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Open Access 01-12-2017 | Study protocol

Core outcomes in periodontal trials: study protocol for core outcome set development

Authors: Thomas J. Lamont, Jan E. Clarkson, David N. J. Ricketts, Peter A. Heasman, Craig R. Ramsay

Published in: Trials | Issue 1/2017

Abstract

Background

There are a large number of clinical outcome measures used to assess the effectiveness of prevention and management strategies of periodontal diseases. This heterogeneity causes difficulties when trying to synthesise data for systematic reviews or clinical guidelines, reducing their impact. Core outcome sets are an agreed, standardised list of outcomes that should be measured and reported in all trials in specific clinical areas. We aim to develop a core outcome set for effectiveness trials investigating the prevention and management of periodontal disease in primary or secondary care.

Methods

To identify existing outcomes we screened the Cochrane systematic reviews and their included studies on the prevention and management of periodontal diseases. The core outcome set will be defined by consensus of key stakeholders using an online e-Delphi process and face-to-face meeting. Key stakeholders involved in the development will include: patients, dentists, hygienists/therapists, specialists, clinical researchers and policy-makers. Stakeholders will be asked to prioritise outcomes and feedback will be provided in the next round(s). Stakeholders will have an opportunity to add outcomes found in the Cochrane review screening process at the end of the first round. If consensus is not reached after the second round we will provide feedback prior to a third round. Remaining outcomes will be discussed at a face-to-face meeting and agreement will be measured via defined consensus rules of outcome inclusion.

Discussion

The inclusive consensus process should provide a core outcome set that is relevant to all key stakeholders. We will actively disseminate our findings to help improve clinical trials, systematic reviews and clinical guidelines with the ultimate aim of improving the prevention and management of periodontal diseases.

Trial registration

COMET (http://www.comet-initiative.org/studies/details/265?result=true). Registered on August 2012.

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Title: Core outcomes in periodontal trials: study protocol for core outcome set development
Authors: Thomas J. Lamont
Jan E. Clarkson
David N. J. Ricketts
Peter A. Heasman
Craig R. Ramsay
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-017-2169-z

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Core outcomes in periodontal trials: study protocol for core outcome set development

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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