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Journal ArticleDOI

Patient‐reported outcome measures in oral lichen planus: A comprehensive review of the literature with focus on psychometric properties and interpretability

TL;DR: The range of PROMs used in clinical studies of patients with OLP is wide and include instruments for oral symptoms, psychosocial status and quality of life, but the vast majority have no evidence of psychometric properties and interpretability for patientswith OLP.
Abstract: Objective To review the range of patient-reported outcome measures (PROMs) used in clinical studies of patients with oral lichen planus (OLP) and to assess their psychometric properties and interpretability. Methods Literature searches were performed on MEDLINE, EMBASE and Web of Science databases (1990-September 2016) to retrieve relevant studies related to the development, psychometric testing and/or use of PROMs assessing oral symptoms, psychosocial status and quality of life in individuals with OLP. The identified PROMs were then categorised by concept measured and assessed for instrument characteristics and evidence for psychometric properties and interpretability. Results We identified a total of 41 PROMs used in clinical studies for the assessment of patient-reported outcomes in patients with OLP. There were three PROMs of oral symptoms, 30 PROMs of psychosocial status and eight PROMs of quality of life. Six instruments (Visual Analog Scale, Numerical Rating Scale, Change in Symptom Scale, Oral Health Impact Profile-14, Oral Health-related Quality of Life-UK and Chronic Oral Mucosal Disease Questionnaire) demonstrated some evidence of psychometric properties but no evidence for interpretability of their results in the OLP population. Conclusion The range of PROMs used in clinical studies of patients with OLP is wide and include instruments for oral symptoms, psychosocial status and quality of life. The vast majority of these instruments have no evidence of psychometric properties and interpretability for patients with OLP. Further qualitative and validation studies are required to investigate whether these instruments are appropriate for use in this patient population.

Summary (2 min read)

Introduction

  • Over the past few decades, there has been a substantial increase in the development, validation and application of patient reported outcome measures for research and/or clinical practice (1).
  • PROMs are required to have adequate psychometric properties as well as good evidence for interpretability for the specific patient population.
  • Therefore medical treatment, often in the form of long-term use of topical corticosteroids or immunosuppressants, is required to reduce patient's painful symptoms (10).
  • Some of these CSS demonstrated good measurement properties for use in clinical studies of patients with OLP including Escudier severity scale (ESS) (12) and Reticulation-Erythema-Ulceration (REU) scoring system (13, 14).
  • Two reviews have previously investigated the use of PROMs in patients with oral mucosal diseases (15, 16), but there remains no comprehensive assessment of the instruments used specifically in studies of OLP patients.

Selection criteria

  • Articles were included in this review if they fulfilled the following criteria: publication in the English language and in a peer-reviewed journal; full text available; and reporting on the development, psychometric testing and/or application of at least one PROM for the assessment of oral symptoms, psychosocial status and quality of life in patients with OLP.
  • The use of PROMs as a screening tool rather than for study outcome measurement; the use of ad hoc instrument or instrument developed without psychometric testing for specific use in one study; literature reviews, editorials and letters, also known as Exclusion criteria included.

Data extraction

  • A specific data extraction form was employed to systematically extract the data of interest from each article including study title, authors and year of publication, country, study design and type of intervention, number of participants, participant characteristics (female-to-male ratio, age, clinical type of OLP) and type of PROMs used.
  • Their number of items, subscales or domains, rating scales and score types and range were reviewed.
  • The assessment of psychometric testing and interpretability of identified PROMs included 1.
  • The degree to which a PROM measures the construct(s) it purports to measure, also known as Validity.
  • The degree to which the measurement is free from measurement error, also known as 2. Reliability.

Search results

  • The initial literature search yielded a total of 2,942 citations.
  • After removing duplicates and spurious references, and following a review of the titles and abstracts, 120 articles were considered to meet the inclusion criteria .
  • All of them were generic instruments (Table 3).
  • PROMs assessing the quality of life of OLP patients A total of 8 PROMs focusing upon quality of life in patients with OLP were identified from 27 studies.

Discussion

  • Oral lichen planus can give rise to longstanding painful symptoms to the oral mucosa, often leading to psychological distress and a reduction in the quality of life (19-21).
  • A wide range of PROMs has been used in clinical studies of OLP patients; however, there remains no comprehensive review of these instruments and, more importantly, there is no thorough critical assessment of their psychometric properties and interpretability.
  • In the present study three PROMs (VAS, NRS and CSS) were identified that have been used to assess oral symptoms of OLP, with VAS being the most common.
  • Instruments focusing upon other psychosocial constructs were few (30, 31) and, again there was no evidence of their psychometric testing or interpretability in the OLP population.
  • Interpretability gives meaning to the scores from these instruments in a clinical context, which facilitates better understanding of PROM results (3, 26).

