# Clinical Interpretation of PROMs in Care of Knee Osteoarthritis and TJR

> **NIH NIH R01** · NORTHWESTERN UNIVERSITY · 2024 · $711,161

## Abstract

This research will define and validate guidelines for interpretation of commonly used patient-reported
outcome measures (PROMs) for pain and physical function domains among patients with advanced knee
osteoarthritis (OA) receiving medical, rehabilitation, or surgical treatment. The Framingham OA study
found that 33% of men and 42% of women have radiographic changes consistent with knee OA. While x-ray
changes do not correlate with symptom severity, validated patient-reported outcome measures (PROMs) can
quantify knee OA pain severity, longitudinal symptom changes, and OA-associated functional limitations in
groups of patients. Thus, professional societies endorse PROM use in knee OA and CMS will mandate PROM
capture and reporting for all knee OA patients electing total knee replacement (TKR) by 2027. Today’s electronic
health records can capture knee-OA PROMs for use in clinical care, yet sparse evidence exists to guide PROM
interpretation in individual patients. This research will generate guidelines tailored to the common comorbidities
of knee OA patients who are likely to be older, obese, and have multiple physical and emotional comorbidities
that influence pain and physical function. Study feasibility and efficiency is supported by the use of two existing
cohorts: (1) the NIAMS-funded Osteoarthritis Initiative cohort (n=4700) and (2) a 12-site cohort of patients
evaluated for TKR (n=4000; PCORI). Both cohorts include identical OA-specific and universal PROMs captured
at initial evaluation and 12 months with varied treatments; demographic and social factors; and medical,
emotional, and musculoskeletal comorbidities. An interdisciplinary team of knee OA experts and stakeholders
will review the clinical utility of statistical PROM interpretation guidelines to generate dissemination tools for use
in clinical care. The Specific Aims include: Aim 1. Define PROM interpretation guidelines specific to patient
attributes and comorbidities, as needed, for both knee OA pain and physical function domains to inform non-
operative and TKR interpretation of symptom changes. Analyses will use existing data with the commonly used
OA-specific (KOOS, WOMAC) and universal PROMs (SF36, VR12, PROMIS), and self-evaluated transitions
(pre-to-one-year post TKR). Patients with key comorbidities (e.g., widespread pain, poor emotional health,
cardiopulmonary conditions) and diverse attributes (sex, age, race and ethnicity) will be examined. Aim 2.
Validate pain and physical function PROM interpretation guidelines in a prospective sample of knee OA
patients (n=800) and assess PROMs bi-monthly for 12 months to define improvement trajectories. Aim 3.
Evaluate use and adoption of knee OA PROM interpretation guidelines through the prospective sample of
orthopedic clinicians and their patients to serve future implementation. As PROMs are adopted widely, these
guidelines will support consistent PROM interpretation and will inform future knee OA clinical care and research.

## Key facts

- **NIH application ID:** 10974353
- **Project number:** 1R01AR083390-01A1
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** PATRICIA D FRANKLIN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $711,161
- **Award type:** 1
- **Project period:** 2024-07-16 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10974353

## Citation

> US National Institutes of Health, RePORTER application 10974353, Clinical Interpretation of PROMs in Care of Knee Osteoarthritis and TJR (1R01AR083390-01A1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10974353. Licensed CC0.

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