World workshop on oral medicine VIII: development of a core outcome set for dry mouth: a consensus study

Niklander, Sven Eric, Simms, Melanie Louise, Wiriyakijja, Paswach, Santos-Silva, Alan Roger, Kuten-Shorrer, Michal, Sankar, Vidya, Kerr, Alexander Ross, Jensen, Siri Beier, Ni Riordain, Richeal, Villa, Alessandro and Delli, Konstantino 2023. World workshop on oral medicine VIII: development of a core outcome set for dry mouth: a consensus study. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology 135 (6) , pp. 885-892. 10.1016/j.oooo.2022.12.016

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Abstract

Objective To develop a consensus-based core outcome set (COS) to be used in clinical trials assessing dry mouth interventions. Study design 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. Results 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. Conclusion 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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Dentistry
Publisher:	Elsevier
ISSN:	2212-4403
Date of First Compliant Deposit:	14 March 2023
Date of Acceptance:	28 December 2022
Last Modified:	29 Feb 2024 16:55
URI:	https://orca.cardiff.ac.uk/id/eprint/157724

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