Race, Ethnicity, and Other Barriers to Access Dental Care During Pregnancy.

BACKGROUND: Historically, women of color showed poorer oral health and lower dental service utilization in the USA. These barriers to dental care during pregnancy included dental coverage, primary language, dental provider availability, safety concerns, affordability of dental care, and perceived oral health benefits during pregnancy. METHODS: The purpose of this study is to examine whether race/ethnicity modified the associations between barriers to accessing dental care and dental service utilization during pregnancy. This cross-sectional study sample included 62,189 women aged 20 and older with a recent birth history in 21 states from the Pregnancy Risk Assessment Monitoring System (PRAMS) data from 2016 to 2019. We introduced a race/ethnicity by barrier interaction term to our multiple logistic regression models. RESULTS: After adjusting for other confounders, dental insurance during pregnancy and perceived oral health benefits were associated with 4.0- and 5.6-fold higher odds, respectively, of dental service utilization during pregnancy. Statistically significant effect modification by race/ethnicity was observed in crude and adjusted analyses of the relationship between dental service utilization for all barriers included in the interaction analyses with all adjusted p-values < 0.001. CONCLUSION: The interaction analysis found that racial/ethnic disparity in visiting dentists during pregnancy was significant among women who reported these dental barriers. In contrast, such racial/ethnic disparity was substantially attenuated among women who did not report such barriers. PRACTICAL IMPLICATIONS: The observed racial/ethnic disparities could be mitigated by such supporting mechanisms: dental coverage, provider availability and willingness to treat pregnant women, oral health education on the safety of dental care during pregnancy, and affordable dental care costs.

Emotional and Financial Stressors in New York City During the COVID-19 Pandemic: A Consecutive Cross-Sectional Analysis.

Mental and financial hardship during the COVID-19 pandemic in New York City was severe, but how vulnerable groups have been disproportionately impacted is incompletely understood. In partnership with community stakeholders, we administered a web-based survey to a convenience sample of New York City residents (18 + years) from May 2020 to April 2021 to evaluate their financial and emotional stressors. We analyzed outcomes by race, ethnicity, and education level. A total of 1854 adults completed the survey across three consecutive non-overlapping samples. Fifty-five percent identified other than non-Latinx White. Sixty-four percent reported emotional stress; 38%, 32%, and 32% reported symptoms of anxiety, depression, and post-traumatic stress disorder respectively; and 21% reported a large adverse financial impact. The leading unmet needs were mental health and food services (both 19%), and health services (18%). Need for both resources grew over time. Adverse financial impact directly correlated with presence of all four adverse mental health outcomes above. In multivariate analysis, non-White race and lack of college degree were associated with adverse financial impact, whereas LGBT identity and lack of college degree were associated with mental health impact. Throughout the COVID-19 pandemic, participants in this research demonstrated a large and growing mental and financial strain, disproportionately associated with lower education level, non-White race, and LGBT status. Our findings suggest an urgent need to differentially target COVID-19 mental health and resource support in New York City to persons in these vulnerable communities.

Depression and anxiety among patients treated for bladder cancer: examining clinical, demographic, and psychosocial predictors.

