Core outcomes in periodontal trials

study protocol for core outcome set development

Thomas J. Lamont (Lead / Corresponding author), Jan E. Clarkson, David N. J. Ricketts, Peter A. Heasman, Craig R. Ramsay

Research output: Contribution to journalArticle

3 Citations (Scopus)
98 Downloads (Pure)

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.

Original languageEnglish
Article number436
Pages (from-to)1-4
Number of pages4
JournalTrials
Volume18
DOIs
Publication statusPublished - 20 Sep 2017

Fingerprint

Periodontal Diseases
Clinical Protocols
Guidelines
Secondary Care
Dentists
Administrative Personnel
Primary Health Care
Research Personnel
Outcome Assessment (Health Care)
Clinical Trials

Keywords

  • Periodontics
  • Delphi technique
  • Dentistry
  • Outcomes
  • Review
  • Clinical trial

Cite this

Lamont, Thomas J. ; Clarkson, Jan E. ; Ricketts, David N. J. ; Heasman, Peter A. ; Ramsay, Craig R. / Core outcomes in periodontal trials : study protocol for core outcome set development. In: Trials. 2017 ; Vol. 18. pp. 1-4.
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Core outcomes in periodontal trials : study protocol for core outcome set development. / Lamont, Thomas J. (Lead / Corresponding author); Clarkson, Jan E.; Ricketts, David N. J.; Heasman, Peter A.; Ramsay, Craig R.

In: Trials, Vol. 18, 436, 20.09.2017, p. 1-4.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Core outcomes in periodontal trials

T2 - study protocol for core outcome set development

AU - Lamont, Thomas J.

AU - Clarkson, Jan E.

AU - Ricketts, David N. J.

AU - Heasman, Peter A.

AU - Ramsay, Craig R.

N1 - No funding

PY - 2017/9/20

Y1 - 2017/9/20

N2 - 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.

AB - 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.

KW - Periodontics

KW - Delphi technique

KW - Dentistry

KW - Outcomes

KW - Review

KW - Clinical trial

U2 - 10.1186/s13063-017-2169-z

DO - 10.1186/s13063-017-2169-z

M3 - Article

VL - 18

SP - 1

EP - 4

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 436

ER -