Core Outcome Measures in Effectiveness Trials

Trigeminal neuralgia defining core outcomes sets

General Information

Summary:
Aim: To develop Core outcome set (COS) for Trigeminal Neuralgia (TN) which can be incorporated into a national patient registry.

Background: (COS) are disease-specific minimum data sets to be collected and reported in
clinical trials. The use of COS allows comparison and synthesis of results in meta-analysis, ensures that appropriate outcomes are reported, prevents selective reporting and allows ranking of outcomes for the development of clinical guidelines. Trigeminal neuralgia (TN) is a rare, severe form of episodic facial pain that impacts on quality of life. Treatment includes medical management and neurosurgery, the latter often providing years of long-term relief. Few outcome measures have been used to capture the impact of TN and this has significantly limited our understanding of the mechanisms and management of this condition.

Methods: COS will be developed using methods recommended by the COMET initiative. Potential core outcomes will be identified using systematic reviews of the literature. Focus groups and interviews will be conducted with stakeholders - patients, carers, clinicians, researchers and industry. An international multidisciplinary group of clinicians will be invited to participate. These potential outcomes will subsequently be reviewed using a three round Delphi survey to select COS. A consensus meeting, involving all stakeholders, will be held to finalise the COS. Once this has been done the outcome measures will be included in the National patient registry.

Dissemination: COS will be disseminated via international conferences and by publication in peer-reviewed journals. Implementation of the COS in publications will be embedded by journals that will specify their inclusion in studies in their ‘authors instructions’. Their use will be essential on future studies in order to improve decision-making on treatment options and any trials.

Contributors:
Joanna Zakrzewska (PI) Oral Medicine/Facial Pain EDH/UCLH
Carolina Venda Nova Oral Medicine/Facial Pain EDH/UCLH
Richeal Ni Riordain Oral Medicine/Facial Pain EDH/UCLH
Sarah Baker School of Clinical Dentistry Sheffield University
Alison Loescher School of Clinical Dentistry Sheffield University
Jillie Abbott TNA UK

Further Study Information

Current Stage:
Planning
Date:
September 2018 - April 2022
Funding source(s):
TBC

Health Area

Disease Category
Dentistry & oral health

Disease Name
Trigeminal neuralgia

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Unknown

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Systematic review

COS will be developed using methods recommended by the COMET initiative. Potential core outcomes will be identified using systematic reviews of the literature. Focus groups and interviews will be conducted with stakeholders - patients, carers, clinicians, researchers and industry. An international multidisciplinary group of clinicians will be invited to participate. These potential outcomes will subsequently be reviewed using a three round Delphi survey to select COS. A consensus meeting, involving all stakeholders, will be held to finalise the COS. Once this has been done the outcome measures will be included in the National patient registry.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (patients)
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research

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