Plasma biomarker data from the FIEBRE-Mozambique Cohort – User Guide

Persistent identifier

10.17037/DATA.00004583

Description

An anonymised dataset of 1,955 paediatric and adult patients with febrile illness in southern Mozambique, who gave informed consent to participate in the prospective observational FIEBRE study between December 2018 and February 2021. Dataset contains variables on biomarker levels in plasma, demographic data, results of basic diagnostic tests and health status data, calculated clinical severity scores, and mortality and other adverse outcomes by day 28 follow-up.

Data collection methods

Study staff collected demographic data, took a standardised clinical history, and performed a physical examination. Lactate levels was measured on-site with a point-of-care analyser. Additional clinical data were collected for inpatients during admission and at discharge. In a follow-up visit at day 28, vital status and data related to the original illness episode were documented. All data were recorded electronically using Open Data Kit (ODK). Plasma samples were analysed at UHN (Toronto, Canada) for biomarkers of immune and endothelial activation using Luminex and ELISA, and the biomarker results were merged with the rest of the dataset using study IDs.

Data analysis and preparation

Data cleaning involved consistency checks and verifying data integrity to ensure accuracy before statistical analysis and sharing.

For biomarker data, duplicate measurements were averaged and concentrations outside the dynamic range were assigned the highest limit of the standard curve or a value of one-third of the lowest limit.

Geographic regions

Southern Mozambique (Manhiça and Maputo).

Key dates

The FIEBRE-Mozambique data capture began in December 2018 and concluded in March 2021. Biomarker measurements at UHN were completed by November 2023. The final version of the dataset was produced in May 2024.

Quality controls

All data were validated during the point of entry and outliers for clinical observations were detected using statistical methods.

Population

Paediatric and adult patients with febrile illness who presented to two hospitals in southern Mozambique and received outpatient or inpatient care.

Privacy

Any personally identifiable data such as dates of birth, names, and address have been removed from the data.

Ethics

Organisation Ethics ID Other information
LSHTM Research Ethics Committee 14538  
CISM’s Institutional Ethics Committee CIBS-CISM/010/2018  
Mozambican National Bioethics Committee 447/CNBS/18  
University Health Network Institutional Review Board UHN REB#18-6186  

Keywords

Biomarkers, fever, prognosis, mortality, risk-stratification

Language of written material

English

Project information

Biomarker analyses were supported by the Canadian Institutes of Health Research (CIHR) Foundation grant FDN-148439 (KCK), the Canada Research Chair Program (KCK), and donations from Kim Kertland and the Tesari Foundation. ISGlobal receives support from the grant CEX2023-0001290-S funded by Agencia Estatal de Investigación (MCIN/AEI/10.13039/501100011033), and support from the Generalitat de Catalunya through the CERCA Program. CISM is supported by the Government of Mozambique and the Spanish Agency for International Development (AECID). NB is supported by an FPU predoctoral fellowship from the Spanish Ministry of Universities (FPU18/04260). BB is a Beatriu de Pinos postdoctoral fellow granted by the Government of Catalonia’s Secretariat for Universities and Research, and by Marie Sklodowska-Curie Actions COFUND Program (BP3, 801370). JB is supported by a career development grant from the EDCTP2 program supported by the European Union (TMA2019SFP-2836 TB lung-FACT2).

Project name Funder/sponsor Grant number
Febrile Illness Evaluation in a Broad Range of Endemicities (FIEBRE) Study Consortium Foreign, Commonwealth and Development Office (FCDO)  

Creators

Forename Surname Faculty / Dept Institution Role
Núria Balanza - ISGlobal Data Creator
Quique Bassat - ISGlobal Project leader
Kevin C Kain - UHN Project leader
Heidi Hopkins Faculty of Infectious and Tropical Diseases London School of Hygiene & Tropical Medicine Project leader
David CW Mabey Faculty of Infectious and Tropical Diseases London School of Hygiene & Tropical Medicine Project leader
Sham Lal Faculty of Infectious and Tropical Diseases London School of Hygiene & Tropical Medicine Data Manager

File description

Filename Description Access status Licence
FIEBRE_biomarkers_data A dataset of 1,955 febrile patients in Mozambique from the FIEBRE study, including plasma biomarker levels, clinical data, and outcomes by day 28. Controlled Data sharing agreement
FIEBRE_biomarkers_data_codebook Codebook for FIEBRE biomarkers data Open Creative Commons Attribution (CCBY)
4583_UserGuide User guide for FIEBRE biomarkers data Open Creative Commons Attribution (CCBY)