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Despite increasing interest in supporting older workers' motivation, retention, and well‐being at work, knowledge about how social networks at work may affect the efficacy of training interventions among older employees is scarce. These social ties are an important source of resources for older workers' careers. This study examined the characteristics of older workers' personal social networks as boundary conditions for the effects of late‐career management intervention on work engagement. Data were used from an earlier randomized controlled trial (RCT) in which senior employees (mean age of 58 years) participated in a peer group‐based training intervention and were asked to complete follow‐up surveys at baseline, post‐intervention, and after 6 months (Vuori et al., 2019, Journal of Vocational Behavior, 115: 103327). The results showed that older workers' social ties at higher organizational levels (upper reachability) and the number of social ties at work moderated the effect of the intervention on work engagement. Specifically, the intervention aimed at enhancing employees' personal resources improved work engagement for senior employees with few or no social ties at work with whom they could discuss important matters, and for those with social ties at higher organizational levels. However, the relationship quality between older workers and their leaders showed no moderation effect. This study encourages human resources professionals to consider the social network characteristics and peer learning of older workers when providing training to enhance their work engagement. [ABSTRACT FROM AUTHOR]

We aimed to investigate the effects of delivering 3 gait retraining interventions (toe-in, toe-out, and placebo gait) on proxy measures of medial knee load (early- and late-stance peak knee adduction moment [KAM], KAM impulse, and varus thrust) in people with knee osteoarthritis, using a hybrid model of face-to-face and telehealth-delivered sessions over 5 months. This was an originally planned 3-arm randomized placebo-controlled clinical trial. However, during the 2021 COVID-19 outbreak and lockdown in Sydney, Australia, the study became a pilot randomized controlled trial with the remainder of interventions delivered via telehealth. Nine individuals with symptomatic medial knee osteoarthritis were allocated to receive either a toe-in, toe-out, or posture re-education (placebo) gait retraining intervention. Primary outcomes of early- and late-stance peak KAM, KAM impulse, and varus thrust were assessed at baseline and follow-up. Eight participants returned for their follow-up gait assessment. Participants in both active intervention groups (toe-in and toe-out) achieved foot progression angle changes at follow-up. Overall, knee biomechanics in the placebo group did not change at follow-up. It is possible to achieve biomechanical changes in individuals with medial knee osteoarthritis when delivering gait retraining interventions via a hybrid model of face-to-face and telehealth. [ABSTRACT FROM AUTHOR]

BACKGROUND: Effective primary care necessitates follow-up actions by the patient beyond the visit. Prior research suggests room for improvement in patient adherence. OBJECTIVE: This study sought to understand patients views on their primary care visits, the plans generated therein, and their self-reported adherence after 3 months. METHODS: As part of a large multisite cluster randomized pragmatic trial in 3 health care organizations, patients completed 2 surveys-the first within 7 days after the index primary care visit and another 3 months later. For this analysis of secondary outcomes, we combined the results across all study participants to understand patient adherence to care plans. We recorded patient characteristics and survey responses. Cross-tabulation and chi-square statistics were used to examine bivariate associations, adjusting for multiple comparisons when appropriate. We used multivariable logistic regression to assess how patients intention to follow, agreement, and understanding of their plans impacted their plan adherence, allowing for differences in individual characteristics. Qualitative content analysis was conducted to characterize the patients self-reported plans and reasons for adhering (or not) to the plan 3 months later. RESULTS: Of 2555 patients, most selected the top box option (9=definitely agree) that they felt they had a clear plan (n=2011, 78%), agreed with the plan (n=2049, 80%), and intended to follow the plan (n=2108, 83%) discussed with their provider at the primary care visit. The most common elements of the plans reported included reference to exercise (n=359, 14.1%), testing (laboratory, imaging, etc; n=328, 12.8%), diet (n=296, 11.6%), and initiation or adjustment of medications; (n=284, 11.1%). Patients who strongly agreed that they had a clear plan, agreed with the plan, and intended to follow the plan were all more likely to report plan completion 3 months later (P

There is a substantial unmet need for effective and patient-acceptable drugs to treat severe mental illnesses such as schizophrenia (SZ). Computational analysis of genomic, transcriptomic, and pharmacologic data generated in the past 2 decades enables repurposing of drugs or compounds with acceptable safety profiles, namely those that are U.S. Food and Drug Administration approved or have reached late stages in clinical trials. We developed a rational approach to achieve this computationally for SZ by studying drugs that target the proteins in its protein interaction network (interactome). This involved contrasting the transcriptomic modulations observed in the disorder and the drug; our analyses resulted in 12 candidate drugs, 9 of which had additional supportive evidence whereby their target networks were enriched for pathways relevant to SZ etiology or for genes that had an association with diseases pathogenically similar to SZ. To translate these computational results to the clinic, these shortlisted drugs must be tested empirically through randomized controlled trials, in which their previous safety approvals obviate the need for time-consuming phase 1 and 2 studies. We selected 2 among the shortlisted candidates based on likely adherence and side-effect profiles. We are testing them through adjunctive randomized controlled trials for patients with SZ or schizoaffective disorder who experienced incomplete resolution of psychotic features with conventional treatment. The integrated computational analysis for identifying and ranking drugs for clinical trials can be iterated as additional data are obtained. Our approach could be expanded to enable disease subtype–specific drug discovery in the future and should also be exploited for other psychiatric disorders. [ABSTRACT FROM AUTHOR]

Perfectionism is a growing concern and leads to multiple psychosocial consequences. Of note, perfectionism greatly impacts relationships and the ability to form meaningful connections. Relational Cultural Theory is an approach to helping clients realize the importance of growth-fostering relationships and focuses on client empowerment. A relational cultural approach can be a highly effective approach for working through perfectionism. This article conceptualizes perfectionism through a relational cultural lens and provides treatment recommendations. [ABSTRACT FROM AUTHOR]

Positive psychological therapy has been found to be effective in psychological health in the broader cancer patient population. However, specific evidence regarding its effectiveness for adolescent and young adult (AYA) cancer patients remains limited. More research is needed to determine the optimal approaches for alleviating distress in this particular group. We evaluated the efficacy of character strength-based cognitive-behavioral therapy (CS-CBT) versus cognitive-behavioral therapy (CBT) for distress in AYA patients with cancer. In a randomized controlled three-arm trial, cancer patients aged 15-39 years were assigned to one of three groups using a random number table to ensure equal group sizes: (1) CS-CBT, which incorporated specific exercises focused on identifying and utilizing character strengths within the CBT framework; (2) CBT; or (3) control group. The primary outcome was improvement in patients' overall mental health on the Distress Thermometer and the Hospital Anxiety and Depression Scale 3 months after assignment to the groups. Analyses used generalized estimating equations. A total of 162 AYAs were randomly and equally assigned to three groups. Improvements in primary outcomes were significantly greater after CS-CBT than after CBT, and no significant differences were found between the CBT and control group. Among all primary and secondary outcomes, the only non-significant difference found was in quality of life with CS-CBT compared to CBT. AYA cancer patients rated their overall mental health and sense of thriving as more improved after CS-CBT than after CBT. However, quality-of-life indicators supported equal intervention effects in both groups. These findings support the effectiveness of the use of CS-CBT intervention in reducing distress and improving thriving. [ABSTRACT FROM AUTHOR]

Background: Within England, children and young people entering police custody are referred to Liaison and Diversion (L&D) teams. These teams liaise with healthcare and other support services aiming to divert children and young people away from the criminal justice system. Although targeted psychological interventions are not typically offered to children and young people by L&D teams, evidence suggests that Solution Focused Brief Therapy (SFBT) leads to a reduction in internalising and externalising behaviour problems. Methods: A two-arm individually randomised controlled trial (RCT) with internal pilot and process evaluation will be conducted with approximately 448 children and young people aged 10–17 years presenting at police custody suites who are referred to the L&D team or recruited via online routes if they have previously presented at any police custody suite in England. The primary outcome is the Self-Report Delinquency Measure (SRDM) at 6 months post-randomisation. Analyses will be performed using intention-to-treat. Results: The statistical analysis plan (SAP) for the trial is described. The plan details of analyses to be undertaken which will be reported in the primary and any secondary publications. The plan was developed and published prior to locking our database and unblinding to treatment allocation. Discussion: This RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites including testing of moderating factors and sensitivity of the primary analyses. Trial registration: ClinicalTrials.gov ISRCTN14195235. Registered on June 16, 2023. [ABSTRACT FROM AUTHOR]

Objective Methods Results and limitations Conclusions To report real‐world outcomes for high‐risk non‐muscle‐invasive bladder cancer (HRNMIBC), including bacillus Calmette‐Guérin (BCG) and radical cystectomy (RC), as randomised comparisons of these have not been possible.We detail consecutive participants screened for the BRAVO randomised controlled trial comparing RC with BCG (International Standard Randomised Controlled Trial Number [ISRCTN]12509361). Patients were prospectively registered and case‐note review used for outcomes. The primary outcome was overall survival. Secondary outcomes included recurrence, progression, metastasis, and bladder cancer‐specific survival.A total of 193 patients were screened, including 106 (54.9%) who received BCG, 43 (22.3%) primary RC, 37 (19.2%) ‘other’ treatment and seven (3.6%) hyperthermic intravesical mitomycin C. All‐cause death occurred in 55 (28.5%) patients at median (interquartile range [IQR]) of 29.0 (19.5–42.0) months. In multivariable analysis, overall mortality was more common in older patients (hazard ratio [HR] 2.63, 95% confidence interval [CI] 1.35–5.13; Cox P = 0.004 for age >70 years), those recruited from district hospitals (HR 0.53, 95% CI 0.3–0.95; P = 0.032) and those who did not undergo RC as their first treatment (HR 2.16, 95% CI 1.17–3.99; P = 0.014). In all, 17 (8.8%) patients died from bladder cancer (BC) at median (IQR) of 22.5 (19–36.25) months. In multivariable analysis, BC‐specific mortality was more common in older patients (HR 4.87, 95% CI 1.1–21.6; P = 0.037) and those with Tis/T1 disease (HR 2.26, 95% CI 1.23–4.16; P = 0.008) but did not vary with initial treatment.Patients with HRNMIBC are at high‐risk of mortality. Those choosing RC as their initial treatment have lower risks of mortality than others, although this may reflect fitness and selection. [ABSTRACT FROM AUTHOR]

