Faculty Bibliography

Introduction/UNASSIGNED:A comprehensive assessment of liver disorders was conducted among people living with HIV (PLWH) on a new antiretroviral regimen based on common core agents. Methods/UNASSIGNED:cohort were included if they had ⩾1 liver chemistry test performed both within 12 months before regimen start and over follow-up. Liver disorders were defined as a diagnosis of drug-induced liver injury (DILI) or moderate/severe liver chemistry elevations (LCE). History of liver disorders experienced within 12 months of initiation was summarized. Liver disorders occurring during follow-up were described as prevalent (all disorders) or incident (disorders occurring among PLWH without a history of liver disorders or advanced liver fibrosis). Results/UNASSIGNED:Out of 16,024 PLWH, 38% initiated DTG, 43% EVG, 5% RAL, and 14% DRV. EVG users were younger and had a lower likelihood of comorbidities or lipid-lowering agent use than DTG users. EVG users were significantly less likely to have a history of moderate/severe LCE or to have prevalent moderate LCE. RAL users were older and had a higher likelihood of comorbidities or lipid-lowering agent use than DTG users. RAL users were significantly more likely to have a history of advanced liver fibrosis and prevalent moderate/severe LCE during follow-up. DRV users were older and had a lower likelihood of lipid-lowering agent use than DTG users. There was no difference in history of LCE, nor in prevalent or incident LCE between DRV and DTG users. No DILI diagnoses were recorded. Discontinuation following a liver disorder was rare (<1%) across all groups. Conclusion/UNASSIGNED:While PLWH with comorbidities may have been channeled away from EVG and toward DTG and RAL, the incidence of moderate/severe LCE did not differ between DTG and EVG, RAL, and DRV. Plain language summary/UNASSIGNED:cohort, which provides anonymous patient-level clinical data from electronic health records. People living with HIV (PLWH) who were starting a new HIV treatment regimen that included one of four common HIV drugs were included in this study. Liver disorders included drug-induced liver injury (DILI) and moderate or severe liver chemistry elevations. History of a disorder was defined as liver disorders that occurred before starting the new treatment. Prevalent disorders were those that occurred after starting the new treatment in the whole population. Incident disorders were those that occurred after starting the new treatment, but only among PLWH without any history of liver disorders.Out of 16,024 PLWH, 38% initiated dolutegravir (DTG), 43% elvitegravir (EVG), 5% raltegravir (RAL), and 14% darunavir (DRV). EVG users were younger and less likely to have other diseases or use cholesterol lowering drugs compared to DTG users. They were also less likely to have a history of moderate/severe liver chemistry elevations or to have prevalent moderate liver chemistry elevations. RAL users were older and more likely to have other diseases or use cholesterol lowering drugs compared to DTG users. They were also more likely to have prevalent moderate/severe liver chemistry elevations than DTG users. DRV users were older and less likely to use cholesterol lowering agents compared to DTG users. There was no difference in history of liver chemistry elevations, or in prevalent, or incident liver chemistry elevations between DRV and DTG users. There were no DILI diagnoses and discontinuation of treatment following liver disorders was rare across all groups. Overall, the incidence of liver disorders after starting a new HIV treatment regimen did not differ between four common antiretroviral drugs.

PURPOSE:To describe the effect of transgender health-related objective structured clinical examination (THOSCE) case exposure on learner activation regarding gender-affirming care. METHOD:A modified grounded theory approach was applied to identify the educational value of THOSCE cases. Focus groups with current and former primary care internal medicine residents who participated in THOSCE cases were conducted in 2018-2019. Transcripts were analyzed and coded until saturation to identify themes. RESULTS:Eighteen (72%) eligible learners participated in the focus groups. Themes were identified relating to gender-affirming care, and modified grounded theory analysis was used as a framework to organize the themes into 4 stages of learner activation: (1) believing the learner role is important, (2) having the confidence and knowledge necessary to take action, (3) taking action to maintain and improve one's skills, and (4) staying the course even under stress. CONCLUSIONS:Residents were grateful for the opportunity to practice the skills involved in transgender health in a simulation. Many felt unprepared and were concerned about how they were perceived by the standardized patient and faculty. Residents identified feeling more comfortable with gender-affirming language in the inpatient setting, which may provide an opportunity for learning in the future. Residents identified the psychosocial skills of gender-affirming care as more directly relevant while biomedical aspects of gender-affirming care seemed less accessible to residents, given the lack of outpatient experience. The authors propose a staged approach to teaching the skills of gender-affirming care using simulation to address learners of all levels.

