Evidence map›Paper›PMID 35658841›Full record

ArticleBMC pregnancy and childbirth2022

Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment.

Jani van der Hoven, Elizabeth Allen, Annibale Cois, Renee de Waal, Gary Maartens, Landon Myer, Thokozile Malaba, Hlengiwe Madlala, Dorothy Nyemba, Florence Phelanyane and 3 more

Abstract read
In one paragraph

Article in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
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

13 authors.

Jani van der HovenDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Elizabeth AllenDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Annibale CoisDivision of Health Systems and Public Health, Department of Global Health, Stellenbosch University, Tygerberg, South Africa.ORCID http://orcid.org/0000-0002-7014-6510
Renee de WaalCentre for Infectious Disease Epidemiology & Research, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.ORCID http://orcid.org/0000-0001-6171-2181
Gary MaartensDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID http://orcid.org/0000-0003-3080-6606
Landon MyerDivision of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Thokozile MalabaDivision of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.ORCID http://orcid.org/0000-0003-0938-5587
Hlengiwe MadlalaDivision of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Dorothy NyembaCentre for Infectious Disease Epidemiology & Research, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Florence PhelanyaneCentre for Infectious Disease Epidemiology & Research, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Andrew BoulleCentre for Infectious Disease Epidemiology & Research, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.ORCID http://orcid.org/0000-0002-7713-8062
Ushma MehtaCentre for Infectious Disease Epidemiology & Research, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Emma KalkCentre for Infectious Disease Epidemiology & Research, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa. emma.kalk@uct.ac.za.ORCID http://orcid.org/0000-0001-7706-6866

Funding

East Africa International Epidemiology Database to evaluate AIDS (IeDEA) Regional ConsortiumU01AI069911 · NIAID · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI AGGREY SEMWENDERO SEMEERE, Kara Kay Wools-Kaloustian · 2006 to 2026
$57.7M
Observational Antiretroviral Studies In Southern Africa (OASIS) CollaborationU01AI069924 · NIAID · UNIVERSITAT BERN · PI Cleophas Chimbetete, Mary-Ann Davies · 2006 to 2026
$55.9M
B positive_A population based evaluation of expanded ART access in pregnancyR01HD080465 · NICHD · UNIVERSITY OF CAPE TOWN · PI KALK, EMMA KATE · 2014 to 2019
$4.3M
National Institute of Allergy and Infectious Diseases U01AI069911NIAID NIH HHS U01 AI069911NIAID NIH HHS U01 AI069924NICHD NIH HHS R01 HD080465
6 · The paper itself

Abstract

backgroundIn the absence of clinical trials, data on the safety of medicine exposures in pregnancy are dependent on observational studies conducted after the agent has been licensed for use. This requires an accurate history of antenatal medicine use to determine potential risks. Medication use is commonly determined by self-report, clinician records, and electronic pharmacy data; different data sources may be more informative for different types of medication and resources may differ by setting. We compared three methods to determine antenatal medicine use (self-report, clinician records and electronic pharmacy dispensing records [EDR]) in women attending antenatal care at a primary care facility in Cape Town, South Africa in a setting with high HIV prevalence.

methodsStructured, interview-administered questionnaires recorded self-reported medicine use. Data were collected from clinician records and EDR on the same participants. We determined agreement between these data sources using Cohen's kappa and, lacking a gold standard, used Latent Class Analysis to estimate sensitivity, specificity and positive predictive value (PPV) for each data source.

resultsBetween 55% and 89% of 967 women had any medicine use documented depending on the data source (median number of medicines/participant = 5 [IQR 3-6]). Agreement between the datasets was poor regardless of class except for antiretroviral therapy (ART; kappa 0.6-0.71). Overall, agreement was better between the EDR and self-report than with either dataset and the clinician records. Sensitivity and PPV were higher for self-report and the EDR and were similar for the two. Self-report was the best source for over-the-counter, traditional and complementary medicines; clinician records for vaccines and supplements; and EDR for chronic medicines.

conclusionsMedicine use in pregnancy was common and no single data source included all the medicines used. ART was the most consistently reported across all three datasets but otherwise agreement between them was poor and dependent on class. Using a single data collection method will under-estimate medicine use in pregnancy and the choice of data source should be guided by the class of the agents being investigated.

Indexed as

HIV InfectionsPregnancy Complications, InfectiousFemaleHumansPregnancyPrenatal CareSouth AfricaSurveys and QuestionnairesAntenatal medicine-useComparison of data sourcesLow- and Middle-income countriesPharmacovigilancePregnancy

Identifiers

PMID35658841
PMCPMC9164333

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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.