Mobile multi-configuration clinical translational Raman system for oral cancer application.

Early diagnosis of oral cancer is critical to improve the survival rate of patients. Raman spectroscopy, a non-invasive spectroscopic technique, has shown potential in identifying early-stage oral cancer biomarkers in the oral cavity environment. However, inherently weak signals necessitate highly sensitive detectors, which restricts widespread usage due to high setup costs. In this research, the fabrication and assembly of a customised Raman system that can adapt three different configurations for the in vivo and ex vivo analysis is reported. This novel design will help in reducing the cost required to have multiple Raman instruments specific for a given application. First, we demonstrated the capability of a customized microscope for acquiring Raman signals from a single cell with high signal-to-noise ratio. Generally, when working with liquid samples with low concentration of analytes (such as saliva) under a microscope, excitation light interacts with a small sample volume, which may not be representative of whole sample. To address this issue, we have designed a novel long-path transmission set-up, which was found to be sensitive towards low concentration of analytes in aqueous solution. We further demonstrated that the same Raman system can be incorporated with the multimodal fibre optical probe to collect in vivo data from oral tissues. In summary, this flexible, portable, multi-configuration Raman system has the potential to provide a cost-effective solution for complete screening of precancer oral lesions.

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.

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.

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.

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.

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.

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.

Meaningful improvement thresholds in measures of pain and quality of life in oral lichen planus.

OBJECTIVES: To evaluate the responsiveness of measures of pain and oral health-related quality of life (OH-QoL) in patients with oral lichen planus (OLP) and to determine thresholds for minimal important change (MIC) and minimal important difference (MID) for use in this patient population. METHODS: Data from baseline and 4-month follow-up including Visual Analog Scale (VAS), Numerical Rating Scale (NRS), 14-item Oral Health Impact Profile (OHIP-14), 15-item and 26-item Chronic Oral Mucosal Disease Questionnaire (COMDQ-15; COMDQ-26) were collected from 157 patients with OLP. Responsiveness was assessed by testing hypotheses and calculating the area under the curve. MIC and MID were established based on triangulation of distribution-based and anchor-based estimates. RESULTS: The results supported adequate responsiveness of VAS, NRS, COMDQ-15 and COMDQ-26 for use in OLP, while the OHIP-14 demonstrated relatively low sensitivity to detect improvement in the OLP status. Recommended meaningful improvement thresholds were as follows: VAS (MIC 16 mm; MID 18 mm), NRS (MIC/MID 2 points), OHIP-14 (MIC/MID 5 points), COMDQ-15 (MIC 5 points; MID 6 points) and COMDQ-26 (MIC/MID 9 points). CONCLUSION: This study provides some evidence of responsiveness as well as establishing meaningful improvement thresholds in scores of pain and OH-QoL measures in OLP.

Validation of the HADS and PSS-10 and psychological status in patients with oral lichen planus.

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 was 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.

Human disease/clinical medical sciences in dentistry: Current state and future development of undergraduate assessments in the UK and Ireland.

INTRODUCTION: The United Kingdom and Ireland teachers of Human Disease/Clinical Medical Science for Dentistry (HD/CMSD) group continue to work together and most recently collaborated to review current and future assessments. MATERIALS AND METHODS: The first part of the review of assessments in HD/CMSD took place at a face-to-face meeting with presentations from delegates on assessments in their home institutions. The second and larger part comprised an online survey where all eighteen schools in the UK and Ireland participated. RESULTS: All schools had some element of formative assessment, and the majority had a stand-alone summative assessment at the end of the HD/CMSD teaching block. Most schools had a written paper and practical elements to their assessments, most commonly a combination of a multiple-choice type question combined with an objective structured clinical examination (OSCE). There was a trend towards the use of single best answer (SBA) questions and a willingness amongst participants to share a question bank. All schools incorporated elements of HD/CMSD in their final examinations. DISCUSSION AND CONCLUSION: This collaboration promoted the sharing of developments in assessment for HD/CMSD and demonstrated a willingness to cooperate between institutions. Assessment in HD/CMSD in the UK and Ireland continues to be refined by those responsible for its content and delivery, and assessment methods are progressing following evidence-based best practice.

