scholarly journals The Effects of a Mediterranean Diet Intervention on Targeted Plasma Metabolic Biomarkers among US Firefighters: A Pilot Cluster-Randomized Trial

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3610
Author(s):  
Mercedes Sotos-Prieto ◽  
Miguel Ruiz-Canela ◽  
Yiqing Song ◽  
Costas Christophi ◽  
Steven Mofatt ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Mediterranean Diet ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Group 2 ◽  
Fire Stations ◽  
Cluster Randomized ◽  
Lipoprotein Composition ◽  
Metabolic Biomarkers ◽  
Time Point

Metabolomics is improving the understanding of the mechanisms of the health effects of diet. Previous research has identified several metabolites associated with the Mediterranean Diet (MedDiet), but knowledge about longitudinal changes in metabolic biomarkers after a MedDiet intervention is scarce. A subsample of 48 firefighters from a cluster-randomized trial at Indianapolis fire stations was randomly selected for the metabolomics study at 12 months of follow up (time point 1), where Group 1 (n = 24) continued for another 6 months in a self-sustained MedDiet intervention, and Group 2 (n = 24), the control group at that time, started with an active MedDiet intervention for 6 months (time point 2). A total of 225 metabolites were assessed at the two time points by using a targeted NMR platform. The MedDiet score improved slightly but changes were non-significant (intervention: 24.2 vs. 26.0 points and control group: 26.1 vs. 26.5 points). The MedDiet intervention led to favorable changes in biomarkers related to lipid metabolism, including lower LDL-C, ApoB/ApoA1 ratio, remnant cholesterol, M-VLDL-CE; and higher HDL-C, and better lipoprotein composition. This MedDiet intervention induces only modest changes in adherence to the MedDiet and consequently in metabolic biomarkers. Further research should confirm these results based on larger study samples in workplace interventions with powerful study designs.

scholarly journals Implementation of French Recommendations for the Prevention and the Treatment of Hospital-acquired Pneumonia: A Cluster-randomized Trial

2020 ◽  
Author(s):  
Antoine Roquilly ◽  
Gérald Chanques ◽  
Sigismond Lasocki ◽  
Arnaud Foucrier ◽  
Brice Fermier ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Baseline Period ◽  
Audit And Feedback ◽  
Control Group ◽  
Icu Stay ◽  
Hospital Acquired Pneumonia ◽  
Cluster Randomized ◽  
Hospital Acquired

Abstract Background We determined whether an audit on the adherence to guidelines for hospital-acquired pneumonia (HAP) can improve the outcomes of patients in intensive care units (ICUs). Methods This study was conducted at 35 ICUs in 30 hospitals. We included consecutive, adult patients hospitalized in ICUs for 3 days or more. After a 3-month baseline period followed by the dissemination of recommendations, an audit on the compliance to recommendations (audit period) was followed by a 3-month cluster-randomized trial. We randomly assigned ICUs to either receive audit and feedback (intervention group) or participate in a national registry (control group). The primary outcome was the duration of ICU stay. Results Among 1856 patients enrolled, 602, 669, and 585 were recruited in the baseline, audit, and intervention periods, respectively. The composite measures of compliance were 47% (interquartile range [IQR], 38–56%) in the intervention group and 42% (IQR, 25–53%) in the control group (P = .001). As compared to the baseline period, the ICU lengths of stay were reduced by 3.2 days in the intervention period (P = .07) and by 2.8 days in the control period (P = .02). The durations of ICU stay were 7 days (IQR, 5–14 days) in the control group and 9 days (IQR, 5–20 days) in the intervention group (P = .10). After adjustment for unbalanced baseline characteristics, the hazard ratio for being discharged alive from the ICU in the control group was 1.17 (95% confidence interval, .69–2.01; P = .10). Conclusions The publication of French guidelines for HAP was associated with a reduction of the ICU length of stay. However, the realization of an audit to improve their application did not further improve outcomes. Clinical Trials Registration NCT03348579.

Prospective, Multicenter, Randomized Trial of a New Organizational Modality for Providing Information and Support to Cancer Patients

2009 ◽  
Vol 27 (11) ◽  
pp. 1794-1799 ◽  
Author(s):  
Rodolfo Passalacqua ◽  
Caterina Caminiti ◽  
Francesco Campione ◽  
Francesca Diodati ◽  
Renata Todeschini ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Randomized Trial ◽  
Cancer Patients ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Context Analysis ◽  
Oncology Nurse ◽  
Implementation Context ◽  
Cluster Randomized ◽  
Intent To Treat

