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Region-specific laboratory reference intervals are important: A systematic review of the data from Africa

Region-specific laboratory reference intervals (RIs) are important for clinical trials and these data are often sparse in priority areas for research, including Africa. We reviewed data on RIs from Africa to identify gaps in the literature with a systematic review of PubMed for RI studies from Afric...

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Autores principales: Price, Matt A., Fast, Patricia E., Mshai, Mercy, Lambrick, Maureen, Machira, Yvonne Wangũi, Gieber, Lisa, Chetty, Paramesh, Muturi-Kioi, Vincent
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10021479/
https://www.ncbi.nlm.nih.gov/pubmed/36962599
http://dx.doi.org/10.1371/journal.pgph.0000783
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author Price, Matt A.
Fast, Patricia E.
Mshai, Mercy
Lambrick, Maureen
Machira, Yvonne Wangũi
Gieber, Lisa
Chetty, Paramesh
Muturi-Kioi, Vincent
author_facet Price, Matt A.
Fast, Patricia E.
Mshai, Mercy
Lambrick, Maureen
Machira, Yvonne Wangũi
Gieber, Lisa
Chetty, Paramesh
Muturi-Kioi, Vincent
author_sort Price, Matt A.
collection PubMed
description Region-specific laboratory reference intervals (RIs) are important for clinical trials and these data are often sparse in priority areas for research, including Africa. We reviewed data on RIs from Africa to identify gaps in the literature with a systematic review of PubMed for RI studies from Africa published ≥2010. Search focus included clinical analytic chemistry, hematology, immunological parameters and RIs. Data from adults, adolescents, children, pregnant women, and the elderly were included. We excluded manuscripts reporting data from persons with conditions that might preclude clinical trial participation in studies enrolling healthy volunteers. Of 179 identified manuscripts, 80 were included in this review, covering 20 countries with the largest number of studies in Ethiopia (n = 23, 29%). Most studies considered healthy, nonpregnant adults (n = 55, 69%). Nine (11%) studies included pregnant women, 13 (16%) included adolescents and 22 (28%) included children. Recruitment, screening, enrollment procedures and definition of age strata varied across studies. The most common type of RIs reported were hematology (66, 83%); 14 studies (18%) included flow cytometry and/or T cell counts. Other common tests or panels included liver function assays (32, 40%), renal function assays (30, 38%), lipid chemistries (17, 21%) and serum electrolytes (17, 21%). The number of parameters characterized ranged from only one (three studies characterized either CD4+ counts, D-dimer, or hemoglobin), to as many as 40. Statistical methods for calculating RIs varied. 56 (70%) studies compared their results to international RI databases. Though most presented their data side-by-side with international data with little accompanying analysis, nearly all reported deviation from comparator RI data, sometimes with half or more of otherwise healthy participants having an “out of range” result. We found there is limited local RI data available in sub-Saharan Africa. Studies to fill this gap are warranted, including efforts to standardize statistical methods to derive RIs, methods to compare with other RIs, and improve representative participant selection.
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spelling pubmed-100214792023-03-17 Region-specific laboratory reference intervals are important: A systematic review of the data from Africa Price, Matt A. Fast, Patricia E. Mshai, Mercy Lambrick, Maureen Machira, Yvonne Wangũi Gieber, Lisa Chetty, Paramesh Muturi-Kioi, Vincent PLOS Glob Public Health Research Article Region-specific laboratory reference intervals (RIs) are important for clinical trials and these data are often sparse in priority areas for research, including Africa. We reviewed data on RIs from Africa to identify gaps in the literature with a systematic review of PubMed for RI studies from Africa published ≥2010. Search focus included clinical analytic chemistry, hematology, immunological parameters and RIs. Data from adults, adolescents, children, pregnant women, and the elderly were included. We excluded manuscripts reporting data from persons with conditions that might preclude clinical trial participation in studies enrolling healthy volunteers. Of 179 identified manuscripts, 80 were included in this review, covering 20 countries with the largest number of studies in Ethiopia (n = 23, 29%). Most studies considered healthy, nonpregnant adults (n = 55, 69%). Nine (11%) studies included pregnant women, 13 (16%) included adolescents and 22 (28%) included children. Recruitment, screening, enrollment procedures and definition of age strata varied across studies. The most common type of RIs reported were hematology (66, 83%); 14 studies (18%) included flow cytometry and/or T cell counts. Other common tests or panels included liver function assays (32, 40%), renal function assays (30, 38%), lipid chemistries (17, 21%) and serum electrolytes (17, 21%). The number of parameters characterized ranged from only one (three studies characterized either CD4+ counts, D-dimer, or hemoglobin), to as many as 40. Statistical methods for calculating RIs varied. 56 (70%) studies compared their results to international RI databases. Though most presented their data side-by-side with international data with little accompanying analysis, nearly all reported deviation from comparator RI data, sometimes with half or more of otherwise healthy participants having an “out of range” result. We found there is limited local RI data available in sub-Saharan Africa. Studies to fill this gap are warranted, including efforts to standardize statistical methods to derive RIs, methods to compare with other RIs, and improve representative participant selection. Public Library of Science 2022-11-14 /pmc/articles/PMC10021479/ /pubmed/36962599 http://dx.doi.org/10.1371/journal.pgph.0000783 Text en © 2022 Price et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Price, Matt A.
Fast, Patricia E.
Mshai, Mercy
Lambrick, Maureen
Machira, Yvonne Wangũi
Gieber, Lisa
Chetty, Paramesh
Muturi-Kioi, Vincent
Region-specific laboratory reference intervals are important: A systematic review of the data from Africa
title Region-specific laboratory reference intervals are important: A systematic review of the data from Africa
title_full Region-specific laboratory reference intervals are important: A systematic review of the data from Africa
title_fullStr Region-specific laboratory reference intervals are important: A systematic review of the data from Africa
title_full_unstemmed Region-specific laboratory reference intervals are important: A systematic review of the data from Africa
title_short Region-specific laboratory reference intervals are important: A systematic review of the data from Africa
title_sort region-specific laboratory reference intervals are important: a systematic review of the data from africa
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10021479/
https://www.ncbi.nlm.nih.gov/pubmed/36962599
http://dx.doi.org/10.1371/journal.pgph.0000783
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