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Background: Poor early childhood development (ECD) is a major global health concern that is associated with various adverse outcomes over the lifecourse. Parenting interventions especially during the earliest years of life can benefit ECD. However, there is limited evidence from Kenya about the effectiveness of parenting interventions for improving ECD outcomes especially across rural disadvantaged communities. This paper describes the study protocol for an impact and implementation evaluation of a community-based group parenting program that aims to improve ECD in rural Kenya. Methods: We will conduct a cluster-randomized controlled trial to determine the effectiveness of a parenting program for caregivers of young children in Homabay and Busia counties in Western Kenya. Sixty-four village clusters will be randomly assigned to either the parenting intervention arm or the waitlist control arm with stratification by county. In each village, 10 primary caregivers with a child aged 0–24 months will be enrolled. The parenting program will be delivered through existing peer groups within communities whereby caregivers will receive counseling and psychosocial support to enhance their parenting skills and wellbeing to in turn promote ECD. The intervention curriculum comprises 21 sessions targeting various nurturing care messages, including early learning, responsive caregiving, child nutrition, health, protection, and caregiver mental health. Group sessions are facilitated by a trained volunteer biweekly for a total of 11 months. The primary trial outcome is an overall measure of ECD using the Global Scales of Early Development long form version. Secondary outcomes include various caregiver outcomes (e.g., parenting practices, mental health) and other child outcomes (e.g., socioemotional development, dietary diversity). All outcomes will be assessed at baseline and endline. We will also conduct a qualitative implementation evaluation at endline and interview various stakeholders to assess program fidelity, quality, and sustainability. Discussion: This trial will evaluate the effectiveness of a parenting intervention on ECD and caregiving outcomes and assess program implementation quality as delivered through existing community-based peer groups. This study will provide rigorous evidence that can be used to inform scale-up of this program model that leverages existing community social networks and resources for improving caregivers' parenting skills and promoting ECD in rural Kenya and other similar settings across LMICs. Trial registration: ClinicalTrials.gov #NCT06165315. Registered on December 11, 2023. [ABSTRACT FROM AUTHOR]

Background : Vulnerable children, including those with neuro-developmental delays and disabilities, often face barriers in accessing early primary education, thus hindering progress toward Sustainable Development Goal 4.2. Evidence-based interventions are essential to enhancing inclusivity and establishing sustainable implementation strategies to address this challenge. This study, Every Newborn—Reach up Early Education Intervention for All Children (EN-REACH), builds on the previous Every Newborn- Simplified Measurement Integrating Longitudinal Neurodevelopmental and Growth (EN-SMILING) observational cohort study. This paper provides the protocol for a cluster randomized controlled trial (cRCT) to evaluate the effectiveness of a parenting group intervention program for enhancing school readiness in Bangladesh, Nepal, and Tanzania, and an embedded process evaluation to inform scalability and feasibility. Methods: EN-REACH is a cRCT with at least 150 clusters to evaluate the impact of a parent training program led by trained parent-teacher facilitator pairs, focusing on children aged 4 ~ 6 years preparing for preschool. Approximately 500 participants from the EN-SMILING cohort at each site have been identified. A geographic information system will define ~ 50 clusters in each of the three countries, each with approximately ten parent–child dyads. Half the clusters will be randomly assigned to intervention and control groups. The primary outcome is "school readiness", assessed using the Measuring Early Learning Quality and Outcomes tool. Secondary outcomes include Intelligence Quotient, child functioning, growth, visual, and hearing assessments. Data will be collected at baseline, and post-intervention data following implementation of the parent group intervention sessions over approximately 5 months. Quantitative data on coverage and quality care, combined with qualitative insights from children, caregivers, facilitators, and stakeholders' perspectives, will be used to conduct a process evaluation applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Discussion: This protocol details a trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aiming to bridge gap from home to early primary education. EN-REACH aims to provide insights into the effectiveness and acceptability of a co-designed disability-inclusive school readiness program in three countries, potentially impacting national and global policies for all children, including those with disabilities. Trial registration: The trial was retrospectively registered on clinicaltrials.gov on 29 February 2024 (NCT06334627). [ABSTRACT FROM AUTHOR]

Aims Design Setting Participants Intervention and comparator Measurements Findings Conclusions To evaluate the effectiveness of mobile smoking cessation (SC) treatment with 1‐week nicotine replacement therapy (NRT) sampling on recruitment and quitting outcomes.Two‐arm cluster RCT (1:1 ratio), single‐blinded, at 244 recruitment sessions in Hong Kong outdoor smoking hotspots from October 2018–December 2019.Participant were recruited by ambassadors and treated at the mobile SC truck.834 adult (≥18 years, male 81.3%) daily smokers, Chinese‐speaking, non‐NRT users in the past month, consented after nurse‐led intervention in mobile SC truck were randomized to the experimental (n = 482 male 79.5%) and the control group (n = 352, male 83.8%).The experimental group received a 1‐week free NRT sample, an NRT instruction card, and mobile SC treatment including onsite nurse‐led brief medication advice (about 15 minutes) and referral to SC clinics. The control group received the same mobile SC treatment.Primary outcome was self‐reported quit attempts at 1‐month follow‐up. Secondary outcomes included SC service use at 1 month, and biochemically validated abstinence (exhaled carbon monoxide < 4 ppm; or saliva cotinine < 10 ng/ml) at 6‐month follow‐up. Additionally, a post‐hoc cost analysis was conducted.By intention‐to‐treat, the two groups showed similar prevalence of quit attempts (44·4% versus 43·5%, risk ratio (RR) = 1·04, 95% confidence interval (CI) = 0·79–1·37, P = 0·79). Compared with the control group, the experimental group showed lower SC service use at clinics (32·4% versus 44·9%, RR = 0·72, 95%CI = 0·57–0·91, P = 0·006), but no significant difference in validated abstinence (4·6% versus 2·8%, RR = 1·64, 95%CI = 0·76–3·50, P = 0·21). The experimental recruitment sessions recruited more smokers for onsite medication advice than the control session (mean 6·7 vs 5·0, adjusted incident rate ratio = 1·30, 95%CI = 1·08–1·56, P = 0·005).Mobile smoking cessation treatment with 1‐week nicotine replacement therapy sampling did not increase quit attempts or abstinence outcomes among recruited daily smokers in Hong Kong. The intervention increased smokers' uptake of onsite medication advice but reduced subsequent smoking cessation service use at clinics. [ABSTRACT FROM AUTHOR]

Background: Hip fracture surgery under general or spinal anesthesia is a common procedure for older adults in the United States (US). Although spinal or general anesthesia can be appropriate for many patients, and the choice between anesthesia types is preference-sensitive, shared decision-making is not consistently used by anesthesiologists counseling patients on anesthesia for this procedure. We designed an Option Grid™-style conversation aid, My Anesthesia Choice─Hip Fracture, to promote shared decision making in this interaction. This study will refine the aid and evaluate its implementation and effectiveness in clinical practice. Methods: The study will be conducted over 2 phases: qualitative interviews with relevant clinicians and patients to refine the aid, followed by a stepped wedge cluster randomized trial of the intervention at 6 settings in the US. Primary outcomes will include the percentage of eligible patients who receive the intervention (intervention reach) and the change in quality of patient/clinician communication (intervention effectiveness). Secondary outcomes addressing other RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) domains will also be collected. Outcomes will be compared between baseline data and an active implementation period and then compared between the active implementation period and a sustainment period. Implementation strategies are guided by three constructs from the Practical, Robust Implementation and Sustainability Model (PRISM): intervention, recipients, and implementation and sustainability infrastructure. Discussion: This is a novel, large-scale trial evaluating and implementing a shared decision-making conversation aid for anesthesia choices. Strong buy-in from site leads and expert advisors will support both the success of implementation and the future dissemination of results and the intervention. Results from this study will inform the broader implementation of this aid for patients with hip fractures and can lead to the development and implementation of similar conversation aids for other anesthesia choices. Trial registration: ClinicalTrials.gov, NCT06438640 [ABSTRACT FROM AUTHOR]

Objective: The university period is a critical stage of personal development, and improving the physical fitness of university students is crucial to their academic performance, quality of life, and future. However, in recent years, the physical fitness level of Chinese university students has shown a decreasing trend. This study aimed to investigate the effects of a blended learning model on the physical fitness of Chinese university students through a 16-week intervention. Methods: A total of 78 first-year students from a public university in Henan Province were recruited for this study via a cluster randomized controlled trial (CRCT) design. The participants were divided into an experimental group (blended learning) and a control group (traditional learning). The intervention lasted for 16 weeks, and physical fitness indices such as body mass index (BMI), lung capacity, sit and reach, pull-ups/sit-ups, standing long jumps, 50-meter runs, and 1000/800-meter runs were measured before and after the intervention. Statistical analyses were conducted via generalized estimating equation (GEE) modeling, with the significance level set at P < 0.05. Results: Both learning models significantly improved students' physical fitness after 16 weeks. However, the blended learning model resulted in more significant improvements in lung capacity, sit and reach, pull-ups/sit-ups, standing long jumps, and 50-meter runs (P < 0.05). No significant differences were found between the two groups in terms of BMI or 1000/800-meter run. Conclusions: The 16-week blended learning model effectively promoted physical fitness among university students, especially in terms of their lung capacity, flexibility, strength and speed. [ABSTRACT FROM AUTHOR]

This document is a letter to the editor discussing a systematic review and meta-analysis on the topic of deprescribing in older inpatients. The analysis found that deprescribing interventions in hospitals were associated with a small but significant reduction in readmissions. The authors suggest that future meta-analyses should focus on randomized controlled trials (RCTs) and analyze observational data separately. They also mention that while longer-term studies may show sustained reductions in rehospitalization, the early benefits of deprescribing may already justify its implementation. The authors disclose their financial interests and affiliations, and the article did not receive any funding. [Extracted from the article]

