Impact of a Social-Emotional and Character Development Program on School-Level Indicators of Academic Achievement, Absenteeism, and Disciplinary Outcomes: A Matched-Pair, Cluster-Randomized, Controlled Trial

ERIC Educational Resources Information Center

Snyder, Frank; Flay, Brian; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit

2010-01-01

This article reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster-randomized, controlled design. The "Positive Action" Hawai'i trial included 20 racially/ethnically diverse…

Cluster Randomized-Controlled Trial of Interventions to Improve Health for Adults with Intellectual Disability Who Live in Private Dwellings

ERIC Educational Resources Information Center

Lennox, Nicholas; Bain, Chris; Rey-Conde, Therese; Taylor, Miriam; Boyle, Frances M.; Purdie, David M.; Ware, Robert S.

2010-01-01

Background: People with intellectual disability who live in the community often have poor health and healthcare, partly as a consequence of poor communication, recall difficulties and incomplete patient health information. Materials and Methods: A cluster randomized-controlled trial with 2 x 2 factorial design was conducted with adults with…

A pilot cluster randomized controlled trial of structured goal-setting following stroke.

PubMed

Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

2012-04-01

To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

Baseline adjustments for binary data in repeated cross-sectional cluster randomized trials.

PubMed

Nixon, R M; Thompson, S G

2003-09-15

Analysis of covariance models, which adjust for a baseline covariate, are often used to compare treatment groups in a controlled trial in which individuals are randomized. Such analysis adjusts for any baseline imbalance and usually increases the precision of the treatment effect estimate. We assess the value of such adjustments in the context of a cluster randomized trial with repeated cross-sectional design and a binary outcome. In such a design, a new sample of individuals is taken from the clusters at each measurement occasion, so that baseline adjustment has to be at the cluster level. Logistic regression models are used to analyse the data, with cluster level random effects to allow for different outcome probabilities in each cluster. We compare the estimated treatment effect and its precision in models that incorporate a covariate measuring the cluster level probabilities at baseline and those that do not. In two data sets, taken from a cluster randomized trial in the treatment of menorrhagia, the value of baseline adjustment is only evident when the number of subjects per cluster is large. We assess the generalizability of these findings by undertaking a simulation study, and find that increased precision of the treatment effect requires both large cluster sizes and substantial heterogeneity between clusters at baseline, but baseline imbalance arising by chance in a randomized study can always be effectively adjusted for. Copyright 2003 John Wiley & Sons, Ltd.

Evaluating the Implementation of a School-Based Emotional Well-Being Programme: A Cluster Randomized Controlled Trial of Zippy's Friends for Children in Disadvantaged Primary Schools

ERIC Educational Resources Information Center

Clarke, Aleisha M.; Bunting, Brendan; Barry, Margaret M.

2014-01-01

Schools are recognized as one of the most important settings for promoting social and emotional well-being among children and adolescents. This clustered randomized controlled trial evaluated Zippy's Friends, an international school-based emotional well-being programme, with 766 children from designated disadvantaged schools. The purpose of this…

The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Newton, Nicola C.; Conrod, Patricia J.; Slade, Tim; Carragher, Natacha; Champion, Katrina E.; Barrett, Emma L.; Kelly, Erin V.; Nair, Natasha K.; Stapinski, Lexine; Teesson, Maree

2016-01-01

Background: This study investigated the long-term effectiveness of Preventure, a selective personality-targeted prevention program, in reducing the uptake of alcohol, harmful use of alcohol, and alcohol-related harms over a 3-year period. Methods: A cluster randomized controlled trial was conducted to assess the effectiveness of Preventure.…

Cluster-Randomized Controlled Trial Evaluating the Effectiveness of Computer-Assisted Intervention Delivered by Educators for Children with Speech Sound Disorders

ERIC Educational Resources Information Center

McLeod, Sharynne; Baker, Elise; McCormack, Jane; Wren, Yvonne; Roulstone, Sue; Crowe, Kathryn; Masso, Sarah; White, Paul; Howland, Charlotte

2017-01-01

Purpose: The aim was to evaluate the effectiveness of computer-assisted input-based intervention for children with speech sound disorders (SSD). Method: The Sound Start Study was a cluster-randomized controlled trial. Seventy-nine early childhood centers were invited to participate, 45 were recruited, and 1,205 parents and educators of 4- and…

Effect of village-wide use of long-lasting insecticidal nets on visceral Leishmaniasis vectors in India and Nepal: a cluster randomized trial.

PubMed

Picado, Albert; Das, Murari L; Kumar, Vijay; Kesari, Shreekant; Dinesh, Diwakar S; Roy, Lalita; Rijal, Suman; Das, Pradeep; Rowland, Mark; Sundar, Shyam; Coosemans, Marc; Boelaert, Marleen; Davies, Clive R

2010-01-26

Visceral leishmaniasis (VL) control in the Indian subcontinent is currently based on case detection and treatment, and on vector control using indoor residual spraying (IRS). The use of long-lasting insecticidal nets (LN) has been postulated as an alternative or complement to IRS. Here we tested the impact of comprehensive distribution of LN on the density of Phlebotomus argentipes in VL-endemic villages. A cluster-randomized controlled trial with household P. argentipes density as outcome was designed. Twelve clusters from an ongoing LN clinical trial--three intervention and three control clusters in both India and Nepal--were selected on the basis of accessibility and VL incidence. Ten houses per cluster selected on the basis of high pre-intervention P. argentipes density were monitored monthly for 12 months after distribution of LN using CDC light traps (LT) and mouth aspiration methods. Ten cattle sheds per cluster were also monitored by aspiration. A random effect linear regression model showed that the cluster-wide distribution of LNs significantly reduced the P. argentipes density/house by 24.9% (95% CI 1.80%-42.5%) as measured by means of LTs. The ongoing clinical trial, designed to measure the impact of LNs on VL incidence, will confirm whether LNs should be adopted as a control strategy in the regional VL elimination programs. The entomological evidence described here provides some evidence that LNs could be usefully deployed as part of the VL control program. ClinicalTrials.gov CT-2005-015374.

Psychoanalytic-Interactional Therapy versus Psychodynamic Therapy by Experts for Personality Disorders: A Randomized Controlled Efficacy-Effectiveness Study in Cluster B Personality Disorders.

PubMed

Leichsenring, Falk; Masuhr, Oliver; Jaeger, Ulrich; Rabung, Sven; Dally, Andreas; Dümpelmann, Michael; Fricke-Neef, Christian; Steinert, Christiane; Streeck, Ulrich

2016-01-01

With regard to cluster B personality disorders, most psychotherapeutic treatments focus on borderline personality disorder. Evidence-based treatments for patients with other cluster B personality disorders are not yet available. Psychoanalytic-interactional therapy (PIT) represents a transdiagnostic treatment for severe personality disorders. PIT has been applied in clinical practice for many years and has proven effective in open studies. In a randomized controlled trial, we compared manual-guided PIT to nonmanualized pychodynamic therapy by experts in personality disorders (E-PDT) in patients with cluster B personality disorders. In an inpatient setting, patients with cluster B personality disorders were randomly assigned to manual-guided PIT (n = 64) or nonmanualized E-PDT (n = 58). In addition, a quasi-experimental control condition was used (n = 46) including both patients receiving treatment as usual and patients waiting for treatment. Primary outcomes were level of personality organization and overall psychological distress. As secondary outcomes, depression, anxiety and interpersonal problems were examined. No significant improvements were found in the control patients. Both PIT and E-PDT achieved significant improvements in all outcome measures and were superior to the control condition. No differences were found between PIT and E-PDT in any outcome measure at the end of treatment. The type of cluster B personality disorder had no impact on the results. In an inpatient setting, both PIT and E-PDT proved to be superior to a control condition in cluster B personality disorders. In a head-to-head comparison, both treatments appeared to be equally effective. Further research on the treatment of cluster B personality disorders is required. © 2016 S. Karger AG, Basel.

Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

PubMed

Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

2016-03-15

Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district. The study included a representative baseline cross-sectional survey, development of a structured intervention model, delivery of intervention for a minimum period of 18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials.

PubMed

Brown, Andrew W; Li, Peng; Bohan Brown, Michelle M; Kaiser, Kathryn A; Keith, Scott W; Oakes, J Michael; Allison, David B

2015-08-01

Cluster randomized controlled trials (cRCTs; also known as group randomized trials and community-randomized trials) are multilevel experiments in which units that are randomly assigned to experimental conditions are sets of grouped individuals, whereas outcomes are recorded at the individual level. In human cRCTs, clusters that are randomly assigned are typically families, classrooms, schools, worksites, or counties. With growing interest in community-based, public health, and policy interventions to reduce obesity or improve nutrition, the use of cRCTs has increased. Errors in the design, analysis, and interpretation of cRCTs are unfortunately all too common. This situation seems to stem in part from investigator confusion about how the unit of randomization affects causal inferences and the statistical procedures required for the valid estimation and testing of effects. In this article, we provide a brief introduction and overview of the importance of cRCTs and highlight and explain important considerations for the design, analysis, and reporting of cRCTs by using published examples. © 2015 American Society for Nutrition.

Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

PubMed

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2013-09-01

Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

PubMed Central

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2016-01-01

Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

Entomological impact and social participation in dengue control: a cluster randomized trial in Fortaleza, Brazil

PubMed Central

Caprara, Andrea; De Oliveira Lima, José Wellington; Rocha Peixoto, Ana Carolina; Vasconcelos Motta, Cyntia Monteiro; Soares Nobre, Joana Mary; Sommerfeld, Johannes; Kroeger, Axel

2015-01-01

Background This study intended to implement a novel intervention strategy, in Brazil, using an ecohealth approach and analyse its effectiveness and costs in reducing Aedes aegypti vector density as well as its acceptance, feasibility and sustainability. The intervention was conducted from 2012 to 2013 in the municipality of Fortaleza, northeast Brazil. Methodology A cluster randomized controlled trial was designed by comparing ten intervention clusters with ten control clusters where routine vector control activities were conducted. The intervention included: community workshops; community involvement in clean-up campaigns; covering the elevated containers and in-house rubbish disposal without larviciding; mobilization of schoolchildren and senior inhabitants; and distribution of information, education and communication (IEC) materials in the community. Results Differences in terms of social participation, commitment and leadership were present in the clusters. The results showed the effectiveness of the intervention package in comparison with the routine control programme. Differences regarding the costs of the intervention were reasonable and could be adopted by public health services. Conclusions Embedding social participation and environmental management for improved dengue vector control was feasible and significantly reduced vector densities. Such a participatory ecohealth approach offers a promising alternative to routine vector control measures. PMID:25604760

Descriptive epidemiology of typhoid fever during an epidemic in Harare, Zimbabwe, 2012.

PubMed

Polonsky, Jonathan A; Martínez-Pino, Isabel; Nackers, Fabienne; Chonzi, Prosper; Manangazira, Portia; Van Herp, Michel; Maes, Peter; Porten, Klaudia; Luquero, Francisco J

2014-01-01

Typhoid fever remains a significant public health problem in developing countries. In October 2011, a typhoid fever epidemic was declared in Harare, Zimbabwe - the fourth enteric infection epidemic since 2008. To orient control activities, we described the epidemiology and spatiotemporal clustering of the epidemic in Dzivaresekwa and Kuwadzana, the two most affected suburbs of Harare. A typhoid fever case-patient register was analysed to describe the epidemic. To explore clustering, we constructed a dataset comprising GPS coordinates of case-patient residences and randomly sampled residential locations (spatial controls). The scale and significance of clustering was explored with Ripley K functions. Cluster locations were determined by a random labelling technique and confirmed using Kulldorff's spatial scan statistic. We analysed data from 2570 confirmed and suspected case-patients, and found significant spatiotemporal clustering of typhoid fever in two non-overlapping areas, which appeared to be linked to environmental sources. Peak relative risk was more than six times greater than in areas lying outside the cluster ranges. Clusters were identified in similar geographical ranges by both random labelling and Kulldorff's spatial scan statistic. The spatial scale at which typhoid fever clustered was highly localised, with significant clustering at distances up to 4.5 km and peak levels at approximately 3.5 km. The epicentre of infection transmission shifted from one cluster to the other during the course of the epidemic. This study demonstrated highly localised clustering of typhoid fever during an epidemic in an urban African setting, and highlights the importance of spatiotemporal analysis for making timely decisions about targetting prevention and control activities and reinforcing treatment during epidemics. This approach should be integrated into existing surveillance systems to facilitate early detection of epidemics and identify their spatial range.

Descriptive Epidemiology of Typhoid Fever during an Epidemic in Harare, Zimbabwe, 2012

PubMed Central

Polonsky, Jonathan A.; Martínez-Pino, Isabel; Nackers, Fabienne; Chonzi, Prosper; Manangazira, Portia; Van Herp, Michel; Maes, Peter; Porten, Klaudia; Luquero, Francisco J.

2014-01-01

Background Typhoid fever remains a significant public health problem in developing countries. In October 2011, a typhoid fever epidemic was declared in Harare, Zimbabwe - the fourth enteric infection epidemic since 2008. To orient control activities, we described the epidemiology and spatiotemporal clustering of the epidemic in Dzivaresekwa and Kuwadzana, the two most affected suburbs of Harare. Methods A typhoid fever case-patient register was analysed to describe the epidemic. To explore clustering, we constructed a dataset comprising GPS coordinates of case-patient residences and randomly sampled residential locations (spatial controls). The scale and significance of clustering was explored with Ripley K functions. Cluster locations were determined by a random labelling technique and confirmed using Kulldorff's spatial scan statistic. Principal Findings We analysed data from 2570 confirmed and suspected case-patients, and found significant spatiotemporal clustering of typhoid fever in two non-overlapping areas, which appeared to be linked to environmental sources. Peak relative risk was more than six times greater than in areas lying outside the cluster ranges. Clusters were identified in similar geographical ranges by both random labelling and Kulldorff's spatial scan statistic. The spatial scale at which typhoid fever clustered was highly localised, with significant clustering at distances up to 4.5 km and peak levels at approximately 3.5 km. The epicentre of infection transmission shifted from one cluster to the other during the course of the epidemic. Conclusions This study demonstrated highly localised clustering of typhoid fever during an epidemic in an urban African setting, and highlights the importance of spatiotemporal analysis for making timely decisions about targetting prevention and control activities and reinforcing treatment during epidemics. This approach should be integrated into existing surveillance systems to facilitate early detection of epidemics and identify their spatial range. PMID:25486292

Cluster Randomized Trial of a Church-Based Peer Counselor and Tailored Newsletter Intervention to Promote Colorectal Cancer Screening and Physical Activity among Older African Americans

ERIC Educational Resources Information Center

Leone, Lucia A.; Allicock, Marlyn; Pignone, Michael P.; Walsh, Joan F.; Johnson, La-Shell; Armstrong-Brown, Janelle; Carr, Carol C.; Langford, Aisha; Ni, Andy; Resnicow, Ken; Campbell, Marci K.

2016-01-01

Action Through Churches in Time to Save Lives (ACTS) of Wellness was a cluster randomized controlled trial developed to promote colorectal cancer screening and physical activity (PA) within urban African American churches. Churches were recruited from North Carolina (n = 12) and Michigan (n = 7) and were randomized to intervention (n = 10) or…

Coordinate based random effect size meta-analysis of neuroimaging studies.

PubMed

Tench, C R; Tanasescu, Radu; Constantinescu, C S; Auer, D P; Cottam, W J

2017-06-01

Low power in neuroimaging studies can make them difficult to interpret, and Coordinate based meta-analysis (CBMA) may go some way to mitigating this issue. CBMA has been used in many analyses to detect where published functional MRI or voxel-based morphometry studies testing similar hypotheses report significant summary results (coordinates) consistently. Only the reported coordinates and possibly t statistics are analysed, and statistical significance of clusters is determined by coordinate density. Here a method of performing coordinate based random effect size meta-analysis and meta-regression is introduced. The algorithm (ClusterZ) analyses both coordinates and reported t statistic or Z score, standardised by the number of subjects. Statistical significance is determined not by coordinate density, but by a random effects meta-analyses of reported effects performed cluster-wise using standard statistical methods and taking account of censoring inherent in the published summary results. Type 1 error control is achieved using the false cluster discovery rate (FCDR), which is based on the false discovery rate. This controls both the family wise error rate under the null hypothesis that coordinates are randomly drawn from a standard stereotaxic space, and the proportion of significant clusters that are expected under the null. Such control is necessary to avoid propagating and even amplifying the very issues motivating the meta-analysis in the first place. ClusterZ is demonstrated on both numerically simulated data and on real data from reports of grey matter loss in multiple sclerosis (MS) and syndromes suggestive of MS, and of painful stimulus in healthy controls. The software implementation is available to download and use freely. Copyright © 2017 Elsevier Inc. All rights reserved.

Efficient design of cluster randomized trials with treatment-dependent costs and treatment-dependent unknown variances.

PubMed

van Breukelen, Gerard J P; Candel, Math J J M

2018-06-10

Cluster randomized trials evaluate the effect of a treatment on persons nested within clusters, where treatment is randomly assigned to clusters. Current equations for the optimal sample size at the cluster and person level assume that the outcome variances and/or the study costs are known and homogeneous between treatment arms. This paper presents efficient yet robust designs for cluster randomized trials with treatment-dependent costs and treatment-dependent unknown variances, and compares these with 2 practical designs. First, the maximin design (MMD) is derived, which maximizes the minimum efficiency (minimizes the maximum sampling variance) of the treatment effect estimator over a range of treatment-to-control variance ratios. The MMD is then compared with the optimal design for homogeneous variances and costs (balanced design), and with that for homogeneous variances and treatment-dependent costs (cost-considered design). The results show that the balanced design is the MMD if the treatment-to control cost ratio is the same at both design levels (cluster, person) and within the range for the treatment-to-control variance ratio. It still is highly efficient and better than the cost-considered design if the cost ratio is within the range for the squared variance ratio. Outside that range, the cost-considered design is better and highly efficient, but it is not the MMD. An example shows sample size calculation for the MMD, and the computer code (SPSS and R) is provided as supplementary material. The MMD is recommended for trial planning if the study costs are treatment-dependent and homogeneity of variances cannot be assumed. © 2018 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

WWC Review of the Report "Closing the Achievement Gap through Modification of Neurocognitive and Neuroendocrine Function: Results from a Cluster Randomized Controlled Trial of an Innovative Approach to the Education of Children in Kindergarten." What Works Clearinghouse Single Study Review

ERIC Educational Resources Information Center

What Works Clearinghouse, 2015

2015-01-01

In the 2014 report, "Closing the Achievement Gap Through Modification of Neurocognitive and Neuroendocrine Function: Results from a Cluster Randomized Controlled Trial of an Innovative Approach to the Education of Children in Kindergarten," researchers examined the impacts of "Tools of the Mind" on cognitive and academic…

The Method of Randomization for Cluster-Randomized Trials: Challenges of Including Patients with Multiple Chronic Conditions

PubMed Central

Esserman, Denise; Allore, Heather G.; Travison, Thomas G.

2016-01-01

Cluster-randomized clinical trials (CRT) are trials in which the unit of randomization is not a participant but a group (e.g. healthcare systems or community centers). They are suitable when the intervention applies naturally to the cluster (e.g. healthcare policy); when lack of independence among participants may occur (e.g. nursing home hygiene); or when it is most ethical to apply an intervention to all within a group (e.g. school-level immunization). Because participants in the same cluster receive the same intervention, CRT may approximate clinical practice, and may produce generalizable findings. However, when not properly designed or interpreted, CRT may induce biased results. CRT designs have features that add complexity to statistical estimation and inference. Chief among these is the cluster-level correlation in response measurements induced by the randomization. A critical consideration is the experimental unit of inference; often it is desirable to consider intervention effects at the level of the individual rather than the cluster. Finally, given that the number of clusters available may be limited, simple forms of randomization may not achieve balance between intervention and control arms at either the cluster- or participant-level. In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC). CRTs, which are often pragmatic, may eschew such restrictions. Failure to account for imbalance may induce bias and reducing validity. This article focuses on the complexities of randomization in the design of CRTs, such as the inclusion of patients with MCC, and imbalances in covariate factors across clusters. PMID:27478520

A clinical carepath for obese pregnant women: A pragmatic pilot cluster randomized controlled trial.

PubMed

McDonald, Sarah D; Viaje, Kristen A; Rooney, Rebecca A; Jarde, Alexander; Giglia, Lucia; Maxwell, Cynthia V; Small, David; Kelly, Tracy Pearce; Midwifery, B H Sc; Sabatino, Lisa; Thabane, Lehana

2018-05-17

Obese women are at increased risks for complications during pregnancy, birth and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a prepregnancy body mass index of ≥ 30 kg/m 2 and a viable singleton < 21 weeks. The primary outcomes were the feasibility of conducting a full-scale cluster RCT (defined as > 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as > 80%: compliance with each step in the carepath, and recommendation of the carepath by clinicians to a colleague). All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in < 80% uptake of eligible women. High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed recommendations for screening, but less so for counselling topics. When the carepath was used in the majority of women, all clinicians, most of whom were midwives, reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (relative risk 1.71, 95% confidence interval 1.57-1.87). In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics. This pragmatic pilot cluster RCT was registered on clinicaltrials.gov (identifier: NCT02534051 ).

A cluster randomized trial of strategies to increase uptake amongst young women invited for their first cervical screen: The STRATEGIC trial.

PubMed

Kitchener, H; Gittins, M; Cruickshank, M; Moseley, C; Fletcher, S; Albrow, R; Gray, A; Brabin, L; Torgerson, D; Crosbie, E J; Sargent, A; Roberts, C

2018-06-01

Objectives To measure the feasibility and effectiveness of interventions to increase cervical screening uptake amongst young women. Methods A two-phase cluster randomized trial conducted in general practices in the NHS Cervical Screening Programme. In Phase 1, women in practices randomized to intervention due for their first invitation to cervical screening received a pre-invitation leaflet and, separately, access to online booking. In Phase 2, non-attenders at six months were randomized to one of: vaginal self-sample kits sent unrequested or offered; timed appointments; nurse navigator; or the choice between nurse navigator or self-sample kits. Primary outcome was uplift in intervention vs. control practices, at 3 and 12 months post invitation. Results Phase 1 randomized 20,879 women. Neither pre-invitation leaflet nor online booking increased screening uptake by three months (18.8% pre-invitation leaflet vs. 19.2% control and 17.8% online booking vs. 17.2% control). Uptake was higher amongst human papillomavirus vaccinees at three months (OR 2.07, 95% CI 1.69-2.53, p < 0.001). Phase 2 randomized 10,126 non-attenders, with 32-34 clusters for each intervention and 100 clusters as controls. Sending self-sample kits increased uptake at 12 months (OR 1.51, 95% CI 1.20-1.91, p = 0.001), as did timed appointments (OR 1.41, 95% CI 1.14-1.74, p = 0.001). The offer of a nurse navigator, a self-sample kits on request, and choice between timed appointments and nurse navigator were ineffective. Conclusions Amongst non-attenders, self-sample kits sent and timed appointments achieved an uplift in screening over the short term; longer term impact is less certain. Prior human papillomavirus vaccination was associated with increased screening uptake.

Prevention of EP Migratory Contamination in a Cluster Randomized Trial to Increase tPA Use in Stroke (The INSTINCT Trial)

PubMed Central

Weston, Victoria C.; Meurer, William J.; Frederiksen, Shirley M.; Fox, Allison K.; Scott, Phillip A.

2016-01-01

Objectives Cluster randomized trials (CRTs) are increasingly utilized to evaluate quality improvement interventions aimed at healthcare providers. In trials testing emergency department interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating emergency departments would prevent migratory contamination in a CRT designed to increase ED delivery of tPA in stroke (The INSTINCT Trial). Methods INSTINCT was a prospective, cluster randomized, controlled trial. 24 Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as >10% of EPs affected. Non-adherence, total crossover (contamination + non-adherence), migration distance and characteristics were determined. Results 307 emergency physicians were identified at all sites. Overall, 7 (2.3%) changed study sites. 1 moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination) and 4 (1.3%) moved from control to intervention (non-adherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. Conclusion The mobile nature of emergency physicians should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. PMID:25440230

A focus group study to understand biases and confounders in a cluster randomized controlled trial on low back pain in primary care in Norway.

PubMed

Werner, Erik L; Løchting, Ida; Storheim, Kjersti; Grotle, Margreth

2018-05-22

Cluster randomized controlled trials are often used in research in primary care but creates challenges regarding biases and confounders. We recently presented a study on low back pain from primary care in Norway with equal effects in the intervention and the control group. In order to understand the specific mechanisms that may produce biases in a cluster randomized trial we conducted a focus group study among the participating health care providers. The aim of this study was to understand how the participating providers themselves influenced on the study and thereby possibly on the results of the cluster randomized controlled trial. The providers were invited to share their experiences from their participation in the COPE study, from recruitment of patients to accomplishment of either the intervention or control consultations. Six clinicians from the intervention group and four from the control group took part in the focus group interviews. The group discussions focused on feasibility of the study in primary care and particularly on identifying potential biases and confounders in the study. The audio-recorded interviews were transcribed verbatim and analyzed according to a systematic text condensation. The themes for the analysis emerged from the group discussions. A personal interest for back pain, logistic factors at the clinics and an assessment of the patients' capacity to accomplish the study prior to their recruitment was reported. The providers were allowed to provide additional therapy to the intervention and it turned out that some of these could be regarded as opposed to the messages of the intervention. The providers seemed to select different items from the educational package according to personal beliefs and their perception of the patients' acceptance. The study disclosed several potential biases to the COPE study which may have impacted on the study results. Awareness of these is highly important when planning and conducting a cluster randomized controlled trial. Procedures in the recruitment of both providers and patients seem to be key factors and the providers should be aware of their role in a scientific study in order to standardize the provision of the intervention.

Study protocol of Prednisone in episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episodic cluster headache with verapamil

PubMed Central

2013-01-01

Background Episodic cluster headache (ECH) is a primary headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of cluster attacks in the beginning of a cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a cluster episode. Methods and design PredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with episodic cluster headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German headache clinics that specialize in the treatment of ECH. Discussion PredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of cluster attacks in the beginning of a cluster episode as compared to monotherapy with verapamil. Trial registration German Clinical Trials Register DRKS00004716 PMID:23889923

Prevention of emergency physician migratory contamination in a cluster randomized trial to increase tissue plasminogen activator use in stroke (the INSTINCT trial).

PubMed

Weston, Victoria C; Meurer, William J; Frederiksen, Shirley M; Fox, Allison K; Scott, Phillip A

2014-12-01

Cluster randomized trials (CRTs) are increasingly used to evaluate quality improvement interventions aimed at health care providers. In trials testing emergency department (ED) interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator (tPA) in stroke (the INSTINCT trial). INSTINCT was a prospective, cluster randomized, controlled trial. Twenty-four Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as greater than 10% of EPs affected. Nonadherence, total crossover (contamination+nonadherence), migration distance, and characteristics were determined. Three hundred seven EPs were identified at all sites. Overall, 7 (2.3%) changed study sites. One moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination); and 4 (1.3%) moved from control to intervention (nonadherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. The mobile nature of EPs should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. Copyright © 2014 Elsevier Inc. All rights reserved.

Citywide cluster randomized trial to restore blighted vacant land and its effects on violence, crime, and fear

Treesearch

Charles C. Branas; Eugenia South; Michelle C. Kondo; Bernadette C. Hohl; Philippe Bourgois; Douglas J. Wiebe; John M. MacDonald

2018-01-01

Vacant and blighted urban land is a widespread and potentially risky environmental condition encountered by millions of people on a daily basis. About 15% of the land in US cities is deemed vacant or abandoned, an area roughly the size of Switzerland. In a citywide cluster randomized controlled trial, we investigated the effects of standardized, reproducible...

Improving Elementary School Quality through the Use of a Social-Emotional and Character Development Program: A Matched-Pair, Cluster-Randomized, Controlled Trial in Hawai'i

ERIC Educational Resources Information Center

Snyder, Frank J.; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J.; Flay, Brian R.

2012-01-01

Background: School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled…

Detecting Intervention Effects in a Cluster-Randomized Design Using Multilevel Structural Equation Modeling for Binary Responses

ERIC Educational Resources Information Center

Cho, Sun-Joo; Preacher, Kristopher J.; Bottge, Brian A.

2015-01-01

Multilevel modeling (MLM) is frequently used to detect group differences, such as an intervention effect in a pre-test--post-test cluster-randomized design. Group differences on the post-test scores are detected by controlling for pre-test scores as a proxy variable for unobserved factors that predict future attributes. The pre-test and post-test…

Clustering and Phase Transitions on a Neutral Landscape

NASA Astrophysics Data System (ADS)

Scott, Adam; King, Dawn; Maric, Nevena; Bahar, Sonya

2012-02-01

The problem of speciation and species aggregation on a neutral landscape, subject to random mutational fluctuations rather than selective drive, has been a focus of research since the seminal work of Kimura on genetic drift. These ideas have received increased attention due to the more recent development of a neutral ecological theory by Hubbell. De Aguiar et al. recently demonstrated, in a computational model, that speciation can occur under neutral conditions; this study bears some comparison with more mathematical studies of clustering on neutral landscapes in the context of branching and annihilating random walks. Here, we show that clustering can occur on a neutral landscape where the dimensions specify the simulated organisms' phenotypes. Unlike the De Aguiar et al. model, we simulate sympatric speciation: the organisms cluster phenotypically, but are not spatially separated. Moreover, we find that clustering occurs not only in the case of assortative mating, but also in the case of asexual fission. Clustering is not observed in a control case where organisms can mate randomly. We find that the population size and the number of clusters undergo phase-transition-like behavior as the maximum mutation size is varied.

Estimators for Clustered Education RCTs Using the Neyman Model for Causal Inference

ERIC Educational Resources Information Center

Schochet, Peter Z.

2013-01-01

This article examines the estimation of two-stage clustered designs for education randomized control trials (RCTs) using the nonparametric Neyman causal inference framework that underlies experiments. The key distinction between the considered causal models is whether potential treatment and control group outcomes are considered to be fixed for…

Clustering and phase transitions on a neutral landscape

NASA Astrophysics Data System (ADS)

Scott, Adam D.; King, Dawn M.; Marić, Nevena; Bahar, Sonya

2013-06-01

Recent computational studies have shown that speciation can occur under neutral conditions, i.e., when the simulated organisms all have identical fitness. These works bear comparison with mathematical studies of clustering on neutral landscapes in the context of branching and coalescing random walks. Here, we show that sympatric clustering/speciation can occur on a neutral landscape whose dimensions specify only the simulated organisms’ phenotypes. We demonstrate that clustering occurs not only in the case of assortative mating, but also in the case of asexual fission; it is not observed in the control case of random mating. We find that the population size and the number of clusters undergo a second-order non-equilibrium phase transition as the maximum mutation size is varied.

A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program.

PubMed

LaChausse, Robert G

2016-09-01

To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use.

A community-wide campaign to promote physical activity in middle-aged and elderly people: a cluster randomized controlled trial

PubMed Central

2013-01-01

Background We aimed to evaluate the effectiveness of a community-wide campaign (CWC) for promoting physical activity in middle-aged and elderly people. Methods A cluster randomized controlled trial (RCT) with a community as the unit of randomization was performed using a population-based random-sampled evaluation by self-administered questionnaires in the city of Unnan, Shimane Prefecture, Japan. The evaluation sample included 6000 residents aged 40 to 79 years. We randomly allocated nine communities to the intervention group and three to the control group. The intervention was a CWC from 2009 to 2010 to promote physical activity, and it comprised information, education, and support delivery. The primary outcome was a change in engaging in regular aerobic, flexibility, and/or muscle-strengthening activities evaluated at the individual level. Results In total, 4414 residents aged 40–79 years responded to a self-administered questionnaire (73.6% response rate). Awareness of the CWC was 79% in the intervention group. Awareness and knowledge were significantly different between the intervention and control groups, although there were no significant differences in belief and intention. The 1-year CWC did not significantly promote the recommended level of physical activity (adjusted odds ratio: 0.97; 95% confidence interval: 0.84–1.14). Conclusions This cluster RCT showed that the CWC did not promote physical activity in 1 year. Significant differences were observed in awareness and knowledge between intervention and control groups as short-term impacts of the campaign. Trial registration UMIN-CTR UMIN000002683 PMID:23570536

Using Cluster Bootstrapping to Analyze Nested Data With a Few Clusters.

PubMed

Huang, Francis L

2018-04-01

Cluster randomized trials involving participants nested within intact treatment and control groups are commonly performed in various educational, psychological, and biomedical studies. However, recruiting and retaining intact groups present various practical, financial, and logistical challenges to evaluators and often, cluster randomized trials are performed with a low number of clusters (~20 groups). Although multilevel models are often used to analyze nested data, researchers may be concerned of potentially biased results due to having only a few groups under study. Cluster bootstrapping has been suggested as an alternative procedure when analyzing clustered data though it has seen very little use in educational and psychological studies. Using a Monte Carlo simulation that varied the number of clusters, average cluster size, and intraclass correlations, we compared standard errors using cluster bootstrapping with those derived using ordinary least squares regression and multilevel models. Results indicate that cluster bootstrapping, though more computationally demanding, can be used as an alternative procedure for the analysis of clustered data when treatment effects at the group level are of primary interest. Supplementary material showing how to perform cluster bootstrapped regressions using R is also provided.

Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial

PubMed Central

Nava-Aguilera, Elizabeth; Arosteguí, Jorge; Morales-Perez, Arcadio; Suazo-Laguna, Harold; Legorreta-Soberanis, José; Hernandez-Alvarez, Carlos; Fernandez-Salas, Ildefonso; Paredes-Solís, Sergio; Balmaseda, Angel; Cortés-Guzmán, Antonio Juan; Serrano de los Santos, René; Coloma, Josefina; Ledogar, Robert J; Harris, Eva

2015-01-01

Objective To test whether community mobilization adds effectiveness to conventional dengue control. Design Pragmatic open label parallel group cluster randomized controlled trial. Those assessing the outcomes and analyzing the data were blinded to group assignment. Centralized computerized randomization after the baseline study allocated half the sites to intervention, stratified by country, evidence of recent dengue virus infection in children aged 3-9, and vector indices. Setting Random sample of communities in Managua, capital of Nicaragua, and three coastal regions in Guerrero State in the south of Mexico. Participants Residents in a random sample of census enumeration areas across both countries: 75 intervention and 75 control clusters (about 140 households each) were randomized and analyzed (60 clusters in Nicaragua and 90 in Mexico), including 85 182 residents in 18 838 households. Interventions A community mobilization protocol began with community discussion of baseline results. Each intervention cluster adapted the basic intervention—chemical-free prevention of mosquito reproduction—to its own circumstances. All clusters continued the government run dengue control program. Main outcome measures Primary outcomes per protocol were self reported cases of dengue, serological evidence of recent dengue virus infection, and conventional entomological indices (house index: households with larvae or pupae/households examined; container index: containers with larvae or pupae/containers examined; Breteau index: containers with larvae or pupae/households examined; and pupae per person: pupae found/number of residents). Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use. Results With cluster as the unit of analysis, serological evidence from intervention sites showed a lower risk of infection with dengue virus in children (relative risk reduction 29.5%, 95% confidence interval 3.8% to 55.3%), fewer reports of dengue illness (24.7%, 1.8% to 51.2%), fewer houses with larvae or pupae among houses visited (house index) (44.1%, 13.6% to 74.7%), fewer containers with larvae or pupae among containers examined (container index) (36.7%, 24.5% to 44.8%), fewer containers with larvae or pupae among houses visited (Breteau index) (35.1%, 16.7% to 55.5%), and fewer pupae per person (51.7%, 36.2% to 76.1%). The numbers needed to treat were 30 (95% confidence interval 20 to 59) for a lower risk of infection in children, 71 (48 to 143) for fewer reports of dengue illness, 17 (14 to 20) for the house index, 37 (35 to 67) for the container index, 10 (6 to 29) for the Breteau index, and 12 (7 to 31) for fewer pupae per person. Secondary per protocol analysis showed no serological evidence of a protective effect of temephos. Conclusions Evidence based community mobilization can add effectiveness to dengue vector control. Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement. Trial registration ISRCTN27581154 PMID:26156323

Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial.

PubMed

Andersson, Neil; Nava-Aguilera, Elizabeth; Arosteguí, Jorge; Morales-Perez, Arcadio; Suazo-Laguna, Harold; Legorreta-Soberanis, José; Hernandez-Alvarez, Carlos; Fernandez-Salas, Ildefonso; Paredes-Solís, Sergio; Balmaseda, Angel; Cortés-Guzmán, Antonio Juan; Serrano de Los Santos, René; Coloma, Josefina; Ledogar, Robert J; Harris, Eva

2015-07-08

To test whether community mobilization adds effectiveness to conventional dengue control. Pragmatic open label parallel group cluster randomized controlled trial. Those assessing the outcomes and analyzing the data were blinded to group assignment. Centralized computerized randomization after the baseline study allocated half the sites to intervention, stratified by country, evidence of recent dengue virus infection in children aged 3-9, and vector indices. Random sample of communities in Managua, capital of Nicaragua, and three coastal regions in Guerrero State in the south of Mexico. Residents in a random sample of census enumeration areas across both countries: 75 intervention and 75 control clusters (about 140 households each) were randomized and analyzed (60 clusters in Nicaragua and 90 in Mexico), including 85,182 residents in 18,838 households. A community mobilization protocol began with community discussion of baseline results. Each intervention cluster adapted the basic intervention-chemical-free prevention of mosquito reproduction-to its own circumstances. All clusters continued the government run dengue control program. Primary outcomes per protocol were self reported cases of dengue, serological evidence of recent dengue virus infection, and conventional entomological indices (house index: households with larvae or pupae/households examined; container index: containers with larvae or pupae/containers examined; Breteau index: containers with larvae or pupae/households examined; and pupae per person: pupae found/number of residents). Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use. With cluster as the unit of analysis, serological evidence from intervention sites showed a lower risk of infection with dengue virus in children (relative risk reduction 29.5%, 95% confidence interval 3.8% to 55.3%), fewer reports of dengue illness (24.7%, 1.8% to 51.2%), fewer houses with larvae or pupae among houses visited (house index) (44.1%, 13.6% to 74.7%), fewer containers with larvae or pupae among containers examined (container index) (36.7%, 24.5% to 44.8%), fewer containers with larvae or pupae among houses visited (Breteau index) (35.1%, 16.7% to 55.5%), and fewer pupae per person (51.7%, 36.2% to 76.1%). The numbers needed to treat were 30 (95% confidence interval 20 to 59) for a lower risk of infection in children, 71 (48 to 143) for fewer reports of dengue illness, 17 (14 to 20) for the house index, 37 (35 to 67) for the container index, 10 (6 to 29) for the Breteau index, and 12 (7 to 31) for fewer pupae per person. Secondary per protocol analysis showed no serological evidence of a protective effect of temephos. Evidence based community mobilization can add effectiveness to dengue vector control. Each site implementing the intervention in its own way has the advantage of local customization and strong community engagement. ISRCTN27581154. © Andersson et al 2015.

The Impact of Combined Music and Tai Chi on Depressive Symptoms Among Community-Dwelling Older Persons: A Cluster Randomized Controlled Trial.

PubMed

Liao, S J; Tan, M P; Chong, M C; Chua, Y P

2018-05-01

The effectiveness of pharmacological treatment may be limited in older persons. Several studies using Tai Chi or music therapy separately confirmed positive effects in the reduction of depressive symptoms. We conducted a cluster randomized controlled trial to evaluate the possible synergistic effect of combined music and Tai Chi on depressive symptoms. One hundred and seven older adults with mild to moderate depressive symptoms were recruited from Ya'an city. Fifty-five participants were cluster randomized to combined music and Tai Chi group for three months, while the other fifty-two individuals were randomized to the control group that entailed routine health education delivered monthly by community nurses. The primary outcome of depressive symptoms was measured with the Geriatric Depression Scale (GDS) at baseline and monthly for three months. At three-month follow-up, a statistically significant improvement in depressive symptoms was found in the intervention group compared with control group (F(3,315) = 69.661, P < 0.001). Following adjustments for socio-demographic data, the true effect of intervention on depressive symptoms was significant (F = 41.725, P < 0.01, η p 2 = 0.574). Combined music and Tai Chi reduced depressive symptoms among community-dwelling older persons. This represents an economically viable solution to the management of depression in highly populous developing nations.

Effectiveness of an HIV/STD risk-reduction intervention for adolescents when implemented by community-based organizations: a cluster-randomized controlled trial.

PubMed

Jemmott, John B; Jemmott, Loretta S; Fong, Geoffrey T; Morales, Knashawn H

2010-04-01

We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (beta = 0.06; 95% CI = 0.00, 0.12) than did the control group. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established.

Effectiveness of an HIV/STD Risk-Reduction Intervention for Adolescents When Implemented by Community-Based Organizations: A Cluster-Randomized Controlled Trial

PubMed Central

Jemmott, Loretta S.; Fong, Geoffrey T.; Morales, Knashawn H.

2010-01-01

Objectives. We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). Methods. In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Results. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (β = 0.06; 95% CI = 0.00, 0.12) than did the control group. Conclusions. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established. PMID:20167903

Sample size determination for GEE analyses of stepped wedge cluster randomized trials.

PubMed

Li, Fan; Turner, Elizabeth L; Preisser, John S

2018-06-19

In stepped wedge cluster randomized trials, intact clusters of individuals switch from control to intervention from a randomly assigned period onwards. Such trials are becoming increasingly popular in health services research. When a closed cohort is recruited from each cluster for longitudinal follow-up, proper sample size calculation should account for three distinct types of intraclass correlations: the within-period, the inter-period, and the within-individual correlations. Setting the latter two correlation parameters to be equal accommodates cross-sectional designs. We propose sample size procedures for continuous and binary responses within the framework of generalized estimating equations that employ a block exchangeable within-cluster correlation structure defined from the distinct correlation types. For continuous responses, we show that the intraclass correlations affect power only through two eigenvalues of the correlation matrix. We demonstrate that analytical power agrees well with simulated power for as few as eight clusters, when data are analyzed using bias-corrected estimating equations for the correlation parameters concurrently with a bias-corrected sandwich variance estimator. © 2018, The International Biometric Society.

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

PubMed

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial.

PubMed

Hustedt, John; Doum, Dyna; Keo, Vanney; Ly, Sokha; Sam, BunLeng; Chan, Vibol; Alexander, Neal; Bradley, John; Prasetyo, Didot Budi; Rachmat, Agus; Muhammad, Shafique; Lopes, Sergio; Leang, Rithea; Hii, Jeffrey

2017-08-04

Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies), in combination with the use of the larvicide pyriproxyfen (Sumilarv® 2MR), and Communication for Behavioral Impact (COMBI) activities to reduce entomological indices in Cambodia. In this cluster randomized controlled, superiority trial, 30 clusters comprising one or more villages each (with approximately 170 households) will be allocated, in a 1:1:1 ratio, to receive either (1) three interventions (guppies, Sumilarv® 2MR, and COMBI activities), (2) two interventions (guppies and COMBI activities), or (3) control (standard vector control). Households will be invited to participate, and entomology surveys among 40 randomly selected households per cluster will be carried out quarterly. The primary outcome will be the population density of adult female Aedes mosquitoes (i.e., number per house) trapped using adult resting collections. Secondary outcome measures will include the House Index, Container Index, Breteau Index, Pupae Per House, Pupae Per Person, mosquito infection rate, guppy fish coverage, Sumilarv® 2MR coverage, and percentage of respondents with knowledge about Aedes mosquitoes causing dengue. In the primary analysis, adult female Aedes density and mosquito infection rates will be aggregated over follow-up time points to give a single rate per cluster. This will be analyzed by negative binomial regression, yielding density ratios. This trial is expected to provide robust estimates of the intervention effect. A rigorous evaluation of these vector-control interventions is vital to developing an evidence-based dengue control strategy and to help direct government resources. Current Controlled Trials, ID: ISRCTN85307778 . Registered on 25 October 2015.

Effects of a Physical Education-Based Programme on Health-Related Physical Fitness and Its Maintenance in High School Students: A Cluster-Randomized Controlled Trial

ERIC Educational Resources Information Center

Mayorga-Vega, Daniel; Montoro-Escaño, Jorge; Merino-Marban, Rafael; Viciana, Jesús

2016-01-01

The purpose of this study was to examine the effects of a physical education-based development and maintenance programme on objective and perceived health-related physical fitness in high school students. A sample of 111 students aged 12-14 years old from six classes were cluster-randomly assigned to an experimental group (n = 54) or a control…

Promoting the Purchase of Low-Calorie Foods from School Vending Machines: A Cluster-Randomized Controlled Study

ERIC Educational Resources Information Center

Kocken, Paul L.; Eeuwijk, Jennifer; van Kesteren, Nicole M.C.; Dusseldorp, Elise; Buijs, Goof; Bassa-Dafesh, Zeina; Snel, Jeltje

2012-01-01

Background: Vending machines account for food sales and revenue in schools. We examined 3 strategies for promoting the sale of lower-calorie food products from vending machines in high schools in the Netherlands. Methods: A school-based randomized controlled trial was conducted in 13 experimental schools and 15 control schools. Three strategies…

Experiences Recruiting Indian Worksites for an Integrated Health Protection and Health Promotion Randomized Control Trial in Maharashtra, India

ERIC Educational Resources Information Center

Shulman Cordeira, L.; Pednekar, M. S.; Nagler, E. M.; Gautam, J.; Wallace, L.; Stoddard, A. M.; Gupta, P. C.; Sorensen, G. C.

2015-01-01

This article provides an overview of the recruitment strategies utilized in the Mumbai Worksites Tobacco Control Study, a cluster randomized trial testing the effectiveness of an integrated tobacco control and occupational safety and health program in Indian manufacturing worksites. From June 2012 to June 2013, 20 companies were recruited.…

Reducing the Mental Health-Related Stigma of Social Work Students: A Cluster RCT

ERIC Educational Resources Information Center

Rubio-Valera, Maria; Aznar-Lou, Ignacio; Vives-Collet, Mireia; Fernández, Ana; Gil-Girbau, Montserrat; Serrano-Blanco, Antoni

2018-01-01

The aim of this study was to evaluate the impact of a social contact and education intervention to improve attitudes to mental illness in first-year social work students. This was a 3-month cluster randomized controlled trial with two parallel arms: intervention (87) and control group (79). The intervention was a workshop led by an OBERTAMENT…

Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment. PMID:21988774

Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial.

PubMed

Doyle, Conor; Panda, Pradeep; Van de Poel, Ellen; Radermacher, Ralf; Dror, David M

2011-10-11

Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment. © 2011 Doyle et al; licensee BioMed Central Ltd.

Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

ERIC Educational Resources Information Center

Dong, Nianbo; Lipsey, Mark W.

2011-01-01

Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

The Effectiveness of Educational Interventions to Enhance the Adoption of Fee-Based Arsenic Testing in Bangladesh: A Cluster Randomized Controlled Trial

PubMed Central

George, Christine Marie; Inauen, Jennifer; Rahman, Sheikh Masudur; Zheng, Yan

2013-01-01

Arsenic (As) testing could help 22 million people, using drinking water sources that exceed the Bangladesh As standard, to identify safe sources. A cluster randomized controlled trial was conducted to evaluate the effectiveness of household education and local media in the increasing demand for fee-based As testing. Randomly selected households (N = 452) were divided into three interventions implemented by community workers: 1) fee-based As testing with household education (HE); 2) fee-based As testing with household education and a local media campaign (HELM); and 3) fee-based As testing alone (Control). The fee for the As test was US$ 0.28, higher than the cost of the test (US$ 0.16). Of households with untested wells, 93% in both intervention groups HE and HELM purchased an As test, whereas only 53% in the control group. In conclusion, fee-based As testing with household education is effective in the increasing demand for As testing in rural Bangladesh. PMID:23716409

The effectiveness of educational interventions to enhance the adoption of fee-based arsenic testing in Bangladesh: a cluster randomized controlled trial.

PubMed

George, Christine Marie; Inauen, Jennifer; Rahman, Sheikh Masudur; Zheng, Yan

2013-07-01

Arsenic (As) testing could help 22 million people, using drinking water sources that exceed the Bangladesh As standard, to identify safe sources. A cluster randomized controlled trial was conducted to evaluate the effectiveness of household education and local media in the increasing demand for fee-based As testing. Randomly selected households (N = 452) were divided into three interventions implemented by community workers: 1) fee-based As testing with household education (HE); 2) fee-based As testing with household education and a local media campaign (HELM); and 3) fee-based As testing alone (Control). The fee for the As test was US$ 0.28, higher than the cost of the test (US$ 0.16). Of households with untested wells, 93% in both intervention groups HE and HELM purchased an As test, whereas only 53% in the control group. In conclusion, fee-based As testing with household education is effective in the increasing demand for As testing in rural Bangladesh.

Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

PubMed

NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

2017-08-01

Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

Implementation of client versus care-provider strategies to improve external cephalic version rates: a cluster randomized controlled trial.

PubMed

Vlemmix, Floortje; Rosman, Ageeth N; Rijnders, Marlies E; Beuckens, Antje; Opmeer, Brent C; Mol, Ben W J; Kok, Marjolein; Fleuren, Margot A H

2015-05-01

To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. Cluster randomized controlled trial. Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the Netherlands. Singleton breech presentation from 32 weeks of gestation onwards. We randomized clusters to a client strategy (written information leaflets and decision aid), a care-provider strategy (1-day counseling course focused on knowledge and counseling skills), a combined client and care-provider strategy and care-as-usual strategy. We performed an intention-to-treat analysis. Rate of external cephalic version in various strategies. Secondary outcomes were the percentage of women counseled and opting for a version attempt. The overall implementation rate of external cephalic version was 72% (1169 of 1613 eligible clients) with a range between clusters of 8-95%. Neither the client strategy (OR 0.8, 95% CI 0.4-1.5) nor the care-provider strategy (OR 1.2, 95% CI 0.6-2.3) showed significant improvements. Results were comparable when we limited the analysis to those women who were actually offered intervention (OR 0.6, 95% CI 0.3-1.4 and OR 2.0, 95% CI 0.7-4.5). Neither a client nor a care-provider strategy improved the external cephalic version implementation rate for breech presentation, neither with regard to the number of version attempts offered nor the number of women accepting the procedure. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

ERIC Educational Resources Information Center

Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

2012-01-01

This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.

PubMed

Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert

2014-03-01

India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.

The advocacy in action study a cluster randomized controlled trial to reduce pedestrian injuries in deprived communities.

PubMed

Lyons, R A; Towner, E; Christie, N; Kendrick, D; Jones, S J; Hayes, M; Kimberlee, R; Sarvotham, T; Macey, S; Brussoni, M; Sleney, J; Coupland, C; Phillips, C

2008-04-01

Road traffic-related injury is a major global public health problem. In most countries, pedestrian injuries occur predominantly to the poorest in society. A number of evaluated interventions are effective in reducing these injuries. Very little research has been carried out into the distribution and determinants of the uptake of these interventions. Previous research has shown an association between local political influence and the distribution of traffic calming after adjustment for historical crash patterns. This led to the hypothesis that advocacy could be used to increase local politicians knowledge of pedestrian injury risk and effective interventions, ultimately resulting in improved pedestrian safety. To design an intervention to improve the uptake of pedestrian safety measures in deprived communities. Electoral wards in deprived areas of England and Wales with a poor record of pedestrian safety for children and older adults. Design mixedmethods study, incorporating a cluster randomized controlled trial. Data mixture of Geographical Information Systems data collision locations, road safety interventions, telephone interviews, and questionnaires. Randomization 239 electoral wards clustered within 57 local authorities. Participants 615 politicians representing intervention and control wards. Intervention a package of tailored information including maps of pedestrian injuries was designed for intervention politicians, and a general information pack for controls. Primary outcome number of road safety interventions 25 months after randomization. Secondary outcomes politicians interest and involvement in injury prevention cost of interventions. Process evaluation use of advocacy pack, facilitators and barriers to involvement, and success.

Estimating the Standard Error of the Impact Estimator in Individually Randomized Trials with Clustering

ERIC Educational Resources Information Center

Weiss, Michael J.; Lockwood, J. R.; McCaffrey, Daniel F.

2016-01-01

In the "individually randomized group treatment" (IRGT) experimental design, individuals are first randomly assigned to a treatment arm or a control arm, but then within each arm, are grouped together (e.g., within classrooms/schools, through shared case managers, in group therapy sessions, through shared doctors, etc.) to receive…

A Randomized Controlled Trial to Measure Spillover Effects of a Combined Water, Sanitation, and Handwashing Intervention in Rural Bangladesh.

PubMed

Benjamin-Chung, Jade; Amin, Nuhu; Ercumen, Ayse; Arnold, Benjamin F; Hubbard, Alan E; Unicomb, Leanne; Rahman, Mahbubur; Luby, Stephen P; Colford, John M

2018-03-27

Water, sanitation, and handwashing interventions may confer spillover effects on neighbors of intervention recipients by interrupting pathogen transmission. We measured geographically local spillovers in WASH Benefits, a cluster-randomized trial in rural Bangladesh, by comparing outcomes among neighbors of intervention vs. control participants. WASH Benefits randomly allocated geographically-defined clusters to a compound-level intervention (chlorinated drinking water, upgraded sanitation, and handwashing promotion) or control. From January to August 2015, in 180 clusters, we enrolled 1,799 neighboring children age-matched to trial participants that would have been eligible for WASH Benefits had they been conceived slightly earlier or later. After 28 months of intervention, we quantified fecal indicator bacteria in toy rinse and drinking water samples, measured soil-transmitted helminth infections, and recorded caregiver-reported diarrhea and respiratory illness. Neighbors' characteristics were balanced across arms. The prevalence of detectable E. coli in tubewell samples was lower for neighbors of intervention vs. control trial participants (prevalence ratio = 0.83; 0.73, 0.95). There was no difference in fecal indicator bacteria prevalence between arms for other environmental samples. Prevalence was similar in neighbors of intervention vs. control participants for soil-transmitted helminth infection, diarrhea, and respiratory illness. A compound-level water, sanitation, and handwashing intervention reduced neighbors' tubewell water contamination but did not impact neighboring children's health.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

PubMed

Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

A participatory physical and psychosocial intervention for balancing the demands and resources among industrial workers (PIPPI): study protocol of a cluster-randomized controlled trial.

PubMed

Gupta, Nidhi; Wåhlin-Jacobsen, Christian Dyrlund; Henriksen, Louise Nøhr; Abildgaard, Johan Simonsen; Nielsen, Karina; Holtermann, Andreas

2015-03-20

Need for recovery and work ability are strongly associated with high employee turnover, well-being and sickness absence. However, scientific knowledge on effective interventions to improve work ability and decrease need for recovery is scarce. Thus, the present study aims to describe the background, design and protocol of a cluster randomized controlled trial evaluating the effectiveness of an intervention to reduce need for recovery and improve work ability among industrial workers. A two-year cluster randomized controlled design will be utilized, in which controls will also receive the intervention in year two. More than 400 workers from three companies in Denmark will be aimed to be cluster randomized into intervention and control groups with at least 200 workers (at least 9 work teams) in each group. An organizational resources audit and subsequent action planning workshop will be carried out to map the existing resources and act upon initiatives not functioning as intended. Workshops will be conducted to train leaders and health and safety representatives in supporting and facilitating the intervention activities. Group and individual level participatory visual mapping sessions will be carried out allowing team members to discuss current physical and psychosocial work demands and resources, and develop action plans to minimize strain and if possible, optimize the resources. At all levels, the intervention will be integrated into the existing organization of work schedules. An extensive process and effect evaluation on need for recovery and work ability will be carried out via questionnaires, observations, interviews and organizational data assessed at several time points throughout the intervention period. This study primarily aims to develop, implement and evaluate an intervention based on the abovementioned features which may improve the work environment, available resources and health of industrial workers, and hence their need for recovery and work ability.

Effects of a Worksite Tobacco Control Intervention in India: The Mumbai Worksite Tobacco Control Study, a Cluster Randomized Trial

PubMed Central

Sorensen, Glorian; Pednekar, Mangesh; Cordeira, Laura Shulman; Pawar, Pratibha; Nagler, Eve; Stoddard, Anne M.; Kim, Hae-Young; Gupta, Prakash C.

2016-01-01

Objectives We assessed a worksite intervention designed to promote tobacco control among manufacturing workers in Greater Mumbai, India. Methods We used a cluster-randomized design to test an integrated health promotion/health protection intervention, which addressed changes at the management and worker levels. Between July 2012 and July 2013, we recruited 20 worksites on a rolling basis and randomly assigned them to intervention or delayed-intervention control conditions. The follow-up survey was conducted between December 2013 and November 2014. Results The difference in 30-day quit rates between intervention and control conditions was statistically significant for production workers (OR=2.25, P=0.03), although not for the overall sample (OR=1.70; P=0.12). The intervention resulted in a doubling of the 6-month cessation rates among workers in the intervention worksites compared to those in the control, for production workers (OR=2.29; P=0.07) and for the overall sample (OR=1.81; P=0.13), but the difference did not reach statistical significance. Conclusions These findings demonstrate the potential impact of a tobacco control intervention that combined tobacco control and health protection programming within Indian manufacturing worksites. PMID:26883793

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

PubMed

Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

2016-01-01

Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

Within-Cluster and Across-Cluster Matching with Observational Multilevel Data

ERIC Educational Resources Information Center

Kim, Jee-Seon; Steiner, Peter M.; Hall, Courtney; Thoemmes, Felix

2013-01-01

When randomized experiments cannot be conducted in practice, propensity score (PS) techniques for matching treated and control units are frequently used for estimating causal treatment effects from observational data. Despite the popularity of PS techniques, they are not yet well studied for matching multilevel data where selection into treatment…

Headache cessation by an educational intervention in grammar schools: a cluster randomized trial.

PubMed

Albers, L; Heinen, F; Landgraf, M; Straube, A; Blum, B; Filippopulos, F; Lehmann, S; Mansmann, U; Berger, U; Akboga, Y; von Kries, R

2015-02-01

Headache is a common health problem in adolescents. There are a number of risk factors for headache in adolescents that are amenable to intervention. The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors. In all, 1674 students in 8th-10th grade at 12 grammar schools in greater Munich, Germany, were cluster randomized into intervention and control groups. A standardized 60-min prevention lesson focusing on preventable risk factors for headache (physical inactivity, coffee consumption, alcohol consumption and smoking) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting. Seven months later, students were reassessed. The main outcome parameter was headache cessation. Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated. Nine hundred students (intervention group N = 450, control group N = 450) with headache at baseline and complete data for headache and confounders were included in the analysis. Headache cessation was observed in 9.78% of the control group compared with 16.22% in the intervention group (number needed to treat = 16). Accounting for cluster effects and confounders, the probability of headache cessation in the intervention group was 1.77 (95% confidence interval = [1.08; 2.90]) higher than in the control group. The effect was most pronounced in adolescents with tension-type headache: odds ratio = 2.11 (95% confidence interval = [1.15; 3.80]). Our study demonstrates the effectiveness of a one-time, classroom-based headache prevention programme. © 2014 EAN.

Effects of physical activity on schoolchildren's academic performance: The Active Smarter Kids (ASK) cluster-randomized controlled trial.

PubMed

Resaland, Geir K; Aadland, Eivind; Moe, Vegard Fusche; Aadland, Katrine N; Skrede, Turid; Stavnsbo, Mette; Suominen, Laura; Steene-Johannessen, Jostein; Glosvik, Øyvind; Andersen, John R; Kvalheim, Olav M; Engelsrud, Gunn; Andersen, Lars B; Holme, Ingar M; Ommundsen, Yngvar; Kriemler, Susi; van Mechelen, Willem; McKay, Heather A; Ekelund, Ulf; Anderssen, Sigmund A

2016-10-01

To investigate the effect of a seven-month, school-based cluster-randomized controlled trial on academic performance in 10-year-old children. In total, 1129 fifth-grade children from 57 elementary schools in Sogn og Fjordane County, Norway, were cluster-randomized by school either to the intervention group or to the control group. The children in the 28 intervention schools participated in a physical activity intervention between November 2014 and June 2015 consisting of three components: 1) 90min/week of physically active educational lessons mainly carried out in the school playground; 2) 5min/day of physical activity breaks during classroom lessons; 3) 10min/day physical activity homework. Academic performance in numeracy, reading and English was measured using standardized Norwegian national tests. Physical activity was measured objectively by accelerometry. We found no effect of the intervention on academic performance in primary analyses (standardized difference 0.01-0.06, p>0.358). Subgroup analyses, however, revealed a favorable intervention effect for those who performed the poorest at baseline (lowest tertile) for numeracy (p=0.005 for the subgroup∗group interaction), compared to controls (standardized difference 0.62, 95% CI 0.19-1.07). This large, rigorously conducted cluster RCT in 10-year-old children supports the notion that there is still inadequate evidence to conclude that increased physical activity in school enhances academic achievement in all children. Still, combining physical activity and learning seems a viable model to stimulate learning in those academically weakest schoolchildren. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Interrupted time-series analysis yielded an effect estimate concordant with the cluster-randomized controlled trial result.

PubMed

Fretheim, Atle; Soumerai, Stephen B; Zhang, Fang; Oxman, Andrew D; Ross-Degnan, Dennis

2013-08-01

We reanalyzed the data from a cluster-randomized controlled trial (C-RCT) of a quality improvement intervention for prescribing antihypertensive medication. Our objective was to estimate the effectiveness of the intervention using both interrupted time-series (ITS) and RCT methods, and to compare the findings. We first conducted an ITS analysis using data only from the intervention arm of the trial because our main objective was to compare the findings from an ITS analysis with the findings from the C-RCT. We used segmented regression methods to estimate changes in level or slope coincident with the intervention, controlling for baseline trend. We analyzed the C-RCT data using generalized estimating equations. Last, we estimated the intervention effect by including data from both study groups and by conducting a controlled ITS analysis of the difference between the slope and level changes in the intervention and control groups. The estimates of absolute change resulting from the intervention were ITS analysis, 11.5% (95% confidence interval [CI]: 9.5, 13.5); C-RCT, 9.0% (95% CI: 4.9, 13.1); and the controlled ITS analysis, 14.0% (95% CI: 8.6, 19.4). ITS analysis can provide an effect estimate that is concordant with the results of a cluster-randomized trial. A broader range of comparisons from other RCTs would help to determine whether these are generalizable results. Copyright © 2013 Elsevier Inc. All rights reserved.

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

PubMed Central

Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

2009-01-01

Abstract Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of – and responsibility for – group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test. PMID:19876544

A stepped wedge cluster randomized control trial of dried blood spot testing to improve the uptake of hepatitis C antibody testing within UK prisons

PubMed Central

Whitaker, Rhiannon; Perrett, Stephanie; Zou, Lu; Hickman, Matthew; Lyons, Marion

2015-01-01

Background: The prevalence of hepatitis C (HCV) is elevated within prison populations, yet diagnosis in prisons remains low. Dried blood spot testing (DBST) is a simple procedure for the detection of HCV antibodies; its impact on testing in the prison context is unknown. Methods: We carried out a stepped-wedge cluster-randomized control trial of DBST for HCV among prisoners within five male prisons and one female prison. Each prison was a separate cluster. The order in which the intervention (training in use of DBST for HCV testing and logistic support) was introduced was randomized across clusters. The outcome measure was the HCV testing rate by prison. Imputation analysis was carried out to account for missing data. Planned and actual intervention times differed in some prisons; data were thus analysed by intention to treat (ITT) and by observed step times. Results: There was insufficient evidence of an effect of the intervention on testing rate using either the ITT intervention time (OR: 0.84; 95% CI: 0.68–1.03; P = 0.088) or using the actual intervention time (OR: 0.86; 95% CI: 0.71–1.06; P = 0.153). This was confirmed by the pooled results of five imputed data sets. Conclusions: DBST as a stand-alone intervention was insufficient to increase HCV diagnosis within the UK prison setting. Factors such as staff training and allocation of staff time for regular clinics are key to improving service delivery. We demonstrate that prisons can conduct rigorous studies of new interventions, but data collection can be problematic. Trial registration: International Standard Randomized Controlled Trial Number Register (ISRCTN number ISRCTN05628482). PMID:25061233

Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project).

PubMed

González-González, Ana Isabel; Orrego, Carola; Perestelo-Perez, Lilisbeth; Bermejo-Caja, Carlos Jesús; Mora, Nuria; Koatz, Débora; Ballester, Marta; Del Pino, Tasmania; Pérez-Ramos, Jeannet; Toledo-Chavarri, Ana; Robles, Noemí; Pérez-Rivas, Francisco Javier; Ramírez-Puerta, Ana Belén; Canellas-Criado, Yolanda; Del Rey-Granado, Yolanda; Muñoz-Balsa, Marcos José; Becerril-Rojas, Beatriz; Rodríguez-Morales, David; Sánchez-Perruca, Luis; Vázquez, José Ramón; Aguirre, Armando

2017-10-30

Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases. This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice. This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases. ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016.

Exploring the transparency mechanism and evaluating the effect of public reporting on prescription: a protocol for a cluster randomized controlled trial.

PubMed

Du, Xin; Wang, Dan; Wang, Xuan; Yang, Shiru; Zhang, Xinping

2015-03-21

The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field. However, little research has been conducted on the transparency mechanism, and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement. The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants. This study involves a cluster randomized controlled trial conducted in 20 primary-care facilities (clusters). Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial. The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score. As the unit of randomization, each pair of facilities is assigned at random to a control or an intervention group through coin flipping. Prescribed ranking information is publicly reported in the intervention group. The public materials include the posters of individuals and of facilities, the ranking lists of general practitioners, and brochures of patients, which are updated monthly. The intervention began on 13th November 2013 and lasted for one year. Specifically, participants are surveyed at five points in time (baseline, quarterly following the intervention) through questionnaires, interviews, and observations. These participants include an average of 600 patients, 300 general practitioners, 15 directors, and 6 health bureau administrators. The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe. Subsequently, the modifications in the transparency mechanism constructs are evaluated. The outcomes are measured at the individual participant level, and the professional who analyzes the data is blind to the randomization status. This study protocol outlines a design that aims to examine the transparency mechanism and to evaluate the effect of public reporting on prescription. The research design is significant in the field of public policy. Furthermore, this study intends to fill the gap of the investigation of the transparency mechanism and the evaluation of public reporting on prescription.

A Cluster Randomized Controlled Trial of the MyFamilyPlan Online Preconception Health Education Tool.

PubMed

Batra, Priya; Mangione, Carol M; Cheng, Eric; Steers, W Neil; Nguyen, Tina A; Bell, Douglas; Kuo, Alice A; Gregory, Kimberly D

2018-05-01

To evaluate whether exposure to MyFamilyPlan-a web-based preconception health education module-changes the proportion of women discussing reproductive health with providers at well-woman visits. Cluster randomized controlled trial. One hundred thirty participants per arm distributed among 34 clusters (physicians) required to detect a 20% change in the primary outcome. Urban academic medical center (California). Eligible women were 18 to 45 years old, were English speaking, were nonpregnant, were able to access the Internet, and had an upcoming well-woman visit. E-mail and phone recruitment between September 2015 and May 2016; 292 enrollees randomized. Intervention participants completed the MyFamilyPlan module online 7 to 10 days before a scheduled well-woman visit; control participants reviewed standard online preconception health education materials. The primary outcome was self-reported discussion of reproductive health with the physician at the well-woman visit. Self-reported secondary outcomes were folic acid use, contraceptive method initiation/change, and self-efficacy score. Multilevel multivariate logistic regression. After adjusting for covariates and cluster, exposure to MyFamilyPlan was the only variable significantly associated with an increase in the proportion of women discussing reproductive health with providers (odds ratio: 1.97, 95% confidence interval: 1.22-3.19). Prespecified secondary outcomes were unaffected. MyFamilyPlan exposure was associated with a significant increase in the proportion of women who reported discussing reproductive health with providers and may promote preconception health awareness; more work is needed to affect associated behaviors.

A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: study design, implementation, and baseline cohort characteristics.

PubMed

Koethe, John R; Westfall, Andrew O; Luhanga, Dora K; Clark, Gina M; Goldman, Jason D; Mulenga, Priscilla L; Cantrell, Ronald A; Chi, Benjamin H; Zulu, Isaac; Saag, Michael S; Stringer, Jeffrey S A

2010-03-12

The benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree). Dedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months. From December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites. A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings. Clinicaltrials.gov NCT00929604.

Structuring Communication Relationships for Interprofessional Teamwork (SCRIPT): a cluster randomized controlled trial.

PubMed

Zwarenstein, Merrick; Reeves, Scott; Russell, Ann; Kenaszchuk, Chris; Conn, Lesley Gotlib; Miller, Karen-Lee; Lingard, Lorelei; Thorpe, Kevin E

2007-09-18

Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT) to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs) in general internal medicine (GIM) divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS); adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Pre-intervention qualitative analysis revealed that a substantial amount of interprofessional interaction lacks key core elements of collaborative communication such as self-introduction, description of professional role, and solicitation of other professional perspectives. Incorporating these findings, a four-component intervention was designed with a goal of creating a culture of communication in which the fundamentals of collaboration become a routine part of interprofessional interactions during unstructured work periods on GIM wards. Registered with National Institutes of Health as NCT00466297.

Impact of Text Message Reminders on Caregivers’ Adherence to a Home Fortification Program Against Child Anemia in Rural Western China: A Cluster-Randomized Controlled Trial

PubMed Central

Zhou, Huan; Sun, Shuai; Sylvia, Sean; Yue, Ai; Shi, Yaojiang; Zhang, Linxiu; Medina, Alexis; Rozelle, Scott

2016-01-01

Objectives. To test whether text message reminders sent to caregivers improve the effectiveness of a home micronutrient fortification program in western China. Methods. We carried out a cluster-randomized controlled trial in 351 villages (clusters) in Shaanxi Province in 2013 and 2014, enrolling children aged 6 to 12 months. We randomly assigned each village to 1 of 3 groups: free delivery group, text messaging group, or control group. We collected information on compliance with treatments and hemoglobin concentrations from all children at baseline and 6-month follow-up. We estimated the intent-to-treat effects on compliance and child anemia using a logistic regression model. Results. There were 1393 eligible children. We found that assignment to the text messaging group led to an increase in full compliance (marginal effect = 0.10; 95% confidence interval [CI] = 0.03, 0.16) compared with the free delivery group and decrease in the rate of anemia at end line relative to the control group (marginal effect = −0.07; 95% CI = −0.12, −0.01), but not relative to the free delivery group (marginal effect = −0.03; 95% CI = −0.09, 0.03). Conclusions. Text messages improved compliance of caregivers to a home fortification program and children’s nutrition. PMID:27077354

Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

ERIC Educational Resources Information Center

Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

2016-01-01

Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial.

