Risk Perceptions in Diabetic Patients Who Have Experienced Adverse Events: Implications for Patient Involvement in Regul
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ORIGINAL RESEARCH ARTICLE
Risk Perceptions in Diabetic Patients Who Have Experienced Adverse Events: Implications for Patient Involvement in Regulatory Decisions Mikkel Lindskov Sachs1,2 • Sofia Ka¨lvemark Sporrong1 • Morten Colding-Jørgensen2 • Sven Frokjaer1 • Per Helboe1 Katarina Jelic2 • Susanne Kaae1
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Published online: 18 July 2017 Ó The Author(s) 2017. This article is an open access publication
Abstract Background Increasingly, patients are expected to influence decisions previously reserved for regulatory agencies, pharmaceutical companies, and healthcare professionals. Individual patients have previously represented their patient population when rare, serious adverse events (AEs) were weighed as part of a benefit-risk assessment. However, the degree of heterogeneity of the patient population is critical for how accurately they can be represented by individuals. Objectives This study aims to explore patients’ risk perception of rare, serious adverse effects of medicines with regard to blood glucose-lowering antidiabetics used by the individual patient. Methods Semi-structured interviews were conducted with 18 patients with diabetes with self-perceived serious, but not necessarily rare, AEs (e.g. stroke or valve or bypass surgery). The interviews explored the patients’ history of disease, perceptions of the terms rare and serious, and overall levels of risk aversion. A thematic analysis of the interviews, including a consensus discussion, was carried out. Results Interestingly, respondents rarely made a clear distinction between medicines-induced AEs and compli-
cations related to disease progression. Concerns regarding AEs were apparently diverse but were systematically related to the personal experiences of the respondents. Respondents routinely ignored information about possible rare, serious AEs, unless it could be related to personal experience. In the absence of experience, concerns were focused on common and less serious AEs, thus disregarding rare and more serious events. Conclusion The study suggests that experience of AEs, related to either medicines or disease, constitutes an important factor of patient risk perception. We therefore propose that serious adverse experiences should be added to the traditional panel of socioeconomic factors that are accounted for when patients are invited to give input on regulatory decisions.
Key Points The interviewed patients primarily described experienced events that had either obstructed everyday life or were particularly frightening as serious, and these were the focus of future concern. Patients who seemed alike were not concerned with the same type of adverse events (AEs), suggesting attitudes towards AEs of diverse patient groups are not easily represented.
& Mikkel Lindskov Sachs [email protected] 1
Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark
2
Novo Nordisk A/S, Soeborg, Denmark
The study suggests that the personal experience of pat
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