Abstract

BackgroundThis report describes the results of recruitment efforts and the subsequent participation of pregnant women in study activities in a 2010–2012 observational study focused on influenza illness and vaccination in California and Oregon, USA.MethodsSocio-demographic and health characteristics extracted from electronic medical records were compared among pregnant women who enrolled in the study, refused to participate, or were never reached for study invitation. These characteristics plus additional self-reported information were compared between women who enrolled in two study tracks: a prospective cohort vs. women enrolled following an acute respiratory illness (ARI) medical encounter. The characteristics of women who participated in weekly ARI surveillance (cohort enrollees, year one) and a 6-month follow-up interview (all enrollees) were also examined.ResultsIn year one, we reached 51% (6938/13,655) of the potential participants we tried to contact by telephone, and 20% (1374/6938) of the women we invited agreed to join the prospective cohort. Women with chronic medical conditions, pregnancy complications, and medical encounters for ARI (prior to pregnancy or during the study period) were more likely to be reached for recruitment and more likely to enroll in the cohort. Twenty percent of cohort enrollees never started weekly surveillance reports; among those who did, reports were completed for 55% of the surveillance weeks. Receipt of the influenza vaccine was higher among women who joined the cohort (76%) than those who refused (56%) or were never reached (54%). In contrast, vaccine uptake among medical enrollees in year one (54%; 53/98) and two (52%; 79/151) was similar to other pregnant women in those years. Study site, white race, non-Hispanic ethnicity, and not having a child aged < 13 years at home were most consistently associated with joining as a cohort or medical enrollee and completing study activities after joining.ConclusionsWe observed systematic differences in socio-demographic and health characteristics across different levels of participant engagement and between cohort and medical enrollees. More methodological research and innovation in conducting prospective observational studies in this population are needed, especially when extended participant engagement and ongoing surveillance are required.

Highlights

  • This report describes the results of recruitment efforts and the subsequent participation of pregnant women in study activities in a 2010–2012 observational study focused on influenza illness and vaccination in California and Oregon, USA

  • Cohort enrollees compared to non-participants in year one Of 13,655 potentially eligible pregnant women that we attempted to recruit across sites for the prospective cohort during year one, we reached half by telephone (51%); a substantially higher proportion of women were reached at site one (70%, 1813/2599) where local staff

  • Medical Enrollees a Medical vs. Reached but Cohort Refused to Enrollees Participate

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Summary

Introduction

This report describes the results of recruitment efforts and the subsequent participation of pregnant women in study activities in a 2010–2012 observational study focused on influenza illness and vaccination in California and Oregon, USA. There is a dearth of information on how best to conduct cohort and active surveillance studies among pregnant women [3,4,5]. This lack of information was especially evident to us in 2009 as we planned a two-year observational study of influenza vaccine effectiveness (IVE) in preventing laboratory-confirmed influenza illness during pregnancy [5]. We successfully completed the study and have previously reported IVE [6] and other findings on the epidemiology and prevention of influenza during pregnancy [7,8,9,10], many of the planning assumptions we made about cohort recruitment and surveillance participation [5] were proven wrong. After completing the main study objectives, we returned to take a closer look at how pregnant women responded to our study requests and consider possible sources of selection and information bias

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