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.

Project description:BackgroundMelioidosis, an often-fatal infectious disease caused by the environmental Gram-negative bacillus Burkholderia pseudomallei, is endemic in tropical countries. Diabetes mellitus and environmental exposure are important risk factors for melioidosis acquisition. We aim to evaluate the effectiveness of a multifaceted prevention programme for melioidosis in diabetics in northeast Thailand.Methodology/principal findingsFrom April 2014 to December 2018, we conducted a stepped-wedge cluster-randomized controlled behaviour change trial in 116 primary care units (PCUs) in Ubon Ratchathani province, northeast Thailand. The intervention was a behavioural support group session to help diabetic patients adopt recommended behaviours, including wearing rubber boots and drinking boiled water. We randomly allocated the PCUs to receive the intervention starting in March 2016, 2017 and 2018. All diabetic patients were contacted by phone yearly, and the final follow-up was December 2018. Two primary outcomes were hospital admissions involving infectious diseases and culture-confirmed melioidosis. Of 9,056 diabetics enrolled, 6,544 (72%) received a behavioural support group session. During 38,457 person-years of follow-up, we observed 2,195 (24%) patients having 3,335 hospital admissions involved infectious diseases, 80 (0.8%) melioidosis, and 485 (5%) deaths. In the intention-to-treat analysis, implementation of the intervention was not associated with primary outcomes. In the per-protocol analysis, patients who received a behavioural support group session had lower incidence rates of hospital admissions involving infectious diseases (incidence rate ratio [IRR] 0.89; 95%CI 0.80-0.99, p = 0.03) and of all-cause mortality (IRR 0.54; 95%CI 0.43-0.68, p<0.001). However, the incidence rate of culture-confirmed melioidosis was not significantly lower (IRR 0.96, 95%CI 0.46-1.99, p = 0.66).Conclusions/significanceClear benefits of this multifaceted prevention programme for melioidosis were not observed. More compelling invitations for the intervention, modification of or addition to the behaviour change techniques used, and more frequent intervention may be needed.Trial registrationThis trial is registered with ClinicalTrials.gov, number NCT02089152.

Project description:BACKGROUND:Soil-transmitted helminth (STH) and schistosome infections are among the most prevalent neglected tropical diseases (NTDs) in the world. School-aged children are particularly vulnerable to these chronic infections that can impair growth, nutritional status and cognitive ability. Mass drug administration (MDA) delivered either once or twice annually is a safe and effective approach recommended by the World Health Organization (WHO) to reduce worm burden. In 2012, Kenya began a national school-based deworming programme (NSBDP) aimed at reducing infection and associated morbidity. The change in prevalence and intensity of these infections was monitored over five years (2012-2017). Here, we present the changes in STH and schistosome infections between baseline and endline assessments, as well as explore the yearly patterns of infection reductions. METHODS:We used series of pre- and post-MDA intervention, repeat cross-sectional surveys in a representative, stratified, two-stage sample of schools in 16 counties of Kenya. The programme consisted of two tiers of monitoring; a national baseline, midterm and endline surveys consisting of 200 schools, and pre- and post-MDA surveys conducted yearly consisting of 60 schools. Stool and urine samples were collected from randomly selected school children and examined for STH and schistosome infections using Kato-Katz and urine filtration techniques respectively. RESULTS:Overall, 32.3%, 16.4% and 13.5% of the children were infected with any STH species during baseline, midterm and endline assessment, respectively, with a relative reduction of 58.2% over the five-year period. The overall prevalence of S. mansoni was 2.1%, 1.5% and 1.7% and of S. haematobium was 14.8%, 6.8% and 2.4%, respectively, for baseline, midterm and endline surveys. We observed inter-region and inter-county heterogeneity variation in the infection levels. CONCLUSIONS:The analysis provided robust assessment of the programme and outlined the current prevalence, mean intensity and re-infection pattern of these infections. Our findings will allow the Government of Kenya to make informed decisions on the strategy to control and eliminate these NTDs. Our results suggest that complimentary interventions may have to be introduced to sustain the chemotherapeutic gains of MDA and accelerate attainment of elimination of these NTDs as a public health problem in Kenya.

Project description:IntroductionElder abuse is prevalent and associated with different forms of ill health. Despite this, healthcare providers are often unaware of abusive experiences among older patients and many lack training about elder abuse. The overall aim of this study is to determine the effectiveness of an educational intervention on healthcare providers' propensity to ask older patients questions about abusive experiences.Methods and analysisHealthcare providers at hospital clinics and primary healthcare centres in Sweden will undergo full-day education about elder abuse between the fall of 2021 and spring of 2023. The education consists of (1) theory and group discussions; (2) forum theatre, a form of interactive theatre in which participants are given the opportunity to practise how to manage difficult patient encounters; and (3) post-training reflection on changing practices.The design is a non-randomised cluster, stepped wedge trial in which all participants (n=750) gradually transit from control group to intervention group with 6-month interval, starting fall 2021. Data are collected using the Responding to Elder Abuse in GERiAtric care-Provider questionnaire which was distributed to all clusters at baseline. All participants will also be asked to answer the questionnaire in conjunction with participating in the education as well as at 6-month and 12-month follow-up. Main outcome is changes in self-reported propensity to ask older patients questions about abuse post-intervention compared with pre-intervention. Linear mixed models including cluster as a random effect will be used to statistically evaluate the outcome.Ethics and disseminationThe study has been approved by the Swedish Ethical Review Authority. The results will be published in peer-reviewed journals and conference proceedings. If the intervention is successful, a manual of the course content will be published so that the education can be disseminated to other clinics.Trial registration numberNCT05065281.

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.

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Project description:ObjectiveThis study aimed to investigate the effectiveness of workplace active rest programme (WARP) on chronic low back pain (LBP) among office workers.DesignA closed cohort, stepped-wedge cluster randomised trial was conducted. The total duration of the study was 16 weeks (4 weeks for each step). Sequence allocation was randomised, but no one was blinded.SettingThis study was conducted in three offices in a Japanese electronics company. One office was for the administrative department, the others are for the engineering department.ParticipantsWe recruited 29 office workers with LBP greater than 3 months. LBP due to specific injury or disease was excluded. The median age was 38 years, and 26 (90%) were male. All participants completed the study.InterventionsIn the intervention phase, participants performed WARP comprising frequent stand-up and individualised brief exercise/physical activity during work. Physical therapists held an LBP workshop and developed tailor-made programmes before introducing WARP. We instructed participants to perform WARP at five timings during work. Control phase was set before the intervention and participants stayed as usual.Primary and secondary outcome measuresThe primary outcome was pain intensity of LBP assessed using the Brief Pain Inventory. The secondary outcomes were work productivity loss measured using the Work Limitations Questionnaire, LBP disability assessed using the Roland-Morris Disability Questionnaire, psychosocial subscale assessed using the STarT Back Screening Tool and physical activity measured using triaxial accelerometers. These outcomes were collected at baseline and at 4-month follow-up evaluation.ResultsIn the intention-to-treat analysis, WARP did not show any significant effects on pain intensity (β, 0.01; 95% CI -0.50 to 0.52) and on the secondary outcomes. The median adherence to WARP was 28.6% (IQR, 16.8-41.1), which was equal to 1.43 times per day. No adverse effect was observed.ConclusionsThe present study was unable to confirm the effectiveness of active rest in improving LBP. Hence, further study needs to investigate its effectiveness.Trial registration numberUMIN000033210.