Measurement properties of patient-reported outcome measures in radiotherapy-induced trismus.

Trismus or lockjaw is the reduction in mouth opening. Radiotherapy-induced trismus occurs when the masticatory muscles are within range of radiation treating head and neck cancer, resulting in muscular fibrosis and trismus. We aim to assess the measurement properties of available validated patient-reported outcome measures relevant to radiotherapy-induced trismus in head and neck cancer patients. Systematic electronic searches were performed in MEDLINE and EMBASE databases to identify studies validating radiotherapy-induced trismus with patient-reported outcome measures up to January 2018. Two reviewers independently rated the methodological quality of identified validation studies, using the consensus-based standards for the selection of health status measurement instrument (COSMIN) checklist. The level of evidence for measurement properties was then summarised based upon pre-defined criteria. Only one of the 280 retrieved studies were deemed fit for inclusion. The Gothenburg Trismus Questionnaire was assessed and found to have a good methodological quality of measurement properties except for reliability, which was poor. There was a moderate level of evidence supporting internal consistency, content validity, structural validity and hypothesis testing. The evidence for test-retest reliability remains unknown in the population of interest. The Gothenburg Trismus Questionnaire is the only patient-reported outcome measure in the field of showing some good measurement properties, and it may therefore represent a useful instrument for the assessment of radiotherapy-induced trismus in head and neck cancer patients. However, further validation studies are needed especially with respect to the reliability, measurement error and the responsiveness of this instrument.

Novel Oral Lichen Planus Symptom Severity Measure for assessing patients' daily symptom experience.

OBJECTIVE: A novel Oral Lichen Planus Symptom Severity Measure was developed as a clinical outcome assessment of the daily symptom experience of patients with oral lichen planus. METHODS: A literature review and expert input were followed by open-ended concept elicitation interviews with 17 adults with oral lichen planus in the United States and Ireland. Item content was generated, and the interviews continued until input saturation was reached. The final electronic version of the measure was cognitively debriefed in 6 US patients and subsequently translated and linguistically validated in Germany and Denmark. RESULTS: Concept elicitation interviews demonstrated content validity and saturation in identifying symptoms and daily activities that generate symptoms in patients with oral lichen planus. The content and electronic daily diary format demonstrated content validity during cognitive debriefing interviews. Linguistic validation of the 7-item Oral Lichen Planus Symptom Severity Measure in Germany and Denmark confirmed the content validity of the German and Danish versions. CONCLUSIONS: Qualitative research methods generated evidence that the 7-item Oral Lichen Planus Symptom Severity Measure version 1.0 is a well-defined assessment tool to characterize the severity, specificity and variations of symptoms in patients with oral lichen planus.

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

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.

Validity and reliability of the Chronic Oral Mucosal Diseases Questionnaire in a UK population.

OBJECTIVE: The objective of this study was to investigate the validity and reliability of a the Chronic Oral Mucosal Diseases Questionnaire in a UK population METHODS: Two hundred patients with chronic oral mucosal disease (oral lichen planus, recurrent aphthous stomatitis, mucous membrane pemphigoid, pemphigus vulgaris) were enrolled in this study from the Oral Medicine Department of University College London Hospitals Trust (UCLHT) Eastman Dental Hospital. Individuals were interviewed using Oral Health Impact Profile (OHIP-14), Visual Analogue Scale (VAS) and Chronic Oral Mucosal Diseases Questionnaire (COMDQ), and the construct validity and internal reliability were examined. RESULTS: Of the 200 study participants, 100 respondents had oral lichen planus, 42 had recurrent aphthous stomatitis and 58 had vesiculobullous conditions (mucous membrane pemphigoid or pemphigus vulgaris). With regard to construct validity, a moderate to good degree of convergent validity was found between OHIP-14 and VAS and most subscales and the total COMDQ score except the patient support subscale of COMDQ (0.21-0.37). CONCLUSION: COMDQ is a valid and reliable patient-reported outcome measure for patients with chronic oral mucosal diseases in a UK population. It can be considered a valuable instrument in both clinical practice and in oral medicine research.

