Explore the vast range of titles available.

In the first paper in this Series we assessed theoretical and empirical evidence and concluded that the health of people living in slums is a function not only of poverty but of intimately shared physical and social environments. In this paper we extend the theory of so-called neighbourhood effects. Slums offer high returns on investment because beneficial effects are shared across many people in densely populated neighbourhoods. Neighbourhood effects also help explain how and why the benefits of interventions vary between slum and non-slum spaces and between slums. We build on this spatial concept of slums to argue that, in all low-income and-middle-income countries, census tracts should henceforth be designated slum or non-slum both to inform local policy and as the basis for research surveys that build on censuses. We argue that slum health should be promoted as a topic of enquiry alongside poverty and health.

The Poisson regression model using a sandwich variance estimator has become a viable alternative to the logistic regression model for the analysis of prospective studies with independent binary outcomes. The primary advantage of this approach is that it readily provides covariate-adjusted risk ratios and associated standard errors. In this article, the model is extended to studies with correlated binary outcomes as arise in longitudinal or cluster randomization studies. The key step involves a cluster-level grouping strategy for the computation of the middle term in the sandwich estimator. For a single binary exposure variable without covariate adjustment, this approach results in risk ratio estimates and standard errors that are identical to those found in the survey sampling literature. Simulation results suggest that it is reliable for studies with correlated binary data, provided the total number of clusters is at least 50. Data from observational and cluster randomized studies are used to illustrate the methods.

To clarify and illustrate sample size calculations for the cross-sectional stepped wedge cluster randomized trial (SW-CRT) and to present a simple approach for comparing the efficiencies of competing designs within a unified framework. We summarize design effects for the SW-CRT, the parallel cluster randomized trial (CRT), and the parallel cluster randomized trial with before and after observations (CRT-BA), assuming cross-sectional samples are selected over time. We present new formulas that enable trialists to determine the required cluster size for a given number of clusters. We illustrate by example how to implement the presented design effects and give practical guidance on the design of stepped wedge studies. For a fixed total cluster size, the choice of study design that provides the greatest power depends on the intracluster correlation coefficient (ICC) and the cluster size. When the ICC is small, the CRT tends to be more efficient; when the ICC is large, the SW-CRT tends to be more efficient and can serve as an alternative design when the CRT is an infeasible design. Our unified approach allows trialists to easily compare the efficiencies of three competing designs to inform the decision about the most efficient design in a given scenario.

Introduction Differentiated service delivery (DSD) models for HIV treatment decrease health facility visit frequency and limit healthcare facility‐based exposure to severe acute respiratory syndrome coronavirus 2. However, two important evidence gaps include understanding DSD effectiveness amongst clients commencing DSD within 12 months of antiretroviral treatment (ART) initiation and amongst clients receiving only single annual clinical consultations. To investigate these, we pooled data from two cluster‐randomized trials investigating community‐based DSD in Zimbabwe and Lesotho. Methods Individual‐level participant data of newly stable adults enrolled between 6 and 12 months after ART initiation were pooled. Both trials (conducted between August 2017 and July 2019) had three arms: Standard‐of‐care three‐monthly ART provision at healthcare facilities (SoC, control); ART provided three‐monthly in community ART groups (CAGs) (3MC) and ART provided six‐monthly in either CAGs or at community‐distribution points (6MC). Clinical visits were three‐monthly in SoC and annually in intervention arms. The primary outcome was retention in care and secondary outcomes were viral suppression (VS) and number of unscheduled facility visits 12 months after enrolment. Individual‐level regression analyses were conducted by intention‐to‐treat specifying for clustering and adjusted for country. Results and Discussion A total of 599 participants were included; 212 (35.4%), 128 (21.4%) and 259 (43.2%) in SoC, 3MC and 6MC, respectively. Few participants aged <25 years were included (n = 32). After 12 months, 198 (93.4%), 123 (96.1%) and 248 (95.8%) were retained in SoC, 3MC and 6MC, respectively. Retention in 3MC was superior versus SoC, adjusted risk difference (aRD) = 4.6% (95% CI: 0.7%−8.5%). Retention in 6MC was non‐inferior versus SoC, aRD = 1.7% (95% CI: −2.5%−5.9%) (prespecified non‐inferiority aRD margin −3.25%). VS was similar between arms, 99.3, 98.6 and 98.1% in SoC, 3MC and 6MC, respectively. Adjusted risk ratio's for VS were 0.98 (95% CI: 0.92−1.03) for 3MC versus SoC, and 0.98 (CI: 0.95−1.00) for 6MC versus SoC. Unscheduled clinic visits were not increased in intervention arms: incidence rate ratio = 0.53 (CI: 0.16−1.80) for 3MC versus SoC; and 0.82 (CI: 0.25−2.79) for 6MC versus SoC. Conclusions Community‐based DSD incorporating three‐ and six‐monthly ART refills and single annual clinical visits were at least non‐inferior to standard facility‐based care amongst newly stable ART clients aged ≥25 years. ClinicalTrials.gov: NCT03238846 & NCT03438370