PubMed

Roets-Merken, Lieve M; Graff, Maud J L; Zuidema, Sytse U; Hermsen, Pieter G J M; Teerenstra, Steven; Kempen, Gertrudis I J M; Vernooij-Dassen, Myrra J F J

2013-10-07

Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age. In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis. The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program's potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an extensive process evaluation will take place which will offer insight in the quality and feasibility of the sampling and intervention process. If it is shown to be effective and feasible, this Self-Management Program could be widely disseminated. ClinicalTrials.gov, NCT01217502.

Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age. Methods/Design In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis. Discussion The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program’s potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an extensive process evaluation will take place which will offer insight in the quality and feasibility of the sampling and intervention process. If it is shown to be effective and feasible, this Self-Management Program could be widely disseminated. Clinical trials registration ClinicalTrials.gov, NCT01217502. PMID:24099315

Efficacy, Safety and Cost of Insecticide Treated Wall Lining, Insecticide Treated Bed Nets and Indoor Wall Wash with Lime for Visceral Leishmaniasis Vector Control in the Indian Sub-continent: A Multi-country Cluster Randomized Controlled Trial

PubMed Central

Das, Pradeep; Ghosh, Debashis; Priyanka, Jyoti; Matlashewski, Greg; Kroeger, Axel; Upfill-Brown, Alexander

2016-01-01

Background We investigated the efficacy, safety and cost of lime wash of household walls plus treatment of sand fly breeding places with bleach (i.e. environmental management or EM), insecticide impregnated durable wall lining (DWL), and bed net impregnation with slow release insecticide (ITN) for sand fly control in the Indian sub-continent. Methods This multi-country cluster randomized controlled trial had 24 clusters in each three sites with eight clusters per high, medium or low sand fly density stratum. Every cluster included 45–50 households. Five households from each cluster were randomly selected for entomological measurements including sand fly density and mortality at one, three, nine and twelve months post intervention. Household interviews were conducted for socioeconomic information and intervention acceptability assessment. Cost for each intervention was calculated. There was a control group without intervention. Findings Sand fly mortality [mean and 95%CI] ranged from 84% (81%-87%) at one month to 74% (71%-78%) at 12 months for DWL, 75% (71%-79%) at one month to 49% (43%-55%) at twelve months for ITN, and 44% (34%-53%) at one month to 22% (14%-29%) at twelve months for EM. Adjusted intervention effect on sand fly density measured by incidence rate ratio ranged from 0.28 (0.23–0.34) at one month to 0.62 (0.51–0.75) at 12 months for DWL; 0.72 (0.62–0.85) at one month to 1.02 (0.86–1.22) at 12 months for ITN; and 0.89 (0.76–1.03) at one months to 1.49 (1.26–1.74) at 12 months for EM. Household acceptance of EM was 74% compared to 94% for both DWL and ITN. Operational cost per household in USD was about 5, 8, and 2 for EM, DWL and ITN, respectively. Minimal adverse reactions were reported for EM and ITN while 36% of households with DWL reported transient itching. Interpretation DWL is the most effective, durable and acceptable control method followed by ITN. The Visceral Leishmaniasis (VL) Elimination Program in the Indian sub-continent should consider DWL and ITN for sand fly control in addition to IRS. PMID:27533097

Daily use of Sprinkles micronutrient powder for 2 months reduces anemia among children 6 to 36 months of age in the Kyrgyz Republic: a cluster-randomized trial.

PubMed

Lundeen, Elizabeth; Schueth, Tobias; Toktobaev, Nurjan; Zlotkin, Stanley; Hyder, S M Ziauddin; Houser, Robert

2010-09-01

Iron-deficiency anemia is widespread among young children in the Kyrgyz Republic, and there is an urgent need to identify an effective intervention to address this significant public health problem. To test the effectiveness of a 2-month intervention with daily home fortification of complementary food using micronutrient powder (Sprinkles) in reducing anemia among children 6 to 36 months of age in the Kyrgyz Republic. In this cluster-randomized, community-based effectiveness trial conducted in three regions of the Kyrgyz Republic, 24 clusters of children aged 6 to 36 months were randomly assigned to two groups. The intervention group (12 clusters, n = 1,103) received 60 sachets of micronutrient powder (12.5 mg elemental iron), which were taken as one sachet daily for 2 months. The control group (12 clusters, n = 1,090) did not receive micronutrient powder until after the study period. Blood hemoglobin concentration was assessed at the start and end of the intervention. From baseline to follow-up, the mean hemoglobin concentration in the intervention group increased by 7 g/L, whereas it decreased by 2 g/L in the control group (p < .001). The prevalence of anemia (hemoglobin < 110 g/L) in the intervention group decreased from 72% at baseline to 52% at follow-up, whereas it increased from 72% to 75% in the control group (p < .001). Compliance with the intervention was high, with children consuming on average 45 of the 60 sachets given. A course of 60 Sprinkles micronutrient powder sachets taken daily for 2 months is effective in improving hemoglobin levels and reducing the prevalence of anemia among young children in the Kyrgyz Republic.

A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

PubMed Central

2011-01-01

Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD) program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI) strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED) strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service), have been allocated randomly to either the intervention group (CI strategy) or the control group (ED strategy). The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285 PMID:21450063

Sun protection at elementary schools: a cluster randomized trial.

PubMed

Hunter, Seft; Love-Jackson, Kymia; Abdulla, Rania; Zhu, Weiwei; Lee, Ji-Hyun; Wells, Kristen J; Roetzheim, Richard

2010-04-07

Elementary schools represent both a source of childhood sun exposure and a setting for educational interventions. Sun Protection of Florida's Children was a cluster randomized trial promoting hat use at (primary outcome) and outside of schools among fourth-grade students during August 8, 2006, through May 22, 2007. Twenty-two schools were randomly assigned to the intervention (1115 students) or control group (1376 students). Intervention schools received classroom sessions targeting sun protection attitudes and social norms. Each student attending an intervention school received two free wide-brimmed hats. Hat use at school was measured by direct observation and hat use outside of school was measured by self-report. A subgroup of 378 students (178 in the intervention group and 200 in the control group) underwent serial measurements of skin pigmentation to explore potential physiological effects of the intervention. Generalized linear mixed models were used to evaluate the intervention effect by accounting for the cluster randomized trial design. All P values were two-sided and were claimed as statistically significant at a level of .05. The percentage of students observed wearing hats at control schools remained essentially unchanged during the school year (baseline = 2%, fall = 0%, and spring = 1%) but increased statistically significantly at intervention schools (baseline = 2%, fall = 30%, and spring = 41%) (P < .001 for intervention effect comparing the change in rate of hat use over time at intervention vs control schools). Self-reported use of hats outside of school did not change statistically significantly during the study (control: baseline = 14%, fall = 14%, and spring = 11%; intervention: baseline = 24%, fall = 24%, and spring = 23%) nor did measures of skin pigmentation. The intervention increased use of hats among fourth-grade students at school but had no effect on self-reported wide-brimmed hat use outside of school or on measures of skin pigmentation.

Intravenous levetiracetam vs phenytoin for status epilepticus and cluster seizures: A prospective, randomized study.

PubMed

Gujjar, Arunodaya R; Nandhagopal, Ramachandiran; Jacob, Poovathoor C; Al-Hashim, Abdulhakeem; Al-Amrani, Khalfan; Ganguly, Shyam S; Al-Asmi, Abdullah

2017-07-01

Status Epilepticus (SE) is a common medical emergency carrying a high morbidity and mortality. Levetiracetam (LEV) is a novel anticonvulsant effective against varied seizures. Few prospective studies have addressed its use in SE. We aimed to examine the efficacy of intravenous LEV in controlling SE and cluster attacks of seizures (CS), in comparison with IV phenytoin (DPH), using a prospective, randomized study design. Adult patients with SE or CS, following an initial dose of IV benzodiazepine to control ongoing seizure, were randomized to receive either medication. Rates of seizure control over 24h, adverse effects and outcomes were compared. A logistic regression model was used to identify outcome predictors. 52 patients with SE and 63 with CS received either LEV or DPH. In the SE group, LEV was effective in18/22(82%) and DPH in 22/30(73.3%) patients in controlling seizures. Among patients with CS, LEV was effective in 31/38(81.6%) and DPH in 20/25(80%). With the use of LEV, DPH or both, SE and CS were controlled among 92% and 96% of patients respectively. Adverse events included hypotension (in 2 on DPH) and transient agitation (2 on LEV). IV Levetiracetam controls status epilepticus or cluster seizures with an efficacy comparable to that of phenytoin. Use of these two agents consecutively may control >90% of all such conditions without resort to anaesthetic agents. Further studies should explore its efficacy in larger cohorts of epileptic emergencies. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Learning Historical Thinking with Oral History Interviews: A Cluster Randomized Controlled Intervention Study of Oral History Interviews in History Lessons

ERIC Educational Resources Information Center

Bertram, Christiane; Wagner, Wolfgang; Trautwein, Ulrich

2017-01-01

The present study examined the effectiveness of the oral history approach with respect to students' historical competence. A total of 35 ninth-grade classes (N = 900) in Germany were randomly assigned to one of four conditions--live, video, text, or a (nontreated) control group--in a pretest, posttest, and follow-up design. Comparing the three…

An Evaluation of the Implementation of Hand Held Health Records with Adults with Learning Disabilities: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Turk, Vicky; Burchell, Sarah; Burrha, Sukhjinder; Corney, Roslyn; Elliott, Sandra; Kerry, Sally; Molloy, Catherine; Painter, Kerry

2010-01-01

Background: Personal health records were implemented with adults with learning disabilities (AWLD) to try to improve their health-care. Materials and Method: Forty GP practices were randomized to the Personal Health Profile (PHP) implementation or control group. Two hundred and one AWLD were interviewed at baseline and 163 followed up after 12…

Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees.

PubMed

Stedman-Smith, Maggie; DuBois, Cathy L Z; Grey, Scott F; Kingsbury, Diana M; Shakya, Sunita; Scofield, Jennifer; Slenkovich, Ken

2015-04-01

To determine the effectiveness of an office-based multimodal hand hygiene improvement intervention in reducing self-reported communicable infections and work-related absence. A randomized cluster trial including an electronic training video, hand sanitizer, and educational posters (n = 131, intervention; n = 193, control). Primary outcomes include (1) self-reported acute respiratory infections (ARIs)/influenza-like illness (ILI) and/or gastrointestinal (GI) infections during the prior 30 days; and (2) related lost work days. Incidence rate ratios calculated using generalized linear mixed models with a Poisson distribution, adjusted for confounders and random cluster effects. A 31% relative reduction in self-reported combined ARI-ILI/GI infections (incidence rate ratio: 0.69; 95% confidence interval, 0.49 to 0.98). A 21% nonsignificant relative reduction in lost work days. An office-based multimodal hand hygiene improvement intervention demonstrated a substantive reduction in self-reported combined ARI-ILI/GI infections.

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

A longitudinal cluster-randomized controlled study on the accumulating effects of individualized literacy instruction on students' reading from first through third grade.

PubMed

Connor, Carol McDonald; Morrison, Frederick J; Fishman, Barry; Crowe, Elizabeth C; Al Otaiba, Stephanie; Schatschneider, Christopher

2013-08-01

Using a longitudinal cluster-randomized controlled design, we examined whether students' reading outcomes differed when they received 1, 2, or 3 years of individualized reading instruction from first through third grade, compared with a treated control group. More than 45% of students came from families living in poverty. Following students, we randomly assigned their teachers each year to deliver individualized reading instruction or a treated control condition intervention focused on mathematics. Students who received individualized reading instruction in all three grades showed the strongest reading skills by the end of third grade compared with those who received fewer years of such instruction. There was inconsistent evidence supporting a sustained first-grade treatment effect: Individualized instruction in first grade was necessary but not sufficient for stronger third-grade reading outcomes. These effects were achieved by regular classroom teachers who received professional development, which indicates that policies that support the use of evidence-based reading instruction and teacher training can yield increased student achievement.

The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial.

PubMed

Spence, Jessica; Belley-Côté, Emilie; Lee, Shun Fu; Bangdiwala, Shrikant; Whitlock, Richard; LeManach, Yannick; Syed, Summer; Lamy, Andre; Jacobsohn, Eric; MacIsaac, Sarah; Devereaux, P J; Connolly, Stuart

2018-07-01

Increasingly, clinicians and researchers recognize that studies of interventions need to evaluate not only their therapeutic efficacy (i.e., the effect on an outcome in ideal, controlled settings) but also their real-world effectiveness in broad, unselected patient groups. Effectiveness trials inform clinical practice by comparing variations in therapeutic approaches that fall within the standard of care. In this article, we discuss the need for studies of comparative effectiveness in anesthesia and the limitations of individual patient randomized-controlled trials in determining comparative effectiveness. We introduce the concept of randomized cluster crossover trials as a means of answering questions of comparative effectiveness in anesthesia, using the design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial (Clinicaltrials.gov identifier NCT03053869).

The effects of office ergonomic training on musculoskeletal complaints, sickness absence, and psychological well-being: a cluster randomized control trial.

PubMed

Mahmud, Norashikin; Kenny, Dianna T; Md Zein, Raemy; Hassan, Siti Nurani

2015-03-01

This study explored whether musculoskeletal complaints can be reduced by the provision of ergonomics education. A cluster randomized controlled trial study was conducted in which 3 units were randomized to intervention and received training and 3 units were given a leaflet. The effect of intervention on knowledge, workstation practices, musculoskeletal complaints, sickness absence, and psychological well-being were assessed at 6 and 12 months. Although there was no increment of knowledge among workers, significant improvements in workstation practices in the use of monitor, keyboard, and chair were observed. There were significant reductions in neck and upper and lower back complaints among workers but these did not translate into fewer days lost from work. Workers' stress was found to be significantly reduced across the studies. In conclusion, office ergonomics training can be beneficial in reducing musculoskeletal risks and stress among workers. © 2011 APJPH.

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

PubMed Central

Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

2017-01-01

Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014–2015 school year. The study’s rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area. PMID:28936104

Effects of community health interventions on under-5 mortality in rural Guinea-Bissau (EPICS): a cluster-randomised controlled trial.

PubMed

Boone, Peter; Elbourne, Diana; Fazzio, Ila; Fernandes, Samory; Frost, Chris; Jayanty, Chitra; King, Rebecca; Mann, Vera; Piaggio, Gilda; dos Santos, Albino; Walker, Polly R

2016-05-01

Evidence suggests that community-based interventions that promote improved home-based practices and care-seeking behaviour can have a large impact on maternal and child mortality in regions where rates are high. We aimed to assess whether an intervention package based on the WHO Integrated Management of Childhood Illness handbook and community mobilisation could reduce under-5 mortality in rural Guinea-Bissau, where the health service infrastructure is weak. We did a non-masked cluster-randomised controlled trial (EPICS) in the districts of Tombali and Quinara in Guinea-Bissau. Clusters of rural villages were stratified by ethnicity and distance from a regional health centre, and randomly assigned (1:1) to intervention or control using a computerised random number generator. Women were eligible if they lived in one of the clusters at baseline survey prior to randomisation and if they were aged 15-49 years or were primary caregivers of children younger than 5 years. Their children were eligible if they were younger than 5 years or were liveborn after intervention services could be implemented on July 1, 2008. In villages receiving the intervention, community health clubs were established, community health workers were trained in case management, and traditional birth attendants were trained to care for pregnant women and newborn babies, and promote facility-based delivery. Registered nurses supervised community health workers and offered mobile clinic services. Health centres were not improved. The control group received usual services. The primary outcome was the proportion of children dying under age 5 years, and was analysed in all eligible children up to final visits to villages between Jan 1 and March 31, 2011. This trial is registered with ISRCTN, number ISRCTN52433336. On Aug 30, 2007, we randomly assigned 146 clusters to intervention (73 clusters, 5669 women, and 4573 children) or control (73 clusters, 5840 women, and 4675 children). From randomisation until the end of the trial (last visit by June 30, 2011), the intervention clusters had 3093 livebirths and the control clusters had 3194. 6729 children in the intervention group and 6894 in the control group aged 0-5 years on July 1, 2008, or liveborn subsequently were analysed for mortality outcomes. 311 (4·6%) of 6729 children younger than 5 years died in the intervention group compared with 273 (4·0%) of 6894 in the control group (relative risk 1·16 [95% CI 0·99-1·37]). Our package of community-based interventions did not reduce under-5 mortality in rural Guinea-Bissau. The short timeframe and other trial limitations might have affected our results. Community-based health promotion and basic first-line services in fragile contexts with weak secondary health service infrastructure might be insufficient to reduce child deaths. Effective Intervention. Copyright © 2016 Boone et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd.. All rights reserved.

Designing and evaluating health systems level hypertension control interventions for African-Americans: lessons from a pooled analysis of three cluster randomized trials.

PubMed

Pavlik, Valory N; Chan, Wenyaw; Hyman, David J; Feldman, Penny; Ogedegbe, Gbenga; Schwartz, Joseph E; McDonald, Margaret; Einhorn, Paula; Tobin, Jonathan N

2015-01-01

African-Americans (AAs) have a high prevalence of hypertension and their blood pressure (BP) control on treatment still lags behind other groups. In 2004, NHLBI funded five projects that aimed to evaluate clinically feasible interventions to effect changes in medical care delivery leading to an increased proportion of AA patients with controlled BP. Three of the groups performed a pooled analysis of trial results to determine: 1) the magnitude of the combined intervention effect; and 2) how the pooled results could inform the methodology for future health-system level BP interventions. Using a cluster randomized design, the trials enrolled AAs with uncontrolled hypertension to test interventions targeting a combination of patient and clinician behaviors. The 12-month Systolic BP (SBP) and Diastolic BP (DBP) effects of intervention or control cluster assignment were assessed using mixed effects longitudinal regression modeling. 2,015 patients representing 352 clusters participated across the three trials. Pooled BP slopes followed a quadratic pattern, with an initial decline, followed by a rise toward baseline, and did not differ significantly between intervention and control clusters: SBP linear coefficient = -2.60±0.21 mmHg per month, p<0.001; quadratic coefficient = 0.167± 0.02 mmHg/month, p<0.001; group by time interaction group by time group x linear time coefficient=0.145 ± 0.293, p=0.622; group x quadratic time coefficient= -0.017 ± 0.026, p=0.525). RESULTS were similar for DBP. The individual sites did not have significant intervention effects when analyzed separately. Investigators planning behavioral trials to improve BP control in health systems serving AAs should plan for small effect sizes and employ a "run-in" period in which BP can be expected to improve in both experimental and control clusters.

Serological Markers of Sand Fly Exposure to Evaluate Insecticidal Nets against Visceral Leishmaniasis in India and Nepal: A Cluster-Randomized Trial

PubMed Central

Gidwani, Kamlesh; Picado, Albert; Rijal, Suman; Singh, Shri Prakash; Roy, Lalita; Volfova, Vera; Andersen, Elisabeth Wreford; Uranw, Surendra; Ostyn, Bart; Sudarshan, Medhavi; Chakravarty, Jaya; Volf, Petr; Sundar, Shyam; Boelaert, Marleen; Rogers, Matthew Edward

2011-01-01

Background Visceral leishmaniasis is the world' second largest vector-borne parasitic killer and a neglected tropical disease, prevalent in poor communities. Long-lasting insecticidal nets (LNs) are a low cost proven vector intervention method for malaria control; however, their effectiveness against visceral leishmaniasis (VL) is unknown. This study quantified the effect of LNs on exposure to the sand fly vector of VL in India and Nepal during a two year community intervention trial. Methods As part of a paired-cluster randomized controlled clinical trial in VL-endemic regions of India and Nepal we tested the effect of LNs on sand fly biting by measuring the antibody response of subjects to the saliva of Leishmania donovani vector Phlebotomus argentipes and the sympatric (non-vector) Phlebotomus papatasi. Fifteen to 20 individuals above 15 years of age from 26 VL endemic clusters were asked to provide a blood sample at baseline, 12 and 24 months post-intervention. Results A total of 305 individuals were included in the study, 68 participants provided two blood samples and 237 gave three samples. A random effect linear regression model showed that cluster-wide distribution of LNs reduced exposure to P. argentipes by 12% at 12 months (effect 0.88; 95% CI 0.83–0.94) and 9% at 24 months (effect 0.91; 95% CI 0.80–1.02) in the intervention group compared to control adjusting for baseline values and pair. Similar results were obtained for P. papatasi. Conclusions This trial provides evidence that LNs have a limited effect on sand fly exposure in VL endemic communities in India and Nepal and supports the use of sand fly saliva antibodies as a marker to evaluate vector control interventions. PMID:21931871

Serological markers of sand fly exposure to evaluate insecticidal nets against visceral leishmaniasis in India and Nepal: a cluster-randomized trial.

PubMed

Gidwani, Kamlesh; Picado, Albert; Rijal, Suman; Singh, Shri Prakash; Roy, Lalita; Volfova, Vera; Andersen, Elisabeth Wreford; Uranw, Surendra; Ostyn, Bart; Sudarshan, Medhavi; Chakravarty, Jaya; Volf, Petr; Sundar, Shyam; Boelaert, Marleen; Rogers, Matthew Edward

2011-09-01

Visceral leishmaniasis is the world' second largest vector-borne parasitic killer and a neglected tropical disease, prevalent in poor communities. Long-lasting insecticidal nets (LNs) are a low cost proven vector intervention method for malaria control; however, their effectiveness against visceral leishmaniasis (VL) is unknown. This study quantified the effect of LNs on exposure to the sand fly vector of VL in India and Nepal during a two year community intervention trial. As part of a paired-cluster randomized controlled clinical trial in VL-endemic regions of India and Nepal we tested the effect of LNs on sand fly biting by measuring the antibody response of subjects to the saliva of Leishmania donovani vector Phlebotomus argentipes and the sympatric (non-vector) Phlebotomus papatasi. Fifteen to 20 individuals above 15 years of age from 26 VL endemic clusters were asked to provide a blood sample at baseline, 12 and 24 months post-intervention. A total of 305 individuals were included in the study, 68 participants provided two blood samples and 237 gave three samples. A random effect linear regression model showed that cluster-wide distribution of LNs reduced exposure to P. argentipes by 12% at 12 months (effect 0.88; 95% CI 0.83-0.94) and 9% at 24 months (effect 0.91; 95% CI 0.80-1.02) in the intervention group compared to control adjusting for baseline values and pair. Similar results were obtained for P. papatasi. This trial provides evidence that LNs have a limited effect on sand fly exposure in VL endemic communities in India and Nepal and supports the use of sand fly saliva antibodies as a marker to evaluate vector control interventions.

Educational and Skills-Based Interventions to Prevent Relationship Violence in Young People

ERIC Educational Resources Information Center

Fellmeth, Gracia; Heffernan, Catherine; Nurse, Joanna; Habibula, Shakiba; Sethi, Dinesh

2015-01-01

Objectives: To assess the efficacy of educational and skills-based interventions to prevent relationship and dating violence in adolescents and young adults. Methods: We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO, and other databases for randomized, cluster-randomized, and quasi-randomized…

Recommendations for choosing an analysis method that controls Type I error for unbalanced cluster sample designs with Gaussian outcomes.

PubMed

Johnson, Jacqueline L; Kreidler, Sarah M; Catellier, Diane J; Murray, David M; Muller, Keith E; Glueck, Deborah H

2015-11-30

We used theoretical and simulation-based approaches to study Type I error rates for one-stage and two-stage analytic methods for cluster-randomized designs. The one-stage approach uses the observed data as outcomes and accounts for within-cluster correlation using a general linear mixed model. The two-stage model uses the cluster specific means as the outcomes in a general linear univariate model. We demonstrate analytically that both one-stage and two-stage models achieve exact Type I error rates when cluster sizes are equal. With unbalanced data, an exact size α test does not exist, and Type I error inflation may occur. Via simulation, we compare the Type I error rates for four one-stage and six two-stage hypothesis testing approaches for unbalanced data. With unbalanced data, the two-stage model, weighted by the inverse of the estimated theoretical variance of the cluster means, and with variance constrained to be positive, provided the best Type I error control for studies having at least six clusters per arm. The one-stage model with Kenward-Roger degrees of freedom and unconstrained variance performed well for studies having at least 14 clusters per arm. The popular analytic method of using a one-stage model with denominator degrees of freedom appropriate for balanced data performed poorly for small sample sizes and low intracluster correlation. Because small sample sizes and low intracluster correlation are common features of cluster-randomized trials, the Kenward-Roger method is the preferred one-stage approach. Copyright © 2015 John Wiley & Sons, Ltd.

Speckle lithography for fabricating Gaussian, quasi-random 2D structures and black silicon structures.

PubMed

Bingi, Jayachandra; Murukeshan, Vadakke Matham

2015-12-18

Laser speckle pattern is a granular structure formed due to random coherent wavelet interference and generally considered as noise in optical systems including photolithography. Contrary to this, in this paper, we use the speckle pattern to generate predictable and controlled Gaussian random structures and quasi-random structures photo-lithographically. The random structures made using this proposed speckle lithography technique are quantified based on speckle statistics, radial distribution function (RDF) and fast Fourier transform (FFT). The control over the speckle size, density and speckle clustering facilitates the successful fabrication of black silicon with different surface structures. The controllability and tunability of randomness makes this technique a robust method for fabricating predictable 2D Gaussian random structures and black silicon structures. These structures can enhance the light trapping significantly in solar cells and hence enable improved energy harvesting. Further, this technique can enable efficient fabrication of disordered photonic structures and random media based devices.

The effectiveness of job rotation to prevent work-related musculoskeletal disorders: protocol of a cluster randomized clinical trial.

PubMed

Comper, Maria Luiza Caires; Padula, Rosimeire Simprini

2014-05-22

Job rotation has often been used in situations where the level of exposure cannot be reduced due to the characteristics of the job or through physical measures. However, the effectiveness of the job rotation strategy at preventing musculoskeletal complaints lacks adequate scientific data. A cluster randomized controlled trial will be used to investigate the effectiveness of job rotation to prevent musculoskeletal disorders in industrial workers. The randomized cluster was based in characteristics of production sectors. A total cluster will be 4 sectors, and 957 workers will be recruited from a textile industry and randomly allocated into intervention or control groups. Both groups will receive training on ergonomics guidelines. In addition, the intervention group will perform job rotation, switching between tasks with low, moderate, and high risk for musculoskeletal complaints. The primary outcome will be the number of working hours lost due to sick leave by musculoskeletal injuries recorded in employee administrative data bases. Secondary outcomes measured via survey include: body parts with musculoskeletal pain, the intensity of this pain, physical workload, fatigue, general health status, physical activity level, and work productivity. Secondary outcome measures will be assessed at baseline and after 3, 6, 9, and 12 months. The cost-effectiveness analysis will be performed from the societal and company perspective. Prevention of work-related musculoskeletal disorders is beneficial for workers, employers, and society. The results of this study will provide new information about the effectiveness of job rotation as a strategy to reduce work-related musculoskeletal disorders. NCT01979731, November 3, 2013.

The effectiveness of job rotation to prevent work-related musculoskeletal disorders: protocol of a cluster randomized clinical trial

PubMed Central

2014-01-01

Background Job rotation has often been used in situations where the level of exposure cannot be reduced due to the characteristics of the job or through physical measures. However, the effectiveness of the job rotation strategy at preventing musculoskeletal complaints lacks adequate scientific data. Methods/Design A cluster randomized controlled trial will be used to investigate the effectiveness of job rotation to prevent musculoskeletal disorders in industrial workers. The randomized cluster was based in characteristics of production sectors. A total cluster will be 4 sectors, and 957 workers will be recruited from a textile industry and randomly allocated into intervention or control groups. Both groups will receive training on ergonomics guidelines. In addition, the intervention group will perform job rotation, switching between tasks with low, moderate, and high risk for musculoskeletal complaints. The primary outcome will be the number of working hours lost due to sick leave by musculoskeletal injuries recorded in employee administrative data bases. Secondary outcomes measured via survey include: body parts with musculoskeletal pain, the intensity of this pain, physical workload, fatigue, general health status, physical activity level, and work productivity. Secondary outcome measures will be assessed at baseline and after 3, 6, 9, and 12 months. The cost-effectiveness analysis will be performed from the societal and company perspective. Discussion Prevention of work-related musculoskeletal disorders is beneficial for workers, employers, and society. The results of this study will provide new information about the effectiveness of job rotation as a strategy to reduce work-related musculoskeletal disorders. Trial registration NCT01979731, November 3, 2013 PMID:24885958

The effectiveness of a near-infrared vascular imaging device to support intravenous cannulation in children with dark skin color: a cluster randomized clinical trial.

PubMed

van der Woude, Olga C P; Cuper, Natascha J; Getrouw, Chavalleh; Kalkman, Cor J; de Graaff, Jurgen C

2013-06-01

Poor vein visibility can make IV cannulation challenging in children with dark skin color. In the operating room, we studied the effectiveness of a near-infrared vascular imaging device (VascuLuminator) to facilitate IV cannulation in children with dark skin color. In the operating room of a general hospital in Curacao, all consecutive children (0-15 years of age) requiring IV cannulation were included in a pragmatic cluster randomized clinical trial. The VascuLuminator was made available to anesthesiologists at the operating complex in randomized clusters of 1 week. Success at first attempt was 63% (27/43, 95% confidence interval [CI], 47%-77%) in the VascuLuminator group vs 51% (23 of 45 patients, 95% CI, 36%-66%) in the control group (P = 0.27). Median time to successful cannulation was 53 seconds (interquartile range: 34-154) in the VascuLuminator group and 68 seconds (interquartile range: 40-159) in the control group (P = 0.54), and hazard ratio was 1.12 (95% CI, 0.73-1.71). The VascuLuminator has limited value in improving success at first attempt of facilitating IV cannulation in children with dark skin color.

Process Evaluation of a Multi-Component Intervention to Reduce Infectious Diseases and Improve Hygiene and Well-Being among School Children: The Hi Five Study

ERIC Educational Resources Information Center

Bonnesen, C. T.; Plauborg, R.; Denbaek, A. M.; Due, P.; Johansen, A.

2015-01-01

The Hi Five study was a three-armed cluster randomized controlled trial designed to reduce infections and improve hygiene and well-being among pupils. Participating schools (n = 43) were randomized into either control (n = 15) or one of two intervention groups (n = 28). The intervention consisted of three components: (i) a curriculum (ii)…

A Cluster Randomized Evaluation of a Health Department Data to Care Intervention Designed to Increase Engagement in HIV Care and Antiretroviral Use.

PubMed

Dombrowski, Julia C; Hughes, James P; Buskin, Susan E; Bennett, Amy; Katz, David; Fleming, Mark; Nunez, Angela; Golden, Matthew R

2018-06-01

Many US health departments have implemented Data to Care interventions, which use HIV surveillance data to identify persons who are inadequately engaged in HIV medical care and assist them with care reengagement, but the effectiveness of this strategy is uncertain. We conducted a stepped-wedge, cluster-randomized evaluation of a Data to Care intervention in King County, Washington, 2011 to 2014. Persons diagnosed as having HIV for at least 6 months were eligible based on 1 of 2 criteria: (1) viral load (VL) greater than 500 copies/mL and CD4 less than 350 cells/μL at the last report in the past 12 months or (2) no CD4 or VL reported to the health department for at least 12 months. The intervention included medical provider contact, patient contact, and a structured individual interview. Health department staff assisted patients with reengagement using health systems navigation, brief counseling, and referral to support services. We clustered all eligible cases in the county by the last known medical provider and randomized the order of clusters for intervention, creating contemporaneous intervention and control periods (cases in later clusters contributed person-time to the control period at the same time that cases in earlier clusters contributed person-time to the intervention period). We compared the time to viral suppression (VL <200 copies/mL) for individuals during intervention and control periods using a Cox proportional hazards model. We identified 997 persons (intention to treat [ITT]), 18% of whom had moved or died. Of the remaining 822 (modified ITT), 161 (20%) had an undetectable VL reported before contact and 164 (20%) completed the individual interview. The hazard ratio (HR) for time to viral suppression did not differ between the intervention and control periods in ITT (HR, 1.21 [95% confidence interval, 0.85-1.71]) or modified ITT (HR, 1.18 [95% confidence interval, 0.83-1.68]) analysis. The Data to Care intervention did not impact time to viral suppression.

Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: study protocol for a randomized controlled trial.

PubMed

Worrall, Linda; Ryan, Brooke; Hudson, Kyla; Kneebone, Ian; Simmons-Mackie, Nina; Khan, Asaduzzaman; Hoffmann, Tammy; Power, Emma; Togher, Leanne; Rose, Miranda

2016-03-22

People with aphasia and their family members are at high risk of experiencing post stroke depression. The impact of early interventions on mood and quality of life for people with aphasia is unknown. This study will determine whether an early intervention for both the person with aphasia after stroke and their family members leads to better mood and quality of life outcomes for people with aphasia, and less caregiver burden and better mental health for their family members. This is a multicenter, cluster-randomized controlled trial. Clusters, which are represented by Health Service Districts, will be randomized to the experimental intervention (Aphasia Action Success Knowledge Program) or an attention control (Secondary Stroke Prevention Information Program). People with aphasia and their family members will be blinded to the study design and treatment allocation (that is, will not know there are two arms to the study). Both arms of the study will receive usual care in addition to either the experimental or the attention control intervention. A total of 344 people with aphasia and their family members will be recruited. Considering a cluster size of 20, the required sample size can be achieved from 18 clusters. However, 20 clusters will be recruited to account for the potential of cluster attrition during the study. Primary outcome measures will be mood and quality of life of people with aphasia at 12 months post stroke. Secondary measures will be family member outcomes assessing the impact of caregiving and mental health, and self-reported stroke risk-related behaviors of people with aphasia. This is the first known program tailored for people with aphasia and their family members that aims to prevent depression in people with aphasia by providing intervention early after the stroke. This trial is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as ACTRN12614000979651 . Date registered: 11 September 2014.

Effectiveness of short-term, enhanced, infection control support in improving compliance with infection control guidelines and practice in nursing homes: a cluster randomized trial.

PubMed

Gopal Rao, G; Jeanes, A; Russell, H; Wilson, D; Atere-Roberts, E; O'Sullivan, D; Donaldson, N

2009-10-01

In this prospective cluster randomized controlled trial we evaluated the impact of short-term provision of enhanced infection control support on infection control practice in nursing homes in South London. Twelve nursing homes were recruited, six each in intervention (300 residents) and control (265 residents) groups. Baseline observations of hand hygiene facilities, environmental cleanliness and safe disposal of clinical waste showed poor compliance in both groups. Post-intervention observations showed improvement in both groups. There was no statistical difference between the two groups in the compliance for hand hygiene facilities (P=0.69); environmental cleanliness (P=0.43) and safe disposal of clinical waste (P=0.96). In both groups, greatest improvement was in compliance with safe disposal of clinical waste and the least improvement was in hand hygiene facilities. Since infection control practice improved in intervention and control groups, we could not demonstrate that provision of short-term, enhanced, infection control support in nursing homes had a significant impact in infection control practice.

Evaluation of Tai Chi Yunshou exercises on community-based stroke patients with balance dysfunction: a study protocol of a cluster randomized controlled trial.

PubMed

Tao, Jing; Rao, Ting; Lin, Lili; Liu, Wei; Wu, Zhenkai; Zheng, Guohua; Su, Yusheng; Huang, Jia; Lin, Zhengkun; Wu, Jinsong; Fang, Yunhua; Chen, Lidian

2015-02-25

Balance dysfunction after stroke limits patients' general function and participation in daily life. Previous researches have suggested that Tai Chi exercise could offer a positive improvement in older individuals' balance function and reduce the risk of falls. But convincing evidence for the effectiveness of enhancing balance function after stroke with Tai Chi exercise is still inadequate. Considering the difficulties for stroke patients to complete the whole exercise, the current trial evaluates the benefit of Tai Chi Yunshou exercise for patients with balance dysfunction after stroke through a cluster randomization, parallel-controlled design. A single-blind, cluster-randomized, parallel-controlled trial will be conducted. A total of 10 community health centers (5 per arm) will be selected and randomly allocated into Tai Chi Yunshou exercise group or balance rehabilitation training group. Each community health centers will be asked to enroll 25 eligible patients into the trial. 60 minutes per each session, 1 session per day, 5 times per week and the total training round is 12 weeks. Primary and secondary outcomes will be measured at baseline and 4-weeks, 8-weeks, 12-weeks, 6-week follow-up, 12-week follow-up after randomization. Safety and economic evaluation will also be assessed. This protocol aims to evaluate the effectiveness of Tai Chi Yunshou exercise for the balance function of patients after stroke. If the outcome is positive, this project will provide an appropriate and economic balance rehabilitation technology for community-based stroke patients. Chinese Clinical Trial Registry: ChiCTR-TRC-13003641. Registration date: 22 August, 2013 http://www.chictr.org/usercenter/project/listbycreater.aspx .

No Effect of Insecticide Treated Curtain Deployment on Aedes Infestation in a Cluster Randomized Trial in a Setting of Low Dengue Transmission in Guantanamo, Cuba

PubMed Central

Lambert, Isora; Montada, Domingo; Baly, Alberto; Van der Stuyft, Patrick

2015-01-01

Objective & Methodology The current study evaluated the effectiveness and cost-effectiveness of Insecticide Treated Curtain (ITC) deployment for reducing dengue vector infestation levels in the Cuban context with intensive routine control activities. A cluster randomized controlled trial took place in Guantanamo city, east Cuba. Twelve neighborhoods (about 500 households each) were selected among the ones with the highest Aedes infestation levels in the previous two years, and were randomly allocated to the intervention and control arms. Long lasting ITC (PermaNet) were distributed in the intervention clusters in March 2009. Routine control activities were continued in the whole study area. In both study arms, we monitored monthly pre- and post-intervention House Index (HI, number of houses with at least 1 container with Aedes immature stages/100 houses inspected), during 12 and 18 months respectively. We evaluated the effect of ITC deployment on HI by fitting a generalized linear regression model with a negative binomial link function to these data. Principal Findings At distribution, the ITC coverage (% of households using ≥1 ITC) reached 98.4%, with a median of 3 ITC distributed/household. After 18 months, the coverage remained 97.4%. The local Aedes species was susceptible to deltamethrin (mosquito mortality rate of 99.7%) and the residual deltamethrin activity in the ITC was within acceptable levels (mosquito mortality rate of 73.1%) after one year of curtain use. Over the 18 month observation period after ITC distribution, the adjusted HI rate ratio, intervention versus control clusters, was 1.15 (95% CI 0.57 to 2.34). The annualized cost per household of ITC implementation was 3.8 USD, against 16.8 USD for all routine ACP activities. Conclusion Deployment of ITC in a setting with already intensive routine Aedes control actions does not lead to reductions in Aedes infestation levels. PMID:25794192

Assessment of community-level effects of intermittent preventive treatment for malaria in schoolchildren in Jinja, Uganda (START-IPT trial): a cluster-randomised trial.

PubMed

Staedke, Sarah G; Maiteki-Sebuguzi, Catherine; Rehman, Andrea M; Kigozi, Simon P; Gonahasa, Samuel; Okiring, Jaffer; Lindsay, Steve W; Kamya, Moses R; Chandler, Clare I R; Dorsey, Grant; Drakeley, Chris

2018-06-01

Intermittent preventive treatment (IPT) is a well established malaria control intervention. Evidence that delivering IPT to schoolchildren could provide community-level benefits is limited. We did a cluster-randomised controlled trial to assess the effect of IPT of primary schoolchildren with dihydroartemisinin-piperaquine (DP) on indicators of malaria transmission in the community, in Jinja, Uganda. We included 84 clusters, each comprising one primary school and the 100 closest available households. The clusters were randomly assigned 1:1 to receive IPT with DP or standard care (control) by restricted randomisation to ensure balance by geography and school type. Children in intervention schools received IPT monthly for up to six rounds (June to December, 2014). We did cross-sectional community surveys in randomly selected households at baseline and in January to April, 2015, during which we measured participants' temperatures and obtained finger-prick blood smears for measurement of parasite prevalence by microscopy. We also did entomological surveys 1 night per month in households from 20 randomly selected IPT and 20 control clusters. The primary trial outcome was parasite prevalence in the final community survey. The primary entomological survey outcome was the annual entomological inoculation rate (aEIR) from July, 2014, to April, 2015. This trial is registered at ClinicalTrials.gov, number NCT02009215. Among 23 280 students registered in the 42 intervention schools, 10 079 (43%) aged 5-20 years were enrolled and received at least one dose of DP. 9286 (92%) of 10 079 received at least one full course of DP (three doses). Community-level parasite prevalence was lower in the intervention clusters than in the control clusters (19% vs 23%, adjusted risk ratio 0·85, 95% CI 0·73-1·00, p=0·05). The aEIR was lower in the intervention group than in the control group, but not significantly so (10·1 vs 15·2 infective bites per person, adjusted incidence rate ratio 0·80, 95% CI 0·36-1·80, p=0·59). IPT of schoolchildren with DP might have a positive effect on community-level malaria indicators and be operationally feasible. Studies with greater IPT coverage are needed. UK Medical Research Council, UK Department for International Development, and Wellcome Trust. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Community-based intermittent mass testing and treatment for malaria in an area of high transmission intensity, western Kenya: study design and methodology for a cluster randomized controlled trial.

PubMed

Samuels, Aaron M; Awino, Nobert; Odongo, Wycliffe; Abong'o, Benard; Gimnig, John; Otieno, Kephas; Shi, Ya Ping; Were, Vincent; Allen, Denise Roth; Were, Florence; Sang, Tony; Obor, David; Williamson, John; Hamel, Mary J; Patrick Kachur, S; Slutsker, Laurence; Lindblade, Kim A; Kariuki, Simon; Desai, Meghna

2017-06-07

Most human Plasmodium infections in western Kenya are asymptomatic and are believed to contribute importantly to malaria transmission. Elimination of asymptomatic infections requires active treatment approaches, such as mass testing and treatment (MTaT) or mass drug administration (MDA), as infected persons do not seek care for their infection. Evaluations of community-based approaches that are designed to reduce malaria transmission require careful attention to study design to ensure that important effects can be measured accurately. This manuscript describes the study design and methodology of a cluster-randomized controlled trial to evaluate a MTaT approach for malaria transmission reduction in an area of high malaria transmission. Ten health facilities in western Kenya were purposively selected for inclusion. The communities within 3 km of each health facility were divided into three clusters of approximately equal population size. Two clusters around each health facility were randomly assigned to the control arm, and one to the intervention arm. Three times per year for 2 years, after the long and short rains, and again before the long rains, teams of community health volunteers visited every household within the intervention arm, tested all consenting individuals with malaria rapid diagnostic tests, and treated all positive individuals with an effective anti-malarial. The effect of mass testing and treatment on malaria transmission was measured through population-based longitudinal cohorts, outpatient visits for clinical malaria, periodic population-based cross-sectional surveys, and entomological indices.

Short-Term Impact of a Teen Pregnancy-Prevention Intervention Implemented in Group Homes.

PubMed

Oman, Roy F; Vesely, Sara K; Green, Jennifer; Fluhr, Janene; Williams, Jean

2016-11-01

Youth living in group home settings are at significantly greater risk for sexual risk behaviors; however, there are no sexual health programs designed specifically for these youth. The study's purpose was to assess the effectiveness of a teen pregnancy-prevention program for youth living in group home foster care settings and other out-of-home placements. The study design was a cluster randomized controlled trial involving youth (N = 1,037) recruited from 44 residential group homes located in California, Maryland, and Oklahoma. Within each state, youth (mean age = 16.2 years; 82% male; 37% Hispanic, 20% African-American, 20% white, and 17% multiracial) in half the group homes were randomly assigned to the intervention group (n = 40 clusters) and the other half were randomly assigned to a control group that offered "usual care" (n = 40 clusters). The intervention (i.e., Power Through Choices [PTC]) was a 10-session, age-appropriate, and medically accurate sexual health education program. Compared to the control group, youth in the PTC intervention showed significantly greater improvements (p < .05) from preintervention to postintervention in all three knowledge areas, one of two attitude areas, all three self-efficacy areas, and two of three behavioral intention areas. This is the first published randomized controlled trial of a teen pregnancy-prevention program designed for youth living in foster care settings and other out-of-home placements. The numerous significant improvements in short-term outcomes are encouraging and provide preliminary evidence that the PTC program is an effective pregnancy-prevention program. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Cluster-randomized, controlled trial of computer-based decision support for selecting long-term anti-thrombotic therapy after acute ischaemic stroke.

PubMed

Weir, C J; Lees, K R; MacWalter, R S; Muir, K W; Wallesch, C-W; McLelland, E V; Hendry, A

2003-02-01

Identifying the appropriate long-term anti-thrombotic therapy following acute ischaemic stroke is a challenging area in which computer-based decision support may provide assistance. To evaluate the influence on prescribing practice of a computer-based decision support system (CDSS) that provided patient-specific estimates of the expected ischaemic and haemorrhagic vascular event rates under each potential anti-thrombotic therapy. Cluster-randomized controlled trial. We recruited patients who presented for a first investigation of ischaemic stroke or TIA symptoms, excluding those with a poor prognosis or major contraindication to anticoagulation. After observation of routine prescribing practice (6 months) in each hospital, centres were randomized for 6 months to either control (routine practice observed) or intervention (practice observed while the CDSS provided patient-specific information). We compared, between control and intervention centres, the risk reduction (estimated by the CDSS) in ischaemic and haemorrhagic vascular events achieved by long-term anti-thrombotic therapy, and the proportions of subjects prescribed the optimal therapy identified by the CDSS. Sixteen hospitals recruited 1952 subjects. When the CDSS provided information, the mean relative risk reduction attained by prescribing increased by 2.7 percentage units (95%CI -0.3 to 5.7) and the odds ratio for the optimal therapy being prescribed was 1.32 (0.83 to 1.80). Some 55% (5/9) of clinicians believed the CDSS had influenced their prescribing. Cluster-randomized trials provide excellent frameworks for evaluating novel clinical management methods. Our CDSS was feasible to implement and acceptable to clinicians, but did not substantially influence prescribing practice for anti-thrombotic drugs after acute ischaemic stroke.

A reanalysis of cluster randomized trials showed interrupted time-series studies were valuable in health system evaluation.

PubMed

Fretheim, Atle; Zhang, Fang; Ross-Degnan, Dennis; Oxman, Andrew D; Cheyne, Helen; Foy, Robbie; Goodacre, Steve; Herrin, Jeph; Kerse, Ngaire; McKinlay, R James; Wright, Adam; Soumerai, Stephen B

2015-03-01

There is often substantial uncertainty about the impacts of health system and policy interventions. Despite that, randomized controlled trials (RCTs) are uncommon in this field, partly because experiments can be difficult to carry out. An alternative method for impact evaluation is the interrupted time-series (ITS) design. Little is known, however, about how results from the two methods compare. Our aim was to explore whether ITS studies yield results that differ from those of randomized trials. We conducted single-arm ITS analyses (segmented regression) based on data from the intervention arm of cluster randomized trials (C-RCTs), that is, discarding control arm data. Secondarily, we included the control group data in the analyses, by subtracting control group data points from intervention group data points, thereby constructing a time series representing the difference between the intervention and control groups. We compared the results from the single-arm and controlled ITS analyses with results based on conventional aggregated analyses of trial data. The findings were largely concordant, yielding effect estimates with overlapping 95% confidence intervals (CI) across different analytical methods. However, our analyses revealed the importance of a concurrent control group and of taking baseline and follow-up trends into account in the analysis of C-RCTs. The ITS design is valuable for evaluation of health systems interventions, both when RCTs are not feasible and in the analysis and interpretation of data from C-RCTs. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Cognitive-behavioral conjoint therapy for PTSD improves various PTSD symptoms and trauma-related cognitions: Results from a randomized controlled trial.

PubMed

Macdonald, Alexandra; Pukay-Martin, Nicole D; Wagner, Anne C; Fredman, Steffany J; Monson, Candice M

2016-02-01

Numerous studies document an association between posttraumatic stress disorder (PTSD) and impairments in intimate relationship functioning, and there is evidence that PTSD symptoms and associated impairments are improved by cognitive-behavioral conjoint therapy for PTSD (CBCT for PTSD; Monson & Fredman, 2012). The present study investigated changes across treatment in clinician-rated PTSD symptom clusters and patient-rated trauma-related cognitions in a randomized controlled trial comparing CBCT for PTSD with waitlist in a sample of 40 individuals with PTSD and their partners (N = 40; Monson et al., 2012). Compared with waitlist, patients who received CBCT for PTSD immediately demonstrated greater improvements in all PTSD symptom clusters, trauma-related beliefs, and guilt cognitions (Hedge's gs -.33 to -1.51). Results suggest that CBCT for PTSD improves all PTSD symptom clusters and trauma-related cognitions among individuals with PTSD and further supports the value of utilizing a couple-based approach to the treatment of PTSD. (c) 2016 APA, all rights reserved).

Leveraging microfinance to impact HIV and financial behaviors among adolescents and their mothers in West Bengal: a cluster randomized trial.

PubMed

Spielberg, Freya; Crookston, Benjamin T; Chanani, Sheila; Kim, Jaewhan; Kline, Sean; Gray, Bobbi L

2013-01-01

Microfinance can be used to reach women and adolescent girls with HIV prevention education. We report findings from a cluster-randomized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge, attitudes and behaviors for HIV prevention and savings. Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics. Women and girls who received HIV education showed significant gains in HIV knowledge, awareness that condoms can prevent HIV, self-efficacy for HIV prevention, and confirmed use of clean needles, as compared to the control group. Condom use was rare and did not improve for women. While HIV testing was uncommon, knowledge of HIV-testing resources significantly increased among girls, and trended in the positive direction among women in intervention groups. Conversely, the savings education showed no impact on financial knowledge or behavior change.

Implementation of a guideline for low back pain management in primary care: a cost-effectiveness analysis.

PubMed

Becker, Annette; Held, Heiko; Redaelli, Marcus; Chenot, Jean F; Leonhardt, Corinna; Keller, Stefan; Baum, Erika; Pfingsten, Michael; Hildebrandt, Jan; Basler, Heinz-Dieter; Kochen, Michael M; Donner-Banzhoff, Norbert; Strauch, Konstantin

2012-04-15

Cost-effectiveness analysis alongside a cluster randomized controlled trial. To study the cost-effectiveness of 2 low back pain guideline implementation (GI) strategies. Several evidence-based guidelines on management of low back pain have been published. However, there is still no consensus on the effective implementation strategy. Especially studies on the economic impact of different implementation strategies are lacking. This analysis was performed alongside a cluster randomized controlled trial on the effectiveness of 2 GI strategies (physician education alone [GI] or physician education in combination with motivational counseling [MC] by practice nurses)--both compared with the postal dissemination of the guideline (control group, C). Sociodemographic data, pain characteristics, and cost data were collected by interview at baseline and after 6 and 12 months. low back pain-related health care costs were valued for 2004 from the societal perspective. For the cost analysis, 1322 patients from 126 general practices were included. Both interventions showed lower direct and indirect costs as well as better patient outcomes during follow-up compared with controls. In addition, both intervention arms showed superiority of cost-effectiveness to C. The effects attenuated when adjusting for differences of health care utilization prior to patient recruitment and for clustering of data. Trends in cost-effectiveness are visible but need to be confirmed in future studies. Researchers performing cost-evaluation studies should test for baseline imbalances of health care utilization data instead of judging on the randomization success by reviewing non-cost parameters like clinical data alone.

Assessing different measures of population-level vaccine protection using a case-control study.

PubMed

Ali, Mohammad; You, Young Ae; Kanungo, Suman; Manna, Byomkesh; Deen, Jacqueline L; Lopez, Anna Lena; Wierzba, Thomas F; Bhattacharya, Sujit K; Sur, Dipika; Clemens, John D

2015-11-27

Case-control studies have not been examined for their utility in assessing population-level vaccine protection in individually randomized trials. We used the data of a randomized, placebo-controlled trial of a cholera vaccine to compare the results of case-control analyses with those of cohort analyses. Cases of cholera were selected from the trial population followed for three years following dosing. For each case, we selected 4 age-matched controls who had not developed cholera. For each case and control, GIS was used to calculate vaccine coverage of individuals in a surrounding "virtual" cluster. Specific selection strategies were used to evaluate the vaccine protective effects. 66,900 out of 108,389 individuals received two doses of the assigned regimen. For direct protection among subjects in low vaccine coverage clusters, we observed 78% (95% CI: 47-91%) protection in a cohort analysis and 84% (95% CI: 60-94%) in case-control analysis after adjusting for confounding factors. Using our GIS-based approach, estimated indirect protection was 52% (95% CI: 10-74%) in cohort and 76% (95% CI: 47-89%) in case control analysis. Estimates of total and overall effectiveness were similar for cohort and case-control analyses. The findings show that case-control analyses of individually randomized vaccine trials may be used to evaluate direct as well as population-level vaccine protection. Copyright © 2015. Published by Elsevier Ltd.

Effect of Reassuring Information About Musculoskeletal and Mental Health Complaints at the Workplace: A Cluster Randomized Trial of the atWork Intervention.

PubMed

Johnsen, Tone Langjordet; Eriksen, Hege Randi; Baste, Valborg; Indahl, Aage; Odeen, Magnus; Tveito, Torill Helene

2018-05-21

Purpose The purpose of this study was to investigate the possible difference between the Modified atWork intervention (MAW) and the Original atWork intervention (OAW) on sick leave and other health related outcomes. atWork is a group intervention using the workplace as an arena for distribution of evidence-based knowledge about musculoskeletal and mental health complaints. Methods A cluster randomized controlled trial with 93 kindergartens, comprising a total of 1011 employees, was conducted. Kindergartens were stratified by county and size and randomly allocated to MAW (45 clusters, 324 respondents) or OAW (48 clusters, 313 respondents). The randomization and intervention allocation processes were concealed. There was no blinding to group allocation. Primary outcome was register data on sick leave at cluster level. Secondary outcomes were health complaints, job satisfaction, social support, coping, and beliefs about musculoskeletal and mental health complaints, measured at the individual level. Results The MAW group reduced sick leave by 5.7% during the intervention year, while the OAW group had a 7.5% increase. Overall, the changes were not statistically significant, and no difference was detected between groups, based on 45 and 47 kindergartens. Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression. Conclusions The MAW did not have a different effect on sick leave at cluster level compared to the OAW. Trial registration https://Clinicaltrials.gov/ : NCT02396797. Registered March 23th, 2015.

Differential effect of exposure-based therapy and cognitive therapy on post-traumatic stress disorder symptom clusters: A randomized controlled trial.

PubMed

Horesh, Danny; Qian, Meng; Freedman, Sara; Shalev, Arieh

2017-06-01

A question remains regarding differential effects of exposure-based versus non-exposure-based therapies on specific post-traumatic stress disorder (PTSD) symptom clusters. Traumatized emergency room patients were randomized to receive prolonged exposure (PE) or cognitive therapy (CT) without exposure. PE/CT had no differential effect on individual symptom clusters, and change in total PTSD score remained significant even after controlling for the reductions in all three symptom clusters. In addition, baseline levels of PTSD avoidance/intrusion/hyperarousal did not moderate the effects of PE and CT on total PTSD symptom scores. Taken together, these findings challenge the notion that PE and CT are specifically, and differentially, useful in treating one particular PTSD symptom cluster. Despite their different theoretical backgrounds and techniques, the notion that PE and CT (without exposure) target different PTSD symptoms was not confirmed in this study. Thus, both interventions may in fact be equally effective for treating intrusion, avoidance and hyperarousal symptoms. Baseline levels of avoidance, intrusion and hyperarousal may not be good a priori indicators for PTSD treatment selection. The effect of PE and CT on PTSD as a whole does not seem to depend on a reduction in any specific symptom cluster. These findings indicate that exposure and non-exposure interventions may lead to similar results in terms of reductions in specific PTSD symptoms. It is quite possible that individual PTSD clusters may respond to therapy in an inter-related fashion, with one cluster affecting the other. © 2016 The British Psychological Society.

Impact of community-based interventions on maternal and neonatal health indicators: Results from a community randomized trial in rural Balochistan, Pakistan.

PubMed

Midhet, Farid; Becker, Stan

2010-11-05

Pakistan has high maternal mortality, particularly in the rural areas. The delay in decision making to seek medical care during obstetric emergencies remains a significant factor in maternal mortality. We present results from an experimental study in rural Pakistan. Village clusters were randomly assigned to intervention and control arms (16 clusters each). In the intervention clusters, women were provided information on safe motherhood through pictorial booklets and audiocassettes; traditional birth attendants were trained in clean delivery and recognition of obstetric and newborn complications; and emergency transportation systems were set up. In eight of the 16 intervention clusters, husbands also received specially designed education materials on safe motherhood and family planning. Pre- and post-intervention surveys on selected maternal and neonatal health indicators were conducted in all 32 clusters. A district-wide survey was conducted two years after project completion to measure any residual impact of the interventions. Pregnant women in intervention clusters received prenatal care and prophylactic iron therapy more frequently than pregnant women in control clusters. Providing safe motherhood education to husbands resulted in further improvement of some indicators. There was a small but significant increase in percent of hospital deliveries but no impact on the use of skilled birth attendants. Perinatal mortality reduced significantly in clusters where only wives received information and education in safe motherhood. The survey to assess residual impact showed similar results. We conclude that providing safe motherhood education increased the probability of pregnant women having prenatal care and utilization of health services for obstetric complications.

Informing resource-poor populations and the delivery of entitled health and social services in rural India: a cluster randomized controlled trial.

PubMed

Pandey, Priyanka; Sehgal, Ashwini R; Riboud, Michelle; Levine, David; Goyal, Madhav

2007-10-24

A lack of awareness about entitled health and social services may contribute to poor delivery of such services in developing countries, especially among individuals of low socioeconomic status. To determine the impact of informing resource-poor rural populations about entitled services. Community-based, cluster randomized controlled trial conducted from May 2004 to May 2005 in 105 randomly selected village clusters in Uttar Pradesh state in India. Households (548 intervention and 497 control) were selected by a systematic sampling design, including both low-caste and mid- to high-caste households. Four to 6 public meetings were held in each intervention village cluster to disseminate information on entitled health services, entitled education services, and village governance requirements. No intervention took place in control village clusters. Visits by nurse midwife; prenatal examinations, tetanus vaccinations, and prenatal supplements received by pregnant women; vaccinations received by infants; excess school fees charged; occurrence of village council meetings; and development work in villages. At baseline, there were no significant differences in self-reported delivery of health and social services. After 1 year, intervention villagers reported better delivery of several services compared with control villagers: in a multivariate analysis, 30% more prenatal examinations (95% confidence interval [CI], 17%-43%; P < .001), 27% more tetanus vaccinations (95% CI, 12%-41%; P < .001), 24% more prenatal supplements (95% CI, 8%-39%; P = .003), 25% more infant vaccinations (95% CI, 8%-42%; P = .004), and decreased excess school fees of 8 rupees (95% CI, 4-13 rupees; P < .001). In a difference-in-differences analysis, 21% more village council meetings were reported (95% CI, 5%-36%; P = .01). There were no improvements in visits by a nurse midwife or in development work in the villages. Both low-caste and mid- to high-caste intervention households reported significant improvements in service delivery. Informing resource-poor rural populations in India about entitled services enhanced the delivery of health and social services among both low- and mid- to high-caste households. Interventions that emphasize educating resource-poor populations about entitled services may improve the delivery of such services. clinicaltrials.gov Identifier: NCT00421291.

Microfluidic cell trap array for controlled positioning of single cells on adhesive micropatterns.

PubMed

Lin, Laiyi; Chu, Yeh-Shiu; Thiery, Jean Paul; Lim, Chwee Teck; Rodriguez, Isabel

2013-02-21

Adhesive micropattern arrays permit the continuous monitoring and systematic study of the behavior of spatially confined cells of well-defined shape and size in ordered configurations. This technique has contributed to defining mechanisms that control cell polarity and cell functions, including proliferation, apoptosis, differentiation and migration in two-dimensional cell culture systems. These micropattern studies often involve isolating a single cell on one adhesive protein micropattern using random seeding methods. Random seeding has been successful for isolated and, to a lesser degree, paired patterns, where two patterns are placed in close proximity. Using this method, we found that the probability of obtaining one cell per pattern decreases significantly as the number of micropatterns in a cluster increases, from 16% for paired micropatterns to 0.3% for clusters of 6 micropatterns. This work presents a simple yet effective platform based on a microfludic sieve-like trap array to exert precise control over the positioning of single cells on micropatterns. We observed a 4-fold improvement over random seeding in the efficiency of placing a pair of single cells on paired micropattern and a 40-fold improvement for 6-pattern clusters. The controlled nature of this platform can also allow the juxtaposition of two different cell populations through a simple modification in the trap arrangement. With excellent control of the identity, number and position of neighbouring cells, this cell-positioning platform provides a unique opportunity for the extension of two-dimensional micropattern studies beyond paired micropatterns to organizations containing many cells or different cell types.

Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster-randomized pragmatic trial.

PubMed

Choudhry, Niteesh K; Isaac, Thomas; Lauffenburger, Julie C; Gopalakrishnan, Chandrasekar; Khan, Nazleen F; Lee, Marianne; Vachon, Amy; Iliadis, Tanya L; Hollands, Whitney; Doheny, Scott; Elman, Sandra; Kraft, Jacqueline M; Naseem, Samrah; Gagne, Joshua J; Jackevicius, Cynthia A; Fischer, Michael A; Solomon, Daniel H; Sequist, Thomas D

2016-10-01

Approximately half of patients with chronic cardiometabolic conditions are nonadherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may not need adherence assistance. To evaluate the effect of a multicomponent, behaviorally tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. The STIC2IT trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multicomponent intervention that uses behavioral interviewing, text messaging, mailed progress reports, and video visits. Targeted patients are those who are nonadherent to glucose-lowering, antihypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients' individual health barriers and their level of health activation. We cluster-randomized 14 practice sites of a large multispecialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients who will be followed up for 12months after randomization. The trial's primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and health care resource utilization. This trial will determine whether a technologically enabled, behaviorally targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need. Copyright © 2016 Elsevier Inc. All rights reserved.

Community-based control of Aedes aegypti by adoption of eco-health methods in Chennai City, India

PubMed Central

Arunachalam, Natarajan; Tyagi, Brij Kishore; Samuel, Miriam; Krishnamoorthi, R; Manavalan, R; Tewari, Satish Chandra; Ashokkumar, V; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

2012-01-01

Background Dengue is highly endemic in Chennai city, South India, in spite of continuous vector control efforts. This intervention study was aimed at establishing the efficacy as well as the favouring and limiting factors relating to a community-based environmental intervention package to control the dengue vector Aedes aegypti. Methods A cluster randomized controlled trial was designed to measure the outcome of a new vector control package and process analysis; different data collection tools were used to determine the performance. Ten randomly selected intervention clusters (neighbourhoods with 100 houses each) were paired with ten control clusters on the basis of ecological/entomological indices and sociological parameters collected during baseline studies. In the intervention clusters, Aedes control was carried out using a community-based environmental management approach like provision of water container covers through community actors, clean-up campaigns, and dissemination of dengue information through schoolchildren. The main outcome measure was reduction in pupal indices (pupae per person index), used as a proxy measure of adult vectors, in the intervention clusters compared to the control clusters. Results At baseline, almost half the respondents did not know that dengue is serious but preventable, or that it is transmitted by mosquitoes. The stakeholder analysis showed that dengue vector control is carried out by vertically structured programmes of national, state, and local administrative bodies through fogging and larval control with temephos, without any involvement of community-based organizations, and that vector control efforts were conducted in an isolated and irregular way. The most productive container types for Aedes pupae were cement tanks, drums, and discarded containers. All ten intervention clusters with a total of 1000 houses and 4639 inhabitants received the intervention while the ten control clusters with a total of 1000 houses and 4439 inhabitants received only the routine government services and some of the information education and communication project materials. The follow-up studies showed that there was a substantial increase in dengue understanding in the intervention group with only minor knowledge changes in the control group. Community involvement and the partnership among stakeholders (particularly women’s self-help groups) worked well. After 10 months of intervention, the pupae per person index was significantly reduced to 0.004 pupae per person from 1.075 (P = 0.020) in the intervention clusters compared to control clusters. There were also significant reductions in the Stegomyia indices: the house index was reduced to 4.2%, the container index to 1.05%, and the Breteau index to 4.3 from the baseline values of 19.6, 8.91, and 30.8 in the intervention arm. Conclusion A community-based approach together with other stakeholders that promoted interventions to prevent dengue vector breeding led to a substantial reduction in dengue vector density. PMID:23318241

Community-based control of Aedes aegypti by adoption of eco-health methods in Chennai City, India.

PubMed

Arunachalam, Natarajan; Tyagi, Brij Kishore; Samuel, Miriam; Krishnamoorthi, R; Manavalan, R; Tewari, Satish Chandra; Ashokkumar, V; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

2012-12-01

Dengue is highly endemic in Chennai city, South India, in spite of continuous vector control efforts. This intervention study was aimed at establishing the efficacy as well as the favouring and limiting factors relating to a community-based environmental intervention package to control the dengue vector Aedes aegypti. A cluster randomized controlled trial was designed to measure the outcome of a new vector control package and process analysis; different data collection tools were used to determine the performance. Ten randomly selected intervention clusters (neighbourhoods with 100 houses each) were paired with ten control clusters on the basis of ecological/entomological indices and sociological parameters collected during baseline studies. In the intervention clusters, Aedes control was carried out using a community-based environmental management approach like provision of water container covers through community actors, clean-up campaigns, and dissemination of dengue information through schoolchildren. The main outcome measure was reduction in pupal indices (pupae per person index), used as a proxy measure of adult vectors, in the intervention clusters compared to the control clusters. At baseline, almost half the respondents did not know that dengue is serious but preventable, or that it is transmitted by mosquitoes. The stakeholder analysis showed that dengue vector control is carried out by vertically structured programmes of national, state, and local administrative bodies through fogging and larval control with temephos, without any involvement of community-based organizations, and that vector control efforts were conducted in an isolated and irregular way. The most productive container types for Aedes pupae were cement tanks, drums, and discarded containers. All ten intervention clusters with a total of 1000 houses and 4639 inhabitants received the intervention while the ten control clusters with a total of 1000 houses and 4439 inhabitants received only the routine government services and some of the information education and communication project materials. The follow-up studies showed that there was a substantial increase in dengue understanding in the intervention group with only minor knowledge changes in the control group. Community involvement and the partnership among stakeholders (particularly women's self-help groups) worked well. After 10 months of intervention, the pupae per person index was significantly reduced to 0·004 pupae per person from 1·075 (P = 0·020) in the intervention clusters compared to control clusters. There were also significant reductions in the Stegomyia indices: the house index was reduced to 4·2%, the container index to 1·05%, and the Breteau index to 4·3 from the baseline values of 19·6, 8·91, and 30·8 in the intervention arm. A community-based approach together with other stakeholders that promoted interventions to prevent dengue vector breeding led to a substantial reduction in dengue vector density.

Effects of Slow-Stroke Back Massage on Symptom Cluster in Adult Patients With Acute Leukemia: Supportive Care in Cancer Nursing.

PubMed

Miladinia, Mojtaba; Baraz, Shahram; Shariati, Abdolali; Malehi, Amal Saki

Patients with acute leukemia usually experience pain, fatigue, and sleep disorders, which affect their quality of life. Massage therapy, as a nondrug approach, can be useful in controlling such problems. However, very few studies have been conducted on the effects of massage therapy on the complications of leukemia. The aim of this study was to examine the effects of slow-stroke back massage (SSBM) on the symptom cluster in acute leukemia adult patients undergoing chemotherapy. In this randomized controlled trial, 60 patients with acute leukemia were allocated randomly to either the intervention or control group. The intervention group received SSBM 3 times a week (every other day for 10 minutes) for 4 weeks. The pain, fatigue, and sleep disorder intensities were measured using the numeric rating scale. The sleep quality was measured using the Pittsburgh Sleep Quality Index. Statistical tests of χ, t test, and the repeated-measure analysis of variance were used for data analysis. Results showed that the SSBM intervention significantly reduced the progressive sleep disorder, pain, fatigue, and improved sleep quality over time. Slow-stroke back massage, as a simple, noninvasive, and cost-effective approach, along with routine nursing care, can be used to improve the symptom cluster of pain, fatigue, and sleep disorders in leukemia patients. Oncology nurses can increase their knowledge regarding this symptom cluster and work to diminish the cluster components by using SSBM in adult leukemia patients.

Clustering effects in ionic polymers: Molecular dynamics simulations.

PubMed

Agrawal, Anupriya; Perahia, Dvora; Grest, Gary S

2015-08-01

Ionic clusters control the structure, dynamics, and transport in soft matter. Incorporating a small fraction of ionizable groups in polymers substantially reduces the mobility of the macromolecules in melts. These ionic groups often associate into random clusters in melts, where the distribution and morphology of the clusters impact the transport in these materials. Here, using molecular dynamic simulations we demonstrate a clear correlation between cluster size and morphology with the polymer mobility in melts of sulfonated polystyrene. We show that in low dielectric media ladderlike clusters that are lower in energy compared with spherical assemblies are formed. Reducing the electrostatic interactions by enhancing the dielectric constant leads to morphological transformation from ladderlike clusters to globular assemblies. Decrease in electrostatic interaction significantly enhances the mobility of the polymer.

Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial.

PubMed

Barbee, Anita P; Cunningham, Michael R; van Zyl, Michiel A; Antle, Becky F; Langley, Cheri N

2016-09-01

To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention.

Cluster-randomized controlled trial of the effects of free glasses on purchase of children's glasses in China: The PRICE (Potentiating Rural Investment in Children's Eyecare) study.

