Introduction to Cluster Randomized Trial

We evaluated participant outcomes and compared out-of-facility MMD models using data from cluster-randomized trials in Southern Africa.

Methods: This qualitative analysis of clinic staff interviews (N = 20), collected during a large cluster-randomized trial to implement two models of adolescent SBIRT, examined barriers and facilitating factors to overall acceptability of SBIRT.

Methods A cluster-randomized trial was performed.

Background Biannual distribution of azithromycin to children 1–59 months old reduced mortality by 14% in a cluster-randomized trial.

EPIC is an observational study that builds on a completed cluster-randomized trial (CRT).

METHODS The Diabetes Complication Control in Community Clinics (D4C) study is a cluster-randomized trial conducted among 38 community health centers in Xiamen City, China.

Design: We conducted a secondary analysis of a cluster-randomized trial to observe characteristics associated with women who chose to use long-acting reversible contraceptives (LARC) compared to those who chose a short-acting method 12 months after enrollment.

METHODS The cluster-randomized trial included three triennial rounds of visual inspection (seven clusters, n = 96,516) versus standard of care (six clusters, n = 95,354) and up to 9 years of follow-up.

METHODS This was a cluster-randomized trial comparing RCDP and PSD from January 2018 to April 2019.

Methods and findings We conducted a pragmatic stepped-wedge cluster-randomized trial including all adults treated for drug-susceptible pulmonary TB at 18 health facilities across Uganda over 8 months (1 December 2018–31 July 2019).

The study applies a two-armed cluster-randomized trial design of a problem-solving intervention conducted in private-sector companies.

METHODS A cluster-randomized trial was conducted in 24 college counseling centers.

The present study examined a cluster-randomized trial of 1,198 undergraduates in 96 lab sections.

Therefore, the researchers conducted an openlabel, cluster-randomized trial involving 20,995 individuals from 600 villages in rural China.

Method and analysis: This review will report on overall studies that include randomized control trials, randomized cross-over studies and cluster-randomized trials designs that consider curative effect in children with ASD by probiotic supplements.

In group or cluster-randomized trials (GRTs), matching is a technique that can be used to improve covariate balance.

The Building Up Trial is a cluster-randomized trial that aims to address the issue of the leaky career pathway for under-represented faculty in biomedical fields.

Methods We designed the Prostate Cancer Imaging Stewardship (PCIS) intervention: a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on Veterans Health Administration (VHA) prostate cancer imaging use.

This is a cluster-randomized trial of a multi-component public health intervention.

Here, we describe a cluster-randomized trial to investigate population-level protection of TYPBAR-TCV®, a Vi-polysaccharide conjugated to a tetanus-toxoid protein carrier (Vi-TT) against blood-culture-confirmed typhoid fever, and the synthesis of health economic evidence to inform policy decisions.

METHODS We conducted an open-label, cluster-randomized trial involving persons from 600 villages in rural China.

Methods This community-based, placebo-controlled, double-blinded, cluster-randomized trial study was conducted in Wenchi Municipal and Tain District of Bono Region.

In a cluster-randomized trial (CRT), the number of participants enrolled often varies across clusters.

Therefore, the researchers conducted an openlabel, cluster-randomized trial involving 20,995 individuals from 600 villages in rural China.

In cluster-randomized trials, sometimes the effect of the intervention being studied differs between clusters, commonly referred to as treatment effect heterogeneity.

METHODS We executed a cluster-randomized trial to determine if provision of contraception in the home setting increased uptake of postpartum methods.

This study aimed to identify limitations and enabling factors impacting involvement at different stages of a large cluster-randomized trial assessing the effect of combining dihydroartemisinin-piperaquine (DP) and ivermectin (IVM) in malaria transmission in The Gambia.

This paper reports on findings from a parallel cluster-randomized trial that compared an organizationally tailored with a standard (core components only) approach for institutionalizing ("integrating") an evidence-based cancer control intervention into African American churches.

A cluster-randomized trial is needed to explore impact on patient-related outcomes.

Methods Using household survey data from the baseline round of a cluster-randomized trial, including precise geolocation data from all households and public sector primary health facilities, we used a multilevel model to assess influences at the individual, household, community, and health system levels on women’s modern contraceptive use.

This post hoc analysis used data from a cluster-randomized trial of a physician/pharmacist collaborative model that randomized medical offices to either a 9- or 24-month pharmacist intervention or control group.

Methods We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control).

Methods: We conducted a controlled, open-label, pragmatic cluster-randomized trial in 42 general practices in Switzerland.

Using a latent profile approach (LPA), this paper examines multiple organizational and neighborhood contextual factors that might affect the degree to which afterschool programs effectively implement evidence-based practices in the context of a cluster-randomized trial of the Paxis Good Behavior Game (PaxGBG).

