A paradigm shift in understanding vulvovaginal melanoma as a distinct tumor type compared with cutaneous melanoma.

OBJECTIVE: Our goal was to compare molecular and immune profiles of vulvovaginal melanoma (VVM) with cutaneous melanoma (CM) and explore the significance of immune checkpoint inhibitor (ICI) agents on survival. METHODS: Samples from VVM and CM tumors underwent comprehensive molecular and immune profiling. Treatment and survival data were extracted from insurance claims data and OS was calculated from time of ICI treatment to last contact. Statistical significance was determined using chi-square and Wilcoxon rank sum test and adjusted for multiple comparisons. RESULTS: Molecular analysis was performed on 142 VVM and 3823 CM tumors. VVM demonstrated significantly (q < 0·01) less frequent BRAF and more frequent KIT, ATRX, and SF3B1 mutations. Alterations in pathways involving DNA damage and mRNA splicing were more common in VVM, while alterations in cell cycle and chromatin remodeling were less common. Immunogenicity of VVM was lower than CM, with an absence of high TMB (0% vs 46.9%) and lower PD-L1 positivity (18·0% vs 29·5%). Median immune checkpoint gene expression was lower in VVM, as were cell fractions for type I macrophages and CD8+ T-cells(q < 0·01). Myeloid dendritic cells were increased in VVM(q < 0·01). Median OS was shorter for VVM than for CM patients treated with ICIs (17·6 versus 37·9 months, HR:1·65 (95% CI 1·02-2·67) p = 0·04). CONCLUSIONS: VVM has a distinct molecular and immune profile compared to CM, which may contribute to the worse survival in VVM compared to CM patients treated with ICI therapy. Though ICIs have been a mainstay of treatment in recent years, our findings suggest that new therapeutic strategies are needed.

Understanding facilitators of research participation among adults with self-reported chronic pain - a survey examining hypothetical research participation.

BACKGROUND: An inability to successfully recruit participants into clinical research has consequences that negatively affect the conduct and reliability of research studies. Understanding facilitators of research participation, namely motives for participation and preferred research outcomes, may improve recruitment and retention of clinical trials related to chronic pain. The present study explored research participation facilitators among individuals with chronic pain and their association with demographic characteristics, pain-related characteristics, and factors related to future research engagement. METHODS: Individuals from Michigan who were 18 years or older and self-reported having chronic pain completed an online survey assessing motives for research participation and desired research outcomes. Analyses were conducted in three stages. First, we evaluated underlying factors of motives for participation and research outcome preferences using principal components analysis. Second, we classified individuals according to their patterns of facilitators using latent profile analysis. Finally, we evaluated differences between facilitator profiles in demographic characteristics, pain-related characteristics, and factors related to future research engagement using χ2 analyses and Kruskal-Wallis rank sum tests. RESULTS: Three components of motives for research participation were identified: social engagement/enjoyment; pain improvement/advancing science; and compensation. Three components of research outcome preferences were identified: co-occurring symptom reduction; behavior reduction modification; and pain and function improvement. Four potential patient-centered profiles utilizing these dimensions of facilitators were identified that had unique demographic characteristics, research participation willingness, and treatment interest. CONCLUSIONS: Our data provide a framework of motives and research outcome preferences that may inform recruitment and retention in chronic pain research. It also gives an indication of who may respond best to active or passive recruitment strategies that appeal to a given motive or preferred outcome. This information may be useful for improving recruitment and to monitor any potential biases in participant samples.

Broadening the Scope of Resilience in Chronic Pain: Methods, Social Context, and Development.

