title: Core Outcomes and Common Data Elements in Chronic Subdural Hematoma: A Systematic Review of the Literature Focusing on Reported Outcomes.
abstract: The plethora of studies in chronic subdural hematoma (CSDH) has not resulted in the development of an evidence-based treatment strategy, largely due to heterogeneous outcome measures that preclude cross-study comparisons and guideline development. This study aimed to identify and quantify the heterogeneity of outcome measures reported in the CSDH literature and to build a case for the development of a consensus-based core outcome set. This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and was registered with the PROSPERO international prospective register of systematic reviews (CRD42014007266). All full-text English language studies with >10 patients (prospective) or >100 patients (retrospective) published after 1990 examining clinical outcomes in CSDH were eligible for inclusion. One hundred two eligible studies were found. There were 14 (13.7%) randomized controlled trials, one single arm trial (1.0%), 25 (24.5%) cohort comparison studies, and 62 (60.8%) prospective or retrospective cohort studies. Outcome domains reported by the studies included mortality (63.8% of included studies), recurrence (94.1%), complications (48.0%), functional outcomes (40.2%), and radiological (38.2%) outcomes. There was significant heterogeneity in the definitions of the outcome measures, as evidenced by the seven different definitions of the term "recurrence," with no definition given in 19 studies. The time-points of assessment for all the outcome domains varied greatly from inpatient/hospital discharge to 18 months. This study establishes and quantifies the heterogeneity of outcome measure reporting in CSDH and builds the case for the development of a robust consensus-based core outcome set for future studies to adhere to as part of the Core Outcomes and Common Data Elements in CSDH (CODE-CSDH) project.
authors: 1 Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .
authors: Aswin
authors: A
authors: Chari
authors: 1 Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .
authors: Katie C
authors: KC
authors: Hocking
authors: 1 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: Ellie
authors: E
authors: Broughton
authors: 1 Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .|3 Surgery Theme, Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust , Cambridge, United Kingdom .
authors: Carole
authors: C
authors: Turner
authors: 1 Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .
authors: Thomas
authors: T
authors: Santarius
authors: 1 Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .|3 Surgery Theme, Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust , Cambridge, United Kingdom .
authors: Peter J
authors: PJ
authors: Hutchinson
authors: 1 Department of Clinical Neurosciences, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .|3 Surgery Theme, Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust , Cambridge, United Kingdom .
authors: Angelos G
authors: AG
authors: Kolias
mesh_terms: D020200:Hematoma, Subdural, Chronic / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*
keywords: chronic subdural hematoma; core outcomes; outcome measures