Sachs Mikkel Lindskov, Sporrong Sofia Kälvemark, Colding-Jørgensen Morten, Frokjaer Sven, Helboe Per, Jelic Katarina, Kaae Susanne
Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark.
Novo Nordisk A/S, Soeborg, Denmark.
Pharmaceut Med. 2017;31(4):245-255. doi: 10.1007/s40290-017-0200-z. Epub 2017 Jul 18.
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.
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.
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.
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.
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.
如今，患者越来越多地被期望去影响以往由监管机构、制药公司和医疗保健专业人员做出的决策。在进行获益-风险评估时，当权衡罕见、严重不良事件（AE）时，个别患者曾代表其患者群体。然而，患者群体的异质性程度对于个体能够多准确地代表他们而言至关重要。
本研究旨在探讨患者对于个体患者所使用的降血糖抗糖尿病药物罕见、严重不良反应的风险认知。
对18名患有糖尿病且自我感觉有严重但不一定罕见的不良事件（如中风、瓣膜或搭桥手术）的患者进行了半结构化访谈。访谈探讨了患者的疾病史、对罕见和严重这两个术语的认知以及总体风险厌恶水平。对访谈进行了主题分析，包括共识讨论。
有趣的是，受访者很少能明确区分药物引起的不良事件和与疾病进展相关的并发症。对不良事件的担忧显然多种多样，但与受访者的个人经历系统相关。受访者通常会忽略关于可能的罕见、严重不良事件的信息，除非它与个人经历有关。在缺乏相关经历的情况下，担忧集中在常见且不太严重的不良事件上，从而忽视了罕见且更严重的事件。
该研究表明，与药物或疾病相关的不良事件经历是患者风险认知的一个重要因素。因此，我们建议在邀请患者对监管决策提供意见时，应将严重不良经历纳入传统的社会经济因素考量范围。