PURPOSE OF REVIEW: A wellspring of new research has offered varying models of resilience in chronic pain populations; however, resilience is a multifaceted and occasionally nebulous construct. The current review explores definitional and methodological issues in existing observational and clinical studies and offers new directions for future studies of pain resilience. RECENT FINDINGS: Definitions of pain resilience have historically relied heavily upon self-report and from relatively narrow scientific domains (e.g., positive psychology) and in narrow demographic groups (i.e., Caucasian, affluent, or highly educated adults). Meta-analytic and systematic reviews have noted moderate overall quality of resilience-focused assessment and treatment in chronic pain, which may be attributable to these narrow definitions. Integration of research from affiliated fields (developmental models, neuroimaging, research on historically underrepresented groups, trauma psychology) has the potential to enrich current models of pain resilience and ultimately improve the empirical and clinical utility of resilience models in chronic pain.

Initial validation of the 12-item Tampa Scale of Kinesiophobia in a retrospective sample of adults with chronic headache.

INTRODUCTION: An area of emerging interest in chronic pain populations concerns fear of pain and associated fear of movement (kinesiophobia)-a cognitive appraisal pattern that is well-validated in non-headache chronic pain. However, there is limited research on whether this construct can be measured in a similar manner in headache populations. METHODS: The current project details a confirmatory factor analysis of the 12-Item Tampa Scale of Kinesiophobia (TSK-12) using a clinical data set from 210 adults with diverse headache diagnoses presenting for care at a multidisciplinary pain clinic. One item (concerning an "accident" that initiated the pain condition) was excluded from analysis. RESULTS: Results of the confirmatory factor analysis for the remaining 12 items indicated adequate model fit for the previously established 2-factor structure (activity avoidance and bodily harm/somatic focus subscales). In line with previous literature, total TSK-12 scores showed moderate correlations with pain severity, pain-related interference, positive and negative affect, depressive and anxious symptoms, and pain catastrophizing. DISCUSSION: The current study is the first to examine the factor structure of the TSK-12 in an adult headache population. The results support the relevance of pain-related fear to the functional and psychosocial status of adults with chronic headache, although model fit of the TSK-12 could be characterized as adequate rather than optimal. Limitations of the study include heterogeneity in headache diagnosis and rates of comorbid non-headache chronic pain in the sample. Future studies should replicate these findings in more homogenous headache groups (eg, chronic migraine) and examine associations with behavioral indices and treatment response.

Historical cosmetic talc consumption and incidence of mesothelioma in the United States.

Jointpoint Regression Software from the National Cancer Institute was used to model age-adjusted male and female pleural and peritoneal mesothelioma rates in the surveillance, epidemiology, and end results (SEER) 8, SEER 12, and SEER 22 cancer registries. Linear mixed models were then used to determine if there was a statistical association between U.S. cosmetic talc consumption and the 30-year lagged age-adjusted mesothelioma rates (1) over the reporting period for each registry and (2) for the periods of time identified by the jointpoint model where changes in the rate of mesothelioma occurred. Regardless of the SEER registry used, from the early-1980s through 2020, rates of peritoneal mesothelioma have remained steady or declined. Female pleural mesothelioma rates were unchanged from the early-1980s until 2017 when rates declined, while male rates peaked in the early 1990s and have since declined. Cosmetic talc consumption was not statistically associated with an increased rate of pleural or peritoneal mesothelioma in males or females, suggesting that the use of cosmetic talc products is not associated with the development of mesothelioma.

Evaluation of dermal exposure to phthalates and parabens resulting from the use of hair relaxers.

