Prognosis of oral epithelial dysplasia in individuals with and without oral lichen planus.

OBJECTIVES: To investigate the role of oral lichen planus (OLP) on the long-term prognosis of oral epithelial dysplasia (OED). METHODS: Retrospective single-centre cohort study using the 2007-2019 database of the Head and Neck Cancer and Oral Medicine units of University College London Hospital. The exposure of interest was the presence of OLP, and the prognostic outcomes included the development of new primary episodes of OED, progression to malignancy and mortality. Cox proportional hazard and Poisson regression models were performed. RESULTS: A total of 299 patients, of whom 144 had OED arising on the background of OLP (OLP/OED) and 155 had OED without underlying OLP (non-OLP/OED), were included. A pre-existing diagnosis of OLP was significantly associated with a twofold increased risk of subsequent primary OED events (HR = 2.02, p = 0.04), which also developed faster (1.46 vs. 2.96 years, p = 0.04) and with more involvement of non-cancer-prone sites (p = 0.001) than in the non-OLP/OED group. There was no difference between groups in the progression to malignancy or mortality. CONCLUSIONS: Oral lichen planus/OED patients are at higher risk of multiple episodes of primary OED, which can develop faster and at non-cancer-prone sites as compared to non-OLP/OED individuals. Further research is needed to clarify the effects of OLP upon progression to OSCC and mortality.

The development and cognitive testing of a patient-reported experience measure for patients with chronic pain of temporomandibular disorders.

INTRODUCTION: The importance of the patients' clinical experience has been reinforced several times over the last decade by healthcare organisations and policy makers. Routine gathering of experience data can help in enhancing patient-centred care and provide guidance to quality improvement schemes. Patient-reported experience measures can help to that end. The aim of this study was to develop a patient-reported experience measure to evaluate the experience of patients with temporomandibular disorders while receiving healthcare. METHODS: Input from several sources was utilised to develop the tool; previous literature, patients with temporomandibular disorders, and experts in the field. A qualitative study was conducted following the COnsensus-based Standards for the selection of health Measurement Instruments guidance to generate the items of the questionnaire, which subsequently underwent cognitive testing. RESULTS: Seventeen patients took part in the qualitative study, in addition to six healthcare professionals. The preliminary questionnaire consisted of 28 questions with six response options. CONCLUSIONS: This patient-reported experience measure is a brief tool to evaluate the clinical experience of patients with temporomandibular disorders. Patients' involvement ensured face and content validity of the questionnaire, in addition to the relevance, comprehensibility and comprehensiveness of the items.

Long-term effectiveness of a novel intra-oral electro-stimulator for the treatment of dry mouth in patients with Sjogren's syndrome: A randomised sham-controlled feasibility study (LEONIDAS-1).

BACKGROUND: Effective treatments for dry mouth of Sjogren's syndrome are limited and hampered by adverse effects. The aim of LEONIDAS-1 was to explore the feasibility of salivary electrostimulation in individuals with primary Sjogren's syndrome, as well as parameters required to inform the design of a future phase III trial. METHODS: Multicentre, parallel-group, double-blind, randomised sham-controlled trial in two UK centres. Participants were randomised (1:1, computer-generated) to active or sham electrostimulation. The feasibility outcomes included screening/eligibility ratio, consent, and recruitment and drop-out rates. Preliminary efficacy outcome included dry mouth visual analogue scale, Xerostomia Inventory, the EULAR Sjögren's syndrome patient reported index-Q1, and unstimulated sialometry. RESULTS: Forty-two individuals were screened, of whom 30 (71.4%) met the eligibility criteria. All eligible individuals consented to recruitment. Out of the 30 randomised participants (active n = 15, sham n = 15), 4 dropped out and 26 (13 vs. 13) completed all study visits as per protocol. Recruitment rate was 2.73 participants/month. At 6-month post-randomisation the difference in mean reduction in visual analogue scale, xerostomia inventory and EULAR Sjögren's syndrome patient reported index-Q1 scores between groups were 0.36 (95% CI: -0.84, 1.56), 3.31 (0.43, 6.18), and 0.23 (-1.17, 1.63), respectively; unstimulated salivary flow increased by a mean of 0.98 mL/15 min, all in favour of the active group. No adverse events were reported. CONCLUSION: LEONIDAS-1 results support progression to a phase III definitive randomised controlled trial of salivary electrostimulation in individuals with Sjogren's syndrome. Xerostomia inventory could be considered the primary patient-centred outcome measure and the corresponding observed treatment effect could inform the sample size of a future trial.

