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The effectiveness of universal, school-based interventions in preventing the emergence, maintenance, or escalation of behavioral difficulties in children and adolescents is supported by a growing body of research. Nevertheless, this understanding is somewhat limited to "what works" assessments, leaving aside fundamental questions on relevant underlying mechanisms that make an intervention effective under specific circumstances, for some groups, or even at certain times. Using data from the cluster randomized controlled trial of the Good Behavior Game in England, involving 3,084 children in 77 schools, we showcase the latent adherence growth curve model, a multilevel structural equation modeling approach that takes account simultaneously of intervention compliance, subgroup moderator effects, change over time, and higher-level data structures. This statistical framework allowed a more nuanced view of the effects of the Good Behavior Game on the long-term developmental trajectories of disruptive behavior among male and female students. Our approach enabled us to ascertain the effect of child- and school-level covariates on intervention compliance and change in disruptive behavior over time, as well as the effects of both compliance and noncompliance on outcomes. In doing so, we found evidence of positive effects (reduction of disruptive behavior) on female compliers, but also iatrogenic effects among male noncompliers (increased disruptive behavior). We discuss the implications of our approach and findings for further research and practice. Educational Impact and Implications Statement: Analyzing compliance can be as important as noncompliance to understand why interventions in schools may or may not work. We illustrated how to implement a statistical approach that addresses the challenges of understanding why, how, when, and for whom interventions work, by simultaneously addressing longitudinal outcomes, multilevel structures, and unobserved compliance groups. We found not only that compliance with the Good Behavior Game had a positive effect on female pupils' disruptive behavior, but also that noncompliance had an unintended negative effect on male pupils. [ABSTRACT FROM AUTHOR]

Measurement-based care (MBC), which collects session-by-session symptom data from patients and provides clinicians with feedback on treatment response, is a highly generalizable evidence-based practice with significant potential to improve the outcomes of mental health treatment in youth when implemented with fidelity; however, it is rarely used in community settings. This study tested whether an implementation strategy targeting organizational leadership and organizational implementation climate could improve MBC fidelity and clinical outcomes for youth in outpatient mental health clinics. In a cluster randomized trial, 21 clinics were assigned to the Leadership and Organizational Change for Implementation strategy plus training and technical assistance in MBC (k = 11, n = 117) or training and technical assistance only (k = 10, n = 117). Primary outcomes of MBC fidelity (assessed via electronic metadata) and youth symptom improvement (assessed via caregiver-reported change on the Shortform Assessment for Children Total Problem Score) were collected for consecutively enrolled youths (ages 4-18 years) who initiated treatment in the 12 months following MBC training. Outcomes of each youth were assessed for 6 months following baseline. A total of 234 youths were enrolled and included in intent-to-treat analyses. At baseline, there were no significant differences by condition in clinic, clinician, or youth characteristics. Youths in clinics using the Leadership and Organizational Change for Implementation strategy experienced significantly higher MBC fidelity compared with youths in control clinics (23.1% vs 3.4%, p =.014), and exhibited significantly greater reductions in symptoms from baseline to 6 months (d = 0.31, 95% CI: 0.04-0.58, p =.023). Implementation strategies targeting organizational leadership and focused implementation climate can improve fidelity to evidence-based practices and clinical outcomes of youth mental health services. Measurement-based care is an evidence-based intervention that has been shown to improve the outcomes of mental health services in dozens of randomized trials; however, it is not widely used in routine practice. In this randomized controlled trial of 21 outpatient mental health clinics and 234 youth, the authors found an organizational intervention which trained clinic leaders in skills to support the use of measurement-based care increased the extent to which patients received measurement-based care compared to control clinics where clinic leaders did not receive this training (23% vs. 3%). Youth receiving services in the clinics that received the organizational intervention also had greater reductions in mental health symptoms. Working to Implement and Sustain Digital Outcome Measures (WISDOM); https://clinicaltrials.gov/ ; NCT04096274. [ABSTRACT FROM AUTHOR]

Background: Opioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips can identify fentanyl and some fentanyl analogs in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. Fentanyl test strips are a promising harm reduction strategy; however, little is known about the real-world acceptability and impact of fentanyl test strip use. This study investigates fentanyl test strip distribution and education as a harm reduction strategy to prevent overdoses among people who use drugs. Methods: The research team will recruit 2400 individuals ≥ 18 years with self-reported use of illicit drugs or drugs purchased on the street within the past 6 months. Recruitment will occur at opioid overdose education and naloxone distribution programs in 16 urban and 12 rural Ohio counties. Participating sites will be randomized at the county level to the intervention or non-intervention study arm. A brief fentanyl test strip educational intervention and fentanyl test strips will be provided to participants recruited from sites in the intervention arm. These participants will be eligible to receive additional fentanyl test strips for 2 years post-enrollment. Participants recruited from sites in the non-intervention arm will not receive fentanyl test strip education or fentanyl test strips. All participants will be followed for 2 years post-enrollment using biweekly, quarterly, and 6-month surveys. Primary outcomes include (1) identification of perceived barriers and facilitating factors associated with incorporating fentanyl test strip education and distribution into opioid overdose education and naloxone distribution programs; (2) differences in knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for reducing overdose risk between the intervention and non-intervention groups; and (3) differences in non-fatal and fatal overdose rates between the intervention and non-intervention groups. Discussion: Findings from this cluster randomized controlled trial will contribute valuable information about the feasibility, acceptability, and impact of integrating fentanyl test strip drug checking in rural and urban communities in Ohio and help guide future overdose prevention interventions. Trial registration: ClinicalTrials.gov NCT05463341. Registered on July 19, 2022. https://clinicaltrials.gov/study/NCT05463341 [ABSTRACT FROM AUTHOR]

Background: Opioids kill more people than any other class of drug. Naloxone is an opioid antagonist which can be distributed in kits for peer administration. We assessed the feasibility of implementing a Take-home Naloxone (THN) intervention in emergency settings, as part of designing a definitive randomised controlled trial (RCT). Methods: We undertook a clustered RCT on sites pairing UK Emergency Departments (ED) and ambulance services. At intervention sites, we recruited emergency healthcare practitioners to supply THN to patients presenting with opioid overdose or related condition, with recruitment across 2019–2021. We assessed feasibility of intervention implementation against four predetermined progression criteria covering site sign up and staff training; identification of eligible patients; issue of THN kits and Serious Adverse Events. Results: At two intervention sites, randomly selected from 4, 299/687 (43.5%) clinical staff were trained (ED1 = 107, AS1 = 121, ED2 = 25, AS2 = 46). Sixty THN kits were supplied to eligible patients (21.7%) (n: ED1 = 36, AS1 = 4, ED2 = 16, AS2 = 4). Across sites, kits were not issued to eligible patients on a further 164 occasions, with reasons reported including: staff forgot (n = 136), staff too busy (n = 15), and suspected intentional overdose (n = 3), no kit available (n = 2), already given by drugs nurse (n = 4), other (n = 4). Staff recorded 626 other patients as ineligible but considered for inclusion, with reasons listed as: patient admitted to hospital (n = 194), patient absconded (n = 161) already recruited (n = 64), uncooperative or abusive (n = 55), staff not trained (n = 43), reduced consciousness level (n = 41), lack of capacity (n = 35), patient in custody (n = 21), other (n = 12). No adverse events were reported. Conclusion: Staff and patient recruitment were low and varied widely by site. This feasibility study did not meet progression criteria; a fully powered RCT is not planned. Trial Registration: ISRCTN13232859 (Registered 16/02/2018). [ABSTRACT FROM AUTHOR]

[Display omitted] • The utility of two Letrozole regimens was compared to MTX in treating tubal EPs. • The MTX, 5-day, and 10-day Letrozole groups showed 76 %, 75 %, and 90 % success rates. • This suggests Letrozole as an effective, safer alternative to MTX in EP management. • Future research is needed to find the optimal Letrozole regimen for treating EP. To evaluate the efficacy of two different regimens of Letrozole, an aromatase inhibitor, in the management of ectopic pregnancy compared to methotrexate. This randomized controlled trial was conducted on 88 women diagnosed with ectopic pregnancy with a baseline level of serum beta-human chorionic gonadotropin under 3000 mIU/mL between June 30, 2023, and December 30, 2023, at the Department of Obstetrics and Gynecology of the Vali-e-Asr Hospital affiliated with Tehran University of Medical Sciences. Participants were allocated into either methotrexate (n = 43), 5-day course Letrozole (n = 24), or 10-day course Letrozole (n = 21) treatments. The methotrexate group received a single dose of 50 mg/m2 dosage intramuscular methotrexate. The 5-day Letrozole group received a 2.5 mg Letrozole tablet three times daily for 5 days, whereas the 10-day Letrozole group received a 2.5 mg Letrozole tablet twice daily for 10 days. The primary outcome was the treatment response, defined as the achievement of a negative serum beta-human chorionic level without the need for additional methotrexate treatment or surgery. The secondary outcomes were the need for additional methotrexate dose or laparoscopic surgery intervention. The trial protocol was prospectively registered in ClinicalTrials.gov with code NCT05918718. The treatment response rates in methotrexate, 5-day Letrozole, and 10-day Letrozole groups were 76.7 %, 75.0 %, and 90.5 %, respectively, with no significant differences between the groups (P-value = 0.358). A total of 10 (23.3 %) patients from the methotrexate group, 3 (12.5 %) from the 5-day Letrozole group, and 2 (9.5 %) from the 10-day Letrozole group required an additional methotrexate dose, with no significant differences between the groups (P-value = 0.307). Furthermore, only 3 (12.5 %) patients, all from the 5-day Letrozole group, were suspected of tubal rupture and underwent surgery (P-value = 0.016). Our findings suggest Letrozole as a safe alternative to methotrexate in treating stable ectopic pregnancies, with a favorable treatment response rate. However, there is still a need for future larger studies to determine the applicability of Letrozole in the EP management. Also, the non-significant higher effectiveness of the 10-day Letrozole regimen than the 5-day Letrozole group underscores the need for future research to determine the optimal Letrozole regimen for the management of ectopic pregnancy. [ABSTRACT FROM AUTHOR]