PubMed

Wang, Xiuqin; Congdon, Nathan; Ma, Yue; Hu, Min; Zhou, Yuan; Liao, Weiqi; Jin, Ling; Xiao, Baixiang; Wu, Xiaoyi; Ni, Ming; Yi, Hongmei; Huang, Yiwen; Varga, Beatrice; Zhang, Hong; Cun, Yongkang; Li, Xianshun; Yang, Luhua; Liang, Chaoguang; Huang, Wan; Rozelle, Scott; Ma, Xiaochen

2017-01-01

Offering free glasses can be important to increase children's wear. We sought to assess whether "Upgrade glasses" could avoid reduced glasses sales when offering free glasses to children in China. In this cluster-randomized, controlled trial, children with uncorrected visual acuity (VA)< = 6/12 in either eye correctable to >6/12 in both eyes at 138 randomly-selected primary schools in 9 counties in Guangdong and Yunnan provinces, China, were randomized by school to one of four groups: glasses prescription only (Control); Free Glasses; Free Glasses + offer of $15 Upgrade Glasses; Free Glasses + offer of $30 Upgrade Glasses. Spectacle purchase (main outcome) was assessed 6 months after randomization. Among 10,234 children screened, 882 (8.62%, mean age 10.6 years, 45.5% boys) were eligible and randomized: 257 (29.1%) at 37 schools to Control; 253 (28.7%) at 32 schools to Free Glasses; 187 (21.2%) at 31 schools to Free Glasses + $15 Upgrade; and 185 (21.0%) at 27 schools to Free Glasses +$30 Upgrade. Baseline ownership among these children needing glasses was 11.8% (104/882), and 867 (98.3%) children completed follow-up. Glasses purchase was significantly less likely when free glasses were given: Control: 59/250 = 23.6%; Free glasses: 32/252 = 12.7%, P = 0.010. Offering Upgrade Glasses eliminated this difference: Free + $15 Upgrade: 39/183 = 21.3%, multiple regression relative risk (RR) 0.90 (0.56-1.43), P = 0.65; Free + $30 Upgrade: 38/182 = 20.9%, RR 0.91 (0.59, 1.42), P = 0.69. Upgrade glasses can prevent reductions in glasses purchase when free spectacles are provided, providing important program income. ClinicalTrials.gov Identifier: NCT02231606. Registered on 31 August 2014.

Outcomes of a Pilot Hand Hygiene Randomized Cluster Trial to Reduce Communicable Infections Among US Office-Based Employees

PubMed Central

DuBois, Cathy L.Z.; Grey, Scott F.; Kingsbury, Diana M.; Shakya, Sunita; Scofield, Jennifer; Slenkovich, Ken

2015-01-01

Objective: To determine the effectiveness of an office-based multimodal hand hygiene improvement intervention in reducing self-reported communicable infections and work-related absence. Methods: A randomized cluster trial including an electronic training video, hand sanitizer, and educational posters (n = 131, intervention; n = 193, control). Primary outcomes include (1) self-reported acute respiratory infections (ARIs)/influenza-like illness (ILI) and/or gastrointestinal (GI) infections during the prior 30 days; and (2) related lost work days. Incidence rate ratios calculated using generalized linear mixed models with a Poisson distribution, adjusted for confounders and random cluster effects. Results: A 31% relative reduction in self-reported combined ARI-ILI/GI infections (incidence rate ratio: 0.69; 95% confidence interval, 0.49 to 0.98). A 21% nonsignificant relative reduction in lost work days. Conclusions: An office-based multimodal hand hygiene improvement intervention demonstrated a substantive reduction in self-reported combined ARI-ILI/GI infections. PMID:25719534

Structuring communication relationships for interprofessional teamwork (SCRIPT): a cluster randomized controlled trial

PubMed Central

Zwarenstein, Merrick; Reeves, Scott; Russell, Ann; Kenaszchuk, Chris; Conn, Lesley Gotlib; Miller, Karen-Lee; Lingard, Lorelei; Thorpe, Kevin E

2007-01-01

Background Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT) to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. Objectives The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. Methods The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs) in general internal medicine (GIM) divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS); adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Discussion Pre-intervention qualitative analysis revealed that a substantial amount of interprofessional interaction lacks key core elements of collaborative communication such as self-introduction, description of professional role, and solicitation of other professional perspectives. Incorporating these findings, a four-component intervention was designed with a goal of creating a culture of communication in which the fundamentals of collaboration become a routine part of interprofessional interactions during unstructured work periods on GIM wards. Trial registration Registered with National Institutes of Health as NCT00466297. PMID:17877830

Nurse-Facilitated Health Checks for Persons With Severe Mental Illness: A Cluster-Randomized Controlled Trial.

PubMed

White, Jacquie; Lucas, Joanne; Swift, Louise; Barton, Garry R; Johnson, Harriet; Irvine, Lisa; Abotsie, Gabriel; Jones, Martin; Gray, Richard J

2018-05-01

This study tested the effectiveness of a nurse-delivered health check with the Health Improvement Profile (HIP), which takes approximately 1.5 hours to complete and code, for persons with severe mental illness. A single-blind, cluster-randomized controlled trial was conducted in England to test whether health checks improved the general medical well-being of persons with severe mental illness at 12-month follow-up. Sixty nurses were randomly assigned to the HIP group or the treatment-as-usual group. From their case lists, 173 patients agreed to participate. HIP group nurses completed health checks for 38 of their 90 patients (42%) at baseline and 22 (24%) at follow-up. No significant between-group differences were noted in patients' general medical well-being at follow-up. Nurses who had volunteered for a clinical trial administered health checks only to a minority of participating patients, suggesting that it may not be feasible to undertake such lengthy structured health checks in routine practice.

Reaching the unreached through trained and skilled birth attendants in Ethiopia: a cluster randomized controlled trial study protocol.

PubMed

Zerfu, Taddese Alemu; Taddese, Henok; Nigatu, Tariku; Tenkolu, Girma; Vogel, Joshua P; Khan-Neelofur, Dina; Biadgilign, Sibhatu; Deribew, Amare

2017-01-26

Despite improvements since 1990 to 2014, maternal mortality ratio (MMR) remains high in Ethiopia. One of the key drivers of maternal mortality in Ethiopia is the very low coverage of Skilled Birth attendance (SBA) in rural Ethiopia. This cluster randomized trial piloted an innovative approach of deploying trained community reproductive nurses (CORN) to hard to reach/unreachable rural Ethiopia to improve the coverage of SBA. We used a three-arm cluster randomized trial to test the effect of deploying CORN in rural communities in South Ethiopia to improve SBA and other maternal health indicators. A total of 282 villages/clusters (94 from each arm) were randomly selected in the three districts of the zone for the study. The intervention was implemented in four consecutive phases that aimed at of provision of essential maternal, neonatal and child health (MNCH) services mainly focusing on SBA. The CORN were trained and deployed in health centres (arm 1) and in the community/health posts (arm2). A third arm (arm 3) consisting control villages without the intervention. A baseline and end line assessment was conducted to compare the difference in the proportion of SBA and other MNCH service uptake across the three arms Data was entered into computer, edited, cleaned, and analyzed using Epi-data statistical software. The presentation followed the Consolidated Standards of Reporting Trials (CONSORT) statement guidelines for cluster-randomized trials. This trial is designed to test the impact of an innovative and newly designed means of distribution for the national health extension program strategy with additional service package with no change to the target population. The focus is on effect of CORN in revitalizing the Health Extension Program (HEP) through improving SBA service uptake and other maternal health service uptake indicators. The study findings may guide national policy to strengthen and shape the already existing HEP that has certain limitations to improve maternal health indicators. The competency based training methodology could provide feedback for health science colleges to improve the national nursing or midwifery training curriculum. clinicaltrails.gov NCT02501252 dated on July 14, 2015.

A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

PubMed

Li, Nicole; Yan, Lijing L; Niu, Wenyi; Labarthe, Darwin; Feng, Xiangxian; Shi, Jingpu; Zhang, Jianxin; Zhang, Ruijuan; Zhang, Yuhong; Chu, Hongling; Neiman, Andrea; Engelgau, Michael; Elliott, Paul; Wu, Yangfeng; Neal, Bruce

2013-11-01

Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24-hour urine. The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide. © 2013.

Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial.

PubMed

Musekamp, Gunda; Gerlich, Christian; Ehlebracht-König, Inge; Faller, Hermann; Reusch, Andrea

2016-02-03

Fibromyalgia syndrome (FMS) is a complex chronic condition that makes high demands on patients' self-management skills. Thus, patient education is considered an important component of multimodal therapy, although evidence regarding its effectiveness is scarce. The main objective of this study is to assess the effectiveness of an advanced self-management patient education program for patients with FMS as compared to usual care in the context of inpatient rehabilitation. We conducted a multicenter cluster randomized controlled trial in 3 rehabilitation clinics. Clusters are groups of patients with FMS consecutively recruited within one week after admission. Patients of the intervention group receive the advanced multidisciplinary self-management patient education program (considering new knowledge on FMS, with a focus on transfer into everyday life), whereas patients in the control group receive standard patient education programs including information on FMS and coping with pain. A total of 566 patients are assessed at admission, at discharge and after 6 and 12 months, using patient reported questionnaires. Primary outcomes are patients' disease- and treatment-specific knowledge at discharge and self-management skills after 6 months. Secondary outcomes include satisfaction, attitudes and coping competences, health-promoting behavior, psychological distress, health impairment and participation. Treatment effects between groups are evaluated using multilevel regression analysis adjusting for baseline values. The study evaluates the effectiveness of a self-management patient education program for patients with FMS in the context of inpatient rehabilitation in a cluster randomized trial. Study results will show whether self-management patient education is beneficial for this group of patients. German Clinical Trials Register, DRKS00008782 , Registered 8 July 2015.

A cluster randomized control field trial of the ABRACADABRA web-based reading technology: replication and extension of basic findings

PubMed Central

Piquette, Noella A.; Savage, Robert S.; Abrami, Philip C.

2014-01-01

The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA), an evidence-based and web-based literacy intervention (http://abralite.concordia.ca) with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes) from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10–12 h of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d= +0.66), phonological blending (d = +0.52), and word reading (d = +0.52), over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years. PMID:25538663

HIV risk reduction intervention among traditionally circumcised young men in South Africa: a cluster randomized control trial.

PubMed

Peltzer, Karl; Simbayi, Leickness; Banyini, Mercy; Kekana, Queen

2011-01-01

The aim of this study was to test a 180-minute group HIV risk-reduction counseling intervention trial with men undergoing traditional circumcision in South Africa to reduce behavioral disinhibition (false security) as a result of the procedure. A cluster randomized controlled trial design was employed using a sample of 160 men, 80 in the experimental group and 80 in the control group. Comparisons between baseline and 3-month follow-up assessments on key behavioral outcomes were completed. We found that behavioral intentions, risk-reduction skills, and male role norms did not change in the experimental compared to the control condition. However, HIV-related stigma beliefs were significantly reduced in both conditions over time. These findings show that one small-group HIV risk-reduction intervention did not reduce sexual risk behaviors in recently traditionally circumcised men at high risk for behavioral disinhibition. Copyright © 2011 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

Quasi-experimental designs in practice-based research settings: design and implementation considerations.

PubMed

Handley, Margaret A; Schillinger, Dean; Shiboski, Stephen

2011-01-01

Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered "controlled" trials. Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings--the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.

Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial.

PubMed

Lund, Stine; Rasch, Vibeke; Hemed, Maryam; Boas, Ida Marie; Said, Azzah; Said, Khadija; Makundu, Mkoko Hassan; Nielsen, Birgitte Bruun

2014-03-26

Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse. We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting. This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality. Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74). Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings. ClinicalTrials.gov NCT01821222; http://www.clinicaltrials.gov/ct2/show/NCT01821222 (Archived by WebCite at http://www.webcitation.org/6NqxnxYn0).

A Randomized Controlled Trial of a School-Implemented School-Home Intervention for ADHD Symptoms and Impairment

ERIC Educational Resources Information Center

Pfiffner, L. J.; Rooney, M.; Haack, L.; Villodas, M.; Delucchi, K.; McBurnett, K.

2016-01-01

Objectives: This study evaluated the efficacy of a novel psychosocial intervention (Collaborative Life Skills, CLS) for primary-school students with ADHD symptoms. CLS is a 12-week program consisting of integrated school, parent, and student treatments delivered by school-based mental health providers. Using a cluster randomized design, CLS was…

Big Math for Little Kids: The Effectiveness of a Preschool and Kindergarten Mathematics Curriculum

ERIC Educational Resources Information Center

Lewis Presser, Ashley; Clements, Margaret; Ginsburg, Herbert; Ertle, Barbrina

2015-01-01

Research Findings: Big Math for Little Kids (BMLK) is a mathematics curriculum developed for use with 4- and 5-year-old children. To investigate the BMLK curriculum's effect on children's mathematics knowledge, this cluster-randomized controlled trial randomly assigned child care centers to provide mathematics instruction to children, using either…

An Evaluation of Second Step: What Are the Benefits for Youth With and Without Disabilities?

ERIC Educational Resources Information Center

Sullivan, Terri N.; Sutherland, Kevin S.; Farrell, Albert D.; Taylor, Katherine A.

2015-01-01

The impact of a school-based violence prevention program, Second Step, on peer victimization and aggression, and emotion regulation was evaluated among 457 sixth graders. A cluster-randomized trial was conducted with classrooms randomly assigned to intervention (n = 14) or control (n = 14) conditions. A repeated measures analysis of covariance on…

Apathy in nursing home residents with dementia: results from a cluster-randomized controlled trial.

PubMed

Treusch, Y; Majic, T; Page, J; Gutzmann, H; Heinz, A; Rapp, M A

2015-02-01

Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy. A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n=117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months. We found significant group differences with respect to apathy during the 10 month intervention period (F2,82=7.79, P<0.01), which reflected an increase in apathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P=0.55). Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Speckle lithography for fabricating Gaussian, quasi-random 2D structures and black silicon structures

PubMed Central

Bingi, Jayachandra; Murukeshan, Vadakke Matham

2015-01-01

Laser speckle pattern is a granular structure formed due to random coherent wavelet interference and generally considered as noise in optical systems including photolithography. Contrary to this, in this paper, we use the speckle pattern to generate predictable and controlled Gaussian random structures and quasi-random structures photo-lithographically. The random structures made using this proposed speckle lithography technique are quantified based on speckle statistics, radial distribution function (RDF) and fast Fourier transform (FFT). The control over the speckle size, density and speckle clustering facilitates the successful fabrication of black silicon with different surface structures. The controllability and tunability of randomness makes this technique a robust method for fabricating predictable 2D Gaussian random structures and black silicon structures. These structures can enhance the light trapping significantly in solar cells and hence enable improved energy harvesting. Further, this technique can enable efficient fabrication of disordered photonic structures and random media based devices. PMID:26679513

Impact of preoperative patient education on the prevention of postoperative complications after major visceral surgery: the cluster randomized controlled PEDUCAT trial.

PubMed

Klaiber, Ulla; Stephan-Paulsen, Lisa M; Bruckner, Thomas; Müller, Gisela; Auer, Silke; Farrenkopf, Ingrid; Fink, Christine; Dörr-Harim, Colette; Diener, Markus K; Büchler, Markus W; Knebel, Phillip

2018-05-24

The prevention of postoperative complications is of prime importance after complex elective abdominal operations. Preoperative patient education may prevent postoperative complications and improve patients' wellbeing, but evidence for its efficacy is poor. The aims of the PEDUCAT trial were (a) to assess the impact of preoperative patient education on postoperative complications and patient-reported outcomes in patients scheduled for elective complex visceral surgery and (b) to evaluate the feasibility of cluster randomization in this setting. Adult patients (age ≥ 18 years) scheduled for elective major visceral surgery were randomly assigned in clusters to attend a preoperative education seminar or to the control group receiving the department's standard care. Outcome measures were the postoperative complications pneumonia, deep vein thrombosis (DVT), pulmonary embolism, burst abdomen, and in-hospital fall, together with patient-reported outcomes (postoperative pain, anxiety and depression, patient satisfaction, quality of life), length of hospital stay (LOS), and postoperative mortality within 30 days after the index operation. Statistical analysis was primarily by intention to treat. In total 244 patients (60 clusters) were finally included (intervention group 138 patients; control group 106 patients). Allocation of hospital wards instead of individual patients facilitated study conduct and reduced confusion about group assignment. In the intervention and control groups respectively, pneumonia occurred in 7.4% versus 8.3% (p = 0.807), pulmonary embolism in 1.6% versus 1.0% (p = 0.707), burst abdomen in 4.2% versus 1.0% (p = 0.165), and in-hospital falls in 0.0% versus 4.2% of patients (p = 0.024). DVT did not occur in any of the patients. Mortality rates (1.4% versus 1.9%, p = 0.790) and LOS (14.2 (+/- 12.0) days versus 16.1 (+/- 15.0) days, p = 0.285) were also similar in the intervention and control groups. Cluster randomization was feasible in the setting of preoperative patient education and reduced the risk of contamination effects. The results of this trial indicate good postoperative outcomes in patients undergoing major visceral surgery without superiority of preoperative patient education compared to standard patient care at a high-volume center. However, preoperative patient education is a helpful instrument not only for teaching patients but also for training the nursing staff. German Clinical Trials Registry, DRKS00004226 . Registered on 23 October 2012. Registered 8 days after the first enrollment.

E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

PubMed

Antypas, Konstantinos; Wangberg, Silje C

2012-07-09

Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority. Trial registry http://www.clinicaltrials.gov: NCT01223170.

Safety of Spectacles for Children's Vision: A Cluster-Randomized Controlled Trial.

PubMed

Ma, Xiaochen; Congdon, Nathan; Yi, Hongmei; Zhou, Zhongqiang; Pang, Xiaopeng; Meltzer, Mirjam E; Shi, Yaojiang; He, Mingguang; Liu, Yizhi; Rozelle, Scott

2015-11-01

To study safety of children's glasses in rural China, where fear that glasses harm vision is an important barrier for families and policy makers. Exploratory analysis from a cluster-randomized, investigator-masked, controlled trial. Among primary schools (n = 252) in western China, children were randomized by school to 1 of 3 interventions: free glasses provided in class, vouchers for free glasses at a local facility, or glasses prescriptions only (Control group). The main outcome of this analysis is uncorrected visual acuity after 8 months, adjusted for baseline acuity. Among 19 934 children randomly selected for screening, 5852 myopic (spherical equivalent refractive error ≤-0.5 diopters) eyes of 3001 children (14.7%, mean age 10.5 years) had VA ≤6/12 without glasses correctable to >6/12 with glasses, and were eligible. Among these, 1903 (32.5%), 1798 (30.7%), and 2151 (36.8%) were randomized to Control, Voucher, and Free Glasses, respectively. Intention-to-treat analyses were performed on all 1831 (96.2%), 1699 (94.5%), and 2007 (93.3%) eyes of children with follow-up in Control, Voucher, and Free Glasses groups. Final visual acuity for eyes of children in the treatment groups (Free Glasses and Voucher) was significantly better than for Control children, adjusting only for baseline visual acuity (difference of 0.023 logMAR units [0.23 vision chart lines, 95% CI: 0.03, 0.43]) or for other baseline factors as well (0.025 logMAR units [0.25 lines, 95% CI 0.04, 0.45]). We found no evidence that spectacles promote decline in uncorrected vision with aging among children. Copyright © 2015 Elsevier Inc. All rights reserved.

Mitigating aflatoxin exposure to improve child growth in Eastern Kenya: study protocol for a randomized controlled trial.

PubMed

Hoffmann, Vivian; Jones, Kelly; Leroy, Jef

2015-12-03

While the few studies that have looked at the association between stunting and aflatoxin exposure have found surprisingly large effects, the results remain inconclusive due to a lack of randomized controlled studies. This protocol describes a non-blinded, cluster-randomized controlled trial with the specific objective of testing the impact of reduced aflatoxin exposure on (individual) child linear growth. Participants were recruited from among households containing women in the last 5 months of pregnancy in 28 maize-growing villages within Meru and Tharaka-Nithi Counties in Kenya. Households in villages assigned to the intervention group are offered rapid testing of their stored maize for the presence of aflatoxin each month; any maize found to contain more than 10 ppb aflatoxin is replaced with an equal amount of maize that contains less than this concentration of the toxin. They are also offered the opportunity to buy maize that has been tested and found to contain less than 10 ppb aflatoxin at local shops. Clusters (villages) were allocated to the intervention group (28 villages containing 687 participating households) or control group (28 villages containing 536 participating households) using a random number generator. The trial, which is funded by United Kingdom (UK) aid from the UK government, the Global Food Security Portal, and the Ministry for Foreign Affairs of Finland, is currently ongoing. This study is the first randomized controlled trial (RCT) to test for a causal impact of aflatoxin exposure on child growth. Whether or not this relationship is found, its results will have implications for the prioritization of aflatoxin control efforts by governments in affected regions, as well as international donors. American Economic Association RCT Registry # 0000105 . Initial registration date: 6 November 2013, last updated 30 December 2014.

A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol.

PubMed

Hoque, Dewan Md Emdadul; Chowdhury, Mohiuddin Ahsanul Kabir; Rahman, Ahmed Ehsanur; Billah, Sk Masum; Bari, Sanwarul; Tahsina, Tazeen; Hasan, Mohammad Mehedi; Islam, Sajia; Islam, Tajul; Mori, Rintaro; Arifeen, Shams El

2018-05-03

Despite considerable progress in reduction of both under-five and maternal mortality in recent decades, Bangladesh is still one of the low and middle income countries with high burden of maternal and neonatal mortality. The primary objective of the current study is to measure the impact of a comprehensive package of interventions on maternal and neonatal mortality. In addition, changes in coverage, quality and utilization of maternal and newborn health (MNH) services, social capital, and cost effectiveness of the interventions will be measured. A community-based, cluster randomized controlled trial design will be adopted and implemented in 30 unions of three sub-districts of Chandpur district of Bangladesh. Every union, the lowest administrative unit of the local government with population of around 20,000-30,000, will be considered a cluster. Based on the baseline estimates, 15 clusters will be paired for random assignment as intervention and comparison clusters. The primary outcome measure is neonatal mortality, and secondary outcomes are coverage of key interventions like ANC, PNC, facility and skilled provider delivery. Baseline, midterm and endline household survey will be conducted to assess the key coverage of interventions. Health facility assessment surveys will be conducted periodically to assess facility readiness and utilization of MNH services in the participating health facilities. The current study is expected to provide essential strong evidences on the impact of a comprehensive package of interventions to the Bangladesh government, and other developmental partners. The study results may help in prioritizing, planning, and scaling-up of Safe Motherhood Promotional interventions in other geographical areas of Bangladesh as well as to inform other developing countries of similar settings. NCT03032276 .

Epidemiology of bovine brucellosis in Costa Rica: Lessons learned from failures in the control of the disease

PubMed Central

Hernández-Mora, Gabriela; Ruiz-Villalobos, Nazareth; Bonilla-Montoya, Roberto; Romero-Zúniga, Juan-José; Jiménez-Arias, Julio; González-Barrientos, Rocío; Barquero-Calvo, Elías; Chacón-Díaz, Carlos; Rojas, Norman; Chaves-Olarte, Esteban; Guzmán-Verri, Caterina

2017-01-01

Brucellosis, caused by Brucella abortus is a major disease of cattle and a zoonosis. In order to estimate the bovine brucellosis prevalence in Costa Rica (CR), a total 765 herds (13078 bovines) from six regions of CR were randomly sampled during 2012–2013. A non-random sample of 7907 herds (532199 bovines) of the six regions, arriving for diagnoses during 2014–2016 to the Costa Rican Animal Health Service was also studied. The prevalence estimated by Rose Bengal test (RBT) ranged from 10.5%-11.4%; alternatively, the prevalence estimated by testing the RBT positives in iELISA, ranged from 4.1%-6.0%, respectively. However, cattle in CR are not vaccinated with B. abortus S19 but with RB51 (vaccination coverage close to 11%), and under these conditions the RBT displays 99% specificity and 99% sensitivity. Therefore, the RBT herd depicted in the random analysis stands as a feasible assessment and then, the recommended value in case of planning an eradication program in CR. Studies of three decades reveled that bovine brucellosis prevalence has increased in CR. B. abortus was identified by biochemical and molecular studies as the etiological agent of bovine brucellosis. Multiple locus variable-number tandem repeat analysis-16 revealed four B. abortus clusters. Cluster one and three are intertwined with isolates from other countries, while clusters two and four have only representatives from CR. Cluster one is widely distributed in all regions of the country and may be the primary B. abortus source. The other clusters seem to be restricted to specific areas in CR. The implications of our findings, in relation to the control of the disease in CR, are critically discussed. PMID:28797045

Epidemiology of bovine brucellosis in Costa Rica: Lessons learned from failures in the control of the disease.

PubMed

Hernández-Mora, Gabriela; Ruiz-Villalobos, Nazareth; Bonilla-Montoya, Roberto; Romero-Zúniga, Juan-José; Jiménez-Arias, Julio; González-Barrientos, Rocío; Barquero-Calvo, Elías; Chacón-Díaz, Carlos; Rojas, Norman; Chaves-Olarte, Esteban; Guzmán-Verri, Caterina; Moreno, Edgardo

2017-01-01

Brucellosis, caused by Brucella abortus is a major disease of cattle and a zoonosis. In order to estimate the bovine brucellosis prevalence in Costa Rica (CR), a total 765 herds (13078 bovines) from six regions of CR were randomly sampled during 2012-2013. A non-random sample of 7907 herds (532199 bovines) of the six regions, arriving for diagnoses during 2014-2016 to the Costa Rican Animal Health Service was also studied. The prevalence estimated by Rose Bengal test (RBT) ranged from 10.5%-11.4%; alternatively, the prevalence estimated by testing the RBT positives in iELISA, ranged from 4.1%-6.0%, respectively. However, cattle in CR are not vaccinated with B. abortus S19 but with RB51 (vaccination coverage close to 11%), and under these conditions the RBT displays 99% specificity and 99% sensitivity. Therefore, the RBT herd depicted in the random analysis stands as a feasible assessment and then, the recommended value in case of planning an eradication program in CR. Studies of three decades reveled that bovine brucellosis prevalence has increased in CR. B. abortus was identified by biochemical and molecular studies as the etiological agent of bovine brucellosis. Multiple locus variable-number tandem repeat analysis-16 revealed four B. abortus clusters. Cluster one and three are intertwined with isolates from other countries, while clusters two and four have only representatives from CR. Cluster one is widely distributed in all regions of the country and may be the primary B. abortus source. The other clusters seem to be restricted to specific areas in CR. The implications of our findings, in relation to the control of the disease in CR, are critically discussed.

Case-control geographic clustering for residential histories accounting for risk factors and covariates.

PubMed

Jacquez, Geoffrey M; Meliker, Jaymie R; Avruskin, Gillian A; Goovaerts, Pierre; Kaufmann, Andy; Wilson, Mark L; Nriagu, Jerome

2006-08-03

Methods for analyzing space-time variation in risk in case-control studies typically ignore residential mobility. We develop an approach for analyzing case-control data for mobile individuals and apply it to study bladder cancer in 11 counties in southeastern Michigan. At this time data collection is incomplete and no inferences should be drawn - we analyze these data to demonstrate the novel methods. Global, local and focused clustering of residential histories for 219 cases and 437 controls is quantified using time-dependent nearest neighbor relationships. Business address histories for 268 industries that release known or suspected bladder cancer carcinogens are analyzed. A logistic model accounting for smoking, gender, age, race and education specifies the probability of being a case, and is incorporated into the cluster randomization procedures. Sensitivity of clustering to definition of the proximity metric is assessed for 1 to 75 k nearest neighbors. Global clustering is partly explained by the covariates but remains statistically significant at 12 of the 14 levels of k considered. After accounting for the covariates 26 Local clusters are found in Lapeer, Ingham, Oakland and Jackson counties, with the clusters in Ingham and Oakland counties appearing in 1950 and persisting to the present. Statistically significant focused clusters are found about the business address histories of 22 industries located in Oakland (19 clusters), Ingham (2) and Jackson (1) counties. Clusters in central and southeastern Oakland County appear in the 1930's and persist to the present day. These methods provide a systematic approach for evaluating a series of increasingly realistic alternative hypotheses regarding the sources of excess risk. So long as selection of cases and controls is population-based and not geographically biased, these tools can provide insights into geographic risk factors that were not specifically assessed in the case-control study design.

Reduced frequency and severity of residential fires following delivery of fire prevention education by on-duty fire fighters: cluster randomized controlled study.

PubMed

Clare, Joseph; Garis, Len; Plecas, Darryl; Jennings, Charles

2012-04-01

In 2008, Surrey Fire Services, British Columbia, commenced a firefighter-delivered, door-to-door fire-prevention education and smoke alarm examination/installation initiative with the intention of reducing the frequency and severity of residential structure fires in the City of Surrey. High-risk zones within the city were identified and 18,473 home visits were undertaken across seven temporal delivery cohorts (13.8% of non-apartment dwellings in the city). The frequency and severity of fires pre- and post- the home visit intervention was examined in comparison to randomized high-risk cluster controls. Overall, the frequency of fires was found to have reduced in the city overall, however, the reduction in the intervention cohorts was significantly larger than for controls. Furthermore, when fires did occur within the intervention cohorts, smoke detectors were activated more frequently and the fires were confined to the object of origin more often post-home visits. No equivalent pattern was observed for the cluster control. On-duty fire fighters can reduce the frequency and severity of residential fires through targeted, door-to-door distribution of fire prevention education in high-risk areas. Copyright © 2012 Elsevier Ltd. All rights reserved.

Effectiveness of a community-based nutrition programme to improve child growth in rural Ethiopia: a cluster randomized trial.

PubMed

Kang, Yunhee; Kim, Sungtae; Sinamo, Sisay; Christian, Parul

2017-01-01

Few trials have shown that promoting complementary feeding among young children is effective in improving child linear growth in resource-challenged settings. We designed a community-based participatory nutrition promotion (CPNP) programme adapting a Positive Deviance/Hearth approach that engaged mothers in 2-week nutrition sessions using the principles of 'learning by doing' around child feeding. We aimed to test the effectiveness of the CPNP for improving child growth in rural Ethiopia. A cluster randomized trial was implemented by adding the CPNP to the existing government nutrition programmes (six clusters) vs. government programmes only (six clusters). A total of 1790 children aged 6 to 12 months (876 in the intervention and 914 in the control areas) were enrolled and assessed on anthropometry every 3 months for a year. Multi-level mixed-effect regression analysis of longitudinal outcome data (n = 1475) examined the programme impact on growth, adjusting for clustering and enrollment characteristics. Compared with children 6 to 24 months of age in the control area, those in the intervention area had a greater increase in z scores for length-for-age [difference (diff): 0.021 z score/month, 95% CI: 0.008, 0.034] and weight-for-length (diff: 0.042 z score/month, 95% CI: 0.024, 0.059). At the end of the 12-month follow-up, children in the intervention area showed an 8.1% (P = 0.02) and 6.3% (P = 0.046) lower prevalence of stunting and underweight, respectively, after controlling for differences in the prevalence at enrollment, compared with the control group. A novel CPNP programme was effective in improving child growth and reducing undernutrition in this setting. © 2016 John Wiley & Sons Ltd. © 2016 John Wiley & Sons Ltd.

Using Social-Emotional and Character Development to Improve Academic Outcomes: A Matched-Pair, Cluster-Randomized Controlled Trial in Low-Income, Urban Schools

ERIC Educational Resources Information Center

Bavarian, Niloofar; Lewis, Kendra M.; DuBois, David L.; Acock, Alan; Vuchinich, Samuel; Silverthorn, Naida; Snyder, Frank J.; Day, Joseph; Ji, Peter; Flay, Brian R.

2013-01-01

Background: School-based social-emotional and character development (SECD) programs can influence not only SECD but also academic-related outcomes. This study evaluated the impact of one SECD program, Positive Action (PA), on educational outcomes among low-income, urban youth. Methods: The longitudinal study used a matched-pair, cluster-randomized…

Correction to: The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial.

PubMed

Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohamed; Azizan, Nurul Ain; Hairi, Farizah Mohd; Thangiah, Nithiah; Dahlui, Maznah; Bulgiba, Awang; Murray, Liam J

2017-11-06

After publication of the article [1], it has been brought to our attention that the methodology outlined in the original article was not able to be fully carried out. The article planned a two armed randomized control trial. However, due to a lower response than expected and one housing complex dropping out from the study, the method was changed to pre- and post-intervention with no control group. All other methods were conducted as outlined in the original article.

Clustering effects in ionic polymers: Molecular dynamics simulations

DOE PAGES

Agrawal, Anupriya; Perahia, Dvora; Grest, Gary S.

2015-08-18

Ionic clusters control the structure, dynamics, and transport in soft matter. Incorporating a small fraction of ionizable groups in polymers substantially reduces the mobility of the macromolecules in melts. Furthermore, these ionic groups often associate into random clusters in melts, where the distribution and morphology of the clusters impact the transport in these materials. Here, using molecular dynamic simulations we demonstrate a clear correlation between cluster size and morphology with the polymer mobility in melts of sulfonated polystyrene. We show that in low dielectric media ladderlike clusters that are lower in energy compared with spherical assemblies are formed. Reducing themore » electrostatic interactions by enhancing the dielectric constant leads to morphological transformation from ladderlike clusters to globular assemblies. Finally, decrease in electrostatic interaction significantly enhances the mobility of the polymer.« less

Extending cluster Lot Quality Assurance Sampling designs for surveillance programs

PubMed Central

Hund, Lauren; Pagano, Marcello

2014-01-01

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance based on the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible non-parametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. PMID:24633656

Extending cluster lot quality assurance sampling designs for surveillance programs.

PubMed

Hund, Lauren; Pagano, Marcello

2014-07-20

Lot quality assurance sampling (LQAS) has a long history of applications in industrial quality control. LQAS is frequently used for rapid surveillance in global health settings, with areas classified as poor or acceptable performance on the basis of the binary classification of an indicator. Historically, LQAS surveys have relied on simple random samples from the population; however, implementing two-stage cluster designs for surveillance sampling is often more cost-effective than simple random sampling. By applying survey sampling results to the binary classification procedure, we develop a simple and flexible nonparametric procedure to incorporate clustering effects into the LQAS sample design to appropriately inflate the sample size, accommodating finite numbers of clusters in the population when relevant. We use this framework to then discuss principled selection of survey design parameters in longitudinal surveillance programs. We apply this framework to design surveys to detect rises in malnutrition prevalence in nutrition surveillance programs in Kenya and South Sudan, accounting for clustering within villages. By combining historical information with data from previous surveys, we design surveys to detect spikes in the childhood malnutrition rate. Copyright © 2014 John Wiley & Sons, Ltd.

Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial

PubMed Central

2012-01-01

Background Hand hygiene is considered as an important means of infection control. We explored whether guided hand hygiene together with transmission-limiting behaviour reduces infection episodes and lost days of work in a common work environment in an open cluster-randomized 3-arm intervention trial. Methods A total of 21 clusters (683 persons) were randomized to implement hand hygiene with soap and water (257 persons), with alcohol-based hand rub (202 persons), or to serve as a control (224 persons). Participants in both intervention arms also received standardized instructions on how to limit the transmission of infections. The intervention period (16 months) included the emergence of the 2009 influenza pandemic and the subsequent national hand hygiene campaign influencing also the control arm. Results In the total follow-up period there was a 6.7% reduction of infection episodes in the soap-and water arm (p = 0.04). Before the onset of the anti-pandemic campaign, a statistically significant (p = 0.002) difference in the mean occurrence of infection episodes was observed between the control (6.0 per year) and the soap-and-water arm (5.0 per year) but not between the control and the alcohol-rub arm (5.6 per year). Neither intervention had a decreasing effect on absence from work. Conclusions We conclude that intensified hand hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment. Surprisingly, the occurrence of reported sick leaves also increased in the soap-and water-arm. Trial Registration ClinicalTrials.gov: NCT00981877 Source of funding The Finnish Work Environment Fund and the National Institute for Health and Welfare. PMID:22243622

Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial.

PubMed

Savolainen-Kopra, Carita; Haapakoski, Jaason; Peltola, Piia A; Ziegler, Thedi; Korpela, Terttu; Anttila, Pirjo; Amiryousefi, Ali; Huovinen, Pentti; Huvinen, Markku; Noronen, Heikki; Riikkala, Pia; Roivainen, Merja; Ruutu, Petri; Teirilä, Juha; Vartiainen, Erkki; Hovi, Tapani

2012-01-16

Hand hygiene is considered as an important means of infection control. We explored whether guided hand hygiene together with transmission-limiting behaviour reduces infection episodes and lost days of work in a common work environment in an open cluster-randomized 3-arm intervention trial. A total of 21 clusters (683 persons) were randomized to implement hand hygiene with soap and water (257 persons), with alcohol-based hand rub (202 persons), or to serve as a control (224 persons). Participants in both intervention arms also received standardized instructions on how to limit the transmission of infections. The intervention period (16 months) included the emergence of the 2009 influenza pandemic and the subsequent national hand hygiene campaign influencing also the control arm. In the total follow-up period there was a 6.7% reduction of infection episodes in the soap-and water arm (p = 0.04). Before the onset of the anti-pandemic campaign, a statistically significant (p = 0.002) difference in the mean occurrence of infection episodes was observed between the control (6.0 per year) and the soap-and-water arm (5.0 per year) but not between the control and the alcohol-rub arm (5.6 per year). Neither intervention had a decreasing effect on absence from work. We conclude that intensified hand hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment. Surprisingly, the occurrence of reported sick leaves also increased in the soap-and water-arm. ClinicalTrials.gov: NCT00981877 The Finnish Work Environment Fund and the National Institute for Health and Welfare.

Does poverty alleviation decrease depression symptoms in post-conflict settings? A cluster-randomized trial of microenterprise assistance in Northern Uganda.

PubMed

Green, E P; Blattman, C; Jamison, J; Annan, J

2016-01-01

By 2009, two decades of war and widespread displacement left the majority of the population of Northern Uganda impoverished. This study used a cluster-randomized design to test the hypothesis that a poverty alleviation program would improve economic security and reduce symptoms of depression in a sample of mostly young women. Roughly 120 villages in Northern Uganda were invited to participate. Community committees were asked to identify the most vulnerable women (and some men) to participate. The implementing agency screened all proposed participants, and a total of 1800 were enrolled. Following a baseline survey, villages were randomized to a treatment or wait-list control group. Participants in treatment villages received training, start-up capital, and follow-up support. Participants, implementers, and data collectors were not blinded to treatment status. Villages were randomized to the treatment group (60 villages with 896 participants) or the wait-list control group (60 villages with 904 participants) with an allocation ration of 1:1. All clusters participated in the intervention and were included in the analysis. The intent-to-treat analysis included 860 treatment participants and 866 control participants (4.1% attrition). Sixteen months after the program, monthly cash earnings doubled from UGX 22 523 to 51 124, non-household and non-farm businesses doubled, and cash savings roughly quadrupled. There was no measurable effect on a locally derived measure of symptoms of depression. Despite finding large increases in business, income, and savings among the treatment group, we do not find support for an indirect effect of poverty alleviation on symptoms of depression.

Community involvement in dengue vector control: cluster randomised trial.

PubMed

Vanlerberghe, V; Toledo, M E; Rodríguez, M; Gómez, D; Baly, A; Benítez, J R; Van der Stuyft, P

2010-01-01

To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Design Cluster randomised trial. Setting Guantanamo, Cuba. Participants 32 circumscriptions (around 2000 inhabitants each). Interventions The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, source reduction, selective adulticiding, and health education) and to intervention clusters (n=16) comprising the routine Aedes control programme combined with a community based environmental management approach. The primary outcome was levels of Aedes infestation: house index (number of houses positive for at least one container with immature stages of Ae aegypti per 100 inspected houses), Breteau index (number of containers positive for immature stages of Ae aegypti per 100 inspected houses), and the pupae per inhabitant statistic (number of Ae aegypti pupae per inhabitant). All clusters were subjected to the intended intervention; all completed the study protocol up to February 2006 and all were included in the analysis. At baseline the Aedes infestation levels were comparable between intervention and control clusters: house index 0.25% v 0.20%, pupae per inhabitant 0.44 x 10(-3) v 0.29 x 10(-3). At the end of the intervention these indices were significantly lower in the intervention clusters: rate ratio for house indices 0.49 (95% confidence interval 0.27 to 0.88) and rate ratio for pupae per inhabitant 0.27 (0.09 to 0.76). A community based environmental management embedded in a routine control programme was effective at reducing levels of Aedes infestation. Trial Registration Current Controlled Trials ISRCTN88405796.

Community involvement in dengue vector control: cluster randomised trial.

PubMed

Vanlerberghe, V; Toledo, M E; Rodríguez, M; Gomez, D; Baly, A; Benitez, J R; Van der Stuyft, P

2009-06-09

To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Cluster randomised trial. Guantanamo, Cuba. 32 circumscriptions (around 2000 inhabitants each). The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, source reduction, selective adulticiding, and health education) and to intervention clusters (n=16) comprising the routine Aedes control programme combined with a community based environmental management approach. The primary outcome was levels of Aedes infestation: house index (number of houses positive for at least one container with immature stages of Ae aegypti per 100 inspected houses), Breteau index (number of containers positive for immature stages of Ae aegypti per 100 inspected houses), and the pupae per inhabitant statistic (number of Ae aegypti pupae per inhabitant). All clusters were subjected to the intended intervention; all completed the study protocol up to February 2006 and all were included in the analysis. At baseline the Aedes infestation levels were comparable between intervention and control clusters: house index 0.25% v 0.20%, pupae per inhabitant 0.44x10(-3) v 0.29x10(-3). At the end of the intervention these indices were significantly lower in the intervention clusters: rate ratio for house indices 0.49 (95% confidence interval 0.27 to 0.88) and rate ratio for pupae per inhabitant 0.27 (0.09 to 0.76). A community based environmental management embedded in a routine control programme was effective at reducing levels of Aedes infestation. Current Controlled Trials ISRCTN88405796.

Applying the Transtheoretical Model to evaluate the effect of a call-recall program in enhancing Pap smear practice: a cluster randomized trial.

PubMed

Abdullah, Fauziah; Su, Tin Tin

2013-01-01

The objective of this study was to evaluate the effect of a call-recall approach in enhancing Pap smear practice by changes of motivation stage among non-compliant women. A cluster randomized controlled trial with parallel and un-blinded design was conducted between January and November 2010 in 40 public secondary schools in Malaysia among 403 female teachers who never or infrequently attended for a Pap test. A cluster randomization was applied in assigning schools to both groups. An intervention group received an invitation and reminder (call-recall program) for a Pap test (20 schools with 201 participants), while the control group received usual care from the existing cervical screening program (20 schools with 202 participants). Multivariate logistic regression was performed to determine the effect of the intervention program on the action stage (Pap smear uptake) at 24 weeks. In both groups, pre-contemplation stage was found as the highest proportion of changes in stages. At 24 weeks, an intervention group showed two times more in the action stage than control group (adjusted odds ratio 2.44, 95% CI 1.29-4.62). The positive effect of a call-recall approach in motivating women to change the behavior of screening practice should be appreciated by policy makers and health care providers in developing countries as an intervention to enhance Pap smear uptake. Copyright © 2013 Elsevier Inc. All rights reserved.

Impact of adding hand-washing and water disinfection promotion to oral cholera vaccination on diarrhoea-associated hospitalization in Dhaka, Bangladesh: evidence from a cluster randomized control trial

PubMed Central

Najnin, Nusrat; Leder, Karin; Qadri, Firdausi; Forbes, Andrew; Unicomb, Leanne; Winch, Peter J; Ram, Pavani K; Leontsini, Elli; Nizame, Fosiul A; Arman, Shaila; Begum, Farzana; Biswas, Shwapon K; Clemens, John D; Ali, Mohammad; Cravioto, Alejandro; Luby, Stephen P

2017-01-01

Abstract Background Information on the impact of hygiene interventions on severe outcomes is limited. As a pre-specified secondary outcome of a cluster-randomized controlled trial among >400 000 low-income residents in Dhaka, Bangladesh, we examined the impact of cholera vaccination plus a behaviour change intervention on diarrhoea-associated hospitalization. Methods Ninety neighbourhood clusters were randomly allocated into three areas: cholera-vaccine-only; vaccine-plus-behaviour-change (promotion of hand-washing with soap plus drinking water chlorination); and control. Study follow-up continued for 2 years after intervention began. We calculated cluster-adjusted diarrhoea-associated hospitalization rates using data we collected from nearby hospitals, and 6-monthly census data of all trial households. Results A total of 429 995 people contributed 500 700 person-years of data (average follow-up 1.13 years). Vaccine coverage was 58% at the start of analysis but continued to drop due to population migration. In the vaccine-plus-behaviour-change area, water plus soap was present at 45% of hand-washing stations; 4% of households had detectable chlorine in stored drinking water. Hospitalization rates were similar across the study areas [events/1000 person-years, 95% confidence interval (CI), cholera-vaccine-only: 9.4 (95% CI: 8.3–10.6); vaccine-plus-behaviour-change: 9.6 (95% CI: 8.3–11.1); control: 9.7 (95% CI: 8.3–11.6)]. Cholera cases accounted for 7% of total number of diarrhoea-associated hospitalizations. Conclusions Neither cholera vaccination alone nor cholera vaccination combined with behaviour-change intervention efforts measurably reduced diarrhoea-associated hospitalization in this highly mobile population, during a time when cholera accounted for a small fraction of diarrhoea episodes. Affordable community-level interventions that prevent infection from multiple pathogens by reliably separating faeces from the environment, food and water, with minimal behavioural demands on impoverished communities, remain an important area for research. PMID:29025064

Assessing the feasibility of interrupting the transmission of soil-transmitted helminths through mass drug administration: The DeWorm3 cluster randomized trial protocol.

PubMed

Ásbjörnsdóttir, Kristjana Hrönn; Ajjampur, Sitara S Rao; Anderson, Roy M; Bailey, Robin; Gardiner, Iain; Halliday, Katherine E; Ibikounle, Moudachirou; Kalua, Khumbo; Kang, Gagandeep; Littlewood, D Timothy J; Luty, Adrian J F; Means, Arianna Rubin; Oswald, William; Pullan, Rachel L; Sarkar, Rajiv; Schär, Fabian; Szpiro, Adam; Truscott, James E; Werkman, Marleen; Yard, Elodie; Walson, Judd L

2018-01-01

Current control strategies for soil-transmitted helminths (STH) emphasize morbidity control through mass drug administration (MDA) targeting preschool- and school-age children, women of childbearing age and adults in certain high-risk occupations such as agricultural laborers or miners. This strategy is effective at reducing morbidity in those treated but, without massive economic development, it is unlikely it will interrupt transmission. MDA will therefore need to continue indefinitely to maintain benefit. Mathematical models suggest that transmission interruption may be achievable through MDA alone, provided that all age groups are targeted with high coverage. The DeWorm3 Project will test the feasibility of interrupting STH transmission using biannual MDA targeting all age groups. Study sites (population ≥80,000) have been identified in Benin, Malawi and India. Each site will be divided into 40 clusters, to be randomized 1:1 to three years of twice-annual community-wide MDA or standard-of-care MDA, typically annual school-based deworming. Community-wide MDA will be delivered door-to-door, while standard-of-care MDA will be delivered according to national guidelines. The primary outcome is transmission interruption of the STH species present at each site, defined as weighted cluster-level prevalence ≤2% by quantitative polymerase chain reaction (qPCR), 24 months after the final round of MDA. Secondary outcomes include the endline prevalence of STH, overall and by species, and the endline prevalence of STH among children under five as an indicator of incident infections. Secondary analyses will identify cluster-level factors associated with transmission interruption. Prevalence will be assessed using qPCR of stool samples collected from a random sample of cluster residents at baseline, six months after the final round of MDA and 24 months post-MDA. A smaller number of individuals in each cluster will be followed with annual sampling to monitor trends in prevalence and reinfection throughout the trial. ClinicalTrials.gov NCT03014167.

The Role of Melatonin in the Treatment of Primary Headache Disorders

PubMed Central

Gelfand, Amy A.; Goadsby, Peter J.

2016-01-01

Objective To provide a summary of knowledge about the use of melatonin in the treatment of primary headache disorders. Background Melatonin is secreted by the pineal gland; its production is regulated by the hypothalamus and increases during periods of darkness. Methods We undertook a narrative review of the literature on the role of melatonin in the treatment of primary headache disorders. Results There are randomized placebo-controlled trials examining melatonin for preventive treatment of migraine and cluster headache. For cluster headache, melatonin 10 mg was superior to placebo. For migraine, a randomized placebo-controlled trial of melatonin 3 mg (immediate release) was positive, though an underpowered trial of melatonin 2 mg (sustained release) was negative. Uncontrolled studies, case series, and case reports cover melatonin’s role in treating tension-type headache, hypnic headache, hemicrania continua, SUNCT/SUNA and primary stabbing headache. Conclusions Melatonin may be effective in treating several primary headache disorders, particularly cluster headache and migraine. Future research should focus on elucidating the underlying mechanisms of benefit of melatonin in different headache disorders, as well as clarifying optimal dosing and formulation. PMID:27316772

Three estimates of the association between linear growth failure and cognitive ability.

PubMed

Cheung, Y B; Lam, K F

2009-09-01

To compare three estimators of association between growth stunting as measured by height-for-age Z-score and cognitive ability in children, and to examine the extent statistical adjustment for covariates is useful for removing confounding due to socio-economic status. Three estimators, namely random-effects, within- and between-cluster estimators, for panel data were used to estimate the association in a survey of 1105 pairs of siblings who were assessed for anthropometry and cognition. Furthermore, a 'combined' model was formulated to simultaneously provide the within- and between-cluster estimates. Random-effects and between-cluster estimators showed strong association between linear growth and cognitive ability, even after adjustment for a range of socio-economic variables. In contrast, the within-cluster estimator showed a much more modest association: For every increase of one Z-score in linear growth, cognitive ability increased by about 0.08 standard deviation (P < 0.001). The combined model verified that the between-cluster estimate was significantly larger than the within-cluster estimate (P = 0.004). Residual confounding by socio-economic situations may explain a substantial proportion of the observed association between linear growth and cognition in studies that attempt to control the confounding by means of multivariable regression analysis. The within-cluster estimator provides more convincing and modest results about the strength of association.

A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial.

PubMed

Berwanger, Otávio; Guimarães, Hélio P; Laranjeira, Ligia N; Cavalcanti, Alexandre B; Kodama, Alessandra; Zazula, Ana Denise; Santucci, Eliana; Victor, Elivane; Flato, Uri A; Tenuta, Marcos; Carvalho, Vitor; Mira, Vera Lucia; Pieper, Karen S; Mota, Luiz Henrique; Peterson, Eric D; Lopes, Renato D

2012-03-01

Translating evidence into clinical practice in the management of acute coronary syndromes (ACS) is challenging. Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes. We designed a pragmatic, 2-arm, cluster-randomized trial involving 34 clusters (Brazilian public hospitals). Clusters were randomized to receive a multifaceted quality improvement intervention (experimental group) or routine practice (control group). The 6-month educational intervention included reminders, care algorithms, a case manager, and distribution of educational materials to health care providers. The primary end point was a composite of evidence-based post-ACS therapies within 24 hours of admission, with the secondary measure of major cardiovascular clinical events (death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke). Prescription of evidence-based therapies at hospital discharge were also evaluated as part of the secondary outcomes. All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling (generalized estimating equations). If proven effective, this multifaceted intervention would have wide use as a means of promoting optimal use of evidence-based interventions for the management of ACS. Copyright © 2012 Mosby, Inc. All rights reserved.

Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial.

PubMed

Margolis, Karen L; Kerby, Tessa J; Asche, Stephen E; Bergdall, Anna R; Maciosek, Michael V; O'Connor, Patrick J; Sperl-Hillen, JoAnn M

2012-07-01

Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. The Home Blood Pressure Telemonitoring and Case Management to Control Hypertension study (HyperLink) is a cluster-randomized trial designed to determine whether an intervention that combines home BP telemonitoring with pharmacist case management improves BP control compared to usual care at 6 and 12 months in patients with uncontrolled hypertension. Secondary outcomes are maintenance of BP control at 18 months, patient satisfaction with their health care, and costs of care. HyperLink enrolled 450 hypertensive patients with uncontrolled BP from 16 primary care clinics. Eight clinics were randomized to provide usual care (UC) to their patients (n=222) and 8 were randomized to provide the telemonitoring intervention (TI) (n=228). TI patients received home BP telemonitors that internally store and electronically transmit BP data to a secure database. Pharmacist case managers adjust antihypertensive therapy based on the home BP data under a collaborative practice agreement with the clinics' primary care teams. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention. We will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care. Copyright © 2012 Elsevier Inc. All rights reserved.

A Cluster Randomized Trial of the Social Skills Improvement System-Classwide Intervention Program (SSIS-CIP) in First Grade

ERIC Educational Resources Information Center

DiPerna, James Clyde; Lei, Puiwa; Cheng, Weiyi; Hart, Susan Crandall; Bellinger, Jillian

2018-01-01

The purpose of this study was to evaluate the efficacy of a universal social skills program, the Social Skills Improvement System Classwide Intervention Program (SSIS-CIP; Elliott & Gresham, 2007), for students in first grade. Classrooms from 6 elementary schools were randomly assigned to treatment or business-as-usual control conditions.…

Universal-Based Prevention of Syndromal and Subsyndromal Social Anxiety: A Randomized Controlled Study

ERIC Educational Resources Information Center

Aune, Tore; Stiles, Tore C.

2009-01-01

This article reports results from a universal preventive program aimed at (a) reducing social anxiety and (b) preventing the development of syndromal social anxiety among a population-based sample of older children and young adolescents during a 1-year period. Pupils (N = 1,748) from 2 counties were cluster randomized to either an intervention or…

Yoga Improves Academic Performance in Urban High School Students Compared to Physical Education: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Hagins, Marshall; Rundle, Andrew

2016-01-01

Yoga programs within schools have become more widespread but research regarding the potential effect on academic achievement remains limited. This study cluster-randomized 112 students within a single New York City public high school to participate in either school-based yoga or physical education (PE) for an entire academic year. The primary…

Impacts of an Enhanced Family Health and Sexuality Module of the HealthTeacher Middle School Curriculum: A Cluster Randomized Trial

PubMed Central

Scott, Mindy E.; Cook, Elizabeth

2016-01-01

Objectives. To evaluate the impacts of an enhanced version of the Family Life and Sexuality Module of the HealthTeacher middle school curriculum. Methods. We conducted a cluster randomized trial of Chicago, Illinois, middle schools. We randomly assigned schools to a treatment group that received the intervention during the 2010–2011 school year or a control group that did not. The primary analysis sample included 595 students (7 schools) in the treatment group and 594 students (7 schools) in the control group. Results. Students in the treatment schools reported greater exposure to information on reproductive health topics such as sexually transmitted infections (STIs; 78% vs 60%; P < .01), abstinence (64% vs 37%; P < .01), and birth control (45% vs 29%; P < .01). They also reported higher average scores on an index of knowledge of contraceptive methods and STI transmission (0.5 vs 0.3; P = .02). We found no statistically significant differences in rates of sexual intercourse (12% vs 12%; P = .99), oral sex (12% vs 9%; P = .18), or other intermediate outcomes. Conclusions. The program had modest effects when tested among Chicago middle school students. PMID:27689479

Impact of Free Glasses and a Teacher Incentive on Children's Use of Eyeglasses: A Cluster-Randomized Controlled Trial.

PubMed

Yi, Hongmei; Zhang, Haiqing; Ma, Xiaochen; Zhang, Linxiu; Wang, Xiuqin; Jin, Ling; Naidoo, Kovin; Minto, Hasan; Zou, Haidong; Lu, Lina; Rozelle, Scott; Congdon, Nathan

2015-11-01

To study the effect of free glasses combined with teacher incentives on in-school glasses wear among Chinese urban migrant children. Cluster-randomized controlled trial. Children with visual acuity (VA) ≤6/12 in either eye owing to refractive error in 94 randomly chosen primary schools underwent randomization by school to receive free glasses, education on their use, and a teacher incentive (Intervention), or glasses prescriptions only (Control). Intervention group teachers received a tablet computer if ≥80% of children given glasses wore them during unannounced visits 6 weeks and 6 months (main outcome) after intervention. Among 4376 children, 728 (16.7%, mean age 10.9 years, 51.0% boys) met enrollment criteria and were randomly allocated, 358 (49.2%, 47 schools) to Intervention and 370 (50.8%, 47 schools) to Control. Among these, 693 children (95.2%) completed the study and underwent analysis. Spectacle wear was significantly higher at 6 months among Intervention children (Observed [main outcome]: 68.3% vs 23.9%, adjusted odds ratio [OR] = 11.5, 95% confidence interval [CI] 5.91-22.5, P < .001; Self-reported: 90.6% vs 32.1%, OR = 43.7, 95% CI = 21.7-88.5, P < .001). Other predictors of observed wear at 6 months included baseline spectacle wear (P < .001), uncorrected VA <6/18 (P = .01), and parental spectacle wear (P = .02). The 6-month observed wear rate was only 41% among similar-aged children provided free glasses in our previous trial without teacher incentives. Free spectacles and teacher incentives maintain classroom wear in the large majority of children needing glasses over a school year. Low wear among Control children demonstrates the need for interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

Dispensing good sleep health behaviours not pills--a cluster-randomized controlled trial to test the feasibility and efficacy of pharmacist-provided brief behavioural treatment for insomnia.

PubMed

Fuller, Joanne M; Wong, Keith K; Hoyos, Camilla; Krass, Ines; Saini, Bandana

2016-02-01

Behavioural therapies are recommended as the first-line treatment of insomnia; however, sedatives and hypnotics constitute the main treatment modality used in primary care. Community pharmacies provide a unique conduit for identifying and providing appropriate treatment for those with insomnia either purchasing prescription sedatives or seeking over-the-counter treatments. A feasibility study using a cluster-randomized controlled trial, testing the efficacy of trained pharmacists providing behavioural interventions such as stimulus control and sleep restriction to patients with insomnia, in improving insomnia severity was conducted. The intervention involved three pharmacy visits (baseline, 1 and 3 months follow-up). The control group received usual care and information sheets on insomnia. The primary outcome was the Insomnia Severity Index. Twelve community pharmacists (five control, seven intervention) in New South Wales, Australia were recruited and trained. These pharmacists, in turn, recruited 46 patients (22 control, 24 intervention (mean age 53.7 ± 18.4, 72% females) and delivered a brief behavioural therapy intervention. The overall decrease in Insomnia Severity Index from baseline to the 3-month follow-up in the intervention group, n = 17 (7.6 ± 4.3 points), was significantly greater than for the control group, n = 19 (2.9 ± 8.8 points) (mean difference 4.6, 95% confidence interval: 0.005-9.2, P = 0.05). However, when the effect of clustering was taken into account using a mixed-effects model, the estimated difference in Insomnia Severity Index (change from baseline to visit 3) between the intervention and control groups was not significant (group difference in Insomnia Severity Index change = 3.78, 95% confidence interval: -0.81 to 8.37, P = 0.11; intracluster correlation = 0.18). The study highlights the use of a novel venue to deliver brief behavioural therapies for insomnia using trained non-psychologist health professionals. Although, when cluster effect was taken into account, the difference in Insomnia Severity Index reduction between the intervention versus control groups was non-significant, the results highlight that reductions in insomnia severity can be gained using trained pharmacists providing brief behavioural interventions. Future research in this area is warranted, with appropriately sized studies using the conventional, robust randomized trial design. © 2015 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.

Effect on mental health of a participatory intervention to improve psychosocial work environment: a cluster randomized controlled trial among nurses.

PubMed

Uchiyama, Ayako; Odagiri, Yuko; Ohya, Yumiko; Takamiya, Tomoko; Inoue, Shigeru; Shimomitsu, Teruichi

2013-01-01

Improvement of psychosocial work environment has proved to be valuable for workers' mental health. However, limited evidence is available for the effectiveness of participatory interventions. The purpose of this study was to investigate the effect on mental health among nurses of a participatory intervention to improve the psychosocial work environment. A cluster randomized controlled trial was conducted in hospital settings. A total of 434 nurses in 24 units were randomly allocated to 11 intervention units (n=183) and 13 control units (n=218). A participatory program was provided to the intervention units for 6 months. Depressive symptoms as mental health status and psychosocial work environment, assessed by the Job Content Questionnaire, the Effort-Reward Imbalance Questionnaire, and the Quality Work Competence questionnaire, were measured before and immediately after the 6-month intervention by a self-administered questionnaire. No significant intervention effect was observed for mental health status. However, significant intervention effects were observed in psychosocial work environment aspects, such as Coworker Support (p<0.01) and Goals (p<0.01), and borderline significance was observed for Job Control (p<0.10). It is suggested that a 6-month participatory intervention is effective in improving psychosocial work environment, but not mental health, among Japanese nurses.

Integrating participatory community mobilization processes to improve dengue prevention: an eco-bio-social scaling up of local success in Machala, Ecuador.

PubMed

Mitchell-Foster, Kendra; Ayala, Efraín Beltrán; Breilh, Jaime; Spiegel, Jerry; Wilches, Ana Arichabala; Leon, Tania Ordóñez; Delgado, Jefferson Adrian

2015-02-01

This project investigates the effectiveness and feasibility of scaling-up an eco-bio-social approach for implementing an integrated community-based approach for dengue prevention in comparison with existing insecticide-based and emerging biolarvicide-based programs in an endemic setting in Machala, Ecuador. An integrated intervention strategy (IIS) for dengue prevention (an elementary school-based dengue education program, and clean patio and safe container program) was implemented in 10 intervention clusters from November 2012 to November 2013 using a randomized controlled cluster trial design (20 clusters: 10 intervention, 10 control; 100 households per cluster with 1986 total households). Current existing dengue prevention programs served as the control treatment in comparison clusters. Pupa per person index (PPI) is used as the main outcome measure. Particular attention was paid to social mobilization and empowerment with IIS. Overall, IIS was successful in reducing PPI levels in intervention communities versus control clusters, with intervention clusters in the six paired clusters that followed the study design experiencing a greater reduction of PPI compared to controls (2.2 OR, 95% CI: 1.2 to 4.7). Analysis of individual cases demonstrates that consideration for contexualizing programs and strategies to local neighborhoods can be very effective in reducing PPI for dengue transmission risk reduction. In the rapidly evolving political climate for dengue control in Ecuador, integration of successful social mobilization and empowerment strategies with existing and emerging biolarvicide-based government dengue prevention and control programs is promising in reducing PPI and dengue transmission risk in southern coastal communities like Machala. However, more profound analysis of social determination of health is called for to assess sustainability prospects. © The author 2015. The World Health Organization has granted Oxford University Press permission for the reproduction of this article.

Integrating participatory community mobilization processes to improve dengue prevention: an eco-bio-social scaling up of local success in Machala, Ecuador

PubMed Central

Mitchell-Foster, Kendra; Ayala, Efraín Beltrán; Breilh, Jaime; Spiegel, Jerry; Wilches, Ana Arichabala; Leon, Tania Ordóñez; Delgado, Jefferson Adrian

2015-01-01

Background This project investigates the effectiveness and feasibility of scaling-up an eco-bio-social approach for implementing an integrated community-based approach for dengue prevention in comparison with existing insecticide-based and emerging biolarvicide-based programs in an endemic setting in Machala, Ecuador. Methods An integrated intervention strategy (IIS) for dengue prevention (an elementary school-based dengue education program, and clean patio and safe container program) was implemented in 10 intervention clusters from November 2012 to November 2013 using a randomized controlled cluster trial design (20 clusters: 10 intervention, 10 control; 100 households per cluster with 1986 total households). Current existing dengue prevention programs served as the control treatment in comparison clusters. Pupa per person index (PPI) is used as the main outcome measure. Particular attention was paid to social mobilization and empowerment with IIS. Results Overall, IIS was successful in reducing PPI levels in intervention communities versus control clusters, with intervention clusters in the six paired clusters that followed the study design experiencing a greater reduction of PPI compared to controls (2.2 OR, 95% CI: 1.2 to 4.7). Analysis of individual cases demonstrates that consideration for contexualizing programs and strategies to local neighborhoods can be very effective in reducing PPI for dengue transmission risk reduction. Conclusions In the rapidly evolving political climate for dengue control in Ecuador, integration of successful social mobilization and empowerment strategies with existing and emerging biolarvicide-based government dengue prevention and control programs is promising in reducing PPI and dengue transmission risk in southern coastal communities like Machala. However, more profound analysis of social determination of health is called for to assess sustainability prospects. PMID:25604763

The effect of asthma education program on knowledge of school teachers: a randomized controlled trial.

PubMed

Kawafha, Mariam M; Tawalbeh, Loai Issa

2015-04-01

The purpose of this study was to examine the effect of an asthma education program on schoolteachers' knowledge. Pre-test-post-test experimental randomized controlled design was used. A multistage-cluster sampling technique was used to randomly select governorate, primary schools, and schoolteachers. Schoolteachers were randomly assigned either to the experimental group (n = 36) and attended three educational sessions or to the control group (n = 38) who did not receive any intervention. Knowledge about asthma was measured using the Asthma General Knowledge Questionnaire for Adults (AGKQA). The results indicated that teachers in the experimental group showed significantly (p < .001) higher knowledge of asthma in the first post-test and the second post-test compared with those in the control group. Implementing asthma education enhanced schoolteachers' knowledge of asthma. The asthma education program should target schoolteachers to improve knowledge about asthma. © The Author(s) 2014.

Percolation of the site random-cluster model by Monte Carlo method

NASA Astrophysics Data System (ADS)

Wang, Songsong; Zhang, Wanzhou; Ding, Chengxiang

2015-08-01

We propose a site random-cluster model by introducing an additional cluster weight in the partition function of the traditional site percolation. To simulate the model on a square lattice, we combine the color-assignation and the Swendsen-Wang methods to design a highly efficient cluster algorithm with a small critical slowing-down phenomenon. To verify whether or not it is consistent with the bond random-cluster model, we measure several quantities, such as the wrapping probability Re, the percolating cluster density P∞, and the magnetic susceptibility per site χp, as well as two exponents, such as the thermal exponent yt and the fractal dimension yh of the percolating cluster. We find that for different exponents of cluster weight q =1.5 , 2, 2.5 , 3, 3.5 , and 4, the numerical estimation of the exponents yt and yh are consistent with the theoretical values. The universalities of the site random-cluster model and the bond random-cluster model are completely identical. For larger values of q , we find obvious signatures of the first-order percolation transition by the histograms and the hysteresis loops of percolating cluster density and the energy per site. Our results are helpful for the understanding of the percolation of traditional statistical models.

A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF COMMUNITY-BASED DIETARY SODIUM REDUCTION – THE CHINA RURAL HEALTH INITIATIVE SODIUM REDUCTION STUDY

PubMed Central

Li, Nicole; Yan, Lijing L.; Niu, Wenyi; Labarthe, Darwin; Feng, Xiangxian; Shi, Jingpu; Zhang, Jianxin; Zhang, Ruijuan; Zhang, Yuhong; Chu, Hongling; Neiman, Andrea; Engelgau, Michael; Elliott, Paul; Wu, Yangfeng; Neal, Bruce

2013-01-01

Background Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. Design This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24 hour urine. Trial status The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. Discussion The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide. PMID:24176436

Effect Sizes in Cluster-Randomized Designs

ERIC Educational Resources Information Center

Hedges, Larry V.

2007-01-01

Multisite research designs involving cluster randomization are becoming increasingly important in educational and behavioral research. Researchers would like to compute effect size indexes based on the standardized mean difference to compare the results of cluster-randomized studies (and corresponding quasi-experiments) with other studies and to…

Cluster Randomized Controlled Trial Evaluation of a Gender Equity and Family Planning Intervention for Married Men and Couples in Rural India

PubMed Central

Raj, Anita; Ghule, Mohan; Ritter, Julie; Battala, Madhusudana; Gajanan, Velhal; Nair, Saritha; Dasgupta, Anindita; Silverman, Jay G.; Balaiah, Donta; Saggurti, Niranjan

2016-01-01

Background Despite ongoing recommendations to increase male engagement and gender-equity (GE) counseling in family planning (FP) services, few such programs have been implemented and rigorously evaluated. This study evaluates the impact of CHARM, a three-session GE+FP counseling intervention delivered by male health care providers to married men, alone (sessions 1&2) and with their wives (session 3) in India. Methods and Findings A two-armed cluster randomized controlled trial was conducted with young married couples (N = 1081 couples) recruited from 50 geographic clusters (25 clusters randomized to CHARM and a control condition, respectively) in rural Maharashtra, India. Couples were surveyed on demographics, contraceptive behaviors, and intimate partner violence (IPV) attitudes and behaviors at baseline and 9 &18-month follow-ups, with pregnancy testing at baseline and 18-month follow-up. Outcome effects on contraceptive use and incident pregnancy, and secondarily, on contraceptive communication and men’s IPV attitudes and behaviors, were assessed using logistic generalized linear mixed models. Most men recruited from CHARM communities (91.3%) received at least one CHARM intervention session; 52.5% received the couple’s session with their wife. Findings document that women from the CHARM condition, relative to controls, were more likely to report contraceptive communication at 9-month follow-up (AOR = 1.77, p = 0.04) and modern contraceptive use at 9 and 18-month follow-ups (AORs = 1.57–1.58, p = 0.05), and they were less likely to report sexual IPV at 18-month follow-up (AOR = 0.48, p = 0.01). Men in the CHARM condition were less likely than those in the control clusters to report attitudes accepting of sexual IPV at 9-month (AOR = 0.64, p = 0.03) and 18-month (AOR = 0.51, p = 0.004) follow-up, and attitudes accepting of physical IPV at 18-month follow-up (AOR = 0.64, p = 0.02). No significant effect on pregnancy was seen. Conclusions Findings demonstrate that men can be engaged in FP programming in rural India, and that such an approach inclusive of GE counseling can improve contraceptive practices and reduce sexual IPV in married couples. Trial Registration ClinicalTrials.gov NCT01593943 PMID:27167981

Probabilistic Analysis of Hierarchical Cluster Protocols for Wireless Sensor Networks

NASA Astrophysics Data System (ADS)

Kaj, Ingemar

Wireless sensor networks are designed to extract data from the deployment environment and combine sensing, data processing and wireless communication to provide useful information for the network users. Hundreds or thousands of small embedded units, which operate under low-energy supply and with limited access to central network control, rely on interconnecting protocols to coordinate data aggregation and transmission. Energy efficiency is crucial and it has been proposed that cluster based and distributed architectures such as LEACH are particularly suitable. We analyse the random cluster hierarchy in this protocol and provide a solution for low-energy and limited-loss optimization. Moreover, we extend these results to a multi-level version of LEACH, where clusters of nodes again self-organize to form clusters of clusters, and so on.

Effectiveness of a multifaceted implementation strategy on physicians' referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial.