This document is a reply to a letter to the editor regarding a meta-analysis of randomized controlled trials (RCTs) on the association between deprescribing and reduced hospital readmission rates. The authors address concerns raised in the letter and provide additional details on their methodology and calculations. The updated meta-analysis confirms that deprescribing interventions are associated with a 15% reduced hazard of readmission at 1-3 months compared to the control group. The analysis also shows a trend towards a reduced hazard over longer follow-up periods. The given text appears to be a table or chart that presents data on various studies related to a specific topic, providing a comprehensive overview of the studies and their findings. The given text is a letter to the editor discussing the findings of a systematic review and meta-analysis on the effects of medication review and deprescribing interventions in older inpatients. The authors found that these interventions were not associated with a reduced mortality rate but had a protective effect on rehospitalization, especially during the first three months after hospital discharge. The authors acknowledge their funding sources and declare no conflicts of interest. [Extracted from the article]

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]

Introduction The DoD has prioritized programs to optimize readiness by enhancing resilience of its service members. Problematic anger in the military is an issue that impacts psychological well-being and resilience. Leader support is a potential tactic for reducing anger and its effects. Currently military resilience training is focused on individual level resilience. A gap exists in such training and there is a need to train leaders to provide mental health and resilience support to their subordinates. The present study developed and tested a theory-based training aimed at platoon leaders that focused on how to engage in proactive and responsive mental health and resilience-supportive behaviors through guided discussion, scenarios, and computer-based training with embedded quizzes. Materials and Methods We conducted an Institutional Review Board–approved cluster randomized controlled trial to test the effects of a leadership training with Army platoon leaders (n  = 99) and soldiers (n  = 276) in 2 brigades at an active duty military installation in the USA. Training was conducted in person with a computer-based component. Soldiers completed online surveys 1 month prior and again 3 months after the leader training. Results Post-training results demonstrated significant leader learning effects (Cohen's d  = 1.56) and leader positive reactions to the training information, with leaders reporting the information as useful and relevant to their work. Service members in the treatment group reported significantly lower levels of anger at time 2 (b  = −0.18, SE  = 0.06, P  = .002, pseudo Δ R 2 = 0.01; d  = 0.27) compared to the control group. We also found an indirect effect of the intervention on increased life satisfaction at time 2 via decreased anger (b  = 0.035, SE  = 0.023, 95% CI = [0.004-0.24]). Conclusions This study provides an initial evaluation of training for platoon leaders that educates them on proactive and responsive behavioral strategies to support the mental health and resilience of their service members via decreased problematic anger and increased well-being. Further adaptations and evaluations should be conducted with other military branches and civilian occupations, as the benefits of the relatively brief and noninvasive training could be widespread. [ABSTRACT FROM AUTHOR]

Background: The positive effects of regular physical activity on children and adolescents' physical and mental health are well-established. Despite these health benefits, most Swiss adolescents do not meet WHO's recommended level of physical activity, which includes a daily minimum of 60 min of moderate-to-vigorous physical activity. Due to their inclusivity, schools are identified as a key setting to promote physical activity. Recently, the comprehensive school physical activity program (CSPAP), in which teachers as physical activity leaders (PALs) play a crucial role to advance comprehensive school-based physical activity promotion, has been discussed. However, such comprehensive approaches are still lacking in Switzerland, and specific PAL trainings do not exist. Therefore, the aim of this study is to implement and evaluate Active School, a comprehensive school-based physical activity program for Swiss secondary schools with integrated PAL training. Methods/design: A cluster randomized controlled trial (RCT) involving 12 secondary schools (6 experimental, 6 waiting control schools) will assess baseline data and effectiveness of Active School at 12 and 24 months. Active School includes five components based on the CSPAP. Each school is encouraged to set individual physical activity goals in this regard. This process is guided by the PALs, who will participate in professional development training before and during Active School implementation. As a primary outcome, students' moderate-to-vigorous physical activity will be assessed via accelerometers. As secondary outcomes, inactivity, light physical activity, step counts, aerobic fitness and coordination will be measured, and students' general wellbeing, learning behavior, and multiple psychosocial measures related to physical activity will be assessed by questionnaires. The effectiveness evaluation is accompanied by a process evaluation that focuses on the implementation outcomes of dose of delivery, reach, feasibility, and sustainability. A mixed methods approach, including ripple effect mapping, will be employed to reconstruct and understand the implementation process. Discussion: This study will be the first to implement and evaluate a CSPAP in the Swiss school system. The specific PAL training and the simultaneous application of effectiveness and process evaluation are considered strengths of the study. Trial registration: German Clinical Trials Register (DRKS00033362). Date of registration: January 25, 2024. Retrospectively registered. [ABSTRACT FROM AUTHOR]

PURPOSE We undertook a trial to test the efficacy of a technology-assisted health coaching intervention for weight management, called Goals for Eating and Moving (GEM), within primary care. METHODS This cluster-randomized controlled trial enrolled 19 primary care teams with 63 clinicians; 9 teams were randomized to GEM and 10 to enhanced usual care (EUC). The GEM intervention included 1 in-person and up to 12 telephone-delivered coaching sessions. Coaches supported goal setting and engagement with weight management programs, facilitated by a software tool. Patients in the EUC arm received educational handouts. We enrolled patients who spoke English or Spanish, were aged 18 to 69 years, and either were overweight (body mass index 25-29 kg/m²) with a weight-related comorbidity or had obesity (body mass index ≥30 kg/m²). The primary outcome (weight change at 12 months) and exploratory outcomes (eg, program attendance, diet, physical activity) were analyzed according to intention to treat. RESULTS We enrolled 489 patients (220 in the GEM arm, 269 in the EUC arm). Their mean (SD) age was 49.8 (12.1) years; 44% were male, 41% Hispanic, and 44% non-Hispanic Black. At 12 months, the mean adjusted weight change (standard error) was −1.4 (0.8) kg in the GEM arm vs −0.8 (1.6) kg in the EUC arm, a nonsignificant difference (P = .48). There were no statistically significant differences in secondary outcomes. Exploratory analyses showed that the GEM arm had a greater change than the EUC arm in mean number of weekly minutes of moderate to vigorous physical activity other than walking, a finding that may warrant further exploration. CONCLUSIONS The GEM intervention did not achieve clinically important weight loss in primary care. Although this was a negative study possibly affected by health system resource limitations and disruptions, its findings can guide the development of similar interventions. Future studies could explore the efficacy of higher-intensity interventions and interventions that include medication and bariatric surgery options, in addition to lifestyle modification. [ABSTRACT FROM AUTHOR]

Linear mixed models are commonly used in analyzing stepped-wedge cluster randomized trials. A key consideration for analyzing a stepped-wedge cluster randomized trial is accounting for the potentially complex correlation structure, which can be achieved by specifying random-effects. The simplest random effects structure is random intercept but more complex structures such as random cluster-by-period, discrete-time decay, and more recently, the random intervention structure, have been proposed. Specifying appropriate random effects in practice can be challenging: assuming more complex correlation structures may be reasonable but they are vulnerable to computational challenges. To circumvent these challenges, robust variance estimators may be applied to linear mixed models to provide consistent estimators of standard errors of fixed effect parameters in the presence of random-effects misspecification. However, there has been no empirical investigation of robust variance estimators for stepped-wedge cluster randomized trials. In this article, we review six robust variance estimators (both standard and small-sample bias-corrected robust variance estimators) that are available for linear mixed models in R, and then describe a comprehensive simulation study to examine the performance of these robust variance estimators for stepped-wedge cluster randomized trials with a continuous outcome under different data generators. For each data generator, we investigate whether the use of a robust variance estimator with either the random intercept model or the random cluster-by-period model is sufficient to provide valid statistical inference for fixed effect parameters, when these working models are subject to random-effect misspecification. Our results indicate that the random intercept and random cluster-by-period models with robust variance estimators performed adequately. The CR3 robust variance estimator (approximate jackknife) estimator, coupled with the number of clusters minus two degrees of freedom correction, consistently gave the best coverage results, but could be slightly conservative when the number of clusters was below 16. We summarize the implications of our results for the linear mixed model analysis of stepped-wedge cluster randomized trials and offer some practical recommendations on the choice of the analytic model. [ABSTRACT FROM AUTHOR]

Introduction: Careful monitoring of patients who receive intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is resource-intensive, and potentially less relevant in those with mild degrees of neurological impairment who are at low risk of symptomatic intracerebral hemorrhage (sICH) and other complications. Methods: OPTIMISTmain is an international, multicenter, prospective, stepped wedge, cluster randomized, blinded outcome assessed trial aims to determine whether a less-intensity monitoring protocol is at least as effective, safe, and efficient as standard post-IVT monitoring in patients with mild deficits post-AIS. Clinically stable adult patients with mild AIS (defined by a NIHSS <10) who do not require intensive care within 2 h post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, USA, and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7,200 IVT-treated AIS patients will provide 90% power (one-sided α 0.025). The initiation of eligible hospitals is based on a rolling process whenever ready, stratified by country. Hospitals are randomly allocated using permuted blocks into 3 sequences of implementation, stratified by country and the projected number of patients to be recruited over 12 months. These sequences have four periods that dictate the order in which they are to switch from control (usual care) to intervention (implementation of low intensity monitoring protocol) to different clusters of patients in a stepped manner. Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 min for 2 h, 2 hourly (vs. every 30 min) for 8 h, and 4 hourly (vs. every 1 h) until 24 h, post-IVT. The primary outcome measure is functional recovery, defined by the modified Rankin scale (mRS) at 90 days, a seven-point ordinal scale (0 [no residual symptom] to 6 [death]). Secondary outcomes include death or dependency, length of hospital stay, and health-related quality of life, sICH, and serious adverse events. Conclusion: OPTIMISTmain will provide level I evidence for the safety and effectiveness of a low-intensity post-IVT monitoring protocol in patients with mild severity of AIS. [ABSTRACT FROM AUTHOR]

