TRINCOS - Defining Core Outcome Set in Trigeminal Neuralgia
Research type
Research Study
Full title
Defining Core Outcome Set in Trigeminal Neuralgia
IRAS ID
240304
Contact name
Joanna Zakrzewska
Contact email
Sponsor organisation
UCL
Clinicaltrials.gov Identifier
17/0901
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Background: Core outcome sets (COS) are disease-specific minimum data sets to be collected and reported in clinical trials. As well as allowing comparison and synthesis of results in meta-analysis and ensuring that appropriate outcomes are reported, the use of COS prevents selective reporting and allows ranking of outcomes for the development of clinical guidelines. \nTrigeminal neuralgia (TN) is a rare, severe form of episodic facial pain that significantly impacts on quality of life. It can be managed both medically and neurosurgically, the latter often providing many years of long term relief. Currently few outcome measures have been used to capture the impact of TN and this has significantly limited our management of this condition. \nAim: To develop a COS for TN in order to determine the clinical presentation, time course of disorder and the factors that influence it. \nMethods: COS will be developed using robust methods recommended by the Core Outcomes Measures in Effectiveness Trials (COMET) initiative. Potential core outcomes will be identified using systematic reviews of the literature. Focus groups with stakeholders which include patients, carers, clinicians, researchers and industry will be conducted. An international multidisciplinary group of clinicians (currently updating the clinical guidelines for TN) will be invited to participate by Email. These potential outcomes will then be reviewed using a three round Delphi survey to select core outcomes. A consensus meeting, involving all key stakeholders, will be held to finalise the COS. \nDissemination: Once COS have been finalised they will be disseminated via key international conferences and by publication in peer-reviewed journals. Implementation of the COS in publications will be embedded by journals who will specify their inclusion in studies in their ‘authors instructions’. Their use will be essential on all future studies in order to enable improved decision making on treatment options. \n
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0153
Date of REC Opinion
13 Sep 2019
REC opinion
Favourable Opinion