PubMed

Döpp, Carola M E; Graff, Maud J L; Teerenstra, Steven; Nijhuis-van der Sanden, Maria W G; Olde Rikkert, Marcel G M; Vernooij-Dassen, Myrra J F J

2013-05-30

To evaluate the effectiveness of a multifaceted implementation strategy on physicians' referral rate to and knowledge on the community occupational therapy in dementia program (COTiD program). A cluster randomized controlled trial with 28 experimental and 17 control clusters was conducted. Cluster included a minimum of one physician, one manager, and two occupational therapists. In the control group physicians and managers received no interventions and occupational therapists received a postgraduate course. In the experimental group physicians and managers had access to a website, received newsletters, and were approached by telephone. In addition, physicians were offered one outreach visit. In the experimental group occupational therapists received the postgraduate course, training days, outreach visits, regional meetings, and access to a reporting system. Main outcome measure was the number of COTiD referrals received by each cluster which was assessed at 6 and 12 months after the start of the intervention. Referrals were included from both participating physicians (enrolled in the study and received either the control or experimental intervention) and non-participating physicians (not enrolled but of whom referrals were received by participating occupational therapists). Mixed model analyses were used to analyze the data. All analyses were based on the principle of intention-to-treat. At 12 months experimental clusters received significantly more referrals with an average of 5,24 referrals (SD 5,75) to the COTiD program compared to 2,07 referrals in the control group (SD 5,14). The effect size at 12 months was 0.58. Although no difference in referral rate was found for the physicians participating in the study, the number of referrals from non-participating physicians (t -2,55 / 43 / 0,02) differed significantly at 12 months. Passive dissemination strategies are less likely to result in changes in professional behavior. The amount of physicians exposed to active strategies was limited. In spite of this we found a significant difference in the number of referrals which was accounted for by more referrals of non-participating physicians in the experimental clusters. We hypothesize that the increase in referrals was caused by an increase in occupational therapists' efforts to promote their services within their network. NCT01117285.

Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials.

PubMed

Scott, JoAnna M; deCamp, Allan; Juraska, Michal; Fay, Michael P; Gilbert, Peter B

2017-04-01

Stepped wedge designs are increasingly commonplace and advantageous for cluster randomized trials when it is both unethical to assign placebo, and it is logistically difficult to allocate an intervention simultaneously to many clusters. We study marginal mean models fit with generalized estimating equations for assessing treatment effectiveness in stepped wedge cluster randomized trials. This approach has advantages over the more commonly used mixed models that (1) the population-average parameters have an important interpretation for public health applications and (2) they avoid untestable assumptions on latent variable distributions and avoid parametric assumptions about error distributions, therefore, providing more robust evidence on treatment effects. However, cluster randomized trials typically have a small number of clusters, rendering the standard generalized estimating equation sandwich variance estimator biased and highly variable and hence yielding incorrect inferences. We study the usual asymptotic generalized estimating equation inferences (i.e., using sandwich variance estimators and asymptotic normality) and four small-sample corrections to generalized estimating equation for stepped wedge cluster randomized trials and for parallel cluster randomized trials as a comparison. We show by simulation that the small-sample corrections provide improvement, with one correction appearing to provide at least nominal coverage even with only 10 clusters per group. These results demonstrate the viability of the marginal mean approach for both stepped wedge and parallel cluster randomized trials. We also study the comparative performance of the corrected methods for stepped wedge and parallel designs, and describe how the methods can accommodate interval censoring of individual failure times and incorporate semiparametric efficient estimators.

Randomized controlled trial to test the RHANI Wives HIV intervention for women in India at risk for HIV from husbands.

PubMed

Raj, Anita; Saggurti, Niranjan; Battala, Madhusudana; Nair, Saritha; Dasgupta, Anindita; Naik, D D; Abramovitz, Daniela; Silverman, Jay G; Balaiah, Donta

2013-11-01

This study involved evaluation of the short-term impact of the RHANI Wives HIV intervention among wives at risk for HIV from husbands in Mumbai, India. A two-armed cluster RCT was conducted with 220 women surveyed on marital sex at baseline and 4-5 month follow-up. RHANI Wives was a multisession intervention focused on safer sex, marital communication, gender inequities and violence; control participants received basic HIV prevention education. Generalized linear mixed models were conducted to assess program impact, with cluster as a random effect and with time, treatment group, and the time by treatment interaction as fixed effects. A significant time by treatment effect on proportion of unprotected sex with husband (p = 0.01) was observed, and the rate of unprotected sex for intervention participants was lower than that of control participants at follow-up (RR = 0.83, 95 % CI = 0.75, 0.93). RHANI Wives is a promising model for women at risk for HIV from husbands.

Impact of a care pathway for COPD on adherence to guidelines and hospital readmission: a cluster randomized trial

PubMed Central

Vanhaecht, Kris; Lodewijckx, Cathy; Sermeus, Walter; Decramer, Marc; Deneckere, Svin; Leigheb, Fabrizio; Boto, Paulo; Kul, Seval; Seys, Deborah; Panella, Massimiliano

2016-01-01

Purpose Current in-hospital management of exacerbations of COPD is suboptimal, and patient outcomes are poor. The primary aim of this study was to evaluate whether implementation of a care pathway (CP) for COPD improves the 6 months readmission rate. Secondary outcomes were the 30 days readmission rate, mortality, length of stay and adherence to guidelines. Patients and methods An international cluster randomized controlled trial was performed in Belgium, Italy and Portugal. General hospitals were randomly assigned to an intervention group where a CP was implemented or a control group where usual care was provided. The targeted population included patients with COPD exacerbation. Results Twenty-two hospitals were included, whereof 11 hospitals (n=174 patients) were randomized to the intervention group and 11 hospitals (n=168 patients) to the control group. The CP had no impact on the 6 months readmission rate. However, the 30 days readmission rate was significantly lower in the intervention group (9.7%; 15/155) compared to the control group (15.3%; 22/144) (odds ratio =0.427; 95% confidence interval 0.222–0.822; P=0.040). Performance on process indicators was significantly higher in the intervention group for 2 of 24 main indicators (8.3%). Conclusion The implementation of this in-hospital CP for COPD exacerbation has no impact on the 6 months readmission rate, but it significantly reduces the 30 days readmission rate. PMID:27920516

A 2-year integrated agriculture and nutrition and health behavior change communication program targeted to women in Burkina Faso reduces anemia, wasting, and diarrhea in children 3-12.9 months of age at baseline: a cluster-randomized controlled trial.

PubMed

Olney, Deanna K; Pedehombga, Abdoulaye; Ruel, Marie T; Dillon, Andrew

2015-06-01

Among young children in Burkina Faso, anemia and chronic and acute undernutrition are widespread. This study assessed the impact of Helen Keller International's (HKI) 2-y integrated agriculture [homestead food production (HFP)] and nutrition and health behavior change communication (BCC) program, targeted to women, on children's (3-12.9 mo old at baseline) anthropometry (stunting, wasting, and underweight), mean hemoglobin (Hb), anemia (Hb < 11 g/dL), and diarrhea prevalence. We used a cluster-randomized controlled trial, with 55 villages randomly assigned to a control group (n = 25) or 1 of 2 treatment groups (n = 15 each), which differed by who delivered the BCC messages [older women leaders or health committee (HC) members]. We used difference-in-difference (DID) estimates to assess impacts on child outcomes. We found marginally significant (P < 0.10) impacts on Hb (DID: 0.51 g/dL; P = 0.07) and wasting [DID: -8.8 percentage point (pp); P = 0.08] and statistically significant (P < 0.05) impacts on diarrhea (-15.9 pp; P = 0.00) in HC compared with control villages among children aged 3-12.9 mo and larger impacts for anemia (DID: -14.6 pp; P = 0.03) and mean Hb (DID: 0.74 g/dL; P = 0.03) among younger children (aged 3-5.9 mo). However, we found no significant impacts on stunting or underweight prevalence. Plausibility was supported by greater improvements in women's agricultural production and maternal infant and young child feeding and care knowledge and practices in HC compared with control villages. HKI's 2-y integrated HFP+BCC program (HC group) significantly improved several child outcomes, including wasting (marginal), diarrhea, Hb, and anemia, especially among the youngest children. This is the first cluster-randomized controlled trial of an HFP program that documents statistically significant positive effects on these child nutrition outcomes. This trial was registered at clinicaltrials.gov as NCT01825226. © 2015 American Society for Nutrition.

Feasibility and effectiveness of an evidence-based asthma service in Australian community pharmacies: a pragmatic cluster randomized trial.

PubMed

Armour, Carol L; Reddel, Helen K; LeMay, Kate S; Saini, Bandana; Smith, Lorraine D; Bosnic-Anticevich, Sinthia Z; Song, Yun Ju Christine; Alles, M Chehani; Burton, Deborah L; Emmerton, Lynne; Stewart, Kay; Krass, Ines

2013-04-01

To test the feasibility, effectiveness, and sustainability of a pharmacy asthma service in primary care. A pragmatic cluster randomized trial in community pharmacies in four Australian states/territories in 2009. Specially trained pharmacists were randomized to deliver an asthma service in two groups, providing three versus four consultations over 6 months. People with poorly controlled asthma or no recent asthma review were included. Follow-up for 12 months after service completion occurred in 30% of randomly selected completing patients. Outcomes included change in asthma control (poor and fair/good) and Asthma Control Questionnaire (ACQ) score, inhaler technique, quality of life, perceived control, adherence, asthma knowledge, and asthma action plan ownership. Ninety-six pharmacists enrolled 570 patients, with 398 (70%) completing. Asthma control significantly improved with both the three- and four-visit service, with no significant difference between groups (good/fair control 29% and 21% at baseline, 61% and 59% at end, p = .791). Significant improvements were also evident in the ACQ (mean change 0.56), inhaler technique (17-33% correct baseline, 57-72% end), asthma action plan ownership (19% baseline, 56% end), quality of life, adherence, perceived control, and asthma knowledge, with no significant difference between groups for any variable. Outcomes were sustained at 12 months post-service. The pharmacy asthma service delivered clinically important improvements in both a three-visit and four-visit service. Pharmacists were able to recruit and deliver the service with minimal intervention, suggesting it is practical to implement in practice. The three-visit service would be feasible and effective to implement, with a review at 12 months.

Testing a workplace physical activity intervention: a cluster randomized controlled trial

PubMed Central

2011-01-01

Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

PubMed

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

The additional benefit of residual spraying and insecticide-treated curtains for dengue control over current best practice in Cuba: Evaluation of disease incidence in a cluster randomized trial in a low burden setting with intensive routine control

PubMed Central

Rosales, Julio Popa; Mirabal, Mayelin; Cabrera, Pedro; Fonseca, Viviana; Gómez Padrón, Tania; Pérez Menzies, Mirtha; Montada, Domingo; Van der Stuyft, Patrick

2017-01-01

Background Aedes control interventions are considered the cornerstone of dengue control programmes, but there is scarce evidence on their effect on disease. We set-up a cluster randomized controlled trial in Santiago de Cuba to evaluate the entomological and epidemiological effectiveness of periodical intra- and peri-domiciliary residual insecticide (deltamethrin) treatment (RIT) and long lasting insecticide treated curtains (ITC). Methodology/Principal findings Sixty three clusters (around 250 households each) were randomly allocated to two intervention (RIT and ITC) and one control arm. Routine Aedes control activities (entomological surveillance, source reduction, selective adulticiding, health education) were applied in the whole study area. The outcome measures were clinical dengue case incidence and immature Aedes infestation. Effectiveness of tools was evaluated using a generalized linear regression model with a negative binomial link function. Despite significant reduction in Aedes indices (Rate Ratio (RR) 0.54 (95%CI 0.32–0.89) in the first month after RIT, the effect faded out over time and dengue incidence was not reduced. Overall, in this setting there was no protective effect of RIT or ITC over routine in the 17months intervention period, with for house index RR of 1.16 (95%CI 0.96–1.40) and 1.25 (95%CI 1.03–1.50) and for dengue incidence RR of 1.43 (95%CI 1.08–1.90) and 0.96 (95%CI 0.72–1.28) respectively. The monthly dengue incidence rate (IR) at cluster level was best explained by epidemic periods (Incidence Rate Ratio (IRR) 5.50 (95%CI 4.14–7.31)), the IR in bordering houseblocks (IRR 1.03 (95%CI 1.02–1.04)) and the IR pre-intervention (IRR 1.02 (95%CI 1.00–1.04)). Conclusions Adding RIT to an intensive routine Aedes control programme has a transient effect on the already moderate low entomological infestation levels, while ITC did not have any effect. For both interventions, we didn’t evidence impact on disease incidence. Further studies are needed to evaluate impact in settings with high Aedes infestation and arbovirus case load. PMID:29117180

The additional benefit of residual spraying and insecticide-treated curtains for dengue control over current best practice in Cuba: Evaluation of disease incidence in a cluster randomized trial in a low burden setting with intensive routine control.

PubMed

Toledo, Maria Eugenia; Vanlerberghe, Veerle; Rosales, Julio Popa; Mirabal, Mayelin; Cabrera, Pedro; Fonseca, Viviana; Gómez Padrón, Tania; Pérez Menzies, Mirtha; Montada, Domingo; Van der Stuyft, Patrick

2017-11-01

Aedes control interventions are considered the cornerstone of dengue control programmes, but there is scarce evidence on their effect on disease. We set-up a cluster randomized controlled trial in Santiago de Cuba to evaluate the entomological and epidemiological effectiveness of periodical intra- and peri-domiciliary residual insecticide (deltamethrin) treatment (RIT) and long lasting insecticide treated curtains (ITC). Sixty three clusters (around 250 households each) were randomly allocated to two intervention (RIT and ITC) and one control arm. Routine Aedes control activities (entomological surveillance, source reduction, selective adulticiding, health education) were applied in the whole study area. The outcome measures were clinical dengue case incidence and immature Aedes infestation. Effectiveness of tools was evaluated using a generalized linear regression model with a negative binomial link function. Despite significant reduction in Aedes indices (Rate Ratio (RR) 0.54 (95%CI 0.32-0.89) in the first month after RIT, the effect faded out over time and dengue incidence was not reduced. Overall, in this setting there was no protective effect of RIT or ITC over routine in the 17months intervention period, with for house index RR of 1.16 (95%CI 0.96-1.40) and 1.25 (95%CI 1.03-1.50) and for dengue incidence RR of 1.43 (95%CI 1.08-1.90) and 0.96 (95%CI 0.72-1.28) respectively. The monthly dengue incidence rate (IR) at cluster level was best explained by epidemic periods (Incidence Rate Ratio (IRR) 5.50 (95%CI 4.14-7.31)), the IR in bordering houseblocks (IRR 1.03 (95%CI 1.02-1.04)) and the IR pre-intervention (IRR 1.02 (95%CI 1.00-1.04)). Adding RIT to an intensive routine Aedes control programme has a transient effect on the already moderate low entomological infestation levels, while ITC did not have any effect. For both interventions, we didn't evidence impact on disease incidence. Further studies are needed to evaluate impact in settings with high Aedes infestation and arbovirus case load.

Electronic laboratory system reduces errors in National Tuberculosis Program: a cluster randomized controlled trial.

PubMed

Blaya, J A; Shin, S S; Yale, G; Suarez, C; Asencios, L; Contreras, C; Rodriguez, P; Kim, J; Cegielski, P; Fraser, H S F

2010-08-01

To evaluate the impact of the e-Chasqui laboratory information system in reducing reporting errors compared to the current paper system. Cluster randomized controlled trial in 76 health centers (HCs) between 2004 and 2008. Baseline data were collected every 4 months for 12 months. HCs were then randomly assigned to intervention (e-Chasqui) or control (paper). Further data were collected for the same months the following year. Comparisons were made between intervention and control HCs, and before and after the intervention. Intervention HCs had respectively 82% and 87% fewer errors in reporting results for drug susceptibility tests (2.1% vs. 11.9%, P = 0.001, OR 0.17, 95%CI 0.09-0.31) and cultures (2.0% vs. 15.1%, P < 0.001, OR 0.13, 95%CI 0.07-0.24), than control HCs. Preventing missing results through online viewing accounted for at least 72% of all errors. e-Chasqui users sent on average three electronic error reports per week to the laboratories. e-Chasqui reduced the number of missing laboratory results at point-of-care health centers. Clinical users confirmed viewing electronic results not available on paper. Reporting errors to the laboratory using e-Chasqui promoted continuous quality improvement. The e-Chasqui laboratory information system is an important part of laboratory infrastructure improvements to support multidrug-resistant tuberculosis care in Peru.

New Beginnings for mothers and babies in prison: A cluster randomized controlled trial

PubMed Central

Sleed, Michelle; Baradon, Tessa; Fonagy, Peter

2013-01-01

Mothers in prison represent a high-risk parenting population. New Beginnings is an attachment-based group intervention designed specifically for mothers and babies in prison. This cluster randomized trial examined the outcomes for 88 mothers and babies participating in the New Beginnings program and 75 dyads residing in prisons where the intervention did not take place. Outcomes were measured in terms of parental reflective functioning, the quality of parent–infant interaction, maternal depression, and maternal representations. Mothers in the control group deteriorated in their level of reflective functioning and behavioral interaction with their babies over time, whereas the mothers in the intervention group did not. There were no significant group effects on levels of maternal depression or mothers' self-reported representations of their babies over time. An attachment-based intervention may mitigate some of the risks to the quality of the parent–infant relationship for these dyads. PMID:23550526

Cluster randomized trial of text message reminders to retail staff in tanzanian drug shops dispensing artemether-lumefantrine: effect on dispenser knowledge and patient adherence.

PubMed

Bruxvoort, Katia; Festo, Charles; Kalolella, Admirabilis; Cairns, Matthew; Lyaruu, Peter; Kenani, Mitya; Kachur, S Patrick; Goodman, Catherine; Schellenberg, David

2014-10-01

Artemisinin combination therapies are available in private outlets, but patient adherence might be compromised by poor advice from dispensers. In this cluster randomized trial in drug shops in Tanzania, 42 of 82 selected shops were randomized to receive text message reminders about what advice to provide when dispensing artemether-lumefantrine (AL). Eligible patients purchasing AL at shops in both arms were followed up at home and questioned about each dose taken. Dispensers were interviewed regarding knowledge of AL dispensing practices and receipt of the malaria-related text messages. We interviewed 904 patients and 110 dispensers from 77 shops. Although there was some improvement in dispenser knowledge, there was no difference between arms in adherence measured as completion of all doses (intervention 68.3%, control 69.8%, p [adjusted] = 0.6), or as completion of each dose at the correct time (intervention 33.1%, control 32.6%, p [adjusted] = 0.9). Further studies on the potential of text messages to improve adherence are needed. © The American Society of Tropical Medicine and Hygiene.

Community involvement in dengue vector control: cluster randomised trial

PubMed Central

Toledo, M E; Rodríguez, M; Gomez, D; Baly, A; Benitez, J R; Van der Stuyft, P

2009-01-01

Objective To assess the effectiveness of an integrated community based environmental management strategy to control Aedes aegypti, the vector of dengue, compared with a routine strategy. Design Cluster randomised trial. Setting Guantanamo, Cuba. Participants 32 circumscriptions (around 2000 inhabitants each). Interventions The circumscriptions were randomly allocated to control clusters (n=16) comprising routine Aedes control programme (entomological surveillance, source reduction, selective adulticiding, and health education) and to intervention clusters (n=16) comprising the routine Aedes control programme combined with a community based environmental management approach. Main outcome measures The primary outcome was levels of Aedes infestation: house index (number of houses positive for at least one container with immature stages of Ae aegypti per 100 inspected houses), Breteau index (number of containers positive for immature stages of Ae aegypti per 100 inspected houses), and the pupae per inhabitant statistic (number of Ae aegypti pupae per inhabitant). Results All clusters were subjected to the intended intervention; all completed the study protocol up to February 2006 and all were included in the analysis. At baseline the Aedes infestation levels were comparable between intervention and control clusters: house index 0.25% v 0.20%, pupae per inhabitant 0.44×10−3 v 0.29×10−3. At the end of the intervention these indices were significantly lower in the intervention clusters: rate ratio for house indices 0.49 (95% confidence interval 0.27 to 0.88) and rate ratio for pupae per inhabitant 0.27 (0.09 to 0.76). Conclusion A community based environmental management embedded in a routine control programme was effective at reducing levels of Aedes infestation. Trial registration Current Controlled Trials ISRCTN88405796. PMID:19509031

On the limiting characteristics of quantum random number generators at various clusterings of photocounts

NASA Astrophysics Data System (ADS)

Molotkov, S. N.

2017-03-01

Various methods for the clustering of photocounts constituting a sequence of random numbers are considered. It is shown that the clustering of photocounts resulting in the Fermi-Dirac distribution makes it possible to achieve the theoretical limit of the random number generation rate.

Cluster randomization and political philosophy.

PubMed

Chwang, Eric

2012-11-01

In this paper, I will argue that, while the ethical issues raised by cluster randomization can be challenging, they are not new. My thesis divides neatly into two parts. In the first, easier part I argue that many of the ethical challenges posed by cluster randomized human subjects research are clearly present in other types of human subjects research, and so are not novel. In the second, more difficult part I discuss the thorniest ethical challenge for cluster randomized research--cases where consent is genuinely impractical to obtain. I argue that once again these cases require no new analytic insight; instead, we should look to political philosophy for guidance. In other words, the most serious ethical problem that arises in cluster randomized research also arises in political philosophy. © 2011 Blackwell Publishing Ltd.

Walking Away from Type 2 diabetes: a cluster randomized controlled trial.

PubMed

Yates, T; Edwardson, C L; Henson, J; Gray, L J; Ashra, N B; Troughton, J; Khunti, K; Davies, M J

2017-05-01

This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months. © 2016 Diabetes UK.

A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample.

PubMed

Abebe, Kaleab Z; Jones, Kelley A; Rofey, Dana; McCauley, Heather L; Clark, Duncan B; Dick, Rebecca; Gmelin, Theresa; Talis, Janine; Anderson, Jocelyn; Chugani, Carla; Algarroba, Gabriela; Antonio, Ashley; Bee, Courtney; Edwards, Clare; Lethihet, Nadia; Macak, Justin; Paley, Joshua; Torres, Irving; Van Dusen, Courtney; Miller, Elizabeth

2018-02-01

Sexual violence (SV) on college campuses is common, especially alcohol-related SV. This is a 2-arm cluster randomized controlled trial to test a brief intervention to reduce risk for alcohol-related sexual violence (SV) among students receiving care from college health centers (CHCs). Intervention CHC staff are trained to deliver universal SV education to all students seeking care, to facilitate patient and provider comfort in discussing SV and related abusive experiences (including the role of alcohol). Control sites provide participants with information about drinking responsibly. Across 28 participating campuses (12 randomized to intervention and 16 to control), 2292 students seeking care at CHCs complete surveys prior to their appointment (baseline), immediately after (exit), 4months later (T2) and one year later (T3). The primary outcome is change in recognition of SV and sexual risk. Among those reporting SV exposure at baseline, changes in SV victimization, disclosure, and use of SV services are additional outcomes. Intervention effects will be assessed using generalized linear mixed models that account for clustering of repeated observations both within CHCs and within students. Slightly more than half of the participating colleges have undergraduate enrollment of ≥3000 students; two-thirds are public and almost half are urban. Among participants there were relatively more Asian (10 v 1%) and Black/African American (13 v 7%) and fewer White (58 v 74%) participants in the intervention compared to control. This study will offer the first formal assessment for SV prevention in the CHC setting. Clinical Trials #: NCT02355470. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

In a rural area of Bangladesh, traditional birth attendant training improved early infant feeding practices: a pragmatic cluster randomized trial.

PubMed

Talukder, Shamim; Farhana, Dina; Vitta, Bineti; Greiner, Ted

2017-01-01

In rural Bangladesh, most births take place at home. There is little evidence regarding the influence of traditional birth attendants (TBAs) or community volunteers (CVs) on early infant feeding practices. We conducted a pragmatic cluster randomized controlled trial in Panchagarh District to examine the effects of training and post-training supervision of TBAs/CVs on early breastfeeding practices. Nine unions were randomized into three groups of three unions. We compared outcomes between mothers in a control group (CG), those living in unions where TBAs/CVs had received a 5-day training in early feeding practices (TG) and those living in unions where TBAs/CVs were both trained and supervised (SG). A total of 1182 mothers of infants aged 0-6 months were interviewed at baseline. After 6 months of intervention, an endline survey was conducted on a different sample of 1148 mothers of infants aged 0-6 months in the same areas. In both intervention areas, TBAs/CVs made regular home visits and attended births whenever possible. Rates of early initiation of breastfeeding, avoidance of prelacteal feeds and exclusive breastfeeding were compared between groups using cluster-controlled mixed model logistic regression. At endline, both intervention groups had significantly higher proportions of mothers who reported early initiation of breastfeeding (CG: 88%, TG: 96%, SG: 96%) and avoidance of prelacteal feeds (CG: 48%, TG: 80%, SG: 88%) compared with the control group; there were no significant differences between the two intervention groups. The endline rates of reported exclusive breastfeeding were not significantly different among groups (CG: 67%, TG: 76%, SG: 83%). © 2016 John Wiley & Sons Ltd.

Fast Constrained Spectral Clustering and Cluster Ensemble with Random Projection

PubMed Central

Liu, Wenfen

2017-01-01

Constrained spectral clustering (CSC) method can greatly improve the clustering accuracy with the incorporation of constraint information into spectral clustering and thus has been paid academic attention widely. In this paper, we propose a fast CSC algorithm via encoding landmark-based graph construction into a new CSC model and applying random sampling to decrease the data size after spectral embedding. Compared with the original model, the new algorithm has the similar results with the increase of its model size asymptotically; compared with the most efficient CSC algorithm known, the new algorithm runs faster and has a wider range of suitable data sets. Meanwhile, a scalable semisupervised cluster ensemble algorithm is also proposed via the combination of our fast CSC algorithm and dimensionality reduction with random projection in the process of spectral ensemble clustering. We demonstrate by presenting theoretical analysis and empirical results that the new cluster ensemble algorithm has advantages in terms of efficiency and effectiveness. Furthermore, the approximate preservation of random projection in clustering accuracy proved in the stage of consensus clustering is also suitable for the weighted k-means clustering and thus gives the theoretical guarantee to this special kind of k-means clustering where each point has its corresponding weight. PMID:29312447

Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

PubMed

Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

2017-10-18

The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic information exchange methods, technical assistance through a knowledge broker, and organizational changes to support evidence-based public health approaches. Evaluation methods comprise surveys at baseline and the three crossover time points, abstraction of local-level diabetes and chronic disease control program plans and progress reports, and social network analysis to understand the relationships and contextual issues that influence EBPP adoption. ClinicalTrial.gov, NCT03211832.

The Impacts of a Scalable Intervention on the Language and Literacy Development of Rural Pre-Kindergartners

ERIC Educational Resources Information Center

Mashburn, Andrew; Justice, Laura M.; McGinty, Anita; Slocum, Laura

2016-01-01

Read It Again (RIA) is a curriculum for pre-kindergarten (pre-K) classrooms that targets children's development of language and literacy skills. A cluster randomized trial was conducted in which 104 pre-K classrooms in the Appalachian region of the United States were randomly assigned to one of three study conditions: Control (n = 30), RIA only…

Optimizing polypharmacy among elderly hospital patients with chronic diseases--study protocol of the cluster randomized controlled POLITE-RCT trial.

PubMed

Löffler, Christin; Drewelow, Eva; Paschka, Susanne D; Frankenstein, Martina; Eger, Julia; Jatsch, Lisa; Reisinger, Emil C; Hallauer, Johannes F; Drewelow, Bernd; Heidorn, Karen; Schröder, Helmut; Wollny, Anja; Kundt, Günther; Schmidt, Christian; Altiner, Attila

2014-10-06

Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient's discharge from hospital. The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited. In case of positive evaluation, the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy. Current Controlled Trials ISRCTN42003273.

ACT2 peer-driven intervention increases enrollment into HIV/AIDS medical studies among African-Americans/Blacks and Hispanics: A cluster randomized controlled trial

PubMed Central

Gwadz, Marya; Cleland, Charles M.; Belkin, Mindy; Ritchie, Amanda; Leonard, Noelle; Riedel, Marion; Banfield, Angela; Colon, Pablo; Elharrar, Vanessa; Kagan, Jonathan; Mildvan, Donna

2014-01-01

African American/Black and Hispanic persons living with HIV/AIDS (“AABH-PLHA”) are under-represented in HIV/AIDS medical studies (HAMS). This paper evaluates the efficacy of a social/behavioral intervention to increase rates of screening for and enrollment into HAMS in these populations. Participants (N=540) were enrolled into a cluster randomized controlled trial of an intervention designed to overcome multi-level barriers to HAMS. Primary endpoints were rates of screening for and enrollment into therapeutic/treatment-oriented and observational studies. Intervention arm participants were 30 times more likely to be screened than controls (49.3% vs. 3.7%; p < .001). Half (55.5%) of those screened were eligible for HAMS, primarily observational studies. Nine out of ten found eligible enrolled (91.7%), almost all into observational studies (95.2%), compared to no enrollments among controls. Achieving appropriate representation of AABH-PLHA in HAMS necessitates modification of study inclusion criteria to increase the proportion found eligible for therapeutic HAMS, in addition to social/behavioral interventions. PMID:24961193

Activity Begins in Childhood (ABC) - inspiring healthy active behaviour in preschoolers: study protocol for a cluster randomized controlled trial.

PubMed

Adamo, Kristi B; Barrowman, Nick; Naylor, Patti Jean; Yaya, Sanni; Harvey, Alysha; Grattan, Kimberly P; Goldfield, Gary S

2014-07-29

Today's children are more overweight than previous generations and physical inactivity is a contributing factor. Modelling and promoting positive behaviour in the early years is imperative for the development of lifelong health habits. The social and physical environments where children spend their time have a powerful influence on behaviour. Since the majority of preschool children spend time in care outside of the home, this provides an ideal setting to examine the ability of an intervention to enhance movement skills and modify physical activity behaviour. This study aims to evaluate the efficacy of the Activity Begins in Childhood (ABC) intervention delivered in licensed daycare settings alone or in combination with a parent-driven home physical activity-promotion component to increase preschoolers' overall physical activity levels and, specifically, the time spent in moderate to vigorous physical activity. This study is a single site, three-arm, cluster-randomized controlled trial design with a daycare centre as the unit of measurement (clusters). All daycare centres in the National Capital region that serve children between the ages of 3 and 5, expressing an interest in receiving the ABC intervention will be invited to participate. Those who agree will be randomly assigned to one of three groups: i) ABC program delivered at a daycare centre only, ii) ABC program delivered at daycare with a home/parental education component, or iii) regular daycare curriculum. This study will recruit 18 daycare centres, 6 in each of the three groups. The intervention will last approximately 6 months, with baseline assessment prior to ABC implementation and follow-up assessments at 3 and 6 months. Physical activity is an acknowledged component of a healthy lifestyle and childhood experiences as it has an important impact on lifelong behaviour and health. Opportunities for physical activity and motor development in early childhood may, over the lifespan, influence the maintenance of a healthy body weight and reduce cardiovascular disease risk. If successful, the ABC program may be implemented in daycare centres as an effective way of increasing healthy activity behaviours of preschoolers. Current Controlled Trials: ISRCTN94022291. Registered in December 2012, first cluster randomized in April 2013.

Effects of promoting longer-term and exclusive breastfeeding on childhood eating attitudes: a cluster-randomized trial.

PubMed

Skugarevsky, Oleg; Wade, Kaitlin H; Richmond, Rebecca C; Martin, Richard M; Tilling, Kate; Patel, Rita; Vilchuck, Konstantin; Bogdanovich, Natalia; Sergeichick, Natalia; Davey Smith, George; Gillman, Matthew W; Oken, Emily; Kramer, Michael S

2014-08-01

Observational studies suggest that breastfeeding benefits later maternal child-feeding practices, which in turn may contribute to positive eating attitudes. We investigated the effect of a randomized intervention to increase duration and exclusivity of breastfeeding on pre-adolescent eating attitudes. Long-term follow-up of the Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized trial in 31 maternity hospitals and affiliated polyclinics in Belarus. Sites were randomly assigned an experimental intervention to promote longer duration and exclusivity of breastfeeding in mothers who initiated breastfeeding (n = 16 sites), or a control intervention of continuing usual care (n = 15 sites); 17 046 healthy infants were enrolled in 1996-7, of whom 13 751 (80.7%) completed the Children's Eating Attitude Test (ChEAT) at 11.5 years of age. A ChEAT score ≥ 22.5 (85th percentile) was used as an indicator of problematic eating attitudes. Analysis was based on intention-to-treat, accounting for clustering within hospitals/clinics. Compared with the control arm, the experimental intervention substantially increased breastfeeding exclusivity (43.3% vs 6.4% exclusively breastfed at 3 months of age) and duration of any breastfeeding throughout infancy. The proportion of children with ChEAT scores ≥ 22.5 was lower in the experimental than control arm (boys 11.4% vs 17.2%; girls 18.5% vs 23.4%) [cluster-adjusted odds ratio (OR), boys: 0.44; 95% confidence interval (CI): 0.21,0.93; girls: 0.51; 95% CI: 0.27,0.99). Results were robust to adjustment for potential confounders and using a ChEAT score ≥ 25.5 (91st percentile) as the outcome (OR: 0.53; 95% CI: 0.28,1.03). An intervention to improve the duration and exclusivity of breastfeeding among term infants in Belarus was associated with a reduction in problematic eating attitudes at 11.5 years of age. © The Author 2014; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Detecting space-time cancer clusters using residential histories

NASA Astrophysics Data System (ADS)

Jacquez, Geoffrey M.; Meliker, Jaymie R.

2007-04-01

Methods for analyzing geographic clusters of disease typically ignore the space-time variability inherent in epidemiologic datasets, do not adequately account for known risk factors (e.g., smoking and education) or covariates (e.g., age, gender, and race), and do not permit investigation of the latency window between exposure and disease. Our research group recently developed Q-statistics for evaluating space-time clustering in cancer case-control studies with residential histories. This technique relies on time-dependent nearest neighbor relationships to examine clustering at any moment in the life-course of the residential histories of cases relative to that of controls. In addition, in place of the widely used null hypothesis of spatial randomness, each individual's probability of being a case is instead based on his/her risk factors and covariates. Case-control clusters will be presented using residential histories of 220 bladder cancer cases and 440 controls in Michigan. In preliminary analyses of this dataset, smoking, age, gender, race and education were sufficient to explain the majority of the clustering of residential histories of the cases. Clusters of unexplained risk, however, were identified surrounding the business address histories of 10 industries that emit known or suspected bladder cancer carcinogens. The clustering of 5 of these industries began in the 1970's and persisted through the 1990's. This systematic approach for evaluating space-time clustering has the potential to generate novel hypotheses about environmental risk factors. These methods may be extended to detect differences in space-time patterns of any two groups of people, making them valuable for security intelligence and surveillance operations.

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

PubMed

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs from participants in the PT-led primary care sites. If this pilot demonstrates feasibility, a fully powered trial will provide evidence that has the potential to transform primary care for back pain. The full trial will inform future service design, whether these models should be more widely implemented, and training agendas. ClinicalTrials.gov, NCT03320148 . Submitted for registration on 17 September 2017.

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

PubMed Central

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies. PMID:28584874

Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial.

PubMed

Dalal, Anuj K; Roy, Christopher L; Poon, Eric G; Williams, Deborah H; Nolido, Nyryan; Yoon, Cathy; Budris, Jonas; Gandhi, Tejal; Bates, David W; Schnipper, Jeffrey L

2014-01-01

Physician awareness of the results of tests pending at discharge (TPADs) is poor. We developed an automated system that notifies responsible physicians of TPAD results via secure, network email. We sought to evaluate the impact of this system on self-reported awareness of TPAD results by responsible physicians, a necessary intermediary step to improve management of TPAD results. We conducted a cluster-randomized controlled trial at a major hospital affiliated with an integrated healthcare delivery network in Boston, Massachusetts. Adult patients with TPADs who were discharged from inpatient general medicine and cardiology services were assigned to the intervention or usual care arm if their inpatient attending physician and primary care physician (PCP) were both randomized to the same study arm. Patients of physicians randomized to discordant study arms were excluded. We surveyed these physicians 72 h after all TPAD results were finalized. The primary outcome was awareness of TPAD results by attending physicians. Secondary outcomes included awareness of TPAD results by PCPs, awareness of actionable TPAD results, and provider satisfaction. We analyzed data on 441 patients. We sent 441 surveys to attending physicians and 353 surveys to PCPs and received 275 and 152 responses from 83 different attending physicians and 112 different PCPs, respectively (attending physician survey response rate of 63%). Intervention attending physicians and PCPs were significantly more aware of TPAD results (76% vs 38%, adjusted/clustered OR 6.30 (95% CI 3.02 to 13.16), p<0.001; 57% vs 33%, adjusted/clustered OR 3.08 (95% CI 1.43 to 6.66), p=0.004, respectively). Intervention attending physicians tended to be more aware of actionable TPAD results (59% vs 29%, adjusted/clustered OR 4.25 (0.65, 27.85), p=0.13). One hundred and eighteen (85%) and 43 (63%) intervention attending physician and PCP survey respondents, respectively, were satisfied with this intervention. Automated email notification represents a promising strategy for managing TPAD results, potentially mitigating an unresolved patient safety concern. ClinicalTrials.gov (NCT01153451).

A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial.

PubMed

Pasha, Omrana; McClure, Elizabeth M; Wright, Linda L; Saleem, Sarah; Goudar, Shivaprasad S; Chomba, Elwyn; Patel, Archana; Esamai, Fabian; Garces, Ana; Althabe, Fernando; Kodkany, Bhala; Mabeya, Hillary; Manasyan, Albert; Carlo, Waldemar A; Derman, Richard J; Hibberd, Patricia L; Liechty, Edward K; Krebs, Nancy; Hambidge, K Michael; Buekens, Pierre; Moore, Janet; Jobe, Alan H; Koso-Thomas, Marion; Wallace, Dennis D; Stalls, Suzanne; Goldenberg, Robert L

2013-10-03

Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care. This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention. This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be. ClinicalTrials.gov NCT01073488.

Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial

PubMed Central

Dalal, Anuj K; Roy, Christopher L; Poon, Eric G; Williams, Deborah H; Nolido, Nyryan; Yoon, Cathy; Budris, Jonas; Gandhi, Tejal; Bates, David W; Schnipper, Jeffrey L

2014-01-01

Background and objective Physician awareness of the results of tests pending at discharge (TPADs) is poor. We developed an automated system that notifies responsible physicians of TPAD results via secure, network email. We sought to evaluate the impact of this system on self-reported awareness of TPAD results by responsible physicians, a necessary intermediary step to improve management of TPAD results. Methods We conducted a cluster-randomized controlled trial at a major hospital affiliated with an integrated healthcare delivery network in Boston, Massachusetts. Adult patients with TPADs who were discharged from inpatient general medicine and cardiology services were assigned to the intervention or usual care arm if their inpatient attending physician and primary care physician (PCP) were both randomized to the same study arm. Patients of physicians randomized to discordant study arms were excluded. We surveyed these physicians 72 h after all TPAD results were finalized. The primary outcome was awareness of TPAD results by attending physicians. Secondary outcomes included awareness of TPAD results by PCPs, awareness of actionable TPAD results, and provider satisfaction. Results We analyzed data on 441 patients. We sent 441 surveys to attending physicians and 353 surveys to PCPs and received 275 and 152 responses from 83 different attending physicians and 112 different PCPs, respectively (attending physician survey response rate of 63%). Intervention attending physicians and PCPs were significantly more aware of TPAD results (76% vs 38%, adjusted/clustered OR 6.30 (95% CI 3.02 to 13.16), p<0.001; 57% vs 33%, adjusted/clustered OR 3.08 (95% CI 1.43 to 6.66), p=0.004, respectively). Intervention attending physicians tended to be more aware of actionable TPAD results (59% vs 29%, adjusted/clustered OR 4.25 (0.65, 27.85), p=0.13). One hundred and eighteen (85%) and 43 (63%) intervention attending physician and PCP survey respondents, respectively, were satisfied with this intervention. Conclusions Automated email notification represents a promising strategy for managing TPAD results, potentially mitigating an unresolved patient safety concern. Clinical Trial Registration: ClinicalTrials.gov (NCT01153451) PMID:24154834

The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial.

PubMed

Hardy, Victoria; O'Connor, Yvonne; Heavin, Ciara; Mastellos, Nikolaos; Tran, Tammy; O'Donoghue, John; Fitzpatrick, Annette L; Ide, Nicole; Wu, Tsung-Shu Joseph; Chirambo, Griphin Baxter; Muula, Adamson S; Nyirenda, Moffat; Carlsson, Sven; Andersson, Bo; Thompson, Matthew

2017-10-11

There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the added value of the Supporting LIFE electronic Community Case Management Application (SL eCCM App) compared to paper-based CCM on urgent referral, re-consultation and hospitalization rates, in two districts in Northern Malawi. This is a pragmatic, stepped-wedge cluster-randomized trial assessing the added value of the SL eCCM App on urgent referral, re-consultation and hospitalization rates of children aged 2 months and older to up to 5 years, within 7 days of the index visit. One hundred and two health surveillance assistants (HSAs) were stratified into six clusters based on geographical location, and clusters randomized to the timing of crossover to the intervention using simple, computer-generated randomization. Training workshops were conducted prior to the control (paper-CCM) and intervention (paper-CCM + SL eCCM App) in assigned clusters. Neither participants nor study personnel were blinded to allocation. Outcome measures were determined by abstraction of clinical data from patient records 2 weeks after recruitment. A nested qualitative study explored perceptions of adherence to urgent referral recommendations and a cost evaluation determined the financial and time-related costs to caregivers of subsequent health care utilization. The trial was conducted between July 2016 and February 2017. This is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5 years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle-income countries. ClinicalTrials.gov, ID: NCT02763345 . Registered on 3 May 2016.

Cluster-randomized controlled trial of the effects of free glasses on purchase of children's glasses in China: The PRICE (Potentiating Rural Investment in Children's Eyecare) study

PubMed Central

Wang, Xiuqin; Ma, Yue; Hu, Min; Zhou, Yuan; Liao, Weiqi; Jin, Ling; Xiao, Baixiang; Wu, Xiaoyi; Ni, Ming; Yi, Hongmei; Huang, Yiwen; Varga, Beatrice; Zhang, Hong; Cun, Yongkang; Li, Xianshun; Yang, Luhua; Liang, Chaoguang; Huang, Wan; Rozelle, Scott; Ma, Xiaochen

2017-01-01

Background Offering free glasses can be important to increase children’s wear. We sought to assess whether “Upgrade glasses” could avoid reduced glasses sales when offering free glasses to children in China. Methods In this cluster-randomized, controlled trial, children with uncorrected visual acuity (VA)< = 6/12 in either eye correctable to >6/12 in both eyes at 138 randomly-selected primary schools in 9 counties in Guangdong and Yunnan provinces, China, were randomized by school to one of four groups: glasses prescription only (Control); Free Glasses; Free Glasses + offer of $15 Upgrade Glasses; Free Glasses + offer of $30 Upgrade Glasses. Spectacle purchase (main outcome) was assessed 6 months after randomization. Results Among 10,234 children screened, 882 (8.62%, mean age 10.6 years, 45.5% boys) were eligible and randomized: 257 (29.1%) at 37 schools to Control; 253 (28.7%) at 32 schools to Free Glasses; 187 (21.2%) at 31 schools to Free Glasses + $15 Upgrade; and 185 (21.0%) at 27 schools to Free Glasses +$30 Upgrade. Baseline ownership among these children needing glasses was 11.8% (104/882), and 867 (98.3%) children completed follow-up. Glasses purchase was significantly less likely when free glasses were given: Control: 59/250 = 23.6%; Free glasses: 32/252 = 12.7%, P = 0.010. Offering Upgrade Glasses eliminated this difference: Free + $15 Upgrade: 39/183 = 21.3%, multiple regression relative risk (RR) 0.90 (0.56–1.43), P = 0.65; Free + $30 Upgrade: 38/182 = 20.9%, RR 0.91 (0.59, 1.42), P = 0.69. Conclusions Upgrade glasses can prevent reductions in glasses purchase when free spectacles are provided, providing important program income. Trial registration ClinicalTrials.gov Identifier: NCT02231606. Registered on 31 August 2014. PMID:29161286

Evaluation of Effectiveness and Cost‐Effectiveness of a Clinical Decision Support System in Managing Hypertension in Resource Constrained Primary Health Care Settings: Results From a Cluster Randomized Trial

PubMed Central

Anchala, Raghupathy; Kaptoge, Stephen; Pant, Hira; Di Angelantonio, Emanuele; Franco, Oscar H.; Prabhakaran, D.

2015-01-01

Background Randomized control trials from the developed world report that clinical decision support systems (DSS) could provide an effective means to improve the management of hypertension (HTN). However, evidence from developing countries in this regard is rather limited, and there is a need to assess the impact of a clinical DSS on managing HTN in primary health care center (PHC) settings. Methods and Results We performed a cluster randomized trial to test the effectiveness and cost‐effectiveness of a clinical DSS among Indian adult hypertensive patients (between 35 and 64 years of age), wherein 16 PHC clusters from a district of Telangana state, India, were randomized to receive either a DSS or a chart‐based support (CBS) system. Each intervention arm had 8 PHC clusters, with a mean of 102 hypertensive patients per cluster (n=845 in DSS and 783 in CBS groups). Mean change in systolic blood pressure (SBP) from baseline to 12 months was the primary endpoint. The mean difference in SBP change from baseline between the DSS and CBS at the 12th month of follow‐up, adjusted for age, sex, height, waist, body mass index, alcohol consumption, vegetable intake, pickle intake, and baseline differences in blood pressure, was −6.59 mm Hg (95% confidence interval: −12.18 to −1.42; P=0.021). The cost‐effective ratio for CBS and DSS groups was $96.01 and $36.57 per mm of SBP reduction, respectively. Conclusion Clinical DSS are effective and cost‐effective in the management of HTN in resource‐constrained PHC settings. Clinical Trial Registration URL: http://www.ctri.nic.in. Unique identifier: CTRI/2012/03/002476. PMID:25559011

Effectiveness of a cognitive behavioural workbook for changing beliefs about antipsychotic polypharmacy: analysis from a cluster randomized controlled trial.

PubMed

Thompson, Andrew; Sullivan, Sarah; Barley, Maddi; Moore, Laurence; Rogers, Paul; Sipos, Attila; Harrison, Glynn

2010-06-01

Educational workbooks have been used in psychiatry to influence patient but not clinician behaviour. Targeted education interventions to change prescribing practice in other areas of medicine have only looked at changes in prescribing and not attitudes or beliefs related to the prescribing. We aimed to examine whether clinicians' beliefs about a common prescribing issue in psychiatry (antipsychotic polypharmacy prescription) changed alongside behaviour as a result of a complex intervention. Medical and nursing staff were recruited from 19 general adult psychiatry units in the south-west of the UK as part of a cluster randomized controlled trial. A questionnaire was used to assess beliefs on the prescribing of antipsychotic polypharmacy as a secondary outcome before and after completion of a cognitive behavioural 'self-help' style workbook (one part of a complex intervention). A factor analysis suggested three dimensions of the questionnaire that corresponded to predetermined themes. The data were analysed using a random-effects regression model (adjusting for clustering) controlling for possible confounders. There was a significant change in beliefs on both of the factors: antipsychotic polypharmacy (coefficient = -0.89, P < 0.01) and rapid tranquilization (coefficient = -0.68, P = 0.01) specifically targeted by the workbook. There was a modest but statistically significant change in antipsychotic polypharmacy prescribing (odds ratio 0.43, 95% confidence intervals 0.21-0.90). The workbook appeared to change staff beliefs about antipsychotic polypharmacy, but achieving substantial changes in clinician behaviour may require further exploration of other factors important in complex prescribing issues.

Multiple behaviour change intervention for diarrhoea control in Lusaka, Zambia: a cluster randomised trial.

PubMed

Greenland, Katie; Chipungu, Jenala; Curtis, Val; Schmidt, Wolf-Peter; Siwale, Zumbe; Mudenda, Mweetwa; Chilekwa, Joyce; Lewis, James J; Chilengi, Roma

2016-12-01

Effective prevention and control of diarrhoea requires caregivers to comply with a suite of proven measures, including exclusive breastfeeding, handwashing with soap, correct use of oral rehydration salts, and zinc administration. We aimed to assess the effect of a novel behaviour change intervention using emotional drivers on caregiver practice of these behaviours. We did a cluster randomised controlled trial in Lusaka Province, Zambia. A random sample of 16 health centres (clusters) were selected from a sampling frame of 81 health centres in three of four districts in Lusaka Province using a computerised random number generator. Each cluster was randomly assigned 1:1 to either the intervention-clinic events, community events, and radio messaging-or to a standard care control arm, both for 6 months. Primary outcomes were exclusive breastfeeding (self-report), handwashing with soap (observation), oral rehydration salt solution preparation (demonstration), and zinc use in diarrhoea treatment (self-report). We measured outcome behaviours at baseline before start of intervention and 4-6 weeks post-intervention through repeat cross-sectional surveys with mothers of an infant younger than 6 months and primary caregivers of a child younger than 5 years with recent diarrhoea. We compared outcomes on an intention-to-treat population between intervention and control groups adjusted for baseline behaviour. The study was registered with ClinicalTrials.gov, number NCT02081521. Between Jan 20 and Feb 3, 2014, we recruited 306 mothers of an infant aged 0-5 months (156 intervention, 150 standard care) and 343 primary caregiver of a child aged 0-59 months with recent diarrhoea (176 intervention, 167 standard care) at baseline. Between Oct 20 to Nov 7, 2014, we recruited 401 mothers of an infant 0-5 months (234 intervention, 167 standard care) and 410 primary caregivers of a child 0-59 months with recent diarrhoea (257 intervention, 163 standard care) at endline. Intervention was associated with increased prevalence of self-reported exclusive breastfeeding of infants aged 0-5 months (adjusted difference 10·5%, 95% CI 0·9-19·9). Other primary outcomes were not affected by intervention. Cluster intervention exposure ranged from 11-81%, measured by participant self-report with verification questions. Comparison of control and intervention clusters with coverage greater than 35% provided strong evidence of an intervention effect on oral rehydration salt solution preparation and breastfeeding outcomes. The intervention may have improved exclusive breastfeeding (assessed by self-reporting), but intervention effects were diluted in clusters with low exposure. Complex caregiver practices can improve through interventions built around human motives, but these must be implemented more intensely. Absolute Return for Kids (ARK) and Comic Relief. Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

Bayesian network meta-analysis for cluster randomized trials with binary outcomes.

PubMed

Uhlmann, Lorenz; Jensen, Katrin; Kieser, Meinhard

2017-06-01

Network meta-analysis is becoming a common approach to combine direct and indirect comparisons of several treatment arms. In recent research, there have been various developments and extensions of the standard methodology. Simultaneously, cluster randomized trials are experiencing an increased popularity, especially in the field of health services research, where, for example, medical practices are the units of randomization but the outcome is measured at the patient level. Combination of the results of cluster randomized trials is challenging. In this tutorial, we examine and compare different approaches for the incorporation of cluster randomized trials in a (network) meta-analysis. Furthermore, we provide practical insight on the implementation of the models. In simulation studies, it is shown that some of the examined approaches lead to unsatisfying results. However, there are alternatives which are suitable to combine cluster randomized trials in a network meta-analysis as they are unbiased and reach accurate coverage rates. In conclusion, the methodology can be extended in such a way that an adequate inclusion of the results obtained in cluster randomized trials becomes feasible. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial

PubMed Central

2012-01-01

Background Decreasing salt consumption can prevent cardiovascular diseases (CVD). Practically, it is difficult to promote people’s awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health. Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases. Methods/Design This is a cluster randomized trial. A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand, will be studied with informed consent. A health center recruiting 100 participants is a cluster, the unit of randomization. Eight clusters will be randomized into intervention and control arms and followed up for 1 year. Within the intervention clusters the following will be undertaken: (1) salt content in the daily diet will be measured and shown to study participants; (2) 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; (3) a dietician will assist small group health education classes in cooking meals with less salt. The primary outcome is blood pressure change at the 1-year follow-up. Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake, incidence of CVD events and CVD death. The intention-to-treat analysis will be followed. Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up. Clinical CVD events and deaths will be analyzed by time-event analysis. Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally. Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model (SEM). Multilevel regression analyses will be applied. Finally, the cost effectiveness of the intervention will be analyzed. Discussion This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system. Dietary salt reduction will be applied as a prioritized, community level intervention for the prevention of CVD in a developing country. Trial registration ISRCTN39416277 PMID:22947342

Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial.

PubMed

Aung, Myo Nyein; Yuasa, Motoyuki; Moolphate, Saiyud; Nedsuwan, Supalert; Yokokawa, Hidehiro; Kitajima, Tsutomu; Minematsu, Kazuo; Tanimura, Susumu; Fukuda, Hiroshi; Hiratsuka, Yoshimune; Ono, Koichi; Kawai, Sachio; Marui, Eiji

2012-09-04

Decreasing salt consumption can prevent cardiovascular diseases (CVD). Practically, it is difficult to promote people's awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health. Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases. This is a cluster randomized trial. A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District, Chiang Rai province, Thailand, will be studied with informed consent. A health center recruiting 100 participants is a cluster, the unit of randomization. Eight clusters will be randomized into intervention and control arms and followed up for 1 year. Within the intervention clusters the following will be undertaken: (1) salt content in the daily diet will be measured and shown to study participants; (2) 24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants; (3) a dietician will assist small group health education classes in cooking meals with less salt. The primary outcome is blood pressure change at the 1-year follow-up. Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake, incidence of CVD events and CVD death. The intention-to-treat analysis will be followed.Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up. Clinical CVD events and deaths will be analyzed by time-event analysis. Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally. Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model (SEM). Multilevel regression analyses will be applied. Finally, the cost effectiveness of the intervention will be analyzed. This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system. Dietary salt reduction will be applied as a prioritized, community level intervention for the prevention of CVD in a developing country. ISRCTN39416277.

Percolation and epidemics in random clustered networks

NASA Astrophysics Data System (ADS)

Miller, Joel C.

2009-08-01

The social networks that infectious diseases spread along are typically clustered. Because of the close relation between percolation and epidemic spread, the behavior of percolation in such networks gives insight into infectious disease dynamics. A number of authors have studied percolation or epidemics in clustered networks, but the networks often contain preferential contacts in high degree nodes. We introduce a class of random clustered networks and a class of random unclustered networks with the same preferential mixing. Percolation in the clustered networks reduces the component sizes and increases the epidemic threshold compared to the unclustered networks.

Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial.

PubMed

Leung, K S; Li, C Y; Tse, Y K; Choy, T K; Leung, P C; Hung, V W Y; Chan, S Y; Leung, A H C; Cheung, W H

2014-06-01

This study is a prospective cluster-randomized controlled clinical trial involving 710 elderly subjects to investigate the long-term effects of low-magnitude high-frequency vibration (LMHFV) on fall and fracture rates, muscle performance, and bone quality. The results confirmed that LMHFV is effective in reducing fall incidence and enhancing muscle performance in the elderly. Falls are direct causes of fragility fracture in the elderly. LMHFV has been shown to improve muscle function and bone quality. This study is to investigate the efficacy of LMHFV in preventing fall and fractures among the elderly in the community. A cluster-randomized controlled trial was conducted with 710 postmenopausal females over 60 years. A total of 364 participants received daily 20 min LMHFV (35 Hz, 0.3 g), 5 days/week for 18 months; 346 participants served as control. Fall or fracture rate was taken as the primary outcome. Also, quadriceps muscle strength, balancing abilities, bone mineral density (BMD), and quality of life (QoL) assessments were done at 0, 9, and 18 months. With an average of 66.0% compliance in the vibration group, 18.6% of 334 vibration group subjects reported fall or fracture incidences compared with 28.7% of 327 in the control (adjusted HR = 0.56, p = 0.001). The fracture rate of vibration and control groups were 1.1 and 2.3 % respectively (p = 0.171). Significant improvements were found in reaction time, movement velocity, and maximum excursion of balancing ability assessment, and also the quadriceps muscle strength (p < 0.001). No significant differences were found in the overall change of BMD. Minimal adverse effects were documented. LMHFV is effective in fall prevention with improved muscle strength and balancing ability in the elderly. We recommend its use in the community as an effective fall prevention program and to decrease related injuries.

Intraclass Correlations for Three-Level Multi-Site Cluster-Randomized Trials of Science Achievement

ERIC Educational Resources Information Center

Westine, Carl D.

2015-01-01

A cluster-randomized trial (CRT) relies on random assignment of intact clusters to treatment conditions, such as classrooms or schools (Raudenbush & Bryk, 2002). One specific type of CRT, a multi-site CRT (MSCRT), is commonly employed in educational research and evaluation studies (Spybrook & Raudenbush, 2009; Spybrook, 2014; Bloom,…

Feedback on oral presentations during pediatric clerkships: a randomized controlled trial.

PubMed

Sox, Colin M; Dell, Michael; Phillipi, Carrie A; Cabral, Howard J; Vargas, Gabriela; Lewin, Linda O

2014-11-01

To measure the effects of participating in structured oral presentation evaluation sessions early in pediatric clerkships on students' subsequent presentations. We conducted a single-blind, 3-arm, cluster randomized controlled trial during pediatric clerkships at Boston University School of Medicine, University of Maryland School of Medicine, Oregon Health & Science University, and Case Western Reserve University School of Medicine. Blocks of students at each school were randomly assigned to experience either (1) no formal presentation feedback (control) or a small-group presentation feedback session early in pediatric clerkships in which students gave live presentations and received feedback from faculty who rated their presentations by using a (2) single-item (simple) or (3) 18-item (detailed) evaluation form. At the clerkship end, overall quality of subjects' presentations was rated by faculty blinded to randomization status, and subjects reported whether their presentations had improved. Analyses included multivariable linear and logistic regressions clustered on clerkship block that controlled for medical school. A total of 476 participants were evenly divided into the 3 arms, which had similar characteristics. Compared with controls, presentation quality was significantly associated with participating in detailed (coefficient: 0.38; 95% confidence interval [CI]: 0.07-0.69) but not simple (coefficient: 0.16; 95% CI: -0.12-0.43) feedback sessions. Similarly, student self-report of presentation improvement was significantly associated with participating in detailed (odds ratio: 2.16; 95% CI: 1.11-4.18] but not simple (odds ratio: 1.89; 95% CI: 0.91-3.93) feedback sessions. Small-group presentation feedback sessions led by faculty using a detailed evaluation form resulted in clerkship students delivering oral presentations of higher quality compared with controls. Copyright © 2014 by the American Academy of Pediatrics.

A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

PubMed Central

Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

2010-01-01

Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

The effects of motivation feedback in patients with severe mental illness: a cluster randomized controlled trial

PubMed Central

Jochems, Eline C; van der Feltz-Cornelis, Christina M; van Dam, Arno; Duivenvoorden, Hugo J; Mulder, Cornelis L

2015-01-01

Objective To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968). Participants: adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians, treated in 12 community mental health teams (the clusters) of two mental health institutions in the Netherlands. Interventions: monthly motivation feedback (MF) generated by clinicians additional to treatment as usual (TAU) and TAU by the community mental health teams. Primary outcome: treatment engagement at patient level, assessed at 12 months by clinicians. Randomization: teams were allocated to MF or TAU by a computerized randomization program that randomized each team to a single treatment by blocks of varying size. All participants within these teams received similar treatment. Clinicians and patients were not blind to treatment allocation at the 12-month assessment. Results The 294 randomized patients (148 MF, 146 TAU) and 57 clinicians (29 MF, 28 TAU) of 12 teams (6 MF, 6 TAU) were analyzed according to the intention-to-treat principle. No statistically significant differences between treatment groups on treatment engagement were found (adjusted mean difference =0.1, 95% confidence interval =−2.2 to 2.3, P=0.96, d=0). Preplanned ancillary analyses showed statistically significant interaction effects between treatment group and primary diagnosis on treatment motivation and quality of life (secondary outcomes), which were beneficial for patients with a primary diagnosis of a personality disorder but not for those with a psychotic disorder. There were no reports of adverse events. Conclusion The current findings imply that monitoring and discussing the patient’s motivation is insufficient to improve motivation and treatment engagement, and suggests that more elaborate interventions for severe mental illness patients are needed. PMID:26715847

Case-control geographic clustering for residential histories accounting for risk factors and covariates

PubMed Central

2006-01-01

Background Methods for analyzing space-time variation in risk in case-control studies typically ignore residential mobility. We develop an approach for analyzing case-control data for mobile individuals and apply it to study bladder cancer in 11 counties in southeastern Michigan. At this time data collection is incomplete and no inferences should be drawn – we analyze these data to demonstrate the novel methods. Global, local and focused clustering of residential histories for 219 cases and 437 controls is quantified using time-dependent nearest neighbor relationships. Business address histories for 268 industries that release known or suspected bladder cancer carcinogens are analyzed. A logistic model accounting for smoking, gender, age, race and education specifies the probability of being a case, and is incorporated into the cluster randomization procedures. Sensitivity of clustering to definition of the proximity metric is assessed for 1 to 75 k nearest neighbors. Results Global clustering is partly explained by the covariates but remains statistically significant at 12 of the 14 levels of k considered. After accounting for the covariates 26 Local clusters are found in Lapeer, Ingham, Oakland and Jackson counties, with the clusters in Ingham and Oakland counties appearing in 1950 and persisting to the present. Statistically significant focused clusters are found about the business address histories of 22 industries located in Oakland (19 clusters), Ingham (2) and Jackson (1) counties. Clusters in central and southeastern Oakland County appear in the 1930's and persist to the present day. Conclusion These methods provide a systematic approach for evaluating a series of increasingly realistic alternative hypotheses regarding the sources of excess risk. So long as selection of cases and controls is population-based and not geographically biased, these tools can provide insights into geographic risk factors that were not specifically assessed in the case-control study design. PMID:16887016

Decreasing Inappropriate Use of Antibiotics in Primary Care in Four Countries in South America—Cluster Randomized Controlled Trial

PubMed Central

Urbiztondo, Inés; Caballero, Lidia; Suarez, Miguel Angel; Olinisky, Monica

2017-01-01

High antibiotic prescribing and antimicrobial resistance in patients attending primary care have been reported in South America. Very few interventions targeting general practitioners (GPs) to decrease inappropriate antibiotic prescribing have been investigated in this region. This study assessed the effectiveness of online feedback on reducing antibiotic prescribing in patients with suspected respiratory tract infections (RTIs) attending primary care. The aim was to reduce antibiotic prescribing in patients with acute bronchitis and acute otitis media. Both are RTIs for which antibiotics have a very limited effect. A cluster randomized two-arm control trial was implemented. Healthcare centres from Bolivia, Argentina, Paraguay and Uruguay participating in the quality improvement program HAPPY AUDIT were randomly allocated to either intervention or control group. During ten consecutive weeks, GPs in the intervention group received evidence-based online feedback on the management of suspected RTIs. In patients with acute bronchitis, the intervention reduced the antibiotic prescribing rate from 71.6% to 56% (control group from 61.2% to 52%). In patients with acute otitis media, the intervention reduced the antibiotic prescribing from 94.8% to 86.2% (no change in the control group). In all RTIs, the intervention reduced antibiotic prescribing rate from 37.4% to 28.1% (control group from 29% to 27.2%). Online evidence-based feedback is effective for reducing antibiotic prescribing in patients with RTIs attending primary care in South America. PMID:29240687

Implementation of patient education at first and second dispensing of statins in Dutch community pharmacies: the sequel of a cluster randomized trial

PubMed Central

2011-01-01

Background As a result of the previous part of this trial, many patients with cardiovascular disease were expected to receive a statin for the first time. In order to provide these patients with comprehensive information on statins, as recommended by professional guidance, education at first and second dispensing of statins had to be implemented. This study was designed to assess the effectiveness of an intensive implementation program targeted at pharmacy project assistants on the frequency of providing education at first dispensing (EAFD) and education at second dispensing (EASD) of statins in community pharmacies. Methods The participating community pharmacies were clustered on the basis of local collaboration, were numbered by a research assistant and subsequently an independent statistician performed a block randomization, in which the cluster size (number of pharmacies in each cluster) was balanced. The pharmacies in the control group received a written manual on the implementation of EAFD and EASD; the pharmacies in the intervention group received intensive support for the implementation. The impact of the intensive implementation program on the implementation process and on the primary outcomes was examined in a random coefficient logistic regression model, which took into account that patients were grouped within pharmacy clusters. Results Of the 37 pharmacies in the intervention group, 17 pharmacies (50%) provided EAFD and 12 pharmacies (35.3%) provided EASD compared to 14 pharmacies (45.2%, P = 0.715) and 12 pharmacies (38.7%, P = 0.899), respectively, of the 34 pharmacies in the control group. In the intervention group a total of 72 of 469 new statin users (15.4%) received education and 49 of 393 patients with a second statin prescription (12.5%) compared to 78 of 402 new users (19.4%, P = 0.944) and 35 of 342 patients with a second prescription (10.2%, P = 0.579) in the control group. Conclusion The intensive implementation program did not increase the frequency of providing EAFD and EASD of statins in community pharmacies. Trial Registration clinicaltrials.gov NCT00509717 PMID:22087850

Community resource centres to improve the health of women and children in Mumbai slums: study protocol for a cluster randomized controlled trial.

PubMed

Shah More, Neena; Das, Sushmita; Bapat, Ujwala; Rajguru, Mahesh; Alcock, Glyn; Joshi, Wasundhara; Pantvaidya, Shanti; Osrin, David

2013-05-08

The trial addresses the general question of whether community resource centers run by a non-government organization improve the health of women and children in slums. The resource centers will be run by the Society for Nutrition, Education and Health Action, and the trial will evaluate their effects on a series of public health indicators. Each resource center will be located in a vulnerable Mumbai slum area and will serve as a base for salaried community workers, supervised by officers and coordinators, to organize the collection and dissemination of health information, provision of services, home visits to identify and counsel families at risk, referral of individuals and families to appropriate services and support for their access, meetings of community members and providers, and events and campaigns on health issues. A cluster randomized controlled trial in which 20 urban slum areas with resource centers are compared with 20 control areas. Each cluster will contain approximately 600 households and randomized allocation will be in three blocked phases, of 12, 12 and 16 clusters. Any resident of an intervention cluster will be able to participate in the intervention, but the resource centers will target women and children, particularly women of reproductive age and children under 5.The outcomes will be assessed through a household census after 2 years of resource center operations. The primary outcomes are unmet need for family planning in women aged 15 to 49 years, proportion of children under 5 years of age not fully immunized for their ages, and proportion of children under 5 years of age with weight for height less than 2 standard deviations below the median for age and sex. Secondary outcomes describe adolescent pregnancies, home deliveries, receipt of conditional cash transfers for institutional delivery, other childhood anthropometric indices, use of public sector health and nutrition services, indices of infant and young child feeding, and consultation for violence against women and children. ISRCTN Register: ISRCTN56183183Clinical Trials Registry of India: CTRI/2012/09/003004.

Household costs of dengue illness: secondary outcomes from a randomised controlled trial of dengue prevention in Guerrero state, Mexico.

PubMed

Legorreta-Soberanis, José; Paredes-Solís, Sergio; Morales-Pérez, Arcadio; Nava-Aguilera, Elizabeth; Serrano-de Los Santos, Felipe René; Dimas-Garcia, Diana Lisseth; Ledogar, Robert J; Cockcroft, Anne; Andersson, Neil

2017-05-30

Dengue is a serious public health problem with an important economic impact. This study used data from a cluster randomised controlled trial of community mobilisation for dengue prevention to estimate the household costs of treatment of dengue illness. It examined the economic impact of the trial intervention in the three coastal regions of Mexico's Guerrero State. The 2010 baseline survey covered households in a random sample of 90 clusters in the coastal regions; the clusters were randomly allocated to intervention or control and re-surveyed in 2012. The surveys asked about dengue cases in the last 12 months, expenditures on their treatment, and work or school days lost by patients and care givers. We did not assign monetary value to days lost, since a lost day to a person of low earning power is of equal or higher value to that person than to one who earns more. The 12,312 households in 2010 reported 1020 dengue cases in the last 12 months (1.9% of the sample population). Most (78%) were ambulatory cases, with a mean cost of USD 51 and 10.8 work/school days, rising to USD 96 and 11.4 work/school days if treated by a private physician. Hospitalised cases cost USD 28-94 in government institutions and USD 392 in private hospitals (excluding additional inpatient charges), as well as 9.6-17.3 work/school days. Dengue cases cost households an estimated 412,825 work/school days throughout the three coastal regions. In the follow up survey, 6.1% (326/5349) of households in intervention clusters and 7.9% (405/5139) in control clusters reported at least one dengue case. The mean of days lost per case was similar in intervention and control clusters, but the number of days lost from dengue and all elements of costs for dengue cases per 1000 population were lower in intervention clusters. If the total population of the three coastal regions had received the intervention, some 149,401 work or school days lost per year could have been prevented. The economic effect of dengue on households, including lost work days, is substantial. The Camino Verde trial intervention reduced household costs for treatment of dengue cases. The trial was registered as ISRCTN:27,581,154 .

Prediction models for clustered data: comparison of a random intercept and standard regression model

PubMed Central

2013-01-01

Background When study data are clustered, standard regression analysis is considered inappropriate and analytical techniques for clustered data need to be used. For prediction research in which the interest of predictor effects is on the patient level, random effect regression models are probably preferred over standard regression analysis. It is well known that the random effect parameter estimates and the standard logistic regression parameter estimates are different. Here, we compared random effect and standard logistic regression models for their ability to provide accurate predictions. Methods Using an empirical study on 1642 surgical patients at risk of postoperative nausea and vomiting, who were treated by one of 19 anesthesiologists (clusters), we developed prognostic models either with standard or random intercept logistic regression. External validity of these models was assessed in new patients from other anesthesiologists. We supported our results with simulation studies using intra-class correlation coefficients (ICC) of 5%, 15%, or 30%. Standard performance measures and measures adapted for the clustered data structure were estimated. Results The model developed with random effect analysis showed better discrimination than the standard approach, if the cluster effects were used for risk prediction (standard c-index of 0.69 versus 0.66). In the external validation set, both models showed similar discrimination (standard c-index 0.68 versus 0.67). The simulation study confirmed these results. For datasets with a high ICC (≥15%), model calibration was only adequate in external subjects, if the used performance measure assumed the same data structure as the model development method: standard calibration measures showed good calibration for the standard developed model, calibration measures adapting the clustered data structure showed good calibration for the prediction model with random intercept. Conclusion The models with random intercept discriminate better than the standard model only if the cluster effect is used for predictions. The prediction model with random intercept had good calibration within clusters. PMID:23414436

Prediction models for clustered data: comparison of a random intercept and standard regression model.

