Search

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]

ABSTRACT A simplified, combined protocol treats children with moderate acute malnutrition (MAM), defined by mid‐upper arm circumference (MUAC) of < 125 and ≥ 115 mm and no oedema, with 1 daily sachet of ready‐to‐use therapeutic food (RUTF) and those with severe acute malnutrition (SAM), defined by MUAC < 115 mm and/or oedema, with two daily sachets of RUTF. This protocol was previously shown to result in non‐inferior recovery compared to standard treatment that used higher, weight‐based RUTF dosing among children with SAM and ready‐to‐use supplementary food (RUSF) for MAM in a cluster‐based randomised controlled trial in Kenya and South Sudan. We conducted a secondary analysis of this trial to compare linear growth among children admitted with MUAC < 115 mm. Linear and ponderal growth were calculated from admission to discharge and visualised using aggregate growth curves. HAZ change adjusted for admission characteristics was negative across the course of treatment but similar across arms [−0.21 ± 0.18 SE in the standard arm, −0.24 ± 0.18 SE in simplified; difference (95% confidence interval) 0.03 (−0.12, 0.18)]. The unadjusted mean ± SE linear growth velocity from admission to discharge was 1.8 ± 0.7 mm/week in the standard arm compared to 1.7 ± 0.7 mm/week in the simplified arm [difference = 0.09 (−0.36, 0.53)] and similar in adjusted analysis. MUAC and weight gain velocities were not significantly different by treatment arm. Reducing the RUTF dose prescribed to children during SAM treatment does not appear to affect linear growth or other growth velocities during treatment. [ABSTRACT FROM AUTHOR]

The National Hospital Insurance Fund (NHIF) of Kenya was upgraded to improve access to healthcare for impoverished households, expand universal health coverage, and boost the uptake of essential reproductive, maternal, newborn and child health (RMNCH) services. However, premiums may be unaffordable for the poorest households. The Innovative Partnership for Universal Sustainable Healthcare (i -PUSH) programme targets low-income women and their households to improve their access to and utilization of quality healthcare, including RMNCH services, by providing subsidized, mobile phone-based NHIF coverage in combination with enhanced, digital training of community health volunteers and upgrading of health facilities. This study evaluated whether expanded NHIF coverage increased the accessibility and utilization of quality basic RMNCH services in areas where i -PUSH was implemented using a longitudinal cluster randomized controlled trial in Kakamega, Kenya. A total of 24 pair-matched villages were randomly assigned either to the treatment or the control group. Within each village, 10 eligible households (i.e. with a woman aged 15–49 years who was either pregnant or with a child <4 years old) were randomly selected. The study applied a difference-in-difference methodology based on a pooled cross-sectional analysis of baseline, midline and endline data, with robustness checks based on balanced panels and Analysis of Covariance methods. The analysis sample included 346 women, of whom 248 had had a live birth in the 3 years prior to any of the surveys, and 424 children aged 0–59 months. Improved NHIF coverage did not have a statistically significant impact on any of the RMNCH outcome indicators at midline nor endline. Uptake of RMNCH services, however, improved substantially in both control and treatment areas at endline compared to baseline. For instance, significant increases were observed in the number of antenatal care visits from baseline to midline (mean = 2.62–2.92, P  < 0.01) and delivery with a skilled birth attendant from baseline to midline (mean = 0.91–0.97, P  < 0.01). Expanded NHIF coverage, providing enhanced access to RMNCH services of unlimited duration at both public and private facilities, did not result in an increased uptake of care, in a context where access to basic public RMNCH services was already widespread. However, the positive overall trend in RMNCH utilization indicators, in a period of constrained access due to the COVID-19 pandemic, suggests that the other components of the i -PUSH programme may have been beneficial. Further research is needed to better understand how the provision of insurance, enhanced community health volunteer training and improved healthcare quality interact to ensure pregnant women and young children can make full use of the continuum of care. [ABSTRACT FROM AUTHOR]

Background: Opisthorchis viverrini (OV) and soil-transmitted helminths (STH) are two of the most common helminths contributing to the Neglected Tropical Disease (NTDs) burden in the Lower Mekong Basin. Although mass drug administration is the cornerstone of control programs to reduce morbidity caused by these infections, this approach has limitations in preventing re-infections. Elimination requires additional measures such as reservoir host treatment, improved hygiene and health education to reinforce MDA's impact. This study aims to examine the impact of a scalable multi-component One Health Helminth Elimination program in the Lower Mekong Basin (HELM) that combines human praziquantel (PZQ) and albendazole (ALB) treatment with a program that includes the "Magic Glasses" and the "Lawa Model" interventions with health promotion at their core. Methods: This study will employ a cluster randomized controlled trial (cRCT) in 18 rural communities (with sub-district or villages as cluster units) across Cambodia, Laos and Thailand. The control arm will receive one round of PZQ/ALB treatment, while in the intervention arm, multi-component HELM program will be implemented, which includes PZQ/ALB treatment together with the Magic Glasses and Lawa Model interventions. OV and STH infections levels will be evaluated in individuals aged 5–75 years at baseline and will be repeated at follow-up (12 months after the HELM intervention), using modified formalin ethyl-acetate concentration technique and quantitative PCR. The primary outcome of the study will be cumulative incidence of human OV and STH infections. Outcomes between the study arms will be compared using generalized linear mixed models, accounting for clustering. Discussion: Evidence from this trial will quantify the impact of a multi-component One Health control strategy in interrupting Ov and STH infections in the Lower Mekong Basin. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000353796. Prospectively registered 28 February 2022. [ABSTRACT FROM AUTHOR]

Introduction: Increasing knowledge of obstetric danger signs (ODS) and encouraging birth preparedness and complication readiness (BPCR) practices are strategies to increase skilled maternal health service utilization in low-income countries. One of the methods to increase mothers' knowledge about ODS and promote BPCR practice is through health education intervention (HEI). However, the effect of context-specific community-based health education led by women's groups on these outcomes has yet to be comprehensively studied, and the existing evidence is inconclusive. Thus, we aimed to evaluate the effect of a context-specific community-based HEI led by women's groups on mothers' knowledge regarding ODS and BPCR practices in southern Ethiopia. Methods: An open-label, two-arm parallel group cluster-randomized controlled trial was conducted from January to August 2023 on pregnant women from 24 clusters (kebeles) (12 interventions and 12 controls) in the northern zone of the Sidama region. The Open Data Kit smartphone application was utilized to collect data. The intention-to-treat analysis was used to compare outcomes between groups. We fitted multilevel mixed-effects modified Poisson regression with robust standard error to account for between and within cluster effects. Results: One thousand and seventy pregnant women (540 in the intervention and 530 in the control clusters) responded to this study, making the overall response rate 95.02%. Excessive vaginal bleeding (94.3% in the interventional group vs. 88.7% in the control group) was the commonest ODS mentioned during childbirth. Overall, 68.7% of women in the intervention group and 36.2% of mothers in the control group had good knowledge of ODS (P-value < 0.001). Saving money and materials (97.1% in the interventional group vs. 92.7% in the control group) was the most frequently practiced BPCR plan. Overall, 64.3% of women in the intervention group and 38.9% of mothers in the control group practiced BPCR (P-value < 0.001). HEI significantly increased overall knowledge of ODS (adjusted risk ratio [ARR]: 1.71; 99% CI: 1.14–2.57) and improved overall BPCR practice (ARR: 1.55; 99% CI: 1.02–2.39). Conclusions: A community-based HEI led by women's groups improved mothers' knowledge regarding ODS and BPCR practices in a rural setting in southern Ethiopia. Interventions designed to increase women's knowledge of ODS and improve BPCR practice must implement context-specific, community-based HEI that aligns with World Health Organization recommendations. Trial registration: NCT05865873. [ABSTRACT FROM AUTHOR]

Background: Influenza vaccination confers broad benefits in the elderly and certain high-risk populations, but its effectiveness in patients with acute heart failure (HF) is uncertain. Rates of influenza vaccination are low in China due to poor awareness, cultural misunderstandings, and cost. Aims: To determine the effectiveness of influenza vaccination in patients with acute HF admitted to hospitals in China. Methods: The second Population Assessment of Influenza and Disease Activity (PANDA II) study is a two-arm, parallel-group, county-level hospital-based, cluster randomized controlled trial to determine the benefits and risks of full access to routine free influenza vaccination before hospital discharge, compared to routine limited use of influenza vaccination, on the primary endpoint of death or hospital readmission. Consecutive hospitalized patients at each site are enrolled to a target of 50 participants in each autumn–winter influenza outbreak period (October to March) over 3 consecutive years to reach the required sample size. Patients are centrally followed up at 1, 3, 6, and 12 months after hospital discharge (or death if earlier). Site numbers varied across year according to predicted influenza activity and logistical reasons. Conclusions: This study offers a unique chance to clarify uncertainties surrounding the effectiveness of influenza vaccination in patients with HF and to lay the groundwork for future prevention strategies. Trial registration: This trial was registered with the acronym PANDA II (Population Assessment of Influenza and Disease Activity) at ChiCTR.org.cn (ChiCTR2100053264). Registered on 17 November 2021. [ABSTRACT FROM AUTHOR]

Background: Increasing HIV testing and treatment coverage among people living with HIV (PLHIV) is essential for achieving global HIV epidemic control. However, compared to women, cis-gender heterosexual men living with HIV are significantly less likely to know their HIV status, initiate anti-retroviral therapy (ART) and achieve viral suppression. This is particularly true in South Africa, where men are also at increased risk of mortality resulting from AIDS-related illnesses. While there is growing knowledge of Treatment as Prevention or the concept Undetectable = Untransmittable (U = U) among PLHIV in Western and high-income countries, the reach and penetration of the U = U message in sub-Saharan Africa remains limited, and few studies have evaluated the impact of accessible and relatable U = U messages on ART initiation and adherence. To address these gaps, rigorous evaluations of interventions that incorporate U = U messages are needed, especially among men in high prevalence settings. Methods: Building on our U = U messages that we previously developed for men using behavioral economics insights and a human-centered design, we will conduct two sequential hybrid type 1 effectiveness-implementation trials to evaluate the impact of U = U messages on men's uptake of community-based HIV testing and ART initiation (Trial 1), and retention in care and achievement of viral suppression (Trial 2). For trial 1, a cluster randomized trial will be implemented with HIV testing service site-days (each day at one testing site) randomized to U = U or standard-of-care (SoC) messages inviting men to test for HIV. For trial 2, an individual-level randomized control trial will be implemented, with men initiating ART at six government clinics randomized to receive U = U counselling or SoC treatment adherence messaging. We will incorporate a multi-method evaluation to inform future implementation of U = U messaging interventions. The study will be conducted in the Buffalo City Metro Health District of the Eastern Cape Province and in the Cape Town Metro Health District in the Western Cape Province in South Africa. Discussion: These trials are the first to rigorously evaluate the impact of U = U messaging on HIV testing uptake, ART initiation and achievement of viral suppression among African men. If effective, these messaging interventions can shape global HIV testing, treatment and adherence counselling guidelines and practices. [ABSTRACT FROM AUTHOR]

