Early technology review: towards an expedited pathway.

OBJECTIVES: Evidence development for medical devices is often focused on satisfying regulatory requirements with the result that health professional and payer expectations may not be met, despite considerable investment in clinical trials. Early engagement with payers and health professionals could allow companies to understand these expectations and reflect them in clinical study design, increasing chances of positive coverage determination and adoption into clinical practice. METHODS: An example of early engagement through the EXCITE International model using an early technology review (ETR) is described which includes engagement with payers and health professionals to better inform companies to develop data that meet their expectations. ETR is based on an early evidence review, a framework of expectations that guides the process and identified gaps in evidence. The first fourteen ETRs were reviewed for examples of advice to companies that provided additional information from payers and health professionals that was thought likely to impact on downstream outcomes or strategic direction. Given that limitations were imposed by confidentiality, examples were genericized. RESULTS: Advice through early engagement can inform evidence development that coincides with expectations of payers and health professionals through a structured, objective, evidence-based approach. This could reduce the risk of business-related adverse outcomes such as failure to secure a positive coverage determination and/or acceptance by expert health professionals. CONCLUSIONS: Early engagement with key stakeholders exemplified by the ETR approach offers an alternative to the current approach of focusing on regulatory expectations. This could reduce the time to reimbursement and clinical adoption and benefit patient outcomes and/or health system efficiencies.

Validity of individual self-report oral health measures in assessing periodontitis for causal research applications.

BACKGROUND: Self-reported measures of periodontitis developed for use in population surveillance are increasingly used in causal research. Numerous studies evaluate the validity of these measures against clinical parameters of periodontitis, yet few include validation parameters outside of multivariable models. Individual item validity is necessary to adequately inform use of these measures in causal research. METHODS: We used data from the National Health and Nutrition Examination Survey 2011-2014 in which dentate participants completed full-mouth periodontal examinations (N = 6966). We evaluated six self-report questionnaire items related to periodontal disease status against periodontitis case definitions developed by the Centers for Disease Control and Prevention and American Academy of Periodontology (CDC-AAP). We estimated the sensitivity and specificity of individual items using severe and moderate-to-severe periodontitis classifications. We additionally combined items to evaluate the validity of joint measures. RESULTS: Sensitivity was highest when measures were evaluated against severe periodontitis. Self-rated oral health of fair/poor demonstrated the highest sensitivity for severe (0.60) and moderate-to-severe periodontitis (0.48). Specificity was highest when evaluated against moderate-to-severe periodontitis, with self-reported history of tooth mobility as the most specific measure (0.87 for severe disease; 0.92 for moderate-to-severe) followed by a history of bone loss (0.88 for severe; 0.91 for moderate-to-severe). Combining questions generally improved specificity at the expense of sensitivity. CONCLUSIONS: Our findings related to item-specific validity and the associated clinical profiles facilitate needed considerations for the use of self-reported measures of periodontitis in causal research. Additionally, item-specific validity can be used to inform assessments of misclassification bias within such investigations.

Depression and Differential Oral Health Status Among U.S. Adults With and Without Prior Active Duty Service in the U.S. Military, National Health and Nutrition Examination Survey 2011-2018.

INTRODUCTION: Veterans suffer from lower overall well-being than non-veterans because of their unique life course. This study aims to compare the impact of depression on oral health for veteran and non-veteran populations. MATERIALS AND METHODS: Data from 11,693 adults (18+) participating in the National Health and Nutrition Examination Survey (2011-2018) were analyzed. The outcome variables were dichotomous (at/above mean) decayed, missing, and filled teeth due to caries (DMFT), as well as the components, namely, missing teeth, filled teeth (FT), and decayed teeth (DT). The primary predictor variable combined depression screening outcome and veteran status (veteran/depressed, veteran/not depressed, non-veteran/depressed, and non-veteran/not depressed). Covariates included socioeconomic factors, demographics, wellness factors, and oral health-related habits. Associations between outcome and predictor variables were assessed with a fully adjusted logistic regression analysis. RESULTS: Veterans, regardless of depression status, had more DMFT, FT, missing teeth, and DT compared to non-veterans. After controlling for covariates, veterans suffering from depression had higher odds of DT (1.5, 95% CI, 1.0-2.4) compared to non-veterans without depression. In general, veterans who screened negative for depression had better oral health compared to all groups, with lower odds of DT (0.7, 95% CI, 0.6-0.9) and higher odds of FT (1.4, 95% CI, 1.1-1.7) compared to non-veterans with and without depression. CONCLUSIONS: This study found that not only veterans have higher odds of overall caries experience, but also veterans suffering from depression have higher odds of active caries compared to non-depressed veterans. Most veterans lack Veterans Health Administration dental benefits and face challenges maintaining oral health on top of medical and mental health burdens. Our results add further urgency to increasing dental care access for this vulnerable population because of the exacerbation of unmet oral health care needs attributable to the additional mental health challenges veterans face.

Oral health risk factors and overall dental treatment needs for incoming air force recruits.