• This 12-week Goldilocks Work intervention was delivered almost as planned with high quality and adherence to the predefined protocol. • Despite the high level of adherence, the intervention did not result in a change towards the intended 'just right' ergonomic balance in physical behaviors. • This Goldilocks Work intervention did not promote musculoskeletal health or change productivity among industrial workers with physically demanding work. • Further research is needed to identify effective implementation strategies that can change physical behaviors within an industrial setting. Introduction: Industrial workers with physically demanding work have increased risk of musculoskeletal pain. The present 12-week Goldilocks Work intervention aimed to organize work among industrial workers to comprise a 'just right' ergonomic balance of physical behaviors (i.e., sit, stand and active) intended to promote musculoskeletal health. The paper investigates the effectiveness of the intervention in reducing low back pain after work. Methods: 83 workers across 28 workteams in a biotech organization were recruited. Workteams were randomly allocated to receive the intervention or work as usual (control). Intervention workteams implemented the Goldilocks Work planning tool to organize their work tasks towards a predefined 'just right' ergonomic balance (i.e., composition of 60% sitting, 30% standing, 10% active work and hourly task alternation). The primary outcome was low back pain intensity. Secondary outcomes were bodily pain, fatigue, physical exertion, productivity and energy after work measured in the survey, and composition and alternations of physical behaviors measured using wearable sensors. Results: The intervention was delivered almost as planned, with good quality and high adherence among most workteams. However, the intervention did not change physical behaviors towards the intended 'just right' ergonomic balance. No significant reduction in low back pain (0.07, CI 95%: −0.68; 0.82), bodily pain (0.10, CI 95%: −0.57; 0.76), tiredness (−0.53, CI 95%: −1.24; 0.19), physical exertion (−0.18, CI 95%: −0.83; 0.48), or improvement in energy (0.39, CI 95%: −1.02; 0.23) or productivity (−0.03, CI 95%: −0.77; 0.72) were found. Conclusion: This Goldilocks Work intervention did not promote musculoskeletal health among industrial workers and did not change physical behaviors as intended. Thus, more research is needed into implementation strategies to change physical behaviors during productive work towards an evidence-based 'just right' ergonomic balance. [ABSTRACT FROM AUTHOR]

This study used a cluster randomized controlled trial to investigate the effectiveness of two approaches to increasing middle school students' science learning when using an inquiry‐based science curriculum. Eighty‐nine schools, with 253 teachers and 20,591 students, were randomly assigned into one of three conditions: (a) a treatment condition in which the textbook curriculum was modified based on three principles of cognitive science coupled with teacher professional development (PD), (b) a second treatment condition in which teachers received PD designed to improve their knowledge of the science content, and (c) a business‐as‐usual control group. The cognitive science treatment had a small but statistically significant positive effect on content learning, with a stronger impact on students of higher prior achievement. Compared to business‐as‐usual, the intervention to increase teacher content knowledge had no impact. [ABSTRACT FROM AUTHOR]

Background: Physical therapy interventions play a crucial role in the daily care of patients recovering from severe stroke. However, the efficacy of these interventions and associated modalities, including duration, intensity, and frequency, have not been fully elucidated. In 2020, a systematic review reported the beneficial effects of physical therapy for patients with severe stroke but did not assess therapeutic modalities. We aim to update the current evidence on the effects of physical therapy interventions and their modalities in relation to the recovery phase in people with severe stroke in a hospital or inpatient rehabilitation facility. Methods: We searched CENTRAL, MEDLINE, Web of Science, and three other relevant databases between December 2018 and March 2021 and updated the search between April 2021 and March 2023. ClinicalTrials.gov and ICTRP for searching trial registries helped to identify ongoing RCTs since 2023. We included individual and cluster randomized controlled trials in the English and German languages that compared physical therapy interventions to similar or other interventions, usual care, or no intervention in a hospital or rehabilitation inpatient setting. We screened the studies from this recent review for eligibility criteria, especially according to the setting. Critical appraisal was performed according to the Cochrane risk-of-bias tool 2.0. The data were synthesized narratively. Results: The update identified 15 new studies, cumulating in a total of 30 studies (n = 2545 participants) meeting the eligibility criteria. These studies reported 54 outcomes and 20 physical therapy interventions. Two studies included participants during the hyperacute phase, 4 during the acute phase,18 during the early subacute phase, and 3 in the late subacute phase. Three studies started in the chronic phase. Summarised evidence has revealed an uncertain effect of physical therapy on patient outcomes (with moderate to low-quality evidence). Most studies showed a high risk of bias and did not reach the optimal sample size. Little was stated about the standard care and their therapy modalities. Discussion: There is conflicting evidence for the effectiveness of physical therapy interventions in patients with severe stroke. There is a need for additional high-quality studies that also systematically report therapeutic modalities from a multidimensional perspective in motor stroke recovery. Due to the high risk of bias and the generally small sample size of the included studies, the generalizability of the findings to large and heterogeneous volumes of outcome data is limited. Systematic review registration: PROSPERO CRD42021244285. [ABSTRACT FROM AUTHOR]

In the cluster randomized crossover trial, a sequence of treatment conditions, rather than just one treatment condition, is assigned to each cluster. This contribution studies the optimal number of time periods in studies with a treatment switch at the end of each time period, and the optimal number of treatment switches in a trial with a fixed number of time periods. This is done for trials with a fixed number of clusters, and for trials in which the costs per cluster, subject, and treatment switch are taken into account using a budgetary constraint. The focus is on trials with a cross-sectional design where a continuous outcome variable is measured at the end of each time period. An exponential decay correlation structure is used to model dependencies among subjects within the same cluster. A linear multilevel mixed model is used to estimate the treatment effect and its associated variance. The optimal design minimizes this variance. Matrix algebra is used to identify the optimal design and other highly efficient designs. For a fixed number of clusters, a design with the maximum number of time periods is optimal and treatment switches should occur at each time period. However, when a budgetary constraint is taken into account, the optimal design may have fewer time periods and fewer treatment switches. The Shiny app was developed to facilitate the use of the methodology in this contribution. [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]

Maternal malnutrition is pervasive throughout the world, notably in sub-Saharan Africa (SSA), including Ethiopia. This study aimed to assess the effect of nutrition education on the nutritional status of pregnant women in urban settings in Southeast Ethiopia. A community-based two-arm parallel cluster randomized controlled trial was conducted among 447 randomly selected pregnant women attending antenatal care (224 intervention and 223 control). We used a multistage cluster sampling technique followed by systematic sampling to select the pregnant women. Pregnant women who participated in the intervention arm received six nutrition education sessions. Women in the control group received standard care. A nonstretchable mid-upper arm circumference (MUAC) tape was used to measure the MUAC. A linear mixed effects model (LMM) was used to evaluate the effect of the intervention on MUAC, accounting for the clustering. The net mean ± standard error of MUAC between the intervention and control groups was 0.59 ± 0.05 (P < 0.0001). The multivariable LMM indicated that having received nutrition education interventions (β = 0.85, 95% CI 0.60, 1.12, P < 0.0001) improved the MUAC measurement of pregnant women. Thus, nutrition education during pregnancy will combat undernutrition among pregnant women. Trial Registration: Clinicaltrials.gov (PACTR202201731802989), retrospectively registered on 24/01/2022. [ABSTRACT FROM AUTHOR]

Introduction: Sexual and reproductive health and rights (SRHR) are vital for both individual well-being and development. Bangladesh has made long strides in improving SRHR over the last few decades. However, the progress has been uneven across various groups of reproductive-aged females, with the married adolescent girls (MAGs) often being more vulnerable to denial of SRHR than other women. This study intends to develop Balika Bodhu, a combined empowerment and social norm intervention for promoting SRHR among the MAGs and assess its impact. Methods: The evaluation will employ a mixed-method two-arm Cluster Randomized Controlled Trial (CRCT) design, where Arm 1 receives the intervention, and Arm 2 serves as the control. The trial will cover 32 clusters (villages) in Rajbari Sadar sub-district, randomized into two equally distributed study arms. A total of 1,120 MAGs aged 15–19 years will be randomly selected from the clusters (35 per cluster) to form a cohort. The MAGs, their husbands, selected elderly women (26 per village) and influential community members (26 per village) will receive group sessions in the intervention clusters. The MAGs and their husbands will be interviewed at baseline and endline. A randomly selected cross-sectional sample of community members aged 35–59 years at baseline and endline will also be surveyed to measure attitudes and social norm regarding SRHR of MAGs. Qualitative data will be collected using 32 In-depth Interviews, six Key Informant Interviews, and eight Focus Group Discussions from two intervention villages. Intention-to-treat (ITT) analysis will be performed to assess the impact of the intervention. Narrative analysis and the Grounded Theory approach will be used to analyze the qualitative data. Conclusion: Rigorous evaluation of Balika Bodhu should contribute to the literature on what works and what does not in addressing denial of SRHR to MAGs using empowerment and social norm intervention and inform policies and programs. Trial registration: Clinicaltrials.gov: identifier: NCT06126770; Date: Oct 7, 2023. Version 1. [ABSTRACT FROM AUTHOR]

Background: Inadequate menstrual hygiene management can result in physical, social, psychological, and educational challenges for schoolgirls. To address these issues, researchers have conducted intervention studies, but the impact on school attendance has varied. This review has systematically collected and evaluated evidence about the effects of menstrual hygiene interventions on schoolgirls. Method: A systematic search of the literature was done and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA statement). Both peer-reviewed journals and gray literature were searched using PubMed and Google Scholar. The search included individual, or cluster randomized controlled trials, and quasi-experimental studies, and covered the period from the date of indexing until January 3, 2023. Result: A review of sixteen trial studies showed that menstrual hygiene interventions have a positive effect on schoolgirls' school attendance, performance, and dropout rates, as well as on their menstrual knowledge, attitudes, practices, and emotional well-being. There was a low to medium risk of bias in most of the studies. Additionally, the literature overlooked the impact of interventions that involve parental and male engagement, interventions correcting community misperceptions about menstruation, and the impact of infrastructure improvements on water, sanitation, and hygiene. Conclusion: Interventions aimed at improving menstrual hygiene management can enhance schoolgirls' educational outcomes, and can improve their menstrual knowledge, attitudes, and practices by helping them manage their periods more effectively. Most interventions have focused on the provision of menstrual products and menstrual education but have neglected improvements in the physical environment at home and school and the social norms surrounding menstruation. Trial studies should take a holistic approach that considers the total socio-cultural environment in which menstrual hygiene management takes place, thus enabling stakeholders and policymakers to develop sustainable, long-term solutions to these problems. [ABSTRACT FROM AUTHOR]