Context: At least 40% of cancers are linked to environmental or behavioral factors, and dietary behavior appears to be a major lever. Epidaure Market is a prevention initiative developed using a method for co-constructing health promotion initiatives and prevention programs that stratifies evidence from the scientific literature and combines it with experiential knowledge (DEVA, TPB, BCT). It promotes a sustainable diet (i.e., healthy, ecological and ethical nutrition) among 5th and 4th grade students during the crucial period of adolescence, when these behaviors are often far from the recommendations. Method: The protocol implemented was carried out in 72 middle school classes in the Montpellier and Dijon academies. The intervention included teaching sessions and a virtual supermarket game, integrated into the school curriculum and delivered by science teachers. Effectiveness is tested in a cluster randomized controlled trial with 3 evaluation times (pre- and post-intervention and 1 follow-up). The study also includes an implementation assessment, with process analysis and implementation elements, as well as a transferability assessment based on key functions (FIC model and Astaire grid). Expected outcomes: The study is still underway within the school. The primary expected outcome is a positive influence on the motives underlying food choices to move towards a sustainable diet. Secondary expectations involve changes in variables such as self-efficacy and perceived social norms, as well as an increase in knowledge about healthy eating. We also expect the qualitative approaches to provide information on the deployment process in the new territories. Discussion: The study aims not only to demonstrate the effectiveness of Epidaure Market, but also to identify the optimal conditions for its nationwide implementation in France's middle schools. Ultimately, the initiative aims to help reduce the incidence of cancer by promoting healthier eating habits among teenagers. [ABSTRACT FROM AUTHOR]

Introduction: Medications for opioid use disorders (MOUD) remain the gold standard for treating OUD, but treatment initiation and adherence remain challenging. Exclusive utilization of pharmacotherapy as a treatment modality for OUD is sub-optimal, and a combination of psychotherapies and pharmacotherapies is recommended. General trends indicate the benefits of peer mentoring and MBRP separately. Therefore, we hypothesize that the combined effect of MBRP and Peer mentoring will produce synergistic improvements in MOUD adherence compared to an enhanced twelve-step facilitation (TSF). Methods: This paper describes the methods and baseline characteristics of a multi-site randomized controlled trial evaluating the effectiveness of a combination of MBRP and peer support (MiMP) compared to an enhanced TSF in improving adherence to MOUD. Both MiMP and TSF are 12-week manualized protocols that utilize licensed therapists. The interventions are delivered in weekly group sessions that last about 75-90 minutes per session. The primary outcome is MOUD adherence. Secondary and exploratory outcomes include relapse, cravings, depression, anxiety, stress, quality of life, and pain catastrophizing. Results: The participants' ages ranged from 21 years to 77 years, with a mean age of 44.5 (SD ± 11.5 years). There was an almost equal distribution of gender and place of residence. Overall, 51.9% (n=54) of participants identified as female and 48.1% (n=50) were male. Similarly, 51.9% (n=54) of participants resided in urban areas, while 48.1% (n=50) resided in rural areas. Participants identified as either black or white, with over three-quarters identifying as white (77.9%, n= 81) and 22.1% (n= 23) as black. Most participants randomized to the 12-step facilitation group were white (93.1%). Relationships and employment status were well distributed between categories. Over half of the participants reported some college or higher education. Over 90% of the participants made less than $75,000 per year. Some participants indicated that they had both public and private health insurance. Discussion and conclusion: This study is innovative in several ways including combining MBRP and peer support, addressing comorbid mental health issues among individuals with OUD, utilizing manualized protocols, and evaluating of both physiological and self-reported measures in assessing cortisol reactivity as a predictor of relapse and treatment outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Community-based health interventions often demonstrate efficacy in clinical trial settings but fail to be implemented in the real-world. We sought to identify the key operational and contextual elements of the Los Angeles Barbershop Blood Pressure Study (LABBPS), an objectively successful community-based health intervention primed for real-world implementation. LABBPS was a cluster randomized control trial that paired the barbers of Black-owned barbershops with clinical pharmacists to manage uncontrolled hypertension in Black male patrons, demonstrating a substantial 21.6 mmHg reduction in systolic blood pressure. Despite this success, the LABBPS intervention has not expanded beyond the original clinical trial setting. The aim of this study was to determine the facilitating and limiting factors to expansion of the LABBPS intervention. Methods: We undertook a qualitative assessment of semi-structured interviews with study participants performed after trial completion. Interviews included a total of 31 participants including 20 (6%) of the 319 LABBPS program participants ("patrons"), 10 (19%) barbers, and one (50%) clinical pharmacist. The semi-structured interviews were focused on perceptions of the medical system, study intervention, and influence of social factors on health. Results: Several common themes emerged from thematic analysis of interview responses including: importance of care provided in a convenient and safe environment, individual responsibility for health and health-related behaviors, and engagement of trusted community members. In particular, patrons reported that receiving the intervention from their barber in a familiar environment positively influenced the formation of relationships with clinical pharmacists around shared efforts to improve medication adherence and healthy habits. All interviewee groups identified the trust diad, comprising the familiar environment and respected community member, as instrumental in increasing health-related behaviors to a degree not usually achieved by traditional healthcare providers. Discussion: In conclusion, participants of an objectively successful community-based intervention trial consistently identified key features that could facilitate wider implementation and efficacy: social trust relationships, soliciting insights of trust bearers, and consistent engagement in a familiar community setting. These findings can help to inform the design and operations of future community-based studies and programs aiming to achieve a broad and sustainable impact. [ABSTRACT FROM AUTHOR]

• An RCT was conducted for Chinese cross-boundary families. • Two arms, emotion regulation (ER) and information provision (IP), were delivered. • Both interventions increased parental self-efficacy. • Both interventions reduced children's problem behaviors. • A moderation effect on children's outcome was found in the IP intervention. Daily cross-boundary schooling between Shenzhen and Hong Kong constitutes a constant challenge for Chinese cross-boundary families in terms of parenting burden. To address their most urgent parenting needs, we adapted and evaluated two intervention approaches—improving emotional regulation and providing knowledge about Hong Kong. A cluster randomized controlled trial with repeated assessments (pre-, post-intervention, and one-month follow-up) was adopted to evaluate the intervention effects on the increases of parental resilience resources and reduction of children's problem behaviors. We further conducted moderation analyses to investigate whether parents with more increases in parental resilience resources would report a greater reduction in children's problem behaviors. A total of 214 mothers of cross-boundary families were randomly assigned to the emotional regulation arm (ER, n = 120) or the information provision arm (IP, n = 94). Both intervention arms showed positive effects on emotional regulation strategies, and the IP arm outperformed the ER arm in knowledge acquisition. Both arms showed significant and comparable improvements in parental self-efficacy and children's problem behaviors. Moreover, participants in the IP arm who reported more improvements in parental resilience resources showed a greater reduction in children's problem behaviors. By adapting two interventions to a new population of cross-boundary families, this trial extended the benefits from parents to children and demonstrated that the improvement of parental resilience resources makes a difference in reducing children's problem behaviors in the IP arm. Future studies are suggested to focus on parental resilience resources and maximize the benefits on children's outcomes. [ABSTRACT FROM AUTHOR]

Applying tension to a transcervical Foley balloon during cervical ripening did not significantly affect delivery times or other outcomes in labor induction among nulliparous women. OBJECTIVE: To investigate the effects of applying tension to a transcervical Foley balloon on delivery time in term nulliparous patients undergoing labor induction. METHODS: This cluster randomized clinical trial included 279 term nulliparous women presenting for labor induction with a plan for cervical ripening through transcervical Foley balloon placement. Participants were assigned to either the tension group (n=138) or the no-tension group (n=141) on the basis of randomized, weekly clusters (26 total clusters). The primary outcome measured was the time from initial Foley balloon insertion to delivery. Secondary outcomes included cesarean delivery rates, peripartum infection, and neonatal intensive care unit (NICU) admission. Our prior data suggested that delivery time in the tension group would be about 1,053 minutes. We estimated a sample size of 260 (130 per group, 26 clusters) on the basis of a 25% difference, power of 80%, and two-sided α of 0.05. RESULTS: A total of 279 term nulliparous patients were included in the analysis. The median time from Foley placement to delivery was 1,596 minutes (range 430–3,438 minutes) for the tension group and 1,621 minutes (range 488–3,323 minutes) for the no-tension group (P =.8); similar results were noted for time to vaginal delivery. No significant differences were observed in the secondary outcomes, including the rates of cesarean delivery (34.1% vs 29.8%, P =.7), peripartum infection, and NICU admission, between the two groups. CONCLUSION: Applying tension to a transcervical Foley balloon in term nulliparous women undergoing labor induction did not significantly reduce delivery time or improve secondary outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05404776. [ABSTRACT FROM AUTHOR]

