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Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol.

Schwendicke F, Lamont T, Innes N - Trials (2015)

Bottom Line: 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.By using an explicit, transparent and inclusive multi-step consensus process, the planned core outcome set should be justifiable, relevant and comprehensive.

View Article: PubMed Central - PubMed

Affiliation: Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin, Aßmannshauser Str. 4-6, 14197, Berlin, Germany. falk.schwendicke@charite.de.

ABSTRACT

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 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.

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.

Trial registration: Registered 12 April 2015 at COMET ( http://www.comet-initiative.org).

No MeSH data available.


Related in: MedlinePlus

Study flow
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Fig1: Study flow

Mentions: To help increase the uptake of COS we will engage with relevant groups such as the Cochrane Oral Health Group, ORCA (the European Organization for Caries Research), the International Association for Dental Research Cariology Group, guideline development groups including National Institute for Clinical Excellence, the Scottish Intercollegiate Guideline Network and the Scottish Dental Clinical Effectiveness Program, journal editors, trial registries and major funding bodies such as the UK National Institute for Health Research (NIHR) Health Technology Assessment or the German Research Foundation. An overview of the trial can be found in Fig. 1.Fig. 1


Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol.

Schwendicke F, Lamont T, Innes N - Trials (2015)

Study flow
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4562350&req=5

Fig1: Study flow
Mentions: To help increase the uptake of COS we will engage with relevant groups such as the Cochrane Oral Health Group, ORCA (the European Organization for Caries Research), the International Association for Dental Research Cariology Group, guideline development groups including National Institute for Clinical Excellence, the Scottish Intercollegiate Guideline Network and the Scottish Dental Clinical Effectiveness Program, journal editors, trial registries and major funding bodies such as the UK National Institute for Health Research (NIHR) Health Technology Assessment or the German Research Foundation. An overview of the trial can be found in Fig. 1.Fig. 1

Bottom Line: 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.By using an explicit, transparent and inclusive multi-step consensus process, the planned core outcome set should be justifiable, relevant and comprehensive.

View Article: PubMed Central - PubMed

Affiliation: Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin, Aßmannshauser Str. 4-6, 14197, Berlin, Germany. falk.schwendicke@charite.de.

ABSTRACT

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 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.

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.

Trial registration: Registered 12 April 2015 at COMET ( http://www.comet-initiative.org).

No MeSH data available.


Related in: MedlinePlus