Background: The incidence of mental health issues in children is increasing worldwide. In Chile, a recent surge in reports of deteriorating mental health among school populations and an increase in complaints related to poor school climate have been observed. Physical activity, specifically active breaks in the classroom, has shown positive effects on children's health. However, evidence regarding its impact on mental health and school climate in children is limited. Objective: This work outlines the design, measurements, intervention program, and potential efficacy of the "Active Classes + School Climate and Mental Health" project. This project will assess a 12-week program of active breaks through guided videos with curricular content in the school classroom, and its effects on mental health and school climate as its primary indicators. Additionally, it will measure physical activity, physical fitness, motor competence, and academic performance in students aged 6-10 years in the Biobío province, Chile, as secondary indicators. Methodology: A multicenter randomized controlled trial involving 823 students from 1st to 4th grade (6-10 years old), six schools (three intervention and three control) will be conducted in the Biobío region, Chile. Participants belonging to the intervention group will implement video-guided active breaks through the "Active Classes" web platform, featuring curricular content, lasting 5-10 min and of moderate to vigorous intensity physical activity, twice a day, Monday to Friday, over a span of 12 weeks. Expected Results/Discussion: To our knowledge, this will be the first study in Chile to evaluate the effects of incorporating video-guided active breaks with curricular content on mental health variables and school climate in schoolchildren. Thus, this study contributes to the scarce evidence on the effects of video-guided active breaks on mental health variables and school climate in schoolchildren worldwide. Additionally, it will provide crucial information about active teaching methodologies that have the potential to positively contribute to the wellbeing of students, thus addressing the problems of mental health and climate in Chilean schools. ClinicalTrials.gov ID NCT06423404. [ABSTRACT FROM AUTHOR]

Aims Design Setting Participants Interventions Measurements Findings Conclusions To determine whether nicotine mouth spray provides rapid and prolonged relief of urges to vape and measure the steady‐state plasma nicotine levels during vaping and ad libitum mouth spray usage in e‐cigarette users.Randomized, parallel group, double‐blind trial.Single site at Hammersmith Medicines Research Ltd (HMR), London, UK.216 (25.9% females, average age 27.6 ± 7.63 [standard deviation, SD]) exclusive vapers who used their e‐cigarette within 30 minutes of waking up and had vaped about 2 years on average.Two sprays of 1 mg nicotine mouth spray (Nicorette QuickMist Freshmint, n = 109), or placebo (identical in appearance and presentation, n = 107).Urge to vape was rated on a 100 mm visual analogue scale before and repeatedly for 2 hours after administration. The primary outcome measured average change from baseline in urges to vape ratings during the first hour.Nicotine mouth spray achieved statistically significantly greater reductions in urges to vape than placebo from the first assessment point at 30 seconds to 1 hour, when the estimated mean treatment difference was 11.90 mm (95% confidence interval [CI] = 6.86–16.95, P < 0.001). The integrated urge to vape over 11 hours ad libitum usage showed a statistically significant benefit compared with placebo (2.00 [0.88 SD] vs 2.51 [0.84 SD], P < 0.001). Mean steady‐state plasma nicotine concentrations were lower after nicotine mouth spray usage compared with vaping (6.22 [4.70 SD] ng/ml vs 9.91 [7.59 SD] ng/ml, respectively). Adverse events were more commonly reported in the nicotine mouth spray group and were mostly mild.Among regular e‐cigarette users, nicotine mouth spray provided statistically significant and fast relief of urges to vape one hour after dosing. Nicotine mouth spray showed statistically significant reductions in urges to vape as soon as 30 seconds and up to 2 hours after dosing compared with placebo, and nicotine mouth spray was well‐tolerated and safe. [ABSTRACT FROM AUTHOR]

Introduction: Lack of sufficient agricultural information has led smallholders' to rely on traditional agricultural farming technologies in Sub-Saharan African countries, resulting in low adoption of modern inputs and low yield. Understanding the effect of information dissemination is essential for smallholder farmers in rural areas. Therefore, this study aimed to examine the effect of a randomized agricultural information provision on technology adoption and yield of cassava producers in Sodo Zuria, Offa, and Kindo Koysha Woredas in Wolaita Zone, South Ethiopia Regional Sate. Methods: The study utilized panel data collected in two rounds from 1040 farmers in 2021 and 2023. A Randomized control trial (RCT) design was applied to evaluate the effect agricultural information provision on technology adoption and yields, comparing the results between treatment and control groups. The study employed three related information interventions for beneficiaries of the Ethiopian Rural Productive Safety Net Program: (i) agronomic technical information, (ii) productivity and profitability information, and (iii) pooled information on both treatments. Results and discussion: The study found that agricultural information provision increases the adoption of modern agricultural technologies, land allocated to cassava, and yield. The provision of agricultural information is negatively related to access to media exposure, access to cell phones, and access to infrastructure while positively associated with participation in social groups, farm size, and farm income. Further policy research and evaluation are needed to assess the effectiveness of information intervention in different contexts and settings and factors that influence the improved cassava adoption and yield. [ABSTRACT FROM AUTHOR]

We conduct a randomised control trial at an Italian university to investigate the impact of test anxiety on high-stakes exams. Students are subjected to two different interventions – silence and music – designed to influence their pre-test anxiety levels. We monitored and compared individual biomarkers before and after each treatment to measure anxiety changes and their influence on exam scores. Our findings revealed that decreased mean arterial and systolic pressures enhanced performance in females, particularly under the silence treatment. However, no significant effect was observed in male students. This study suggests that test anxiety could contribute to gender-based performance disparities. [ABSTRACT FROM AUTHOR]

Background/Objectives: In osteopathy, it becomes necessary to produce high-quality evidence to demonstrate its effectiveness. The aim of this meta-research study is to assess the reporting quality of RCTs published in the osteopathic field. Methods: The protocol was preliminarily registered on the "Open Science Framework (OSF)" website. For reporting, we considered the PRISMA 2020 checklist. We included all the RCTs, published between 2011 and 2023, investigating the effectiveness of Osteopathic Manipulative Treatment (OMT) in any possible condition. The search process was conducted on four major biomedical databases including PubMed, Central, Scopus and Embase. A data extraction form was implemented to collect all relevant information. The completeness of reporting was calculated as the percentage of adherence to the CONSORT checklist; the Cochrane ROB 2 tool was considered to assess the risk of bias (RoB) in the following five major domains: randomization (D1), interventions (D2), missing data (D3), outcome measurement (D4), selective reporting (D5). Results: A total of 131 studies were included and the overall adherence was 57%, with the worst section being "other information" (42%). Studies with a lower RoB showed higher adherence to the CONSORT. The "results" section presented the highest differences as follows: D1 (−36.7%), D2 (−27.2%), D3 (−21.5%) and D5 (−25.5%). Significant correlations were also found between the preliminary protocol registration, higher journal quartile, publication in hybrid journals and the completeness of reporting (β: 19.22, CI: 14.45–24.00, p < 0.001; β: 5.41; CI: 2.80–8.02, p ≤ 0.001; β: 5.64, CI: 1.06–10.23, p = 0.016, respectively). Conclusions: The adherence to the CONSORT checklist in osteopathic RCTs is lacking. An association was found between a lower completeness of reporting and a higher RoB, a good journal ranking, publication in hybrid journals and a prospective protocol registration. Journals and authors should adopt all the strategies to adhere to reporting guidelines to guarantee generalization of the results arising from RCTs. [ABSTRACT FROM AUTHOR]

Evidence on the optimal follow-up schedule after endometrial cancer is lacking. The study aim was to compare satisfaction with care between women who received reduced follow-up care and women who received usual guideline-directed follow-up care for three years after surgery. The ENSURE (ENdometrial cancer SURvivors' follow-up carE) trial was a non-inferiority randomized controlled multicenter trial in 42 hospitals in the Netherlands. The intervention arm received reduced follow-up care (4 visits/3 years), while the control group received usual follow-up care (8–11 visits/3 years). Primary outcome was overall satisfaction with care, PSQIII score, over three years follow-up, with a non-inferiority margin of 6. Mixed linear regression, intention-to-treat and per-protocol analyses (presented below) were used. Among 316 women included, overall satisfaction with care was not lower in the reduced follow-up (mean 82; SD = 15) compared with the usual follow-up group (mean 80; SD = 15) group (B = 1.80(−2.09;5.68)). At 6, 12 and 36 months, more women (93/94/90%) in the reduced follow-up group were satisfied with their follow-up schedule than in the usual follow-up group (79/79/82%; p < 0.001; p < 0.001; p = 0.050). Women with low-risk, early-stage endometrial cancer who received reduced follow-up care were no less satisfied with their care than women receiving usual follow-up care. Compared with usual follow-up, women in the reduced follow-up group had fewer clinical visits and, at the same time, more often reported being satisfied with their follow-up schedule. Findings suggest that reduced follow-up care may be the new standard, but should be tailored to meet additional needs where indicated. • Reduced follow-up does not compromise satisfaction with care or worry. • Patients prefer the schedule of reduced follow-up. • Reduced follow-up care may be the new standard for endometrial cancer. • Follow-up should be tailored to meet individual patient needs in case of worry. • Findings may be relevant for other low-risk cancers. [ABSTRACT FROM AUTHOR]

