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Estimation of minimum clinically important difference for pain in fibromyalgia

dc.contributor.authorMease, Philip J.en_US
dc.contributor.authorSpaeth, Michaelen_US
dc.contributor.authorClauw, Daniel J.en_US
dc.contributor.authorArnold, Lesley M.en_US
dc.contributor.authorBradley, Laurence A.en_US
dc.contributor.authorRussell, I. Jonen_US
dc.contributor.authorKajdasz, Daniel K.en_US
dc.contributor.authorWalker, Daniel J.en_US
dc.contributor.authorChappell, Amy S.en_US
dc.date.accessioned2011-11-10T15:37:26Z
dc.date.available2012-07-12T17:42:24Zen_US
dc.date.issued2011-06en_US
dc.identifier.citationMease, Philip J.; Spaeth, Michael; Clauw, Daniel J.; Arnold, Lesley M.; Bradley, Laurence A.; Russell, I. Jon; Kajdasz, Daniel K.; Walker, Daniel J.; Chappell, Amy S. (2011). "Estimation of minimum clinically important difference for pain in fibromyalgia ." Arthritis Care & Research 63(6): 821-826. <http://hdl.handle.net/2027.42/87063>en_US
dc.identifier.issn2151-464Xen_US
dc.identifier.issn2151-4658en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/87063
dc.description.abstractObjective To estimate the minimum clinically important difference (MCID) for several pain measures obtained from the Brief Pain Inventory (BPI) for patients with fibromyalgia. Methods Data were pooled across 12‐week treatment periods from 4 randomized, double‐blind, placebo‐controlled studies designed to evaluate the safety and efficacy of duloxetine for the treatment of fibromyalgia. Each study enrolled subjects with American College of Rheumatology–defined fibromyalgia who presented with moderate to severe pain. The MCIDs for the BPI average pain item score and the BPI severity score (the mean of the BPI pain scale values: right now, average, least, and worst) were estimated by anchoring against the Patient's Global Impressions of Improvement scale. Results The anchor‐based MCIDs for the BPI average pain item and severity scores were 2.1 and 2.2 points, respectively. These MCIDs correspond to 32.3% and 34.2% reductions from baseline in scores. Conclusion In these analyses, the MCIDs for several pain measures obtained from the BPI were similar (∼2 points) and corresponded to a 30–35% improvement from baseline to end point. These findings may be beneficial for use in designing clinical trials in which the BPI is used to evaluate improvements in pain severity.en_US
dc.publisherJohn Wiley & Sons, Inc.en_US
dc.titleEstimation of minimum clinically important difference for pain in fibromyalgiaen_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbsecondlevelGeriatricsen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.contributor.affiliationumUniversity of Michigan Medical Center, Ann Arboren_US
dc.contributor.affiliationotherSwedish Medical Center and University of Washington School of Medicine, Seattleen_US
dc.contributor.affiliationotherPractice for Internal Medicine, Graefelfing, Munich, Germanyen_US
dc.contributor.affiliationotherUniversity of Cincinnati College of Medicine, Cincinnati, Ohioen_US
dc.contributor.affiliationotherUniversity of Alabama at Birminghamen_US
dc.contributor.affiliationotherUniversity of Texas Health Science Center, San Antonioen_US
dc.contributor.affiliationotherTrovis Pharmaceuticals LLC, New Haven, Connecticuten_US
dc.contributor.affiliationotherLilly Research Laboratories, Indianapolis, Indianaen_US
dc.contributor.affiliationotherLilly Research Laboratories and Indiana University School of Medicine, Indianapolisen_US
dc.contributor.affiliationotherSeattle Rheumatology Associates, 1101 Madison Street, Suite 1000, Seattle, WA 98104en_US
dc.identifier.pmid21312349en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/87063/1/20449_ftp.pdf
dc.identifier.doi10.1002/acr.20449en_US
dc.identifier.sourceArthritis Care & Researchen_US
dc.identifier.citedreferenceMease PJ, Clauw DJ, Arnold LM, Goldenberg DL, Witter J, Williams DA, et al. Fibromyalgia syndrome. J Rheumatol 2005; 32: 2270 – 7.en_US
dc.identifier.citedreferenceDeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg 1998; 86: 102 – 6.en_US
dc.identifier.citedreferenceMelzack R. The short‐form McGill Pain Questionnaire. Pain 1987; 30: 191 – 7.en_US
dc.identifier.citedreferenceBurckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol 1991; 18: 728 – 33.en_US
dc.identifier.citedreferenceCleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994; 23: 129 – 38.en_US
dc.identifier.citedreferenceArnold LM, Rosen A, Pritchett YL, D'Souza DN, Goldstein DJ, Iyengar S, et al. A randomized, double‐blind, placebo‐controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 2005; 119: 5 – 15.en_US
dc.identifier.citedreferenceRussell IJ, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, et al. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: results from a 6‐month, randomized, double‐blind, placebo‐controlled, fixed‐dose trial. Pain 2008; 136: 432 – 44.en_US
