Recommendations for a core outcome measurement set for clinical trials in whiplash associated disorders.

ABSTRACT: Inconsistent reporting of outcomes in clinical trials of treatments for whiplash associated disorders (WAD) hinders effective data pooling and conclusions about treatment effectiveness. A multidisciplinary International Steering Committee recently recommended 6 core outcome domains: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life and Pain. This study aimed to reach consensus and recommend a core outcome set (COS) representing each of the 6 domains. Forty-three patient-reported outcome measures (PROMs) were identified for Physical Functioning, 2 for perceived recovery, 37 for psychological functioning, 17 for quality of life, and 2 for pain intensity. They were appraised in 5 systematic reviews following COSMIN methodology. No PROMs of Work and Social Functioning in WAD were identified. No PROMs had undergone evaluation of content validity in patients with WAD, but some had moderate-to-high-quality evidence for sufficient internal structure. Based on these results, the International Steering Committee reached 100% consensus to recommend the following COS: Neck Disability Index or Whiplash Disability Questionnaire (Physical Functioning), the Global Rating of Change Scale (Perceived Recovery), one of the Pictorial Fear of Activity Scale-Cervical, Pain Self-Efficacy Questionnaire, Pain Catastrophizing Scale, Harvard Trauma Questionnaire, or Posttraumatic Diagnostic Scale (Psychological Functioning), EQ-5D-3L or SF-6D (Quality of Life), numeric pain rating scale or visual analogue scale (Pain), and single-item questions pertaining to current work status and percent of usual work (Work and Social Functioning). These recommendations reflect the current status of research of PROMs of the 6 core outcome domains and may be modified as evidence grows.

Factors associated with long term work incapacity following a non-catastrophic road traffic injury: analysis of a two-year prospective cohort study.

BACKGROUND: Road traffic injuries (RTIs), primarily musculoskeletal in nature, are the leading cause of unintentional injury worldwide, incurring significant individual and societal burden. Investigation of a large representative cohort is needed to validate early identifiable predictors of long-term work incapacity post-RTI. Therefore, up until two years post-RTI we aimed to: evaluate absolute occurrence of return-to-work (RTW) and occurrence by injury compensation claimant status; evaluate early factors (e.g., biopsychosocial and injury-related) that influence RTW longitudinally; and identify factors potentially modifiable with intervention (e.g., psychological distress and pain). METHODS: Prospective cohort study of 2019 adult participants, recruited within 28 days of a non-catastrophic RTI, predominantly of mild-to-moderate severity, in New South Wales, Australia. Biopsychosocial, injury, and compensation data were collected via telephone interview within one-month of injury (baseline). Work status was self-reported at baseline, 6-, 12-, and 24-months. Analyses were restricted to participants who reported paid work pre-injury (N = 1533). Type-3 global p-values were used to evaluate explanatory factors for returning to 'any' or 'full duties' paid work across factor subcategories. Modified Poisson regression modelling was used to evaluate factors associated with RTW with adjustment for potential covariates. RESULTS: Only ~ 30% of people with RTI returned to full work duties within one-month post-injury, but the majority (76.7%) resumed full duties by 6-months. A significant portion of participants were working with modified duties (~ 10%) or not working at all (~ 10%) at 6-, 12-, and 24-months. Female sex, low education, low income, physically demanding occupations, pre-injury comorbidities, and high injury severity were negatively associated with RTW. Claiming injury compensation in the fault-based scheme operating at the time, and early identified post-injury pain and psychological distress, were key factors negatively associated with RTW up until two years post-injury. CONCLUSIONS: Long-term work incapacity was observed in 20% of people following RTI. Our findings have implications that suggest review of the design of injury compensation schemes and processes, early identification of those at risk of delayed RTW using validated pain and psychological health assessment tools, and improved interventions to address risks, may facilitate sustainable RTW. TRIAL REGISTRATION: This study was registered prospectively with the Australian New Zealand Clinical Trials Registry (ACTRN12613000889752).

Exploring Injured Persons' Experiences of Engaging and Using Lawyers in Road Traffic Injury Compensation Claims.

Legal services can play a critical role in facilitating claimant access to entitlements and shaping claimant experiences and outcomes in compensation settings. However, much remains unknown about claimants' goals in engaging legal services, experiences of using legal services, and satisfaction with legal advisers. Drawing on semi-structured interviews with claimants in the road traffic injury compensation scheme in the State of Victoria, Australia, this article identified that most claimants engaged legal services to access entitlements when they struggled to do so alone. Claimants often had little understanding of the activities performed by their lawyers: despite this, most viewed legal service use as valuable or worthwhile in terms of outcomes achieved. Claimants' experiences and levels of satisfaction were coloured by the quantity and quality of communication between themselves and their legal representatives. The findings highlight opportunities for schemes, lawyers, and legal profession regulators to increase the responsiveness of services to claimants' needs.