Abstract Background Mass screening and treatment (MST) aims to reduce malaria risk in communities by identifying and treating infected persons without regard to illness. Methods A cluster-randomized trial evaluated malaria incidence with and without MST. Clusters were randomized to 3, 2, or no MST interventions: MST3, 6 clusters (156 households/670 individuals); MST2, 5 clusters (89 households/423 individuals); and MST0, 5 clusters (174 households/777 individuals). All clusters completed the study with 14 residents withdrawing. In a cohort of 324 schoolchildren (MST3, n = 124; MST2, n = 57; MST0, n = 143) negative by microscopy at enrollment, we evaluated the incidence density of malaria during 3 months of MST and 3 months following. The MST intervention involved community-wide expert malaria microscopic screening and standard therapy with dihydroartemisinin-piperaquine and primaquine for glucose-6 phosphate dehydrogenase-normal subjects. All blood examinations included polymerase chain reaction assays, which did not guide on-site treatment. Results The risk ratios for incidence density of microscopically patent malaria in MST3 or MST2 relative to that in MST0 clusters were 1.00 (95% confidence interval [CI], .53-1.91) and 1.22 (95% CI, .42-3.55), respectively. Similar results were obtained with molecular analysis and species-specific (P. falciparum and P. vivax) infections. Microscopically subpatent, untreated infections accounted for 72% of those infected. Conclusions Two or 3 rounds of MST within 3 months did not impact the force of anopheline mosquito-borne infection in these communities. The high rate of untreated microscopically subpatent infections likely explains the observed poor impact. Clinical Trials Registration NCT01878357. This cluster-randomized trial demonstrated a negligible impact of mass microscopic screening in guiding treatment as a means to reduce malaria transmission at a mesoendemic site in Indonesia. Retrospective polymerase chain reaction analysis revealed that the majority of infections were microscopically subpatent.

To summarize intracluster correlation coefficient (ICC) estimates for pupil health outcomes from school-based cluster randomized trials (CRTs) across world regions and describe their relationship with study design characteristics and context. School-based CRTs reporting ICCs for pupil health outcomes were identified through a literature search of MEDLINE (via Ovid). ICC estimates were summarized both overall and for different categories of study characteristics. Two hundred and forty-six articles reporting ICC estimates were identified. The median (interquartile range) ICC was 0.031 (0.011 to 0.08) at the school level (N = 210) and 0.063 (0.024 to 0.1) at the class level (N = 46). The distribution of ICCs at the school level was well described by the beta and exponential distributions. Besides larger ICCs in definitive trials than feasibility studies, there were no clear associations between study characteristics and ICC estimates. The distribution of school-level ICCs worldwide was similar to previous summaries from studies in the United States. The description of the distribution of ICCs will help to inform sample size calculations and assess their sensitivity when designing future school-based CRTs of health interventions.

Background Early prevention is a promising strategy for reducing obesity in childhood, and Early Years settings are ideal venues for interventions. This work evaluated an educational intervention with the primary aim of preventing overweight and obesity in pre-school children. Methods A pragmatic, cluster randomised trial with a parallel, matched-pair design was undertaken. Interventions were targeted at both the cluster (Early Years’ Centres, matched by geographical area) and individual participant level (families: mother and 2-year old child). At the cluster level, a staff training intervention used the educational resource Be Active, Eat Healthy. Policies and provision for healthy eating and physical activity were evaluated at baseline and 12-months. The intervention at participant level was the Healthy Heroes Activity Pack : delivered over 6 months by Centre staff to promote healthy eating and physical activity in a fun, interactive way. Child and parent height and weight were measured at four time-points over 2 years. The trial primary outcome was the change in BMI z-score of the child between ages 2 and 4 years. Secondary outcomes consisted of parent-reported measures administered at baseline and two-year follow-up. Results Five pairs of Early Years’ Centres were recruited. Four pairs were analysed as one Centre withdrew (47 intervention families; 34 control families). At the cluster level, improvement in Centre policies and practices was similar for both groups ( p  = 0.830). At the participant level, the intervention group reduced their mean BMI z-score between age 2 and 4 years ( p  = 0.002; change difference 0.49; 95% CI 0.17 to 0.80) whereas the control group showed increasing BMI z-score throughout. Changes in parent-reported outcomes and parent BMI ( p  = 0.582) were similar in both groups. Conclusions The Healthy Heroes educational resource deterred excess weight gain in pre-school children from poor socioeconomic areas. With training, Early Years’ staff can implement the Healthy Heroes programme. Trial registration ISRCTN22620137 Registered 21st December 2016.