We evaluated the presence of posttraumatic growth (PTG) among survivors of the 9/11 terrorist attack and how indicators of psychosocial well-being, direct 9/11-related exposure, and posttraumatic stress symptoms (PTSS) relate to PTG. PTG was examined among 4934 participants using the Posttraumatic Growth Inventory (PTGI). A confirmatory factor analysis (CFA) was conducted to determine if the original factor structure of the PTGI fits our data and principal component analysis (PCA) to identify the appropriate factor structure. Multivariable linear regression models were used to examine the association between PTG and indicators of psychosocial well-being, 9/11-related exposure, and PTSS, controlling for covariates. CFA identified a two-factor structure of the PTGI as a better fit than the original five-factor model. Participants who experienced very high 9/11-related exposure level (ß = 7.72; 95% CI: 5.75-9.70), higher PTSS at waves 1 (ß = 0.13; 95% CI: 0.08-0.18) and 2 (ß = 0.09; 95% CI: 0.05-0.14), high social integration (ß = 5.71; 95% CI: 4.47, 6.96), greater social support (ß = 0.49; 95% CI: 0.37, 0.61), and higher self-efficacy (ß = 1.26; 95% CI: 1.04, 1.48) had higher PTGI scores. Our findings suggest PTG is present, 15 years following the 9/11 terrorist attack. Very high-level 9/11 exposure, PTSS, and indicators of psychosocial well-being were associated with PTG.

Background/UNASSIGNED:COVID-19 exposed undergraduate medical education curricular gaps in exploring historical pandemics, how to critically consume scientific literature and square it with the lay press, and how to grapple with emerging ethical issues. In addition, as medical students were dismissed from clinical environments, their capacity to build community and promote professional identity formation was compromised. Methods/UNASSIGNED:was developed using a modified guided inquiry approach. Students met daily for 2 weeks in groups of 15 to 18 with a process facilitator. During the first week, students reported on lessons learned from past pandemics; in the second week, students discussed ethical concerns surrounding COVID-19 clinical trials, heard from physicians who provided patient care in the HIV and COVID-19 pandemics, and concluded with an opportunity for reflection. Following the course, students were asked to complete an anonymous, voluntary survey to assess their perceptions of the course. Results/UNASSIGNED:With a response rate of 69%, an overwhelming majority of students agreed or strongly agreed that learning about historical pandemics helped them understand COVID-19 (72, 99%). The course successfully helped students understand current and potential COVID-19 management strategies as 66 (90%) agreed or strongly agreed they developed a better understanding of nonpharmacological interventions and new pharmacological treatments. Students also gained insight into the experiences of healthcare providers who cared for patients with HIV and COVID-19. Qualitative analysis of the open-ended comments yielded 5 main themes: critical appraisal of resources, responsibility of the physician, humanism, knowledge related to pandemics, and learning from history. Conclusions/UNASSIGNED:The onset of the COVID-19 crisis illustrated curricular gaps that could be remedied by introducing the history and biology of pandemics earlier in the curriculum. It was also apparent that learners need more practice in critically reviewing literature and comparing scientific literature with lay press. The flexible format of the course promotes the development of future iterations that could cover evolving topics related to COVID-19. The course could also be repurposed for a graduate or continuing medical education audience.