PubMed

Bouwmeester, Walter; Twisk, Jos W R; Kappen, Teus H; van Klei, Wilton A; Moons, Karel G M; Vergouwe, Yvonne

2013-02-15

When study data are clustered, standard regression analysis is considered inappropriate and analytical techniques for clustered data need to be used. For prediction research in which the interest of predictor effects is on the patient level, random effect regression models are probably preferred over standard regression analysis. It is well known that the random effect parameter estimates and the standard logistic regression parameter estimates are different. Here, we compared random effect and standard logistic regression models for their ability to provide accurate predictions. Using an empirical study on 1642 surgical patients at risk of postoperative nausea and vomiting, who were treated by one of 19 anesthesiologists (clusters), we developed prognostic models either with standard or random intercept logistic regression. External validity of these models was assessed in new patients from other anesthesiologists. We supported our results with simulation studies using intra-class correlation coefficients (ICC) of 5%, 15%, or 30%. Standard performance measures and measures adapted for the clustered data structure were estimated. The model developed with random effect analysis showed better discrimination than the standard approach, if the cluster effects were used for risk prediction (standard c-index of 0.69 versus 0.66). In the external validation set, both models showed similar discrimination (standard c-index 0.68 versus 0.67). The simulation study confirmed these results. For datasets with a high ICC (≥15%), model calibration was only adequate in external subjects, if the used performance measure assumed the same data structure as the model development method: standard calibration measures showed good calibration for the standard developed model, calibration measures adapting the clustered data structure showed good calibration for the prediction model with random intercept. The models with random intercept discriminate better than the standard model only if the cluster effect is used for predictions. The prediction model with random intercept had good calibration within clusters.

Effects of lifestyle education program for type 2 diabetes patients in clinics: study design of a cluster randomized trial.

PubMed

Adachi, Misa; Yamaoka, Kazue; Watanabe, Mariko; Nishikawa, Masako; Hida, Eisuke; Kobayashi, Itsuro; Tango, Toshiro

2010-11-30

The number of patients with type 2 diabetes is drastically increasing worldwide. It is a serious health problem in Japan as well. Lifestyle interventions can reduce progression from impaired glucose tolerance to type 2 diabetes, and glycemic control has been shown to improve postprandial plasma glucose levels. Moreover, several studies have suggested that continuous interventions (combined diet and exercise) can improve the plasma glucose level and reduce dosage of hypoglycemic agents.Although many interventional studies of lifestyle education for persons with diabetes in hospitals have been reported, only a few have been clinic-based studies employing an evidence-based lifestyle education program. This article describes the design of a cluster randomized controlled trial of the effectiveness of lifestyle education for patients with type 2 diabetes in clinics by registered dietitians. In Japan, general practitioners generally have their own medical clinics to provide medical care for outpatients in the community, including those with type 2 diabetes. With the collaboration of such general practitioners, the study patients were enrolled in the present study. Twenty general practitioners were randomly allocated to each provide patients for entry into either an intervention group (10) or a control group (10). In total, 200 participants will be included in the study. The intervention group will receive intensive education on lifestyle improvement related to type 2 diabetes by registered dietitians in clinics. Lifestyle education will be conducted several times during the study period. The control group will receive information on dietary intake and standard advice on glycemic control by registered dietitians. The primary endpoint is the change from the baseline value of HbA1c at 6 months. Data on health behavior and related issues will be gathered continuously over a 6-month period. This is the first study to evaluate lifestyle education in clinics by a cluster randomization trial in Japan. The proposed study will provide practical information about the usefulness of the intensive lifestyle improvement education program in primary care settings. The study was started in September 2007 and entry of subjects was completed in December 2010. Data on the effect evaluation will be available in 2011. UMIN000004049.

Effectiveness and Cost-Effectiveness of Occupation-Based Occupational Therapy Using the Aid for Decision Making in Occupation Choice (ADOC) for Older Residents: Pilot Cluster Randomized Controlled Trial

PubMed Central

Nagayama, Hirofumi; Tomori, Kounosuke; Ohno, Kanta; Takahashi, Kayoko; Ogahara, Kakuya; Sawada, Tatsunori; Uezu, Sei; Nagatani, Ryutaro; Yamauchi, Keita

2016-01-01

Background Care-home residents are mostly inactive, have little interaction with staff, and are dependent on staff to engage in daily occupations. We recently developed an iPad application called the Aid for Decision-making in Occupation Choice (ADOC) to promote shared decision-making in activities and occupation-based goal setting by choosing from illustrations describing daily activities. This study aimed to evaluate if interventions based on occupation-based goal setting using the ADOC could focus on meaningful activities to improve quality of life and independent activities of daily living, with greater cost-effectiveness than an impairment-based approach as well as to evaluate the feasibility of conducting a large cluster, randomized controlled trial. Method In this single (assessor)-blind pilot cluster randomized controlled trial, the intervention group (ADOC group) received occupational therapy based on occupation-based goal setting using the ADOC, and the interventions were focused on meaningful occupations. The control group underwent an impairment-based approach focused on restoring capacities, without goal setting tools. In both groups, the 20-minute individualized intervention sessions were conducted twice a week for 4 months. Main Outcome Measures Short Form-36 (SF-36) score, SF-6D utility score, quality adjusted life years (QALY), Barthel Index, and total care cost. Results We randomized and analyzed 12 facilities (44 participants, 18.5% drop-out rate), with 6 facilities each allocated to the ADOC (n = 23) and control (n = 21) groups. After the 4-month intervention, the ADOC group had a significantly greater change in the BI score, with improved scores (P = 0.027, 95% CI 0.41 to 6.87, intracluster correlation coefficient = 0.14). No other outcome was significantly different. The incremental cost-effectiveness ratio, calculated using the change in BI score, was $63.1. Conclusion The results suggest that occupational therapy using the ADOC for older residents might be effective and cost-effective. We also found that conducting an RCT in the occupational therapy setting is feasible. Trial Registration UMIN Clinical Trials Registry UMIN000012994 PMID:26930191

Effectiveness and Cost-Effectiveness of Occupation-Based Occupational Therapy Using the Aid for Decision Making in Occupation Choice (ADOC) for Older Residents: Pilot Cluster Randomized Controlled Trial.

PubMed

Nagayama, Hirofumi; Tomori, Kounosuke; Ohno, Kanta; Takahashi, Kayoko; Ogahara, Kakuya; Sawada, Tatsunori; Uezu, Sei; Nagatani, Ryutaro; Yamauchi, Keita

2016-01-01

Care-home residents are mostly inactive, have little interaction with staff, and are dependent on staff to engage in daily occupations. We recently developed an iPad application called the Aid for Decision-making in Occupation Choice (ADOC) to promote shared decision-making in activities and occupation-based goal setting by choosing from illustrations describing daily activities. This study aimed to evaluate if interventions based on occupation-based goal setting using the ADOC could focus on meaningful activities to improve quality of life and independent activities of daily living, with greater cost-effectiveness than an impairment-based approach as well as to evaluate the feasibility of conducting a large cluster, randomized controlled trial. In this single (assessor)-blind pilot cluster randomized controlled trial, the intervention group (ADOC group) received occupational therapy based on occupation-based goal setting using the ADOC, and the interventions were focused on meaningful occupations. The control group underwent an impairment-based approach focused on restoring capacities, without goal setting tools. In both groups, the 20-minute individualized intervention sessions were conducted twice a week for 4 months. Short Form-36 (SF-36) score, SF-6D utility score, quality adjusted life years (QALY), Barthel Index, and total care cost. We randomized and analyzed 12 facilities (44 participants, 18.5% drop-out rate), with 6 facilities each allocated to the ADOC (n = 23) and control (n = 21) groups. After the 4-month intervention, the ADOC group had a significantly greater change in the BI score, with improved scores (P = 0.027, 95% CI 0.41 to 6.87, intracluster correlation coefficient = 0.14). No other outcome was significantly different. The incremental cost-effectiveness ratio, calculated using the change in BI score, was $63.1. The results suggest that occupational therapy using the ADOC for older residents might be effective and cost-effective. We also found that conducting an RCT in the occupational therapy setting is feasible. UMIN Clinical Trials Registry UMIN000012994.

Effect of a Nutrition Supplement and Physical Activity Program on Pneumonia and Walking Capacity in Chilean Older People: A Factorial Cluster Randomized Trial

PubMed Central

Dangour, Alan D.; Albala, Cecilia; Allen, Elizabeth; Grundy, Emily; Walker, Damian G.; Aedo, Cristian; Sanchez, Hugo; Fletcher, Olivia; Elbourne, Diana; Uauy, Ricardo

2011-01-01

Background Ageing is associated with increased risk of poor health and functional decline. Uncertainties about the health-related benefits of nutrition and physical activity for older people have precluded their widespread implementation. We investigated the effectiveness and cost-effectiveness of a national nutritional supplementation program and/or a physical activity intervention among older people in Chile. Methods and Findings We conducted a cluster randomized factorial trial among low to middle socioeconomic status adults aged 65–67.9 years living in Santiago, Chile. We randomized 28 clusters (health centers) into the study and recruited 2,799 individuals in 2005 (∼100 per cluster). The interventions were a daily micronutrient-rich nutritional supplement, or two 1-hour physical activity classes per week, or both interventions, or neither, for 24 months. The primary outcomes, assessed blind to allocation, were incidence of pneumonia over 24 months, and physical function assessed by walking capacity 24 months after enrolment. Adherence was good for the nutritional supplement (∼75%), and moderate for the physical activity intervention (∼43%). Over 24 months the incidence rate of pneumonia did not differ between intervention and control clusters (32.5 versus 32.6 per 1,000 person years respectively; risk ratio = 1.00; 95% confidence interval 0.61–1.63; p = 0.99). In intention-to-treat analysis, after 24 months there was a significant difference in walking capacity between the intervention and control clusters (mean difference 33.8 meters; 95% confidence interval 13.9–53.8; p = 0.001). The overall cost of the physical activity intervention over 24 months was US$164/participant; equivalent to US$4.84/extra meter walked. The number of falls and fractures was balanced across physical activity intervention arms and no serious adverse events were reported for either intervention. Conclusions Chile's nutritional supplementation program for older people is not effective in reducing the incidence of pneumonia. This trial suggests that the provision of locally accessible physical activity classes in a transition economy population can be a cost-effective means of enhancing physical function in later life. Trial registration Current Controlled Trials ISRCTN 48153354 Please see later in the article for the Editors' Summary PMID:21526229

Improving care of patients with diabetes and CKD: a pilot study for a cluster-randomized trial.

PubMed

Cortés-Sanabria, Laura; Cabrera-Pivaral, Carlos E; Cueto-Manzano, Alfonso M; Rojas-Campos, Enrique; Barragán, Graciela; Hernández-Anaya, Moisés; Martínez-Ramírez, Héctor R

2008-05-01

Family physicians may have the main role in managing patients with type 2 diabetes mellitus with early nephropathy. It is therefore important to determine the clinical competence of family physicians in preserving renal function of patients. The aim of this study is to evaluate the effect of an educational intervention on family physicians' clinical competence and subsequently determine the impact on kidney function of their patients with type 2 diabetes mellitus. Pilot study for a cluster-randomized trial. Primary health care units of the Mexican Institute of Social Security, Guadalajara, Mexico. The study group was composed of 21 family physicians from 1 unit and a control group of 19 family physicians from another unit. 46 patients treated by study physicians and 48 treated by control physicians also were evaluated. An educative strategy based on a participative model used during 6 months in the study group. Allocation of units to receive or not receive the educative intervention was randomly established. Clinical competence of family physicians and kidney function of patients. To evaluate clinical competence, a validated questionnaire measuring family physicians' capability to identify risk factors, integrate diagnosis, and correctly use laboratory tests and therapeutic resources was applied to all physicians at the beginning and end of educative intervention (0 and 6 months). In patients, serum creatinine level, estimated glomerular filtration rate, and albuminuria were evaluated at 0, 6, and 12 months. At the end of the intervention, more family physicians from the study group improved clinical competence (91%) compared with controls (37%; P = 0.001). Family physicians in the study group who increased their competence improved renal function significantly better than physicians in the same group who did not increase competence and physicians in the control group (with or without increase in competence): change in estimated glomerular filtration rate, 0.9 versus -33, -21, and -16 mL/min/1.73 m(2) (P < 0.05); and change in urinary albumin excretion of -18 versus 226, 142, and 288 mg/d, respectively (P < 0.05). Compared with other groups, study family physicians with clinical competence also controlled systolic blood pressure significantly better and were more likely to increase the use of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and statins and to discontinue nonsteroidal anti-inflammatory drugs. Our analysis did not adjust for clustering. Physicians in only 2 units were randomly assigned; thus, it is not possible to distinguish the effect of the intervention from the effect of the unit. Educative intervention to primary physicians is feasible. Our data may be the basis for additional prospective studies with a cluster-randomized trial design and larger numbers of centers, physicians, and patients.

Ferromagnetic clusters induced by a nonmagnetic random disorder in diluted magnetic semiconductors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bui, Dinh-Hoi; Physics Department, Hue University’s College of Education, 34 Le Loi, Hue; Phan, Van-Nham, E-mail: phanvannham@dtu.edu.vn

In this work, we analyze the nonmagnetic random disorder leading to a formation of ferromagnetic clusters in diluted magnetic semiconductors. The nonmagnetic random disorder arises from randomness in the host lattice. Including the disorder to the Kondo lattice model with random distribution of magnetic dopants, the ferromagnetic–paramagnetic transition in the system is investigated in the framework of dynamical mean-field theory. At a certain low temperature one finds a fraction of ferromagnetic sites transiting to the paramagnetic state. Enlarging the nonmagnetic random disorder strength, the paramagnetic regimes expand resulting in the formation of the ferromagnetic clusters.

Under What Circumstances Does External Knowledge about the Correlation Structure Improve Power in Cluster Randomized Designs?

ERIC Educational Resources Information Center

Rhoads, Christopher

2014-01-01

Recent publications have drawn attention to the idea of utilizing prior information about the correlation structure to improve statistical power in cluster randomized experiments. Because power in cluster randomized designs is a function of many different parameters, it has been difficult for applied researchers to discern a simple rule explaining…

A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol

PubMed Central

Klimek, L; Uhlig, J; Mösges, R; Rettig, K; Pfaar, O

2014-01-01

Background Cluster immunotherapy represents an interesting alternative to conventional up-dosing schedules because it allows achieving the maintenance dose within a shorter time interval. In this study, the efficacy and safety of cluster immunotherapy with a high polymerized allergen extract of a grass/rye pollen mixture have been evaluated in a randomized, double-blind, placebo-controlled, multicenter study. Methods In total, 121 patients with allergic rhinoconjunctivitis due to grass pollen were randomized 1 : 1 to verum or placebo group. A short cluster up-dosing schedule of only 1 week was applied to achieve the maintenance dose which was administered monthly during the study period of 1 year. Total combined symptom and medication score (TCS) was defined as primary outcome parameter. Secondary outcome parameters were individual symptom and medication scores, ‘well days,’ global improvement as well as immunological effects and nasal allergen challenge. The safety profile was evaluated based on the European academy of allergy and clinical immunology grading system. Results Significant reduction in the verum compared to the placebo group (intention-to-treat, population, verum: n = 55; placebo: n = 47) was found regarding TCS (P = 0.005), rhinoconjunctivitis total symptom score (RTSS, P = 0.006), and total rescue medication score (TRMS, P = 0.002). Additionally, secondary outcomes such as ‘well days,’ nasal challenge results, and increase of specific IgG4 were in favor of the active treatment. All systemic adverse reactions (0.8% of all injections in the verum group) were of mild intensity. No severe reactions related to the study medication were observed. Conclusion Cluster immunotherapy with high polymerized grass pollen extracts resulted in significant clinical efficacy and has been shown to be a safe treatment for grass pollen-allergic patients. PMID:25130503

Does routine psychosocial screening improve referral to psychosocial care providers and patient-radiotherapist communication? A cluster randomized controlled trial.

PubMed

Braeken, Anna P B M; Lechner, Lilian; Eekers, Daniëlle B P; Houben, Ruud M A; van Gils, Francis C J M; Ambergen, Ton; Kempen, Gertrudis I J M

2013-11-01

This study tests whether using a screening instrument improves referral to psychosocial care providers (e.g. psychologist) and facilitates patient-radiotherapist communication. A cluster randomized controlled trial was used. Fourteen radiotherapists were randomly allocated to the experimental or control group and 568 of their patients received care in accordance with the group to which their radiotherapist was allocated. Patients in the experimental group were asked to complete a screening instrument before and at the end of the radiation treatment period. All patients were requested to complete questionnaires concerning patient-physician communication after the first consultation and concerning psychosocial care 3 and 12 months post-intervention. Patients who completed the screening instrument were referred to social workers at an earlier stage than patients who did not (P<0.01). No effects were observed for numbers of referred patients, or for improved patient-radiotherapist communication. Our results suggest that a simple screening procedure can be valuable for the timely treatment of psychosocial problems in patients. Future efforts should be directed at appropriate timing of screening and enhancing physicians' awareness regarding the importance of identifying, discussing and treating psychosocial problems in cancer patients. Psychosocial screening can be enhanced by effective radiotherapist-patient communication. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong

PubMed Central

Ho, Henry C. Y.; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M.; Yew, Carol; Lam, Tai Hing; Chan, Sophia S.

2016-01-01

Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275). PMID:27199864

Your Health, an Intervention at Senior Vocational Schools to Promote Adolescents' Health and Health Behaviors

ERIC Educational Resources Information Center

Bannink, Rienke; Broeren, Suzanne; Heydelberg, Jurriën; van 't Klooster, Els; van Baar, Cathelijn; Raat, Hein

2014-01-01

This study evaluates the appreciation, application and effects of an intervention (Your Health), in which adolescents received a consultation with the school nurse. A cluster randomized controlled trial with an intervention and control group (care-as-usual) was conducted among first-grade senior vocational students. Adolescents (n = 418) completed…

A Cluster Randomized Controlled Trial of Child-Focused Psychiatric Consultation and a School Systems-Focused Intervention to Reduce Aggression

ERIC Educational Resources Information Center

Fonagy, Peter; Twemlow, Stuart W.; Vernberg, Eric M.; Nelson, Jennifer Mize; Dill, Edward J.; Little, Todd D.; Sargent, John A.

2009-01-01

Background: While school-based anti-bullying programs are widely used, there have been few controlled trials of effectiveness. This study compared the effect of manualized School Psychiatric Consultation (SPC), CAPSLE (a systems and mentalization focused whole school intervention), and treatment-as-usual (TAU) in reducing aggression and…

Implementation of Possession Laws and the Social Ecology of Tobacco Control

ERIC Educational Resources Information Center

Livingood, William C.; Woodhouse, Lynn D.; Wludyka, Peter

2009-01-01

The objective of this evaluation research was to assess the impact of programs intended to support the enforcement component of a comprehensive youth tobacco control. The research method was a survey of a randomly stratified cluster sample of law enforcement officers. Results of the evaluation showed that the enforcement behaviors of officers were…

How large are the consequences of covariate imbalance in cluster randomized trials: a simulation study with a continuous outcome and a binary covariate at the cluster level.

PubMed

Moerbeek, Mirjam; van Schie, Sander

2016-07-11

The number of clusters in a cluster randomized trial is often low. It is therefore likely random assignment of clusters to treatment conditions results in covariate imbalance. There are no studies that quantify the consequences of covariate imbalance in cluster randomized trials on parameter and standard error bias and on power to detect treatment effects. The consequences of covariance imbalance in unadjusted and adjusted linear mixed models are investigated by means of a simulation study. The factors in this study are the degree of imbalance, the covariate effect size, the cluster size and the intraclass correlation coefficient. The covariate is binary and measured at the cluster level; the outcome is continuous and measured at the individual level. The results show covariate imbalance results in negligible parameter bias and small standard error bias in adjusted linear mixed models. Ignoring the possibility of covariate imbalance while calculating the sample size at the cluster level may result in a loss in power of at most 25 % in the adjusted linear mixed model. The results are more severe for the unadjusted linear mixed model: parameter biases up to 100 % and standard error biases up to 200 % may be observed. Power levels based on the unadjusted linear mixed model are often too low. The consequences are most severe for large clusters and/or small intraclass correlation coefficients since then the required number of clusters to achieve a desired power level is smallest. The possibility of covariate imbalance should be taken into account while calculating the sample size of a cluster randomized trial. Otherwise more sophisticated methods to randomize clusters to treatments should be used, such as stratification or balance algorithms. All relevant covariates should be carefully identified, be actually measured and included in the statistical model to avoid severe levels of parameter and standard error bias and insufficient power levels.

Micro-Loans, Insecticide-Treated Bednets, and Malaria: Evidence from a Randomized Controlled Trial in Orissa, India.

PubMed

Tarozzi, Alessandro; Mahajan, Aprajit; Blackburn, Brian; Kopf, Dan; Krishnan, Lakshmi; Yoong, Joanne

2014-07-01

We describe findings from the first large-scale cluster randomized controlled trial in a developing country that evaluates the uptake of a health-protecting technology, insecticide-treated bednets (ITNs), through micro-consumer loans, as compared to free distribution and control conditions. Despite a relatively high price, 52 percent of sample households purchased ITNs, highlighting the role of liquidity constraints in explaining earlier low adoption rates. We find mixed evidence of improvements in malaria indices. We interpret the results and their implications within the debate about cost sharing, sustainability and liquidity constraints in public health initiatives in developing countries.

Design and protocol of the weight loss lottery- a cluster randomized trial.

PubMed

van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Polder, Johan J; Prast, Henriëtte M

2016-07-01

People often intend to exercise but find it difficult to attend their gyms on a regular basis. At times, people seek and accept deadlines with consequences to realize their own goals (i.e. commitment devices). The aim of our cluster randomized controlled trial is to test whether a lottery-based commitment device can promote regular gym attendance. The winners of the lottery always get feedback on the outcome but can only claim their prize if they attended their gyms on a regular basis. In this paper we present the design and baseline characteristics of a three-arm trial which is performed with 163 overweight participants in six in-company fitness centers in the Netherlands. Copyright © 2016 Elsevier Inc. All rights reserved.

Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial.

PubMed

Allison, Jeroan J; Nguyen, Hoa L; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Phan, Ngoc T; Vu, Nguyen C; Kim, Minjin; Goldberg, Robert J

2016-01-14

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. At present, the major risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam; inasmuch, the burden of CVD will continue to increase in this country unless effective prevention and control measures are put in place. A national survey in 2008 found that the prevalence of hypertension (HTN) was approximately 25 % among Vietnamese adults and it increased with advancing age. Therefore, novel, large-scale, and sustainable interventions for public health education to promote engagement in the process of detecting and treating HTN in Vietnam are urgently needed. A feasibility randomized trial will be conducted in Hung Yen province, Vietnam to evaluate the feasibility and acceptability of a novel community-based intervention using the "storytelling" method to enhance the control of HTN in adults residing in four rural communities. The intervention will center on stories about living with HTN, with patients speaking in their own words. The stories will be obtained from particularly eloquent patients, or "video stars," identified during Story Development Groups. The study will involve two phases: (i) developing a HTN intervention using the storytelling method, which is designed to empower patients to facilitate changes in their lifestyle practices, and (ii) conducting a feasibility cluster-randomized trial to investigate the feasibility, acceptability, and potential efficacy of the intervention compared with usual care in HTN control among rural residents. The trial will be conducted at four communes, and within each commune, 25 individuals 50 years or older with HTN will be enrolled in the trial resulting in a total sample size of 100 patients. This feasibility trial will provide the necessary groundwork for a subsequent large-scale, fully powered, cluster-randomized controlled trial to test the efficacy of our novel community-based intervention. Results from the full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam and other developing countries. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02483780 (registration date June 22, 2015).

Deposition of Size-Selected Cu Nanoparticles by Inert Gas Condensation

PubMed Central

2010-01-01

Nanometer size-selected Cu clusters in the size range of 1–5 nm have been produced by a plasma-gas-condensation-type cluster deposition apparatus, which combines a grow-discharge sputtering with an inert gas condensation technique. With this method, by controlling the experimental conditions, it was possible to produce nanoparticles with a strict control in size. The structure and size of Cu nanoparticles were determined by mass spectroscopy and confirmed by atomic force microscopy (AFM) and scanning electron transmission microscopy (STEM) measurements. In order to preserve the structural and morphological properties, the energy of cluster impact was controlled; the energy of acceleration of the nanoparticles was in near values at 0.1 ev/atom for being in soft landing regime. From SEM measurements developed in STEM-HAADF mode, we found that nanoparticles are near sized to those values fixed experimentally also confirmed by AFM observations. The results are relevant, since it demonstrates that proper optimization of operation conditions can lead to desired cluster sizes as well as desired cluster size distributions. It was also demonstrated the efficiency of the method to obtain size-selected Cu clusters films, as a random stacking of nanometer-size crystallites assembly. The deposition of size-selected metal clusters represents a novel method of preparing Cu nanostructures, with high potential in optical and catalytic applications. PMID:20652132

Improving healthy eating in families with a toddler at risk for overweight: A cluster randomized controlled trial

PubMed Central

Hammer, Lawrence D.; Huffman, Lynne C.; Mascola, Anthony; Bryson, Susan W.; Danaher, Carol

2012-01-01

Objective To ascertain whether a parent education program based on Satter’s division of responsibility in feeding children (DOR) is effective in enhancing parent/child feeding interactions for children with an overweight/obese parent. The primary hypothesis was that the intervention would decrease parental pressure to eat. Methods Sixty-two families with a child aged 2–4 years with at least one overweight/obese parent were randomly allocated using a cluster design to either the DOR intervention or a control group. The control group focused on increasing family consumption of healthy foods and activity levels, and enhancing child sleep duration. The primary outcome was parent pressure on their child to eat. Results The DOR intervention was superior to the control group in reducing pressure to eat. Two moderators of pressure to eat were found: disinhibition of eating and hunger. DOR group parents irrespective of disinhibition levels lowered pressure to eat whereas control group parents with low disinhibition increased pressure to eat. There were similar findings for hunger. Gender moderated restrictive feeding with DOR parents lowering restriction more than the control group in girls only. Conclusion The DOR intervention was more effective in reducing parent pressure to eat and food restriction (in girls only) than the control group. PMID:22947882

K-Means Algorithm Performance Analysis With Determining The Value Of Starting Centroid With Random And KD-Tree Method

NASA Astrophysics Data System (ADS)

Sirait, Kamson; Tulus; Budhiarti Nababan, Erna

2017-12-01

Clustering methods that have high accuracy and time efficiency are necessary for the filtering process. One method that has been known and applied in clustering is K-Means Clustering. In its application, the determination of the begining value of the cluster center greatly affects the results of the K-Means algorithm. This research discusses the results of K-Means Clustering with starting centroid determination with a random and KD-Tree method. The initial determination of random centroid on the data set of 1000 student academic data to classify the potentially dropout has a sse value of 952972 for the quality variable and 232.48 for the GPA, whereas the initial centroid determination by KD-Tree has a sse value of 504302 for the quality variable and 214,37 for the GPA variable. The smaller sse values indicate that the result of K-Means Clustering with initial KD-Tree centroid selection have better accuracy than K-Means Clustering method with random initial centorid selection.

Long-term efficacy of a rural community-based integrated intervention for prevention and management of chronic obstructive pulmonary disease: a cluster randomized controlled trial in China's rural areas.

PubMed

Yuan, X; Tao, Y; Zhao, J P; Liu, X S; Xiong, W N; Xie, J G; Ni, W; Xu, Y J; Liu, H G

2015-11-01

This study aimed to assess the efficacy of a rural community-based integrated intervention for early prevention and management of chronic obstructive pulmonary disease (COPD) in China. This 18-year cluster-randomized controlled trial encompassing 15 villages included 1008 patients (454 men and 40 women in the intervention group [mean age, 54 ± 10 years]; 482 men and 32 women in the control group [mean age, 53 ± 10 years]) with confirmed COPD or at risk for COPD. Villages were randomly assigned to the intervention or the control group, and study participants residing within the villages received treatment accordingly. Intervention group patients took part in a program that included systematic health education, smoking cessation counseling, and education on management of COPD. Control group patients received usual care. The groups were compared after 18 years regarding the incidence of COPD, decline in lung function, and mortality of COPD. COPD incidence was lower in the intervention group than in the control group (10% vs 16%, <0.05). A decline in lung function was also significantly delayed in the intervention group compared to the control group of COPD and high-risk patients. The intervention group showed significant improvement in smoking cessation compared with the control group, and smokers in the intervention group had lower smoking indices than in the control group (350 vs 450, <0.05). The intervention group also had a significantly lower cumulative COPD-related death rate than the control group (37% vs 47%, <0.05). A rural community-based integrated intervention is effective in reducing the incidence of COPD among those at risk, delaying a decline in lung function in COPD patients and those at risk, and reducing mortality of COPD.

Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study.

PubMed

Bellini, Cristina; Petignat, Christiane; Masserey, Eric; Büla, Christophe; Burnand, Bernard; Rousson, Valentin; Blanc, Dominique S; Zanetti, Giorgio

2015-04-01

The risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs. Cluster randomized controlled trial. NHs of the state of Vaud, Switzerland. Of 157 total NHs in Vaud, 104 (67%) participated in the study. Standard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers. NHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%-100%) in control NHs and 87% (20%-100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%-43%) and intervention NHs (range, 0%-38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66). Universal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.

A Framework for Designing Cluster Randomized Trials with Binary Outcomes

ERIC Educational Resources Information Center

Spybrook, Jessaca; Martinez, Andres

2011-01-01

The purpose of this paper is to provide a frame work for approaching a power analysis for a CRT (cluster randomized trial) with a binary outcome. The authors suggest a framework in the context of a simple CRT and then extend it to a blocked design, or a multi-site cluster randomized trial (MSCRT). The framework is based on proportions, an…

Understanding Statistical Power in Cluster Randomized Trials: Challenges Posed by Differences in Notation and Terminology

ERIC Educational Resources Information Center

Spybrook, Jessaca; Hedges, Larry; Borenstein, Michael

2014-01-01

Research designs in which clusters are the unit of randomization are quite common in the social sciences. Given the multilevel nature of these studies, the power analyses for these studies are more complex than in a simple individually randomized trial. Tools are now available to help researchers conduct power analyses for cluster randomized…

A Comparison of Single Sample and Bootstrap Methods to Assess Mediation in Cluster Randomized Trials

ERIC Educational Resources Information Center

Pituch, Keenan A.; Stapleton, Laura M.; Kang, Joo Youn

2006-01-01

A Monte Carlo study examined the statistical performance of single sample and bootstrap methods that can be used to test and form confidence interval estimates of indirect effects in two cluster randomized experimental designs. The designs were similar in that they featured random assignment of clusters to one of two treatment conditions and…

Assessing the feasibility of interrupting the transmission of soil-transmitted helminths through mass drug administration: The DeWorm3 cluster randomized trial protocol

PubMed Central

Ajjampur, Sitara S. Rao; Anderson, Roy M.; Bailey, Robin; Gardiner, Iain; Halliday, Katherine E.; Ibikounle, Moudachirou; Kalua, Khumbo; Kang, Gagandeep; Littlewood, D. Timothy J.; Luty, Adrian J. F.; Means, Arianna Rubin; Oswald, William; Pullan, Rachel L.; Sarkar, Rajiv; Schär, Fabian; Szpiro, Adam; Truscott, James E.; Werkman, Marleen; Yard, Elodie; Walson, Judd L.

2018-01-01

Current control strategies for soil-transmitted helminths (STH) emphasize morbidity control through mass drug administration (MDA) targeting preschool- and school-age children, women of childbearing age and adults in certain high-risk occupations such as agricultural laborers or miners. This strategy is effective at reducing morbidity in those treated but, without massive economic development, it is unlikely it will interrupt transmission. MDA will therefore need to continue indefinitely to maintain benefit. Mathematical models suggest that transmission interruption may be achievable through MDA alone, provided that all age groups are targeted with high coverage. The DeWorm3 Project will test the feasibility of interrupting STH transmission using biannual MDA targeting all age groups. Study sites (population ≥80,000) have been identified in Benin, Malawi and India. Each site will be divided into 40 clusters, to be randomized 1:1 to three years of twice-annual community-wide MDA or standard-of-care MDA, typically annual school-based deworming. Community-wide MDA will be delivered door-to-door, while standard-of-care MDA will be delivered according to national guidelines. The primary outcome is transmission interruption of the STH species present at each site, defined as weighted cluster-level prevalence ≤2% by quantitative polymerase chain reaction (qPCR), 24 months after the final round of MDA. Secondary outcomes include the endline prevalence of STH, overall and by species, and the endline prevalence of STH among children under five as an indicator of incident infections. Secondary analyses will identify cluster-level factors associated with transmission interruption. Prevalence will be assessed using qPCR of stool samples collected from a random sample of cluster residents at baseline, six months after the final round of MDA and 24 months post-MDA. A smaller number of individuals in each cluster will be followed with annual sampling to monitor trends in prevalence and reinfection throughout the trial. Trial registration ClinicalTrials.gov NCT03014167 PMID:29346377

Effect of health promotion and fluoride varnish on dental caries among Australian Aboriginal children: results from a community-randomized controlled trial*

PubMed Central

Slade, Gary D; Bailie, Ross S; Roberts-Thomson, Kaye; Leach, Amanda J; Raye, Iris; Endean, Colin; Simmons, Bruce; Morris, Peter

2011-01-01

Objectives We tested a dental health program in remote Aboriginal communities of Australia's Northern Territory, hypothesizing that it would reduce dental caries in preschool children. Methods In this 2-year, prospective, cluster-randomized, concurrent controlled, open trial of the dental health program compared to no such program, 30 communities were allocated at random to intervention and control groups. All residents aged 18–47 months were invited to participate. Twice per year for 2 years in the 15 intervention communities, fluoride varnish was applied to children's teeth, water consumption and daily tooth cleaning with toothpaste were advocated, dental health was promoted in community settings, and primary health care workers were trained in preventive dental care. Data from dental examinations at baseline and after 2 years were used to compute net dental caries increment per child (d3mfs). A multi-level statistical model compared d3mfs between intervention and control groups with adjustment for the clustered randomization design; four other models used additional variables for adjustment. Results At baseline, 666 children were examined; 543 of them (82%) were re-examined 2 years later. The adjusted d3mfs increment was significantly lower in the intervention group compared to the control group by an average of 3.0 surfaces per child (95% CI = 1.2, 4.9), a prevented fraction of 31%. Adjustment for additional variables yielded caries reductions ranging from 2.3 to 3.5 surfaces per child and prevented fractions of 24–36%. Conclusions These results corroborate findings from other studies where fluoride varnish was efficacious in preventing dental caries in young children. PMID:20707872

A cluster randomized controlled trial to increase the availability and acceptability of voluntary medical male circumcision in Zambia: The Spear and Shield Project

PubMed Central

Weiss, Stephen M; Zulu, Robert; Jones, Deborah L; Redding, Colleen A; Cook, Ryan; Chitalu, Ndashi

2015-01-01

Background Widespread voluntary medical male circumcision (VMMC) in Africa could avert an estimated 3·436 million HIV infections and 300,000 deaths over the next 10 years. Most Zambian men, however, have expressed little interest in undergoing VMMC. This study tested the effect of an intervention designed to increase demand for VMMC among these “hard to reach” men. Methods This cluster randomized controlled trial was conducted from 2012 to 2014 in Lusaka, Zambia (HIV prevalence = 20·8%). 13 Community Health Centers (CHCs) were stratified by HIV voluntary counseling and testing (VCT) rates and patient census and randomly assigned (5:5:3) to Experimental, Control or Observation Only conditions. CHC health care providers at all 13 sites received VMMC training. Trial statisticians did not participate in randomization. 800 uncircumcised HIV-, post-VCT men, 400 per condition, were recruited; female partners were invited to participate. The primary outcome was the likelihood of VMMC by 12 months post-intervention. The trial registration is NCT 01688167. Findings 161 participants in the Experimental condition underwent VMMC as compared to 96 Control participants [adjusted odds ratio = 2·45, 95% CI = (1·24, 4·90) p = ·0166]. Post-VMMC condom use among Experimental condition participants increased compared to baseline, with no change among Control participants. No adverse events related to study participation were reported. Interpretation The Spear and Shield intervention combined with VMMC training was associated with a significant increase in the number of VMMCs performed as well as in condom use among “hard to reach” Zambian men. Results support the importance of comprehensive HIV prevention programs that increase supply of and demand for VMMC services. Funding NIH/NIMH R01MH095539. PMID:26120594

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

PubMed

Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

Association between intensive handwashing promotion and child development in Karachi, Pakistan: a cluster randomized controlled trial.

PubMed

Bowen, Anna; Agboatwalla, Mubina; Luby, Stephen; Tobery, Timothy; Ayers, Tracy; Hoekstra, R M

2012-11-01

To evaluate associations between handwashing promotion and child growth and development. Cluster randomized controlled trial. Informal settlements in Karachi, Pakistan. A total of 461 children who were enrolled in a trial of household-level handwashing promotion in 2003 and were younger than 8 years at reassessment in 2009. In 2003, neighborhoods were randomized to control (n = 9), handwashing promotion (n = 9), or handwashing promotion and drinking water treatment (n = 10); intervention households received free soap and weekly handwashing promotion for 9 months. Anthropometrics and developmental quotients measured with the Battelle Developmental Inventory II at 5 to 7 years of age. Overall, 24.9% (95% CI, 20.0%-30.6%) and 22.1% (95% CI, 18.0%-26.8%) of children had z scores that were more than 2 SDs below the expected z scores for height and body mass index for age, respectively; anthropometrics did not differ significantly across study groups. Global developmental quotients averaged 104.4 (95% CI, 101.9-107.0) among intervention children and 98.3 (95% CI, 93.1-103.4) among control children (P = .04). Differences of similar magnitude were measured across adaptive, personal-social, communication, cognitive, and motor domains. Although growth was similar across groups, children randomized to the handwashing promotion during their first 30 months of age attained global developmental quotients 0.4 SDs greater than those of control children at 5 to 7 years of age. These gains are comparable to those of at-risk children enrolled in publicly funded preschools in the United States and suggest that handwashing promotion could improve child well-being and societal productivity. clinicaltrials.gov Identifier: NCT01538953.

Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.

PubMed

Forster, Anne; Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-08-01

We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. © 2015 Bradford Teaching Hospitals NHS Foundation Trust.

Cluster Randomized Controlled Trial

PubMed Central

Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-01-01

Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

Effect of a multifaceted educational intervention for anti-infectious measures on sepsis mortality: a cluster randomized trial.

PubMed

Bloos, Frank; Rüddel, Hendrik; Thomas-Rüddel, Daniel; Schwarzkopf, Daniel; Pausch, Christine; Harbarth, Stephan; Schreiber, Torsten; Gründling, Matthias; Marshall, John; Simon, Philipp; Levy, Mitchell M; Weiss, Manfred; Weyland, Andreas; Gerlach, Herwig; Schürholz, Tobias; Engel, Christoph; Matthäus-Krämer, Claudia; Scheer, Christian; Bach, Friedhelm; Riessen, Reimer; Poidinger, Bernhard; Dey, Karin; Weiler, Norbert; Meier-Hellmann, Andreas; Häberle, Helene H; Wöbker, Gabriele; Kaisers, Udo X; Reinhart, Konrad

2017-11-01

Guidelines recommend administering antibiotics within 1 h of sepsis recognition but this recommendation remains untested by randomized trials. This trial was set up to investigate whether survival is improved by reducing the time before initiation of antimicrobial therapy by means of a multifaceted intervention in compliance with guideline recommendations. The MEDUSA study, a prospective multicenter cluster-randomized trial, was conducted from July 2011 to July 2013 in 40 German hospitals. Hospitals were randomly allocated to receive conventional continuous medical education (CME) measures (control group) or multifaceted interventions including local quality improvement teams, educational outreach, audit, feedback, and reminders. We included 4183 patients with severe sepsis or septic shock in an intention-to-treat analysis comparing the multifaceted intervention (n = 2596) with conventional CME (n = 1587). The primary outcome was 28-day mortality. The 28-day mortality was 35.1% (883 of 2596 patients) in the intervention group and 26.7% (403 of 1587 patients; p = 0.01) in the control group. The intervention was not a risk factor for mortality, since this difference was present from the beginning of the study and remained unaffected by the intervention. Median time to antimicrobial therapy was 1.5 h (interquartile range 0.1-4.9 h) in the intervention group and 2.0 h (0.4-5.9 h; p = 0.41) in the control group. The risk of death increased by 2% per hour delay of antimicrobial therapy and 1% per hour delay of source control, independent of group assignment. Delay in antimicrobial therapy and source control was associated with increased mortality but the multifaceted approach was unable to change time to antimicrobial therapy in this setting and did not affect survival.

Effect of a brief outreach educational intervention on the translation of acute poisoning treatment guidelines to practice in rural Sri Lankan hospitals: a cluster randomized controlled trial.

PubMed

Senarathna, Lalith; Buckley, Nick A; Dibley, Michael J; Kelly, Patrick J; Jayamanna, Shaluka F; Gawarammana, Indika B; Dawson, Andrew H

2013-01-01

In developing countries, including Sri Lanka, a high proportion of acute poisoning and other medical emergencies are initially treated in rural peripheral hospitals. Patients are then usually transferred to referral hospitals for further treatment. Guidelines are often used to promote better patient care in these emergencies. We conducted a cluster randomized controlled trial (ISRCTN73983810) which aimed to assess the effect of a brief educational outreach ('academic detailing') intervention to promote the utilization of treatment guidelines for acute poisoning. This cluster RCT was conducted in the North Central Province of Sri Lanka. All peripheral hospitals in the province were randomized to either intervention or control. All hospitals received a copy of the guidelines. The intervention hospitals received a brief out-reach academic detailing workshop which explained poisoning treatment guidelines and guideline promotional items designed to be used in daily care. Data were collected on all patients admitted due to poisoning for 12 months post-intervention in all study hospitals. Information collected included type of poison exposure, initial investigations, treatments and hospital outcome. Patients transferred from peripheral hospitals to referral hospitals had their clinical outcomes recorded. There were 23 intervention and 23 control hospitals. There were no significant differences in the patient characteristics, such as age, gender and the poisons ingested. The intervention hospitals showed a significant improvement in administration of activated charcoal [OR 2.95 (95% CI 1.28-6.80)]. There was no difference between hospitals in use of other decontamination methods. This study shows that an educational intervention consisting of brief out-reach academic detailing was effective in changing treatment behavior in rural Sri Lankan hospitals. The intervention was only effective for treatments with direct clinician involvement, such as administering activated charcoal. It was not successful for treatments usually administered by non-professional staff such as forced emesis for poisoning. Controlled-Trials.com ISRCTN73983810 ISRCTN73983810.

Bias and inference from misspecified mixed-effect models in stepped wedge trial analysis.

PubMed

Thompson, Jennifer A; Fielding, Katherine L; Davey, Calum; Aiken, Alexander M; Hargreaves, James R; Hayes, Richard J

2017-10-15

Many stepped wedge trials (SWTs) are analysed by using a mixed-effect model with a random intercept and fixed effects for the intervention and time periods (referred to here as the standard model). However, it is not known whether this model is robust to misspecification. We simulated SWTs with three groups of clusters and two time periods; one group received the intervention during the first period and two groups in the second period. We simulated period and intervention effects that were either common-to-all or varied-between clusters. Data were analysed with the standard model or with additional random effects for period effect or intervention effect. In a second simulation study, we explored the weight given to within-cluster comparisons by simulating a larger intervention effect in the group of the trial that experienced both the control and intervention conditions and applying the three analysis models described previously. Across 500 simulations, we computed bias and confidence interval coverage of the estimated intervention effect. We found up to 50% bias in intervention effect estimates when period or intervention effects varied between clusters and were treated as fixed effects in the analysis. All misspecified models showed undercoverage of 95% confidence intervals, particularly the standard model. A large weight was given to within-cluster comparisons in the standard model. In the SWTs simulated here, mixed-effect models were highly sensitive to departures from the model assumptions, which can be explained by the high dependence on within-cluster comparisons. Trialists should consider including a random effect for time period in their SWT analysis model. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

Bias and inference from misspecified mixed‐effect models in stepped wedge trial analysis

PubMed Central

Fielding, Katherine L.; Davey, Calum; Aiken, Alexander M.; Hargreaves, James R.; Hayes, Richard J.

2017-01-01

Many stepped wedge trials (SWTs) are analysed by using a mixed‐effect model with a random intercept and fixed effects for the intervention and time periods (referred to here as the standard model). However, it is not known whether this model is robust to misspecification. We simulated SWTs with three groups of clusters and two time periods; one group received the intervention during the first period and two groups in the second period. We simulated period and intervention effects that were either common‐to‐all or varied‐between clusters. Data were analysed with the standard model or with additional random effects for period effect or intervention effect. In a second simulation study, we explored the weight given to within‐cluster comparisons by simulating a larger intervention effect in the group of the trial that experienced both the control and intervention conditions and applying the three analysis models described previously. Across 500 simulations, we computed bias and confidence interval coverage of the estimated intervention effect. We found up to 50% bias in intervention effect estimates when period or intervention effects varied between clusters and were treated as fixed effects in the analysis. All misspecified models showed undercoverage of 95% confidence intervals, particularly the standard model. A large weight was given to within‐cluster comparisons in the standard model. In the SWTs simulated here, mixed‐effect models were highly sensitive to departures from the model assumptions, which can be explained by the high dependence on within‐cluster comparisons. Trialists should consider including a random effect for time period in their SWT analysis model. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:28556355

Impact of adding hand-washing and water disinfection promotion to oral cholera vaccination on diarrhoea-associated hospitalization in Dhaka, Bangladesh: evidence from a cluster randomized control trial.

PubMed

Najnin, Nusrat; Leder, Karin; Qadri, Firdausi; Forbes, Andrew; Unicomb, Leanne; Winch, Peter J; Ram, Pavani K; Leontsini, Elli; Nizame, Fosiul A; Arman, Shaila; Begum, Farzana; Biswas, Shwapon K; Clemens, John D; Ali, Mohammad; Cravioto, Alejandro; Luby, Stephen P

2017-12-01

Information on the impact of hygiene interventions on severe outcomes is limited. As a pre-specified secondary outcome of a cluster-randomized controlled trial among >400 000 low-income residents in Dhaka, Bangladesh, we examined the impact of cholera vaccination plus a behaviour change intervention on diarrhoea-associated hospitalization. Ninety neighbourhood clusters were randomly allocated into three areas: cholera-vaccine-only; vaccine-plus-behaviour-change (promotion of hand-washing with soap plus drinking water chlorination); and control. Study follow-up continued for 2 years after intervention began. We calculated cluster-adjusted diarrhoea-associated hospitalization rates using data we collected from nearby hospitals, and 6-monthly census data of all trial households. A total of 429 995 people contributed 500 700 person-years of data (average follow-up 1.13 years). Vaccine coverage was 58% at the start of analysis but continued to drop due to population migration. In the vaccine-plus-behaviour-change area, water plus soap was present at 45% of hand-washing stations; 4% of households had detectable chlorine in stored drinking water. Hospitalization rates were similar across the study areas [events/1000 person-years, 95% confidence interval (CI), cholera-vaccine-only: 9.4 (95% CI: 8.3-10.6); vaccine-plus-behaviour-change: 9.6 (95% CI: 8.3-11.1); control: 9.7 (95% CI: 8.3-11.6)]. Cholera cases accounted for 7% of total number of diarrhoea-associated hospitalizations. Neither cholera vaccination alone nor cholera vaccination combined with behaviour-change intervention efforts measurably reduced diarrhoea-associated hospitalization in this highly mobile population, during a time when cholera accounted for a small fraction of diarrhoea episodes. Affordable community-level interventions that prevent infection from multiple pathogens by reliably separating faeces from the environment, food and water, with minimal behavioural demands on impoverished communities, remain an important area for research. © The Author 2017. Published by Oxford University Press on behalf of the International Epidemiological Association

Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.

PubMed

Rockers, Peter C; Zanolini, Arianna; Banda, Bowen; Chipili, Mwaba Moono; Hughes, Robert C; Hamer, Davidson H; Fink, Günther

2018-04-01

Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia. We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads) or control (15 clusters, 258 caregiver-child dyads). Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs) and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III). In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73%) in the intervention group and 182/258 children (71%) in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028) and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039). The intervention did not significantly impact cognition (β 0.11, 95% CI -0.06 to 0.29; p = 0.196), motor skills (β -0.01, 95% CI -0.25 to 0.24; p = 0.964), adaptive behavior (β 0.21, 95% CI -0.03 to 0.44; p = 0.088), or social-emotional development (β 0.20, 95% CI -0.04 to 0.44; p = 0.098). Observed impacts may have been due in part to home visits by CDAs during the first year of the intervention. The results of this trial suggest that parenting groups hold promise for improving child development, particularly physical growth, in low-resource settings like Zambia. ClinicalTrials.gov NCT02234726.

Motivational Interviewing for Workers with Disabling Musculoskeletal Disorders: Results of a Cluster Randomized Control Trial.

PubMed

Park, Joanne; Esmail, Shaniff; Rayani, Fahreen; Norris, Colleen M; Gross, Douglas P

2018-06-01

Purpose Although functional restoration programs appear effective in assisting injured workers to return-to-work (RTW) after a work related musculoskeletal (MSK) disorder, the addition of Motivational Interviewing (MI) to these programs may result in higher RTW. Methods We conducted a cluster randomized controlled trial with claimants attending an occupational rehabilitation facility from November 17, 2014 to June 30, 2015. Six clinicians provided MI in addition to the standard functional restoration program and formed an intervention group. Six clinicians continued to provide the standard functional restoration program based on graded activity, therapeutic exercise, and workplace accommodations. Independent t tests and chi square analysis were used to compare groups. Multivariable logistic regression was used to obtain the odds ratio of claimants' confirmed RTW status at time of program discharge. Results 728 workers' compensation claimants with MSK disorders were entered into 1 of 12 therapist clusters (MI group = 367, control group = 361). Claimants were predominantly employed (72.7%), males (63.2%), with moderate levels of pain and disability (mean pain VAS = 5.0/10 and mean Pain Disability Index = 48/70). Claimants were stratified based on job attachment status. The proportion of successful RTW at program discharge was 12.1% higher for unemployed workers in the intervention group (intervention group 21.6 vs. 9.5% in control, p = 0.03) and 3.0% higher for job attached workers compared to the control group (intervention group 97.1 vs. 94.1% in control, p = 0.10). Adherence to MI was mixed, but RTW was significantly higher among MI-adherent clinicians. The odds ratio for unemployed claimants was 2.64 (0.69-10.14) and 2.50 (0.68-9.14) for employed claimants after adjusting for age, sex, pain intensity, perceived disability, and therapist cluster. Conclusion MI in addition to routine functional restoration is more effective than routine functional restoration program alone in improving RTW among workers with disabling MSK disorders.

A Youth-Led, Social Marketing Intervention Run by Adolescents to Encourage Healthy Lifestyles among Younger School Peers (EYTO-Kids Project): A Protocol for Pilot Cluster Randomized Controlled Trial (Spain)

PubMed Central

Aceves-Martins, Magaly; Papell-Garcia, Ignasi; Arola, Lluís; Giralt, Montse; Solà, Rosa

2017-01-01

Introduction: The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement. Methods: This study is a pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015–2016 and 2016–2017), with eight primary schools and three high schools randomized into and designated the control group and eight primary schools and four high schools designated the intervention group in Reus, Spain. At least 301 younger school peers per group should be included. At the intervention high schools, the adolescent creators (ACs) receive an initial 16-h training session. In total, 26–32 high school ACs (12–14 years) from the four high schools will design and implement four health-promotion activities (1 h/each) for their younger (8–10 years), primary school peers. The control group will not receive any intervention. The outcomes (fruit, vegetable, fast food and sugary drink consumption; physical activity; and sedentary behaviors) of the control and intervention groups will be measured pre- and post-intervention. Conclusion: This study describes a protocol for pilot, peer-led, social marketing and youth-involved intervention, where adolescents design and implement activities for their younger peers to promote healthy lifestyles.

Results of a lay health education intervention to increase colorectal cancer screening among Filipino Americans: A cluster randomized controlled trial.

PubMed

Cuaresma, Charlene F; Sy, Angela U; Nguyen, Tung T; Ho, Reginald C S; Gildengorin, Ginny L; Tsoh, Janice Y; Jo, Angela M; Tong, Elisa K; Kagawa-Singer, Marjorie; Stewart, Susan L

2018-04-01

Filipino colorectal cancer (CRC) screening rates fall below Healthy People 2020 goals. In this study, the authors explore whether a lay health educator (LHE) approach can increase CRC screening among Filipino Americans ages 50 to 75 years in Hawai'i. A cluster randomized controlled trial from 2012 through 2015 compared an intervention, which consisted of LHEs delivering 2 education sessions and 2 telephone follow-up calls on CRC screening plus a CRC brochure versus an attention control, in which 2 lectures and 2 follow-up calls on nutrition and physical activity plus a CRC brochure were provided. The primary outcome was change in self-reported ever receipt of CRC screening at 6 months. Among 304 participants (77% women, 86% had > 10 years of residence in the United States), the proportion of participants who reported ever having received CRC screening increased significantly in the intervention group (from 80% to 89%; P = .0003), but not in the control group (from 73% to 74%; P = .60). After covariate adjustment, there was a significant intervention effect (odds ratio, 1.9; 95% confidence interval, 1.0-3.5). There was no intervention effect on up-to-date screening. This first randomized controlled trial for CRC screening among Hawai'i's Filipinos used an LHE intervention with mixed, but promising, results. Cancer 2018;124:1535-42. © 2018 American Cancer Society. © 2018 American Cancer Society.

Integrating data from randomized controlled trials and observational studies to predict the response to pregabalin in patients with painful diabetic peripheral neuropathy.

PubMed

Alexander, Joe; Edwards, Roger A; Savoldelli, Alberto; Manca, Luigi; Grugni, Roberto; Emir, Birol; Whalen, Ed; Watt, Stephen; Brodsky, Marina; Parsons, Bruce

2017-07-20

More patient-specific medical care is expected as more is learned about variations in patient responses to medical treatments. Analytical tools enable insights by linking treatment responses from different types of studies, such as randomized controlled trials (RCTs) and observational studies. Given the importance of evidence from both types of studies, our goal was to integrate these types of data into a single predictive platform to help predict response to pregabalin in individual patients with painful diabetic peripheral neuropathy (pDPN). We utilized three pivotal RCTs of pregabalin (398 North American patients) and the largest observational study of pregabalin (3159 German patients). We implemented a hierarchical cluster analysis to identify patient clusters in the Observational Study to which RCT patients could be matched using the coarsened exact matching (CEM) technique, thereby creating a matched dataset. We then developed autoregressive moving average models (ARMAXs) to estimate weekly pain scores for pregabalin-treated patients in each cluster in the matched dataset using the maximum likelihood method. Finally, we validated ARMAX models using Observational Study patients who had not matched with RCT patients, using t tests between observed and predicted pain scores. Cluster analysis yielded six clusters (287-777 patients each) with the following clustering variables: gender, age, pDPN duration, body mass index, depression history, pregabalin monotherapy, prior gabapentin use, baseline pain score, and baseline sleep interference. CEM yielded 1528 unique patients in the matched dataset. The reduction in global imbalance scores for the clusters after adding the RCT patients (ranging from 6 to 63% depending on the cluster) demonstrated that the process reduced the bias of covariates in five of the six clusters. ARMAX models of pain score performed well (R 2 : 0.85-0.91; root mean square errors: 0.53-0.57). t tests did not show differences between observed and predicted pain scores in the 1955 patients who had not matched with RCT patients. The combination of cluster analyses, CEM, and ARMAX modeling enabled strong predictive capabilities with respect to pain scores. Integrating RCT and Observational Study data using CEM enabled effective use of Observational Study data to predict patient responses.

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance.

PubMed

Dutton, Gareth R; Gowey, Marissa A; Tan, Fei; Zhou, Dali; Ard, Jamy; Perri, Michael G; Lewis, Cora E

2017-08-15

Behavioral interventions for obesity produce clinically meaningful weight loss, but weight regain following treatment is common. Extended care programs attenuate weight regain and improve weight loss maintenance. However, less is known about the most effective ways to deliver extended care, including contact schedules. We compared the 12-month weight regain of an extended care program utilizing a non-conventional, clustered campaign treatment schedule and a self-directed program among individuals who previously achieved ≥5% weight reductions. Participants (N = 108; mean age = 51.6 years; mean weight = 92.6 kg; 52% African American; 95% female) who achieved ≥5% weight loss during an initial 16-week behavioral obesity treatment were randomized into a 2-arm, 12-month extended care trial. A clustered campaign condition included 12 group-based visits delivered in three, 4-week clusters. A self-directed condition included provision of the same printed intervention materials but no additional treatment visits. The study was conducted in a U.S. academic medical center from 2011 to 2015. Prior to randomization, participants lost an average of -7.55 ± 3.04 kg. Participants randomized to the 12-month clustered campaign program regained significantly less weight (0.35 ± 4.62 kg) than self-directed participants (2.40 ± 3.99 kg), which represented a significant between-group difference of 2.28 kg (p = 0.0154) after covariate adjustments. This corresponded to maintaining 87% and 64% of lost weight in the clustered campaign and self-directed conditions, respectively, which was a significant between-group difference of 29% maintenance of lost weight after covariate adjustments, p = 0.0396. In this initial test of a clustered campaign treatment schedule, this novel approach effectively promoted 12-month maintenance of lost weight. Future trials should directly compare the clustered campaigns with conventional (e.g., monthly) extended care schedules. Clinicaltrials.gov NCT02487121 . Registered 06/26/2015 (retrospectively registered).

Effect of a brief smoking cessation intervention on adult tobacco smokers with pulmonary tuberculosis: A cluster randomized controlled trial from North India.

PubMed

Goel, Sonu; Kathiresan, Jeyashree; Singh, Preeti; Singh, Rana J

2017-09-01

An association between smoking and poor tuberculosis (TB) treatment outcomes has been globally established. Various smoking cessation interventions (SCIs) have been proven worldwide to curb smoking behavior. There is a need for evidence to assess if SCI increases the chance of successful treatment outcome among TB patients. To assess the effectiveness of a brief SCI; The Ask, Brief, Cessation support (ABC) package, on treatment outcomes and smoking cessation in smear-positive adult pulmonary TB patients. A cluster, randomized controlled trial was conducted wherein 17 designated microscopic centers of Chandigarh, India were randomly assigned using a computer-generated randomization sequence to receive SCI within directly observed treatment, short (DOTS) services, or existing standard of care. Eligible and consenting smokers (15 + years) registered as smear-positive pulmonary TB for DOTS (n = 156) between January and June 2013 were enrolled. Smoking cessation (self-reported) was assessed at intervals till the end of treatment. End TB treatment outcomes were extracted from patient records. Treatment success was lower in intervention arm (83.6%) as compared control arm (88.2%), but the difference was statistically insignificant (P = 0.427). Smoking cessation was higher in intervention arm (80.2%) compared to comparison arm (57.5%) (adjusted incidence risk ratio = 1.56; 95% confidence interval = 1.24-1.93; P < 0.0001). SCI is effective in inducing smoking cessation among TB patients. No association of SCI with TB treatment outcomes could be detected.

Effects of improved sanitation on diarrheal reduction for children under five in Idiofa, DR Congo: a cluster randomized trial.

PubMed

Cha, Seungman; Lee, JaeEun; Seo, DongSik; Park, Byoung Mann; Mansiangi, Paul; Bernard, Kabore; Mulakub-Yazho, Guy Jerome Nkay; Famasulu, Honore Minka

2017-09-19

The lack of safe water and sanitation contributes to the rampancy of diarrhea in many developing countries. This study describes the design of a cluster-randomized trial in Idiofa, the Democratic Republic of the Congo, seeking evidence of the impact of improved sanitation on diarrhea for children under four. Of the 276 quartiers, 18 quartiers were randomly allocated to the intervention or control arm. Seven hundred and-twenty households were sampled and the youngest under-four child in each household was registered for this study. The primary endpoint of the study is diarrheal incidence, prevalence and duration in children under five. Material subsidies will be provided only to the households who complete pit digging plus superstructure and roof construction, regardless of their income level. This study employs a Sanitation Calendar so that the mother of each household can record the diarrheal episodes of her under-four child on a daily basis. The diary enables examination of the effect of the sanitation intervention on diarrhea duration and also resolves the limitation of the small number of clusters in the trial. In addition, the project will be monitored through the 'Sanitation Map', on which all households in the study area, including both the control and intervention arms, are registered. To avoid information bias or courtesy bias, photos will be taken of the latrine during the household visit, and a supervisor will determine well-equipped latrine uptake based on the photos. This reduces the possibility of recall bias and under- or over-estimation of diarrhea, which was the main limitation of previous studies. The study was approved by the Institutional Review Board of the School of Public Health, Kinshasa University (ESP/CE/040/15; April 13, 2015) and registered as an International Standard Randomized Controlled Trial (ISRCTN: 10,419,317) on March 13, 2015.

"Healthy Habits, Healthy Girls-Brazil": an obesity prevention program with added focus on eating disorders.

PubMed

Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva; Thompson, Debbe; Nicklas, Theresa; Baranowski, Tom

2018-05-05

To evaluate the immediate post-intervention and 6-month post-intervention effects of a Brazilian school-based randomized controlled trial for girls targeting shared risk factors for obesity and disordered eating. Total of 253 girls, mean of 15.6 (0.05) years from 1st to 3rd grades of high school participated in this 6-month school-based cluster randomized controlled trial. "Healthy Habits, Healthy Girls-Brazil (H3G-Brazil)", originally developed in Australia, emphasized 10 key nutrition and physical activity (PA) messages delivered over 6 months. Disordered eating prevention procedures, i.e., prevention of weight-teasing, body satisfaction, and unhealthy weight control behavior, were added to the intervention. Body dissatisfaction, unhealthy weight control behaviors and social cognitive-related diet, and physical activity variables were assessed at baseline, immediate post-intervention, and 6-month post-intervention. Intervention effects were determined by one-way analysis of covariance or logistic regression, after checking for the clustering effects of school. The control group did not receive intervention prior to follow-up assessment. A conservative significance level was set at p < 0.01. Beneficial effects were detected for PA social support (F = 6.005, p = 0.01), and healthy eating strategies (F = 6.08, p = 0.01) immediate post-intervention; and healthy eating social support (F = 14.731, p = 0.00) and healthy eating strategies (F = 5.812, p = 0.01) at 6-month post-intervention. Intervention group was more likely to report unhealthy weight control behaviors (OR = 1.92, 95% CI 1.15-3.21, p = 0.01) at 6-month post-intervention. No other significant immediate or 6-month post effects were detected. H3G-Brazil demonstrated positive 6-month effects on some social cognitive variables but an adverse effect on unhealthy weight control behaviors. Thus, this study was not able to achieve synergy by combining obesity and disordered eating prevention procedures in an intervention among low-income girls in Brazil. Level I: cluster randomized controlled trial.

Protocol for digital intervention for effective health promotion of small children-A cluster randomized trial.

PubMed

Pakarinen, Anni; Flemmich, Magda; Parisod, Heidi; Selänne, Laura; Hamari, Lotta; Aromaa, Minna; Leppänen, Ville; Löyttyniemi, Eliisa; Smed, Jouni; Salanterä, Sanna

2018-03-08

This article introduces the protocol of a study aiming to evaluate the effectiveness of digital WellWe intervention in supporting the participation of families with small children in the promotion of their health. Early childhood is a meaningful period for building a strong base for good health. Parents play a key role in affecting the health behaviour and psychosocial development of their children. A family-centred approach makes it possible to support families' individual health literacy needs and empower them to take actions towards promoting healthier behaviour. However, there are a lack of family-centred digital health interventions intended for parents and their small children. The study is designed as a two-arm cluster, randomized, controlled trial with a 4-month follow-up. The data are being collected from 200 families with a 4-year-old child. Cluster randomization is being performed at the municipality level. Municipalities (N = 4) located in Southwest Finland, comprising child health clinics (N = 15) with their family clients, were randomly allocated to either an intervention (WellWe intervention) or a control group (usual care). The outcome measures include parental self-efficacy for healthy behaviours, mindfulness in parenting and the family-centred approach of the extensive health examination. Data collection is being performed at baseline, after the intervention and at a 4-month follow-up. The results from this study will make it possible to determine whether this new method can be recommended for implementation in child health clinic settings to support the participation of families with small children in promoting their health. © 2018 John Wiley & Sons Ltd.

Classification of childhood asthma phenotypes and long-term clinical responses to inhaled anti-inflammatory medications.

PubMed

Howrylak, Judie A; Fuhlbrigge, Anne L; Strunk, Robert C; Zeiger, Robert S; Weiss, Scott T; Raby, Benjamin A

2014-05-01

Although recent studies have identified the presence of phenotypic clusters in asthmatic patients, the clinical significance and temporal stability of these clusters have not been explored. Our aim was to examine the clinical relevance and temporal stability of phenotypic clusters in children with asthma. We applied spectral clustering to clinical data from 1041 children with asthma participating in the Childhood Asthma Management Program. Posttreatment randomization follow-up data collected over 48 months were used to determine the effect of these clusters on pulmonary function and treatment response to inhaled anti-inflammatory medication. We found 5 reproducible patient clusters that could be differentiated on the basis of 3 groups of features: atopic burden, degree of airway obstruction, and history of exacerbation. Cluster grouping predicted long-term asthma control, as measured by the need for oral prednisone (P < .0001) or additional controller medications (P = .001), as well as longitudinal differences in pulmonary function (P < .0001). We also found that the 2 clusters with the highest rates of exacerbation had different responses to inhaled corticosteroids when compared with the other clusters. One cluster demonstrated a positive response to both budesonide (P = .02) and nedocromil (P = .01) compared with placebo, whereas the other cluster demonstrated minimal responses to both budesonide (P = .12) and nedocromil (P = .56) compared with placebo. Phenotypic clustering can be used to identify longitudinally consistent and clinically relevant patient subgroups, with implications for targeted therapeutic strategies and clinical trials design.

On the Analysis of Case-Control Studies in Cluster-correlated Data Settings.

PubMed

Haneuse, Sebastien; Rivera-Rodriguez, Claudia

2018-01-01

In resource-limited settings, long-term evaluation of national antiretroviral treatment (ART) programs often relies on aggregated data, the analysis of which may be subject to ecological bias. As researchers and policy makers consider evaluating individual-level outcomes such as treatment adherence or mortality, the well-known case-control design is appealing in that it provides efficiency gains over random sampling. In the context that motivates this article, valid estimation and inference requires acknowledging any clustering, although, to our knowledge, no statistical methods have been published for the analysis of case-control data for which the underlying population exhibits clustering. Furthermore, in the specific context of an ongoing collaboration in Malawi, rather than performing case-control sampling across all clinics, case-control sampling within clinics has been suggested as a more practical strategy. To our knowledge, although similar outcome-dependent sampling schemes have been described in the literature, a case-control design specific to correlated data settings is new. In this article, we describe this design, discuss balanced versus unbalanced sampling techniques, and provide a general approach to analyzing case-control studies in cluster-correlated settings based on inverse probability-weighted generalized estimating equations. Inference is based on a robust sandwich estimator with correlation parameters estimated to ensure appropriate accounting of the outcome-dependent sampling scheme. We conduct comprehensive simulations, based in part on real data on a sample of N = 78,155 program registrants in Malawi between 2005 and 2007, to evaluate small-sample operating characteristics and potential trade-offs associated with standard case-control sampling or when case-control sampling is performed within clusters.

The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial.

PubMed

García-Escalera, Julia; Valiente, Rosa M; Chorot, Paloma; Ehrenreich-May, Jill; Kennedy, Sarah M; Sandín, Bonifacio

2017-08-21

Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017. We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers. Clinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR). ©Julia García-Escalera, Rosa M Valiente, Paloma Chorot, Jill Ehrenreich-May, Sarah M Kennedy, Bonifacio Sandín. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.08.2017.

The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial

PubMed Central

García-Escalera, Julia; Valiente, Rosa M; Ehrenreich-May, Jill; Kennedy, Sarah M; Sandín, Bonifacio

2017-01-01

Background Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. Objective The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. Methods A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. Results We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017. Conclusions We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers. Trial Registration Clinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR) PMID:28827212

A cluster randomized controlled trial to reduce childhood diarrhea using hollow fiber water filter and/or hygiene-sanitation educational interventions.

PubMed

Lindquist, Erik D; George, C M; Perin, Jamie; Neiswender de Calani, Karen J; Norman, W Ray; Davis, Thomas P; Perry, Henry

2014-07-01

Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15-0.30) for the filter arm and 0.27 (95% CI = 0.22-0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59-0.86). © The American Society of Tropical Medicine and Hygiene.

A Cluster Randomized Controlled Trial to Reduce Childhood Diarrhea Using Hollow Fiber Water Filter and/or Hygiene–Sanitation Educational Interventions

PubMed Central

Lindquist, Erik D.; George, C. M.; Perin, Jamie; Neiswender de Calani, Karen J.; Norman, W. Ray; Davis, Thomas P.; Perry, Henry

2014-01-01

Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15–0.30) for the filter arm and 0.27 (95% CI = 0.22–0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59–0.86). PMID:24865680

Closing the Achievement Gap through Modification of Neurocognitive and Neuroendocrine Function: Results from a Cluster Randomized Controlled Trial of an Innovative Approach to the Education of Children in Kindergarten

PubMed Central

Blair, Clancy; Raver, C. Cybele

2014-01-01

Effective early education is essential for academic achievement and positive life outcomes, particularly for children in poverty. Advances in neuroscience suggest that a focus on self-regulation in education can enhance children’s engagement in learning and establish beneficial academic trajectories in the early elementary grades. Here, we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation, particularly executive functions, into literacy, mathematics, and science learning activities. Results from a cluster randomized controlled trial involving 29 schools, 79 classrooms, and 759 children indicated positive effects on executive functions, reasoning ability, the control of attention, and levels of salivary cortisol and alpha amylase. Results also demonstrated improvements in reading, vocabulary, and mathematics at the end of kindergarten that increased into the first grade. A number of effects were specific to high-poverty schools, suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap. PMID:25389751

Closing the achievement gap through modification of neurocognitive and neuroendocrine function: results from a cluster randomized controlled trial of an innovative approach to the education of children in kindergarten.

