xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06016647</url>
    </required_header>
    <id_info>
      <org_study_id>121883</org_study_id>
      <nct_id>NCT06016647</nct_id>
    </id_info>
    <brief_title>Multi-axis Assessment of Injured Workers</brief_title>
    <official_title>Precision Multi-Axis Pain Assessment of Injured Workers to Improve Treatment and Work Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dave Walton</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CBI Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Western University, Canada</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The percentage of loss time claims receiving Loss of Earnings benefits at 3 months has&#xD;
        continued to rise amongst injured workers in Ontario despite the Workplace Safety and&#xD;
        Insurance Board (WSIB) approach of &quot;Better at Work&quot;. The primary health services to address&#xD;
        loss time claims associated with musculoskeletal injuries include the evidenced-based&#xD;
        programs of care, occupational health assessment program and musculoskeletal specialty&#xD;
        programs, however, these are set to be revised and relaunched in Q1 2023. Across treatment&#xD;
        protocols there are challenges that, at least in part, appear to contribute to the increasing&#xD;
        percentage of workers on full loss of earnings at 3 months include (1) inconsistent early&#xD;
        identification of workers who should be triaged to various health services and (2) reliable&#xD;
        determination of the optimal timing of referral to the most targeted care to enable a safe&#xD;
        and sustainable return to work. The investigators aim to develop and evaluate a predictive&#xD;
        assessment model to triage workers to the best service within the first 8 weeks of their&#xD;
        claim to increase the rate of early return to work, with the long-term goal that the triage&#xD;
        protocol becomes part of a person-centric protocol that reduces the duration of work-related&#xD;
        disability.&#xD;
  &#xD;
        The investigators will develop and evaluate an assessment protocol for injured workers that&#xD;
        enter any of the musculoskeletal-specific WSIB programs of care, which have been consolidated&#xD;
        into a single program as of 2023. This study will be a prospective inception cohort design&#xD;
        using data collected from injured workers receiving WSIB musculoskeletal programs of care&#xD;
        services at CBI Health clinics in Ontario Canada. Worker data will be collected at intake to&#xD;
        the program of care service and again approximately four and eight weeks after intake (or&#xD;
        earlier if a worker completes the program of care). The investigators will complete data&#xD;
        analysis in three steps including descriptive and bivariate associations, Maximum&#xD;
        Likelihood-based Latent Profile Analysis, and evaluation of results against successful work&#xD;
        outcomes and secondary outcomes. Qualitative data will be mined for alternative indicators of&#xD;
        recovery / non-recovery. The study recruitment goal is 300 - 350 workers with complete&#xD;
        follow-up within a 2-year period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background and Rationale It has long been known that early and targeted acute-stage&#xD;
        intervention is the best way to prevent chronic pain. For 15 years the Principal Investigator&#xD;
        has been developing novel tools, strategies, and frameworks for predicting and preventing the&#xD;
        acute-to-chronic transition in other populations. These include self-report tools that have&#xD;
        individually demonstrated &gt;75% accuracy in predicting 12-month outcomes when administered in&#xD;
        the first weeks from injury, new interpretations of common pain assessment and evaluation&#xD;
        tools, and new frameworks for understanding pain and its management at both the acute and&#xD;
        chronic stages. The investigators have used advanced analytic techniques to identify and&#xD;
        describe the recovery trajectories present in a sample of people with mixed musculoskeletal&#xD;
        injuries using data collected within days to weeks, predicting outcomes up to 12 months&#xD;
        post-injury. In a recently-completed project, some of these innovations were integrated into&#xD;
        a single online questionnaire targeting Canadian military veterans with chronic pain. The&#xD;
        results of that analysis revealed a 5-cluster solution based on responses to self-report&#xD;
        measures of 7 domains (or axes) of drivers of the pain experience. The investigators believe&#xD;
        this strategy will also have value when translated and implemented in more acutely injured&#xD;
        workers in Canada as a single risk stratification and management protocol. The longer-term&#xD;
        goal is to use this type of simple self-assessment protocol to empower injured workers and&#xD;
        claims managers to triage into the right care pathway, reduce time off work, and improve the&#xD;
        likelihood of successful outcomes.&#xD;
  &#xD;
        Based on our team's extensive work in the prognosis of post-traumatic musculoskeletal&#xD;
        injuries, the investigators propose that it is possible to identify those who can be expected&#xD;
        to achieve a full return to work within only the programs of care and differentiate them from&#xD;
        those who will experience some form of delayed or non-return to work and can do so within the&#xD;
        first 3 weeks (21 days) from injury with &gt;80% accuracy.&#xD;
  &#xD;
        Objective Development and validation of a multi-axis 'risk/prognosis' worker-reported&#xD;
        screening tool comprising tools that can be administered within the first 8 weeks of&#xD;
        work-related injury and provide &gt;80% accuracy in predicting work recovery trajectories over&#xD;
        the subsequent 2 months.&#xD;
  &#xD;
        Recruitment Recruitment will occur through CBIH programs of care provider clinics for injured&#xD;
        workers, using both emailed and posted invitations. In both cases explicit opt-in consent&#xD;
        will be obtained for this study following the protocol for digital online consent procedures&#xD;
        from Western's Research Ethics Board (REB).&#xD;
  &#xD;
        Members of the research team at Western will monitor the portal for new participants daily.&#xD;
        New participants will be entered into a Master List that includes only name, contact email&#xD;
        address, and a study-specific randomly-generated 4-digit ID number. The Master List is&#xD;
        necessary to permit the linking of responses across data collection periods and will be&#xD;
        stored separately from the raw data file that will include only ID number. The research team&#xD;
        member will subsequently create a unique survey link tied to the participant's email&#xD;
        addresses and send that to the participant within two working days. That survey will start&#xD;
        with the screening questions for inclusion. Those who pass the screen will proceed with the&#xD;
        full set of survey questions, while those who are screen-failed will be presented with a&#xD;
        thank participant screen and their study involvement will end. Upon entry into the Master&#xD;
        List, follow-up dates at 1 and 2 months post-inception will be automatically calculated, and&#xD;
        the research team members will use those to ensure follow-up survey forms are sent on time.&#xD;