Background: Older adults commonly experience chronic medical conditions and are at risk of cognitive impairment as a result of age, chronic comorbidity, and medications prescribed to manage multiple chronic conditions. Anticholinergic medications are common treatments for chronic conditions and have been repeatedly associated with poor cognitive outcomes, including delirium and dementia, in epidemiologic studies. However, no study has definitively evaluated the causal relationship between anticholinergics and cognition in a randomized controlled trial design. Utilizing our prior experience in deprescribing anticholinergic medications in various clinical environments, we designed an outpatient deprescribing intervention to prospectively test the potential causal relationship between anticholinergics and cognition in primary care older adults. Methods: This cluster randomized clinical trial will be conducted to evaluate the impact of an anticholinergic deprescribing intervention compared to usual care on outcomes of cognition and safety in primary care older adults. Participants will include those aged 65 years and over, receiving primary care in the greater Indianapolis area, using a strong anticholinergic within the last 2 weeks or with evidence of high-risk exposure in the past year. Those excluded will have a diagnosis of Alzheimer's disease or related dementia, or serious mental illness. The trial plans to enroll 344 participants who will be cluster-randomized at the level of primary care physician to avoid contamination. Participants will complete outcome assessments every 6 months up to 2 years by blinded outcome assessors. The primary outcome of the study is a composite measure of cognition that includes domains assessing executive cognitive function, language, and memory. Secondary outcomes include patient-reported measures of pain intensity, depression, anxiety, sleep disturbance, and health-related quality of life. Discussion: The R2D2 trial will be the largest and longest prospective randomized trial testing the impact of an anticholinergic-specific deprescribing intervention on cognition in primary care older adults. Results could influence deprescribing methodology and provide new insight on the relationship between anticholinergics and cognition. Trial registration: ClinicalTrials.gov NCT04270474. Registered on February 17, 2020. [ABSTRACT FROM AUTHOR]

Background: Excessive sodium intake is associated with high blood pressure and an increased risk of cardiovascular disease. However, reducing dietary salt has been challenging due to a lack of awareness and a high threshold in detecting saltiness. Objectives: The goal of this study is to evaluate the effectiveness of a combined intervention (intensive dietary education, food reformulation, environmental changes to facilitate salt reduction, and salt meter utilization), in comparison to standard education only, on salt intake and blood pressure. Methods: A cluster randomized-controlled trial was conducted on 219 hypertensive adults aged 18 to 70 years in Uthaithani, Thailand. Participants were randomized 1:1 into the intervention group (n = 111) and the control group (n = 108). Results: There were no differences in baseline characteristics between groups. The mean systolic and diastolic blood pressure was 143.6 and 82.1 mmHg and 142.2 and 81.4 mmHg in the intervention group, and the control group, respectively. The median 24-hour urinary sodium excretion was 3565 and 3312 mg/day, in the intervention and the control group, respectively. After 12 weeks, the change in systolic blood pressure was -13.5 versus -9.5 mmHg (P = 0.030) and diastolic blood pressure was -6.4 versus -4.8 mmHg (P = 0.164) in the intervention and control groups, respectively. Moreover, a reduction in 24-hour urine sodium excretion was observed [-575 versus -299 mg/day in the intervention and control groups, respectively (P = 0.194)]. The change in 24-hour urine sodium excretion was statistically significant and reduced from baseline in the intervention group (P = 0.004). The dietary salt intake was significantly improved and was statistically different between groups (P = 0.035). Conclusions: The combined intervention significantly decreased systolic blood pressure and showed a trend towards reduced urine sodium excretion in hypertensive patients. These comprehensive approaches may be beneficial in reducing blood pressure and salt intake in the community. Clinical trial registration: This trial was registered at Clinicaltrials.gov with the identifier NCT05397054. https://classic.clinicaltrials.gov/ct2/show/NCT05397054 [ABSTRACT FROM AUTHOR]

Background: There is limited evidence to assess if interventions implemented during pregnancy proactively mitigate parental vaccine hesitancy and promote timely vaccination among children after birth. This study protocol describes the evaluation of an ADaptivE PrenaTal (ADEPT) intervention to increase childhood vaccinations that is implemented with first-time pregnant individuals (PIs). Methods: Within the framework of a type 1 effectiveness-implementation hybrid study design, a cluster-randomized trial (CRT) will determine the effectiveness of ADEPT at increasing childhood vaccinations, and a nested explanatory mixed methods (NMM) study will assess changes in parental vaccine hesitancy. Study practices will be randomized to deliver ADEPT in addition to standard of care or standard of care alone. Providers at intervention sites will participate in a 4-part training program on childhood vaccines and effective communication. During a routine prenatal visit, providers will discuss vaccines recommended for the PI during pregnancy and for the child after birth, following which PIs will be screened for vaccination intention. Vaccine-hesitant PIs will be offered adaptive components of the intervention, which include an educational website and phone call with a vaccine navigator to discuss concerns. They will also be offered enrollment into the NMM study, where their vaccination intention will be assessed post-intervention. After PIs give birth, their child's vaccination outcomes at 2 months will be extracted from the state immunization registry. The primary study outcome is the difference in timely childhood vaccination at 2 months between the intervention and control arms. The secondary outcome is reduction in vaccine hesitancy assessed among PIs in the NMM study as the pre-post intervention change in vaccination intention. Discussion: The study findings are expected to contribute evidence on the effectiveness of prenatal interventions to proactively mitigate parental vaccine hesitancy and promote timely vaccinations after the child's birth. Trial registration: The study protocol is registered in ClinicalTrials.gov (NCT05795855). [ABSTRACT FROM AUTHOR]

The Break4Brain project aims to elucidate the effects of both acute and chronic physical activity (PA) on educational achievement in children with and without Attention Deficit Hyperactivity Disorder (ADHD). This study will be conducted in two phases: a cross-over design followed by a hybrid type 1 implementation-effectiveness trial, which includes both a cluster randomized controlled trial (RCT) and a qualitative study. In phase I, 60 children aged 10–12, with 30 each from ADHD and non-ADHD groups, will participate in a laboratory-based study over 4 days within 1 month. They will participate in three counterbalanced experimental conditions: (i) PA with cognitive engagement, (ii) PA without cognitive engagement, and (iii) a cognitively engaging control. This phase will assess acute changes in brain function, academic performance, working memory, inhibitory control, and sustained attention. Phase II will involve 600 children aged 10–12, randomly assigned to either a video-based PA program or a control group (300 children per group) in an 8-week cluster RCT. This phase will also incorporate a qualitative approach to explore the implementation context through pre- and post-intervention semi-structured interviews with teachers and school staff, and questionnaires for students. The outcomes of interest in this phase will include working memory, cognitive flexibility, selective attention, and academic performance. For the cross-over study, we hypothesize that PA conditions will enhance the studied outcomes compared to the control condition. In the RCT, we anticipate that the 8-week active breaks program will result in significant improvements in the selected outcomes compared to the control group. This study is expected to make pioneering contributions by including novel variables and focusing on the ADHD population. Furthermore, if the cluster RCT proves effective, it could offer a practical and cost-effective resource for integrating active breaks into daily school routines. [ABSTRACT FROM AUTHOR]

Background: As the opioid epidemic continues to have a major negative impact across the US, community pharmacies have come under scrutiny from legal systems attempting to hold them accountable for their role in over dispensing and lack of patient intervention. While the most available tool for monitoring patients' opioid use is Prescription Drug Monitoring Programs (PDMP), these do not provide pharmacists with actionable information and decision support. Our study addresses this gap through three objectives: [1] incorporate validated opioid risk metric thresholds into a PDMP platform to create the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool; [2] assess ORRCDS' ability to reduce patient opioid risk; [3] assess ORRCDS' sustainability and viability for broader dissemination in community pharmacy. Methods: For objective 1, our team is partnering with leadership from the largest US PDMP organization and a top-five pharmacy chain to implement ORRCDS into the pharmacy chain's workflow following the Guideline Implementation with Decision Support (GUIDES) framework. For objective 2, our team will conduct a type-1 implementation mixed methods study using a 2-arm parallel group clustered randomized design. We anticipate enrolling ~ 6,600 patients with moderate and high opioid use risk during the 6-month enrollment phase across 80 pharmacies. This sample size will provide 96.3% power to detect a 5% or greater difference in responder rate between the intervention and control arm. Responders are patients with moderate-risk at baseline who reduce to low-risk or those with high-risk at baseline who reduce to moderate or low-risk at 180 days post last intervention. To accomplish objective 3, we will use the Consolidated Framework for Implementation Research (CFIR) to develop and execute cross-sectional qualitative interviews with pharmacists (n = 15), pharmacy leaders (n = 15), and PDMP leaders (n = 15) regarding long term adoption and sustainability of the ORRCDS tool. Conclusions: A PDMP tool that addresses moderate- and high-risk opioid use is not available in community pharmacy. This study will implement ORRCDS in a large retail pharmacy chain that will include additional screening and guidance to pharmacy staff to address risky opioid medication use. Our results will make critical advancements for protecting patient health and addressing the opioid epidemic. [ABSTRACT FROM AUTHOR]

ABSTRACT A male partner or husband is the most influential person in the family, especially in Ethiopia. The role of a male partner or husband in promoting and supporting breastfeeding has hardly been investigated in low‐ and middle‐income countries, including Ethiopia. Therefore, the objective of this study was to evaluate the effect of breastfeeding education and support interventions that focus on male partners, with the goal of promoting optimal breastfeeding practices in central Ethiopia. A two‐arm parallel design cluster randomized controlled trial was carried out among couples in a community setting in the Hadiya Zone, Central Ethiopia. Fathers and mothers in the intervention group received breastfeeding education and support via social events, home visits and using printed materials, while those in the control group received existing routine care. A total of 408 couples from 16 clusters were randomly assigned to either the intervention group (n = 204) or the control group (n = 204). A Generalized Estimating Equation (GEE) model was used to evaluate the effectiveness of the interventions. At the end of the interventions, the proportion of optimal breastfeeding practice increased by 19.5% in the intervention group and by 2% in the control group. The differences‐in‐difference in optimal breastfeeding practice between the intervention and control groups was 17.5% [95% CI: 13.8%–21.2%; p = 0.001]. In the GEE model, babies born to mothers in the mother‐father pair group had a 38% higher likelihood [RR = 1.38, 95% CI (1.106, 1.723)] of being optimally breastfed at the sixth month compared with babies born to mothers who received standard care. Breastfeeding education and support interventions targeting male partners in low‐resource settings improve optimal breastfeeding practices, highlighting the need to give due emphasis to integrating breastfeeding promotion and counselling for male partners into existing maternal and child health services.Trial Registration: ClinicalTrials.gov identifier (NCT number): NCT05173454, First registered on 30/12/2021. [ABSTRACT FROM AUTHOR]

