JMIR Publications

ABSTRACT

Background:

In recent years, use of digital mobile measurement devices (DMMD) for self-documentation in cardiovascular care in Western industrialized health care systems has increased. Chronic Heart Failure (cHF) patients are one of those patient groups with cardiovascular findings for whom digital self-documentation plays an increasingly important role in self-management. Data from DMMD can also be integrated into telemonitoring programs or data-intensive medical research to collect and evaluate patient reported outcome measures via data sharing. However, implementation of data-intensive devices and data sharing pose several challenges for physicians and patients as well as for the ethical governance of data-driven medical research.

Objective:

This study explored the potential and challenges of digital device data for cardiology research from patients’ perspectives. Leading research questions of the study concerned cHF patients’ attitudes towards: (1) health-related data collected in the use of digital devices for self-documentation; and (2) sharing health data and consenting to data sharing for research purposes.

Methods:

A cross-sectional survey study among patients of a research use case in cardiology was conducted at a German university medical center (n=105). Eligible participants were German speaking adult cHF patients at that center. The pen and pencil-questionnaire was send by mail.

Results:

The majority of participants approved digital documentation, as they expected the device data to help them observe their body and its functions more objectively. Digital device data was believed to provide ‘cognitive support’ both for patients’ self-assessment and physicians’ evaluation of patients’ current health condition. Interestingly, positive attitudes to DMMD data providing cognitive support were in particular voiced by older patients (≥65 years). However, approximately half of the participants (53.33%, 56/105) also reported unease when dealing with self-documented data that lay outside the optimal medical target range. Furthermore, our findings revealed preferences for self-management of DMMD data disclosed for data-intensive medical research which are best implemented with a dynamic consent model

Conclusions:

Our findings provide insights for implementing DMMD in cardiac research with a number of practical implications, such as how divergent attitudes and preferences among CHF patients towards different recipient bodies affect consent to sharing data for research. We suggest addressing patients’ plural views on consenting and data sharing in institutional normative governance frameworks for data-intensive medical research.