Development and deployment of a histopathology-based deep learning algorithm for patient prescreening in a clinical trial.

Accurate identification of genetic alterations in tumors, such as Fibroblast Growth Factor Receptor, is crucial for treating with targeted therapies; however, molecular testing can delay patient care due to the time and tissue required. Successful development, validation, and deployment of an AI-based, biomarker-detection algorithm could reduce screening cost and accelerate patient recruitment. Here, we develop a deep-learning algorithm using >3000 H&E-stained whole slide images from patients with advanced urothelial cancers, optimized for high sensitivity to avoid ruling out trial-eligible patients. The algorithm is validated on a dataset of 350 patients, achieving an area under the curve of 0.75, specificity of 31.8% at 88.7% sensitivity, and projected 28.7% reduction in molecular testing. We successfully deploy the system in a non-interventional study comprising 89 global study clinical sites and demonstrate its potential to prioritize/deprioritize molecular testing resources and provide substantial cost savings in the drug development and clinical settings.

Expanding Access to Psychiatric Care Through Universal Depression Screening: Lessons from an Urban Student-Run Free Clinic.

The purpose of this study is to report the utility of a universal depression screening in a student-run free clinic (SRFC) to improve bridging to psychiatric care. Patients (n = 224) seen by an SRFC between April 2017 and November 2022 were screened for depression in the patient's primary language using the standardized Patient Health Questionnaire (PHQ-9). A PHQ-9 score greater or equal to 5 prompted psychiatry referral. Retrospective chart review was conducted to determine clinical characteristics and length of psychiatry follow-up. Out of 224 patients screened, 77 patients had positive depression screens and were referred to the SRFC's adjacent psychiatry clinic. Of these 77 patients, 56 patients (73%) were female, the average age was 43.7 (SD = 14.5), and the mean PHQ score was 10 (SD = 5.13). Thirty-seven patients (48%) accepted referral, while 40 (52%) declined or were lost to follow-up. There were no statistical differences in age or number of medical comorbidities between the two groups. Patients who accepted referrals were more likely to be female, as well as to have psychiatric histories, higher PHQ-9 scores, and a history of trauma. Reasons for declining and being lost to follow-up included transition to insurance, geographic relocation and deferral due to hesitancy in seeking psychiatric care. Implementation of a standardized depression screening reveals a significant rate of depressive symptoms among an urban uninsured primary care population. Universal screening may serve as a tool to improve the delivery of psychiatric care to underserved patients.

A Medical Student-Run Telehealth Primary Care Clinic During the COVID-19 Pandemic: Maintaining Care for the Underserved.

BACKGROUND: In this report, we outline our approach to implementing a hybrid in-person and virtual clinic model at a student-run free clinic (SRFC) during the COVID-19 pandemic. Individuals of low socioeconomic status (SES) are at an increased risk for COVID-19 infection and severe clinical outcomes. It is unclear if telehealth is a viable continuity of care enabler for the underserved. METHODS: The Weill Cornell Community Clinic (WCCC) implemented a novel telehealth clinic model to serve uninsured patients in May 2020. A phone survey of was conducted to assess WCCC patients access to technology needed for telehealth visits (eg, personal computers, smartphones). Patient no-show rates were retrospectively assessed for both in-person (pre-pandemic) and hybrid continuity of care models. RESULTS: The phone survey found that 90% of WCCC patients had access to technology needed for telehealth visits. In the 8 months following implementation of the hybrid model, telehealth and in-person no-show rates were 11% (14/128) and 15% (10/67) respectively; the combined hybrid no-show rate was 12% (24/195). For comparison, the in-person 2019 no-show rate was 23% (84/367). This study aligns with previous reports that telehealth improves patient attendance. CONCLUSION: Literature on the transition of SRFCs from in-person to telehealth care delivery models is limited. At the WCCC, the reduction in no-show rates supports the feasibility and benefits of adopting telehealth for the delivery of care to underserved patient populations. We believe the hybrid telehealth model described here is a viable model for other student run free clinics to increase access to care in low SES communities.

Blood pressure and mortality in a prospective cohort of HIV-infected adults in Port-au-Prince, Haiti.

OBJECTIVE: The objective of this study was to determine how baseline blood pressure and incident hypertension related to antiretroviral therapy (ART) initiation, HIV-related inflammation and mortality in HIV-infected adults in a low-income country. METHODS: We conducted long-term follow-up of HIV-infected adults who had participated in a trial of early vs. delayed initiation of ART in Port-au-Prince, Haiti. Between 2005 and 2008, 816 HIV-infected adults were randomized to early (N = 408) vs. delayed ART (when CD4 cell count <200 cells/µl or AIDS-defining condition; N = 408). Blood pressure was measured every 3 months. Hypertension was diagnosed according to the Joint National Committee (JNC-7) guidelines. Biomarkers of inflammation and coagulation were measured from banked enrolment plasma samples. Survival analyses were performed using Stata 14. RESULTS: The median age at enrolment was 39 years. The median follow-up time was 7.3 years. The hypertension incidence rate was 3.41 per 100 person-years, and was similar in early and delayed ART groups. In multivariable models, independent predictors of incident hypertension were older age, higher BMI and plasma interleukin (IL)-6 levels (adjusted hazard ratio, aHR = 1.23, P < 0.001). Systolic pressure more than 140 mmHg at enrolment was associated with increased mortality (aHR = 2.47, P = 0.03) as was systolic pressure less than 90 mmHg (aHR = 2.25, P = 0.04). Prevalent and incident hypertension were also significantly associated with mortality. CONCLUSION: In a large prospective study of HIV-infected adults, we found a high incidence of hypertension associated with HIV-related inflammation. Baseline hypertension conferred a more than two-fold increased risk of death. Among HIV-infected adults in low-income countries, hypertension should be considered a serious threat to long-term survival.

