JMIR Publications

ABSTRACT

Background:

Patient-Generated Health Data (PGHD) collected from innovative wearables are enabling healthcare to shift to outside clinical settings through Remote Patient Monitoring (RPM) initiatives. However, PGHD are collected continuously under the patient’s responsibilities in rapidly changing circumstances during the patient’s daily life. This poses risks to the quality of PGHD and, in turn, reduces their trustworthiness and fitness for use in clinical practice.

Objective:

Using a socio-technical health informatics lens, this research aimed to investigate how Data Quality Management (DQM) principles can be applied to ensure that PGHD from wearables can reliably inform clinical decision making in RPM.

Methods:

First, clinicians, health information specialists and MedTech industry representatives with experience in RPM were interviewed to identify DQM challenges. Second, those groups were joined by patients in a workshop to co-design potential solutions to meet the expectations of all stakeholders. Third, the findings along with literature and policy review results, were interpreted to construct a guideline. Finally, we validated the guideline through a Delphi survey of international health informatics and health information management experts.

Results:

The resulting guideline comprised 19 recommendations across seven aspects of DQM. It explicitly addressed the needs of patients and clinicians but implied that there must be collaboration among all stakeholders, to meet these needs.

Conclusions:

The increasing proliferation of PGHD from wearables in RPM requires a systematic approach to DQM so that these data can be reliably used in clinical care. The developed guideline is a significant next step toward safe RPM.