Objectives
To develop a Core Outcome Set suitable for adults and children for use in studies of Dental Behaviour Support (DBS) techniques, including non-pharmacological DBS, sedation and General Anaesthesia research.
Methods
Two systematic reviews generated a preliminary list of candidate outcomes that were shared with Key Stakeholders (KSG) and Public Patient Involvement (PPI) groups, who shortlisted outcomes for further exploration. Patients, carers, clinicians, and researchers were invited to participate in a Delphi panel. A modified e-Delphi was used to generate prioritisation and consensus across outcomes. A subsequent series of consensus meetings with panellists, patient groups and professional stakeholder groups determined the final outcomes within the COS.
Results
Twenty-three candidate outcomes were rated by 88 panellists in Round 1. The attrition rate between Rounds 1 and 3 was 21.6%. Thirty-four to 32 panellists attended the consensus meetings. The BeSiDe core outcome set for Dental Behaviour Support consisted of nine outcomes: acceptability, adverse effect, anxiety, behavioural response, cost, pain, therapeutic alliance, time and treatment completion. An additional subset of three core outcomes for use in pharmacological DBS studies was agreed upon: recovery, sedation effect and physiological monitoring. Each outcome was presented with a plain-language label and description to support consistent interpretation across stakeholders.
Conclusions
A core outcome set to be used across all DBS studies was produced covering both adults and children, with supplementary additional outcomes available to use in studies exploring only pharmacological DBS approaches. The list is for use in research, though there is obvious transferability to clinical practice.
Caoimhin Mac Giolla Phadraig, Isabel C. Olegário, Shaelynn Hsu, Maryam Al Zayer, Aisyah Binti Ahmad Fisal, Alison Dougall, Gareth B. Kitchen, Henry F. Duncan, Sarah Baker, Sharat Pani, Sreekanth Kumar Mallineni, Mandy Daly, The BeSiDe COS Collaboration, Andrew Geddis-Regan
Disease Category: Dentistry & oral health
Disease Name: Dental anxiety
Age Range: 16 - 120
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Patient/ support group representatives
- Researchers
- Service providers
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Interview
- Systematic review
A systematic review will be undertaken to explore outcomes relevant to DBS. This will use search terms drawn from COS research for anaesthesia and peri-operative care and relevant clinical guidelines specific to certain DBS approaches. This review will explore but not be limited to outcomes relevant to non-pharmacological DBS approaches, sedation, and general anaesthesia.
Qualitative methods will be used to further explore potentially relevant outcomes and to prioritise those identified from the systematic review. Qualitative interviews will be planned with dentists, patients, patient representatives, and anaesthetists involved in dental sedation or general anaesthesia. Interviews will be thematically analysed to provide a degree of insight into perceptions on the importance and appropriateness of outcomes identified through the review.
A modified Delphi approach will be used to gain consensus on appropriate outcomes. Outcome measures will also be presented to patient groups to gather insight into patient-reported outcomes and which of these may be suitable to include in a 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.