Core Outcome Measures in Effectiveness Trials

Outcomes in MIH Intervention Studies: Systematic Review to Develop a Core Outcome Set (COS)

General Information

Summary:
Introduction: Increasing efforts in dental research are focused on the treatment of Molar Incisor Hypomineralization (MIH). Inconsistent or selectively reported outcomes are a hurdle to implementing clinical trial results into practice. Core outcome sets (COSs) define those outcomes that intervention studies should at least elevate. To develop a COS on MIH intervention studies, outcomes used so far have been systematically evaluated in this work.
Methods: Medline, Embase, Cochrane Central, Google Scholar, opengrey.eu as well as DRKS and Clinicaltrials.gov were searched and cross referenced performed. The search covered the period from 01.01.1980 to 15.05.2018. Clinical studies in people with MIH who reported on prevention / treatment interventions will be included. The primary outcomes will be extracted and categorized.


Contributors:
Karim Elhennawy
Charité - Universitätsmedizin Berlin
Dep. of Orthodontics, Dentofacial Orthopedics and Pedodontics

Further Study Information

Current Stage:
Ongoing
Date:
May 2018 - December 2018
Funding source(s):
None

Health Area

Disease Category
Dentistry & oral health

Disease Name
Molar Incisor Hypomineralization (MIH)

Target Population

Age Range
6 - 60

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Interview
Semi structured discussion
Systematic review

To identify existing outcomes, trials on prevention and trials on management of Molar Incisor Hypomineralization (MIH) will be screened systematically in different databases. Screening, extraction and deduplication will be performed by two researchers until consensus is reached. The definition of the core outcome set (COS) 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 panelists 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. If resources allow, we will investigate features that influence decision making for different groups.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Economists
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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