Background: Gender inequities remain critical determinants influencing maternal health. Harmful gender norms and gender-based violence adversely affect maternal health. Gendered division of labour, lack of access to and control of resources, and limited women's decision-making autonomy impede women's access to maternal healthcare services. We undertook a cluster randomized controlled trial of universal home visits to pregnant women and their spouses in one local government area in Bauchi State, North-Eastern Nigeria. The trial demonstrated a significant improvement in maternal and child health outcomes and male knowledge, attitudes and behaviours. This paper qualitatively evaluates gender equity in the home visits programme. Methods: The research team explored participants' views about gender equity in the home visits programme. We conducted nine key informant interviews with policymakers and 14 gender and age-stratified focus group discussions with men and women from visited households, with women and men home visitors and supervisors, and with men and women community leaders. Analysis used an adapted conceptual framework exploring gender equity in mainstream health. A deductive thematic analysis of interviews and focus group reports looked for patterns and meanings. Results: All respondents considered the home visits programme to have a positive impact on gender equity, as they perceived gender equity. Visited women and men and home visitors reported increased male support for household chores, with men doing heavy work traditionally pre-assigned to women. Men increased their support for women's maternal health by paying for healthcare and providing nutritious food. Households and community members confirmed that women no longer needed their spouses' permission to use health services for their own healthcare. Households and home visitors reported an improvement in spousal communication. They perceived a significant reduction in domestic violence, which they attributed to the changing attitudes of both women and men due to the home visits. All stakeholder groups stressed the importance of engaging male spouses in the home visits programme. Conclusion: The home visits programme, as implemented, contributed to gender equity. [ABSTRACT FROM AUTHOR]

Background: The disruption of health and medical education by the COVID-19 pandemic made educators question the effect of online setting on students' learning, motivation, self-efficacy and preference. In light of the health care staff shortage online scalable education seemed relevant. Reviews on the effect of online medical education called for high quality RCTs, which are increasingly relevant with rapid technological development and widespread adaption of online learning in universities. The objective of this trial is to compare standardized and feasible outcomes of an online and an onsite setting of a research course regarding the efficacy for PhD students within health and medical sciences: Primarily on learning of research methodology and secondly on preference, motivation, self-efficacy on short term and academic achievements on long term. Based on the authors experience with conducting courses during the pandemic, the hypothesis is that student preferred onsite setting is different to online setting. Methods: Cluster randomized trial with two parallel groups. Two PhD research training courses at the University of Copenhagen are randomized to online (Zoom) or onsite (The Parker Institute, Denmark) setting. Enrolled students are invited to participate in the study. Primary outcome is short term learning. Secondary outcomes are short term preference, motivation, self-efficacy, and long-term academic achievements. Standardized, reproducible and feasible outcomes will be measured by tailor made multiple choice questionnaires, evaluation survey, frequently used Intrinsic Motivation Inventory, Single Item Self-Efficacy Question, and Google Scholar publication data. Sample size is calculated to 20 clusters and courses are randomized by a computer random number generator. Statistical analyses will be performed blinded by an external statistical expert. Discussion: Primary outcome and secondary significant outcomes will be compared and contrasted with relevant literature. Limitations include geographical setting; bias include lack of blinding and strengths are robust assessment methods in a well-established conceptual framework. Generalizability to PhD education in other disciplines is high. Results of this study will both have implications for students and educators involved in research training courses in health and medical education and for the patients who ultimately benefits from this training. Trial registration: Retrospectively registered at ClinicalTrials.gov: NCT05736627. SPIRIT guidelines are followed. [ABSTRACT FROM AUTHOR]

Background: The incidence of sexually transmitted infections (STIs) is increasing, especially among young people. Tools are needed to increase knowledge about sex education and STI prevention and treatment. Gamification can be a good training tool for both young people and health professionals. The primary objective of this study is to assess the impact of a training intervention on STI prevention, detection, and treatment in primary care professionals. Methods/design: Multicentre cluster randomized controlled trial. Groups of primary care professionals will receive an intervention (online video game on sex education and STIs [SEXIT]) and will be compared with control groups that will not receive the intervention. Group assignments will be randomized by clusters. The study will consist of a pre-post evaluation of the intervention: a knowledge test will be administered before and after the intervention and 3 months after the intervention. This test will also be carried out on the same time sequence in the control groups. The impact of the training intervention will be assessed over a 6-month period, focusing on various variables associated with the clinical management of STIs. This evaluation entails the clinical records of diagnostic tests and antibiotic prescriptions related to the clinical approach to STIs. The required sample size is 262 (131 per group). Discussion: Compared with those in the control group, improvements in knowledge and clinical behavioural outcomes after the intervention are expected for participants in the intervention groups. We plan to develop an educational video game to increase the knowledge about sexuality, STIs and violence. Protocol registered at ISRCTN with reference number ISRCTN17783607. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has claimed around 170,000 lives among nursing home residents and staff in the United States through April 2023. In a cluster randomized controlled trial (RCT) with 136 nursing homes, we delivered training to improve COVID-19 infection control best practices. We sought to assess the implementation of infection control practices in participating nursing homes. Methods: Concurrent with the delivery of the RCT (January-November 2021), we surveyed nursing home administrators (NHAs, n = 38) at baseline and 6-month follow-up. Using validated items from the Centers for Disease Control and Prevention (CDC), the surveys inquired about 80 infection control best-practice activities (yes/no). The survey also asked seven scales corresponding to inner setting factors that may have impacted implementation. We assessed changes in infection control practices and inner setting factors between baseline and 6-month follow-up. Results: Overall, the implementation of 11 best practices changed over time. NHAs reported an increase in the availability of informational materials for residents and families (84% vs. 100%, p = 0.031), the use of alcohol-based hand sanitizer over soap (76% vs. 97%, p = 0.008), and the development of contingency plans for increased postmortem care (53% vs. 82%, p = 0.013). The implementation of four best-practice visitation policies and three communal restrictions decreased between baseline and 6-month follow-up (all p < 0.05). Regarding inner setting factors, only culture stress (perceived strain, stress, and role overload) increased between surveys (mean scores: 3.14 vs. 3.58, p = 0.004). Conclusion: This study was among the first to report changes in implementing COVID-19 infection control best practices in nursing homes amid the pandemic. Culture stress was an important inner setting factor that may have impacted implementation activities. Trial registration: NCT04499391 Date of registration: August 3rd, 2020 [ABSTRACT FROM AUTHOR]

Background: Germline genetic testing is recommended for an increasing number of conditions with underlying genetic etiologies, the results of which impact medical management. However, genetic testing is underutilized in clinics due to system, clinician, and patient level barriers. Behavioral economics provides a framework to create implementation strategies, such as nudges, to address these multi-level barriers and increase the uptake of genetic testing for conditions where the results impact medical management. Methods: Patients meeting eligibility for germline genetic testing for a group of conditions will be identified using electronic phenotyping algorithms. A pragmatic, type 3 hybrid cluster randomization study will test nudges to patients and/or clinicians, or neither. Clinicians who receive nudges will be prompted to either refer their patient to genetics or order genetic testing themselves. We will use rapid cycle approaches informed by clinician and patient experiences, health equity, and behavioral economics to optimize these nudges before trial initiation. The primary implementation outcome is uptake of germline genetic testing for the pre-selected health conditions. Patient data collected through the electronic health record (e.g. demographics, geocoded address) will be examined as moderators of the effect of nudges. Discussion: This study will be one of the first randomized trials to examine the effects of patient- and clinician-directed nudges informed by behavioral economics on uptake of genetic testing. The pragmatic design will facilitate a large and diverse patient sample, allow for the assessment of genetic testing uptake, and provide comparison of the effect of different nudge combinations. This trial also involves optimization of patient identification, test selection, ordering, and result reporting in an electronic health record-based infrastructure to further address clinician-level barriers to utilizing genomic medicine. The findings may help determine the impact of low-cost, sustainable implementation strategies that can be integrated into health care systems to improve the use of genomic medicine. Trial registration: ClinicalTrials.gov. NCT06377033. Registered on March 31, 2024. https://clinicaltrials.gov/study/NCT06377033?term=NCT06377033&rank=1 [ABSTRACT FROM AUTHOR]

