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Review
. 2017 Sep 20;18(1):436.
doi: 10.1186/s13063-017-2169-z.

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

Thomas J Lamont  1 , Jan E Clarkson  2 , David N J Ricketts  2 , Peter A Heasman  3 , Craig R Ramsay  4
Affiliations
Review

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

Thomas J Lamont et al. Trials. .

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.

Keywords: Clinical trial; Delphi technique; Dentistry; Outcomes; Periodontics; Review.

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Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

The East of Scotland Research Ethics Service (EoSRES) confirmed that NHS ethical approval would not be required for this project. The University of Dundee Schools of Nursing and Health Sciences and Dentistry Research Ethics Committee (SREC) provided institutional ethical approval in December 2016 (Ref: 2016028_Lamont). Informed consent will be obtained from all participants when they opt in to participate in the study at the start of the e-Delphi process.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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