  &#xD;
        Clinician Feedback: The emailed link to the clinician feedback survey will be sent to all&#xD;
        members of the CBI Health Inc. network of physiotherapists in Canada, along with the new&#xD;
        classification tool/algorithm. The CBI Health collaborators on this protocol will facilitate&#xD;
        dissemination of the link through internal CBI Health email channels. Any clinician who is a&#xD;
        registered physiotherapist within the CBI Health Inc. network will be eligible to&#xD;
        participate. They will receive the new stratification algorithm and a link to a single-page&#xD;
        feedback survey. In this way emails will be stored in a separate database from survey&#xD;
        responses. The list of emails will remain with the Western researchers and will not be shared&#xD;
        with the CBI Health leadership.&#xD;
  &#xD;
        Methodology This is an observational prospective inception cohort using data collected from&#xD;
        injured workers entering one of the CBIH programs of care. Clinicians within this network&#xD;
        provide care under a standardized framework that limits confounding from different&#xD;
        interventions and the researchers will not manipulate treatment decisions.&#xD;
  &#xD;
        Duration: All eligible Workers will be invited to participate. Participants will be in the&#xD;
        study for two months (8 weeks) total, from inception to outcome. A single interim data&#xD;
        collection at 4 weeks post-inception will permit longitudinal trajectories to be established&#xD;
        for each outcome as a tertiary analytic target (interpreted as slope/rate of recovery).&#xD;
  &#xD;
        DATA ANALYSIS: 1. Descriptive and bivariate associations to describe the sample and evaluate&#xD;
        associations between the predictors and the outcomes; 2. Maximum likelihood-based latent&#xD;
        profile analysis in which the predictors (and their subscales where available) are used to&#xD;
        identify meaningful profiles ('clusters') of injured Workers. This will be guided by 3 core&#xD;
        principles of i) statistical justification, ii) parsimony, and iii) clinical meaningfulness;&#xD;
        3. The profiles will then be evaluated to determine the proportion of successful primary&#xD;
        (work) and secondary outcomes within each. The investigators anticipate that one profile will&#xD;
        comprise a majority who achieve Full return to work by 8 weeks and another will comprise a&#xD;
        majority who fail to achieve return to work, with other clusters including mixed outcomes.&#xD;
        Prognostic accuracy of the new clusters will also be compared against the TIDS to determine&#xD;
        whether the use of additional scales offers improved utility over the single scale.&#xD;
  &#xD;
        SAMPLE SIZE: Prior authors have endorsed at least 250 unique people in the data for robust&#xD;
        Maximum likelihood-based latent profile analyses, and our own work in a sample of Canadian&#xD;
        military veterans with chronic pain that used almost identical indicators to the current&#xD;
        project successfully identified 5 latent classes with n = 322 respondents. The investigators&#xD;
        will target up to n = 350 over a two-year project window.&#xD;
  &#xD;
        Quality Assurance: All Western members of the research team have completed either or both of&#xD;
        the Good Clinical Practice or Tri-Council Policy Statement 2 training modules. Certificates&#xD;
        of completion are available upon request. Further, the Principal Investigator has completed&#xD;
        the CIHR Institute of Gender training module on sex- and gender-based analyses, Equity,&#xD;
        Diversity and Inclusion training through Western University, and Ownership, Control, Access&#xD;
        and Possession training for research with Indigenous peoples.&#xD;
  &#xD;
        The investigators acknowledge a potential for conflict of interest regarding the&#xD;
        collaboration with the CBIH team. Importantly, CBIH will be instrumental for helping meet the&#xD;
        recruitment targets as one of Canada's largest networks of rehabilitation providers for&#xD;
        injured workers. Members of the CBIH team will also be critical for ensuring the design&#xD;
        described herein can be expected to lead to implementable findings, and they will facilitate&#xD;
        clinical interpretation of analytic results, and facilitate dissemination of the findings&#xD;
        throughout their network of clinics. Importantly, all findings of this work will be published&#xD;
        in scientifically-rigourous peer-reviewed journals relevant to the field, and no part of the&#xD;
        data or findings will be the proprietary property of CBIH. Participants will be made aware of&#xD;
        this arrangement prior to providing their informed consent to participate.&#xD;
  &#xD;
        Expected Outcomes:&#xD;
  &#xD;
        This work is anticipated to result in a new risk/prognosis screening tool to discriminate&#xD;
        between those injured workers most likely to transition back to full return to work quickly&#xD;
        from those most likely to experience delayed or incomplete recovery, and the investigators&#xD;
        further anticipate that the latent classes identified will be useful for directing injured&#xD;
        workers to the most appropriate health discipline in the patient-centred spirit of 'right&#xD;
        care, right person, right time'. Logical next steps from this work will be to use the most&#xD;
        accurate predictor variables found herein to create and test intervention strategies that&#xD;
        specifically target the risks present in higher-risk injured workers. Through this program of&#xD;
        research, the investigators anticipate reducing the burden of delayed return to work borne by&#xD;
        both injured workers and those who insure them.&#xD;
  &#xD;
        Ethics: All methods for this study have been approved by the Health Sciences Research Ethics&#xD;
        Board of Western University (London Ontario, Canada), REB No. 121883, having been evaluated&#xD;
        by an independent peer reviewer against the standards of the Declaration of Helsinki and in&#xD;
        accordance with the Tri-Council Policy Statement 2.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Work status</measure>
      <time_frame>8 weeks</time_frame>
      <description>Full Return-to-Work, Return-to-Work with temporary restrictions, or redirected to other treatment options. With the Full RTW category serving as the reference against which the other outcomes will be considered.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain severity</measure>
      <time_frame>8 weeks</time_frame>
      <description>Brief Pain Inventory: These are four 0-10 rating scales that ask about pain at its best, least, on average, and right now.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQoL-5D (EQ5D-5L)</measure>
      <time_frame>8 weeks</time_frame>
      <description>EuroQoL-5D and the three additional questions. The EQ-5D has been used in its original form, and we have added 3 additional questions related to fatigue, sleep, and connections with others that patient partners have repeatedly indicated are important but are not captured in the current scale. For purposes of this analysis, and in keeping with terms of use of the EQ-5D-5L, those final 3 questions will be interpreted separately from the original items for reporting purposes. A final question on how the respondent has defined their sense of recovered/not recovered will be collected through open text to give richer information on the ways that injured workers make sense of the very notion of what it is to be 'recovered' from a workplace injury. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body diagram</measure>
