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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 It is well-recognized that maintaining a regular yogic practice is associated with numerous physical and psychological health benefits. However, few studies have explored the possible psychological and neurophysiological mediators through which the component parts of yoga—ethics, breath regulation, postures, and meditation—work to produce salutary effects. Purpose To address this gap, we conducted a cluster randomized trial to test the following set of theory-based mechanisms: emotion regulation for ethics, self-control for breath regulation, discomfort and distress tolerance for postures, and mindfulness for meditation. We also explored yoga's effects on the autonomic nervous system by examining salivary acetylcholinesterase levels. Methods Participants (N = 260) were randomly assigned in clusters (n = 37) to a single, hour-long standard or postures-only yoga class. Results Findings suggest that a single yoga class may confer both psychological and neurophysiological benefits, yet there were few differences between the two types of yoga classes. Pre- to post-session main effects of time, all in the expected direction, emerged for five of eight theoretical mediators, as well as for salivary acetylcholinesterase levels. Time X condition interactions observed for three of the mediators—cognitive reappraisal, discomfort tolerance, and expressive suppression—along with findings from the exploratory mediation analysis suggest potential unique benefits of the two yoga sessions for certain outcomes. Conclusions Additional studies are needed to replicate these results and to test other potential mediators and/or primary outcomes through which yoga might work to promote health. [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]

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]

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

Cluster randomized trials (CRTs) often enroll large numbers of participants; yet due to resource constraints, only a subset of participants may be selected for outcome assessment, and those sampled may not be representative of all cluster members. Missing data also present a challenge: if sampled individuals with measured outcomes are dissimilar from those with missing outcomes, unadjusted estimates of arm-specific endpoints and the intervention effect may be biased. Further, CRTs often enroll and randomize few clusters, limiting statistical power and raising concerns about finite sample performance. Motivated by SEARCH-TB, a CRT aimed at reducing incident tuberculosis infection, we demonstrate interlocking methods to handle these challenges. First, we extend Two-Stage targeted minimum loss-based estimation to account for three sources of missingness: (i) subsampling; (ii) measurement of baseline status among those sampled; and (iii) measurement of final status among those in the incidence cohort (persons known to be at risk at baseline). Second, we critically evaluate the assumptions under which subunits of the cluster can be considered the conditionally independent unit, improving precision and statistical power but also causing the CRT to behave like an observational study. Our application to SEARCH-TB highlights the real-world impact of different assumptions on measurement and dependence; estimates relying on unrealistic assumptions suggested the intervention increased the incidence of TB infection by 18% (risk ratio [RR] = 1.18, 95% confidence interval [CI]: 0.85–1.63), while estimates accounting for the sampling scheme, missingness, and within community dependence found the intervention decreased the incident TB by 27% (RR = 0.73, 95% CI: 0.57–0.92). [ABSTRACT FROM AUTHOR]

Recurrent events are common in clinical studies and are often subject to terminal events. In pragmatic trials, participants are often nested in clinics and can be susceptible or structurally unsusceptible to the recurrent events. We develop a Bayesian shared random effects model to accommodate this complex data structure. To achieve robustness, we consider the Dirichlet processes to model the residual of the accelerated failure time model for the survival process as well as the cluster-specific shared frailty distribution, along with an efficient sampling algorithm for posterior inference. Our method is applied to a recent cluster randomized trial on fall injury prevention. [ABSTRACT FROM AUTHOR]

The article discusses the use of high sensitivity cardiac troponin (hs-cTn) assays in the diagnosis and triage of patients with suspected acute myocardial infarction (MI). These assays, which detect even minute changes in cTn levels, have been shown to provide earlier diagnosis of MI compared to conventional assays. The article focuses on the performance of a 0/2-hour triage algorithm using a point-of-care-testing (POCT) assay, the Siemens Atellica VTLi, in patients with suspected MI. The algorithm was found to be effective in identifying low-risk patients and may be particularly useful in smaller hospitals or ambulatory care settings. However, the article also highlights several challenges that need to be addressed before routine clinical implementation of hs-cTn POCT, including differences in study cohorts, diagnostic and prognostic performance, time delays in emergency rooms, and the need for comprehensive medical examination and follow-up. The authors suggest that further research is needed to fully explore the potential of hs-cTn POCT in improving patient management and outcomes. [Extracted from the article]

Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov). EAGLE was a stepped-wedge cluster-randomized trial testing a behavioural change intervention aimed at reducing anastomotic leak after right colectomy. In teams with high engagement, there were higher levels of implementation of the intervention and lower rates of anastomotic leak. [ABSTRACT FROM AUTHOR]

Background: The WHO Trauma Care Checklist improved key performance indicators (KPIs) of trauma care at tertiary hospitals. A standardized trauma intake form (TIF) with real-time clinical decision support prompts was developed by adapting the WHO Trauma Care Checklist for use in smaller low- and middle-income country hospitals, where care is delivered by non-specialized providers and without trauma teams. This study aimed to determine the effectiveness of the TIF for improving KPIs in initial trauma care and reducing mortality at non-tertiary hospitals in Ghana. Methods: A stepped-wedge cluster randomized trial was conducted by stationing research assistants at emergency units of eight non- tertiary hospitals for 17.5 months to observe management of injured patients before and after introduction of the TIF. Differences in performance of KPIs in trauma care (primary outcomes) and mortality (secondary outcome) were estimated using generalized linear mixed regression models. Results: Management of 4077 injured patients was observed (2067 before TIF introduction, 2010 after). There was improvement in 14 of 16 primary survey and initial care KPIs after TIF introduction. Airway assessment increased from 72.9 to 98.4 per cent (adjusted OR 25.27, 95 per cent c.i. 2.47 to 258.94; P = 0.006) and breathing assessment from 62.1 to 96.8 per cent (adjusted OR 38.38, 4.84 to 304.69; P = 0.001). Documentation of important clinical data improved from 52.4 to 76.7 per cent (adjusted OR 2.14, 1.17 to 3.89; P = 0.013). The mortality rate decreased from 17.7 to 12.1 per cent among 302 patients (186 before, 116 after) with impaired physiology on arrival (hypotension or decreased level of consciousness) (adjusted OR 0.10, 0.02 to 0.56; P = 0.009). Conclusion: The TIF improved overall initial trauma care and reduced mortality for more seriously injured patients. [ABSTRACT FROM AUTHOR]

Private sector engagement in health reform has been suggested to help reduce healthcare inequities in sub-Saharan Africa, where populations with the most need seek the least care. We study the effects of African Health Markets for Equity (AHME), a cluster randomized controlled trial carried out in Kenya from 2012 to 2020 at 199 private health clinics. AHME included four clinic-level interventions: social health insurance, social franchising, SafeCare quality-of-care certification programme and business support. This paper evaluates whether AHME increased the capacity of private health clinics to serve poor clients while maintaining or enhancing the quality of care provided. At endline, clinics that received AHME were 14.5 percentage points (pp) more likely to be empanelled with the National Health Insurance Fund (NHIF), served 51% more NHIF clients and served more clients from the middle three quintiles of the wealth distribution compared to control clinics. Comparing individuals living in households near AHME treatment and control clinics (N  = 8241), AHME led to a 6.7-pp increase in the probability of holding any health insurance on average. We did not find any additional effect of AHME on insurance holding among poor households. We measured quality of care using a standardized patient (SP) experiment (N  = 596 SP–provider interactions) where recruited and trained SPs were randomized to present as either 'not poor', and able to afford all services provided, or 'poor' by telling the provider they could only afford ∼300 Kenyan Shillings (US$3) in fees. We found that poor SPs received lower levels of both correct and unnecessary services, and AHME did not affect this. More work must be done to ensure that clients of all wealth levels receive high-quality care. [ABSTRACT FROM AUTHOR]