High-intensity interval training is the gold standard for cardiac rehabilitation although current revascularization therapy focuses on the recovery of autonomic nervous system balance through heart rate variability (HRV). The main objective was to analyze the effect of HRV-guided training versus high-intensity interval training on cardiorespiratory fitness, heart rate variability, quality of life, and training volume at high intensity, as well as exercise adherence, safety, and feasibility in ischemic patients. This is an 8-week cluster randomized controlled trial with an HRV-based training group (HRV-G) and a traditional HIIT group (HIIT-G). Maximal oxygen consumption, heart rate, and blood pressure were measured during the Bruce protocol treadmill test. HRV was measured with the HRV4Training application, and quality of life with the MacNew QLMI. The repeated measures ANCOVA was used with the age and the baseline scores as covariables. Forty-six patients (mean age 55 ± 11.03 years) were randomized and assigned either to HRV-G (n = 23) or HIIT-G (n = 23). Both groups improved maximal oxygen consumption and METS (P >.05). However, the resting systolic blood pressure was lower in HRV-G (4.3 ± 1.2 mmHg, P =.05). In HRV-G, the resting diastolic, maximal diastolic, and systolic blood pressure decreased (5.4 ± 5.96 mmHg, P =.007; 11.4 ± 12.46 mmHg, P =.005; and 5 ± 5.98 mmHg, P =.013, respectively) whereas the recovery heart rate increased significantly (−21.5 ± 23.16 beats/min, P =.003). The LnrMSSDcv ([LnrMSSDSD/LnrMSSDMEAN] × 100) was lower in HRV-G (1.23 ± 0.91 mmHg, P =.03) while the training volume at high intensity was higher in HIIT-G (31.4 ± 29.2 min, P =.024). HRV-guided training presents a better cardioprotective effect than HIIT-G at a lower high-intensity training volume. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular diseases (CVDs) are a leading cause of morbidity and mortality globally. Arterial hypertension is one of the main cardiovascular risk factors. Despite this, individuals with hypertension often fail to follow medical advice to counteract cardiovascular risks. A physically active lifestyle is one of the most challenging behaviors to adopt. This study aimed to preliminarily investigate the effectiveness of a tailored print message intervention to increase physical activity in patients with arterial hypertension. Methods: A sample of 188 patients with hypertension (mean age = 63 years; SD = 10.9; 50% men) participated in a theory-based tailored health communication intervention. Participants were randomly assigned to three parallel groups: (1) the tailored group, which received tailored health brochures; (2) the non-tailored group, which received non-tailored health brochures; or (3) the usual care group, which received no informative print materials. The longitudinal physical activity trajectories (baseline, 6- and 12-month follow-ups) were examined using repeated measures ANOVA and growth curve models. Results: At the baseline, 38.8% of patients achieved the target physical activity. This percentage rose to 43.0% at 6-month follow-up and 46.0% at 12-month follow-up. The descriptive statistics divided in function of the experimental group suggested differences in the longitudinal trend of the mean physical activity depending on the experimental group. However, statistical significance using repeated measures ANOVA did not support this observation. The analysis of the growth curves suggested that the tailored group showed a progressive increase in physical activity over twelve months (the model that best described the longitudinal trajectory was a linear growth model). The non-tailored group showed an increase in physical activity six months after the beginning of the intervention, followed by a decrease (free time score model). The usual care group did not change over time (no-growth model). Conclusions: Findings suggest the effectiveness of the tailored intervention proposed. However, further investigations and empirical confirmations are required. Trial registration: ISRCTN13415993 (https://doi.org/10.1186/ISRCTN13415993). Registration date: 08/04/2019. [ABSTRACT FROM AUTHOR]

In conventional randomized controlled trials, adjustment for baseline values of covariates known to be at least moderately associated with the outcome increases the power of the trial. Recent work has shown a particular benefit for more flexible frequentist designs, such as information adaptive and adaptive multi-arm designs. However, covariate adjustment has not been characterized within the more flexible Bayesian adaptive designs, despite their growing popularity. We focus on a subclass of these which allow for early stopping at an interim analysis given evidence of treatment superiority. We consider both collapsible and non-collapsible estimands and show how to obtain posterior samples of marginal estimands from adjusted analyses. We describe several estimands for three common outcome types. We perform a simulation study to assess the impact of covariate adjustment using a variety of adjustment models in several different scenarios. This is followed by a real-world application of the compared approaches to a COVID-19 trial with a binary endpoint. For all scenarios, it is shown that covariate adjustment increases power and the probability of stopping the trials early, and decreases the expected sample sizes as compared to unadjusted analyses. [ABSTRACT FROM AUTHOR]

Background and purpose: Rasagiline might be disease modifying in patients with amyotrophic lateral sclerosis (ALS). The aim was to evaluate the effect of rasagiline 2 mg/day on neurofilament light chain (NfL), a prognostic biomarker in ALS. Methods: In 65 patients with ALS randomized in a 3:1 ratio to rasagiline 2 mg/day (n = 48) or placebo (n = 17) in a completed randomized controlled multicentre trial, NfL levels in plasma were measured at baseline, month 6 and month 12. Longitudinal changes in NfL levels were evaluated regarding treatment and clinical parameters. Results: Baseline NfL levels did not differ between the study arms and correlated with disease progression rates both pre‐baseline (r = 0.64, p < 0.001) and during the study (r = 0.61, p < 0.001). NfL measured at months 6 and 12 did not change significantly from baseline in both arms, with a median individual NfL change of +1.4 pg/mL (interquartile range [IQR] −5.6, 14.2) across all follow‐up time points. However, a significant difference in NfL change at month 12 was observed between patients with high and low NfL baseline levels treated with rasagiline (high [n = 13], −6.9 pg/mL, IQR −20.4, 6.0; low [n = 18], +5.9 pg/mL, IQR −1.4, 19.7; p = 0.025). Additionally, generally higher longitudinal NfL variability was observed in patients with high baseline levels, whereas disease progression rates and disease duration at baseline had no impact on the longitudinal NfL course. Conclusion: Post hoc NfL measurements in completed clinical trials are helpful in interpreting NfL data from ongoing and future interventional trials and could provide hypothesis‐generating complementary insights. Further studies are warranted to ultimately differentiate NfL response to treatment from other factors. [ABSTRACT FROM AUTHOR]

Background: Electronic clinical decision-making support systems (eCDSS) aim to assist clinicians making complex patient management decisions and improve adherence to evidence-based guidelines. Integrated management of Childhood Illness (IMCI) provides guidelines for management of sick children attending primary health care clinics and is widely implemented globally. An electronic version of IMCI (eIMCI) was developed in South Africa. Methods: We conducted a cluster randomized controlled trial comparing management of sick children with eIMCI to the management when using paper-based IMCI (pIMCI) in one district in KwaZulu-Natal. From 31 clinics in the district, 15 were randomly assigned to intervention (eIMCI) or control (pIMCI) groups. Computers were deployed in eIMCI clinics, and one IMCI trained nurse was randomly selected to participate from each clinic. eIMCI participants received a one-day computer training, and all participants received a similar three-day IMCI update and two mentoring visits. A quantitative survey was conducted among mothers and sick children attending participating clinics to assess the quality of care provided by IMCI practitioners. Sick child assessments by participants in eIMCI and pIMCI groups were compared to assessment by an IMCI expert. Results: Self-reported computer skills were poor among all nurse participants. IMCI knowledge was similar in both groups. Among 291 enrolled children: 152 were in the eIMCI group; 139 in the pIMCI group. The mean number of enrolled children was 9.7 per clinic (range 7-12). IMCI implementation was sub-optimal in both eIMCI and pIMCI groups. eIMCI consultations took longer than pIMCI consultations (median duration 28 minutes vs 25 minutes; p = 0.02). eIMCI participants were less likely than pIMCI participants to correctly classify children for presenting symptoms, but were more likely to correctly classify for screening conditions, particularly malnutrition. eIMCI participants were less likely to provide all required medications (124/152; 81.6% vs 126/139; 91.6%, p= 0.026), and more likely to prescribe unnecessary medication (48/152; 31.6% vs 20/139; 14.4%, p = 0.004) compared to pIMCI participants. Conclusions: Implementation of eIMCI failed to improve management of sick children, with poor IMCI implementation in both groups. Further research is needed to understand barriers to comprehensive implementation of both pIMCI and eIMCI. (349) Clinical trials registration: Clinicaltrials.gov ID: BFC157/19, August 2019. [ABSTRACT FROM AUTHOR]

Researchers are increasingly using web-based technologies to deliver family-based, prevention programming. Few studies have examined the success of such approaches for families with low incomes. The purpose of this study was to describe the level of in-class and online engagement in a childhood obesity prevention program for parents with low incomes, to examine the demographic correlates of parent engagement, and to examine dosage effects on parental feeding outcomes as a function of online exposure. All participants attended in-class nutrition education classes (Eating Smart · Being Active) as part of the Expanded Food and Nutrition Education Program (EFNEP) in Colorado and Washington State (classes were offered in English and Spanish). Participants in this analysis were 168 parents from a larger cluster randomized controlled trial who had been randomly assigned to also receive a newly developed, mobile-based version of an efficacious, feeding-focused, childhood obesity prevention program. Results showed that despite high levels of in-person attendance (70%), participants only accessed 47% of the videos (online content). Older parents and parents of girls showed higher levels of in-person attendance; currently employed parents showed lower levels. Online engagement varied as a function of ethnicity and acculturation: non-Hispanic parents accessed the most videos, low-acculturated Hispanic parents accessed the second most, and highly acculturated Hispanic parents accessed the least. In contrast, low-acculturated Hispanic parents showed the highest in-person attendance. For all but one outcome, significant online program effects were found only for parents who accessed at least half of the videos. Implications for mobile-based, family-based prevention programs for parents with low incomes are considered. ClinicalTrials.gov Identifier: NCT03170700; Registration Date: March 08, 2017. [ABSTRACT FROM AUTHOR]

Background: Robotic-assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic-assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy. Methods: Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room (OR) is assigned to either robotic-assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients, and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024. Discussion: RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic-assisted bronchoscopy. Trial registration: ClinicalTrials.gov registration (NCT05705544) on January 30, 2023. [ABSTRACT FROM AUTHOR]

