PMID- 28824274 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20191120 IS - 1178-2595 (Print) IS - 1178-2595 (Linking) VI - 31 IP - 4 DP - 2017 TI - Risk Perceptions in Diabetic Patients Who Have Experienced Adverse Events: Implications for Patient Involvement in Regulatory Decisions. PG - 245-255 LID - 10.1007/s40290-017-0200-z [doi] AB - 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 complications 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. FAU - Sachs, Mikkel Lindskov AU - Sachs ML AUID- ORCID: 0000-0001-5731-4308 AD - Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark. ISNI: 0000 0001 0674 042X. GRID: grid.5254.6 AD - Novo Nordisk A/S, Soeborg, Denmark. GRID: grid.425956.9 FAU - Sporrong, Sofia Kalvemark AU - Sporrong SK AUID- ORCID: 0000-0001-5848-8625 AD - Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark. ISNI: 0000 0001 0674 042X. GRID: grid.5254.6 FAU - Colding-Jorgensen, Morten AU - Colding-Jorgensen M AD - Novo Nordisk A/S, Soeborg, Denmark. GRID: grid.425956.9 FAU - Frokjaer, Sven AU - Frokjaer S AUID- ORCID: 0000-0001-6311-8266 AD - Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark. ISNI: 0000 0001 0674 042X. GRID: grid.5254.6 FAU - Helboe, Per AU - Helboe P AUID- ORCID: 0000-0002-3189-3177 AD - Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark. ISNI: 0000 0001 0674 042X. GRID: grid.5254.6 FAU - Jelic, Katarina AU - Jelic K AUID- ORCID: 0000-0002-1465-2603 AD - Novo Nordisk A/S, Soeborg, Denmark. GRID: grid.425956.9 FAU - Kaae, Susanne AU - Kaae S AUID- ORCID: 0000-0002-8187-365X AD - Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark. ISNI: 0000 0001 0674 042X. GRID: grid.5254.6 LA - eng PT - Journal Article DEP - 20170718 PL - New Zealand TA - Pharmaceut Med JT - Pharmaceutical medicine JID - 101471195 PMC - PMC5539258 COIS- ETHICAL APPROVAL: The confidentiality and anonymity of the data were ensured according to acting law. The study and the related data management was approved by the Head of Faculty and the Data Management Unit of the University of Copenhagen, Faculty of Health and Medicines. The Danish Data Protection Agency approved the study (Reference: SUND-2016-47). The study was conducted with the ethical standards of the Declaration of Helsinki. This includes adherence to the use of informed consent specified in the declaration. FUNDING: Funding for this study was provided by Innovation Fund Denmark (Department of the Ministry of Higher Education and Science) and Novo Nordisk A/S as part of a public-industrial co-funded PhD project. The funders did not have a role in the study's execution or reporting. Publication of the study results was not dependent on the approval of either funder. CONFLICT OF INTEREST: Mikkel Lindskov Sachs is currently employed as a full-time industrial PhD student at the University of Copenhagen and Novo Nordisk A/S. Morten Colding-Jorgensen is a consultant and shareholder, Novo Nordisk A/S. Katarina Jelic, full-time employee and shareholder, Novo Nordisk A/S. Per Helboe, Sven Frokjaer, Sofia Kalvemark Sporrong, and Susanne Kaae have no conflicts of interest to declare. EDAT- 2017/08/22 06:00 MHDA- 2017/08/22 06:01 PMCR- 2017/07/18 CRDT- 2017/08/22 06:00 PHST- 2017/08/22 06:00 [entrez] PHST- 2017/08/22 06:00 [pubmed] PHST- 2017/08/22 06:01 [medline] PHST- 2017/07/18 00:00 [pmc-release] AID - 200 [pii] AID - 10.1007/s40290-017-0200-z [doi] PST - ppublish SO - Pharmaceut Med. 2017;31(4):245-255. doi: 10.1007/s40290-017-0200-z. Epub 2017 Jul 18.