OBJECTIVE: To determine if relationships exist between the total dental treatment needs of incoming Air Force recruits and non-clincal demographic and oral-health related factors. METHODS: Data from the 2018 Air Force Recruit Oral Health Study (ROHS) was used, an anonymized sample of 1330 AF recruits that included a comprehensive oral exam and survey collecting demographic and oral health behavior information. The primary outcome variable was the total number of dental treatment needs for recruits, and independent predictor variables included select socio-demographic factors and wellness behaviors. Along with descriptive statistics, a multivariable negative binomial regression analysis was performed to assess the relationship between variables with a normalized weight making the final results representative of all incoming recruits. RESULTS: The final adjusted analysis showed that an incoming recruit's self-rated oral health, dental coverage prior to enlistment, need for a dental visit within the last 12 months, sugar intake, and tobacco use increased their risk for dental treatment needs. CONCLUSION: This is the first study to assess the relationship between specific risk indicators and increased dental treatment needs while adjusting other related covariates. Factors associated with dental treatment needs were identified that provide Air Force leaders with actionable information to directly improve recruit oral health and military readiness by identifying new airmen at the highest risk for excessive dental care needs while at basic military training.

Effect of being overweight and obese on periodontal treatment costs.

BACKGROUND: Obesity can increase a person's risk of developing periodontal disease, and patients with obesity have greater health care costs. However, the effect of obesity on periodontal treatment costs has not been examined. METHODS: This retrospective cohort study used data from the electronic dental records of adult patients examined from July 1, 2010, through July 31, 2019 at a US dental school. Primary exposure was body mass index, which was categorized as obese, overweight, or normal. Periodontal disease was categorized using clinical probing measures. Fee schedules and procedure codes were used to compute the primary outcome, which was total periodontal treatment costs. A generalized linear model with gamma distribution was used to examine the relationship between body mass index and periodontal costs after controlling for initial periodontal disease severity and other confounding variables. Parameter coefficients and mean ratios with 95% CIs were estimated. RESULTS: The study sample included 3,443 adults, of whom 39% were normal weight, 37% were overweight, and 24% were obese. Mean (SD) total periodontal treatment costs for patients who were obese were considerably higher ($420 [$719]) than those for patients who were overweight ($402 [$761]) and patients who were normal weight ($268 [$601]). After controlling for covariates and disease severity, patients who were obese had 27% higher periodontal treatment costs than patients who were normal weight. The additional periodontal treatment costs attributable to obesity were greater than those attributable to either diabetes or smoking. CONCLUSIONS: The study results suggest that among patients at a dental school, those who were obese incurred substantially higher periodontal treatment costs than patients who were normal weight, independent of initial periodontal disease severity. PRACTICAL IMPLICATIONS: The study findings have important implications for clinical guidelines and dental benefit design and coverage policies.

Dental students' knowledge, attitudes, and perceptions about marijuana and its effects on patients' oral health.

PURPOSE/OBJECTIVES: This article seeks to determine dental students' knowledge, attitudes, and perceptions toward patients' marijuana use and whether dental students would like additional marijuana education. METHODS: Predoctoral dental students were invited in 2021 to complete a questionnaire regarding marijuana's oral health effects, their comfort discussing marijuana with patients and their interest in additional training. RESULTS: Among participants (n = 206, 32.7% response rate), most were familiar with smoked, smokeless and edible methods, but only 39.3% were familiar with topical applications. Only 29.6% of preclinical and 32.2% of clinical Doctor of Dental Medicine students agreed that smoking marijuana was detrimental to one's health, compared to 64.6% of internationally trained Advanced Standing students. Significantly more clinical students (70.6%) could identify how often they treat patients having used marijuana compared to the estimates of preclinical students (36.7%), although 44.2% of all students indicated they were unsure. Not surprisingly, more preclinical students were uncomfortable treating patients during routine dental procedures (45.6% preclinical vs. 32.8% clinical) and when administering local anesthesia (45.6% preclinical vs. 38.8% clinical) due to not yet providing direct patient care. A majority of both preclinical (92.2%) and clinical (89.7%) students agreed they would benefit from more marijuana education. Clinical students preferred adding a brief introductory seminar while preclinical students preferred multiple lectures throughout the curriculum. CONCLUSION: As states legalize medical and recreational marijuana use, dental schools need to evaluate marijuana education in their curriculum and develop resources so students can feel comfortable and confident in their ability to identify and safely treat patients who use marijuana.

Periodontitis is associated with an increased hazard of mortality in a longitudinal cohort study over 50 years.