Background: Healthy lifestyles are crucial for preventing chronic diseases. Nonetheless, approximately 90% of Chinese community residents regularly engage in at least one unhealthy lifestyle. Mobile smart devices-based health interventions (mHealth) that incorporate theoretical frameworks regarding behavioral change in interaction with the environment may provide an appealing and cost-effective approach for promoting sustainable adaptations of healthier lifestyles. We designed a randomized controlled trial (RCT) to evaluate the effectiveness of a socioecological model-guided, smart device-based, and self-management-oriented lifestyles (3SLIFE) intervention, to promote healthy lifestyles among Chinese community residents. Methods: This two-arm, parallel, cluster-RCT with a 6-month intervention and 6-month follow-up period foresees to randomize a total of 20 communities/villages from 4 townships in a 1:1 ratio to either intervention or control. Within these communities, a total of at least 256 community residents will be enrolled. The experimental group will receive a multi-level intervention based on the socioecological model supplemented with a multi-dimensional empowerment approach. The control group will receive information only. The primary outcome is the reduction of modifiable unhealthy lifestyles at six months, including smoking, excess alcohol consumption, physical inactivity, unbalanced diet, and overweight/obesity. A reduction by one unhealthy behavior measured with the Healthy Lifestyle Index Score (HLIS) will be considered favorable. Secondary outcomes include reduction of specific unhealthy lifestyles at 3 months, 9 months, and 12 months, and mental health outcomes such as depression measured with PHQ-9, social outcomes such as social support measured with the modified Multidimensional Scale of Perceived Social Support, clinical outcomes such as obesity, and biomedical outcomes such as the development of gut microbiota. Data will be analyzed with mixed effects generalized linear models with family and link function determined by outcome distribution and accounting for clustering of participants in communities. Discussion: This study will provide evidence concerning the effect of a mHealth intervention that incorporates a behavioral change theoretical framework on cultivating and maintaining healthy lifestyles in community residents. The study will provide insights into research on and application of similar mHealth intervention strategies to promote healthy lifestyles in community populations and settings. Trial registration number: ChiCTR2300070575. Date of registration: April 17, 2023. https://www.chictr.org.cn/index.aspx. [ABSTRACT FROM AUTHOR]

As an example of how historical events may influence the findings and interpretations of a randomized trial, we use a school-based evaluation of a classroom management program that was conducted in a nearby district before and after the shooting of Michael Brown in Ferguson, Missouri (N = 102 teachers and 1,450 students). The findings suggest that the event differentially affected teacher and student response within and across conditions. Black teachers benefited more from the intervention as evidenced by their independently observed classroom management skills and praise-to-reprimand ratios; however, these effects were minimized or disappeared after the event. Additionally, although the intervention equally benefited the academic achievement of Black and White students before the event, the opportunity gap widened after the event. Implications for the design, analysis, and reporting of findings from randomized controlled trials are discussed. Supplemental data for this article is available online at http://dx.doi.org/10.1080/2372966X.2021.2024768 Impact Statement This cluster randomized trial conducted before and after the Michael Brown shooting revealed that historical events can differentially effect participants both within and across conditions. Moreover, findings suggest that the Black–White opportunity gap will not be reduced by schools alone. [ABSTRACT FROM AUTHOR]

Background: Process evaluations of randomized controlled trials (RCTs) of community exercise programs are important to help explain the results of a trial and provide evidence of the feasibility for community implementation. The objectives of this process evaluation for a multi-centre RCT of outdoor walking interventions for older adults with difficulty walking outdoors, were to determine: 1) implementation fidelity (the extent to which elements of the intervention were delivered as specified in the original protocol) and 2) participant engagement (the receipt of intervention components by the participants) in the Getting Older Adults Outdoors (GO-OUT) trial. Methods: GO-OUT participants attended an active 1-day workshop designed to foster safe, outdoor walking skills. After the workshop, 190 people at 4 sites were randomized to an outdoor walk group (OWG) (n = 98) which met 2x/week for 10 weeks, or the weekly reminders (WR) group (n = 92) which received a phone reminder 1x/week for 10 weeks. The OWG had 5 components – warm-up, continuous distance walk, task-oriented walking activities, 2nd continuous distance walk, and cool-down. Data on implementation fidelity and participant engagement were gathered during the study through site communications, use of standardized forms, reflective notes of the OWG leaders, and accelerometry and GPS assessment of participants during 2 weeks of the OWG. Results: All sites implemented the workshop according to the protocol. Participants were engaged in all 8 activity stations of the workshop. WR were provided to 96% of the participants in the WR intervention group. The 5 components of the OWG sessions were implemented in over 95% of the sessions, as outlined in the protocol. Average attendance in the OWG was not high – 15% of participants did not attend any sessions and 64% of participants in the OWG attended > 50% of the sessions. Evaluations with accelerometry and GPS during week 3 and 9 OWG sessions suggest that participants who attended were engaged and active during the OWG. Conclusions: This process evaluation helps explain the main study findings and demonstrates the flexibility required in the protocol for safe and feasible community implementation. Future research could explore the use of additional behaviour change strategies to optimize attendance for community implementation. Trial registration: ClinicalTrials.gov NCT03292510 Date of registration: September 25, 2017. [ABSTRACT FROM AUTHOR]

Introduction: The Enhanced Recovery After Surgery (ERAS) protocol reduces surgery-related stress and hospital stays for complicated surgical patients. It speeds recovery, reduces readmissions, and lowers morbidity and mortality. However, the efficacy of ERAS in colorectal surgery is still debatable. Aim: To evaluate the effectiveness and safety of the ERAS program for patients undergoing colorectal surgery. Material and methods: PRISMA-compliant searches were performed on Medline, Embase, PubMed, the Web of Sciences, and the Cochrane Database up to March 2023. The included articles compared ERAS protocol results for colorectal surgery patients to those of conventional care. RevMan was used for the meta-analysis, and the Cochrane RoB Tool was used to assess the study quality. Results: The meta-analysis included 12 randomized controlled trials with a total of 1920 participants. There were 880 individuals in ERAS care and 1002 in conventional care. Weighted mean difference: --1.07 days, 95% confidence interval (CI): --1.53 to --0.60, p = 0.00001), overall length of stay: --4.12 days, 95% CI: --5.86 to --2.38, p = 0.00001), and post-operative hospital stay: --1.91 days, 95% CI: --4.73 to --0.91, p = 0.00001). Readmissions were higher in the ERAS group than in the normal care group (odds ratio (OR) = 1.20, 95% CI: 0.82 to 1.75, p = 0.35). Post-operative complications were lower in the ERAS care group (OR = 0.42; 95% CI: 0.27 to 0.65, p < 0.0001) and SSIs (OR = 0.75; 95% CI 0.52 to 1.08, p = 0.00001) than in the routine care group. Conclusions: Care provided in line with the ERAS protocol has been shown to be successful and beneficial for patients following colorectal surgery, because it minimizes post-operative problems and length of hospital stay, and improves outcomes. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the mediating mechanisms of a Brazilian school-based program to prevent drug use among adolescents. In this study, we enrolled 4,030 students in two cluster randomized controlled trials to evaluate two PROERD curricula (fifth and seventh grades) in 30 public schools. Mediation analysis was used to evaluate the program's indirect effects on drug use through communication skills, decision-making skills, attitudes toward drugs, and refusal skills. Evidence regarding differences in mediator variables and drug use between the intervention and control groups is lacking. A clear association was noted between drug use and mediators, independent of group allocation; therefore, program activities should be revised and improved to influence these mediators. [ABSTRACT FROM AUTHOR]

Background: Adolescent hazardous alcohol use is prevalent and has serious short- and long-term consequences. The trial 'Our Choice' examines efficacy, feasibility and acceptability of prevention interventions targeting school, parent, and student levels at Danish high schools. We hypothesize that students in a structural intervention (school and parent levels) reduce hazardous alcohol use and related health behaviors compared to students in an assessment only control group 12 months post baseline; and that adding group-based Motivational Interviewing (group MI) yields further improvements. The study examines the efficacy of interventions targeting multiple levels with the aim of providing novel insights into prevention of adolescent hazardous alcohol use and related health outcomes. Method: The study employs a parallel group cluster randomized controlled trial design with three conditions: (1) structural condition targeting school and parent levels, (2) structural condition combined with group MI which also targets the student level, and (3) assessment-only control condition. A participatory approach is used to adapt and develop interventions. Sixteen high schools in Denmark and about N = 3100 first-year students (15–18 years) enrolled in high school in August 2023 will be recruited. Data will be collected via online questionnaires pre-interventions (baseline), 2, 6, 9 and 12 month post baseline and analyzed with generalized linear mixed models. The primary outcome is past month high intensity drinking; secondary outcomes are alcohol use, alcohol-related consequences, well-being, tobacco, and illegal substance use. Feasibility and acceptability will be assessed via surveys (students) and interviews (high school staff) to inform future implementation. Discussion: 'Our Choice' is the first trial to compare the efficacy of a structural intervention targeting school- and parent levels to an intervention targeting these levels and the student level via group MI – on hazardous drinking and related health outcomes among students. Preventing and reducing hazardous alcohol use during adolescence is crucial due to the short- and long-term negative consequences. The tested interventions can be implemented at low cost. The study has significant implications for adolescent health and well-being and has potential to inform evidence-based decisions on alcohol prevention policy, education, and health professions. Trial Registration Number: The trial was retrospectively registered at ClinicalTrials.gov on August 24th, 2023. Trial Registration Number: ID NCT06018389. [ABSTRACT FROM AUTHOR]

Background: The Long-Term Care QUERI program supported implementation of the Life-Sustaining Treatment Decisions Initiative in US Veterans Health Administration long-term care settings. The program worked with eleven Community Living Centers (CLCs) and twelve Home-Based Primary Care (HBPC) programs to increase rates of completed templates, using audit with feedback. We distributed monthly feedback reports to site champions showing the number of Veterans with appropriate documentation. Although feedback reports are a common implementation tool, little is known about the most effective ways to design, distribute, and support them. We sought to test tailoring reports with tips using site-specific data, as well as national comparator data. Methods: We conducted a cluster randomized controlled trial of monthly feedback reports utilizing site-tailored tips and national comparator data compared to our original feedback reports that included only graphical and numerical data. CLC and HBPC team members were invited to participate in brief surveys each quarter to determine if they had received and used the feedback reports. The outcome for CLC residents was the percent with a completed LST template any time prior to the 14th day of their stay. The outcome for HBPC residents was the percent of Veterans with a completed LST template by their second HBPC visit. Results: The response rate to the survey ranged between 6.8 and 19.3% of staff members across the CLC and HBPC sites with 12.8–25.5% of survey respondents reporting that they had seen the feedback reports. The linear regression models showed no significant association between receiving the enhanced feedback reports and having a higher documentation completion rate. Conclusions: Receiving feedback reports tailored to sites by including tips based on baseline context assessments and qualitative findings, and reports showing national comparator data, did not have an impact on the number of Veterans with a completed LST template. Having a higher proportion of CLC or HBPC team members view the reports was not associated with an increase in LST template completion. These findings suggest that tailored audit with feedback may not have been effective at the program level, although the proportion of respondents who reported seeing the reports was small. [ABSTRACT FROM AUTHOR]

