Study Protocol on Defining Core Outcomes and Data Elements in Chronic Subdural Haematoma

Neurosurgery, vol. 89, pp. 720–725

Abstract

BACKGROUND: Core Outcome Sets (COSs) are necessary to standardize reporting in research studies. This is urgently required in the field of chronic subdural hematoma (CSDH), one of the most common disease entities managed in neurosurgery and the topic of several recent trials. To complement the development of a COS, a standardized definition and baseline Data Elements (DEs) to be collected in CSDH patients, would further improve study quality and comparability in this heterogeneous population. OBJECTIVE: To, first, define a standardized COS for reporting in all future CSDH studies; and, second, to identify a unified CSDH Definition and set of DEs for reporting in future CSDH studies. METHODS: The overall study design includes a Delphi survey process among 150 respondents from 2 main stakeholder groups: healthcare professionals or researchers (HCPRs) and Patients or carers. HCPR, patients and carers will all be invited to complete the survey on the COS, only the HCPR survey will include questions on definition and DE. EXPECTED OUTCOMES: It is expected that the COS, definition, and DE will be developed through this Delphi survey and that these can be applied in future CSDH studies. This is necessary to help align future research studies on CSDH and to understand the effects of different treatments on patient function and recovery. DISCUSSION: This Delphi survey should result in consensus on a COS and a standardized CSDH Definition and DEs to be used in future CSDH studies.

Authors 8

1. Dana C. Holl corresponding

   Erasmus MC

   Affiliation as printed

   Department of Neurosurgery, Erasmus Medical Centre, Erasmus MC Stroke Centre, Rotterdam, the Netherlands

2. Ajai Chari

   Great Ormond Street Hospital · University College London

   Affiliation as printed

   Department of Neurosurgery, Great Ormond Street Hospital, London, UK

   Developmental Neurosciences, Great Ormond Street Institute of Child Health, University College London, London, UK

3. Christian Iorio‐Morin

   Université de Sherbrooke

   Affiliation as printed

   Division of Neurosurgery, Université de Sherbrooke, Sherbrooke, Canada

4. Rúben Dammers

   Erasmus MC

   Affiliation as printed

   Department of Neurosurgery, Erasmus Medical Centre, Erasmus MC Stroke Centre, Rotterdam, the Netherlands

5. Niels Anthony Van Der Gaag Aachen Haaglanden Medical Center

   Leiden University · Leiden University Medical Center · Medisch Centrum Haaglanden · Haga Hospital · Stichting Haaglanden Medisch Centrum

   Affiliation as printed

   University Neurosurgical Centre Holland (UNCH), Leiden University Medical Centre, Haaglanden Medical Centre, Haga Teaching Hospital, the Netherlands

6. Angelos Georgiou Kolias

   University of Cambridge · Cambridge University Hospitals NHS Foundation Trust · Addenbrooke's Hospital

   Affiliation as printed

   Division of Neurosurgery, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK

   NIHR Global Health Research Group on Neurotrauma, University of Cambridge, Cambridge, UK

7. Peter J. Hutchinson

   University of Cambridge · Cambridge University Hospitals NHS Foundation Trust · Addenbrooke's Hospital

   Affiliation as printed

   Division of Neurosurgery, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK

   NIHR Global Health Research Group on Neurotrauma, University of Cambridge, Cambridge, UK

8. Ellie Edlmann

   University Hospitals Plymouth NHS Trust · University of Plymouth

   Affiliation as printed

   Department of Neurosurgery, South West Neurosurgical Centre, University Hospitals Plymouth NHS Trust, Plymouth, UK

   Faculty of Health, Peninsula Medical School, University of Plymouth, Plymouth, UK