PubMed

Blair, Clancy; Raver, C Cybele

2014-01-01

Effective early education is essential for academic achievement and positive life outcomes, particularly for children in poverty. Advances in neuroscience suggest that a focus on self-regulation in education can enhance children's engagement in learning and establish beneficial academic trajectories in the early elementary grades. Here, we experimentally evaluate an innovative approach to the education of children in kindergarten that embeds support for self-regulation, particularly executive functions, into literacy, mathematics, and science learning activities. Results from a cluster randomized controlled trial involving 29 schools, 79 classrooms, and 759 children indicated positive effects on executive functions, reasoning ability, the control of attention, and levels of salivary cortisol and alpha amylase. Results also demonstrated improvements in reading, vocabulary, and mathematics at the end of kindergarten that increased into the first grade. A number of effects were specific to high-poverty schools, suggesting that a focus on executive functions and associated aspects of self-regulation in early elementary education holds promise for closing the achievement gap.

A Comparison of Seventh Grade Thai Students' Reading Comprehension and Motivation to Read English through Applied Instruction Based on the Genre-Based Approach and the Teacher's Manual

ERIC Educational Resources Information Center

Sawangsamutchai, Yutthasak; Rattanavich, Saowalak

2016-01-01

The objective of this research is to compare the English reading comprehension and motivation to read of seventh grade Thai students taught with applied instruction through the genre-based approach and teachers' manual. A randomized pre-test post-test control group design was used through the cluster random sampling technique. The data were…

Effect of an environmental school-based obesity prevention program on changes in body fat and body weight: a randomized trial.

PubMed

Williamson, Donald A; Champagne, Catherine M; Harsha, David W; Han, Hongmei; Martin, Corby K; Newton, Robert L; Sothern, Melinda S; Stewart, Tiffany M; Webber, Larry S; Ryan, Donna H

2012-08-01

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized three-arm controlled design, with 28 months of follow-up. Children (N = 2,060; mean age = 10.5 years, SD = 1.2) from rural communities in grades 4-6 participated in the study. Seventeen school clusters (mean = 123 children/cluster) were randomly assigned to one of three prevention arms: (i) primary prevention (PP), an environmental modification (EM) program, (ii) primary + secondary prevention (PP+SP), the environmental program with an added classroom and internet education component, or (iii) control (C). Primary outcomes were changes in percent body fat and BMI z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an EM arm. Relative to C, EM decreased body fat for boys (-1.7 ± 0.38% vs. -0.14 ± 0.69%) and attenuated fat gain for girls (2.9 ± 0.22% vs. 3.93 ± 0.37%), but standardized effect sizes were relatively small (<0.30). In conclusion, this school-based EM programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children.

Effect of an Environmental School-based Obesity Prevention Program On Changes in Body Fat and Body Weight: A Randomized Trial

PubMed Central

Williamson, D.A.; Champagne, C.M.; Harsha, D.; Han, H.; Martin, C.K.; Newton, R.L.; Sothern, M.; Stewart, T.M.; Webber, L.S.; Ryan, D.

2012-01-01

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized 3-arm controlled design, with 28 months of follow-up. Children (N=2060; M age = 10.5 years, SD = 1.2) from rural communities in Grades 4 to 6 participated in the study. 17 school clusters (M = 123 children/cluster) were randomly assigned to one of three prevention arms: 1) Primary Prevention (PP), an environmental modification program, 2) Primary + Secondary Prevention (PP+SP), the environmental program with an added classroom and internet education component, or 3) Control (C). Primary outcomes were changes in percent body fat and body mass index z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an environmental modification arm (EM). Relative to C, EM decreased body fat for boys (−1.7% ± 0.38% versus −0.14% ± 0.69%) and attenuated fat gain for girls (2.9% ± 0.22% versus 3.93% ± 0.37%), but standardized effect sizes were relatively small (< 0.30). In conclusion, this school-based environmental modification programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children. PMID:22402733

New Estimates of Design Parameters for Clustered Randomization Studies: Findings from North Carolina and Florida. Working Paper 43

ERIC Educational Resources Information Center

Xu, Zeyu; Nichols, Austin

2010-01-01

The gold standard in making causal inference on program effects is a randomized trial. Most randomization designs in education randomize classrooms or schools rather than individual students. Such "clustered randomization" designs have one principal drawback: They tend to have limited statistical power or precision. This study aims to…

Quantifying opening-mode fracture spatial organization in horizontal wellbore image logs, core and outcrop: Application to Upper Cretaceous Frontier Formation tight gas sandstones, USA

NASA Astrophysics Data System (ADS)

Li, J. Z.; Laubach, S. E.; Gale, J. F. W.; Marrett, R. A.

2018-03-01

The Upper Cretaceous Frontier Formation is a naturally fractured gas-producing sandstone in Wyoming. Regionally, random and statistically more clustered than random patterns exist in the same upper to lower shoreface depositional facies. East-west- and north-south-striking regional fractures sampled using image logs and cores from three horizontal wells exhibit clustered patterns, whereas data collected from east-west-striking fractures in outcrop have patterns that are indistinguishable from random. Image log data analyzed with the correlation count method shows clusters ∼35 m wide and spaced ∼50 to 90 m apart as well as clusters up to 12 m wide with periodic inter-cluster spacings. A hierarchy of cluster sizes exists; organization within clusters is likely fractal. These rocks have markedly different structural and burial histories, so regional differences in degree of clustering are unsurprising. Clustered patterns correspond to fractures having core quartz deposition contemporaneous with fracture opening, circumstances that some models suggest might affect spacing patterns by interfering with fracture growth. Our results show that quantifying and identifying patterns as statistically more or less clustered than random delineates differences in fracture patterns that are not otherwise apparent but that may influence gas and water production, and therefore may be economically important.

When is informed consent required in cluster randomized trials in health research?

PubMed Central

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation. PMID:21906277

Handling Correlations between Covariates and Random Slopes in Multilevel Models

ERIC Educational Resources Information Center

Bates, Michael David; Castellano, Katherine E.; Rabe-Hesketh, Sophia; Skrondal, Anders

2014-01-01

This article discusses estimation of multilevel/hierarchical linear models that include cluster-level random intercepts and random slopes. Viewing the models as structural, the random intercepts and slopes represent the effects of omitted cluster-level covariates that may be correlated with included covariates. The resulting correlations between…

Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol).

PubMed

Clyne, Barbara; Bradley, Marie C; Smith, Susan M; Hughes, Carmel M; Motterlini, Nicola; Clear, Daniel; McDonnell, Ronan; Williams, David; Fahey, Tom

2013-03-13

Potentially inappropriate prescribing in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. In Ireland, 36% of those aged 70 years or over received at least one potentially inappropriate medication, with an associated expenditure of over €45 million.The main objective of this study is to determine the effectiveness and acceptability of a complex, multifaceted intervention in reducing the level of potentially inappropriate prescribing in primary care. This study is a pragmatic cluster randomized controlled trial, conducted in primary care (OPTI-SCRIPT trial), involving 22 practices (clusters) and 220 patients. Practices will be allocated to intervention or control arms using minimization, with intervention participants receiving a complex multifaceted intervention incorporating academic detailing, medicines review with web-based pharmaceutical treatment algorithms that provide recommended alternative treatment options, and tailored patient information leaflets. Control practices will deliver usual care and receive simple patient-level feedback on potentially inappropriate prescribing. Routinely collected national prescribing data will also be analyzed for nonparticipating practices, acting as a contemporary national control. The primary outcomes are the proportion of participant patients with potentially inappropriate prescribing and the mean number of potentially inappropriate prescriptions per patient. In addition, economic and qualitative evaluations will be conducted. This study will establish the effectiveness of a multifaceted intervention in reducing potentially inappropriate prescribing in older people in Irish primary care that is generalizable to countries with similar prescribing challenges. Current controlled trials ISRCTN41694007.

A pattern-mixture model approach for handling missing continuous outcome data in longitudinal cluster randomized trials.

PubMed

Fiero, Mallorie H; Hsu, Chiu-Hsieh; Bell, Melanie L

2017-11-20

We extend the pattern-mixture approach to handle missing continuous outcome data in longitudinal cluster randomized trials, which randomize groups of individuals to treatment arms, rather than the individuals themselves. Individuals who drop out at the same time point are grouped into the same dropout pattern. We approach extrapolation of the pattern-mixture model by applying multilevel multiple imputation, which imputes missing values while appropriately accounting for the hierarchical data structure found in cluster randomized trials. To assess parameters of interest under various missing data assumptions, imputed values are multiplied by a sensitivity parameter, k, which increases or decreases imputed values. Using simulated data, we show that estimates of parameters of interest can vary widely under differing missing data assumptions. We conduct a sensitivity analysis using real data from a cluster randomized trial by increasing k until the treatment effect inference changes. By performing a sensitivity analysis for missing data, researchers can assess whether certain missing data assumptions are reasonable for their cluster randomized trial. Copyright © 2017 John Wiley & Sons, Ltd.

Preventing Peer Violence Against Children: Methods and Baseline Data of a Cluster Randomized Controlled Trial in Pakistan

PubMed Central

McFarlane, Judith; Karmaliani, Rozina; Maqbool Ahmed Khuwaja, Hussain; Gulzar, Saleema; Somani, Rozina; Saeed Ali, Tazeen; Somani, Yasmeen H; Shehzad Bhamani, Shireen; Krone, Ryan D; Paulson, Rene M; Muhammad, Atta; Jewkes, Rachel

2017-01-01

ABSTRACT Background: Violence against and among children is a global public health problem that annually affects 50% of youth worldwide with major impacts on child development, education, and health including increased probability of major causes of morbidity and mortality in adulthood. It is also associated with the experience of and perpetration of later violence against women. The aim of this article is to describe the intervention, study design, methods, and baseline findings of a cluster randomized controlled trial underway in Pakistan to evaluate a school-based play intervention aiming to reduce peer violence and enhance mental health. Methods: A cluster randomized controlled design is being conducted with boys and girls in grade 6 in 40 schools in Hyderabad, Pakistan, over a period of 2 years. The Multidimensional Peer-Victimization and Peer Perpetration Scales and the Children's Depression Inventory 2 (CDI 2) are being used to measure the primary outcomes while investigator-derived scales are being used to assess domestic violence within the family. Specifics of the intervention, field logistics, ethical, and fidelity management issues employed to test the program's impact on school age youth in a volatile and politically unstable country form this report. Baseline Results: A total of 1,752 school-age youth were enrolled and interviewed at baseline. Over the preceding 4 weeks, 94% of the boys and 85% of the girls reported 1 or more occurrences of victimization, and 85% of the boys and 66% of the girls reported 1 or more acts of perpetration. Boys reported more depression compared with girls, as well as higher negative mood and self-esteem scores and more interpersonal and emotional problems. Interpretation: Globally, prevalence of youth violence perpetration and victimization is high and associated with poor physical and emotional health. Applying a randomized controlled design to evaluate a peer violence prevention program built on a firm infrastructure and that is ready for scale-up and sustainability will make an important contribution to identifying evidence-informed interventions that can reduce youth victimization and perpetration. PMID:28351880

Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial

PubMed Central

Spijker, Anouk; Verhey, Frans; Graff, Maud; Grol, Richard; Adang, Eddy; Wollersheim, Hub; Vernooij-Dassen, Myrra

2009-01-01

Background Care for people with dementia and their informal caregivers is a challenging aim in healthcare. There is an urgent need for cost-effective support programs that prevent informal caregivers of people with dementia from becoming overburdened, which might result in a delay or decrease of patient institutionalization. For this reason, we have developed the Systematic Care Program for Dementia (SCPD). The SCPD consists of an assessment of caregiver's sense of competence and suggestions on how to deal with competence deficiencies. The efficiency of the SCPD will be evaluated in our study. Methods and design In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses) have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads) coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives. Discussion A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in costs in the management of dementia. Implementation on a national level will be started if the SCPD proves to be efficient. Trial Registration NCT00147693 PMID:19500421

Preventing Peer Violence Against Children: Methods and Baseline Data of a Cluster Randomized Controlled Trial in Pakistan.

PubMed

McFarlane, Judith; Karmaliani, Rozina; Maqbool Ahmed Khuwaja, Hussain; Gulzar, Saleema; Somani, Rozina; Saeed Ali, Tazeen; Somani, Yasmeen H; Shehzad Bhamani, Shireen; Krone, Ryan D; Paulson, Rene M; Muhammad, Atta; Jewkes, Rachel

2017-03-24

Violence against and among children is a global public health problem that annually affects 50% of youth worldwide with major impacts on child development, education, and health including increased probability of major causes of morbidity and mortality in adulthood. It is also associated with the experience of and perpetration of later violence against women. The aim of this article is to describe the intervention, study design, methods, and baseline findings of a cluster randomized controlled trial underway in Pakistan to evaluate a school-based play intervention aiming to reduce peer violence and enhance mental health. A cluster randomized controlled design is being conducted with boys and girls in grade 6 in 40 schools in Hyderabad, Pakistan, over a period of 2 years. The Multidimensional Peer-Victimization and Peer Perpetration Scales and the Children's Depression Inventory 2 (CDI 2) are being used to measure the primary outcomes while investigator-derived scales are being used to assess domestic violence within the family. Specifics of the intervention, field logistics, ethical, and fidelity management issues employed to test the program's impact on school age youth in a volatile and politically unstable country form this report. A total of 1,752 school-age youth were enrolled and interviewed at baseline. Over the preceding 4 weeks, 94% of the boys and 85% of the girls reported 1 or more occurrences of victimization, and 85% of the boys and 66% of the girls reported 1 or more acts of perpetration. Boys reported more depression compared with girls, as well as higher negative mood and self-esteem scores and more interpersonal and emotional problems. Globally, prevalence of youth violence perpetration and victimization is high and associated with poor physical and emotional health. Applying a randomized controlled design to evaluate a peer violence prevention program built on a firm infrastructure and that is ready for scale-up and sustainability will make an important contribution to identifying evidence-informed interventions that can reduce youth victimization and perpetration. © McFarlane et al.

Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial.

PubMed

Tan, Ai May; LaMontagne, Anthony D; English, Dallas R; Howard, Peter

2016-08-24

Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005) and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005). Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p < .0005) and 50.9 min/week (95 % CI =49.3 to 52.6, p < .0005) respectively. This workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016 (retrospectively registered).

Can peer support be cost saving? An economic evaluation of RAPSID: a randomized controlled trial of peer support in diabetes compared to usual care alone in East of England communities.

PubMed

Wingate, La'Marcus; Graffy, Jonathan; Holman, Daniel; Simmons, David

2017-01-01

Diabetes peer support, where one person with diabetes helps others, may improve diabetes management. The objective of this study was to perform a cost analysis of peer support strategies used in RAndomized controlled trial of Peer Support in type 2 Diabetes. We performed a 2×2 factorial randomized cluster controlled trial in England. People with type 2 diabetes were invited to participate as either 'peer' or 'peer support facilitator' (PSF) through postal invitation predominantly from general practice. Clusters, based on local communities, were each randomly assigned to one arm of group, 1:1, both group and 1:1 or control interventions. The intervention was delivered over 8-12 months by trained PSFs, supported by monthly meetings with a diabetes nurse. Out-of-pocket expenses/service utilization were self-reported at baseline, midpoint and on trial completion. Intervention costs were collated. Non-hospital costs used National Health Service (NHS) reference costs. Hospital payments were obtained from one local commissioning group and mean payments calculated. The analysis employed a societal perspective. Costs were evaluated at the conclusion of the trial. Participants (n=1299) were recruited across 130 clusters. The four arms were well balanced and matched (60% male, mean diabetes duration 9.5 years, mean glycated haemoglobin (HbA1c) 7.4+/-1.3%, 17% insulin treated). Implementation costs at 2013 rates were £13.84/participant/annum, participant out-of-pocket expenses for any intervention were £11.41/participant/annum and the NHS-incurred costs were reduced by £138.38/participant/annum. Savings for the 1:1, group and any intervention were £233.65, £90.52 and £113.13/participant/annum, respectively. We conclude that both 1:1 and group diabetes peer support over 8-12 months are cost saving in this setting, although much of the benefit is largely derived by differences in self-reported healthcare utilization. Long-term benefits should be investigated. ISRCTN66963621.

Methods for sample size determination in cluster randomized trials

PubMed Central

Rutterford, Clare; Copas, Andrew; Eldridge, Sandra

2015-01-01

Background: The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. Methods: We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. Results: We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. Conclusions: There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials. PMID:26174515

Teleconferenced Educational Detailing: Diabetes Education for Primary Care Physicians

ERIC Educational Resources Information Center

Harris, Stewart B.; Leiter, Lawrence A.; Webster-Bogaert, Susan; Van, Daphne M.; O'Neill, Colleen

2005-01-01

Introduction: Formal didactic continuing medical education (CME) is relatively ineffective for changing physician behavior. Diabetes mellitus is an increasingly prevalent disease, and interventions to improve adherence to clinical practice guidelines (CPGs) are needed. Methods: A stratified, cluster-randomized, controlled trial design was used to…

Design of a cluster-randomized minority recruitment trial: RECRUIT.

PubMed

Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

2017-06-01

Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

Search for Directed Networks by Different Random Walk Strategies

NASA Astrophysics Data System (ADS)

Zhu, Zi-Qi; Jin, Xiao-Ling; Huang, Zhi-Long

2012-03-01

A comparative study is carried out on the efficiency of five different random walk strategies searching on directed networks constructed based on several typical complex networks. Due to the difference in search efficiency of the strategies rooted in network clustering, the clustering coefficient in a random walker's eye on directed networks is defined and computed to be half of the corresponding undirected networks. The search processes are performed on the directed networks based on Erdös—Rényi model, Watts—Strogatz model, Barabási—Albert model and clustered scale-free network model. It is found that self-avoiding random walk strategy is the best search strategy for such directed networks. Compared to unrestricted random walk strategy, path-iteration-avoiding random walks can also make the search process much more efficient. However, no-triangle-loop and no-quadrangle-loop random walks do not improve the search efficiency as expected, which is different from those on undirected networks since the clustering coefficient of directed networks are smaller than that of undirected networks.

Impact of Probiotics on Necrotizing Enterocolitis

PubMed Central

Underwood, Mark A.

2016-01-01

A large number of randomized placebo-controlled clinical trials and cohort studies have demonstrated a decrease in the incidence of necrotizing enterocolitis with administration of probiotic microbes. These studies have prompted many neonatologists to adopt routine prophylactic administration of probiotics while others await more definitive studies and/or probiotic products with demonstrated purity and stable numbers of live organisms. Cross-contamination and inadequate sample size limit the value of further traditional placebo-controlled randomized controlled trials. Key areas for future research include mechanisms of protection, optimum probiotic species or strains (or combinations thereof) and duration of treatment, interactions between diet and the administered probiotic, and the influence of genetic polymorphisms in the mother and infant on probiotic response. Next generation probiotics selected based on bacterial genetics rather than ease of production and large cluster-randomized clinical trials hold great promise for NEC prevention. PMID:27836423

Cluster Tails for Critical Power-Law Inhomogeneous Random Graphs

NASA Astrophysics Data System (ADS)

van der Hofstad, Remco; Kliem, Sandra; van Leeuwaarden, Johan S. H.

2018-04-01

Recently, the scaling limit of cluster sizes for critical inhomogeneous random graphs of rank-1 type having finite variance but infinite third moment degrees was obtained in Bhamidi et al. (Ann Probab 40:2299-2361, 2012). It was proved that when the degrees obey a power law with exponent τ \\in (3,4), the sequence of clusters ordered in decreasing size and multiplied through by n^{-(τ -2)/(τ -1)} converges as n→ ∞ to a sequence of decreasing non-degenerate random variables. Here, we study the tails of the limit of the rescaled largest cluster, i.e., the probability that the scaling limit of the largest cluster takes a large value u, as a function of u. This extends a related result of Pittel (J Combin Theory Ser B 82(2):237-269, 2001) for the Erdős-Rényi random graph to the setting of rank-1 inhomogeneous random graphs with infinite third moment degrees. We make use of delicate large deviations and weak convergence arguments.

Small Sample Performance of Bias-corrected Sandwich Estimators for Cluster-Randomized Trials with Binary Outcomes

PubMed Central

Li, Peng; Redden, David T.

2014-01-01

SUMMARY The sandwich estimator in generalized estimating equations (GEE) approach underestimates the true variance in small samples and consequently results in inflated type I error rates in hypothesis testing. This fact limits the application of the GEE in cluster-randomized trials (CRTs) with few clusters. Under various CRT scenarios with correlated binary outcomes, we evaluate the small sample properties of the GEE Wald tests using bias-corrected sandwich estimators. Our results suggest that the GEE Wald z test should be avoided in the analyses of CRTs with few clusters even when bias-corrected sandwich estimators are used. With t-distribution approximation, the Kauermann and Carroll (KC)-correction can keep the test size to nominal levels even when the number of clusters is as low as 10, and is robust to the moderate variation of the cluster sizes. However, in cases with large variations in cluster sizes, the Fay and Graubard (FG)-correction should be used instead. Furthermore, we derive a formula to calculate the power and minimum total number of clusters one needs using the t test and KC-correction for the CRTs with binary outcomes. The power levels as predicted by the proposed formula agree well with the empirical powers from the simulations. The proposed methods are illustrated using real CRT data. We conclude that with appropriate control of type I error rates under small sample sizes, we recommend the use of GEE approach in CRTs with binary outcomes due to fewer assumptions and robustness to the misspecification of the covariance structure. PMID:25345738

Vaccines for preventing anthrax.

PubMed

Donegan, Sarah; Bellamy, Richard; Gamble, Carrol L

2009-04-15

Anthrax is a bacterial zoonosis that occasionally causes human disease and is potentially fatal. Anthrax vaccines include a live-attenuated vaccine, an alum-precipitated cell-free filtrate vaccine, and a recombinant protein vaccine. To evaluate the effectiveness, immunogenicity, and safety of vaccines for preventing anthrax. We searched the following databases (November 2008): Cochrane Infectious Diseases Group Specialized Register; CENTRAL (The Cochrane Library 2008, Issue 4); MEDLINE; EMBASE; LILACS; and mRCT. We also searched reference lists. We included randomized controlled trials (RCTs) of individuals and cluster-RCTs comparing anthrax vaccine with placebo, other (non-anthrax) vaccines, or no intervention; or comparing administration routes or treatment regimens of anthrax vaccine. Two authors independently considered trial eligibility, assessed risk of bias, and extracted data. We presented cases of anthrax and seroconversion rates using risk ratios (RR) and 95% confidence intervals (CI). We summarized immunoglobulin G (IgG) concentrations using geometric means. We carried out a sensitivity analysis to investigate the effect of clustering on the results from one cluster-RCT. No meta-analysis was undertaken. One cluster-RCT (with 157,259 participants) and four RCTs of individuals (1917 participants) met the inclusion criteria. The cluster-RCT from the former USSR showed that, compared with no vaccine, a live-attenuated vaccine (called STI) protected against clinical anthrax whether given by a needleless device (RR 0.16; 102,737 participants, 154 clusters) or the scarification method (RR 0.25; 104,496 participants, 151 clusters). Confidence intervals were statistically significant in unadjusted calculations, but when a small amount of association within clusters was assumed, the differences were not statistically significant. The four RCTs (of individuals) of inactivated vaccines (anthrax vaccine absorbed and recombinant protective antigen) showed a dose response relationship for the anti-protective antigen IgG antibody titre. Intramuscular administration was associated with fewer injection site reactions than subcutaneous injection, and injection site reaction rates were lower when the dosage interval was longer. One cluster-RCT provides limited evidence that a live-attenuated vaccine is effective in preventing cutaneous anthrax. Vaccines based on anthrax antigens are immunogenic in most vaccinees with few adverse events or reactions. Ongoing randomized controlled trials are investigating the immunogenicity and safety of anthrax vaccines.

Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial.

PubMed

Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

2018-04-01

Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40-79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78-83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3-3.4%, P ≥ 0.138). Linear dose-response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. The 5-year CWI using the focused social marketing strategy increased the population-level of PA.

Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial

PubMed Central

Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

2018-01-01

Abstract Background Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. Methods We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40–79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78–83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Results Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3–3.4%, P ≥ 0.138). Linear dose–response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. Conclusions The 5-year CWI using the focused social marketing strategy increased the population-level of PA. PMID:29228255

Lay health educators increase colorectal cancer screening among Hmong Americans: A cluster randomized controlled trial.

PubMed

Tong, Elisa K; Nguyen, Tung T; Lo, Penny; Stewart, Susan L; Gildengorin, Ginny L; Tsoh, Janice Y; Jo, Angela M; Kagawa-Singer, Marjorie L; Sy, Angela U; Cuaresma, Charlene; Lam, Hy T; Wong, Ching; Tran, Mi T; Chen, Moon S

2017-01-01

Asian Americans have lower colorectal cancer (CRC) screening rates than non-Hispanic white individuals. Hmong Americans have limited socioeconomic resources and literacy. The current randomized controlled trial was conducted to determine whether bilingual/bicultural lay health educator (LHE) education could increase CRC screening among Hmong Americans. A cluster randomized controlled trial was conducted among Hmong Americans in Sacramento, California. LHEs and recruited participants were randomized to intervention or control groups. The intervention group received CRC education over 3 months delivered by an LHE. The control group received education regarding nutrition and physical activity delivered by a health educator. The outcomes were changes in self-reported ever-screening and up-to-date CRC screening after 6 months. All 329 participants were foreign-born with mostly no formal education, limited English proficiency, and no employment. The majority of the participants were insured and had a regular source of health care. The intervention group experienced greater changes after the intervention than the control group for ever-screening (P = .068) and being up-to-date with screening (P<.0001). In multivariable regression analyses, the intervention group demonstrated a greater increase than the control group in reporting ever-screening (adjusted odds ratio, 1.73; 95% confidence interval, 1.07-2.79) and being up-to-date with screening (adjusted odds ratio, 1.71; 95% confidence interval, 1.26-2.32). Individuals who had health insurance were found to have >4 times the odds of receiving screening, both ever-screening and up-to-date screening. A higher CRC knowledge score mediated the intervention effect for both screening outcomes. A culturally and linguistically appropriate educational intervention delivered by trained LHEs was found to increase CRC screening in an immigrant population with low levels of education, employment, English proficiency, and literacy. Cancer 2017;98-106. © 2016 American Cancer Society. © 2016 American Cancer Society.

Defective functional connectivity between posterior hypothalamus and regions of the diencephalic-mesencephalic junction in chronic cluster headache.

PubMed

Ferraro, Stefania; Nigri, Anna; Bruzzone, Maria Grazia; Brivio, Luca; Proietti Cecchini, Alberto; Verri, Mattia; Chiapparini, Luisa; Leone, Massimo

2018-01-01

Objective We tested the hypothesis of a defective functional connectivity between the posterior hypothalamus and diencephalic-mesencephalic regions in chronic cluster headache based on: a) clinical and neuro-endocrinological findings in cluster headache patients; b) neuroimaging findings during cluster headache attacks; c) neuroimaging findings in drug-refractory chronic cluster headache patients improved after successful deep brain stimulation. Methods Resting state functional magnetic resonance imaging, associated with a seed-based approach, was employed to investigate the functional connectivity of the posterior hypothalamus in chronic cluster headache patients (n = 17) compared to age and sex-matched healthy subjects (n = 16). Random-effect analyses were performed to study differences between patients and controls in ipsilateral and contralateral-to-the-pain posterior hypothalamus functional connectivity. Results Cluster headache patients showed an increased functional connectivity between the ipsilateral posterior hypothalamus and a number of diencephalic-mesencephalic structures, comprising ventral tegmental area, dorsal nuclei of raphe, and bilateral substantia nigra, sub-thalamic nucleus, and red nucleus ( p < 0.005 FDR-corrected vs . control group). No difference between patients and controls was found comparing the contralateral hypothalami. Conclusions The observed deranged functional connectivity between the posterior ipsilateral hypothalamus and diencephalic-mesencephalic regions in chronic cluster headache patients mainly involves structures that are part of (i.e. ventral tegmental area, substantia nigra) or modulate (dorsal nuclei of raphe, sub-thalamic nucleus) the midbrain dopaminergic systems. The midbrain dopaminergic systems could play a role in cluster headache pathophysiology and in particular in the chronicization process. Future studies are needed to better clarify if this finding is specific to cluster headache or if it represents an unspecific response to chronic pain.

Person mobility in the design and analysis of cluster-randomized cohort prevention trials.

PubMed

Vuchinich, Sam; Flay, Brian R; Aber, Lawrence; Bickman, Leonard

2012-06-01

Person mobility is an inescapable fact of life for most cluster-randomized (e.g., schools, hospitals, clinic, cities, state) cohort prevention trials. Mobility rates are an important substantive consideration in estimating the effects of an intervention. In cluster-randomized trials, mobility rates are often correlated with ethnicity, poverty and other variables associated with disparity. This raises the possibility that estimated intervention effects may generalize to only the least mobile segments of a population and, thus, create a threat to external validity. Such mobility can also create threats to the internal validity of conclusions from randomized trials. Researchers must decide how to deal with persons who leave study clusters during a trial (dropouts), persons and clusters that do not comply with an assigned intervention, and persons who enter clusters during a trial (late entrants), in addition to the persons who remain for the duration of a trial (stayers). Statistical techniques alone cannot solve the key issues of internal and external validity raised by the phenomenon of person mobility. This commentary presents a systematic, Campbellian-type analysis of person mobility in cluster-randomized cohort prevention trials. It describes four approaches for dealing with dropouts, late entrants and stayers with respect to data collection, analysis and generalizability. The questions at issue are: 1) From whom should data be collected at each wave of data collection? 2) Which cases should be included in the analyses of an intervention effect? and 3) To what populations can trial results be generalized? The conclusions lead to recommendations for the design and analysis of future cluster-randomized cohort prevention trials.

Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial.

PubMed

Muckelbauer, Rebecca; Libuda, Lars; Clausen, Kerstin; Toschke, André Michael; Reinehr, Thomas; Kersting, Mathilde

2009-04-01

The study tested whether a combined environmental and educational intervention solely promoting water consumption was effective in preventing overweight among children in elementary school. The participants in this randomized, controlled cluster trial were second- and third-graders from 32 elementary schools in socially deprived areas of 2 German cities. Water fountains were installed and teachers presented 4 prepared classroom lessons in the intervention group schools (N = 17) to promote water consumption. Control group schools (N = 15) did not receive any intervention. The prevalence of overweight (defined according to the International Obesity Task Force criteria), BMI SD scores, and beverage consumption (in glasses per day; 1 glass was defined as 200 mL) self-reported in 24-hour recall questionnaires, were determined before (baseline) and after the intervention. In addition, the water flow of the fountains was measured during the intervention period of 1 school year (August 2006 to June 2007). Data on 2950 children (intervention group: N = 1641; control group: N = 1309; age, mean +/- SD: 8.3 +/- 0.7 years) were analyzed. After the intervention, the risk of overweight was reduced by 31% in the intervention group, compared with the control group, with adjustment for baseline prevalence of overweight and clustering according to school. Changes in BMI SD scores did not differ between the intervention group and the control group. Water consumption after the intervention was 1.1 glasses per day greater in the intervention group. No intervention effect on juice and soft drink consumption was found. Daily water flow of the fountains indicated lasting use during the entire intervention period, but to varying extent. Our environmental and educational, school-based intervention proved to be effective in the prevention of overweight among children in elementary school, even in a population from socially deprived areas.

Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial

PubMed Central

2014-01-01

Background The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. Methods/Design This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder (primary outcome) and physical exertion during work, social capital and work ability (secondary outcomes) is assessed at baseline and 10-week follow-up. Further, postural balance and mechanical muscle function is assessed during clinical examination at baseline and follow-up. Discussion This cluster randomized trial will investigate the change in self-rated average pain intensity in the back, neck and shoulder after either 10 weeks of physical exercise at the workplace or at home. Trial registration ClinicalTrials.gov (NCT01921764). PMID:24708570

Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial.

PubMed

Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Kristensen, Anne Zoëga; Jay, Kenneth; Stelter, Reinhard; Lavendt, Ebbe; Aagaard, Per; Andersen, Lars L

2014-04-07

The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder (primary outcome) and physical exertion during work, social capital and work ability (secondary outcomes) is assessed at baseline and 10-week follow-up. Further, postural balance and mechanical muscle function is assessed during clinical examination at baseline and follow-up. This cluster randomized trial will investigate the change in self-rated average pain intensity in the back, neck and shoulder after either 10 weeks of physical exercise at the workplace or at home. ClinicalTrials.gov (NCT01921764).

Effects of an Interactive School-Based Program for Preventing Adolescent Sexual Harassment: A Cluster-Randomized Controlled Evaluation Study.

PubMed

de Lijster, Gaby P A; Felten, Hanneke; Kok, Gerjo; Kocken, Paul L

2016-05-01

Many adolescents experience sexual harassment and victims of sexual harassment have higher risks regarding well-being and health behaviors such as higher risks of suicidal thoughts, suicidal ideation and feeling unsafe at school. A peer-performed play and school lessons on preventing sexual harassment behavior were presented to secondary school students. We evaluated its effectiveness, using a cluster-randomized controlled design to assign schools to an experimental condition [n = 14 schools; 431 students (51 % female)] and a control condition [n = 11 schools; 384 students (51 % female)]. To measure the effects of the intervention at first post-test and 6-month follow-up, our multilevel analyses used a two-level random intercept model. Outcome measures were sexual harassment behaviors, behavioral determinants and distal factors influencing these behaviors. At post-test, students in the experimental group reported a reduced intention to commit sexual harassment behavior and higher self-efficacy in rejecting it. At post-test and follow-up there was a significant positive effect on social norms for rejecting sexual harassment behavior. At follow-up, sexual self-esteem was higher in students in the experimental group than in the control group. Effects on these determinants will benefit adolescents' future sexual behaviors. In combination, the play and lessons, possibly together with continued sexual health education and skills programs on social-emotional learning in subsequent school years, have potential for preventing sexual harassment behavior.

The Aged Residential Care Healthcare Utilization Study (ARCHUS): a multidisciplinary, cluster randomized controlled trial designed to reduce acute avoidable hospitalizations from long-term care facilities.

PubMed

Connolly, Martin J; Boyd, Michal; Broad, Joanna B; Kerse, Ngaire; Lumley, Thomas; Whitehead, Noeline; Foster, Susan

2015-01-01

To assess effect of a complex, multidisciplinary intervention aimed at reducing avoidable acute hospitalization of residents of residential aged care (RAC) facilities. Cluster randomized controlled trial. RAC facilities with higher than expected hospitalizations in Auckland, New Zealand, were recruited and randomized to intervention or control. A total of 1998 residents of 18 intervention facilities and 18 control facilities. A facility-based complex intervention of 9 months' duration. The intervention comprised gerontology nurse specialist (GNS)-led staff education, facility bench-marking, GNS resident review, and multidisciplinary (geriatrician, primary-care physician, pharmacist, GNS, and facility nurse) discussion of residents selected using standard criteria. Primary end point was avoidable hospitalizations. Secondary end points were all acute admissions, mortality, and acute bed-days. Follow-up was for a total of 14 months. The intervention did not affect main study end points: number of acute avoidable hospital admissions (RR 1.07; 95% CI 0.85-1.36; P = .59) or mortality (RR 1.11; 95% CI 0.76-1.61; P = .62). This multidisciplinary intervention, packaging selected case review, and staff education had no overall impact on acute hospital admissions or mortality. This may have considerable implications for resourcing in the acute and RAC sectors in the face of population aging. Australian and New Zealand Clinical Trials Registry (ACTRN12611000187943). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Entomological efficacy of durable wall lining with reduced wall surface coverage for strengthening visceral leishmaniasis vector control in Bangladesh, India and Nepal.

PubMed

Huda, M Mamun; Kumar, Vijay; Das, Murari Lal; Ghosh, Debashis; Priyanka, Jyoti; Das, Pradeep; Alim, Abdul; Matlashewski, Greg; Kroeger, Axel; Alfonso-Sierra, Eduardo; Mondal, Dinesh

2016-10-06

New methods for controlling sand fly are highly desired by the Visceral Leishmaniasis (VL) elimination program of Bangladesh, India and Nepal for its consolidation and maintenance phases. To support the program we investigated safety, efficacy and cost of Durable Wall Lining to control sand fly. This multicentre randomized controlled study in Bangladesh, India and Nepal included randomized two intervention clusters and one control cluster. Each cluster had 50 households except full wall surface coverage (DWL-FWSC) cluster in Nepal which had 46 households. Ten of 50 households were randomly selected for entomological activities except India where it was 6 households. Interventions were DWL-FWSC and reduced wall surface coverage (DWL-RWSC) with DWL which covers 1.8 m and 1.5 m height from floor respectively. Efficacy was measured by reduction in sand fly density by intervention and sand fly mortality assessment by the WHO cone bioassay test at 1 month after intervention. Trained field research assistants interviewed household heads for socio-demographic information, knowledge and practice about VL, vector control, and for their experience following the intervention. Cost data was collected using cost data collection tool which was designed for this study. Statistical analysis included difference-in-differences estimate, bivariate analysis, Poisson regression model and incremental cost-efficacy ratio calculation. Mean sand fly density reduction by DWL-FWSC and DWL-RWSC was respectively -4.96 (95 % CI, -4.54, -5.38) and -5.38 (95 % CI, -4.89, -5.88). The sand fly density reduction attributed by both the interventions were statistically significant after adjusting for covariates (IRR = 0.277, p < 0.001 for DWL-RWSC and IRR = 0.371, p < 0.001 for DWL-FWSC). The efficacy of DWL-RWSC and DWL-FWSC on sand fly density reduction was statistically comparable (p = 0.214). The acceptability of both interventions was high. Transient burning sensations, flash on face and itching were most common adverse events and were observed mostly in Indian site. There was no serious adverse event. DWL-RWSC is cost-saving compared to DWL-FWSC. The incremental cost-efficacy ratio was -6.36, where DWL-RWSC dominates DWL-FWSC. DWL-RWSC intervention is safe, efficacious, cost-saving and cost-effective in reducing indoor sand fly density. The VL elimination program in the Indian sub-continent may consider DWL-RWSC for sand fly control for its consolidation and maintenance phases.

[Efficacy of motivational interviewing for reducing medication errors in chronic patients over 65 years with polypharmacy: Results of a cluster randomized trial].

PubMed

Pérula de Torres, Luis Angel; Pulido Ortega, Laura; Pérula de Torres, Carlos; González Lama, Jesús; Olaya Caro, Inmaculada; Ruiz Moral, Roger

2014-10-21

To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over 65 with polypharmacy. Cluster randomized trial that included doctors and nurses of 16 Primary Care centers and chronic patients with polypharmacy over 65 years. The professionals were assigned to the experimental or the control group using stratified randomization. Interventions consisted of training of professionals and revision of patient treatments, application of motivational interviewing in the experimental group and also the usual approach in the control group. The primary endpoint (medication error) was analyzed at individual level, and was estimated with the absolute risk reduction (ARR), relative risk reduction (RRR), number of subjects to treat (NNT) and by multiple logistic regression analysis. Thirty-two professionals were randomized (19 doctors and 13 nurses), 27 of them recruited 154 patients consecutively (13 professionals in the experimental group recruited 70 patients and 14 professionals recruited 84 patients in the control group) and completed 6 months of follow-up. The mean age of patients was 76 years (68.8% women). A decrease in the average of medication errors was observed along the period. The reduction was greater in the experimental than in the control group (F=5.109, P=.035). RRA 29% (95% confidence interval [95% CI] 15.0-43.0%), RRR 0.59 (95% CI:0.31-0.76), and NNT 3.5 (95% CI 2.3-6.8). Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over 65 with polypharmacy. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

Effect of cooking classes for housewives on salt reduction in family members: a cluster randomized controlled trial.

PubMed

Takada, T; Imamoto, M; Fukuma, S; Yamamoto, Y; Sasaki, S; Uchida, M; Miura, Y; Shimizu, S; Nihata, K; Fukuhara, S

2016-11-01

Sodium reduction is very important in preventing cardiovascular diseases, especially in regions with high salt intake such as Japan. One strategy for salt reduction is to raise consumer awareness of the need to reduce daily salt intake. We investigated whether cooking classes given to housewives focussing on salt reduction would influence not only their own consumption behaviour but also that of their family members. Single-blinded, cluster randomized trial. We randomly assigned housewives to participate in cooking classes focussing on salt reduction (intervention group) or lectures about a healthy lifestyle (control group). The main outcome measure was the difference in estimated daily salt intake by spot urine sampling of housewives and their family members 2 months after intervention between the groups. A total of 35 housewives and 33 family members were randomized. The mean daily salt intake was 10.00 (standard deviation [SD] 1.75) g/day in the control group (17 housewives and 15 family members) and 9.57 (SD 2.45) g/day in the intervention group (18 housewives and 18 family members) at baseline. Two months after the intervention, the mean salt intake was 10.30 (SD 1.78) g/day in the control group and 8.95 (SD 2.45) g/day in the intervention group. The mean difference was -1.19 g/day (95% confidence interval -2.29, -0.09; P = 0.034). A similar tendency was observed in the subgroups of housewives and family members. Our trial suggested that the effects of cooking classes focussing on salt reduction for housewives could be transferred to family members (UMIN-CTR: 000018870). Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

PubMed

Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

2014-02-01

Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial.

PubMed

Tannenbaum, Cara; Martin, Philippe; Tamblyn, Robyn; Benedetti, Andrea; Ahmed, Sara

2014-06-01

The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older. The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown. To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults. Cluster randomized trial (EMPOWER [Eliminating Medications Through Patient Ownership of End Results] study [2010-2012, 6-month follow-up]). Community pharmacies were randomly allocated to the intervention or control arm in nonstratified, blocked groups of 4. Participants (303 long-term users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies) were screened and enrolled prior to randomization: 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the "wait list" control included 155 participants. Participants, physicians, pharmacists, and evaluators were blinded to outcome assessment. The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol. The control arm received usual care. Benzodiazepine therapy discontinuation at 6 months after randomization, ascertained by pharmacy medication renewal profiles. A total of 261 participants (86%) completed the 6-month follow-up. Of the recipients in the intervention group, 62% initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist. At 6 months, 27% of the intervention group had discontinued benzodiazepine use compared with 5% of the control group (risk difference, 23% [95% CI, 14%-32%]; intracluster correlation, 0.008; number needed to treat, 4). Dose reduction occurred in an additional 11% (95% CI, 6%-16%). In multivariate subanalyses, age greater than 80 years, sex, duration of use, indication for use, dose, previous attempt to taper, and concomitant polypharmacy (10 drugs or more per day) did not have a significant interaction effect with benzodiazepine therapy discontinuation. Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults. clinicaltrials.gov Identifier: NCT01148186.

Effect Sizes in Three-Level Cluster-Randomized Experiments

ERIC Educational Resources Information Center

Hedges, Larry V.

2011-01-01

Research designs involving cluster randomization are becoming increasingly important in educational and behavioral research. Many of these designs involve two levels of clustering or nesting (students within classes and classes within schools). Researchers would like to compute effect size indexes based on the standardized mean difference to…

Impact of a Text-Messaging Program on Adolescent Reproductive Health: A Cluster-Randomized Trial in Ghana.

PubMed

Rokicki, Slawa; Cohen, Jessica; Salomon, Joshua A; Fink, Günther

2017-02-01

To evaluate whether text-messaging programs can improve reproductive health among adolescent girls in low- and middle-income countries. We conducted a cluster-randomized controlled trial among 756 female students aged 14 to 24 years in Accra, Ghana, in 2014. We randomized 38 schools to unidirectional intervention (n = 12), interactive intervention (n = 12), and control (n = 14). The unidirectional intervention sent participants text messages with reproductive health information. The interactive intervention engaged adolescents in text-messaging reproductive health quizzes. The primary study outcome was reproductive health knowledge at 3 and 15 months. Additional outcomes included self-reported pregnancy and sexual behavior. Analysis was by intent-to-treat. From baseline to 3 months, the unidirectional intervention increased knowledge by 11 percentage points (95% confidence interval [CI] = 7, 15) and the interactive intervention by 24 percentage points (95% CI = 19, 28), from a control baseline of 26%. Although we found no changes in reproductive health outcomes overall, both unidirectional (odds ratio [OR] = 0.14; 95% CI = 0.03, 0.71) and interactive interventions (OR = 0.15; 95% CI = 0.03, 0.86) lowered odds of self-reported pregnancy for sexually active participants. Text-messaging programs can lead to large improvements in reproductive health knowledge and have the potential to lower pregnancy risk for sexually active adolescent girls.

The effect of a physical activity intervention on preschoolers' fundamental motor skills - A cluster RCT.

PubMed

Wasenius, Niko S; Grattan, Kimberly P; Harvey, Alysha L J; Naylor, Patti-Jean; Goldfield, Gary S; Adamo, Kristi B

2018-07-01

To assess the effect of a physical activity intervention delivered in the childcare centres (CC), with or without a parent-driven home physical activity component, on children's fundamental motor skills (FMS). Six-month 3-arm cluster randomized controlled trial. Preschoolers were recruited from 18 licensed CC. CC were randomly assigned to a typical curriculum comparison group (COM), childcare intervention alone (CC), or childcare intervention with parental component (CC+HOME). FMS was measured with the Test of Gross Motor Development-2. Linear mixed models were performed at the level of the individual while accounting for clustering. Raw locomotor skills score increased significantly in the CC group (mean difference=2.5 units, 95% Confidence Intervals, CI, 1.0-4.1, p<0.001) and the CC+HOME group (mean difference=2.4 units, 95% CI, 0.8-4.0, p<0.001) compared to the COM group. No significant (p>0.05) between group differences were observed in the raw object control skills, sum of raw scores, or gross motor quotient. No significant sex differences were found in any of the measured outcomes. A physical activity intervention delivered in childcare with or without parents' involvement was effective in increasing locomotor skills in preschoolers. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

A Randomized Controlled Trial to Improve the Success of Women Assistant Professors.

PubMed

Grisso, Jeane Ann; Sammel, Mary Dupuis; Rubenstein, Arthur H; Speck, Rebecca M; Conant, Emily F; Scott, Patricia; Tuton, Lucy Wolf; Westring, Alyssa Friede; Friedman, Stewart; Abbuhl, Stephanie B

2017-05-01

Given the persistent disparity in the advancement of women compared with men faculty in academic medicine, it is critical to develop effective interventions to enhance women's careers. We carried out a cluster-randomized, multifaceted intervention to improve the success of women assistant professors at a research-intensive medical school. Twenty-seven departments/divisions were randomly assigned to intervention or control groups. The three-tiered intervention included components that were aimed at (1) the professional development of women assistant professors, (2) changes at the department/division level through faculty-led task forces, and (3) engagement of institutional leaders. Generalized linear models were used to test associations between assignment and outcomes, adjusting for correlations induced by the clustered design. Academic productivity and work self-efficacy improved significantly over the 3-year trial in both intervention and control groups, but the improvements did not differ between the groups. Average hours worked per week declined significantly more for faculty in the intervention group as compared with the control group (-3.82 vs. -1.39 hours, respectively, p = 0.006). The PhD faculty in the intervention group published significantly more than PhD controls; however, no differences were observed between MDs in the intervention group and MDs in the control group. Significant improvements in academic productivity and work self-efficacy occurred in both intervention and control groups, potentially due to school-wide intervention effects. A greater decline in work hours in the intervention group despite similar increases in academic productivity may reflect learning to "work smarter" or reveal efficiencies brought about as a result of the multifaceted intervention. The intervention appeared to benefit the academic productivity of faculty with PhDs, but not MDs, suggesting that interventions should be more intense or tailored to specific faculty groups.

Prevention of illicit drug use through a school-based program: results of a longitudinal, cluster-randomized controlled trial.

PubMed

Guo, Jong-Long; Lee, Tzu-Chi; Liao, Jung-Yu; Huang, Chiu-Mieh

2015-03-01

To evaluate the long-term effects of an illicit drug use prevention program for adolescents that integrates life skills into the theory of planned behavior. We conducted a cluster-randomized trial in which 24 participating schools were randomized to either an intervention group (12 schools, n = 1,176 students) or a control group (12 schools, n = 915 students). Participants were grade 7 students. The intervention comprised a main intervention of 10 sessions and two booster interventions. Booster 1 (four sessions) and booster 2 (two sessions) were performed at 6 months and 12 months, respectively, after completion of the main intervention. Assessments were made at baseline, after the main intervention, and after each booster session using specific questionnaires for measuring participants' attitudes, subjective norms, perceived behavioral control, and life skills. Retention rates were 71.9% (845/1,176) in the intervention group and 90.7% (830/915) in the control group after the 12-month follow-up. A significantly lower proportion of intervention group participants reported illicit drug use after the first and second booster sessions compared with control group participants (.1% vs. 1.7% and .2% vs. 1.7%, respectively; both p < .05). Attitudes, subjective norms, perceived behavioral control, life skills, and behavioral intention scores of the intervention group were significantly higher than those of control group after the first and second booster sessions (all p < .001), suggesting that intervention group students tended to avoid drug use. A drug use prevention program integrating life skills into the theory of planned behavior may be effective for reducing illicit drug use and improving planned behavior-related constructs in adolescents. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

The Flies and Eyes project: design and methods of a cluster-randomised intervention study to confirm the importance of flies as trachoma vectors in The Gambia and to test a sustainable method of fly control using pit latrines.

PubMed

Emerson, Paul M; Lindsay, Steve W; Walraven, Gijs E L; Dibba, Sheikh Mafuji; Lowe, Kebba O; Bailey, Robin L

2002-04-01

The Flies and Eyes project is a community-based, cluster-randomised, intervention trial based in a rural area of The Gambia. It was designed to prove whether flies are mechanical vectors of trachoma; to quantify the relative importance of flies as vectors of trachoma and to test the effectiveness of insecticide spraying and the provision of latrines in trachoma control. A total of 21 clusters, each composed of 300-550 people, are to be recruited in groups of three. One cluster from each group is randomly allocated to receive insecticide spraying, one to receive pit latrines and the remaining to act as a control. The seven groups of clusters are recruited on a step-wise basis separated by two months to aid logistics and allow all seasons to be covered. Standardised, validated trachoma surveys are conducted for people of all ages and both sexes at baseline and six months post intervention. The Muscid fly population is monitored using standard traps and fly-eye contact is measured with catches of flies direct from children's faces. The Flies and Eyes project has been designed to strengthen the evidence base for the 'E' component of the SAFE strategy for trachoma control. The results will assist programme planners and country co-ordinators to make informed decisions on the environmental aspects of trachoma control.

Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

PubMed

Udsen, Flemming Witt; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars Holger

2014-05-21

Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone. The present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight). There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial. Clinicaltrials.gov, http://NCT01984840, November 14, 2013.

The Impact of a School-Based Hygiene, Water Quality and Sanitation Intervention on Soil-Transmitted Helminth Reinfection: A Cluster-Randomized Trial

PubMed Central

Freeman, Matthew C.; Clasen, Thomas; Brooker, Simon J.; Akoko, Daniel O.; Rheingans, Richard

2013-01-01

We conducted a cluster-randomized trial to assess the impact of a school-based water treatment, hygiene, and sanitation program on reducing infection with soil-transmitted helminths (STHs) after school-based deworming. We assessed infection with STHs at baseline and then at two follow-up rounds 8 and 10 months after deworming. Forty government primary schools in Nyanza Province, Kenya were randomly selected and assigned to intervention or control arms. The intervention reduced reinfection prevalence (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.31–1.00) and egg count (rate ratio [RR] 0.34, CI 0.15–0.75) of Ascaris lumbricoides. We found no evidence of significant intervention effects on the overall prevalence and intensity of Trichuris trichiura, hookworm, or Schistosoma mansoni reinfection. Provision of school-based sanitation, water quality, and hygiene improvements may reduce reinfection of STHs after school-based deworming, but the magnitude of the effects may be sex- and helminth species-specific. PMID:24019429

The Effects of Including Observed Means or Latent Means as Covariates in Multilevel Models for Cluster Randomized Trials

ERIC Educational Resources Information Center

Aydin, Burak; Leite, Walter L.; Algina, James

2016-01-01

We investigated methods of including covariates in two-level models for cluster randomized trials to increase power to detect the treatment effect. We compared multilevel models that included either an observed cluster mean or a latent cluster mean as a covariate, as well as the effect of including Level 1 deviation scores in the model. A Monte…

The balance between keystone clustering and bed roughness in experimental step-pool stabilization

NASA Astrophysics Data System (ADS)

Johnson, J. P.

2016-12-01

Predicting how mountain channels will respond to environmental perturbations such as floods requires an improved quantitative understanding of morphodynamic feedbacks among bed topography, surface grain size and sediment sorting. In boulder-rich gravel streams, transport and sorting often lead to the development of step pool morphologies, which are expressed both in bed topography and coarse grain clustering. Bed stability is difficult to measure, and is sometimes inferred from the presence of step pools. I use scaled flume experiments to explore feedbacks among surface grain sizes, coarse grain clustering, bed roughness and hydraulic roughness during progressive bed stabilization and over a range of sediment transport rates. While grain clusters are sometimes identified by subjective interpretation, I quantify the degree of coarse surface grain clustering using spatial statistics, including a novel normalization of Ripley's K function. This approach is objective and provides information on the strength of clustering over a range of length scales. Flume experiments start with an initial bed surface with a broad grain size distribution and spatially random positions. Flow causes the bed surface to progressively stabilize in response to erosion, surface coarsening, roughening and grain reorganization. At 95% confidence, many but not all beds stabilized with coarse grains becoming more clustered than complete spatial randomness (CSR). I observe a tradeoff between topographic roughness and clustering. Beds that stabilized with higher degrees of coarse-grain clustering were topographically smoother, and vice-versa. Initial conditions influenced the degree of clustering at stability: Beds that happened to have fewer initial coarse grains had more coarse grain reorganization during stabilization, leading to more clustering. Finally, regressions demonstrate that clustering statistics actually predict hydraulic roughness significantly better than does D84 (the size at which 84% of grains are smaller). In the experimental data, the spatial organization of surface grains is a stronger control on flow characteristics than the size of surface grains.

Local drinking water filters reduce diarrheal disease in Cambodia: a randomized, controlled trial of the ceramic water purifier.

PubMed

Brown, Joe; Sobsey, Mark D; Loomis, Dana

2008-09-01

A randomized, controlled intervention trial of two household-scale drinking water filters was conducted in a rural village in Cambodia. After collecting four weeks of baseline data on household water quality, diarrheal disease, and other data related to water use and handling practices, households were randomly assigned to one of three groups of 60 households: those receiving a ceramic water purifier (CWP), those receiving a second filter employing an iron-rich ceramic (CWP-Fe), and a control group receiving no intervention. Households were followed for 18 weeks post-baseline with biweekly follow-up. Households using either filter reported significantly less diarrheal disease during the study compared with a control group of households without filters as indicated by longitudinal prevalence ratios CWP: 0.51 (95% confidence interval [CI]: 0.41-0.63); CWP-Fe: 0.58 (95% CI: 0.47-0.71), an effect that was observed in all age groups and both sexes after controlling for clustering within households and within individuals over time.

Structuring Process Evaluation to Forecast Use and Sustainability of an Intervention: Theory and Data from the Efficacy Trial for "Lunch Is in the Bag"

ERIC Educational Resources Information Center

Roberts-Gray, Cindy; Sweitzer, Sara J.; Ranjit, Nalini; Potratz, Christa; Rood, Magdalena; Romo-Palafox, Maria Jose; Byrd-Williams, Courtney E.; Briley, Margaret E.; Hoelscher, Deanna M.

2017-01-01

Background: A cluster-randomized trial at 30 early care and education centers (Intervention = 15, waitlist Control = 15) showed the "Lunch Is in the Bag" intervention increased parents' packing of fruits, vegetables, and whole grains in their preschool children's bag lunches (parent-child dyads = 351 Intervention, 282 Control). Purpose:…

Effect of neuromuscular warm-up on injuries in female soccer and basketball athletes in urban public high schools: cluster randomized controlled trial.

PubMed

LaBella, Cynthia R; Huxford, Michael R; Grissom, Joe; Kim, Kwang-Youn; Peng, Jie; Christoffel, Katherine Kaufer

2011-11-01

To determine the effectiveness of coach-led neuromuscular warm-up on reducing lower extremity (LE) injuries in female athletes in a mixed-ethnicity, predominantly low-income, urban population. Cluster randomized controlled trial. Chicago public high schools. Of 258 coaches invited to participate, 95 (36.8%) enrolled (1558 athletes). Ninety coaches and 1492 athletes completed the study. We randomized schools to intervention and control groups. We trained intervention coaches to implement a 20-minute neuromuscular warm-up. Control coaches used their usual warm-up. Coach compliance was tracked by self-report and direct observation. Coaches reported weekly athlete exposures (AEs) and LE injuries causing a missed practice or game. Research assistants interviewed injured athletes. Injury rates were compared between the control and intervention groups using χ(2) and Fisher exact tests. Significance was set at P < .05. Poisson regression analysis adjusted for clustering and covariates in an athlete subset reporting personal information (n = 855; 57.3%). There were 28 023 intervention AEs and 22 925 control AEs. Intervention coaches used prescribed warm-up in 1425 of 1773 practices (80.4%). Intervention athletes had lower rates per 1000 AEs of gradual-onset LE injuries (0.43 vs 1.22, P < .01), acute-onset noncontact LE injuries (0.71 vs 1.61, P < .01), noncontact ankle sprains (0.25 vs 0.74, P = .01), and LE injuries treated surgically (0 vs 0.17, P = .04). Regression analysis showed significant incidence rate ratios for acute-onset noncontact LE injuries (0.33; 95% CI, 0.17-0.61), noncontact ankle sprains (0.38; 95% CI, 0.15-0.98), noncontact knee sprains (0.30; 95% CI, 0.10-0.86), and noncontact anterior cruciate ligament injuries (0.20; 95% CI, 0.04-0.95). Coach-led neuromuscular warm-up reduces noncontact LE injuries in female high school soccer and basketball athletes from a mixed-ethnicity, predominantly low-income, urban population. TRIAL REGISTRATION CLINICALTRIALS.ORG IDENTIFIER: NCT01092286.

The Design of Cluster Randomized Trials with Random Cross-Classifications

ERIC Educational Resources Information Center

Moerbeek, Mirjam; Safarkhani, Maryam

2018-01-01

Data from cluster randomized trials do not always have a pure hierarchical structure. For instance, students are nested within schools that may be crossed by neighborhoods, and soldiers are nested within army units that may be crossed by mental health-care professionals. It is important that the random cross-classification is taken into account…

Evaluating the effectiveness of an empowerment program for self-care in type 2 diabetes: a cluster randomized trial.

PubMed

Cortez, Daniel Nogueira; Macedo, Maísa Mara Lopes; Souza, Débora Aparecida Silva; Dos Santos, Jéssica Caroline; Afonso, Gesana Sousa; Reis, Ilka Afonso; Torres, Heloísa de Carvalho

2017-01-06

The prevalence of type 2 diabetes mellitus is increasing substantially worldwide, leading to serious economic effects, complications and deaths. This study evaluated the effectiveness of an empowerment program providing support for psychosocial, behavioral, and clinical aspects of diabetes to help Brazilian users of public health services obtain metabolic control of this condition. In this cluster randomized trial, participants aged 30-80 diagnosed with type 2 diabetes were recruited from ten Brazilian public health units in 2014 and 2015. Five units were randomly assigned to receive the empowerment program based on a behavior change protocol, and five continued to receive only conventional treatment. The primary outcome was the biochemical and anthropometric parameters, and the secondary outcomes were self-care, attitude, knowledge and empowerment related to diabetes. The effect of the experiment was defined as the percentage variation between the values at the initial and final periods. To evaluate this effect and to compare it in the two groups, tests were used for paired and independent samples, respectively. There were 238 participants: 127 and 111 in the intervention and control group, respectively. For glycated hemoglobin, the mean effect in the control and intervention groups was 3.93 and -5.13, respectively (p < 0.001). Levels of glycated hemoglobin and other metabolic indicators, as well as the most part of the secondary outcomes showed a significant difference in the experimental group compared to the control group. The empowerment program improved metabolic control of type 2 diabetes in Brazilian users. NCT02132338 - April 22, 2014.

The Efficacy of a Group Cognitive Behavioral Therapy for War-Affected Young Migrants Living in Australia: A Cluster Randomized Controlled Trial

PubMed Central

Ooi, Chew S.; Rooney, Rosanna M.; Roberts, Clare; Kane, Robert T.; Wright, Bernadette; Chatzisarantis, Nikos

2016-01-01

Background: Preventative and treatment programs for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade. However, there is still much contention about evidence-based and culturally sensitive interventions for children. The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioral outcomes of war-affected children resettled in Australia. Methods and Findings: A cluster randomized controlled trial with pre-test, post-test, and 3-month follow-up design was employed. A total of 82 participants (aged 10–17 years) were randomized by school into the 8-week intervention (n = 45) or the waiting list (WL) control condition (n = 37). Study outcomes included symptoms of post-traumatic stress disorder, depression, internalizing and externalizing problems, as well as psychosocial functioning. A medium intervention effect was found for depression symptoms. Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition, F(1, 155) = 5.20, p = 0.024, partial η2 = 0.07. This improvement was maintained at the 3-month follow-up, F(2, 122) = 7.24, p = 0.001, partial η2 = 0.20. Conclusions: These findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes, when compared to a waiting list control group. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12611000 948998. PMID:27843435

Effectiveness of an intervention at construction worksites on work engagement, social support, physical workload, and need for recovery: results from a cluster randomized controlled trial

PubMed Central

2012-01-01

Background To prolong sustainable healthy working lives of construction workers, a worksite prevention program was developed which aimed to improve the health and work ability of construction workers. The aim of the current study was to investigate the effectiveness of this program on social support at work, work engagement, physical workload and need for recovery. Methods Fifteen departments from six construction companies participated in this cluster randomized controlled trial; 8 departments (n=171 workers) were randomized to an intervention group and 7 departments (n=122 workers) to a control group. The intervention consisted of two individual training sessions of a physical therapist to lower the physical workload, a Rest-Break tool to improve the balance between work and recovery, and two empowerment training sessions to increase the influence of the construction workers at the worksite. Data on work engagement, social support at work, physical workload, and need for recovery were collected at baseline, and at three, six and 12 months after the start of the intervention using questionnaires. Results No differences between the intervention and control group were found for work engagement, social support at work, and need for recovery. At 6 months follow-up, the control group reported a small but statistically significant reduction of physical workload. Conclusion The intervention neither improved social support nor work engagement, nor was it effective in reducing the physical workload and need for recovery among construction workers. Trial registration NTR1278 PMID:23171354

Continued smoking abstinence in diabetic patients in primary care: a cluster randomized controlled multicenter study.

PubMed

Pérez-Tortosa, Santiago; Roig, Lydia; Manresa, Josep M; Martin-Cantera, Carlos; Puigdomènech, Elisa; Roura, Pilar; Armengol, Angelina; Advani, Mamta

2015-01-01

To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, p<0.001). Contemplation stage at baseline also showed a protective effect, decreasing the odds of continuing smoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Physically Active Math and Language Lessons Improve Academic Achievement: A Cluster Randomized Controlled Trial.

PubMed

Mullender-Wijnsma, Marijke J; Hartman, Esther; de Greeff, Johannes W; Doolaard, Simone; Bosker, Roel J; Visscher, Chris

2016-03-01

Using physical activity in the teaching of academic lessons is a new way of learning. The aim of this study was to investigate the effects of an innovative physically active academic intervention ("Fit & Vaardig op School" [F&V]) on academic achievement of children. Using physical activity to teach math and spelling lessons was studied in a cluster-randomized controlled trial. Participants were 499 children (mean age 8.1 years) from second- and third-grade classes of 12 elementary schools. At each school, a second- and third-grade class were randomly assigned to the intervention or control group. The intervention group participated in F&V lessons for 2 years, 22 weeks per year, 3 times a week. The control group participated in regular classroom lessons. Children's academic achievement was measured before the intervention started and after the first and second intervention years. Academic achievement was measured by 2 mathematics tests (speed and general math skills) and 2 language tests (reading and spelling). After 2 years, multilevel analysis showed that children in the intervention group had significantly greater gains in mathematics speed test (P < .001; effect size [ES] 0.51), general mathematics (P < .001; ES 0.42), and spelling (P < .001; ES 0.45) scores. This equates to 4 months more learning gains in comparison with the control group. No differences were found on the reading test. Physically active academic lessons significantly improved mathematics and spelling performance of elementary school children and are therefore a promising new way of teaching. Copyright © 2016 by the American Academy of Pediatrics.

ENHANCEMENT OF LEARNING ON SAMPLE SIZE CALCULATION WITH A SMARTPHONE APPLICATION: A CLUSTER-RANDOMIZED CONTROLLED TRIAL.

PubMed

Ngamjarus, Chetta; Chongsuvivatwong, Virasakdi; McNeil, Edward; Holling, Heinz

2017-01-01

Sample size determination usually is taught based on theory and is difficult to understand. Using a smartphone application to teach sample size calculation ought to be more attractive to students than using lectures only. This study compared levels of understanding of sample size calculations for research studies between participants attending a lecture only versus lecture combined with using a smartphone application to calculate sample sizes, to explore factors affecting level of post-test score after training sample size calculation, and to investigate participants’ attitude toward a sample size application. A cluster-randomized controlled trial involving a number of health institutes in Thailand was carried out from October 2014 to March 2015. A total of 673 professional participants were enrolled and randomly allocated to one of two groups, namely, 341 participants in 10 workshops to control group and 332 participants in 9 workshops to intervention group. Lectures on sample size calculation were given in the control group, while lectures using a smartphone application were supplied to the test group. Participants in the intervention group had better learning of sample size calculation (2.7 points out of maximnum 10 points, 95% CI: 24 - 2.9) than the participants in the control group (1.6 points, 95% CI: 1.4 - 1.8). Participants doing research projects had a higher post-test score than those who did not have a plan to conduct research projects (0.9 point, 95% CI: 0.5 - 1.4). The majority of the participants had a positive attitude towards the use of smartphone application for learning sample size calculation.

A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes.

PubMed

Stuebe, Alison M; Bonuck, Karen; Adatorwovor, Reuben; Schwartz, Todd A; Berry, Diane C

2016-12-01

Women with gestational diabetes mellitus (GDM) and their infants are at increased risk of developing metabolic disease; however, longer breastfeeding is associated with a reduction in these risks. We tested an intervention to increase breastfeeding duration among women with GDM. We conducted a cluster randomized trial to determine the efficacy of a breastfeeding education and support program for women with GDM. Women were enrolled between 22 and 36 weeks of pregnancy and cluster randomized to an experimental lifestyle intervention or wait-list control group. Breastfeeding duration and intensity were prespecified secondary outcomes of the trial. Duration of exclusive and any breastfeeding was assessed at 6 weeks and at 4, 7, and 10 months postpartum. We quantified differences in breastfeeding rates using Kaplan-Meier estimates, log-rank tests, and Cox regression models. We enrolled 100 women, of whom 52% were African American, 31% non-Hispanic white, 11% Hispanic, 9% American Indian or Alaskan Native, 2% Asian, 2% other, and 4% more than one race. In models accounting for within-cluster correlation and adjusted for study site, breastfeeding intention, and African American race, women allocated to the intervention group were less likely to stop breastfeeding (adjusted hazard ratio [HR] 0.40, 95% confidence interval [CI] 0.21-0.74) or to introduce formula (adjusted HR 0.50, 95% CI 0.34-0.72). Our results suggest that targeted breastfeeding education for women with GDM is feasible and efficacious. http://clinicaltrials.gov/ct2/show/NCT01809431.

Effects of a tobacco control intervention for teachers in India: results of the Bihar school teachers study.

PubMed

Sorensen, Glorian; Pednekar, Mangesh S; Sinha, Dhirendra N; Stoddard, Anne M; Nagler, Eve; Aghi, Mira B; Lando, Harry A; Viswanath, Kasisomayajula; Pawar, Pratibha; Gupta, Prakash C

2013-11-01

We assessed a school-based intervention designed to promote tobacco control among teachers in the Indian state of Bihar. We used a cluster-randomized design to test the intervention, which comprised educational efforts, tobacco control policies, and cessation support and was tailored to the local social context. In 2009 to 2011, we randomly selected 72 schools from participating school districts and randomly assigned them in blocks (rural or urban) to intervention or delayed-intervention control conditions. Immediately after the intervention, the 30-day quit rate was 50% in the intervention and 15% in the control group (P = .001). At the 9-month postintervention survey, the adjusted 6-month quit rate was 19% in the intervention and 7% in the control group (P = .06). Among teachers employed for the entire academic year of the intervention, the adjusted 6-month abstinence rates were 20% and 5%, respectively, for the intervention and control groups (P = .04). These findings demonstrate the potent impact of an intervention that took advantage of social resources among teachers, who can serve as role models for tobacco control in their communities.

Testing use of payers to facilitate evidence-based practice adoption: protocol for a cluster-randomized trial

PubMed Central

2013-01-01

Background More effective methods are needed to implement evidence-based findings into practice. The Advancing Recovery Framework offers a multi-level approach to evidence-based practice implementation by aligning purchasing and regulatory policies at the payer level with organizational change strategies at the organizational level. Methods The Advancing Recovery Buprenorphine Implementation Study is a cluster-randomized controlled trial designed to increase use of the evidence-based practice buprenorphine medication to treat opiate addiction. Ohio Alcohol, Drug Addiction, and Mental Health Services Boards (ADAMHS), who are payers, and their addiction treatment organizations were recruited for a trial to assess the effects of payer and treatment organization changes (using the Advancing Recovery Framework) versus treatment organization changes alone on the use of buprenorphine. A matched-pair randomization, based on county characteristics, was applied, resulting in seven county ADAMHS boards and twenty-five treatment organizations in each arm. Opioid dependent patients are nested within cluster (treatment organization), and treatment organization clusters are nested within ADAMHS county board. The primary outcome is the percentage of individuals with an opioid dependence diagnosis who use buprenorphine during the 24-month intervention period and the 12-month sustainability period. The trial is currently in the baseline data collection stage. Discussion Although addiction treatment providers are under increasing pressure to implement evidence-based practices that have been proven to improve patient outcomes, adoption of these practices lags, compared to other areas of healthcare. Reasons frequently cited for the slow adoption of EBPs in addiction treatment include, regulatory issues, staff, or client resistance and lack of resources. Yet the way addiction treatment is funded, the payer’s role—has not received a lot of attention in research on EBP adoption. This research is unique because it investigates the role of payers in evidence-based practice implementation using a randomized controlled design instead of case examples. The testing of the Advancing Recovery Framework is designed to broaden the understanding of the impact payers have on evidence-based practice (EBP) adoption. Trial registration http://NCT01702142 (ClinicalTrials.gov registry, USA) PMID:23663749

Development of an e-supported illness management and recovery programme for consumers with severe mental illness using intervention mapping, and design of an early cluster randomized controlled trial.