Point-of-care Analysis for Non-invasive Diagnosis of Oral cancer (PANDORA): A technology-development proof of concept diagnostic accuracy study of dielectrophoresis in patients with oral squamous cell carcinoma and dysplasia.

BACKGROUND: Delays in the identification and referral of oral cancer remain frequent. An accurate and non-invasive diagnostic test to be performed in primary care may help identifying oral cancer at an early stage and reduce mortality. Point-of-care Analysis for Non-invasive Diagnosis of Oral cancer (PANDORA) was a proof-of-concept prospective diagnostic accuracy study aimed at advancing the development of a dielectrophoresis-based diagnostic platform for oral squamous cell carcinoma (OSCC) and epithelial dysplasia (OED) using a novel automated DEPtech 3DEP analyser. METHODS: The aim of PANDORA was to identify the set-up of the DEPtech 3DEP analyser associated with the highest diagnostic accuracy in identifying OSCC and OED from non-invasive brush biopsy samples, as compared to the gold standard test (histopathology). Measures of accuracy included sensitivity, specificity, positive and negative predictive value. Brush biopsies were collected from individuals with histologically proven OSCC and OED, histologically proven benign mucosal disease, and healthy mucosa (standard test), and analysed via dielectrophoresis (index test). RESULTS: 40 individuals with OSCC/OED and 79 with benign oral mucosal disease/healthy mucosa were recruited. Sensitivity and specificity of the index test was 86.8% (95% confidence interval [CI], 71.9%-95.6%) and 83.6% (95% CI, 73.0%-91.2%). Analysing OSCC samples separately led to higher diagnostic accuracy, with 92.0% (95% CI, 74.0%-99.0%) sensitivity and 94.5% (95% CI, 86.6%-98.5%) specificity. CONCLUSION: The DEPtech 3DEP analyser has the potential to identify OSCC and OED with notable diagnostic accuracy and warrants further investigation as a potential triage test in the primary care setting for patients who may need to progress along the diagnostic pathway and be offered a surgical biopsy.

Patient and clinician perspectives of information needs concerning oral epithelial dysplasia.

OBJECTIVES: Individuals diagnosed with a chronic oral disease that increase the risk of mouth cancer, such as oral epithelial dysplasia (OED), require appropriate knowledge to make informed decisions. The present study aimed to assess whether patient information needs of a group of patients concerning dysplasia were met and to what degree clinicians agree with patients on 'important' topics. SUBJECTS AND METHODS: This represented secondary analyses of a cross-sectional study to assess the information needs of 86 patients diagnosed with dysplasia compared with those of 77 clinicians using the validated OED Information Needs Questionnaire. Descriptive, concordance and regression analyses were performed for the collected data. RESULTS: The mean and median total scores for all items in the amount of information received subscale were 2.33 and 2.44, indicating overall unmet needs concerning dysplasia. Clinicians were generally able to predict topics of greatest importance to patients, although their scores were mainly lower than those of patients (k = 0.06). There was a higher agreement between patients (k = 0.25) than clinicians (k = 0.09). CONCLUSION: Clinicians are encouraged to assess a patient's information needs to ensure tailored and patient-centred communication concerning OED during all clinical consultations.

Healthcare priorities in patients with chronic facial pain of temporomandibular disorders.

OBJECTIVES: To explore the experiences of patients with temporomandibular disorders (TMDs) with the National Health Service and to discover their healthcare priorities when seeking treatment. METHODS: Semi-structured interviews were used. They were directed using a topic guide covering subjects such as initial visits in primary care, referrals to secondary care, and the effect on symptoms. The discussions were audiotaped and transcribed verbatim. Thematic analysis was utilised to analyse the data. RESULTS: In total, 15 participants took part in three focus groups. Six themes were identified: "access to appropriate care", "organised and coordinated care", "receiving a diagnosis and enough information", "interaction with the clinical staff", "treatment strategies and having an 'action plan'" and "support and social networks". CONCLUSIONS: The participants gave accounts of the difficulties encountered in healthcare in general terms and specific to TMD. Most notable was the struggle to access appropriate care, receive a diagnosis and be understood. Our findings suggest that delays in delivering appointments with people of expertise may have caused the worsening of symptoms. However, when a pleasant experience was encountered, access to care was fast, the clinician was understanding and communication with the clinical team was good. These provided positive experiences and were appreciated by the patients.

