Cluster analysis identifies novel real-world lung disease-pulmonary hypertension subphenotypes: implications for treatment response.

Background: Clinical trials repurposing pulmonary arterial hypertension (PAH) therapies to patients with lung disease- or hypoxia-pulmonary hypertension (PH) (classified as World Health Organization Group 3 PH) have failed to show a consistent benefit. However, Group 3 PH clinical heterogeneity suggests robust phenotyping may inform detection of treatment-responsive subgroups. We hypothesised that cluster analysis would identify subphenotypes with differential responses to oral PAH therapy. Methods: Two k-means analyses were performed on a national cohort of US veterans with Group 3 PH; an inclusive model (I) of all treated patients (n=196) and a haemodynamic model (H) limited to patients with right heart catheterisations (n=112). The primary outcome was organ failure or all-cause mortality by cluster. An exploratory analysis evaluated within-cluster treatment effects. Results: Three distinct clusters of Group 3 PH patients were identified. In the inclusive model (C1I n=43, 21.9%; C2I n=102, 52.0%; C3I n=51, 26.0%), lung disease and spirometry drove cluster assignment. By contrast, in the haemodynamic model (C1H n=44, 39.3%; C2H n=43, 38.4%; C3H n=25, 22.3%), right heart catheterisation data surpassed the importance of lung disease and spirometry. In the haemodynamic model, compared to C3H, C1H experienced the greatest hazard for respiratory failure or death (HR 6.1, 95% CI 3.2-11.8). In an exploratory analysis, cluster determined treatment response (p=0.006). Conclusions regarding within-cluster treatment responses were limited by significant differences between select variables in the treated and untreated groups. Conclusions: Cluster analysis identifies novel real-world subphenotypes of Group 3 PH patients with distinct clinical trajectories. Future studies may consider this methodological approach to identify subgroups of heterogeneous patients that may be responsive to existing pulmonary vasodilatory therapies.

Self-medication of pain and discomfort with alcohol and other substances by people with HIV infection and substance use disorder: preliminary findings from a secondary analysis.

There is a limited literature regarding factors associated with self-medication of pain and discomfort using alcohol, non-prescription substances or overuse of prescription medications among people living with Human Immunodeficiency Virus (HIV). This cross-sectional analysis used data from the Boston ARCH Cohort among participants with HIV infection and a history of alcohol or other substance use. Among 248 participants, 37% were female, 50% Black, 25% Latinx; 36% reported fair to poor health and 89% had CD4 cell counts >200/mm3. Half reported self-medication and of those, 8.8% reported doing so only with alcohol, 48.8% only with other substances and 42.4% with both alcohol and other substances. Those reporting self-medication were significantly (p < .05) younger (mean 47 vs 50 years), less employed (11% vs 21%), and less likely to have HIV viral suppression (60% vs. 80%). Depression, anxiety, and HIV symptoms were associated with significantly greater odds of self-medicating, as were substance dependence, recent injection substance use, heavy alcohol use, cocaine use, opioid use, sedative use, and cannabis use. Self-medication, highly prevalent and associated with worse mental health symptoms, greater substance use, and lesser HIV disease control, should be explored by HIV clinicians caring for people who use substances.

Alcohol Consumption and Illicit Drug Use: Associations With Fall, Fracture, and Acute Health Care Utilization Among People With HIV Infection.

BACKGROUND: Given alcohol and/or other drug (AOD) use occurs among people with HIV (PWH), we examined its association with falls and fall-related outcomes and whether frailty moderates the association. SETTING: Northeastern US city. METHODS: We analyzed an observational cohort of PWH with current or past AOD use. Alcohol measures were any past 14-day heavy use, average alcohol/day, and days with heavy use. Drug use measures were past 30-day illicit use of cocaine, opioids, and sedatives. Repeated cross-sectional associations were estimated with separate multivariable generalized estimating equation regression models for each fall-related outcome. RESULTS: Among PWH (n = 251; mean age 52 [SD = 10]), 35% reported heavy alcohol use, 24% cocaine, 16% illicit opioids, 13% illicit sedatives, and 35% any fall; 27% were frail. Heavy alcohol use was associated with a fall (AOR = 1.49, 95% CI: 1.08 to 2.07), multiple falls (AOR = 1.55 95% CI: 1.10 to 2.19), and fall/fracture-related emergency department visit or hospitalization (AOR = 1.81, 95% CI: 1.10 to 2.97). Higher average alcohol/day and more heavy drinking days were associated with multiple falls. Illicit sedative use was associated with a fall, multiple falls, and emergency department visit/hospitalization and opioid use with fracture. Frailty moderated the association of heavy alcohol use and a fall (AOR = 2.26, 95% CI: 1.28 to 4.01 in those frail) but not in those not frail. CONCLUSION: The effect of AOD use on falls and fall-related outcomes was most pronounced with alcohol, particularly among frail PWH. Heavy alcohol, illicit sedative, and illicit opioid use are high-priority targets for preventing falls and fall-related consequences for PWH.

