Recommendations for the Quality Management of Patient-Generated Health Data in Remote Patient Monitoring: Mixed Methods Study

Abstract

Background: Patient-generated health data (PGHD) collected from innovative wearables are enabling health care to shift to outside clinical settings through remote patient monitoring (RPM) initiatives. However, PGHD are collected continuously under the patient’s responsibility 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 sociotechnical health informatics lens, we developed a data quality management (DQM) guideline for PGHD captured from wearable devices used in RPM with the objective of investigating how DQM principles can be applied to ensure that PGHD 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, these stakeholder groups were joined by patient representatives in a workshop to co-design potential solutions to meet the expectations of all the stakeholders. Third, the findings, along with the 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 guideline constructed in this study comprised 19 recommendations across 7 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 an important next step toward safe RPM.