Background: Acute respiratory illness (ARI) is one of the most common reasons children receive antibiotic treatment. Measurement of C-reaction protein (CRP) has been shown to reduce unnecessary antibiotic use among children with ARI in a range of clinical settings. In many resource-constrained contexts, patients seek care outside the formal health sector, often from lay community health workers (CHWs). This study's objective was to determine the impact of CRP measurement on antibiotic use among children presenting with febrile ARI to CHW in Uganda. Methods and findings: We conducted a cross-sectional, stepped wedge cluster randomized trial in 15 villages in Bugoye subcounty comparing a clinical algorithm that included CRP measurement by CHW to guide antibiotic treatment (STAR Sick Child Job Aid [SCJA]; intervention condition) with the Integrated Community Care Management (iCCM) SCJA currently in use by CHW in the region (control condition). Villages were stratified into 3 strata by altitude, distance to the clinic, and size; in each stratum, the 5 villages were randomly assigned to one of 5 treatment sequences. Children aged 2 months to 5 years presenting to CHW with fever and cough were eligible. CHW conducted follow-up assessments 7 days after the initial visit. Our primary outcome was the proportion of children who were given or prescribed an antibiotic at the initial visit. Our secondary outcomes were (1) persistent fever on day 7; (2) development of prespecified danger signs; (3) unexpected visits to the CHW; (4) hospitalizations; (5) deaths; (6) lack of perceived improvement per the child's caregiver on day 7; and (7) clinical failure, a composite outcome of persistence of fever on day 7, development of danger signs, hospitalization, or death. The 65 participating CHW enrolled 1,280 children, 1,220 (95.3%) of whom had sufficient data. Approximately 48% (587/1,220) and 52% (633/1,220) were enrolled during control (iCCM SCJA) and intervention periods (STAR SCJA), respectively. The observed percentage of children who were given or prescribed antibiotics at the initial visit was 91.8% (539/587) in the control periods as compared to 70.8% (448/633) during the intervention periods (adjusted prevalence difference −24.6%, 95% CI: −36.1%, −13.1%). The odds of antibiotic prescription by the CHW were over 80% lower in the intervention as compared to the control periods (OR 0.18, 95% CI: 0.06 to 0.49). The frequency of clinical failure (iCCM SCJA 3.9% (23/585) v. STAR SCJA 1.8% (11/630); OR 0.41, 95% CI: 0.09, 1.83) and lack of perceived improvement by the caregiver (iCCM SCJA 2.1% (12/584) v. STAR SCJA 3.5% (22/627); OR 1.49, 95% CI: 0.37, 6.52) was similar. There were no unexpected visits or deaths in either group within the follow-up period. Conclusions: Incorporating CRP measurement into iCCM algorithms for evaluation of children with febrile ARI by CHW in rural Uganda decreased antibiotic use. There is evidence that this decrease was not associated with worse clinical outcomes, although the number of adverse events was low. These findings support expanded access to simple, point-of-care diagnostics to improve antibiotic stewardship in rural, resource-constrained settings where individuals with limited medical training provide a substantial proportion of care. Trial registration: ClinicalTrials.govNCT05294510. The study was reviewed and approved by the University of North Carolina Institutional Review Board (#18–2803), Mbarara University of Science and Technology Research Ethics Committee (14/03-19), and Uganda National Council on Science and Technology (HS 2631). Emily J. Ciccone and colleagues investigate if measuring C-reactive protein levels can lead to decreased antibiotic use in rural Uganda's children with fever and respiratory illness. Author summary: Why was this study done?: Globally, antibiotics are frequently used to treat children with fever and respiratory symptoms. However, most of these illnesses are likely viral and/or self-resolving and therefore do not require antibiotics. This overuse can lead to the development and spread of antimicrobial resistance (AMR). Measurement of C-reactive protein (CRP) levels in blood can decrease antibiotic use in children with fever and respiratory illness in health care facilities in low- and middle-income countries (LMICs). Many children in sub-Saharan Africa, when ill, present first to lay community health workers, outside of the formal health care system. What did the researchers do and find?: We conducted a stepped wedge cluster randomized trial involving 65 community health workers (CHW) in 15 villages in rural western Uganda that compared the Integrated Community Care Management (iCCM) algorithm currently in use by CHW in the region with an amended study algorithm (STAR Sick Child Job Aid [SCJA]) that included semiquantitative CRP measurement by CHW to guide antibiotic treatment decisions among children presenting with fever and respiratory symptoms. We enrolled 1,280 children, 1,220 of whom were included in the analyses. Our primary outcome of interest was antibiotics given or prescribed at the initial visit. As secondary outcomes, we assessed for adverse effects at 7 days after initial visit to the CHW, including clinical failure (a composite outcome that included persistent fever, development of danger signs, hospitalization, or death) and perceived improvement by the child's caregiver. We observed a decrease in antibiotic use of 24.6% (95% CI: −36.1%, −13.1%) in the SCJA (intervention) group compared to the iCCM (control) group. There was no statistical difference in rates of clinical failure, perceived improvement by the caregiver, or other safety outcomes at day 7, although the number of these events in both groups was small, and therefore, our estimates are imprecise. What do these findings mean?: This study shows that point-of-care CRP testing by CHW with limited clinical training outside of the formal healthcare system is feasible and has the potential to decrease unnecessary antibiotic use. We did not observe a concomitant increased risk of adverse effects in the SCJA group, although our study was not specifically designed to detect a difference in these outcomes. The results provide rationale for larger-scale studies of clinical algorithms for CHW including CRP that focus on safety outcomes, implementation, and cost-effectiveness. This research supports the use of simple, point-of-care diagnostics in rural, resource-constrained settings to improve antibiotic stewardship. [ABSTRACT FROM AUTHOR]

Background: As utilization of individual antenatal care (I-ANC) has increased throughout sub-Saharan Africa, questions have arisen about whether individual versus group-based care might yield better outcomes. We implemented a trial of group-based antenatal care (G-ANC) to determine its impact on birth preparedness and complication readiness (BPCR) among pregnant women in Ghana. Methods: We conducted a cluster randomized controlled trial comparing G-ANC to routine antenatal care in 14 health facilities in the Eastern Region of Ghana. We recruited women in their first trimester to participate in eight two-hour interactive group sessions throughout their pregnancies. Meetings were facilitated by midwives trained in G-ANC methods, and clinical assessments were conducted in addition to group discussions and activities. Data were collected at five timepoints, and results are presented comparing baseline (T0) to 34 weeks' gestation to 3 weeks post-delivery (T1) for danger sign recognition, an 11-point additive scale of BPCR, as well as individual items comprising the scale. Results: 1285 participants completed T0 and T1 assessments (N = 668 I-ANC, N = 617, G-ANC). At T1, G-ANC participants were able to identify significantly more pregnancy danger signs than I-ANC participants (mean increase from 1.8 to 3.4 in G-ANC vs. 1.7 to 2.2 in I-ANC, p < 0.0001). Overall BPCR scores were significantly greater in the G-ANC group than the I-ANC group. The elements of BPCR that showed the greatest increases included arranging for emergency transport (I-ANC increased from 1.5 to 11.5% vs. G-ANC increasing from 2 to 41% (p < 0.0001)) and saving money for transportation (19–32% in the I-ANC group vs. 19–73% in the G-ANC group (p < 0.0001)). Identifying someone to accompany the woman to the facility rose from 1 to 3% in the I-ANC group vs. 2–20% in the G-ANC group (p < 0.001). Conclusions: G-ANC significantly increased BPCR among women in rural Eastern Region of Ghana when compared to routine antenatal care. Given the success of this intervention, future efforts that prioritize the implementation of G-ANC are warranted. Trial registration: ClinicalTrials.gov Identifier: NCT04033003 (25/07/2019). Protocol available: Protocol Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9508671/. [ABSTRACT FROM AUTHOR]

Background: Since no specific environmental cleaning instructions and methods have been developed for schools to tackle pandemics, and cleaning methods, this study aims to investigate the feasibility of a new effective school cleaning protocol in reducing the environmental contamination in kindergarten and primary school settings. Methods: This study implemented a cluster randomized controlled trial with three-arms, namely two intervention arms - groups A and B, and one control arm – group C. The first intervention arm included the cleaning staff who would participate in an educational workshop and be equipped with disposable wipes, while the second arm, group B, participated in the educational workshop only. The third arm, group C, received no treatments. Results: 1080 sample points were collected from pre-determined sites in the study within the 6 schools. At the 2-week follow-up post-intervention assessment, all sites were found to be clean for group A that used disposable wipes, while group B, without disposable wipes, were found to have left more sites contaminated. Staphylococcus aureus was found in the sites cleaned by group C. Conclusion: Based on the findings in this pilot study, a further study at a larger scale focusing on the education program with enhancement and use of the cleaning protocol can be conducted to train cleaning staff for effective environmental cleaning in a school setting. [ABSTRACT FROM AUTHOR]

Background: Community acceptance is an important criterion to assess in community trials, particularly for new tools that require high coverage and use by a target population. Installed on exterior walls of household structures, the attractive targeted sugar bait (ATSB) is a new vector control tool designed to attract and kill mosquitoes. ATSBs were evaluated in Western Zambia during a two-year cluster randomized controlled trial to assess the efficacy of ATSBs in reducing malaria transmission. Community acceptance of ATSBs was critical for successful trial implementation. Methods: A community engagement strategy outlined activities and key messages to promote acceptance. Annual cross-sectional surveys, conducted during the peak transmission period, assessed households for presence of ATSBs as well as perceived benefits, concerns, and willingness to use ATSBs. Sixteen focus group discussions and 16 in-depth interviews, conducted at the end of each ATSB station deployment period, obtained a range of perceptions and household experiences with ATSB stations, as well as ITN use in the context of ATSB deployment. Results: Methods used during the study to promote acceptance and continued use of ATSBs were effective in achieving greater than 90% coverage, a high (greater than 70%) level of perceived benefits, and fewer than 10% of households reporting safety concerns. Common facilitators of acceptance included the desire for protection against malaria and reduction of mosquitoes, trust in health initiatives, and understanding of the product. Common barriers to acceptance included misconceptions of product impact on mosquitoes, continued cases of malaria, association with satanism, and damage to household structures. Discussion: Future use of the ATSB intervention will likely require activities that foster community acceptance before, during, and after the intervention is introduced. Additional research may be needed to understand the impact of different levels of community engagement on ATSB station coverage, ATSB station perception, and ITN use. Conclusion: There was high acceptance of ATSB stations during the trial in Western Zambia. Continuous and intense community engagement efforts contributed to sustained ATSB coverage and trust in the product. Acceptance of ATSBs during programmatic delivery requires further research. [ABSTRACT FROM AUTHOR]

