Perinatal pharmacoepidemiology: How often are key methodological elements reported in publications?
epidemiology
observational
pharmacoepidemiology
pregnancy
reproductive
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
revised:
26
08
2021
received:
03
05
2021
accepted:
03
09
2021
pubmed:
10
9
2021
medline:
4
1
2022
entrez:
9
9
2021
Statut:
ppublish
Résumé
Publications provide important information for clinicians, researchers, and patients. Key methodological elements must be reported for maximum transparency. We identified key methodological elements necessary for fully understanding perinatal pharmacoepidemiology research and quantified the proportion of studies that reported these elements in a sample of publications. Key methodological elements were identified from guidelines from regulatory agencies, literature, and subject-matter knowledge: source of information to determine pregnancy start; mother- or father-infant linkages (process, success rate); unit of analysis; and whether non-live births and fetuses with various anomalies were included in the study population. We conducted a literature review for recent observational studies on medical product utilization or safety during pregnancy and estimated the prevalence of reporting these elements. Data were extracted from a random sample of 100 publications; 8% were published in epidemiology/pharmacoepidemiology journals; 85% were medical product-safety studies. Of publications for which each element was applicable, 43% reported the source for determining pregnancy start; 57%, whether the study population included multifetal pregnancies; 39%, whether it included more than one pregnancy per woman; 27%, whether it included fetuses with chromosomal abnormalities; 60%, fetuses with major congenital malformations; and 93%, non-live births. Of the 20 studies with mother-infant linkage, 35% described the process; 21% reported the linkage success rate. Among studies with more than one pregnancy/offspring per woman, 22% reported methods addressing sibling correlation. In this sample of pregnancy-related pharmacoepidemiology publications, completeness of reporting could have been improved. A pregnancy-specific checklist would increase transparency in the dissemination of study results.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
61-71Informations de copyright
© 2021 John Wiley & Sons Ltd.
Références
Viswanathan M, Ansari MT, Berkman ND, et al. Assessing the risk of bias of individual studies in systematic reviews of health care interventions. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Agency for Healthcare Research and Quality (US); 2008. https://www.ncbi.nlm.nih.gov/pubmed/22479713
EQUATOR network. Library for health research reporting. Enhancing the QUAlity and Transparency Of health Research (EQUATOR); 2021. https://www.equator-network.org/reporting-guidelines/. .
Food and Drug Administration. Postapproval Pregnancy Safety Studies. Guidance for Industry. Draft Guidance. US Department of Health and Human Services; May 2019. https://www.fda.gov/media/124746/download. https://doi.org/10.1177/2471549219897661.
European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Product- or population-specific considerations III: pregnant and breastfeeding women. Draft for public consultation; Dec 4, 2019. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-product-population-specific-considerations-iii_en.pdf. https://doi.org/10.1177/2471549219897661.
Butler M, Epstein RA, Totten A, et al. AHRQ series on complex intervention systematic reviews-paper 3: adapting frameworks to develop protocols. J Clin Epidemiol. 2017;90:19-27. https://doi.org/10.1016/j.jclinepi.2017.06.013
Regan AK, Tracey LE, Blyth CC, Richmond PC, Effler PV. A prospective cohort study assessing the reactogenicity of pertussis and influenza vaccines administered during pregnancy. Vaccine. 2016;34:2299-2304. https://doi.org/10.1016/j.vaccine.2016.03.084
Rivero-Ferrer E, Martinez D, Rasouliyan L, et al. Do ICPE pregnancy abstracts make it to term? [conference abstract]. Pharmacoepidemiol Drug Saf. 2018;27:241-521. https://doi.org/10.1002/pds.4629, https://www.rtihs.org/sites/default/files/29155%20RiveroFerrer%202018%20Do%20ICPE%20pregnancy%20abstracts%20make%20it%20to%20term.pdf
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ENCePP checklist for study protocols (revision 4); October 15, 2018. http://www.encepp.eu/standards_and_guidances/checkListProtocols.shtml. https://doi.org/10.1111/cup.13313.