Association between resilience promotion factors during childhood and risk of drug use disorder during adulthood.

Few studies have been conducted on the relationship between "outside-residing" resilience characteristics and the risk of developing drug use disorder later in life. These characteristics include responsive and caring parenting, household routines involving regular family meals and bedtime routines, social support from peers, participation in organized activities, and religious service attendance. We quantified the association between these resilience promotion factors during childhood and the risk of developing criteria for drug use disorder during adulthood using data from a retrospective cohort study of 618 adults born in Massachusetts during 1969-1983, including those with adverse childhood experiences (ACEs). Self-administered questionnaires gathered information on criteria for drug use disorder, ACEs, and family and community resilience promotion factors. Compared to individuals with "low" numbers of resilience promotion factors, 30% (95% CI: 0.5-0.9) and 50% reductions (95% CI: 0.4-0.8) in the risk of developing one or more criteria for drug use disorder were observed among those with "moderate" and "high" numbers of resilience factors, respectively (p value for trend=0.003). Overall, family factors were associated with greater risk reductions than comparable numbers of community factors. Among individuals with ACEs, a "high" number of family factors but not community factors were associated with a reduction in risk (RR:0.6, 95% CI:0.4-1.0 for family factors, RR:1.0, 95% CI:0.5-1.8 for community factors). These results suggest that the risk of developing criteria for drug use disorder decreases in a dose-response fashion according to the number of "outside-residing" resilience promotion factors during childhood, and that family factors are associated with greater risk reductions than community factors, particularly among individuals with ACEs. Coordinated prevention efforts at the family and community level are recommended to reduce the risk of this important societal problem.

Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial.

BACKGROUND: Medically underserved people with type 2 diabetes mellitus face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap. OBJECTIVE: The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A1c (HbA1c) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. METHODS: This study is a noninferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety net health system and community health center. We enrolled adult women (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA1c ≥8%. Participants attended 8 weekly DMGVs, which included diabetes self-management education, peer support, and clinician counseling using a culturally adapted curriculum in English or Spanish. In-person participants convened in clinical settings, while virtual world (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA1c and physical activity at 6 months, with noninferiority margins of 0.7% and 12 MET-hours, respectively. Secondary outcomes included changes in diabetes distress and depressive symptoms. RESULTS: Of 309 female participants (mean age 55, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA1c by group at 6 months (IP: -0.8%, SD 1.9%; VW: -0.5%, SD 1.8%; mean difference 0.3, 97.5% CI -∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: -6.5, SD 43.6; VW: -9.6, SD 44.8 MET-hours; mean difference -3.1, 97.5% CI -6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups. CONCLUSIONS: In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425.

Impact of alcohol use disorder severity on human immunodeficiency virus (HIV) viral suppression and CD4 count in three international cohorts of people with HIV.