Fixed‐dose combination (FDC) therapy is recommended for hypertension management in Nigeria based on randomized trials at the individual level. This cluster‐randomized trial evaluates effectiveness and safety of a treatment protocol that used two‐drug FDC therapy as the second and third steps for hypertension control compared with a protocol that used free pill combinations. From January 2021 to June 2021, 60 primary healthcare centers in the Federal Capital Territory of Nigeria were randomized to a protocol using FDC therapy as second and third steps compared with a protocol that used the same medications in free pill combination therapy for these steps. Eligible patients were adults (≥18 years) with hypertension. The primary outcome was the odds of a patient being controlled at their last visit between baseline to 6‐month follow‐up in the FDC group compared to the free pill group. 4427 patients (mean [SD] age: 49.0 [12.4] years, 70.5% female) were registered with mean (SD) baseline systolic/diastolic blood pressure 155 (20.6)/96 (13.1) mm Hg. Baseline characteristics of groups were similar. After 6‐months, hypertension control rate improved in the two treatment protocols, but there were no differences between the groups after adjustment (FDC = 53.9% versus free pill combination = 47.9%, cluster‐adjusted p = .29). Adverse events were similarly low (<1%) in both groups. Both protocols improved hypertension control rates at 6‐months in comparison to baseline, though no differences were observed between groups. Further work is needed to determine if upfront FDC therapy is more effective and efficient to improve hypertension control rates.

Background and Aims Declining sleep quality is common among hemodialysis patients, adversely affecting their quality of life and treatment adherence. Improving sleep is a nursing priority, and targeted interventions might be beneficial. This study aimed to evaluate the effect of a spiritual care program on treatment adherence and sleep quality in hemodialysis patients. Methods This study was a parallel, two‐group, cluster‐randomized clinical trial with a pretest–posttest design. In 2023, 80 hemodialysis patients from two teaching hospitals in Urmia, Iran, were enrolled via convenience sampling and cluster‐randomized by hospital unit to intervention (n = 39) or control (n = 37 completers) groups. The intervention involved four 1 h spiritual care sessions twice weekly post‐dialysis. Outcomes were measured using the End‐Stage Renal Disease Adherence Questionnaire (ESRD‐AQ) and Pittsburgh Sleep Quality Index (PSQI) at baseline and 1 month post‐intervention. Data were analyzed in SPSS v26.0. Normality was checked with Kolmogorov−Smirnov, between‐group differences with independent t‐tests, and within‐group changes with paired t‐tests. Results The mean age of the 76 participants was 52.09 years (range: 20–84 years); 65 participants (85.5%) were male, and 11 (14.5%) were female. Baseline scores showed no significant between‐group differences (adherence: p = 0.848; sleep quality: p = 0.891). Post‐intervention, the intervention group had significantly higher adherence (mean difference: 219.60 [95% CI: 159.51–279.69]; p < 0.001; Cohen's d = 1.92) and better sleep quality (mean difference: −2.67 [95% CI: −1.46 to −3.88]; p = 0.006; Cohen's d = 0.68) compared to the control group. Within the intervention group, adherence improved (p < 0.001; Cohen's d = 2.15) and sleep quality enhanced (p < 0.001; Cohen's d = 0.79); no changes were observed in the control group (p > 0.05). Conclusion A spiritual care program improves treatment adherence and sleep quality in hemodialysis patients. Hospital administrators should integrate spiritual interventions like meditation and counseling, considering barriers such as staffing. Future studies should include diverse populations and longer follow‐ups. Reporting Tool The CONSORT 2010 checklist was used. Summary What does this paper contribute to the wider global community? The Spiritual Care Program can improve treatment adherence and enhance sleep quality in hemodialysis patients. This study's results emphasize the importance of spiritual care for patients receiving hemodialysis. This report urges health authorities to take spiritual care seriously for hemodialysis patients. As the number of hemodialysis patients increases in Iran and worldwide, these findings could significantly help reduce complications and mortality rates.

To explore challenges in recruitment and intervention implementation in recent stepped-wedge cluster randomized trials (SW-CRTs). We searched PubMed to identify primary reports of SW-CRTs (2019–2020). Two reviewers independently screened studies and extracted data from each report. A recruitment challenge was defined as a planned number of clusters or participants not achieved or any reported changes made to the design to address recruitment difficulties. An implementation challenge was defined as early, late, or no implementation of the intervention in at least one cluster. Of 55 SW-CRTs, 18 (33%) had a recruitment challenge, 23 (42%) had none, and for 14 (26%) it was impossible to judge. At least one implementation challenge was present in 24 (44%), eight (15%) had none, and for 23 (42%) it was impossible to judge. Of the 35 (64%) trials with recruitment or implementation challenges, 18 (72%) had one or more modifications of their design, most often a modification of the trial duration. Investigators must be aware of the risks of recruitment or implementation challenges when considering the use of an SW-CRT design. Mitigating strategies should be adopted when planning the trial. More transparent reporting of planned and actual design features is required. • Recruitment and implementation challenges are common in stepped-wedge cluster randomized trials.• Investigators must be aware of the risks of recruitment or implementation challenges when considering the use of a stepped-wedge cluster randomized trial. Mitigating strategies should be adopted when planning the trial.• Improvement in transparency of reporting on the planned and actual design features of stepped-wedge cluster randomized trials is required.