Standardized Reporting in Heart Failure Noninvasive Remote Monitoring Trials

BACKGROUND: Noninvasive remote patient monitoring (RPM) captures and transmits physiological (eg, weight) and symptom data to the patient's care team for monitoring outside of the clinic, creating opportunities for early intervention (eg, medical therapy optimization) to avoid decompensation events. Mixed results in studies of noninvasive RPM may stem from the complex design of heart failure programs. In current RPM study reports, many workflow components including data review and clinical responses are reported ambiguously or not at all. Opaque workflows prevent robust evaluation, replication in other studies, and community implementation of heart failure RPM programs. OBJECTIVES: The purpose of this study was to create a set of recommendations and a template for reporting workflow design in the publication of noninvasive RPM studies. METHODS: The Heart Failure Collaboratory, Canadian Heart Failure Society, and members of the European Society of Cardiology formed a multidisciplinary working group. Through an extensive consensus-building process, the authors reviewed existing workflows and data reporting practices and developed "the 6 Rs" of RPM Reporting. RESULTS: The authors created a set of recommendations and a template for reporting workflows that is organized around 6 Rs: patient Representativeness, ambulatory data Recording, data Relay to clinicians, clinician data Review, Response, and Recommendations from patients and providers. CONCLUSIONS: Systematic use of the 6 Rs of RPM Reporting template will improve the completeness and transparency of workflow reporting of RPM studies. The authors encourage investigators to use this framework and accompanying template during noninvasive RPM trial planning and include completed templates in study publications or as supplemental materials.