title: An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy.
abstract: BACKGROUND
  Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited.
  
  
  OBJECTIVE
  To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a study of self-reported gestational exposures and pregnancy outcomes.
  
  
  METHODS
  The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) pregnancy study is a non-interventional, prospective pilot study of self-reported medication use and obstetric outcomes provided by a cohort of pregnant women that was conducted in Denmark, the Netherlands, Poland, and the United Kingdom. Direct-to-participant advertisements were provided via websites, emails, leaflets, television, and social media platforms.
  
  
  RESULTS
  Over a 70-week recruitment period direct-to-participant advertisements engaged 43,234 individuals with the study website or telephone system; 4.78% (2065/43,234) of which were successfully enrolled and provided study data. Of these 90.4% (1867/2065) were recruited via paid advertising methods, 23.0% (475/2065) of whom were in the first trimester of pregnancy. The overall costs per active recruited participant were lowest for email (€23.24) and website (€24.41) advertisements and highest for leaflet (€83.14) and television (€100.89). Website adverts were substantially superior in their ability to recruit participants during their first trimester of pregnancy (317/668, 47.5%) in comparison with other advertising methods (P<.001). However, we identified international variations in both the cost-effectiveness of the various advertisement methods used and in their ability to recruit participants in early pregnancy.
  
  
  CONCLUSIONS
  Recruitment of a pregnant cohort using direct-to-participant advertisement methods is feasible, but the total costs incurred are not insubstantial. Future research is needed to identify advertising strategies capable of recruiting large numbers of demographically representative pregnant women, preferentially in early pregnancy.
authors.affiliation: The UK Teratology Information ServiceNewcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon TyneUnited Kingdom.|Institute of Cellular MedicineNewcastle UniversityNewcastle upon TyneUnited Kingdom.
authors.forename: Jonathan Luke
authors.identifier: 0000-0003-3494-9559
authors.initials: JL
authors.lastname: Richardson
authors.affiliation: The UK Teratology Information ServiceNewcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon TyneUnited Kingdom.|Institute of Cellular MedicineNewcastle UniversityNewcastle upon TyneUnited Kingdom.
authors.forename: Sally
authors.identifier: 0000-0003-4567-4781
authors.initials: S
authors.lastname: Stephens
authors.affiliation: The UK Teratology Information ServiceNewcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon TyneUnited Kingdom.|Institute of Cellular MedicineNewcastle UniversityNewcastle upon TyneUnited Kingdom.
authors.forename: Simon Hugh Lynton
authors.identifier: 0000-0002-0581-6389
authors.initials: SHL
authors.lastname: Thomas
authors.affiliation: Department of Medical GeneticsPoznan University of Medical SciencesPoznanPoland.
authors.forename: Anna
authors.identifier: 0000-0001-6102-4274
authors.initials: A
authors.lastname: Jamry-Dziurla
authors.affiliation: Unit of PharmacoEpidemiology and PharmacoEconomicsDepartment of PharmacyUniversity of GroningenGroningenNetherlands.
authors.forename: Lolkje
authors.identifier: 0000-0002-9589-3432
authors.initials: L
authors.lastname: de Jong-van den Berg
authors.affiliation: Unit of PharmacoEpidemiology and PharmacoEconomicsDepartment of PharmacyUniversity of GroningenGroningenNetherlands.
authors.forename: Priscilla
authors.identifier: 0000-0002-8411-6654
authors.initials: P
authors.lastname: Zetstra-van der Woude
authors.affiliation: Department of Data Delivery and Medicinal Product StatisticsThe Danish Health Data AuthorityCopenhagenDenmark.
authors.forename: Maja
authors.identifier: 0000-0003-3096-1630
authors.initials: M
authors.lastname: Laursen
authors.affiliation: Quintiles Real-World and Late Phase ResearchSt. PrexSwitzerland.
authors.forename: Valerie
authors.identifier: 0000-0002-1252-0033
authors.initials: V
authors.lastname: Hliva
authors.affiliation: Imperial Clinical Trials UnitSchool of Public HealthImperial College LondonLondonUnited Kingdom.
authors.forename: Shahrul
authors.identifier: 0000-0002-7163-8402
authors.initials: S
authors.lastname: Mt-Isa
authors.affiliation: Real World Evidence SolutionsIMS HealthLondonUnited Kingdom.
authors.forename: Alison
authors.identifier: 0000-0002-0005-9016
authors.initials: A
authors.lastname: Bourke
authors.affiliation: Quintiles Real-World & Late Phase ResearchCambridge, MAUnited States.
authors.forename: Nancy A
authors.identifier: 0000-0003-0153-8286
authors.initials: NA
authors.lastname: Dreyer
authors.affiliation: Quintiles Real-World and Late Phase ResearchReadingUnited Kingdom.
authors.forename: Stella Cf
authors.identifier: 0000-0001-5937-1277
authors.initials: SC
authors.lastname: Blackburn
keywords: advertisement; pharmacovigilance recruitment; pregnancy; surveillance; teratogen