Core Outcome Measures in Effectiveness Trials

Adopting IMMPACT recommended outcome measures in clinical trials in burning mouth syndrome: A Delphi method

General Information

Summary:
Aim: To reach a consensus for adopting the standardized Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) outcome domains for burning mouth syndrome (BMS) clinical trials and clinical practice.
Background: A COS represents the agreed minimum set of domains and measurement instruments that should be measured and reported in any clinical trial for a given condition to ensure comparable outcome assessment. The outcomes identified in the existing literature regarding the efficacy of therapeutic interventions in BMS RCTs are numerous and diverse. Though the standardized Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) core outcome domains has been developed for measurement of outcomes in chronic pain RCTs, no BMS-specific COS have been adopted and validated. With the evolving landscape of BMS management end points and the development of new therapies, a consensus agreement on a COS for use in future BMS trials is of vital importance. A COS for the management of BMS will reduce outcome reporting bias and heterogeneity, improve RCT quality and facilitate more vigorous data synthesis of management interventions for systematic reviews and meta-analysis. This would ensure more reliable evidence for clinical management of the condition.
Methods: A BMS-specific COS will be developed using the method recommended by the COMET initiative. Selection of questionnaire outcome measures was informed by the IMMPACT consensus and previous systematic review of randomised control trials in BMS conducted by members of the consortium. Additional core outcomes will be identified through clinician and researcher involvement. An international group of clinicians and researchers will be invited to participate in several rounds of a Delphi survey to develop a COS. A consensus meeting will be held with the objective of ratifying the outcomes for inclusion in the COS. A finalised COS explanatory document will be drafted, including all outcomes and measurements as determined by the Delphi rounds and consensus meeting.

Dissemination: The final COS will be disseminated by high-impact publication and through conference meetings. The use of the COS will be mandatory in future clinical studies evaluating management strategies for BMS.

Contributors:
*Barbara Carey, Guy’s and St Thomas’s NHS Foundation Trust; Kings College London
*Rui Albuquerque, Guy’s and St Thomas’s NHS Foundation Trust; Kings College London
*Arwa M Farag, King AbdulAziz University, Jeddah, Saudi Arabia; Tufts School of Dental Medicine Boston, Massachusetts
Cibele Nasri-Heir, Rutgers School of Dental Medicine, Newark, New Jersey
Milda Chmieliauskaite, Case Western Reserve University, Cleveland, Ohio
Lina M Mejia, College of Dental Medicine, Nova Southeastern University, Fort Lauderdale, Florida
Andrea Sardella, University of Milan, Milano, Italy
Craig Miller, College of Dentistry, University of Kentucky, Lexington, Kentucky
Gary Klasser, Louisiana State University Health Sciences Center, New Orleans, Louisiana
Charles Carlson, University of Kentucky, Lexington, Kentucky
Anura Aryawardana, College of Medicine and Dentistry, James Cook University and Metro South Oral Health, Brisbane, Queensland, Australia

*Principal investigators

Further Study Information

Current Stage:
Ongoing
Date:
June 2019 - June 2020
Funding source(s):
None

Health Area

Disease Category
Dentistry & oral health

Disease Name
Burning mouth syndrome

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Unknown

Method(s)

Consensus meeting
Delphi process

A COS will be developed using the method recommended by the COMET initiative. Selection of questionnaire outcome measures was informed by the IMMPACT consensus and previous systematic review of randomised control trials in BMS conducted by members of the consortium. Additional core outcomes will be identified through clinician and researcher involvement. An international group of clinicians and researchers will be invited to participate in several rounds of a Delphi survey to develop a COS. A consensus meeting will be held with the objective of ratifying the outcomes for inclusion in the COS. A finalised COS explanatory document will be drafted, including all outcomes and measurements as determined by the Delphi rounds and consensus meeting.


Stakeholders Involved

Clinical experts
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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