Purpose No structured modality for providing information and support to patients in oncology wards has been validated in clinical trials. Methods This is a pragmatic, two-arm, cluster randomized trial, with the oncology ward as random assignment unit. Centers were allocated to implement a Point of Information and Support (PIS) or to a control group. The PIS included a library for cancer patients and a specifically trained oncology nurse. End points, measured at patient level, were psychological distress and satisfaction with received information. Both intent-to-treat and per-protocol analyses considering clustering were performed. Results Thirty-eight Italian cancer centers were randomly assigned, and 6 months after PIS creation, 3,286 unselected, consecutive cancer patients were surveyed (1,654 in the experimental group and 1,632 in the control group). Three thousand one hundred ninety-seven (97%) questionnaires were collected and deemed valid. Fifty-two percent of centers (11 of 21 centers) in the experimental arm did not implement the PIS in accordance with the protocol. Overall, 34% of patients showed moderate to severe psychological distress, and only 9% declared dissatisfaction. Intent-to-treat analysis did not yield significant differences. Although the per-protocol analysis did show a reduction in psychological distress (28.9% for functioning PIS v 33.3% for no PIS) and dissatisfaction (6.4% for functioning PIS v 9.3% for no PIS), differences did not reach significance. Conclusion This is the first cluster randomized trial aiming to demonstrate that a structured modality of providing information reduces psychological distress. We did not find this, but we believe results should be interpreted cautiously, particularly because of the low compliance with PIS implementation. Context analysis preceding such interventions is essential.

scholarly journals Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yaseen M. Arabi ◽  
Ramesh Kumar Vishwakarma ◽  
Hasan M. Al-Dorzi ◽  
Eman Al Qasim ◽  
Sheryl Ann Abdukahil ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Relative Risk ◽  
Hospital Mortality ◽  
Randomized Trial ◽  
Fixed Effects ◽  
Cluster Randomized Trial ◽  
Statistical Analysis Plan ◽  
Control Group ◽  
Stepped Wedge ◽  
Cluster Randomized

Abstract Background It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) trial is to evaluate whether an electronic screening for sepsis compared to no screening among hospitalized ward patients reduces all-cause 90-day in-hospital mortality. Methods and design This study is designed as a stepped-wedge cluster randomized trial in which the unit of randomization or cluster is the hospital ward. An electronic alert for sepsis was developed in the electronic medical record (EMR), with the feature of being active (visible to treating team) or masked (inactive in EMR frontend for the treating team but active in the backend of the EMR). Forty-five clusters in 5 hospitals are randomized into 9 sequences of 5 clusters each to receive the intervention (active alert) over 10 periods, 2 months each, the first being the baseline period. Data are extracted from EMR and are compared between the intervention (active alert) and control group (masked alert). During the study period, some of the hospital wards were allocated to manage patients with COVID-19. The primary outcome of all-cause hospital mortality by day 90 will be compared using a generalized linear mixed model with a binary distribution and a log-link function to estimate the relative risk as a measure of effect. We will include two levels of random effects to account for nested clustering within wards and periods and two levels of fixed effects: hospitals and COVID-19 ward status in addition to the intervention. Results will be expressed as relative risk with a 95% confidence interval. Conclusion The SCREEN trial provides an opportunity for a novel trial design and analysis of routinely collected and entered data to evaluate the effectiveness of an intervention (alert) for a common medical problem (sepsis in ward patients). In this statistical analysis plan, we outline details of the planned analyses in advance of trial completion. Prior specification of the statistical methods and outcome analysis will facilitate unbiased analyses of these important clinical data. Trial registration ClinicalTrials.gov NCT04078594. Registered on September 6, 2019

scholarly journals Improving service delivery of water, sanitation, and hygiene in primary schools: a cluster-randomized trial in western Kenya

2013 ◽  
Vol 11 (3) ◽  
pp. 507-519 ◽  
Author(s):  
Kelly T. Alexander ◽  
Robert Dreibelbis ◽  
Matthew C. Freeman ◽  
Betty Ojeny ◽  
Richard Rheingans
Keyword(s):  
Service Delivery ◽  
Randomized Trial ◽  
Primary Schools ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Sanitation And Hygiene ◽  
Community Monitoring ◽  
Additional Funding ◽  
Cluster Randomized ◽  
Treated Drinking Water

