Establishing Clinically Significant Patient-reported Outcomes for Diverticular Disease

Area of Science:

• Gastroenterology
• Health Outcomes Research
• Patient-Reported Outcomes

Background:

• Diverticular disease significantly impacts patients' health-related quality of life.
• The Diverticulitis Quality of Life (DV-QOL) instrument measures the burden of diverticular disease.
• Minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds for DV-QOL were previously undefined.

Purpose of the Study:

• To establish the MCID and PASS for the DV-QOL instrument.
• To characterize patients experiencing a DV-QOL score above the PASS threshold.

Main Methods:

• A prospective cohort study involving 177 adults with diverticular disease across seven centers.
• Patients completed the DV-QOL survey at baseline and quarterly for up to 30 months.
• Distribution- and anchor-based approaches were used to determine MCID and PASS values.

Main Results:

• A PASS threshold of 3.2/10 accurately distinguished between patients with and without quality of life-impacting diverticulitis (AUC 0.76).
• The most appropriate MCID was determined to be a 2.2-point change in DV-QOL (AUC 0.70).
• Patients with DV-QOL scores at or above PASS were more likely to be male, younger, have Medicaid, experience more severe diverticulitis episodes, and have lower educational attainment.

Conclusions:

• This study provides the first defined MCID and PASS values for the DV-QOL instrument.
• These established thresholds are crucial for accurately assessing the impact of diverticular disease.
• The findings will aid in evaluating treatment effectiveness and understanding patient experiences with diverticular disease.