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

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Supplemental Digital Content is Available in the Text.

          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.

          Abstract

          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 108

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          The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.

          A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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            EuroQol--a new facility for the measurement of health-related quality of life.

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            In the course of developing a standardised, non-disease-specific instrument for describing and valuing health states (based on the items in Table 1), the EuroQol Group (whose members are listed in the Appendix) conducted postal surveys in England, The Netherlands and Sweden which indicate a striking similarity in the relative valuations attached to 14 different health states. The data were collected using a visual analogue scale similar to a thermometer. The EuroQol instrument is intended to complement other quality-of-life measures and to facilitate the collection of a common data set for reference purposes. Others interested in participating in the extension of this work are invited to contact the EuroQol Group.
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              A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.

              Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population (n=2,333). The resulting 12-item short-form (SF-12) achieved multiple R squares of 0.911 and 0.918 in predictions of the SF-36 Physical Component Summary and SF-36 Mental Component Summary scores, respectively. Scoring algorithms from the general population used to score 12-item versions of the two components (Physical Components Summary and Mental Component Summary) achieved R squares of 0.905 with the SF-36 Physical Component Summary and 0.938 with SF-36 Mental Component Summary when cross-validated in the Medical Outcomes Study. Test-retest (2-week)correlations of 0.89 and 0.76 were observed for the 12-item Physical Component Summary and the 12-item Mental Component Summary, respectively, in the general US population (n=232). Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the 12-item Mental Component Summary, including comparisons between patient groups known to differ or to change in terms of the presence and seriousness of physical and mental conditions, acute symptoms, age and aging, self-reported 1-year changes in health, and recovery for depression. In 14 validity tests involving physical criteria, relative validity estimates for the 12-item Physical Component Summary ranged from 0.43 to 0.93 (median=0.67) in comparison with the best 36-item short-form scale. Relative validity estimates for the 12-item Mental Component Summary in 6 tests involving mental criteria ranged from 0.60 to 107 (median=0.97) in relation to the best 36-item short-form scale. Average scores for the 2 summary measures, and those for most scales in the 8-scale profile based on the 12-item short-form, closely mirrored those for the 36-item short-form, although standard errors were nearly always larger for the 12-item short-form.
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                Author and article information

                Journal
                Pain
                Pain
                JPAIN
                Pain
                JOP
                Pain
                Wolters Kluwer (Philadelphia, PA )
                0304-3959
                1872-6623
                March 2018
                24 January 2018
                : 159
                : 3
                : 481-495
                Affiliations
                [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).
                Article
                PAIN-D-17-00770 00011
                10.1097/j.pain.0000000000001117
                5828378
                29194127
                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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