Short-term (4 weeks) supplementation with n-3 polyunsaturated fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) has recently been shown to improve protein metabolism in a dose dependent way in normal weight patients with Chronic Obstructive Pulmonary Disease (COPD). Furthermore, EPA/DHA supplementation was able to increase extremity lean soft tissue but not muscle function. No studies are available combining n-3 PUFAs and the leucine metabolite β-hydroxy-β-methylbutyrate (HMB) supplementation in chronic clinical conditions. Whether adding HMB to daily EPA/DHA supplementation for 10 weeks enhances muscle and brain health, daily functional performance, and quality of life of patients with COPD by further improving their protein and amino acid homeostasis remains unknown. Patients with COPD (GOLD: II-IV, n = 46) received daily for 10 weeks, according to a randomized double-blind placebo-controlled three-group design, EPA/DHA (n = 16), EPA/DHA to which HMB was added (n = 14), or placebo (n = 16). The daily dose of 2.0 g of EPA/DHA or soy + corn oil as the placebo was provided via gel capsules, and 3.0 g of Ca-HMB or maltodextrin as placebo as powders. At pre- and post-intervention, a pulse mixture of multiple amino acids was administered to measure postabsorptive net protein breakdown (netPB as primary endpoint) and whole body production (WBP) and conversion rates of the amino acids. As secondary endpoints, lean soft tissue and fat mass were assessed by dual-energy X-ray absorptiometry, upper and lower muscle function by handgrip and single leg isokinetic dynamometry, brain (cognitive, wellbeing) health by assessments, daily functional performance by measuring 6-min walk distance, 4-m gait speed, and postural balance, and quality of life by questionnaire. Plasma enrichments and concentrations were analyzed by LC-MS/MS, and systemic inflammatory profile and metabolic hormones by Luminex. HMB + EPA/DHA but not EPA/DHA supplementation increased postabsorptive netPB (p = 0.028), and WBPs of glutamine (p = 0.024), taurine (p = 0.039), and tyrosine (p = 0.036). Both EPA/DHA and HMB + EPA/DHA supplementation resulted in increased WBP of phenylalanine (p < 0.05). EPA/DHA but not HMB + EPA/DHA was able to increase WBP of arginine (p = 0.030), citrulline (p = 0.008), valine (p = 0.038), and conversion of citrulline to arginine (p = 0.009). Whole body and extremity fat mass were reduced after HMB + EPA/DHA supplementation only, whereas lean soft tissue was increased after EPA/DHA (p = 0.049) and HMB + EPA/DHA (p = 0.073). No other significant findings were observed. Reductions in several proinflammatory cytokines were observed in the HMB + EPA/DHA group including IL-2, IL-17, IL-6, IL-12P40, and TNF-β (p < 0.05). Ten weeks of supplementation with 2 g of EPA/DHA daily is sufficient to induce muscle gain in COPD but HMB is needed to induce fat loss. Whether HMB is solely responsible for the fat mass loss or has a synergistic effect with EPA/DHA remains unclear. The increase in net protein breakdown observed with HMB + EPA/DHA supplementation may indicate a beneficial enhanced protein turnover cycling associated with increased lean soft tissue. ClinicalTrials.gov; NCT03796455. [ABSTRACT FROM AUTHOR]

This article reports on the largest randomized control trial (with followup) to examine the effects of mindfulness among police officers and staff. The benefits of mindfulness for wellbeing are established, but less is known about long-term impact on employee wellbeing and the implications of individual outcomes at organizational level. In the RCT, both the wellbeing and performance of users of two mindfulness apps over 24 weeks improved as compared to a control group. In responding to calls for consideration of relevance alongside rigor in public administration field experiments, the study also investigated how a large-scale wellbeing intervention was implemented and applied cost-effectiveness methodology to link individual and organizational outcomes and demonstrate cost savings. This additional contextualization showed how to improve implementation of wellbeing interventions for public personnel and demonstrated a method for rigorously assessing whether interventions deliver on both an individual and organizational level. [ABSTRACT FROM AUTHOR]

Background: Domestic violence during pregnancy is especially concerning due to its significant detrimental impact on a woman's health and that of her unborn child. The study aims to evaluate the effects of a behavioural intervention package (BIP) delivered during pregnancy on the quality of life (QOL), domestic violence (DV), and reproductive and child health (RCH) of women experiencing DV. Methods: A randomised controlled trial was conducted on 211 pregnant women recruited between 18 and 20 weeks of pregnancy and randomly assigned to one of two groups: intervention (n = 105) or control (n = 106). The intervention group received BIP and standard care, while the control group received only standard care for 28 weeks. Study tools included socio-demographic variables, a short-form health survey, an abuse assessment screening tool, and an RCH checklist. The tools were completed once before the intervention and again at 6 weeks postnatal. The tools and their subscales were compared pre- and post-intervention using a paired t-test, or Wilcoxon signed test as appropriate to estimate the effect size at baseline and post-intervention. Results: Post-intervention, the QOL scores were found to be significant, with a positive effect favouring the intervention as compared to the control group. The BIP intervention, which was found to be significantly effective (P ≤ 0.001) in reducing DV for pregnant women experiencing DV, was higher in the intervention group than in the control group. Conclusion: The BIP may be an appropriate method for treating pregnant women experiencing DV from low socioeconomic strata who attend public hospitals in India to improve their QOL. The approach may offer an intervention that healthcare institutions or other organizations in contact with women at risk of violence can implement. Trial registration: Indian Registry of Clinical Trials CTRI/2019/01/017009. Registered on 09/01/2019. [ABSTRACT FROM AUTHOR]

Introduction: Global inequality in clinical research capacity and service delivery can be indicated simply by the proportion of clinical trials that a country or region has registered in clinical trial registry databases. The proportion of clinical trials registered in Africa is very low at 0.02%, even though the region accounts for approximately 15% of the world's population. Despite the economic challenges in most African countries, they have shown potential for growth and change in recent years. Methods: We conducted desk reviews on the interventional clinical trials done in Kenya, Ethiopia, and Nigeria between 2015 to May 2023. The search was done in clinical trials repositories, and journal repositories. The search focused on intervention clinical trials. Data was extracted by screening through the publications and clinical trial platforms. The data extracted from the publications included the type of clinical trial, clinical trial phase, diseases, etc. The data extracted from the reports included: challenges in conducting clinical trials, capacity-building efforts, and the impact of the clinical trial. Results: The number of clinical trial studies identified in Kenya was 113 (28 were on infant clinical trials). The study identified 97 clinical trials in Nigeria, of which 11 studies were on infant clinical trials. In Ethiopia, there were 28 clinical trials and only five were on infant clinical trials. The landscape review also expanded to capacity and gaps in clinical trials in the three countries. The largest proportion of clinical trials carried out in Kenya was on injury, occupational disease, and poisoning, 30.5% (n = 18) and the smallest proportion was on kidney disease, neonatal disease, obstetrics, and gynecology. Most Infant clinical trials were carried out in the area of infections and infestations 33.3% (n=7). Most of the challenges faced by clinical trials in the three countries include a lack of infrastructure, a lack of human resources, and a lack of financial resources. Implications: There is a need to map clinical trials done by African researchers based in Africa to exclude the trials done by non-African researchers based in Africa. Opportunities for clinical trials should be supported and challenges addressed. [ABSTRACT FROM AUTHOR]

Eating disorders (ED) usually involve hospital admission and a high relapse rate, with the return home being a critical moment for patients and their families. After their return home, they often have trouble incorporating the guidelines they have learned into their daily context. ECHOMANTRA intervention program aims to facilitate this transition by offering psychological strategies that involve both patients and their families and carers. Specifically, the ECHO program is aimed at the relatives of these patients. The present study aimed to analyze the efficacy of adding the ECHO program to the usual treatment (TAU) of relatives through a novel format based on individual intervention and with an online format and to examine the acceptability and feasibility of this new format. The study design was multi‐center, randomized, controlled, with a longitudinal design and comparing two parallel groups. A total of 108 family members participated. Results indicated that relatives from both groups, TAU and ECHO + TAU, showed improvements in expressed emotion, accommodation, impact of the ED, emotional well‐being, and caregiver skills. However, effect sizes in the ECHO + TAU group were slightly larger than the TAU group. In addition, the changes were greater in depression and caregiver skills when the ECHO component was added. Most caregivers (81.48%) completed the ECHO and indicated a high level of satisfaction with the program. These results suggest the efficacy and the feasibility of adding the ECHO intervention program to the usual treatment in an individual online format. [ABSTRACT FROM AUTHOR]

Background: Oral language skills provide the foundation for formal education, yet many children enter school with language weaknesses. This study evaluated the efficacy of a new language enrichment programme, the Nuffield Early Language Intervention—Preschool (NELI Preschool), delivered to children in the year before they enter formal education. Methods: We conducted a preregistered cluster randomised controlled trial in 65 nursery schools in England (https://doi.org/10.1186/ISRCTN29838552). NELI Preschool consists of a 20‐week whole‐class language enrichment programme delivered by a teacher each day for 20 min. In addition, children with the weakest language skills in each class are allocated to receive additional targeted support delivered by classroom assistants (whole‐class + targeted). The language skills of all children (n = 1,586) in participating classrooms were assessed using the LanguageScreen automated app (https://oxedandassessment.com/languagescreen/). Settings were then randomly allocated to an intervention or control group. The children with the weakest language in each class (whole‐class + targeted children n = 438), along with four randomly selected children in each class allocated to the whole‐class only programme (n = 288) were individually tested on a range of language measures. Results: Children receiving NELI Preschool made larger gains than children in the control group on an oral language latent variable (whole‐class children d =.26; whole‐class + targeted children d =.16). Conclusions: This study provides good evidence that whole‐class intervention delivered in preschool can produce educationally significant improvements in children's language skills. The intervention is scaleable and relatively low cost. These findings have important implications for educational and social policy. [ABSTRACT FROM AUTHOR]

• Tax penalty collection is a challenge faced by tax administrations worldwide. • We nudge taxpayers in Indonesia to pay their tax penalties on time. • Simplification by providing billing codes outperforms the other nudge letters. • Emphasising deterrence is also effective in increasing timely payment. • The nudge letters prove to be a cost-effective strategy for changing behaviour. We conduct a randomised controlled trial in Indonesia to evaluate the effect of three intervention letters on tax penalty compliance behaviour. Over 10,000 individual taxpayers are randomly assigned to receive either a deterrence, information, or simplification letter, or no letter. Our results indicate that simplification, which makes paying a penalty less burdensome administratively by providing billing codes to pay the penalties, yields the highest probability of timely settlement, increasing compliance by 32% compared to the control group. Deterrence also positively impacts penalty compliance, increasing timely settlement rates by 27%. The least effective intervention is the information letter. Although associated with a 10% increase in timely settlement, this effect is statistically insignificant at the 10% confidence level. Our results suggest that strategic messaging by tax authorities in developing countries can be a cost-effective tool for improving tax penalty payment compliance. [ABSTRACT FROM AUTHOR]

