TY - JOUR
T1 - World Workshop on Oral Medicine VIII
T2 - Development of a core outcome set for dry mouth: A Consensus Study
AU - Niklander, Sven Eric
AU - Simms, Melanie Louise
AU - Wiriyakijja, Paswach
AU - Santos-Silva, Alan Roger
AU - Kuten-Shorrer, Michal
AU - Sankar, Vidya
AU - Kerr, Alexander Ross
AU - Jensen, Siri Beier
AU - Riordain, Richeal Ni
AU - Villa, Alessandro
AU - Delli, Konstantina
PY - 2023/6
Y1 - 2023/6
N2 - Objective: This study aimed to develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions. Study Design: Through 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. Results: After 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. Conclusions: We 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 - Objective: This study aimed to develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions. Study Design: Through 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. Results: After 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. Conclusions: We 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.
KW - Delphi Technique
KW - Humans
KW - Outcome Assessment, Health Care
KW - Patient Satisfaction
KW - Quality of Life
KW - Research Design
KW - Salivary Glands
KW - Treatment Outcome
KW - Xerostomia/therapy
UR - http://www.scopus.com/inward/record.url?scp=85152711659&partnerID=8YFLogxK
U2 - 10.1016/j.oooo.2022.12.016
DO - 10.1016/j.oooo.2022.12.016
M3 - Journal article
C2 - 37045698
AN - SCOPUS:85152711659
SN - 2212-4403
VL - 135
SP - 885
EP - 892
JO - Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
JF - Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
IS - 6
ER -