AIM: To evaluate the association between periodontal disease and all-cause mortality in a longitudinal cohort study over 50 years. MATERIALS AND METHODS: Participants (N = 1156) in the Veterans Affairs Dental Longitudinal Study, aged 25-85 years at enrollment in 1968, received comprehensive medical and oral exams approximately every 3 years through 2007. Periodontal status was defined using person-level, mean whole-mouth radiographic alveolar bone loss (ABL) scores using a five-point Schei ruler, each unit representing 20% increments of ABL. Time-varying Cox regression models estimated hazard ratios (HRs) for the association between continuous and categorical ABL and mortality, adjusting for covariates. RESULTS: Each one-unit increase in mean ABL score was associated with a 14% increase in the hazard of mortality (adjusted HR = 1.14, 95% confidence interval [CI] 1.02, 1.27). When assessed categorically, HRs for average scores of 2 to <3 and 3 to ≤5 showed increasing associations with hazard of mortality, relative to 0 to <1 (adjusted HR = 1.17, 95% CI 0.94, 1.46; and HR = 1.65, 95% CI 0.94, 2.85, respectively). By contrast, we observed null associations for average scores of 1 to <2 relative to 0 to <1 (adjusted HR = 1.00, 95% CI 0.86, 1.17). CONCLUSIONS: Time-varying periodontal status assessed using radiographic ABL was positively associated with all-cause mortality even after confounder adjustment.

Edentulism is associated with increased risk of all-cause mortality in adult men.

BACKGROUND: Prior reports of positive associations between edentulism and all-cause mortality have been limited by onetime assessments of edentulism and inadequate control of known confounding variables. The authors aimed to assess the association between edentulism and mortality using a longitudinal clinical oral health cohort. METHODS: The authors used data from the Department of Veterans Affairs Dental Longitudinal Study, an ongoing, closed-panel cohort study from 1968 through 2019 (N = 1,229). Dentition status was evaluated through triennial clinical examinations. Mortality was assessed via the National Death Registry. The authors used Cox regression models to estimate the association between edentulism and all-cause mortality after covariate adjustment. Furthermore, the authors calculated propensity scores and assessed hazard ratios (HRs) in a trimmed, matched, and inverse probability weighted sample. RESULTS: Participants who were edentulous (N = 112) had 1.24 (95% CI, 1.00 to 1.55) times the hazard of all-cause mortality compared with those who were nonedentulous, after adjustment with time-varying covariates. Use of propensity scores in the model resulted in slightly elevated HRs compared with the standard Cox model, regardless of propensity score method; adjusted HRs were 1.35 (95% CI, 1.01 to 1.80) after matching, 1.26 (95% CI, 1.00 to 1.59) after trimming, and 1.29 (95% CI, 1.18 to 1.42) after inverse probability weighting. CONCLUSIONS: Edentulism was associated with an increased risk of all-cause mortality in a cohort that captured incident edentulism. This association was consistent after multiple methods to account for confounding. PRACTICAL IMPLICATIONS: The findings of this study suggest that edentulism is associated with an increase in risk of mortality, after accounting for salient confounding variables using multiple approaches. Efforts to improve equitable access to tooth-preserving treatments are critical.

Design of an adjustable wheelchair for table tennis participation.

PURPOSE: Physical activity and recreation are very important for people with disabilities and provide benefits for self-esteem, social relationships, employment, rehabilitation, and education. Para Table Tennis is an adaptive sport where participants compete in table tennis while sitting in a wheelchair. However, athletes generally use their everyday wheelchair instead of a device specifically designed for the sport. The specific support, movements, and posture needed to participate in table tennis at the highest level are different than general day-to-day mobility and a device could be optimized for the sport. This research describes the development of a wheelchair specifically designed for para table tennis. MATERIALS AND METHODS: The design followed a participatory action design approach which identified the specific needs for a wheelchair to be used during para table tennis. RESULTS: Three design needs were identified which included 1) locking the casters in the forward direction, 2) ability to raise the seat height as high as possible while allowing the user's knees to fit under the table, and 3) adjustable seat angle which will allow some users to have anterior tilt to get their trunk even higher while other users could have posterior tilt for stability. A new chair meeting these needs was designed and prototyped. CONCLUSIONS: Para table tennis has some specific requirements related to movements and posture which were improved by a new wheelchair design specific for the sport.IMPLICATIONS FOR REHABILITATIONMany adaptive sports are improved with sport specific technology.A model client was used to develop a wheelchair specifically for adaptive table tennis.The height and angle of the seat of the new wheelchair can be adjusted for optimal stability and reach.The casters of the new wheelchair can be locked to allow only forward and backward motion.

Core Clinical Data Elements for Cancer Genomic Repositories: A Multi-stakeholder Consensus.

The Center for Medical Technology Policy and the Molecular Evidence Development Consortium gathered a diverse group of more than 50 stakeholders to develop consensus on a core set of data elements and values essential to understanding the clinical utility of molecularly targeted therapies in oncology.

Diagnosis and Management of Lower Urinary Tract Dysfunction.

Lower urinary tract dysfunction is an umbrella diagnosis that covers difficulty evacuating urine from the bladder. In its most simple form, it is either an inability to store urine or an inability to empty the bladder of urine appropriately. The normal and the abnormal bladder, the role of urodynamics in evaluation of lower urinary tract dysfunction, and the medical and behavioral management of some of these disorders are reviewed.