Best Practice Injury Compensation Processes Following Intentional Vehicular Assaults and Other Large Scale Transport Incidents: A Delphi Review.

OBJECTIVE: Intentional vehicular assaults on civilians have become more frequent worldwide, with some resulting in mass casualties, injuries, and traumatized witnesses. Health care costs associated with these vehicular assaults usually fall to compensation agencies. There is, however, little guidance around how compensation agencies should respond to mental and physical injury claims arising from large-scale transport incidents. METHODS: A Delphi review methodology was used to establish expert consensus recommendations on the major components of "no fault" injury claim processes for mental and physical injury. RESULTS: Thirty-three international experts participated in a 3-round online survey to rate their agreement on key statements generated from the literature. Consensus was achieved for 45 of 60 (75%) statements, which were synthesized into 36 recommendations falling within the domains of (1) facilitating claims, (2) eligibility rules, (3) payments and benefits for clients, (4) claims management procedures, (5) making and explaining decisions, (6) support and information resources for clients, (7) managing scheme staff and organizational response, (8) clients with special circumstances, and (9) scheme values and integrity. CONCLUSIONS: The recommendations present an opportunity for agencies to review their existing claims management systems and procedures. They also provide the basis for the development of best practice guidelines, which may be adapted for application to compensation schemes in different contexts worldwide.

The Impact of Work Loss on Mental and Physical Health During the COVID-19 Pandemic: Baseline Findings from a Prospective Cohort Study.

Purpose To determine if losing work during the COVID-19 pandemic is associated with mental and physical health status. To determine if social interactions and financial resources moderate the relationship between work loss and health. Methods Participants were Australians aged 18 + years that were employed in paid work prior to the COVID-19 pandemic who responded to an online or telephone survey from 27th March to 12th June 2020 as part of a prospective longitudinal cohort study. Outcome measures include Kessler-6 score > 18 indicating high psychological distress, and Short Form 12 (SF-12) mental health or physical health component score < = 45 indicating poor mental or physical health. Results The cohort consisted of 2,603 respondents, including groups who had lost their job (N = 541), were not working but remained employed (N = 613), were working less (N = 660), and whose work was unaffected (N = 789). Three groups experiencing work loss had greater odds of high psychological distress (AOR = 2.22-3.66), poor mental (AOR = 1.78-2.27) and physical health (AOR = 2.10-2.12) than the unaffected work group. Poor mental health was more common than poor physical health. The odds of high psychological distress (AOR = 5.43-8.36), poor mental (AOR = 1.92-4.53) and physical health (AOR = 1.93-3.90) were increased in those reporting fewer social interactions or less financial resources. Conclusion Losing work during the COVID-19 pandemic is associated with mental and physical health problems, and this relationship is moderated by social interactions and financial resources. Responses that increase financial security and enhance social connections may alleviate the health impacts of work loss. Registration Australian New Zealand Clinical Trials Registry: ACTRN12620000857909.

Trends in lawyer use in road traffic injury compensation claims.

Injury compensation claimants use legal services to help them navigate compensation schemes, including accessing benefits and resolving disputes. Little is known, however, about the extent of lawyer use by compensation claimants, including changes over time. This paper presents findings from one of the largest empirical investigations of lawyer use in an injury compensation setting to date. Using evidence from more than 275,000 claims in the road traffic injury scheme in the state of Victoria, Australia, this study examines the prevalence of, and changes in, lawyer use between 2000 and 2015. The analysis identifies a significant increase in the use of lawyers in the scheme, and explores possible explanations. This study provides critical insights into lawyer use in compensation settings: the steep increase in lawyer involvement has both access to justice and financial implications for compensation schemes, given the associations between lawyer use, claimant outcomes, and long-term scheme viability.

A systematic review of the association between fault or blame-related attributions and procedures after transport injury and health and work-related outcomes.