Background: The fixed effects model is a useful alternative to the mixed effects model for analyzing stepped-wedge cluster randomized trials (SW-CRTs). It controls for all time-invariant cluster-level confounders and has proper control of type I error when the number of clusters is small. While all clusters in a SW-CRT are typically designed to crossover from the control to receive the intervention, some trials can end with unexposed clusters (clusters that never receive the intervention), such as when a trial is terminated early due to safety concerns. It was previously unclear whether unexposed clusters would contribute to the estimation of the intervention effect in a fixed effects analysis. However, recent work has demonstrated that including an unexposed cluster can improve the precision of the intervention effect estimator in a fixed effects analysis of SW-CRTs with continuous outcomes. Still, SW-CRTs are commonly designed with binary outcomes and it is unknown if those previous results extend to SW-CRTs with non-continuous outcomes. Methods: In this article, we mathematically prove that the inclusion of unexposed clusters improves the precision of the fixed effects intervention effect estimator for SW-CRTs with binary and count outcomes. We then explore the benefits of including an unexposed cluster in simulated datasets with binary or count outcomes and a real palliative care data example with binary outcomes. Results: The simulations show that including unexposed clusters leads to tangible improvements in the precision, power, and root mean square error of the intervention effect estimator. The inclusion of the unexposed cluster in the SW-CRT of a novel palliative care intervention with binary outcomes yielded smaller standard errors and narrower 95% Wald Confidence Intervals. Conclusions: In this article, we demonstrate that the inclusion of unexposed clusters in the fixed effects analysis can lead to the improvements in precision, power, and RMSE of the fixed effects intervention effect estimator for SW-CRTs with binary or count outcomes. [ABSTRACT FROM AUTHOR]

Background : The community-based social healing (CBSH) model, developed by Ubuntu Centre for Peace, aims to support individuals with traumatic experiences and mental health challenges in achieving better mental health. CBSH combines BREATH-BODY-MIND™ (BBM) practices with collective narrative and rituals, facilitated by Community Healing Assistants in therapeutic groups. A previous pilot study involving 1889 Rwandan CBSH participants showed significant mental health improvements, including reductions in depression, anxiety, and PTSD, along with enhanced work productivity, and decreased intimate partner violence. The trial investigates the CBSH model's impact on Ubuntu and mental health. Ubuntu, a concept that encompasses humanness, compassion, and interconnectedness, is deeply rooted in the African philosophy. Methods/design: This cluster randomized controlled trial will involve 54 villages randomly selected in the Kirehe district, with 1080 participants randomly allocated equally to the CBSH intervention or a wait-list control group. While the trial will be conducted at the village (cluster) level, both primary and secondary outcomes will be measured individually for participants within each cluster. The Primary outcome "Ubuntu" will be measured using a context-adapted Ubuntu measurement scale. Secondary outcomes include psychosocial indicators which will be assessed through standardized tools such as the Patient Health Questionnaire for depression (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Warwick-Edinburgh Mental Wellbeing scale (WEMWS), Connor-Davidson Resilience scale (CD-RISK-10), Somatic Symptom Severity Scale (PHQ-15), Revised Conflict Tactics scale (CTS2S), and Adapted Social Capital Assessment Tool (SASCAT). Conclusion: This trial aims to evaluate the CBSH model's impacts on Ubuntu, mental health, and social functioning among trauma-affected Rwandans, including those impacted by the 1994 Genocide against the Tutsi, mass killings, sexual abuse, and domestic violence. The findings could be of value to the Ubuntu Centre for Peace, policymakers, healthcare practitioners, and other stakeholders, by highlighting the significance of promoting Ubuntu as a foundation for addressing mental health challenges and the consequences of psychosocial trauma. Trial registration: ISRCTN ISRCTN17659369. Registered on February 09, 2024. [ABSTRACT FROM AUTHOR]

Background: Maternal recognition of neonatal danger signs following birth is a strong predictor of care-seeking for newborn illness, which increases the odds of newborn survival. However, research suggests that maternal knowledge of newborn danger signs is low. Similarly, maternal knowledge of optimal newborn care practices has also been shown to be low. Since both issues are typically addressed during antenatal care, this study sought to determine whether group antenatal care (G-ANC) could lead to improvements in maternal recognition of danger signs and knowledge of healthy newborn practices, as well as boosting postnatal care utilization. Methods: This cluster randomized controlled trial of G-ANC compared to routine individual antenatal care (I-ANC) was conducted at 14 health facilities in Ghana, West Africa, from July 2019 to July 2023. Facilities were randomized to intervention or control, and pregnant participants at each facility were recruited into groups and followed for the duration of their pregnancies. 1761 participants were recruited: 877 into G-ANC; 884 into I-ANC. Data collection occurred at enrollment (T0), 34 weeks' gestation to 3 weeks postdelivery (T1) and 6–12 weeks postpartum (T2). Comparisons were made across groups and over time using logistic regression adjusted for clustering. Results: Overall, knowledge of newborn danger signs was significantly higher for women in G-ANC, both in aggregate (13-point scale) and for many of the individual items over time. Likewise, knowledge of what is needed to keep a newborn healthy was higher among women in G-ANC compared to I-ANC over time for the aggregate (7-point scale) and for many of the individual items. Women in G-ANC were less likely to report postnatal visits for themselves and their babies within 2 days of delivery than women in I-ANC, and there was no difference between groups regarding postnatal visits at one week or 6 weeks after birth. Conclusion: This study illustrates that group ANC significantly improves knowledge of newborn danger signs and healthy newborn practices when compared to routine care, suggesting that the impact of G-ANC extends beyond impacts on maternal health. Further research elucidating care pathways for ill newborns and maternal behaviors around healthy newborn practices is warranted. Trial registration: : ClinicalTrials.gov Identifier: NCT04033003, Registered: July 25, 2019 Protocol Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9508671/. [ABSTRACT FROM AUTHOR]

Background: Individuals with diabetes and co-existing psychiatric disorders have more diabetes complications and lower life expectancy than those with diabetes but no co-existing psychiatric disorders. Psychiatric health professionals may have a role in improving these outcomes but often lack diabetes knowledge and skills. This study aims to examine the effectiveness of a diabetes training course for psychiatric health professionals on their diabetes knowledge and skills and clinical outcomes, diabetes support and diabetes distress among individuals with diabetes and psychiatric disorders treated in psychiatric outpatient clinics. Methods: A pragmatic non-randomized controlled cluster trial was conducted in eight psychiatric outpatient clinics in Denmark. All psychiatric health professionals from four clinics participated in the diabetes training course (the intervention) and completed a questionnaire on experience of the training course and a 20-item pre- and post-test to measure diabetes knowledge and skills. Difference in pre- and post-tests were analyzed using t-tests. From August 2018 – June 2019, individuals with diabetes were recruited from the intervention clinics (n = 49) and from four control clinics continuing usual clinical practice (n = 57). Differences in clinical outcomes, diabetes support and diabetes distress between the intervention and control groups at six and 12 months after the training course, were analyzed using logistic and linear regression models adjusted for baseline levels. Results: Psychiatric health professionals (n = 64) had more correct answers after completing the course, with a mean increase of 6.3 [95% CI 5.6 to 7.0] correct answers. A total of 49 and 57 individuals were recruited for the intervention and control group, respectively. At follow-up, individuals treated in the intervention group had lower levels (clinical improvement) of systolic blood pressure, but had lower receipt of annual assessment of blood pressure, and body mass index (BMI) (worsening of process measures). While there were observed differences in odds and means for several other outcomes, none of these received statistical significance (see Table 2 and Fig. 2). Conclusions: Training psychiatric health professionals in diabetes care improved their diabetes knowledge and skills and improved clinical levels of systolic blood pressure in individuals treated in the intervention group. However, this training intervention was associated with a lower likelihood of receiving annual assessment of blood pressure and BMI. Trial registration: ISRCTN registry registration number ISRCTN15523920, registration date: 02/10/2019. [ABSTRACT FROM AUTHOR]

Background: Refugees are exposed to various risk factors in shared accommodations in Germany where they are housed after their arrival. Due to their often traumatic experiences before, during, and after their flight and socio-structural post-migration stressors, refugees are potentially vulnerable to hazardous substance use. They form a structurally disadvantaged group for substance use prevention and intervention. Various barriers make it difficult for them to access the healthcare system and to get health information. Therefore, a participatory multi-component prevention concept for refugees in shared accommodations was developed. The aim of the trial is to evaluate the efficacy of this concept regarding the increase in knowledge about substance use among refugees living in shared accommodations. Methods: Based on a randomized controlled stepped-wedge design, the study will be conducted in a multicenter setting in nine shared accommodations and will aim to include refugees living in shared accommodations as well as social workers and psychologists working there. Discussion: This trial will be one of the first to generate evidence about effective participatory prevention concepts for refugees in shared accommodations. Evidence-based concepts for refugees can improve access to health care and might be helpful for the multidisciplinary workforce in shared accommodations. Trial registration: OSF Registry: osf.io/ebnj3. Registered on May 24, 2024. Registration DOI: https://doi.org/10.17605/OSF.IO/EBNJ3. [ABSTRACT FROM AUTHOR]

Background: Attractive targeted sugar bait (ATSB) stations containing bait (to attract) and ingestion toxicant (to kill) sugar-foraging mosquitoes are hypothesized to reduce malaria transmission by shortening the lifespan of Anopheles vectors. Methods: A two-arm cluster-randomized controlled trial (cRCT) was conducted in Western Province Zambia. Seventy clusters of 250–350 households were assigned (1:1) by restricted randomization to an intervention arm (ATSB) or control arm (no ATSB) in the context of standard of care vector control (insecticide-treated nets and/or indoor residual spraying). Two ATSB stations (Westham Sarabi, 0.11% dinotefuran w/w) were maintained on exterior walls of eligible household structures for a 7-month deployment period (December-June) during the high malaria transmission season. The primary outcome was clinical malaria incidence among two consecutive seasonal cohorts of children aged 1–14 years, followed-up monthly from January-June in 2022 and 2023. Secondary outcome was Plasmodium falciparum prevalence among individuals aged over six months. Analysis compared clinical malaria incidence and prevalence between arms among the intention-to-treat population. Results: ATSB coverage, assessed by cross-sectional survey, was 98.3% in March–April 2022 and 89.5% in March–April 2023. 4494 children contributed any follow-up time to the cohort, with 2313 incident malaria cases in the intervention arm (1.28 per child per six-month transmission season), and 2449 in the control arm (1.38 per child-season). The incidence rate ratio between the two arms was 0.91 (95% CI 0.72–1.15, p = 0.42). 2536 individuals participated in cross-sectional surveys, with prevalence of P. falciparum 50.7% in the intervention arm and 53.5% in the control arm. The odds ratio between the two arms was 0.89 (95% CI 0.66–1.18, p = 0.42). Secondary covariable-adjusted and subgroup analyses did not substantially alter the findings. No serious adverse events associated with the intervention were reported. Conclusions: Two ATSB stations deployed per eligible structure for two consecutive transmission seasons did not result in a statistically significant reduction in clinical malaria incidence among children aged 1–14 years or in P. falciparum prevalence in rural western Zambia. Further studies are needed to assess the efficacy of ATSB stations in different settings and with different deployment strategies. Trial registration: The trial is registered with Clinicaltrials.gov (NCT04800055). [ABSTRACT FROM AUTHOR]