INTRODUCTION AND OBJECTIVE: The significant impact of bladder cancer and treatment on patient health related quality of life (HRQoL) and emotional wellbeing has been documented. Increasing evidence from cancer research emphasizes the importance of examining patients supportive care needs and received social support as factors that could influence their emotional adjustment. The purpose of the study was to assess the demographic and clinical predictors of depression and anxiety among bladder cancer patients and its associations with patient reported supportive care needs and perceived availability of social support. METHODS: A cross-sectional design was used to investigate the study questions. Bladder cancer patients were recruited from the Bladder Cancer Advocacy Network (BCAN) to complete a questionnaire that included the Hospital Anxiety and Depression Scale (HADS), bladder cancer patient need survey (BCNAS-32), and the social provisions scale (SPS). The inclusion criteria restricted our sample to include bladder cancer patients who were English speakers, aged 18-85 years, and were able and willing to provide informed consent. Patients who had metastatic disease, cancer recurrence, or other primary cancers at the time of assessment were excluded from the study. RESULTS: Participants included 159 bladder cancer patients. The mean age was 62±9.4 years and 51% were male. Almost two-thirds (62%) of patients reported a diagnosis of muscle invasive bladder cancer (MIBC), 25% patient reported clinically significant levels of anxiety, 17% reported clinically significant levels of depression, and 13% and 17% reported abnormal borderline abnormal levels for anxiety and depression, respectively. Univariate regression analyses revealed significant associations between HADS total score, HADS depression and anxiety subscales, patient age, physical functioning/daily living needs, sexuality needs, and perceived social support with higher total scores, anxiety, and depression scores associated with younger age, higher unmet needs, and lower levels of social support. Multivariate regression analyses, showed similar findings confirming the associations depicted by the univariate regression analyses. CONCLUSIONS: Bladder cancer patients experience significant levels of depression and anxiety and these levels are associated with patient age, supportive care unmet needs and lack of social support. Patient focused interventions could be tailored to address these issues with the goal to improve patient HRQoL and emotional adjustment.

Autonomic Neuropathy is Associated with More Densely Interconnected Cytokine Networks in People with HIV.

The autonomic nervous system (ANS) plays a complex role in the regulation of the immune system, with generally inhibitory effects via activation of ß-adrenergic receptors on immune cells. We hypothesized that HIV-associated autonomic neuropathy (HIV-AN) would result in immune hyperresponsiveness which could be depicted using network analyses. Forty-two adults with well-controlled HIV underwent autonomic testing to yield the Composite Autonomic Severity Score (CASS). The observed range of CASS was 2-5, consistent with normal to moderate HIV-AN. To construct the networks, participants were divided into 4 groups based on the CASS (i.e., 2, 3, 4 or 5). Forty-four blood-based immune markers were included as nodes in all networks and the connections (i.e., edges) between pairs of nodes were determined by their bivariate Spearman's Rank Correlation Coefficient. Four centrality measures (strength, closeness, betweenness and expected influence) were calculated for each node in each network. The median value of each centrality measure across all nodes in each network was calculated as a quantitative representation of network complexity. Graphical representation of the four networks revealed greater complexity with increasing HIV-AN severity. This was confirmed by significant differences in the median value of all four centrality measures across the networks (p ≤ 0.025 for each). Among people with HIV, HIV-AN is associated with stronger and more numerous positive correlations between blood-based immune markers. Findings from this secondary analysis can be used to generate hypotheses for future studies investigating HIV-AN as a mechanism contributing to the chronic immune activation observed in HIV.

Autonomic Neuropathy is Associated with More Densely Interconnected Cytokine Networks in People with HIV.

Introduction: The autonomic nervous system (ANS) plays a complex role in the regulation of the immune system, with generally inhibitory effects via activation of ß-adrenergic receptors on immune cells. We hypothesized that HIV-associated autonomic neuropathy (HIV-AN) would result in immune hyperresponsiveness which could be depicted using network analyses. Methods: Forty-two adults with well-controlled HIV underwent autonomic testing to yield the Composite Autonomic Severity Score (CASS). The observed range of CASS was 2-5, consistent with normal to moderate HIV-AN. To construct the networks, participants were divided into 4 groups based on the CASS (i.e., 2, 3, 4 or 5). Forty-four blood-based immune markers were included as nodes in all networks and the connections (i.e., edges) between pairs of nodes were determined by their bivariate Spearman's Rank Correlation Coefficient. Four centrality measures (strength, closeness, betweenness and expected influence) were calculated for each node in each network. The median value of each centrality measure across all nodes in each network was calculated as a quantitative representation of network complexity. Results: Graphical representation of the four networks revealed greater complexity with increasing HIV-AN severity. This was confirmed by significant differences in the median value of all four centrality measures across the networks (p≤0.025 for each). Conclusion: Among people with HIV, HIV-AN is associated with stronger and more numerous positive correlations between blood-based immune markers. Findings from this secondary analysis can be used to generate hypotheses for future studies investigating HIV-AN as a mechanism contributing to the chronic immune activation observed in HIV.

