scholarly journals Does #Tamojunto alter the dynamic between drug use and school violence among youth? Secondary analysis from a large cluster-randomized trial

2021 ◽  
Author(s):  
Hugo Cogo-Moreira ◽  
Julia D. Gusmões ◽  
Juliana Y. Valente ◽  
Michael Eid ◽  
Zila M. Sanchez
Keyword(s):  
Drug Use ◽  
School Violence ◽  
Causal Effect ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cluster Randomized Trial ◽  
Random Intercept ◽  
Carry Over ◽  
Cluster Randomized ◽  
Use Behavior

AbstractThe present study investigated how intervention might alter the relationship between perpetrating violence and later drug use. A cluster-randomized controlled trial design involving 72 schools (38 intervention, 34 control) and 6390 students attending grades 7 and 8 was employed in Brazil. Drug use and violence were assessed at three points. A random-intercept cross-lagged panel model examined the reciprocal association between drug use and school violence domains across the three data collection waves. For both groups, we found that the cross-lagged effect of perpetration on further drug use in adolescents was stronger than the reverse, but the interrelationship was not statistically significant between #Tamojunto and control schools. The carry-over effects of drug use and violence were also not significantly different between groups. There is a lack of evidence showing that #Tamojunto can modify the dynamics between drug use and school violence across the 21-month period. The direction of the causal effect (i.e., the more perpetration behavior, the more subsequent drug use behavior) is present, but weak in both groups. The trial registration protocol at the national Brazilian Register of Clinical Trials (REBEC) is #RBR-4mnv5g.

scholarly journals Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Abdou Amza ◽  
Boubacar Kadri ◽  
Beido Nassirou ◽  
Ahmed M. Arzika ◽  
Ariana Austin ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Signs ◽  
Cluster Randomized Trial ◽  
World Health ◽  
Baseline Assessment ◽  
Randomized Controlled ◽  
Registration Number ◽  
Cluster Randomized ◽  
Health Organization

Abstract Background The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. Methods The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. Discussion The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. Trial registration number This study is registered at clinicaltrials.gov (NCT04185402). Registered December 4, 2019; prospectively registered pre-results.

scholarly journals Emerging pesticides responsible for suicide in rural Sri Lanka following the 2008-2014 pesticide bans

2020 ◽  
Author(s):  
Manjula Weerasinghe ◽  
Melissa Pearson ◽  
Flemming Konradsen ◽  
Suneth Agampodi ◽  
J.A. Sumith ◽  
...  
Keyword(s):  
Sri Lanka ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Relative Importance ◽  
Government Regulations ◽  
Curve Estimation ◽  
Randomized Controlled ◽  
Increasing Trend ◽  
Important Means ◽  
Cluster Randomized

Abstract Background Sri Lanka has reduced its overall suicide rate by 70% over the last two decades through means restriction, through means restriction, through a series of government regulations and bans removing highly hazardous pesticides from agriculture. We aimed to identify the key pesticide(s) now responsible for suicides in rural Sri Lanka to provide data for further pesticide regulation.Methods We performed a secondary analysis of data collected prospectively during a cluster randomized controlled trial in the Anuradhapura district of Sri Lanka from 2011-16. The identity of pesticides responsible for suicides were sought from medical or judicial medical notes, coroners’ records, and the person’s family. Trend analysis was done using a regression analysis with curve estimation to identify relative importance of key pesticides. Results We identified 337 suicidal deaths. Among them, the majority 193 (57.3%) were due to ingestion of pesticides while 82 (24.3%) were due to hanging. A specific pesticide was identified in 105 (54.4%) of the pesticide suicides. Ingestion of carbosulfan or profenofos was responsible for 59 (56.2%) of the suicides with a known pesticide and 17.5% of all suicides. The increasing trend of suicides due to carbosulfan and profenofos over time was statistically significant (R square 0.846, F 16.541, p 0.027). Conclusion Ingestion of pesticides remains the most important means of suicides in rural Sri Lanka. The pesticides that were once responsible for most pesticide suicides have now been replaced by carbosulfan and profenofos. Their regulation and replacement in agriculture with less hazardous pesticides will further reduce the incidence of both pesticide and overall suicides in rural Sri Lanka.

scholarly journals Emerging pesticides responsible for suicide in rural Sri Lanka following the 2008-2014 pesticide bans

2020 ◽  
Author(s):  
Manjula Weerasinghe ◽  
Melissa Pearson ◽  
Flemming Konradsen ◽  
Suneth Agampodi ◽  
J.A. Sumith ◽  
...  
Keyword(s):  
Sri Lanka ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Government Regulations ◽  
Curve Estimation ◽  
Randomized Controlled ◽  
Increasing Trend ◽  
Important Means ◽  
Pesticide Regulation ◽  
Cluster Randomized