      <time_frame>8 weeks</time_frame>
      <description>An interactive 'body diagram', or pain map, will be provided to allow participants to indicate the areas and extent (distribution) of their pain, which will be evaluated as a secondary prognostic indicator under the hypothesis that more widespread pain is a poor prognostic indicator for rapid recovery.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>MultiDimensional Symptom Index (MSI)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The MultiDimensional Symptom Index (MSI), a 10-item self-report tool that uses a scoring matrix to create a profile of symptom type, frequency, and interference across 10 different symptom types. It will be primarily used to discriminate between pain of nociceptive (primarily somatic) origin and that of more central (non-somatic) dominance.</description>
    </other_outcome>
    <other_outcome>
      <measure>A shortened 4-item version of The Self-Report version of the Leeds Assessment of Neuropathic Signs and Symptoms (S-LANSS).</measure>
      <time_frame>8 weeks</time_frame>
      <description>A shortened 4-item version of The Self-Report version of the Leeds Assessment of Neuropathic Signs and Symptoms (S-LANSS). The S-LANSS is a 7-item scale with each item offering a simple yes/no response option. It has been well-validated against clinical diagnoses of neuropathic pain with a score ≥12 providing over 80% accuracy. We have previously used statistical triangulation to identify 4 of the items that combined provide a nearly perfect association with the full 7 items and offers the advantage of brevity.</description>
    </other_outcome>
    <other_outcome>
      <measure>The Fremantle Body Awareness questionnaire - general version (FreBAQ-general)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The Fremantle Body Awareness questionnaire - general version (FreBAQ-general). This is a 6-item questionnaire derived from original version of the FreBAQ, dedicated to specific body regions (e.g., back, neck, knee, shoulder) that makes use of digital text piping to first ask the respondent about their most problematic body region, then uses that answer to populate the 6 FreBAQ-general items. A higher score indicates a greater sense of sensorimotor disconnection with painful body regions.</description>
    </other_outcome>
    <other_outcome>
      <measure>The Brief Pain Catastrophizing Scale (BriefPCS-4)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The Brief Pain Catastrophizing Scale (BriefPCS-4), a 4-item version of the original 13-item PCS that captures catastrophic beliefs about pain, such as 'it's awful and I feel that it overwhelms me'. The 4 items were correlated with the full 13-item version at r = 0.97 in a prior study, providing a near-perfect estimate of the full version with lower respondent burden.</description>
    </other_outcome>
    <other_outcome>
      <measure>The short Patient Health Questionnaire-4 item version</measure>
      <time_frame>8 weeks</time_frame>
      <description>The short Patient Health Questionnaire-4 item version. This tool comprises two items useful as a brief screen for anxiety disorders and two as a brief screen for depressive disorders. With so few items it is far more sensitive than specific as a diagnostic tool, but as a combined score it provides a metric of negative emotional state on a 0-12 scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>The Intersectional Discrimination Index - Major (InDI-M)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The Intersectional Discrimination Index - Major (InDI-M), a newer 13-item questionnaire is intended to capture experiences of discrimination/exclusion or interpersonal violence perpetrated against the respondent that is perceived to have been due to some aspect of their identity (e.g., skin colour, sex, gender, body size, age, disability, etc…). We have previously used this tool in a sample of military veterans with chronic pain and found that it shows a small but significant association with pain severity, and is a dominant driver in one sub-category of that sample with a trauma-dominant pain profile.</description>
    </other_outcome>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Musculoskeletal Injury</condition>
    <condition>Musculoskeletal Strain</condition>
    <condition>Low Back Pain</condition>
    <condition>Neck Pain</condition>
    <condition>Upper Extremity Injury</condition>
    <condition>Lower Extremity Problem</condition>
    <condition>Work-related Injury</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Musculoskeletal-specific WSIB programs of care</intervention_name>
      <description>Clinicians within this network provide care under a standardized framework that limits confounding from different interventions and the researchers will not manipulate treatment decisions.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This is an observational prospective inception cohort using data collected from injured&#xD;
          workers entering one of the CBIH programs of care.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria: Eligible participants are those aged ≥18 years, able to read 6th grade&#xD;
          English, presenting to a program of care for rehabilitation of a workplace injury with a&#xD;
          primary musculoskeletal or Low Back Pain component.&#xD;
  &#xD;
          Exclusion Criteria: Participants with significant cognitive impairment or learning&#xD;
          disability (self-reported) that interfere with following multi-step instructions will be&#xD;
          excluded from this study. The exclusive focus on those entering program of care-based rehab&#xD;
          will naturally exclude workers with catastrophic injuries (e.g., loss of limb, multiple&#xD;
          fractures, burns) or those for whom a mental health disorder (e.g., PTSD, depression) is&#xD;
          the primary diagnosis, thereby homogenizing the types of injuries included.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>David Walton, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CANSpine Lab, School of Physical Therapy, Western University, Canada</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>David Walton, PhD</last_name>
      <phone>519-878-3746</phone>
      <email>dwalton5@uwo.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Aliyu Lawan, PhD</last_name>
      <email>alawan@uwo.ca</email>
    </overall_contact_backup>
    <reference>
      <citation>Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.</citation>
      <PMID>15772908</PMID>
    </reference>
    <reference>
      <citation>Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.</citation>
      <PMID>8080219</PMID>
    </reference>
    <reference>
      <citation>Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.</citation>
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      <citation>Tein JY, Coxe S, Cham H. Statistical Power to Detect the Correct Number of Classes in Latent Profile Analysis. Struct Equ Modeling. 2013 Oct 1;20(4):640-657. doi: 10.1080/10705511.2013.824781.</citation>
      <PMID>24489457</PMID>
    </reference>
    <reference>
