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      A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set

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          Abstract

          Background

          Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials.

          Methods/Design

          An International Steering Committee including researchers, clinicians, and patient representatives from four continents was formed to guide the development of this COS. The approach of initiatives like Core Outcome Measures in Effectiveness Trials (COMET) and Outcome Measures in Rheumatology (OMERACT) was followed. Participants were invited to participate in a Delphi study aimed at generating a consensus-based core domain set for NSLBP. A list of potential core domains was drafted and presented to the Delphi participants who were asked to judge which domains were core. Participant suggestions about overlap, aggregation, or addition of potential core domains were addressed during the study. The patients’ responses were isolated to assess whether there was substantial disagreement with the rest of the Delphi panel. A priori thresholds for consensus were established before each Delphi round. All participants’ responses were analysed from a quantitative and qualitative perspective to ascertain that no substantial discrepancies between the two approaches emerged.

          Discussion

          We present the initial step in developing a COS for NSLBP. The next step will be to determine which measurement instruments adequately cover the domains.

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          Most cited references26

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          Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes.

          Our model proposes a taxonomy or classification scheme for different measures of health outcome. We divide these outcomes into five levels: biological and physiological factors, symptoms, functioning, general health perceptions, and overall quality of life. In addition to classifying these outcome measures, we propose specific causal relationships between them that link traditional clinical variables to measures of HRQL. As one moves from left to right in the model, one moves outward from the cell to the individual to the interaction of the individual as a member of society. The concepts at each level are increasingly integrated and increasingly difficult to define and measure. AT each level, there are an increasing number of inputs that cannot be controlled by clinicians or the health care system as it is traditionally defined.
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            The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews

            To examine the prevalence of outcome reporting bias-the selection for publication of a subset of the original recorded outcome variables on the basis of the results-and its impact on Cochrane reviews.
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              Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

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                Author and article information

                Contributors
                a.chiarotto@vu.nl
                cb.terwee@vumc.nl
                deyor@ohsu.edu
                m.boers@vumc.nl
                clin@georgeinstitute.org.au
                rachelle.buchbinder@monash.edu
                terry@terrypcorbin.com
                leonardo.costa@unicid.edu.br
                n.foster@keele.ac.uk
                margreth.grotle@medisin.uio.no
                b.koes@erasmusmc.nl
                fmkovacs@kovacs.org
                cmaher@georgeinstitute.org.au
                Adam.M.Pearson@hitchcock.org
                W.C.Peul@lumc.nl
                mlschoene@aol.com
                turkdc@u.washington.edu
                maurits.van.tulder@vu.nl
                r.ostelo@vu.nl
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                26 December 2014
                2014
                : 15
                : 1
                : 511
                Affiliations
                [ ]Department of Health Sciences, Faculty of Earth & Life Sciences, EMGO+ Institute for Health and Care Research, VU University, de Boelelaan 1085, 1081HV Amsterdam, The Netherlands
                [ ]Department of Epidemiology & Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Center, van der Boechorstraat 7, 1081 BT Amsterdam, The Netherlands
                [ ]Departments of Family Medicine, Internal Medicine, Public Health and Preventive Medicine, Oregon Institute of Occupational Health Sciences, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239 USA
                [ ]The George Institute for Global Health, Sydney Medical School, The University of Sydney, PO Box M201, Missenden Rd, Kragujevac, NSW 2050 Australia
                [ ]Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia - Cabrini Medical Centre, 183 Wattletree Rd, Melbourne, VIC Australia
                [ ]Consumer Representative, Cochrane Collaboration Back Review Group, Maple Grove, MN 55311 USA
                [ ]Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de Sao Paulo, Rua Cesário Galeno 448, Sao Paulo, Brazil
                [ ]Arthritis Research UK Primary Care Centre, Institute of Primary Care and Health Sciences, Keele University, Keele, Staffordshire, ST5 5BG UK
                [ ]Oslo and Akershus University College of Applied Sciences, Faculty of Health Sciences and FORMI, Oslo University Hospital, Ullevaal, N-0407 Oslo, Norway
                [ ]Department of General Practice, Erasmus MC, University Medical Center, PO Box 2040, 3000CA Rotterdam, The Netherlands
                [ ]Spanish Back Pain Research Network (REIDE), Fundacion Kovacs, Paseo de Mallorca 36, 07012 Palma de Mallorca, Spain
                [ ]Department of Orthopaedic Surgery, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH03756 USA
                [ ]Department of Neurosurgery, Leiden University Medical Center, Postzone J11-R, Postbus 9600, 2300RC Leiden, The Netherlands
                [ ]Consumer Representative, Cochrane Collaboration Back Review Group, Newbury, MA 01951 USA
                [ ]Department of Anesthesiology & Pain Medicine and Center for Pain Research on Impact, Measurement & Effectiveness, University of Washington, 1949 NE Pacific Street, Seattle, WA 98195-6540 USA
                Article
                2373
                10.1186/1745-6215-15-511
                4308079
                25540987
                350f372c-e5ef-4975-b5ae-7ec8c926630b
                © Chiarotto et al.; licensee BioMed Central. 2014

                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 13 August 2014
                : 11 December 2014
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2014

                Medicine
                non-specific low back pain,core outcome set,domains,clinical trials,efficacy,effectiveness,health interventions

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