Benchimol EI, Smeeth L, Guttmann A, et al. The REporting of studies conducted using observational routinely-collected health data (RECORD) statement. PLoS Med. 2015;12:e1001885. https://doi.org/10.1371/journal.pmed.1001885
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007;370:1453-1457. https://doi.org/10.1016/S0140-6736(07)61602-X
Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ. 2018;363:k3532. https://doi.org/10.1136/bmj.k3532
Wang SV, Schneeweiss S, Berger ML, et al. Reporting to improve reproducibility and facilitate validity assessment for healthcare database studies V1.0. Pharmacoepidemiol Drug Saf. 2017;26:1018-1032. https://doi.org/10.1002/pds.4295
Horvat O, Tomic Z, Mijatovic V, Sabo A. Drug utilization in treatment of thyroid disorders during pregnancy in Serbia. Med Pregl. 2016;69:11-15. https://doi.org/10.2298/mpns1602011h
Garne E, Vinkel Hansen A, Morris J, et al. Risk of congenital anomalies after exposure to asthma medication in the first trimester of pregnancy - a cohort linkage study. BJOG. 2016;123:1609-1618. https://doi.org/10.1111/1471-0528.14026
Griffin JB, Yu L, Watson D, et al. Pertussis immunisation in pregnancy safety (PIPS) study: a retrospective cohort study of safety outcomes in pregnant women vaccinated with Tdap vaccine. Vaccine. 2018;36:5173-5179. https://doi.org/10.1016/j.vaccine.2018.07.011
Nezvalova-Henriksen K, Wood M, Spigset O, et al. Association of prenatal ibuprofen exposure with birth weight and gestational age: a population-based sibling study. PLoS One. 2016;11:e0166971. https://doi.org/10.1371/journal.pone.0166971
Ventura M, Maraschini A, D'Aloja P, et al. Drug prescribing during pregnancy in a central region of Italy, 2008-2012. BMC Public Health. 2018;18:623. https://doi.org/10.1186/s12889-018-5545-z
Shihman B, Goldstein L, Amiel N, Benninger F. Antiepileptic drug treatment during pregnancy and delivery in women with epilepsy-a retrospective single center study. Epilepsy Res. 2019;149:66-69. https://doi.org/10.1016/j.eplepsyres.2018.11.010
Tennis P, Chan KA, Curkendall SM, et al. Topiramate use during pregnancy and major congenital malformations in multiple populations. Birth Defects Res A Clin Mol Teratol. 2015;103:269-275. https://doi.org/10.1002/bdra.23357
Tsao NW, Lynd LD, Sadatsafavi M, Hanley G, de Vera MA. Patterns of biologics utilization and discontinuation before and during pregnancy in women with autoimmune diseases: a population-based cohort study. Arthritis Care Res (Hoboken). 2018;70:979-986. https://doi.org/10.1002/acr.23434
Li DK, Ferber JR, Odouli R, Quesenberry C. Use of nonsteroidal antiinflammatory drugs during pregnancy and the risk of miscarriage. Am J Obstet Gynecol. 2018;219:275.e271-275.e278. https://doi.org/10.1016/j.ajog.2018.06.002
Zipori Y, Lauterbach R, Matanes E, Beloosesky R, Weiner Z, Weissman A. Vaginal progesterone for the prevention of preterm birth and the risk of gestational diabetes. Eur J Obstet Gynecol Reprod Biol. 2018;230:6-9. https://doi.org/10.1016/j.ejogrb.2018.09.011
Huttel E, Padberg S, Meister R, et al. Pregnancy outcome of first trimester exposure to the vitamin K antagonist phenprocoumon depends on duration of treatment. Thromb Haemost. 2017;117:870-879. https://doi.org/10.1160/th16-11-0838