      <citation>Lee JY, Walton DM, Tremblay P, May C, Millard W, Elliott JM, MacDermid JC. Defining pain and interference recovery trajectories after acute non-catastrophic musculoskeletal trauma through growth mixture modeling. BMC Musculoskelet Disord. 2020 Sep 17;21(1):615. doi: 10.1186/s12891-020-03621-7.</citation>
      <PMID>32943021</PMID>
    </reference>
    <reference>
      <citation>Modarresi S, Suh N, Walton DM, MacDermid JC. Depression affects the recovery trajectories of patients with distal radius fractures: A latent growth curve analysis. Musculoskelet Sci Pract. 2019 Oct;43:96-102. doi: 10.1016/j.msksp.2019.07.012. Epub 2019 Jul 27.</citation>
      <PMID>31374477</PMID>
    </reference>
    <reference>
      <citation>Scheim AI, Bauer GR. The Intersectional Discrimination Index: Development and validation of measures of self-reported enacted and anticipated discrimination for intercategorical analysis. Soc Sci Med. 2019 Apr;226:225-235. doi: 10.1016/j.socscimed.2018.12.016. Epub 2019 Jan 21.</citation>
      <PMID>30674436</PMID>
    </reference>
    <reference>
      <citation>Shi Q, Sinden K, MacDermid JC, Walton D, Grewal R. A systematic review of prognostic factors for return to work following work-related traumatic hand injury. J Hand Ther. 2014 Jan-Mar;27(1):55-62; quiz 62. doi: 10.1016/j.jht.2013.10.001. Epub 2013 Oct 21.</citation>
      <PMID>24268193</PMID>
    </reference>
    <reference>
      <citation>Walton, D. et al. (2008) 'Prognostic Factors After Acute Whiplash Injury: Results Of A Meta-analysis', Journal of Orthopaedic &amp; Sports Physical, 38(1), p. A23.</citation>
    </reference>
    <reference>
      <citation>Walton DM, Carroll LJ, Kasch H, Sterling M, Verhagen AP, Macdermid JC, Gross A, Santaguida PL, Carlesso L; ICON. An Overview of Systematic Reviews on Prognostic Factors in Neck Pain: Results from the International Collaboration on Neck Pain (ICON) Project. Open Orthop J. 2013 Sep 20;7:494-505. doi: 10.2174/1874325001307010494. eCollection 2013.</citation>
      <PMID>24115971</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Krebs D, Moulden D, Wade P, Levesque L, Elliott J, MacDermid JC. The Traumatic Injuries Distress Scale: A New Tool That Quantifies Distress and Has Predictive Validity With Patient-Reported Outcomes. J Orthop Sports Phys Ther. 2016 Oct;46(10):920-928. doi: 10.2519/jospt.2016.6594. Epub 2016 Sep 3.</citation>
      <PMID>27594662</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Mehta S, Seo W, MacDermid JC. Creation and validation of the 4-item BriefPCS-chronic through methodological triangulation. Health Qual Life Outcomes. 2020 May 7;18(1):124. doi: 10.1186/s12955-020-01346-8.</citation>
      <PMID>32381020</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Elliott JM, Lee J, Fakhereddin M, Seo W. Identification of clinically-useful cut scores of the Traumatic Injuries Distress Scale (TIDS) for predicting rate of recovery following musculoskeletal trauma. PLoS One. 2021 Mar 23;16(3):e0248745. doi: 10.1371/journal.pone.0248745. eCollection 2021.</citation>
      <PMID>33755664</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Elliott JM. An Integrated Model of Chronic Whiplash-Associated Disorder. J Orthop Sports Phys Ther. 2017 Jul;47(7):462-471. doi: 10.2519/jospt.2017.7455. Epub 2017 Jun 16.</citation>
      <PMID>28622487</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Elliott JM. A new clinical model for facilitating the development of pattern recognition skills in clinical pain assessment. Musculoskelet Sci Pract. 2018 Aug;36:17-24. doi: 10.1016/j.msksp.2018.03.006. Epub 2018 Apr 9.</citation>
      <PMID>29669311</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Marsh J. Reliability, Discriminative, and Prognostic Validity of the Multidimensional Symptom Index in Musculoskeletal Trauma. Clin J Pain. 2020 Sep;36(9):700-706. doi: 10.1097/AJP.0000000000000856.</citation>
      <PMID>32520818</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Phares P. The potential and perils of prognosticating persistent post-traumatic problems from a postpositivist perspective. Spine J. 2018 Aug;18(8):1483-1488. doi: 10.1016/j.spinee.2018.01.015. Epub 2018 Jan 31.</citation>
      <PMID>29355787</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Beattie T, Putos J, MacDermid JC. A Rasch analysis of the Brief Pain Inventory Interference subscale reveals three dimensions and an age bias. J Clin Epidemiol. 2016 Jun;74:218-26. doi: 10.1016/j.jclinepi.2015.10.022. Epub 2016 Jan 6.</citation>
      <PMID>26769256</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Putos J, Beattie T, MacDermid JC. Confirmatory factor analysis of 2 versions of the Brief Pain Inventory in an ambulatory population indicates that sleep interference should be interpreted separately. Scand J Pain. 2016 Jul;12:110-116. doi: 10.1016/j.sjpain.2016.05.002. Epub 2016 May 25.</citation>
      <PMID>28850482</PMID>
    </reference>
    <reference>
      <citation>Walton DM, Elliott JM, Salim S, Al-Nasri I. A reconceptualization of the pain numeric rating scale: Anchors and clinically important differences. J Hand Ther. 2018 Apr-Jun;31(2):179-183. doi: 10.1016/j.jht.2017.12.008. Epub 2018 Feb 9. No abstract available.</citation>
      <PMID>29433765</PMID>
    </reference>
    <reference>
      <citation>Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.</citation>
      <PMID>27327235</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Western University, Canada</investigator_affiliation>
      <investigator_full_name>Dave Walton</investigator_full_name>
      <investigator_title>Associate Professor, School of Physical Therapy (cross-appt. Dept. of Psychiatry)</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Low Back Pain</mesh_term>
      <mesh_term>Neck Pain</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Arm Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Upon study completion, we will pursue options for making the de-identified data open-access through engagement with the REB around safe and ethical data sharing.</ipd_description>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Upon study completion</ipd_time_frame>
      <ipd_access_criteria>Open access and administrative database.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06016647
  org study id: 121883
  nct id: NCT06016647
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The percentage of loss time claims receiving Loss of Earnings benefits at 3 months has
        continued to rise amongst injured workers in Ontario despite the Workplace Safety and
        Insurance Board (WSIB) approach of "Better at Work". The primary health services to address
        loss time claims associated with musculoskeletal injuries include the evidenced-based
        programs of care, occupational health assessment program and musculoskeletal specialty
        programs, however, these are set to be revised and relaunched in Q1 2023. Across treatment
        protocols there are challenges that, at least in part, appear to contribute to the increasing
        percentage of workers on full loss of earnings at 3 months include (1) inconsistent early
        identification of workers who should be triaged to various health services and (2) reliable
        determination of the optimal timing of referral to the most targeted care to enable a safe
        and sustainable return to work. The investigators aim to develop and evaluate a predictive
        assessment model to triage workers to the best service within the first 8 weeks of their
        claim to increase the rate of early return to work, with the long-term goal that the triage
        protocol becomes part of a person-centric protocol that reduces the duration of work-related
        disability.
  
