Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations

Robert H. Dworkin; Dennis C. Turk; Michael P. McDermott; Sarah Peirce-Sandner; Laurie B. Burke; Penney Cowan; John T. Farrar; Sharon Hertz; Srinivasa N. Raja; Bob A. Rappaport; Christine Rauschkolb; Cristina Sampaio

doi:10.1016/j.pain.2009.08.019

journal article Dec 01, 2009

Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations

Dennis C. Turk Michael P. McDermott Sarah Peirce-Sandner Laurie B. Burke Penney Cowan John T. Farrar Sharon Hertz Srinivasa N. Raja Bob A. Rappaport Christine Rauschkolb Cristina Sampaio

Pain Vol. 146 No. 3 pp. 238-244 · Ovid Technologies (Wolters Kluwer Health)

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References

36

[1]

Attal "EFNS guidelines on pharmacological treatment of neuropathic pain." Eur J Neurol (2006) 10.1111/j.1468-1331.2006.01511.x

[2]

Arezzo "Efficacy and safety of pregabalin 600 mgd for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial." BMC Neurol (2008) 10.1186/1471-2377-8-33

[3]

Beaton "Looking for important changedifferences in studies of responsiveness." J Rheumatol (2001)

[4]

Bjordal "Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: a meta-analysis of randomised placebo-controlled trials." Eur J Pain (2007) 10.1016/j.ejpain.2006.02.013

[5]

Cella "Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life." Mayo Clin Proc (2002) 10.4065/77.4.384

[6]

Copay "Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales." Spine J (2008) 10.1016/j.spinee.2007.11.006

[7]

Dionne "Individual responder analyses for pain: does one pain scale fit all." Trends Pharmacol Sci (2005) 10.1016/j.tips.2005.01.009

[8]

Dworkin "Pharmacologic management of neuropathic pain: evidence-based clinical recommendations." Pain (2007) 10.1016/j.pain.2007.08.033

[9]

Dworkin "Core outcome measures for chronic pain clinical trials: IMMPACT recommendations." Pain (2005) 10.1016/j.pain.2004.09.012

[10]

Dworkin "Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations." J Pain (2008) 10.1016/j.jpain.2007.09.005

[11]

Farrar "What is clinically meaningful: outcome measures in pain clinical trials." Clin J Pain (2000) 10.1097/00002508-200006001-00018

[12]

Farrar "Use of the cumulative proportion of responders analysis graph to present pain data over a range of cut-off points: making clinical trial data more understandable." J Pain Symptom Manage (2006) 10.1016/j.jpainsymman.2005.08.018

[13]

Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale

John T. Farrar, James P. Young, Linda LaMoreaux et al.

Pain 2001 10.1016/s0304-3959(01)00349-9

[14]

Fischer "Capturing the patients view of change as a clinical outcome measure." JAMA (1999) 10.1001/jama.282.12.1157

[15]

Goldstein "Duloxetine vs. placebo in patients with painful diabetic neuropathy." Pain (2005) 10.1016/j.pain.2005.03.029

[16]

Guyatt "Making sense of quality-of-life data." Med Care (2000) 10.1097/00005650-200009002-00027

[17]

Guyatt "Measuring health-related quality of life." Ann Intern Med (1993) 10.7326/0003-4819-118-8-199304150-00009

[18]

Hanley "Clinically significant change in pain intensity ratings in persons with spinal cord injury or amputation." Clin J Pain (2006) 10.1097/01.ajp.0000148628.69627.82

[19]

Jaeschke "Measurement of health status. Ascertaining the minimal clinically important difference." Control Clin Trials (1989) 10.1016/0197-2456(89)90005-6

[20]

Jordan "EULAR recommendations 2003: an evidence based approach to the management of knee osteoarthritis: report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT)." Ann Rheum Dis (2003) 10.1136/ard.2003.011742

[21]

Katz "Clinical trial outcome in neuropathic pain: relationship to study characteristics." Neurology (2008) 10.1212/01.wnl.0000275528.01263.6c

[22]

Lesser "Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial." Neurology (2004) 10.1212/01.wnl.0000145767.36287.a1

[23]

Lydick "Interpretation of quality of life changes." Qual Life Res (1993) 10.1007/bf00435226

[24]

Moulin "Pharmacological management of chronic neuropathic pain: consensus statement and guidelines from the Canadian Pain Society." Pain Res Manage (2007) 10.1155/2007/730785

[25]

Quessy "Placebo response in neuropathic pain trials." Pain (2008) 10.1016/j.pain.2008.06.024

[26]

Raskin "A double-blind, randomized multicenter trial comparing duloxetine with placebo in the management of diabetic peripheral neuropathic pain." Pain Med (2005) 10.1111/j.1526-4637.2005.00061.x

[27]

Richter "Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial." J Pain (2005) 10.1016/j.jpain.2004.12.007

[28]

Rosenstock "Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial." Pain (2004) 10.1016/j.pain.2004.05.001

[29]

Schunemann "Interpreting the results of patient reported outcome measures in clinical trials: the clinicians perspective." Health Qual Life Outcomes (2006) 10.1186/1477-7525-4-62

[30]

ten Klooster "Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patients perspective." Pain (2006) 10.1016/j.pain.2005.12.021

[31]

Testa "Interpretation of quality-of-life outcomes: issues that affect magnitude and meaning." Med Care (2000) 10.1097/00005650-200009002-00026

[32]

Tolle "Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study." Eur J Pain (2008) 10.1016/j.ejpain.2007.05.003

[33]

Turk "Core outcome domains for chronic pain clinical trials: IMMPACT recommendations." Pain (2003) 10.1016/j.pain.2003.08.001

[34]

Turk "Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations." Pain (2008) 10.1016/j.pain.2008.06.025

[35]

Wernicke "A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain." Neurology (2006) 10.1212/01.wnl.0000240225.04000.1a

[36]

Zhang "OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines." Osteoarthritis Cartilage (2008) 10.1016/j.joca.2007.12.013

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References

Details

Published: Dec 01, 2009
Vol/Issue: 146(3)
Pages: 238-244

Authors

Cite This Article

Robert H. Dworkin, Dennis C. Turk, Michael P. McDermott, et al. (2009). Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain, 146(3), 238-244. https://doi.org/10.1016/j.pain.2009.08.019

Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations

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