Effect of the Integrated Management of Childhood Illness strategy on childhood mortality and nutrition in a rural area in Bangladesh: a cluster randomised trial

Abstract Background The Integrated eDiagnosis Approach (IeDA), centred on an electronic Clinical Decision Support System (eCDSS) developed in line with national Integrated Management of Childhood Illness (IMCI) guidelines, was implemented in primary health facilities of two regions of Burkina Faso. An evaluation was performed using a stepped-wedge cluster randomised design with the aim of determining whether the IeDA intervention increased Health Care Workers’ (HCW) adherence to the IMCI guidelines. Methods Ten randomly selected facilities per district were visited at each step by two trained nurses: One observed under-five consultations and the second conducted a repeat consultation. The primary outcomes were: overall adherence to clinical assessment tasks; overall correct classification ignoring the severity of the classifications; and overall correct prescription according to HCWs’ classifications. Statistical comparisons between trial arms were performed on cluster/step-level summaries. Results On average, 54 and 79% of clinical assessment tasks were observed to be completed by HCWs in the control and intervention districts respectively (cluster-level mean difference = 29.9%; P-value = 0.002). The proportion of children for whom the validation nurses and the HCWs recorded the same classifications (ignoring the severity) was 73 and 79% in the control and intervention districts respectively (cluster-level mean difference = 10.1%; P-value = 0.004). The proportion of children who received correct prescriptions in accordance with HCWs’ classifications were similar across arms, 78% in the control arm and 77% in the intervention arm (cluster-level mean difference = − 1.1%; P-value = 0.788). Conclusion The IeDA intervention improved substantially HCWs’ adherence to IMCI’s clinical assessment tasks, leading to some overall increase in correct classifications but to no overall improvement in correct prescriptions. The largest improvements tended to be observed for less common conditions. For more common conditions, HCWs in the control districts performed relatively well, thus limiting the scope to detect an overall impact. Trial registration ClinicalTrials.gov NCT02341469; First submitted August 272,014, posted January 19, 2015.

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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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