The minimally important difference for the Xerostomia Inventory among Sjögren's disease patients

Zainab Assy; William Murray Thomson; Henk S. Brand; Seunghee Cha; Merve M. Susam; Gary A. Weisman; Arjan Vissink; Floris J. Bikker; Derk Hendrik Jan Jager

doi:10.1111/odi.14841

The minimally important difference for the Xerostomia Inventory among Sjögren's disease patients

Zainab Assy^*, William Murray Thomson, Henk S. Brand, Seunghee Cha, Merve M. Susam, Gary A. Weisman, Arjan Vissink, Floris J. Bikker, Derk Hendrik Jan Jager

^*Corresponding author for this work

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Objective: Until now, the clinically relevant improvement for the Xerostomia Inventory (XI) has not been defined. Therefore, our aim was to determine the Minimally Important Difference (MID) of the XI for improvement in dry-mouth symptoms in SjD patients. Method: The study recruited 34 SjD patients who underwent sialendoscopy of major salivary glands and 15 SjD patients in a nonintervention control group. XI scores were assessed at several time points. The MID was determined from the mean difference in XI scores between the groups with and without improvement. Results: In the control group, no significant XI score changes were seen. In the sialendoscopy group, a clinically relevant XI score change of four scale points was identified after 1 week. For a prolonged duration (≥16 weeks), a minimum reduction of seven scale points in the XI score was required to indicate clinically relevant improvement. Conclusion: In SjD patients, a minimum change of four points in the XI score indicates a clinically relevant improvement for evaluating short-term effects. For prolonged effects, a clinically relevant improvement requires a MID of seven points. The determination of the MID in XI could assist in future studies that evaluate changes in xerostomia.

Original language	English
Pages (from-to)	4356-4363
Number of pages	8
Journal	Oral Diseases
Volume	30
Issue number	7
Early online date	26 Dec 2023
DOIs	https://doi.org/10.1111/odi.14841
Publication status	Published - Oct 2024

Bibliographical note

Publisher Copyright:
© 2023 The Authors. Oral Diseases published by Wiley Periodicals LLC.

Funding

We thank Dr. Floor Maarse (FM) and Dr. Hakki Karagozoglu (KHK) for performing all assessments and the sialendoscopy. All our gratitude to the Nationale Vereniging Sj\u00F6grenpati\u00EBnten (Dutch Association for Sj\u00F6gren's Patients) for their help and support in designing the study and bringing this research into attention of SjD patients. D.H.J. Jager, S. Cha, and G.A. Weisman received a grant from National Institute Of Allergy And Infectious Diseases of the National Institutes of Health under Award Number R34AI155318. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. All other authors were entirely funded by their own institutions.

Funders	Funder number
Nationale Vereniging Sjögrenpatiënten
Dutch Association for Sjögren
National Institute of Allergy and Infectious Diseases
National Institutes of Health	R34AI155318

Keywords

clinical trials
endpoint determination
patient reported outcome measures
Sjögren's syndrome
xerostomia
Xerostomia Inventory

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10.1111/odi.14841

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title = "The minimally important difference for the Xerostomia Inventory among Sj{\"o}gren's disease patients",

abstract = "Objective: Until now, the clinically relevant improvement for the Xerostomia Inventory (XI) has not been defined. Therefore, our aim was to determine the Minimally Important Difference (MID) of the XI for improvement in dry-mouth symptoms in SjD patients. Method: The study recruited 34 SjD patients who underwent sialendoscopy of major salivary glands and 15 SjD patients in a nonintervention control group. XI scores were assessed at several time points. The MID was determined from the mean difference in XI scores between the groups with and without improvement. Results: In the control group, no significant XI score changes were seen. In the sialendoscopy group, a clinically relevant XI score change of four scale points was identified after 1 week. For a prolonged duration (≥16 weeks), a minimum reduction of seven scale points in the XI score was required to indicate clinically relevant improvement. Conclusion: In SjD patients, a minimum change of four points in the XI score indicates a clinically relevant improvement for evaluating short-term effects. For prolonged effects, a clinically relevant improvement requires a MID of seven points. The determination of the MID in XI could assist in future studies that evaluate changes in xerostomia.",

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author = "Zainab Assy and Thomson, \{William Murray\} and Brand, \{Henk S.\} and Seunghee Cha and Susam, \{Merve M.\} and Weisman, \{Gary A.\} and Arjan Vissink and Bikker, \{Floris J.\} and Jager, \{Derk Hendrik Jan\}",

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doi = "10.1111/odi.14841",

language = "English",

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AU - Susam, Merve M.

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N2 - Objective: Until now, the clinically relevant improvement for the Xerostomia Inventory (XI) has not been defined. Therefore, our aim was to determine the Minimally Important Difference (MID) of the XI for improvement in dry-mouth symptoms in SjD patients. Method: The study recruited 34 SjD patients who underwent sialendoscopy of major salivary glands and 15 SjD patients in a nonintervention control group. XI scores were assessed at several time points. The MID was determined from the mean difference in XI scores between the groups with and without improvement. Results: In the control group, no significant XI score changes were seen. In the sialendoscopy group, a clinically relevant XI score change of four scale points was identified after 1 week. For a prolonged duration (≥16 weeks), a minimum reduction of seven scale points in the XI score was required to indicate clinically relevant improvement. Conclusion: In SjD patients, a minimum change of four points in the XI score indicates a clinically relevant improvement for evaluating short-term effects. For prolonged effects, a clinically relevant improvement requires a MID of seven points. The determination of the MID in XI could assist in future studies that evaluate changes in xerostomia.

AB - Objective: Until now, the clinically relevant improvement for the Xerostomia Inventory (XI) has not been defined. Therefore, our aim was to determine the Minimally Important Difference (MID) of the XI for improvement in dry-mouth symptoms in SjD patients. Method: The study recruited 34 SjD patients who underwent sialendoscopy of major salivary glands and 15 SjD patients in a nonintervention control group. XI scores were assessed at several time points. The MID was determined from the mean difference in XI scores between the groups with and without improvement. Results: In the control group, no significant XI score changes were seen. In the sialendoscopy group, a clinically relevant XI score change of four scale points was identified after 1 week. For a prolonged duration (≥16 weeks), a minimum reduction of seven scale points in the XI score was required to indicate clinically relevant improvement. Conclusion: In SjD patients, a minimum change of four points in the XI score indicates a clinically relevant improvement for evaluating short-term effects. For prolonged effects, a clinically relevant improvement requires a MID of seven points. The determination of the MID in XI could assist in future studies that evaluate changes in xerostomia.

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The minimally important difference for the Xerostomia Inventory among Sjögren's disease patients

Abstract

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Keywords

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