Abstract Background Sri Lanka has reduced its overall suicide rate by 70% over the last two decades through means restriction, through means restriction, through a series of government regulations and bans removing highly hazardous pesticides from agriculture. We aimed to identify the key pesticide(s) now responsible for suicides in rural Sri Lanka to provide data for further pesticide regulation.Methods We performed a secondary analysis of data collected prospectively during a cluster randomized controlled trial in the Anuradhapura district of Sri Lanka from 2011-16. The identity of pesticides responsible for suicides were sought from medical or judicial medical notes, coroners’ records, and the person’s family. Trend analysis was done using a regression analysis with curve estimation to identify relative importance of key pesticides. Results We identified 337 suicidal deaths. Among them, the majority 193 (57.3%) were due to ingestion of pesticides while 82 (24.3%) were due to hanging. A specific pesticide was identified in 105 (54.4%) of the pesticide suicides. Ingestion of carbosulfan or profenofos was responsible for 59 (56.2%) of the suicides with a known pesticide and 17.5% of all suicides. The increasing trend of suicides due to carbosulfan and profenofos over time was statistically significant (R square 0.846, F 16.541, p 0.027). Conclusion Ingestion of pesticides remains the most important means of suicides in rural Sri Lanka. The pesticides that were once responsible for most pesticide suicides have now been replaced by carbosulfan and profenofos. Their regulation and replacement in agriculture with less hazardous pesticides will further reduce the incidence of both pesticide and overall suicides in rural Sri Lanka.

Azithromycin distribution and childhood mortality in compliance-related subgroups in Niger: complier average causal effect and spillovers in a cluster-randomized, placebo-controlled trial

2021 ◽  
Author(s):  
Kieran S O’Brien ◽  
Ahmed M Arzika ◽  
Ramatou Maliki ◽  
Abdou Amza ◽  
Farouk Manzo ◽  
...  
Keyword(s):  
Incidence Rate ◽  
Rate Ratio ◽  
Incidence Rate Ratio ◽  
Causal Effect ◽  
Controlled Trial ◽  
Effect Analysis ◽  
Intention To Treat ◽  
Average Causal Effect ◽  
Cluster Randomized ◽  
Complier Average Causal Effect

Abstract Background Biannual azithromycin distribution to children 1–59 months old reduced all-cause mortality by 18% [incidence rate ratio (IRR) 0.82, 95% confidence interval (CI): 0.74, 0.90] in an intention-to-treat analysis of a randomized controlled trial in Niger. Estimation of the effect in compliance-related subgroups can support decision making around implementation of this intervention in programmatic settings. Methods The cluster-randomized, placebo-controlled design of the original trial enabled unbiased estimation of the effect of azithromycin on mortality rates in two subgroups: (i) treated children (complier average causal effect analysis); and (ii) untreated children (spillover effect analysis), using negative binomial regression. Results In Niger, 594 eligible communities were randomized to biannual azithromycin or placebo distribution and were followed from December 2014 to August 2017, with a mean treatment coverage of 90% [standard deviation (SD) 10%] in both arms. Subgroup analyses included 2581 deaths among treated children and 245 deaths among untreated children. Among treated children, the incidence rate ratio comparing mortality in azithromycin communities to placebo communities was 0.80 (95% CI: 0.72, 0.88), with mortality rates (deaths per 1000 person-years at risk) of 16.6 in azithromycin communities and 20.9 in placebo communities. Among untreated children, the incidence rate ratio was 0.91 (95% CI: 0.69, 1.21), with rates of 33.6 in azithromycin communities and 34.4 in placebo communities. Conclusions As expected, this analysis suggested similar efficacy among treated children compared with the intention-to-treat analysis. Though the results were consistent with a small spillover benefit to untreated children, this trial was underpowered to detect spillovers.

scholarly journals Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jaameeta Kurji ◽  
Lakew Abebe Gebretsadik ◽  
Muluemebet Abera Wordofa ◽  
Sudhakar Morankar ◽  
Kunuz Haji Bedru ◽  
...  
Keyword(s):  
Usual Care ◽  
Randomized Trial ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Safe Motherhood ◽  
Link Type ◽  
Local Leader ◽  
Maternity Waiting Homes ◽  
Leader Training ◽  
Cluster Randomized

Abstract Background Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia. Methods A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions. Results Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH+ & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22). Conclusions Both the combined MWH+ & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women’s use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated. Trial registration The trial was retrospectively registered on the Clinical Trials website (https://clinicaltrials.gov) on 3rd October 2017. The trial identifier is NCT03299491.

scholarly journals Impact of group-based dietary education on the dietary habits of female adolescents: a cluster randomized trial