We present an aggregation scheme that increases power in randomized controlled trials and quasi-experiments when the intervention possesses a robust and well-articulated theory of change. Intervention studies using longitudinal data often include multiple observations on individuals, some of which may be more likely to manifest a treatment effect than others. An intervention's theory of change provides guidance as to which of those observations are best situated to exhibit that treatment effect. Our power-maximizing weighting for repeated-measurements with delayed-effects scheme, PWRD aggregation, converts the theory of change into a test statistic with improved asymptotic relative efficiency, delivering tests with greater statistical power. We illustrate this method on an IES-funded cluster randomized trial testing the efficacy of a reading intervention designed to assist early elementary students at risk of falling behind their peers. The salient theory of change holds program benefits to be delayed and non-uniform, experienced after a student's performance stalls. In this instance, the PWRD technique's effect on power is found to be comparable to that of doubling the number of clusters in the experiment. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess the effect of intensive nutrition education and counseling on hemoglobin level during pregnancy. Methods and materials: The study was a one year two-arm parallel design cluster randomized controlled trial in East Shoa zone, Ethiopia. End-line data were collected from 163 intervention and 163 control group pregnant women. The intervention was a three consecutive trimester based counseling sessions using health belief model, weekly regular SMS sent on mobile phone containing core message and providing leaflet with food menu of Iron rich diet. The women in the control group received routine nutrition education from facilities. After adjusting for potential confounders, a linear mixed-effects model was used to assess the intervention effect. Results: There was a significant change in both hemoglobin level and proportion of anemia in the intervention group. The mean hemoglobin level within intervention group before and after intervention was (12.08± 1.15, 12.53± 1.18) with p value of 0.01. The prevalence of anemia among intervention group declined from 14.7 % at the baseline to 9.2% after intervention. At the end of the trial, women in the intervention group had significantly better hemoglobin level than women in the control group (β = 0.50, p < 0.01). Conclusion: The intervention was effective in improving the hemoglobin level and consumption of iron rich diet among pregnant women. Therefore, employing trimester based counseling by using HBM constructs and regular reminding messages have to be provided to pregnant women as part of the regular antenatal care service. [ABSTRACT FROM AUTHOR]

Objectives: The authors aimed to develop a moral intervention and to determine whether it was more effective in preventing doping than an educational (i.e., knowledge-based) intervention; their primary outcome was doping likelihood, and the secondary outcomes were moral identity, moral disengagement, moral atmosphere, and anticipated guilt.Methods: Eligible athletes (N = 303) in the United Kingdom and Greece took part in the study. The authors randomly assigned 33 clubs to either the moral or the educational intervention. They measured outcomes pre- and postintervention and at 3- and 6-month follow-up.Results: Athletes in both interventions in both countries reported lower doping likelihood and moral disengagement and higher guilt from pre- to postintervention. These effects were maintained at the 3- and 6-month follow-ups. There were no effects on moral identity or moral atmosphere.Conclusions: In addition to disseminating information about doping, doping prevention programs should include content that focuses on moral variables. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Although wearable electronic devices have demonstrated potential utility as intervention tools to enhance physical activity, comprehensive evaluations of their specific effects on the healthy adolescent population remain scarce. Consequently, this article aims to systematically explore and summarize the impact of interventions based on wearable electronic devices on the physical activity and sedentary behavior of healthy adolescents, thereby providing more precise and reliable evidence-based support for public health practices. METHODS: Randomized controlled trials assessing the effects of wearable electronic device-based interventions on the physical activity and sedentary behavior of healthy adolescents were retrieved from databases including Web of Science, PubMed, Scopus, The Cochrane Library, and EBSCO. Meta-analysis was conducted using Review Manager 5.4 and Stata 17, evaluating the effects of interventions on physical activity and sedentary behavior through the standardized mean difference. To ensure the robustness of the research findings, a Leave-One-Out sensitivity analysis was conducted, and subgroup analyses were carried out to explore the potential influence of different factors on the results. The review protocol was registered with the International Prospective Register of Systematic Reviews (CRD42023406645). RESULTS: (1) Twelve publications were ultimately included, consisting of three randomized controlled trials and nine cluster-randomized controlled trials, involving a total of 4 933 healthy adolescents. (2) Meta-analysis results revealed that interventions based on wearable electronic devices had a positive effect on moderate to vigorous physical activity [standardized mean difference (SMD)=0.10; 95% confidence interval (CI): 0.04 to 0.17; P < 0.05). However, the interventions did not significantly improve low-intensity physical activity (SMD=-0.15; 95% CI: -0.32 to 0.02; P > 0.05), daily step count (SMD=0.13; 95% CI: -0.65 to 0.91; P > 0.05), and sedentary behavior (SMD=0.00; 95% CI: -0.09 to 0.09; P > 0.05). (3) Subgroup analyses indicated that short-term interventions (≤ 12 weeks) (SMD=0.11; 95% CI: 0.03 to 0.18; P=0.008), studies using pedometers worn at the waist or hip (SMD=0.10; 95% CI: 0.04 to 0.17; P=0.002), and experiments registered at clinical trial centers (SMD=0.11; 95% CI: 0.04 to 0.17; P=0.001) had a more significant effect on enhancing daily moderate to vigorous physical activity. CONCLUSION: The current evidence suggests that interventions based on wearable electronic devices possess certain advantages in enhancing the daily moderate-to-vigorous physical activity of healthy adolescents. It is recommended that interventions not exceeding 12 weeks and utilizing pedometers positioned at the waist or hip may yield more favorable results. However, the effects of these interventions on daily step count, low-intensity physical activity, and sedentary behavior exhibit some limitations. Consequently, future investigations necessitate higher-quality, larger-scale randomized controlled trials for further validation. [ABSTRACT FROM AUTHOR]

In a randomized controlled trial, outcomes of different subjects may be independent at baseline, but correlated at a follow‐up measurement due to treatment. This treatment‐related clustering at follow‐up can arise for instance because the treatment is given in a group or because subjects are treated individually but by the same therapist (therapist effect). There is substantial literature on the design and analysis of such trials when estimation of the intervention effect is based on a follow‐up measurement (eg, directly after treatment or at a later time point). However, often the baseline measurement of the outcome is highly correlated with the follow‐up measurement, and this information can be used in the analysis. For a randomized design with a baseline and a follow‐up measurement, we compare sample size requirements for analyses with and without adjustment for this baseline measure. We show that adjusting for baseline reduces required sample size. This reduction depends on the variance of the difference between arms at baseline, the variance of this difference at follow‐up, and the correlation between the two. From this, we derive sample size formulas for partially or fully nested designs, and cluster randomized trials with treatment as a partially or fully cross‐classified factor. Also, we discuss situations where clusters are already present at baseline or where treatment by cluster interaction is present. For the partially nested design, we work out practical design considerations (eg, use of content‐matter input, design factors and optimal allocation ratio) and investigate small sample properties of the sample size formula. [ABSTRACT FROM AUTHOR]

To compare the efficacy of nonpharmacological interventions in improving the symptoms of the pain-fatigue-sleep disturbance symptom cluster in breast cancer patients.Methods: A comprehensive literature search was conducted in the PubMed, EMBASE, Cochrane Library, CINAHL, CNKI, and Wanfang databases to identify randomized controlled studies from database inception to May 2022. Two reviewers independently performed data retrieval and risk of bias assessments. The consistency model was used to conduct network meta-analyses (NMA) based on the frequentist framework to assess the interventions, which were ranked by the surface under the cumulative ranking curve (SUCRA). Finally, the CINeMA application was used to evaluate the results of the NMA and the evidence of quality. The results Twenty-three eligible studies assessing 14 interventions were included. According to SUCRA values, among the management effects of the three symptoms, the effect of progressive muscle relaxation (PMR) ranked first, followed by mindfulness-based stress reduction (MBSR). The overall evidence quality of our study ranges from very low to moderate.Conclusion: PMR and MBSR were effective interventions for the pain-fatigue-sleep disturbance symptom cluster in breast cancer patients. Clinical recommendations prioritize PMR for symptom management, followed by MBSR. However, this should be interpreted cautiously, as the confidence in the evidence was not high. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus (T2DM) has increased globally; with a disproportionate burden in South and Southeast Asian countries, including Nepal. There is an urgent need for clinically and cost-effective culturally adapted T2DM management programs. In this study, we aim to assess the effectiveness of community based culturally appropriate lifestyle intervention in improving the management and care of people with T2DM. Methods: We will conduct a cluster randomized control trial to evaluate the effectiveness of community based culturally appropriate lifestyle intervention in improving T2DM outcomes. The trial will be conducted in 30 randomly selected healthcare facilities from two purposively selected districts (Kavrepalanchowk and Nuwakot districts) of Bagmati province, Nepal. The selected healthcare facilities are being randomized into 15 interventions (n = 15) and usual care (n = 15) groups. Those in the intervention will receive group-based 12 an hour-long fortnightly session delivered over 6 months period. The intervention package includes 12 planned modules related to diabetes care, ongoing support, supervision and monitoring, follow-up from the trained community health workers, and educational materials on diabetes self-management. The participants in the usual care groups will receive pictorial brochure on diabetes management and they will continue receiving the usual care available from the local health facilities. The primary outcome is HbA1c level, and the secondary outcomes include quality of life, health care utilization, and practice of self-care behaviour, depression, oral health quality of life, and economic assessment of the intervention. Two points measurements will be collected by the trained research assistants at baseline and at the end of the intervention. Discussion: This study will provide tested approaches for culturally adapting T2DM interventions in the Nepalese context. The findings will also have practice and policy implications for T2DM prevention and management in Nepal. Trial registration: Australia and New Zealand Clinical Trial Registry (ACTRN12621000531819). Registered on May 6, 2021. [ABSTRACT FROM AUTHOR]

