What German experts expect from individualized medicine: problems of uncertainty and future complication in physician–patient interaction

Abstract

'Individualized medicine' is an emerging paradigm in clinical life science research. We conducted a socioempirical interview study in a leading German clinical research group, aiming at implementing 'individualized medicine' of colorectal cancer. The goal was to investigate moral and social issues related to physician-patient interaction and clinical care, and to identify the points raised, supported and rejected by the physicians and researchers. Up to now there has been only limited insight into how experts dedicated to individualized medicine view its problems. Interviews with researchers and clinicians (n ¼ 19) were based on a prestructured questionnaire. The content analysis revealed a broad spectrum of opinions. Major findings were (a) disappointments with the limits of the current therapy regimen and clinical practice; (b) problematic impacts on physician-patient relationship; and (c) an informed consent procedure which is mainly based on paternalistic assumptions. According to our analysis, major problems will be uncertainties related to the biomarker's sensitivity and specificity, and the identification of 'nonresponders'. However, the findings also indicate that experts expect evidence-based medicine to replace decisions based on gut feeling or hierarchical structures. Arndt Heßling is a final-year medical student at the University Medical Center Goettingen. His doctoral thesis is about the exploration of physicians' and researchers' understanding of the implications of individualized prognostics and diagnostics of locally advanced colorectal cancer on medical ethics.

Re-focusing the ethical discourse on personalized medicine: a qualitative interview study with stakeholders in the German healthcare system

“…Besides, the respondents did neither mention (potential) distributional issues regarding personalized preventive measures nor did they allude to concerns of data protection, right to know/not to know or potential (genetic) discrimination regarding personalized therapeutic measures. Concerning the issues of data protection as well as the right to know/not to know, it is intriguing that another German interview study found that experts in the field of PM pointed exactly to these issues [10]. It is, however, important to realize that the study’s sample (n=19) consisted exclusively of researchers and clinicians involved in the same research group working on PM in the field of colorectal cancer.…”

“…This difference in sample composition might explain the different focus of the involved experts regarding ethical concerns in the field of PM. It has to be noticed, however, that the results of the two studies generally are difficult to compare as we used a different methodological approach with open questions and no concrete PM-example as stimulus (the experts in [10] were asked explicitly about the implications of their own development, the Rectumchip).…”

“…However, approaches of PM raise several ethical concerns: [1-3,5-10] first, with regard to research on PM, measures of adequately implementing informed consent for biomarker studies is discussed as well as issues of confidentiality, data protection and the individuals’ right to know/not to know. Furthermore, it is debated how to allocate resources into as well as within different fields of research on PM in ethically justified ways.…”

Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care

“…Thus, AI-driven decision support tools can significantly change the way treatment decisions are made. Importantly, to assist in achieving sustainable healthcare systems the relationship of patients and physicians needs to be redefined and the future role of physicians clarified [132, 137].…”

A Network-Based Mixed Methods Approach to Analyze Current Perspectives on Personalized Oncological Medicine in Austria

“…In the study by Budin-Ljøsne et al [ 15 ] for example, semi-structured telephone interviews among patient and interest organizations’ representatives in Europe and North America were carried out to investigate their views on PM. Stakeholders of the German HC system—including amongst others patient organizations, clinicians, researchers, representatives of the pharmaceutical industry and regulatory authorities [ 16 ], and clinical researchers working on PM in colorectal cancer [ 17 ]—were asked to share their thoughts on the new medical concept. The former study focused in particular on ethical issues and the latter on patient-doctor interactions.…”