Evidence map›Paper›PMID 27473737›Full record

ArticleAmerican journal of clinical pathology2016

Challenges of Maintaining Good Clinical Laboratory Practices in Low-Resource Settings:  A Health Program Evaluation Framework Case Study From East Africa.

Helen L Zhang, Michael W Omondi, Augustine M Musyoka, Isaac A Afwamba, Remigi P Swai, Francis P Karia, Charles Muiruri, Elizabeth A Reddy, John A Crump, Matthew P Rubach

Abstract read
In one paragraph

Article in American journal of clinical pathology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Helen L ZhangFrom the Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Durham, NC.
Michael W OmondiDuke Global Health Institute, Duke University, Durham, NC.
Augustine M MusyokaKilimanjaro Christian Medical Centre, Moshi, Tanzania Kilimanjaro Christian Medical University College, Moshi, Tanzania.
Isaac A AfwambaKilimanjaro Christian Medical Centre, Moshi, Tanzania.
Remigi P SwaiKilimanjaro Christian Medical Centre, Moshi, Tanzania.
Francis P KariaKilimanjaro Christian Medical Centre, Moshi, Tanzania Kilimanjaro Christian Medical University College, Moshi, Tanzania.
Charles MuiruriDuke Global Health Institute, Duke University, Durham, NC.
Elizabeth A ReddyDivision of Infectious Diseases, Department of Medicine, State University of New York Upstate, Syracuse, NY.
John A CrumpFrom the Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Durham, NC Kilimanjaro Christian Medical University College, Moshi, Tanzania Centre for International Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Matthew P RubachFrom the Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Durham, NC.

Funding

Investigating Febrile Deaths in Tanzania (INDITe)R01AI121378 · NIAID · DUKE UNIVERSITY · PI RUBACH, MATTHEW P · 2016 to 2020
$2.7M
The Impact and Society Ecology of Bacterial Zoonoses in Northern Tanzania: UnderR01TW009237 · FIC · DUKE UNIVERSITY · PI CRUMP, JOHN ANDREW · 2011 to 2014
$1.7M
Biotechnology and Biological Sciences Research Council BB/J010367/1Biotechnology and Biological Sciences Research Council BB/L018845/1Biotechnology and Biological Sciences Research Council BB/L018926/1FIC NIH HHS R01 TW009237NIAID NIH HHS R01 AI121378
6 · The paper itself

Abstract

objectivesUsing a clinical research laboratory as a case study, we sought to characterize barriers to maintaining Good Clinical Laboratory Practice (GCLP) services in a developing world setting.

methodsUsing a US Centers for Disease Control and Prevention framework for program evaluation in public health, we performed an evaluation of the Kilimanjaro Christian Medical Centre-Duke University Health Collaboration clinical research laboratory sections of the Kilimanjaro Clinical Research Institute in Moshi, Tanzania. Laboratory records from November 2012 through October 2014 were reviewed for this analysis.

resultsDuring the 2-year period of study, seven instrument malfunctions suspended testing required for open clinical trials. A median (range) of 9 (1-55) days elapsed between instrument malfunction and biomedical engineer service. Sixteen (76.1%) of 21 suppliers of reagents, controls, and consumables were based outside Tanzania. Test throughput among laboratory sections used a median (range) of 0.6% (0.2%-2.7%) of instrument capacity. Five (55.6%) of nine laboratory technologists left their posts over 2 years.

conclusionsThese findings demonstrate that GCLP laboratory service provision in this setting is hampered by delays in biomedical engineer support, delays and extra costs in commodity procurement, low testing throughput, and high personnel turnover.

Indexed as

Developing CountriesProgram EvaluationQuality Assurance, Health CareClinical Laboratory ServicesEquipment FailureHumansTanzaniaAfricaGood Clinical Laboratory PracticeLaboratory medicineQuality assurance

Identifiers

PMID27473737
PMCPMC6410885

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.