Abstract
IMPORTANCE: Although remote patient-reported outcome measure (PROM) monitoring has shown promising results in cancer care, there is a lack of research on PROM monitoring in orthopedics. OBJECTIVE: To determine whether PROM monitoring can improve health outcomes for patients with joint replacement compared with the standard of care. DESIGN, SETTING, AND PARTICIPANTS: A 2-group, patient-level randomized clinical trial (PROMoting Quality) across 9 German hospitals recruited patients aged 18 years or older with primary hip or knee replacement from October 1, 2019, to December 31, 2020, with follow-up until March 31, 2022. INTERVENTIONS: Intervention and control groups received the standard of care and PROMs at hospital admission, discharge, and 12 months after surgery. In addition, the intervention group received PROMs at 1, 3, and 6 months after surgery. Based on prespecified PROM score thresholds, at these times, an automated alert signaled critical recovery paths to hospital study nurses. On notification, study nurses contacted patients and referred them to their physicians if necessary. MAIN OUTCOMES AND MEASURES: The prespecified outcomes were the mean change in PROM scores (European Quality of Life 5-Dimension 5-Level version [EQ-5D-5L; range, -0.661 to 1.0, with higher values indicating higher levels of health-related quality of life (HRQOL)], European Quality of Life Visual Analogue Scale [EQ-VAS; range, 0-100, with higher values indicating higher levels of HRQOL], Hip Disability and Osteoarthritis Outcome Score-Physical Function Shortform [HOOS-PS; range, 0-100, with lower values indicating lower physical impairment] or Knee Injury and Osteoarthritis Outcome Score-Physical Function Shortform [KOOS-PS; range, 0-100, with lower values indicating lower physical impairment], Patient-Reported Outcomes Measurement Information System [PROMIS]-fatigue [range, 33.7-75.8, with lower values indicating lower levels of fatigue], and PROMIS-depression [range, 41-79.4, with lower values indicating lower levels of depression]) from baseline to 12 months after surgery. Analysis was on an intention-to-treat basis. RESULTS: The study included 3697 patients with hip replacement (mean [SD] age, 65.8 [10.6] years; 2065 women [55.9%]) and 3110 patients with knee replacement (mean [SD] age, 66.0 [9.2] years; 1669 women [53.7%]). Exploratory analyses showed significantly better health outcomes in the intervention group on all PROMs except the EQ-5D-5L among patients with hip replacement, with a 2.10-point increase on the EQ-VAS in the intervention group compared with the control group (HOOS-PS, -1.86 points; PROMIS-fatigue, -0.69 points; PROMIS-depression, -0.57 points). Patients in the intervention group with knee replacement had a 1.24-point increase on the EQ-VAS, as well as significantly better scores on the KOOS-PS (-0.99 points) and PROMIS-fatigue (-0.84 points) compared with the control group. Mixed-effect models showed a significant difference in improvement on the EQ-VAS (hip replacement: effect estimate [EE], 1.66 [95% CI, 0.58-2.74]; knee replacement: EE, 1.71 [95% CI, 0.53-2.90]) and PROMIS-fatigue (hip replacement: EE, -0.65 [95% CI, -1.12 to -0.18]; knee replacement: EE, -0.71 [95% CI, -1.23 to -0.20]). The PROMIS-depression score was significantly reduced in the hip replacement group (EE, -0.60 [95% CI, -1.01 to -0.18]). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the PROM-based monitoring intervention led to a small improvement in HRQOL and fatigue among patients with hip or knee replacement, as well as in depression among patients with hip replacement. TRIAL REGISTRATION: Deutsches Register Klinischer Studien ID: DRKS00019916.