Undue burden: Black faculty, COVID-19, and the racial justice movement.

A crucial reckoning was initiated when the COVID-19 pandemic began to expose and intensify long-standing racial/ethnic health inequities, all while various sectors of society pursued racial justice reform. As a result, there has been a contextual shift towards broader recognition of systemic racism, and not race, as the shared foundational driver of both societal maladies. This confluence of issues is of particular relevance to Black populations disproportionately affected by the pandemic and racial injustice. In response, institutions have initiated diversity, equity, and inclusion (DEI) efforts as a way forward. This article considers how the dual pandemic climate of COVID-19-related health inequities and the racial justice movement could exacerbate the "time and effort tax" on Black faculty to engage in DEI efforts in academia and biomedicine. We discuss the impact of this "tax" on career advancement and well-being, and introduce an operational framework for considering the interconnected influence of systemic racism, the dual pandemics, and DEI work on the experience of Black faculty. If not meaningfully addressed, the "time and effort tax" could contribute to Black and other underrepresented minority faculty leaving academia and biomedicine - consequently, the very diversity, equity, and inclusion work meant to increase representation could decrease it.

Use of hospitals in the New York City Metropolitan Region, by race: how separate? How equal in resources and quality?

BACKGROUND: Although racial and ethnic minorities disproportionately use some hospitals, hospital-based racial and ethnic composition relative to geographic region and its association with quality indicators has not been systematically analyzed. METHODS: We used four race and ethnicity categories: non-Hispanic white (NHW), non-Hispanic black (NHB), Hispanic, and Asian/Pacific Islander/Alaskan Native/American Indian (API/AIAN), as well as a combined non-NHW category, from the 2010 (latest year publicly available) Medicare Institutional Provider & Beneficiary Summary public use file for 84 hospitals in the New York City region. We assessed the relative distribution of race and ethnicity across hospitals grouped at different geographic levels (region, county, hospital referral region [HRR], or hospital service areas [HSA]) using the dissimilarity index. Hospital characteristics included quality star ratings, essential professional services and diagnostic/treatment equipment, bed size, total expenses, and patients with dual Medicare and Medicaid enrollment. We assessed Spearman's rank correlation between hospital-based racial and ethnic composition and quality/structural measures. RESULTS: Dissimilarity Index decreases from region (range 30.3-40.1%) to county (range 13.7-23.5%), HRR (range 10.5-27.5%), and HSA (range 12.0-16.9%) levels. Hospitals with larger non-NHW patients tended to have lower hospital ratings and higher proportions of dually-enrolled patients. They were also more likely to be safety net hospitals and non-federal governmental hospitals. CONCLUSIONS: In the NYC metropolitan region, there is considerable hospital-based racial and ethnic segregation of Medicare patients among non-NHW populations, extending previous research limited to NHB. Availability of data on racial and ethnic composition of hospitals should be made publicly available for researchers and consumers.

Interpreting resting heart rate variability in complex populations: the role of autonomic reflexes and comorbidities.

PURPOSE: Resting heart rate variability (HRV) is an important biomarker linking mental health to cardiovascular outcomes. However, resting HRV is also impaired in autonomic neuropathy, a common and underdiagnosed complication of common medical conditions which is detected by testing autonomic reflexes. We sought to describe the relationship between autonomic reflex abnormalities and resting HRV, taking into consideration medical comorbidities and demographic variables. METHODS: Participants (n = 209) underwent a standardized autonomic reflex screen which was summarized as the Composite Autonomic Severity Score (CASS) and included measures of reflexive HRV, e.g., heart rate with deep breathing (HRDB). Resting HRV measures were: pNN50 (percentage of NN intervals that differ by > 50 ms) and cvRMSSD (adjusted root mean square of successive differences). RESULTS: In univariate analyses, lower resting HRV was associated with: older age, higher CASS, neuropathy on examination, hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, and psychiatric disease. Adaptive regression spline analysis revealed that HRDB explained 27% of the variability in resting HRV for participants with values of HRDB in the normal range. Outside this range, there was no linear relationship because: (1) when HRDB was low (indicating autonomic neuropathy), resting HRV was also low with low variance; and (2) when HRDB was high, the variance in resting HRV was high. In multivariate models, only HRDB was significantly independently associated with cvRMSSD and pNN50. CONCLUSION: Subclinical autonomic neuropathy, as evidenced by low HRDB and other autonomic reflexes, should be considered as a potential confounder of resting HRV in research involving medically and demographically diverse populations.

Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial.

BACKGROUND: The 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting. METHODS: TOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination). RESULTS: PCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs). CONCLUSIONS: CDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939 . Registration date: 9/13/2018.

Disparities in telehealth utilization in patients with pain during COVID-19.

Introduction: The shift from in-person visits to telehealth visits during the COVID-19 pandemic presented unique challenges for patients with pain. Disparities in health care access already existed, and the impact of telehealth on these inequities has not been studied. Objectives: To identify sociodemographic characteristics of patients with pain obtaining care through video, telephone, and in-person visits as social distancing restrictions evolved during the COVID-19 pandemic. Methods: Using our institutional clinical data warehouse, we identified 3314 patients with pain receiving care at a large academic institution in New York City during a baseline period (September 23, 2019-March 22, 2020) and counted telephone, video, and in-person visits during the following conditions: a shutdown period (March 23, 2020-May 23, 2020), when nonessential in-person visits were strictly limited, and a reopening period (May 23, 2020-September 23, 2020), when restrictions were relaxed and in-person visits were available. Patients were categorized into 4 groups based on the technology used to complete a visit: (1) video, (2) telephone, (3) in-person, and (4) no visit. Results: Patients who were older, publicly insured, and identified as Black or Hispanic were overrepresented in the telephone visit group during shutdown and the in-person group during reopening. A video visit during shutdown increased the likelihood of continued video visit use during reopening despite the return of in-person visits. Conclusions: Results show differences in how patients with pain accessed clinical care in a socially distanced world and that flexibility in method of health care delivery may reduce barriers to access. Future research will identify factors (eg, Internet access, digital literacy, provider-patient relationships) driving heterogeneity in telehealth use in patients with pain.

COVID-19 in patients with and without cancer: Examining differences in patient characteristics and outcomes.

This study examines differences between patients with and without cancer in patient demographic and clinical characteristics and COVID-19 mortality and discusses the implications of these differences in relation to existing cancer disparities and COVID-19 vulnerabilities. Data was collected as a part of a retrospective study on a cohort of COVID-19 positive patients across Mount Sinai Health System from March 28, 2020 to April 26, 2020. Descriptive, comparative, and regression analyses were applied to examine differences between patients with and without cancer in demographic and clinical characteristics and COVID-19 mortality and whether cancer status predicts COVID-19 mortality controlling for these covariates using SAS 9.4. Results showed that, of 4641 patients who tested positive for COVID-19, 5.1% (N=236) had cancer. The median age of the total sample was 58 years (Q1-Q3: 41-71); 55.3% were male, 19.2% were current/former smokers, 6.1% were obese. The most commonly reported comorbidities were hypertension (22.6%) and diabetes (16.0%). Overall, the COVID-19 mortality rate was 8.3%. Examining differences between COVID-19 patients with and without cancer revealed significant differences (p<0.05) in COVID-19 mortality, hospitalization rates, age, gender, race, smoking status, obesity, and comorbidity indicators (e.g., diabetes) with cancer patients more likely to be older, male, black, obese, smokers, and with existing comorbidities. Controlling for these clinical, demographic, and behavioral characteristics, results of logistic regression analyses showed significant effects of older age and male gender on COVID-19 mortality (p<0.05). While cancer patients with COVID-19 were more likely to experience worse COVID-19 outcomes, these associations might be related to common cancer and COVID-19 vulnerability factors such as older age and gender. The coexistence of these vulnerability age and gender factors in both cancer and COVID-19 populations emphasizes the need for better understanding of their implications for cancer and COVID-19 disparities, both diseases prevention efforts, policies, and clinical management.