        The investigators will develop and evaluate an assessment protocol for injured workers that
        enter any of the musculoskeletal-specific WSIB programs of care, which have been consolidated
        into a single program as of 2023. This study will be a prospective inception cohort design
        using data collected from injured workers receiving WSIB musculoskeletal programs of care
        services at CBI Health clinics in Ontario Canada. Worker data will be collected at intake to
        the program of care service and again approximately four and eight weeks after intake (or
        earlier if a worker completes the program of care). The investigators will complete data
        analysis in three steps including descriptive and bivariate associations, Maximum
        Likelihood-based Latent Profile Analysis, and evaluation of results against successful work
        outcomes and secondary outcomes. Qualitative data will be mined for alternative indicators of
        recovery / non-recovery. The study recruitment goal is 300 - 350 workers with complete
        follow-up within a 2-year period.
  Background and Rationale It has long been known that early and targeted acute-stage
        intervention is the best way to prevent chronic pain. For 15 years the Principal Investigator
        has been developing novel tools, strategies, and frameworks for predicting and preventing the
        acute-to-chronic transition in other populations. These include self-report tools that have
        individually demonstrated >75% accuracy in predicting 12-month outcomes when administered in
        the first weeks from injury, new interpretations of common pain assessment and evaluation
        tools, and new frameworks for understanding pain and its management at both the acute and
        chronic stages. The investigators have used advanced analytic techniques to identify and
        describe the recovery trajectories present in a sample of people with mixed musculoskeletal
        injuries using data collected within days to weeks, predicting outcomes up to 12 months
        post-injury. In a recently-completed project, some of these innovations were integrated into
        a single online questionnaire targeting Canadian military veterans with chronic pain. The
        results of that analysis revealed a 5-cluster solution based on responses to self-report
        measures of 7 domains (or axes) of drivers of the pain experience. The investigators believe
        this strategy will also have value when translated and implemented in more acutely injured
        workers in Canada as a single risk stratification and management protocol. The longer-term
        goal is to use this type of simple self-assessment protocol to empower injured workers and
        claims managers to triage into the right care pathway, reduce time off work, and improve the
        likelihood of successful outcomes.
  
