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临床试验/NCT04850612
NCT04850612已完成不适用

Defining Core Outcomes and Data Elements (CODE) in Chronic Subdural

University Hospital Plymouth NHS Trust1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
184
试验地点
1
主要终点
CSDH Core Outcome Set (COS)

研究概览

简要总结

This study is aimed at improving reporting in Chronic Subdural Haematoma (CSDH) research studies, through development of a standardised Core Outcome Set (COS), a unified CSDH Definition and set of Data Elements (DE) for reporting.

The study design includes a Delphi survey process from two main stakeholder groups: Health-Care Professionals or Researchers (HCPR) 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. Results of the Delphi Survey will be discussed at a final consensus meeting before results are confirmed and published.

详细描述

Chronic subdural haematoma (CSDH) is a collection of blood and fluid surrounded by membranes that accumulates on the brain surface over weeks to months. It predominately affects older people and often has a delayed association with a preceding head trauma.

There has been significant growth in the number of CSDH publications in recent years mirroring progress in potential management options but there is wide variation in how and when patient outcome is measured amongst studies. Much could be gained by agreeing a minimum set of standardized outcomes that should be measured and reported in all CSDH studies, known as a Core Outcome Set (COS).

The overall study design includes a Delphi survey process.This is a process whereby all outcomes and data elements from the CSDH literature and expert opinion are presented to a large group of patients, carers and HCPR via a survey. Each survey participant has the opportunity to rank the elements and outcomes in levels of importance to them, and the survey is then repeated including presentation of the results from the first round, in order to attempt to gain agreement between participants on what is important. All elements are then reviewed at a final "consensus" meeting

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All invited participants who provide consent to take part in 2 rounds of survey

排除标准

  • 未提供

结局指标

主要结局

CSDH Core Outcome Set (COS)

时间窗: 3 months

Definition of a Core Outcome Set (COS) for reporting in all future CSDH studies through a Delphi survey process including all relevant stakeholders.

次要结局

  • CSDH Definition and Data Elements(3 months)

研究者

发起方
University Hospital Plymouth NHS Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellie Edlmann

Clinical Lecturer in Neurosurgery

University Hospital Plymouth NHS Trust

研究点 (1)

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