Core Outcome Measures in Effectiveness Trials

Core outcomes and common data elements in chronic subdural haematoma (CODE-CSDH)

General Information

Summary:
Chronic subdural haematoma (CSDH) is one of the most common subtypes of head injury, with an incidence of approximately 10/100,000/year. It is predominantly a disease affecting the elderly and its incidence is expected to rise, primarily due to an ageing population and the increasing use of anticoagulant/antiplatelet medication. Despite a plethora of studies investigating the management of CSDH, there remain a number of unanswered questions about the choice of surgical technique, adjuvant therapies, and post-operative care. Many of the studies published in the literature are small retrospective case series reporting disparate baseline data, using variable terminology and definitions of operative technique, and evaluating heterogeneous outcome measures. This poses significant barriers to establishing an evidence-based approach to the management of CSDH. The CODE-CSDH project aims to develop a set of core outcomes for CSDH. In addition to the development of a core outcome set, CODE-CSDH also aims to develop a set of common data elements for CSDH in order to standardise the data elements to be collected by CSDH studies, ensuring homogeneous and consistent reporting of demographic data, pre-operative status, and intra-operative details to further facilitate evidence synthesis.

Contributors:
Angelos Kolias, Aswin Chari, Katie Hocking, Ellie Edlmann, Carole Turner, Thomas Santarius, Peter Hutchinson. Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.

PI – Angelos Kolias and Peter Hutchinson

Further Study Information

Current Stage:
Ongoing
Date:
2014 - 2017
Funding source(s):
NIHR Cambridge BRC

Health Area

Disease Category
Health care of older people
Neurology
Orthopaedics & trauma

Disease Name
Chronic subdural haematoma

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Drug
Surgery

Method(s)

Consensus meeting
Delphi process
Systematic review

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Patient/ support group representatives
Service users

Study Type

COS for clinical trials or clinical research
COS for practice
Minimum dataset

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