Hair relaxers have been suggested as a source of exposure to parabens and phthalates. However, dermally absorbed doses of these chemicals resulting from consumer use of hair relaxers have yet to be quantified, and results from epidemiological studies have consistently demonstrated that there is no increased risk for hormone-sensitive, reproductive cancers associated with use of hair relaxers among Black women. Therefore, dermal absorption of parabens and phthalates associated with hair relaxer use for several commercially available hair relaxer kits was modeled using IH SkinPerm™. The chemicals detected in the hair relaxer kits included methylparaben (MP), ethylparaben (EP), butylparaben (BP), diethyl phthalate (DEP), bis(2-ethylhexyl) phthalate (DEHP), and the phthalate substitute bis(2-ethylhexyl) adipate (DEHA). The daily absorbed dose ranges (mg/kg/day), standardized over a year of product use, were as follows: 8.64 × 10-5-0.00116 MP, 2.30 × 10-8-3.07 × 10-6 EP, 3.24 × 10-8-4.33 × 10-6 BP, 8.65 × 10-9-1.15 × 10-6 DEP, and 8.94 × 10-7-0.000119 DEHP for Kit #1; 8.44 × 10-5-0.00113 MP and 7.91 × 10-5-0.00106 DEP for Kit #2; and 2.49 × 10-6-3.33 × 10-5 MP, 1.52 × 10-8-2.03 × 10-6 EP, 3.29 × 10-9-4.39 × 10-7 DEP, and 3.11 × 10-6-4.14 × 10-5 DEHA for Kit #3. These absorbed doses were well below applicable health-based guidance values, indicating consumer exposure from product use is not expected to pose a health risk. These results provide valuable information for health risk evaluations for hair relaxer use.

Early and recent exposure to adversity, TLR-4 stimulated inflammation, and diurnal cortisol in women with interstitial cystitis/bladder pain syndrome: A MAPP research network study.

Both early (ELA) and recent life adversity (RLA) have been linked with chronic pain conditions and persistent alterations of neuroendocrine and inflammatory responses. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic urologic disorder characterized by bladder and/or pelvic pain, and excessive urinary frequency and/or urgency. IC/BPS has been associated with high levels of ELA as well as a distinct inflammatory signature. However, associations between ELA and RLA with inflammatory mechanisms in IC/BPS that might underlie the link between adversity and symptoms have not been examined. Here we investigated ELA and RLA in women with IC/BPS as potential risk factors for inflammatory processes and hypothalamic-pituitaryadrenal (HPA) abnormalities using data from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. Women with IC/BPS and healthy controls (n = 154 and 32, respectively) completed surveys, collected salivary cortisol at awakening and bedtime for 3 days, and gave a blood sample which was analyzed for 7 LPS-stimulated cytokines and chemokines (IL-6, TNFα, IL-1ß, MIP1α, MCP1, IL-8, and IL-10). Two cytokine/chemokine composites were identified using principal components analysis. Patients with greater exposure to RLA or cumulative ELA and RLA of at least moderate severity showed elevated levels of a composite of all cytokines, adjusting for age, body mass index, and study site. Furthermore, there was a trending relationship between ELA and the pro-inflammatory composite score. Nocturnal cortisol and cortisol slope were not associated with ELA, RLA, or inflammation. The present findings support the importance of adverse events in IC/BPS via a biological mechanism and suggest that ELA and RLA should be assessed as risk factors for inflammation as part of a clinical workup for IC/BPS.

An updated evaluation of reported no-observed adverse effect levels for chrysotile, amosite, and crocidolite asbestos for lung cancer and mesothelioma.

This analysis updates two previous analyses that evaluated the exposure-response relationships for lung cancer and mesothelioma in chrysotile-exposed cohorts. We reviewed recently published studies, as well as updated information from previous studies. Based on the 16 studies considered for chrysotile (<10% amphibole), we identified the "no-observed adverse effect level" (NOAEL) for lung cancer and/or mesothelioma; it should be noted that smoking or previous or concurrent occupational exposure to amphiboles (if it existed) was not controlled for. NOAEL values ranged from 2.3-<11.5 f/cc-years to 1600-3200 f/cc-years for lung cancer and from 100-<400 f/cc-years to 800-1599 f/cc-years for mesothelioma. The range of best-estimate NOAELs was estimated to be 97-175 f/cc-years for lung cancer and 250-379 f/cc-years for mesothelioma. None of the six cohorts of cement or friction product manufacturing workers exhibited an increased risk at any exposure level, while all but one of the six studies of textile workers reported an increased risk at one or more exposure levels. This is likely because friction and cement workers were exposed to much shorter chrysotile fibers. Only eight cases of peritoneal mesothelioma were reported in all studies on predominantly chrysotile-exposed cohorts combined. This analysis also proposed best-estimate amosite and crocidolite NOAELs for mesothelioma derived by the application of relative potency estimates to the best-estimate chrysotile NOAELs for mesothelioma and validated by epidemiology studies with exposure-response information. The best-estimate amosite and crocidolite NOAELs for mesothelioma were 2-5 f/cc-years and 0.6-1 f/cc-years, respectively. The rate of peritoneal mesothelioma in amosite- and crocidolite-exposed cohorts was between approximately 70- to 100-fold and several-hundred-fold higher than in chrysotile-exposed cohorts, respectively. These findings will help characterize potential worker and consumer health risks associated with historical and current chrysotile, amosite, and crocidolite exposures.

