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

doi:10.1097/PR9.0000000000001202

Validation of a holistic composite outcome measure for the evaluation of chronic pain interventions

Pain Rep. 2024 Oct 14;9(6):e1202. doi: 10.1097/PR9.0000000000001202. eCollection 2024 Dec.

Authors

Rod S Taylor¹, Quinton Neville², Christopher M Mullin³, Nagy A Mekhail⁴, Jan W Kallewaard^{5

6}, Salim Hayek⁷, Jason E Pope⁸, Corey W Hunter⁹, Shrif J Costandi⁴, Leonardo Kapural¹⁰, Christopher A Gilmore¹⁰, Erika A Petersen¹¹, Kiran V Patel^{12

13}, Sam Eldabe¹⁴, Robert M Levy¹⁵, Christopher Gilligan¹⁶, Shravani Durbhakula¹⁷, Alaa Abd-Elsayed¹⁸, Marshall Bedder¹⁹, Patrick Buchanan²⁰, Erin Hanson²¹, Angela Leitner²¹, Nicole Soliday²¹, Rui V Duarte^{21

22}, Daniel J Clauw²³, Turo J Nurmikko²⁴

Affiliations

¹ MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Glasgow, United Kingdom.
² Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.
³ North American Science Associates, Minneapolis, MN, USA.
⁴ Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA.
⁵ Department of Anaesthesiology and Pain Management, Rijnstate Hospital, Velp, the Netherlands.
⁶ Department of Anesthesiology and Pain Medicine, Amsterdam University Medical Centre, Amsterdam, the Netherlands.
⁷ Division of Pain Medicine, University Hospitals, Cleveland Medical Center, Cleveland, OH, USA.
⁸ Evolve Restorative Center, Santa Rosa, CA, USA.
⁹ Ainsworth Institute of Pain Management, New York, NY, USA.
¹⁰ Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA.
¹¹ Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
¹² The Spine & Pain Institute of New York, New York, NY, USA.
¹³ Department of Anesthesiology, NYU Langone Medical Center, New York, NY, USA.
¹⁴ Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.
¹⁵ Neurosurgical Services, Clinical Research, Anesthesia Pain Care Consultants, Tamarac, FL, USA.
¹⁶ Robert Wood Johnson University Hospital, New Brunswick, NJ, USA.
¹⁷ Department of Anesthesiology & Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.
¹⁸ Department of Anesthesiology and Pain Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
¹⁹ Department of Surgery and the Pain Medicine Service, Charlie Norwood Veterans Administration Medical Center, Augusta, GA, USA.
²⁰ Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA.
²¹ Saluda Medical Pty Ltd., Artarmon, New South Wales, Australia.
²² Department of Health Data Science, University of Liverpool, Liverpool, United Kingdom.
²³ Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA.
²⁴ 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.

Keywords: Chronic pain; Construct validity; Holistic composite outcome measure; Internal consistency; Minimal clinical important difference; Pain measurement.