Patient-Reported Outcomes 

Access the Final Report: Patient-Reported Outcomes in Performance Measurement 

The Opportunity

The increasing integration of delivery systems provides an opportunity to manage the entire patient-focused episode of care and to assess the impact of care on patient outcomes, including patient-reported outcomes (PROs). PROs have been defined as "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." In other words, PRO tools measure what patients are able to do and how they feel by asking questions. These tools enable assessment of patient–reported health status for physical, mental, and social well–being. A wide variety of patient-level instruments to measure PROs have been used for clinical research purposes; many have been evaluated and catalogued within NIH's Patient Reported Outcomes Measurement Information System (PROMIS). While PROMIS and other initiatives have validated patient-level outcome measures and instruments, there are two major challenges to using them for purposes of accountability and performance improvement:

1. They are not in widespread use in clinical practice.
2. Little is known about aggregating these patient-level outcomes for measuring performance of the healthcare entity delivering care.

While there has been great interest in using PROs, foundational work needs to be done to address methodologic and data challenges. Efforts are currently underway to develop and test mechanisms for collecting patient-reported data. Accordingly, this is an opportune time to also consider the methodological issues surrounding use of such data when available in performance measurement. These issues include collecting patient-reported outcome data in the clinical environment and the aggregation of the data to assess organization/provider-level performance.

About the Project

This project will include convening an expert panel, two commissioned white papers on the methodological issues, and two workshops to review the papers and identify recommendations regarding PRO-based performance measures.

Two commissioned papers will help inform next steps regarding 1) selection of PROs for use in performance measures and 2) the path to developing reliable and valid performance measures eligible for NQF endorsement that can be used for accountability and to inform quality improvement. The papers will describe and explain the key methodological issues and how they can be addressed, and identify best practices for measure construction and testing so that the NQF criteria for endorsement can be met. This work is cross-cutting in two aspects. First, the methodological issues apply to any PRO-based performance measure whether general or condition-specific. Second, PRO-based performance measures could be applicable across multiple settings of care and/or multiple conditions.

The workshops will bring together stakeholders needed to make PRO-based performance measures a reality, including researchers, clinicians, performance measure developers, and consumer and purchaser representatives.

The purpose of the workshops is to:

• identify and promote understanding of the key methodological issues that need to be addressed in developing and using PRO-based accountability measures and implications for applying NQF endorsement criteria;
• identify the capacity required for PRO-based accountability measure development and testing;
• identify the capacity required for potential test beds for measure testing; and
• identify a critical pathway including timetable with key milestones for submitting measures to NQF for endorsement.

The workshops will be sequenced to allow for the results of the first workshop and paper to inform that of the second workshop and paper. The first paper and workshop will focus on individual patient data from instruments constructed to measure patient-reported outcomes. The second paper and workshop will focus on the aggregation of the individual patient-reported outcome data to measure the performance of an accountable entity providing healthcare (e.g., hospital, physician, accountable care organization).

Key Definitions 

NQF endorses performance measures. The following definitions are used to clarify the distinction between patient-level patient-reported outcome measures and performance measures to assess the quality of care provided by accountable healthcare entities.

Patient-reported outcome (PRO): 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. (U.S. FOOD AND DRUG ADMINISTRATION. Guidance for Industry.Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Federal Register 2009;74(35):65132-133.)

PRO patient-level measure/instrument: Tools to assess health condition (e.g., health status and status of physical, mental, and functioning) as perceived by the patient obtained by directly asking the patient to self-report (e.g., PHQ-9).

Performance measure: Numeric quantification of healthcare quality for a designated accountable healthcare entity, such as hospital, health plan, nursing home, clinician, etc.

PRO-based performance measure: A performance measure that is based on patient-reported outcome data aggregated for an accountable healthcare entity (e.g., percentage of patients in an accountable care organization whose depression score as measured by the PHQ-9 improved).

Funding 

This project is supported under a contract provided by the Department of Health and Human Services.

Contact Information 

For more information, please contact Karen Pace, PhD, MSN at 202-559-9476. You may also contact us via email at pro@qualityforum.org.