Association between chronic kidney disease and COVID-19-related mortality in New York.

PURPOSE: To evaluate mortality risk of CKD patients infected with COVID-19, and assess shared characteristics associated with health disparities in CKD outcome. METHODS: We extracted the data from a case series of 7624 patients presented at Mount Sinai Health System, in New York for testing between 3/28/2020 and 4/16/2020. De-identified patient data set is being produced by the Scientific Computing department and made available to the Mount Sinai research community at the following website: https://msdw.mountsinai.org/ . RESULTS: Of 7624 COVID-19 patients, 7.8% (n = 597) had CKD on hospital admission, and 11.2% (n = 856) died of COVID-19 infection. CKD patients were older, more likely to have diabetes, hypertension, and chronic obstructive pulmonary disease (COPD), were current or former smokers, had a longer time to discharge, and had worse survival compared to non-CKD patients (p < 0.05). COVID-19 mortality rate was significantly higher in CKD patients (23.1% vs 10.2%) with a 1.51 greater odds of dying (95% CI: 1.19-1.90). Controlling for demographic, behavioral, and clinical covariates, the logistic regression analysis showed significant and consistent effects of CKD, older age, male gender, and hypertension with mortality (p < 0.05). CONCLUSION: CKD was a significant independent predictor of COVID-19 mortality, along with older age, male gender, and hypertension. Future research will investigate the effects of COVID-19 on long-term renal function.

Characteristics of telehealth users in NYC for COVID-related care during the coronavirus pandemic.

OBJECTIVE: To explore whether racial/ethnic differences in telehealth use existed during the peak pandemic period among NYC patients seeking care for COVID-19 related symptoms. MATERIALS AND METHODS: This study used data from a large health system in NYC - the epicenter of the US crisis - to describe characteristics of patients seeking COVID-related care via telehealth, ER, or office encounters during the peak pandemic period. Using multinomial logistic regression, we estimated the magnitude of the relationship between patient characteristics and the odds of having a first encounter via telehealth versus ER or office visit, and then used regression parameter estimates to predict patients' probabilities of using different encounter types given their characteristics. RESULTS: Demographic factors, including race/ethnicity and age, were significantly predictive of telehealth use. As compared to Whites, Blacks had higher adjusted odds of using both the ER versus telehealth (OR: 4.3, 95% CI: 4.0-4.6) and office visits versus telehealth (OR: 1.4, 95% CI: 1.3-1.5). For Hispanics versus Whites, the analogous ORs were 2.5 (95% CI: 2.3-2.7) and 1.2 (95% CI: 1.1-1.3). Compared to any age groups, patients 65+ had significantly higher odds of using either ER or office visits versus telehealth. CONCLUSIONS: The response to COVID-19 has involved an unprecedented expansion in telehealth. While older Americans and minority populations among others are known to be disadvantaged by the digital divide, few studies have examined disparities in telehealth specifically, and none during COVID-19. Additional research into sociodemographic heterogeneity in telehealth use is needed to prevent potentially further exacerbating health disparities overall.

Sympathetic function and markers of inflammation in well-controlled HIV.