Insurance Enrollment at a Student-Run Free Clinic After the Patient Protection and Affordable Care Act.

The Patient Protection and Affordable Care Act (ACA) aims to increase insurance coverage through government subsidies. Medical student-run free clinics (SRFC) are an important entry point into the healthcare system for the uninsured. SRFCs do not have a standardized approach for navigating the complexities of enrollment. The Weill Cornell Community Clinic (WCCC) developed a unique enrollment model that may inform other SRFCs. Our objective is to describe enrollment processes at SRFCs throughout New York City, and to evaluate enrollment outcomes and persistent barriers to coverage at WCCC. We surveyed SRFC leadership throughout NYC to understand enrollment processes. We evaluated enrollment outcomes at WCCC through chart review and structured phone interviews. Subjects included WCCC patients seen in clinic between October 1, 2013 and September 30, 2015 (N = 140). Demographic information, method of insurance enrollment, and qualitative description of enrollment barriers were collected. SRFCs in New York City have diverse enrollment processes. 48% (N = 42) of WCCC patients obtained health insurance. Immigration status was a barrier to coverage in 21% of patients. Failure to gain coverage was predicted by larger household size (p = 0.02). Gender and employment status were not associated with remaining uninsured. The main barriers to enrollment were inability to afford premiums and lack of interest. Insurance enrollment processes at SRFCs in New York City are mostly ad hoc and outcomes are rarely tracked. Following implementation of the ACA, WCCC stands out for its structured approach, with approximately half of eligible WCCC patients gaining coverage during the study period.

Diagnosis of HIV-Associated Oral Lesions in Relation to Early versus Delayed Antiretroviral Therapy: Results from the CIPRA HT001 Trial.

Oral mucosal lesions that are associated with HIV infection can play an important role in guiding the decision to initiate antiretroviral therapy (ART). The incidence of these lesions relative to the timing of ART initiation has not been well characterized. A randomized controlled clinical trial was conducted at the GHESKIO Center in Port-au-Prince, Haiti between 2004 and 2009. 816 HIV-infected ART-naïve participants with CD4 T cell counts between 200 and 350 cells/mm3 were randomized to either immediate ART initiation (early group; N = 408), or initiation when CD4 T cell count was less than or equal 200 cells/mm3 or with the development of an AIDS-defining condition (delayed group; N = 408). Every 3 months, all participants underwent an oral examination. The incidence of oral lesions was 4.10 in the early group and 17.85 in the delayed group (p-value <0.01). In comparison to the early group, there was a significantly higher incidence of candidiasis, hairy leukoplakia, herpes labialis, and recurrent herpes simplex in the delayed group. The incidence of oral warts in delayed group was 0.97 before therapy and 4.27 post-ART initiation (p-value <0.01). In the delayed group the incidence of oral warts post-ART initiation was significantly higher than that seen in the early group (4.27 versus 1.09; p-value <0.01). The incidence of oral warts increased after ART was initiated, and relative to the early group there was a four-fold increase in oral warts if ART was initiated following an AIDS diagnosis. Based upon our findings, candidiasis, hairy leukoplakia, herpes labialis, and recurrent herpes simplex indicate immune suppression and the need to start ART. In contrast, oral warts are a sign of immune reconstitution following ART initiation.

Adherence to antiretroviral therapy in patients participating in a graduated cost recovery program at an HIV care center in South India.

In resource-constrained settings, the most frequently cited barrier to optimal antiretroviral therapy (ART) adherence among HIV-infected patients has been the cost of medications. In recent years many subsidized medication programs have been developed to improve ART affordability. A Graduated Cost Recovery program at the largest care center in South India has enrolled 839 eligible patients into four tiers based on an evaluation of their financial information and willingness to pay, of these patients 635 consented to participate in this study. Patients in Tier 1 receive first-line ART at no cost, whereas patients in Tiers 2, 3, and 4 pay 50, 75, and 100%, respectively of the cost of first-line medications based on an assessment of their means. Adherence rates of 95% or greater on 3-day recall were achieved by 84.6% of Tier 1 (n = 156), 71.6% of Tier 2 (n = 141), 72.3% of Tier 3 (n = 242), and 79.2% of Tier 4 (n = 96). These findings suggest patients are highly motivated and that the provision of no-cost ART can promote higher rates of optimal adherence.