Capturing and Measuring Patient Voice with PRO-PMs

Patient and family engagement is increasingly recognized as an essential component of high-quality clinical care. Patients as partners in care has long been a priority for national healthcare and physician organizations and plays an important role in assessing the quality of care, including patient experience and clinical outcomes.

Clinicians and organizations use different approaches to assess the quality of care from a patient’s perspective including: 

• Patient-reported outcomes
• Patient-reported outcome measures
• Patient-reported outcome-based performance measures

A patient-reported outcome (PRO) is “any report of the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by a clinician or anyone else. (FDA 2009) PROs may include reports of symptoms, functional status, or quality of care. 

Patient-reported outcome-based measures (PROMs) are instruments—usually self-reported questionnaires—that are used to measure PROs.

A patient-reported outcome-based performance measure (PRO-PM) is a performance measure that is based on aggregated PROM data collected directly from patients. 

Incorporating PROs within quality measures are important focuses of both the Centers for Medicare & Medicaid Services (CMS) and the Academy. In a 2022 report, CMS prioritized PRO-PM in its Meaningful Measures 2.0 framework. The design and implementation of PROs, PROMs, and subsequent PRO-PMs present unique challenges. The Academy is assessing approaches to develop meaningful, otolaryngology-specific tools to measure patient voice in the Reg-ent^SM registry. 

The Academy’s inaugural PROM centered on shared decision making for age-related hearing loss. Our current review focuses on postsurgical outcomes in patients with chronic sinusitis, via the Sino-Nasal Outcome Test (SNOT-22). The Academy looks forward to sharing updates on this progress. You may also visit the Reg-ent Registry Patient-Reported Outcomes web page at https://www.entnet.org/quality-practice/reg-ent-clinical-data-registry/reg-ent-registry-patient-reported-outcomes/. 

References

U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for industry: patient-reported outcomes measures: use in medical product development to support labeling claims. 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed April 18, 2022.

U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services. 2022 measures under consideration list program-specific measure needs and priorities. 2022. https://www.cms.gov/files/document/2022-muc-list-program-specific-measure-needs-and-priorities.pdf-0. Accessed April 22, 2022.