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The patient acceptable symptom state in oral lichen planus: identification of cut-off threshold scores in measures of pain and quality of life

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Abstract

Objectives

To establish thresholds of pain and quality of life scores corresponding to patient acceptable symptom state (PASS) in patients with oral lichen planus (OLP) and to assess demographic and clinical factors associated with achieving the PASS.

Methods

Prospective data from baseline and 4-month follow-up including Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), 14-item Oral Health Impact Profile (OHIP-14) and 15-item and 26-item Chronic Oral Mucosal Disease Questionnaire (COMDQ-15; COMDQ-26) were collected from 281 patients with OLP. An anchoring approach based upon the patient’s opinion on acceptability of OLP status was applied. Associated factors for achieving the PASS were analysed using multivariate logistic regression.

Results

About two-thirds (68.7%) of participants rated their OLP status as acceptable. Cut-off thresholds for PASS were as follows: ≤ 28 mm for VAS, ≤ 3 for NRS, ≤ 18 for total OHIP-14, ≤ 26 for total COMDQ-15 and ≤ 48 for total COMDQ-26. Based upon results of multivariate logistic analysis, factors associated with being in PASS were lower pain intensity, lower depressive symptoms and lower disease activity of OLP.

Conclusion

The present study established PASS cut-off thresholds as a tool facilitating interpretation of pain and quality of life outcomes relevant to individuals with OLP.

Clinical relevance

Identified PASS estimates could be utilised as clinically important endpoints in clinical practice of OLP as well as eligibility criteria for recruiting participants in clinical trials assessing effectiveness of symptomatic intervention of OLP.

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Acknowledgements

Paswach Wiriyakijja would like to thank Dr Emma Hayes, Dr Priya Thakrar, Dr Krupali Patel, Dr Barbara Carey, Dr Carolina Venda Nova, Dr Craig Whitelaw, Dr Sanjeet Singhota, Dr Thomas Saunsbury and Dr Valeria Mercadante for their substantial help and supports towards the recruitment process of the study.

Funding

Paswach Wiriyakijja received a PhD Scholarship from the Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand. Stefano Fedele received funding from the National Institute for Health Research University College London Hospitals Biomedical Research Centre. The MEAN-IT study received service support funding from the National Institute for Health Research University College London Hospitals Biomedical Research Centre and the NIHR Clinical Research Network Portfolio.

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Authors and Affiliations

Authors

Contributions

Paswach Wiriyakijja contributed to conceptualisation, methodology, data acquisition, formal analysis and investigation and drafted the original manuscript. Stephen Porter and Stefano Fedele provided supervision and resource and drafted the original manuscript. Tim Hodgson and Roddy McMillan provided resource and drafted the original manuscript. Martina Shephard provided resource. Richeal Ni Riordain contributed to conceptualisation and methodology, provided supervision and drafted the original manuscript.

Corresponding author

Correspondence to Paswach Wiriyakijja.

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The authors declare that they have no conflicts of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards (REC reference number: 17/LO/1825).

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Informed consent was obtained from all individual participants included in the study.

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Wiriyakijja, P., Porter, S., Fedele, S. et al. The patient acceptable symptom state in oral lichen planus: identification of cut-off threshold scores in measures of pain and quality of life. Clin Oral Invest 25, 3699–3709 (2021). https://doi.org/10.1007/s00784-020-03695-6

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  • DOI: https://doi.org/10.1007/s00784-020-03695-6

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