        Based on our team's extensive work in the prognosis of post-traumatic musculoskeletal
        injuries, the investigators propose that it is possible to identify those who can be expected
        to achieve a full return to work within only the programs of care and differentiate them from
        those who will experience some form of delayed or non-return to work and can do so within the
        first 3 weeks (21 days) from injury with >80% accuracy.
  
        Objective Development and validation of a multi-axis 'risk/prognosis' worker-reported
        screening tool comprising tools that can be administered within the first 8 weeks of
        work-related injury and provide >80% accuracy in predicting work recovery trajectories over
        the subsequent 2 months.
  
        Recruitment Recruitment will occur through CBIH programs of care provider clinics for injured
        workers, using both emailed and posted invitations. In both cases explicit opt-in consent
        will be obtained for this study following the protocol for digital online consent procedures
        from Western's Research Ethics Board (REB).
  
        Members of the research team at Western will monitor the portal for new participants daily.
        New participants will be entered into a Master List that includes only name, contact email
        address, and a study-specific randomly-generated 4-digit ID number. The Master List is
        necessary to permit the linking of responses across data collection periods and will be
        stored separately from the raw data file that will include only ID number. The research team
        member will subsequently create a unique survey link tied to the participant's email
        addresses and send that to the participant within two working days. That survey will start
        with the screening questions for inclusion. Those who pass the screen will proceed with the
        full set of survey questions, while those who are screen-failed will be presented with a
        thank participant screen and their study involvement will end. Upon entry into the Master
        List, follow-up dates at 1 and 2 months post-inception will be automatically calculated, and
        the research team members will use those to ensure follow-up survey forms are sent on time.
  
        Clinician Feedback: The emailed link to the clinician feedback survey will be sent to all
        members of the CBI Health Inc. network of physiotherapists in Canada, along with the new
        classification tool/algorithm. The CBI Health collaborators on this protocol will facilitate
        dissemination of the link through internal CBI Health email channels. Any clinician who is a
        registered physiotherapist within the CBI Health Inc. network will be eligible to
        participate. They will receive the new stratification algorithm and a link to a single-page
        feedback survey. In this way emails will be stored in a separate database from survey
        responses. The list of emails will remain with the Western researchers and will not be shared
        with the CBI Health leadership.
  
        Methodology This is an observational prospective inception cohort using data collected from
        injured workers entering one of the CBIH programs of care. Clinicians within this network
        provide care under a standardized framework that limits confounding from different
        interventions and the researchers will not manipulate treatment decisions.
  
        Duration: All eligible Workers will be invited to participate. Participants will be in the
        study for two months (8 weeks) total, from inception to outcome. A single interim data
        collection at 4 weeks post-inception will permit longitudinal trajectories to be established
        for each outcome as a tertiary analytic target (interpreted as slope/rate of recovery).
  
        DATA ANALYSIS: 1. Descriptive and bivariate associations to describe the sample and evaluate
        associations between the predictors and the outcomes; 2. Maximum likelihood-based latent
        profile analysis in which the predictors (and their subscales where available) are used to
        identify meaningful profiles ('clusters') of injured Workers. This will be guided by 3 core
        principles of i) statistical justification, ii) parsimony, and iii) clinical meaningfulness;
        3. The profiles will then be evaluated to determine the proportion of successful primary
        (work) and secondary outcomes within each. The investigators anticipate that one profile will
        comprise a majority who achieve Full return to work by 8 weeks and another will comprise a
        majority who fail to achieve return to work, with other clusters including mixed outcomes.
        Prognostic accuracy of the new clusters will also be compared against the TIDS to determine
        whether the use of additional scales offers improved utility over the single scale.
  
        SAMPLE SIZE: Prior authors have endorsed at least 250 unique people in the data for robust
        Maximum likelihood-based latent profile analyses, and our own work in a sample of Canadian
        military veterans with chronic pain that used almost identical indicators to the current
        project successfully identified 5 latent classes with n = 322 respondents. The investigators
        will target up to n = 350 over a two-year project window.
  
        Quality Assurance: All Western members of the research team have completed either or both of
        the Good Clinical Practice or Tri-Council Policy Statement 2 training modules. Certificates
        of completion are available upon request. Further, the Principal Investigator has completed
        the CIHR Institute of Gender training module on sex- and gender-based analyses, Equity,
        Diversity and Inclusion training through Western University, and Ownership, Control, Access
        and Possession training for research with Indigenous peoples.
  
        The investigators acknowledge a potential for conflict of interest regarding the
        collaboration with the CBIH team. Importantly, CBIH will be instrumental for helping meet the
        recruitment targets as one of Canada's largest networks of rehabilitation providers for
        injured workers. Members of the CBIH team will also be critical for ensuring the design
        described herein can be expected to lead to implementable findings, and they will facilitate
        clinical interpretation of analytic results, and facilitate dissemination of the findings
        throughout their network of clinics. Importantly, all findings of this work will be published
        in scientifically-rigourous peer-reviewed journals relevant to the field, and no part of the
        data or findings will be the proprietary property of CBIH. Participants will be made aware of
        this arrangement prior to providing their informed consent to participate.
  
        Expected Outcomes:
  
        This work is anticipated to result in a new risk/prognosis screening tool to discriminate
        between those injured workers most likely to transition back to full return to work quickly
        from those most likely to experience delayed or incomplete recovery, and the investigators
        further anticipate that the latent classes identified will be useful for directing injured
        workers to the most appropriate health discipline in the patient-centred spirit of 'right
        care, right person, right time'. Logical next steps from this work will be to use the most
        accurate predictor variables found herein to create and test intervention strategies that
        specifically target the risks present in higher-risk injured workers. Through this program of
        research, the investigators anticipate reducing the burden of delayed return to work borne by
        both injured workers and those who insure them.
  