Percutaneous ultrasound-guided needle tenotomy for treatment of chronic tendinopathy and fasciopathy: a meta-analysis.

OBJECTIVES: To systematically assess the efficacy of percutaneous ultrasound-guided needle tenotomy (PUNT) in the treatment of chronic tendinopathy and fasciopathy. METHODS: A comprehensive literature search was performed with the following search terms: tendinopathy, tenotomy, needling, Tenex, fasciotomy, ultrasound-guided, and percutaneous. Inclusion criteria consisted of original studies evaluating pain or function improvement after PUNT. Meta-analyses investigating standard mean differences were performed to assess the pain and function improvement. RESULTS: Thirty-five studies with 1674 participants (1876 tendons) were enrolled in this article. Of which 29 articles were included in meta-analysis and the remaining 9 articles without enough numeric data were included in descriptive analysis. PUNT significantly alleviated pain with the standard mean difference of 2.5 (95% CI: 2.0-3.0; p < 0.05), 2.2 (95% confidence interval (CI): 1.8-2.7; p < 0.05), and 3.6 (95% CI: 2.8-4.5; p < 0.05) points in short-term, intermediate-term, and long-term follow-up intervals, respectively. It was also associated with marked improvement in function with 1.4 (95% CI: 1.1-1.8; p < 0.05), 1.8 (95% CI: 1.3-2.2; p < 0.05), and 2.1 (95% CI: 1.6-2.6; p < 0.05) points, respectively in short-term, intermediate-term, and long-term follow-ups. CONCLUSION: PUNT improved pain and function at short-term intervals with persistent results on intermediate- and long-term follow-ups. PUNT can be considered an appropriate minimally invasive treatment for chronic tendinopathy with a low rate of complications and failures. CLINICAL RELEVANCE: Tendinopathy and fasciopathy are two common musculoskeletal complaints that can cause prolonged pain and disability. PUNT as a treatment option could improve pain intensity and function. KEY POINTS: • The best improvement in pain and function was achieved after the first 3 months following PUNT and was continued to the intermediate- and long-term follow-ups. • No significant difference was found between different tenotomy methods in terms of pain and function improvement. • PUNT is a minimally invasive procedure with promising results and low complication rates for treatments of chronic tendinopathy.

Occupational exposure to cosmetic talc and mesothelioma in barbers, hairdressers, and cosmetologists: A systematic review of the epidemiology.

