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.
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
- COS for clinical trials or clinical research
- 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 a systematic review of the literature and through focus group work with patients. These potential outcomes will subsequently be reviewed using a three round online Delphi survey. The survey will be conducted with different groups of stakeholders: clinicians, researchers, patients, industry/pharmaceutical companies. A consensus meeting, involving all stakeholders, will be held to finalise the COS. We will also aim to identify potential outcome measures for the final COS, through a systematic review. Once this has been done the outcomes and outcomes measures will be included in a National Patient Registry.