        Ethics: All methods for this study have been approved by the Health Sciences Research Ethics
        Board of Western University (London Ontario, Canada), REB No. 121883, having been evaluated
        by an independent peer reviewer against the standards of the Declaration of Helsinki and in
        accordance with the Tri-Council Policy Statement 2.
  observational model: Cohort
  time perspective: Prospective
  measure: Work status
  time frame: 8 weeks
  description: Full Return-to-Work, Return-to-Work with temporary restrictions, or redirected to other treatment options. With the Full RTW category serving as the reference against which the other outcomes will be considered.
  measure: Pain severity
  time frame: 8 weeks
  description: Brief Pain Inventory: These are four 0-10 rating scales that ask about pain at its best, least, on average, and right now.
  measure: EuroQoL-5D (EQ5D-5L)
  time frame: 8 weeks
  description: EuroQoL-5D and the three additional questions. The EQ-5D has been used in its original form, and we have added 3 additional questions related to fatigue, sleep, and connections with others that patient partners have repeatedly indicated are important but are not captured in the current scale. For purposes of this analysis, and in keeping with terms of use of the EQ-5D-5L, those final 3 questions will be interpreted separately from the original items for reporting purposes. A final question on how the respondent has defined their sense of recovered/not recovered will be collected through open text to give richer information on the ways that injured workers make sense of the very notion of what it is to be 'recovered' from a workplace injury. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').
  measure: Body diagram
  time frame: 8 weeks
  description: An interactive 'body diagram', or pain map, will be provided to allow participants to indicate the areas and extent (distribution) of their pain, which will be evaluated as a secondary prognostic indicator under the hypothesis that more widespread pain is a poor prognostic indicator for rapid recovery.
  measure: MultiDimensional Symptom Index (MSI)
  time frame: 8 weeks
  description: The MultiDimensional Symptom Index (MSI), a 10-item self-report tool that uses a scoring matrix to create a profile of symptom type, frequency, and interference across 10 different symptom types. It will be primarily used to discriminate between pain of nociceptive (primarily somatic) origin and that of more central (non-somatic) dominance.
  measure: A shortened 4-item version of The Self-Report version of the Leeds Assessment of Neuropathic Signs and Symptoms (S-LANSS).
  time frame: 8 weeks
  description: A shortened 4-item version of The Self-Report version of the Leeds Assessment of Neuropathic Signs and Symptoms (S-LANSS). The S-LANSS is a 7-item scale with each item offering a simple yes/no response option. It has been well-validated against clinical diagnoses of neuropathic pain with a score ≥12 providing over 80% accuracy. We have previously used statistical triangulation to identify 4 of the items that combined provide a nearly perfect association with the full 7 items and offers the advantage of brevity.
  measure: The Fremantle Body Awareness questionnaire - general version (FreBAQ-general)
  time frame: 8 weeks
  description: The Fremantle Body Awareness questionnaire - general version (FreBAQ-general). This is a 6-item questionnaire derived from original version of the FreBAQ, dedicated to specific body regions (e.g., back, neck, knee, shoulder) that makes use of digital text piping to first ask the respondent about their most problematic body region, then uses that answer to populate the 6 FreBAQ-general items. A higher score indicates a greater sense of sensorimotor disconnection with painful body regions.
  measure: The Brief Pain Catastrophizing Scale (BriefPCS-4)
  time frame: 8 weeks
  description: The Brief Pain Catastrophizing Scale (BriefPCS-4), a 4-item version of the original 13-item PCS that captures catastrophic beliefs about pain, such as 'it's awful and I feel that it overwhelms me'. The 4 items were correlated with the full 13-item version at r = 0.97 in a prior study, providing a near-perfect estimate of the full version with lower respondent burden.
  measure: The short Patient Health Questionnaire-4 item version
  time frame: 8 weeks
  description: The short Patient Health Questionnaire-4 item version. This tool comprises two items useful as a brief screen for anxiety disorders and two as a brief screen for depressive disorders. With so few items it is far more sensitive than specific as a diagnostic tool, but as a combined score it provides a metric of negative emotional state on a 0-12 scale.
  measure: The Intersectional Discrimination Index - Major (InDI-M)
  time frame: 8 weeks
  description: The Intersectional Discrimination Index - Major (InDI-M), a newer 13-item questionnaire is intended to capture experiences of discrimination/exclusion or interpersonal violence perpetrated against the respondent that is perceived to have been due to some aspect of their identity (e.g., skin colour, sex, gender, body size, age, disability, etc…). We have previously used this tool in a sample of military veterans with chronic pain and found that it shows a small but significant association with pain severity, and is a dominant driver in one sub-category of that sample with a trauma-dominant pain profile.
  intervention type: Other
  intervention name: Musculoskeletal-specific WSIB programs of care
  description: Clinicians within this network provide care under a standardized framework that limits confounding from different interventions and the researchers will not manipulate treatment decisions.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  last name: David Walton, PhD
  role: Principal Investigator