PubMed

Beentjes, Titus A A; van Gaal, Betsie G I; Goossens, Peter J J; Schoonhoven, Lisette

2016-01-19

E-mental health is a promising medium to keep mental health affordable and accessible. For consumers with severe mental illness the evidence of the effectiveness of e-health is limited. A number of difficulties and barriers have to be addressed concerning e-health for consumers with severe mental illness. One possible solution might be to blend e-health with face-to-face delivery of a recovery-oriented treatment, like the Illness Management & Recovery (IMR) programme. This paper describes the development of an e-health application for the IMR programme and the design of an early clustered randomized controlled trial. We developed the e-IMR intervention according to the six-step protocol of Intervention Mapping. Consumers joined the development group to address important and relevant issues for the target group. Decisions during the six-step development process were based on qualitative evaluations of the Illness Management & Recovery programme, structured interviews, discussion in the development group, and literature reviews on qualitative papers concerning consumers with severe mental illness, theoretical models, behavioural change techniques, and telemedicine for consumers with severe mental illness. The aim of the e-IMR intervention is to help consumers with severe mental illness to involve others, manage achieving goals, and prevent relapse. The e-IMR intervention consists of face-to-face delivery of the Illness Management & Recovery programme and an e-health application containing peer-testimonials on videos, follow up on goals and coping strategies, monitoring symptoms, solving problems, and communication opportunities. We designed an early cluster randomized controlled trial that will evaluate the e-IMR intervention. In the control condition the Illness Management & Recovery programme is provided. The main effect-study parameters are: illness management, recovery, psychiatric symptoms severity, self-management, quality of life, and general health. The process of the IMR program will be evaluated on fidelity and feasibility in semi-structured interviews with participants and trainers. Intervention Mapping provided a systematic procedure for the development of this e-health intervention for consumers with severe mental illness and the preparation of an early randomized controlled trial. The trial is registered in the Dutch Trial Register: NTR4772 .

Combining long-lasting insecticidal nets and indoor residual spraying for malaria prevention in Ethiopia: study protocol for a cluster randomized controlled trial.

PubMed

Deressa, Wakgari; Loha, Eskindir; Balkew, Meshesha; Hailu, Alemayehu; Gari, Taye; Kenea, Oljira; Overgaard, Hans J; Gebremichael, Teshome; Robberstad, Bjarne; Lindtjørn, Bernt

2016-01-12

Long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) are the main malaria prevention interventions in Ethiopia. There is conflicting evidence that the combined application of both interventions is better than either LLINs or IRS used alone. This trial aims to investigate whether the combination of LLINs (PermaNet 2.0, Vestergaard Frandsen, Lausanne, Switzerland) with IRS using propoxur will enhance the protective benefits and cost-effectiveness of the interventions against malaria and its effect on mosquito behavior, as compared to each intervention alone. This 2 x 2 factorial cluster randomized controlled trial is being carried out in the Adami Tullu district in south-central Ethiopia for about 116 weeks from September 2014 to December 2016. The trial is based on four arms: LLINs + IRS, LLINs alone, IRS alone and control. Villages (or clusters) will be the unit of randomization. The sample size includes 44 clusters per arm, with each cluster comprised of approximately 35 households (about 175 people). Prior to intervention, all households in the LLINs + IRS and LLINs alone arms will be provided with LLINs free of charge. Households in the LLINs + IRS and IRS alone arms will be sprayed with carbamate propoxur once a year just before the main malaria transmission season throughout the investigation. The primary outcome of this trial will be a malaria incidence based on the results of the rapid diagnostic tests in patients with a fever or history of fever attending health posts by passive case detection. Community-based surveys will be conducted each year to assess anemia among children 5-59 months old. In addition, community-based malaria prevalence surveys will be conducted each year on a representative sample of households during the main transmission season. The cost-effectiveness of the interventions and entomological studies will be simultaneously conducted. Analysis will be based on an intention-to-treat principle. This trial aims to provide evidence on the combined use of LLINs and IRS for malaria prevention by answering the following research questions: Can the combined use of LLINs and IRS significantly reduce the incidence of malaria compared with the use of either LLINs or IRS alone? And is the reduced incidence justifiable compared to the added costs? Will the combined use of LLINs and IRS reduce vector density, infection, longevity and the entomological inoculation rate? These data are crucial in order to maximize the impact of vector control interventions on the morbidity and mortality of malaria. PACTR201411000882128 (8 September 2014).

Is Office-Based Counseling About Media Use, Timeouts, and Firearm Storage Effective? Results From a Cluster-Randomized, Controlled Trial

PubMed Central

Barkin, Shari L.; Finch, Stacia A.; Ip, Edward H.; Scheindlin, Benjamin; Craig, Joseph A.; Steffes, Jennifer; Weiley, Victoria; Slora, Eric; Altman, David; Wasserman, Richard C.

2015-01-01

Objective The objective of this study was to determine whether patients' families' violence-prevention behaviors would be affected by their primary care practitioner's use of a violence-prevention clinical intervention during the routine well-child examination. Methods In this cluster-randomized, controlled trial (2002–2006), 137 Pediatric Research in Office Settings practices were randomly assigned and initiated patient recruitment for either an office-based violence-prevention intervention or a control group (educational handout on literacy promotion provided). Primary caregivers of children who were aged 2 to 11 years and presented for a well-child visit were surveyed at baseline and 1 and 6 months. Practitioners were trained to (1) review a parent previsit summary regarding patient-family behavior and parental concern about media use, discipline strategies, and children's exposure to firearms, (2) counsel using brief principles of motivational interviewing, (3) identify and provide local agency resources for anger and behavior management when indicated, and (4) instruct patient-families on use of tangible tools (minute timers to monitor media time/timeouts and firearm cable locks to store firearms more safely where children live or play). Main outcomes were change over time in self-reported media use < 120 minutes per day, use of timeouts, and use of firearm cable locks. Results Generalized estimating equation analysis revealed a significant effect at 6 months for decreased media use and safer firearm storage. The intervention group compared with the control group showed an increase in limiting media use to < 120 minutes per day. There was no significant effect for timeout use. There was a substantial increase in storing firearms with cable locks for the intervention group versus a decrease for the control group. Conclusions This randomized, controlled trial demonstrated decreased media exposure and increased safe firearm storage as a result of a brief office-based violence-prevention approach. PMID:18595960

Is office-based counseling about media use, timeouts, and firearm storage effective? Results from a cluster-randomized, controlled trial.

PubMed

Barkin, Shari L; Finch, Stacia A; Ip, Edward H; Scheindlin, Benjamin; Craig, Joseph A; Steffes, Jennifer; Weiley, Victoria; Slora, Eric; Altman, David; Wasserman, Richard C

2008-07-01

The objective of this study was to determine whether patients' families' violence-prevention behaviors would be affected by their primary care practitioner's use of a violence-prevention clinical intervention during the routine well-child examination. In this cluster-randomized, controlled trial (2002-2006), 137 Pediatric Research in Office Settings practices were randomly assigned and initiated patient recruitment for either an office-based violence-prevention intervention or a control group (educational handout on literacy promotion provided). Primary caregivers of children who were aged 2 to 11 years and presented for a well-child visit were surveyed at baseline and 1 and 6 months. Practitioners were trained to (1) review a parent previsit summary regarding patient-family behavior and parental concern about media use, discipline strategies, and children's exposure to firearms, (2) counsel using brief principles of motivational interviewing, (3) identify and provide local agency resources for anger and behavior management when indicated, and (4) instruct patient-families on use of tangible tools (minute timers to monitor media time/timeouts and firearm cable locks to store firearms more safely where children live or play). Main outcomes were change over time in self-reported media use <120 minutes per day, use of timeouts, and use of firearm cable locks. Generalized estimating equation analysis revealed a significant effect at 6 months for decreased media use and safer firearm storage. The intervention group compared with the control group showed an increase in limiting media use to <120 minutes per day. There was no significant effect for timeout use. There was a substantial increase in storing firearms with cable locks for the intervention group versus a decrease for the control group. This randomized, controlled trial demonstrated decreased media exposure and increased safe firearm storage as a result of a brief office-based violence-prevention approach.

Hand washing with soap and WASH educational intervention reduces under-five childhood diarrhoea incidence in Jigjiga District, Eastern Ethiopia: A community-based cluster randomized controlled trial.

PubMed

Hashi, Abdiwahab; Kumie, Abera; Gasana, Janvier

2017-06-01

Despite the tremendous achievement in reducing child mortality and morbidity in the last two decades, diarrhoea is still a major cause of morbidity and mortality among children in many developing countries, including Ethiopia. Hand washing with soap promotion, water quality improvements and improvements in excreta disposal significantly reduces diarrhoeal diseases. The objective of this study was to evaluate the effect of hand washing with soap and water, sanitation and hygiene (WASH) educational Intervention on the incidence of under-five children diarrhoea. A community-based cluster randomized controlled trial was conducted in 24 clusters (sub-Kebelles) in Jigjiga district, Somali region, Eastern Ethiopia from February 1 to July 30, 2015. The trial compared incidence of diarrhoea among under-five children whose primary caretakers receive hand washing with soap and water, sanitation, hygiene educational messages with control households. Generalized estimating equation with a log link function Poisson distribution family was used to compute adjusted incidence rate ratio and the corresponding 95% confidence interval. The results of this study show that the longitudinal adjusted incidence rate ratio (IRR) of diarrhoeal diseases comparing interventional and control households was 0.65 (95% CI 0.57, 0.73) suggesting an overall diarrhoeal diseases reduction of 35%. The results are similar to other trials of WASH educational interventions and hand washing with soap. In conclusion, hand washing with soap practice during critical times and WASH educational messages reduces childhood diarrhoea in the rural pastoralist area.

Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

PubMed Central

Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

2016-01-01

Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States.

PubMed

Olson, Ryan; Wipfli, Brad; Thompson, Sharon V; Elliot, Diane L; Anger, W Kent; Bodner, Todd; Hammer, Leslie B; Perrin, Nancy A

2016-09-01

To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = -0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers.

Cluster-level statistical inference in fMRI datasets: The unexpected behavior of random fields in high dimensions.

PubMed

Bansal, Ravi; Peterson, Bradley S

2018-06-01

Identifying regional effects of interest in MRI datasets usually entails testing a priori hypotheses across many thousands of brain voxels, requiring control for false positive findings in these multiple hypotheses testing. Recent studies have suggested that parametric statistical methods may have incorrectly modeled functional MRI data, thereby leading to higher false positive rates than their nominal rates. Nonparametric methods for statistical inference when conducting multiple statistical tests, in contrast, are thought to produce false positives at the nominal rate, which has thus led to the suggestion that previously reported studies should reanalyze their fMRI data using nonparametric tools. To understand better why parametric methods may yield excessive false positives, we assessed their performance when applied both to simulated datasets of 1D, 2D, and 3D Gaussian Random Fields (GRFs) and to 710 real-world, resting-state fMRI datasets. We showed that both the simulated 2D and 3D GRFs and the real-world data contain a small percentage (<6%) of very large clusters (on average 60 times larger than the average cluster size), which were not present in 1D GRFs. These unexpectedly large clusters were deemed statistically significant using parametric methods, leading to empirical familywise error rates (FWERs) as high as 65%: the high empirical FWERs were not a consequence of parametric methods failing to model spatial smoothness accurately, but rather of these very large clusters that are inherently present in smooth, high-dimensional random fields. In fact, when discounting these very large clusters, the empirical FWER for parametric methods was 3.24%. Furthermore, even an empirical FWER of 65% would yield on average less than one of those very large clusters in each brain-wide analysis. Nonparametric methods, in contrast, estimated distributions from those large clusters, and therefore, by construct rejected the large clusters as false positives at the nominal FWERs. Those rejected clusters were outlying values in the distribution of cluster size but cannot be distinguished from true positive findings without further analyses, including assessing whether fMRI signal in those regions correlates with other clinical, behavioral, or cognitive measures. Rejecting the large clusters, however, significantly reduced the statistical power of nonparametric methods in detecting true findings compared with parametric methods, which would have detected most true findings that are essential for making valid biological inferences in MRI data. Parametric analyses, in contrast, detected most true findings while generating relatively few false positives: on average, less than one of those very large clusters would be deemed a true finding in each brain-wide analysis. We therefore recommend the continued use of parametric methods that model nonstationary smoothness for cluster-level, familywise control of false positives, particularly when using a Cluster Defining Threshold of 2.5 or higher, and subsequently assessing rigorously the biological plausibility of the findings, even for large clusters. Finally, because nonparametric methods yielded a large reduction in statistical power to detect true positive findings, we conclude that the modest reduction in false positive findings that nonparametric analyses afford does not warrant a re-analysis of previously published fMRI studies using nonparametric techniques. Copyright © 2018 Elsevier Inc. All rights reserved.

The Effect of Single or Repeated Home Visits on the Hanging and Use of Insecticide-Treated Mosquito Nets following a Mass Distribution Campaign - A Cluster Randomized, Controlled Trial

PubMed Central

Kilian, Albert; Balayo, Connie; Feldman, Mitra; Koenker, Hannah; Lokko, Kojo; Ashton, Ruth A.; Bruce, Jane; Lynch, Matthew; Boulay, Marc

2015-01-01

Background Study objective was to evaluate the effectiveness of commonly used post-campaign hang-up visits on the hanging and use of campaign nets. Methods A cluster-randomized trial was carried out in Uganda following an ITN distribution campaign. Five clusters (parishes, consisting of ∼11 villages each) were randomly selected for each of the three study arms with between 7,534 and 9,401 households per arm. Arm 1 received one hang-up visit, while Arm 2 received two visits by volunteers four and seven months after the campaign. Visits consisted of assistance hanging the net and education on net use. The control arm was only exposed to messages during the campaign itself. Three cross-sectional surveys with a two-stage cluster sampling design, representative of the study populations, were carried out to capture the two key outcome variables of net hanging and ITN use. Sample size was calculated to detect at least a 15 percentage-points change in net use, and was 1811 at endline. The analysis used an intention-to-treat approach. Findings Both hanging and use of ITN increased during follow-up in a similar way in all three study arms. The proportion of the population using an ITN the previous night was 64.0% (95% CI 60.8, 67.2), for one additional visit, 68.2% (63.8, 72.2) for two visits and 64.0% (59.4, 68.5) for the control. The proportion of households with all campaign nets hanging increased from 55.7% to 72.5% at endline (p<0.0005 for trend), with no difference between study arms. Financial cost per household visited was estimated as USD 2.33 for the first visit and USD 2.24 for the second. Conclusions Behavior change communication provided during the campaign or through other channels was sufficient to induce high levels of net hanging and use and additional “hang-up” activities were not cost-effective. PMID:25774676

A new approach to hierarchical data analysis: Targeted maximum likelihood estimation for the causal effect of a cluster-level exposure.

PubMed

Balzer, Laura B; Zheng, Wenjing; van der Laan, Mark J; Petersen, Maya L

2018-01-01

We often seek to estimate the impact of an exposure naturally occurring or randomly assigned at the cluster-level. For example, the literature on neighborhood determinants of health continues to grow. Likewise, community randomized trials are applied to learn about real-world implementation, sustainability, and population effects of interventions with proven individual-level efficacy. In these settings, individual-level outcomes are correlated due to shared cluster-level factors, including the exposure, as well as social or biological interactions between individuals. To flexibly and efficiently estimate the effect of a cluster-level exposure, we present two targeted maximum likelihood estimators (TMLEs). The first TMLE is developed under a non-parametric causal model, which allows for arbitrary interactions between individuals within a cluster. These interactions include direct transmission of the outcome (i.e. contagion) and influence of one individual's covariates on another's outcome (i.e. covariate interference). The second TMLE is developed under a causal sub-model assuming the cluster-level and individual-specific covariates are sufficient to control for confounding. Simulations compare the alternative estimators and illustrate the potential gains from pairing individual-level risk factors and outcomes during estimation, while avoiding unwarranted assumptions. Our results suggest that estimation under the sub-model can result in bias and misleading inference in an observational setting. Incorporating working assumptions during estimation is more robust than assuming they hold in the underlying causal model. We illustrate our approach with an application to HIV prevention and treatment.

Efficient sampling of complex network with modified random walk strategies

NASA Astrophysics Data System (ADS)

Xie, Yunya; Chang, Shuhua; Zhang, Zhipeng; Zhang, Mi; Yang, Lei

2018-02-01

We present two novel random walk strategies, choosing seed node (CSN) random walk and no-retracing (NR) random walk. Different from the classical random walk sampling, the CSN and NR strategies focus on the influences of the seed node choice and path overlap, respectively. Three random walk samplings are applied in the Erdös-Rényi (ER), Barabási-Albert (BA), Watts-Strogatz (WS), and the weighted USAir networks, respectively. Then, the major properties of sampled subnets, such as sampling efficiency, degree distributions, average degree and average clustering coefficient, are studied. The similar conclusions can be reached with these three random walk strategies. Firstly, the networks with small scales and simple structures are conducive to the sampling. Secondly, the average degree and the average clustering coefficient of the sampled subnet tend to the corresponding values of original networks with limited steps. And thirdly, all the degree distributions of the subnets are slightly biased to the high degree side. However, the NR strategy performs better for the average clustering coefficient of the subnet. In the real weighted USAir networks, some obvious characters like the larger clustering coefficient and the fluctuation of degree distribution are reproduced well by these random walk strategies.

Comparison of two modes of vitamin B12 supplementation on neuroconduction and cognitive function among older people living in Santiago, Chile: a cluster randomized controlled trial. a study protocol [ISRCTN 02694183

PubMed Central

2011-01-01

Background Older people have a high risk of vitamin B12 deficiency; this can lead to varying degrees of cognitive and neurological impairment. CBL deficiency may present as macrocytic anemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. Less is known about subclinical vitamin B12 deficiency and concurrent neuroconduction and cognitive impairment. A Programme of Complementary Feeding for the Older Population (PACAM) in Chile delivers 2 complementary fortified foods that provide approximately 1.4 μg/day of vitamin B12 (2.4 μg/day elderly RDA). The aim of the present study is to assess whether supplementation with vitamin B12 will improve neuroconduction and cognitive function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of clinical deficiency. Methods We designed a cluster double-blind placebo-controlled trial involving community dwelling people aged 70-79 living in Santiago, Chile. We randomized 15 clusters (health centers) involving 300 people (20 per cluster). Each cluster will be randomly assigned to one of three arms: a) a 1 mg vitamin B12 pill taken daily and a routine PACAM food; b) a placebo pill and the milk-PACAM food fortified to provide 1 mg of vitamin B12; c) the routine PACAM food and a placebo pill. The study has been designed as an 18 month follow up period. The primary outcomes assessed at baseline, 4, 9 and 18 months will be: serum levels of vitamin B12, neuroconduction and cognitive function. Conclusions In view of the high prevalence of vitamin B12 deficiency in later life, the present study has potential public health interest because since it will measure the impact of the existing program of complementary feeding as compared to two options that provide higher vitamin B12 intakes that might potentially may contribute in preserving neurophysiologic and cognitive function and thus improve quality of life for older people in Chile. Trial registration ISRCTN: ISRCTN02694183 PMID:21952034

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

PubMed Central

2011-01-01

Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. Trial Registration http://www.clinicaltrials.gov NCT00302718 PMID:21967830

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

PubMed

Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

2015-07-01

Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

PubMed

Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

2016-12-01

The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial.

PubMed

Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

2011-01-01

To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of 'late' DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of 'late' DSTs (p=0.57) compared with the control. Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial

PubMed Central

Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

2010-01-01

Objective To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Methods Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. Results For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of ‘late’ DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of ‘late’ DSTs (p=0.57) compared with the control. Conclusions Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting. PMID:21113076

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol.

PubMed

Petersen, Laura A; Urech, Tracy; Simpson, Kate; Pietz, Kenneth; Hysong, Sylvia J; Profit, Jochen; Conrad, Douglas; Dudley, R Adams; Lutschg, Meghan Z; Petzel, Robert; Woodard, Lechauncy D

2011-10-03

Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. http://www.clinicaltrials.govNCT00302718.

Quenched Large Deviations for Simple Random Walks on Percolation Clusters Including Long-Range Correlations

NASA Astrophysics Data System (ADS)

Berger, Noam; Mukherjee, Chiranjib; Okamura, Kazuki

2018-03-01

We prove a quenched large deviation principle (LDP) for a simple random walk on a supercritical percolation cluster (SRWPC) on {Z^d} ({d ≥ 2}). The models under interest include classical Bernoulli bond and site percolation as well as models that exhibit long range correlations, like the random cluster model, the random interlacement and the vacant set of random interlacements (for {d ≥ 3}) and the level sets of the Gaussian free field ({d≥ 3}). Inspired by the methods developed by Kosygina et al. (Commun Pure Appl Math 59:1489-1521, 2006) for proving quenched LDP for elliptic diffusions with a random drift, and by Yilmaz (Commun Pure Appl Math 62(8):1033-1075, 2009) and Rosenbluth (Quenched large deviations for multidimensional random walks in a random environment: a variational formula. Ph.D. thesis, NYU, arXiv:0804.1444v1) for similar results regarding elliptic random walks in random environment, we take the point of view of the moving particle and prove a large deviation principle for the quenched distribution of the pair empirical measures of the environment Markov chain in the non-elliptic case of SRWPC. Via a contraction principle, this reduces easily to a quenched LDP for the distribution of the mean velocity of the random walk and both rate functions admit explicit variational formulas. The main difficulty in our set up lies in the inherent non-ellipticity as well as the lack of translation-invariance stemming from conditioning on the fact that the origin belongs to the infinite cluster. We develop a unifying approach for proving quenched large deviations for SRWPC based on exploiting coercivity properties of the relative entropies in the context of convex variational analysis, combined with input from ergodic theory and invoking geometric properties of the supercritical percolation cluster.

Quenched Large Deviations for Simple Random Walks on Percolation Clusters Including Long-Range Correlations

NASA Astrophysics Data System (ADS)

Berger, Noam; Mukherjee, Chiranjib; Okamura, Kazuki

2017-12-01

We prove a quenched large deviation principle (LDP) for a simple random walk on a supercritical percolation cluster (SRWPC) on {Z^d} ({d ≥ 2} ). The models under interest include classical Bernoulli bond and site percolation as well as models that exhibit long range correlations, like the random cluster model, the random interlacement and the vacant set of random interlacements (for {d ≥ 3} ) and the level sets of the Gaussian free field ({d≥ 3} ). Inspired by the methods developed by Kosygina et al. (Commun Pure Appl Math 59:1489-1521, 2006) for proving quenched LDP for elliptic diffusions with a random drift, and by Yilmaz (Commun Pure Appl Math 62(8):1033-1075, 2009) and Rosenbluth (Quenched large deviations for multidimensional random walks in a random environment: a variational formula. Ph.D. thesis, NYU, arXiv:0804.1444v1) for similar results regarding elliptic random walks in random environment, we take the point of view of the moving particle and prove a large deviation principle for the quenched distribution of the pair empirical measures of the environment Markov chain in the non-elliptic case of SRWPC. Via a contraction principle, this reduces easily to a quenched LDP for the distribution of the mean velocity of the random walk and both rate functions admit explicit variational formulas. The main difficulty in our set up lies in the inherent non-ellipticity as well as the lack of translation-invariance stemming from conditioning on the fact that the origin belongs to the infinite cluster. We develop a unifying approach for proving quenched large deviations for SRWPC based on exploiting coercivity properties of the relative entropies in the context of convex variational analysis, combined with input from ergodic theory and invoking geometric properties of the supercritical percolation cluster.

Properties of a new small-world network with spatially biased random shortcuts

NASA Astrophysics Data System (ADS)

Matsuzawa, Ryo; Tanimoto, Jun; Fukuda, Eriko

2017-11-01

This paper introduces a small-world (SW) network with a power-law distance distribution that differs from conventional models in that it uses completely random shortcuts. By incorporating spatial constraints, we analyze the divergence of the proposed model from conventional models in terms of fundamental network properties such as clustering coefficient, average path length, and degree distribution. We find that when the spatial constraint more strongly prohibits a long shortcut, the clustering coefficient is improved and the average path length increases. We also analyze the spatial prisoner's dilemma (SPD) games played on our new SW network in order to understand its dynamical characteristics. Depending on the basis graph, i.e., whether it is a one-dimensional ring or a two-dimensional lattice, and the parameter controlling the prohibition of long-distance shortcuts, the emergent results can vastly differ.

Knowledge Gains Following a Child Sexual Abuse Prevention Program Among Urban Students: A Cluster-Randomized Evaluation

PubMed Central

Dauber, Sarah; Tully, Brenda A.; Hamilton, Paige; Smith, Michael J.; Freeman, Katherine

2015-01-01

Objectives. We evaluated a school-based child sexual abuse (CSA) prevention program, Safe Touches, in a low–socioeconomic status, racially diverse sample. Methods. Participants were 492 second- and third-grade students at 6 public elementary schools in New York City. The study period spanned fall 2012 through summer 2014. We cluster-randomized classrooms to the Safe Touches intervention or control groups and assessed outcomes with the Children’s Knowledge of Abuse Questionnaire. Hierarchical models tested change in children’s knowledge of inappropriate and appropriate touch. Results. The intervention group showed significantly greater improvement than the control group on knowledge of inappropriate touch. Children in second grade and children in schools with a greater proportion of students in general (vs special) education showed greater gains than other participants in knowledge of inappropriate touch. We observed no significant change in knowledge of appropriate touch among control or intervention groups. Conclusions. Young children benefited from a school-based, 1-time CSA prevention program. Future research should explore the efficacy of CSA prevention programs with children before the second grade to determine optimal age for participation. PMID:25973809

The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial of a training intervention for community mental health teams in recovery-oriented practice.

PubMed

Shawyer, Frances; Enticott, Joanne C; Brophy, Lisa; Bruxner, Annie; Fossey, Ellie; Inder, Brett; Julian, John; Kakuma, Ritsuko; Weller, Penelope; Wilson-Evered, Elisabeth; Edan, Vrinda; Slade, Mike; Meadows, Graham N

2017-05-08

Recovery features strongly in Australian mental health policy; however, evidence is limited for the efficacy of recovery-oriented practice at the service level. This paper describes the Principles Unite Local Services Assisting Recovery (PULSAR) Specialist Care trial protocol for a recovery-oriented practice training intervention delivered to specialist mental health services staff. The primary aim is to evaluate whether adult consumers accessing services where staff have received the intervention report superior recovery outcomes compared to adult consumers accessing services where staff have not yet received the intervention. A qualitative sub-study aims to examine staff and consumer views on implementing recovery-oriented practice. A process evaluation sub-study aims to articulate important explanatory variables affecting the interventions rollout and outcomes. The mixed methods design incorporates a two-step stepped-wedge cluster randomized controlled trial (cRCT) examining cross-sectional data from three phases, and nested qualitative and process evaluation sub-studies. Participating specialist mental health care services in Melbourne, Victoria are divided into 14 clusters with half randomly allocated to receive the staff training in year one and half in year two. Research participants are consumers aged 18-75 years who attended the cluster within a previous three-month period either at baseline, 12 (step 1) or 24 months (step 2). In the two nested sub-studies, participation extends to cluster staff. The primary outcome is the Questionnaire about the Process of Recovery collected from 756 consumers (252 each at baseline, step 1, step 2). Secondary and other outcomes measuring well-being, service satisfaction and health economic impact are collected from a subset of 252 consumers (63 at baseline; 126 at step 1; 63 at step 2) via interviews. Interview-based longitudinal data are also collected 12 months apart from 88 consumers with a psychotic disorder diagnosis (44 at baseline, step 1; 44 at step 1, step 2). cRCT data will be analyzed using multilevel mixed-effects modelling to account for clustering and some repeated measures, supplemented by thematic analysis of qualitative interview data. The process evaluation will draw on qualitative, quantitative and documentary data. Findings will provide an evidence-base for the continued transformation of Australian mental health service frameworks toward recovery. Australian and New Zealand Clinical Trial Registry: ACTRN12614000957695 . Date registered: 8 September 2014.

A cluster randomized controlled trial of strategies to increase adolescents' physical activity and motivation in physical education: results of the Motivating Active Learning in Physical Education (MALP) trial.

PubMed

Lonsdale, Chris; Rosenkranz, Richard R; Sanders, Taren; Peralta, Louisa R; Bennie, Andrew; Jackson, Ben; Taylor, Ian M; Lubans, David R

2013-11-01

Physical education (PE) programs aim to promote physical activity (PA) and reach most school-aged youth. However, PA levels within PE lessons are often low. In this cluster-randomized controlled trial, we examined the effects of three self-determination theory-based motivational strategies on PA and sedentary behavior, as well as their hypothesized antecedents during PE lessons. Data were collected in Sydney, Australia (October-December 2011). After baseline testing, teachers (n=16) and their classes (n=288 students; M=13.6 years, 50.4% male) were randomly assigned to one of four teaching strategy conditions: (1) explaining relevance; (2) providing choice; (3) complete free choice; or (4) usual practice. Teachers then delivered the assigned strategy. Primary outcomes were accelerometer-assessed PA and student motivation during lessons. Secondary outcomes included sedentary behavior, perceptions of teachers' support and psychological needs satisfaction. The 'free choice' intervention increased PA (p<.05). 'Providing choice' and 'free choice' interventions decreased sedentary behavior (p<.05). The interventions did not influence motivation, but students' autonomy increased during both choice-based interventions (p<.05). Promoting choice can produce short-term increases in PA and decreases in sedentary behavior, as well as increased perceived autonomy during PE lessons. © 2013.

Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomized, controlled trial.

PubMed

Snyder, Frank; Flay, Brian; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit

2010-01-01

This paper reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools (mean enrollment = 544) and was conducted from the 2002-03 through the 2005-06 academic years. Using school-level archival data, analyses comparing change from baseline (2002) to one-year post trial (2007) revealed that intervention schools scored 9.8% better on the TerraNova (2 nd ed.) test for reading and 8.8% on math; 20.7% better in Hawai'i Content and Performance Standards scores for reading and 51.4% better in math; and that intervention schools reported 15.2% lower absenteeism and fewer suspensions (72.6%) and retentions (72.7%). Overall, effect sizes were moderate to large (range 0.5-1.1) for all of the examined outcomes. Sensitivity analyses using permutation models and random-intercept growth curve models substantiated results. The results provide evidence that a comprehensive school-based program, specifically developed to target student behavior and character, can positively influence school-level achievement, attendance, and disciplinary outcomes concurrently.

What do You Need to Get Male Partners of Pregnant Women Tested for HIV in Resource Limited Settings? The Baby Shower Cluster Randomized Trial.

PubMed

Ezeanolue, Echezona E; Obiefune, Michael C; Yang, Wei; Ezeanolue, Chinenye O; Pharr, Jennifer; Osuji, Alice; Ogidi, Amaka G; Hunt, Aaron T; Patel, Dina; Ogedegbe, Gbenga; Ehiri, John E

2017-02-01

Male partner involvement has the potential to increase uptake of interventions to prevent mother-to-child transmission of HIV (PMTCT). Finding cultural appropriate strategies to promote male partner involvement in PMTCT programs remains an abiding public health challenge. We assessed whether a congregation-based intervention, the Healthy Beginning Initiative (HBI), would lead to increased uptake of HIV testing among male partners of pregnant women during pregnancy. A cluster-randomized controlled trial of forty churches in Southeastern Nigeria randomly assigned to either the HBI (intervention group; IG) or standard of care referral to a health facility (control group; CG) was conducted. Participants in the IG received education and were offered onsite HIV testing. Overall, 2498 male partners enrolled and participated, a participation rate of 88.9%. Results showed that male partners in the IG were 12 times more likely to have had an HIV test compared to male partners of pregnant women in the CG (CG = 37.71% vs. IG = 84.00%; adjusted odds ratio = 11.9; p < .01). Culturally appropriate and community-based interventions can be effective in increasing HIV testing and counseling among male partners of pregnant women.

Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial.

PubMed

Thompson, Kirsten M J; Rocca, Corinne H; Kohn, Julia E; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J Joseph; Darney, Philip D; Harper, Cynthia C

2016-03-01

We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011-2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Public funding and provider training substantially improve LARC access.

Clustering of galaxies near damped Lyman-alpha systems with (z) = 2.6

NASA Technical Reports Server (NTRS)

Wolfe, A. M

1993-01-01

The galaxy two-point correlation function, xi, at (z) = 2.6 is determined by comparing the number of Ly-alpha-emitting galaxies in narrowband CCD fields selected for the presence of damped L-alpha absorption to their number in randomly selected control fields. Comparisons between the presented determination of (xi), a density-weighted volume average of xi, and model predictions for (xi) at large redshifts show that models in which the clustering pattern is fixed in proper coordinates are highly unlikely, while better agreement is obtained if the clustering pattern is fixed in comoving coordinates. Therefore, clustering of Ly-alpha-emitting galaxies around damped Ly-alpha systems at large redshifts is strong. It is concluded that the faint blue galaxies are drawn from a parent population different from normal galaxies, the presumed offspring of damped Ly-alpha systems.

Effect of a Brief Outreach Educational Intervention on the Translation of Acute Poisoning Treatment Guidelines to Practice in Rural Sri Lankan Hospitals: A Cluster Randomized Controlled Trial

PubMed Central

Senarathna, Lalith; Buckley, Nick A.; Dibley, Michael J.; Kelly, Patrick J.; Jayamanna, Shaluka F.; Gawarammana, Indika B.; Dawson, Andrew H.

2013-01-01

Background In developing countries, including Sri Lanka, a high proportion of acute poisoning and other medical emergencies are initially treated in rural peripheral hospitals. Patients are then usually transferred to referral hospitals for further treatment. Guidelines are often used to promote better patient care in these emergencies. We conducted a cluster randomized controlled trial (ISRCTN73983810) which aimed to assess the effect of a brief educational outreach (‘academic detailing’) intervention to promote the utilization of treatment guidelines for acute poisoning. Methods and Findings This cluster RCT was conducted in the North Central Province of Sri Lanka. All peripheral hospitals in the province were randomized to either intervention or control. All hospitals received a copy of the guidelines. The intervention hospitals received a brief out-reach academic detailing workshop which explained poisoning treatment guidelines and guideline promotional items designed to be used in daily care. Data were collected on all patients admitted due to poisoning for 12 months post-intervention in all study hospitals. Information collected included type of poison exposure, initial investigations, treatments and hospital outcome. Patients transferred from peripheral hospitals to referral hospitals had their clinical outcomes recorded. There were 23 intervention and 23 control hospitals. There were no significant differences in the patient characteristics, such as age, gender and the poisons ingested. The intervention hospitals showed a significant improvement in administration of activated charcoal [OR 2.95 (95% CI 1.28–6.80)]. There was no difference between hospitals in use of other decontamination methods. Conclusion This study shows that an educational intervention consisting of brief out-reach academic detailing was effective in changing treatment behavior in rural Sri Lankan hospitals. The intervention was only effective for treatments with direct clinician involvement, such as administering activated charcoal. It was not successful for treatments usually administered by non-professional staff such as forced emesis for poisoning. Trial Registration Controlled-Trials.com ISRCTN73983810 ISRCTN73983810 PMID:23990989

Clustering, randomness, and regularity in cloud fields. 4. Stratocumulus cloud fields

NASA Astrophysics Data System (ADS)

Lee, J.; Chou, J.; Weger, R. C.; Welch, R. M.

1994-07-01

To complete the analysis of the spatial distribution of boundary layer cloudiness, the present study focuses on nine stratocumulus Landsat scenes. The results indicate many similarities between stratocumulus and cumulus spatial distributions. Most notably, at full spatial resolution all scenes exhibit a decidedly clustered distribution. The strength of the clustering signal decreases with increasing cloud size; the clusters themselves consist of a few clouds (less than 10), occupy a small percentage of the cloud field area (less than 5%), contain between 20% and 60% of the cloud field population, and are randomly located within the scene. In contrast, stratocumulus in almost every respect are more strongly clustered than are cumulus cloud fields. For instance, stratocumulus clusters contain more clouds per cluster, occupy a larger percentage of the total area, and have a larger percentage of clouds participating in clusters than the corresponding cumulus examples. To investigate clustering at intermediate spatial scales, the local dimensionality statistic is introduced. Results obtained from this statistic provide the first direct evidence for regularity among large (>900 m in diameter) clouds in stratocumulus and cumulus cloud fields, in support of the inhibition hypothesis of Ramirez and Bras (1990). Also, the size compensated point-to-cloud cumulative distribution function statistic is found to be necessary to obtain a consistent description of stratocumulus cloud distributions. A hypothesis regarding the underlying physical mechanisms responsible for cloud clustering is presented. It is suggested that cloud clusters often arise from 4 to 10 triggering events localized within regions less than 2 km in diameter and randomly distributed within the cloud field. As the size of the cloud surpasses the scale of the triggering region, the clustering signal weakens and the larger cloud locations become more random.

Clustering, randomness, and regularity in cloud fields. 4: Stratocumulus cloud fields

NASA Technical Reports Server (NTRS)

Lee, J.; Chou, J.; Weger, R. C.; Welch, R. M.

1994-01-01

To complete the analysis of the spatial distribution of boundary layer cloudiness, the present study focuses on nine stratocumulus Landsat scenes. The results indicate many similarities between stratocumulus and cumulus spatial distributions. Most notably, at full spatial resolution all scenes exhibit a decidedly clustered distribution. The strength of the clustering signal decreases with increasing cloud size; the clusters themselves consist of a few clouds (less than 10), occupy a small percentage of the cloud field area (less than 5%), contain between 20% and 60% of the cloud field population, and are randomly located within the scene. In contrast, stratocumulus in almost every respect are more strongly clustered than are cumulus cloud fields. For instance, stratocumulus clusters contain more clouds per cluster, occupy a larger percentage of the total area, and have a larger percentage of clouds participating in clusters than the corresponding cumulus examples. To investigate clustering at intermediate spatial scales, the local dimensionality statistic is introduced. Results obtained from this statistic provide the first direct evidence for regularity among large (more than 900 m in diameter) clouds in stratocumulus and cumulus cloud fields, in support of the inhibition hypothesis of Ramirez and Bras (1990). Also, the size compensated point-to-cloud cumulative distribution function statistic is found to be necessary to obtain a consistent description of stratocumulus cloud distributions. A hypothesis regarding the underlying physical mechanisms responsible for cloud clustering is presented. It is suggested that cloud clusters often arise from 4 to 10 triggering events localized within regions less than 2 km in diameter and randomly distributed within the cloud field. As the size of the cloud surpasses the scale of the triggering region, the clustering signal weakens and the larger cloud locations become more random.

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial.

PubMed

Pai, Menaka; Lloyd, Nancy S; Cheng, Ji; Thabane, Lehana; Spencer, Frederick A; Cook, Deborah J; Haynes, R Brian; Schünemann, Holger J; Douketis, James D

2013-01-02

Venous thromboembolism (VTE) is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. We conducted a 16-week pilot cluster randomized controlled trial (RCT) to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines) within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians' orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters) in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place). Blinding was not used. A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group) were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022), and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE prophylaxis strategy, including local champions, support from clinical and administrative leaders, mandatory use, and a simple, clinically relevant risk assessment tool. Hospitals allocated to our multicomponent intervention did not have a higher rate of medical inpatients appropriately managed for thromboprophylaxis than did hospitals that were not allocated to this strategy.

A cluster-randomized effectiveness trial of a physician-pharmacist collaborative model to improve blood pressure control.

PubMed

Carter, Barry L; Clarke, William; Ardery, Gail; Weber, Cynthia A; James, Paul A; Vander Weg, Mark; Chrischilles, Elizabeth A; Vaughn, Thomas; Egan, Brent M

2010-07-01

Numerous studies have demonstrated the value of team-based care to improve blood pressure (BP) control, but there is limited information on whether these models would be adopted in diverse populations. The purpose of this study was to evaluate whether a collaborative model between physicians and pharmacists can improve BP control in multiple primary care medical offices with diverse geographic and patient characteristics and whether long-term BP control can be sustained. This study is a randomized prospective trial in 27 primary care offices first stratified by the percentage of underrepresented minorities and the level of clinical pharmacy services within the office. Each office is then randomized to either a 9- or 24-month intervention or a control group. Patients will be enrolled in this study until 2012. The results of this study should provide information on whether this model can be implemented in large numbers of diverse offices, if it is effective in diverse populations, and whether BP control can be sustained long term. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00935077.

Selection of Variables in Cluster Analysis: An Empirical Comparison of Eight Procedures

ERIC Educational Resources Information Center

Steinley, Douglas; Brusco, Michael J.

2008-01-01

Eight different variable selection techniques for model-based and non-model-based clustering are evaluated across a wide range of cluster structures. It is shown that several methods have difficulties when non-informative variables (i.e., random noise) are included in the model. Furthermore, the distribution of the random noise greatly impacts the…

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

General Framework for Effect Sizes in Cluster Randomized Experiments

ERIC Educational Resources Information Center

VanHoudnos, Nathan

2016-01-01

Cluster randomized experiments are ubiquitous in modern education research. Although a variety of modeling approaches are used to analyze these data, perhaps the most common methodology is a normal mixed effects model where some effects, such as the treatment effect, are regarded as fixed, and others, such as the effect of group random assignment…

Improving Language Comprehension in Preschool Children with Language Difficulties: A Cluster Randomized Trial

ERIC Educational Resources Information Center

Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne

2017-01-01

Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…

Effect of peer-based low back pain information and reassurance at the workplace on sick leave: a cluster randomized trial.

PubMed

Odeen, Magnus; Ihlebæk, Camilla; Indahl, Aage; Wormgoor, Marjon E A; Lie, Stein A; Eriksen, Hege R

2013-06-01

To evaluate whether information and reassurance about low back pain (LBP) given to employees at the workplace could reduce sick leave. A Cluster randomized controlled trial with 135 work units of about 3,500 public sector employees in two Norwegian municipalities, randomized into two intervention groups; Education and peer support (EPS) (n = 45 units), education and "peer support and access to an outpatient clinic" (EPSOC) (n = 48 units), and a control group (n = 42 units). Both interventions consisted of educational meetings based on a "non-injury model" and a "peer adviser" appointed by colleagues. Employees in the EPSOC group had access to an outpatient clinic for medical examination and further education. The control group received no intervention. The main outcome was sick leave based on municipal records. Secondary outcomes were self-reported pain, pain related fear of movement, coping, and beliefs about LBP from survey data of 1,746 employees (response rate about 50 %). EPS reduced sick leave by 7 % and EPSOC reduced sick leave by 4 % during the intervention year, while sick leave in the control group was increased by 7 % during the same period. Overall, Rate Ratios (RR) were statistically significant for EPSOC (RR = .84 (C.I = 0.71-.99) but not EPS (RR = .92 (C.I = 0.78-1.09)) in a mixed Poisson regression analysis. Faulty beliefs about LBP were reduced in both intervention groups. Educational meetings, combined with peer support and access to an outpatient clinic, were effective in reducing sick leave in public sector employees.

Quantifying the impact of fixed effects modeling of clusters in multiple imputation for cluster randomized trials

PubMed Central

Andridge, Rebecca. R.

2011-01-01

In cluster randomized trials (CRTs), identifiable clusters rather than individuals are randomized to study groups. Resulting data often consist of a small number of clusters with correlated observations within a treatment group. Missing data often present a problem in the analysis of such trials, and multiple imputation (MI) has been used to create complete data sets, enabling subsequent analysis with well-established analysis methods for CRTs. We discuss strategies for accounting for clustering when multiply imputing a missing continuous outcome, focusing on estimation of the variance of group means as used in an adjusted t-test or ANOVA. These analysis procedures are congenial to (can be derived from) a mixed effects imputation model; however, this imputation procedure is not yet available in commercial statistical software. An alternative approach that is readily available and has been used in recent studies is to include fixed effects for cluster, but the impact of using this convenient method has not been studied. We show that under this imputation model the MI variance estimator is positively biased and that smaller ICCs lead to larger overestimation of the MI variance. Analytical expressions for the bias of the variance estimator are derived in the case of data missing completely at random (MCAR), and cases in which data are missing at random (MAR) are illustrated through simulation. Finally, various imputation methods are applied to data from the Detroit Middle School Asthma Project, a recent school-based CRT, and differences in inference are compared. PMID:21259309

Self-Management Education for Rehabilitation Inpatients Suffering from Inflammatory Bowel Disease: A Cluster-Randomized Controlled Trial

ERIC Educational Resources Information Center

Reusch, A.; Weiland, R.; Gerlich, C.; Dreger, K.; Derra, C.; Mainos, D.; Tuschhoff, T.; Berding, A.; Witte, C.; Kaltz, B.; Faller, H.

2016-01-01

Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management…

Writing Week-Journals to Improve the Writing Quality of Fourth-Graders' Compositions

ERIC Educational Resources Information Center

Rosário, Pedro; Högemann, Julia; Núñez, José Carlos; Vallejo, Guillermo; Cunha, Jennifer; Oliveira, Vera; Fuentes, Sonia; Rodrigues, Celestino

2017-01-01

Students' writing problems are a global educational concern and is in need of particular attention. This study aims to examine the impact of providing extra writing opportunities (i.e., writing journals) on the quality of writing compositions. A longitudinal cluster-randomized controlled design using a multilevel modeling analysis with 182 fourth…

Power Analysis for Models of Change in Cluster Randomized Designs

ERIC Educational Resources Information Center

Li, Wei; Konstantopoulos, Spyros

2017-01-01

Field experiments in education frequently assign entire groups such as schools to treatment or control conditions. These experiments incorporate sometimes a longitudinal component where for example students are followed over time to assess differences in the average rate of linear change, or rate of acceleration. In this study, we provide methods…

On the Hedges Correction for a "t"-Test

ERIC Educational Resources Information Center

VanHoudnos, Nathan M.; Greenhouse, Joel B.

2016-01-01

When cluster randomized experiments are analyzed as if units were independent, test statistics for treatment effects can be anticonservative. Hedges proposed a correction for such tests by scaling them to control their Type I error rate. This article generalizes the Hedges correction from a posttest-only experimental design to more common designs…

Effects of a Preschool and Kindergarten Mathematics Curriculum: Big Math for Little Kids

ERIC Educational Resources Information Center

Presser, Ashley Lewis; Clements, Margaret; Ginsburg, Herbert; Ertle, Barbrina

2012-01-01

"Research Findings: Big Math for Little Kids" ("BMLK") is a mathematics curriculum designed for 4- and 5-year-old children. In this study, the curriculum was evaluated for effectiveness over two years, using a cluster-randomized controlled study. Over 750 children participated in the study and experienced either the…

A Statistical Model for Misreported Binary Outcomes in Clustered RCTs of Education Interventions

ERIC Educational Resources Information Center

Schochet, Peter Z.

2013-01-01

In randomized control trials (RCTs) of educational interventions, there is a growing literature on impact estimation methods to adjust for missing student outcome data using such methods as multiple imputation, the construction of nonresponse weights, casewise deletion, and maximum likelihood methods (see, for example, Allison, 2002; Graham, 2009;…

Theory-Driven Process Evaluation of a Complementary Feeding Trial in Four Countries

ERIC Educational Resources Information Center

Newman, Jamie E.; Garces, Ana; Mazariegos, Manolo; Hambidge, K. Michael; Manasyan, Albert; Tshefu, Antoinette; Lokangaka, Adrien; Sami, Neelofar; Carlo, Waldemar A.; Bose, Carl L.; Pasha, Omrana; Goco, Norman; Chomba, Elwyn; Goldenberg, Robert L.; Wright, Linda L.; Koso-Thomas, Marion; Krebs, Nancy F.

2014-01-01

We conducted a theory-driven process evaluation of a cluster randomized controlled trial comparing two types of complementary feeding (meat versus fortified cereal) on infant growth in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo. We examined process evaluation indicators for the entire study cohort (N = 1236) using chi-square…

Evaluation of a Classroom-Based Psychosocial Intervention in Conflict-Affected Nepal: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Jordans, Mark J. D.; Komproe, Ivan H.; Tol, Wietse A.; Kohrt, Brandon A.; Luitel, Nagendra P.; Macy, Robert D.; de Jong, Joop T. V. M.

2010-01-01

Background: In situations of ongoing violence, childhood psychosocial and mental health problems require care. However, resources and evidence for adequate interventions are scarce for children in low- and middle-income countries. This study evaluated a school-based psychosocial intervention in conflict-affected, rural Nepal. Methods: A cluster…

Effectiveness and Cost of Insecticide-Treated Bed Nets and Indoor Residual Spraying for the Control of Cutaneous Leishmaniasis: A Cluster-Randomized Control Trial in Morocco

PubMed Central

Faraj, Chafika; Yukich, Joshua; Adlaoui, El Bachir; Wahabi, Rachid; Mnzava, Abraham Peter; Kaddaf, Mustapha; El Idrissi, Abderrahmane Laamrani; Ameur, Btissam; Kleinschmidt, Immo

2016-01-01

Cutaneous leishmaniasis (CL) remains an important public health problem in Morocco. A cluster-randomized trial was conducted with the following three study arms: 1) long-lasting insecticide-treated nets (LLINs) plus standard of care environmental management (SoC-EM), 2) indoor residual spraying (IRS) with α-cypermethrin plus SoC-EM, and 3) SoC-EM alone. Incidence of new CL cases by passive and active case detection, sandfly abundance, and cost and cost-effectiveness was compared between study arms over 5 years. Incidence of CL and sandfly abundance were significantly lower in the IRS arm compared with SoC-EM (CL incidence rate ratio = 0.32, 95% confidence interval [CI] = 0.15–0.69, P = 0.005 and sandfly abundance ratio = 0.39, 95% CI = 0.18–0.85, P = 0.022). Reductions in the LLIN arm of the study were not significant, possibly due to poor compliance. IRS was effective and more cost-effective for the prevention of CL in Morocco. PMID:26811431

Improving the social and emotional climate of classrooms: a clustered randomized controlled trial testing the RULER Approach.

PubMed

Rivers, Susan E; Brackett, Marc A; Reyes, Maria R; Elbertson, Nicole A; Salovey, Peter

2013-02-01

The RULER Approach ("RULER") is a setting-level, social and emotional learning program that is grounded in theory and evidence. RULER is designed to modify the quality of classroom social interactions so that the climate becomes more supportive, empowering, and engaging. This is accomplished by integrating skill-building lessons and tools so that teachers and students develop their emotional literacy. In a clustered randomized control trial, we tested the hypothesis that RULER improves the social and emotional climate of classrooms. Depending upon condition assignment, 62 schools either integrated RULER into fifth- and sixth-grade English language arts (ELA) classrooms or served as comparison schools, using their standard ELA curriculum only. Multi-level modeling analyses showed that compared to classrooms in comparison schools, classrooms in RULER schools were rated as having higher degrees of warmth and connectedness between teachers and students, more autonomy and leadership among students, and teachers who focused more on students' interests and motivations. These findings suggest that RULER enhances classrooms in ways that can promote positive youth development.

Geographic analysis of vaccine uptake in a cluster-randomized controlled trial in Hue, Vietnam.

PubMed

Ali, Mohammad; Thiem, Vu Dinh; Park, Jin-Kyung; Ochiai, Rion Leon; Canh, Do Gia; Danovaro-Holliday, M Carolina; Kaljee, Linda M; Clemens, John D; Acosta, Camilo J

2007-09-01

This paper identifies spatial patterns and predictors of vaccine uptake in a cluster-randomized controlled trial in Hue, Vietnam. Data for this study result from the integration of demographic surveillance, vaccine record, and geographic data of the study area. A multi-level cross-classified (non-hierarchical) model was used for analyzing the non-nested nature of individual's ecological data. Vaccine uptake was unevenly distributed in space and there was spatial variability among predictors of vaccine uptake. Vaccine uptake was higher among students with younger, male, or not literate family heads. Students from households with higher per-capita income were less likely to participate in the trial. Residency south of the river or further from a hospital/polyclinic was associated with higher vaccine uptake. Younger students were more likely to be vaccinated than older students in high- or low-risk areas, but not in the entire study area. The findings are important for the management of vaccine campaigns during a trial and for interpretation of disease patterns during vaccine-efficacy evaluation.

Comprehensive geriatric intervention program with and without weekly class-style exercise: research protocol of a cluster randomized controlled trial in Kyoto-Kameoka Study

PubMed Central

Yoshida, Tsukasa; Yoshinaka, Yasuko; Yoshimoto, Mie; Tanaka, Yoko; Itoi, Aya; Yamagata, Emi; Ebine, Naoyuki; Ishikawa-Takata, Kazuko; Kimura, Misaka

2018-01-01

Objective The number of long-term care (LTC) users and the associated expenditures in Japan are increasing dramatically. The national government recommends LTC prevention through activation of communities. However, there is no clear evidence of the effect of population-based comprehensive geriatric intervention program (CGIP) for restraints of LTC users and the associated expenditures in the future. The aims of the current paper are to describe the study protocol and progress of a cluster randomized controlled trial (RCT) with a CGIP in Kameoka City. Methods The cluster RCT involved random allocation of regions as intervention (n=4,859) and nonintervention (n=7,195). Participants were elderly persons aged ≥65 years without LTC certification who had responded to a mailing survey. The residents living in intervention regions were invited to a physical check-up, and 1,463 people participated (30.3%). These individuals were invited to the CGIP, and 526 accepted. The CGIP comprised instructions on: 1) low-load resistance training using bodyweight, ankle weights, and elastic bands; 2) increasing daily physical activity; 3) oral motor exercise and care; and 4) a well-balanced diet based on a program from Ministry of Health, Labour and Welfare. We allocated the intervention regions randomly into home-based self-care program alone (HB group, 5 regions, n=275) and home-based program+weekly class-style session (CS group, 5 regions, n=251). We evaluated the effects of the CGIP at 12 weeks and at 12 or 15 months on physical function, and are conducting follow-up data collection for an indefinite period regarding LTC certification, medical costs, and mortality. Results and discussion The study was launched with good response rates in each phase. Participants of both groups significantly increased their step counts by ~1,000 per day from the baseline during the CGIP. This RCT will provide valuable information and evidence about effectiveness of a community-based CGIP. PMID:29872280

Detecting Intervention Effects in a Cluster-Randomized Design Using Multilevel Structural Equation Modeling for Binary Responses

PubMed Central

Cho, Sun-Joo; Preacher, Kristopher J.; Bottge, Brian A.

2015-01-01

Multilevel modeling (MLM) is frequently used to detect group differences, such as an intervention effect in a pre-test–post-test cluster-randomized design. Group differences on the post-test scores are detected by controlling for pre-test scores as a proxy variable for unobserved factors that predict future attributes. The pre-test and post-test scores that are most often used in MLM are summed item responses (or total scores). In prior research, there have been concerns regarding measurement error in the use of total scores in using MLM. To correct for measurement error in the covariate and outcome, a theoretical justification for the use of multilevel structural equation modeling (MSEM) has been established. However, MSEM for binary responses has not been widely applied to detect intervention effects (group differences) in intervention studies. In this article, the use of MSEM for intervention studies is demonstrated and the performance of MSEM is evaluated via a simulation study. Furthermore, the consequences of using MLM instead of MSEM are shown in detecting group differences. Results of the simulation study showed that MSEM performed adequately as the number of clusters, cluster size, and intraclass correlation increased and outperformed MLM for the detection of group differences. PMID:29881032

A Gender Bias Habit-Breaking Intervention Led to Increased Hiring of Female Faculty in STEMM Departments.

PubMed

Devine, Patricia G; Forscher, Patrick S; Cox, William T L; Kaatz, Anna; Sheridan, Jennifer; Carnes, Molly

2017-11-01

Addressing the underrepresentation of women in science is a top priority for many institutions, but the majority of efforts to increase representation of women are neither evidence-based nor rigorously assessed. One exception is the gender bias habit-breaking intervention (Carnes et al., 2015), which, in a cluster-randomized trial involving all but two departmental clusters ( N = 92) in the 6 STEMM focused schools/colleges at the University of Wisconsin - Madison, led to increases in gender bias awareness and self-efficacy to promote gender equity in academic science departments. Following this initial success, the present study compares, in a preregistered analysis, hiring rates of new female faculty pre- and post-manipulation. Whereas the proportion of women hired by control departments remained stable over time, the proportion of women hired by intervention departments increased by an estimated 18 percentage points ( OR = 2.23, d OR = 0.34). Though the preregistered analysis did not achieve conventional levels of statistical significance ( p < 0.07), our study has a hard upper limit on statistical power, as the cluster-randomized trial has a maximum sample size of 92 departmental clusters. These patterns have undeniable practical significance for the advancement of women in science, and provide promising evidence that psychological interventions can facilitate gender equity and diversity.

Detecting Intervention Effects in a Cluster-Randomized Design Using Multilevel Structural Equation Modeling for Binary Responses.

PubMed

Cho, Sun-Joo; Preacher, Kristopher J; Bottge, Brian A

2015-11-01

Multilevel modeling (MLM) is frequently used to detect group differences, such as an intervention effect in a pre-test-post-test cluster-randomized design. Group differences on the post-test scores are detected by controlling for pre-test scores as a proxy variable for unobserved factors that predict future attributes. The pre-test and post-test scores that are most often used in MLM are summed item responses (or total scores). In prior research, there have been concerns regarding measurement error in the use of total scores in using MLM. To correct for measurement error in the covariate and outcome, a theoretical justification for the use of multilevel structural equation modeling (MSEM) has been established. However, MSEM for binary responses has not been widely applied to detect intervention effects (group differences) in intervention studies. In this article, the use of MSEM for intervention studies is demonstrated and the performance of MSEM is evaluated via a simulation study. Furthermore, the consequences of using MLM instead of MSEM are shown in detecting group differences. Results of the simulation study showed that MSEM performed adequately as the number of clusters, cluster size, and intraclass correlation increased and outperformed MLM for the detection of group differences.

Effectiveness and feasibility of long-lasting insecticide-treated curtains and water container covers for dengue vector control in Colombia: a cluster randomised trial

PubMed Central

Quintero, Juliana; García-Betancourt, Tatiana; Cortés, Sebastian; García, Diana; Alcalá, Lucas; González-Uribe, Catalina; Brochero, Helena; Carrasquilla, Gabriel

2015-01-01

Background Long-lasting insecticide-treated net (LLIN) window and door curtains alone or in combination with LLIN water container covers were analysed regarding effectiveness in reducing dengue vector density, and feasibility of the intervention. Methods A cluster randomised trial was conducted in an urban area of Colombia comparing 10 randomly selected control and 10 intervention clusters. In control clusters, routine vector control activities were performed. The intervention delivered first, LLIN curtains (from July to August 2013) and secondly, water container covers (from October to March 2014). Cross-sectional entomological surveys were carried out at baseline (February 2013 to June 2013), 9 weeks after the first intervention (August to October 2013), and 4–6 weeks after the second intervention (March to April 2014). Results Curtains were installed in 922 households and water container covers in 303 households. The Breteau index (BI) fell from 14 to 6 in the intervention group and from 8 to 5 in the control group. The additional intervention with LLIN covers for water containers showed a significant reduction in pupae per person index (PPI) (p=0.01). In the intervention group, the PPI index showed a clear decline of 71% compared with 25% in the control group. Costs were high but options for cost savings were identified. Conclusions Short term impact evaluation indicates that the intervention package can reduce dengue vector density but sustained effect will depend on multiple factors. PMID:25604762

A randomized controlled trial of cluster audit and feedback on the quality of dental sealant for rural schoolchildren.

PubMed

Tianviwat, S; Hintao, J; Chongsuvivatwong, V; Thitasomakul, S

2016-03-01

To examine whether audit and feedback could improve the quality of the application of dental sealant in rural Thai school children. A single blind, cluster randomized controlled trial was conducted. Hospital-based and school-based school sealant applied by dental nurses in Southern province of Thailand. Dental nurses and school children who received dental sealant were involved. The intervention consisted of confidential feedback of data and tailor-made problem-solving workshops. Sealant quality was measured by sealant retention and caries on sealed surfaces at six-month after sealing. The teeth examinations were done among different groups of children prior and after the intervention. After the intervention, the sealant retention rate increased dramatically in the intervention group, whereas in the control group the rate was similar to that found at baseline. The rate of caries after the intervention was stable in the intervention group and increased slightly in the control group. At the beginning of the study, the adjusted odds ratio of complete sealant retention between the intervention and control group was 0.47 which increased to 1.99 at the end of the study. However, no effect on caries on sealed surfaces was observed. The intensive focus on actual problems during the audit and feedback improved the dental nurses' performance and the quality of the dental service, although it had no statistical impact on the incidence of caries.

Supporting stress management for women undergoing the early stages of fertility treatment: a cluster-randomized controlled trial.

PubMed

Mori, Akiko

2009-06-01

The purpose of this study was to determine the effects of a support program for the stress management of women undergoing fertility treatment to reduce stress related to infertility and treatment. We randomly assigned seven institutions into an experimental group (four institutions, n = 96) and a control group (three institutions, n = 44) using cluster randomization. The women in the experimental group were asked to continue stress management homework for 3 months. A nurse provided feedback on the homework every month. Those in the control group were given only the booklet. The primary outcomes were the risk ratios of "depression" and "anxiety" according to the Hospital Anxiety and Depression Scale. The secondary outcomes were "health status" from the Medical Outcomes Study Short-Form 36-item Health Survey (SF-36) v2 and "satisfaction" from the Visual Analogue Scale. We excluded 15 women who became pregnant and performed an intention-to-treat analysis of 125 women. There were no differences in the incidence of depression and anxiety between the experimental and control groups. There were significant interaction effects between the program and time in the scores of the two subscales of SF-36 and the summary. There was no difference in satisfaction. The use of ovulation-enhancing agents showed that the scores of "role functioning physical" and "physical component summary" in the non-use subgroup were higher at 2 and 3 months in the experimental group, compared to the control group. Positive effects of the support program were observed on two subscales of the SF-36 in the subgroup that did not use ovulation-enhancing agents.

Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial.

PubMed

Redeker, Nancy S; Knies, Andrea K; Hollenbeak, Christopher; Klar Yaggi, H; Cline, John; Andrews, Laura; Jacoby, Daniel; Sullivan, Anna; O'Connell, Meghan; Iennaco, Joanne; Finoia, Lisa; Jeon, Sangchoon

2017-04-01

Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients. The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF. We will estimate the cost-effectiveness of CBT-I and explore the effects of CBT-I on event-free survival (EFS). Two hundred participants will be randomized in clusters to a single center parallel group (CBT-I vs. attention control) RCT. Wrist actigraphy and self-report will elicit insomnia, sleep characteristics, symptoms, and functional performance. We will use the psychomotor vigilance test to evaluate sleep loss effects and the Six Minute Walk Test to evaluate effects on daytime function. Medical record review and interviews will elicit health care utilization and EFS. Statistical methods will include general linear mixed models and latent transition analysis. Stochastic cost-effectiveness analysis with a competing risk approach will be employed to conduct the cost-effectiveness analysis. The results will be generalizable to HF patients with chronic comorbid insomnia and pave the way for future research focused on the dissemination and translation of CBT-I into HF settings. Copyright © 2017 Elsevier Inc. All rights reserved.

Improving Decision Making for Feeding Options in Advanced Dementia: A Randomized, Controlled Trial

PubMed Central

Hanson, Laura C.; Carey, Timothy S.; Caprio, Anthony J.; Lee, Tae Joon; Ersek, Mary; Garrett, Joanne; Jackman, Anne; Gilliam, Robin; Wessell, Kathryn; Mitchell, Susan L.

2011-01-01

Background Feeding problems are common in dementia, and decision-makers have limited understanding of treatment options. Objectives To test whether a decision aid improves quality of decision-making about feeding options in advanced dementia. Design Cluster randomized controlled trial. Setting 24 nursing homes in North Carolina Participants Residents with advanced dementia and feeding problems and their surrogates. Intervention Intervention surrogates received an audio or print decision aid on feeding options in advanced dementia. Controls received usual care. Measurements Primary outcome was the Decisional Conflict Scale (range 1–5) measured at 3 months; other main outcomes were surrogate knowledge, frequency of communication with providers, and feeding treatment use. Results 256 residents and surrogate decision-makers were recruited. Residents’ average age was 85; 67% were Caucasian and 79% were women. Surrogates’ average age was 59; 67% were Caucasian, and 70% were residents’ children. The intervention improved knowledge scores (16.8 vs 15.1, p<0.001). After 3 months, intervention surrogates had lower Decisional Conflict Scale scores than controls (1.65 vs. 1.90, p<0.001) and more often discussed feeding options with a health care provider (46% vs. 33%, p=0.04). Residents in the intervention group were more likely to receive a dysphagia diet (89% vs.76%, p=0.04), and showed a trend toward increased staff eating assistance (20% vs.10%, p=0.08). Tube feeding was rare in both groups even after 9 months (1 intervention vs. 3 control, p=0.34). Limitations Cluster randomization was necessary to avoid contamination, but limits blinding and may introduce bias by site effect. Conclusion A decision aid about feeding options in advanced dementia reduced decisional conflict for surrogates and increased their knowledge and communication about feeding options with providers. PMID:22091750

Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

PubMed

Heisler, Michele; Hofer, Timothy P; Klamerus, Mandi L; Schmittdiel, Julie; Selby, Joe; Hogan, Mary M; Bosworth, Hayden B; Tremblay, Adam; Kerr, Eve A

2010-10-12

Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. The ClinicalTrials.gov registration number is NCT00495794.

A Cluster Randomized Trial of Tailored Breastfeeding Support for Women with Gestational Diabetes

PubMed Central

Bonuck, Karen; Adatorwovor, Reuben; Schwartz, Todd A.; Berry, Diane C.

2016-01-01

Abstract Background: Women with gestational diabetes mellitus (GDM) and their infants are at increased risk of developing metabolic disease; however, longer breastfeeding is associated with a reduction in these risks. We tested an intervention to increase breastfeeding duration among women with GDM. Materials and Methods: We conducted a cluster randomized trial to determine the efficacy of a breastfeeding education and support program for women with GDM. Women were enrolled between 22 and 36 weeks of pregnancy and cluster randomized to an experimental lifestyle intervention or wait-list control group. Breastfeeding duration and intensity were prespecified secondary outcomes of the trial. Duration of exclusive and any breastfeeding was assessed at 6 weeks and at 4, 7, and 10 months postpartum. We quantified differences in breastfeeding rates using Kaplan–Meier estimates, log-rank tests, and Cox regression models. Results: We enrolled 100 women, of whom 52% were African American, 31% non-Hispanic white, 11% Hispanic, 9% American Indian or Alaskan Native, 2% Asian, 2% other, and 4% more than one race. In models accounting for within-cluster correlation and adjusted for study site, breastfeeding intention, and African American race, women allocated to the intervention group were less likely to stop breastfeeding (adjusted hazard ratio [HR] 0.40, 95% confidence interval [CI] 0.21–0.74) or to introduce formula (adjusted HR 0.50, 95% CI 0.34–0.72). Conclusion: Our results suggest that targeted breastfeeding education for women with GDM is feasible and efficacious. Clinical Trials Registration: http://clinicaltrials.gov/ct2/show/NCT01809431 PMID:27782758

Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial.

PubMed

Ward, Dianne S; Vaughn, Amber E; Hales, Derek; Viera, Anthony J; Gizlice, Ziya; Bateman, Lori A; Grummon, Anna H; Arandia, Gabriela; Linnan, Laura A

2018-05-01

Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff. Centers are randomized (1:1) into the Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program. Healthy Lifestyles is delivered over six months including a kick-off event and three 8-week health campaigns (magazines, goal setting, behavior monitoring, tailored feedback, prompts, center displays, director coaching). The primary outcome is minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety. In total, 56 centers and 553 participants have been recruited and randomized. Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7%). Most participants (63.4%) are obese. They accumulate 17.4 (±14.2) minutes/day of MVPA and consume 1.3 (±1.4) and 1.3 (±0.8) servings/day of fruits and vegetables, respectively. Also, 14.2% are smokers; they report 6.4 (±1.4) hours/night of sleep; and 34.9% are high risk for depression. Baseline data demonstrate several serious health risks, confirming the importance of workplace interventions in child care. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.

PubMed

Von Korff, Michael; Vitiello, Michael V; McCurry, Susan M; Balderson, Benjamin H; Moore, Amy L; Baker, Laura D; Yarbro, Patricia; Saunders, Kathleen; Keefe, Francis J; Rybarczyk, Bruce D

2012-07-01

Six weekly sessions of group cognitive-behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). Persons with osteoarthritis age 60 or older were screened for osteoarthritis pain and insomnia severity via mailed survey. Primary outcomes were pain severity (pain intensity and interference ratings from the Graded Chronic Pain Scale) and insomnia severity (Insomnia Severity Index). Secondary outcomes were arthritis pain (AIMS-2 symptom scale) and sleep efficiency assessed by wrist actigraphy. Ancillary outcomes included: cognitive function, depression, and health care use. A clustered randomized design provided adequate power to identify moderate effects on primary outcomes (effect size>0.35). Modified intent to treat analyses, including all participants who attended the first session, assessed effects across CBT-PI, CBT-P, and EOC groups. Treatment effects were assessed post-intervention (2 months) and at 9 months, with durability of intervention effects evaluated at 18 months. The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9 month assessments were 96.7% and 92.9% respectively. This hybrid efficacy-effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting. Copyright © 2012 Elsevier Inc. All rights reserved.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

PubMed

Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

2008-06-01

To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial

PubMed Central

Ward, Dianne S.; Vaughn, Amber E.; Hales, Derek; Viera, Anthony J.; Gizlice, Ziya; Bateman, Lori A.; Grummon, Anna H.; Arandia, Gabriela; Linnan, Laura A.

