An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system

Current Medical Research and Opinion

Volumn 21, Issue 6, 2005, Pages 849-862

  Kosinski, Mark R ^a,d   Schei, Jeff R ^b   Vallow, Sue M ^b   Ascher, Steven ^b   Harte, Clare ^b   Shikiar, Richard ^c   Frank, Lori ^c   Margolis, Mary Kay ^c   Vorsanger, Gary ^b  

^a QualityMetric Incorporated   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^c UNITED BIOSOURCE CORPORATION   (United States)

^d NONE   (United States)

Author keywords

Chronic low back pain; Health related quality of life; Opioid therapy

Indexed keywords

FENTANYL; OPIATE DERIVATIVE;

ADULT; AGED; ANALGESIC ACTIVITY; CANCER PAIN; CHRONIC DRUG ADMINISTRATION; CHRONIC PAIN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FOLLOW UP; HUMAN; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROPATHIC PAIN; PAIN ASSESSMENT; QUALITY OF LIFE; RATING SCALE; REVIEW; TREATMENT OUTCOME; UNITED STATES;

ADMINISTRATION, CUTANEOUS; ADULT; AGED; AGED, 80 AND OVER; ANALGESICS, OPIOID; CHRONIC DISEASE; DATA COLLECTION; FEMALE; FENTANYL; HUMANS; LOW BACK PAIN; MALE; MIDDLE AGED; QUALITY OF LIFE; UNITED STATES;

EID: 21244456466     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079905X46377     Document Type: Review

References (73)