Depression is a growing public health concern, and exercise is an adjunctive treatment modality to improve depression, but the optimal form of exercise and the optimal dose are still unclear. This systematic review examined the efficacy of four major types of exercise (aerobic, resistance, mixed, and mind-body) on depression, as well as the dose-response relationship between total and specific exercise and depressive symptoms. We included randomized controlled trials that included participants aged 18 years or older with a diagnosis of major depressive disorder or a depressive symptom score above a threshold as determined by a validated screening measure, implemented one or more exercise therapy groups, and assessed depressive symptoms at baseline and follow-up. Forty-six studies (3164 patients) were included in the meta-analysis. Aerobic (standardised mean difference (SMD) = -0.93; 95% CI: -1.25 to -0.62) and mind-body exercise (SMD) = -0.81; 95% CI: -1.19 to -0.42) improved depressive symptoms better compared to controls, followed by mixed (SMD = -0.77; 95% CI: -1.20 to -0.34) and resistance exercise (SMD = -0.76; 95% CI: -1.24 to -0.28). This dose-response meta-analysis showed a U-shaped curve between exercise dose and depressive symptoms. The minimum effective dose was estimated to be 320 metabolic equivalent (METs) -min per week and the optimal response was 860 METs-min per week. These findings lead us to advocate that clinicians carefully select the appropriate dose of exercise based on the patient's individual characteristics and needs, in conjunction with psychological care interventions. • Aerobic, resistance, mixed and mind-body exercise interventions have significant and comparable benefits in improving clinical depressive symptoms in patients with MDD. • There was a U-shaped dose-response relationship between overall exercise volume and depression level, with the maximum significant response occurring at 860 METs-min, and a minimal clinically meaningful difference (MCID) in depression improvement with 477 METs-min of exercise per week. [ABSTRACT FROM AUTHOR]

Background: Given the degenerative nature of the condition, people living with motor neuron disease (MND) experience high levels of psychological distress. The purpose of this research was to investigate the cost‐effectiveness of acceptance and commitment therapy (ACT), adapted for the specific needs of this population, for improving quality of life. Methods: A trial‐based cost–utility analysis over a 9‐month period was conducted comparing ACT plus usual care (n = 97) versus usual care alone (n = 94) from the perspective of the National Health Service. In the primary analysis, quality‐adjusted life years (QALYs) were computed using health utilities generated from the EQ‐5D‐5L questionnaire. Sensitivity analyses and subgroup analyses were also carried out. Results: Difference in costs was statistically significant between the two arms, driven mainly by the intervention costs. Effects measured by EQ‐5D‐5L were not statistically significantly different between the two arms. The incremental cost‐effectiveness was above the £20,000 to £30,000 per QALY gained threshold used in the UK. However, the difference in effects was statistically significant when measured by the McGill Quality of Life‐Revised (MQOL‐R) questionnaire. The intervention was cost‐effective in a subgroup experiencing medium deterioration in motor neuron symptoms. Conclusions: Despite the intervention being cost‐ineffective in the primary analysis, the significant difference in the effects measured by MQOL‐R, the low costs of the intervention, the results in the subgroup analysis, and the fact that ACT was shown to improve the quality of life for people living with MND, suggest that ACT could be incorporated into MND clinical services. [ABSTRACT FROM AUTHOR]

STUDY QUESTION Does a purpose-designed Decision Aid for women considering elective egg freezing (EEF) impact decisional conflict and other decision-related outcomes? SUMMARY ANSWER The Decision Aid reduces decisional conflict, prepares women for decision-making, and does not cause distress. WHAT IS ALREADY KNOWN Elective egg-freezing decisions are complex, with 78% of women reporting high decisional conflict. Decision Aids are used to support complex health decisions. We developed an online Decision Aid for women considering EEF and demonstrated that it was acceptable and useful in Phase 1 testing. STUDY DESIGN, SIZE, DURATION A single-blind, two-arm parallel group randomized controlled trial was carried out. Target sample size was 286 participants. Randomization was 1:1 to the control (existing website information) or intervention (Decision Aid plus existing website information) group and stratified by Australian state/territory and prior IVF specialist consultation. Participants were recruited between September 2020 and March 2021 with outcomes recorded over 12 months. Data were collected using online surveys and data collection was completed in March 2022. PARTICIPANTS/MATERIALS, SETTING, METHODS Females aged ≥18 years, living in Australia, considering EEF, proficient in English, and with internet access were recruited using multiple methods including social media posts, Google advertising, newsletter/noticeboard posts, and fertility clinic promotion. After completing the baseline survey, participants were emailed their allocated website link(s). Follow-up surveys were sent at 6 and 12 months. Primary outcome was decisional conflict (Decisional Conflict Scale). Other outcomes included distress (Depression Anxiety and Stress Scale), knowledge about egg freezing and female age-related infertility (study-specific measure), whether a decision was made, preparedness to decide about egg freezing (Preparation for Decision-Making Scale), informed choice (Multi-Dimensional Measure of Informed Choice), and decision regret (Decision Regret Scale). MAIN RESULTS AND THE ROLE OF CHANCE Overall, 306 participants (mean age 30 years; SD: 5.2) were randomized (intervention n = 150, control n = 156). Decisional Conflict Scale scores were significantly lower at 12 months (mean score difference: −6.99 [95% CI: −12.96, −1.02], P  = 0.022) for the intervention versus control group after adjusting for baseline decisional conflict. At 6 months, the intervention group felt significantly more prepared to decide about EEF than the control (mean score difference: 9.22 [95% CI: 2.35, 16.08], P  = 0.009). At 12 months, no group differences were observed in distress (mean score difference: 0.61 [95% CI: −3.72, 4.93], P  = 0.783), knowledge (mean score difference: 0.23 [95% CI: −0.21, 0.66], P  = 0.309), or whether a decision was made (relative risk: 1.21 [95% CI: 0.90, 1.64], P  = 0.212). No group differences were found in informed choice (relative risk: 1.00 [95% CI: 0.81, 1.25], P  = 0.983) or decision regret (median score difference: −5.00 [95% CI: −15.30, 5.30], P  = 0.337) amongst participants who had decided about EEF by 12 months (intervention n = 48, control n = 45). LIMITATIONS, REASONS FOR CAUTION Unknown participant uptake and potential sampling bias due to the recruitment methods used and restrictions caused by the coronavirus disease 2019 pandemic. Some outcomes had small sample sizes limiting the inferences made. The use of study-specific or adapted validated measures may impact the reliability of some results. WIDER IMPLICATIONS OF THE FINDINGS This is the first randomized controlled trial to evaluate a Decision Aid for EEF. The Decision Aid reduced decisional conflict and improved women's preparation for decision making. The tool will be made publicly available and can be tailored for international use. STUDY FUNDING/COMPETING INTEREST(S) The Decision Aid was developed with funding from the Royal Women's Hospital Foundation and McBain Family Trust. The study was funded by a National Health and Medical Research Council (NHMRC) Project Grant APP1163202, awarded to M. Hickey, M. Peate, R.J. Norman, and R. Hart (2019–2021). S.S. M.P. D.K. and S.B. were supported by the NHMRC Project Grant APP1163202 to perform this work. R.H. is Medical Director of Fertility Specialists of Western Australia and National Medical Director of City Fertility. He has received grants from MSD, Merck-Serono, and Ferring Pharmaceuticals unrelated to this study and is a shareholder of CHA-SMG. R.L. is Director of Women's Health Melbourne (Medical Practice), ANZSREI Executive Secretary (Honorary), RANZCOG CREI Subspecialty Committee Member (Honorary), and a Fertility Specialist at Life Fertility Clinic Melbourne and Royal Women's Hospital Public Fertility Service. R.A.A. has received grants from Ferring Pharmaceuticals unrelated to this study. M.H. K.H. and R.J.N. have no conflicts to declare. TRIAL REGISTRATION NUMBER ACTRN12620001032943 TRIAL REGISTRATION DATE 11 August 2020 DATE OF FIRST PATIENT'S ENROLMENT 29 September 2020 [ABSTRACT FROM AUTHOR]

Background: To systematically evaluate the safety and efficacy of Deucravacitinib for moderate to severe plaque psoriasis. Materials and Methods: Randomized controlled trials (RCTs) of Deucravacitinib for moderate to severe plaque psoriasis in PubMed, Cochrane Library, Embase, and Web of Science were searched from database establishment to April 2023. Literature quality was independently evaluated by two investigators using the Cochrane risk‐of‐bias assessment tool, and the systematic analysis was made using StateSE15 and RevMan 5.3 software. Results: Four RCTs were included, including 1751 patients with moderate to severe plaque psoriasis. Meta‐analysis showed that the differences in efficacy and adverse events (AEs) between the Deucravacitinib group and placebo group were significant (p < 0.05). The patients in the Deucravacitinib group took orally 3–12 mg daily for 12 sequential weeks or 6 mg daily for 52 sequential weeks. Psoriasis Area and Severity Index (PASI) reduced by 75% (PASI 75), (PASI 90), and (PASI 100), static Physician Global Assessment (sPGA) of 0 or 1 (sPGA 0/1), Dermatology Life Quality Index of 0 or 1 (DLQI 0/1), and Psoriasis Symptoms and Signs Diary (PSSD) were significantly higher in the Deucravacitinib group compared to the placebo group, with significant differences (p < 0.05). The most frequently encountered AEs after treatment in the Deucravacitinib group was nasopharyngitis. Conclusion: Oral administration of Deucravacitinib is effective for moderate to severe plaque psoriasis. Attention should be paid to the occurrence of AEs, and more RCTs are required to evaluate the relationship between the dose and safety and efficacy. [ABSTRACT FROM AUTHOR]