Water, sanitation, and hygiene (WASH) programs in schools have been shown to improve health and reduce absence. In resource-poor settings, barriers such as inadequate budgets, lack of oversight, and competing priorities limit effective and sustained WASH service delivery in schools. We employed a cluster-randomized trial to examine if schools could improve WASH conditions within existing administrative structures. Seventy schools were divided into a control group and three intervention groups. All intervention schools received a budget for purchasing WASH-related items. One group received no further intervention. A second group received additional funding for hiring a WASH attendant and making repairs to WASH infrastructure, and a third group was given guides for student and community monitoring of conditions. Intervention schools made significant improvements in provision of soap and handwashing water, treated drinking water, and clean latrines compared with controls. Teachers reported benefits of monitoring, repairs, and a WASH attendant, but quantitative data of WASH conditions did not determine whether expanded interventions out-performed our budget-only intervention. Providing schools with budgets for WASH operational costs improved access to necessary supplies, but did not ensure consistent service delivery to students. Further work is needed to clarify how schools can provide WASH services daily.

scholarly journals Developing and Evaluating a Continuous Education Program for Healthcare Assistants in Macao: A Cluster-Randomized Trial

2021 ◽  
Vol 18 (9) ◽  
pp. 4990
Author(s):  
Pak-Leng Cheong ◽  
Nanly Hsu
Keyword(s):  
Nursing Homes ◽  
Randomized Trial ◽  
Education Program ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Chi Square ◽  
Continuous Education ◽  
Group 3 ◽  
Cluster Randomized ◽  
Experimental Group

The shortage of healthcare human resources is an important challenge for coping with the aging society in Macao. Since little attention has been paid to continuous education of healthcare assistants, this study aims to develop and evaluate a continuous education program, supporting the expansion and optimization of the competence of healthcare assistants. It is a cluster-randomized trial study. All healthcare assistants who were employed in nursing homes in Macao were eligible for this study. Six nursing homes were recruited and randomly assigned either an experimental group (3 nursing homes; 45 healthcare assistants) or a control group (3 nursing homes; 40 healthcare assistants). Healthcare assistants were assessed at baseline and after intervention with the Healthcare Assistants Care Knowledge Test and the Healthcare Assistants Care Competence Self-Assessment. The experimental group received a continuous education program with 10 themes during 2017–2018 while the control groups did not. The results of the generalized estimating equation showed that care knowledge in the experimental group was significantly different from that of the control group (Wald Chi Square = 3.848, p < 0.05) as well as care competence (Wald Chi Square = 13.361, p < 0.001). This study developed a continuous program for health assistants and provided evidence that continuous education programs improve and maintain the level of care knowledge and care competency of healthcare assistants.

Mathematics Learned by Young Children in an Intervention Based on Learning Trajectories: A Large-Scale Cluster Randomized Trial

2011 ◽  
Vol 42 (2) ◽  
pp. 127-166 ◽  
Author(s):  
Douglas H. Clements ◽  
Julie Sarama ◽  
Mary Elaine Spitler ◽  
Alissa A. Lange ◽  
Christopher B. Wolfe
Keyword(s):  
Young Children ◽  
Randomized Trial ◽  
Large Scale ◽  
Mathematics Curriculum ◽  
Block Design ◽  
Cluster Randomized Trial ◽  
Building Blocks ◽  
Control Group ◽  
Learning Trajectories ◽  
Cluster Randomized

This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the Building Blocks mathematics curriculum, which is structured in research-based learning trajectories, and congruous professional development emphasizing teaching for understanding via learning trajectories and technology. A total of 42 schools serving low-resource communities were randomly selected and randomly assigned to 3 treatment groups using a randomized block design involving 1,375 preschoolers in 106 classrooms. Teachers implemented the intervention with adequate fidelity. Pre- to posttest scores revealed that the children in the Building Blocks group learned more mathematics than the children in the control group (effect size, g = 0.72). Specific components of a measure of the quantity and quality of classroom mathematics environments and teaching partially mediated the treatment effect.

Effects of a Knowledge-Translation Intervention on Early Dialysis Initiation: A Cluster Randomized Trial

2021 ◽  
pp. ASN.2020091254
Author(s):  
Navdeep Tangri ◽  
Amit X. Garg ◽  
Thomas W. Ferguson ◽  
Stephanie Dixon ◽  
Claudio Rigatto ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Randomized Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Dialysis Initiation ◽  
Secondary Outcome ◽  
Control Group ◽  
Inpatient Setting ◽  
Link Type ◽  
Cluster Randomized

