What is clinically meaningful: Outcome measures in pain clinical trials

Clinical Journal of Pain

Volumn 16, Issue 2 SUPPL., 2000, Pages

  Farrar, John T ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Clinical trials; Pain measurement; Randomized controlled trials; Reproducibility of results; Treatment outcome

Indexed keywords

CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; MEDICAL RESEARCH; METHODOLOGY; OUTCOMES RESEARCH; PAIN; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; SCORING SYSTEM; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

EID: 0034040826     PISSN: 07498047     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002508-200006001-00018     Document Type: Conference Paper

References (36)

1. Newswise. Available at: http://www.newswise.com/articles/1998/ 6/ZOMCO.ZEN.html. Accessed May 8, 2000.
2. Sternbach RA. Pain patients: traits and treatment. New York: Academic Press, 1974.
3. Grossman SA, Sheidler VR, Swedeen K, et al. Correlation of patient and caregiver ratings of cancer pain. J Pain Symptom Manage 1991;6:53-7.
4. Ware JE, Jr, Kosinski M, Bayliss MS, et al. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care 1995;33(Suppl):S264-79.
5. Gracely RH, McGrath F, Dubner R. Ratio scales of sensory and affective verbal pain descriptors. Pain 1978;5:5-18.
6. Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs 1997; 20:88-93.
7. Choiniere M, Amsel R. A visual analogue thermometer for measuring pain intensity. J Pain Symptom Manage 1996;11:299-311.
8. De Conno F, Caraceni A, Gamba A, et al. Pain measurement in cancer patients: a comparison of six methods. Pain 1994;57:161-6.
9. Ahmedzai S. Recent clinical trials of pain control: impact on quality of life. Eur J Cancer 1995;31(Suppl):S2-7.
10. Broadbent DE. A difficulty in assessing bimodality in certain distributions. Br J Math Stat Psychol 1966;19:125-6.
11. Mogil JS, Flodman P, Spence MA, et al. Oligogenic determination of morphine analgesic magnitude: a genetic analysis of selectively bred mouse lines. Behav Genet 1995;25:397-406.
12. Rowbotham M, Harden N, Stacey B, et al. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA 1998;280:1837-42.
13. ter Kuile MM, Spinhoven P, Linssen AC. Responders and nonresponders to autogenic training and cognitive self-hypnosis: prediction of short- and long-term success in tension-type headache patients. Headache 1995;35:630-6.
14. Loeser JD. Tic douloureux and atypical facial pain. In: Wall PD, Melzack R, eds. Textbook of pain, 3rd ed. London: Churchill Livingstone;1994:699-710.
15. McQuay H, Carroll D, Jadad AR, et al. Anticonvulsant drugs for management of pain: a systematic review. BMJ 1995;311:1047-52.
16. Max MB, Lynch SA, Muir J, et al. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med 1992;326:1250-6.
17. LeResche L. Assessment of physical and behavioral outcomes of treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997;83:82-6.
18. Max MB, Portenoy RK. Methodological challenges for clinical trials of cancer pain treatments. In: Chapman CR, Foley KM, eds. Current and emerging issues in cancer pain: research and practice. New York: Raven Press;1993:283-99.
19. Houde RW. Methods for measuring clinical pain in humans. Acta Anaesthesiol Scand Suppl 1982;74:25-9.
20. Scott J, Huskisson EC. Graphic representation of pain. Pain 1976; 2:175-84.
21. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain 1983;17:45-56.
22. Max MB. Antidepressants as analgesics. Pharmacological approaches to the treatment of chronic pain. In: The fourth annual Bristol-Meyers Squibb symposium on pain research. Seattle: IASP Press, 1994.
23. Goldsmith CH, Boers M, Bombardier C, Tugwell P. Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. OMERACT Committee. J Rheumatol 1993;20:561-5.
24. Serlin RC, Mendoza TR, Nakamura Y, et al. When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain 1995;61:277-84.
25. Redelmeier DA, Guyatt GH, Goldstein RS. Assessing the minimal important difference in symptoms: a comparison of two techniques. J Clin Epidemiol 1996;49:1215-9 (see comments).
26. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994;47:81-7.
27. Grootendorst PV, Feeny DH, Furlong W. Does it matter whom and how you ask? Inter- and intra-rater agreement in the Ontario Health Survey. J Clin Epidemiol 1997;50:127-35.
28. Ware JE, Jr. Effects of acquiescent response set on patient satisfaction ratings. Med Care 1978;16:327-36.
29. Moore A, Moore O, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: use of pain intensity and visual analogue scales. Pain 1997;69:311-5.
30. Cranney A, Welch V, Tugwell P, et al. Responsiveness of endpoints in osteoporosis clinical trials - an update. J Rheumatol 1999;26:222-8.
31. Todd KH, Funk JP. The minimum clinically important difference in physician-assigned visual analog pain scores. Acad Emerg Med 1996;3:142-6.
32. Farrar JT, Cleary J, Rauck R, et al. Oral transmucosal fentanyl citrate: randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients. J Natl Cancer Inst 1998;90:611-6.
33. Farrar JT, Portenoy RK, Berlin JA, et al. Defining the clinically important difference in pain outcome measures. Pain (in press).
34. Moore A, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics. Pain 1996;66:229-37.
35. Sheiner LB. A new approach to the analysis of analgesic drug trials, illustrated with bromfenac data. Clin Pharmacol Ther 1994; 56:309-22.
36. Leijon G, Boivie J. Central post-stroke pain - a controlled trial of amitriptyline and carbamazepine. Pain 1989;36:27-36.