Biopsychosocial sequelae of chronically painful injuries sustained in motor vehicle accidents contributing to non-recovery: A retrospective cohort study.

BACKGROUND: Claimants with chronically painful injuries sustained in motor vehicle accidents (MVAs) undergo assessment and management influenced by insurance and medico-legal processes defined by a biomedical paradigm which is discordant with best evidence. We aim to demonstrate the impact of biopsychosocial factors on post-MVA sequelae which contribute to non-recovery. METHODS: This was a retrospective cohort study of medico-legal documents and reports on 300 consecutive claimants referred to a pain medicine physician over 7 years (2012-2018) for assessment of painful musculoskeletal injuries post-MVA. One hundred data items were extracted from the medico-legal documents and reports for each claimant and entered into an electronic database. Post-MVA sequelae were analysed using chi-square analysis (OR >2) for significant associations with demographic, pre-MVA and post-MVA variables. Factors with significant associations were entered into a logistic regression model to determine significant statistical predictors of post-MVA sequelae contributing to non-recovery. RESULTS: The claimants were aged 17 to 80 years (mean age 42 years), and approximately half (53%, n=159) were female. The time from MVA to interview averaged 2.5 years. Widespread pain was present in 18% (n=54), and widespread somatosensory signs implying central sensitisation (OR=9.85, p<.001) was the most significant multivariate association. Long-term opiate use post-MVA (32%) was predicted by pre-MVA sleep disturbance (OR=5.08, p=.001), post-MVA major depressive disorder (MDD) (OR=3.02, p=.003) and long-term unemployment (OR=2.22. p=.007). Approximately half (47%, n=142) required post-MVA support from a psychologist or psychiatrist. Post-traumatic stress disorder (PTSD) was diagnosed by a psychiatrist or psychologist in 20% (n=59), yet early identification of risk of PTSD was rare. Pre-MVA, 89.4% (n=268) were studying or employed. Permanent unemployability post-MVA occurred in 35% (n=104) and was predicted by MDD (OR=3.59, p=.001) and antidepressant use (OR=2.17, p=.005). Major social change post-MVA (70%) was predicted by older age (OR=.966, p=.003), depressive symptoms (OR=3.71, p<.001) and opiate use (OR=2.00, p=.039). CONCLUSIONS: Biomedical factors, including older age, impaired sleep and indicators of widespread central sensitisation, and psychological factors, including stress, anxiety and depression, were the most prominent multivariate associations as statistical predictors of major adverse sequelae contributing to non-recovery for claimants with chronic pain post-MVA.

Data sharing-trialists' plans at registration, attitudes, barriers and facilitators: A cohort study and cross-sectional survey.

Data unavailability impedes research transparency and is a major problem for individual participant data (IPD) meta-analyses as it reduces statistical power, increases risk of bias, and may even preclude completion. The primary objectives of this study were to determine IPD sharing plans reported in recently registered clinical trial registration records, how data sharing commitment relates to clinical trial characteristics, and principal investigators' attitudes, motivations and barriers to data sharing. The secondary objective was to derive recommendations to overcome identified barriers to data sharing. This was a retrospective cohort study of all interventional trials registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) from 1 December 2018 to 30 November 2019, and an online cross-sectional survey of their principal investigators. In the cohort study of all clinical trials registered on the ANZCTR in the study period (n = 1517), commitment to share data was low (22%, 329/1517). In the cross-sectional survey (n = 281, 23% response rate), principal investigators showed strong support for the concept of data sharing (77%, 216/281) but a substantially lower intention to actually share data from their clinical trials (40%, 111/281). Major barriers to data sharing included lacking informed consent to share data, protecting participant confidentiality and preventing misinterpretation of data or misleading secondary analyses. There is a gap between high in-principle support for data sharing, and low in-practice intention from investigators to share data from their own clinical trials. Multiple pathways exist to bridge this gap by addressing the identified barriers to data sharing.

International representation of authors, editors and research in neurology journals.

BACKGROUND: Published research informs international healthcare, yet only a few studies have assessed the representation of authors, editors, and research from developing countries in biomedical journals. METHODS: We reviewed all research articles published in five high-ranking peer-reviewed neurology journals (The Lancet Neurology, Acta Neuropathologica, Nature Reviews Neurology, Brain and Annals of Neurology) in 2010 and 2019 to determine the extent of contributions of authors, editors and research from developing countries, and the degree of international research collaboration between developed and developing countries. RESULTS: First authorship was attributed to authors from developing countries in only 2% (11/729) of research articles in 2010 and 3% (19/647) of research articles in 2019. All 144 editorial board members in 2019 were from developed countries. International research collaboration between developing and developed countries accounted for only 4% (30/729) of all research articles in 2010 and 6% (40/647) of all research articles in 2019. CONCLUSIONS: There is urgent need for strategies to support high-quality and contextually appropriate biomedical research in developing countries. Supporting high quality and contextually appropriate biomedical research now is necessary for developing countries to meet the rising healthcare needs of their populations in the future.

Health and support service needs of individuals with disability from culturally and linguistically diverse backgrounds: a scoping review protocol.