Background: Evidence shows that using the AWARD (Ask, Warn, Advise, Refer, Do-it-again) model with service-learning model in youngsters may be an appropriate strategy to refer young smokers for early smoking cessation services. Therefore this study aims to promote smoking cessation by training secondary school students as anti-smoke ambassadors (ASAs) with increased knowledge, skills and self-efficacy on smoking cessation and AWARD model using service-learning model. Methods: A cluster randomized controlled trial will be conducted in 14 secondary schools in Hong Kong. Also, a hybrid type 1 effectiveness-implementation design with the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework will be adopted. For the intervention group, participants (n = 184) will attend a 3-hour training workshop, followed by hands-on sessions supervised by trained nursing students, then a 6-month smoker referral competition and an award presentation ceremony. The control group (n = 184) will only attend the 3-hour training workshop. The research assistant will contact participants at the start and the end of training program, and at 3, 6, and 12 months after the end of the training program by telephone to complete a set of questionnaires. Participating secondary schools, participating nursing students, ASAs, and responsible organizational staff will be randomly invited for a one-to-one semi-structured interview. The primary outcome will be the number of smokers who referred by secondary school students. Descriptive statistics, mixed between-within-subjects ANOVA, logistic regressions, and content analysis will be used. Discussion: This study will bridge the gap in existing literature by determining the effectiveness and exploring facilitators and barriers in implementing our intervention with the use of the AWARD model and service-learning model in training young people to refer smokers to anti-smoke organizations in the real-world. This can enhance our community capacity and enable youngsters to take a proactive role to support smoking cessation. Trial registration: ClinicalTrials.gov, NCT05897346. Registered on 11 May 2023. [ABSTRACT FROM AUTHOR]

Background: Women in the early postpartum period face substantial unmet needs in contraception to encourage birth intervals and reduce unintended pregnancies. The widespread ownership of mobile devices offers an opportunity to employ mobile health strategies for enhancing communication between healthcare providers and clients. However, little is known about the effectiveness of mobile health interventions to improve early adoption of contraceptive methods after childbirth in Ehiopia. Objective: This study aimed to evaluate the effectiveness of a mobile health intervention in enhancing the uptake of modern contraceptive methods in the early postpartum period in Dessie and Kombolcha cities, northeast Ethiopia. Methods: The research was conducted in Dessie and Kombolcha cities zones located in the Amhara region of Northeast Ethiopia from 15th January to 15th June, 2023. Pregnant women with a confirmed gestation of 30 weeks were enrolled and followed up to the 45-day postpartum period. The study employed a cluster randomized control trial involving 764 participants (381 controls and 383 in the intervention group). The intervention group received a new mobile health intervention in addition to the existing healthcare practices, while the control group solely adhered to the current healthcare practices. Data were collected using the Open Data Kit (ODK) and exported to STATA 17 for analysis. The marginal model Generalized Estimating Equations (GEE) through the application of an exchangeable working correlation was applied. The effect of the intervention on the outcome was measured using the odds ratio with a 95% confidence interval at a p-value less than 0.05 significant level. Results: The study found that 78.7% of participants in the control group and 77.3% in the intervention group had sexual practice after childbirth. The proportion of early postpartum contraceptive uptake in the intervention group (51.6%) was significantly higher than in the control group (38%). The odds of adopting modern contraceptive methods during the early postpartum period were 1.6 times higher among mothers who received the mHealth intervention compared to those in the control group (AOR: 1.6, 95% CI: 1.249–2.123). The study identified significant predictors for the uptake of contraceptive methods during the early postpartum period, including having a live newborn (AOR: 3.7, 95% CI: 1.034–13.353), parity (AOR: 1.7, 95% CI: 1.069–2.695), and previous experience with contraceptive initiation (AOR: 0.5, 95% CI: 0.358–0.912). Conclusion: This study findings demonstrated that the potential effectiveness of mobile health interventions in promoting timely contraceptive adoption during early postpartum period. The mobile health intervention, combined with factors such as timing of previous contraceptive initiation, newborn status, and maternal parity, significantly enhances the likelihood of early contraceptive adoption. These nuanced insights provide a strong foundation for developing targeted health interventions and policies aimed at improving early postpartum contraception. Registration: The trial was registered on December 23, 2022, in the Protocol Registration and Results System (PRS) Clinical Trial Registry, www.ClinicalTrials.gov, ID: ClinicalTrials.gov ID: NCT05666037. [ABSTRACT FROM AUTHOR]

Background: Policing is a stressful occupation. Police officers are exposed to stressors that are inherent in the organization and operations of law enforcement. Similar to their counterparts around the world, many Nigeria police officers are exposed to high levels of stress, making them vulnerable to stress-related mental health conditions and other noncommunicable diseases. Despite these risks and their consequences to the health and safety of police officers and the larger society, interventions are currently not available to address this challenge in Nigeria. This pilot study aims to assess the burden of stress from a national sample of police officers and test the feasibility of an intervention for stress prevention, management, and coping mechanisms among police officers in Nigeria. Methods: This is a three-phase study: (1) a needs assessment and situational analysis using a convergent parallel, mixed-methods approach to determine the prevalence of stress and mental health burden among 1200 police officers in four randomly selected states in four geopolitical zones of the country, (2) the development of a peer-led intervention for stress prevention, management, and coping mechanism which will be tested using a cluster randomized trial among 200 police officers, and (3) the preliminary evaluation of the intervention based on knowledge about stress management and mental disorders and psychological distress and reduction in stress levels. These measures will be obtained at baseline (T0), immediate (T1), and 6-month post-intervention (T2). Feasibility will be determined based on enrollment rate, attendance, and completion of the group sessions. Multivariable linear regression models taking into account clustering effects will be used to estimate between-group differences in outcome measures. Discussion: Findings from the study will inform policy review and the development of a pragmatic intervention on stress prevention and management among police officers. This will enhance the policing role of officers, thus contributing to the safety of the communities they serve. Trial registration: PACTR Registry: PACTR202310474721238. Registered on 6 October, 2023. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25663. Protocol version number 1.0 (date: 6 October, 2023). [ABSTRACT FROM AUTHOR]

Background: Poverty is a key social determinant of mental health among forcibly displaced persons. This study aimed to design and pilot test a strategy to integrate existing mental health and economic inclusion interventions for displaced families in Ecuador. Methods: We conducted a series of qualitative interviews (n = 30), focus groups (n = 6), and workshops (n = 3) to develop a set of strategies for integrating cross-cutting and focused mental health and psychosocial support (MHPSS) strategies into an existing economic inclusion program for displaced families in Quito. We non-randomly assigned two field offices in Quito to (1) integrate cross-cutting strategies focused on improving economic outcomes or (2) integrate both those cross-cutting strategies plus focused MHPSS strategies into an economic inclusion program. We measured site-level implementation outcomes (adoption, appropriateness, acceptability, feasibility, fidelity, reach, retention, usability) and participant-level psychosocial (wellbeing, depressive symptoms, anxiety symptoms, functioning) and economic inclusion outcomes (financial resources, diet diversity, social capital/networks, self-reliance) over six months. We conducted a mixed-methods analysis to explore the acceptability and feasibility of the integration strategies and the ability to evaluate their effects in a future cluster randomized trial. Results: We developed a toolkit that included 10 strategies for integrating MHPSS into economic inclusion interventions. Fifty displaced persons participating in an existing economic inclusion program (25 per study condition) were enrolled and 88% remained in the study through the six-month follow-up. Participants and implementers reported that the integration strategy was appropriate, acceptable, feasible, and usable. Implementers, including people without prior experience in delivering mental health services, were able to deliver the intervention with high fidelity. Integration of focused MHPSS intervention components into an economic inclusion program appeared to improve MHPSS outcomes, the strength of social capital and networks, and engagement in economic and other programs. Conclusions: This study provides preliminary evidence of the acceptability and feasibility of integrating MHPSS into economic inclusion programs for displaced people. We found evidence supporting evaluation methods that can be employed in a future study to definitively test the added value of integrated approaches to mental health and economic wellbeing for displaced persons. [ABSTRACT FROM AUTHOR]

ABSTRACT The management of hypertension and diabetes poses significant challenges to China's healthcare system, necessitating seamless patient progression through screening, diagnosis, management, and control. Utilizing the care cascade model, this study aims to systematically identify patient drop‐offs and devise strategies to address healthcare delivery bottlenecks for hypertension and diabetes in rural China. This study consists of three phases. In Phase 1, qualitative interviews are conducted to explore healthcare experiences and identify determinants across the care cascade. Phase 2 involves systematically assessing barriers identified in Phase 1 and collaborating with local stakeholders using intervention mapping and co‐design to generate interventions and implementation strategies. Phase 3 is a cluster randomized controlled trial involving 48 villages, randomly assigned in a 1:1 ratio, to compare changes in hypertension and diabetes care. Intervention villages will implement interventions developed in Phase 2 for 1 year, while control villages will continue with usual care. Primary outcomes include between‐group differences in achieving blood pressure and glycemic targets, along with service and implementation outcomes. This study aims to identify the stage with the largest patient retention gap in the care cascade and develop intervention strategies through participatory co‐design with practitioners, emphasizing feasible, low‐cost approaches. The pragmatic cluster RCT will assess strategy effectiveness, offering valuable insights for practical interventions to enhance hypertension and diabetes care in rural settings, potentially shaping impactful programs and improving healthcare outcomes.Trial Registration: ClinicalTrials.gov. identifier: NCT06141278 [ABSTRACT FROM AUTHOR]

We used the Total Worker Health® approach to develop a multi-component workplace sedentary behavior intervention and tested intervention effectiveness in a cluster randomized trial. Participants (n = 198; 75% female) were recruited from three call-centers (two intervention and one usual practice control). All worksites received pedal stand active workstations. The usual practice site received no additional support, while the intervention group completed a six-month program of activities including computer-based training, behavioral self-monitoring, health and safety discussions, and pedaling competitions. Data collection included a survey, a physical health assessment, and accelerometer measures of sedentary behavior, physical activity, and sitting/standing time. Primary analyses were generalized estimating equations comparing changes between intervention and usual practice conditions over time, along with analyses of changes in both groups combined over time. Six-month results revealed less prolonged sitting and reductions in musculoskeletal pain in both groups (all p < 0.05), while the intervention group showed additional improvements in moderate physical activity (p < 0.001) and use of pedal stands (p < 0.01). At 12-months, the additional physical activity and pedal stand use in the intervention group regressed to baseline levels, while reductions in prolonged sitting in both groups were durable (p < 0.01). This study adds to previous research showing the effectiveness of the Total Worker Health® approach for workplace health and safety. Results also show that, while providing employees with health and safety resources is beneficial, providing ongoing support for the adoption and use of resources is more effective. [ABSTRACT FROM AUTHOR]

Background: Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs. Methods: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation. Discussion: Optimizing cardiac rehabilitation centres' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI. Trial registration: ClinicalTrials.gov. Identifier: NCT05889416. Registered 2023-03-23. [ABSTRACT FROM AUTHOR]

Introduction: Unwanted pregnancy constitutes a huge health issue. Long‐acting reversible contraception (LARC) are the most effective methods for preventing unwanted pregnancy, especially among young women. This study evaluates the intervention effect of structured contraceptive counseling on the choice, initiation, and use of LARC in young women. Material and Methods: This is a secondary analysis of women aged 18–25, enrolled in a multicenter cluster randomized controlled trial performed in abortion, youth, and maternal health clinics across the Stockholm County in Sweden. Clinics were randomized (1:1) to provide structured contraceptive counseling (intervention) or standard counseling (control). Surveys were administered at the clinic visit and follow‐ups at 3, 6, and 12 months. Primary outcome focused on the choice of LARC among women 18–25 years of age. Secondary outcomes included initiation, and use of LARC at 3 and 12 months, satisfaction with the counseling received and information on extended use of combined hormonal contraceptives. The study was registered at Clinicaltrials.gov (NCT03269357). Results: From September 2017 to May 2019, 770 women aged 18–25 years from 28 clinics/clusters were recruited. There was a significant intervention effect on LARC choice (aOR 5.96, 95% CI 3.25–10.94), initiation (aOR 4.43, 95% CI 2.32–8.46), and use at 12 months (aOR 2.21, 95% CI 1.31–3.73). The odds of LARC choice at pre‐booked visits were higher and more women received information about extended‐use regimen for short‐acting reversible contraception in the intervention group compared to the control group. The intervention package was well received, but with higher satisfaction at pre‐booked compared to drop‐in visits. Conclusions: Our study demonstrates that comprehensive structured contraceptive counseling significantly increases LARC choice, initiation and use, with high satisfaction among young participants, especially at pre‐booked visits. The results highlight an approach that merits implementation to increase quality of care in contraceptive services, to enhance reproductive health for adolescents and young adults. [ABSTRACT FROM AUTHOR]

