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.
Similar content being viewed by others
References
Alrashdan MS, Cirillo N, McCullough M (2016) Oral lichen planus: a literature review and update. Arch Dermatol Res 308(8):539–551. https://doi.org/10.1007/s00403-016-1667-2
Ni Riordain R, Meaney S, McCreary C (2011) Impact of chronic oral mucosal disease on daily life: preliminary observations from a qualitative study. Oral Dis 17(3):265–269. https://doi.org/10.1111/j.1601-0825.2010.01734.x
Lodi G, Manfredi M, Mercadante V, Murphy R, Carrozzo M (2020) Interventions for treating oral lichen planus: corticosteroid therapies. Cochrane Database Syst Rev 2:Cd001168. https://doi.org/10.1002/14651858.CD001168.pub3
Coon CD, Cappelleri JC (2016) Interpreting change in scores on patient-reported outcome instruments. Ther Innov Regul Sci 50(1):22–29. https://doi.org/10.1177/2168479015622667
Pham T, Tubach F (2009) Patient acceptable symptomatic state (PASS). Joint Bone Spine 76(4):321–323. https://doi.org/10.1016/j.jbspin.2009.03.008
Wiriyakijja P, Porter S, Fedele S, Hodgson T, McMillan R, Shephard M, Ni Riordain R (2020) Meaningful improvement thresholds in measures of pain and quality of life in oral lichen planus. Oral Dis. 26:1464–1473. https://doi.org/10.1111/odi.13379
Tubach F, Ravaud P, Beaton D, Boers M, Bombardier C, Felson DT, van der Heijde D, Wells G, Dougados M (2007) Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders. J Rheumatol 34(5):1188–1193
Christie A, Dagfinrud H, Garratt AM, Ringen Osnes H, Hagen KB (2011) Identification of shoulder-specific patient acceptable symptom state in patients with rheumatic diseases undergoing shoulder surgery. J Hand Ther 24(1):53–60; quiz 61. https://doi.org/10.1016/j.jht.2010.10.006
Seror R, Bootsma H, Saraux A, Bowman SJ, Theander E, Brun JG, Baron G, Le Guern V, Devauchelle-Pensec V, Ramos-Casals M, Valim V, Dorner T, Tzioufas A, Gottenberg JE, Solans Laque R, Mandl T, Hachulla E, Sivils KL, Ng WF, Fauchais AL, Bombardieri S, Priori R, Bartoloni E, Goeb V, Praprotnik S, Sumida T, Nishiyama S, Caporali R, Kruize AA, Vollenweider C, Ravaud P, Meiners P, Brito-Zeron P, Vitali C, Mariette X (2016) Defining disease activity states and clinically meaningful improvement in primary Sjogren’s syndrome with EULAR primary Sjogren’s syndrome disease activity (ESSDAI) and patient-reported indexes (ESSPRI). Ann Rheum Dis 75(2):382–389. https://doi.org/10.1136/annrheumdis-2014-206008
Emerson Kavchak AJ, Cook C, Hegedus EJ, Wright AA (2013) Identification of cut-points in commonly used hip osteoarthritis-related outcome measures that define the patient acceptable symptom state (PASS). Rheumatol Int 33(11):2773–2782. https://doi.org/10.1007/s00296-013-2813-1
Tubach F, Dougados M, Falissard B, Baron G, Logeart I, Ravaud P (2006) Feeling good rather than feeling better matters more to patients. Arthritis Rheum 55(4):526–530. https://doi.org/10.1002/art.22110
Wiriyakijja P, Porter S, Fedele S, Hodgson T, McMillan R, Shephard M, Ni Riordain R (2020) Development and validation of a short version of Chronic Oral Mucosal Disease Questionnaire (COMDQ-15). J Oral Pathol Med 49(1):55–62. https://doi.org/10.1111/jop.12964
Escudier M, Ahmed N, Shirlaw P, Setterfield J, Tappuni A, Black MM, Challacombe SJ (2007) A scoring system for mucosal disease severity with special reference to oral lichen planus. Br J Dermatol 157(4):765–770. https://doi.org/10.1111/j.1365-2133.2007.08106.x
Department of Health (2016) Alcohol guidelines review—report from the guidelines development group to the UK chief medical officers.
Chainani-Wu N, Silverman S Jr, Reingold A, Bostrom A, Lozada-Nur F, Weintraub J (2008) Validation of instruments to measure the symptoms and signs of oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 105(1):51–58. https://doi.org/10.1016/j.tripleo.2007.06.022
Slade GD (1997) Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol 25(4):284–290. https://doi.org/10.1111/j.1600-0528.1997.tb00941.x
Ni Riordain R, McCreary C (2011) Validity and reliability of a newly developed quality of life questionnaire for patients with chronic oral mucosal diseases. J Oral Pathol Med 40(8):604–609. https://doi.org/10.1111/j.1600-0714.2011.01021.x
Ni Riordain R, Hodgson T, Porter S, Fedele S (2016) Validity and reliability of the Chronic Oral Mucosal Diseases Questionnaire in a UK population. J Oral Pathol Med 45(8):613–616. https://doi.org/10.1111/jop.12425
Bjelland I, Dahl AA, Haug TT, Neckelmann D (2002) The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 52(2):69–77. https://doi.org/10.1016/s0022-3999(01)00296-3
Schellekens MPJ, van den Hurk DGM, Prins JB, Molema J, van der Drift MA, Speckens AEM (2016) The suitability of the Hospital Anxiety and Depression Scale, Distress Thermometer and other instruments to screen for psychiatric disorders in both lung cancer patients and their partners. Journal of affective disorders 203:176–183. https://doi.org/10.1016/j.jad.2016.05.044
Alharbi H, Alshehry A (2019) Perceived stress and coping strategies among ICU nurses in government tertiary hospitals in Saudi Arabia: a cross-sectional study. Ann Saudi Med 39(1):48–55. https://doi.org/10.5144/0256-4947.2019.48
Wiriyakijja P, Porter S, Fedele S, Hodgson T, McMillan R, Shephard M, Ni Riordain R (2020) Validation of the HADS and PSS-10 and psychological status in patients with oral lichen planus. Oral Dis 26(1):96–110. https://doi.org/10.1111/odi.13220
Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC (2007) Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 60(1):34–42. https://doi.org/10.1016/j.jclinepi.2006.03.012
King MT (2011) A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res 11(2):171–184. https://doi.org/10.1586/erp.11.9
Gonzalez-Moles MA, Ruiz-Avila I, Gonzalez-Ruiz L, Ayen A, Gil-Montoya JA, Ramos-Garcia P (2019) Malignant transformation risk of oral lichen planus: a systematic review and comprehensive meta-analysis. Oral Oncol 96:121–130. https://doi.org/10.1016/j.oraloncology.2019.07.012
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.
Author information
Authors and Affiliations
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
Ethics declarations
Conflict of interest
The authors declare that they have no conflicts of interest.
Ethical approval
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).
Informed consent
Informed consent was obtained from all individual participants included in the study.
Additional information
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary information
ESM 1
(DOCX 14 kb)
Rights and permissions
About this article
Cite this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00784-020-03695-6