BACKGROUND: Alcohol use has been linked to worse human immunodeficiency virus (HIV) immunologic/virologic outcomes, yet few studies have explored the effects of alcohol use disorder (AUD). This study assessed whether AUD severity is associated with HIV viral suppression and CD4 count in the three cohorts of the Uganda Russia Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH) Consortium. METHODS: People with HIV (PWH) in Uganda (n = 301), Russia (n = 400), and Boston (n = 251), selected in-part based on their alcohol use, were included in analyses. Logistic and linear regressions were used to assess the cross-sectional associations between AUD severity (number of DSM-5 diagnostic criteria) and (1) HIV viral suppression, and (2) CD4 count (cells/mm3 ) adjusting for covariates. Analyses were conducted separately by site. RESULTS: The proportion of females was 51% (Uganda), 34% (Russia), and 33% (Boston); mean age (SD) was 40.7 (9.6), 38.6 (6.3), and 52.1 (10.5), respectively. All participants in Uganda and all but 27% in Russia and 5% in Boston were on antiretroviral therapy. In Uganda, 32% met criteria for AUD, 92% in Russia, and 43% in Boston. The mean (SD) number of AUD criteria was 1.6 (2.4) in Uganda, 5.6 (3.3) in Russia, and 2.4 (3.1) in Boston. Most participants had HIV viral suppression (Uganda 92%, Russia 57%, Boston 87%); median (IQR) CD4 count was 673 (506, 866), 351 (201, 542), and 591 (387, 881), respectively. In adjusted models, there were no associations between AUD severity and HIV viral suppression: adjusted odds ratios (AOR) (95%CI) per 1 additional AUD criterion in Uganda was 1.08 (0.87, 1.33); Russia 0.98 (0.92, 1.04); and Boston 0.95 (0.84, 1.08) or CD4 count: mean difference (95%CI) per 1 additional criterion: 5.78 (-7.47, 19.03), -3.23 (-10.91, 4.44), and -8.18 (-24.72, 8.35), respectively. CONCLUSIONS: In three cohorts of PWH, AUD severity was not associated with HIV viral suppression or CD4 count. PWH with AUD in the current era of antiretroviral therapy can achieve virologic control.

Polysubstance Use Patterns Associated With HIV Disease Severity Among Those With Substance Use Disorders: A Latent Class Analysis.

OBJECTIVE: Polysubstance use is common among people with HIV infection (PWH) and with substance use disorder (SUD), but its effects are understudied. We aimed to identify polysubstance use patterns over time and assess their associations with HIV disease severity. METHOD: In 233 PWH with current or past SUD, latent class analysis identified polysubstance use patterns based on the Alcohol Use Disorders Identification Test-Consumption and past-30-day use of cannabis, cocaine, opioids, and tranquilizers at baseline. We categorized changes in use patterns and tested associations between those changes and CD4 count and HIV viral suppression at 12 months in linear and logistic regressions. RESULTS: Three patterns were identified at baseline: 18% did not use any substance (NONE--a priori defined); 63% used mostly cannabis and alcohol (CA); and 19% used opioids along with other drugs, including cocaine, tranquilizers, cannabis, and alcohol (MULTI). At 12 months, 40% moved from a high to a lower substance use class (MULTI to CA, either to NONE) or remained as NONE, 43% were in CA both times and 17% increased (NONE to CA, either to MULTI) or remained as MULTI. The adjusted mean CD4 count (for baseline covariates and baseline CD4 count) was significantly lower among participants increasing or remaining in MULTI (523, 95% CI [448, 598], cells/mm3) compared with those who decreased/abstained throughout (607, 95% CI [552, 663], p = .02). No significant difference was observed for HIV viral suppression. CONCLUSIONS: We identified distinct polysubstance use patterns among PWH with SUD: cannabis/alcohol and opioids with alcohol and other drugs. Changes over time toward fewer substances/no use were associated with lower HIV disease severity based on CD4 count but not based on HIV viral suppression.

Digital Global Recruitment for Women's Health Research: Cross-sectional Study.

BACKGROUND: With the increased popularity of mobile menstrual tracking apps and boosted Facebook posts, there is a unique opportunity to recruit research study participants from across the globe via these modalities to evaluate women's health. However, no studies to date have assessed the feasibility of using these recruitment sources for epidemiological research on ovulation and menstruation. OBJECTIVE: The objective of this study was to assess the feasibility of recruiting a diverse sample of women to an epidemiological study of ovulation and menstruation (OM) health (OM Global Health Study) using digital recruitment sources. The feasibility and diversity were assessed via click and participation rates, geographic location, BMI, smoking status, and other demographic information. METHODS: Participants were actively recruited via in-app messages using the menstrual tracking app Clue (BioWink GmbH) and a boosted Facebook post by DivaCup (Diva International Inc.). Other passive recruitment methods also took place throughout the recruitment period (eg, email communications, blogs, other social media). The proportion of participants who visited the study website after viewing and clicking the hypertext link (click rates) in the in-app messages and boosted Facebook post and the proportion of participants who completed the surveys per the number of completed consent and eligibility screeners (participation rates) were used to quantify the success of recruiting participants to the study website and study survey completion, respectively. Survey completion was defined as finishing the pregnancy and birth history section of the OM Global Health Study questionnaire. RESULTS: The recruitment period was from February 27, 2018, through January 24, 2020. In-app messages and the boosted Facebook post were seen by 104,000 and 21,400 people, respectively. Overall, 215 participants started the OM Global Health Study survey, of which 140 (65.1%), 39 (18.1%), and 36 (16.8%) participants were recruited via the app, the boosted Facebook post, and other passive recruitment methods, respectively. The click rate via the app was 18.9% (19,700 clicks/104,000 ad views) and 1.6% via the boosted Facebook post (340 clicks/21,400 ad views.) The overall participation rate was 44.6% (198/444), and the average participant age was 21.8 (SD 6.1) years. In terms of geographic and racial/ethnic diversity, 91 (44.2%) of the participants resided outside the United States and 147 (70.7%) identified as non-Hispanic White. In-app recruitment produced the most geographically diverse stream, with 44 (32.8%) of the 134 participants in Europe, 77 (57.5%) in North America, and 13 (9.8%) in other parts of the world. Both human error and nonhuman procedural breakdowns occurred during the recruitment process, including a computer programming error related to age eligibility and a hacking attempt by an internet bot. CONCLUSIONS: In-app messages using the menstrual tracking app Clue were the most successful method for recruiting participants from many geographic regions and producing the greatest numbers of started and completed surveys. This study demonstrates the utility of digital recruitment to enroll participants from diverse geographic locations and provides some lessons to avoid technical recruitment errors in future digital recruitment strategies for epidemiological research.