BACKGROUND: All individuals should have the right to engage meaningfully in occupations that meet their aspirations and life goals as well as promote their health and well-being. For individuals with disability, meaningful engagement in occupations is supported by timely, effective, and adaptive health and support services. However, research has revealed multiple barriers preventing utilization of these services by individuals with disability from culturally and linguistically diverse (CALD) backgrounds. This review aims to identify gaps and solutions in health and support services of individuals with disability from CALD backgrounds to meaningfully engage in occupations. METHODS: A scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews. A detailed search strategy will be used to search CINAHL, PubMed, Embase, Scopus, PsycInfo, JBI, and Cochrane Library, as well as grey literature in Trove, Mednar, and OpenGrey from January 1974 onwards. Two reviewers will independently screen all citations and full-text articles for eligibility against specific inclusion and exclusion criteria. Potential conflicts will be resolved through discussion. Data will be extracted and presented in a diagrammatic or tabular form accompanied by a narrative summary. DISCUSSION: The scoping review will present the health and support service needs of individuals with disability from CALD backgrounds and will extend the current reviews as it focuses the engagement in meaningful occupation. Findings from this review have the potential to inform local policy discussions and practice-based disability care. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework ( 10.17605/OSF.IO/HW2FB ).

Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study.

OBJECTIVES: To determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors. DESIGN: Methodological study. DATA SOURCES: MEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies. ELIGIBILITY CRITERIA: Protocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language. MAIN OUTCOME: Primary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement. RESULTS: 300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p<0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. While 40% of individual checklist items had a significant improvement in adequate reporting after the SPIRIT statement, 11.3% had a significant deterioration and there were no RCT protocols in which all individual checklist items were complete. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement. CONCLUSION: The overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Continued and concerted efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.

Why Unidimensional Pain Measurement Prevails in the Pediatric Acute Pain Context and What Multidimensional Self-Report Methods Can Offer.

Although pain is widely recognized to be a multidimensional experience and defined as such, unidimensional pain measurement focusing on pain intensity prevails in the pediatric acute pain context. Unidimensional assessments fail to provide a comprehensive picture of a child's pain experience and commonly do little to shape clinical interventions. The current review paper overviews the theoretical and empirical literature supporting the multidimensional nature of pediatric acute pain. Literature reporting concordance data for children's self-reported sensory, affective and evaluative pain scores in the acute pain context has been reviewed and supports the distinct nature of these dimensions. Multidimensional acute pain measurement holds particular promise for identifying predictive markers of chronicity and may provide the basis for tailoring clinical management. The current paper has described key reasons contributing to the widespread use of unidimensional, rather than multidimensional, acute pediatric pain assessment protocols. Implications for clinical practice, education and future research are considered.

Data quality audit of a clinical quality registry: a generic framework and case study of the Australian and New Zealand Hip Fracture Registry.

OBJECTIVES: The value of a clinical quality registry is contingent on the quality of its data. This study aims to pilot methodology for data quality audits of the Australian and New Zealand Hip Fracture Registry, a clinical quality registry of hip fracture clinical care and secondary fracture prevention. METHODS: A data quality audit was performed by independently replicating the data collection and entry process for 163 randomly selected patient records from three contributing hospitals, and then comparing the replicated data set to the registry data set. Data agreement, as a proxy indicator of data accuracy, and data completeness were assessed. RESULTS: An overall data agreement of 82.3% and overall data completeness of 95.6% were found, reflecting a moderate level of data accuracy and a very high level of data completeness. Half of all data disagreements were caused by information discrepancies, a quarter by missing discrepancies and a quarter by time, date and number discrepancies. Transcription discrepancies only accounted for 1 in every 50 data disagreements. The sources of inaccurate and incomplete data have been identified with the intention of implementing data quality improvement. CONCLUSIONS: Regular audits of data abstraction are necessary to improve data quality, assure data validity and reliability and guarantee the integrity and credibility of registry outputs. A generic framework and model for data quality audits of clinical quality registries is proposed, consisting of a three-step data abstraction audit, registry coverage audit and four-step data quality improvement process. Factors to consider for data abstraction audits include: central, remote or local implementation; single-stage or multistage random sampling; absolute, proportional, combination or alternative sample size calculation; data quality indicators; regular or ad hoc frequency; and qualitative assessment.

Prevalence of trial registration varies by study characteristics and risk of bias.

OBJECTIVES: The objective of this study was to determine the prevalence of trial registration in health research, whether trial registration status and timing vary depending on trial characteristics, and the relationship between trial registration status and risk of bias. STUDY DESIGN AND SETTING: We systematically reviewed all clinical trials published from January to June 2017 in 28 high- and low-impact factor general and specialty medicine journals. RESULTS: We identified 370 trials and assessed risk of bias in 183 trials. Trial registration rates were high; 95% of trials were registered prospectively or retrospectively before enrollment completion. Larger sample size, multiple recruitment countries, and primary industry funding were all predictors of earlier trial registration. Prospectively registered trials had a significantly lower risk of bias compared to unregistered trials across all domains. Prospectively registered trials had a similar risk of bias compared to retrospectively registered trials across four out of six domains, and a lower risk of bias across the remaining two domains. CONCLUSION: Trial registration is an imperfect proxy for risk of bias. Systematic reviewers should assess risk of bias on a case-by-case basis and conduct sensitivity analyses excluding high risk of bias studies. In the longer term, mechanisms should be implemented to facilitate prospective registration of all trials.