Inhalation exposure to cosmetic talc has generated much scientific debate regarding its potential as a risk factor for mesothelioma, a rare, but fatal cancer. Barbers, hairdressers, and cosmetologists have regularly used cosmetic talc-containing products, but the collective epidemiological evidence for mesothelioma in these occupations has yet to be described. As such, we conducted a systematic review of PubMed and the National Institute for Occupational Safety and Health's (NIOSH) Numbered Publications list to identify original epidemiological literature reporting measures of association between these occupations and incidence of or death from mesothelioma. Literature screening was performed independently twice, the results of which were summarized and tabulated and underwent a review for their accuracy. A total of 12 studies met our inclusion criteria, including three cohort, six case-control, and three proportionate mortality/registration studies. The data from these studies were collected in 13 European and North American countries, spanning more than 50 years. We supplemented this review with queries of occupational mortality databases that are managed by the Washington State Department of Health and NIOSH for 26 U.S. states. Most findings were null and if statistically significant, nearly all showed an inverse relationship, indicative of a protective effect of these occupations on mesothelioma risk. Overall, the epidemiological evidence does not support an increased risk of mesothelioma for these occupations. This research fills an important data gap on the etiology of mesothelioma in barbers, hairdressers, and cosmetologists, and provides a benchmark for those with comparatively less exposure, such as non-occupational users of similar cosmetic talc-containing products.

Distribution of microbiota in cervical preneoplasia of racially disparate populations.

BACKGROUNDS: Microbiome dysbiosis is an important contributing factor in tumor development and thus may be a risk predictor for human malignancies. In the United States, women with Hispanic/Latina (HIS) and African American (AA) background have a higher incidence of cervical cancer and poorer outcomes than Caucasian American (CA) women. METHODS: Here, we assessed the distribution pattern of microbiota in cervical intraepithelial neoplasia (CIN) lesions obtained from HIS (n = 12), AA (n = 12), and CA (n = 12) women, who were screened for CC risk assessment. We employed a 16S rRNA gene sequencing approach adapted from the NIH-Human Microbiome Project to identify the microbial niche in all CIN lesions (n = 36). RESULTS: We detected an appreciably decreased abundance of beneficial Lactobacillus in the CIN lesions of the AA and HIS women compared to the CA women. Differential abundance of potentially pathogenic Prevotella, Delftia, Gardnerella, and Fastidiosipila was also evident among the various racial groups. An increased abundance of Micrococcus was also evident in AA and HIS women compared to the CA women. The detection level of Rhizobium was higher among the AA ad CA women compared to the HIS women. In addition to the top 10 microbes, a unique niche of 27 microbes was identified exclusively in women with a histopathological diagnosis of CIN. Among these microbes, a group of 8 microbiota; Rubellimicrobium, Podobacter, Brevibacterium, Paracoccus, Atopobium, Brevundimonous, Comamonous, and Novospingobium was detected only in the CIN lesions obtained from AA and CA women. CONCLUSIONS: Microbial dysbiosis in the cervical epithelium represented by an increased ratio of potentially pathogenic to beneficial microbes may be associated with increased CC risk disparities. Developing a race-specific reliable panel of microbial markers could be beneficial for CC risk assessment, disease prevention, and/or therapeutic guidance.

Reasons for Preoperative Opioid Use Are Associated with Persistent Use following Surgery Among Patients Undergoing Total Knee and Hip Arthroplasty.

OBJECTIVE: Most studies on preoperative opioid use only describe whether or not patients use opioids without characterizing reasons for use. Knowing why patients use opioids can help inform perioperative opioid management. The objective of this study was to explore pain specific reasons for preoperative opioid use prior to total hip and knee arthroplasty (THA and TKA) and their association with persistent use. METHODS: This is a prospective study of 197 patients undergoing THA (n = 99) or TKA (n = 98) enrolled in the Analgesic Outcomes Study between December 2015 and November 2018. All participants reported preoperative opioid use. RESULTS: Reasons for preoperative opioid use were categorized as surgical site pain only (81 [41.1%]); pain in other body areas only (22 [11.2%]); and combined pain (94 [47.7%]). Compared to patients taking opioids for surgical site pain, those with combined reasons for use had 1.24 (P = .40) and 2.28 (P = .16) greater odds of persistent use at 3 and 6 months postoperatively, adjusting for relevant covariates. CONCLUSIONS: This study provides novel insights into the heterogeneity of reasons for presurgical opioid use in patients undergoing a THA or TKA. One key take away is that not all preoperative opioid use is the same and many patients are taking opioids preoperatively for more than just pain at the surgical site. Combined reasons for use was associated with long-term use, suggesting nonsurgical pain, in part, drives persistent opioid use after surgery. Future directions in perioperative care should focus on pain and non-pain reasons for presurgical opioid use to create tailored postoperative opioid weaning plans.

