Dataset Information

Re-analysis of health and educational impacts of a school-based deworming programme in western Kenya: a statistical replication of a cluster quasi-randomized stepped-wedge trial.

ABSTRACT:

Introduction

Helminth (worm) infections cause morbidity among poor communities worldwide. An influential study conducted in Kenya in 1998-99 reported that a school-based drug-and-educational intervention had benefits for worm infections and school attendance.

Methods

In this statistical replication, we re-analysed data from this cluster quasi-randomized stepped-wedge trial, specifying two co-primary outcomes: school attendance and examination performance. We estimated intention-to-treat effects using year-stratified cluster-summary analysis and observation-level random-effects regression, and combined both years with a random-effects model accounting for year. The participants were not blinded to allocation status, and other interventions were concurrently conducted in a sub-set of schools. A protocol guiding outcome data collection was not available.

Results

Quasi-randomization resulted in three similar groups of 25 schools. There was a substantial amount of missing data. In year-stratified cluster-summary analysis, there was no clear evidence for improvement in either school attendance or examination performance. In year-stratified regression models, there was some evidence of improvement in school attendance [adjusted odds ratios (aOR): year 1: 1.48, 95% confidence interval (CI) 0.88-2.52, P = 0.147; year 2: 1.23, 95% CI 1.01-1.51, P = 0.044], but not examination performance (adjusted differences: year 1: -0.135, 95% CI -0.323-0.054, P = 0.161; year 2: -0.017, 95% CI -0.201-0.166, P = 0.854). When both years were combined, there was strong evidence of an effect on attendance (aOR 1.82, 95% CI 1.74-1.91, P < 0.001), but not examination performance (adjusted difference -0.121, 95% CI -0.293-0.052, P = 0.169).

Conclusions

The evidence supporting an improvement in school attendance differed by analysis method. This, and various other important limitations of the data, caution against over-interpretation of the results. We find that the study provides some evidence, but with high risk of bias, that a school-based drug-treatment and health-education intervention improved school attendance and no evidence of effect on examination performance.

SUBMITTER: Davey C

PROVIDER: S-EPMC4681108 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundHelminth (worm) infections cause morbidity among poor communities worldwide. An influential study conducted in Kenya in 1998-99 reported that a school-based drug-and-educational intervention had benefits regarding worm infections and school attendance. Effects were seen among children treated with deworming drugs, untreated children in intervention schools and children in nearby non-intervention schools. Combining these effects, the intervention was reported to increase school attendance by 7.5% in treated children. Effects on other outcomes (worm infections, anaemia, nutritional status and examination performance) were also investigated.MethodsIn this pure replication, we used data provided by the original authors to re-analyse the study according to their methods. We compared these results against those presented in the original paper.ResultsAlthough most results were reproduced as originally reported, we identified discrepancies of several types between the original findings and re-analysis. For worm infections, re-analysis showed reductions similar to those originally reported. For anaemia prevalence, in contrast to the original findings, re-analysis found no evidence of benefit. For nutritional status, both original findings and re-analysis described modest evidence for a small improvement. For school attendance, re-analysis showed benefits similar to those originally found in intervention schools for both children who did and those who did not receive deworming drugs. However, after correction of coding errors, there was little evidence of an indirect effect on school attendance among children in schools close to intervention schools. Combining these effects gave a total increase in attendance of 3.9% among treated children, which was no longer statistically significant. As in the original results, re-analysis found no effect of the intervention on examination performance.ConclusionsRe-applying analytical approaches originally used, but correcting various errors, we found little evidence for some previously-reported indirect effects of a deworming intervention. Effects on worm infections, nutritional status, examination performance and school attendance on children in intervention schools were largely unchanged.

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Project description:IntroductionThere is an epidemic of opioid use related to adverse events and deaths in the USA. The rates of chronic pain, mental illness and substance use disorder are higher at the Veterans Health Administration (VHA) compared with the general US population. The 2016 Comprehensive Addiction and Recovery Act requires the VHA to improve opioid therapy strategies in treating patients and to ensure responsible prescribing practices. The Stratification Tool for Opioid Risk Mitigation (STORM) is a web-based dashboard that prioritises review of VHA patients receiving opioids based on their risk. The VHA Partnered Evidence-based Policy Resource Center is coordinating a multiyear evaluation of STORM and aspects of the VHA policy that mandate case review of patients identified by STORM as very high risk.Methods and analysisThis stepped-wedge cluster randomised controlled trial will test two hypotheses: (1) VHA medical centres randomised to facilitation for not meeting the targeted case review rate will achieve lower opioid-related serious adverse events (SAEs), relative to facilities not randomised to facilitation and (2) Patients whose cases are required to be reviewed will have a lower rate of opioid-related SAEs compared with comparable risk patients whose cases are not required to be reviewed. Patients who receive an opioid prescription at VHA medical centres will be followed for a minimum of 3 months after their first opioid prescription. Follow-up will continue until the last day of the project or death. The data will be analysed using an intention-to-treat approach with patient-month-level Cox proportional hazards models for both interventions.Ethics and disseminationEvaluation of the randomised roll-out was approved by the VA Boston Healthcare System Institutional Review Board (IRB) and Research & Development Committees (Protocol # 3069). Findings will be published in peer-reviewed journals and presentations at national conference meetings.Trial registration numberISRCTN16012111.

Project description:BackgroundSuccessful and sustainable models for HIV pre-exposure prophylaxis (PrEP) delivery in public health systems in Africa are needed. We aimed to evaluate the implementation of PrEP delivery integrated in public HIV care clinics in Kenya.MethodsAs part of Kenya's national PrEP roll-out, we conducted a stepped-wedge cluster-randomised pragmatic trial to catalyse scale-up of PrEP delivery integrated in 25 public HIV care clinics. We selected high-volume clinics in these regions (ie, those with a high number of people living with HIV enrolled in HIV care and treatment). Clinics (each representing a cluster) were stratified by region and randomly assigned to the order in which clinic staff would receive PrEP training and ongoing technical support using numbered opaque balls picked from a bag. There was no masking. PrEP provision was done by clinic staff without additional financial support. Data were abstracted from records of individuals initiating PrEP. The primary outcome was the number of people initiating PrEP per clinic per month comparing intervention to control periods. Other outcomes included PrEP continuation, adherence, and incident HIV infections. This trial is registered with ClinicalTrials.gov, NCT03052010.FindingsAfter the baseline period, which started in January, 2017, every month two to six HIV care clinics crossed over from control to intervention, until August, 2017, when all clinics were implementing the intervention. Of 4898 individuals initiating PrEP (27 during the control period and 4871 during the intervention period), 2640 (54%) were women, the median age was 31 years (IQR 25-39), and 4092 (84%) reported having a partner living with HIV. The mean monthly number of PrEP initiations per clinic was 0·1 (SD 0·5) before the intervention and 7·5 (2·7) after intervention introduction (rate ratio 23·7, 95% CI 14·2-39·5, p<0·0001). PrEP continuation was 57% at 1 month, 44% at 3 months, and 34% at 6 months, and 12% of those who missed a refill returned later for PrEP re-initiation. Tenofovir diphosphate was detected in 68 (96%) of 71 blood samples collected from a randomly selected subset of participants. Six HIV infections were observed over 2531 person-years of observation (incidence 0·24 cases per 100 person-years), three of which occurred at the first visit after PrEP initiation.InterpretationWe observed high uptake, reasonable continuation with high adherence, frequent PrEP restarts, and low HIV incidence. Integration of PrEP services within public HIV care clinics in Africa is feasible.FundingNational Institute of Mental Health and Bill & Melinda Gates Foundation.

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