title: Core Outcomes and Common Data Elements in Chronic Subdural Hematoma: A Systematic Review of the Literature Focusing on Baseline and Peri-Operative Care Data Elements.
abstract: Chronic subdural hematoma (CSDH) is an increasingly common subtype of head injury, especially in the elderly population. The optimization of treatment strategies has been hampered by the collection of heterogeneous outcome measures and data elements, precluding cross-study comparisons. This study aimed to quantify the heterogeneity of data elements in the pre-operative, operative, and post-operative phases of care, and build the basis for the development of a set of common data elements (CDEs) for CSDH. This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and was registered with the PROSPERO register of systematic reviews (CRD42014007266). All full-text English studies with more than 10 patients (prospective) or more than 100 patients (retrospective) published after 1990 examining clinical outcomes in CSDH were eligible for inclusion. One hundred two eligible studies were found. Only 40 studies (39.2%) reported the main presenting symptom/feature and 24 (23.5%) reported additional symptoms/features. Admitting neurological/functional status was classified by the Glasgow Coma Scale (25 studies; 24.5%), the Markwalder Score (26 studies; 25.5%) and the modified Rankin Scale (three studies; 2.9%). Fifty-four studies (52.9%) made some mention of patient comorbidities and 58 studies (56.9%) reported the proportion or excluded patients on anticoagulant medication. Eighteen studies (17.6%) reported baseline coagulation status. Sixty-four studies (62.7%) stratified or assessed severity based on radiological findings, although the methods used varied widely. There was variable reporting of surgical technique and post-operative care; 32 studies (31.4%) made no mention of whether the operations were performed under general or local anesthetic. This study, a part of the Core Outcomes and Common Data Elements in CSDH (CODE-CSDH) project, confirms and quantifies the heterogeneity of data elements collected and reported in CSDH studies to date. It establishes the basis for the consensus-based development of a set of common data elements, facilitating robust cross-study comparisons and resulting improvements in patient outcomes.
authors.affiliation: 1 Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .
authors.forename: Aswin
authors.initials: A
authors.lastname: Chari
authors.affiliation: 1 Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .
authors.forename: Katie C
authors.initials: KC
authors.lastname: Hocking
authors.affiliation: 1 Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .|2 South West Neurosurgical Centre, Derriford Hospital , Plymouth, United Kingdom .
authors.forename: Ellie
authors.initials: E
authors.lastname: Edlmann
authors.affiliation: 1 Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .|3 Surgery Theme, Cambridge Clinical Trials Unit, Cambridge University Hospitals National Health Service Foundation Trust , Cambridge, United Kingdom .
authors.forename: Carole
authors.initials: C
authors.lastname: Turner
authors.affiliation: 1 Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .
authors.forename: Thomas
authors.initials: T
authors.lastname: Santarius
authors.affiliation: 1 Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .|3 Surgery Theme, Cambridge Clinical Trials Unit, Cambridge University Hospitals National Health Service Foundation Trust , Cambridge, United Kingdom .
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Hutchinson
authors.affiliation: 1 Division of Neurosurgery, Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .|3 Surgery Theme, Cambridge Clinical Trials Unit, Cambridge University Hospitals National Health Service Foundation Trust , Cambridge, United Kingdom .
authors.forename: Angelos G
authors.initials: AG
authors.lastname: Kolias
mesh_terms: D006801:Humans; D065709:Common Data Elements; D020200:Hematoma, Subdural, Chronic
keywords: clinical trials; common data elements; operative terminology; traumatic brain injury