Conclusions

  • A wide range of PROMs have been used in clinical studies of OLP patients.
  • As there is little convincing evidence regarding their psychometric properties and interpretability in patients with OLP.
  • Concerns exist about their appropriateness as well as the clinical meaningfulness of their results.
  • Furthermore, their review showed a high heterogeneity among published studies in the use of PROMs in OLP population.

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Patient reported outcome measures in oral lichen planus: A comprehensive
review of the literature with focus on psychometric properties and
interpretability
Wiriyakijja P,
1,2
Fedele S,
1,3
Porter S,
1
Mercadante V,
1
Ni Riordain R.
1
Running title:
PROMs used in oral lichen planus
Key words:
Oral Lichen planus, Patient Reported Outcome Measures, Psychometric properties,
Interpretability
Authors
1
UCL Eastman Dental Institute London, UK
2
Department of Oral Medicine, Faculty of Dentistry, Chulalongkorn University,
Bangkok, Thailand
3
NIHR University College London Hospitals Biomedical Research Centre, London,
United Kingdom
Corresponding author:
Paswach Wiriyakijja, DDS, MSc
Oral Medicine, UCL Eastman Dental Institute
256 Grays’ Inn Road
London, WC1X 8LD

paswach.w@gmail.com

Abstract
Objective: To review the range of patient reported outcome measures (PROMs)
used in clinical studies of patients with oral lichen planus (OLP) and to assess their
psychometric properties and interpretability.
Methods: Literature searches were performed on MEDLINE, Embase and Web of
Science databases (1990 - September 2016) to retrieve relevant studies related to
the development, psychometric testing and/or use of PROMs assessing oral
symptoms, psychosocial status, and quality of life in individuals with OLP. The
identified PROMs were then categorized by concept measured and assessed for
instrument characteristics and evidence for psychometric properties and
interpretability.
Results: We identified a total of 41 PROMs used in clinical studies for the
assessment of patient reported outcomes in patients with OLP. There were 3
PROMs of oral symptoms, 30 PROMs of psychosocial status and 8 PROMs of
quality of life. Six instruments (Visual Analog Scale, Numerical Rating Scale, Change
in Symptom Scale, Oral Health Impact Profile-14, Oral Health related Quality of Life-
UK and Chronic Oral Mucosal Disease Questionnaire) demonstrated some
evidence of psychometric properties but no evidence for interpretability of their
results in the OLP population.
Conclusion: The range of PROMs used in clinical studies of patients with OLP is
wide and include instruments for oral symptoms, psychosocial status and quality of
life. The vast majority of these instruments have no evidence of psychometric
properties and interpretability for patients with OLP. Further qualitative and validation

studies are required to investigate whether these instruments are appropriate for use
in this patient population.

Introduction
Over the past few decades, there has been a substantial increase in the
development, validation and application of patient reported outcome measures
(PROMs) for research and/or clinical practice (1). A PROM is a standardized
instrument (usually a questionnaire) for patients to directly evaluate one or more
aspects of their own health (2). The aim is to quantify, evaluate and monitor the
subjective perception of the impact of the disease from patient’s perspective in a
standardized way, and to incorporate the patient’s voice regarding the perception of
their health condition and related treatment into clinical practice and research (2).
PROMs are required to have adequate psychometric properties as well as good
evidence for interpretability for the specific patient population. From the perspective
of clinical research, a vital step in the design of clinical trial is to select a PROM with
appropriate psychometric properties to ensure that the instrument is suitable for its
proposed application, valid (measure what it is intended to measure), reliable
(produce consistent results on repeated measurement under identical conditions)
and responsive (able to detect change over time) in a specific group of patients (3).
Further to the psychometric properties, it is necessary that scores or outcomes
generated by the PROMs are interpretable or clinically meaningful (3).
Little is known regarding the use of PROMs in patients with oral lichen planus (OLP),
a common chronic inflammatory disease (4, 5) that can cause long-standing painful
ulceration of the oral mucosa (6, 7) and is also known to increase the risk of oral
cancer development (8). The persistent painful symptoms of OLP can have
significant negative impact on daily activities (e.g. eating, swallowing, speaking) but

