Rationale and design of the Oxycodone Users Registry: a prospective, multicenter registry of patients with nonmalignant pain

Abstract

Objective: This article describes the rationale and design of the Oxycodone Users Registry (OUR) study and lessons learned during study development and data collection.

Design: The OUR study used a prospective registry design.

Setting: Sixty-five academic and private medical practices across the United States, including both specialists and primary care settings.

Participants: A total of 814 patients with 1) injury or trauma of the head, neck, back, chest, or extremities; 2) fibromyalgia; 3) arthritis; 4) neuropathic pain; 5) other back or neck pain; or 6) postoperative pain following outpatient orthopedic surgery.

Interventions: Patients received immediate-release oxycodone either as monotherapy or as combination therapy, starting within 3 days following the baseline visit and continuing as needed for at least 5 days.

Main outcome measures: Patient demographics and disease information were recorded at baseline. Follow-up assessments at days 3, 7, 14, 21, and 28 included pain intensity, pain relief, opioid-related symptoms, a sleep scale, the Brief Pain Inventory-Short Form, and the Work Limitations Questionnaire-Short Form. Adverse events, medical resource utilization, and changes to the oxycodone prescription were recorded during the study. At the end of study treatment, patients rated global treatment satisfaction, how bothersome side effects were, and the most important factor that would discourage them from future oxycodone therapy.

Results: This report describes the study design, rationale, and lessons learned.

Conclusions: Understanding the rationale, design, and lessons learned from the conduct of the OUR study provides insight that can used in future registry studies.