BackgroundThe Initiating Dialysis Early and Late (IDEAL) trial, published in 2009, found no clinically measurable benefit with respect to risk of mortality or early complications with early dialysis initiation versus deferred dialysis start. After these findings, guidelines recommended an intent-to-defer approach to dialysis initiation, with the goal of deferring it until clinical symptoms arise.MethodsTo evaluate a four-component knowledge translation intervention aimed at promoting an intent-to-defer strategy for dialysis initiation, we conducted a cluster randomized trial in Canada between October 2014 and November 2015. We randomized 55 clinics, 27 to the intervention group and 28 to the control group. The educational intervention, using knowledge-translation tools, included telephone surveys from a knowledge-translation broker, a 1-year center-specific audit with feedback, delivery of a guidelines package, and an academic detailing visit. Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention. The primary efficacy outcome was the proportion of patients who initiated dialysis early (at eGFR >10.5 ml/min per 1.73 m2). The secondary outcome was the proportion of patients who initiated in the acute inpatient setting.ResultsThe analysis included 3424 patients initiating dialysis in the 1-year follow-up period. Of these, 509 of 1592 (32.0%) in the intervention arm and 605 of 1832 (33.0%) in the control arm started dialysis early. There was no difference in the proportion of individuals initiating dialysis early or in the proportion of individuals initiating dialysis as an acute inpatient.ConclusionsA multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics.Clinical Trial registry name and registration number:ClinicalTrials.gov, NCT02183987. Available at: https://clinicaltrials.gov/ct2/show/NCT02183987

scholarly journals Cluster Randomized Trial: Sun Protection Intervention ‘Clever in Sun and Shade for Preschools’—Effectiveness and Dissemination

Children ◽  
2021 ◽  
Vol 8 (8) ◽  
pp. 651
Author(s):  
Nadja Seidel ◽  
Vera Fieber ◽  
Eckhard Wilhem Breitbart ◽  
Martin Bornhäuser ◽  
Friederike Stölzel
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Sun Protection ◽  
Drop Out ◽  
Control Group ◽  
The Sun ◽  
Staff Members ◽  
Sun And Shade ◽  
Cluster Randomized ◽  
Preschool Staff

Skin cancer is one of the most common types of cancer and UV radiation is one of the main risk factors. Therefore, sun protection, especially in childhood, is strongly recommended. We examined the effectiveness of the ‘Clever in Sun and Shade for Preschools’ program (CLEVER) in promoting sun protection behavior among preschool staff (trial registration: DRKS00023468) and describe its dissemination. Within a cluster randomized trial with 24 preschools (n = 273 staff members) stating a high need for sun protection measures, an educational workshop for preschool staff and a project kit with materials applicable in preschool groups was provided. Staff members of preschools taking part in CLEVER report significantly stronger sun protection behavior to avoid the sun (effect size [ES] 0.70, 95% confidence interval [CI] 0.04 0.71, p < 0.05) and less perceived impediments to avoid the sun (ES −0.56, CI −0.82 −0.17, p < 0.01) after 12 months as well as higher self-efficacy to avoid the sun (ES 1.09, CI 0.39 1.07, p < 0.001) and to use sunscreen (ES 0.71, CI 0.03 0.88, p < 0.05) after 1 month. Compared to the control group, there was no significant effect on sunscreen use and further psychosocial outcomes. The effectiveness of CLEVER may be underrated due to a high drop-out rate. Within three years, an enhanced free-of-charge program kit, including a media-based workshop and materials, had reached over 4000 preschools, i.e., 7.1% of all daycare centers in Germany. The results show that CLEVER can strengthen sun protection, offer high-quality information at low cost, and is easily disseminable.

scholarly journals Community Hand-Dug Wells for Trachoma: A Cluster-Randomized Trial

2021 ◽  
Author(s):  
Solomon Aragie ◽  
Sintayehu Gebresillasie ◽  
Ambahun Chernet ◽  
Ayalew Shiferaw ◽  
Zerihun Tadesse ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Public Health Problem ◽  
Cluster Randomized Trial ◽  
Chlamydia Infection ◽  
Control Group ◽  
Sanitation Services ◽  
Dug Wells ◽  
Cluster Randomized ◽  
Dug Well ◽  
The Impact

The WHO recommends improving access to water as part of a comprehensive strategy for elimination of trachoma as a public health problem; however, this recommendation is not based on evidence from randomized trials. In a region of Ethiopia with hyperendemic trachoma, seven communities were randomized to a hand-dug well (HDW) and seven communities to no intervention to determine the impact of HDWs on the community prevalence of ocular chlamydia infection (primary prespecified outcome). All communities continued to receive government hygiene and sanitation services and outreach. Participants were not masked, given the nature of the intervention, but laboratory personnel were masked to treatment allocation. Hand-dug wells were successfully built in six of the seven communities; five of these wells were still functional at the conclusion of the trial. At the end of the trial, an average of 74% of households reported traveling < 30 minutes to collect water in the HDW arm, compared with 45% in the control arm, and the daily volume of water used for hygiene was similar (e.g., mean of 0.7 L per person in each arm). The pseudo-median prevalence of ocular chlamydia among 0- to 50-year old people at the 24-month visit was 23% in the HDW group and 13% in the control group (P > 0.99). 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.

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