Objective: This meta-epidemiological study aimed to determine whether optimal sample size calculation was applied in orthodontic cluster randomized trials (CRTs). Methods: Orthodontic randomized clinical trials with a cluster design, published between January 1, 2017 to December 31, 2023, in leading orthodontic journals were sourced. Study selection was undertaken by two independent authors. The study characteristics and variables required for sample size calculation were also extracted by the authors. The design effect for each trial was calculated using an intra-cluster correlation coefficient of 0.1 and the number of teeth in each cluster to recalculate the sample size. Descriptive statistics for the study characteristics, summary values for the design effect, and sample sizes were provided. Results: One-hundred and five CRTs were deemed eligible for inclusion. Of these, 100 reported sample size calculation. Nine CRTs (9.0%) did not report any effect measures for the sample size calculation, and a few did not report any power assumptions or significance levels or thresholds. Regarding the specific variables for the cluster design, only one CRT reported a design effect and adjusted the sample size accordingly. Recalculations indicated that the sample size of orthodontic CRTs should be increased by a median of 50% to maintain the same statistical power and significance level. Conclusions: Sample size calculations in orthodontic cluster trials were suboptimal. Greater awareness of the cluster design and variables is required to calculate the sample size adequately, to reduce the practice of underpowered studies. [ABSTRACT FROM AUTHOR]

Type 2 diabetes (T2D) represents a growing disease burden in South Africa. While glycated haemoglobin (HbA1c) testing is the gold standard for long-term blood glucose management, recommendations for HbA1c monitoring frequency are based on expert opinion. This study investigates the effectiveness and cost-effectiveness of alternative HbA1c monitoring intervals in the management of T2D. A Markov model with three health states (HbA1c <7%, HbA1c ≥ 7%, Dead) was used to estimate lifetime costs and quality-adjusted life years (QALYs) of alternative HbA1c monitoring intervals among patients with T2D, using a provider's perspective and a 3% discount rate. HbA1c monitoring strategies (three-monthly, four-monthly, six-monthly and annual tests) were evaluated with respect to the incremental cost-effectiveness ratio (ICER) assessing each comparator against a less costly, undominated alternative. The scope of costs included the direct medical costs of managing diabetes. Transition probabilities were obtained from routinely collected public sector HbA1c data, while health service utilization and health-related-quality-of-life (HRQoL) data were obtained from a local cluster randomized controlled trial. Other parameters were obtained from published studies. Robustness of findings was evaluated using one-way and probabilistic sensitivity analyses. A South African indicative cost-effectiveness threshold of USD2665 was adopted. Annual and lifetime costs of managing diabetes increased with HbA1c monitoring, while increased monitoring provides higher QALYs and life years. For the overall cohort, the ICER for six-monthly vs annual monitoring was cost-effective (USD23 22.37 per QALY gained), whereas the ICER of moving from six-monthly to three-monthly monitoring was not cost effective (USD6437.79 per QALY gained). The ICER for four-monthly vs six-monthly monitoring was extended dominated. The sensitivity analysis showed that the ICERs were most sensitive to health service utilization rates. While the factors influencing glycaemic control are multifactorial, six-monthly monitoring is potentially cost-effective while more frequent monitoring could further improve patient HrQoL. [ABSTRACT FROM AUTHOR]

Background: Cluster randomized trials (CRTs) are increasingly important for evaluating interventions embedded in health care systems. An essential parameter in sample size calculation to detect both overall and heterogeneous treatment effects for CRTs is the intra-cluster correlation coefficient (ICC) of both outcome and covariates of interest. However, obtaining advance estimates for the ICC can be challenging. When trial outcomes will be obtained from routinely collected data sources, there is an opportunity to obtain reliable ICC estimates in advance of the trial. Using USA national Medicare data, we estimated ICCs for a range of outcomes to inform the design of CRTs for people living with Alzheimer's and related dementias (ADRD). Method: Data from 2018 Medicare Fee-for-Service beneficiaries, specifically, 1,898,812 individuals (≥ 65 years) with diagnosis of ADRD within 3436 hospital service areas (treated as clusters) and 306 hospital referral regions (treated as fixed strata), were used to calculate unadjusted and adjusted ICC estimates for three outcomes: death, any hospitalizations, and any emergency department (ED) visits and three covariates: age, race and sex. We present both overall and stratum-specific ICC estimates. We illustrate their use in sample size calculations for overall treatment effects as well as detecting treatment effect heterogeneity. Results: The unadjusted overall ICCs for death, hospitalizations, and ED visits were 0.001, 0.010, and 0.017 respectively. Stratum-specific ICCs varied widely across the 306 HRRs: median 0.001, 0.010 and 0.025 for death, hospitalizations, and ED visits respectively and 0.007, 0.001, and 0.080 for age, sex and race. An interactive R Shiny app is provided that allows users to retrieve estimates overlayed on a map of the USA. Conclusions: We presented both adjusted and unadjusted ICCs for outcomes as well as unadjusted ICCs for covariates of potential interest from population-level data in the USA and demonstrated how the estimates may be used in sample size calculations for CRTs in ADRD. [ABSTRACT FROM AUTHOR]

Background: In supporting primary healthcare in delivering high-quality care for individuals with type 2 diabetes mellitus (T2DM), previous research emphasized strategies to facilitate communication and collaboration between primary healthcare providers and hospitals. This study aims to evaluate the effectiveness of case discussion conferences between specialists from hospitals and primary healthcare providers in China on the optimization of diabetes management and the improvement of patient health outcomes. Methods: This study will be a parallel cluster randomized controlled trial in which primary healthcare institutions in Shouguang city and Shangsi County will be randomly allocated to the intervention and control groups. The intervention will involve regular case discussion conferences where attendants will meet to discuss complex cases with patients diagnosed with type 2 diabetes mellitus, exchange experiences, and seek and provide expert advice. Family doctor teams from primary healthcare institutions and specialists from secondary or tertiary hospitals will engage in these conferences. Data will be collected at baseline and at the 6- and 12-month follow-ups. The primary clinical outcome measures will focus on the changes in the HbA1c and FBG levels of patients under management. The secondary outcomes will include other physiological indicators, such as blood pressure, BMI, and cholesterol. The evaluation will extend to changes in the capabilities and behaviors of primary healthcare providers. Furthermore, the feasibility and adherence of this intervention will be thoroughly assessed. Discussion: This study is designed to generate robust evidence on the effectiveness of case discussion conferences, an interprofessional collaboration strategy, in enhancing diabetes care delivery in primary healthcare, with the ultimate goal of improving patient health outcomes. Trial registration: Chinese Clinical Trial Registry ChiCTR2300078829. Registered on December 19, 2023. https://www.chictr.org.cn/showproj.html?proj=210293 [ABSTRACT FROM AUTHOR]

Background: Stepped-wedge cluster trials (SW-CTs) describe a cluster trial design where treatment rollout is staggered over the course of the trial. Clusters are commonly randomized to receive treatment beginning at different time points in this study design (commonly referred to as a Stepped-wedge cluster randomized trial; SW-CRT), but they can also be non-randomized. Trials with this design regularly have a low number of clusters and can be vulnerable to covariate imbalance. To address such covariate imbalance, previous work has examined covariate-constrained randomization and analysis adjustment for imbalanced covariates in mixed-effects models. These methods require the imbalanced covariate to always be known and measured. In contrast, the fixed-effects model automatically adjusts for all imbalanced time-invariant covariates, both measured and unmeasured, and has been implicated to have proper type I error control in SW-CTs with a small number of clusters and binary outcomes. Methods: We present a simulation study comparing the performance of the fixed-effects model against the mixed-effects model in randomized and non-randomized SW-CTs with small numbers of clusters and continuous outcomes. Additionally, we compare these models in scenarios with cluster-level covariate imbalances or confounding. Results: We found that the mixed-effects model can have low coverage probabilities and inflated type I error rates in SW-CTs with continuous outcomes, especially with a small number of clusters or when the ICC is low. Furthermore, mixed-effects models with a Satterthwaite or Kenward-Roger small sample correction can still result in inflated or overly conservative type I error rates, respectively. In contrast, the fixed-effects model consistently produced the target level of coverage probability and type I error rates without dramatically compromising power. Furthermore, the fixed-effects model was able to automatically account for all time-invariant cluster-level covariate imbalances and confounding to robustly yield unbiased estimates. Conclusions: We recommend the fixed-effects model for robust analysis of SW-CTs with a small number of clusters and continuous outcomes, due to its proper type I error control and ability to automatically adjust for all potential imbalanced time-invariant cluster-level covariates and confounders. [ABSTRACT FROM AUTHOR]

Background: Retrospective and descriptive molecular epidemiology studies have shown that Mycobacterium tuberculosis whole genome sequencing can identify outbreaks and disease transmission events with higher resolution than conventional epidemiological investigations. Those studies have strengthened our understanding of genomic polymorphisms correlating with person-to-person transmission and helped resolve putative transmission clusters. To date, systematic genomic surveillance programs implemented for M. tuberculosis were only implemented in low-incidence settings. The purpose of this study is to determine whether there is an impact of routine M. tuberculosis whole genome sequencing on tuberculosis case detection in a high-incidence setting. Methods: A cluster randomized controlled trial will be performed. Forty-eight rural village groups (or Fokontany) in the Vohibato district of Madagascar will be randomized to one of three interventions arms. Arm 1 (standard of care) involves healthcare facility-based passive case detection with smear microscopy testing. Arm 2 (best practice) consists of active case finding and Xpert MTB/RIF Ultra PCR testing followed by household contact investigations. Arm 3 (novel intervention) includes the same interventions as arm 2, with addition of sputum culture and M. tuberculosis whole genome sequencing for all newly diagnosed cases. In arm 3, molecular suggested putative outbreaks are investigated, and additional TB suspects are appropriately tested. The intervention observational period will be 2 years. The primary outcome will be the number of detected cases/100,000/year in each arm after 1 year of intervention. Discussion: This study is designed to determine whether there is an impact of prospective whole genome sequencing-based molecular typing on tuberculosis case detection in high-incidence settings. Investigating potential outbreaks and focusing active case finding in spatiotemporal settings where disease transmission is suggested by genomic typing is hypothesized to improve case detection in rural communities. Trial registration: ClinicalTrials.gov NCT05406453. Retrospectively registered on June 6, 2022. [ABSTRACT FROM AUTHOR]

