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      Development and validation of a screening tool to predict the risk of chronic low back pain in patients presenting with acute low back pain: a study protocol

      protocol

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          Abstract

          Introduction

          Around 40% of people presenting to primary care with an episode of acute low back pain develop chronic low back pain. In order to reduce the risk of developing chronic low back pain, effective secondary prevention strategies are needed. Early identification of at-risk patients allows clinicians to make informed decisions based on prognostic profile, and researchers to select appropriate participants for secondary prevention trials. The aim of this study is to develop and validate a prognostic screening tool that identifies patients with acute low back pain in primary care who are at risk of developing chronic low back pain. This paper describes the methods and analysis plan for the development and validation of the tool.

          Methods/analysis

          The prognostic screening tool will be developed using methods recommended by the Prognosis Research Strategy (PROGRESS) Group and reported using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement. In the development stage, we will use data from 1248 patients recruited for a prospective cohort study of acute low back pain in primary care. We will construct 3 logistic regression models to predict chronic low back pain according to 3 definitions: any pain, high pain and disability at 3 months. In the validation stage, we will use data from a separate sample of 1643 patients with acute low back pain to assess the performance of each prognostic model. We will produce validation plots showing Nagelkerke R 2 and Brier score (overall performance), area under the curve statistic (discrimination) and the calibration slope and intercept (calibration).

          Ethics and dissemination

          Ethical approval from the University of Sydney Ethics Committee was obtained for both of the original studies that we plan to analyse using the methods outlined in this protocol (Henschke et al, ref 11-2002/3/3144; Williams et al, ref 11638).

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          Most cited references28

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          Grading the severity of chronic pain.

          Michael Von Korff, Johan Ormel, Francis Keefe … (1992)
          This research develops and evaluates a simple method of grading the severity of chronic pain for use in general population surveys and studies of primary care pain patients. Measures of pain intensity, disability, persistence and recency of onset were tested for their ability to grade chronic pain severity in a longitudinal study of primary care back pain (n = 1213), headache (n = 779) and temporomandibular disorder pain (n = 397) patients. A Guttman scale analysis showed that pain intensity and disability measures formed a reliable hierarchical scale. Pain intensity measures appeared to scale the lower range of global severity while disability measures appeared to scale the upper range of global severity. Recency of onset and days in pain in the prior 6 months did not scale with pain intensity or disability. Using simple scoring rules, pain severity was graded into 4 hierarchical classes: Grade I, low disability--low intensity; Grade II, low disability--high intensity; Grade III, high disability--moderately limiting; and Grade IV, high disability--severely limiting. For each pain site, Chronic Pain Grade measured at baseline showed a highly statistically significant and monotonically increasing relationship with unemployment rate, pain-related functional limitations, depression, fair to poor self-rated health, frequent use of opioid analgesics, and frequent pain-related doctor visits both at baseline and at 1-year follow-up. Days in Pain was related to these variables, but not as strongly as Chronic Pain Grade. Recent onset cases (first onset within the prior 3 months) did not show differences in psychological and behavioral dysfunction when compared to persons with less recent onset. Using longitudinal data from a population-based study (n = 803), Chronic Pain Grade at baseline predicted the presence of pain in the prior 2 weeks. Chronic Pain Grade and pain-related functional limitations at 3-year follow-up. Grading chronic pain as a function of pain intensity and pain-related disability may be useful when a brief ordinal measure of global pain severity is required. Pain persistence, measured by days in pain in a fixed time period, provides useful additional information.
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            A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain.

            Tamar Pincus, A Burton, Steve Vogel … (2002)
            A systematic review of prospective cohort studies in low back pain. To evaluate the evidence implicating psychological factors in the development of chronicity in low back pain. The biopsychosocial model is gaining acceptance in low back pain, and has provided a basis for screening measurements, guidelines and interventions; however, to date, the unique contribution of psychological factors in the transition from an acute presentation to chronicity has not been rigorously assessed. A systematic literature search was followed by the application of three sets of criteria to each study: methodologic quality, quality of measurement of psychological factors, and quality of statistical analysis. Two reviewers blindly coded each study, followed by independent assessment by a statistician. Studies were divided into three environments: primary care settings, pain clinics, and workplace. Twenty-five publications (18 cohorts) included psychological factors at baseline. Six of these met acceptability criteria for methodology, psychological measurement, and statistical analysis. Increased risk of chronicity (persisting symptoms and/or disability) from psychological distress/depressive mood and, to a lesser extent, somatization emerged as the main findings. Acceptable evidence generally was not found for other psychological factors, although weak support emerged for the role of catastrophizing as a coping strategy. Psychological factors (notably distress, depressive mood, and somatization) are implicated in the transition to chronic low back pain. The development and testing of clinical interventions specifically targeting these factors is indicated. In view of the importance attributed to other psychological factors (particularly coping strategies and fear avoidance) there is a need to clarify their role in back-related disability through rigorous prospective studies.
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              Prognosis and prognostic research: validating a prognostic model.

              Douglas G. Altman, Yvonne Vergouwe, Patrick Royston … (2009)
              Article 0 comments Cited 201 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2015
                Publication date (Electronic): 15 July 2015
                Volume: 5
                Issue: 7
                Electronic Location Identifier: e007916
                Affiliations
                [1 ]School of Medical Sciences, University of New South Wales , Sydney, New South Wales, Australia
                [2 ]Neuroscience Research Australia , Sydney, New South Wales, Australia
                [3 ]Institute of Public Health, University of Heidelberg , Heidelberg, Germany
                [4 ]Hunter Medical Research Institute and School of Medicine and Public Health, University of Newcastle , Newcastle, New South Wales, Australia
                [5 ]The George Institute for Global Health, University of Sydney , Sydney, New South Wales, Australia
                [6 ]Sansom Institute for Health Research, University of South Australia , Adelaide, South Australia, Australia
                Author notes
                [Correspondence to ] Dr James McAuley; j.mcauley@ 123456neura.edu.au
                Article
                Publisher ID: bmjopen-2015-007916
                DOI: 10.1136/bmjopen-2015-007916
                PMC ID: 4513486
                PubMed ID: 26179647
                SO-VID: e9e3450d-a6f7-46c6-9e92-a5f73aa02d01
                Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions
                License:

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                Date received : 10 February 2015
                Date revision received : 28 May 2015
                Date accepted : 12 June 2015
                Categories
                Subject: Epidemiology
                Subject: Protocol
                Subject: 1506
                Subject: 1692
                Subject: 1730
                Subject: 1727
                Subject: 1724

                ScienceOpen disciplines: Medicine
                Keywords: epidemiology,primary care
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: epidemiology, primary care

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