Web-based information on the treatment of oral leukoplakia - quality and readability.

OBJECTIVE: To categorise the content and assess the quality and readability of the online information regarding the treatment for oral leukoplakia. METHODS: An online search using the term 'leukoplakia treatment' was carried out on 8th June 2015 using the Google search engine. The content, quality and readability of the first 100 sites were explored. The quality of the web information was assessed using the following tools, the DISCERN instrument and the Journal of the American Medical Association (JAMA) benchmarks for website analysis and the HON seal. Readability was assessed via the Flesch Reading Ease Score. RESULTS: The search strategy generated 357 000 sites on the Google search engine. Due to duplicate links, non-operating links and irrelevant links, a total of 47 of the first 100 websites were included in this study. The mean overall rating achieved by included websites using the DISCERN instrument was 2.3. With regard to the JAMA benchmarks, the vast majority of examined websites (95.7%) completely fulfilled the disclosure benchmark and less than 50% of included websites met the three remaining criteria. A mean total readability score of 47.5 was recorded with almost 90% of websites having a readability level ranging from fairly difficult to very difficult. CONCLUSION: Based on this study, the online health information regarding oral leukoplakia has challenging readability with content of questionable accuracy. As patients often search for health information online, it would be prudent for clinicians to highlight the caution with which online information should be interpreted.

Cost of illness of oral lichen planus in a U.K. population--a pilot study.

OBJECTIVE: To assess the economic burden of oral lichen planus (OLP) from the perspective of the healthcare provider in a U.K. population. METHODS: This prevalence-based cost-of-illness analysis was carried out via a cross-sectional study conducted in the Oral Medicine Unit of the Eastman Dental Hospital. This study was conducted in three phases - phase 1 involved framing of the cost-of-illness analysis, development of the cost inventory and design of the patient questionnaire for ease of data collection. Data collected from patients were inputted during phase 2, and costings were determined. The final phase consisted of the calculation of the cost of illness of OLP. RESULTS: One hundred patients were enrolled in the study, 30 males and 70 females, with an average age of 59.9 years (±13.4 years). The average OLP patient, based on our cohort, attends the oral medicine unit 2.64 times per year, their general medical practitioner 1.13 times annually, their general dental practitioner 0.82 times in a year and fills on average 3.37 prescriptions annually. This leads to an average annual cost of £398.58 (€541.16) per patient per year from the perspective of the healthcare provider. CONCLUSION: The annual average cost of OLP to the healthcare provider in the U.K. is substantial. The prevalence-based cost-of-illness data generated in this study will facilitate comparison with other chronic oral mucosal diseases and with chronic diseases managed in allied medical specialties.

Mapping the legacy of the world workshop on oral medicine: a 35-year global bibliometric analysis.