Not only do cluster randomized trials require a larger sample size than individually randomized trials, they also face many additional complexities. The potential for contamination is the most commonly used justification for using cluster randomization, but the risk of contamination should be carefully weighed against the more serious problem of questionable scientific validity in settings with post-randomization identification or recruitment of participants unblinded to the treatment allocation. In this paper we provide some simple guidelines to help researchers conduct cluster trials in a way that minimizes potential biases and maximizes statistical efficiency. The overarching theme of this guidance is that methods that apply to individually randomized trials rarely apply to cluster randomized trials. We recommend that cluster randomization be only used when necessary—balancing the benefits of cluster randomization with its increased risks of bias and increased sample size. Researchers should also randomize at the lowest possible level—balancing the risks of contamination with ensuring an adequate number of randomization units—as well as exploring other options for statistically efficient designs. Clustering should always be allowed for in the sample size calculation; and the use of restricted randomization (and adjustment in the analysis for covariates used in the randomization) should be considered. Where possible, participants should be recruited before randomizing clusters and, when recruiting (or identifying) participants post-randomization, recruiters should be masked to the allocation. In the analysis, the target of inference should align with the research question, and adjustment for clustering and small sample corrections should be used when the trial includes less than about 40 clusters. [ABSTRACT FROM AUTHOR]

It is well-known that designing a cluster randomized trial (CRT) requires an advance estimate of the intra-cluster correlation coefficient (ICC). In the case of longitudinal CRTs, where outcomes are assessed repeatedly in each cluster over time, estimates for more complex correlation structures are required. Three common types of correlation structures for longitudinal CRTs are exchangeable, nested/block exchangeable and exponential decay correlations—the latter two allow the strength of the correlation to weaken over time. Determining sample sizes under these latter two structures requires advance specification of the within-period ICC and cluster autocorrelation coefficient as well as the intra-individual autocorrelation coefficient in the case of a cohort design. How to estimate these coefficients is a common challenge for investigators. When appropriate estimates from previously published longitudinal CRTs are not available, one possibility is to re-analyse data from an available trial dataset or to access observational data to estimate these parameters in advance of a trial. In this tutorial, we demonstrate how to estimate correlation parameters under these correlation structures for continuous and binary outcomes. We first introduce the correlation structures and their underlying model assumptions under a mixed-effects regression framework. With practical advice for implementation, we then demonstrate how the correlation parameters can be estimated using examples and we provide programming code in R, SAS, and Stata. An Rshiny app is available that allows investigators to upload an existing dataset and obtain the estimated correlation parameters. We conclude by identifying some gaps in the literature. [ABSTRACT FROM AUTHOR]

Cluster randomized trials often exhibit a three-level structure with participants nested in subclusters such as health care providers, and subclusters nested in clusters such as clinics. While the average treatment effect has been the primary focus in planning three-level randomized trials, interest is growing in understanding whether the treatment effect varies among prespecified patient subpopulations, such as those defined by demographics or baseline clinical characteristics. In this article, we derive novel analytical design formulas based on the asymptotic covariance matrix for powering confirmatory analyses of treatment effect heterogeneity in three-level trials, that are broadly applicable to the evaluation of cluster-level, subcluster-level, and participant-level effect modifiers and to designs where randomization can be carried out at any level. We characterize a nested exchangeable correlation structure for both the effect modifier and the outcome conditional on the effect modifier, and generate new insights from a study design perspective for conducting analyses of treatment effect heterogeneity based on a linear mixed analysis of covariance model. A simulation study is conducted to validate our new methods and two real-world trial examples are used for illustrations. [ABSTRACT FROM AUTHOR]

Background Low back pain (LBP) is a common reason for primary care consultation; yet doctors often find managing it challenging. An electronic decision support system for LBP (DeSSBack) was developed based on an evidence-based risk stratification tool to improve the management of patients with LBP in a Malaysian primary care setting. This pilot study aimed to assess the feasibility, acceptability, and preliminary effectiveness of DeSSBack for the conduct of a future definitive trial. Methods A pilot cluster randomized controlled trial (cRCT) with qualitative interviews was conducted. Each primary care doctor was considered a cluster and randomized to either the control (usual practice) or intervention (DeSSBack) group. Patient outcomes including Roland-Morris Disability Questionnaire (RMDQ), Hospital Anxiety and Depression Scale, and a 10-point pain rating scale were measured at baseline and 2-month postintervention. The doctors in the intervention group were interviewed to explore feasibility and acceptability of using DeSSBack. Results Thirty-six patients with nonspecific LBP participated in this study (intervention n = 23; control n = 13). Fidelity was poor among patients but good among doctors. The RMDQ and anxiety score had medium effect sizes of 0.718 and 0.480, respectively. The effect sizes for pain score (0.070) and depression score were small (0.087). There was appreciable acceptability and satisfaction with use of DeSSBack, as it was helpful in facilitating thorough and standardized management, providing appropriate treatment plans based on risk stratification, improving consultation time, empowering patient-centred care, and easy to use. Conclusions A future cRCT to evaluate the effectiveness of DeSSBack is feasible to be conducted in a primary care setting with minor modifications. DeSSBack was found useful by doctors and can be improved to enhance efficiency. Trial registration The protocol of the cluster randomized controlled trial was registered at ClinicalTrials.gov (NCT04959669). [ABSTRACT FROM AUTHOR]

Background Older patients with multimorbidity are under-represented in experimental research. Objective To explore the barriers and facilitators to general practitioner (GP) and older patient recruitment and retention in a cluster randomized controlled trial (RCT). Method This descriptive study uses qualitative and quantitative data from a cluster RCT, designed to evaluate the effectiveness of a medicines optimization intervention. The SPPiRE cluster RCT enrolled 51 general practices and 404 patients aged ≥65 years and prescribed ≥15 medicines. Quantitative data were collected from all recruited practices and 32 additional practices who were enrolled, but unable to recruit sufficient participants. Qualitative data were collected from purposive samples of intervention GPs (18/26), patients (27/208), and researcher logs and analysed thematically using inductive coding. Results Enrolment rates for practices and patients were 37% and 25%, respectively. Barriers to GP recruitment were lack of resources and to patient recruitment were difficulty understanding trial material and concern about medicines being taken away. GPs' primary motivation was perceived importance of the research question, whereas patients' primary motivation was trust in their GP. All general practices were retained. Thirty-five patients (8.6%) were lost to follow-up for primary outcomes, mainly because they had died and 45% did not return patient-reported outcome measures (PROMs). Conclusion Patient retention for the primary outcome was high, as it was collected directly from patient records. Patient completion of PROM data was poor, reflecting difficulty in understanding trial material. Recruiting older patients with multimorbidity to clinical trials is possible but requires significant resource and planning. Trial registration ISRCTN Registry ISRCTN12752680. [ABSTRACT FROM AUTHOR]