Background: To reduce leprosy risk in contacts of patients with leprosy by around 50%, the World Health Organization (WHO) recommends leprosy post-exposure prophylaxis (PEP) using single-dose rifampicin (SDR). Results from a cluster randomized trial in the Comoros and Madagascar suggest that PEP with a double dose of rifampicin led to a similar reduction in incident leprosy, prompting the need for stronger PEP. The objective of this Phase 2 trial was to assess safety of a bedaquiline-enhanced PEP regimen (intervention arm, bedaquiline 800 mg with rifampicin 600 mg, BE-PEP), relative to the WHO recommended PEP with rifampicin 600 mg alone (control arm, SDR-PEP). Methods and findings: From July 2022 to January 2023, consenting participants were screened for eligibility, including a heart rate-corrected QT interval (QTc) <450 ms and liver enzyme tests (ALT/AST) below 3× the upper limit of normal (ULN), before they were individually randomized 1:1 in an open-label design. Recruitment was sequential, by age group. Pediatric dosages were weight adjusted. Follow-up was done at day 1 post-dose (including ECG) and day 14 (including ALT/AST), with repeat of ALT/AST on the last follow-up at day 30 in case of elevation on day 14. The primary outcome was non-inferiority of BE-PEP based on a <10 ms difference in QTc 24 h after treatment administration, both unadjusted and adjusted for baseline QTc. Of 408 screened participants, 313 were enrolled, starting with 187 adults, then 38 children aged 13 to 17 years, and finally 88 children aged 5 to 12 years, of whom 310 (99%) completed all visits. Across all ages, the mean QTc change on BE-PEP was from 393 ms to 396 ms, not significantly different from the change from 392 ms to 394 ms on SDR-PEP (difference between arms 1.8 ms, 95% CI −1.8, 5.3, p = 0.41). No individual's QTc increased by >50 ms or exceeded 450 ms after PEP administration. Per protocol, all children were analyzed together, with no significant difference in mean QTc increase for BE-PEP compared to SDR-PEP, although non-inferiority of BE-PEP in children was not demonstrated in unadjusted analysis, as the upper limit of the 95% CI of 10.4 ms exceeded the predefined margin of 10 ms. Adjusting for baseline QTc, the regression coefficient and 95% CI (3.3; −1.4, 8.0) met the 10 ms non-inferiority margin. No significant differences in ALT or AST levels were noted between the intervention and control arms, although a limitation of the study was false elevation of ALT/AST during adult recruitment due to a technical error. In both study arms, one serious adverse event was reported, both considered unlikely related to the study drugs. Dizziness, nausea, headache, and diarrhea among adults, and headaches in children, were nonsignificantly more frequently observed in the BE-PEP group. Conclusions: In this study, we observed that safety of single-dose bedaquiline 800 mg in combination with rifampicin is comparable to rifampicin alone, although non-inferiority of QTc changes was demonstrated in children only after adjusting for the baseline QTc measurements. A Phase 3 cluster randomized efficacy trial is currently ongoing in the Comoros. Trial Registration: ClinicalTrials.gov NCT05406479. Bouke C. de Jong and team assess the safety of a Bedaquiline enhanced post-exposure prophylaxis regimen in the Comoros Islands. Author summary: Why was this study done?: Worldwide, leprosy is diagnosed in 200,000 persons annually. Those living near a patient with leprosy can reduce their risk of developing leprosy by half if they take a single dose of the antibiotic rifampicin, known as "post-exposure prophylaxis," or PEP. Dual antibiotic treatment given as PEP may reduce the risk further, and bedaquiline has been shown to have a high degree of effectiveness against leprosy in animal studies, although the safety of PEP containing bedaquiline had not previously been tested. What did the researchers do and find?: In a village in the Comoros affected by leprosy, first adults and then children were invited to participate in a randomized study in which they could receive either a single dose of the regular PEP, or bedaquiline-enhanced PEP, in which regular rifampicin PEP was combined with bedaquiline. They had their heart rhythm and liver enzymes checked before and after taking PEP to screen for asymptomatic drug toxicity. There was no statistically significant difference in the heart rhythm or liver function between the 2 groups. While the analysis in children showed that the spread around the difference just exceeded the predetermined safety margin, the analysis controlled for baseline values did not show increased risk. What do these findings mean?: The findings suggest that regular PEP can safely be combined with bedaquiline, although it is not yet known if this provides stronger protection against developing leprosy. Limitations in this study include a technical error in liver function testing of adult participants, which may have hidden a low-level elevation. [ABSTRACT FROM AUTHOR]

Background: We previously performed a pragmatic cluster randomized controlled trial (RCT) in general practices and older adult care organizations in Poland, the Netherlands, Norway, and Sweden. We found that a multifaceted antibiotic stewardship intervention (ASI) substantially reduced antibiotic use for suspected urinary tract infections (UTIs) in frail older adults compared with usual care. We aimed to evaluate the implementation process of the ASI to provide recommendations for clinical practice. Methods: We conducted a process evaluation alongside the cluster RCT. The ASI consisted of a decision-tool and a toolbox, which were implemented using a participatory-action-research (PAR) approach with sessions for education and evaluation. We documented the implementation process of the intervention and administered a questionnaire to health care professionals (HCPs) from participating organizations in the intervention and usual care clusters. We evaluated the multiple components of the intervention and its implementation following a structured framework. Results: The questionnaire was completed by 254 HCPs from the 38 participating clusters. All components were largely delivered according to plan and evaluated as useful. The decision-tool and toolbox materials were reported to facilitate decision-making on UTIs. Regarding the PAR approach, educational sessions focusing on the distinction between UTIs and asymptomatic bacteriuria were held in all 19 intervention clusters. In 17 out of these 19 clusters, evaluation sessions took place, which were reported to help remind HCPs to implement the ASI. During both sessions, HCPs valued the reflection that took place and the resulting awareness of their behavior. It allowed them to explore implementation barriers and to tailor their local implementation process to overcome these. For example, HCPs organized extra educational sessions or revised local policies to incorporate the use of the decision-tool. Various HCPs took key roles in implementation. Staff changes and the COVID-19 pandemic were important contextual barriers. Conclusions: We found each component of the multifaceted ASI and its implementation to have added value in the process to improve antibiotic prescribing for suspected UTIs in a heterogeneous older adult care setting. We recommend using a multifaceted, multidisciplinary approach that enables HCPs to reflect on their current practice and accordingly tailor local implementation. Trial registration: ClinicalTrials.gov NCT03970356. Registered on May 31, 2019. [ABSTRACT FROM AUTHOR]

Background: Management of rheumatoid arthritis (RA) relies on symptoms reported by patients during infrequent outpatient clinic visits. These reports are often incomplete and inaccurate due to poor recall, leading to suboptimal treatment decisions and outcomes. Asking people to track symptoms in-between visits and integrating the data into clinical pathways may improve this. However, knowledge on how to implement this into practice and its impact on services and outcomes remains scarce in RA. Therefore, we evaluate the comparative effectiveness and cost-effectiveness of integrated symptom tracking in people with RA over and above usual care, while generating insights on factors for successful implementation. Methods: In this superiority stepped wedge cluster-randomized controlled trial with continuous recruitment short exposure design, 16 rheumatology outpatient departments (clusters) recruit a total of 732 people with active RA. They initially offer clinic visits according to standard of care before switching in pairs to visits with integrated symptom tracking. Clusters switch in randomized order every 3 weeks. Integrated symptom tracking consists of (1) a mobile app for patients to track their symptoms daily and other RA aspects weekly/monthly, and (2) an interactive dashboard visualizing the app data, which healthcare professionals access from their electronic health record system. Clinic visits happen according to usual practice, with tracked symptom data only reviewed during visits. Our primary outcome is a difference in marginal mean disease activity score at 12 ± 3 months between standard of care and integrated symptom tracking, after accounting for baseline values, cluster, and other covariates. Secondary outcomes include patient-reported disease activity, quality of life and quality-adjusted life-years, medication/resource use, consultation and decision-making experience, self-management, and illness perception. We also conduct interviews and observations as part of a parallel process evaluation to gather information on implementation. Discussion: Our trial will generate high-quality evidence of comparative and cost-effectiveness of integrated symptom tracking compared to standard of care in people with RA, with our process evaluation delivering knowledge on successful implementation. This optimizes the chances of integrated symptom tracking being adopted more widely if we find it is (cost-) effective. Trial registration: Registered 4-Jun-2024 on https://www.isrctn.com/, ISRCTN51539448. Trial open science framework repository: https://osf.io/sj9ha/. [ABSTRACT FROM AUTHOR]

Background: Some settings continue to experience a high malaria burden despite scale-up of malaria vector control to high levels of coverage. Characterisation of persistent malaria transmission in the presence of standard control measures, also termed residual malaria transmission, to understand where and when individuals are exposed to vector biting is critical to inform refinement of prevention and control strategies. Methods: Secondary analysis was performed using data collected during a phase III cluster randomized trial of attractive targeted sugar bait stations in Western Province, Zambia. Two seasonal cohorts of children aged 1–14 years were recruited and monitored monthly during the malaria transmission season, concurrent with entomological surveillance using a combination of human landing catch (HLC) and Centres for Disease Control (CDC) light traps at randomly selected households in study clusters. Behavioural data from cohort participants were combined with measured Anopheles funestus landing rates and sporozoite positivity to estimate the human behaviour-adjusted entomological inoculation rate (EIR). Results: Behavioural data from 1237 children over 5456 child-visits in 20 entomology surveillance clusters were linked with hourly landing rates from 8131 female An. funestus trapped by HLC. Among all An. funestus tested by enzyme-linked immunosorbent assay (ELISA), 3.3% were sporozoite-positive. Mean EIR directly measured from HLC was 0.07 infectious bites per person per night (ib/p/n). When accounting for child locations over the evening and night, the mean behaviour-adjusted EIR was 0.02 ib/p/n. Children not sleeping under insecticide-treated nets (ITNs) experienced 13.6 infectious bites per person per 6 month season, 8% of which occurred outdoors, while ITN users received 1.3 infectious bites per person per 6 month season, 86% of which were received outdoors. Sleeping under an ITN can prevent approximately 90% of potential An. funestus bites among children. Conclusions: In this setting ITNs have a high personal protective efficacy owing to peak An. funestus biting occurring indoors while most individuals are asleep. However, despite high household possession of ITNs (>90%) and high individual use (>70%), children in this setting experience more than one infectious bite per person per 6 month transmission season, sufficient to maintain high malaria transmission and burden. New tools and strategies are required to reduce the malaria burden in such settings. [ABSTRACT FROM AUTHOR]

Background: Soil-transmitted helminths (STH) affect approximately 1.5 billion people globally. The current STH control strategy is annual or twice-annual preventive chemotherapy, typically school-based deworming targeting children and women of reproductive age. Mathematical modeling suggests that it may be possible to interrupt STH transmission through high-coverage community-wide mass drug administration (cMDA). DeWorm3 is a cluster randomized trial testing cMDA for prevalence reduction and transmission interruption. The purpose of this study is to describe coverage of cMDA in study clusters over time and correlates of coverage at individual and cluster levels. Methods: From 2018–2020, DeWorm3 delivered six rounds of cMDA with 400 mg albendazole at sites in Benin, India, and Malawi. We report coverage, treatment uptake, and directly observed therapy across all rounds. Factors associated with coverage at the cluster level were identified using binomial generalized estimating equations, while factors associated with non-treatment at the individual level were identified using binomial mixed-effects models. Results: Coverage was high across all clusters and rounds, exceeding the WHO target of 75% in all sites and across all rounds (78% to 95%); cluster-level coverage tended to increase over time. Younger, unmarried, and migratory adults were more likely to be untreated at all sites; adult males were more likely to be untreated in Benin and Malawi. Among children, girls were more likely to be untreated, as were non-school-attending and migratory children. Higher adult education was associated with greater odds of non-treatment among adults, but lower odds among children in the household. Belonging to a less wealthy or minority language-speaking household was associated with non-treatment among both adults and children. Conclusions: It is possible to deliver community-wide MDA with high coverage. Unique individual and community-level factors influence treatment across settings, and these may be addressed through targeted programming. Trial Registration: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH), NCT03014167. [ABSTRACT FROM AUTHOR]