Audiovisual information of oral epithelial dysplasia: Quality, understandability and actionability.

OBJECTIVES: Online information on oral epithelial dysplasia (OED) is insufficient and of low quality. While only written information has been previously assessed, this study aims to evaluate the content and quality of audiovisual (AV) online information about OED. METHODS: One hundred and twenty-seven materials were initially considered using six key words across two search engines (YouTube and Google). Ultimately, 29 materials remained for the final assessment. These materials were then analysed for content, quality (DISCERN instrument, JAMA benchmarks), understandability and actionability. RESULTS: Most contents were scientific (n = 25), while three videos were educational, and one video was a personal experience with OED. On a scale of 1-5, the overall DISCERN score was (mean ± SD = 2.26 ± 0.79), suggesting poor quality of information. Regarding JAMA benchmarks, there was no single material that fulfilled or lacked all four benchmarks. The overall mean understandability score was 82% and the actionability mean score was significantly low at 29%. CONCLUSION: Although the vast majority of AV materials on OED were primarily produced for scientific purposes, these materials could be helpful as resources for patient education. Keeping in mind, however, that the desired quality and essential patient information about OED available online remains largely poor and missing.

Validity and internal consistency of four scales in patients with TMD: PHQ8, GAD7, PHQ15 and JFLS20.

OBJECTIVES: The aim of this cross-sectional study was to explore the structural validity and internal consistency reliability of General Anxiety Disorder-7, Patient Health Questionnaire-8, 15 and Jaw Functional Limitation Scale-20 in patients with chronic pain of temporomandibular disorders. MATERIALS AND METHODS: Validity and reliability were assessed in 129 patients diagnosed according to the diagnostic criteria for temporomandibular disorders. Structural validity was explored using factor analysis, and internal consistency by calculating Cronbach α. RESULTS: Confirmatory factor analysis revealed a suitable 2-factor model for Patient Health Questionnaire-8, with Cronbach α of 0.89, and 0.86. One and 2-factor models were suitable for General Anxiety Disorder-7, with overall Cronbach α of 0.93 for the 1-factor model, and 0.91 and 0.84 for both factors in a 2-factor model. A 4-factor solution was appropriate for Patient Health Questionnaire-15, with Cronbach α of 0.72, 0.57, 0.71 and 0.73 for each factor separately. Exploratory factor analysis was conducted to explore the factor structure of Jaw Functional Limitation Scale 20, and a 3-factor solution was appropriate. CONCLUSIONS: This study provides positive evidence of structural validity and internal consistency of these questionnaires in patients with pain of temporomandibular disorders. However, additional testing is required to explore further psychometric properties.

Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial.

BACKGROUND: Oral lichen planus (OLP) is a chronic inflammatory disorder of the oral mucosa. Currently there is no approved treatment for OLP. We report on the efficacy and safety of a novel mucoadhesive clobetasol patch (Rivelin® -CLO) for the treatment of OLP. METHODS: Patients with confirmed OLP and measurable symptomatic ulcer(s) participated in a randomized, double-blind, placebo-controlled, multicenter clinical trial testing a novel mucoadhesive clobetasol patch (Rivelin® -CLO) in OLP across Europe, Canada, and the United States. Patients were randomized to placebo (nonmedicated), 1, 5, 20 µg Clobetasol/patch, twice daily, for 4 weeks. The primary endpoint was change in total ulcer area compared to baseline. Secondary endpoints included improvement from baseline in pain, disease activity, and quality of life. RESULTS: Data were analyzed and expressed as mean [SD]. One hundred thirty-eight patients were included in the study; 99 females and 39 males, mean age was 61.1 [11.6] years. Statistical analyses revealed that treatment with 20-µg Rivelin® -CLO patches demonstrated significant improvement with ulcer area (p = 0.047), symptom severity (p = 0.001), disease activity (p = 0.022), pain (p = 0.012), and quality of life (p = 0.003) as compared with placebo. Improvement in OLP symptoms from beginning to the end of the study was reported as very much better (best rating) in the 20-µg group (25/32) patients compared to the placebo group (11/30), (p = 0.012). Adverse events were mild/moderate. Candidiasis incidence was low (2%). CONCLUSIONS: Rivelin® -CLO patches were superior to placebo demonstrating statistically significant, clinically relevant efficacy in objective and subjective improvement and, with a favorable safety profile.

Information needs and oral epithelial dysplasia: Development and psychometric evaluation of a novel instrument.

