JMIR Publications

ABSTRACT

Background:

A large amount of data is generated in healthcare facilities. Nevertheless, this data is rarely made available for secondary research use. The reasons for this are manifold. Most importantly, there are different stakeholders whose needs have to be balanced. However, there are currently hardly any feasible solutions for this.

Objective:

The aim of this study was to develop a data trust model along with its supporting user interface applications to provide a legally and ethically sound framework for the secondary use of medical data. The development was based on extensive surveys of various stakeholders.

Methods:

Semi-structured interviews were conducted with researchers (data users) and institutional representatives of the Medical Center – University of Freiburg and online questionnaires were administered to patients (data subjects), data users and institutional representatives. The questionnaire for data subjects covered the dimensions trust (measured with a 5-point Likert scale), quality of interaction and involvement (measured with a 4-point Likert scale), subjective and objective understanding and usability (measured with the user version of the Mobile Application Rating Scale, uMARS). For all other stakeholder groups, the questionnaire focused on usability measured using the uMARS. The surveys comprised three phases. Following an initial requirements elicitation, two rounds of evaluation took place.

Results:

We devised SouveMed, a framework for secondary use of medical data, applied to the use case of sleep research data. The model includes secure onboarding of data subjects and digital use of consent, a digital interface for data users for onboarding, defining research aims, querying the amount of available data and, finally, either downloading data or having algorithms run on it; and, crucially, a data trust entity which matches the descriptions, consents and constraints of all stakeholders using digital representations and constraint solving techniques. Fourteen participants took part in the requirements elicitation, 22 in the first evaluation phase and 16 in the second evaluation phase. In the final evaluation, data subjects showed a high level of trust in the concept with an average rating of 4.28 (± 0.80) of 5 points on the trust scale. In terms of usability, the functionality of the system was rated as high with a mean score of 4.50 (± 0.81) of 5 points, with higher scores indicating higher perceived functionality. Each of the data users and institutional representatives surveyed in phase 2 (n = 6) rated SouveMed as having all the functionalities they desired. This is also reflected in a high functionality rating in the uMARS of 4.58 (± 0.52) of 5 points for this group.

Conclusions:

The SouveMed concept provides a comprehensive framework for the secondary use of medical data. The developed processes can easily be adapted to other areas of medical research. Clinical Trial: German Clinical Trial Register DRKS00031093