  affiliation: CANSpine Lab, School of Physical Therapy, Western University, Canada
  last name: David Walton, PhD
  phone: 519-878-3746
  email: dwalton5@uwo.ca
  last name: Aliyu Lawan, PhD
  email: alawan@uwo.ca
  citation: Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.
  PMID: 15772908
  citation: Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
  PMID: 8080219
  citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
  PMID: 21479777
  citation: Tein JY, Coxe S, Cham H. Statistical Power to Detect the Correct Number of Classes in Latent Profile Analysis. Struct Equ Modeling. 2013 Oct 1;20(4):640-657. doi: 10.1080/10705511.2013.824781.
  PMID: 24489457
  citation: Lee JY, Walton DM, Tremblay P, May C, Millard W, Elliott JM, MacDermid JC. Defining pain and interference recovery trajectories after acute non-catastrophic musculoskeletal trauma through growth mixture modeling. BMC Musculoskelet Disord. 2020 Sep 17;21(1):615. doi: 10.1186/s12891-020-03621-7.
  PMID: 32943021
  citation: Modarresi S, Suh N, Walton DM, MacDermid JC. Depression affects the recovery trajectories of patients with distal radius fractures: A latent growth curve analysis. Musculoskelet Sci Pract. 2019 Oct;43:96-102. doi: 10.1016/j.msksp.2019.07.012. Epub 2019 Jul 27.
  PMID: 31374477
  citation: Scheim AI, Bauer GR. The Intersectional Discrimination Index: Development and validation of measures of self-reported enacted and anticipated discrimination for intercategorical analysis. Soc Sci Med. 2019 Apr;226:225-235. doi: 10.1016/j.socscimed.2018.12.016. Epub 2019 Jan 21.
  PMID: 30674436
  citation: Shi Q, Sinden K, MacDermid JC, Walton D, Grewal R. A systematic review of prognostic factors for return to work following work-related traumatic hand injury. J Hand Ther. 2014 Jan-Mar;27(1):55-62; quiz 62. doi: 10.1016/j.jht.2013.10.001. Epub 2013 Oct 21.
  PMID: 24268193
  citation: Walton, D. et al. (2008) 'Prognostic Factors After Acute Whiplash Injury: Results Of A Meta-analysis', Journal of Orthopaedic & Sports Physical, 38(1), p. A23.
  citation: Walton DM, Carroll LJ, Kasch H, Sterling M, Verhagen AP, Macdermid JC, Gross A, Santaguida PL, Carlesso L; ICON. An Overview of Systematic Reviews on Prognostic Factors in Neck Pain: Results from the International Collaboration on Neck Pain (ICON) Project. Open Orthop J. 2013 Sep 20;7:494-505. doi: 10.2174/1874325001307010494. eCollection 2013.
  PMID: 24115971
  citation: Walton DM, Krebs D, Moulden D, Wade P, Levesque L, Elliott J, MacDermid JC. The Traumatic Injuries Distress Scale: A New Tool That Quantifies Distress and Has Predictive Validity With Patient-Reported Outcomes. J Orthop Sports Phys Ther. 2016 Oct;46(10):920-928. doi: 10.2519/jospt.2016.6594. Epub 2016 Sep 3.
  PMID: 27594662
  citation: Walton DM, Mehta S, Seo W, MacDermid JC. Creation and validation of the 4-item BriefPCS-chronic through methodological triangulation. Health Qual Life Outcomes. 2020 May 7;18(1):124. doi: 10.1186/s12955-020-01346-8.
  PMID: 32381020
  citation: Walton DM, Elliott JM, Lee J, Fakhereddin M, Seo W. Identification of clinically-useful cut scores of the Traumatic Injuries Distress Scale (TIDS) for predicting rate of recovery following musculoskeletal trauma. PLoS One. 2021 Mar 23;16(3):e0248745. doi: 10.1371/journal.pone.0248745. eCollection 2021.
  PMID: 33755664
  citation: Walton DM, Elliott JM. An Integrated Model of Chronic Whiplash-Associated Disorder. J Orthop Sports Phys Ther. 2017 Jul;47(7):462-471. doi: 10.2519/jospt.2017.7455. Epub 2017 Jun 16.
  PMID: 28622487
  citation: Walton DM, Elliott JM. A new clinical model for facilitating the development of pattern recognition skills in clinical pain assessment. Musculoskelet Sci Pract. 2018 Aug;36:17-24. doi: 10.1016/j.msksp.2018.03.006. Epub 2018 Apr 9.
  PMID: 29669311
  citation: Walton DM, Marsh J. Reliability, Discriminative, and Prognostic Validity of the Multidimensional Symptom Index in Musculoskeletal Trauma. Clin J Pain. 2020 Sep;36(9):700-706. doi: 10.1097/AJP.0000000000000856.
  PMID: 32520818
  citation: Walton DM, Phares P. The potential and perils of prognosticating persistent post-traumatic problems from a postpositivist perspective. Spine J. 2018 Aug;18(8):1483-1488. doi: 10.1016/j.spinee.2018.01.015. Epub 2018 Jan 31.
  PMID: 29355787
  citation: Walton DM, Beattie T, Putos J, MacDermid JC. A Rasch analysis of the Brief Pain Inventory Interference subscale reveals three dimensions and an age bias. J Clin Epidemiol. 2016 Jun;74:218-26. doi: 10.1016/j.jclinepi.2015.10.022. Epub 2016 Jan 6.
  PMID: 26769256
  citation: Walton DM, Putos J, Beattie T, MacDermid JC. Confirmatory factor analysis of 2 versions of the Brief Pain Inventory in an ambulatory population indicates that sleep interference should be interpreted separately. Scand J Pain. 2016 Jul;12:110-116. doi: 10.1016/j.sjpain.2016.05.002. Epub 2016 May 25.
  PMID: 28850482
  citation: Walton DM, Elliott JM, Salim S, Al-Nasri I. A reconceptualization of the pain numeric rating scale: Anchors and clinically important differences. J Hand Ther. 2018 Apr-Jun;31(2):179-183. doi: 10.1016/j.jht.2017.12.008. Epub 2018 Feb 9. No abstract available.
  PMID: 29433765
  citation: Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.
  PMID: 27327235
  responsible party type: Sponsor-Investigator
  investigator affiliation: Western University, Canada
  investigator full name: Dave Walton
  investigator title: Associate Professor, School of Physical Therapy (cross-appt. Dept. of Psychiatry)
  mesh term: Low Back Pain
  mesh term: Neck Pain
  mesh term: Wounds and Injuries
  mesh term: Arm Injuries
  sharing ipd: Yes
  ipd description: Upon study completion, we will pursue options for making the de-identified data open-access through engagement with the REB around safe and ethical data sharing.
  ipd info type: Analytic Code
  ipd time frame: Upon study completion
  ipd access criteria: Open access and administrative database.