Establishing Clinically Significant Patient-reported Outcomes for Diverticular Disease

Background: Diverticular disease can undermine health-related quality of life. The diverticulitis quality of life (DV-QOL) instrument was designed and validated to measure patient-reported burden of diverticular disease. However, values reflecting meaningful improvement (i.e., minimal clinically important difference [MCID]) and the patient acceptable symptom state (PASS) have yet to be established. We sought to establish the MCID and PASS of the DV-QOL and describe the characteristics of those with DV-QOL above the PASS threshold. Materials and methods: We performed a prospective cohort study of adults with diverticular disease from seven centers in Washington and California (2016-2018). Patients were surveyed at baseline, then quarterly up to 30 mo. To determine the MCID and PASS for DVQOL, we applied various previously established distribution- and anchor-based approaches and compared the resulting values. Results: The study included 177 patients (mean age 57 y, 43% women). A PASS threshold of 3.2/10 distinguished between those with and without health-related quality of life eimpacting diverticulitis with acceptable accuracy (area under the curve 0.76). A change of 2.2 points in the DV-QOL was the most appropriate MCID: above the distribution-based MCIDs and corresponding to patient perception of importance of change (AUC 0.70). Patients with DV-QOL >= PASS were more often men, younger, had Medicaid, had more serious episodes of diverticulitis, and had an occupational degree or high-school education or less. Conclusions: Our study is the first to define MCID and PASS for DV-QOL. These thresholds are critical for measuring the impact of diverticular disease and the evaluation of treatment effectiveness. (C) 2021 Elsevier Inc. All rights reserved.

Automated summary

This study established the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) for DV-QOL, providing crucial thresholds for measuring the impact of diverticular disease and evaluating treatment effectiveness.