Background: Mental health symptoms among healthcare professionals (HCP) in intensive care units (ICUs) are a significant concern affecting both HCP well-being and patient care outcomes. Cross-sectional studies among members of the European Society of Intensive Care Medicine (ESICM) report up to 50% burnout rates. Determinants of burnout include communication, team cohesion, psychological support, and well-being promotion. We designed the 'Hello Bundle' intervention to mitigate burnout among ICU-HCPs by fostering positive social interactions and a supportive work environment. This justification synthesizes evidence from social psychology, positive psychology, and healthcare communication research to support the intervention. The 'Hello Bundle' aims to enhance interpersonal relationships, improve team cohesion, and reduce burnout rates. The six components include: Hello campaign posters, email reminders, integrating greetings in morning huddles, hello jars, lead-by-example initiatives, and a daily updated hello board in each ICU. This protocol describes a cluster randomized controlled trial to evaluate the effectiveness of the intervention. Methods: This protocol describes a cluster randomized controlled trial (RCT) conducted among ESICM-affiliated ICUs, consisting of at least 73 clusters with in average of 50 respondents per cluster, totaling approximately 7300 participants. Intervention clusters will implement the 6-component Hello Bundle between October 14 and November 10, 2024, while control clusters will be wait-listed to receive the intervention in January 2025 after the RCT concludes. Clusters will be matched based on ICU size (fewer or more than 20 beds), region, and average 2023 mortality. The primary outcome is the proportion of HCPs with burnout between intervention and control clusters at the end of the intervention. Secondary outcomes include comparing the following between clusters: (1) number of HCPs with high emotional exhaustion; (2) number with high depersonalization; (3) number with loss of accomplishment; (4) perception of ethical climate (5) satisfaction at work (VAS); (6) professional conflicts; (7) intention to leave the ICU (VAS); (8) patient-centered care rating; (9) family-centered care rating. The last secondary outcome is the comparison of burnout rates before and after the intervention in the intervention cluster. Outcomes will be based on HCP reports collected within four weeks before and after the intervention. Discussion: This is the first large trial of healthcare communication, social, and positive psychology intervention among ICU-HCPs. It holds the potential to provide valuable insights into effective strategies for addressing burnout in ICU settings, ultimately benefiting both HCPs and patients. Trial registration: This trial was registered on ClinicalTrials.Gov on June 18, 2024. Registration: NCT06453616. [ABSTRACT FROM AUTHOR]

Background: Provision of essential newborn care at home, rapid identification of illness, and care-seeking by caregivers can prevent neonatal mortality. Mobile technology can connect caregivers with information and healthcare worker advice more rapidly and frequently than healthcare visits. Community health workers (CHWs) are well-suited to deliver such interventions. We developed an interactive short message service (SMS) intervention for neonatal health in Kenya, named CHV-NEO. CHV-NEO sends automated, theory-based, actionable, messages throughout the peripartum period that guide mothers to evaluate maternal and neonatal danger signs and facilitate real-time dialogue with a CHW via SMS. We integrated this intervention into Kenya's national electronic community health information system (eCHIS), which is currently used at scale to support CHW workflow. Methods: The effect of CHV-NEO on clinical and implementation outcomes will be evaluated through a non-blinded cluster randomized controlled trial. Twenty sites across Kisumu County in Western Kenya were randomized 1:1 to provide either the national eCHIS with integrated CHV-NEO messaging (intervention) or standard of care using eCHIS without CHV-NEO (control). We will compare neonatal mortality between arms based on abstracted eCHIS data from 7200 pregnant women. Secondary outcomes include self-reported provision of essential newborn care (appropriate cord care, thermal care, and timely initiation of breastfeeding), knowledge of neonatal danger signs, and care-seeking for neonatal illness, compared between arms based on questionnaires with a subgroup of 2000 women attending study visits at enrollment in pregnancy and 6 weeks postpartum. We will also determine CHV-NEO's effect on CHW workflows and evaluate determinants of intervention acceptability, adoption, and fidelity of use through questionnaires, individual interviews, and messaging data. Discussion: We hypothesize that the CHV-NEO direct-to-client communication strategy can be successfully integrated within existing CHW workflows and infrastructure, improve the provision of at-home essential newborn care, increase timely referral of neonatal illness to facilities, and reduce neonatal mortality. The intervention's integration into the national eCHIS tool will facilitate rapid scale-up if it is clinically effective and successfully implemented. Trial registration: ClinicalTrials.gov, NCT05187897. The CHV-NEO study was registered on January 12, 2022. [ABSTRACT FROM AUTHOR]

Heterogeneity of outcomes across different clinical trial study sites is often inevitable. Understanding how outcomes differ by site is important for planning future programs and studies. We examined the extent of heterogeneity of hepatitis C virus (HCV) treatment cascade outcomes among persons who inject drugs (PWIDs) across sixteen clinical sites utilized in the HERO Study—a pragmatic randomized trial of HCV treatment support. Treatment cascade outcomes included averages of overall treatment adherence and proportions of treatment initiation, treatment completion, sustained virologic response (SVR) test completion, and SVR achievement. The HERO study utilized 16 clinical sites across the United States (US): eight opioid treatment programs (OTPs) and eight community health centers (CHCs). Variability of the outcomes across the 16 clinical sites was assessed using ranges and intraclass correlation coefficients (ICC) estimated from mixed-effects linear or logistic regression models. Treatment initiation was analyzed in the intention-to-treat (ITT) sample (N = 755); treatment completion, adherence, and SVR test completion in the modified ITT (mITT) sample, which is the sample that initiated treatment (N = 623); and SVR achievement in the mITT and per-protocol (PP, N = 501) samples. Across the 16 clinical sites, the range observed in the averages of overall treatment adherence was from 68% to 81% [ICC = 0.026 (0.005, 0.054)], and the ranges of proportions observed were from 68% to 96% for treatment initiation [ICC (95% CI) = 0.086 (0.051, 0.155)], 60% to 100% for treatment completion [ICC = 0.049 (0.008, 0.215)], 54% to 95% for SVR test completion [ICC = 0.096 (0.006, 0.177)], 46% to 90% for SVR achievement in the mITT sample [ICC = 0.070 (0.014, 0.122)], and 76% to 100% for SVR achievement in the PP sample [ICC = 0.143 (0.021, 0.422)]. The variability of the outcomes across 16 US sites treating HCV among PWIDs appears to be substantial in view of the ranges and ICC values of the outcomes. It is imperative to develop tailored interventions to target the sources of variability and reduce barriers at the patient, provider, clinic, and state policy levels to facilitate more equitable access to HCV treatment and reduce heterogeneity in treatment outcomes. [ABSTRACT FROM AUTHOR]

The Proactive Community Case Management (ProCCM) trial in Mali reinforced the health system across both arms with user fee removal, professional community health workers (CHWs) and upgraded primary health centres (PHCs)—and randomized village-clusters to receive proactive home visits by CHWs (intervention) or fixed site-based services by passive CHWs (control). Across both arms, sick children's 24-hour treatment and pregnant women's four or more antenatal visits doubled, and under-5 mortality halved, over 3 years compared with baseline. In the intervention arm, proactive CHW home visits had modest effects on children's curative and women's antenatal care utilization, but no effect on under-5 mortality, compared with the control arm. We aimed to explain these results by examining implementation, mechanisms and context in both arms We conducted a process evaluation with a mixed method convergent design that included 79 in-depth interviews with providers and participants over two time-points, surveys with 195 providers and secondary analyses of clinical data. We embedded realist approaches in novel ways to test, refine and consolidate theories about how ProCCM worked, generating three context-intervention-actor-mechanism-outcome nodes that unfolded in a cascade. First, removing user fees and deploying professional CHWs in every cluster enabled participants to seek health sector care promptly and created a context of facilitated access. Second, health systems support to all CHWs and PHCs enabled equitable, respectful, quality healthcare, which motivated increased, rapid utilization. Third, proactive CHW home visits facilitated CHWs and participants to deliver and seek care, and build relationships, trust and expectations, but these mechanisms were also activated in both arms. Addressing multiple structural barriers to care, user fee removal, professional CHWs and upgraded clinics interacted with providers' and patients' agency to achieve rapid care and child survival in both arms. Proactive home visits expedited or compounded mechanisms that were activated and changed the context across arms. [ABSTRACT FROM AUTHOR]

Background: The Ryan White Medical Case Management System, which serves more than half of people living with HIV (PLWH) in the USA, is an opportune setting for identifying and addressing depression among PLWH. A growing body of research suggests that interventions that promote positive emotion may lessen symptoms of depression and improve physical and psychological well-being among people experiencing a variety of health-related stress, including living with HIV. Research on how best to integrate standardized mental health screening and referral to evidence-based interventions in Ryan White Medical Case Management settings has the potential to improve the health and wellbeing of PLWH. Methods: This mixed-methods study will enroll up to N = 300 Ryan White clients who screen positive for depressive symptoms in ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery), a web-based, self-guided positive emotion regulation intervention. The study will be conducted in 16 Ryan White Medical Case Management clinics in Chicago, IL. Following pre-implementation surveys and interviews with Medical Case Managers (MCMs) and Supervisors to develop an implementation facilitation strategy, we will conduct a hybrid type 2 implementation-effectiveness stepped wedge cluster randomized trial to iteratively improve the screening and referral process via interviews with MCMs in each wedge. We will test the effectiveness of ORCHID on depression and HIV care outcomes for PLWH enrolled in the program. RE-AIM is the implementation outcomes framework and the Consolidated Framework for Implementation Research is the implementation determinants framework. Discussion: Study findings have the potential to improve mental health and substance use screening of Ryan White clients, decrease depression and improve HIV care outcomes, and inform the implementation of other evidence-based interventions in the Ryan White Medical Case Management System. Trial registration: ClinicalTrials.gov NCT05123144. Trial registered 6/24/2021 [ABSTRACT FROM AUTHOR]