Evaluation of asbestos exposure resulting from simulated application of spiked talcum powders.

This study characterizes airborne asbestos exposures resulting from the adult application of cosmetic talc body powders spiked with known concentrations of tremolite. Raw talc ores were spiked with 0.005% and 0.1% asbestiform or non-asbestiform tremolite. Personal samples were collected during 16 simulated events, including puff and shaker application and associated clean-up activities. Airborne fiber levels (PCM) were not significantly different for simulations involving talc spiked with asbestiform and non-asbestiform tremolite (p = 0.6104). For application and clean-up of talc spiked with 0.005% asbestiform tremolite, 2 of 24 (8.3%) samples were above the LOD for TEM (0.003 f/cc). For application of talc spiked with 0.1% asbestiform tremolite, 21 of 24 (87.5%) were above the LOD for TEM. The corresponding mean PCME asbestos concentrations were 0.016 f/cc for puff and shaker for samples collected in the first 15 min, 0.002 f/cc for puff and 0.004 f/cc for shaker in the second 15 min, and 0.005 f/cc for puff and 0.013 f/cc for shaker for the full 30 min. Mean PCME concentrations for samples collected during clean-up following application of talc spiked with 0.1% asbestiform tremolite were 0.003 f/cc for samples collected in the first 15 min following puff application, 0.005 f/cc for samples collected in the second 15 min following shaker application, and 0 f/cc for the remaining clean-up samples. Using the EPA's exposure factors, we determined the range of cumulative asbestiform fiber exposures that would result from product use, assuming asbestiform tremolite was present at 0.1%.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

Sexual function after hysterectomy according to surgical indication: a prospective cohort study.

BACKGROUND: Our aims were to describe characteristics of sexual function prior to and 6months following benign hysterectomy in patients with three common surgical indications, and to identify preoperative factors that influence the magnitude and direction of change in sexual function after the procedure. METHODS: This prospective observational cohort study enrolled women (n =80) undergoing hysterectomy for benign indications. Patients were categorised into three groups according to surgical indication: (1) pelvic pain (PP), (2) abnormal uterine bleeding (AUB), and (3) pelvic organ prolapse (POP). Primary outcome was Female Sexual Function Index (FSFI), which patients completed preoperatively and 6months postoperatively. RESULTS: The study included 80 patients, of whom 25.0% (n =20) had surgical indication of PP, 46.3% (n =37) of AUB, and 28.7% (n =23) of POP. PP patients experienced a significant improvement in overall sexual function, as well as orgasm and pain domains following hysterectomy. Significant improvements were not found in AUB and POP patients. In multivariate analysis, lower baseline sexual function (P <0.001), younger age (P =0.013), and pelvic pain<6months (P =0.020) were each independently associated with improvement in sexual function, but surgical indication was not significant. CONCLUSION: Individual patient factors including younger age, lower baseline sexual function, and short duration of pelvic pain are associated with a higher likelihood of improvement in sexual function after hysterectomy. Surgical indication does not appear to be predictive of postoperative sexual function once accounting for other factors.

Evaluation of ventilation, indoor air quality, and probability of viral infection in an outdoor dining enclosure.

