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Using flow cytometry for paediatric leukaemia diagnosis in Kenya: a protocol for mixed methods study

Por: Severance · T. · Lotodo · T. · Serem · E. · Njuguna · F. · Melly · B. · Orido · M. · Tonui · R. · Olbara · G. · Koima · R. · Kigen · N. · Kussick · S. · Ratliff · V. · Holl · E. · Monahan · P. O. · Boova · T. · Vik · T.
Introduction

Each year, an estimated 1700 children should be diagnosed with cancer in western Kenya, with leukaemia making up nearly one-third of cases. However, far fewer are actually diagnosed, highlighting significant delays or errors in diagnosis. Flow cytometry, which the WHO considers essential for leukaemia diagnosis, remains underused across sub-Saharan Africa due to high costs, outdated equipment and a lack of trained personnel. In Kenya, decades-old cytometers have been adapted for leukaemia detection, but these systems are now outdated. Newer platforms, such as simplified single-tube multiparametric assays, provide a scalable and sustainable alternative. This study presents a protocol to evaluate the accuracy of diagnosis and the potential for implementing a streamlined flow cytometry assay using peripheral blood, supported by a regional educational initiative.

Methods and analysis

This prospective, mixed-methods implementation study has three aims: (1) to assess the concordance between the Beckman Coulter ClearLLab 10C gold standard 4-tube assay and the streamlined ClearLLab LS 1-tube assay using paired bone marrow and peripheral blood samples; (2) to evaluate the feasibility of peripheral facility referrals and transport logistics with couriered peripheral blood samples from referring sites across western Kenya; and (3) to measure training effectiveness and knowledge gain through a multimodal educational programme using the Project ECHO (Extension for Community Healthcare Outcomes) model. Up to 300 patients at Moi Teaching and Referral Hospital in Eldoret, Kenya, will be enrolled in Aim 1. A separate sample of 100 patients from peripheral facilities will be included in Aim 2. Surveys, knowledge assessments and structured interviews will be used to evaluate training impact under Aim 3. Diagnostic concordance, sensitivity, specificity and knowledge gain will be measured through appropriate quantitative and qualitative methods.

Ethics and dissemination

The protocol has received approval from institutional ethics committees at Moi University, MTRH and Indiana University. De-identified data will be analysed and shared through peer-reviewed publications, stakeholder presentations and educational platforms.

Prevalence of limited health literacy in blue-collar workers: a systematic review protocol

Por: Pires Rodrigues · G. A. · Duong · P. · Luthi · F. · Leger · B. · Melly · P. · Durand · M.-A.
Introduction

Health literacy (HL) is defined as the ability to access, understand, evaluate and apply health-related information, which can influence individuals’ health outcomes. Blue-collar workers, who often have lower educational attainment and experience language barriers, are at increased risk of limited HL. This systematic review aims to assess the prevalence of limited HL among blue-collar workers to inform the development of appropriate interventions for its improvement.

Methods and analysis

The systematic review will assess the prevalence of limited HL among blue-collar workers. We will include all quantitative study designs using any instrument for measuring general HL. We will exclude studies that focus on specific types of HL and specific health conditions. We have performed a literature search from inception up to 30 April 2025, in the Medline, Embase, CINAHL, Web of Science and Cochrane Central Register of Controlled Trials (CENTRAL) databases. We will also search eligible articles from Google Scholar and Open Grey as sources of unpublished studies/gray literature. Two independent reviewers will conduct the primary screening of articles, data extraction and quality assessment (using the Cochrane risk-of-bias tool for randomised trials and risk of bias in non-randomised studies of exposure), with a third individual available to resolve conflicts. We will assess heterogeneity using the ² test and I² test. If there is sufficient homogeneity, we will pool studies in a meta-analysis or summarise the findings narratively if heterogeneity is too high. We will use a random effects model for our analysis, and we will use funnel plots to evaluate potential publication bias. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to assess the certainty of findings.

Ethics and dissemination

Ethical approval will not be required for this review as there is no primary data collection involving humans. The results will be published in a peer-reviewed journal and presented at relevant conferences.

PROSPERO registration number

CRD42024597732.

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