BACKGROUND:A discharge against medical advice (DAMA) is associated with adverse health outcomes. Its association with postdischarge healthcare resource utilization (HcRU) outside an inpatient setting is unknown. This information can help us understand how a DAMA may affect healthcare-seeking behavior following a hospital stay. We evaluated the relationship between a DAMA and 30-day postdischarge HcRU. METHODS:Plus database. We included individuals aged 18 to 64 years with an inpatient admission during 2007-2015 and continuous insurance coverage. We defined comparison groups as DAMA and routine discharge. Both groups were matched on baseline covariates. We quantified the association between a DAMA and 30-day HcRU, as well as 90-day for sensitivity analysis, with use of generalized linear models for binary outcomes (inpatient readmissions, emergency department [ED] visits) and count outcomes (physician office visits, nonphysician outpatient encounters, prescription drug fills). RESULTS:Of the 457,530 individuals in the unmatched sample, 2,245 (0.5%) had a DAMA. In the matched sample, a DAMA was positively associated with an ED visit (adjusted odds ratio, 2.28; 95% confidence interval, 1.90-2.72) but not with an inpatient readmission. There were no differences between groups based on the count outcomes. A DAMA was positively associated with 90-day HcRU (ie, inpatient readmission, ED visit, and prescription drug fills). CONCLUSION/CONCLUSIONS:The relationship between a DAMA and HcRU varied with the HcRU category and postdischarge time interval. This examination of HcRU in the inpatient and outpatient settings provides important information about outcomes following a DAMA.

INTRODUCTION: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. Following 8 weeks of tofacitinib 10 mg twice daily (BID) in OCTAVE Induction 1&2, modest and reversible increases in serum lipid levels were reported in patients with UC, which were associated with reduced C-reactive protein (CRP) levels [1].
METHOD(S): OCTAVE Induction 1&2 (NCT01465763; NCT01458951) were 2 identical, 8-week, Phase 3 studies in which patients with moderately to severely active UC received tofacitinib 10 mg BID or placebo (total n = 1,139). In this post hoc analysis of the pooled induction studies, we assessed changes from baseline (CFB) in lipid levels (total cholesterol [total-c], high-density lipo-protein cholesterol [HDL-c], low-density lipoprotein cholesterol [LDL-c]) at Week 8 by responder and remitter status in patients who received tofacitinib 10 mg BID or placebo; analysis of variance was performed to estimate differences for responders or remitters vs non-responders. The association between CFB in lipid levels and CFB in CRP levels (log-transformed), by responder and remitter status, was assessed using a linear regression model at Week 8 in patients who received tofacitinib 10 mg BID.
RESULT(S): Increases in lipid levels from baseline to Week 8 were observed in responders, non-responders, and remitters (Table), which were greater with tofacitinib 10 mg BID vs placebo. There were significantly greater increases from baseline in total-c, HDL-c, and LDL-c for responders vs non-responders (all P < 0.0001), and in total-c and HDL-c for remitters vs non-responders (both P # 0.0001) in patients who received tofacitinib 10 mg BID (Table). Significant differences in lipid levels by responder and remitter status were not reported with placebo (data not shown). In patients who received tofacitinib 10 mg BID, linear regression modeling showed a significant association between CFB in total-c, HDL-c, and LDL-c and CFB in CRP in responders and non-responders, and between CFB in total-c and HDL-c and CFB in CRP in remitters (all P < 0.01) (Table).
CONCLUSION(S): These data suggest an association between increases in lipid levels and tofacitinib responder and remitter status. Further research is necessary to determine if increases in lipid levels can be used as a surrogate marker of reduced inflammation, and to establish lipid levels as potential predictors of patient outcomes to tofacitinib treatment

