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      Core outcome measurement instruments for clinical trials in nonspecific low back pain


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          Consensus-based recommendations are provided on outcome measurement instruments for physical functioning, pain intensity, and health-related quality of life in patients with nonspecific low back pain.


          To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments.

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          Most cited references 73

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          EuroQol: the current state of play.

          The EuroQol Group first met in 1987 to test the feasibility of jointly developing a standardised non-disease-specific instrument for describing and valuing health-related quality of life. From the outset the Group has been multi-country, multi-centre, and multi-disciplinary. The EuroQol instrument is intended to complement other forms of quality of life measures, and it has been purposefully developed to generate a cardinal index of health, thus giving it considerable potential for use in economic evaluation. Considerable effort has been invested by the Group in the development and valuation aspects of health status measurement. Earlier work was reported upon in 1990; this paper is a second 'corporate' effort detailing subsequent developments. The concepts underlying the EuroQol framework are explored with particular reference to the generic nature of the instrument. The valuation task is reviewed and some evidence on the methodological requirements for measurement is presented. A number of special issues of considerable interest and concern to the Group are discussed: the modelling of data, the duration of health states and the problems surrounding the state 'dead'. An outline of some of the applications of the EuroQol instrument is presented and a brief commentary on the Group's ongoing programme of work concludes the paper.
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            Non-specific low back pain.

            Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management guidelines endorse triage to identify the rare cases of low back pain that are caused by medically serious pathology, and so require diagnostic work-up or specialist referral, or both. Because non-specific low back pain does not have a known pathoanatomical cause, treatment focuses on reducing pain and its consequences. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable, thus many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. The overuse of imaging, opioids, and surgery remains a widespread problem.
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              The West Haven-Yale Multidimensional Pain Inventory (WHYMPI).

               D Turk,  James Kerns,  T A Rudy (1985)
              The complexity of chronic pain has represented a major dilemma for clinical researchers interested in the reliable and valid assessment of the problem and the evaluation of treatment approaches. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI) was developed in order to fill a widely recognized void in the assessment of clinical pain. Assets of the inventory are its brevity and clarity, its foundation in contemporary psychological theory, its multidimensional focus, and its strong psychometric properties. Three parts of the inventory, comprised of 12 scales, examine the impact of pain on the patients' lives, the responses of others to the patients' communications of pain, and the extent to which patients participate in common daily activities. The instrument is recommended for use in conjunction with behavioral and psychophysiological assessment strategies in the evaluation of chronic pain patients in clinical settings. The utility of the WHYMPI in empirical investigations of chronic pain is also discussed.

                Author and article information

                Wolters Kluwer (Philadelphia, PA )
                March 2018
                24 January 2018
                : 159
                : 3
                : 481-495
                [a ]Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, the Netherlands
                [b ]Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences Research Institute, Vrije Universiteit, Amsterdam, the Netherlands
                [c ]Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands
                [d ]Department of Family Medicine, Department of Internal Medicine, and Oregon Institute of Occupational Health Sciences, Oregon Health and Science University, Portland, OR, USA
                [e ]Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
                [f ]Monash Department of Clinical Epidemiology, Cabrini Institute, Malvern, Australia
                [g ]Cochrane Collaboration, Back and Neck Review Group, Maple Grove, MN, USA
                [h ]Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, Sao Paulo, Brazil
                [i ]Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, United Kingdom
                [j ]Oslo and Akershus University College, Faculty of Health Science, Oslo, Norway
                [k ]Communication and Research Unit for Musculoskeletal Disorders (FORMI), Oslo University Hospital & University of Oslo, Oslo, Norway
                [l ]Department of General Practice, Erasmus MC University Medical Center, Rotterdam, the Netherlands
                [m ]Spanish Back Pain Research Network, Hospital Universitario HLA-Moncloa, Madrid, Spain
                [n ]Sydney School of Public Health, Sydney Medical School, University of Sydney, Sydney, Australia
                [o ]Department of Orthopaedic Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, PA, USA
                [p ]Department of Neurosurgery, Leiden University Medical Center, Leiden, the Netherlands
                [q ]Cochrane Collaboration, Back and Neck Review Group, Newbury, MA, USA
                [r ]Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA
                Author notes
                [* ]Corresponding author. Address: Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Amsterdam Movement Sciences Research Institute, Vrije Universiteit, de Boelelaan 1085, Room U-601, 1081HV Amsterdam, the Netherlands. E-mail address: a.chiarotto@ 123456vu.nl (A. Chiarotto).
                PAIN-D-17-00770 00011
                Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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