Developing a Core Outcome Set for Caries: The Long List

Objectives: Inconsistent selection and reporting of outcomes compromises evidence synthesis, wastes research funding and can lead to inappropriate patient care. A Core Outcome Set (COS) can help to reduce these risks by identifying important outcomes, prioritised by patients and clinicians, which should be measured and reported in all trials for that condition. A COS for carious lesion management will help standardise outcome selection and reporting, improving the evidence base. The aim of this work was to develop a Core Outcome Set (COS) for carious lesion management trials.
Methods: An international two-stage eDelphi survey involving key stakeholders was conducted to identify missing outcomes from previous literature and prioritise a combined list of outcomes. The key stakeholders were formed of two sub-groups: patients and clinicians/researchers. Each outcome was given a technical and lay definition. In each round, panellists were asked to score outcomes as: limited importance; important but not critical; and critical. In round 2, panellists received feedback based on their round 1 score and the distribution of responses amongst sub-panels. Panellists were able to change their score after comparison with the group response.
Results: 57 panellists completed both rounds of the eDelphi (9 patients and 48 clinicians). One additional outcome was added after round one resulting in 77 outcomes scored in round 2. According to predefined consensus rules, 23 outcome domains met criteria for inclusion in the long list. These are shown alphabetically in table 1. Notably, the activity of the lesion, was not considered to be critically important to patients despite the increasing emphasis on this in current clinical research.
Conclusions: Using an eDelphi methodology, a long-list of potentially important outcomes to patients and clinicians was identified.

Next Steps: A face-to-face consensus meeting using a modified nominal group technique is planned to establish a focussed carious lesion management COS.