INTRODUCTION: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. The duration of active disease prior to starting treatment may impact treatment effects. We evaluated the association between duration of the latest flare before starting tofacitinib therapy and efficacy outcomes in the tofacitinib UC clinical program.
METHOD(S): Patients (pts) received tofacitinib 10 mg twice daily (BID) or placebo in OCTAVE Induction 1&2 (NCT01465763; NCT01458951) and responders received tofacitinib 5 or 10 mg BID or placebo during OCTAVE Sustain (final efficacy assessment at Wk52; NCT01458574). Pts were stratified by UC flare duration (ie duration of active disease; <3 and >=3 mo) prior to enrollment in OCTAVE Induction 1&2. Differences between the change from baseline Mayo stool frequency subscore (SF), Mayo rectal bleeding subscore (RB), and partial Mayo score (PMS) at Wk2 of OCTAVE Induction 1&2 between flare duration groups were assessed using ANOVA. Associations between flare duration and efficacy endpoints were assessed using the Cochran-Mantel-Haenszel chi-squared test.
RESULT(S): Among the 905 pts who received tofacitinib 10 mg BID in OCTAVE Induction 1&2, 443 and 462 pts had flare durations of <3 and >=3 mo, respectively. A higher proportion of pts with >=3 mo flare duration had pancolitis (53.7%) vs pts with <3 mo flare duration (48.8%); this was also true for prior TNFi failure (60% vs 42%). Mean baseline total Mayo score in both groups was 9.0. In OCTAVE Induction 1&2, a numerically higher proportion of pts with <3 mo flare duration met efficacy endpoints vs pts with >=3 mo, with a significant association. Changes from baseline SF, RB, and PMS at Wk2 were significantly greater in pts with <3 vs >=3 mo flare duration. Among pts who received tofacitinib 5 mg BID in OCTAVE Sustain, a numerically higher proportion with <3 mo flare duration met efficacy endpoints at Wk52 vs pts with >=3 mo; similar proportions of tofacitinib 10 mg BID-treated pts across flare duration groups met efficacy endpoints (Table).
CONCLUSION(S): These post hoc analyses showed that latest flare duration was significantly associated with the efficacy of tofacitinib 10 mg BID induction therapy at Wk8, with shorter duration (,3 mo) associated with greater efficacy, potentially implying that a timely intervention during a new flare may, as expected, lead to a better outcome for induction. During maintenance, flare duration had less impact on efficacy, with similar responses at Wk52 between tofacitinib 10 mg BID groups

BACKGROUND:New York City (NYC) bore the greatest burden of COVID-19 in the United States early in the pandemic. In this case series, we describe characteristics and outcomes of racially and ethnically diverse patients tested for and hospitalized with COVID-19 in New York City's public hospital system. METHODS:We reviewed the electronic health records of all patients who received a SARS-CoV-2 test between March 5 and April 9, 2020, with follow up through April 16, 2020. The primary outcomes were a positive test, hospitalization, and death. Demographics and comorbidities were also assessed. RESULTS:22254 patients were tested for SARS-CoV-2. 13442 (61%) were positive; among those, the median age was 52.7 years (interquartile range [IQR] 39.5-64.5), 7481 (56%) were male, 3518 (26%) were Black, and 4593 (34%) were Hispanic. Nearly half (4669, 46%) had at least one chronic disease (27% diabetes, 30% hypertension, and 21% cardiovascular disease). Of those testing positive, 6248 (46%) were hospitalized. The median age was 61.6 years (IQR 49.7-72.9); 3851 (62%) were male, 1950 (31%) were Black, and 2102 (34%) were Hispanic. More than half (3269, 53%) had at least one chronic disease (33% diabetes, 37% hypertension, 24% cardiovascular disease, 11% chronic kidney disease). 1724 (28%) hospitalized patients died. The median age was 71.0 years (IQR 60.0, 80.9); 1087 (63%) were male, 506 (29%) were Black, and 528 (31%) were Hispanic. Chronic diseases were common (35% diabetes, 37% hypertension, 28% cardiovascular disease, 15% chronic kidney disease). Male sex, older age, diabetes, cardiac history, and chronic kidney disease were significantly associated with testing positive, hospitalization, and death. Racial/ethnic disparities were observed across all outcomes. CONCLUSIONS AND RELEVANCE/CONCLUSIONS:This is the largest and most racially/ethnically diverse case series of patients tested and hospitalized for COVID-19 in New York City to date. Our findings highlight disparities in outcomes that can inform prevention and testing recommendations.

Persons with HIV demonstrate increased risk for aging-associated complications and have reduced telomere length (TL) compared with age-matched persons without HIV. Our data show that greater visceral fat is related to reduced TL in HIV, independent of age and smoking. Fat redistribution may be a relevant mediator of TL attrition in HIV.