Blais L, Kettani FZ, Forget A, Beauchesne MF, Lemière C, Rey E. Long-acting beta2-agonists and risk of hypertensive disorders of pregnancy: a cohort study. J Allergy Clin Immunol Pract. 2018;6:555-561.e552. https://doi.org/10.1016/j.jaip.2017.07.004
King RW, Baca MJ, Armenti VT, Kaplan B. Pregnancy outcomes related to mycophenolate exposure in female kidney transplant recipients. Am J Transplant. 2017;17:151-160. https://doi.org/10.1111/ajt.13928
Alami Z, Agier MS, Ahid S, et al. Pregnancy outcome following in utero exposure to azathioprine: a French comparative observational study. Therapie. 2018;73:199-207. https://doi.org/10.1016/j.therap.2017.06.006
Fisher SC, Van Zutphen AR, Romitti PA, et al. Maternal hypertension, antihypertensive medication use, and small for gestational age births in the National Birth Defects Prevention Study, 1997-2011. Matern Child Health J. 2018;22:237-246. https://doi.org/10.1007/s10995-017-2395-8
Friend S, Richman S, Bloomgren G, Cristiano LM, Wenten M. Evaluation of pregnancy outcomes from the Tysabri(R) (natalizumab) pregnancy exposure registry: a global, observational, follow-up study. BMC Neurol. 2016;16:150. https://doi.org/10.1186/s12883-016-0674-4
Furu K, Kieler H, Haglund B, et al. Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design. BMJ. 2015;350:h1798. https://doi.org/10.1136/bmj.h1798
Desai RJ, Bateman BT, Huybrechts KF, et al. Risk of serious infections associated with use of immunosuppressive agents in pregnant women with autoimmune inflammatory conditions: cohort study. BMJ. 2017;356:j895. https://doi.org/10.1136/bmj.j895
Layton JB, Butler AM, Li D, et al. Prenatal Tdap immunization and risk of maternal and newborn adverse events. Vaccine. 2017;35:4072-4078. https://doi.org/10.1016/j.vaccine.2017.06.071
Dathe K, Padberg S, Hultzsch S, et al. Exposure to cox-2 inhibitors (coxibs) during the first trimester and pregnancy outcome: a prospective observational cohort study. Eur J Clin Pharmacol. 2018;74:489-495. https://doi.org/10.1007/s00228-017-2385-1
Morken NH, Diaz-Garcia C, Reisaeter AV, et al. Obstetric and neonatal outcome of pregnancies fathered by males on immunosuppression after solid organ transplantation. Am J Transplant. 2015;15:1666-1673. https://doi.org/10.1111/ajt.13159
Liu X, Agerbo E, Ingstrup KG, et al. Antidepressant use during pregnancy and psychiatric disorders in offspring: Danish nationwide register based cohort study. BMJ. 2017;358:j3668. https://doi.org/10.1136/bmj.j3668
Chaparro M, Verreth A, Lobaton T, et al. Long-term safety of in utero exposure to anti-TNFα drugs for the treatment of inflammatory bowel disease: results from the multicenter European TEDDY study. Am J Gastroenterol. 2018;113:396-403. https://doi.org/10.1038/ajg.2017.501
Berenson AB, Hirth JM, Rahman M, Laz TH, Rupp RE, Sarpong KO. Maternal and infant outcomes among women vaccinated against pertussis during pregnancy. Hum Vaccin Immunother. 2016;12:1965-1971. https://doi.org/10.1080/21645515.2016.1157241
Ishibashi K, Aiba T, Kamiya C, et al. Arrhythmia risk and beta-blocker therapy in pregnant women with long QT syndrome. Heart. 2017;103:1374-1379. https://doi.org/10.1136/heartjnl-2016-310617
Moher D, Liberati A, Tetzlaff J, Altman DG, for the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535. https://doi.org/10.1136/bmj.b2535