Alcohol and falls among people with HIV infection: A view from Russia and the United States.

BACKGROUND: Both human immunodeficiency virus (HIV) infection and alcohol use predispose to autonomic/sensory neuropathy, imbalance symptoms, and cognitive impairment-conditions associated with a greater risk of falls-yet it is unclear how to identify people with HIV (PWH) whose drinking is associated with falls. Research on alcohol and falls using the same instruments in different countries could help to specify the level of alcohol use associated with fall risk. We examined whether a consumption-based measure (the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]) and/or a symptom-based measure (DSM-5 criteria for alcohol use disorder [AUD]) are associated with sustaining a fall among PWH in St Petersburg, Russia and Boston, Massachusetts in the United States. METHODS: Separate multivariate logistic regressions were used for each cohort to examine cross-sectional associations for each alcohol measure predicting fall. Potential confounders included physical functioning, depressive symptoms, and other substance use (measured with the Addiction Severity Index). RESULTS: A fall was reported by 35% (87/251) of the sample in Boston and 12% (46/400) in St Petersburg. Each additional AUD criterion-but not higher AUDIT-C score-was significantly associated with a fall in both Boston (odds ratio [OR] = 1.10; 95% confidence interval [CI] 1.02, 1.18) and St Petersburg (adjusted OR AOR = 1.10; 95% CI 1.02, 1.18). Heavy alcohol use (>6 drinks/occasion, any vs. none) was associated with more than twice the odds of a fall (AOR = 2.24; 95% CI 1.21, 4.13) in Boston. CONCLUSIONS: These findings suggest that while fall risk may vary by setting and population, heavy alcohol use and AUD symptom severity are potential targets for interventions to prevent falls. Studies in diverse global settings advance our understanding of the relationship between alcohol and falls in PWH.

Study protocol for Video Images about Decisions to Improve Ethical Outcomes with Palliative Care Educators (VIDEO-PCE): a pragmatic stepped wedge cluster randomised trial of older patients admitted to the hospital

INTRODUCTION: Despite the known benefit to patients and families, discussions about goals, values and preferences for medical care in advancing serious illness often do not occur. Many system and clinician factors, such as patient and clinician reticence and shortage of specialty palliative care teams, contribute to this lack of communication. To address this gap, we designed an intervention to promote goals-of-care conversations and palliative care referrals in the hospital setting by using trained palliative care educators and video decision aids. This paper presents the rationale, design and methods for a trial aimed at addressing barriers to goals-of-care conversations for hospitalised adults aged 65 and older and those with Alzheimer's disease and related Dementias, regardless of age. METHODS AND ANALYSIS: The Video Image about Decisions to Improve Ethical Outcomes with Palliative Care Educators is a pragmatic stepped wedge, cluster randomised controlled trial, which aims to improve and extend goals-of-care conversations in the hospital setting with palliative care educators trained in serious illness communication and video decision aids. The primary outcome is the proportion of patients with goals-of-care documentation in the electronic health record. We estimate that over 9000 patients will be included. ETHICS AND DISSEMINATION: The Institutional Review Board (IRB) at Boston Medical Center will serve as the single IRB of record for all regulatory and ethical aspects of this trial. BMC Protocol Number: H-41482. Findings will be presented at national meetings and in publications. This trial is registered at ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT04857060; ClinicalTrials.gov.