OBJECTIVE: This study utilized bibliometric methodologies to explore the body of research presented at the World Workshop on Oral Medicine (WWOM) over the past 35 years. METHODS: A systematic tracking of articles across 8 editions of WWOM was conducted using databases such as Web of Science, Scopus, and PubMed. Comprehensive bibliographic analysis and data visualization were executed through Bibliometrix, Rstudio, and VOSviewer, facilitating an in-depth examination of citation metrics and collaborative networks. RESULTS: The investigation revealed that WWOM, held in 6 cities spanning four countries and addressing 33 distinct topics, demonstrated an annual citation growth rate of 8.29%, with an average of 49.31 citations per article. Notably, WWOM IV garnered the highest number of citations (1,342), reaching its peak in 2021 with 365 citations. Key contributors to the most-cited articles include Al-Hashimi, Dawes, and Syrjänen et al. Since its inception, the workshops have engaged 505 faculty members from 37 nations, with significant participation from the Americas and Europe, notably the United States and the United Kingdom, which also led in terms of publications. Network analysis delineated 6 country clusters, underscoring robust connections between the US and the UK. Co-authorship analysis revealed 18 clusters involving 267 authors. CONCLUSION: The influence of the WWOM on the field of oral medicine is clearly demonstrated by the outcomes of its publications, reflecting a collaborative effort to enhance comprehension and treatment modalities for patients with oral diseases. The study's findings provide insights into future research directions within the WWOM legacy.

Patient-Reported Outcome Measures Used in Temporomandibular Disorders: A Review of the Literature.

AIMS: To identify the range of patient-reported outcome measures (PROMs) used in TMD studies, summarize the available evidence for their psychometric properties, and provide guidance for the selection of such measures. METHODS: A comprehensive search was conducted to retrieve articles published between 2009 and 2018 containing a patient-reported measure of the effects of TMDs. Three databases were searched: MEDLINE, Embase, and Web of Science. RESULTS: A total of 517 articles containing at least one PROM were included in the review, and 57 additional studies were also located describing the psychometric properties of some tools in a TMD population. A total of 106 PROMs were identified and fell into the following categories: PROMs describing the severity of symptoms; PROMs describing psychologic status; and PROMs describing quality of life and general health. The most commonly used PROM was the visual analog scale. However, a wide range of verbal descriptors was employed. The Oral Health Impact Profile-14 and Beck Depression Inventory were the most commonly used PROMs describing the effect of TMDs on quality of life and psychologic status, respectively. Additionally, the Oral Health Impact Profile (various versions) and the Research Diagnostic Criteria Axis ll questionnaires were the instruments most repeatedly tested in a TMD population, and these instruments have undergone cross-cultural validation in several languages. CONCLUSION: A wide range of PROMs have been used to describe the impact of TMDs on patients. Such variability may limit the ability of researchers and clinicians to evaluate the efficacy of different treatments and make meaningful comparisons.

An international Delphi survey and consensus meeting to define the core outcome set for trigeminal neuralgia clinical trials.

BACKGROUND: Trigeminal neuralgia (TN) is an excruciating unilateral facial pain, which negatively affects patient's quality of life. Historically, it has been difficult to compare treatment efficacy due to the lack of standardized outcomes. In addition, patients' perspective has seldomly been acknowledged. The aim of this study was to reach consensus on what outcomes of treatment are important to different TN stakeholders (patients, clinicians and researchers), to identify the TN Core Outcome Set (TRINCOS). METHODS: A list of outcomes identified through a systematic review and focus group work was used to develop the survey questionnaire. A three-round Delphi was conducted. Participants were asked to score the outcomes on scale from 1 to 9 (1-3 not important;4-6 important but not critical;7-9 critical). Outcomes scored as critical by ≥70% and not important by <15% were retained, and those for which no consensus was reached were discussed at a consensus meeting. RESULTS: Of the 70 participants who completed the Delphi, 26 were patients, 38 were clinicians and six were researchers. Of the 40 outcomes presented, 17 were scored as critical and no consensus was met for 23 outcomes. Agreement was reached during a consensus meeting on 10 outcomes across six domains (pain, side effects, social impact, quality of life, global improvement, and satisfaction with treatment). CONCLUSION: Implementation of TRINCOS in future clinical trials will improve homogeneity of studies' results, reduce the redundancy in the outcome assessment and effectively allow comparison of different treatments to better inform researchers, clinicians and most importantly patients, about the efficacy of the different treatments. SIGNIFICANCE: Implementation of a 10-item core outcome set in trigeminal neuralgia will improve comparability between studies allowing patients to have faster access to better treatments.