Background: Chronic obstructive pulmonary disease (COPD) is a common respiratory disease with acute exacerbation (AECOPD) being a common sequalae which negatively impact health status, rates of hospitalization and readmission, and disease progression. N‐acetylcysteine (NAC) has been studied in COPD in both stable state and acute exacerbations, which has been shown to have small beneficial effects in stable COPD, as well as AECOPD. Yet, there has been lack of study with well‐designed protocol to assess the role of NAC in more objective outcomes in AECOPD. Methods: This is a double‐blind randomized controlled trial. Patients will be randomized in 1:1 ratio to receive oral NAC at 600 mg twice daily or placebo twice daily with standard of care. Partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2) and the ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaO2/FiO2) will be measured on days 1 and 7. The following will be measure at baseline and on day 4 and 7: Forced expiratory volume in one second (FEV1), 24‐hour sputum volume, oxygen saturation (SaO2), end‐tidal CO2, Leicester Cough Questionnaire (LCQ) score, COPD Assessment Test (CAT) score, grading of wheeze and grade of dyspnoea; blood inflammatory markers (leucocyte count, neutrophil count, erythrocyte sedimentation rate (ESR), C‐reactive protein (CRP) and high sensitivity CRP (hs‐CRP)). Patients will be randomized to oral NAC at 600 mg twice daily or placebo for 7 days. The main outcome measures include: The difference in PaO2 on day 7. Secondary outcome: Change in following parameters on day 4/7 from baseline: FEV1, sputum volume, CAT score, LCQ score, SaO2, grade of wheeze; mMRC Dyspnoea Scale, end‐tidal CO2, blood inflammatory marker, change in PaO2/FiO2 ratio from baseline to day 7, PaCO2 on day 7, 28 and 90 days' mortality, time to wean off supplemental oxygen, length of stay. Primary and secondary outcomes will be compared among the two treatment groups with two‐sample t‐test. Discussion: We hypothesize that NAC use in COPD exacerbation can provide benefits in clinical and laboratory parameters. Trial Registration: Name of the registry: ClinicalTrials.gov Trial registration number: NCT05706402. URL of the trial registry record for this trial: https://classic.clinicaltrials.gov/ct2/show/NCT05706402 Date of registration: Registered on 11th January 2023 Funding of the trial: The Health and Medical Research Fund (HMRF). Name and contact information for the trial sponsor: Wang Chung Kwok, Clinical Assistant Professor, Honorary Associate Consultant, Queen Mary Hospital, The University of Hong Kong, Hong Kong. Role of sponsor: The funder is not involved in the planning of the study, gathering, analysing, and interpreting the data, or in preparing the manuscript. [ABSTRACT FROM AUTHOR]

Most methodologically rigorous, ED-based, comparative effectiveness analgesic studies completed in the last two decades failed to find a clinically important difference between the comparators. We believe that many of these comparative effectiveness studies were biased towards the null hypothesis because some ED patients with intense pain will respond to relatively mild interventions. We hypothesized that including a run-in period would alter the results of an acute pain RCT. We conducted a sequential, multiple-assignment, randomized study. Adults with acute moderate/severe musculoskeletal pain were randomized (3:1 ratio) to run-in period or no run-in. We administered 650 mg acetaminophen to run-in participants. Those run-in patients who reported insufficient relief one-hour later were randomized (1:1 ratio) to ibuprofen 800mg PO or ketorolac 20mg PO as were all participants randomized to no run-in. The primary outcome was achieving a clinically important improvement, defined as improvement ≥1.3 on a 0–10 scale. We built a logistic regression model including run-in/no run-in, ketorolac/ibuprofen, age and sex. Of 307 participants who received acetaminophen, 100 (32.6%) reported inadequate relief and were randomized to an NSAID. Of the 100 patients randomized to no run-in, 84/100 (84%) achieved the primary outcome versus 246/287 (86%) run-in participants (95% CI for difference = 2%:−7,10%). Among run-in participants who received an NSAID, 82/99(83%) achieved the primary outcome versus 84/100(84%) no run-in participants (p = 0.82). Among all ibuprofen participants, 44/49(90%) randomized to run-in and 42/50(84%) randomized to no run-in achieved the primary outcome. Among all ketorolac participants, 38/50(76%) randomized to run-in and 42/50 (84%) randomized to no run-in achieved the primary outcome. We observed the following results in a multivariable analysis: OR for ketorolac versus ibuprofen:0.60 (95% CI: 0.28, 1.28); OR for run-in versus no run-in:0.91(95% CI: 0.43, 1.93). Among patients with acute musculoskeletal pain, using an acetaminophen first strategy did not alter pain outcomes. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of perioperative dexamethasone on postoperative complications after pancreaticoduodenectomy. Background: The glucocorticoid dexamethasone has been shown to improve postoperative outcomes in surgical patients, but its effects on postoperative complications after pancreaticoduodenectomy are unclear. Methods: This multicenter, double-blind, randomized controlled trial was conducted in four Chinese high-volume pancreatic centers. Adults undergoing elective pancreaticoduodenectomy were randomized to receive either 0.2 mg/kg dexamethasone or a saline placebo as an intravenous bolus within 5 minutes after anesthesia induction. The primary outcome was the Comprehensive Complication Index (CCI) score within 30 days after the operation, analyzed using the modified intention-totreat principle. Results: Among 428 patients for eligibility, 300 participants were randomized and 265 were included in the modified intention-to-treat analyses. One hundred thirty-four patients received dexamethasone and 131 patients received a placebo. The mean (SD) CCI score was 14.0 (17.5) in the dexamethasone group and 17.9 (20.3) in the placebo group (mean difference: -3.8; 95% CI: -8.4 to 0.7; P = 0.100). The incidence of major complications (Clavien-Dindo grade =III; 12.7% vs 16.0%, risk ratio: 0.79; 95% CI: 0.44 to 1.43; P = 0.439) and postoperative pancreatic fistula (25.4% vs 31.3%, risk ratio: 0.81; 95% CI: 0.55 to 1.19; P = 0.286) were not significantly different between the two groups. In the stratum of participants with a main pancreatic duct =3 mm (n = 202), the CCI score was significantly lower in the dexamethasone group (mean difference: -6.4; 95% CI: -11.2 to -1.6; P = 0.009). Conclusions: Perioperative dexamethasone did not significantly reduce postoperative complications within 30 days after pancreaticoduodenectomy. [ABSTRACT FROM AUTHOR]

Objective: Post-endodontic pain (PEP) after endodontic treatment (ET) might be reduced by adding cortisone to the composition of root canal sealer (RCS). This study aimed to test this hypothesis using grade A methodology. Methods: A multicentric prospective randomised controlled clinical trial was performed in general practice. Adult patients with an indication of ET in a molar or premolar performed in one session were included between 2021 and 2022 in 15 centres. The main objective was to demonstrate the superiority of Endomethasone N RCS (EndoN), compared to its hydrocortisone-free equivalent Endomethasone SP RCS (EndoSP), regarding the reduction of the maximum spontaneous PEP pain during the 7 days following the ET, self-estimated on a 0-100 mm Visual Analogic Scale (VAS). The secondary objectives were to assess 1) spontaneous PEP, 2) provoked (masticatory) PEP, 3) intake of analgesics, 4) quality of life and anxiety before and after ET, and 5) safety. Results: The final sample consisted of 286 patients with a mean age of 47.7 years, including 51% men and 49% women. Before ET, 49.7% of the teeth were asymptomatic; provoked pain occurred in 29.4% and spontaneous pain in 21.0%. The study evidenced a lower maximum spontaneous PEP intensity during the 7 days following ET in EndoN compared to the EndoSP group (13.5±17.9 vs 23.9±26.6, IC 95% 10.5 [5.2-15.8], p=0.0001 Wilcoxon test). Maximal masticatory PEP was also lower in the EndoN group (12.3±19.1 vs 24.0±27.8, IC 95% 11.7 [5.8-17.6], p<0.0001 Wilcoxon test). At every evaluation time, the masticatory PEP in the EndoSP group was higher than in the EndoN group. In addition, no serious adverse events occurred during the study. Conclusion: This RCT demonstrated EndoN's superiority over EndoSP in reducing spontaneous and masticatory PEP during the 7 days following ET. This study was funded by the Septodont company (Saint Maur des Fossés, France) and registered at ClinicalTrials.gov # NCT04885686. [ABSTRACT FROM AUTHOR]

Background: Coronavirus disease 2019 (COVID-19) is a newly emerging human disease caused by a novel coronavirus, causing a global pandemic crisis. Probiotics and/or colchicine may be considered as options for treatment since they have anti-viral, antiinflammatory, and immunomodulatory effects. Methods: A total of 150 patients with mild and moderate severity of COVID-19 were randomly enrolled in the study,50 patients in each arm. Results: around one third (34.7%) of the participants were aged between 29 and 39 years; one-quarter (24.7%) were aged between 18 and 28 years and 40.6% were aged 40 years and above. The mean duration of symptoms improvement was 12, 11 and 12 in the colchicine, probiotic, and control groups, respectively. Improvement of inflammatory markers over time occurred in each of the three groups, with no statistically significant difference between them. Conclusion: Probiotic Lactobacillus acidophilus and colchicine shows no significant effect on the symptoms, duration, and progression of mild and moderate cases of COVID-19. [ABSTRACT FROM AUTHOR]

A randomized controlled trial in Pakistan tests whether one-on-one engagement with community religious leaders can encourage them to instruct congregants to follow government regulations. Treated religious leaders are 25 percent more likely to comply with government requirements to tell congregants they should wear a mask to prevent COVID transmission when attending prayers. Treatment effects do not depend on the religious content of the message. Effects are driven by respondents who already understand the mechanics of COVID transmission at baseline, suggesting the treatment does not work by correcting basic knowledge about the disease, but rather through a mechanism of persuasion. [ABSTRACT FROM AUTHOR]

