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

Dana C Holl1, Aswin Chari2,3, Christian Iorio-Morin4

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Neurosurgery
|July 28, 2021
PubMed
Summary

This study aims to standardize reporting for chronic subdural hematoma (CSDH) by developing a Core Outcome Set (COS) and defining key data elements (DEs). This will improve research quality and patient outcome comparability in neurosurgery.

Keywords:
Chronic subdural hematomaCore Outcomes and Data ElementsDelphi

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Area of Science:

  • Neurosurgery
  • Clinical Trials
  • Health Outcomes Research

Background:

  • Chronic subdural hematoma (CSDH) is a common neurosurgical condition requiring standardized research reporting.
  • Current research lacks uniformity in data collection and outcome measurement for CSDH.
  • Standardized Core Outcome Sets (COSs) and Data Elements (DEs) are crucial for improving study quality and comparability.

Purpose of the Study:

  • To establish a standardized COS for all future CSDH research.
  • To define a unified CSDH definition and essential DEs for consistent reporting.
  • To enhance the quality and comparability of CSDH studies.

Main Methods:

  • A Delphi survey methodology will be employed.
  • 150 respondents from two key stakeholder groups will participate: healthcare professionals/researchers (HCPRs) and patients/carers.
  • HCPRs will exclusively address questions regarding CSDH definition and DEs.

Main Results:

  • Consensus is expected on a COS for CSDH research.
  • Agreement is anticipated for a standardized CSDH definition and DEs.
  • The developed COS, definition, and DEs will be applicable to future CSDH studies.

Conclusions:

  • The Delphi survey is projected to yield consensus on a COS, CSDH definition, and DEs.
  • Implementation of these standards will align future CSDH research.
  • This standardization will facilitate a better understanding of treatment effects on patient function and recovery.