Direct-from-patient information on medication use: Protect pregnancy study results

Background: The PROTECT Pregnancy Study is a non-interventional, prospective study of pregnant women who provide information about medication use and key lifestyle factors at set intervals throughout their pregnancy, and pregnancy outcome. Objectives: This study was designed to pilot new methods of collecting pharmacovigilance data in natural language directly from reporters, whoever they are. Methods: Pregnant volunteers were sought mainly via the internet and leaflets in pharmacies. They were provided with study information and could choose to participate on-line or by phone using an interactive voice response system (IVRS). Internet participants could choose to provide data every 2 or 4weeks during pregnancy. In Denmark and the UK we also sought individual permission to link with electronic healthcare records to compare the reports of prescribed medication use, and where possible, birth outcomes. Results: Following informed consent, 2521 pregnant women from Denmark, the Netherlands, Poland, and the United Kingdom were recruited. Of these, only 14 (0.5%) chose to provide data via IVRS. After study entry, 82% of “internet” women and 1 (7%) “IVRS” woman went on to complete a detailed baseline questionnaire. The choice of follow up period varied between country, but overall 43% (range 28-49%) chose every two weeks and 58%, (range 49-72%) every 4 weeks. To date, 38% have provided followup data, despite all receiving reminders at each follow- up time point. Limited information was available as to why participants stopped participating as few subjects completed the discontinuation forms, which inquired about reasons. Conclusions: Pregnant women can be recruited directly to provide information for research via the internet but recruitment for data provision by IVRS was poor. Our research suggests additional tools are needed to enhance retention of recruited volunteers. These results should help guide future study designs using direct-to-patient enrolment and follow-up. Additional research from this project will examine self-reported medication use.