐randomisation (T2). This intervention is feasible and highly acceptable for persons with MCI. The intervention group showed significant improvements in subjective and objective sleep‐related outcomes compared with the control group. Moreover, the intervention group showed greater improvements in global cognition, processing speed, attention, and mental flexibility than the control group at T1 and/or T2. No significant between‐group differences were observed in memory or HRQoL scores. The qualitative data converged with the quantitative data. In conclusion, empowerment‐based CBT‐I was well received by persons with MCI and had potential positive effects on improving sleep and cognition in this cohort. [ABSTRACT FROM AUTHOR]

Purpose: Agriculture and food production contribute to climate change. There is mounting pressure to transition to diets with less environmental impact while maintaining nutritional adequacy. MyPlanetDiet aimed to reduce diet-related greenhouse gas emissions (GHGE) in a safe, nutritionally adequate, and acceptable manner. This paper describes the trial protocol, development, and testing of personalised nutrition feedback in the MyPlanetDiet randomised controlled trial (RCT). Methods: MyPlanetDiet was a 12-week RCT that provided standardised personalised nutrition feedback to participants based on new sustainable healthy eating guidelines (intervention) or existing healthy eating guidelines (control) using decision trees and corresponding feedback messages. To test the personalised nutrition feedback, we modelled a sample of 20 of the MyPlanetDiet participants baseline diets. Diets were modelled to adhere to control and intervention decision trees and feedback messages. Modelled nutrient intakes and environmental metrics were compared using repeated measure one-way analysis of covariance. Results: Intervention diets had significantly lower (p < 0.001) diet-related GHGE per 2500 kilocalories (kcal) (4.7 kg CO2-eq) relative to control (6.6 kg CO2-eq) and baseline (7.1 kg CO2-eq). Modelled control and intervention diets had higher mean daily intakes of macronutrients (carbohydrates, fibre, and protein) and micronutrients (calcium, iron, zinc, and iodine). Modelled control and intervention diets had lower percent energy from fat and saturated fat relative to baseline. Conclusions: Adherence to the MyPlanetDiet personalised nutrition feedback would be expected to lead to better nutrient intakes and reduced diet-related GHGE. The MyPlanetDiet RCT will test the effectiveness and safety of personalised feedback for a more sustainable diet. Trial registration number and date of registration: Clinical trials registration number: NCT05253547, 23 February 2022 [ABSTRACT FROM AUTHOR]

Background and Aims: Potentially harmful polypharmacy is a growing public health concern. This article aims to evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) framework. Methods: We recruited patients at metropolitan hospitals for a randomised controlled trial with 12 months of follow‐up. The intervention included a comprehensive medicines history, multidisciplinary meeting and medicines review prior to discharge, with engagement with the participants' general practitioner extending after discharge. The primary outcome was the change in the number of regular medicines used at 12 months from baseline. A cost consequence was performed to estimate costs per participant during the study period. Results: There were 98 participants enrolled in the study. The number of regular medicines was significantly reduced from baseline in both groups (−1.7 ± 4.3, t = 2.38, P = 0.02 in the control group vs −2.7 ± 3.6, t = 4.48, P = 0.0001 in the intervention group), although there was no statistical difference detected between the two groups (1.0 (SE 0.9), t = 1.03, P = 0.31). The intervention was estimated to cost AU$644.17 and was associated with cost savings of AU$552.53 per participant in sustained reduced medicines cost. Health outcomes and healthcare costs were similar in both groups. Discussion: Medicines were significantly reduced in both groups, with a trend to a larger reduction in medicines at 12 months in the intervention group. The intervention cost was approximately offset by sustained reduced medicines cost, although these results should be regarded cautiously because of the absence of significance in the differences in outcomes between groups. [ABSTRACT FROM AUTHOR]

Background: Tackling poor mental health in university students has been identified as a priority in higher education. However, there are few evidence-based prevention initiatives designed for students. Repetitive Negative Thought (RNT, e.g. worry, rumination) is elevated in university students and is a well-established vulnerability factor for anxiety and depression. Furthermore, there are now evidence-based cognitive-behavioural interventions to tackle RNT. A mobile self-help cognitive-behavioural app targeting RNT, adapted for students may therefore be an effective, scalable, and acceptable way to improve prevention in students. Methods: An online single blind, two-arm parallel-group Randomised Controlled Trial (RCT) to examine the incidence of major depression and symptoms of anxiety and depression across 12 months in university students aged over 16 who screen into the study with self-reported high levels of worry and/or rumination and no current diagnosis of major depression. Eligible participants will be randomised to the active intervention arm (usual practice plus using a self-guided mobile app targeting RNT) or to the control arm (usual practice). In total, 648 participants aged over 16, with no current major depression, bipolar disorder or psychosis will be recruited from UK universities. Assessments will take place at baseline (pre-randomisation), 3 months and 12 months post- randomisation. Primary endpoint and outcome is incidence of major depression as determined by self-reported diagnostic criteria at 12-month follow-up. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and academic outcomes are secondary outcomes. Compliance, adverse events, and potentially mediating variables will be carefully monitored. Discussion: The trial aims to provide a better understanding of the causal role of tackling RNT (worry, rumination) using a self-help mobile app with respect to preventing depression in university students. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective mobile-health public health strategies for preventing common mental health problems. Trial registration: https://www.isrctn.com/ISRCTN86795807 Date of registration: 27 October 2022 [ABSTRACT FROM AUTHOR]