Objectives: The study examined the effects of awareness and notification of body-worn cameras (BWCs) on encounter-based citizen perceptions including procedural justice, police lawfulness, compliance with police, and global-level perceptions including police legitimacy, cooperation, and compliance with law. Methods: A vignette-based cluster randomized controlled trial was conducted. As a cluster, participants were randomly selected and then randomly assigned to one of the four conditions (non-BWC, unawareness of BWC, awareness of BWC, and notification of BWC). Participants in the experimental conditions (i.e., unawareness of BWC, awareness of BWC, and notification of BWC) viewed a video of a real traffic stop in which the officer used a BWC. The data were obtained from a survey about participants' perceptions. A one-way ANOVA test for bivariate analysis and a hierarchical generalized linear model for multivariate analysis were conducted. Results: Compared with the control condition, the three experimental conditions significantly improved encounter-based citizen perceptions. Compared with unawareness of BWC, notification of BWC significantly improved the perceptions of procedural justice and police lawfulness, while awareness of BWC significantly improved the perceptions of police lawfulness. Conclusions: BWC awareness improves citizen encounter-based perceptions. Police should notify citizens of the use of BWCs to increase the effectiveness of BWCs. [ABSTRACT FROM AUTHOR]

Family members, who provide the majority of informal care during the recovery period from first-episode psychosis (FEP), experience high levels of psychological distress. However, there is a lack of effective and accessible interventions for FEP carers. To determine the effectiveness of an online intervention ("Altitudes") in relation to the primary outcome of FEP-carer stress at 6 months follow-up. We conducted a cluster randomized controlled trial in which FEP carers were randomized to Altitudes combined with specialized treatment as usual (STAU) or STAU alone. In addition to questionnaires, we included multiple waves of intensive ecological momentary assessment (EMA) to measure carer stress and family outcomes in 164 carers of young (15–27 years) FEP patients. Both groups improved over time on stress and a range of secondary outcomes, including mental health symptoms, self-efficacy, and expressed emotion with no group by time interactions. At 12 months there were significantly fewer visits to emergency departments by FEP patients in the Altitudes group (p = 0.022). Modelling of multiple EMA waves revealed that more time spent by carers with FEP patients predicted greater worry, expressed emotion, and adaptive coping. Engagement and usability findings for Altitudes were positive. Further refinements to our online carer interventions may be needed to engage carers in purposeful skill development for improved management of stress and communication with the young person compared with existing specialist family interventions. ACTRN12616000968471. [ABSTRACT FROM AUTHOR]

Background: The Fédération Internationale de Football Association (FIFA) 11+ Kids is an exercise-based injury prevention program developed by an international group of experts to prevent injuries among child soccer players. Hypothesis: It was hypothesized that the FIFA 11+ Kids program would be more effective than performing a typical warm-up regimen in reducing overall injuries among soccer players aged 7 to 13 years. Study Design: A clustered randomized controlled trial. Level of Evidence: Level 1. Methods: A total of 94 boys' soccer teams, including 780 players, were randomly allocated into an experimental or control group. Complete datasets were collected from 45 teams (377 players) and 43 teams (363 players) in the experimental and control groups, respectively. The experimental group underwent the FIFA 11+ Kids program as a warm-up during training sessions and matches at least twice a week, and the control group continued performing their usual warm-ups. Participants were prospectively followed during 1 season (6 months). The primary outcomes included the incidence of overall and recurrent injuries and their mechanism and severity. The secondary outcome was the rate of compliance with the intervention program. Results: A total of 43 injuries were reported in the experimental group in 50,120 hours of exposure (0.85 injuries/1000 exposure hours). A total of 86 injuries were reported in the control group in 42,616 hours of exposure (2.01 injuries/1000 exposure hours). The injury risk ratio was 0.43 (0.29-0.61), suggesting that the experimental group experienced 57% fewer injuries than those in the control group. Conclusion: The FIFA 11+ Kids program reduced overall injury rates in children playing soccer more than the usual warm-ups. Clinical Relevance: The results of this study provide evidence for children's coaches to consider including the FIFA 11+ Kids program in their warm-up regimen. Such a program may prevent injury risk and decrease absenteeism and injury-related financial burdens. [ABSTRACT FROM AUTHOR]

Despite the decline in under-five mortality by over 60% in the last three decades, majority of child mortality is still attributable to communicable and infectious diseases that are not only preventable, but they are also treatable. We evaluated the potential impact of a participatory community engagement and innovative community incentivization (C3I) strategy for improving the coverage of child health interventions in a rural setting in Pakistan. We first undertook formative research to assess community knowledge and the likelihood of collective community strategy and conditional incentives for improving existing preventive and care-seeking practices for childhood diarrhea and pneumonia. We developed options for community incentivization and improving group practices, taking local norms and customs into account in the design of the community mobilization strategies and messages. These interventions were then formally evaluated prospectively in a three-arm cluster randomized controlled trial. Clusters were randomly assigned by a computer algorithm using restricted randomization by an external statistician (1:1:1) into three groups: community mobilization and incentivization (CMI); community mobilization only using an enhanced communication package (CM); and control group. The C3I was an innovative strategy as it involved serial incremental targets of collective improvement in community behavior related to improvement in the coverage of a composite indicator of fully immunized children (FIC), oral rehydration salt (ORS), and the sanitation index (SI). The evaluation was done by an independent data collection and analysis team at baseline and end line (after 24 months). [ABSTRACT FROM AUTHOR]

Background: The effectiveness of malaria vector control interventions is often evaluated using cluster randomized trials (CRT) with outcomes assessed using repeated cross-sectional surveys. A key requirement for appropriate design and analysis of longitudinal CRTs is accounting for the intra-cluster correlation coefficient (ICC). In addition to exchangeable correlation (constant ICC over time), correlation structures proposed for longitudinal CRT are block exchangeable (allows a different within- and between-period ICC) and exponential decay (allows between-period ICC to decay exponentially). More flexible correlation structures are available in statistical software packages and, although not formally proposed for longitudinal CRTs, may offer some advantages. Our objectives were to empirically explore the impact of these correlation structures on treatment effect inferences, identify gaps in the methodological literature, and make practical recommendations. Methods: We obtained data from a parallel-arm CRT conducted in Tanzania to compare four different types of insecticide-treated bed-nets. Malaria prevalence was assessed in cross-sectional surveys of 45 households in each of 84 villages at baseline, 12-, 18- and 24-months post-randomization. We re-analyzed the data using mixed-effects logistic regression according to a prespecified analysis plan but under five different correlation structures as well as a robust variance estimator under exchangeable correlation and compared the estimated correlations and treatment effects. A proof-of-concept simulation was conducted to explore general conclusions. Results: The estimated correlation structures varied substantially across different models. The unstructured model was the best-fitting model based on information criteria. Although point estimates and confidence intervals for the treatment effect were similar, allowing for more flexible correlation structures led to different conclusions based on statistical significance. Use of robust variance estimators generally led to wider confidence intervals. Simulation results showed that under-specification can lead to coverage probabilities much lower than nominal levels, but over-specification is more likely to maintain nominal coverage. Conclusion: More flexible correlation structures should not be ruled out in longitudinal CRTs. This may be particularly important in malaria trials where outcomes may fluctuate over time. In the absence of robust methods for selecting the best-fitting correlation structure, researchers should examine sensitivity of results to different assumptions about the ICC and consider robust variance estimators. [ABSTRACT FROM AUTHOR]

Background: Community health workers (CHWs) can supplement professional medical providers, especially in rural settings where resources are particularly scarce. Yet, outcomes of studies evaluating CHWs effectiveness have been highly variable and lack impact when scaled nationally. This study examines if child and maternal outcomes are better when existing government CHWs, who are perinatal home visitors, receive ongoing enhanced supervision and monitoring, compared to standard care. Methods and findings: A cluster randomized controlled effectiveness trial was conducted comparing outcomes over 2 years when different supervision and support are provided. Primary health clinics were randomized by clinic to receive monitoring and supervision from either (1) existing supervisors (Standard Care (SC); n = 4 clinics, 23 CHWs, 392 mothers); or (2) supervisors from a nongovernmental organization that provided enhanced monitoring and supervision (Accountable Care [AC]; n = 4 clinic areas, 20 CHWs, 423 mothers). Assessments were conducted during pregnancy and at 3, 6, 15, and 24 months post-birth with high retention rates (76% to 86%). The primary outcome was the number of statistically significant intervention effects among 13 outcomes of interest; this approach allowed us to evaluate the intervention holistically while accounting for correlation among the 13 outcomes and considering multiple comparisons. The observed benefits were not statistically significant and did not show the AC's efficacy over the SC. Only the antiretroviral (ARV) adherence effect met the significance threshold established a priori (SC mean 2.3, AC mean 2.9, p < 0.025; 95% CI = [0.157, 1.576]). However, for 11 of the 13 outcomes, we observed an improvement in the AC compared to the SC. While the observed outcomes were not statistically significant, benefits were observed for 4 outcomes: increasing breastfeeding for 6 months, reducing malnutrition, increasing ARV adherence, and improving developmental milestones. The major study limitation was utilizing existing CHWs and being limited to a sample of 8 clinics. There were no major study-related adverse events. Conclusions: Supervision and monitoring were insufficient to improve CHWs' impact on maternal and child outcomes. Alternative strategies for staff recruitment and narrowing the intervention outcomes to the specific local community problems are needed for consistently high impact. Trial registration: Clinicaltrials.gov, NCT02957799. In a randomised controlled trial, Dr. Mary Jane Rotheram-Borus and colleagues investigate the effect of supervision on community health workers' effectiveness in households of rural South Africa. Author summary: Why was this study done?: There are too few health professionals in low- and middle-income countries, and there will be too few until about 2050. Healthcare tasks are being shifted to 2 million community health workers (CHWs). Yet, the efficacy of these CHWs often disappears when randomized controlled trials (RCTs) are ended and national programs are implemented. What did the researchers do and find?: Existing government-employed CHWs serving 8 deeply rural health clinics were randomized by clinic in a cluster effectiveness RCT to either standard supervision or enhanced accountable monitoring and supervision by a nongovernment organization. The CHWs and perinatal mothers/children were monitored at 5 points over the first 2 years of life. Supervision did not lead to significantly better outcomes for mothers and children. Yet, it is noteworthy that 11 of 13 outcomes were better when CHWs received enhanced, accountable supervision, compared to standard care. What do these findings mean?: A key component of implementation at scale in the real world is the ability to hold CHWs accountable and to release CHWs not meeting expectations. To successfully deploy CHWs in a manner that has significant and sustained improvements, the procedures for selecting and recruiting CHWs may be critical. [ABSTRACT FROM AUTHOR]