Objectives: White collar workers spend an increasing amount of time in occupational sedentary behavior (OSB) and are thereby at risk for adverse health outcomes. Nevertheless, the association between OSB and the need for recovery (NFR), an important indicator of wellbeing, is unknown and therefore examined. Methods: Baseline data from a cluster randomized controlled trial was used. A subgroup of 89 white collar workers wore a triaxial accelerometer for 7 days. NFR was measured using the Questionnaire on the Experience and Evaluation of Work. Compositional data analysis was applied to determine the composition of different OSB bouts (short, medium and long) and occupational physical activity (OPA) (light, moderate and vigorous and standing). Linear regression analyses were performed to explore the associations between occupational compositions and NFR. Results: Relatively more time spent in long OSB bouts was associated with a lower NFR (β: -11.30, 95% CI: -20.2 to -2.4). Short and medium OSB bouts and OPA were not associated with NFR. Conclusion: Associations between OSB bouts, OPA and NFR hinted at contrasting trends, suggesting the need to consider different bout lengths of OSB in future studies. [ABSTRACT FROM AUTHOR]

The purpose of this study was to evaluate the effect of male partners' targeted antenatal and postnatal breastfeeding education and support interventions on maternal breastfeeding self-efficacy in central Ethiopia. A two-arm parallel group cluster randomized controlled trial was carried out among couples in a community setting in the Hadiya Zone, central Ethiopia. A total of 408 couples from 16 clusters were randomly assigned to either the intervention (n = 204) or control group (n = 204). The analysis was conducted using an intention-to-treat approach. A generalized estimating equation (GEE) analysis was done to evaluate the effectiveness of the interventions. Maternal BFSE was significantly higher among mothers whose male partner received breastfeeding education and support interventions than those who did not receive the interventions (130 (65.0%) v 90 (45.9%), P < 0.001). The net effect of the intervention on improving maternal BFSE was 20.9% [95% CI: 16.9%–24.9%]. In the GEE model, maternal BFSE was 48% [RR = 1.48, 95% CI: 1.23, 1.79] higher in the intervention group than the control group. Involving male partners in breastfeeding promotion activities can enhance the mother's self-efficacy and confidence in breastfeeding. Trial registration: ClinicalTrials.gov identifier (NCT number), NCT05173454. Registered on 30/12/2021. [ABSTRACT FROM AUTHOR]

Objective Data Sources and Study Setting Study Design Data Collection/Extraction Methods Principal Findings Conclusions To assess whether a team collaboration strategy (CONNECT) improves implementation outcomes of a family caregiver skills training program (iHI‐FIVES).iHI‐FIVES was delivered to caregivers at eight Veterans Affairs (VA) medical centers. Data sources were electronic health records, staff surveys, and interviews.In a stepped wedge cluster randomized trial, sites were randomized to a 6‐month time interval start date for iHI‐FIVES launch. Sites were then randomized 1:1 to either (i) CONNECT, a team collaboration training strategy plus Replicating Effective Programs (REP), brief technical support training for staff, or (ii) REP only (non‐CONNECT arm). Implementation outcomes included reach (proportion of eligible caregivers enrolled) and fidelity (proportion of expected trainings delivered). Staff interviews and surveys assessed team function including communication, implementation experience, and their relation to CONNECT and iHI‐FIVES implementation outcomes.The sample for assessing implementation outcomes included 571 Veterans referred to VA home‐ and community‐based services and their family caregivers eligible for iHI‐FIVES. Prior to iHI‐FIVES launch, staff completed 65 surveys and 62 interviews. After the start of iHI‐FIVES, staff completed 52 surveys and 38 interviews. Mixed methods evaluated reach and fidelity by arm.Fidelity was high overall with 88% of expected iHI‐FIVES trainings delivered, and higher among REP only (non‐CONNECT) compared with CONNECT sites (95% vs. 80%). Reach was 18% (average proportion of reach across eight sites) and higher among non‐CONNECT compared with CONNECT sites (22% vs. 14%). Qualitative interviews revealed strong leadership support at high‐reach sites. CONNECT did not influence self‐reported team function.A team collaboration strategy (CONNECT), added to REP, required more resources to implement iHI‐FIVES than REP only and did not substantially enhance reach or fidelity. Leadership support was a key condition of implementation success and may be an important factor for improving iHI‐FIVES reach with national expansion. [ABSTRACT FROM AUTHOR]

Cluster randomized crossover and stepped wedge cluster randomized trials are two types of longitudinal cluster randomized trials that leverage both the within- and between-cluster comparisons to estimate the treatment effect and are increasingly used in healthcare delivery and implementation science research. While the variance expressions of estimated treatment effect have been previously developed from the method of generalized estimating equations for analyzing cluster randomized crossover trials and stepped wedge cluster randomized trials, little guidance has been provided for optimal designs to ensure maximum efficiency. Here, an optimal design refers to the combination of optimal cluster-period size and optimal number of clusters that provide the smallest variance of the treatment effect estimator or maximum efficiency under a fixed total budget. In this work, we develop optimal designs for multiple-period cluster randomized crossover trials and stepped wedge cluster randomized trials with continuous outcomes, including both closed-cohort and repeated cross-sectional sampling schemes. Local optimal design algorithms are proposed when the correlation parameters in the working correlation structure are known. MaxiMin optimal design algorithms are proposed when the exact values are unavailable, but investigators may specify a range of correlation values. The closed-form formulae of local optimal design and MaxiMin optimal design are derived for multiple-period cluster randomized crossover trials, where the cluster-period size and number of clusters are decimal. The decimal estimates from closed-form formulae can then be used to investigate the performances of integer estimates from local optimal design and MaxiMin optimal design algorithms. One unique contribution from this work, compared to the previous optimal design research, is that we adopt constrained optimization techniques to obtain integer estimates under the MaxiMin optimal design. To assist practical implementation, we also develop four SAS macros to find local optimal designs and MaxiMin optimal designs. [ABSTRACT FROM AUTHOR]

Background: Hypertension is a major public health challenge, globally. Recently, we reported findings from cluster randomized trial in 8 primary care clinics in Singapore and showed that a multicomponent "SingHypertension" intervention comprising 1) motivational conversation by trained nurses, 2) telephone-based follow-ups, 3) standardized algorithm with single-pill combination (SPC) antihypertensive medications, and 4) subsidy on SPC antihypertensive drugs was effective on improving BP control. This paper presents the acceptability of SingHypertension multicomponent intervention among the key stakeholders. Methods: We conducted post-implementation interviews of 38 stakeholders, including 18 patients and 20 healthcare providers (HCPs) in 4 primary care clinics randomized to the multicomponent "SingHypertension" intervention in Singapore. We used Theoretical Framework for Acceptability (TFA) framework with a focus on affective attitude, burden, ethicality, intervention coherence, opportunity cost, perceived effectiveness and self-efficacy to assess stakeholders' acceptability of the intervention. Results: SingHypertension multicomponent intervention had high perceived effectiveness and a good fit with the value system and ethics of patients and HCPs. Physicians appreciated the guidance from standardized training in hypertension management. Although workload was increased, the nurses felt rewarded for their positive interactions with the patients during motivational conversation sessions and the telephone follow-ups. Most patients reported high self-efficacy levels, improved lifestyles, and adherence to antihypertensive medications. The limited choice of SPC medication, lack of subsidy beyond the trial duration, and shortage of nurses were significant challenges to wide-scale implementation. All HCPs and patients supported scaling up the intervention across primary care clinics. Conclusion: SingHypertension multicomponent intervention is acceptable to the key stakeholders in Singapore. Taken together with the effectiveness of the intervention, our findings make a compelling case for scaling-up SingHypertension in primary care clinics in Singapore and possibly other countries with similar healthcare infrastructure. [ABSTRACT FROM AUTHOR]

Background: Heart Failure (HF) is a common chronic disease that has a high readmission rate and is associated with worsening symptoms and major financial impacts. Disease management implemented during or after an HF hospitalization has been shown to reduce hospitalization and mortality rates. Particularly for outpatients, it is necessary to provide self-care interventions. Structured nurse-led support such as timely follow-ups, including phone calls, is beneficial for improving self-care assessments. Evidence for nurse-led support has been investigated but is less than conclusive. The aim of this study is to compare the effectiveness of a nurse-led structured intervention for outpatients with chronic HF against the usual medical care in terms of self-care behaviors and occurrence of symptom exacerbation or rehospitalization. Methods and analysis: This is a cluster-randomized controlled trial. A total of 40 facilities with certified HF nurses will be allocated to two-arm clusters at a 1:1 ratio, randomly to the intervention or usual care arms. A total of 210 participants will be assigned from the hospital. Participants will be adults aged 18 years or older diagnosed with chronic HF who are classified as Stage C according to the ACCF/AHA Heart Failure staging system. In the intervention group, patients will receive structured nursing support. This begins with weekly support, including phone calls, for the first month, then transitions to monthly support thereafter. The aim is to ensure the stability of their living conditions, promote medication adherence, and encourage self-management. In the control group, patients will receive the usual care. Primary outcomes will assess the improvement or continuation of self-care behavior as measured by changes in EHFScBS (European Heart Failure Self-Care Behavior Scale) scores. Secondary outcomes include occurrence of readmission within 30 days, 3 months, 6 months, and 1 year after discharge, duration of home care until readmission, and blood levels of BNP and NT-proBNP. [ABSTRACT FROM AUTHOR]

The Hong Kong Journal of Emergency Medicine has collaborated with international emergency medicine journals to share important research studies. One study from the African Journal of Emergency Medicine examined the assessment and reassessment of injured patients in non-tertiary hospitals in Ghana. The study found that while initial assessments were generally adequate, reassessment rates were very low, even for seriously injured patients. Another study from the Annals of Emergency Medicine discussed the dangers of xylazine, a veterinary sedative, being associated with opioid overdose deaths in the United States. The study emphasized the importance of providing ventilatory support and naloxone in overdose management. This article focuses on a randomized controlled trial conducted at an Australian level 1 trauma center, which investigated the effects of integrating pharmacists into trauma response teams to enhance analgesia delivery and medication management. The trial involved 82 patients, and the primary outcome was the proportion of patients who received the first dose of analgesia within 30 minutes. The results demonstrated that the inclusion of an emergency medicine pharmacist in the trauma response team improved the time to analgesia and optimized medication management. This intervention may enable other team members to concentrate on life-saving interventions. [Extracted from the article]

