Statement of clinical relevance
- •There is great heterogeneity in terms of the outcomes assessed in trials reporting dry mouth, highlighting the need for the development of a core outcome set. This would help in generating more comparable results across studies, improving clinical recommendations.
To develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions.
Through two systematic reviews of the literature 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, May 2022 (n = 104) and ten dry mouth patients at Cork University Dental School and Hospital, Republic of Ireland. Outcome domains for which no consensus was reached were subsequently discussed in a second consensus process led by a virtual Special Interest Group (SIG) of 11 oral medicine experts from the World Workshop on Oral Medicine VIII dry mouth working group.
After the two-step consensus process, consensus was reached for 12 dry mouth outcome domains (salivary gland flow, signs of hyposalivation, mucosal moisture/wetness, severity of xerostomia, duration of xerostomia, overall impact of xerostomia, impact on physical functioning, impact of hyposalivation on general health, impact on social activities, quality of life, economic impact of dry mouth, patient satisfaction) to be included in the final COS.
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.
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Accepted: December 28, 2022
Received in revised form: December 26, 2022
Received: November 2, 2022
Publication stageIn Press Journal Pre-Proof
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