Conceptualising, operationalising and utilising equity, diversity and inclusion in clinical trials: a scoping review.

Introduction: Equity, diversity and inclusion (EDI) are social constructs which when used in clinical trials help generate the highest quality evidence for interventions in the populations most likely to benefit. However, the incorporation of these constructs in clinical trials is unclear and inconsistent. This scoping review sought to understand how EDI is applied in clinical trials.

Data sharing policies across health research globally: Cross-sectional meta-research study.

Background: Data sharing improves the value, synthesis, and integrity of research, but rates are low. Data sharing might be improved if data sharing policies were prominent and actionable at every stage of research. We aimed to systematically describe the epidemiology of data sharing policies across the health research lifecycle.

Development of a checklist of standard items for processing individual participant data from randomised trials for meta-analyses: Protocol for a modified e-Delphi study.

Individual participant data meta-analyses enable detailed checking of data quality and more complex analyses than standard study-level synthesis of summary data based on publications. However, there is limited existing guidance on the specific systematic checks that should be undertaken to confirm and enhance data quality for individual participant data meta-analyses and how to conduct these checks. We aim to address this gap by developing a checklist of items for data quality checking and cleaning to be applied to individual participant data meta-analyses of randomised trials.

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.

Electrical injury: Chronic pain, somatosensory dysfunction, post traumatic stress and movement disorders.

Introduction And Aims: We aimed in this case series to identify shortcomings in assessment of long-term painful and psychosocial consequences of EI and to demonstrate the value of biopsychosocial assessment and the commonalities in outcomes.

Methods: We retrospectively analyzed 15 cases from 2004 to 2019 of adult claimants assessed in a medico-legal practice for complex chronic pain disorders secondary to EI. Extensive biopsychosocial information, including 165 data items on pre- and post-injury observations, were collected on each.

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.

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.

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.

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.

Is retrospective assessment of health-related quality of life valid?

Background: Health-related quality of life (HRQoL) is a commonly used health outcome. For many acute conditions (e.g.

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.

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.

Chronic Widespread Pain and Fibromyalgia Syndrome: Life-Course Risk Markers in Young People.

Although the life-course concept of risk markers as potential etiological influences is well established in epidemiology, it has not featured in academic publications or clinical practice in the context of chronic widespread pain (CWP) and fibromyalgia syndrome (FMS). Studies of risk markers are required considerations for evaluation of patients and for research because there is no single cause, pathological feature, laboratory finding, or biomarker for CWP or FMS. The early-life risk markers identified by extensive literature review with best evidence for potential causal influence on the development and progression of CWP and FMS include genetic factors, premature birth, female sex, early childhood adversity, cognitive and psychosocial influences, impaired sleep, primary pain disorders, multiregional pain, physical trauma, infectious illness, obesity and inactivity, hypermobility of joints, iron deficiency, and small-fiber polyneuropathy.

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.