OBJECTIVES: Oral epithelial dysplasia (OED) can lead to significant information needs (IN) related to the risk of cancer development, the need for long-term monitoring and potential intervention. The present study aimed to develop and perform preliminary psychometric testing for a novel IN instrument specific to OED. SUBJECTS AND METHODS: Patients diagnosed with OED were invited to complete the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), which was developed based on a known theoretical framework and with items generated via expert input and the literature. Face validity and content validity were initially assessed prior to finalisation of the tool. ODIN-Q was tested for internal consistency and test-retest reliability along with construct validity. RESULTS: ODIN-Q consists of 35 items, categorised under six domains, and rated by dual 4-point Likert scales (amount of information received and degree of importance). Internal consistency (Cronbach's alpha) was rated "excellent" for the scale (0.93) and both subscales (0.92/0.94). For test-retest reliability, moderate agreement was found (κ = 0.49-0.53). Regarding construct validity, a significant but limited relationship was found between ODIN-Q and the Krantz Health Opinion Survey. CONCLUSION: ODIN-Q showed adequate psychometric properties of reliability and validity. Further validation is, however, needed to assess its structural validity and responsiveness.

Validity and responsiveness of pain rating scales in patients with chronic oral mucosal diseases.

OBJECTIVES: To validate the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) for measuring pain intensity in chronic oral mucosal diseases. METHODS: Secondary analyses of data including the VAS, NRS, demographic, clinical and quality-of-life outcomes at baseline and 4-month follow-up were retrieved from a clinical study of chronic oral mucosal diseases. Construct and criterion validity and responsiveness of the VAS and NRS were assessed through testing hypotheses based upon strength of Spearman's correlation coefficients. RESULTS: Data of 500 and 290 patients with chronic oral mucosal diseases were used for the assessment of validity and responsiveness, respectively. Moderate-to-high correlations between both pain scores and scores of clinical and quality-of-life outcomes were observed, supporting construct validity of the VAS and NRS. Their criterion validity was confirmed by significantly strong association between scores of both scales. Responsiveness of both scales was adequate based on moderate association between their change scores and global rating of change scale. CONCLUSION: The present results provide evidence supporting validity and responsiveness of the VAS and NRS for pain intensity assessment in patients with chronic oral mucosal diseases. Future research examining other pain intensity domains and standardizing composite scores for pain intensity in this population is required.

A proof of concept pilot trial of probiotics in symptomatic oral lichen planus (CABRIO).

OBJECTIVE: To preliminary evaluate the clinical effects of probiotics in individuals with symptomatic oral lichen planus and the possible mechanisms of action. SUBJECTS AND METHODS: A group of 30 individuals with symptomatic oral lichen planus were recruited in a randomised double-blind parallel group controlled (1:1) proof-of-concept pilot trial of probiotic VSL#3 vs placebo. Efficacy outcomes included changes in pain numeric rating scale, oral disease severity score and the chronic oral mucosal disease questionnaire. Adverse effects, home diary and withdrawals were assessed as feasibility outcomes. Mechanistic outcomes included changes in salivary and serum levels of CXCL10 and IFN-γ and in oral microbial composition. RESULTS: The probiotic VSL#3 was safe and well tolerated. We observed no statistically significant change in pain, disease activity, quality of life, serum/salivary CXCL10 or oral microbial composition with respect to placebo. Salivary IFN-γ levels demonstrate a trend for a reduced level in the active group (p = 0.082) after 30 days of probiotic consumption. CONCLUSIONS: The present proof-of-concept study provides some weak not convincing indication of biological and clinical effects of probiotic VSL#3 in individuals with painful oral lichen planus. Further research in this field is needed, with the current study providing useful information to the design of future clinical trials.

Psychosocial impacts of oral epithelial dysplasia.