The science of pilot trials is evolving, and understanding of their role in medical research is increasing. Perioperative randomised controlled trials often test interventions that are inherently multidisciplinary and complex; therefore, there might be compelling reasons to conduct pilot studies to assess feasibility and inform trial design. As pilot studies themselves require resources, investigators should not squander this opportunity; they should design them so that they properly address the sources of uncertainty regarding the success of the definitive trial. [ABSTRACT FROM AUTHOR]

Prolonged sitting is associated with an increased risk of musculoskeletal pain, especially in nightshift workers. However, research investigating effects of breaking up sitting on musculoskeletal pain during nightshifts is lacking. This study evaluated effects of prolonged sitting or breaking up sitting with short bouts of light-intensity physical activity on pain in healthy adults during simulated nightshifts. An in-laboratory randomised controlled trial was undertaken with 52 healthy adults completing five simulated nightshifts. Participants were randomised to prolonged sitting (Sit9; n = 26) or breaking up prolonged sitting (Break9; n = 26). Break9 group completed 3-min walking every 30 min during nightshifts, while Sit9 group remained seated. Musculoskeletal pain intensity and sensory/affective pain experiences were assessed. Linear mixed models examined pain within nights (pre-to post-shift) and across nights (pre-shift-night-1 to pre-shift-night-5). Musculoskeletal pain intensity increased within nights for both Sit9 (mean change [95%CI] points: 0.14 [0.05, 0.24]) and Break9 (0.09 [0.001, 0.19], but not across nights (Sit9: −0.13 [-0.33, 0.08]; Break9: 0.07 [-0.14, 0.29]). Sensory-pain experience improved across nights for Sit9 (−3.08 [-4.72, −1.45]), but not within nights (0.77 [-0.004, 1.55]). There was no change in affective-pain experience in either group. Between-group difference was observed favouring Sit9 for improving sensory-pain across nights (β: 3.71 [1.42, 5.99]). No other between-group difference was observed. Both prolonged sitting and breaking up sitting were associated with a within-night increase in musculoskeletal pain intensity. Compared to prolonged sitting, breaking up sitting did not induce benefits on pain in healthy adults working simulated nightshifts. ACTRN12619001516178. • Prolonged sitting during nightshifts associated with increase in musculoskeletal pain. • Breaking up sitting with 3-min walking every 30 min was insufficient to reduce musculoskeletal pain. • Findings would inform appropriate designs of workplace interventions. [ABSTRACT FROM AUTHOR]

Do five baseline moderators identify patients with chronic low back pain who respond best to cognitive functional therapy (CFT) when compared with usual care? Secondary analysis of the RESTORE randomised controlled trial. A total of 492 adults with low back pain for > 3 months with at least moderate pain-related activity limitation. Participants were allocated to CFT alone or CFT plus biofeedback; these two groups were combined for this secondary analysis. The control group was usual care. The outcome was activity limitation measured using the Roland Morris Disability Questionnaire (RMDQ) at 3, 6, 13, 26, 40 and 52 weeks. Investigated effect modifiers were baseline measures of activity limitation, cognitive flexibility, pain intensity, self-efficacy and catastrophising. Baseline levels of activity limitation and, potentially, cognitive flexibility were associated with different effects of CFT treatment, while pain intensity, self-efficacy and catastrophising were not. Patients who had higher baseline activity limitation had greater treatment effects at 13 and 52 weeks. A person with a baseline RMDQ score of 18 (90th percentile) would on average be 6.1 (95% CI 4.8 to 7.4) points better at 13 weeks if they received CFT compared with usual care. However, a person with a baseline score of 7 (10th percentile) would on average be 3.6 (95% CI 2.6 to 4.6) points better at 13 weeks. The finding that CFT is most effective among patients who are most disabled and incur the greatest burden strongly suggests that CFT should be considered as a treatment for this group of patients. ACTRN12618001396213. [ABSTRACT FROM AUTHOR]

