World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: A Consensus Study

Sven Eric Niklander; Melanie Louise Simms; Paswach Wiriyakijja; Alan Roger Santos-Silva; Michal Kuten-Shorrer; Vidya Sankar; Alexander Ross Kerr; Siri Beier Jensen; Richeal Ni Riordain; Alessandro Villa; Konstantina Delli

doi:10.1016/j.oooo.2022.12.016

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: A Consensus Study

Sven Eric Niklander^*, Melanie Louise Simms, Paswach Wiriyakijja, Alan Roger Santos-Silva, Michal Kuten-Shorrer, Vidya Sankar, Alexander Ross Kerr, Siri Beier Jensen, Richeal Ni Riordain, Alessandro Villa, Konstantina Delli

^*Corresponding author for this work

Department of Dentistry and Oral Health - Institutledelsen, Odontologi og Oral Sundhed

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

4 Citations (Scopus)

Abstract

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.

Original language	English
Journal	Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
Volume	135
Issue	6
Pages (from-to)	885-892
Number of pages	8
ISSN	2212-4403
DOIs	https://doi.org/10.1016/j.oooo.2022.12.016
Publication status	Published - Jun 2023

Keywords

Delphi Technique
Humans
Outcome Assessment, Health Care
Patient Satisfaction
Quality of Life
Research Design
Salivary Glands
Treatment Outcome
Xerostomia/therapy

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10.1016/j.oooo.2022.12.016

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Niklander, S. E., Simms, M. L., Wiriyakijja, P., Santos-Silva, A. R., Kuten-Shorrer, M., Sankar, V., Kerr, A. R., Jensen, S. B., Riordain, R. N., Villa, A., & Delli, K. (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), 885-892. https://doi.org/10.1016/j.oooo.2022.12.016

@article{b2021b3ef2ce4733a866fd36aa935e1e,

title = "World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: A Consensus Study",

abstract = "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.",

keywords = "Delphi Technique, Humans, Outcome Assessment, Health Care, Patient Satisfaction, Quality of Life, Research Design, Salivary Glands, Treatment Outcome, Xerostomia/therapy",

author = "Niklander, {Sven Eric} and Simms, {Melanie Louise} and Paswach Wiriyakijja and Santos-Silva, {Alan Roger} and Michal Kuten-Shorrer and Vidya Sankar and Kerr, {Alexander Ross} and Jensen, {Siri Beier} and Riordain, {Richeal Ni} and Alessandro Villa and Konstantina Delli",

year = "2023",

month = jun,

doi = "10.1016/j.oooo.2022.12.016",

language = "English",

volume = "135",

pages = "885--892",

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Niklander, SE, Simms, ML, Wiriyakijja, P, Santos-Silva, AR, Kuten-Shorrer, M, Sankar, V, Kerr, AR, Jensen, SB, Riordain, RN, Villa, A & Delli, K 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, vol. 135, no. 6, pp. 885-892. https://doi.org/10.1016/j.oooo.2022.12.016

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 et al.
In: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, Vol. 135, No. 6, 06.2023, p. 885-892.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

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

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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 -

World Workshop on Oral Medicine VIII: Development of a core outcome set for dry mouth: A Consensus Study

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