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Papers of the Week


Papers: 15 Aug 2020 - 21 Aug 2020


Human Studies


2020 Aug 12


Trials


21


1

IMMPACT-recommended outcome measures and tools of assessment in burning mouth syndrome RCTs: an international Delphi survey protocol.

Authors

Carey B, Farag AM, Nasri-Heir C, Klasser GD, Ariyawardana A, Chmieliauskaite M, Sardella A, Carlson CR, Miller CS, Mejia L, O'Neill FE, Albuquerque R
Trials. 2020 Aug 12; 21(1):711.
PMID: 32787910.

Abstract

A core outcome set (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. In BMS randomized controlled trials (RCTs), the outcomes identified in the existing literature regarding the efficacy of therapeutic interventions are numerous and diverse. Although the standardized 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 on a COS for use in future BMS trials is paramount to reduce heterogeneity in outcome reporting. The aim of this study was to reach a consensus for adopting the standardized Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) outcome domains, and their tools of assessment, for burning mouth syndrome (BMS) clinical trials and clinical practice.