A stepped‐wedge cluster randomized trial (CRT) is a unidirectional crossover study in which timings of treatment initiation for clusters are randomized. Because the timing of treatment initiation is different for each cluster, an emerging question is whether the treatment effect depends on the exposure time, namely, the time duration since the initiation of treatment. Existing approaches for assessing exposure‐time treatment effect heterogeneity either assume a parametric functional form of exposure time or model the exposure time as a categorical variable, in which case the number of parameters increases with the number of exposure‐time periods, leading to a potential loss in efficiency. In this article, we propose a new model formulation for assessing treatment effect heterogeneity over exposure time. Rather than a categorical term for each level of exposure time, the proposed model includes a random effect to represent varying treatment effects by exposure time. This allows for pooling information across exposure‐time periods and may result in more precise average and exposure‐time‐specific treatment effect estimates. In addition, we develop an accompanying permutation test for the variance component of the heterogeneous treatment effect parameters. We conduct simulation studies to compare the proposed model and permutation test to alternative methods to elucidate their finite‐sample operating characteristics, and to generate practical guidance on model choices for assessing exposure‐time treatment effect heterogeneity in stepped‐wedge CRTs. [ABSTRACT FROM AUTHOR]

Although patient centredness is part of providing high-quality health care, little is known about the effectiveness of care transition interventions that involve patients and their families on readmissions to the hospital or emergency visits post-discharge. This systematic review (SR) aimed to examine the evidence on patient- and family-centred (PFC) care transition interventions and evaluate their effectiveness on adults' hospital readmissions and emergency department (ED) visits after discharge. Searches of Medline, CINAHL, and Embase databases were conducted from the earliest available online year of indexing up to and including 14 March 2021. The studies included: (i) were about care transitions (hospital to home) of ≥18-year-old patients; (ii) had components of patient-centred care and care transition frameworks; (iii) reported on one or more outcomes were among hospital readmissions and ED visits after discharge; and (iv) were cluster-, pilot- or randomized-controlled trials published in English or French. Study selection, data extraction, and risk of bias assessment were completed by two independent reviewers. A narrative synthesis was performed, and pooled odd ratios, standardized mean differences, and mean differences were calculated using a random-effects meta-analysis. Of the 10,021 citations screened, 50 trials were included in the SR and 44 were included in the meta-analyses. Care transition intervention types included health assessment, symptom and disease management, medication reconciliation, discharge planning, risk management, complication detection, and emotional support. Results showed that PFC care transition interventions significantly reduced the risk of hospital readmission rates compared to usual care [incident rate ratio (IRR), 0.86; 95% confidence interval (CI), 0.75–0.98; I 2 = 73%] regardless of time elapsed since discharge. However, these same interventions had minimal impact on the risk of ED visit rates compared to usual care group regardless of time passed after discharge (IRR, 1.00; 95% CI, 0.85–1.18; I 2 = 29%). PFC care transition interventions containing a greater number of patient-centred care (IRR, 0.73; 95% CI, 0.57–0.94; I 2 = 59%) and care transition components (IRR, 0.76; 95% CI, 0.64–0.91; I 2 = 4%) significantly decreased the risk of patients being readmitted. However, these interventions did not significantly increase the risk of patients visiting the ED after discharge (IRR, 1.54; CI 95%, 0.91–2.61). Future interventions should focus on patients' and families' values, beliefs, needs, preferences, race, age, gender, and social determinants of health to improve the quality of adults' care transitions. [ABSTRACT FROM AUTHOR]

Pragmatic trials evaluating health care interventions often adopt cluster randomization due to scientific or logistical considerations. Systematic reviews have shown that coprimary endpoints are not uncommon in pragmatic trials but are seldom recognized in sample size or power calculations. While methods for power analysis based on K (K≥2$K\ge 2$) binary coprimary endpoints are available for cluster randomized trials (CRTs), to our knowledge, methods for continuous coprimary endpoints are not yet available. Assuming a multivariate linear mixed model (MLMM) that accounts for multiple types of intraclass correlation coefficients among the observations in each cluster, we derive the closed‐form joint distribution of K treatment effect estimators to facilitate sample size and power determination with different types of null hypotheses under equal cluster sizes. We characterize the relationship between the power of each test and different types of correlation parameters. We further relax the equal cluster size assumption and approximate the joint distribution of the K treatment effect estimators through the mean and coefficient of variation of cluster sizes. Our simulation studies with a finite number of clusters indicate that the predicted power by our method agrees well with the empirical power, when the parameters in the MLMM are estimated via the expectation‐maximization algorithm. An application to a real CRT is presented to illustrate the proposed method. [ABSTRACT FROM AUTHOR]

Background Drowning is the leading cause of death for children under the age of 15 years in Guangdong Province, China. This serious public health issue also exists in low- and middle-income countries (LMICs), which have few value-integrated intervention programs. The current study presents an integrated intervention project that aims to explore an effective pattern of prevention for child drowning in rural areas and feasibility to perform in other LMICs. Methods We conducted a cluster randomized controlled trial by comparing the incidence of non-fatal drowning among children in two groups in rural areas of southern China. We recruited the participants in two phases and reached a total of 10 687 students from 23 schools at two towns in Guangdong Province, China. At the first and second phases, 8966 and 1721 students were recruited, respectively. Results The final evaluation questionnaires were collected after 18 months of integrated intervention, where we obtained 9791 data from Grades 3–9. The incidence of non-fatal drowning between the intervention and control groups after intervention did not differ significantly from the baseline according to the total number of students, male students, female students and Grades 6–9 [0.81; 95% confidence interval (CI): [0.66, 1.00]; p  =   0.05, 1.17; 95% CI: [0.90, 1.51]; p  =   0.25, 1.40; 95% CI: [0.97, 2.02]; p  =   0.07 and 0.97; 95% CI: [0.70, 1.34]; p  =   0.86], except for Grades 3–5 (1.36; 95% CI: [1.02, 1.82]; p  =   0.037). The study observed a significantly positive benefit of awareness and risk behaviours of non-fatal drowning between the intervention and control groups (0.27, 95% CI: [0.21, 0.33]; p  =   0.00, −0.16; 95% CI: [−0.24, −0.08]; p  =   0.00). Conclusions The integrated intervention exerted a significant impact on the prevention and management of child non-fatal drowning, especially in rural areas. [ABSTRACT FROM AUTHOR]

Background Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD), but currently available treatments do not improve kidney function or prevent the initiation of dialysis/kidney replacement therapy. A previous study demonstrated that bardoxolone methyl improves the estimated glomerular filtration rate (eGFR), but the study was prematurely terminated because of an imbalance in heart failure between treatment groups. The subsequent phase 2 TSUBAKI study demonstrated no incidence of heart failure and an improved eGFR and GFR as determined by inulin clearance in DKD patients. Methods This randomized, double-blind, placebo-controlled multicentre phase 3 study was designed to assess the efficacy and safety of bardoxolone methyl in DKD patients with an eGFR ≥15.0–<60.0 ml/min/1.73 m2 and a urinary albumin:creatinine ratio (UACR) ≤3500 mg/g but without risk factors for heart failure. The primary endpoint is the time to onset of a ≥30% decrease in the eGFR or ESKD. Randomized patients (1:1) have been under treatment with once-daily oral bardoxolone methyl (5, 10 or 15 mg by intrapatient dose adjustment) or placebo for at least 3 years. Results The mean age of the 1013 patients is 65.9 years, 21.5% are female, the mean eGFR is 37.84 ml/min/1.73 m2 and the median UACR is 351.80 mg/g. Conclusions Appropriate patients are enrolled in this study. This study will investigate the long-term efficacy and safety of bardoxolone methyl in DKD patients covering a wider range of eGFR (≥15.0–<60.0 ml/min/1.73 m2) and albuminuria (≤3500 mg/g) compared with previous studies. [ABSTRACT FROM AUTHOR]