Testing and treatment for latent tuberculosis infection in people living with HIV and substance dependence: a prospective cohort study.

OBJECTIVE: To quantify the proportion of people living with HIV (PLWH) with other tuberculosis (TB) risk factors that completed the latent tuberculosis infection (LTBI) care cascade and describe factors associated with attrition. The care cascade was defined as follows: (1) receipt of an LTBI test and result, (2) initiation of LTBI treatment and (3) completion of LTBI treatment. DESIGN: Prospective cohort study. SETTING: Reactivation of LTBI remains a large source of active TB disease in the USA. PLWH and those who use substances are at greater risk and are harder to engage and retain in care. PARTICIPANTS: Participants enrolled in a Boston cohort of PLWH from 2012 to 2014. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcome was the number and proportion of participants who completed each stage of the cascade and the factors associated with completing each stage. Our secondary outcomes were differences between participants tested with an interferon gamma release assay (IGRA) versus tuberculin skin test and differences between participants who tested positive versus negative for LTBI. RESULTS: Only 189 of 219 (86.3%) participants completed testing. Five of the 11 with LTBI initiated and three completed treatment. Participants tested with an IGRA were more likely to complete testing (OR 3.87, 95% CI 1.05 to 14.30) while among participants successfully tested, being foreign-born was associated with a positive test result (OR 3.95; 95% CI 1.13 to 13.77). CONCLUSIONS: Although the majority completed LTBI testing, our findings warrant further investigation in a larger cohort to better understand factors that lead to suboptimal treatment initiation and completion in a low-burden country.

Interprofessional education in the clinical learning environment: a mixed-methods evaluation of a longitudinal experience in the primary care setting.

Team collaboration in our healthcare workforce is necessary to effectively address multifaceted medical and social needs, especially for those impacted by systemic inequities. Effective interprofessional practice and education models including curricula are needed to prepare a practice ready healthcare workforce for team collaboration. Most healthcare trainee interprofessional experiences take place episodically in classroom settings. However, creating a culture that supports team-based learning and interprofessional clinical practice requires teaching skills (e.g., communication, collaboration, shared decision-making, coordination of care) longitudinally in the clinical setting. A weekly interprofessional clinic for patients/clients with chronic health conditions was organized in three primary care practices. Trainees from nutrition, social work, medicine, and physician assistant programs worked with supervising clinicians from each field. Surveys, interviews, and focus groups assessed the effects of interprofessional education and training in the primary care setting. Results show the longitudinal experiential IPE program significantly improved knowledge, attitudes, skills, and values addressing key interprofessional competencies. Qualitative results complement survey data and highlight key themes addressing patient-centered care and team dynamics. These findings demonstrate the importance of longitudinal, immersive team-based interprofessional training in the clinical learning environment.

Food insecurity and substance use in people with HIV infection and substance use disorder.

BACKGROUND: Food insecurity and substance use are common among people living with HIV (PLWH). Substance use may help people cope with hunger and thus be associated with food insecurity, but the association is uncertain. This study assessed whether, in PLWH and substance dependence, if there was an association between food insecurity and substance use.Methods: We studied adults with HIV and current substance dependence or ever injection drug use interviewed at 12 and 24 months after enrollment in a prospective cohort study. The presence of food insecurity (insufficient food quantity or quality, or anxiety about its availability) was assessed using the Household Food Insecurity Assessment Scale questionnaire (HFIAS). Unhealthy alcohol use was assessed with the Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) and past 30-day other drug use with the Addiction Severity Index. Associations using repeat cross-sectional data from each of two time-points, 12 months apart, from the same participants were tested using generalized estimating equations logistic regressions.Results: The 233 participants had a mean age of 50 years and 65% were male. At the first interview, 44% reported food insecurity, 40% unhealthy alcohol use, 25% past 30-day cocaine use, and 17% past 30-day illicit opioid use. In analyses adjusted for demographics, social factors, physical and mental health function, and substance use related variables, there was no significant association between food insecurity and unhealthy alcohol use (adjusted odds ratio (aOR) = 1.06 (95% CI: 0.59, 1.87)). Those with food insecurity had higher odds of illicit opioid use (aOR = 2.5 (95% CI: 1.12, 5.58)) and cocaine use (aOR = 1.95 (CI 95%: 1.00, 3.81)).Conclusion: Food insecurity was not associated with unhealthy alcohol use but was associated with cocaine and illicit opioid use. Given the prevalence and impact substance use has on PLWH, food insecurity should be identified and addressed.

