TY - JOUR
T1 - World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: a consensus study
AU - SE, Niklander
AU - ML, Simms
AU - Wiriyakijja, P
AU - AR, Santos-Silva
AU - Kuten-Shorrer, M
AU - Sankar, V
AU - AR, Kerr
AU - SB, Jensen
AU - RN, Riordain
AU - Villa, A
AU - Delli, K
PY - 2023/3/1
Y1 - 2023/3/1
N2 - ObjectiveThis study aimed to develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions.Study designThrough 2 systematic literature reviews and interviews with dry mouth patients, we identified relevant outcome domains for dry mouth assessment. A Delphi survey was presented to health care providers attending the American Academy of Oral Medicine annual meeting in Memphis, Tennessee, USA, on May 2022 (n = 104) and 10 dry mouth patients at Cork University Dental School and Hospital, Republic of Ireland. The outcome domains for which no consensus was reached were subsequently discussed in a second consensus process led by a virtual Special Interest Group of 11 oral medicine experts from the World Workshop on Oral Medicine VIII dry mouth working group.ResultsAfter the 2-step consensus process, a consensus was reached for 12 dry mouth outcome domains (i.e., salivary gland flow, signs of hyposalivation, mucosal moisture/wetness, the severity of xerostomia, duration of xerostomia, the overall impact of xerostomia, impact on physical functioning, impact of hyposalivation on general health, impact on social activities, quality of life, the economic impact of dry mouth, patient satisfaction) to be included in the final COS.ConclusionsWe propose a consensus-based COS to assess dry mouth interventions in clinical trials. This COS includes the minimum but mandatory set of domains that all clinical trials evaluating dry mouth treatments should assess.
AB - ObjectiveThis study aimed to develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions.Study designThrough 2 systematic literature reviews and interviews with dry mouth patients, we identified relevant outcome domains for dry mouth assessment. A Delphi survey was presented to health care providers attending the American Academy of Oral Medicine annual meeting in Memphis, Tennessee, USA, on May 2022 (n = 104) and 10 dry mouth patients at Cork University Dental School and Hospital, Republic of Ireland. The outcome domains for which no consensus was reached were subsequently discussed in a second consensus process led by a virtual Special Interest Group of 11 oral medicine experts from the World Workshop on Oral Medicine VIII dry mouth working group.ResultsAfter the 2-step consensus process, a consensus was reached for 12 dry mouth outcome domains (i.e., salivary gland flow, signs of hyposalivation, mucosal moisture/wetness, the severity of xerostomia, duration of xerostomia, the overall impact of xerostomia, impact on physical functioning, impact of hyposalivation on general health, impact on social activities, quality of life, the economic impact of dry mouth, patient satisfaction) to be included in the final COS.ConclusionsWe propose a consensus-based COS to assess dry mouth interventions in clinical trials. This COS includes the minimum but mandatory set of domains that all clinical trials evaluating dry mouth treatments should assess.
UR - https://doi.org/10.1016/j.oooo.2022.12.016
U2 - 10.1016/j.oooo.2022.12.016
DO - 10.1016/j.oooo.2022.12.016
M3 - Article
C2 - 37045698
SN - 2212-4403
JO - Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
JF - Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
ER -