Background High rates of hypertension and poverty in the rural south contribute to health disparities with Black adults experiencing higher rates of cardiovascular disease than White adults, underscoring the need to identify prevention strategies. Methods The equity in prevention and progression of hypertension by addressing barriers to nutrition and physical activity (EPIPHANY) study is a cluster randomized controlled trial testing a multilevel intervention to reduce barriers to a healthy lifestyle to lower blood pressure (BP) among rural, Black adults. Health education fairs offered to 20 churches in the Alabama Black Belt are being used to screen and enroll adults with elevated BP or stage 1 hypertension (systolic BP 120–139 mmHg and diastolic BP < 90 mmHg) who are not recommended for antihypertensive medication, according to the 2017 American College of Cardiology/American Heart Association BP guideline. Participants (n = 240) in churches randomized to the control condition are offered access to online resources including cooking and exercise classes. Participants (n = 240) in churches randomized to the intervention are receiving access to online resources; telephone-based peer support for lifestyle modification; funding for churches to develop programs to address food access and/or barriers to physical activity; and training of church members to serve as church champions to deliver training for church members on lifestyle modification. We will employ a Type 1 hybrid implementation-effectiveness design to assess effectiveness and implementation. Conclusions The EPIPHANY study is designed to prevent hypertension among rural, Black adults by addressing structural and individual barriers to lifestyle modification through peer support. [ABSTRACT FROM AUTHOR]

Background Black men in the United States have higher hypertension (HTN) prevalence than other groups, largely due to adverse social determinants of health, including poor healthcare access. The Community-to-Clinic Linkage Implementation Program (CLIP) is effective for HTN screening in Black-owned barbershops. However, its effect on HTN prevention among Black men is untested. Here, we describe the rationale and study protocol for the development and testing of a barbershop facilitation (BF) strategy, with trained Community Health Workers, to implement and scale CLIP for HTN prevention in Black men. Methods The study is part of the American Heart Association (AHA)-funded RESTORE (Add re ssing S ocial Determinants to P r event Hyp e rtension) Health Equity Research Network. The study is tri-phasic: (i) pre-implementation—qualitative examination of factors affecting adoption of CLIP and development of BF strategy, (ii) implementation—cluster randomized control trial to test the effectiveness of CLIP with and without BF. We will partner with 20 barbershops and enroll 420 Black men with elevated blood pressure (BP)/Stage 1 HTN (2017 ACC/AHA HTN guidelines). Outcomes include reduction in BP, rate of CLIP adoption and linkage to care, and incidence of Stage 2 HTN. The study time frame is 12 months, (iii) post-implementation—we will evaluate program sustainability (6 months post-trial conclusion) and cost-effectiveness (up to 10 years). Conclusions This study harnesses community-based resources to address HTN prevention in Black men, who are more adversely impacted by HTN than other groups. It has major policy relevance for health departments and other stakeholders to address HTN prevention in Black communities. ClinicalTrials.gov Identifier NCT05447962. [ABSTRACT FROM AUTHOR]

Cluster randomized trials (CRTs) randomly assign an intervention to groups of individuals (e.g. clinics or communities) and measure outcomes on individuals in those groups. While offering many advantages, this experimental design introduces challenges that are only partially addressed by existing analytic approaches. First, outcomes are often missing for some individuals within clusters. Failing to appropriately adjust for differential outcome measurement can result in biased estimates and inference. Second, CRTs often randomize limited numbers of clusters, resulting in chance imbalances on baseline outcome predictors between arms. Failing to adaptively adjust for these imbalances and other predictive covariates can result in efficiency losses. To address these methodological gaps, we propose and evaluate a novel two-stage targeted minimum loss-based estimator to adjust for baseline covariates in a manner that optimizes precision, after controlling for baseline and postbaseline causes of missing outcomes. Finite sample simulations illustrate that our approach can nearly eliminate bias due to differential outcome measurement, while existing CRT estimators yield misleading results and inferences. Application to real data from the SEARCH community randomized trial demonstrates the gains in efficiency afforded through adaptive adjustment for baseline covariates, after controlling for missingness on individual-level outcomes. [ABSTRACT FROM AUTHOR]

The stepped wedge cluster randomized trial (SW‐CRT) is an increasingly popular design for evaluating health service delivery or policy interventions. An essential consideration of this design is the need to account for both within‐period and between‐period correlations in sample size calculations. Especially when embedded in health care delivery systems, many SW‐CRTs may have subclusters nested in clusters, within which outcomes are collected longitudinally. However, existing sample size methods that account for between‐period correlations have not allowed for multiple levels of clustering. We present computationally efficient sample size procedures that properly differentiate within‐period and between‐period intracluster correlation coefficients in SW‐CRTs in the presence of subclusters. We introduce an extended block exchangeable correlation matrix to characterize the complex dependencies of outcomes within clusters. For Gaussian outcomes, we derive a closed‐form sample size expression that depends on the correlation structure only through two eigenvalues of the extended block exchangeable correlation structure. For non‐Gaussian outcomes, we present a generic sample size algorithm based on linearization and elucidate simplifications under canonical link functions. For example, we show that the approximate sample size formula under a logistic linear mixed model depends on three eigenvalues of the extended block exchangeable correlation matrix. We provide an extension to accommodate unequal cluster sizes and validate the proposed methods via simulations. Finally, we illustrate our methods in two real SW‐CRTs with subclusters. [ABSTRACT FROM AUTHOR]

Vertical global health programs often evaluate success with a narrow focus on programmatic outcomes. However, evaluation of broader patient-centred and unintended outcomes is critical to assess impacts on patient choice and autonomy. Here, we evaluate the effects of a postpartum IUD (PPIUD) intervention on outcomes related to contraceptive method choice. The stepped-wedge cluster RCT took place in five Tanzanian hospitals. Hospitals were randomised to receive immediate (Group 1; n=11,483 participants) or delayed (Group 2; n=8148 participants) intervention. The intervention trained providers on PPIUD insertion and counselling. The evaluation surveyed eligible women (18+, resided in Tanzania, gave birth at a study hospital) on provider postpartum contraceptive counselling during pregnancy or immediately postpartum. In our completed study, participants were considered exposed (n=9786) or unexposed (n=10,145) to the intervention based on the location and timing of their birth (no blinding). Our secondary analysis examined differences by intervention exposure on the likelihood of being counselled on IUD only, multiple methods, multiple method durations, a broad method mix; and on the number of methods women were counselled across two samples: all eligible women, and only women who reported receiving any contraceptive counselling. Among all eligible women, counselling on the IUD alone was seven percentage-points higher among the exposed (95% CI:0.02, 0.12). Among women who received any counselling, those exposed to the intervention were counselled on 1.12 fewer contraceptive methods (95% CI:0.10, 2.34). Likelihood of receiving counselling on any non-IUD method decreased among those exposed, while the likelihood of being counselled on IUD alone was fourteen percentage-points higher among the exposed (95% CI:0.06, 0.22), suggesting this intervention increased IUD-specific counselling but reduced informed contraceptive choice. These findings underscore the importance of broad metrics that capture autonomy and rights (in addition to programmatic goals) at all stages of health program planning and implementation. [ABSTRACT FROM AUTHOR]