1. Deyo RA. Low back pain. Sci Am 1998;279(2):48-53
2. Borenstein D. Epidemiology, etiology, diagnostic evaluation, and treatment of low back pain. Curr Opin Rheumatol 1996;8(2):124-9
3. Andersson GJB. The epidemiology of spinal disorders. In: Frymoyer JW, editor. The adult spine: principles and practice, 2nd ed. New York: Raven Press; 1997. p. 93-141
4. Branch Jr CL. Low back pain. AAFP home study self-assessment monograph series; 1994. No 185, p 11
5. Frymoyer JW, Cats-Baril WL. An overview of incidences and costs of low back pain. Orthop Clin North Am 1991;22:263-71
6. Borenstein DG, Weisel SW, Boden SD. Low back pain: medical diagnosis and comprehensive management. , Philadelphia (PA): WB Sounders Company; 1994
7. Mayer TG, Gatchel RJ. Functional restoration for spinal disorders: the sports medicine approach. Philadelphia (PA): Williams and Wilkins; 1988
8. Pope MH, Fleming B. Biomechanics of low back pain. Surg Rounds Orthop 1990;4(10):35-42
9. Hart LG, Deyo RA, Gherkin DC. Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a US national survey. Spine 1995;20:11-9
10. Gherkin DC, Deyo RA, Loeser JD. An international comparison of back surgery rates. Spine 1994;19(11):1201-6
11. Linton SJ. The socioeconomic impact of chronic back pain: is anyone benefiting? Pain 1998;75:163-8
12. Hashemi L, Webster BS, Clancy EA. Trends in disability duration and cost of workers' compensation low back pain claims (1988-1996). J Occup Environ Med 1998;40:1110-9
13. Frymoyer JW, Durett C. The economics of spinal disorders. In: Frymoyer JW, editor. The adult spine: principles and practice, 2nd ed. Philadelphia (PA): Lippincott-Raven Press; 1997
14. Gureje O, Von Korff M, Simon GE, et al. Persistent pain and well being: a World Health Organization study in primary care. J Am Med Assoc 1998;280:147-51
15. Becker N, Thomsen AB, Sjorgen P, Bech P, Erikses J. Pain epidemiology and health related quality of life in chronic non-malignant pain patients referred to a Danish multidisciplinary pain center. Pain 1997;73:393-400
16. Joint Commission on Accreditation of Healthcare Organizations. Assessment of persons with pain. In: Pain assessment and management: an organizational approach. Oakbrook Terrace (IL): Joint Commission on Accreditation of Healthcare Organizations; 2000. p. 13-25
17. Won A, Lapane K, Gambassi G, et al. Correlates and management of nonmalignant pain in the nursing home. J Am Geriatr Soc 1999;47:936-42
18. Hagen KB, Kvien TK, Bjorndal A. Musculoskeletal pain and quality of life in patients with noninflammatory joint pain compared to rheumatoid arthritis: a population survey. J Rheumatol 1997;24:1703-9
19. Arnold LM, Witzeman KA, Swank ML, McElroy SL, Keck PE. Health-related quality of life using the SF-36 in patients with bipolar disorder compared with patients with chronic back pain and the general population. J Affect Disord 2000;57:235-9
20. Rudy TE, Kerns RD, Turk DC. Chronic pain and depression towards a cognitive-behavioral model. Pain 1988;35:129-40
21. Leidig-Bruckner G, Minne HW, Schlaich C, et al. Clinical grading of spinal osteoporosis: quality of life components and spinal deformity in women with chronic low back pain and women with vertebral osteoporosis. J Bone Miner Res 1997;12:663-75
22. Skevington SM. Investigating the relationship between pain and discomfort and quality of life using WHOQOL. Pain 1998;76:395-406
23. Katz N, Davis MW, Dworkin R. Topical lidocaine patch produces a significant improvement in mean pain scores in treated PHN patients: results of a multicenter open-label trial. In: Posters of the 20th annual scientific meeting of the American Pain Society, Phoenix, AZ, April 19-22; 2001. Poster 741
24. Zhao SZ, Dedhiya SD, Bocanegra TS, et al. Health-related quality of life effects of oxyprozin and nabumetone in patients with osteoarthritis of the knee. Clin Ther 1999;21: 205-17
25. Mannix LK, Chandurkar RS, Rybicki LA, Tusek DL, Solomon GD. Effect of guided imagery on quality of life for patients with chronic tension-type headache. Headache 1999;39:326-34
26. Aparasu R, McCoy RA, Weber C, Mair D, Parasuraman TV. Opioid-induced emesis among hospitalized nonsurgical patients: effect on pain and quality of life. J Pain Symptom Manage 1999;18:280-8
27. McCarberg BH, Barkin RL. Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther 2001;8:181-6
28. Rowbotham M, Harden N, Stacey B, et al. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. J Am Med Assoc 1998;280:1837-42
29. Ehrich EW, Bolognese JA, Watson DJ, et al. Effect of rofecoxib on measures of health-related quality of life in patients with osteoarthritis. Am J Managed Care 2001;7:609-16
30. Gherkin DC, Wheeler KJ, Barlow W, et al. Medication use for low back pain in primary care. Spine 1998;23:607-14
31. McNairy SL, Maruta T, Ivnik RJ, Swanson DW, Ilstrup DM. Prescription medication dependence and neuropsychologic function. Pain 1984;18:169-77
32. Portenoy RK. Opioid therapy for chronic nonmalignant pain. Pain Res Manage 1996;1:17-28
33. Arkinstall W, Sandler A, Goughnour B, Babul N, Harsanyi Z, Darke AC. Efficacy of controlled-release codeine in chronic non-malignant pain: a randomized, placebo-controlled trial. Pain 1995;62:169-78
34. Moulin DE, Iezzi A, Amireh R, Sharpe WK, Boyd D, Merskey H. Randomised trial of oral morphine for chronic non-cancer pain. Lancet 1996;347:143-7
35. Watson CP, Babul N. Efficacy of oxycodone in neuropathic pain: a randomized trial in postherpetic neuralgia. Neurology 1998;50:1837-41
36. Jeal W, Benfield P. Transdermal fentanyl: a review of its pharmacological properties and therapeutic efficacy in pain control. Drugs 1997;53:109-38