Design: MyTEMP is a pragmatic, 2-arm, parallel-group, registry-based, open-label, cluster-randomized trial.

We conducted a cluster-randomized trial in 48 rural villages of Ethiopia to assess the effect of community-led total sanitation (CLTS) on the diarrhea incidence of children.

This study describes the adaptation process and the impacts of the SWSC on Escherichia coli contamination in household stored water in a cluster-randomized trial with 49 intervention villages (274 households) and 50 no-intervention control villages (290 households).

Methods: A cluster-randomized trial was conducted in 24 preschools in Kingston, Jamaica.

This cost-effectiveness and feasibility study were piggybacked on a cluster-randomized trial that assessed the impact of an adolescent-centred service delivery intervention.

DESIGN This cross-sectional study used baseline data from TX Sprouts, a one-year school-based gardening, nutrition, and cooking cluster-randomized trial, implemented in 16 elementary schools in Austin, TX, in 2016-2019.

Also, 4 times daily application of a CHX 2% solution led to oral mucosal side effects in a multicenter cluster-randomized trial and was therefore replaced by CHX 1% gel [10].

Method: Non-inferiority trial research, cluster-randomized trial was conducted to children aged 11-15 years old.

Post hoc analysis of the Lumbar Imaging with Reporting of Epidemiology cluster-randomized trial.

Methods We performed a quality improvement, cluster-randomized trial at seven tertiary IBD centres.

Methods A single-blind, 5-arm, cluster-randomized trial will be conducted in kindergarten in Shanghai, China.

Methods Two cluster-randomized trials were carried out to assess the outcomes of different invitation strategies.

This study estimates the overall effect of two influenza vaccination programs consecutively administered in a cluster-randomized trial in western Senegal over the course of two influenza seasons from 2009-2011.

Cross-sectional sample recruited using respondent-driven sampling in a cluster-randomized trial.

This study aimed to determine whether use of a real-time feedback (RTF) device improved patient experience scores in a cluster-randomized trial.

Background: Cluster-randomized trials allow for the evaluation of a community-level or group-/cluster-level intervention.

The three-armed cluster-randomized trial ARena (sustainable reduction of antibiotic-induced antimicrobial resistance) aimed to foster appropriate antibiotic use and reduce overprescribing in German ambulatory care to counter antibiotic resistance.

Patients and methods SANO is a cluster-randomized trial with 30 participating regions across Germany aiming to enrol 2,790 patients (drks.

Community health workers (CHWs) delivered the lead component of the intervention during group sessions with pregnant women and mother-child dyads (<15 months old) in a cluster-randomized trial.

METHODS We used data from a national geriatric assessment cluster-randomized trial (URCC 13070) that recruited patients aged ≥70 with incurable cancer considering any line of cancer treatment at community oncology practices, their caregivers, and their oncologists.

METHODS We conducted secondary analyses of data from a cluster-randomized trial.

Methods We performed a post-hoc analysis of the AMI-OPTIMA study, a cluster-randomized trial evaluating a knowledge translation intervention at 24 hospitals in Quebec, Canada (years: 2009 and 2012).

INFORM was a complex, theory-based, three-arm, parallel cluster-randomized trial.

METHODS: In a cluster-randomized trial, sites were randomly assigned to the Greenlight intervention or an attention-control arm.

We examine baseline data from a cluster-randomized trial (Healthy Start/Comienzos Sanos) to improve food and PA environments in FCCHs.

DESIGN A cluster-randomized trial was conducted from 2016 to 2017 with baseline and follow-up surveys.

Methods A cluster-randomized trial was performed.

Objective The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India.

In a double-blind, cluster-randomized trial (JiVitA-3) of multiple micronutrient or iron-folic acid supplementation from pregnancy ascertainment to 3 mo postpartum, maternal and infant hemoglobin (Hb), anthropometry, and plasma were obtained 3 mo after birth.

Methods: This study was a 2×2 factorial, 40-cluster-randomized trial (10 clusters per group) with three intervention groups (SMS, IPC, and SMS+IPC) and a usual care (or ‘control’) among households  containing a pregnant woman and/or a child <12 m of age at baseline (600 per group).

METHODS: The study draws from a cluster-randomized trial comparing SBIRT to usual care (UC) for adolescents endorsing past-year substance use and recent mood symptoms during visits to a general pediatrics clinic between November 1, 2011, and October 31, 2013, in a large, integrated health system (N = 1851); this sample examined the subset of adolescents endorsing both problems (n = 289).

We conducted a cluster-randomized trial in rural Guinea Bissau to understand the effectiveness and cost of concerted supply-based interventions in such contexts.

Methods This was a 5-arm, cluster-randomized trial among under-5 children hospitalized with severe anemia at Zomba Central Hospital in Southern Malawi.