Objectives: In this study, we conducted a cluster randomized controlled trial to verify the effectiveness of a treatment work balance support (TWBS) program promoted by occupational health nurses (OHNs) in small and medium‐sized enterprises (SMEs) using a web meeting system. Methods: We analyzed data from 64 managers (32 each in the control and intervention groups) and 541 workers (246 and 295 in the control and intervention groups, respectively) from 22 SMEs (11 in each group) with less than 200 workers. The TWBS program comprised online consultations for managers and seminars for workers by an OHN. TWBS leaflets were distributed among both groups. The "Recognition and Attitude Scale toward TWBS" was administered and workplace climate, psychological safety (PS), and work engagement (WE) scores were measured at baseline and endpoint. The increase in scores of each group was analyzed using a linear mixed‐effects model. Results: Increases in managers' scores on all three recognition and attitude subscales were significantly greater in the intervention than in the control group (P =.048,.003, and.032, respectively). Workers' score increases were significantly higher on two subscales—recognition of workplace initiatives and understanding of professionals' roles—in the intervention than in the control group (P =.043 and.001, respectively). There was no difference between the two groups in the amount of increase in PS and WE, as perceived by managers and workers. Conclusions: The TWBS program promoted by OHN increased recognition and attitude among SME managers and workers, indicating the usability of promoting TWBS in SMEs. [ABSTRACT FROM AUTHOR]

Objectives: Despite evidence of breast cancer screening efficacy, the screening rate has remained less than 50% in Japan. This study aimed to evaluate the effect of an environmental approach offering on‐site mammography in workplaces. Methods: Supermarket stores were randomly assigned into two groups, the intervention group (leaflet and mammography) and the control group (leaflet). From May to July 2018, participants in the intervention group were given a leaflet informing them of the subsidies for breast cancer screening and offered the opportunity to have mammography in their workplaces. Participants in the control group were given the same leaflet, but had to arrange their own screening outside the workplace. The primary outcome was the breast cancer screening rate in 2018. The odds ratio (OR) and 95% confidence interval (CI) for having screening in the intervention group compared with the control group were estimated using multilevel logistic regression. Results: We analyzed data from 1624 participants (mean age 53 years) from 25 supermarket stores (intervention: 8 stores, control: 17 stores). Among participants who had not attended screening in the previous year, the screening rate was 7% in the control group and 53% in the intervention group, with an adjusted OR (95% CI) of 14.22 (8.97–22.54). The effect was greater in those who had never attended screening before. Conclusion: In a worksite‐based cluster randomized controlled trial in Japanese supermarket stores, an environmental approach offering mammography in workplaces substantially increased the breast cancer screening rate within 1 year (UMIN000030465). [ABSTRACT FROM AUTHOR]

We propose group sequential methods for cluster randomized trials (CRTs) with time‐to‐event endpoint. The alpha spending function approach is used for sequential data monitoring. The key to this approach is determining the joint distribution of test statistics and the information fraction at the time of interim analysis. We prove that the sequentially computed log‐rank statistics in CRTs do not have independent increment property. We also propose an information fraction for group sequential trials with clustered survival data and a corresponding sample size determination approach. Extensive simulation studies are conducted to evaluate the performance of our proposed testing procedure using some existing alpha spending functions in terms of expected sample size and maximal sample size. Real study examples are taken to demonstrate our method. [ABSTRACT FROM AUTHOR]

Recent years have seen a surge of interest in stepped-wedge cluster randomized trials (SW-CRTs). SW-CRTs include several design variations and methodology is rapidly developing. Accordingly, a variety of power and sample size calculation software for SW-CRTs has been developed. However, each calculator may support only a selected set of design features and may not be appropriate for all scenarios. Currently, there is no resource to assist researchers in selecting the most appropriate calculator for planning their trials. In this paper, we review and classify 18 existing calculators that can be implemented in major platforms, such as R, SAS, Stata, Microsoft Excel, PASS and nQuery. After reviewing the main sample size considerations for SW-CRTs, we summarize the features supported by the available calculators, including the types of designs, outcomes, correlation structures and treatment effects; whether incomplete designs, cluster-size variation or secular trends are accommodated; and the analytical approach used. We then discuss in more detail four main calculators and identify their strengths and limitations. We illustrate how to use these four calculators to compute power for two real SW-CRTs with a continuous and binary outcome and compare the results. We show that the choice of calculator can make a substantial difference in the calculated power and explain these differences. Finally, we make recommendations for implementing sample size or power calculations using the available calculators. An R Shiny app is available for users to select the calculator that meets their requirements (https://douyang.shinyapps.io/swcrtcalculator/). [ABSTRACT FROM AUTHOR]

Background In northern rural Malawi, the majority of households cook using open fires and there is also a high burden of adverse birth outcomes. The use of open fires or highly polluting cookstoves is associated with low birthweight in babies. There is mixed evidence on whether implementation of cleaner burning cookstoves reduces the number of babies born with low birthweight. Methods This is a secondary analysis of a cluster randomized control trial in Malawi, conducted over 2014–17. Households were randomized to receive improved cookstoves or to continue current practices. For this analysis, the primary outcome was low birthweight in households under routine demographic surveillance, among births occurring within the trial time frame (N  = 4010). A subset of data with stricter exposure definitions respecting the original randomized allocation was also analysed (N  = 1050). A causal, forwards modelling approach was used. Results The main dataset showed evidence of effect of the intervention on low birthweight [adjusted odds ratio (aOR) 0.69; 95% CI 0.48–0.99, n  = 2788). The subset analysis lacked power to provide evidence of association between improved cookstoves and low birthweight in the stricter exposure definition (aOR 0.62; 95% CI 0.35–1.09, n  = 932). Conclusions This study provides some evidence that an improved cookstove intervention in rural Malawi reduced the number of babies born with low birthweight by 30%. This direction of the effect was also seen in the subset analysis. The analysis suggests that the intervention reduced the number of infants born prematurely or with intra-uterine growth restriction, indicating that improved cookstoves could be a useful maternal health intervention. [ABSTRACT FROM AUTHOR]

Background Understanding the influence of participatory video-making on the nutrition-related behavior of video creators may help shape nutrition education interventions. Objectives This study assessed the perceived value and influence of a participatory video intervention among participants and stakeholders. Methods A 2018–2019 cluster randomized controlled trial (registered at clinicaltrials.gov as NCT03704649) selected 20 schools (10 intervention, n  = 181; 10 control, n  = 170) in 1 Ghanaian rural district, enrolled adolescent girls aged 13–16 y, and provided a nutrition curriculum. Each intervention school also participated in 2 series of activities designed to help adolescents plan, film, and screen 2 nutrition-related videos. The Most Significant Change method involved intervention participants and local stakeholders to assess the value and influence of the intervention – a secondary outcome of the trial. Project staff collected 116 stories of change from the adolescents. Stories described shifts in 4 domains: participant, peer, and family behavior, and structural changes in the school. The project team used a selection rubric to identify 14 stories that reflected heightened nutrition literacy. Staff conducted interviews with the 14 adolescents whose stories were selected to elaborate on details and perceived resonance. Finally, local stakeholders assessed the stories to identify the 4 most significant changes of the intervention – 1 per domain. A separate thematic analysis identified emerging patterns of motivation and action across the 14 interviews. Results The chosen Most Significant Change stories revealed how adolescents found creative solutions to acquire iron-rich foods, encouraged neighbors to eat iron-rich foods, taught their family new agricultural practices, and promoted change in their school canteen. Local stakeholders valued stories that addressed common community nutrition issues in a creative and sustainable way, whereas adolescents prioritized stories that showed a change in health outcomes. Conclusion Stories of change revealed that the intervention promoted a transformative influence; participants modified their eating habits, lifestyle, and their environment. [ABSTRACT FROM AUTHOR]