BACKGROUND: The psychosocial impact of receiving the diagnosis of oral epithelial dysplasia, which presents up to 3.5% increased annual risk of mouth cancer, remains unknown. Using validated instruments, the present study aimed to investigate the prevalence and existing correlations between anxiety, depression and dental anxiety symptoms and burden on oral health-related quality of life. METHODS: A clinical cohort of 82 patients with oral dysplasia was asked to complete the Hospital Anxiety and Depression Scale, the Modified Dental Anxiety Scale and the shortened version of the Oral Health Impact Profile. Spearman's correlation coefficient and regression analyses were performed. RESULTS: The participants' scores were in keeping with the presence of anxiety, depression and emotional distress symptoms in 30%, 16% and 26%, respectively. However, 69% experienced anxiety related to procedures that may be required as part of long-term management of oral dysplasia (e.g. local anaesthetic injection). The oral health-related quality of life scores showed 41.5% reporting a recent daily problem due to their oral or dental health. Significant correlations [p >0.05] were found among and between all of the used instruments. Being a female with oral dysplasia also predicted increased odds of indicating higher anxiety and dental anxiety scores than males [p >0.05]. CONCLUSION: Oral dysplasia can adversely impact on the psychosocial well-being of affected persons. Establishing a causal relationship between the measured variables may, however, be challenging and would need further longitudinal studies.

Measuring the impact of systemic sclerosis on oral health-related quality of life in a UK population.

BACKGROUND: The objective of the present study was to identify the impact of systemic sclerosis (SSc) upon oral health-related quality of life (OHRQoL) of affected individuals resident in the UK. METHODS: A total of 100 patients and their partners or carers were invited to complete questionnaires regarding the impact of SSc on quality of life and psychological well-being using valid and reliable patient-reported outcome measures (OHIP-14, MHISS, OIDP, MDAS and HADS). A total of 50 patients with SSc and 18 partners or carers who acted as controls returned the completed questionnaires. Statistical analyses were performed for comparisons of different variables. RESULTS: All the mean scores of OHIP-14 (SSc [16.5 ± 12.4] Vs controls [6.06 ± 7.6, p = 0.001]) and MHISS components were significantly higher in patients than those of control group (SSc [21.26 ± 12] Vs controls [4.8 ± 7.3, p < 0.0001]). Majority of OIDP mean scores were significantly worse in patients compared with controls [SSc (10 ± 8.7) Vs controls (1.72 ± 3.4, p < 0.0001)]. The mean of total MDAS [SSc (11.7 ± 5.3) Vs controls (9.5 ± 4.4)] and HADS scores were higher in patients compared to controls (SSc depression [4.8 ± 3.3] and anxiety [6 ± 4.6] Vs controls [3.7 ± 3.1] [4.7 ± 3.9]). CONCLUSIONS: Although the present study is limited by the low response rate and its cross-sectional design, present results highlighted that systemic sclerosis has a negative impact on OHRQoL of the affected individuals; hence, the evaluation of associated psychological impact including anxiety and depression symptoms is needed to better understand, monitor and evaluate the disease comorbidity in patients with SSc.

Evaluating the measurement properties of patient-reported outcome measures in radiotherapy-induced xerostomia.

OBJECTIVE: Radiotherapy-induced xerostomia (RIX) is one of the most common adverse effects of radiotherapy to the head and neck, and a major determinant of survivors' quality of life. A number of patient-reported outcome measures (PROMs) have been used in clinical trials of therapeutic interventions for RIX; however, little is known regarding their measurement properties and methodological quality. METHODS: We conducted a systematic literature search in Embase, MEDLINE and PsycINFO for articles published up to May 2019 and evaluating at least one measurement property of PROMs relevant to RIX. The COSMIN guidelines were used to assess relevant measurement properties and methodological quality. RESULTS: Nine validations studies were identified reporting on four PROMs relevant to RIX. The Xerostomia Questionnaire (XQ) showed overall high-quality evidence for structural validity and internal consistency, but low-quality evidence supporting reliability. The methodological quality of the Groningen Radiotherapy-Induced Xerostomia scale (GRIX), Xerostomia Inventory (XI) and the Xerostomia Quality of Life Scale (XeQoLS) was relatively low for all measurement properties. CONCLUSIONS: The XQ was found to have the highest potential to capture changes in RIX according to COSMIN guidelines. Additional validation studies are required to further understand the methodological quality of the XI, GRIX and XeQoLS.

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

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.

Validity and reliability of the Mouth Handicap of Systemic Sclerosis questionnaire in a UK population.

