Arwa M Farag1,2, Rui Albuquerque3, Anura Ariyawardana4,5, Milda Chmieliauskaite6, Heli Forssell7, Cibele Nasri-Heir8, Gary D Klasser9, Andrea Sardella10, Michele D Mignogna11, Mark Ingram12, Charles R Carlson13, Craig S Miller14. 1. Department of Oral Diagnostic Sciences, Faculty of Dentistry, King AbdulAziz University, Jeddah, Saudi Arabia. 2. Division of Oral Medicine, Department of Diagnostic Sciences, Tufts School of Dental Medicine, Boston, Massachusetts. 3. Oral Medicine Department, Guy's and St. Thomas Hospital NHS Foundation Trust, King's College London, London, UK. 4. College of Medicine and Dentistry, James Cook University, Brisbane, Queensland, Australia. 5. Clinical Principal Dentist, Metro South Oral Health, Brisbane, Queensland, Australia. 6. Department of Oral and Maxillofacial Medicine and Diagnostic Sciences, School of Dental Medicine, Case Western Reserve University, Cleveland, Ohio. 7. Department of Oral and Maxillofacial Surgery, Institute of Dentistry, University of Turku, Turku, Finland. 8. Department of Diagnostic Sciences, Center for Temporomandibular Disorders and Orofacial Pain, Rutgers School of Dental Medicine, The State University of New Jersey, Newark, New Jersey. 9. Department of Diagnostic Sciences, School of Dentistry, Louisiana State University Health Sciences Center, New Orleans, Los Angeles. 10. Department of Biomedical, Surgical and Dental Sciences, Unit of Oral Medicine, Oral Pathology and Gerodontology, University of Milan, Milano, Italy. 11. Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, Federico II University of Naples, Naples, Italy. 12. Medical Center Library, College of Communication and Information, University of Kentucky, Lexington, Kentucky. 13. Orofacial Pain Clinic, College of Dentistry, University of Kentucky, Lexington, Kentucky. 14. Department of Oral Health Practice, College of Dentistry, University of Kentucky, Lexington, Kentucky.
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.
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.