Attributions of fault are often associated with worse injury outcomes; however, the consistency and magnitude of these impacts is not known. This review examined the prognostic role of fault on health, mental health, pain and work outcomes after transport injury. A systematic search of five electronic databases (Medline, Embase, CINAHL, PsycINFO, Cochrane Library) yielded 16,324 records published between 2000 and January 2018. Eligibility criteria were: adult transport injury survivors; prospective design; multivariable analysis; fault-related factor analysed; pain, mental health, general health or work-related outcome. Citations (n = 10,558, excluding duplicates) and full text articles (n = 555) were screened manually (Reviewer 1), and using concurrent machine learning and text mining (Reviewer 2; using Abstrackr, WordStat and QDA miner). Data from 55 papers that met all inclusion criteria were extracted, papers were evaluated for risk of bias using the QUIPS tool, and overall level of evidence was assessed using the GRADE tool. There were six main fault-related factors classified as: fault or responsibility, fault-based compensation, lawyer involvement or litigation, blame or guilt, road user or position in vehicle, and impact direction. Overall there were inconsistent associations between fault and transport injury outcomes, and 60% of papers had high risk of bias. There was moderate evidence that fault-based compensation claims were associated with poorer health-related outcomes, and that lawyer involvement was associated with poorer work outcomes beyond 12 months post-injury. However, the evidence of negative associations between fault-based compensation claims and work-related outcomes was limited. Lawyer involvement and fault-based compensation claims were associated with adverse mental health outcomes six months post-injury, but not beyond 12 months. The most consistent associations between fault and negative outcomes were not for fault attributions, per se, but were related to fault-related procedures (e.g., lawyer engagement, fault-based compensation claims).

Injured worker experiences of insurance claim processes and return to work: a national, cross-sectional study.

BACKGROUND: Insurance claims management practices may have a significant impact on the health and experiences of injured workers claiming in workers' compensation systems. There are few multi-jurisdictional studies of the way workers experience compensation processes, and limited data on the association between claims experience and return to work outcomes. This study sought to identify worker, claim and injury related factors associated with injured worker experiences of workers' compensation claims management processes, and to examine associations between claims experience and return to work. METHODS: A national, cross-sectional survey of injured workers involved in ten Australian workers' compensation schemes. A total of 10,946 workers completed a telephone survey at 6 to 24 months post claim acceptance. Predictors of positive or negative/neutral claims experience were examined using logistic regression. Associations between claims experience, return to work status and duration of time loss were examined using logistic regression. RESULTS: Nearly one-quarter (23.0%, n = 2515) of workers reported a negative or neutral claims experience. Injury type, jurisdiction of claim, and time to lodge claim were most strongly associated with claims experience. Having a positive claims experience was strongly associated with having returned to work after accounting for injury, worker, claim and employer factors. CONCLUSIONS: There is a strong positive association between worker experiences of the insurance claims process and self-reported return to work status. Revision and reform of workers' compensation claims management practices to enhance worker experience and the fairness of procedures may contribute to improved return to work outcomes.

Recommendations For Core Outcome Domain Set For Whiplash-Associated Disorders (CATWAD).

OBJECTIVE: Inconsistent reporting of outcomes in clinical trials of treatments for Whiplash-associated Disorders (WAD) hinders effective data pooling and conclusions that can be drawn about the effectiveness of tested treatments. The aim of this study was to provide recommendations for core outcome domains that should be included in clinical trials of WAD. MATERIALS AND METHODS: A 3-step process was used: (1) A list of potential core outcome domains were identified from the published literature. (2) Researchers, health care providers, patients, and insurance personnel participated and rated the importance of each domain via a 3-round Delphi survey. A priori criteria for consensus were established. (3) Experts comprising researchers, health care providers, and a consumer representative participated in a multidisciplinary consensus meeting that made final decisions on the recommended core outcome domains. RESULTS: The literature search identified 63 potential core domains. A total of 223 participants were invited to partake in the Delphi surveys, with 41.7% completing round 1, 45.3% round 2, and 51.4% round 3. Eleven core domains met the criteria for inclusion across the entire sample. After the expert consensus meeting, 6 core domains were recommended: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life, and Pain. DISCUSSION: A 3-step process was used to recommend core outcome domains for clinical trials in WAD. Six core domains were recommended: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life, and Pain. The next step is to determine the outcome measurement instruments for each of these domains.

Development of prediction models of stress and long-term disability among claimants to injury compensation systems: a cohort study.