Background: Dental caries is one of the most common diseases affecting children world widely as well as in the Kingdom of Saudi Arabia. Supervised tooth brushing programs are implemented throughout the world to provide young children's developing teeth with additional fluoride as a form of dental caries prevention. While school-based supervised tooth brushing programs have been proven to improve young children's oral health, virtual supervised teeth brushing programs have not been assessed. The purpose of this protocol is to assess the impact of virtual supervised tooth brushing on caries experience and quality of life among primary school students in Riyadh, Saudi Arabia. Methods: This is a cluster randomized controlled trial comparing a virtual supervised tooth brushing program against no intervention applied. A total of 1192 (596 in each group) 8–9-year-old children in Riyadh primary schools, Saudi Arabia, will be recruited for the trial. Schools (cluster) will be randomly selected and allocated to either group. Clinical assessment for caries experience will be conducted in six points (baseline, + 3 months, + 6 months, + 12 months, + 24 months, + 36 months) by dental hygienists using the World Health Organization criteria. Data on sociodemographic behavioral factors and children's quality of life will be collected with every clinical assessment through a structured questionnaire. The primary outcome is the change in caries experience (the number of teeth with untreated dental caries, filled and missing teeth) in both primary and permanent teeth over 36 months. Discussion: Virtual education as well as some health consultation through the pandemic period had enabled an effective IT infrastructure in Saudi Arabia. Virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years. This project should provide high level evidence on the effectiveness of virtual supervised tooth brushing. The findings should potentially inform policies related to the continuation/implementation of school-based programs in Saudi Arabia. Trial registration: ClinicalTrials.gov, ID: NCT05217316. Registered on 19 January 2022. [ABSTRACT FROM AUTHOR]

Background: Lower respiratory tract infections (LRTIs) in primary care are a promising target for antibiotic stewardship. A clinical trial in Switzerland showed a large decrease in antibiotic prescriptions with procalcitonin guidance (cut-off < 0.25 µg/L) compared with usual care. However, one-third of patients with low procalcitonin at baseline received antibiotics by day 28. Aim: To explore the factors associated with the overruling of initial procalcitonin guidance. Design and Setting: Secondary analysis of a cluster randomized trial in which patients with an LRTI were included. Method: Using the characteristics of patients, their disease, and general practitioners (GPs), we conducted a multivariate logistic regression, adjusted for clustering. Results: Ninety-five out of 301 (32%) patients with low procalcitonin received antibiotics by day 28. Factors associated with an overruling of procalcitonin guidance were: a history of chest pain (adjusted OR [aOR] 1.81, 95% confidence interval 1.03–3.17); a prescription of chest X-ray by the GP (aOR 4.65, 2.32–9.34); a C-reactive protein measured retrospectively above 100 mg/L (aOR 7.48, 2.34–23.93, reference ≤ 20 mg/L); the location of the GP practice in an urban setting (aOR 2.27, 1.18–4.37); and the GP's number of years of experience (aOR per year 1.05, 1.01–1.09). Conclusions: Overruling of procalcitonin guidance was associated with GPs' socio-demographic characteristics, pointing to the general behavioral problem of overprescription by physicians. Continuous medical education and communication training might support the successful implementation of procalcitonin point-of-care tests aimed at antibiotic stewardship. [ABSTRACT FROM AUTHOR]

Background: Evidence-based interventions, which are typically supported by data from randomized controlled trials (RCTs), are highly valued by providers of human services like child welfare. However, implementing such interventions in the context of a randomized clinical trial is a complex process, as conducting an RCT adds extra tasks for providers and complicating factors for provider organizations. Utilizing the Exploration, Preparation, Implementation, and Sustainment Framework, this study examines factors that facilitate or impede success in the implementation of evidence-based interventions in the context of a largescale trial of SafeCare,® a child maltreatment intervention. Methods: Qualitative data were obtained as part of a larger mixed-methods study involving a cluster randomized trial comparing SafeCare to usual services for caregivers within nine child welfare agencies across four states. Between May and October 2017, individual interviews were conducted with a purposive sample of 21 child welfare administrators and 24 supervisors, and 19 focus groups were conducted with 84 providers. Data were coded iteratively and grouped into themes. Results: Several interconnected themes centered on facilitators and barriers to SafeCare implementation in the context of a randomized clinical trial. Facilitators included: (1) Benefits afforded through RCT participation; (2) Shared vision and sustained buy-in across system and organizational levels; and (3) Ongoing leadership support for SafeCare and the RCT. Barriers that hindered SafeCare were: (1) Insufficient preparation to incorporate SafeCare into services; (2) Perceived lack of fit, leading to mixed support for SafeCare and the RCT; and (3) Requirements of RCT participation at the provider level. Conclusions: These data yield insight into an array of stakeholder perspectives on the experience of implementing a new intervention in the context of a largescale trial. This research also sheds light on how the dynamics of conducting an RCT may affect efforts to implement interventions in complex and high-pressure contexts. Findings highlight the importance of aligning knowledge and expectations among researchers, administrators of organizations, and supervisors and providers. Researchers should work to alleviate the burdens of study involvement and promote buy-in among frontline staff not only for the program but also for the research itself. [ABSTRACT FROM AUTHOR]

Background: The UK is rolling out a national childhood influenza immunisation programme for children, delivered through primary care and schools. Behaviourally-informed letters and reminders have been successful at increasing uptake of other public health interventions. Therefore, we investigated the effects of a behaviourally-informed letter on uptake of the vaccine at GP practices, and of a letter and a reminder (SMS/ email) on uptake at schools. Methods and results: Study 1 was a cluster-randomised parallel trial of 21,786 two- and three-year olds in 250 GP practices, conducted during flu season (September to January inclusive) 2016/7. The intervention was a centrally-sent behaviourally-informed invitation letter, control was usual care. The proportion of two- and three-year olds in each practice who received a vaccination by 31st January 2017 was 23.4% in the control group compared to 37.1% in the intervention group (OR = 1.93; 95% CI = 1.82, 2.05, p < 0.001). Study 2 was a 2 (behavioural letter vs standard letter) × 2 (reminder vs no reminder) factorial trial of 1108 primary schools which included 3010 school years 1–3. Letters were sent to parents from providers, and reminders sent to parents from the schools. In the standard-letter-no-reminder arm, an average of 61.6% of eligible children in each school year were vaccinated, compared to 61.9% in the behavioural-letter-no-reminder arm, 63.5% in the standard-letter-plus-reminder arm, and 62.9% in the behavioural-letter-plus reminder condition, F(3, 2990) = 2.68, p = 0.046. In a multi-level model, with demographic variables as fixed effects, the proportion of eligible students in the school year who were vaccinated increased with the reminder, β = 0.086 (0.041), p < 0.036, but there was no effect of the letter nor any interaction effect. Conclusion: Sending a behaviourally informed invitation letter can increase uptake of childhood influenza vaccines at the GP surgery compared to usual practice. A reminder SMS or email can increase uptake of the influenza vaccine in schools, but the effect size was minimal. Trial registration: Study 1: Trial registration: ClinicalTrials.gov Identifier: NCT02921633. Study 2: Trial registration: ClinicalTrials.gov Identifier: NCT02883972. [ABSTRACT FROM AUTHOR]

Background: Narrative medicine has become a solution to cultivate medical students' ability of empathy and humanistic care. However, the role of narrative medicine is lacking in the study of professionalism. The aim of this study was to analyze the effects of narrative medical theory learning and narrative writing on professionalism, empathy and humanistic care ability of nursing students. Methods: This cluster randomized controlled trial was conducted between June 2021 and June 2022 in two universities in Jiangsu, China. The participants of this study were 85 nursing students who were randomly divided into the intervention group (n = 43) or the control group (n = 42). Participants in the intervention group were trained in narrative medical theory learning and narrative writing based on a Web-based platform, while those in the control group were not. Self-report questionnaires of professionalism, empathy and humanistic care ability were used before and after intervention. Results: The results showed that the professionalism score of the intervention group was (68.7 ± 6.8 vs. 64.5 ± 7.5; P = 0.005), empathy (99.4 ± 15.7 vs. 92.2 ± 14.6; P = 0.014) and humanistic care ability (127.6 ± 20.0 vs. 113.3 ± 18.8; P = 0.004) were better than the control group. Conclusion: The results of this quantitative study suggest that narrative medical theory education and narrative writing based on the network platform can promote the development of professionalism, empathy and humanistic care ability of nursing undergraduates. [ABSTRACT FROM AUTHOR]