Introduction: We Can Quit" (WCQ) is community-based stop-smoking program delivered by trained community facilitators, based on the socio-ecological framework and developed using a Community-based Participatory Research approach, targeting women living in socioeconomically disadvantaged (SED) areas of Ireland.Aims and Methods: The We Can Quit2 (WCQ2) pilot trial assessed the feasibility of WCQ. A pragmatic cluster randomized controlled trial with a process evaluation WCQ2, was conducted in four matched pairs of SED districts (8-10 000 women per district). Districts were independently randomized to WCQ (group support + nicotine replacement therapy), or to individual support delivered by health professionals. Participants were adult women smokers interested in quitting, who were living or working in trial districts. Recruitment of districts and 194 women in four waves (49 women per wave); retention at 12 weeks and 6 months; fidelity to intervention delivery and acceptability of trial-related processes were assessed. Validated smoking abstinence at 12-week and 6-month post-intervention was recorded, missing data assumed as continued smoking.Results: Eight districts were recruited. 125/188 (66.5%) eligible women consented. The 49 women target was reached in wave4. Retention at 12 weeks was (Intervention [I]: 55.4%; Control [C]: 51.7%), at 6 months (I: 47.7%; C: 46.7%). Smoking abstinence at 12 weeks was (I: 23.1%, [95% CI: 14.5 to 34.7]; C: 13%, [95% CI: 6.9 to 24.1]). 83.8% of session activities were delivered. Trial-related processes were acceptable to facilitators. Low literacy was highlighted as a barrier for participants' acceptability.Conclusions: WCQ was feasible to deliver by trained facilitators and indicated a positive direction in abstinence rates. Low literacy will need to be addressed in a future trial design.Implications: This pilot trial showed that a stop-smoking intervention tailored to a group of women smokers living in SED areas which was delivered by trained local women within their local communities was feasible. Furthermore, although not formally compared, more WCQ women were abstinent from smoking at the end of treatment. The results are relevant to enhance the design of a fully powered effectiveness trial, and provide important evidence on the barriers to deliver a tailored smoking cessation service to SED women smokers in Ireland. [ABSTRACT FROM AUTHOR]

In fact, a cluster-level approach, without any weighting of cluster sizes, even when cluster sizes vary, will allow estimation of the impact of the intervention for the average cluster. In particular, the treatment effect will differ when cluster sizes are informative - which essentially means either the outcomes vary across clusters depending on cluster size and/or the treatment effect varies across clusters depending on cluster size (i.e. a cluster size by treatment interaction).[7],[8] Informative cluster sizes are not expected to be uncommon in practice. [Extracted from the article]

Background Little is known about how the level of program participation affects child nutrition in rural interventions. Objectives This study examined the association between participation level in a nutrition-sensitive agriculture intervention and children's diet and anthropometric outcomes in rural Ghana. Methods Nutrition Links was a cluster randomized controlled trial (clinicaltrials.gov NCT01985243), which enrolled caregivers with children (aged less than 2 mo in 2014–2015 and less than 18 mo in 2016–2017). Of the 287 caregivers in 19 intervention communities who enrolled, 233 adopted the intervention and received layer poultry, garden inputs, and weekly child feeding education. The egg production and repayment of poultry were monitored, and feed was sold at the weekly meetings. After endline, the nutrition educators rated each woman who adopted the intervention on a scale [very poor (1) to excellent (5)] for: 1) meeting attendance, 2) egg productivity, 3) feed and poultry loan payment, 4) contributions during meetings, and 5) attentiveness towards group members. Participation level was classified as high, medium, and low by dividing the sum of these 5 items into tertiles; 54 women who did not adopt the intervention were classified as "no participation." Generalized mixed linear models tested the difference in changes in children's diet and anthropometric indices between the participation levels and the control category – 213 caregiver-child dyads in 20 communities who received standard-of-care health and agricultural services. Results Compared with the control category, only high participation was associated with egg consumption [adjusted OR (aOR) = 3.03; 95% CI: 1.15, 7.94]. Both medium and high participation levels were associated with length‐for‐age z ‐scores (LAZ)/height‐for‐age z ‐scores (HAZ) [adjusted β-coefficients (aβ) = 0.44; 95% CI: 0.16, 0.72 and 0.40; 95% CI: 0.12, 0.67, respectively]. Conclusion These results highlight the importance of promoting and monitoring the level of beneficiary participation to estimate the full potential of nutrition-sensitive agriculture interventions to improve nutritional outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Strategies are needed to increase implementation of evidence-based tobacco dependence treatment (TDT) in health care systems in low-and middle-income countries (LMICs).Aims and Methods: We conducted a two-arm cluster randomized controlled trial to compare the effectiveness of two strategies for implementing TDT guidelines in community health centers (n = 26) in Vietnam. Arm 1 included training and a tool kit (eg, reminder system) to promote and support delivery of the 4As (Ask about tobacco use, Advise to quit, Assess readiness, Assist with brief counseling) (Arm 1). Arm 2 included Arm 1 components plus a system to refer smokers to a community health worker (CHW) for more intensive counseling (4As + R). Provider surveys were conducted at baseline, 6 months, and 12 months to assess the hypothesized effect of the strategies on provider and organizational-level factors. The primary outcome was provider adoption of the 4As.Results: Adoption of the 4As increased significantly across both study arms (all p < .001). Perceived organizational priority for TDT, compatibility with current workflow, and provider attitudes, norms, and self-efficacy related to TDT also improved significantly across both arms. In Arm 2 sites, 41% of smokers were referred to a CHW for additional counseling.Conclusions: The study demonstrated the effectiveness of a multicomponent and multilevel strategy (ie, provider and system) for implementing evidence-based TDT in the Vietnam public health system. Combining provider-delivered brief counseling with opportunities for more in-depth counseling offered by a trained CHW may optimize outcomes and offers a potentially scalable model for increasing access to TDT in health care systems like Vietnam.Implications: Improving implementation of evidence-based TDT guidelines is a necessary step toward reducing the growing burden of noncommunicable diseases and premature death in LMICs. The findings provide new evidence on the effectiveness of multilevel strategies for adapting and implementing TDT into routine care in Vietnam and offer a potentially scalable model for meeting Framework Convention on Tobacco Control Article 14 goals in other LMICs with comparable public health systems. The study also demonstrates that combining provider-delivered brief counseling with referral to a CHW for more in-depth counseling and support can optimize access to evidence-based treatment for tobacco use.Clinical trials number: NCT01967654. [ABSTRACT FROM AUTHOR]

Objectives: This study is to evaluate the efficacy of participatory ergonomic (PE) intervention on musculoskeletal disorders (MSDs) and work ability among young dental professionals in China. Methods: A cluster randomized controlled trail was conducted during 2015–2016. Twenty‐nine departments from five hospitals in the South of China were randomized into intervention (14 departments) and control (15 departments), with individuals of 125 and 138 dental professionals, respectively. Main participatory ergonomic interventions involved work posture, repetitive motions, tool usage, work break relaxation and work time re‐arrangement with total 235 ergonomic changes in the trail. Individual ergonomic risk exposure was assessed by investigator's observation using quick exposure check (QEC). Work ability index (WAI) and MSDs were collected by questionnaires at baseline, and every 3 months during the 1‐year follow‐up. Results: Follow‐up rate was 91% and 96% for the intervention and control group, respectively. Significant reductions in ergonomic risk exposure and MSD prevalence on six anatomic sites were found in the PE group during the different follow‐up stages. WAI scores improved by 1.1 (95% CI 0.43, 1.89) after the 9‐month intervention. Compared to the control, the PE participants significantly reduced MSDs on neck (OR = 2.93, 95% CI: 1.25, 4.03) and wrists/hands (OR = 2.33, 95% CI: 1.08, 4.21), marginally increased WAI scores by 0.53 (95% CI: −0.02, 1.56) due to the interventions. Conclusion: PE intervention is effective in reducing ergonomic risk exposure and MSDs on neck and wrists/hands among young dental professionals. PE ought to be offered in the early dental career for preventing MSDs. [ABSTRACT FROM AUTHOR]