Vaccination rates for mumps, measles, and rubella (MMR) and tetanus, diphtheria, pertussis, and polio (Tdap‐IPV) fall short of global targets, highlighting the need for vaccination interventions. This study examines the effectiveness of a city‐wide school‐based educational vaccination intervention as part of an on‐site vaccination program aimed at increasing MMR and Tdap‐IPV vaccination rates versus on‐site vaccination alone among sociodemographically diverse students from Berlin, Germany. The study was a 1:1 two‐arm cluster randomized controlled trial, with schools randomly assigned to either the Educational Class Condition (ECC) or the Low‐Intensity Information Condition (LIIC). Both received an on‐site vaccination program, while students in the ECC received an additional educational unit. Primary outcomes were MMR and Tdap‐IPV vaccination rates. In total, 6512 students from 25 randomly selected urban area secondary schools participated. For students providing their vaccination documents on the day of the intervention (2273, 34.9%), adjusted Poisson mixed models revealed significant between‐group differences in favor of the ECC (MMR: logRR = 0.47, 95%CI [0.01,0.92], RR = 1.59; Tdap‐IPV: logRR = 0.28, 95%CI [0.10,0.47], RR = 1.32). When adjusting for socioeconomic and migration background, between‐group differences became non‐significant for MMR but remained significant for Tdap‐IPV. Findings suggest that educational, school‐based on‐site vaccination appears to be a promising strategy for increasing vaccination uptake in adolescents. [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]

Objectives: Workplaces are suitable areas for smoking cessation programs and incentives. This study was carried out to determine the effectiveness of interventions in the workplace for smoking cessation in working individuals. Methods: All studies published in English between 2013 and 2022 were searched in Pub Med, Science Direct, Scopus, Web of Science, and CINAHL databases. Meta‐analysis was based on PRISMA 2020. The study protocol was registered with PROSPERO. A random effects model was applied to the meta‐analysis processes, and Hedges' g was used to calculate the effect size. Results: Of the included studies, 11 were randomized controlled trials, and 8 were cluster randomized controlled trials. In different working sectors, various interventions such as motivational/individual interviews, group counseling, telephone coaching, web‐based training, mindfulness meditation, and financial interventions were implemented. These interventions were carried out alone or in combination with one or more other interventions. The interventions generally have short‐term effects, and financial incentives or supports were the factors that positively motivate the interventions. The joint effect size of attempts to quit smoking in the workplace (Hedges' g) was 1.171. Heterogeneity between studies was significant (Q = 199.762, p = 0.015, I2 = 80.477%). No publication bias was detected. Conclusions: We determined that smoking cessation interventions applied in the workplace have a large effect. We recommend that the long‐term effects of increasing effectiveness of these interventions be considered and planned in line with the needs of working groups. [ABSTRACT FROM AUTHOR]

Background: Despite success in HIV treatment, diagnosis and management of hypertension (HTN) and cardiovascular disease (CVD) remains suboptimal among people living with HIV (PLWH) in Botswana, with an overall HTN control of only 19% compared to 98% HIV viral suppressed. These gaps persist despite CVD primary care national guidelines and availability of free healthcare including antihypertensive medications. Our study aims to develop and test strategies to close the HTN care gap in PLWH, through integration into HIV care, leveraging the successful national HIV care and treatment program and strategies. Methods: The InterCARE trial is a cluster randomized controlled hybrid type 2 effectiveness-implementation trial at 14 sites designed to enroll 4652 adults living with HIV and HTN plus up to 2326 treatment partners. Primary outcomes included effectiveness (HTN control) and implementation outcomes using the Reach Effectiveness Adoption Implementation and Maintenance framework, with explanatory mixed methods used to understand variability in outcomes. InterCARE trial's main strategies include healthcare worker HTN and CVD care training plus long-term practice facilitation, electronic health record (EHR) documentation of key indicators and use of reminders, and use of treatment partners to provide social support to people living with HIV and HTN. InterCARE started with formative research to identify contextual factors influencing care gaps using the Consolidated Framework for Implementation Research. Results were used to adapt initial and develop additional implementation strategies to address barriers and leverage facilitators. The package was pilot tested in two clinics, with findings used to further adapt or add strategies for the clinical trial. Discussion: If successful, the InterCARE model can be scaled up to HIV clinics nationwide to improve diagnosis, management, and support in Botswana. The trial will provide insights for scale-up of HTN integration into HIV care in the region. Trial registration: ClinicalTrials.gov reference NCT05414526. Registered 18 May 2022, https://clinicaltrials.gov/study/NCT05414526?term=NCT05414526.&rank=1. [ABSTRACT FROM AUTHOR]

Introduction: The consumption of alcohol, tobacco, and cannabis is a public health problem that impacts the cognitive, social, and emotional development of adolescents. Prevention strategies such as the "Unplugged" program are effective in delaying the progression of daily smoking and episodes of drunkenness among adolescents. "Yo Se Lo Que Quiero" (YSLQQ) corresponds to the adaptation of this program to the Chilean context. This study assesses the acceptability and feasibility of implementing this program to the local reality. Material and methods: This was a cluster-randomized controlled pilot study conducted on six public schools. All consented students attending 6th, 7th, and 8th grades (n = 1,180) participated in the study. The schools were randomly assigned to one of two conditions in a 1:1 ratio: (1) the "YSLQQ" intervention group (n = 526), and (2) the Control group (n = 654). The program consisted of a 12-hour class-based curriculum based on a comprehensive social-influence approach delivered by a trained facilitator. The acceptability and feasibility were assessed in the intervention group at the end of the intervention using questionnaires answered by students and facilitators. The quality and fidelity of the program were evaluated during the implementation using self-ported surveys answered by the facilitators and the assessment of video-recorded sessions rated by external observers. Finally, a pre-test and a post-test survey assessing past and current substance use and risk and protective factors were conducted before and immediately after the program's implementation. Results: A high proportion of students (49.6%) liked the sessions. 79.2% reported that the YSLQQ helped them learn about the dangers of substances, while 65.8% reported having more skills to avoid substance use in the future. Regarding students' satisfaction with YSLQQ, 62.9% reported being happy or very happy with the program. Facilitators reported implementing the intervention according to the manual in 73.9% of sessions. Regarding substance use, students who participated in the intervention groups reported a significant reduction in drunkenness in the last year and last 30-day prevalence and also a significant reduction in a lifetime and 30-day prevalence of cannabis use when compared with those students in the control group. Conclusions: Our results suggest that YSLQQ has adequate acceptability and feasibility to be implemented in the Chilean context, and there were promising results in reducing drunkenness and cannabis use. Future research should confirm these results in a larger RCT study. Trial registration: The trial was registered in ClinicalTrials.gov, NCT04566627; registration date: 01/03/2019 [ABSTRACT FROM AUTHOR]

Stepped wedge trials (SWTs) are a type of cluster randomized trial that involve repeated measures on clusters and design‐induced confounding between time and treatment. Although mixed models are commonly used to analyze SWTs, they are susceptible to misspecification particularly for cluster‐longitudinal designs such as SWTs. Mixed model estimation leverages both "horizontal" or within‐cluster information and "vertical" or between‐cluster information. To use horizontal information in a mixed model, both the mean model and correlation structure must be correctly specified or accounted for, since time is confounded with treatment and measurements are likely correlated within clusters. Alternative non‐parametric methods have been proposed that use only vertical information; these are more robust because between‐cluster comparisons in a SWT preserve randomization, but these non‐parametric methods are not very efficient. We propose a composite likelihood method that focuses on vertical information, but has the flexibility to recover efficiency by using additional horizontal information. We compare the properties and performance of various methods, using simulations based on COVID‐19 data and a demonstration of application to the LIRE trial. We found that a vertical composite likelihood model that leverages baseline data is more robust than traditional methods, and more efficient than methods that use only vertical information. We hope that these results demonstrate the potential value of model‐based vertical methods for SWTs with a large number of clusters, and that these new tools are useful to researchers who are concerned about misspecification of traditional models. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines are crucial for enhancing healthcare quality and patient outcomes. Yet, their implementation remains inconsistent across various professions and disciplines. Previous findings on the implementation of the German guideline for schizophrenia (2019) revealed low adherence rates among healthcare professionals. Barriers to guideline adherence are multifaceted, influenced by individual, contextual, and guideline-related factors. This study aims to investigate the effectiveness of a digital guideline version compared to print/PDF formats in enhancing guideline adherence. Methods: A multicenter, cluster-randomized controlled trial was conducted in South Bavaria, Germany, involving psychologists and physicians. Participants were divided into two groups: implementation of the guideline using a digital online version via the MAGICapp platform and the other using the traditional print/PDF version. The study included a baseline assessment and a post-intervention assessment following a 6-month intervention phase. The primary outcome was guideline knowledge, which was assessed using a guideline knowledge questionnaire. Results: The study included 217 participants at baseline and 120 at post-intervention. Both groups showed significant improvements in guideline knowledge; however, no notable difference was found between both study groups regarding guideline knowledge at either time points. At baseline, 43.6% in the control group (CG) and 52.5% of the interventional group (IG) met the criterion. There was no significant difference in the primary outcome between the two groups at either time point (T0: Chi2(1) = 1.65, p = 0.199, T1: Chi2(1) = 0.34, p = 0.561). At post-intervention, both groups improved, with 58.2% in the CG and 63.5% in the IG meeting this criterion. Conclusions: While the study did not include a control group without any implementation strategy, the overall improvement in guideline knowledge following an implementation strategy, independent of the format, was confirmed. The digital guideline version, while not superior in enhancing knowledge, showed potential benefits in shared decision-making skills. However, familiarity with traditional formats and various barriers to digital application may have influenced these results. The study highlights the importance of tailored implementation strategies, especially for younger healthcare providers. Trial registration: https://drks.de/search/de/trial/DRKS00028895 [ABSTRACT FROM AUTHOR]

