The Core Outcome Set for Carious Lesion Management Trials
Objectives: Unwanted variation in the selection and reporting of outcomes in randomised controlled trials impedes evidence synthesis, wastes research funding and can result in inappropriate patient care. A Core Outcome Set (COS) can help by identifying key outcomes, prioritised by patients and healthcare workers, which researchers can incorporate into the design of their trials. To date, there is no published COS for the management of dental carious lesions. A COS for carious lesion management will provide researchers with an evidence-informed standard for selection and reporting of outcomes in trials investigating the treatment of established carious lesions. Therefore, the aim of this work was to develop a COS for carious lesion management trials comprising of between three and seven outcomes. Methods: Following an international two-stage eDelphi survey to prioritise previously published outcomes, a-face-to-face consensus meeting was conducted to agree the COS. A modified nominal group design, involving patients, researchers and clinicians was used. Participants were divided into two mixed groups to prioritise the 23 outcomes from the eDelphi. After discussing each outcome, participants used anonymous electronic voting to identify the COS. Participants voted to include or exclude each outcome in turn. Outcomes had to be considered essential by > 70% of participants for inclusion in the COS. The results for each outcome were not revealed until all voting ceased. Results: Thirteen participants attended the face-to-face consensus meeting. Seven patients and six clinicians and/or researchers participated. Six outcomes met the pre-defined consensus criteria for inclusion in the COS. The results of the anonymous electronic voting are shown in Table 1. The final COS is: Irreversible pulpitis; Oral function; Patient satisfaction with treatment; Quality of life; Survival of the restoration (where applicable) and tooth survival. Conclusions: A COS for carious lesion management clinical trials has been agreed with co-design from patients, clinicians and researchers.
Division:IADR/AADR/CADR General Session
Meeting:2020 IADR/AADR/CADR General Session (Washington, D.C., USA) Location:Washington, D.C., USA
Year: 2020 Final Presentation ID:0315 Abstract Category|Abstract Category(s):Evidence-based Dentistry Network
Authors
Levey, Colin
( Dundee Dental Hospital and School
, Dundee
, United Kingdom
)
Gillies, Katie
( Univeristy of Aberdeen
, Aberdeen
, United Kingdom
)
Cassie, Heather
( University of Dundee
, Dundee
, United Kingdom
)
Lamont, Thomas
( Dundee Dental Hospital and School
, Dundee
, United Kingdom
)
Clarkson, Jan
( University of Dundee
, Dundee
, Angus
, United Kingdom
; University of Dundee
, Dundee
, United Kingdom
)
Ricketts, David
( Dundee Dental Hospital and School
, Dundee
, United Kingdom
)
Financial Interest Disclosure: NONE
SESSION INFORMATION
Oral Session
Evidence-based Dentistry Network I
TABLES
Results of Anonymous Electronic voting
Outcome Name
Yes n= (%)
No n= (%)
Abscess development after treatment of caries
9 (69%)
4 (31%)
Caries increment
7 (54%)
6 (46%)
Carious pulp exposure during treatment of caries
4 (31%)
9 (69%)
Irreversible pulpitis following treatment of caries
10 (77%)
3 (23%)
New caries adjacent to the restoration
9 (69%)
4 (31%)
Non carious pulp exposure during treatment
4 (31%)
9 (69%)
Oral function following treatment of dental caries
10 (77%)
3 (23%)
Pain during treatment of caries
9 (69%)
4 (31%)
Patient (or guardian) satisfaction with treatment
13 (100%)
0 (0%)
Periapical periodontitis development (Apical inflammation) after treatment of caries