Presentation (CTI)

OBJECTIVES: Guideline on Good Pharmacovigilance Practices Module XVI revision 3 introduced Addendum II, focusing on methods for evaluating risk minimization measures (RMMs) effectiveness. One major addition is the identification of qualitative methods, such as Grounded Theory, as additional tools to explore reasons for RMMs achieving (or not) their intended outcomes. Following evidence of insufficient compliance with valproate RMMs, this Grounded Theory study design, aligned with Addendum II, was approved by European Union Member States authorities.
METHODS: This safety study will include 5 European countries (France, Germany, Poland, Spain, Sweden, involved in a previous quantitative survey, EUPAS34465), representative of different healthcare systems and cultural backgrounds providing diversity in clinical practice, valproate RMMs implementations, access to contraception and counselling. The objective is to qualify and describe the barriers and reasons for insufficient compliance to valproate RMMs among diverse types of Healthcare Professionals (HCPs) prescribing/dispensing valproate and women of childbearing potential/pregnant women/female adolescents treated with valproate for epilepsy or bipolar disorder. Overall minimal recruitment is set to 100 patients and 60 HCPs individual semi-structured interviews, complemented by focus groups involving 120 HCPs, adjustable according to data saturation per country. Recruitment favors diversity, relying on purposeful sampling, targeting specific websites/platforms/associations/panels/advocacy groups. Analysis will be descriptive and iterative, using thematic coding of interview transcripts. Results will be presented as a dendrogram displaying concepts and domains hierarchization.
RESULTS: Study methods using Grounded Theory are aligned with Addendum II recent qualitative research guidelines: extensive use of interviews and focus groups, variables as domains of investigation, sampling strategies, iterative and comparative processes, data saturation concept, targeting diversity over representativeness.
CONCLUSIONS: The qualitative approach will capture different concepts providing insights into valproate-treated patients’ medical journeys and technical/operational hurdles faced by HCPs regarding RMMs adoption. This design represents a concrete example of Addendum II Grounded Theory guidance.