BACKGROUND: The objective of this study was to explore the psychometric properties of the Mouth Handicap in Systemic Sclerosis (MHISS) specifically exploring aspects of validity and reliability of MHISS in UK SSc patients. METHODS: A total of 150 questionnaires were distributed in this study at the Oral Medicine Department of UCLHT Eastman Dental Hospital, the Outpatient Rheumatology Clinic of the Royal Free Hospital and Scleroderma Family Day. Participants were asked to complete three questionnaires (SF-36, OHIP-14 and MHISS) along with a pro forma of demographic and disease-specific questions. Both convergent validity and internal consistency reliability were examined. The convergent validity was assessed by Spearman's correlation coefficient, and internal consistency reliability was assessed by Cronbach's alpha. RESULTS: Of the 150 questionnaires distributed to participants, 68 respondents were included. With regard to construct validity, a low to moderate degree of convergent validity was found between MHISS total score and all SF-36 subscales. However, the total MHISS score was highly correlated to all OHIP subscales. CONCLUSION: MHISS questionnaire is a self-administered patient-reported outcome measure that assesses the mouth disability in SSc patients. However, improving the global and oral health of SSc patients is important as there is no cure for the disease; thus, instruments that record the impact of the condition and indicate the effect of treatment on the lives of patients are of paramount importance. Current results demonstrate good preliminary psychometric properties (validity and reliability) in a UK population with further exploration of psychometric properties with an emphasis on interpretability required.

Development and validation of a short version of Chronic Oral Mucosal Disease Questionnaire (COMDQ-15).

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.

Validation of the HADS and PSS-10 and a cross-sectional study of psychological status in patients with recurrent aphthous stomatitis.

OBJECTIVES: To validate the Hospital Anxiety and Depression Scale (HADS) and the 10-item Perceived Stress Scale (PSS-10) for use in clinical studies of recurrent aphthous stomatitis (RAS) and to provide cross-sectional assessment of anxiety, depressive, and distress symptoms and perceived stress in patients with RAS. METHODS: The validity and reliability of the HADS and PSS-10 were evaluated in 120 individuals with RAS through confirmatory factor analysis and calculation of Cronbach's alpha and omega coefficients. The prevalence of comorbid anxiety, depression, distress, and moderate-to-high perceived stress, and their association with demographics and clinical factors were assessed through cutoff scores of the HADS and PSS-10 and bivariate analyses, respectively. RESULTS: A bi-factor model, with all items loading onto general factor with two group factors, provides the best fit to the HADS and PSS-10 data of this RAS cohort. While omega values suggested adequate reliability of total score of both scales, relatively low ranges of coefficient omega hierarchical limit utility of their subscale scores. The prevalence of anxiety, depression, distress, and moderate-to-high perceived stress was 42.5%, 18.33%, 28.33%, and 71.67%, respectively. Ethnicity, alcohol consumption, disease comorbidities, clinical type of RAS, ulcer size, pain, and RAS disease activity were found to be associated with negative psychological symptoms. CONCLUSION: The HADS and PSS-10 are valid and reliable as general scales of psychological distress and stress in patients with RAS. Significant mental burden among RAS patients makes the use of these validated instruments a sensible and prudent practice for psychological assessment of this patient group.

Diclofenac Mouthwash as a potential therapy for reducing pain and discomfort in chemo-radiotherapy-induced oral mucositis.

AIMS: Oral and/or oropharyngeal acute mucositis during and after chemo-radiotherapy (chemo-RT) for head and neck squamous cell carcinoma (HNSCC) can be extremely painful, sometimes requiring nasogastric feeding to enable adequate nutrition. The MASCC/ISOO evidence-based guidelines recommend benzydamine mouthwash for mucositis prevention in RT (recently updated to include chemo-RT), and a Cochrane systematic review found other agents to be effective in prophylaxis. Diclofenac mouthwash is licensed for painful oral mucosal inflammatory conditions but to our knowledge has not been assessed in chemo-RT-associated oral mucositis. METHOD: A clinical observation and service evaluation study in 10 patients undergoing chemo-RT for HNSCC to assess the potential value of diclofenac mouthwash (0.74 mg/mL) in reducing symptoms. Patients used 20ml of mouthwash up to 4 times a day starting in week 3 (of a 6-week course of treatment), recording pain and discomfort scores using a visual analogue scale on days 0, 1,7 and 14 (until the end of week 4). As per our current clinical practice, oral mucositis was not clinically scored as an outcome. Statistical analysis was performed using a one-way ANOVA. RESULTS: Using diclofenac mouthwash, 9/10 patients experienced pain score reduction from day 0 (mean score 6.75 ± SD 1.83) to day 2 (5.05 ± SD 1.62) and day 14 (4.09 ± SD 1.96). CONCLUSIONS: Diclofenac mouthwash may be beneficial for managing chemo-RT-induced oral mucositis. While a prospective randomised clinical trial is needed, it can be prescribed for this condition within its current licence.