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Maternal Recall of Prescription Medication Use During Pregnancy Using a Paper-Based Questionnaire

A Validation Study in The Netherlands

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Abstract

Background

In case-control studies that assess associations between medication use and birth defects, detailed information on type of medication and timing of use is essential to prevent misclassification. However, data on the accuracy of recall of medication use during pregnancy are scarce.

Objective

The aim of this study was to validate a self-administered questionnaire to assess prescription medication use in the 3 months before and during pregnancy.

Methods

This validation study was embedded in Eurocat Northern Netherlands, a population-based birth defects registry that covers 10 % of all births in The Netherlands. The questionnaire was validated among 560 mothers of infants with major birth defects registered from 1 January 2009 through 30 June 2010 by comparing it with a reference standard consisting of pharmacy data which were checked for compliance by maternal interviews. Sensitivity and specificity were calculated to quantify validity for any prescription medication use, groups of medications and individual medications. In addition, we determined whether maternal characteristics influenced disagreement between the questionnaire and the reference standard using logistic regression analyses.

Results

The sensitivity for any prescription medication use was 0.57, ranging between 0.07 (dermatological corticosteroids) and 0.83 (antihypertensives) for medication groups, and between 0.00 (naproxen) and 0.73 (salbutamol) for individual medications. Overall, specificity was high (0.93–1.00). Smoking during pregnancy and completing the questionnaire >2 years after delivery were associated with increased disagreement between the questionnaire for prescription medication use and the reference standard.

Conclusions

The validity of the self-administered questionnaire for prescription medication use during pregnancy was moderate to poor for most medications and disagreement differed by some maternal characteristics. As many epidemiological studies use similar questionnaires to assess medication use these studies may need additional data sources such as pharmacy records or prescription databases for medication use next to self-reported methods. Also, previous knowledge on the effect of questionnaire design should be taken into account.

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Acknowledgments

Eurocat-NNL is funded by the Dutch Ministry of Health, Welfare and Sports. Marleen van Gelder was supported by grant 021.001.008 from the Netherlands Organisation for Scientific Research (NWO). The funding organizations had no role in the design and conduct of the study; in the collection, management, analysis and interpretation of the data; or in the preparation, review or approval of the manuscript. The authors have no conflicts of interest to declare that are directly relevant to the content of this study. The authors thank Jennita Reefhuis and Gerhard Zielhuis for their valuable contributions to this manuscript.

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Authors and Affiliations

  1. Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands

    Marleen M. H. J. van Gelder, Iris A. L. M. van Rooij & Nel Roeleveld

  2. Eurocat Northern Netherlands, Department of Genetics, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands

    Hermien E. K. de Walle & Marian K. Bakker

Authors
  1. Marleen M. H. J. van Gelder
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  2. Iris A. L. M. van Rooij
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  3. Hermien E. K. de Walle
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  4. Nel Roeleveld
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  5. Marian K. Bakker
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Correspondence to Marleen M. H. J. van Gelder.

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van Gelder, M.M.H.J., van Rooij, I.A.L.M., de Walle, H.E.K. et al. Maternal Recall of Prescription Medication Use During Pregnancy Using a Paper-Based Questionnaire. Drug Saf 36, 43–54 (2013). https://doi.org/10.1007/s40264-012-0004-8

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