Validation of a holistic composite outcome measure for the evaluation of chronic pain interventions
Rod S. Taylor,
Quinton Neville,
Christopher M. Mullin,
Nagy A. Mekhail,
Jan W. Kallewaard,
Salim Hayek,
Jason E. Pope,
Corey W. Hunter,
Shrif J. Costandi,
Leonardo Kapural,
Christopher A. Gilmore,
Erika A. Petersen,
Kiran V. Patel,
Sam Eldabe,
Robert M. Levy,
Christopher Gilligan,
Shravani Durbhakula,
Alaa Abd-Elsayed,
Marshall Bedder,
Patrick Buchanan,
Erin Hanson,
Angela Leitner,
Nicole Soliday,
Rui V. Duarte,
Daniel J. Clauw,
Turo J. Nurmikko
Affiliations
Rod S. Taylor
a MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Glasgow, United Kingdom
Quinton Neville
b Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA
Christopher M. Mullin
c North American Science Associates, Minneapolis, MN, USA
Nagy A. Mekhail
d Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA
Jan W. Kallewaard
e Department of Anaesthesiology and Pain Management, Rijnstate Hospital, Velp, the Netherlands
Salim Hayek
g Division of Pain Medicine, University Hospitals, Cleveland Medical Center, Cleveland, OH, USA
Jason E. Pope
h Evolve Restorative Center, Santa Rosa, CA, USA
Corey W. Hunter
i Ainsworth Institute of Pain Management, New York, NY, USA
Shrif J. Costandi
d Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA
Leonardo Kapural
j Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA
Christopher A. Gilmore
j Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA
Erika A. Petersen
k Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA
Kiran V. Patel
l The Spine & Pain Institute of New York, New York, NY, USA
Sam Eldabe
n Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom
Robert M. Levy
o Neurosurgical Services, Clinical Research, Anesthesia Pain Care Consultants, Tamarac, FL, USA
Christopher Gilligan
p Robert Wood Johnson University Hospital, New Brunswick, NJ, USA
Shravani Durbhakula
q Department of Anesthesiology & Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA
Alaa Abd-Elsayed
r Department of Anesthesiology and Pain Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
Marshall Bedder
s Department of Surgery and the Pain Medicine Service, Charlie Norwood Veterans Administration Medical Center, Augusta, GA, USA
Patrick Buchanan
t Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA
Erin Hanson
u Saluda Medical Pty Ltd., Artarmon, New South Wales, Australia
Angela Leitner
u Saluda Medical Pty Ltd., Artarmon, New South Wales, Australia
Nicole Soliday
u Saluda Medical Pty Ltd., Artarmon, New South Wales, Australia
Rui V. Duarte
u Saluda Medical Pty Ltd., Artarmon, New South Wales, Australia
Daniel J. Clauw
w Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA
Turo J. Nurmikko
x Department of Pain Medicine, The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom
Abstract. Introduction:. Chronic pain is a personal experience influenced by multiple biopsychosocial factors. Using a pain intensity measure alone to assess the effectiveness of a chronic pain intervention fails to fully evaluate its impact on the multifaceted chronic pain experience. The holistic minimal clinically important difference (MCID) is a composite outcome developed to provide a comprehensive assessment of chronic pain in response to intervention, across 5 outcome domains: pain intensity, health-related quality of life, sleep quality, physical, and emotional function. To focus on domains where the individual need is greatest, the holistic MCID reflects the cumulative MCID averaged over only the domains where subjects were impaired preintervention. Objectives:. To assess the internal and construct validity of the Holistic MCID score to inform its future use as an evidence-based tool. Methods:. This validation study was undertaken using data from the EVOKE trial with 111 patients up to 24-month follow-up. Internal consistency of the holistic MCID was assessed using Cronbach alpha statistic and dimensional exploration using principal component analysis. Results:. The holistic MCID measure demonstrated strong internal consistency with Cronbach alpha >0.7 at all follow-ups. Principal component analysis showed one overarching holistic dimension to be present in the composite. Construct validity was demonstrated by an increase in the holistic MCID score being associated with both increased Patients' Global Impression of Change, EuroQol visual analogue scale score, and each of the outcome domains in a “leave-one-out” analysis (all P < 0.001). Conclusion:. The holistic MCID provides a valid measure for the comprehensive, personalized assessment of response after a chronic pain intervention. The validity of the holistic MCID requires further confirmation in other chronic pain populations and with different interventions.
