Patient reported outcome and experience measures of oral disease in oral medicine

A recent meeting of health ministers from over 40 countries worldwide deemed that time and money should be spent on outcome and experience measures that would allow us to determine whether our health systems deliver outcomes that truly matter to patients. This meeting, along with recent national programmes to promote the use of outcome measures in evaluating medical and surgical interventions, highlighted the important role that patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) have in healthcare. Oral medicine as a speciality has promoted the use of PROMs to some extent in the recent past with the use of generic and oral health specific measures in the literature and the delivery of plenary lectures at international scientific meetings. We could find no publications regarding the use of PREMs in oral medicine. This article highlights the commonly used PROM tools in the oral mucosal disease and salivary gland literature and makes recommendations for the evaluation of the development properties of currently used instruments and the establishment of core outcome sets in the commonly managed conditions in an oral medicine setting. It is also hoped that by looking at the types of PREM tools available we can determine a suitable instrument for the evaluation of patient experience in oral medicine practice

A meta-synthesis of qualitative data exploring the experience of living with temporomandibular disorders: The patients' voice

Objective: The aim of this review was to systematically review the qualitative evidence related to the experience of patients with temporomandibular disorder (TMD) and to explore the effect it has on their lives. Materials and methods: The following databases were searched systemically: Medline, Embase, PsycINFO, Web of Science, CINAHL Complete and the Cochrane database. Thematic synthesis was used to analyse and synthesise the data from the qualitative studies which explored the experience of adult patients with TMD. The Critical Appraisal Skills Programme (CASP) tool was used to critically appraise the quality of the included studies. Results: The search strategies yielded 3588 articles across all databases. A total of 20 articles were eventually included. Six themes were derived: TMD causes uncertainty and doubt, TMD had disruptive effects on life, TMD causes distress, understanding TMD—the illness and the causes, dealing with the pain and aims and hopes. Conclusion: The findings highlight the impact TMD could have on the quality of life and confirms the psychological and social challenges these patients experience

Web-based information on oral dysplasia and precancer of the mouth - Quality and readability

OBJECTIVES: The numbers of individuals with oral cancer are increasing. This cancer is preceded by oral epithelial dysplasia (OED). There remains no detailed study of the online information presently available for patients with OED or indeed what information such patients may require to be appropriately informed regarding their condition. Hence, the aim of the present study is to assess the patient-oriented web content with respect to OED. METHODS: The first 100 websites yielded from nine searches performed using different search terms and engines were considered. These were assessed for content, quality (DISCERN instrument, Journal of the American Medical Association benchmarks, and Health on Net seal) and readability (Flesch Reading Ease Score and Flesch-Kincaid Grade Level). RESULTS: There was a general scarcity of OED content across the identified websites. Information about authors, sources used to compile the publication, treatment, and shared decision were limited or absent. Only 6% and 27% of the websites achieved all the four JAMA benchmarks and HON seal, respectively. The average readability level was at 10th grade (US schools), which far exceeds the recommended levels of written health information. CONCLUSION: At present patients seeking information on OED are likely to have difficulty in finding reliable information from the Web about this disorder and its possible impact upon their life. Further work is thus required to develop a web-based resource regarding OED that addresses the shortfalls demonstrated by the current study

Readability and quality of online information regarding dental treatment for patients with ischaemic heart disease

Background: Healthcare information is increasingly being sought on the Internet. Ischaemic heart disease (IHD) poses a significant health burden. Concern often arises for patients with IHD when undergoing dental treatment, leading to online searching for relevant healthcare information. / Objective: To evaluate the readability and quality of webpages regarding IHD and dental treatment. / Materials and methods: Three searches were performed on the Google search engine. The first hundred results of each search were collated and exclusion criteria applied. The remaining 66 webpages were categorised. Readability was assessed using the FRES and SMOG readability tools. Quality was assessed using the PEMAT questionnaire, the JAMA benchmarks and the Health On the Net (HON) seal. / Results: Most examined webpages were commercial. Readability of 90.1% of webpages was deemed fairly to very difficult. Understandability and actionability scores were generally below the comprehension level of the general population. Less than 50% of websites achieved the authorship, attribution and disclosure JAMA benchmarks. Only 12.1% of websites displayed the HON seal. / Conclusions: Online health information related to IHD and dental treatment is generally too difficult for the average individual to read, understand, or act upon, and may be of questionable quality. Given the low health literacy rates among the general population, future revisions of educational materials by non-commercial sources regarding IHD and dental treatment are warranted, in order to ensure online health information is understandable and of genuine benefit to patients and/or their carers

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

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: 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 proforma of demographic and disease-specific questions. Both convergent validity and internal consistency reliability were examined. The convergent validity was assessed by the Spearman's correlation coefficient and internal consistency reliability was assessed by Cronbach's alpha RESULTS: Of the 150 questionnaires distributed to participants, 68 respondents 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 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 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

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

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 2 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 4 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 4 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

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