2018-01-01

Background Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. Methods Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff. Centers are randomized (1:1) into the Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program. Healthy Lifestyles is delivered over six months including a kick-off event and three 8-week health campaigns (magazines, goal setting, behavior monitoring, tailored feedback, prompts, center displays, director coaching). The primary outcome is minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety. Results In total, 56 centers and 553 participants have been recruited and randomized. Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7%). Most participants (63.4%) are obese. They accumulate 17.4 ( ± 14.2) minutes/day of MVPA and consume 1.3 ( ± 1.4) and 1.3 ( ± 0.8) servings/day of fruits and vegetables, respectively. Also, 14.2% are smokers; they report 6.4 ( ± 1.4) hours/night of sleep; and 34.9% are high risk for depression. Conclusions Baseline data demonstrate several serious health risks, confirming the importance of workplace interventions in child care. PMID:29501740

The KiVa antibullying program in primary schools in Chile, with and without the digital game component: study protocol for a randomized controlled trial.

PubMed

Gaete, Jorge; Valenzuela, Daniela; Rojas-Barahona, Cristian; Valenzuela, Eduardo; Araya, Ricardo; Salmivalli, Christina

2017-02-20

Bullying is a major problem worldwide and Chile is no exception. Bullying is defined as a systematic aggressive behavior against a victim who cannot defend him or herself. Victims suffer social isolation and psychological maladjustment, while bullies have a higher risk for conduct problems and substance use disorders. These problems appear to last over time. The KiVa antibullying program has been evaluated in Finland and other European countries, showing preventive effects on victimization and self-reported bullying. The aims of this study are (1) to develop a culturally appropriate version of the KiVa material and (2) to test the effectiveness of the KiVa program, with and without the online game, on reducing experiences of victimization and bullying behavior among vulnerable primary schools in Santiago (Chile), using a cluster randomized controlled trial (RCT) design with three arms: (1) full KiVa program group, (2) partial KiVa (without online game) program group and (3) control group. This is a three-arm, single-blind, cluster randomized controlled trial (RCT) with a target enrolment of 1495 4th and 5th graders attending 13 vulnerable schools per arm. Students in the full and partial KiVa groups will receive universal actions: ten 2-h lessons delivered by trained teachers during 1 year; they will be exposed to posters encouraging them to support victims and behave constructively when witnessing bullying; and a person designated by the school authorities will be present in all school breaks and lunchtimes using a visible KiVa vest to remind everybody that they are in a KiVa school. KiVa schools also will have indicated actions, which consist of a set of discussion groups with the victims and with the bullies, with proper follow-up. Only full KiVa schools will also receive an online game which has the aim to raise awareness of the role of the group in bullying, increase empathy and promote strategies to support victimized peers. Self-reported victimization, bullying others and peer-reported bullying actions, psychological and academic functioning, and sense of school membership will be measured at baseline and 12 months after randomization. This is the first cluster RCT of the KiVa antibullying program in Latin America. ClinicalTrials.gov, Identifier: NCT02898324 . Registered on 8 September 2016.

Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

PubMed

Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

2016-01-01

Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95 % confidence intervals for parameters of a priori interest (recruitment, retention, adherence, pain intensity, Neck Disability Index). Results of this study will inform the design of a larger cluster-randomized controlled trial aimed at evaluating the effectiveness of the theory-based tailored intervention and increasing the use of multimodal care by chiropractors managing patients with NSNP. https://clinicaltrials.gov/, NCT02483091.

The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial.

PubMed

Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohamed; Azizan, Nurul Ain; Hairi, Farizah Mohd; Thangiah, Nithiah; Dahlui, Maznah; Bulgiba, Awang; Murray, Liam J

2014-01-01

Death rates due to hypertension in low and middle income countries are higher compared to high income countries. The present study is designed to combine life style modification and home blood pressure monitoring for control of hypertension in the context of low and middle income countries. The study is a two armed, parallel group, un-blinded, cluster randomized controlled trial undertaken within lower income areas in Kuala Lumpur. Two housing complexes will be assigned to the intervention group and the other two housing complexes will be allocated in the control group. Based on power analysis, 320 participants will be recruited. The participants in the intervention group (n = 160) will undergo three main components in the intervention which are the peer support for home blood pressure monitoring, face to face health coaching on healthy diet and demonstration and training for indoor home based exercise activities while the control group will receive a pamphlet containing information on hypertension. The primary outcomes are systolic and diastolic blood pressure. Secondary outcome measures include practice of self-blood pressure monitoring, dietary intake, level of physical activity and physical fitness. The present study will evaluate the effect of lifestyle modification and peer support home blood pressure monitoring on blood pressure control, during a 6 month intervention period. Moreover, the study aims to assess whether these effects can be sustainable more than six months after the intervention has ended.

Can group-based reassuring information alter low back pain behavior? A cluster-randomized controlled trial

PubMed Central

Indahl, Aage; Andersen, Lars L.; Burton, Kim; Hertzum-Larsen, Rasmus

2017-01-01

Background Low back pain (LBP) is common in the population and multifactorial in nature, often involving negative consequences. Reassuring information to improve coping is recommended for reducing the negative consequences of LBP. Adding a simple non-threatening explanation for the pain (temporary muscular dysfunction) has been successful at altering beliefs and behavior when delivered with other intervention elements. This study investigates the isolated effect of this specific information on future occupational behavior outcomes when delivered to the workforce. Design A cluster-randomized controlled trial. Methods Publically employed workers (n = 505) from 11 Danish municipality centers were randomized at center-level (cluster) to either intervention (two 1-hour group-based talks at the workplace) or control. The talks provided reassuring information together with a simple non-threatening explanation for LBP—the ‘functional-disturbance’-model. Data collections took place monthly over a 1-year period using text message tracking (SMS). Primary outcomes were self-reported days of cutting down usual activities and work participation. Secondary outcomes were self-reported back beliefs, work ability, number of healthcare visits, bothersomeness, restricted activity, use of pain medication, and sadness/depression. Results There was no between-group difference in the development of LBP during follow-up. Cumulative logistic regression analyses showed no between-group difference on days of cutting down activities, but increased odds for more days of work participation in the intervention group (OR = 1.83 95% CI: 1.08–3.12). Furthermore, the intervention group was more likely to report: higher work ability, reduced visits to healthcare professionals, lower bothersomeness, lower levels of sadness/depression, and positive back beliefs. Conclusion Reassuring information involving a simple non-threatening explanation for LBP significantly increased the odds for days of work participation and higher work ability among workers who went on to experience LBP during the 12-month follow-up. Our results confirm the potential for public-health education for LBP, and add to the discussion of simple versus multidisciplinary interventions. PMID:28346472

A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.

PubMed

Brown, Devin L; Conley, Kathleen M; Sánchez, Brisa N; Resnicow, Kenneth; Cowdery, Joan E; Sais, Emma; Murphy, Jillian; Skolarus, Lesli E; Lisabeth, Lynda D; Morgenstern, Lewis B

2015-10-01

The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the 3 outcomes was significant at the 0.05/3 level. Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53 years; 84% subjects were Hispanic/Latino; and 64% subjects were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day [95% confidence interval: 0.08, 0.42], P=0.002), a greater decrease in sodium intake (-123.17 mg/d [-194.76, -51.59], P=0.04), but no difference in change in moderate- or greater-intensity physical activity (-27 metabolic equivalent-minutes per week [-526, 471], P=0.56). This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary end point. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780. © 2015 American Heart Association, Inc.

The effect of financial incentives on top of behavioral support on quit rates in tobacco smoking employees: study protocol of a cluster-randomized trial.

PubMed

van den Brand, F A; Nagelhout, G E; Winkens, B; Evers, S M A A; Kotz, D; Chavannes, N H; van Schayck, C P

2016-10-06

Stimulating successful tobacco cessation among employees has multiple benefits. Employees who quit tobacco are healthier, more productive, less absent from work, and longer employable than employees who continue to use tobacco. Despite the evidence for these benefits of tobacco cessation, a successful method to stimulate employees to quit tobacco is lacking. The aim of this study is to evaluate whether adding a financial incentive to behavioral support (compared with no additional incentive) is effective and cost-effective in increasing abstinence rates in tobacco smoking employees participating in a smoking cessation group training. In this cluster-randomized trial employees in the intervention and control group both participate in a smoking cessation group training consisting of seven weekly counseling sessions of ninety minutes each. In addition to the training, employees in the intervention group receive a voucher as an incentive for being abstinent from smoking at the end of the training (€50), after three months (€50), after six months (€50), and after one year (€200). The control group does not receive any incentive. The primary outcome is carbon monoxide validated 12-month continuous abstinence from smoking (Russel's standard). Additionally, an economic evaluation is performed from a societal and an employer perspective. The present paper describes the methods and design of this cluster-randomized trial in detail. We hypothesize that the financial incentive for abstinence in the form of vouchers increases abstinence rates over and above the group training. The results of this study can provide important recommendations for enhancement of employee tobacco cessation. Dutch Trial Register: NTR5657 . First received 27-01-2016.

Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial).

PubMed

Denti, Licia; Caminiti, Caterina; Scoditti, Umberto; Zini, Andrea; Malferrari, Giovanni; Zedde, Maria Luisa; Guidetti, Donata; Baratti, Mario; Vaghi, Luca; Montanari, Enrico; Marcomini, Barbara; Riva, Silvia; Iezzi, Elisa; Castellini, Paola; Olivato, Silvia; Barbi, Filippo; Perticaroli, Eva; Monaco, Daniela; Iafelice, Ilaria; Bigliardi, Guido; Vandelli, Laura; Guareschi, Angelica; Artoni, Andrea; Zanferrari, Carla; Schulz, Peter J

2017-12-01

Public campaigns to increase stroke preparedness have been tested in different contexts, showing contradictory results. We evaluated the effectiveness of a stroke campaign, designed specifically for the Italian population in reducing prehospital delay. According to an SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial) design, the campaign was launched in 4 provinces in the northern part of the region Emilia Romagna at 3-month intervals in randomized sequence. The units of analysis were the patients admitted to hospital, with stroke and transient ischemic attack, over a time period of 15 months, beginning 3 months before the intervention was launched in the first province to allow for baseline data collection. The proportion of early arrivals (within 2 hours of symptom onset) was the primary outcome. Thrombolysis rate and some behavioral end points were the secondary outcomes. Data were analyzed using a fixed-effect model, adjusting for cluster and time trends. We enrolled 1622 patients, 912 exposed and 710 nonexposed to the campaign. The proportion of early access was nonsignificantly lower in exposed patients (354 [38.8%] versus 315 [44.4%]; adjusted odds ratio, 0.81; 95% confidence interval, 0.60-1.08; P =0.15). As for secondary end points, an increase was found for stroke recognition, which approximated but did not reach statistical significance ( P =0.07). Our campaign was not effective in reducing prehospital delay. Even if some limitations of the intervention, mainly in terms of duration, are taken into account, our study demonstrates that new communication strategies should be tested before large-scale implementation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01881152. © 2017 American Heart Association, Inc.

Study protocol for a cluster randomized trial of the Community of Voices choir intervention to promote the health and well-being of diverse older adults.

PubMed

Johnson, Julene K; Nápoles, Anna M; Stewart, Anita L; Max, Wendy B; Santoyo-Olsson, Jasmine; Freyre, Rachel; Allison, Theresa A; Gregorich, Steven E

2015-10-13

Older adults are the fastest growing segment of the United States population. There is an immediate need to identify novel, cost-effective community-based approaches that promote health and well-being for older adults, particularly those from diverse racial/ethnic and socioeconomic backgrounds. Because choral singing is multi-modal (requires cognitive, physical, and psychosocial engagement), it has the potential to improve health outcomes across several dimensions to help older adults remain active and independent. The purpose of this study is to examine the effect of a community choir program (Community of Voices) on health and well-being and to examine its costs and cost-effectiveness in a large sample of diverse, community-dwelling older adults. In this cluster randomized controlled trial, diverse adults age 60 and older were enrolled at Administration on Aging-supported senior centers and completed baseline assessments. The senior centers were randomly assigned to either start the choir immediately (intervention group) or wait 6 months to start (control). Community of Voices is a culturally tailored choir program delivered at the senior centers by professional music conductors that reflects three components of engagement (cognitive, physical, and psychosocial). We describe the nature of the study including the cluster randomized trial study design, sampling frame, sample size calculation, methods of recruitment and assessment, and primary and secondary outcomes. The study involves conducting a randomized trial of an intervention as delivered in "real-world" settings. The choir program was designed using a novel translational approach that integrated evidence-based research on the benefits of singing for older adults, community best practices related to community choirs for older adults, and the perspective of the participating communities. The practicality and relatively low cost of the choir intervention means it can be incorporated into a variety of community settings and adapted to diverse cultures and languages. If successful, this program will be a practical and acceptable community-based approach for promoting health and well-being of older adults. ClinicalTrials.gov NCT01869179 registered 9 January 2013.

Determining the Number of Clusters in a Data Set Without Graphical Interpretation

NASA Technical Reports Server (NTRS)

Aguirre, Nathan S.; Davies, Misty D.

2011-01-01

Cluster analysis is a data mining technique that is meant ot simplify the process of classifying data points. The basic clustering process requires an input of data points and the number of clusters wanted. The clustering algorithm will then pick starting C points for the clusters, which can be either random spatial points or random data points. It then assigns each data point to the nearest C point where "nearest usually means Euclidean distance, but some algorithms use another criterion. The next step is determining whether the clustering arrangement this found is within a certain tolerance. If it falls within this tolerance, the process ends. Otherwise the C points are adjusted based on how many data points are in each cluster, and the steps repeat until the algorithm converges,

Effects of a Tobacco Control Intervention for Teachers in India: Results of the Bihar School Teachers Study

PubMed Central

Sorensen, Glorian; Pednekar, Mangesh S.; Sinha, Dhirendra N.; Stoddard, Anne M.; Nagler, Eve; Aghi, Mira B.; Lando, Harry A.; Viswanath, Kasisomayajula; Pawar, Pratibha; Gupta, Prakash C.

2013-01-01

Objectives. We assessed a school-based intervention designed to promote tobacco control among teachers in the Indian state of Bihar. Methods. We used a cluster-randomized design to test the intervention, which comprised educational efforts, tobacco control policies, and cessation support and was tailored to the local social context. In 2009 to 2011, we randomly selected 72 schools from participating school districts and randomly assigned them in blocks (rural or urban) to intervention or delayed-intervention control conditions. Results. Immediately after the intervention, the 30-day quit rate was 50% in the intervention and 15% in the control group (P = .001). At the 9-month postintervention survey, the adjusted 6-month quit rate was 19% in the intervention and 7% in the control group (P = .06). Among teachers employed for the entire academic year of the intervention, the adjusted 6-month abstinence rates were 20% and 5%, respectively, for the intervention and control groups (P = .04). Conclusions. These findings demonstrate the potent impact of an intervention that took advantage of social resources among teachers, who can serve as role models for tobacco control in their communities. PMID:24028234

Clustering of time-course gene expression profiles using normal mixture models with autoregressive random effects

PubMed Central

2012-01-01

Background Time-course gene expression data such as yeast cell cycle data may be periodically expressed. To cluster such data, currently used Fourier series approximations of periodic gene expressions have been found not to be sufficiently adequate to model the complexity of the time-course data, partly due to their ignoring the dependence between the expression measurements over time and the correlation among gene expression profiles. We further investigate the advantages and limitations of available models in the literature and propose a new mixture model with autoregressive random effects of the first order for the clustering of time-course gene-expression profiles. Some simulations and real examples are given to demonstrate the usefulness of the proposed models. Results We illustrate the applicability of our new model using synthetic and real time-course datasets. We show that our model outperforms existing models to provide more reliable and robust clustering of time-course data. Our model provides superior results when genetic profiles are correlated. It also gives comparable results when the correlation between the gene profiles is weak. In the applications to real time-course data, relevant clusters of coregulated genes are obtained, which are supported by gene-function annotation databases. Conclusions Our new model under our extension of the EMMIX-WIRE procedure is more reliable and robust for clustering time-course data because it adopts a random effects model that allows for the correlation among observations at different time points. It postulates gene-specific random effects with an autocorrelation variance structure that models coregulation within the clusters. The developed R package is flexible in its specification of the random effects through user-input parameters that enables improved modelling and consequent clustering of time-course data. PMID:23151154

Camino Verde (The Green Way): evidence-based community mobilisation for dengue control in Nicaragua and Mexico: feasibility study and study protocol for a randomised controlled trial.

PubMed

Andersson, Neil; Arostegui, Jorge; Nava-Aguilera, Elizabeth; Harris, Eva; Ledogar, Robert J

2017-05-30

Since the Aedes aegypti mosquitoes that transmit dengue virus can breed in clean water, WHO-endorsed vector control strategies place sachets of organophosphate pesticide, temephos (Abate), in household water storage containers. These and other pesticide-dependent approaches have failed to curb the spread of dengue and multiple dengue virus serotypes continue to spread throughout tropical and subtropical regions worldwide. A feasibility study in Managua, Nicaragua, generated instruments, intervention protocols, training schedules and impact assessment tools for a cluster randomised controlled trial of community-based approaches to vector control comprising an alternative strategy for dengue prevention and control in Nicaragua and Mexico. The Camino Verde (Green Way) is a pragmatic parallel group trial of pesticide-free dengue vector control, adding effectiveness to the standard government dengue control. A random sample from the most recent census in three coastal regions of Guerrero state in Mexico will generate 90 study clusters and the equivalent sampling frame in Managua, Nicaragua will generate 60 clusters, making a total of 150 clusters each of 137-140 households. After a baseline study, computer-driven randomisation will allocate to intervention one half of the sites, stratified by country, evidence of recent dengue virus infection in children aged 3-9 years and, in Nicaragua, level of community organisation. Following a common evidence-based education protocol, each cluster will develop and implement its own collective interventions including house-to-house visits, school-based programmes and inter-community visits. After 18 months, a follow-up study will compare dengue history, serological evidence of recent dengue virus infection (via measurement of anti-dengue virus antibodies in saliva samples) and entomological indices between intervention and control sites. Our hypothesis is that informed community mobilisation adds effectiveness in controlling dengue. ISRCTN27581154 .

A fully nonparametric estimator of the marginal survival function based on case–control clustered age-at-onset data

PubMed Central

Gorfine, Malka; Bordo, Nadia; Hsu, Li

2017-01-01

Summary Consider a popular case–control family study where individuals with a disease under study (case probands) and individuals who do not have the disease (control probands) are randomly sampled from a well-defined population. Possibly right-censored age at onset and disease status are observed for both probands and their relatives. For example, case probands are men diagnosed with prostate cancer, control probands are men free of prostate cancer, and the prostate cancer history of the fathers of the probands is also collected. Inherited genetic susceptibility, shared environment, and common behavior lead to correlation among the outcomes within a family. In this article, a novel nonparametric estimator of the marginal survival function is provided. The estimator is defined in the presence of intra-cluster dependence, and is based on consistent smoothed kernel estimators of conditional survival functions. By simulation, it is shown that the proposed estimator performs very well in terms of bias. The utility of the estimator is illustrated by the analysis of case–control family data of early onset prostate cancer. To our knowledge, this is the first article that provides a fully nonparametric marginal survival estimator based on case–control clustered age-at-onset data. PMID:27436674

Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial.

PubMed

Ma, Xiaochen; Zhou, Zhongqiang; Yi, Hongmei; Pang, Xiaopeng; Shi, Yaojiang; Chen, Qianyun; Meltzer, Mirjam E; le Cessie, Saskia; He, Mingguang; Rozelle, Scott; Liu, Yizhi; Congdon, Nathan

2014-09-23

To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia. Cluster randomized, investigator masked, controlled trial. 252 primary schools in two prefectures in western China, 2012-13. 3177 of 19,934 children in fourth and fifth grades (mean age 10.5 years) with visual acuity <6/12 in either eye without glasses correctable to >6/12 with glasses. 3052 (96.0%) completed the study. Children were randomized by school (84 schools per arm) to one of three interventions at the beginning of the school year: prescription for glasses only (control group), vouchers for free glasses at a local facility, or free glasses provided in class. Spectacle wear at endline examination and end of year score on a specially designed mathematics test, adjusted for baseline score and expressed in standard deviations. Among 3177 eligible children, 1036 (32.6%) were randomized to control, 988 (31.1%) to vouchers, and 1153 (36.3%) to free glasses in class. All eligible children would benefit from glasses, but only 15% wore them at baseline. At closeout glasses wear was 41% (observed) and 68% (self reported) in the free glasses group, and 26% (observed) and 37% (self reported) in the controls. Effect on test score was 0.11 SD (95% confidence interval 0.01 to 0.21) when the free glasses group was compared with the control group. The adjusted effect of providing free glasses (0.10, 0.002 to 0.19) was greater than parental education (0.03, -0.04 to 0.09) or family wealth (0.01, -0.06 to 0.08). This difference between groups was significant, but was smaller than the prespecified 0.20 SD difference that the study was powered to detect. The provision of free glasses to Chinese children with myopia improves children's performance on mathematics testing to a statistically significant degree, despite imperfect compliance, although the observed difference between groups was smaller than the study was originally designed to detect. Myopia is common and rarely corrected in this setting.Trial Registration Current Controlled Trials ISRCTN03252665. © Ma et al 2014.

Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects.

PubMed

Ogedegbe, Gbenga; Tobin, Jonathan N; Fernandez, Senaida; Cassells, Andrea; Diaz-Gloster, Marleny; Khalida, Chamanara; Pickering, Thomas; Schwartz, Joseph E

2014-05-20

Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure (BP) control in hypertensive blacks who receive care in low-resource primary care practices. Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition (IC) or usual care (UC). Patients at the IC sites received patient education, home BP monitoring, and monthly lifestyle counseling, whereas physicians attended monthly hypertension case rounds and received feedback on their patients' home BP readings and chart audits. Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines, respectively. The primary outcome was BP control, and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months, assessed with an automated BP device. A total of 1059 patients (mean age, 56 years; 28% men, 59% obese, and 36% with diabetes mellitus) were enrolled. The BP control rate was similar in both groups (IC=49.3% versus UC=44.5%; odds ratio, 1.21 [95% confidence interval, 0.90-1.63]; P=0.21). In prespecified subgroup analyses, the intervention was associated with greater BP control in patients without diabetes mellitus (IC=54.0% versus UC=44.7%; odds ratio, 1.45 [confidence interval, 1.02-2.06]); and small-sized community health centers (IC=51.1% versus UC=39.6%; odds ratio, 1.45 [confidence interval, 1.04-2.45]). A practice-based, multicomponent intervention was no better than UC in improving BP control among hypertensive blacks. Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population. http://www.clinicaltrials.gov. Unique identifier: NCT00233220. © 2014 American Heart Association, Inc.

The Impact of Hotspot-Targeted Interventions on Malaria Transmission in Rachuonyo South District in the Western Kenyan Highlands: A Cluster-Randomized Controlled Trial

PubMed Central

Bradley, John; Knight, Philip; Stone, William; Osoti, Victor; Makori, Euniah; Owaga, Chrispin; Odongo, Wycliffe; China, Pauline; Shagari, Shehu; Doumbo, Ogobara K.; Sauerwein, Robert W.; Kariuki, Simon; Drakeley, Chris; Stevenson, Jennifer; Cox, Jonathan

2016-01-01

Background Malaria transmission is highly heterogeneous, generating malaria hotspots that can fuel malaria transmission across a wider area. Targeting hotspots may represent an efficacious strategy for reducing malaria transmission. We determined the impact of interventions targeted to serologically defined malaria hotspots on malaria transmission both inside hotspots and in surrounding communities. Methods and Findings Twenty-seven serologically defined malaria hotspots were detected in a survey conducted from 24 June to 31 July 2011 that included 17,503 individuals from 3,213 compounds in a 100-km2 area in Rachuonyo South District, Kenya. In a cluster-randomized trial from 22 March to 15 April 2012, we randomly allocated five clusters to hotspot-targeted interventions with larviciding, distribution of long-lasting insecticide-treated nets, indoor residual spraying, and focal mass drug administration (2,082 individuals in 432 compounds); five control clusters received malaria control following Kenyan national policy (2,468 individuals in 512 compounds). Our primary outcome measure was parasite prevalence in evaluation zones up to 500 m outside hotspots, determined by nested PCR (nPCR) at baseline and 8 wk (16 June–6 July 2012) and 16 wk (21 August–10 September 2012) post-intervention by technicians blinded to the intervention arm. Secondary outcome measures were parasite prevalence inside hotpots, parasite prevalence in the evaluation zone as a function of distance from the hotspot boundary, Anopheles mosquito density, mosquito breeding site productivity, malaria incidence by passive case detection, and the safety and acceptability of the interventions. Intervention coverage exceeded 87% for all interventions. Hotspot-targeted interventions did not result in a change in nPCR parasite prevalence outside hotspot boundaries (p ≥ 0.187). We observed an average reduction in nPCR parasite prevalence of 10.2% (95% CI −1.3 to 21.7%) inside hotspots 8 wk post-intervention that was statistically significant after adjustment for covariates (p = 0.024), but not 16 wk post-intervention (p = 0.265). We observed no statistically significant trend in the effect of the intervention on nPCR parasite prevalence in the evaluation zone in relation to distance from the hotspot boundary 8 wk (p = 0.27) or 16 wk post-intervention (p = 0.75). Thirty-six patients with clinical malaria confirmed by rapid diagnostic test could be located to intervention or control clusters, with no apparent difference between the study arms. In intervention clusters we caught an average of 1.14 female anophelines inside hotspots and 0.47 in evaluation zones; in control clusters we caught an average of 0.90 female anophelines inside hotspots and 0.50 in evaluation zones, with no apparent difference between study arms. Our trial was not powered to detect subtle effects of hotspot-targeted interventions nor designed to detect effects of interventions over multiple transmission seasons. Conclusions Despite high coverage, the impact of interventions targeting malaria vectors and human infections on nPCR parasite prevalence was modest, transient, and restricted to the targeted hotspot areas. Our findings suggest that transmission may not primarily occur from hotspots to the surrounding areas and that areas with highly heterogeneous but widespread malaria transmission may currently benefit most from an untargeted community-wide approach. Hotspot-targeted approaches may have more validity in settings where human settlement is more nuclear. Trial registration ClinicalTrials.gov NCT01575613 PMID:27071072

Occupational risk factors for Wilms' tumor

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bunin, G.; Kramer, S.; Nass, C.

A matched case-control study of Wilms' tumor investigated parental occupational risk factors. Cases diagnosed in 1970-1983 were identified through a population-based tumor registry and hospital registries in the Greater Philadelphia area. Controls were selected by random digit dialing and were matched to cases on race, birth date (+/- 3 years), and the area code and exchange of the case's telephone number at diagnosis. Parents of 100 matched pairs were interviewed by telephone. Parents of patients and controls were generally similar in demographic characteristics, except that mothers differed in religion. Published schemes were used to group jobs into clusters of similarmore » exposures and to determine exposures from industry and job title. Analyses were done for preconception, pregnancy, and postnatal time periods. More case than control fathers had jobs in a cluster that includes machinists and welders (odds ratios (ORs) = 4.0-5.7, p less than or equal to 0.04). Paternal exposures to lead, silver, tin, and iron (some exposures of this cluster) were associated with Wilms' tumor in some analyses, with moderate odds ratios (ORs = 1.5-3.4). In general, the highest odds ratios were found for the preconception period among the genetic (prezygotic) cases. No maternal job clusters or exposures gave significantly elevated odds ratios. These results support a previous finding that lead is a risk factor, but not radiation, hydrocarbon, or boron exposures.« less

Structure and Dynamics Ionic Block co-Polymer Melts: Computational Study

NASA Astrophysics Data System (ADS)

Aryal, Dipak; Perahia, Dvora; Grest, Gary S.

Tethering ionomer blocks into co-polymers enables engineering of polymeric systems designed to encompass transport while controlling structure. Here the structure and dynamics of symmetric pentablock copolymers melts are probed by fully atomistic molecular dynamics simulations. The center block consists of randomly sulfonated polystyrene with sulfonation fractions f = 0 to 0.55 tethered to a hydrogenated polyisoprene (PI), end caped with poly(t-butyl styrene). We find that melts with f = 0.15 and 0.30 consist of isolated ionic clusters whereas melts with f = 0.55 exhibit a long-range percolating ionic network. Similar to polystyrene sulfonate, a small number of ionic clusters slow the mobility of the center of mass of the co-polymer, however, formation of the ionic clusters is slower and they are often intertwined with PI segments. Surprisingly, the segmental dynamics of the other blocks are also affected. NSF DMR-1611136; NERSC; Palmetto Cluster Clemson University; Kraton Polymers US, LLC.

Who are the healthy active seniors? A cluster analysis.

PubMed

Lai, Claudia K Y; Chan, Engle Angela; Chin, Kenny C W

2014-12-01

This paper reports a cluster analysis of a sample recruited from a randomized controlled trial that explored the effect of using a life story work approach to improve the psychological outcomes of older people in the community. 238 subjects from community centers were included in this analysis. After statistical testing, 169 seniors were assigned to the active ageing (AG) cluster and 69 to the inactive ageing (IG) cluster. Those in the AG were younger and healthier, with fewer chronic diseases and fewer depressive symptoms than those in the IG. They were more satisfied with their lives, and had higher self-esteem. They met with their family members more frequently, they engaged in more leisure activities and were more likely to have the ability to move freely. In summary, active ageing was observed in people with better health and functional performance. Our results echoed the limited findings reported in the literature.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ben-Naim, Eli; Krapivsky, Paul

Here we generalize the ordinary aggregation process to allow for choice. In ordinary aggregation, two random clusters merge and form a larger aggregate. In our implementation of choice, a target cluster and two candidate clusters are randomly selected and the target cluster merges with the larger of the two candidate clusters.We study the long-time asymptotic behavior and find that as in ordinary aggregation, the size density adheres to the standard scaling form. However, aggregation with choice exhibits a number of different features. First, the density of the smallest clusters exhibits anomalous scaling. Second, both the small-size and the large-size tailsmore » of the density are overpopulated, at the expense of the density of moderate-size clusters. Finally, we also study the complementary case where the smaller candidate cluster participates in the aggregation process and find an abundance of moderate clusters at the expense of small and large clusters. Additionally, we investigate aggregation processes with choice among multiple candidate clusters and a symmetric implementation where the choice is between two pairs of clusters.« less

Functional Principal Component Analysis and Randomized Sparse Clustering Algorithm for Medical Image Analysis

PubMed Central

Lin, Nan; Jiang, Junhai; Guo, Shicheng; Xiong, Momiao

2015-01-01

Due to the advancement in sensor technology, the growing large medical image data have the ability to visualize the anatomical changes in biological tissues. As a consequence, the medical images have the potential to enhance the diagnosis of disease, the prediction of clinical outcomes and the characterization of disease progression. But in the meantime, the growing data dimensions pose great methodological and computational challenges for the representation and selection of features in image cluster analysis. To address these challenges, we first extend the functional principal component analysis (FPCA) from one dimension to two dimensions to fully capture the space variation of image the signals. The image signals contain a large number of redundant features which provide no additional information for clustering analysis. The widely used methods for removing the irrelevant features are sparse clustering algorithms using a lasso-type penalty to select the features. However, the accuracy of clustering using a lasso-type penalty depends on the selection of the penalty parameters and the threshold value. In practice, they are difficult to determine. Recently, randomized algorithms have received a great deal of attentions in big data analysis. This paper presents a randomized algorithm for accurate feature selection in image clustering analysis. The proposed method is applied to both the liver and kidney cancer histology image data from the TCGA database. The results demonstrate that the randomized feature selection method coupled with functional principal component analysis substantially outperforms the current sparse clustering algorithms in image cluster analysis. PMID:26196383

Citywide cluster randomized trial to restore blighted vacant land and its effects on violence, crime, and fear

PubMed Central

Branas, Charles C.; South, Eugenia; Kondo, Michelle C.; Hohl, Bernadette C.; Bourgois, Philippe; Wiebe, Douglas J.; MacDonald, John M.

2018-01-01

Vacant and blighted urban land is a widespread and potentially risky environmental condition encountered by millions of people on a daily basis. About 15% of the land in US cities is deemed vacant or abandoned, an area roughly the size of Switzerland. In a citywide cluster randomized controlled trial, we investigated the effects of standardized, reproducible interventions that restore vacant land on the commission of violence, crime, and the perceptions of fear and safety. Quantitative and ethnographic analyses were included in a mixed-methods approach to more fully test and explicate our findings. A total of 541 randomly sampled vacant lots were randomly assigned into treatment and control study arms; outcomes from police and 445 randomly sampled participants were analyzed over a 38-month study period. Participants living near treated vacant lots reported significantly reduced perceptions of crime (−36.8%, P < 0.05), vandalism (−39.3%, P < 0.05), and safety concerns when going outside their homes (−57.8%, P < 0.05), as well as significantly increased use of outside spaces for relaxing and socializing (75.7%, P < 0.01). Significant reductions in crime overall (−13.3%, P < 0.01), gun violence (−29.1%, P < 0.001), burglary (−21.9%, P < 0.001), and nuisances (−30.3%, P < 0.05) were also found after the treatment of vacant lots in neighborhoods below the poverty line. Blighted and vacant urban land affects people’s perceptions of safety, and their actual, physical safety. Restoration of this land can be an effective and scalable infrastructure intervention for gun violence, crime, and fear in urban neighborhoods. PMID:29483246

Multilevel Multidimensional Item Response Model with a Multilevel Latent Covariate

ERIC Educational Resources Information Center

Cho, Sun-Joo; Bottge, Brian A.

2015-01-01

In a pretest-posttest cluster-randomized trial, one of the methods commonly used to detect an intervention effect involves controlling pre-test scores and other related covariates while estimating an intervention effect at post-test. In many applications in education, the total post-test and pre-test scores that ignores measurement error in the…

Alcohol Prevention and School Students: Findings from an Australian 2-Year Trial of Integrated Harm Minimization School Drug Education

ERIC Educational Resources Information Center

Midford, Richard; Ramsden, Robyn; Lester, Leanne; Cahill, Helen; Mitchell, Johanna; Foxcroft, David R.; Venning, Lynne

2014-01-01

The Drug Education in Victorian Schools program provided integrated education about licit and illicit drugs, employed a harm minimization approach that incorporated participatory, critical thinking and skill-based teaching methods, and engaged parental influence through home activities. A cluster-randomized, controlled trial of the program was…

Short Intervention, Sustained Effects: Promoting Students' Math Competence Beliefs, Effort, and Achievement

ERIC Educational Resources Information Center

Brisson, Brigitte Maria; Dicke, Anna-Lena; Gaspard, Hanna; Häfner, Isabelle; Flunger, Barbara; Nagengast, Benjamin; Trautwein, Ulrich

2017-01-01

The present study investigated the effectiveness of two short relevance interventions (writing a text or evaluating quotations about the utility of mathematics) using a sample of 1,916 students in 82 math classrooms in a cluster randomized controlled experiment. Short-term and sustained effects (6 weeks and 5 months after the intervention) of the…

Enhancing Self-Determination in Health: Results of an RCT of the Ask Project, a School-Based Intervention for Adolescents with Intellectual Disability

ERIC Educational Resources Information Center

McPherson, Lyn; Ware, Robert S.; Carrington, Suzanne; Lennox, Nicholas

2017-01-01

Background: Adolescents with intellectual disability have high levels of unrecognized disease and inadequate health screening/promotion which might be addressed by improving health advocacy skills. Methods: A parallel-group cluster randomized controlled trial was conducted to investigate whether a health intervention package, consisting of…

The Impact of Speedometry on Student Knowledge, Interest, and Emotions

ERIC Educational Resources Information Center

Polikoff, Morgan; Le, Q. Tien; Danielson, Robert W.; Sinatra, Gale M.; Marsh, Julie A.

2018-01-01

Given the dearth of high-quality curriculum materials aligned with the new standards (NGSS and CCSS) and low student persistence in STEM fields, we sought to develop and test a STEM curriculum that would improve student knowledge, interest, and emotions. A cluster randomized control trial was conducted to assess the impact of Speedometry, a…

Effects of the "Positive Action" Program on Indicators of Positive Youth Development among Urban Youth

ERIC Educational Resources Information Center

Lewis, Kendra M.; Vuchinich, Samuel; Ji, Peter; DuBois, David L.; Acock, Alan; Bavarian, Niloofar; Day, Joseph; Silverthorn, Naida; Flay, Brian R.

2016-01-01

This study evaluated effects of "Positive Action," a school-based social-emotional and character development intervention, on indicators of positive youth development (PYD) among a sample of low-income, ethnic minority youth attending 14 urban schools. The study used a matched-pair, cluster-randomized controlled design at the school…

Postdeployment Battlemind Training for the U.K. Armed Forces: A Cluster Randomized Controlled Trial

ERIC Educational Resources Information Center

Mulligan, Kathleen; Fear, Nicola T.; Jones, Norman; Alvarez, Helen; Hull, Lisa; Naumann, Ulrike; Wessely, Simon; Greenberg, Neil

2012-01-01

Objective: Combat exposure can increase the risk of subsequent psychological ill-health in armed forces (AF) personnel. A U.S. postdeployment psycho-educational intervention, Battlemind, showed a beneficial effect on mental health in U.S. military personnel exposed to high combat levels. We evaluated the effectiveness of an anglicized version of…

A Statistical Model for Misreported Binary Outcomes in Clustered RCTs of Education Interventions

ERIC Educational Resources Information Center

Schochet, Peter Z.

2013-01-01

In education randomized control trials (RCTs), the misreporting of student outcome data could lead to biased estimates of average treatment effects (ATEs) and their standard errors. This article discusses a statistical model that adjusts for misreported binary outcomes for two-level, school-based RCTs, where it is assumed that misreporting could…

Twelve-Month Effects of the COPE Healthy Lifestyles TEEN Program on Overweight and Depressive Symptoms in High School Adolescents

ERIC Educational Resources Information Center

Melnyk, Bernadette M.; Jacobson, Diana; Kelly, Stephanie A.; Belyea, Michael J.; Shaibi, Gabriel Q.; Small, Leigh; O'Haver, Judith A.; Marsiglia, Flavio F.

2015-01-01

Background: We evaluated the 12-month effects of the COPE (Creating Opportunities for Personal Empowerment) Healthy Lifestyles TEEN (Thinking, Emotions, Exercise, Nutrition) program versus an attention control program (Healthy Teens) on overweight/obesity and depressive symptoms in high school adolescents. Methods: A cluster randomized controlled…

75 FR 79008 - Proposed Collection; Comment Request; Study of Substance Abuse doc.com Module Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-17

... is a request for a two-year generic clearance to a conduct research study to assess the efficacy of a... provide significant services directly to the public to survey customers to determine the kind and quality... utilize a randomized cluster controlled trial design that compares the group that receives educational...

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

PubMed

Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

2017-04-01

Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

The HOPE social media intervention for global HIV prevention in Peru: a cluster randomised controlled trial.

PubMed

Young, Sean D; Cumberland, William G; Nianogo, Roch; Menacho, Luis A; Galea, Jerome T; Coates, Thomas

2015-01-01

Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted odds ratio 2·61, 95% CI 1·55–4·38). No adverse events were reported. Development of peer-mentored social media communities seemed to be an efficacious method to increase HIV testing among high-risk populations in Peru. Results suggest that the HOPE social media intervention could improve HIV testing rates among MSM in Peru. National Institute of Mental Health.

Findings from the SASA! Study: a cluster randomized controlled trial to assess the impact of a community mobilization intervention to prevent violence against women and reduce HIV risk in Kampala, Uganda.

PubMed

Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Nakuti, Janet; Kyegombe, Nambusi; Starmann, Elizabeth; Cundill, Bonnie; Francisco, Leilani; Kaye, Dan; Musuya, Tina; Michau, Lori; Watts, Charlotte

2014-07-31

Intimate partner violence (IPV) and HIV are important and interconnected public health concerns. While it is recognized that they share common social drivers, there is limited evidence surrounding the potential of community interventions to reduce violence and HIV risk at the community level. The SASA! study assessed the community-level impact of SASA!, a community mobilization intervention to prevent violence and reduce HIV-risk behaviors. From 2007 to 2012 a pair-matched cluster randomized controlled trial (CRT) was conducted in eight communities (four intervention and four control) in Kampala, Uganda. Cross-sectional surveys of a random sample of community members, 18- to 49-years old, were undertaken at baseline (n = 1,583) and four years post intervention implementation (n = 2,532). Six violence and HIV-related primary outcomes were defined a priori. An adjusted cluster-level intention-to-treat analysis compared outcomes in intervention and control communities at follow-up. The intervention was associated with significantly lower social acceptance of IPV among women (adjusted risk ratio 0.54, 95% confidence interval (CI) 0.38 to 0.79) and lower acceptance among men (0.13, 95% CI 0.01 to 1.15); significantly greater acceptance that a woman can refuse sex among women (1.28, 95% CI 1.07 to 1.52) and men (1.31, 95% CI 1.00 to 1.70); 52% lower past year experience of physical IPV among women (0.48, 95% CI 0.16 to 1.39); and lower levels of past year experience of sexual IPV (0.76, 95% CI 0.33 to 1.72). Women experiencing violence in intervention communities were more likely to receive supportive community responses. Reported past year sexual concurrency by men was significantly lower in intervention compared to control communities (0.57, 95% CI 0.36 to 0.91). This is the first CRT in sub-Saharan Africa to assess the community impact of a mobilization program on the social acceptability of IPV, the past year prevalence of IPV and levels of sexual concurrency. SASA! achieved important community impacts, and is now being delivered in control communities and replicated in 15 countries. ClinicalTrials.gov #NCT00790959.

"Together at school"--a school-based intervention program to promote socio-emotional skills and mental health in children: study protocol for a cluster randomized controlled trial.

PubMed

Björklund, Katja; Liski, Antti; Samposalo, Hanna; Lindblom, Jallu; Hella, Juho; Huhtinen, Heini; Ojala, Tiina; Alasuvanto, Paula; Koskinen, Hanna-Leena; Kiviruusu, Olli; Hemminki, Elina; Punamäki, Raija-Leena; Sund, Reijo; Solantaus, Tytti; Santalahti, Päivi

2014-10-07

Schools provide a natural context to promote children's mental health. However, there is a need for more evidence-based, high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods. The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the "Together at School" intervention program. The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum, work environment of school staff, and parent-teacher collaboration methods. The evaluation study examines the effects of the intervention on children's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1) an intervention group and 2) an active control group. Altogether 79 primary school participated at baseline. A multi-informant setting involves the children themselves, their parents, and teachers. The primary outcomes are measured using parent and teacher ratings of children's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale. Secondary outcomes for the children include emotional understanding, altruistic behavior, and executive functions (e.g. working memory, planning, and inhibition). Secondary outcomes for the teachers include ratings of e.g. school environment, teaching style and well-being. Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy, child rearing practices, and teacher-parent collaboration. The data was collected at baseline (autumn 2013), 6 months after baseline, and will be collected also 18 months after baseline from the same participants. This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a contextually developed and carefully tested intervention program which is tailored to fit a national school system. Identification of effective intervention elements to promote children's mental health in early school years is crucial for optimal later development. ClinicalTrials.gov register: NCT02178332.

EHLS at School: school-age follow-up of the Early Home Learning Study cluster randomized controlled trial.

PubMed

Westrupp, Elizabeth M; Bennett, Clair; Cullinane, Meabh; Hackworth, Naomi J; Berthelsen, Donna; Reilly, Sheena; Mensah, Fiona K; Gold, Lisa; Bennetts, Shannon K; Levickis, Penny; Nicholson, Jan M

2018-05-02

Targeted interventions during early childhood can assist families in providing strong foundations that promote children's health and wellbeing across the life course. There is growing recognition that longer follow-up times are necessary to assess intervention outcomes, as effects may change as children develop. The Early Home Learning Study, or 'EHLS', comprised two cluster randomized controlled superiority trials of a brief parenting intervention, smalltalk, aimed at supporting parents to strengthen the early childhood home learning environment of infants (6-12 months) or toddlers (12-36 months). Results showed sustained improvements in parent-child interactions and the home environment at the 32 week follow-up for the toddler but not the infant trial. The current study will therefore follow up the EHLS toddler cohort to primary school age, with the aim of addressing a gap in literature concerning long-term effects of early childhood interventions focused on improving school readiness and later developmental outcomes. 'EHLS at School' is a school-aged follow-up study of the toddler cluster randomized controlled trial (n = 1226). Data will be collected by parent-, child- and teacher-report questionnaires, recorded observations of parent-child interactions, and direct child assessment when children are aged 7.5 years old. Data linkage will provide additional data on child health and academic functioning at ages 5, 8 and 10 years. Child outcomes will be compared for families allocated to standard/usual care (control) versus those allocated to the smalltalk program (group program only or group program with additional home coaching). Findings from The Early Home Learning Study provided evidence of the benefits of the smalltalk intervention delivered via facilitated playgroups for parents of toddlers. The EHLS at School Study aims to examine the long-term outcomes of this initiative to determine whether improvements in the quality of the parent-child relationship persist over time and translate into benefits for children's social, academic and behavioral skills that last into the school years. 8 September 2011; ACTRN12611000965909 (for the original EHLS).

A hand hygiene intervention to decrease infections among children attending day care centers: design of a cluster randomized controlled trial.

PubMed

Zomer, Tizza P; Erasmus, Vicki; Vlaar, Nico; van Beeck, Ed F; Tjon-A-Tsien, Aimée; Richardus, Jan Hendrik; Voeten, Hélène A C M

2013-06-03

Day care center attendance has been recognized as a risk factor for acquiring gastrointestinal and respiratory infections, which can be prevented with adequate hand hygiene (HH). Based on previous studies on environmental and sociocognitive determinants of caregivers' compliance with HH guidelines in day care centers (DCCs), an intervention has been developed aiming to improve caregivers' and children's HH compliance and decrease infections among children attending DCCs. The aim of this paper is to describe the design of a cluster randomized controlled trial to evaluate the effectiveness of this intervention. The intervention will be evaluated in a two-arm cluster randomized controlled trial among 71 DCCs in the Netherlands. In total, 36 DCCs will receive the intervention consisting of four components: 1) HH products (dispensers and refills for paper towels, soap, alcohol-based hand sanitizer, and hand cream); 2) training to educate about the Dutch national HH guidelines; 3) two team training sessions aimed at goal setting and formulating specific HH improvement activities; and 4) reminders and cues to action (posters/stickers). Intervention DCCs will be compared to 35 control DCCs continuing usual practice. The primary outcome measure will be observed HH compliance of caregivers and children, measured at baseline and one, three, and six months after start of the intervention. The secondary outcome measure will be the incidence of gastrointestinal and respiratory infections in 600 children attending DCCs, monitored over six months by parents using a calendar to mark the days their child has diarrhea and/or a cold. Multilevel logistic regression will be performed to assess the effect of the intervention on HH compliance. Multilevel poisson regression will be performed to assess the incidence of gastrointestinal and respiratory infections in children attending DCCs. This is one of the first DCC intervention studies to assess HH compliance of both caregivers and children, as well as the incidence of gastrointestinal and respiratory infections in children, as outcome measures. When an effect of the intervention on improving HH compliance and/or reducing incidence of infections is shown, (inter)national dissemination of the intervention in other DCCs may be considered. Netherlands trial registry: NTR3000.

Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial.

PubMed

Yan, Lijing L; Fang, Weigang; Delong, Elizabeth; Neal, Bruce; Peterson, Eric D; Huang, Yining; Sun, Ningling; Yao, Chen; Li, Xian; MacMahon, Stephen; Wu, Yangfeng

2014-04-11

The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China. The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, will be assigned to either intervention (60 villages) or control (60 villages). Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify, treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village. The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years. We will draw two different (independent) random samples, before and after the intervention, 20 men aged≥50 years and 20 women aged≥60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level. The primary outcome will be the pre-post difference in mean systolic blood pressure, analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect. Secondary outcomes will include monthly clinic visits, provision of lifestyle advice, use of antihypertensive medications and use of aspirin. Process and economic evaluations will also be conducted. This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease. The results are expected to provide important information (effectiveness, cost-effectiveness, feasibility and acceptability) to guide policy making for rural China as well as other resource-limited countries. The trial is registered at ClinicalTrials.gov (NCT01259700). Date of initial registration is December 13, 2010.

Nutrition education improves dietary diversity of children 6-23 months at community-level: Results from a cluster randomized controlled trial in Malawi

PubMed Central

Kuchenbecker, Judith; Reinbott, Anika; Mtimuni, Beatrice; Krawinkel, Michael B.

2017-01-01

Background: Low dietary quality and quantity and inappropriate feeding practices can cause undernutrition. Poor nutritional status in early childhood is associated with growth faltering. The objective of the study was to assess the potential of community-based nutrition education to improve height-for-age z-scores in children 6–23 months of age. Methods and Findings: We carried out a cluster-randomized-controlled trial to assess the effectiveness of nutrition education. A total of 24 Extension Planning Area Sections served as clusters. The selection criteria were: the position of the extension officer was staffed and the sections had been selected by the project for activities in its first project year. The sections were randomized into intervention and control restricted on mean height for age Z-score using baseline information. In the intervention area, food security activities and community-based nutrition education was implemented. The control area received food security activities only. At baseline (2011) and endline (2014), caregivers with a child below two years of age were enrolled. Data assessment included anthropometric measurements, interviews on socio-economic status, dietary intake and feeding practices. A difference-in-differences estimator was used to calculate intervention effects. A positive impact on child dietary diversity was observed (B (SE) = 0.39 (0.15), p = 0.01; 95%CI 0.09–0.68). There was a non-significant positive intervention effect on mean height-for-age z-scores (B (SE) = 0.17 (0.12), p = 0.15; 95%CI -0.06–0.41). Limitations: The 24h dietary recalls used to measure dietary diversity did not consider quantities of consumed foods. Unrecorded poor quality of consumed foods might have masked a potential benefit of increased child dietary diversity on growth. Conclusions: Participatory community-based nutrition education for caregivers improved child dietary diversity even in a food insecure area. Nutrition education should be part of programs in food insecure settings aiming at ameliorating food insecurity among communities. PMID:28426678

Propensity score matching with clustered data. An application to the estimation of the impact of caesarean section on the Apgar score.

PubMed

Arpino, Bruno; Cannas, Massimo

2016-05-30

This article focuses on the implementation of propensity score matching for clustered data. Different approaches to reduce bias due to cluster-level confounders are considered and compared using Monte Carlo simulations. We investigated methods that exploit the clustered structure of the data in two ways: in the estimation of the propensity score model (through the inclusion of fixed or random effects) or in the implementation of the matching algorithm. In addition to a pure within-cluster matching, we also assessed the performance of a new approach, 'preferential' within-cluster matching. This approach first searches for control units to be matched to treated units within the same cluster. If matching is not possible within-cluster, then the algorithm searches in other clusters. All considered approaches successfully reduced the bias due to the omission of a cluster-level confounder. The preferential within-cluster matching approach, combining the advantages of within-cluster and between-cluster matching, showed a relatively good performance both in the presence of big and small clusters, and it was often the best method. An important advantage of this approach is that it reduces the number of unmatched units as compared with a pure within-cluster matching. We applied these methods to the estimation of the effect of caesarean section on the Apgar score using birth register data. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Internal Cluster Validation on Earthquake Data in the Province of Bengkulu

NASA Astrophysics Data System (ADS)

Rini, D. S.; Novianti, P.; Fransiska, H.

2018-04-01

K-means method is an algorithm for cluster n object based on attribute to k partition, where k < n. There is a deficiency of algorithms that is before the algorithm is executed, k points are initialized randomly so that the resulting data clustering can be different. If the random value for initialization is not good, the clustering becomes less optimum. Cluster validation is a technique to determine the optimum cluster without knowing prior information from data. There are two types of cluster validation, which are internal cluster validation and external cluster validation. This study aims to examine and apply some internal cluster validation, including the Calinski-Harabasz (CH) Index, Sillhouette (S) Index, Davies-Bouldin (DB) Index, Dunn Index (D), and S-Dbw Index on earthquake data in the Bengkulu Province. The calculation result of optimum cluster based on internal cluster validation is CH index, S index, and S-Dbw index yield k = 2, DB Index with k = 6 and Index D with k = 15. Optimum cluster (k = 6) based on DB Index gives good results for clustering earthquake in the Bengkulu Province.

A cluster randomized-controlled trial of a classroom-based drama workshop program to improve mental health outcomes among immigrant and refugee youth in special classes.

PubMed

Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

2014-01-01

The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences in the observed impact of the theatre intervention. ClinicalTrials.gov NCT01426451.

A Cluster Randomized-Controlled Trial of a Classroom-Based Drama Workshop Program to Improve Mental Health Outcomes among Immigrant and Refugee Youth in Special Classes

PubMed Central

Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D.; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

2014-01-01

Objectives The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Methods Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. Results The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. Conclusion The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences in the observed impact of the theatre intervention. Trial Registration ClinicalTrials.gov NCT01426451 PMID:25127251

Unannounced versus announced hospital surveys: a nationwide cluster-randomized controlled trial.

PubMed

Ehlers, Lars Holger; Simonsen, Katherina Beltoft; Jensen, Morten Berg; Rasmussen, Gitte Sand; Olesen, Anne Vingaard

2017-06-01

To evaluate the effectiveness of unannounced versus announced surveys in detecting non-compliance with accreditation standards in public hospitals. A nationwide cluster-randomized controlled trial. All public hospitals in Denmark were invited. Twenty-three hospitals (77%) (3 university hospitals, 5 psychiatric hospitals and 15 general hospitals) agreed to participate. Twelve hospitals were randomized to receive unannounced surveys (intervention group) and eleven hospitals to receive announced surveys (control group). We hypothesized that the hospitals receiving the unannounced surveys would reveal a higher degree of non-compliance with accreditation standards than the hospitals receiving announced surveys. Nine surveyors trained and employed by the Danish Institute for Quality and Accreditation in Healthcare (IKAS) were randomized into teams and conducted all surveys. The outcome was the surveyors' assessment of the hospitals' level of compliance with 113 performance indicators-an abbreviated set of the Danish Healthcare Quality Programme (DDKM) version 2, covering organizational standards, patient pathway standards and patient safety standards. Compliance with performance indicators was analyzed using binomial regression analysis with bootstrapped robust standard errors. In all, 16 202 measurements were acceptable for data analysis. The risk of observing non-compliance with performance indicators for the intervention group compared with the control group was statistically insignificant (risk difference (RD) = -0.6 percentage points [-2.51-1.31], P = 0.54). A converged analysis of the six patient safety critical standards, requiring 100% compliance to gain accreditation status revealed no statistically significant difference (RD = -0.78 percentage points [-4.01-2.44], P = 0.99). Unannounced hospital surveys were not more effective than announced surveys in detecting quality problems in Danish hospitals. ClinicalTrials.gov NCT02348567, https://clinicaltrials.gov/ct2/show/NCT02348567?term=NCT02348567. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

Clustering of haemostatic variables and the effect of high cashew and walnut diets on these variables in metabolic syndrome patients.

PubMed

Pieters, Marlien; Oosthuizen, Welma; Jerling, Johann C; Loots, Du Toit; Mukuddem-Petersen, Janine; Hanekom, Susanna M

2005-09-01

We investigated the effect of a high walnut and cashew diet on haemostatic variables in people with the metabolic syndrome. Factor analysis was used to determine how the haemostatic variables cluster with other components of the metabolic syndrome and multiple regression to determine possible predictors. This randomized, control, parallel, controlled-feeding trial included 68 subjects who complied with the Third National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol criteria. After a 3-week run-in following the control diet, subjects were divided into three groups receiving either walnuts or cashews (20 energy%) or a control diet for 8 weeks. The nut intervention had no significant effect on von Willebrand factor antigen, fibrinogen, factor VII coagulant activity, plasminogen activator inhibitor 1 activity, tissue plasminogen activator activity or thrombin activatable fibrinolysis inhibitor. Statistically, fibrinogen clustered with the body-mass-correlates and acute phase response factors, and factor VII coagulant activity clustered with high-density lipoprotein cholesterol (HDL-C). Tissue plasminogen activator activity, plasminogen activator inhibitor 1 activity and von Willebrand factor antigen clustered into a separate endothelial function factor. HDL-C and markers of obesity were the strongest predictors of the haemostatic variables. We conclude that high walnut and cashew diets did not influence haemostatic factors in this group of metabolic syndrome subjects. The HDL-C increase and weight loss may be the main focus of dietary intervention for the metabolic syndrome. Furthermore, diet composition may have only limited effects if weight loss is not achieved.

Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study).

PubMed

Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex

2014-06-11

There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD). Two trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis. We obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration. Cluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for research governance approval and intervention implementation. Pretrial data analyses should inform trial design and analysis plans. Current Controlled Trials ISRCTN 47558792 and ISRCTN 35701810 (both registered on 17 March 2010).

Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)

PubMed Central

2014-01-01

Background There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD). Methods Two trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis. Results We obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration. Conclusions Cluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for research governance approval and intervention implementation. Pretrial data analyses should inform trial design and analysis plans. Trial registration Current Controlled Trials ISRCTN 47558792 and ISRCTN 35701810 (both registered on 17 March 2010). PMID:24919485

Cost-effectiveness of a long-term Internet-delivered worksite health promotion programme on physical activity and nutrition: a cluster randomized controlled trial

PubMed Central

Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

2012-01-01

This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a standard programme consisting of a physical health check with face-to-face advice and personal feedback on a website. The intervention consisted of several additional website functionalities: action-oriented feedback, self-monitoring, possibility to ask questions and monthly e-mail messages. Primary outcomes were meeting the guidelines for PA and fruit and vegetable intake. Secondary outcomes were self-perceived health, obesity, elevated blood pressure, elevated cholesterol level and maximum oxygen uptake. Direct and indirect costs were calculated from a societal perspective, and a process evaluation was performed. Of the 924 participants, 72% participated in the first and 60% in the second follow-up. No statistically significant differences were found on primary and secondary outcomes, nor on costs. Average direct costs per participant over the 2-year period were €376, and average indirect costs were €9476. In conclusion, no additional benefits were found in effects or cost savings. Therefore, the programme in its current form cannot be recommended for implementation. PMID:22350194

Primary care guidelines on consultation practices: the effectiveness of computerized versus paper-based versions. A cluster randomized controlled trial among newly qualified primary care physicians.

PubMed

Jousimaa, Jukkapekka; Mäkelä, Marjukka; Kunnamo, Ilkka; MacLennan, Graeme; Grimshaw, Jeremy M

2002-01-01

To compare the effects of computerized and paper-based versions of guidelines on recently qualified physicians' consultation practices. Two arm cluster randomized controlled trial. Physicians were randomized to receive computerized or textbook-based versions of the same guidelines for a 4-week study period. Physicians' compliance with guideline recommendations about laboratory, radiological, physical and other examinations, procedures, nonpharmacologic and pharmacologic treatments, physiotherapy, and referrals were measured by case note review. There were 139 recently qualified physicians working in 96 primary healthcare centers in Finland who participated in the study. Data on 4,633 patient encounters were abstracted, of which 3,484 were suitable for further analysis. Physicians' compliance with guidelines was high (over 80% for use of laboratory, radiology, physical examinations, and referrals). There were no significant differences in physicians' consultation practices in any of the measured outcomes between the computerized and textbook group. Guidelines are a useful source of information for recently qualified physicians working in primary care. However, the method of presentation of the guidelines (electronic or paper) does not have an effect on guideline use or their impact on decisions. Other factors should be considered when choosing the method of presentation of guidelines, such as information-seeking time, ease of use during the consultation, ability to update, production costs, and the physician's own preferences.

Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial

PubMed Central

Rocca, Corinne H.; Kohn, Julia E.; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J. Joseph; Darney, Philip D.; Harper, Cynthia C.

2016-01-01

Objectives. We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. Methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011–2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Results. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Conclusions. Public funding and provider training substantially improve LARC access. PMID:26794168

A study to evaluate the acceptability, feasibility and impact of packaged interventions ("Diarrhea Pack") for prevention and treatment of childhood diarrhea in rural Pakistan.

PubMed

Habib, Muhammad Atif; Soofi, Sajid; Sadiq, Kamran; Samejo, Tariq; Hussain, Musawar; Mirani, Mushtaq; Rehmatullah, Asmatullah; Ahmed, Imran; Bhutta, Zulfiqar A

2013-10-03

Diarrhea remains one of the leading public health issues in developing countries and is a major contributor in morbidity and mortality in children under five years of age. Interventions such as ORS, Zinc, water purification and improved hygiene and sanitation can significantly reduce the diarrhea burden but their coverage remains low and has not been tested as packaged intervention before. This study attempts to evaluate the package of evidence based interventions in a "Diarrhea Pack" through first level health care providers at domiciliary level in community based settings. This study sought to evaluate the acceptability, feasibility and impact of diarrhea Pack on diarrhea burden. A cluster randomized design was used to evaluate the objectives of the project a union council was considered as a cluster for analysis, a total of eight clusters, four in intervention and four in control were included in the study. We conducted a baseline survey in all clusters followed by the delivery of diarrhea Pack in intervention clusters through community health workers at domiciliary level and through sales promoters to health care providers and pharmacies. Four quarterly surveillance rounds were conducted to evaluate the impact of diarrhea pack in all clusters by an independent team of Field workers. Both the intervention and control clusters were similar at the baseline but as the study progress we found a significant increase in uptake of ORS and Zinc along with the reduction in antibiotic use, diarrhea burden and hospitalization in intervention clusters when compared with the control clusters. We found that the Diarrhea Pack was well accepted with all of its components in the community. The intervention was well accepted and had a productive impact on the uptake of ORS and zinc and reduction in the use of antibiotics. It is feasible to deliver interventions such as diarrhea pack through community health workers in community settings. The intervention has the potential to be scaled up at national level.

Mapping Health Data: Improved Privacy Protection With Donut Method Geomasking

PubMed Central

Hampton, Kristen H.; Fitch, Molly K.; Allshouse, William B.; Doherty, Irene A.; Gesink, Dionne C.; Leone, Peter A.; Serre, Marc L.; Miller, William C.

2010-01-01

A major challenge in mapping health data is protecting patient privacy while maintaining the spatial resolution necessary for spatial surveillance and outbreak identification. A new adaptive geomasking technique, referred to as the donut method, extends current methods of random displacement by ensuring a user-defined minimum level of geoprivacy. In donut method geomasking, each geocoded address is relocated in a random direction by at least a minimum distance, but less than a maximum distance. The authors compared the donut method with current methods of random perturbation and aggregation regarding measures of privacy protection and cluster detection performance by masking multiple disease field simulations under a range of parameters. Both the donut method and random perturbation performed better than aggregation in cluster detection measures. The performance of the donut method in geoprivacy measures was at least 42.7% higher and in cluster detection measures was less than 4.8% lower than that of random perturbation. Results show that the donut method provides a consistently higher level of privacy protection with a minimal decrease in cluster detection performance, especially in areas where the risk to individual geoprivacy is greatest. PMID:20817785

Mapping health data: improved privacy protection with donut method geomasking.

PubMed

Hampton, Kristen H; Fitch, Molly K; Allshouse, William B; Doherty, Irene A; Gesink, Dionne C; Leone, Peter A; Serre, Marc L; Miller, William C

2010-11-01

A major challenge in mapping health data is protecting patient privacy while maintaining the spatial resolution necessary for spatial surveillance and outbreak identification. A new adaptive geomasking technique, referred to as the donut method, extends current methods of random displacement by ensuring a user-defined minimum level of geoprivacy. In donut method geomasking, each geocoded address is relocated in a random direction by at least a minimum distance, but less than a maximum distance. The authors compared the donut method with current methods of random perturbation and aggregation regarding measures of privacy protection and cluster detection performance by masking multiple disease field simulations under a range of parameters. Both the donut method and random perturbation performed better than aggregation in cluster detection measures. The performance of the donut method in geoprivacy measures was at least 42.7% higher and in cluster detection measures was less than 4.8% lower than that of random perturbation. Results show that the donut method provides a consistently higher level of privacy protection with a minimal decrease in cluster detection performance, especially in areas where the risk to individual geoprivacy is greatest.

Preventing Depression in Final Year Secondary Students: School-Based Randomized Controlled Trial

PubMed Central

Perry, Yael; Werner-Seidler, Aliza; Calear, Alison; Mackinnon, Andrew; King, Catherine; Scott, Jan; Merry, Sally; Fleming, Theresa; Stasiak, Karolina; Batterham, Philip J

2017-01-01

Background Depression often emerges for the first time during adolescence. There is accumulating evidence that universal depression prevention programs may have the capacity to reduce the impact of depression when delivered in the school environment. Objective This trial investigated the effectiveness of SPARX-R, a gamified online cognitive behavior therapy intervention for the prevention of depression relative to an attention-matched control intervention delivered to students prior to facing a significant stressor—final secondary school exams. It was hypothesized that delivering a prevention intervention in advance of a stressor would reduce depressive symptoms relative to the control group. Methods A cluster randomized controlled trial was conducted in 10 government schools in Sydney, Australia. Participants were 540 final year secondary students (mean 16.7 [SD 0.51] years), and clusters at the school level were randomly allocated to SPARX-R or the control intervention. Interventions were delivered weekly in 7 modules, each taking approximately 20 to 30 minutes to complete. The primary outcome was symptoms of depression as measured by the Major Depression Inventory. Intention-to-treat analyses were performed. Results Compared to controls, participants in the SPARX-R condition (n=242) showed significantly reduced depression symptoms relative to the control (n=298) at post-intervention (Cohen d=0.29) and 6 months post-baseline (d=0.21) but not at 18 months post-baseline (d=0.33). Conclusions This is the first trial to demonstrate a preventive effect on depressive symptoms prior to a significant and universal stressor in adolescents. It demonstrates that an online intervention delivered in advance of a stressful experience can reduce the impact of such an event on the potential development or exacerbation of depression. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000316606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365986 (Archived by WebCite at http://www.webcitation.org/ 6u7ou1aI9) PMID:29097357

A Randomized Controlled Trial to Improve the Success of Women Assistant Professors

PubMed Central

Grisso, Jeane Ann; Sammel, Mary Dupuis; Rubenstein, Arthur H.; Speck, Rebecca M.; Conant, Emily F.; Scott, Patricia; Tuton, Lucy Wolf; Westring, Alyssa Friede; Friedman, Stewart

2017-01-01

Abstract Background: Given the persistent disparity in the advancement of women compared with men faculty in academic medicine, it is critical to develop effective interventions to enhance women's careers. We carried out a cluster-randomized, multifaceted intervention to improve the success of women assistant professors at a research-intensive medical school. Materials and Methods: Twenty-seven departments/divisions were randomly assigned to intervention or control groups. The three-tiered intervention included components that were aimed at (1) the professional development of women assistant professors, (2) changes at the department/division level through faculty-led task forces, and (3) engagement of institutional leaders. Generalized linear models were used to test associations between assignment and outcomes, adjusting for correlations induced by the clustered design. Results: Academic productivity and work self-efficacy improved significantly over the 3-year trial in both intervention and control groups, but the improvements did not differ between the groups. Average hours worked per week declined significantly more for faculty in the intervention group as compared with the control group (−3.82 vs. −1.39 hours, respectively, p = 0.006). The PhD faculty in the intervention group published significantly more than PhD controls; however, no differences were observed between MDs in the intervention group and MDs in the control group. Conclusions: Significant improvements in academic productivity and work self-efficacy occurred in both intervention and control groups, potentially due to school-wide intervention effects. A greater decline in work hours in the intervention group despite similar increases in academic productivity may reflect learning to “work smarter” or reveal efficiencies brought about as a result of the multifaceted intervention. The intervention appeared to benefit the academic productivity of faculty with PhDs, but not MDs, suggesting that interventions should be more intense or tailored to specific faculty groups. PMID:28281865

Cluster randomized controlled trial of the plastic BioSand Water filter in Cambodia.

PubMed

Stauber, C E; Printy, E R; McCarty, F A; Liang, K R; Sobsey, M D

2012-01-17

About half of the rural population of Cambodia lacks access to improved water; an even higher percentage lacks access to latrines. More than 35,000 concrete BioSand Water filters (BSF) have been installed in the country. However, the concrete BSF takes time to produce and weighs hundreds of pounds. A plastic BSF has been developed but may not perform to the same benchmarks established by its predecessor. To evaluate plastic BSF performance and health impact, we performed a cluster randomized controlled trial in 13 communities including 189 households and 1147 participants in the Angk Snoul district of Kandal Province from May to December 2008. The results suggest that villages with plastic BSFs had significantly lower concentrations of E. coli in drinking water and lower diarrheal disease (incidence rate ratio 0.41, 95% confidence interval: 0.24-0.69) compared to control villages. As one of the first studies on the plastic BSF in Cambodia, these are important findings, especially in a setting where the concrete BSF has seen high rates of continued use years after installation. The study suggests the plastic BSF may play an important role in scaling up the distribution/implementation of the BSF, potentially improving water quality and health in the region.

A Physical Activity Intervention for Brazilian Students From Low Human Development Index Areas: A Cluster-Randomized Controlled Trial.

PubMed

Filho, Valter C Barbosa; da Silva, Kelly Samara; Mota, Jorge; Beck, Carmem; da Silva Lopes, Adair

2016-11-01

Promoting physical activity (PA) in low- and middle-income countries is an important public health topic as well as a challenge for practice. This study aimed to assess the effect of a school-based intervention on different PA-related variables among students. This cluster-randomized-controlled trial included 548 students in the intervention group and 537 in the control group (11-18 years-old) from 6 schools in neighborhoods with low Human Development Index (0.170-0.491) in Fortaleza, Brazil. The intervention included strategies focused on training teachers, opportunities for PA in the school environment and health education. Variables measured at baseline and again at the 4-months follow-up included the weekly time in different types of moderate-to-vigorous PA (MVPA), preference for PA during leisure-time, PA behavioral change stage and active commuting to school. Generalized linear models and binary logistic regressions were used. An intervention effect was found by increasing the weekly time in MVPA (effect size = 0.17), popular games (effect size = 0.35), and the amount of PA per week (effect size = 0.27) among students (all P < .05). The intervention was effective in promoting improvements in some PA outcomes, but the changes were not sufficient to increase the proportion of those meeting PA recommendations.

Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

PubMed

Silverman, Michael J

2013-10-01

Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided. © 2013.

The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend) Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity.

PubMed

Campbell, Karen J; Hesketh, Kylie D; McNaughton, Sarah A; Ball, Kylie; McCallum, Zoë; Lynch, John; Crawford, David A

2016-02-18

Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. The Infant Feeding Activity and Nutrition Trial (InFANT) Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month) and enhanced (use of web-based materials, and Facebook® engagement), version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. ACTRN12611000386932. Registered 13 April 2011.