A community-based cluster-randomized trial was conducted in the rural block of Faridabad District, Haryana, India in the year 2017.

Methods The study is a cluster-randomized trial, which will be guided by the behaviour centred design model and theory for behaviour change.

Methods A community-based, open-label, two-armed, cluster-randomized trial [seven clusters (geographical wards) randomized for the intervention, and seven for the control arm].

Bhasin and colleagues recently reported results from a pragmatic, cluster-randomized trial designed to evaluate the effectiveness of a multifactorial intervention to prevent fall injuries.

Statistical inference used a two-stage approach recommended for cluster-randomized trials with <15 clusters/arm.

Design: An open-label, cluster-randomized trial with stepped-wedge design.

A two-armed cluster-randomized trial using parallel groups was conducted.

As part of a cluster-randomized trial to evaluate the effect of reactive treatment in The Gambia, all residents in the compound of a diagnosed clinical malaria patient received dihydro-artemisinin-piperaquine (DP).

Here, we report a case of typhoidal intestinal perforation in a 19 year-old young man detected by passive surveillance during a cluster-randomized trial with Vi-tetanus toxoid conjugate vaccine (Typhoid Vaccine Acceleration Consortium: TyVAC) in an urban slum area in Mirpur, Dhaka, Bangladesh.

Covariate constrained randomization (CCR) is a method of controlling imbalance in important baseline covariates in cluster-randomized trials (CRT).

The DeWorm3 study is designed to assess the feasibility of using community-based MDA with albendazole to interrupt the transmission of STH, through a series of cluster-randomized trials in Benin, India and Malawi.

METHODS We analyzed longitudinal data from a cluster-randomized trial from plains Nepal, stratifying results by child or gestational age.

Methods This cross-sectional study used data from a cluster-randomized trial in two districts of Northern Ghana.

Note CONSORT for cluster-randomized trials was used for the main trial but is not directly applicable to this manuscript.

Methods We use a stepped wedge cluster-randomized trial to evaluate implementation of LEAPS.

METHODS 1275 low-risk women participated in a Dutch nationwide pragmatic cluster-randomized trial and answered questionnaires on pregnancy-specific anxiety (PRAQ-R) and prenatal mother-to-infant bonding (MAAS) before and after a third-trimester routine ultrasound was offered to the intervention group.

METHODS This is a cluster-randomized trial (ClinicalTrials.

METHODS This secondary analysis arose from a nationwide, multisite cluster-randomized trial (ClinicalTrials.

Methods This study was part of baseline data collected for a cluster-randomized trial registered in Pan African Clinical Trials Registry (PACTR202001837195738).

All participants were enrolled in a cluster-randomized trial to evaluate the impact of a depression management program.

Results The 3-year cluster-randomized trial has concluded, and the analysis of primary outcomes is underway.

DESIGN AND INTERVENTION We are conducting two cluster-randomized trials, one in the U.

METHODS We carried out a stepped wedge cluster-randomized trial at six health centers in Bissau, Guinea-Bissau, and Gondar, Ethiopia.

The Stroke Health and Risk Education (SHARE) project, a multicomponent cluster-randomized trial, addressed key stroke risk factors among predominantly Mexican Americans in a Catholic Church setting.

This study estimated sustained impacts and long-term benefits and costs of the Communities That Care (CTC) prevention system, implemented and evaluated in a longitudinal cluster-randomized trial involving 24 communities in seven states.

As part of a two-year cluster-randomized trial of mCCM expansion to all ages in southeastern Madagascar, a cross-sectional survey was conducted to assess baseline malaria prevalence and healthcare-seeking behaviours.

METHODS This prospective cohort study compared women diagnosed with PPH who received and did not receive UBT (UBT group and no-UBT group, respectively) at 18 secondary level hospitals in Uganda, Egypt, and Senegal that participated in a stepped wedge, cluster-randomized trial assessing UBT introduction.

Background and aim Some parallel-group cluster-randomized trials use covariate-constrained rather than simple randomization.

Method: A non-inferiority trial with a margin of 25%, cluster-randomized trial.

We conducted a pragmatic cluster-randomized trial comparing adjuvanted trivalent influenza vaccine (aTIV) versus trivalent influenza vaccine (TIV).

This cost-effectiveness and feasibility study were piggybacked on a cluster-randomized trial that assessed the impact of an adolescent-centred service delivery intervention.

METHODS We used a stepped-wedge, cluster-randomized trial to compare paper-based CCM (control) with and without the use of an e-CCM app on smartphones from November 2016 to February 2017.

This small cluster-randomized trial provided no evidence to suggest that simply constructing HDWs, in the absence of other hygiene promotion activities, is effective for reducing transmission of ocular chlamydia.