Citations
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Journal ArticleDOI
TL;DR: Greater severity of OLP and OLL seems to be associated with increased levels of anxiety, higher scores of oral health impact profile, and decreased QoL.
Abstract: Oral lichen planus (OLP) and oral lichenoid lesions (OLL) are chronic inflammatory diseases whose symptoms can impair patient’s quality of life (QoL). Psychological factors seem to play an important role in these diseases. This study aimed to determine the impact of oral health and anxiety levels on the QoL of patients with OLP and OLL. This was a cross-sectional study composed of OLP and OLL patients and a control group matched by age and sex with no autoimmune/inflammatory or malignant oral lesions. Anxiety levels and oral health impact on QoL were assessed using the Hamilton Anxiety Scale (HAM-A) and the Oral Health Impact Profile-14 (OHIP-14), respectively. The instruments were filled through personal interview before starting the treatment for oral lesions. A total of 87 patients diagnosed with OLP (n = 45) and OLL (n = 42), and 87 controls were included in the study. Statistical differences were observed for the psychic and somatic anxiety dimensions between severities of diseases. Patients with OLP or OLL had higher scores for the OHIP-14 dimensions physiological discomfort and social limitation compared with controls. In addition, higher scores for physical pain, physical disability, social disability, and handicap were detected among patients with greater severity. Greater severity of OLP and OLL seems to be associated with increased levels of anxiety, higher scores of oral health impact profile, and decreased QoL. Patients with severe OLP/OLL may benefit from additional therapeutic treatments, such as psychological and/or psychiatric management, concomitant to treatment specific to oral lesions.

29 citations

Journal ArticleDOI
TL;DR: The HADS and PSS-10 are appropriate to use as general measures of psychological distress and perceived stress in patients with OLP and demonstrated that a bifactor model described the underlying structure of both scales better than other models.
Abstract: OBJECTIVES: To validate the Hospital Anxiety and Depression Scale (HADS) and the 10-item Perceived Stress Scale (PSS-10) for use in patients with oral lichen planus (OLP) and to provide cross-sectional analysis of anxiety, depressive and distress symptoms in patients with OLP. // METHODS: Validity and reliability of both instruments were assessed in 260 participants with OLP in one tertiary Oral Medicine Centre through confirmatory factor analysis and calculation of reliability coefficients. Prevalence, Clinical and demographic predictors of the presence of psychological symptoms in OLP were calculated and identified using multivariated logistic regression. // RESULTS: Factor analysis results demonstrated that a bifactor model described the underlying structure of both scales better than other models. Values of omega indicated adequate reliability of total HADS and PSS-10 score while low coefficient omega hierarchical values limit clinical applicability of their subscale scores. The prevalence of anxiety, depressive and distress symptoms in OLP were 39.23%, 20.77% and 27.69% respectively. Pain intensity, disease comorbidities, age, smoking and alcohol consumption were found to be independent predictors of the presence of psychological symptoms in OLP. // CONCLUSION: The HADS and PSS-10 are appropriate to use as general measures of psychological distress and perceived stress in patients with OLP.

23 citations

Journal ArticleDOI
TL;DR: Overall, the most common clinical OLP form did not impact significantly the OHRQoL of OLP patients, and psychological therapy and meeting the educational needs might improve the O HRQiL of patients with common clinical forms of O LP.
Abstract: The aim of the study was to determine the prevalence of clinical forms in a group of oral lichen planus (OLP) patients and to investigate whether the oral health–related quality of life (OHRQoL) of patients with common clinical OLP forms differs significantly from that of other clinical forms of OLP and healthy patients, respectively. OHRQoL was assessed using the Romanian version of the short form of the Oral Health Impact Profile (OHIP-14). OLP patients rated the pain they were currently experiencing on a visual analog scale (VAS). Statistics was performed using parametric and non-parametric tests and multiple linear regression. Eighty OLP patients and 80 healthy controls were enrolled. The most prevalent OLP clinical form was keratotic form (n = 39, 48.75%, group 1), followed by atrophic (31.25%), erosive-ulcerative (17.5%), and bullous (2.5%) forms, which were included in group 2 (n = 41). The OHRQoL did not differ significantly between group 1 and the other two groups. A negative social impact was reported on psychological discomfort domain for both OLP groups, as compared with healthy controls. VAS scores were significantly associated with OHIP total scores in group 1 (rho = 0.41, n = 39, p = 0.009, Spearman’s correlation coefficient). Within the same group, significantly higher OHIP total scores were recorded in patients lacking academic education (p = 0.0086, Mann-Whitney U test). Overall, the most common clinical OLP form did not impact significantly the OHRQoL of OLP patients. Psychological therapy and meeting the educational needs might improve the OHRQoL of patients with common clinical forms of OLP.

