What are Patient-Reported Outcomes

First of a three-part series of using PROs in measurement

Kevin, here! This is my weekly-ish newsletter on how health-care quality is measured. I wanted to kick-start a series on patient-centered healthcare and measuring its effectiveness using Patient-Reported Outcomes, based in part on my experience at Hospital for Special Surgery and my doctoral classes on performance management.

The use of patient reported outcome performance measures (PRO-PMs) is an important aspect of creating a patient centered health system. The Institute of Medicine listed patient-centered care and effectiveness as two important components of defining quality of care. However, quality measures used by payors such as the Centers for Medicare and Medicaid Services (CMS) do not track patient-centeredness or effectiveness, preferring instead administrative claims-based measures. In one review of a program measuring physician quality, up to 37% of measures were found not to meet validity criteria. CMS has an inventory of up to 2,200 quality measures and spent up to $1.3 billion on measure development  but almost none are measuring the effect of treatment on patient reported outcomes.

Patient-centered performance measures via patient-reported outcomes (PROs) allows for clinicians, health systems, payors, and industry to track changes in health while considering the patient’s voice on what they feel is important. It can involve all facets of a patient’s life and values and allows for greater shared decision making on how treatment is impacting their goals of care.

PROs are outcomes that cannot be typically tracked from existing claims or electronic health records and reflect the patient’s experience of their condition or treatment. These can include domains such as quality of life, function, symptoms, and experience of care.5 Patient-reported outcome measures (PROMs) are instruments, usually psychometrically validated surveys, that track some aspect or domain of PROs. Common examples include the VR-12, which measures quality of life, or PROMIS, a set of surveys that measure multiple domains, including quality of life, function, and symptoms.  PRO-PMs are quality measures that set a quantifiable threshold or change in scores that allow for comparison across populations for the purpose of accountability.

Using PRO-PMs

PRO-PMs can be used in multiple aspects of care delivery and designing a PRO-PM requires understanding what purpose it is being used for. In the past few years, the FDA has emphasized the use of PROs for medical devices,  pharmaceuticals, and even digital therapeutics in an effort to determine the impact of a new technology or treatment on clinical benefits. In that case, PRO-PMs are helpful in comparing two cohorts receiving a new treatment or technology across similar time periods or end points to track mean differences in overall scores.  For researchers, PRO-PMs can be used in a similar way to determine the impact of a new technique or clinical pathway, using clinical registries.

For health system, hospital, and clinician accountability, PRO-PMs can be used to compare how well the measurement unit of interest can treat patients with similar conditions over time. This will also be the primarily focus of measure development of this paper. Measures could be used to track appropriateness of care, effectiveness of care, or patient perceptions of the experience of care depending on the PRO domain of interest and the measure developer’s goals.

Using PRO-PMs - Appropriateness & Effectiveness

If a measure developer is interested in tracking appropriates or effectiveness of care, then a PROM focused on function and symptoms would be more appropriate. For example, if CMS wanted to compare the performance of two hospitals performing joint replacement, they could use the HOOS JR/KOOS JR, which track hip/knee pain and function for joint replacement and adopt a meaningful change threshold. The denominator would be all patients who receive a joint replacement and the numerator would be the number of patients who achieve a meaningful change in function and pain from before surgery to 1 year after surgery according to the HOOS JR/KOOS JR. Hospitals with who are an outlier with a low proportion of patients who achieve a meaningful change may be less effective in treating patients with osteoarthritis and/or maybe operating on patients who are not yet appropriate for terminal joint replacement and could benefit from more conservative therapies to treat their osteoarthritis.

Using PRO-PMs - Tracking Patient Experience of Care (beyond satisfaction)

If a measure developer is interested in tracking a patient’s perception of their experience of care, such as shared decision-making processes or goal-concordant care, the ability of care to align and help achieve a patient’s goals for treatment, then separate PROMs should be used or developed and validated. Short surveys measuring a patient’s perceptions can be used after a care process such as the decision to schedule surgery, with a specific threshold used to determine if a care process was effective. One example of such a PRO-PM is National Quality Forum (NQF) Measure # 2962, the “Shared Decision Making Process_4” which is tracks to what extent patients are involved in the decision-making process after a consult with a provider where a decision was discussed.

Using PRO-PMs - Public Reporting and Consumer Decision Making

A final use case for PRO-PMs is oriented for public-reporting consumer decision making. In this case, PROs should be used that reflect what patients are looking for in treatment. This could include patient experience, quality of life, or functional status. This would require focus groups and cognitive interviewing and has led to the development of several pilot projects with organizations such as the Robert Wood Johnson Foundation and the American Institute of Research, which have included measures reflecting patient desires for cancer survivorship and dialysis. In this case, consumers can use this as a form of determining where they would most like to seek care or engaged in a shared decision-making process with their physician on realistic goals, restoration of function, and/or relief of symptoms.

Thanks for sticking around to the end of this! The next post goes into how to actually interpret PROMs.