Outcomes in Trials for Management of Caries Lesions (OuTMaC)

Background: Clinical trials on caries lesion management use an abundance of outcomes, hampering comparison or combination of different study results and their efficient translation into clinical practice. Core outcome sets are an agreed standardized collection of outcomes which should be measured and reported in all trials for a specific clinical area. We aim to develop a core outcome set for trials investigating management of caries lesions in primary or permanent teeth conducted in primary or secondary care encompassing all stages of disease.

Methods: To identify existing outcomes, trials on prevention and trials on management of caries lesions will be screened systematically in four databases. Screening, extraction and deduplication will be performed by two researchers until consensus is reached. The definition of the core outcome set will by based on an e-Delhi consensus process involving key stakeholders namely patients, dentists, clinical researchers, health economists, statisticians, policy makers and industry representatives. For the first stage of the Delphi process, a patient panel and a separate panel consisting of researchers, clinicians, teachers, industry affiliated researchers, policy makers, and other interested parties will be held. An inclusive approach will be taken to involve patients from a wide variety of socio-economic and geographic backgrounds. Results from the first round will be summarized and fed back to individuals for the second round, where panels will be combined and allowed to modify their scoring in light of the full panel’s opinion. Necessity for a third round will be dependent on the outcome of the first two. Agreement will be measured via defined consensus rules; up to a maximum of seven outcomes.

Discussion: By using an explicit, transparent and inclusive multi-step consensus process, the planned core outcome set should be justifiable, relevant and comprehensive. The dissemination and application of this core outcome set should improve clinical trials on managing caries lesions and allow comparison, synthesis and implementation of scientific data.

PROTOCOL: http://www.trialsjournal.com/content/16/1/397

Contributors

Falk Schwendicke, Department of Operative and Preventive Dentistry, Charité – Universitätsmedizin, Berlin

Nicola Innes, Thomas Lamont
Division of Oral Health Sciences, Dundee Dental School, Park Place, University of Dundee, Dundee, Tayside, UK

PI: Falk Schwendicke and Nicola Innes

Further Study Information

Current Stage: Ongoing
Date: April 2015 - 2016
Funding source(s): None


Health Area

Disease Category: Dentistry & oral health

Disease Name: Dental caries

Target Population

Age Range: 1 - 120

Sex: Either

Nature of Intervention: Behavioural , Drug, Surgery

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Economists
- Journal editors
- Pharmaceutical industry representatives
- Policy makers
- Statisticians

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus conference
- Delphi process
- Systematic review

To identify existing outcomes, trials on prevention and trials on management of caries lesions will be screened systematically in four databases. Screening, extraction and deduplication will be performed by two researchers until consensus is reached. The definition of the core outcome set will by based on an e-Delhi consensus process involving key stakeholders namely patients, dentists, clinical researchers, health economists, statisticians, policy makers and industry representatives. For the first stage of the Delphi process, a patient panel and a separate panel consisting of researchers, clinicians, teachers, industry affiliated researchers, policy makers, and other interested parties will be held. An inclusive approach will be taken to involve patients from a wide variety of socio-economic and geographic backgrounds. Results from the first round will be summarized and fed back to individuals for the second round, where panels will be combined and allowed to modify their scoring in light of the full panel’s opinion. Necessity for a third round will be dependent on the outcome of the first two. Agreement will be measured via defined consensus rules; up to a maximum of seven outcomes.