World Workshop in Oral Medicine VII: reporting of IMMPACT-recommended outcome domains in randomized controlled trials of burning mouth syndrome: a systematic review

Farag, Arwa M., Albuquerque, Rui, Ariyawardana, Anura, Chmieliauskaite, Milda, Forssell, Heli, Nasri-Heir, Cibele, Klasser, Gary D., Sardella, Andrea, Mignogna, Michele D., Ingram, Mark, Carlson, Charles R., and Miller, Craig S. (2019) World Workshop in Oral Medicine VII: reporting of IMMPACT-recommended outcome domains in randomized controlled trials of burning mouth syndrome: a systematic review. Oral Diseases, 25 (S1). pp. 122-140.

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Abstract

Objectives: To determine the frequency of use of the core outcome domains published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) in burning mouth syndrome (BMS) randomized controlled trials (RCTs).

Methods: This systematic review, conducted as part of the World Workshop on Oral Medicine VII (WWOM VII), was performed by searching the literature for studies published in PubMed, Web of Science, PsycINFO, Cochrane Database/Cochrane Central, and Google Scholar from January 1994 (when the first BMS definition came out) through October 2017.

Results: A total of 36 RCTs (n = 2,175 study participants) were included and analyzed. The overall reporting of the IMMPACT core and supplemental outcome domains was low even after the publication of the IMMPACT consensus papers in 2003 and 2005 (mean before IMMPACT consensus publication = 2.6 out of 6; mean after IMMPACT publication = 3.8 out of 6). Use of validated assessment tools recommended by the IMMPACT consensus was scarce (1.9 out of 6). None of the RCTs reviewed cited the IMMPACT consensus papers.

Conclusions: The underreporting of IMMPACT outcome domains in BMS RCTs is significant. Raising awareness regarding the existence of standardized outcome domains in chronic pain research is essential to ensure more accurate, comparable, and consistent interpretation of RCT findings that can be clinically translatable.

Item ID: 61816
Item Type: Article (Research - C1)
ISSN: 1601-0825
Keywords: burning mouth syndrome, clinical trials, IMMPACT, outcome domains
Copyright Information: © 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. All rights reserved
Funders: American Academy of Oral Medicine, European Association of Oral Medicine, British Society for Oral Medicine, The National Institute of Dental and Craniofacial Research, Colgate-Palmolive, Henry Schein Foundation, Unilever, World Dental Education Foundation
Date Deposited: 02 Jun 2020 02:34
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1105 Dentistry > 110505 Oral Medicine and Pathology @ 100%
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