Malnutrition is prevalent among hospitalised patients, and increases the morbidity, mortality, and medical costs; yet nutritional assessments on admission are not routine. This study assessed the clinical and economic benefits of using an artificial intelligence (AI)-based rapid nutritional diagnostic system for routine nutritional screening of hospitalised patients. A nationwide multicentre randomised controlled trial was conducted at 11 centres in 10 provinces. Hospitalised patients were randomised to either receive an assessment using an AI-based rapid nutritional diagnostic system as part of routine care (experimental group), or not (control group). The overall medical resource costs were calculated for each participant and a decision-tree was generated based on an intention-to-treat analysis to analyse the cost-effectiveness of various treatment modalities. Subgroup analyses were performed according to clinical characteristics and a probabilistic sensitivity analysis was performed to evaluate the influence of parameter variations on the incremental cost-effectiveness ratio (ICER). In total, 5763 patients participated in the study, 2830 in the experimental arm and 2933 in the control arm. The experimental arm had a significantly higher cure rate than the control arm (23.24% versus 20.18%; p = 0.005). The experimental arm incurred an incremental cost of 276.52 CNY, leading to an additional 3.06 cures, yielding an ICER of 90.37 CNY. Sensitivity analysis revealed that the decision-tree model was relatively stable. The integration of the AI-based rapid nutritional diagnostic system into routine inpatient care substantially enhanced the cure rate among hospitalised patients and was cost-effective. NCT04776070 (https://clinicaltrials.gov/study/NCT04776070). [ABSTRACT FROM AUTHOR]

Background: Telenursing comprises a set of tools and interventions enabling nurses to provide remote care. This study aims to assess the impact of telenursing interventions on the supportive care needs of patients with melanoma and lung cancer who are receiving targeted therapies. Methods: This six-month monocentric, double-arm, randomised, controlled trial study protocol will assess the effect of telenursing on the supportive care needs (primary outcome) in 40 patients (20 in each group) after one month. The secondary outcomes will be monitored at baseline, one, three and six months: supportive care needs (at three and six months), therapeutic adherence, quality of life, usability and satisfaction, performance status, patient-reported outcomes and main adverse events. The SPIRIT guidelines will be used for the reporting. Results: The results from this trial will assess the impact of a telenursing intervention on cancer care. Conclusions: This trial could be a starting point for more extensive studies on telenursing interventions to promote nurses' skills, as well as the quality and safety of care in patients with cancer, highlighting the impact of more outstanding nursing contributions on cancer care. Trial and Protocol Registration: The study protocol was approved by the relevant Italian Ethics Committee Lazio Area 5 (RS1851/23, 2773; 6 September 2023) and was registered on ClinicalTrials.gov (trial registry number NCT06254196). [ABSTRACT FROM AUTHOR]

Spinal cord injury (SCI) is a severe lesion comporting various motor, sensory and sphincter dysfunctions, abnormal muscle tone and pathological reflex, resulting in a severe and permanent lifetime disability. The primary injury is the immediate effect of trauma and includes compression, contusion, and shear injury to the spinal cord. A secondary and progressive injury usually follows, beginning within minutes and evolving over several hours after the first ones. Because ischemia is one of the most important mechanisms involved in secondary injury, a treatment to increase the oxygen tension of the injured site, such as hyperbaric oxygen therapy, should theoretically help recovery. Although a meta-analysis concluded that hyperbaric oxygen therapy might be helpful for clinical treatment as a safe, promising and effective choice to limit secondary injury when appropriately started, useful and well-defined protocols/guidelines still need to be created, and its application is influenced by local/national practice. The topic is not a secondary issue because a well-designed randomized controlled trial requires a proper sample size to demonstrate the clinical efficacy of a treatment, and the absence of a common practice guideline represents a limit for results generalization. This narrative review aims to reassemble the evidence on hyperbaric oxygen therapy to treat SCI, focusing on adopted protocols in the studies and underlining the critical issues. Furthermore, we tried to elaborate on a protocol with a flowchart for an evidence-based hyperbaric oxygen therapy treatment. In conclusion, a rationale and shared protocol to standardize as much as possible is needed for the population to be studied, the treatment to be adopted, and the outcomes to be evaluated. Further studies, above all, well-designed randomized controlled trials, are needed to clarify the role of hyperbaric oxygen therapy as a strategic tool to prevent/reduce secondary injury in SCI and evaluate its effectiveness based on an evidence-based treatment protocol. We hope that adopting the proposed protocol can reduce the risk of bias and drive future studies.

Abstract 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

Abstract 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.

Abstract 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.