Multimodal Recruitment to Study Ovulation and Menstruation Health: Internet-Based Survey Pilot Study.

BACKGROUND: Multimodal recruitment strategies are a novel way to increase diversity in research populations. However, these methods have not been previously applied to understanding the prevalence of menstrual disorders such as polycystic ovary syndrome. OBJECTIVE: The purpose of this study was to test the feasibility of recruiting a diverse cohort to complete a web-based survey on ovulation and menstruation health. METHODS: We conducted the Ovulation and Menstruation Health Pilot Study using a REDCap web-based survey platform. We recruited 200 women from a clinical population, a community fair, and the internet. RESULTS: We recruited 438 women over 29 weeks between September 2017 and March 2018. After consent and eligibility determination, 345 enrolled, 278 started (clinic: n=43; community fair: n=61; internet: n=174), and 247 completed (clinic: n=28; community fair: n=60; internet: n=159) the survey. Among all participants, the median age was 25.0 (SD 6.0) years, mean BMI was 26.1 kg/m2 (SD 6.6), 79.7% (216/271) had a college degree or higher, and 14.6% (37/254) reported a physician diagnosis of polycystic ovary syndrome. Race and ethnicity distributions were 64.7% (176/272) White, 11.8% (32/272) Black/African American, 7.7% (21/272) Latina/Hispanic, and 5.9% (16/272) Asian individuals; 9.9% (27/272) reported more than one race or ethnicity. The highest enrollment of Black/African American individuals was in clinic (17/42, 40.5%) compared to 1.6% (1/61) in the community fair and 8.3% (14/169) using the internet. Survey completion rates were highest among those who were recruited from the internet (159/174, 91.4%) and community fairs (60/61, 98.4%) compared to those recruited in clinic (28/43, 65.1%). CONCLUSIONS: Multimodal recruitment achieved target recruitment in a short time period and established a racially diverse cohort to study ovulation and menstruation health. There were greater enrollment and completion rates among those recruited via the internet and community fair.

Utility of a virtual counselor (VICKY) to collect family health histories among vulnerable patient populations: A randomized controlled trial.

OBJECTIVES: This study is a randomized controlled trial comparing the efficacy of a virtual counselor (VICKY) to the My Family Health Portrait (MFHP) tool for collecting family health history (FHx). METHODS: A total of 279 participants were recruited from a large safety-net hospital and block randomized by health literacy to use one of the digital FHx tools, followed by a genetic counselor interview. A final sample of 273 participants were included for analyses of primary study aims pertaining to tool concordance, which assessed agreement between tool and genetic counselor. RESULTS: Tool completion differed significantly between tools (VICKY = 97%, MFHP = 51%; p < .0001). Concordance between tool and genetic counselor was significantly greater for participants randomized to VICKY compared to MFHP for ascertaining first- and second-degree relatives (ps<.0001), and most health conditions examined. There was significant interaction by health literacy, with greater differences in concordance observed between tools among those with limited literacy. CONCLUSIONS: A virtual counselor overcomes many of the literacy-related barriers to using traditional digital tools and highlights an approach that may be important to consider when collecting health histories from vulnerable populations. PRACTICE IMPLICATIONS: The usability of digital health history tools will have important implications for the quality of the data collected and its downstream clinical utility.

Influence of Family and Community Socioeconomic Status on the Risk of Adolescent Drug Use.