PURPOSE: HIV-associated autonomic neuropathy (HIV-AN) is common and may be associated with both sympathetic and parasympathetic dysfunction. Sympathetic nervous system (SNS) dysfunction occurs on a continuum of hyper-to hypo-adrenergic function, and may be a mediator between psychological stress and chronic inflammation. We sought to describe patterns of SNS dysfunction in people living with HIV, and to determine whether SNS dysfunction is associated with markers of systemic inflammation (focusing on IL-6 and TNF-α) and pain and anxiety. METHODS: Forty-seven people with well-controlled HIV and without confounding medical conditions or medications completed the Medical Outcomes Survey (MOS-HIV), quantification of a panel of 41 plasma cytokines/chemokines, and a standardized, non-invasive autonomic reflex screen (ARS). Adrenergic baroreflex sensitivity (BRSA) was calculated from the ARS as a measure of SNS function. RESULTS: Pain (46%) and anxiety (52%) were commonly reported on the MOS-HIV. BRSA was reduced in 30% of participants and elevated in 9% with the latter occurring only in participants with normal to mild HIV-AN. BRSA was significantly associated with IL-6, but not with TNF-α, pain or anxiety. Exploratory analyses also revealed positive associations of BRSA with numerous other cytokines with no significant inverse associations. CONCLUSION: Higher BRSA, indicative of a more hyperadrenergic state, can be part of the spectrum of early HIV-AN, and may be associated with elevations in multiple cytokines including IL-6. These associations do not appear to be driven by stressors such as pain or anxiety.

Involving Patients in the Development and Evaluation of an Educational and Training Experiential Intervention (ETEI) to Improve Muscle Invasive Bladder Cancer Treatment Decision-making and Post-operative Self-care: a Mixed Methods Approach.

This study aims to describe the acceptability and feasibility of an educational and training experiential intervention (ETEI) we developed to enhance muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care. Twenty-five patients were randomized to a control group (N = 8) or ETEI group (N = 17). ETEI group participated in a nurse-led session on MIBC education. The control group received diet and nutrition education. Study questionnaires were completed at baseline and at 1-month post-intervention. Our results showed acceptable recruitment (58%) and retention rates (68%). The ETEI group reported increased knowledge (82% vs. 50%), improved decisional support (64% vs. 50%), improved communication (73% vs. 50%), and increased confidence in treatment decisions (73% vs. 50%) compared to the control group. Patients in the control group reported improved diet (50% v. 27%) as well as maintaining a healthy lifestyle (67% vs. 45%) compared to the ETEI group. Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group. The ETEI was feasible, acceptable, and showed a potential for inducing desired changes in cancer worries and efficacy beliefs.

Decreasing risk among HIV patients on opioid therapy for chronic pain: Development of the TOWER intervention for HIV care providers.

Many people with HIV (PWH) experience chronic pain that limits daily function and quality of life. PWH with chronic pain have commonly been prescribed opioids, sometimes for many years, and it is unclear if and how the management of these legacy patients should change in light of the current US opioid epidemic. Guidelines, such as the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain (CDCG), provide recommendations for the management of such patients but have yet to be translated into easily implementable interventions; there is also a lack of strong evidence that adhering to these recommendations improves patient outcomes such as amount of opioid use and pain levels. Herein we describe the development and preliminary testing of a theory-based intervention, called TOWER (TOWard SafER Opioid Prescribing), designed to support HIV primary care providers in CDCG-adherent opioid prescribing practices with PWH who are already prescribed opioids for chronic pain. TOWER incorporates the content of the CDCG into the theoretical and operational framework of the Information Motivation and Behavioral Skills (IMB) model of health-related behavior. The development process included elicitation research and incorporation of feedback from providers and PWH; testing is being conducted via an adaptive feasibility clinical trial. The results of this process will form the basis of a large, well-powered clinical trial to test the effectiveness of TOWER in promoting CDCG-adherent opioid prescribing practices and improving outcomes for PWH with chronic pain.

Randomized-controlled trial of a modified Mediterranean dietary program for multiple sclerosis: A pilot study.