Backgrounds: Hikikomori, pathological social withdrawal, is becoming a crucial mental health issue in Japan and worldwide. We have developed a 3-day family intervention program for hikikomori sufferers based on Mental Health First Aid (MHFA) and Community Reinforcement and Family Training (CRAFT). This study aims to confirm the effectiveness of the 3-day program by a randomized controlled trial. Methods: This study was registered on the UMIN Clinical Trials Registry (UMIN000037289). Fifteen parents were assigned to the treat as usual (TAU) group (TAU only; Age Mean, 65.6; SD, 7.8), and 14 to the Program group (program + TAU; Age Mean, 67.9; SD, 8.6). This study was discontinued due to the COVID-19 pandemic; the recruitment rate was 36.3% of our target sample size of 80. Results: Perceived skills improved temporally and stigma temporally worsened in the TAU group. Confidence decreased and attitude showed no change in both groups. Aggressive behaviors of hikikomori sufferers were significantly worsened in the Program group; however, no serious domestic violence was reported. In the TAU group, Avoidance and irregular life patterns were improved. Activity levels were worsened in both groups. Two participants (16.7%) in the Program group and one participant (7.7%) in the TAU group reported actual behavioral changes (e.g., utilizing support). Conclusion: We could not draw general conclusions on the effectiveness of the program due to the study discontinuation. Nevertheless, this study indicates the necessity for revision of the program to improve family members’ confidence in engaging with hikikomori sufferers, with safer approaching by families. [ABSTRACT FROM AUTHOR]

KID-PROTEKT is a child-centred psychosocial healthcare intervention which aims at improving the identification of psychosocial needs and navigation in the outpatient gynaecologic and paediatric setting. In this cluster randomizedcontrolled trail we examined the effect of KID-PROTEKT on the referrals (to support services) in comparison to the regular gynaecologic and paediatric outpatient healthcare . A variant based on the qualification of the healthcare providers (qualified treatment, QT) and a variant with social worker (supported treatment, ST) were compared to the regular healthcare (treatment as usual, TAU). Twenty-four gynaecologic and paediatric practices were randomized to one of three study arms. Therefore 8,458 pregnant women and families recruited in one of these practices were enrolled in the study. Participating patients reported on average 1.73 (SD = 1.34) psychosocial risks. In total 522 patients were linked to a support service. Compared to TAU, the probability of a referral was significantly higher in QT (OR = 10.70) and ST (OR = 11.28). Also, a higher number of psychosocial risks were linked to a referral (OR = 2.72). These findings support the importance of a psychosocial assessment in the gynaecologic and paediatric setting. [ABSTRACT FROM AUTHOR]

Objective: Despite the high prevalence of obesity and associated health risks in the United States adult population, few primary care providers (PCPs) have time and training to provide weight-management counseling to their patients. This study aims to compare the effect of referral to a comprehensive automated digital weight-loss program, with or without provider email feedback, with usual care on weight loss in patients with overweight or obesity.Methods: A total of 550 adults (mean [SD], 51.4 [11.2] years, BMI = 35.1 [5.5] kg/m2 , 72.0% female) were enrolled through their PCPs (n = 31). Providers were randomly assigned to refer their patients to a 12-month internet weight-loss intervention only (IWL), the intervention plus semiautomated feedback from the provider (IWL + PCP), or to usual care (EUC). Weight was measured at baseline and at 3, 6, and 12 months.Results: Weight changes (mean [SE]) at 12 months were -0.92 (0.46), -3.68 (0.46), and -3.58 (0.48) kg in the EUC, IWL, and IWL + PCP groups, respectively. Outcomes were significantly different in EUC versus IWL and EUC versus IWL + PCP (p < 0.001), but not in IWL versus IWL + PCP.Conclusions: Referral by PCPs to an automated weight-loss program holds promise for patients with obesity. Future research should explore ways to further promote accountability and adherence. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depression are two common psychological disorders in patients with pulmonary tuberculosis. We aimed to explore the effects of cognitive-behavioral therapy (CBT) on psychological stress and quality of life in patients with pulmonary tuberculosis.Methods: From September 2018 to November 2018, 20 communities (461 participants in total) were randomly assigned in an intervention or control group following a two-level cluster random design. The intervention group underwent CBT for 2 months, whereas the control group received routine follow-up. Anxiety, depression, and quality of life were assessed using the Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder questionnaire (GAD-7), and 36-Item Short-Form Health Survey (SF-36) scales, respectively. Comparisons between the two groups were conducted using independent samples t-tests, and differences between the two groups before and after treatment were analyzed using paired samples t-tests.Results: There were a total of 454 participants in the final analysis. After 2 months of CBT intervention, the CBT group had a GAD-7 score that was 1.72 lower than the control group (1.47-1.99, p < 0.001), a PHQ-9 score of the CBT group that was 2.05 lower than that of the control group (1.74-2.37, p < 0.001). The CBT group had a total SF-36 score that was 10.7 lower than that of the control group (95% CI: 7.9-13.5, p < 0.001). In patients with different degrees of anxiety and depression, only those in the intervention group who had mild and moderate anxiety and depression symptoms showed a significant reduction in anxiety and depression scores following the intervention.Conclusions: CBT can relieve anxiety, and depression symptoms and increase the quality of life in subjects with pulmonary tuberculosis.Trials Registration: ChiCTR-TRC-12001958 Date of Registration: 22/02/2012. [ABSTRACT FROM AUTHOR]

Aquaculture in Ghana is experiencing tremendous growth, led mainly by large‐scale commercial cage operators. A major objective of the government and its partners is to ensure that this rapid growth is sustainable and includes small‐scale farmers and poor rural producers. This paper evaluates the aquaculture trainings implemented in six main tilapia‐producing regions in Ghana as part of the Ghana Tilapia Seed Project. The impact evaluation is designed as a cluster randomized controlled trial, with half of the producing districts randomly‐assigned as the treatment and the rest as the control, complemented by qualitative interviews. One year after the trainings, results show positive impacts on the adoption of good record‐keeping, water management, and some biosecurity practices, and on productivity and incomes. In terms of mechanism, improved management practices resulted from reducing overstocking, reducing inbreeding, maintaining water level for fish ponds, regular pond clearing and establishing physical barriers, following advice and recommendations on feeding practices, and complementing feeding practices with farmers' own feed formulation. Half of the trained farmers experienced lower fish mortality, faster growth, and heavier fish at harvest. Marketing and processing advice through the trainings and complementary FishConnect WhatsApp platform likely contributed to higher incomes, although the platform's coverage and regular updating can be improved. [ABSTRACT FROM AUTHOR]

Background: Covid-19 affects health behaviors in terms of less physical activity and increased sedentary behavior of office employees, which is a cause of non-communicable diseases. Objective: To investigate the effectiveness of a motivational enhancement program in work exercise movement (MEP in WEM) based on the Capability Opportunity Motivation Behavior (COM-B) model. Materials and Methods: The cluster randomized controlled trials (RCTs) were designed to collect data and test the program's effectiveness. Fifty-eight officers, divided into two groups, with 28 officers in the experimental group and 30 officers in the control group, were included in this study. This was calculated by statistical power analysis for the behavioral sciences with an effect size of 0.80, p-value 0.05. The data were collected from the Likert rating scale with a Cronbach's reliability score of 0.776 to 0.911. The MEP ran for 11 weeks with 12 intervention activities between April and July 2021. Descriptive statistics and t-tests were used for data analyses. Results: After participation, employees' motivation (mean 3.12, SD 0.520) and sedentary behavior (mean 2.65, SD 0.691) were at a high level, and the MEP in WEM was significantly effective in enhancing motivation. Additionally, the experimental group had the higher motivation and less sedentary behavior than the control group before participating in the intervention at a significance level of 0.05. Conclusion: This ME program should be used to initiate policies in promoting physical activity of office employees. [ABSTRACT FROM AUTHOR]

In this work, we propose nonparametric two-sample tests for population-averaged transition and state occupation probabilities for continuous-time and finite state space processes with clustered, right-censored, and/or left-truncated data. We consider settings where the two groups under comparison are independent or dependent, with or without complete cluster structure. The proposed tests do not impose assumptions regarding the structure of the within-cluster dependence and are applicable to settings with informative cluster size and/or non-Markov processes. The asymptotic properties of the tests are rigorously established using empirical process theory. Simulation studies show that the proposed tests work well even with a small number of clusters, and that they can be substantially more powerful compared to the only, to the best of our knowledge, previously proposed nonparametric test for this problem. The tests are illustrated using data from a multicenter randomized controlled trial on metastatic squamous-cell carcinoma of the head and neck. [ABSTRACT FROM AUTHOR]

Background: Perinatal depression is more common and is associated with greater negative consequences among adolescents than adults. Psychosocial interventions designed for adults may be inadequate at addressing the unique features of adolescent perinatal depression.Methods: In a two-arm parallel cluster randomized trial conducted in thirty primary maternal care clinics in Ibadan, Nigeria (15-intervention and 15-control) we compared age-appropriate intervention consisting of problem-solving therapy, behavioral activation, parenting skills training, and parenting support from a self-identified adult to care as usual. Pregnant adolescents (aged <20 years) at fetal gestational age16-36 weeks with moderate to severe depression were recruited. Primary outcomes were depression symptoms (Edinburgh Postnatal Depression Scale, EPDS) and parenting practices (Infant-Toddler version of the Home Inventory for Measurement of the Environment, HOME-IT) at six-months postnatal.Results: There were 242 participants (intervention arm: 141; Control arm: 101), with a mean age of 18∙0 (SD-1∙2). Baseline mean EPDS score was 14∙2 (SD-2.1); 80∙1 % completed the six-month postnatal follow-up. The intervention group had lower level of depressive symptoms than the control group, mean EPDS scores: 5∙5 (SD-3∙6) versus 7∙2 (SD-4∙0) (adjusted mean difference -1∙84 (95%CI- 3∙06 to -0∙62; p = 0∙003) and better parenting practices, mean total HOME-IT scores: 29∙8 (SD-4∙4) versus 26∙4 (SD-4∙2) (adjusted mean difference 3∙4 (95%Cl- 2∙12 to 4∙69, p = 0∙001).Limitations: This study explored the effect of complex interventions making it difficult to know precisely what aspects produced the outcomes.Conclusions: An age-appropriate psychosocial intervention package holds promise for scaling up care for adolescents with perinatal depression especially in resource-constrained settings.Trial Registration: ISRCTN16775958. Registered on 30 April 2019. [ABSTRACT FROM AUTHOR]