Core Outcome Measures in Effectiveness Trials

Core Outcome Set for trials on the prevention and treatment of enamel White Spot Lesions (COS-WSL)

General Information

Summary:
Aim: To develop a core outcome set for trials on the prevention and treatment of enamel white spot lesions.
Background: Enamel white spot lesions (WSLs) are common in dental and especially orthodontic practice, which can impair both the health and aesthetics of affected teeth. Lots of different outcome measures have been used on trials on the prevention and treatment of enamel WSLs. Such heterogeneity in outcome measures hampers the comparison and synthesis of findings from different studies, which is essential for a better evidence base. It is therefore necessary to develop a core outcome set for trials on the prevention and treatment of enamel WSLs.
Methods: To summarise and analyse the current situation, all existing outcomes that have been used in trials on the prevention and / or treatment of enamel white spot lesions will be identified and summarised in a scoping review. Thereafter, qualitative interviews with patients who are undergoing or have had WSLs, as well as relevant dentists and orthodontists will be conducted to identify the outcomes that they consider important as a supplement to existing outcomes in the literature. For the Delphi process, the opinions of key stakeholders including patients, dentists / orthodontists, researchers, editors, policy-makers and industry representatives will be collected to determine the conceived importance of different outcomes. In the last stage, consensus meetings will be held to produce the final core outcome set
Dissemination: The final COS will be disseminated through academic journals and conferences.

Contributors:
*Hong He,School & Hospital of Stomatology, Wuhan University
*Zhuan Bian,School & Hospital of Stomatology, Wuhan University
Fang Hua,School & Hospital of Stomatology, Wuhan University;Division of Dentistry, The University of Manchester
Yunlei Wang,School & Hospital of Stomatology, Wuhan University
Liuyan Meng,School & Hospital of Stomatology, Wuhan University

*Principal investigators

Further Study Information

Current Stage:
Ongoing
Date:
August 2019 - August 2022
Funding source(s):
None

Health Area

Disease Category
Dentistry & oral health

Disease Name
Enamel white spot lesions

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Interview
Literature review

Brief description of methods 1. To summarise and analyse the current situation, all existing outcomes that have been used in trials on the prevention and / or treatment of enamel white spot lesions will be identified and summarised in a scoping review.
2. Qualitative interviews with patients who are undergoing or have had WSLs, as well as relevant dentists and orthodontists will be conducted to identify the outcomes that they consider important as a supplement to existing outcomes in the literature.
3. For the Delphi process, the opinions of key stakeholders including patients, dentists / orthodontists, researchers, editors, policymakers and industry representatives will be collected to determine the conceived importance of different outcomes.
4. In the last stage, consensus meetings will be held to produce the final core outcome set


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Journal editors
Methodologists
Policy makers
Researchers
Service providers
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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