Functionality and health-status benefits associated with reduction of osteoarthritis pain

Current Medical Research and Opinion

Volumn 24, Issue 5, 2008, Pages 1255-1265

  Schein, Jeff R ^a   Kosinski, Mark R ^b   Janagap Benson, Carmela ^a,e   Gajria, Kavita ^b   Lin, Peggy ^b   Freedman, John D ^c,d  

^a Ortho McNeil Pharmaceutical Incorporated   (United States)

^b QualityMetric Incorporated   (United States)

^c TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d Freedman Healthcare Consulting   (United States)

^e NONE   (United States)

Author keywords

Function; Health status; Osteoarthritis; Pain; Tramadol ER

Indexed keywords

PLACEBO; TRAMADOL;

ADULT; ARTHRITIC PAIN; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; CROSSOVER PROCEDURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG WITHDRAWAL; FEMALE; FLUSHING; FUNCTIONAL STATUS; HEADACHE; HEALTH STATUS; HIP OSTEOARTHRITIS; HUMAN; INSOMNIA; KNEE OSTEOARTHRITIS; MAJOR CLINICAL STUDY; MALE; NAUSEA; PAIN; PRURITUS; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; SIDE EFFECT; SOMNOLENCE; VISUAL ANALOG SCALE; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX; WITHDRAWAL SYNDROME; XEROSTOMIA;

ADOLESCENT; ADULT; AGED; ANALYSIS OF VARIANCE; CHRONIC DISEASE; CROSS-SECTIONAL STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEALTH STATUS; HUMANS; MALE; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; PAIN; PAIN MEASUREMENT; PATIENT SATISFACTION; PROBABILITY; PROGNOSIS; QUALITY OF LIFE; RECOVERY OF FUNCTION; REFERENCE VALUES; SEVERITY OF ILLNESS INDEX; TRAMADOL; TREATMENT OUTCOME;

EID: 44349182549     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079908X291912     Document Type: Article

References (34)

1. Pleis JR, Lethbridge-Çejku M. Summary health statistics for U.S. adults: National health interview survey, 2005 (Available at: http://www.cdc.gov/nchs/data/series/sr_10/sr10_232.pdf). Vital Health Stat 2006;10
2. Salaffi F, Carotti M, Stancati A, et al. Health-related quality of life in older adults with symptomatic hip and knee osteoarthritis: a comparison with matched healthy controls. Aging Clin Exp Res 2005;17:255-63
3. Saltzman CL, Zimmerman MB, O'Rourke M, et al. Impact of comorbidities on the measurement of health in patients with ankle osteoarthritis. J Bone Joint Surg Am 2006;88:2366-72
4. van der Waal JM, Terwee CB, van der Windt DA, et al. Health-related and overall quality of life of patients with chronic hip and knee complaints in general practice. Qual Life Res 2005;14:795-803
5. Rabenda V, Manette C, Lemmens R, et al. Prevalence and impact of osteoarthritis and osteoporosis on health-related quality of life among active subjects. Aging Clin Exp Res 2007;19:55-60
6. Gupta S, Hawker GA, Laporte A, et al. The economic burden of disabling hip and knee osteoarthritis (OA) from the perspective of individuals living with this condition. Rheumatology (Oxford) 2005;44:1531-7
7. Ethgen O, Kahler KH, Kong SX, et al. The effect of health related quality of life on reported use of health care resources in patients with osteoarthritis and rheumatoid arthritis: a longitudinal analysis. J Rheumatol 2002;29:1147-55
8. Kosinski M, Janagap C, Gajria K, et al. Pain relief and pain-related sleep disturbance with extended-release tramadol in patients with osteoarthritis. Curr Med Res Opin 2007;23:1615-26
9. Gana TJ, Pascual MLG, Fleming RRB, et al. Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Curr Med Res Opin 2006;22:1391-401
10. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113:9-19
11. Bellamy N, Buchanan WW, Goldsmith CH, et al. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988;15:1833-40
12. Bellamy N. WOMAC Osteoarthritis Index: User Guide IV. Queensland, Australia: WOMAC, 2000
13. McHorney CA, Ware JE, Jr., Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993;31:247-63
14. McHorney CA, Ware JE, Jr., Lu JF, et al. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care 1994;32:40-66
15. Ware JE, Jr., Snow KK, Kosinski M, et al. SF-36 Health Survey Manual and Interpretation Guide. Boston, MA: The Health Institute, 1993
16. Ware JE, Jr., Kosinski M. SF-36 Physical & Mental Health Summary Scales: A Manual for Users of Version 1 (2nd Edition). Lincoln, RI: QualityMetric, 2001
17. Kosinski M, Keller SD, Ware JE, Jr., et al. The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: relative validity of scales in relation to clinical measures of arthritis severity. Med Care 1999;37:MS23-39
18. Kosinski M, Keller SD, Hatoum HT, et al. The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: tests of data quality, scaling assumptions and score reliability. Med Care 1999;37:MS10-22
19. Farrar JT, Portenoy RK, Berlin JA, et al. Defining the clinically important difference in pain outcome measures. Pain 2000;88:287-94
20. Farrar JT, Young JP, Jr., LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-58
21. Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis 2005;64:29-33
22. Babul N, Noveck R, Chipman H, et al. Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee. J Pain Symptom Manage 2004;28:59-71
23. Sharma L, Cahue S, Song J, et al. Physical functioning over three years in knee osteoarthritis: role of psychosocial, local mechanical, and neuromuscular factors. Arthritis Rheum 2003;48:3359-70
24. Ehrich EW, Davies GM, Watson DJ, et al. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol 2000;27:2635-41
25. Bennett RM, Schein J, Kosinski MR, et al. Impact of fibromyalgia pain on health-related quality of life before and after treatment with tramadol/acetaminophen. Arthritis Rheum 2005;53:519-27
26. Kosinski MR, Schein JR, Vallow SM, et al. An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system. Curr Med Res Opin 2005;21:849-62
27. Moore A, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics. Pain 1996;66:229-37
28. Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum 2001;45:384-91
29. Angst F, Aeschlimann A, Michel BA, et al. Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities. J Rheumatol 2002;29:131-8
30. Escobar A, Quintana JM, Bilbao A, et al. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage 2007;15:273-80
31. ULTRAM® ER (tramadol HCl) Extended-Release Tablets prescribing information. Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc., 2006
32. Hays RD, Woolley JM. The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics 2000;18:419-23
33. Kirwan JR. Minimum clinically important difference: the crock of gold at the end of the rainbow? J Rheumatol 2001;28:439-44
34. Quintana JM, Escobar A, Arostegui I, et al. Health-related quality of life and appropriateness of knee or hip joint replacement. Arch Intern Med 2006;166:220-6