Status:
COMPLETED
A Clinical Decision Aid for Diagnosing Transient Loss of Consciousness
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Consciousness Disorder
Eligibility:
All Genders
16+ years
Brief Summary
BACKGROUND: Transient loss of consciousness (TLOC) - defined as spontaneous disruption of consciousness not due to head trauma and with complete recovery - has a lifetime prevalence of 50%. It is one ...
Eligibility Criteria
Inclusion
- Patients first presenting with TLOC
- Referred to secondary care for diagnostic evaluation OR given firm diagnosis of syncope in accordance with European Society of Cardiology guidelines for syncope presentations not requiring further investigation
- Adult over the age of 16 years
- Able to complete iPEP questionnaire independently
- Participants do not need to be native English speaker but do need to have sufficient English language ability to complete iPEP without support
- Initial
Exclusion
- Unable to give informed consent to participation in research
- Unable to complete iPEP independently
- Previous specialist (neurological or cardiological) assessment of TLOC
- Criteria for exclusion from analysis:
- No firm clinical diagnosis of TLOC (and its cause) at end of 6-month follow-up period
- Mixed diagnosis of multiple TLOC-causing disorders at end of 6-month follow-up; we exclude these participants from analysis as they would not have a single reference standard diagnosis, thus their inclusion in development may reduce model performance (since their questionnaire answers will describe multiple different kinds of episode), and in validation there is no principled way to assess performance of the prediction model if they have more than one reference diagnosis. A previous study of patients with suspected seizures in this population found that only 1.1% of patients could not be given a single aetiological diagnosis, so we do not anticipate this resulting in many exclusions.4
- Evidence of previous specialist (neurological or cardiological) assessment of TLOC.
Key Trial Info
Start Date :
February 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT05367999
Start Date
February 9 2022
End Date
June 30 2023
Last Update
January 3 2024
Active Locations (2)
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1
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
2
Northern General Hospital
Sheffield, South Yorkshire, United Kingdom, S5 7AT