Attitudes of Patients with Chronic Heart Failure Toward Digital Device Data for Self-documentation and Research in Germany: Cross-sectional Survey Study

Abstract

Background: In recent years, the use of digital mobile measurement devices (DMMDs) for self-documentation in cardiovascular care in Western industrialized health care systems has increased. For patients with chronic heart failure (cHF), digital self-documentation plays an increasingly important role in self-management. Data from DMMDs can also be integrated into telemonitoring programs or data-intensive medical research to collect and evaluate patient-reported outcome measures through data sharing. However, the implementation of data-intensive devices and data sharing poses several challenges for doctors and patients as well as for the ethical governance of data-driven medical research. Objective: This study aims to explore the potential and challenges of digital device data in cardiology research from patients’ perspectives. Leading research questions of the study concerned the attitudes of patients with cHF toward health-related data collected in the use of digital devices for self-documentation as well as sharing these data and consenting to data sharing for research purposes. Methods: A cross-sectional survey of patients of a research in cardiology was conducted at a German university medical center (N=159) in 2020 (March to July). Eligible participants were German-speaking adult patients with cHF at that center. A pen-and-pencil questionnaire was sent by mail. Results: Most participants (77/105, 73.3%) approved digital documentation, as they expected the device data to help them observe their body and its functions more objectively. Digital device data were believed to provide cognitive support, both for patients’ self-assessment and doctors’ evaluation of their patients’ current health condition. Interestingly, positive attitudes toward DMMD data providing cognitive support were, in particular, voiced by older patients aged >65 years. However, approximately half of the participants (56/105, 53.3%) also reported difficulty in dealing with self-documented data that lay outside the optimal medical target range. Furthermore, our findings revealed preferences for the self-management of DMMD data disclosed for data-intensive medical research among German patients with cHF, which are best implemented with a dynamic consent model. Conclusions: Our findings provide potentially valuable insights for introducing DMMD in cardiovascular research in the German context. They have several practical implications, such as a high divergence in attitudes among patients with cHF toward different data-receiving organizations as well as a large variance in preferences for the modes of receiving information included in the consenting procedure for data sharing for research. We suggest addressing patients’ multiple views on consenting and data sharing in institutional normative governance frameworks for data-intensive medical research.