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The Longitudinal Examination of Arthritis Pain (LEAP) Study: Relationships Between Weekly Fluctuations in Patient-Rated Joint Pain and Other Health Outcomes
ADAM HUTCHINGS, MICHAEL CALLOWAY, ERNEST CHOY, MICHELE HOOPER, DAVID J. HUNTER, JOANNE M. JORDAN, YUQING ZHANG, ONUR BASER, STACEY LONG, and LIISA PALMER
ABSTRACT. Methods. In this observational study, 287 adults (aged ≥ 50 yrs) with hip or knee OA were recruited from 16 medical practices across the United States. Patients were telephoned weekly for 12 weeks to assess pain/stiffness, daily activities/function, productivity, emotional well-being, quality of life, and healthcare utilization. Associations between changes in joint pain levels and other health outcomes were evaluated using a generalized estimating equation model. Results. The mean (SD) pain score at Week 1 was 4.2 (2.1) on the Western Ontario and McMaster Universities OA index (WOMAC) pain subscale (0 = no pain, 10 = extreme pain); during the study, 49% of patients reported a between-week fluctuation of ≥ 2 points. A 2-point decrease in WOMAC pain subscale score was associated with a 22% decrease in number of days of limited activity/week (ß = –0.107; 95% confidence interval –0.163, –0.051); a 48% decrease in number of days of missed work/week (ß = –0.217; 95% CI –0.395, –0.039); a 14% decrease in number of nights with pain-related sleep interference/week (ß = –0.068; 95% CI –0.109, –0.027). Patients were 1.6 times more likely to contact a healthcare provider when their pain changed from "acceptable" to "unacceptable." Conclusion. Weekly fluctuations in pain levels and other health outcomes were identified among adults with OA. Decreases in patient-reported pain were associated with improvements in daily activities/functioning and decreases in work absenteeism, sleep interference, and healthcare resource use. (First Release Oct 15 2007; J Rheumatol 2007;34:2291-300) Key Indexing Terms:
LONGITUDINAL STUDIES From Global Health Outcomes, GlaxoSmithKline, Research Triangle Park, North Carolina, USA. Supported by GlaxoSmithKline, Research Triangle Park, North Carolina, USA. A. Hutchings, MSc, Associate Director, European Health Outcomes, Baxter Healthcare; M. Calloway, PhD, Manager, Health Outcomes -- USP, GlaxoSmithKline; E. Choy, MD, Director, Sir Alfred Baring Garrod Clinical Trials Unit, Kings College, London, England; M. Hooper, MD, MS, Associate Medical Director, Amgen, Inc., Thousand Oaks, California, USA; D.J. Hunter, MBBS, PhD, Assistant Professor of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA; J.M. Jordan, MD, MPH, Associate Professor, Department of Medicine and Orthopaedics, Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, North Carolina, USA; Y. Zhang, DSc, Professor of Medicine and Epidemiology, Boston University School of Medicine; O. Baser, PhD, MS, Senior Economist, Thomson-Medstat; S. Long, MS, Director, Thomson-Medstat; L. Palmer, PhD, Associate Director, Thomson-Medstat, Washington, DC. At the time the LEAP Study was conducted, Mr. Hutchings was Global Health Outcomes Manager at GlaxoSmithKline and Dr. Hooper was Associate Professor, Division of the Rheumatic Diseases, University Hospitals of Cleveland, Cleveland, Ohio, USA. Address reprint requests to M. Calloway, GlaxoSmithKline, 5 Moore Drive, PO Box 13398, Research Triangle Park, North Carolina 27709-3398. E-mail: michael.o.calloway@gsk.com Accepted for publication May 25, 2007. |