Objectives: To compare self‐reported pain levels across various treatment phases using passive self‐ligating (Damon) and conventional (Victory) standardized fixed appliance systems. Materials and Methods: Adolescents (12–17 years old) with crowding and displaced teeth, planned for non‐extraction treatment, were recruited from four orthodontic clinics. They were randomized into stratified blocks (1:1 ratio) using concealed allocation to receive Damon Q™ (34 boys, 28 girls) or Victory™ (39 boys, 31 girls). Pain and analgesic intake were assessed on seven different occasions with validated self‐report questionnaires using a 10‐grade scale. Results: Of the 132 patients included, six were lost to follow up. Clinically relevant mean pain scores (≥4) were registered in both groups after bonding upper and lower arches and after insertion of 0.019 × 0.025 stainless steel archwire. The highest mean scores were reported on day two after bonding the upper arch (Damon 5.96, Victory 7.18, P =.011). In both groups, at least 40% reported taking analgesics during various treatment phases. The Damon group reported a lower intake of analgesics on days one and two (P =.042 and.037) after treatment initiation. In the entire sample, boys reported significantly higher mean pain scores than girls on the second and third days after bonding (P =.008 and.026, respectively). Conclusions: Lower pain levels were reported from the Damon group after bonding. In general, boys reported higher pain than girls did. Clinicians and adolescents need to be aware that clinically relevant pain levels can be expected not only after bonding but also in later phases. [ABSTRACT FROM AUTHOR]

Introduction: Growth hormone deficiency occurs when the pituitary gland does not produce enough growth hormone. Norditropin®, a recombinant human growth hormone, and Sogroya®, an albumin-binding growth hormone derivative, are prescribed for patients with growth hormone deficiency. This systematic review assesses the efficacy, safety, and patient satisfaction associated with Norditropin and Sogroya. Methods: We systematically searched PubMed, Web of Science, and Scopus databases to identify eligible comparative studies. All studies published until June 2023 were included in our analysis. Our outcomes for children included height velocity and height velocity standard deviation score. In contrast, adult outcomes included adverse events, insulin-like growth factor 1-standard deviation score (IGF-1 SDS), and the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Results are reported as odds ratio (OR) and mean difference (MD) with a 95% confidence interval (95% CI). Results: Ten studies involving 1058 participants (665 children and 393 adults) were included in the meta-analysis. In children, Norditropin at doses of 0.034 and 0.067 mg/kg/day was compared to Sogroya at doses of 0.04, 0.08, 0.16, and 0.24 mg/kg/week. The results showed that 0.034 mg/kg/day Norditropin had a favorable impact on height velocity (MD −2.01, 95% CI −3.7 to −2.12, p < 0.00001) and height velocity standard deviation score (Mean Difference −3.61, 95% CI −5.06 to −2.16, p < 0.00001) when compared to Sogroya 0.04 mg/kg/day. Other doses showed comparable results. In adults, the only significant side effect noted was rash, which favored Sogroya (OR 0.1, 95% CI 0.04–0.27, p < 0.00001). Additionally, IGF-1 SDS was significantly higher in the Sogroya group than in the Norditropin group (MD 0.25, 95% CI 0.02–0.48, p = 0.03). Furthermore, the overall score of the TSQM-9 questionnaire, which includes three domains: convenience, effectiveness, and satisfaction, was significantly higher in the Sogroya group compared to the Norditropin group (OR 6.36, 95% CI 3.92–8.8, p < 0.00001). Conclusion: Norditropin and Sogroya showed comparable efficacy and safety profiles, except for the prevalence of rash in the Norditropin group, and Sogroya has higher satisfaction among adults. More high-quality studies with more patients are required to confirm these results. [ABSTRACT FROM AUTHOR]

Abstract Background Within England, children and young people entering police custody are referred to Liaison and Diversion (L&D) teams. These teams liaise with healthcare and other support services aiming to divert children and young people away from the criminal justice system. Although targeted psychological interventions are not typically offered to children and young people by L&D teams, evidence suggests that Solution Focused Brief Therapy (SFBT) leads to a reduction in internalising and externalising behaviour problems. Methods A two-arm individually randomised controlled trial (RCT) with internal pilot and process evaluation will be conducted with approximately 448 children and young people aged 10–17 years presenting at police custody suites who are referred to the L&D team or recruited via online routes if they have previously presented at any police custody suite in England. The primary outcome is the Self-Report Delinquency Measure (SRDM) at 6 months post-randomisation. Analyses will be performed using intention-to-treat. Results The statistical analysis plan (SAP) for the trial is described. The plan details of analyses to be undertaken which will be reported in the primary and any secondary publications. The plan was developed and published prior to locking our database and unblinding to treatment allocation. Discussion This RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites including testing of moderating factors and sensitivity of the primary analyses. Trial registration ClinicalTrials.gov ISRCTN14195235. Registered on June 16, 2023.

Background: Nail psoriasis remains a challenging condition with limited satisfaction from current treatments. An increasing number of neuropeptides were reported in psoriatic tissue. Objective: To compare the efficacy of botulinum toxin A (BoNT-A) injection, triamcinolone acetonide (TA) injection, topical combination of vitamin D/steroid (VitD/steroid) and placebo in improving nail psoriasis. Methods: A 24-week randomized intraindividual comparative-controlled study involved participants with at least 4 psoriatic fingernails, each with a total target nail psoriasis severity index (NAPSI) score of at least 3 points. Nails were randomly received different treatments; intralesional BoNT-A injection at baseline, intralesional TA at baseline and eighth week, daily topical VitD/steroid application for 16 weeks and placebo. Results: Evaluation of 64 psoriatic fingernails showed a 40% reduction in the total target NAPSI score at 24 weeks following BoNT-A injection (P = .001). BoNT-A significantly improved nail bed lesions more than TA and topical VitD/steroid (P = .038), with no reported serious adverse effects. Limitations: Relatively small sample size; hand hygiene during the COVID-19 pandemic may interfere NAPSI score evaluation. Conclusions: BoNT-A injection emerges as a promising and effective therapy for nail psoriasis, providing sustained efficacy lasting up to 6 months with a single injection.

Abstract Background Domestic violence during pregnancy is especially concerning due to its significant detrimental impact on a woman’s health and that of her unborn child. The study aims to evaluate the effects of a behavioural intervention package (BIP) delivered during pregnancy on the quality of life (QOL), domestic violence (DV), and reproductive and child health (RCH) of women experiencing DV. Methods A randomised controlled trial was conducted on 211 pregnant women recruited between 18 and 20 weeks of pregnancy and randomly assigned to one of two groups: intervention (n = 105) or control (n = 106). The intervention group received BIP and standard care, while the control group received only standard care for 28 weeks. Study tools included socio-demographic variables, a short-form health survey, an abuse assessment screening tool, and an RCH checklist. The tools were completed once before the intervention and again at 6 weeks postnatal. The tools and their subscales were compared pre- and post-intervention using a paired t-test, or Wilcoxon signed test as appropriate to estimate the effect size at baseline and post-intervention. Results Post-intervention, the QOL scores were found to be significant, with a positive effect favouring the intervention as compared to the control group. The BIP intervention, which was found to be significantly effective (P ≤ 0.001) in reducing DV for pregnant women experiencing DV, was higher in the intervention group than in the control group. Conclusion The BIP may be an appropriate method for treating pregnant women experiencing DV from low socioeconomic strata who attend public hospitals in India to improve their QOL. The approach may offer an intervention that healthcare institutions or other organizations in contact with women at risk of violence can implement. Trial registration Indian Registry of Clinical Trials CTRI/2019/01/017009. Registered on 09/01/2019.

To evaluate the effects of different interventions on adolescent internet addiction, a meta-analysis and network meta-analysis were performed to determine the possible intervention effects of these interventions. Computer searches of the China National Knowledge Network, Wanfang, VIP, EMBASE, PubMed, Web of Science, EBSCO, and Cochrane Library databases were performed. The relevant randomized controlled trials were designed to assess the effects of interventions on adolescent internet addiction. The retrieval period ranged from the establishment of the database to January 31, 2024. Literature screening, data extraction, and bias risk assessment were carried out independently by two researchers. CMA 3.3, Stata 17.0 software and Review Manager 5.3 were used for the data analysis. A total of 89 studies with 6876 samples were included. A traditional meta-analysis of 51 single interventions and controlled studies revealed that sports intervention, cognitive behavior therapy, family therapy, mindfulness intervention, attention bias training and group counseling significantly improved adolescent Internet addiction [standardized mean difference (SMD) = −1.75, 95 % CI (−2.07, −1.44), p < 0.01; I2 = 94 %] compared to no-treatment groups. A network meta-analysis showed that combined intervention (Sucra = 93.5) had the highest probability of being the best intervention for adolescent Internet addiction, and acupuncture interventions showed the most promise as a single intervention modality; however, due to the limited number of studies, we believe that sports intervention could be the most appropriate single intervention. The evidence provided by existing studies shows that compared with other single interventions, combined interventions have the greatest effect on adolescent IA, and sports may be the best single intervention. However, because of the limitations of sample size and quality of individual studies, the strength of the evidence still needs to be further verified by additional standardized and high-quality studies. • To evaluate the effects of different interventions on adolescent Internet addiction, and to rank their possible intervention effects. • A total of 89 RCTs with 6876 samples were included. • Combined intervention had the highest probability of being the best intervention for adolescent Internet addiction, and sports intervention could be the most appropriate single intervention. [ABSTRACT FROM AUTHOR]

In this study, we investigated the outcome of goal attainment in individual and group-based neuropsychological intervention for young adults with dyslexia. Participants (N = 120) were randomly assigned to individual intervention, group intervention, or wait-list control group. Attainment of goals set personally before the intervention was evaluated after the intervention using Goal Attainment Scaling. The participants were asked to report the number of concrete changes made in their study or working habits at five months (after intervention or wait-list control time), at ten months, and 15 months post-interventions. Potential predictive factors for predicting goal attainment were evaluated including background and cognitive variables, self-reported psychological variables (mood, cognitive and behavioral strategies, self-esteem, quality of life), and self-reported behavioral variables (concrete changes made, time used to work on intervention matters). Based on the results, personal goals were, on average, met especially in individual intervention. Nearly 50% of goal attainment was explained by intervention type, behavioral and cognitive strategies, concrete changes made, cognitive capacity, and used time. Concrete changes, e.g., adopting new strategies and methods in study or working habits, were reported in both interventions and more than during the wait-list control period. The changes seemed long-lasting as fifteen months post-intervention, 76.4% reported still using the learned strategies. A structured and relatively short neuropsychological intervention for dyslexia in either individual or group format can lead to attaining pre-set personal goals and positive behavioral changes that can last up to over a year post-intervention. [ABSTRACT FROM AUTHOR]

Background: Insomnia is a prevalent health concern in the general population associated with a range of adverse health effects. New, effective, safe and low-cost treatments, suitable for long-term use, are urgently required. Previous studies have shown the potential of electrical vestibular nerve stimulation (VeNS) in improving insomnia symptoms, however only one sham-controlled trial has been conducted on people with chronic insomnia. Objectives/Hypothesis: Repeated VeNS delivered by the Modius Sleep device prior to sleep onset will show superior improvement in Insomnia Severity Index (ISI) scores over a 4-week period compared to sham stimulation. Methods: In this double-blinded, multi-site, randomised, sham-controlled study, 147 participants with moderate to severe insomnia (ISI≥15) were recruited and allocated a VeNS or a sham device (1:1 ratio) which they were asked to use at home for 30 min daily (minimum 5 days per week) for 4 weeks. Results: After 4 weeks, mean ISI score reduction was 2.26 greater in the VeNS treatment group than the sham group (p = 0.002). In the per protocol analysis, the treatment group had a mean ISI score decrease of 5.8 (95 % CI [-6.8, −4.81], approaching the clinically meaningful threshold of a 6-point reduction, with over half achieving a clinically significant decrease. Furthermore, the treatment group showed superior improvement to the sham group in the SF-36 (Quality of Life) energy/fatigue component (PP p = 0.004, effect size 0.26; ITT p = 0.006, effect size 0.22). Conclusions: Modius sleep has the potential to provide a viable, non-invasive and safe clinically meaningful alternative treatment option for insomnia.

