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. METHODS: This was a cross-sectional analysis of the data sharing policies of the largest health research funders, all national ethics committees, all clinical trial registries, the highest-impact medical journals, and all medical research data repositories. Stakeholders' official websites, online reports, and other records were reviewed up to May 2022. The strength and characteristics of their data sharing policies were assessed, including their policies on data sharing intention statements (a.k.a. data accessibility statements) and on data sharing specifically for coronavirus disease studies. Data were manually extracted in duplicate, and policies were descriptively analysed by their stakeholder and characteristics. RESULTS: Nine hundred and thirty-five eligible stakeholders were identified: 110 funders, 124 ethics committees, 18 trial registries, 273 journals, and 410 data repositories. Data sharing was required by 41% (45/110) of funders, no ethics committees or trial registries, 19% (52/273) of journals and 6% (24/410) of data repositories. Among funder types, a higher proportion of private (63%, 35/55) and philanthropic (67%, 4/6) funders required data sharing than public funders (12%, 6/49). CONCLUSION: Data sharing requirements, and even recommendations, were insufficient across health research. Where data sharing was required or recommended, there was limited guidance on implementation. We describe multiple pathways to improve the implementation of data sharing. Public funders and ethics committees are two stakeholders with particularly important untapped opportunities.

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. This study will comprise three phases: 1) a scoping review to identify potential checklist items; 2) two e-Delphi survey rounds among an invited panel of experts followed by a consensus meeting; and 3) pilot testing and refinement of the checklist, including development of an accompanying R-markdown program to facilitate its uptake.

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. Cutaneous and deep pressure somatosensory examination was performed and questionnaires for psychological evaluation and restless legs syndrome completed. A comprehensive literature review and descriptive analysis was conducted. RESULTS: Pre-injury, most claimants worked (12/15), did not receive government benefits (14/15) and had no primary pain disorder (9/15). EIs were severe (14/15), where chronic post-traumatic pain, typically high impact with nociplastic features, was regional in 5 and widespread in 10. Somatosensory signs in wide distribution in all cases implied central sensitization. Movement disorders included digital dyskinesia (5/15), involuntary muscle contractions (7/15) and restless legs syndrome in 7. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) post-traumatic stress disorder (PTSD) criteria were met in 12/15, and 14/15 experienced depression and impaired sleep. Severe social impacts, notably including loss of employment resulting in financial stresses, were common. CONCLUSIONS: Biological, psychological and social consequences of EI revealed extensive similarities. Disability was generally severe, moreso than indicated in clinical records, influenced by relative paucity of primary pathology, inadequate pain-orientated somatosensory testing and insufficient application of biopsychosocial assessment and management.

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. fractures), retrospective measurement of HRQoL is necessary to establish pre-morbid health status. However, the validity of retrospective measurement of HRQoL following an intervening significant health event has not been established. The aim of this study was to test the validity of retrospective measurement (recall) of HRQoL by using a test-retest design to measure reliability and agreement between prospective and retrospective patient-reported HRQoL before and after an intervening health event (elective orthopaedic surgery). METHOD: Participants were recruited from the pre-admission clinic of a metropolitan hospital. Participants were assessed for their HRQoL using the EQ-5D-5L at two time-points; prospectively at 2 weeks prior to their date of surgery and then retrospectively (recalling their pre-operative health) following elective hip or knee joint replacement surgery. Prospective measurements were compared with retrospective measurements for the five domain scores (nominal data) using intra-class correlation and for the EQ-Index score and EQ-Visual Analogue Scale (VAS) score (continuous data), using Pearson's correlation. Agreement was tested in continuous variables using Lin's coefficient of concordance (pc) and Bland-Altman plots. RESULTS: One hundred seventy-four patients consented to participate. Eighty-eight paired prospective and retrospective scores were collected and there was a median between-test period of 15 days. At a group level, the prospective measurements were similar to the retrospective measurements; the modes and means of the five domain scores were not different and the mean differences (MD) between the scores for EQ-Index (MD = 0.02, on a scale of 0-1) and EQ-VAS (MD = 0.53, on a scale of 1-100) were negligible. However, the correlation of paired scores was varied; the range of domain score correlations was 0.52 to 0.74, the concordance was substantial for the EQ-Index scores (pc = 0.76, 95% CI = 0.66, 0.84) and moderate for the EQ-VAS scores (pc = 0.46, 95% CI = 0.28, 0.61). CONCLUSION: Agreement between prospective and retrospective measurements was high at a group level and moderate to substantial at an individual level. Retrospective measurement of HRQoL using the EQ-5D-5L in an orthopaedic clinical context is a valid alternative to using reference data to estimate baseline or pre-morbid health status.

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. The case history illustrates the potential etiological influence of multiple risk markers offset by personal resilience.