Background: Uroflowmetry and ultrasound scanning of the post-void residual volume are diagnostic instruments in specialist urological care of men referred with lower urinary tract symptoms (LUTS). We hypothesized that implementing uroflowmetry and post-void ultrasound bladder scanning in primary care for men with LUTS will reduce the number of referrals to urologists.Objective: To assess the effect on referrals to urologists for new male patients over 50 years of age with LUTS when performing uroflowmetry and post-void ultrasound bladder scanning in primary care.Methods: A cluster randomized controlled trial was conducted among Dutch general practitioners (GPs). The GPs enrolled male patients with the first-time presentation of LUTS, these were randomized to primary-care treatment with or without uroflowmetry and post-void bladder scanning. Primary outcome: percentage of patients referred to urologists within 3 and 12 months. Secondary outcomes: changes in the International Prostate Symptom Score (IPSS) and the IPSS-Quality of Life, patient satisfaction and urologic medication usage after 12 months.Results: Four GPs were randomly assigned to the intervention group (132 patients) and seven to the control group (212 patients). The percentage of patients referred to urologists did not differ significantly between the intervention group vs the control group: within 3 months 19.7% versus 10.4% (OR 1.9, 95% CI 0.8 to 5.0), and within 12 months 28.8% versus 21.2% (OR 1.5, 95% CI 0.9 to 2.5).Conclusions: Performing uroflowmetry and ultrasound bladder scanning in primary care as additional diagnostic tools do not reduce the number of referrals to urologists. We do not recommend using these diagnostic tools in general practice in the diagnostic work-up of these patients. [ABSTRACT FROM AUTHOR]

Background: Finding effective, accessible treatment options such as professional-delivered cognitive behavioral therapy (CBT) for medically complex individuals is challenging in rural communities.Purpose: We examined whether a CBT-based program intended to increase physical activity despite chronic pain in patients with diabetes delivered by community members trained as peer coaches also improved depressive symptoms and perceived stress.Methods: Participants in a cluster-randomized controlled trial received a 3-month telephonic lifestyle modification program with integrated CBT elements. Peer coaches assisted participants in developing skills related to adaptive coping, diabetes self-management goal-setting, stress reduction, and cognitive restructuring. Attention controls received general health advice with an equal number of contacts but no CBT elements. Depressive symptoms and stress were assessed using the Centers for Epidemiologic Studies Depression and Perceived Stress scales. Assessments occurred at baseline, 3 months, and 1 year.Results: Of 177 participants with follow-up data, 96% were African Americans, 79% women, and 74% reported annual income <$20,000. There was a significant reduction in perceived stress in intervention compared to control participants at 3-months (β = -2.79, p = .002 [95% CI -4.52, -1.07]) and 1 year (β = -2.59, p < .0001 [95% CI -3.30, -1.87]). Similarly, intervention participants reported significant decreases in depressive symptoms at 3-months (β = -2.48, p < .0001 [95% CI -2.48, -2.02]) and at 1 year (β = -1.62, p < .0001 [95% CI -2.37, -0.86]).Conclusions: This peer-delivered CBT-based program improved depressive symptoms and stress in individuals with diabetes and chronic pain. Training community members may be a feasible strategy for offering CBT-based interventions in rural and under-resourced communities.Clinical Trial Registration: NCT02538055. [ABSTRACT FROM AUTHOR]

In a cluster randomized trial (CRT), groups of people are randomly assigned to different interventions. Existing parametric and semiparametric methods for CRTs rely on distributional assumptions or a large number of clusters to maintain nominal confidence interval (CI) coverage. Randomization-based inference is an alternative approach that is distribution-free and does not require a large number of clusters to be valid. Although it is well-known that a CI can be obtained by inverting a randomization test, this requires testing a non-zero null hypothesis, which is challenging with non-continuous and survival outcomes. In this article, we propose a general method for randomization-based CIs using individual-level data from a CRT. This approach accommodates various outcome types, can account for design features such as matching or stratification, and employs a computationally efficient algorithm. We evaluate this method's performance through simulations and apply it to the Botswana Combination Prevention Project, a large HIV prevention trial with an interval-censored time-to-event outcome. [ABSTRACT FROM AUTHOR]

Millions of villagers in Bangladesh are exposed to arsenic by drinking contaminated water from private wells. Testing for arsenic can encourage switching from unsafe wells to safer sources. This study describes results from a cluster randomized controlled trial conducted in 112 villages in Bangladesh to evaluate the effectiveness of different test selling schemes at inducing switching from unsafe wells. At a price of about US0.60, only one in four households purchased a test. Sales were not increased by informal inter-household agreements to share water from wells found to be safe, or by visual reminders of well status in the form of metal placards mounted on the well pump. However, switching away from unsafe wells almost doubled in response to agreements or placards relative to the one in three proportion of households that switched away from an unsafe well with simple individual sales. [ABSTRACT FROM AUTHOR]

BACKGROUND In China, hypertension prevalence is high and increasing while the control rate is low, especially in rural areas. Traditionally, village doctors play an important role in infectious disease control and delivering essential health services to rural residents. We aim to test the effectiveness of a village doctor-led multifaceted intervention compared with usual care on blood pressure (BP) control and cardiovascular disease (CVD) among rural residents with hypertension in China. METHODS In the China Rural Hypertension Control Project (CRHCP), a cluster randomized trial, 163 villages were randomly assigned to the village doctor-led intervention and 163 villages to control. A total of 33,995 individuals aged ≥40 years with an untreated BP ≥140/90 mm Hg or treated BP ≥130/80 mm Hg or with an untreated BP ≥130/80 mm Hg and a history of clinical CVD were recruited into the study. The village doctor-led multifaceted intervention is designed to overcome barriers at the healthcare system, provider, patient, and community levels. Village doctors receive training on standard BP measurement, protocol-based hypertension treatment, and health coaching. They also receive technical support and supervision from hypertension specialists/primary care physicians and performance-based financial incentives. Study participants receive health coaching on home BP monitoring, lifestyle changes, and adherence to medications. The primary outcome is BP control (<130/80 mm Hg) at 18 months in phase 1 and CVD events over 36 months in phase 2. CONCLUSIONS The CRHCP will provide critically important data on the effectiveness, implementation, and sustainability of a hypertension control strategy in rural China for reducing the BP-related CVD burden. CLINICAL TRIALS REGISTRATION Trial Number NCT03527719. [ABSTRACT FROM AUTHOR]

Background: the hook plate metallic device showed early promise as an alternative implant to treat unstable acromioclavicular joint dislocation injuries. The hook plate can be used to provide an indirect reduction of a distal clavicle fracture. This indirect reduction technique is useful for comminuted fractures or fractures with very small distal fragments in which conventional reduction and fixation is difficult. Aim of the Work: to evaluate the treatment of acute acromioclavicular joint dislocation and radiographic outcomes. Materials and Methods: Studies were considered eligible if they expressed treatment of acromioclavicular joint dislocation using the hook plate and described the patient's clinical and functional outcomes; intra-operative, post-operative complications, full-text articles were available, randomized controlled trials, including cluster RCTs, controlled (non-randomized) clinical trials or cluster trials, prospective and retrospective comparative cohort studies, and case-control or nested case-control studies. We will exclude cross-sectional studies, case series, case reports and literature not in English. All items that didn't match the above criteria were excluded. Results: The total studies included 270 patients with average mean age 35.5 years and mean follow up 25.33 months. The Constant Murely score average 84 points (The CMS was developed for the evaluation of shoulder function with subjective and objective components) and the p value <.05 that means all patients had significant improvement. Full range of motion could be achieved in the patients. Patients with restrictions of range of motion mainly showed limitations in abduction and external rotation. These limitations are most probably caused by the post-operative immobilization, which is necessary after implantation of hook plates to ensure healing of the ligament structures and avoid damage of the acromion by the hook itself. Other studies also showed restrictions of range of motion for abduction and external rotation after hook plate implantation. Conclusion: it has a good to excellent Constant Murely score (full range of motion) that enables quick return to activities. It is useful for (Rockwood III-VI). So good clinical results can be achieved with hook plate. [ABSTRACT FROM AUTHOR]