Background: Adolescent drug use increases the risk of mental, physical and social problems later in life and so it is important to understand its complex etiology that likely includes socioeconomic status (SES). We undertook the present analysis using data from a population-based retrospective cohort study to examine the influence of family and community SES in relation to adolescent drug use. We hypothesized that lower levels of community and parental SES would increase the risk of use and that there would be stronger associations for the more proximate family-level factors. Methods: We used self-administered questionnaires (N=1,402) to obtain information on use of marijuana, inhalants, heroin, cocaine/crack, psychedelics/hallucinogens, Ritalin without a prescription, and club drugs during adolescence. Family SES was gathered from birth certificate data on maternal educational level and paternal occupation. Community SES characteristics at birth, age 10 and age 18 were obtained from the US Census Bureau. Results: An increased risk of adolescent drug use was associated with lower maternal education, non-white collar occupations among fathers, and lower community median income, and poverty and unemployment levels at age 18. The strongest associations were seen for the use of multiple drugs (Risk Ratio (RR): 1.7, 95% CI: 1.4-2.2), inhalants (RR: 2.5, 95% CI: 1.5-2.2), crack/cocaine (RR: 2.8, 95% CI: 1.7-4.5), psychedelics/hallucinogens (RR: 1.8, 95% CI: 1.4-2.4), and club/designer drugs (RR: 1.8, 95% CI: 1.2-2.7) among adolescents whose mothers had only a high school education. Conclusions: These results suggest that use of certain drugs during adolescence is associated with both family and community SES measures. However, maternal education appears to have the greatest influence on use, suggesting that a multi-level approach that engages mothers is needed to prevent adolescent drug use.

Comparative Effectiveness of Heart Rate Control Medications for the Treatment of Sepsis-Associated Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) with rapid ventricular response frequently complicates the management of critically ill patients with sepsis and may necessitate the initiation of medication to avoid hemodynamic compromise. However, the optimal medication to achieve rate control for AF with rapid ventricular response in sepsis is unclear. RESEARCH QUESTION: What is the comparative effectiveness of frequently used AF medications (ß-blockers, calcium channel blockers, amiodarone, and digoxin) on heart rate (HR) reduction among critically ill patients with sepsis and AF with rapid ventricular response? STUDY DESIGN AND METHODS: We conducted a multicenter retrospective cohort study among patients with sepsis and AF with rapid ventricular response (HR > 110 beats/min). We compared the rate control effectiveness of ß-blockers to calcium channel blockers, amiodarone, and digoxin using multivariate-adjusted, time-varying exposures in competing risk models (for death and addition of another AF medication), adjusting for fixed and time-varying confounders. RESULTS: Among 666 included patients, 50.6% initially received amiodarone, 10.1% received a ß-blocker, 33.8% received a calcium channel blocker, and 5.6% received digoxin. The adjusted hazard ratio for HR of < 110 beats/min by 1 h was 0.50 (95% CI, 0.34-0.74) for amiodarone vs ß-blocker, 0.37 (95% CI, 0.18-0.77) for digoxin vs ß-blocker, and 0.75 (95% CI, 0.51-1.11) for calcium channel blocker vs ß-blocker. By 6 h, the adjusted hazard ratio for HR < 110 beats/min was 0.67 (95% CI, 0.47-0.97) for amiodarone vs ß-blocker, 0.60 (95% CI, 0.36-1.004) for digoxin vs ß-blocker, and 1.03 (95% CI, 0.71-1.49) for calcium channel blocker vs ß-blocker. INTERPRETATION: In a large cohort of patients with sepsis and AF with rapid ventricular response, a ß-blocker treatment strategy was associated with improved HR control at 1 h, but generally similar HR control at 6 h compared with amiodarone, calcium channel blocker, or digoxin.

Prenatal and early childhood exposure to tetrachloroethylene (PCE) and non-medical use of prescription drugs: A retrospective cohort study in Cape Cod, MA.

BACKGROUND: Between 1968 and 1983, public drinking water supplies of Cape Cod, Massachusetts were contaminated with the chlorinated solvent tetrachloroethylene (PCE). We previously found an affinity for risk-taking behaviors, including the use of illicit drugs, following prenatal and early childhood exposure to PCE. Using newly collected data, we investigated the risk of non-medical use of prescription drugs (NMUPD) following prenatal and early childhood PCE exposure. METHODS: Participants were identified from a retrospective cohort study ("Cape Cod Health Study") via cross-matching birth certificates and water system data. The original self-administered questionnaire gathered data on demographics, work and medical history, and alcohol and illicit drug use from 618 individuals (363 exposed and 255 unexposed). The follow-up survey added questions on non-medical use of prescription pain relievers, tranquilizers, stimulants and sedatives. A validated leaching and transport model was used to estimate exposure to PCE exposure in drinking water. RESULTS: There was a wide distribution of cumulative prenatal and early childhood PCE exposure levels (range: 0.04 g-3722.2 g). PCE exposed subjects had a 1.92-fold increase in risk of any non-medical use of prescription drugs [Adjusted RR: 1.92, (95% CI: 1.31, 2.83)]. Furthermore, the association followed a dose-response relationship where the risk of NMUPD was higher for those exposed to PCE levels greater than or equal the median level versus those exposed to levels less than the median [Adjusted RR: 2.05 (95% CI: 1.34, 3.15) vs. 1.83 (95% CI: 1.20, 2.79) (p-value for trend < 0.01)]. Additionally, we found moderate increases in risk by level of non-medical use (any non-medical use, non-medical use of 1 or more categories of prescription drugs, or 2+ categories) as well as by category of drug for pain relivers, stimulants and tranquilizers. CONCLUSION: We found that prenatal and early childhood exposure to PCE was associated with a moderate increase in the risk of NMUPD. Exposed subjects had dose-related increased risks of NMUPD of pain relievers, tranquilizers, and stimulants. This study has a number of limitations and is the first to report this association. Additional longitudinal studies of populations exposed to PCE during early life should be conducted to examine its long-term neurotoxic effects.