BACKGROUND: There is a high level of interest in the potential role of diet among the MS community. There is a limited level of evidence for a Mediterranean-style dietary pattern in MS; the feasibility of conducting studies using educational tools to deliver this type of intervention and study its effects is unknown. OBJECTIVES: To establish clinical trial feasibility for future studies utilizing educational delivery of a dietary intervention in MS; to explore the effects of a modified Mediterranean dietary intervention in MS. METHODS: We randomly assigned women with MS to follow/not follow the prescribed modified Mediterranean dietary intervention for 6 months, delivered through educational sessions. The diet encouraged the intake of fish and other foods high in poly- and monounsaturated fats, fresh fruits, vegetables, and whole grains and eliminated meat, dairy, and most processed foods and limited salt intake to <2 g/day. Primary endpoints related to meeting target enrollment within the specified time frame, adherence, and study completion. Clinical endpoints were evaluated in an exploratory fashion. RESULTS: We screened 128 potential participants and enrolled 36 within 9 months, surpassing target enrollment of 30 participants at a single center in 1 year. Self-reported adherence was excellent (90.3%), with an overall study completion rate of 94.4%. The intervention group exhibited a statistically significant decline in the trajectory of Neurological Fatigue Index-MS scores (p = 0.01), a trend toward reduced Multiple Sclerosis Impact Scale-29 scores that became significant after outlier removal (p = 0.12; p = 0.023), and a reduction in Expanded Disability Status Scale (p = 0.01) over time as compared to the non-intervention group. CONCLUSIONS: It is reasonable to expect a high level of interest and commitment to this type of dietary intervention study in MS, and feasible to deliver it purely through education in a clinical setting with high adherence levels despite restrictive requirements. In this pilot study, a modified Mediterranean dietary intervention reduced fatigue, impact of MS symptoms, and disability. Further work is needed.

The effect of pyridostigmine on small intestinal bacterial overgrowth (SIBO) and plasma inflammatory biomarkers in HIV-associated autonomic neuropathies.

Small intestinal bacterial overgrowth (SIBO) is common among patients with HIV-associated autonomic neuropathies (HIV-AN) and may be associated with increased bacterial translocation and elevated plasma inflammatory biomarkers. Pyridostigmine is an acetylcholinesterase inhibitor which has been used to augment autonomic signaling. We sought preliminary evidence as to whether pyridostigmine could improve proximal gastrointestinal motility, reduce SIBO, reduce plasma sCD14 (a marker of macrophage activation and indirect measure of translocation), and reduce the inflammatory cytokines IL-6 and TNFα in patients with HIV-AN. Fifteen participants with well-controlled HIV, HIV-AN, and SIBO were treated with 8 weeks of pyridostigmine (30 mg PO TID). Glucose breath testing for SIBO, gastric emptying studies (GES) to assess motility, plasma sCD14, IL-6, and TNFα, and gastrointestinal autonomic symptoms were compared before and after treatment. Thirteen participants (87%) experienced an improvement in SIBO following pyridostigmine treatment; with an average improvement of 50% (p = 0.016). There was no change in gastrointestinal motility; however, only two participants met GES criteria for gastroparesis at baseline. TNFα and sCD14 levels declined by 12% (p = 0.004) and 19% (p = 0.015), respectively; there was no significant change in IL-6 or gastrointestinal symptoms. Pyridostigmine may ameliorate SIBO and reduce levels of sCD14 and TNFα in patients with HIV-AN. Larger placebo-controlled studies are needed to definitively delineate how HIV-AN affects gastrointestinal motility, SIBO, and systemic inflammation in HIV, and whether treatment improves clinical outcomes.

Molecular Study of Thyroid Cancer in World Trade Center Responders.

Thyroid cancer incidence is higher in World Trade Center (WTC) responders compared with the general population. It is unclear whether this excess in thyroid cancer is associated with WTC-related exposures or if instead there is an over-diagnosis of malignant thyroid cancer among WTC first responders due to enhanced surveillance and physician bias. To maximize diagnostic yield and determine the false positive rate for malignancy, the histological diagnoses of thyroid cancer tumors from WTC responders and age, gender, and histology matched non-WTC thyroid cancer cases were evaluated using biomarkers of malignancy. Using a highly accurate panel of four biomarkers that are able to distinguish benign from malignant thyroid cancer, our results suggest that over-diagnosis by virtue of misdiagnosis of a benign tumor as malignant does not explain the increased incidence of thyroid cancer observed in WTC responders. Therefore, rather than over-diagnosis due to physician bias, the yearly screening visits by the World Trade Center Health Program are identifying true cases of thyroid cancer. Continuing regular screening of this cohort is thus warranted.