dc.identifier.citedreferenceChappell AS, Bradley LA, Wiltse C, Detke MJ, D'Souza DN, Spaeth M. A six‐month double‐blind, placebo‐controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia. Int J Gen Med 2008; 1: 91 – 102.en_US
dc.identifier.citedreferenceArnold LM, Lu Y, Crofford LJ, Wohlreich M, Detke MJ, Iyengar S, et al. A double‐blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum 2004; 50: 2974 – 84.en_US
dc.identifier.citedreferenceClauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15‐week, multicenter, randomized, double‐blind, placebo‐controlled, multiple‐dose clinical trial. Clin Ther 2008; 30: 1988 – 2004.en_US
dc.identifier.citedreferenceMease PJ, Clauw DJ, Gendreau RM, Rao SG, Kranzler J, Chen W, et al. The efficacy and safety of milnacipran for treatment of fibromyalgia: a randomized, double‐blind, placebo‐controlled trial. J Rheumatol 2009; 36: 398 – 409.en_US
dc.identifier.citedreferenceCrofford LJ, Mease PJ, Simpson SL, Young JP Jr, Martin SA, Haig GM, et al. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6‐month, double‐blind, placebo‐controlled trial with pregabalin. Pain 2008; 136: 419 – 31.en_US
dc.identifier.citedreferenceArnold LM, Russell IJ, Diri EW, Duan WR, Young JP Jr, Sharma U, et al. A 14‐week, randomized, double‐blinded, placebo‐controlled monotherapy trial of pregabalin in patients with fibromyalgia. J Pain 2008; 9: 792 – 805.en_US
dc.identifier.citedreferenceJaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407 – 15.en_US
dc.identifier.citedreferenceBeaton DE, Boers M, Wells GA. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol 2002; 14: 109 – 14.en_US
dc.identifier.citedreferenceCopay AG, Subach BR, Glassman SD, Polly DW Jr, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J 2007; 7: 541 – 6.en_US
dc.identifier.citedreferenceWells G, Beaton D, Shea B, Boers M, Simon L, Strand V, et al. Minimal clinically important differences: review of methods. J Rheumatol 2001; 28: 406 – 12.en_US
dc.identifier.citedreferenceDworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008; 9: 105 – 21.en_US
dc.identifier.citedreferenceGuy W. ECDEU assessment manual for psychopharmacology, revised. US Department of Health, Education, and Welfare publication (ADM). Rockville (MD): National Institute of Mental Health; 1976. p. 76 – 338.en_US
dc.identifier.citedreferenceWolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: report of the Multicenter Criteria Committee. Arthritis Rheum 1990; 33: 160 – 72.en_US
dc.identifier.citedreferenceFarrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11‐point numerical pain rating scale. Pain 2001; 94: 149 – 58.en_US
dc.identifier.citedreferenceDemyttenaere K, Bonnewyn A, Bruffaerts R, Brugha T, de Graaf R, Alonso J. Comorbid painful physical symptoms and depression: prevalence, work loss, and help seeking. J Affect Disord 2006; 92: 185 – 93.en_US
dc.identifier.citedreferenceGarcia‐Cebrian A, Gandhi P, Demyttenaere K, Peveler R. The association of depression and painful physical symptoms: a review of the European literature. Eur Psychiatry 2006; 21: 379 – 88.en_US
dc.identifier.citedreferenceJordan K, Dunn KM, Lewis M, Croft P. A minimal clinically important difference was derived for the Roland‐Morris Disability Questionnaire for low back pain. J Clin Epidemiol 2006; 59: 45 – 52.en_US
dc.identifier.citedreferenceChilds JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine 2005; 30: 1331 – 4.en_US
dc.identifier.citedreferenceCleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil 2008; 89: 69 – 74.en_US
dc.identifier.citedreferenceHagg O, Fritzell P, Nordwall A, for the Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J 2003; 12: 12 – 20.en_US
dc.identifier.citedreferenceSim J, Jordan K, Lewis M, Hill J, Hay EM, Dziedzic K. Sensitivity to change and internal consistency of the Northwick Park Neck Pain Questionnaire and derivation of a minimal clinically important difference. Clin J Pain 2006; 22: 820 – 6.en_US
dc.identifier.citedreferenceFarrar JT, Pritchett YL, Robinson M, Prakash A, Chappell A. The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders. J Pain 2010; 11: 109 – 18.en_US
dc.identifier.citedreferencePerahia DG, Pritchett YL, Desaiah D, Raskin J. Efficacy of duloxetine in painful symptoms: an analgesis or antidepressant effect? Int Clin Psychopharmacol 2006; 21: 311 – 7.en_US
dc.identifier.citedreferencePerahia DG, Quail D, Desaiah D, Montejo AL, Schatzberg AF. Switching to duloxetine in selective serotonin reuptake inhibitor non‐ and partial‐responders: effects on painful physical symptoms of depression. J Psychiatr Res 2009; 43: 512 – 8.en_US
dc.identifier.citedreferenceTubach F, Ravaud P, Beaton D, Boers M, Bombardier C, Felson DT, et al. Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders. J Rheumatol 2007; 34: 1188 – 93.en_US
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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