In 2020, many cities closed indoor dining to curb rising COVID-19 cases. While restaurants in warmer climates were able to serve outdoors year-round, restaurants in colder climates adopted various solutions to continually operate throughout the colder months, such as the use of single-party outdoor dining enclosures to allow for the continuation of outdoor dining. This study evaluates indoor air quality and the air exchange rate using carbon dioxide as a tracer gas in a dining enclosure (12.03 m3) and models the probability of COVID-19 infection within such an enclosure. The air exchange rates were determined during two trials for the following scenarios: (1) door closed, (2) door opened, and (3) door opened intermittently every 15 min for 1 min per opening. The probability of COVID-19 infection was evaluated for each of these scenarios for 1 hr, with occupancy levels of two, four, and six patrons. The Wells-Riley equation was used to predict the probability of infection inside the dining enclosure. The air exchange rates were lowest in the closed-door scenarios (0.29-0.59 ACH), higher in the intermittent scenarios (2.36-2.49 ACH), and highest in the open-door scenarios (3.61 to 33.35 ACH). As the number of subjects inside the enclosure increased, the carbon dioxide accumulation increased in the closed-door and intermittent scenarios. There was no identifiable accumulation of carbon dioxide in the open-door scenario. The probability of infection (assuming one infected person without a mask) was inversely proportional to the airflow rate, and ranged from 0.0002-0.84 in the open-door scenario, 0.0034-0.94 for the intermittent scenarios, and 0.015-1.0 for the closed-door scenarios. The results from this study indicate that under typical use, the indoor air quality inside dining enclosures degrades during occupancy. The probability of patrons and workers inside dining enclosures being infected with COVID-19 is high when dining or serving a party with an infected person.

Characterizing Pain and Generalized Sensory Sensitivity According to Trauma History Among Patients With Knee Osteoarthritis.

BACKGROUND: Childhood trauma and adversity have been linked to chronic pain and pain sensitivity, particularly centralized pain. Yet, there remain numerous gaps in our understanding of this link. PURPOSE: We explored the association between nonviolent and violent childhood trauma and a component of centralized pain (i.e., generalized sensory sensitivity) and pain sensitivity using self-report measures of centralized pain and quantitative sensory testing (QST). METHODS: Patients scheduled for a total knee arthroplasty (n = 129) completed questionnaires and QST prior to surgery. RESULTS: We found that self-report measures of centralized pain (i.e., widespread pain, somatic awareness, and sensory sensitivity) displayed a graded relationship across trauma groups, with patients with a history of violent trauma reporting the highest scores. Univariable multinomial logistic regression analyses showed that higher sensory sensitivity was associated with increased risk of being in the nonviolent trauma group compared to the no trauma group. Furthermore, higher widespread pain, higher somatic awareness, and higher sensory sensitivity distinguished the violent trauma group from the no trauma group. In multivariable analyses, sensory sensitivity is uniquely distinguished between the violent trauma group and the no trauma group. QST did not distinguish between groups. CONCLUSIONS: The findings highlight the need for future research and interventions that reduce sensory sensitivity for chronic pain patients with a history of violent childhood trauma.

Not immune to inequity: minority under-representation in immunotherapy trials for breast and gynecologic cancers.

OBJECTIVE: To describe the participation of minority women in clinical trials using immunologic agents for breast and gynecologic cancers. METHODS: A retrospective review of completed clinical trials involving immunotherapy for breast and gynecologic cancers was performed. Completed trials were examined for data on race, tumor type, and start year. Minority enrollment was stratified by tumor site. Based on Center for Disease Control and Prevention age-adjusted incidence for race, expected and observed ratios of racial participation were calculated and compared using Χ2 testing, p≤0.05. RESULTS: A total of 53 completed immunotherapy clinical trials involving 8820 patients were reviewed. Breast cancer trials were most common (n=24) and involved the most patients (n=6248, 71%). Racial breakdown was provided in 41 studies (77%) for a total of 7201 patients. Race reporting was lowest in uterine (n=4, 67%) and cervical cancer trials (n=6, 67%), and highest in ovarian cancer trials (n=12, 86%). White patients comprised 70% (n=5022) of all the patients included. Only 5% of patients involved were black (n=339), and 83% of these patients (n=282) were enrolled in breast cancer trials. Observed enrollment of black women was 32-fold lower for ovarian, 19-fold lower for cervical, 15-fold lower for uterine, and 11-fold lower for breast cancer than expected. While all trials reported race between 2013 and 2015, no consistent trend was seen towards increasing race reporting or in enrollment of black patients over time. CONCLUSION: Racial disparities exist in clinical trials evaluating immunologic agents for breast and gynecologic cancers. Recruitment of black women is particularly low. In order to address inequity in outcomes for these cancers, it is crucial that significant attention be directed towards minority representation in immuno-oncologic clinical trials.