OBJECTIVES: We sought to develop prognostic risk scores for compensation-related stress and long-term disability using markers collected within 3 months of a serious injury. DESIGN: Cohort study. Predictors were collected at baseline and at 3 months postinjury. Outcome data were collected at 72 months postinjury. SETTING: Hospitalised patients with serious injuries recruited from four major trauma hospitals in Australia. PARTICIPANTS: 332 participants who made claims for compensation for their injuries to a transport accident scheme or a workers' compensation scheme. PRIMARY OUTCOME MEASURES: 12-item WHO Disability Assessment Schedule and 6 items from the Claims Experience Survey. RESULTS: Our model for long-term disability had four predictors (unemployed at the time of injury, history of a psychiatric disorder at time of injury, post-traumatic stress disorder symptom severity at 3 months and disability at 3 months). This model had good discrimination (R2=0.37) and calibration. The disability risk score had a score range of 0-180, and at a threshold of 80 had sensitivity of 56% and specificity of 86%. Our model for compensation-related stress had five predictors (intensive care unit admission, discharged to home, number of traumatic events prior to injury, depression at 3 months and not working at 3 months). This model also had good discrimination (area under the curve=0.83) and calibration. The compensation-related stress risk score had score range of 0-220 and at a threshold of 100 had sensitivity of 74% and specificity of 75%. By combining these two scoring systems, we were able to identify the subgroup of claimants at highest risk of experiencing both outcomes. CONCLUSIONS: The ability to identify at an early stage claimants at high risk of compensation-related stress and poor recovery is potentially valuable for claimants and the compensation agencies that serve them. The scoring systems we developed could be incorporated into the claims-handling processes to guide prevention-oriented interventions.

Compensation seeking and disability after injury: the role of compensation-related stress and mental health.

OBJECTIVE: Claiming for compensation after injury is associated with poor health outcomes. This study examined the degree to which compensation-related stress predicts long-term disability and the mental health factors that contribute to this relationship. METHOD: In a longitudinal, multisite cohort study, 332 injury patients (who claimed for compensation) recruited from April 2004 to February 2006 were assessed during hospitalization and at 3 and 72 months after injury. Posttraumatic stress, depression, and anxiety symptoms (using the Mini-International Neuropsychiatric Interview) were assessed at 3 months; compensation-related stress and disability levels (using the World Health Organization Disability Assessment Schedule II) were assessed at 72 months. RESULTS: A significant direct relationship was found between levels of compensation-related stress and levels of long-term disability (ß = 0.35, P < .001). Three-month posttraumatic stress symptoms had a significant relationship with compensation-related stress (ß = 0.29, P < .001) as did 3-month depression symptoms (ß = 0.39, P < .001), but 3-month anxiety symptoms did not. A significant indirect relationship was found for posttraumatic stress symptoms and disability via compensation stress (ß = 0.099, P = .001) and for depression and disability via compensation stress (ß = 0.136, P < .001). CONCLUSIONS: Stress associated with seeking compensation is significantly related to long-term disability. Posttraumatic stress and depression symptoms increase the perception of stress associated with the claims process, which in turn is related to higher levels of long-term disability. Early interventions targeting those at risk for compensation-related stress may decrease long-term costs for compensation schemes.

Relationship between stressfulness of claiming for injury compensation and long-term recovery: a prospective cohort study.

IMPORTANCE: Each year, millions of persons worldwide seek compensation for transport accident and workplace injuries. Previous research suggests that these claimants have worse long-term health outcomes than persons whose injuries fall outside compensation schemes. However, existing studies have substantial methodological weaknesses and have not identified which aspects of the claiming experience may drive these effects. OBJECTIVE: To determine aspects of claims processes that claimants to transport accident and workers' compensation schemes find stressful and whether such stressful experiences are associated with poorer long-term recovery. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study of a random sample of 1010 patients hospitalized in 3 Australian states for injuries from 2004 through 2006. At 6-year follow-up, we interviewed 332 participants who had claimed compensation from transport accident and workers' compensation schemes ("claimants") to determine which aspects of the claiming experience they found stressful. We used multivariable regression analysis to test for associations between compensation-related stress and health status at 6 years, adjusting for baseline determinants of long-term health status and predisposition to stressful experiences (via propensity scores). MAIN OUTCOMES AND MEASURES: Disability, quality of life, anxiety, and depression. RESULTS: Among claimants, 33.9% reported high levels of stress associated with understanding what they needed to do for their claim; 30.4%, with claim delays; 26.9%, with the number of medical assessments; and 26.1%, with the amount of compensation they received. Six years after their injury, claimants who reported high levels of stress had significantly higher levels of disability (+6.94 points, World Health Organization Disability Assessment Schedule sum score), anxiety and depression (+1.89 points and +2.61 points, respectively, Hospital Anxiety and Depression Scale), and lower quality of life (-0.73 points, World Health Organization Quality of Life instrument, overall item), compared with other claimants. Adjusting for claimants' vulnerability to stress attenuated the strength of these associations, but most remained strong and statistically significant. CONCLUSIONS AND RELEVANCE: Many claimants experience high levels of stress from engaging with injury compensation schemes, and this experience is positively correlated with poor long-term recovery. Intervening early to boost resilience among those at risk of stressful claims experiences and redesigning compensation processes to reduce their stressfulness may improve recovery and save money.