2010 ◽  
Vol 14 (4) ◽  
pp. 702-708 ◽  
Author(s):  
Kazue Yamaoka ◽  
Mariko Watanabe ◽  
Eisuke Hida ◽  
Toshiro Tango
Keyword(s):  
Dietary Intake ◽  
Energy Intake ◽  
Young Women ◽  
Dietary Habits ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Female Adolescents ◽  
Control Group ◽  
Dietary Education ◽  
Cluster Randomized

AbstractObjectiveThe number of extremely thin young women has increased and education at school on maintaining an optimal weight has become important. The aim of the present study was to assess the effectiveness of a group-based home-collaborative dietary education (HCDE) programme to maintain appropriate dietary intake compared to conventional school classroom education.DesignTwo-arm cluster randomized controlled trial. Twelve classes were randomly assigned as clusters to either the HCDE group or the control group. Each participant in the HCDE group received twelve sessions of group counselling aimed at increasing energy intake at breakfast by modifying dietary intake and adopting appropriate habits. The hypothesis underlying the study was that after 6 months of HCDE the total energy intake would be increased by 627 kJ from baseline (primary endpoint). Secondary outcomes were differences in intake of various nutrients from baseline. Outcome measures after log transformation were examined by t tests and linear mixed models (crude and baseline-adjusted).SettingYoung women among Japanese female adolescents in Tokyo.SubjectsFour hundred and seventy-four participants aged 13–15 years.ResultsStudents in twelve classes were used for analysis (n 459). Energy intake was decreased in many of the classes during the 6-month period, especially for those in the control group. After adjustment for the baseline value, significant increases in energy intake and protein, calcium, magnesium and iron intakes at breakfast were observed (P < 0·05)ConclusionsAlthough energy intake was increased in the HCDE group compared to the control group, further study of the HCDE is warranted.

scholarly journals Vital sign monitoring following stroke associated with 90-day independence: A secondary analysis of the QASC cluster randomized trial

2019 ◽  
Vol 89 ◽  
pp. 72-79
Author(s):  
Sandy Middleton ◽  
Patrick McElduff ◽  
Peta Drury ◽  
Catherine D’Este ◽  
Dominique A. Cadilhac ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Vital Sign ◽  
Secondary Analysis ◽  
Cluster Randomized Trial ◽  
Cluster Randomized

Cluster randomized trial of an antibiotic time-out led by a team-based pharmacist

2020 ◽  
Vol 41 (11) ◽  
pp. 1266-1271
Author(s):  
Trevor C. Van Schooneveld ◽  
Mark E. Rupp ◽  
R. Jenifer Cavaleiri ◽  
Elizabeth Lyden ◽  
Kiri Rolek
Keyword(s):  
Controlled Trial ◽  
Early Period ◽  
Cluster Randomized Trial ◽  
Antibiotic Use ◽  
Effective Strategies ◽  
Randomized Controlled ◽  
Time Out ◽  
Academic Medical ◽  
Cluster Randomized ◽  
Medicine Team

AbstractObjective:Antibiotic time-outs (ATOs) have been advocated to improve antibiotic use without dedicated stewardship resources, but their utility is poorly defined. We sought to evaluate the effectiveness of an ATO led by a team-based pharmacist.Design:Cluster randomized controlled trial.Setting:Six medicine teams at an academic medical facility.Patients:Inpatients who received antibiotics and were cared for by a medicine team.Intervention:In phase A (2 months) pharmacist-led ATOs were implemented on 3 medicine teams (ATO-A) while 3 teams maintained usual care (UC-A). In phase B (2 months), ATOs were continued in the ATO group (ATO-B) and ATOs were initiated in the UC group (UC ATO-B). We targeted 2 ATO points: early (<72 hours after antibiotics were initiated) and late (after the early period but ≤5 days after antibiotic initiation).Results:In total, 290 ATOs were documented (181 early, 87 late, and 22 subsequent) among 538 admissions. The most common ATO recommendations were narrow therapy (148 of 290), no change (124 of 290), and change to oral (30 of 290). ATO initiation was lower in the UC ATO-B group than in either ATO group (21.8% UC ATO-B vs 69.2% ATO-A and -B). Overall antibiotic use was not different between the groups (P = .51), although intravenous (IV) levofloxacin use decreased in the UC group after ATO implementation (49 DOT/1,000 PD vs 20 DOT/1,000 PD; P = .022). The ratio of oral (PO) to intravenous (IV) DOT was lower in the UC group than in any of the ATO groups (P = .032). We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.Conclusions:Implementation of a pharmacist-led ATO was feasible and well accepted but did not change overall antibiotic use. An ATO may promote increased use of oral antibiotics, but more effective strategies for self-stewardship are needed.

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