Anthelminthic treatment receipt and its predictors in Lake Victoria fishing communities, Uganda: Intervention coverage results from the LaVIISWA cluster randomised trial

Background: Schistosomiasis and other worm infections have been associated with growth and cognitive impairments; however, whether treatment reverses these effects is uncertain. Moreover, mechanisms linking these infections to cognition are not clear. We aimed to compare growth and cognitive benefits of intensive versus standard anthelminthic treatment in school-aged-children and explore processes that might be involved. We hypothesised that intensive treatment would have greater benefits than standard treatment. Methods: The study was nested within a cluster-randomised trial of either quarterly single-dose praziquantel of 40mg/kg to treat Schistosoma mansoni plus triple dose albendazole of 400mg (intensive treatment) to treat soil-transmitted worms including Ascaris lumbricoides, hookworm and Trichuris trichiura, or annual single-dose praziquantel 40mg/kg plus six-monthly single-dose albendazole 400mg (standard treatment) conducted in the Koome islands in Lake Victoria, Uganda (ISRCTN47196031). Children aged 5-9 years (N=384) were assessed on primary outcomes (height, weight and eight measures of cognitive ability), worm infection, and proposed mediators of worm effects (cytokines, iron status, physical activity) at one year (intensive n=85; standard n=64) and at two years (intensive n=158; standard n=128) of the intervention. Linear regression was used to examine intervention effects on height, weight and cognitive performance. Linear mixed effects models were used to study changes in growth and cognitive performance between the two arms across the two time-points. Results: Intensive treatment resulted in lower Schistosoma mansoni prevalence than standard treatment (at one year, 41% versus 70%; adjusted odds ratio (aOR)=0.24, 95% CI: 0.12, 0.49; at two years, 39% versus 69%; aOR=0.27; 95% CI: 0.16, 0.43) but there were no significant differences in growth and cognitive outcomes at either time-point. Worms and treatment showed no consistent association with the proposed mediators of worm effects. Conclusion: Reduction in worm burden may not improve growth and cognitive outcomes in high S. mansoni transmission settings. Possible implications are discussed.

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Results of the German part of OptiBIRTH (ISRCTN10612254): A cluster randomised trial to increase vaginal birth after one previous caesarean section

10.1055/s-0037-1607690 ◽

2017 ◽

Author(s):

MM Gross ◽

S Grylka-Baeschlin ◽

F Bahlmann ◽

M Fleisch ◽

P Hillemanns ◽

...

Keyword(s):

Caesarean Section ◽

Randomised Trial ◽

Vaginal Birth ◽

Cluster Randomised Trial ◽

Previous Caesarean Section ◽

Cluster Randomised ◽

German Part

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The Acceptability and Utility of Accelerometers to Estimate Physical Activity and Sleep Characteristics in People with Advanced Dementia: A Feasibility Cluster Randomised Trial (NAMASTE)

10.26226/morressier.5c76c8bbe2ea5a72376125fb ◽

2019 ◽

Author(s):

Katherine Froggatt

Keyword(s):

Physical Activity ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Advanced Dementia ◽

Cluster Randomised

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Refining the Namaste Care Intervention for People with Advanced Dementia Prior to a Feasibility Cluster Randomised Trial: A Novel Four Stage Process

10.26226/morressier.5c76c8b8e2ea5a72376123de ◽

2019 ◽

Author(s):

Catherine Walshe

Keyword(s):

Randomised Trial ◽

Cluster Randomised Trial ◽

Advanced Dementia ◽

Cluster Randomised ◽

Care Intervention ◽

Stage Process

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Faculty Opinions recommendation of Implementation of the Canadian C-Spine Rule: prospective 12 centre cluster randomised trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.3268956.2955055 ◽

2010 ◽

Author(s):

Carlos Bagley

Keyword(s):

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised

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Faculty Opinions recommendation of Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.725942556.793512079 ◽

2015 ◽

Author(s):

Anthony Harries

Keyword(s):

South African ◽

Diagnostic Test ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Sputum Microscopy ◽

Roll Out

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The RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status) study: a cluster randomised trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis in communities with a high prevalence of undernutrition, Jharkhand, India

BMJ Open ◽

10.1136/bmjopen-2020-047210 ◽

2021 ◽

Vol 11 (5) ◽

pp. e047210

Author(s):

Anurag Bhargava ◽

Madhavi Bhargava ◽

Banurekha Velayutham ◽

Kannan Thiruvengadam ◽

Basilea Watson ◽

...

Keyword(s):

Risk Factor ◽

Nutritional Status ◽

G Proteins ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Household Contacts ◽

Cluster Randomised ◽

High Prevalence ◽

Secondary Outcomes ◽

The Impact

IntroductionIndia has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition.Methods and analysisWe shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23 g proteins/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function.Ethics and disseminationThe institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations.Trial registration numberClinical Trial Registry of India: CTRI/2019/08/020490.

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