Abstract Background Self-harm is a prevalent behaviour that has a major detrimental impact on a person’s life. Psychological therapies have the potential to help, but evidence of effective interventions remains limited. Access and acceptability of interventions can also be a significant challenge, with individuals either being unable to access help or having to endure long waiting lists. Cognitive analytic therapy (CAT) is a time-limited and relationally-focused psychotherapy that may provide a valuable treatment option for people who self-harm. This protocol outlines the methodology for the first feasibility randomised controlled trial (RCT) of CAT for adults that self-harm. The trial will aim to determine the feasibility, acceptability and safety of undertaking larger-scale evaluations of CAT for self-harm within an RCT context. Method An RCT design with 1:1 allocation to CAT plus treatment as usual (TAU) or TAU alone. Participants will be adult outpatients with three or more instances of self-harm in the past year (target sample of n = 60). CAT will be 8 one-to-one weekly 60-min sessions plus a follow-up session up to 8 weeks after the last session. Assessments will occur at baseline, 12 weeks and 18 weeks after randomisation. Qualitative interviews with participants will gain insights into the feasibility and acceptability of CAT. Feasibility outcomes will be judged against progression criteria. Discussion CAT may be an effective and accessible treatment option for people who self-harm, providing a more relationally orientated alternative to more behavioural therapies. The proposed feasibility RCT is an important first step in evaluating CAT as a treatment for self-harm. Trial registration The trial was pre-registered (21/10/22) on ISR CTN (ISRCTN code: ISRCTN75661422).

Abstract Background Disease-related malnutrition affects a significant number of patients with cancer and poses a major social problem worldwide. Despite both global and national guidelines to prevent and treat malnutrition, the prevalence is high, ranging from 20 to 70% in all patients with cancer. This study aimed to explore the current practice of nutritional support for patients with cancer at a large university hospital in Norway and to explore potential barriers and facilitators of the intervention in the Green Approach to Improved Nutritional support for patients with cancer (GAIN), prior to implementation in a clinical setting. Methods The study used individual interviews and a focus group discussion to collect data. Study participants included different healthcare professionals and patients with cancer treated at a nutrition outpatient clinic. The Consolidated Framework for Implementation Research (CFIR) was used to guide the thematic data analysis. Results Barriers connected to the current nutritional support were limited resources and undefined roles concerning responsibility for providing nutritional support among healthcare professionals. Facilitators included a desire for change regarding the current nutritional practice. The GAIN intervention was perceived as feasible for patients and healthcare professionals. Potential barriers included limited knowledge of technology, lack of motivation among patients, and a potential added burden experienced by the participating patients. Conclusions The identification of the potential barriers and facilitators of the current nutritional support to patients with cancer will be used to plan the implementation of improved nutritional support in a randomized controlled trial for patients with cancer prior to clinical implementation. The current findings may be of value to others trying to implement either or both nutritional support and digital application tools in a clinical healthcare setting. Trial registration The study was registered in the National Institutes of Health Clinical trials 08/09/22. The identification code is NCT05544318.

Abstract Background Stress during pregnancy can lead to adverse maternal and infant health outcomes through epigenetic changes in the hypothalamic–pituitary–adrenal axis. Among farmers in low-income countries, one important stressor is food insecurity, which can be reduced using hermetic storage bags. This study aimed to determine, for the first time, whether a hermetic storage bag intervention during pregnancy positively affects maternal and infant DNA methylation of the hypothalamic–pituitary–adrenal axis-related genes FKBP5 and NR3C1. We further analyzed whether anthropometrics, stress, and mental health were associated with DNA methylation. Methods This study was part of a larger matched-pair randomized controlled trial focusing on the impact of improved on-farm storage on food security, poverty, and net income of smallholder farming households. A total of N = 149 mothers were recruited by telephone and invited to attend a study appointment at health facilities in Kakamega County, Western Kenya, with their infants in April or May 2021. During the appointment, anthropometric measurements were taken, questionnaires on stress and mental health were administered, and saliva samples were collected. Logistic and multiple linear regression were used to examine the effect of the intervention and related measures on DNA methylation. Results Mothers in the intervention group showed higher mean NR3C1 methylation levels than those in the control group, corrected for multiple testing. Maternal postpartum body mass index was positively associated with infant NR3C1 CpG3 DNA methylation. The more stressful life events a mother had experienced in the previous 12 months (including during pregnancy), the lower her FKBP5 CpG3 methylation levels. Conclusions Food insecurity and stressful life events during pregnancy seem to exert significant effects on maternal DNA methylation. While these stressors did not appear to impact infant DNA methylation in the present study, maternal postpartum body mass index was significantly related to infant methylation. These findings suggest that while infants may be protected from excessive maternal glucocorticoids by placental barrier activity, maternal metabolic status is still reflected in their epigenetic make-up. Trial registration This study was part of a larger matched-pair randomized controlled trial on the impact of improved on-farm crop storage on welfare, nutrition, and human health. Registration can be found in the American Economic Association (AEA) RCT Registry, RCT ID: AEARCTR-0005845.

Abstract Background Morbid obesity is a complex chronic condition characterized by a body mass index of 40 kg/m2 or higher. The incidence of the condition is on the rise in developed countries, and bariatric surgery has been proposed as a potential solution to address this trend. Nonetheless, bariatric surgery may also result in adverse effects, including a reduction in bone mineral density (BMD) and muscle mass, as well as an increased risk of fractures. The present study aims to elucidate the effects of bariatric surgery and whole-body vibration (WBV) training on body composition, microbiota, physical fitness, quality of life, and cardiometabolic markers. Methods Twenty-eight participants (14 females), aged 18 to 50 years, will undergo sleeve gastrectomy surgery. They will be randomly allocated into a control group or a WBV training group. The WBV group will train three times per week with increasing intensities and duration ranging from 30 to 45 min over the 4-month training period. Measurements of body composition (dual-energy X-ray absorptiometry and peripheral quantitative computed tomography), physical fitness (muscular strength, agility, cardiorespiratory fitness, and balance), gait biomechanics, cardiometabolic markers, gut microbiota, quality of life, and physical activity levels will be collected at four different time points: (1) prior to the surgery, (2) 45 days post-surgery, (3) 6 months post-surgery, and (4) 18 months post-surgery. Discussion Both groups are expected to experience improvements in most of the aforementioned variables. Nonetheless, we expect the WBV group to show larger improvements proving that the training is effective and safe. Trial registration Clinicaltrials.gov NCT05695599. Registered on January 25, 2023.

Abstract Introduction Parents of children with a neurodevelopmental disorder (NDD) experience more stress than parents of typically developing children. In a cocreation process with experts and parents, a low-threshold application that uses exercises based on the principles of positive psychology and mindfulness was developed. This application, called “Adappt,” aims at enhancing the ability to adapt of the parents and caregivers of children with NDDs and at supporting their mental health. This protocol describes the evaluation study of the effectiveness of Adappt, its core working mechanisms and user experiences. Method A pragmatic international multicenter randomized controlled trial will compare the effectiveness of Adappt with a (delayed) waitlist control condition. At least 212 parents or primary caregivers of children younger than 18 years diagnosed with or suspected of a NDD will be randomly assigned to the intervention or waitlist control condition. Participants are excluded if they have severe anxiety or depression levels or are in treatment for mental health issues. Measures will be collected online at baseline, post-intervention (1 month after baseline), and 4 and 7 months after baseline. The primary outcome is the improvement in generic sense of ability to adapt as measured with the Generic Sense of Ability to Adapt Scale (GSAAS; (Front Psychol 14:985408, 2023)) at 4-month follow-up. Secondary outcomes are mental well-being, (parental) distress, and client satisfaction with “Adappt.” Discussion Results of this study will contribute to knowledge on the effectiveness of a low-threshold application for parents of children with a NDD in multiple countries. If the application is found to be effective in improving mental health, recommendations will be made for implementation in health care. Trial registration This study is registered on clinicaltrials.gov (NCT06248762) on February 8, 2024, and the Open Science Framework ( https://osf.io/5znqv ).

