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

Simple item page
dc.contributor.authorvan der Hoven, Jani
dc.contributor.authorAllen, Elizabeth
dc.contributor.authorCois, Annibale
dc.contributor.authorde Waal, Renee
dc.contributor.authorMaartens, Gary
dc.contributor.authorMyer, Landon
dc.contributor.authorMalaba, Thokozile
dc.contributor.authorMadlala, Hlengiwe
dc.contributor.authorNyemba, Dorothy
dc.contributor.authorPhelanyane, Florence
dc.contributor.authorBoulle, Andrew
dc.contributor.authorMehta, Ushma
dc.contributor.authorKalk, Emma
dc.date.accessioned2022-07-08T08:23:57Z
dc.date.available2022-07-08T08:23:57Z
dc.date.issued2022-06-03
dc.date.updated2022-06-05T03:10:51Z
dc.description.abstractBackground In 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. Methods Structured, 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. Results Between 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. Conclusions Medicine 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.en_US
dc.identifier.apacitationvan der Hoven, J., Allen, E., Cois, A., de Waal, R., Maartens, G., Myer, L., ... Kalk, E. (2022). Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment. <i>BMC Pregnancy and Childbirth</i>, 22(1), 466. http://hdl.handle.net/11427/36635en_ZA
dc.identifier.chicagocitationvan der Hoven, Jani, Elizabeth Allen, Annibale Cois, Renee de Waal, Gary Maartens, Landon Myer, Thokozile Malaba, et al "Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment." <i>BMC Pregnancy and Childbirth</i> 22, 1. (2022): 466. http://hdl.handle.net/11427/36635en_ZA
dc.identifier.citationvan der Hoven, J., Allen, E., Cois, A., de Waal, R., Maartens, G., Myer, L., Malaba, T. & Madlala, H. et al. 2022. Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment. <i>BMC Pregnancy and Childbirth.</i> 22(1):466. http://hdl.handle.net/11427/36635en_ZA
dc.identifier.ris TY - Journal Article AU - van der Hoven, Jani AU - Allen, Elizabeth AU - Cois, Annibale AU - de Waal, Renee AU - Maartens, Gary AU - Myer, Landon AU - Malaba, Thokozile AU - Madlala, Hlengiwe AU - Nyemba, Dorothy AU - Phelanyane, Florence AU - Boulle, Andrew AU - Mehta, Ushma AU - Kalk, Emma AB - Background In 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. Methods Structured, 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. Results Between 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. Conclusions Medicine 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. DA - 2022-06-03 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Pregnancy and Childbirth KW - Pharmacovigilance KW - Pregnancy KW - Antenatal medicine-use KW - Comparison of data sources KW - Low- and Middle-income countries LK - https://open.uct.ac.za PY - 2022 T1 - Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment TI - Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment UR - http://hdl.handle.net/11427/36635 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s12884-022-04765-1
dc.identifier.urihttp://hdl.handle.net/11427/36635
dc.identifier.vancouvercitationvan der Hoven J, Allen E, Cois A, de Waal R, Maartens G, Myer L, et al. Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment. BMC Pregnancy and Childbirth. 2022;22(1):466. http://hdl.handle.net/11427/36635.en_ZA
dc.language.rfc3066en
dc.publisher.departmentCentre for Infectious Disease Epidemiology and Research (CIDER)en_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceBMC Pregnancy and Childbirthen_US
dc.source.journalissue1en_US
dc.source.journalvolume22en_US
dc.source.pagination466en_US
dc.source.urihttps://bmcpregnancychildbirth.biomedcentral.com/
dc.subjectPharmacovigilanceen_US
dc.subjectPregnancyen_US
dc.subjectAntenatal medicine-useen_US
dc.subjectComparison of data sourcesen_US
dc.subjectLow- and Middle-income countriesen_US
dc.titleDetermining antenatal medicine exposures in South African women: a comparison of three methods of ascertainmenten_US
dc.typeJournal Articleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
12884_2022_Article_4765.pdf
Size:
1.15 MB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
0 B
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Journal Articles