Background: This study is a cost-effectiveness study of two implementation strategies designed to train therapists in college and university counseling centers to deliver interpersonal psychotherapy. Costs of implementing a train-the-trainer (TTT) strategy versus an expert consultation strategy were estimated, and their relative effects upon therapist outcomes were calculated and compared. Methods: Twenty four counseling centers were recruited across the United States. These centers were randomized to either a TTT (experimental) condition, in which an in-house therapist trained other center therapists, or an expert consultation condition, in which center therapists participated in a workshop and received 12 months of ongoing supervision. The main outcome was therapist fidelity (adherence and competence) to interpersonal psychotherapy, assessed via audio recordings of therapy sessions, and analyzed using linear mixed models. Costs of each condition were quantified using time-driven activity-based costing methods, and involved a costing survey administered to center directors, follow up interviews and validation checks, and comparison of time tracking logs of trainers in the expert condition. Mean costs to produce one therapist were obtained for each condition. The costs to produce equivalent improvements in therapist-level outcomes were then compared between the two conditions. Results: Mean cost incurred by counseling centers to train one therapist using the TTT strategy was $3,407 (median = $3,077); mean cost to produce one trained therapist in the control condition was $2,055 (median = $1,932). Therapists in the TTT condition, on average, demonstrated a 0.043 higher adherence score compared to therapists in the control condition; however, this difference was not statistically significant. For the competence outcome, effect size for therapists in the TTT condition was in the large range (1.16; 95% CI: 0.85–1.46; p <.001), and therapists in this condition, on average, demonstrated a 0.073 higher competence score compared to those in the expert consultation condition (95% CI, 0.008–0.14; p =.03). Counseling centers that used the TTT model incurred $353 less in training costs to produce equivalent improvements in therapist competence. Conclusions: Despite its higher short run costs, the TTT implementation strategy produces greater increases in therapist competence when compared to expert consultation. Expanding resources to support this platform for service delivery can be an effective way to enhance the mental health care of young people seeking care in college and university counseling centers. Trial registration: ClinicalTrials.gov Identifier: NCT02079142. [ABSTRACT FROM AUTHOR]

Background: Indigenous populations globally have significantly high rates of type 2 diabetes compared to their non-Indigenous counterparts. This study aims to implement and evaluate the effectiveness of a culturally and contextually informed Aboriginal Diabetes Workforce Training Program on Aboriginal primary health care workforce knowledge, attitude, confidence, skill and practice relating to diabetes care. Methods: A Cluster Randomised Crossover Control Trial with two arms (Group A and Group B) will be conducted with Aboriginal primary health care services in South Australia. These services primarily provide primary health care to Aboriginal and Torres Strait Islander people. All healthcare service sites will be randomised into groups A and B to receive the training program. The training program consists of three components: 1) Peer support network, 2) E-Learning modules and 3) onsite support. Aboriginal Health Workers of participating sites will be invited to participate in the monthly online peer support network and all chronic disease staff are eligible to participate in the E-Learning modules and onsite support. The Peer Support Network runs for the entirety of the study, 17 months. Training components 2 and 3 occur simultaneously and are 2.5 months in length, with a six-month washout period between the two randomised groups undertaking the training. All primary outcomes of the study relate to diabetes management in a primary health care settings and measure participants' knowledge, attitude, confidence, practice and skills. These will be collected at seven time points across the entire study. Secondary outcomes measure satisfaction of the peer support network using a survey, interviews to understand enablers and barriers to participation, health service systems characteristics through focus groups, and medical record review to ascertain diabetes patients' care received and their clinical outcomes up to 12 months post training intervention. Discussion: The findings will explore the effectiveness of the training program on Aboriginal primary health care provider knowledge, attitude, confidence, skill and practice relating to diabetes care. The final findings will be published in 2027. Trial registration: The study was prospectively registered in The Australian New Zealand Clinical Trials Registry (ANZCTR), with registration number ACTRN12623000749606 at ANZCTR - Registration. Universal Trial Number (UTN) U1111-1283-5257. [ABSTRACT FROM AUTHOR]

Background: Respiratory tract infections are readily transmitted in care homes. Airborne transmission of pathogens causing respiratory tract illness is largely unmitigated. Portable high-efficiency-particulate-air (HEPA) filtration units capture microbial particles from the air, but it is unclear whether this is sufficient to reduce infections in care home residents. The Air Filtration to prevent symptomatic winter Respiratory Infections (including COVID-19) in care homes (AFRI-c) randomized controlled trial will determine whether using HEPA filtration units reduces respiratory infection episodes in care home residents. Methods: AFRI-c is a cluster randomized controlled trial that will be delivered in residential care homes for older people in England. Ninety-one care homes will be randomised to take part for one winter period. The intervention care homes will receive HEPA filtration units for use in communal areas and private bedrooms. Normal infection control measures will continue in all care homes. Anonymised daily data on symptoms will be collected for up to 30 residents. Ten to 12 of these residents will be invited to consent to a primary care medical notes review and (in intervention homes) to having an air filter switched on in their private room. The primary outcome will be number of symptomatic winter respiratory infection episodes. Secondary outcomes include specific clinical measures of infection, number of falls / near falls, number of laboratory confirmed infections, hospitalisations, staff sickness and cost-effectiveness. A mixed methods process evaluation will assess intervention acceptability and implementation. Discussion: The results of AFRI-c will provide vital information about whether portable HEPA filtration units reduce symptomatic winter respiratory infections in older care home residents. Findings about effectiveness, fidelity, acceptability and cost-effectiveness will support stakeholders to determine the use of HEPA filtration units as part of infection control policies. [ABSTRACT FROM AUTHOR]

Background: Although long-acting reversible contraception (LARC) is more effective and longer lasting than short-acting methods, uptake remains low among post-abortion clients. Using a stepped-wedge, cluster-randomized trial, we evaluate the impact of a provider-level peer-comparison intervention to encourage choice of LARC in Nepal among post-abortion clients. Methods: The intervention used prominently displayed monthly posters comparing the health clinic's previous month performance on LARC uptake against peer clinics. To understand how the intervention affected behavior, while ensuring voluntarism and informed choice, we used mystery client visits, in-depth provider interviews, and client exit survey data. The trial examined 17,680 post-abortion clients in 36 clinics in Nepal from July 2016 to January 2017. The primary outcome was the proportion of clients receiving LARCs. Statistical analysis used ordinary least squares (OLS) regression with ANCOVA estimation to assess the intervention's impact on LARC uptake while controlling for client- and clinic-level characteristics. Results: The intervention increased LARC use among post-abortion clients by 6.6% points [95% CI: 0.85 to 12.3, p-value < 0.05], a 29.5% increase in LARC use compared to control clinics. This effect persisted after the formal experiment ended. Analysis of provider and client experiences showed that the behavioral intervention generated significant change in providers' counseling practices, motivated the sharing of best practices. Quality of care indicators either remained stable or improved. Conclusion: We find that a provider-level behavioral intervention increases LARC uptake among post-abortion clients. This type of intervention represents a low-cost option to contribute to reducing unmet need for contraception through provider behavior change. [ABSTRACT FROM AUTHOR]

BACKGROUND: Disparities in hypertension control are well documented but underaddressed. METHODS: RICH LIFE (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) was a 2-arm, cluster randomized trial comparing the effect on blood pressure (BP) control (systolic BP =140 mm Hg, diastolic BP =90 mm Hg), patient activation, and disparities in BP control of 2 multilevel interventions, standard of care plus (SCP) and collaborative care/stepped care (CC/SC). SCP included BP measurement standardization, audit and feedback, and equity-leadership training. CC/SC added roles to address social or medical needs. Primary outcomes were BP control and patient activation at 12 months. Generalized estimating equations and mixed-effects regression models with fixed effects of time, intervention, and their interaction compared change in outcomes at 12 months from baseline. RESULTS: A total of 1820 adults with uncontrolled BP and =1 other risk factors enrolled in the study. Their mean age was 60.3 years, and baseline BP was 152.3/85.5 mm Hg; 59.4% were women; 57.4% were Black, 33.2% were White, and 9.4% were Hispanic; 74% had hyperlipidemia; and 45.1% had type 2 diabetes. CC/SC did not improve BP control rates more than SCP. Both groups achieved statistically and clinically significant BP control rates at 12 months (CC/SC: 57.3% [95% CI, 52.7%-62.0%]; SCP: 56.7% [95% CI, 51.9%-61.5%]). Pairwise comparisons between racial and ethnic groups showed overall no significant differences in BP control at 12 months. Patients with coronary heart disease showed greater achievement of BP control in CC/SC than in SCP (64.0% [95% CI, 54.1%-73.9%] versus 50.8% [95% CI, 42.6%-59.0%]; P=0.04), as did patients in rural areas (67.3% [95% CI, 49.8%-84.8%] versus 47.8% [95% CI, 32.4%-63.2%]; P=0.01). Individuals in both arms experienced statistically and clinically significant reductions in mean systolic BP (CC/SC: -13.8 mm Hg [95% CI, -15.2 to -12.5]; SCP: -14.6 mm Hg [95% CI, -15.9 to -13.2]) and diastolic BP (CC/SC: -6.9 mm Hg [95% CI, -7.8 to -6.1]; SCP: -5.5 mm Hg [95% CI, -6.4 to -4.6]) over time. The difference in diastolic BP reduction between CC/SC and SCP over time was statistically significant (-1.4 mm Hg [95% CI, -2.6 to -0.2). Patient activation did not differ between arms. CC/SC showed greater improvements in patient ratings of chronic illness care (Patient Assessment of Chronic Illness Care score) over 12 months (0.12 [95% CI, 0.02-0.22]). CONCLUSIONS: Adding a collaborative care team to enhanced standard of care did not improve BP control but did improve patient ratings of chronic illness care. [ABSTRACT FROM AUTHOR]