Abstract Background Worldwide, up to 20 % of hospitalised patients have diabetes mellitus. In-hospital dysglycaemia increases patient mortality, morbidity, and length of hospital stay. Improved in-hospital diabetes management strategies are needed. The DIATEC trial investigates the effects of an in-hospital diabetes team and operational insulin titration algorithms based on either continuous glucose monitoring (CGM) data or standard point-of-care (POC) glucose testing. Methods This is a two-armed, two-site, prospective randomised open-label blinded endpoint (PROBE) trial. We recruit non-critically ill hospitalised general medical and orthopaedic patients with type 2 diabetes treated with basal, prandial, and correctional insulin (N = 166). In both arms, patients are monitored by POC glucose testing and diabetes management is done by ward nurses guided by in-hospital diabetes teams. In one of the arms, patients are monitored in addition to POC glucose testing by telemetric CGM viewed by the in-hospital diabetes teams only. The in-hospital diabetes teams have operational algorithms to titrate insulin in both arms. Outcomes are in-hospital glycaemic and clinical outcomes. Discussion The DIATEC trial will show the glycaemic and clinical effects of in-hospital CGM handled by in-hospital diabetes teams with access to operational insulin titration algorithms in non-critically ill patients with type 2 diabetes. The DIATEC trial seeks to identify which hospitalised patients will benefit from CGM and in-hospital diabetes teams compared to POC glucose testing. This is essential information to optimise the use of healthcare resources before broadly implementing in-hospital CGM and diabetes teams. Trial registration Prospectively registered at ClinicalTrials.gov with identification number NCT05803473 on March 27th 2023.

Ting-Yu Lin, Hao-Chien Cheng, Hung-Wen Liu, Tsung-Min Hung Department of Physical Education and Sport Sciences, National Taiwan Normal University, Taipei, TaiwanCorrespondence: Tsung-Min Hung, Institute for Research Excellence in Learning Sciences, National Taiwan Normal University, 162, Section 1, Heping E. Road, Taipei City, 106, Taiwan, Tel/Fax +886-2-7749-1111, Email ernesthungkimo@yahoo.com.twObjective: Given the recognized benefits of resistance exercise on both physical and cognitive domains, elucidating how to maximize its benefit is pivotal. This study aims to evaluate these effects in terms of their timing and intensity on cognitive performance.Methods: This was a four-arm, crossover randomized controlled trial. Healthy college-aged male adults with recreational resistance training experience participated in this study. Participants completed three separate sessions of circuit barbell resistance exercises, including back squat, press, and deadlift. Each session corresponded to a different intensity level: 65% 1RM, 72% 1RM, and 78% 1RM. Each session consisted of 5 repetitions across 3 sets, with a 3-minute rest between exercises and sets. For the control condition, participants engaged in a reading activity for the same duration. The subjective exercise intensity was measured using the rating of perceived exertion and repetitions in reserve immediately after each set. The primary outcome was the temporal effect of acute resistance exercise on inhibition, measured by the Stroop color-word task. The secondary outcome was the effect of different intensities.Results: 30 out of 31 recruited participants were randomized, with 28 completing all experiment sessions. Using repeated measures correlation (rrm), a linear temporal effect was observed on accuracy-adjusted congruent reaction time: rrm = 0.114, p = 0.045, 95% CI [0.002, 0.223]. Participants responded 19.1 ms faster than the control condition approximately 10 minutes post-intervention. This advantage, however, gradually declined at a rate of 4.3 ms every 15 minutes between 10– 55 minutes post-intervention. In contrast, no significant effects were detected for incongruent trials or the Stroop effect. When examining the linear relationship across exercise intensities, no significant correlations emerged for congruent trials.Conclusion: Resistance exercise demonstrates a temporal effect on cognitive performance, particularly in reaction speed for congruent trials, without significant changes in incongruent trials or the overall Stroop effect. The findings highlight the importance of timing in leveraging the cognitive benefits of acute resistance exercise, suggesting a window of enhanced cognitive performance following exercise. However, this study has a limitation regarding Type I error inflation, due to multiple measurements of cognitive performance being undertaken, suggesting caution in interpreting the observed temporal effects. Practically, scheduling crucial, cognitively demanding tasks within 10– 60 minutes post-exercise may maximize benefits, as positive effects diminish after this period.Keywords: executive function, physical exercise, resistance training, cognition, RCT

Purpose: Exergames are an innovative method that can promote neuroplasticity and improve the cognitive abilities of the elderly. This study aimed to compare the effects of single-task and multi-task exergames on the cognitive ability of the elderly with mild cognitive impairment (MCI). Methods: Computerized literature search was performed using PubMed, Web of Science, EBSCO, Elsevier, ProQuest, China National Knowledge Infrastructure (CNKI), Wanfang and VIP database to identify relevant articles from the establishment of the database from inception to April 1, 2024. The inclusion criteria were: (i) participants aged 60 or older diagnosed with mild cognitive impairment, regardless of gender; (ii) use of randomized controlled trials (RCTs); (iii) interventions involving exergames with physical activity or as the primary variable; and (iv) outcome measures using standardized neuropsychological instruments to assess cognitive function, including statistical data on sample size, mean, and standard deviation. Finally, the included study comprised a total of 526 participants. Mean difference (MD) and 95% confidence interval (CI) were used to synthesize the effect size in the data. Results: 11 studies were included. Due to the differences in the intervention methods, subgroup analysis was performed on the included research. Compared with the control group assessed by the Montreal Cognitive Assessment Scale, the single-task intervention improved the cognitive ability of the elderly with MCI (MD 3.40, 95% CI 2.43-4.37), the Mini-Mental State Examination Scale (MD 2.38, 95% CI μ2.03 to 2.72), the Trail Making Test (MD μ3.89, 95% CI â6.45 to â1.33), and the Digit Span Forward test (MD 1.16, 95% CI 0.73-1.60). Conclusion: This meta-analysis supports that exergames could be an effective cognitive rehabilitation method for MCI patients. Our study recommends that patients implement a customized exergames program and adhere to it for a long time. It is necessary to pay attention to the exercise guidelines and provide evidence from clinicians. [ABSTRACT FROM AUTHOR]

Background: Self-harm is a prevalent behaviour that has a major detrimental impact on a person's life. Psychological therapies have the potential to help, but evidence of effective interventions remains limited. Access and acceptability of interventions can also be a significant challenge, with individuals either being unable to access help or having to endure long waiting lists. Cognitive analytic therapy (CAT) is a time-limited and relationally-focused psychotherapy that may provide a valuable treatment option for people who self-harm. This protocol outlines the methodology for the first feasibility randomised controlled trial (RCT) of CAT for adults that self-harm. The trial will aim to determine the feasibility, acceptability and safety of undertaking larger-scale evaluations of CAT for self-harm within an RCT context. Method: An RCT design with 1:1 allocation to CAT plus treatment as usual (TAU) or TAU alone. Participants will be adult outpatients with three or more instances of self-harm in the past year (target sample of n = 60). CAT will be 8 one-to-one weekly 60-min sessions plus a follow-up session up to 8 weeks after the last session. Assessments will occur at baseline, 12 weeks and 18 weeks after randomisation. Qualitative interviews with participants will gain insights into the feasibility and acceptability of CAT. Feasibility outcomes will be judged against progression criteria. Discussion: CAT may be an effective and accessible treatment option for people who self-harm, providing a more relationally orientated alternative to more behavioural therapies. The proposed feasibility RCT is an important first step in evaluating CAT as a treatment for self-harm. Trial registration: The trial was pre-registered (21/10/22) on ISR CTN (ISRCTN code: ISRCTN75661422). [ABSTRACT FROM AUTHOR]

Background: Immunocompromised hosts (ICH) experience more breakthrough infections and worse clinical outcomes following infection with COVID-19 than immunocompetent people. Prophylactic monoclonal antibody therapies can be challenging to access, and escape variants emerge rapidly. Immunity conferred through vaccination remains a central prevention strategy for COVID-19. COVID-19 vaccines do not elicit optimal immunity in ICH but boosting, through additional doses of vaccine improves humoral and cellular immune responses. This trial aims to assess the immunogenicity and safety of different COVID-19 vaccine booster strategies against SARS-CoV-2 for ICH in Australia. Methods: Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC) is an adaptive randomised trial of one or two additional doses of COVID-19 vaccines 3 months apart in people living with HIV, solid organ transplant (SOT) recipients, or those who have haematological malignancies (chronic lymphocytic leukaemia, non-Hodgkin lymphoma or multiple myeloma). Key eligibility criteria include having received 3 to 7 doses of Australian Therapeutic Goods Administration (TGA)-approved COVID-19 vaccines at least 3 months earlier, and having not received SARS-CoV-2-specific monoclonal antibodies in the 3 months prior to receiving the study vaccine. The primary outcome is the geometric mean concentration of anti-spike SARS-CoV-2 immunoglobulin G (IgG) 28 days after the final dose of the study vaccine. Key secondary outcomes include anti-spike SARS-CoV-2 IgG titres and the proportion of people seroconverting 6 and 12 months after study vaccines, local and systemic reactions in the 7 days after vaccination, adverse events of special interest, COVID-19 infection, mortality and quality of life. Discussion: This study will enhance the understanding of COVID-19 vaccine responses in ICH, and enable the development of safe, and optimised vaccine schedules in people with HIV, SOT, or haematological malignancy. Trial registration: ClinicalTrials.gov NCT05556720. Registered on 23rd August 2022. [ABSTRACT FROM AUTHOR]

Background: Fibromyalgia syndrome (FMs) is a chronic condition characterized by widespread musculoskeletal pain and a range of complex symptoms, with chronic fatigue being a central feature significantly impacting daily life. The aim of this study was to analyze the secondary outcomes, specifically those related to perceived energy and fatigue symptoms in a randomized controlled trial (RCT) assessing the efficacy of heart rate variability biofeedback (HRV-BF) as an adjunctive treatment for FMs. Methods: Sixty-four FMs patients were randomly assigned to either receive 10 HRV-BF training sessions alongside standard pharmacological therapy (experimental group) or standard therapy alone for 10 weeks (control group). For this secondary analysis, potential improvements in specific items were evaluated regarding perceived energy (Item 10 of the Short-Form Health Survey), the ability to walk and climb stairs (Item 7 and Item 11 of the Fibromyalgia Impact Questionnaire, respectively), and the impact of pain on movement ability (Item 17 of the Bodily and Emotional Perception of Pain). Results: The experimental group demonstrated an improvement in the perception of energy, the ability to walk, and the impact of pain on movement ability. However, the same improvement was not observed in the ability to climb stairs. Conclusions: Fatigue assessment has emerged as a crucial factor for evaluating treatment efficacy in FMs and related conditions linked to altered energy levels, such as bipolar depression, and can offer valuable insights for precisely guiding HRV-BF treatments. ClinicalTrials.gov with code: NCT04121832. [ABSTRACT FROM AUTHOR]