Ultrasound-guided percutaneous needle tenotomy using Tenex system for refractory lateral epicondylitis; short and long-term effectiveness and contributing factors.

BACKGROUND: Ultrasound-guided percutaneous needle tenotomy (USPNT) has been proposed as an alternative treatment to surgical intervention for lateral epicondylitis (LE). The Tenex system (Tenex Health Inc., Lake Forest, CA, USA) for USPNT is an ultrasonic device involving a needle which oscillates at high frequency to debride and aspirate diseased tendon under ultrasound image guidance. This investigation evaluates the efficacy of USPNT using the Tenex system for LE refractory to conservative management. We also seek to evaluate patient-specific factors which may correlate with treatment response. MATERIALS AND METHODS: PRTEE (Patient-Rated Tennis Elbow Evaluation) and DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaires were completed before performing the Tenex USPNT for all consecutive patients over a course of 38 months (Feb 2015-Mar 2018). Patients were contacted for follow-up evaluations. Paired t test was used to evaluate significant changes in treatment response (p < 0.05). The univariate Tobit regression model was applied followed by multivariate Tobit model with forward selection algorithm. All models were adjusted by preoperative score and follow-up duration. RESULTS: A total of 37 patients (average age 51± 9 years, M/F:15/22) with refractory LE were included (mean follow-up, 531 days; range, 65-1148 days). Tenex USPNT significantly improved PRTEE and DASH scores (p < 0.001). In some patients, this decrease persisted for up to 3 years after intervention. A significant association between treatment response and post-procedure physical therapy (PT) was present. Post-procedure PT contributes to 60, 68, 59, and 50% of reduction in PRTEE pain, function, total scores, and DASH score, respectively (p < 0.001). No tendon ruptures, post-procedural infections, or other complications were noted. CONCLUSION: USPNT with Tenex significantly improves symptoms and function in individuals with LE even with long-term follow-up for 3 years. Post-procedure PT is associated with improved treatment response and should be considered after USPNT.

Risk Assessment of Glyphosate Exposures from Pilot Study with Simulated Heavy Residential Consumer Application of Roundup® using a Margin of Safety (MOS) Approach.

Due to the widespread application of glyphosate, a nonselective herbicide, to a variety of resistant food crops, the general population is exposed to glyphosate through dietary intake. Despite this, dietary exposures to glyphosate are considered low in comparison to application-related exposures. Although previous studies have evaluated exposure to horticultural and agricultural workers, to date only one study, which we recently conducted, has characterized exposure to glyphosate in consumers following heavy residential application of a glyphosate-containing herbicide in a residential yard and garden setting. In this previous study, we demonstrated that urinary glyphosate concentrations in these applicators were similar to or in some circumstances greater than those in occupational applicators, likely due to the nature of the simulation study, which ensured a heavy application protocol. However, it is unknown whether these urinary glyphosate concentrations in consumer applicators correspond to internal doses that may be of concern. Therefore, the purpose of this study is to provide a comprehensive risk assessment of glyphosate exposure in consumer applicators using a margin of safety approach. Here, we incorporated data collected from multiple spot urine samples across time from our previous study that assessed consumer exposure to glyphosate from Roundup® application. Estimated internal doses, even with the use of conservative assumptions across unique approaches, were below internal doses estimated from established health-based guidance values. Overall, this study demonstrates that glyphosate exposure from even heavy consumer application of a commercially available glyphosate-containing herbicide does not appear to be a health concern.