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Citation

Tappin D, Mackay D, Reynolds L & Fitzgerald N (2022) Minimizing sample bias due to stigmatized behaviours: the representativeness of participants in a cohort study of alcohol in pregnancy. BMC Medical Research Methodology, 22 (1), Art. No.: 138. https://doi.org/10.1186/s12874-022-01629-2

Abstract
Background Stigmatized behaviours are often underreported, especially in pregnancy, making them challenging to address. The Alcohol and Child Development Study (ACDS) seeks to inform prevention of foetal alcohol harm, linking self-report as well as a maternal blood alcohol biomarker with child developmental outcomes. Samples were requested using passive, generic consent. The success of this approach at minimizing bias is presented comparing characteristics of women who provided samples to those who did not. Methods All pregnant women in the study city were sent a Patient Information Sheet (PIS) with their first NHS obstetric appointment letter. The PIS informed them that the NHS would like to take an extra blood sample for research purposes, unless they opted out. Neither the women nor the midwives were informed that the samples might be tested for an alcohol biomarker. This paper examines the extent to which women who provided the extra sample were representative of women where no sample was provided, in terms of routinely collected information: age; body mass index; area-based deprivation; previous pregnancies, abortions and caesarians; smoking status and carbon monoxide level; self-reported alcohol use, gestation and birth weight of their baby. Chi-square and Mann-Whitney U tests were used to compare groups. Results 3436 (85%) of the 4049 pregnant women who attended their appointment provided the extra sample. Women who did not were significantly younger (p?

Keywords
Ethics of informed consent; Clinical markers; Cohort study; Data collection; Demography; Epidemiology

Journal
BMC Medical Research Methodology: Volume 22, Issue 1

• Published version