19 citations

Journal ArticleDOI
TL;DR: The short version of the Chronic Oral Mucosal Disease Questionnaire is a brief, valid and reliable instrument that can give an overview of the patient's quality of life related to their chronic oral mucosal conditions.
Abstract: Background The adoption of the Chronic Oral Mucosal Disease Questionnaire (COMDQ) into clinical practice has been low, despite its rigorous development process. A potential limitation of the COMDQ is the high response burden to patients. Therefore, the aim of the present study was to develop and validate a short version of the 26-item COMDQ. Methods The COMDQ data of 520 patients with chronic oral mucosal diseases were randomly divided into two subsamples. Descriptive item analysis and exploratory factor analysis (EFA) were performed using data from the first subsample for item reduction and development of the shortened COMDQ. The resulting short version was then validated using confirmatory factor analysis (CFA) on the other subsample. Internal consistency reliability of the short-form COMDQ was assessed using Cronbach's alpha. Criterion validity of this new scale was examined against its original version. Results Based upon item analysis, 11 items were dropped. EFA results on the remaining 15 items extracted four factors consistent with the original COMDQ, and CFA results displayed acceptable goodness-of-fit indices of this factor structure on different sample. The COMDQ-15 was then created. Cronbach's alpha of four subscale scores ranged from 0.7 to 0.91, indicating good internal consistency reliability of the COMDQ-15. Correlations between total and subscale scores of the COMDQ-15 and its parent scale were high, supporting good criterion validity of this shortened scale. Conclusion The COMDQ-15 is a brief, valid and reliable instrument that can give an overview of the patient's quality of life related to their chronic oral mucosal conditions.

14 citations

Journal ArticleDOI
TL;DR: Clinicians should expect reduced QoL in OLP patients with high pain levels, high anxiety levels,high perceived stress and use of topical corticosteroids, and the COMDQ-15 instrument performed better than OHIP-14 at capturing the association betweenQoL and pain and disease activity in patients with OLP.

14 citations

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"Patient‐reported outcome measures i..." refers background or methods in this paper

  • ...Further to the psychometric properties, it is necessary that scores or outcomes generated by the PROMs are interpretable or clinically meaningful.(3) Little is known regarding the use of PROMs in patients with oral lichen planus (OLP), a common chronic inflammatory disease(4,5) that can cause long-standing painful ulceration of the oral mucosa(6,7) and is also known to increase the risk of oral cancer development....

    [...]

  • ...We did not find any studies providing information regarding the interpretability of PROMs of oral symptoms in the OLP population, which raises concerns regarding the clinical meaning of their results.(3,25,26) Our review identified a wide range of PROMs focusing on the psychosocial status of OLP patients....

    [...]

  • ...Interpretability: the degree to which one can assign qualitative meaning to an instrument’s quantitative scores or change in scores.(3) 3 | RESULTS 3....

    [...]

  • ...perspective of clinical research, a vital step in the design of clinical trial is to select a PROM with appropriate psychometric properties to ensure that the instrument is suitable for its proposed application, valid (measure what it is intended to measure), reliable (produce consistent results on repeated measurement under identical conditions) and responsive (able to detect change over time) in a specific group of patients.(3) Further to the psychometric properties, it is necessary that scores or outcomes generated by the PROMs are interpretable or clinically meaningful....

    [...]

Frequently Asked Questions (2)
Q1. What contributions have the authors mentioned in the paper "Patient reported outcome measures in oral lichen planus: a comprehensive review of the literature with focus on psychometric properties and interpretability" ?

To review the range of patient reported outcome measures ( PROMs ) used in clinical studies of patients with oral lichen planus ( OLP ) and to assess their psychometric properties and interpretability. The authors identified a total of 41 PROMs used in clinical studies for the assessment of patient reported outcomes in patients with OLP. Further qualitative and validation studies are required to investigate whether these instruments are appropriate for use in this patient population. 

There is thus a need for further studies determining interpretability of PROMs in patients with OLP. Although a wide array of topical and systemic medications are available for patients with OLP, there is currently weak evidence supporting the superiority of any of these medications over placebo ( 12, 39 ), and future large randomized placebo-controlled trials ( RCTs ) are needed. This could enhance the quality of future clinical research, leading to more robust evidence supporting the use of OLP medications and eventually better patient care. Although the present study identified some promising PROMs in several patient-reported concepts with appropriate psychometric properties for use in clinical studies of patients with OLP, there is currently a lack of uniformity in the choice of outcome measures including both PROMs and clinical measures of signs and disease activity ( 11 ) across the OLP literature.