Background: Intraoperative hemorrhage in cardiac surgery increases risk of morbidity and mortality. Low pre-operative and perioperative levels of fibrinogen, a key clotting factor, are associated with severity of hemorrhage and increased transfusion of blood components. The ability to supplement fibrinogen during hemorrhagic resuscitation is delayed 45–60 min because cryoprecipitated antihemophilic factor (cryo AHF) is stored frozen, due to a short post-thaw shelf life. Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) can be kept thawed, at room temperature, for up to 5 days, making it possible to be immediately available for hemorrhaging patients. This trial will investigate if earlier correction of acquired hypofibrinogenemia with IFC in hemorrhaging cardiac surgery patients reduces the total number of perioperatively transfused allogeneic blood products (red blood cells, plasma, and platelets) as compared to cryo AHF. Methods: This is a single center, prospective, cluster randomized trial with an adaptive design. Acquired hypofibrinogenemia will be assessed by rotational thromboelastometry (ROTEM) and the threshold for cryo AHF/IFC transfusion defined as FIBTEM A10 ≤ 10 mm in bleeding patients. IFC/cryo AHF will be randomized by 1-month blocks. Cardiac surgery patients will be enrolled in the study if they have an eligible procedure and at least one dose of a cryo AHF/IFC product (approximately 2 g fibrinogen) is transfused. Data from the electronic health record, including the blood bank and lab information systems, will be prospectively collected from the health system's data warehouse. Discussion: This trial aims to provide evidence of the clinical efficacy of utilizing readily available thawed IFC during acute bleeding in the cardiac surgery setting compared to traditional cryo AHF. Trial registration: ClinicalTrials.gov NCT05711524. Feb 3, 2023. [ABSTRACT FROM AUTHOR]

Background: Previously, we have reported on the efficacy and real-world effectiveness of a parent-oriented mobile health intervention (MINISTOP 1.0 and 2.0), which have shown improvements in pre-school children's lifestyle behaviours. However, there is a need for implementation evidence. The overall aims of this study are to: (i) compare two different implementation strategies for MINISTOP 3.0 (Basic vs. Enhanced) on: acceptability, appropriateness, feasibility, organizational readiness to implement MINISTOP 3.0 within Swedish child healthcare (primary outcomes) as well as reach, costs, and adoption of MINISTOP 3.0 (secondary outcomes); (ii) evaluate cost-effectiveness of MINISTOP 3.0; (iii) explore the sustainability of MINISTOP 3.0; (iv) evaluate the determinants of effectiveness of MINISTOP 3.0 on children's key lifestyle behaviours; and (v) investigate the long-term effects of MINISTOP 3.0 on children's body mass index. Methods: A hybrid type III implementation-effectiveness design will be used. A cluster randomized controlled trial will be conducted to compare the effects of basic versus enhanced implementation strategies on the outcomes at the child healthcare level. A minimum of 50 child healthcare centers across Sweden will participate and we aim to recruit 120 nurses. Child healthcare nurses in both groups will offer the MINISTOP 3.0 app to the families at the 2.5/3-year routine visit. Basic implementation strategies include educational meeting with nurses, formal implementation blueprint, develop/distribute educational materials and enhanced implementation includes all aforementioned strategies plus auditing/providing feedback and ongoing training for nurses. All outcomes will be assessed at baseline and 12 months post-implementation. Implementation outcomes will be assessed quantitatively using questionnaires and sustainability will be assessed qualitatively at 12 months. Children's key lifestyle behaviours will be collected through a parental questionnaire within the MINISTOP app at baseline and 6 months after they have received the app. Children's weight/height will be measured at routine visits at 2.5/3 (baseline), 4 and 5 years of age. Discussion: This study will provide important implementation evidence with regards to implementing mHealth interventions within Swedish child healthcare at scale and these results have the potential to be generalized to other digital interventions being implemented in child healthcare. Trial registration: ClinicalTrials.gov, NCT05667753. Registered December 29, 2022. [ABSTRACT FROM AUTHOR]

Background: Early in the pandemic, the United States population experienced a sharp rise in the prevalence rates of opioid use, social isolation, and pain interference. Given the high rates of pain reported by patients on medication for opioid use disorder (MOUD), the pandemic presented a unique opportunity to disentangle the relationship between opioid use, pain, and social isolation in this high-risk population. We tested the hypothesis that pandemic-induced isolation would partially mediate change in pain interference levels experienced by patients on MOUD, even when controlling for baseline opioid use. Such work can inform the development of targeted interventions for a vulnerable, underserved population. Methods: Analyses used data from a cluster randomized trial (N = 188) of patients on MOUD across eight opioid treatment programs. As part of the parent trial, participants provided pre-pandemic data on pain interference, opioid use, and socio-demographic variables. Research staff re-contacted participants between May and June 2020 and 133 participants (71% response rate) consented to complete a supplemental survey that assessed pandemic-induced isolation. Participants then completed a follow-up interview during the pandemic that again assessed pain interference and opioid use. A path model assessed whether pre-pandemic pain interference had an indirect effect on pain interference during the pandemic via pandemic-induced isolation. Results: Consistent with hypotheses, we found evidence that pandemic-induced isolation partially mediated change in pain interference levels among MOUD patients during the pandemic. Higher levels of pre-pandemic pain interference and opioid use were both significantly associated with higher levels of pandemic-induced isolation. In addition, pre-pandemic pain interference was significantly related to levels of pain interference during the pandemic, and these pain levels were partially explained by the level of pandemic-induced isolation reported. Conclusions: Patients on MOUD with higher use of opioids and higher rates of pain pre-pandemic were more likely to report feeling isolated during COVID-related social distancing and this, in turn, partially explained changes in levels of pain interference. These results highlight social isolation as a key risk factor for patients on MOUD and suggest that interventions promoting social connection could be associated with reduced pain interference, which in turn could improve patient quality of life. Trial registration: NCT03931174 (Registered 04/30/2019). [ABSTRACT FROM AUTHOR]

Background: Women with high-risk breast lesions, such as atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), have a 4- to tenfold increased risk of breast cancer compared to women with non-proliferative breast disease. Despite high-quality data supporting chemoprevention, uptake remains low. Interventions are needed to break down barriers. Methods: The parent trial, MiCHOICE, is a cluster randomized controlled trial evaluating the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. For this pre-implementation analysis, 25 providers participated in semi-structured interviews prior to accessing decision support tools. Interviews sought to understand attitudes/beliefs and barriers/facilitators to chemoprevention. Results: Interviews with 25 providers (18 physicians and 7 advanced practice providers) were included. Providers were predominantly female (84%), white (72%), and non-Hispanic (88%). Nearly all providers (96%) had prescribed chemoprevention for eligible patients. Three themes emerged in qualitative analysis. The first theme describes providers' confidence in chemoprevention and the utility of decision support tools. The second theme elucidates barriers to chemoprevention, including time constraints, risk communication and perceptions of patients' fear of side effects and anxiety. The third theme is the need for early implementation of decision support tools. Conclusions: This qualitative study suggests that providers were interested in the early inclusion of decision aids (DA) in their chemoprevention discussion workflow. The DAs may help overcome certain barriers which were elucidated in these interviews, including patient level concerns about side effects, clinic time constraints and difficulty communicating risk. A multi-faceted intervention with a DA as one active component may be needed. Trial registration: This trial was registered with the NIH clinical trial registry, clinicaltrials.gov, NCT04496739. [ABSTRACT FROM AUTHOR]

Background: Exclusive breastfeeding (EBF) of infants during the first 6 months of their life is strongly recommended. Video‐based communication is an innovative method that could promote EBF. The present study is aimed at assessing the effectiveness of video‐based intervention in promoting breastfeeding practices from birth to 6 months postpartum. This was evaluated through maternal reports, as well as EBF of infants at 3 and 5 months of age, using the deuterium oxide dose‐to‐mother (DTM) technique. Methods: In a cluster randomized community trial, 16 communities were assigned to receive a video‐based behavior change communication (Video‐Health) or standard health care messages (Control). Pregnant women in their first trimester (12 ± 2 weeks) were enrolled and followed up, together with their infants, until 6 months postpartum. Data on breastfeeding practices were collected by questionnaire, monthly, in all the participants (n = 508). Human milk intake (HMI) and nonmilk oral intake (NMOI) were measured in a subsample of 60 mother–infant pairs at 3 and 5 months postpartum using DTM. Mixed models and logistic regression were used to examine the difference in continuous and discrete breastmilk practices between the intervention and the control arms, respectively. Results: The majority of mothers initiated breastfeeding early (92.1%), 82.4% reported colostrum feeding, and 17.5% provided prelacteal feeding. No significant differences were found between Video‐Health and Control arms (p > 0.05). The intervention significantly improved reported EBF rates at 4 and 5 months postpartum (p < 0.05). DTM results showed that the proportion of women practicing EBF was 50%–67% less than reported at 3 months for both arms and at 5 months in the intervention arm. The intervention did not significantly affect measured EBF at 3 and 5 months postpartum but did improve HMI at 3 months. Non significant differences in NMOI were observed at 3 months, but at 5 months, there was a significant difference between the study arms. Conclusions: Video‐based behavior change communication did not result in significant improvements in reported breastfeeding practices, except for a higher reported adherence to EBF beyond 3 months. Additionally, the intervention had no effect on EBF as measured by the DTM. Early introduction of non‐breastmilk foods and liquids persisted, despite self‐reported EBF extending up to 6 months postpartum. Trial Registration: ClinicalTrials.gov identifier: NCT04414527 [ABSTRACT FROM AUTHOR]

Background: Intensive lifestyle interventions were effective to reduce the risk of type 2 diabetes mellitus (T2DM) for women with gestational diabetes mellitus (GDM) history. However, reaching these mothers and maintaining participation in lifestyle interventions is suboptimal in real-world settings. Effective, feasible and sustainable new lifestyle interventions are needed. The objectives of this three-arm trial are to (1) compare diabetes risk outcomes of an evidence-based intensive lifestyle modification (ILSM) intervention, a camp-style lifestyle modification program (CAMP) intervention, and usual care among women with GDM history; and (2) evaluate the comparative efficacy of the CAMP versus ILSM intervention on implementation outcomes. Methods: A three-arm cluster randomized clinical trial (RCT) using a hybrid type 2 implementation design will be conducted in two counties in Hunan province in China. Six towns from each county will be randomly selected and assigned to CAMP, ILSM, and the usual care group (25 women from each of 12 towns, 100 women in each arm). The ILSM includes six biweekly in-person sessions and 3-month telephone health consultations, while the CAMP consists of a 2-day camp-based session and 3-month health consultations via a popular social media platform. Both interventions share the same session content, including six lifestyle skills. Efficacy (T2DM risk score and behavioral, anthropometric, psychosocial, and glycemic variables) and implementation outcomes (recruitment, acceptability, feasibility, fidelity, and cost-effectiveness) will be collected at baseline, 6-month, and 12-month. Pre-planned ANOVA F-test and generalized estimating equations will be included to test time-by-arm interactions. Discussion: The CAMP intervention is expected to have better reach, better attendance, and comparable effectiveness in reducing the risk of T2DM, thus improving postpartum care for GDM in China. The delivery of a concentrated format supplemented with technology-based support may provide an efficient and effective delivery model for implementing maternal health promotion programs in primary care settings. Trial registration: Registered in the Chinese Clinical Trial Registry (ChiCTR2200058150) on 31st March 2022. [ABSTRACT FROM AUTHOR]

A study conducted in Uganda suggests that using C-reactive protein (CRP) levels to guide the evaluation of young children with lower respiratory tract infections (LRTIs) may help reduce the prescription of antimicrobial therapy without increasing treatment failure rates. LRTIs are a leading cause of morbidity and mortality in children, but there is no clinically feasible reference standard for their diagnosis. The study found that incorporating CRP into the routine management of LRTIs among young children resulted in a nearly 25% reduction in antimicrobial therapy prescriptions, with no difference in clinical outcomes. However, further research is needed to determine the optimal CRP level for withholding antimicrobial therapy and to consider the potential inconveniences and costs associated with implementing this approach. [Extracted from the article]