Drug use disorder following early life exposure to tetrachloroethylene (PCE)-contaminated drinking water: a retrospective cohort study.

BACKGROUND: Many studies of adults with occupational exposure to solvents such as tetrachloroethylene (PCE) have shown adverse effects on cognition, mood and behavioral problems. Much less is known about neurotoxic effects in early life at lower exposure levels seen in community settings. We recently reported that illicit drug use was more frequent among adults from Cape Cod, Massachusetts who were exposed to PCE-contaminated drinking water during gestation and early childhood than their unexposed counterparts. Using newly collected data from this population-based retrospective cohort study, the current analysis examines whether early life PCE exposure is also associated with drug use disorder over the life course. METHODS: Three-hundred and sixty-three subjects with prenatal and early childhood PCE exposure and 255 unexposed subjects were studied. These individuals (median age: 40-41 years) completed self-administered questionnaires on the eleven established diagnostic criteria for drug use disorder and confounding variables. A validated leaching and transport model was used to estimate exposure to PCE-contaminated water. RESULTS: Overall, 23.3% of subjects reported having at least one criterion for drug use disorder over their lifetime. Early life PCE exposure was associated with a modest increase in the lifetime presence of one or more diagnostic criteria for drug use disorder (adjusted RR: 1.4, 95% CI: 1.0-1.8). Compared to unexposed subjects, PCE-exposed subjects were more likely to report having most diagnostic criteria of drug use disorder, including neglecting major roles due to drug use, physical and psychological problems related to drug use, and giving up activities due to drug use. No dose-response relationships were observed with increasing levels of PCE exposure. CONCLUSIONS: These results suggest that exposure to PCE-contaminated drinking water during early life modestly increases the risk of developing diagnostic criteria for drug use disorder later in life. Because this study has several limitations, these findings should be confirmed in follow-up investigations of other exposed populations with more diverse racial and socioeconomic characteristics.

Temporal trends in pharmacologic prophylaxis for venous thromboembolism after hip and knee replacement in older adults.

Trends in prescription for venous thromboembolism (VTE) prophylaxis following total hip (THR) and knee replacement (TKR) since the approval of direct oral anticoagulants (DOACs) and the 2012 guideline endorsement of aspirin are unknown, as are the risks of adverse events. We examined practice patterns in the prescription of prophylaxis agents and the risk of adverse events during the in-hospital period (the 'in-hospital sample') and 90 days following discharge (the 'discharge sample') among adults aged ⩾ 65 undergoing THR and TKR in community hospitals in the Institute for Health Metrics database over a 30-month period during 2011 to 2013. Eligible medications included fondaparinux, DOACs, low molecular weight heparin (LMWH), other heparin products, warfarin, and aspirin. Outcomes were validated by physician review of source documents: VTE, major hemorrhage, cardiovascular events, and death. The in-hospital and the discharge samples included 10,503 and 5722 adults from 65 hospitals nationwide, respectively (mean age 73, 74 years; 61%, 63% women). Pharmacologic prophylaxis was near universal during the in-hospital period (93%) and at discharge (99%). DOAC use increased substantially and was the prophylaxis of choice for nearly a quarter (in-hospital) and a third (discharge) of the patients. Aspirin was the sole discharge prophylactic agent for 17% and 19% of patients undergoing THR and TKR, respectively. Warfarin remained the prophylaxis agent of choice for patients aged 80 years and older. The overall risk of adverse events was low, at less than 1% for both the in-hospital and discharge outcomes. The low number of adverse events precluded statistical comparison of prophylaxis regimens.