37. Grond S, Zech D, Lehman KA, Radbruch L, Breintenbach H, Hertel D. Transdermal fentanyl in the long-term treatment of cancer pain: a prospective study of 50 patients with advanced cancer of the gastrointestinal tract or the head and neck region. Pain 1997;69:191-8
38. Donner B, Zenz M, Tryba M, Strumpf M. Direct conversion from oral morphine to transdermal fentanyl: a multicentre study in patients with cancer pain. Pain 1996;64:527-34
39. Donner B, Zenz M, Strumpf M, Raber M. Long-term treatment of cancer pain with transdermal fentanyl. J Pain Symptom Manage 1998;15:168-75
40. Ahmedzai S, Brooks D. Transdermal fentanyl versus sustained release oral morphine in cancer pain: preference, efficacy, and quality of life. J Pain Symptom Manage 1997;13:254-61
41. Payne R, Mathias SD, Pasta DJ, Wanke LA, Williams R, Mahmoud R. Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. J Clin Oncol 1998;16:1588-93
42. Dellemijn PLI, van Dujjn H, Vanneste JAL. Prolonged treatment with transdermal fentanyl in neuropathic pain. J Pain Symptom Manage 1998;16:220-9
43. Dellemijn PLI, Vanneste JAL. Randomized double-blind active-placebo- controlled crossover trial of intravenous fentanyl in neuropathic pain. Lancet 1997;349:753-8
44. Milligan K, Lanteri-Minet M, Borchert K, et al. Evaluation of long-term efficacy and safety of transdermal fentanyl in the treatment of chronic non-cancer pain. J Pain 2001;2(4): 197-204
45. Allan L, Hays H, Jensen NH, et al. Randomized crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. Br Med J 2001;322:1-7
46. Rogers WH, Wittink H, Wagner A, et al. Assessing individual outcomes during outpatient multidisciplinary chronic pain treatment by means of an augmented SF-36. Pain Med 2000;1:44-54
47. Rogers WH, Wittink HM, Ashburn MA, et al. Using the 'TOPS,' an outcomes instrument for multidisciplinary outpatient pain treatment. Pain Med 2000;1:55-67
48. Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83
49. McHorney CA, Ware Jr JE, 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
50. McHorney CA, Ware Jr JE, 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
51. Ware Jr JE, Snow KK, Kosinski M, et al. SF-36 health survey manual and interpretation guide. Boston (MA): The Health Institute, New England Medical Center; 1993
52. Ware Jr JE, Kosinski M, Keller SD. SF-36 physical and mental health summary scales: a user's manual. Boston (MA): Health Assessment Lab; 1994
53. Ware Jr JE, Kosinski M. SF-36 physical and mental health summary scales: a manual for users of version 1, 2nd ed. Lincoln (RI): Quality Metric Incorporated; 2001
54. Ghoname EA, Craig WF, White PF, et al. Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. J Am Med Assoc 1999;281:818-23
55. Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine 2000;25:3100-3
56. Atlas SJ, Deyo RA, Keller RB, et al. The Maine Lumbar Spine Study, part III. 1-year outcomes of surgical and nonsurgical management of lumbar spinal stenosis. Spine 1996;21:1787-94
57. Atlas SJ, Keller RB, Chang Y, et al. Surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: five-year outcomes from the Maine Lumbar Spine Study. Spine 2001;26(1):1179-87
58. Bronfort G, Bouter LM. Responsiveness of general health status in chronic low back pain: a comparison of the COOP charts and the SF-36. Pain 1999;83:201-9
59. Garratt AM, Ruta DA, Abdalla MI, et al. SF 36 health survey questionnaire: II. Responsiveness to changes in health status in four common clinical conditions. Qual Health Care 1994;3:186-92
60. Hacker RJ, Cauthen JC, Gilbert TJ, et al. A prospective randomized multicenter clinical evaluation of an anterior cervical fusion cage. Spine 2000;25:2646-54
61. Hodselmans AP, Jaegers SM, Goeken LN. Short-term outcomes of a back school program for chronic low back pain. Arch Phys Med Rehabil 2001;82:1099-105
62. Lansky D, Butler JB, Waller FT. Using health status measures in the hospital setting: from acute care to 'outcomes management'. Med Care 1992;30:MS57-73
63. Leggett S, Mooney V, Matheson LN, et al. Restorative exercise for clinical low back pain. A prospective two-center study with 1-year follow-up. Spine 1999;24:889-98
64. Turk DC, Melzack R. The measurement of pain and the assessment of people experiencing pain. In: Turk DC, Melzack R, editors. Handbook of pain assessment. New York: Guilford Press; 1992. p. 3-12
65. Cohen J. Statistical power analysis for the behavioral sciences, 2nd ed. Hillsdale (NJ): Lawrence Erlbaum Associates; 1988
66. Hotelling H. The generalization of Student's ratio. Annals of Mathematical Statistics 1931;2:360-78
67. Nunnally JC, Bernstein IH. Psychometric theory. New York (NY): McGraw Hill; 1994
68. Stratford PW, Binkley J, Soloman P. Defining the minimum level of detectable change for the Roland-Morris questionnaire. Phys Ther 196;76:359-68
69. Cuijpers P, van Lammern P, Duzijn B. Relation between quality of life and chronic illnesses in elderly living in residential homes. A prospective study. Int Psychogeriatr 1999;11:445-54
70. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582-92
71. Kosinski M, Kujawski SC, Martin R, et al. Health-related quality of life in early rheumatoid arthritis: impact of disease and treatment response. Am J Managed Care 2002;8(3):231-40
72. Ware JE, Bayliss MS, Mannochia M, Davis GL. Health-related quality of life in chronic hepatitis C: impact of disease and treatment response. Hepatology 1999;30(2):550-5
73. Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining clinically important difference in pain outcome measures. Pain 2000;88:287-94