This paper describes methodology for analyzing data from cluster randomized trials with count outcomes, taking indirect effects as well spatial effects into account. Indirect effects are modeled using a novel application of a measure of depth within the intervention arm. Both direct and indirect effects can be estimated accurately even when the proposed model is misspecified. We use spatial regression models with Gaussian random effects, where the individual outcomes have distributions overdispersed with respect to the Poisson, and the corresponding direct and indirect effects have a marginal interpretation. To avoid spatial confounding, we use orthogonal regression, in which random effects represent spatial dependence using a homoscedastic and dimensionally reduced modification of the intrinsic conditional autoregression model. We illustrate the methodology using spatial data from a pair‐matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela. [ABSTRACT FROM AUTHOR]

Background: Rates of surgery and adjuvant therapy for breast cancer vary widely between breast units. This may contribute to differences in survival. This cluster RCT evaluated the impact of decision support interventions (DESIs) for older women with breast cancer, to ascertain whether DESIs influenced quality of life, survival, decision quality, and treatment choice. Methods: A multicentre cluster RCT compared the use of two DESIs against usual care in treatment decision-making in older women (aged at least ·70 years) with breast cancer. Each DESI comprised an online algorithm, booklet, and brief decision aid to inform choices between surgery plus adjuvant endocrine therapy versus primary endocrine therapy, and adjuvant chemotherapy versus no chemotherapy. The primary outcome was quality of life. Secondary outcomes included decision quality measures, survival, and treatment choice. Results: A total of 46 breast units were randomized (21 intervention, 25 usual care), recruiting 1339 women (670 intervention, 669 usual care). There was no significant difference in global quality of life at 6 months after the baseline assessment on intention-to-treat analysis (difference -0.20, 95 per cent confidence interval (C.I.) -2.69 to 2.29; P=0.900). In women offered a choice of primary endocrine therapy versus surgery plus endocrine therapy, knowledge about treatments was greater in the intervention arm (94 versus 74 per cent; P=0.003). Treatment choice was altered, with a primary endocrine therapy rate among women with oestrogen receptorpositive disease of 21.0 per cent in the intervention versus 15.4 per cent in usual-care sites (difference 5.5 (95 per cent C.I. 1.1 to 10.0) per cent; P=0.029). The chemotherapy rate was 10.3 per cent at intervention versus 14.8 per cent at usual-care sites (difference -4.5 (C.I. -8.0 to 0) per cent; P=0.013). Survival was similar in both arms. Conclusion: The use of DESIs in older women increases knowledge of breast cancer treatment options, facilitates shared decisionmaking, and alters treatment selection. [ABSTRACT FROM AUTHOR]

Summary: Background: Evidence for the effectiveness of vitiligo treatments is limited. Objectives: To determine the effectiveness of (i) handheld narrowband UVB (NB‐UVB) and (ii) a combination of potent topical corticosteroid (TCS) and NB‐UVB, compared with TCS alone, for localized vitiligo. Methods: A pragmatic, three‐arm, placebo‐controlled randomized controlled trial (9‐month treatment, 12‐month follow‐up). Adults and children, recruited from secondary care and the community, aged ≥ 5 years and with active vitiligo affecting < 10% of skin, were randomized 1 : 1 : 1 to receive TCS (mometasone furoate 0·1% ointment + dummy NB‐UVB), NB‐UVB (NB‐UVB + placebo TCS) or a combination (TCS + NB‐UVB). TCS was applied once daily on alternating weeks; NB‐UVB was administered on alternate days in escalating doses, adjusted for erythema. The primary outcome was treatment success at 9 months at a target patch assessed using the participant‐reported Vitiligo Noticeability Scale, with multiple imputation for missing data. The trial was registered with number ISRCTN17160087 on 8 January 2015. Results: In total 517 participants were randomized to TCS (n = 173), NB‐UVB (n = 169) and combination (n = 175). Primary outcome data were available for 370 (72%) participants. The proportions with target patch treatment success were 17% (TCS), 22% (NB‐UVB) and 27% (combination). Combination treatment was superior to TCS: adjusted between‐group difference 10·9% (95% confidence interval 1·0%–20·9%; P = 0·032; number needed to treat = 10). NB‐UVB alone was not superior to TCS: adjusted between‐group difference 5·2% (95% CI − 4·4% to 14·9%; P = 0·29; number needed to treat = 19). Participants using interventions with ≥ 75% expected adherence were more likely to achieve treatment success, but the effects were lost once treatment stopped. Localized grade 3 or 4 erythema was reported in 62 (12%) participants (including three with dummy light). Skin thinning was reported in 13 (2·5%) participants (including one with placebo ointment). Conclusions: Combination treatment with home‐based handheld NB‐UVB plus TCS is likely to be superior to TCS alone for treatment of localized vitiligo. Combination treatment was relatively safe and well tolerated but was successful in only around one‐quarter of participants. What is already known about this topic?Vitiligo is a common condition, and can have a considerable psychological impact.Topical corticosteroids (TCSs) are standard care for vitiligo. Narrowband ultraviolet B (NB‐UVB) is a widely used treatment, but it is usually only available as full‐body treatment, delivered in secondary care.Evidence for the use of handheld NB‐UVB in combination with TCSs is very limited. What does this study add?For people with localized nonsegmental vitiligo, combination therapy with NB‐UVB and a potent TCS (mometasone furoate 0·1% ointment) is likely to result in improved treatment response compared with potent TCS alone, but was successful in only around one‐quarter of participants.Both treatments are relatively safe and well tolerated when used over a period of 9 months.Treatment effects start to be lost soon after cessation of treatment, so ways of maintaining treatment response once treatment is stopped need further investigation Linked Comment: Wolkerstorfer. Br J Dermatol 2021; 184:790. [ABSTRACT FROM AUTHOR]

We have been asked to consider the feasibility of piloting a Citizens' Basic Income (CBI): a basic, unconditional, universal, individual, regular payment that would replace aspects of social security and be introduced alongside changes to taxes. Piloting and evaluating a CBI as a Cluster Randomized Control Trial (RCT) raises the question of whether intervention and comparison groups would be in equipoise, and thus whether randomization would be ethical. We believe that most researchers would accept that additional income, or reduced conditions on receiving income would be likely to improve health, especially at lower income levels. However, there are genuine uncertainties about the impacts on other outcomes, and CBI as a mechanism of providing income. There is also less consensus amongst civil servants and politicians about the impacts on health, and substantial disagreement about whether these would outweigh other impacts. We believe that an RCT is ethical because of these uncertainties. We also argue that the principle of equipoise should apply to randomized and non-randomized trials; that randomization is a fairer means of allocating to intervention and comparison groups; and that there is an ethical case for experimentation to generate higher-quality evidence for policymaking that may otherwise do harm. [ABSTRACT FROM AUTHOR]