Visual Impairment from Uncorrected Refractive Error among Participants in a Novel Program to Improve Eye Care Access among Low-Income Adults in Michigan.

PURPOSE: To assess the rate of visual impairment (VI) from uncorrected refractive error (URE) and associations with demographic and socioeconomic factors among low-income patients presenting to the Michigan Screening and Intervention for Glaucoma and Eye Health through Telemedicine (MI-SIGHT) program. DESIGN: Cross-sectional study. PARTICIPANTS: Adults ≥ 18 years without acute ocular symptoms. METHODS: MI-SIGHT program participants received a telemedicine-based eye disease screening and ordered glasses through an online optical store. Participants were categorized based on refractive error (RE) status: VI from URE (presenting visual acuity [PVA], ≤ 20/50; best-corrected visual acuity [BCVA], ≥ 20/40), URE without VI (PVA, ≥ 20/40; ≥ 2-line improvement to BCVA), and no or adequately corrected RE (PVA, ≥ 20/40; < 2-line improvement to BCVA). Patient demographics, self-reported visual function, and satisfaction with glasses obtained through the program were compared among groups using analysis of variance, Kruskal-Wallis, chi-square, and Fisher exact testing. MAIN OUTCOME MEASURES: PVA, BCVA, and presence of VI (defined as PVA ≤ 20/50). RESULTS: Of 1171 participants enrolled in the MI-SIGHT program during the first year, average age was 55.1 years (SD = 14.5), 37.7% were male, 54.1% identified as Black, and 1166 (99.6%) had both PVA and BCVA measured. VI was observed in 120 participants (10.3%); 96 had VI from URE (8.2%), 168 participants (14.4%) had URE without VI, and 878 (75.3%) had no or adequately corrected RE. A smaller percentage of participants with VI resulting from URE reported having a college degree, and a larger percentage reported income < $10 000 compared with participants with no or adequately corrected RE (3.2% vs. 14.2% [P = 0.02]; 45.5% vs. 21.6% [P < 0.0001], respectively). Visual function was lowest among participants with VI from URE, followed by those with URE without VI, and then those with no or adequately corrected RE (9-item National Eye Institute Visual Function Questionnaire composite score, 67.3 ± 19.6 vs. 77.0 ± 14.4 vs. 82.2 ± 13.3, respectively; P < 0.0001). In total, 71.2% (n = 830) ordered glasses for an average cost of $36.80 ± $32.60; 97.7% were satisfied with their glasses. CONCLUSIONS: URE was the main cause of VI at 2 clinics serving low-income communities and was associated with reduced vision-related quality of life. An online optical store with lower prices made eyeglasses accessible to low-income patients. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

A large-scale retrospective study enabled deep-learning based pathological assessment of frozen procurement kidney biopsies to predict graft loss and guide organ utilization.

Lesion scores on procurement donor biopsies are commonly used to guide organ utilization for deceased-donor kidneys. However, frozen sections present challenges for histological scoring, leading to inter- and intra-observer variability and inappropriate discard. Therefore, we constructed deep-learning based models to recognize kidney tissue compartments in hematoxylin & eosin-stained sections from procurement needle biopsies performed nationwide in years 2011-2020. To do this, we extracted whole-slide abnormality features from 2431 kidneys and correlated with pathologists' scores and transplant outcomes. A Kidney Donor Quality Score (KDQS) was derived and used in combination with recipient demographic and peri-transplant characteristics to predict graft loss or assist organ utilization. The performance on wedge biopsies was additionally evaluated. Our model identified 96% and 91% of normal/sclerotic glomeruli respectively; 94% of arteries/arterial intimal fibrosis; 90% of tubules. Whole-slide features of Sclerotic Glomeruli (GS)%, Arterial Intimal Fibrosis (AIF)%, and Interstitial Space Abnormality (ISA)% demonstrated strong correlations with corresponding pathologists' scores of all 2431 kidneys, but had superior associations with post-transplant estimated glomerular filtration rates in 2033 and graft loss in 1560 kidneys. The combination of KDQS and other factors predicted one- and four-year graft loss in a discovery set of 520 kidneys and a validation set of 1040 kidneys. By using the composite KDQS of 398 discarded kidneys due to "biopsy findings", we suggest that if transplanted, 110 discarded kidneys could have had similar survival to that of other transplanted kidneys. Thus, our composite KDQS and survival prediction models may facilitate risk stratification and organ utilization while potentially reducing unnecessary organ discard.

Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine Program: First-Year Outcomes and Implementation Costs.

PURPOSE: The Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (MI-SIGHT) program aims to engage people who are at high risk of glaucoma; we assess first-year outcomes and costs. DESIGN: Clinical cohort study. METHODS: Participants ≥18 years of age were recruited from a free clinic and a federally qualified health center in Michigan. Ophthalmic technicians in the clinics collected demographic information, visual function, ocular health history, measured visual acuity, refraction, intraocular pressure, pachymetry, pupils, and took mydriatic fundus photographs and retinal nerve fiber layer optical coherence tomography. Data were interpreted by remote ophthalmologists. During a follow-up visit, technicians shared ophthalmologist recommendations, dispensed low-cost glasses, and collected participant satisfaction. The primary outcome measures were prevalence of eye disease, visual function, program satisfaction, and costs. Observed prevalence was compared with national disease prevalence rates using z tests of proportions. RESULTS: Among 1171 participants, the average age was 55 years (SD 14.5 years), 38% were male, 54% identified as Black, 34% as White, 10% as Hispanic, 33% had less than or equal to a high school education, and 70% had an annual income <$30,000. The prevalence of visual impairment was 10.3% (national average 2.2%), glaucoma and suspected glaucoma 24% (national average 9%), macular degeneration 2.0% (national average 1.5%), and diabetic retinopathy 7.3% (national average 3.4%) (P < .0001). Seventy-one percent of participants received low-cost glasses, 41% were referred for ophthalmology follow-up, and 99% were satisfied or very satisfied with the program. Startup costs were $103,185; recurrent costs were $248,103 per clinic. CONCLUSIONS: Telemedicine eye disease detection programs in low-income community clinics effectively identify high rates of pathology.

Artificial intelligence software in pulmonary nodule assessment.

BACKGROUND: This study tests the impact of the addition of autonomous computed tomography (CT) interpreting software to radiologist assessment of pulmonary nodules. METHODS: Computed tomography scans for nodule assessment were identified retrospectively. Lung cancer risk factors, initial radiologist (RAD) report, Philips Lung Nodule software report (computer-aided nodule (CAD)) and radiologist report following the review of CT images and CAD (RAD + CAD) were collected. Follow-up recommendations based on current guidelines were derived from each report. RESULTS: In all, 100 patients were studied. Median maximal diameter of the largest nodule reported by RAD and RAD + CAD were similar at 10.0 and 9.0 mm, respectively (p = 0.06) but were reported as larger by CAD at 11.8 mm (p < 0.001). Follow-up recommendations derived from RAD + CAD were less intensive in 23 (23%) and more intensive in 34 (34%) than that of RAD. DISCUSSION: This study suggests that autonomous software use can alter radiologist assessment of pulmonary nodules such that suggested follow-up is altered.

Improved economic and clinical outcomes with oritavancin versus a comparator group for treatment of acute bacterial skin and skin structure infections in a community hospital.

BACKGROUND: Oritavancin is a lipoglycopeptide antibiotic with in vitro bactericidal activity against gram-positive pathogens indicated for use in adults with acute bacterial skin and skin structure infections (ABSSSI). Its concentration-dependent activity and prolonged half-life provide a convenient single-dose alternative to multi-dose daily therapies for ABSSSI. This retrospective cohort study was conducted to quantify the clinical and economic advantages of using oritavancin compared to other antibiotic agents that have been historically effective for ABSSSI. METHODS: Seventy-nine patients received oritavancin who had failed previous outpatient antibiotic therapy (OPAT) for cellulitis or abscess and were subsequently readmitted to the hospital as an inpatient between 2016 and 2018. These patients were compared to a cohort of 28 patients receiving other antibiotics following OPAT failure and subsequent hospitalization for these two infection types. The primary clinical end point was average length of stay (aLOS) and secondary endpoints included readmission rates for the same indication at 30 and 90 days after discharge and the average hospital cost (aHC). RESULTS: A total of 107 patients were hospitalized for treatment of cellulitis or abscess. Demographic characteristics of both the oritavancin and comparator groups were similar except for the presence of diabetes. The primary clinical endpoint showed a non-significant decrease in aLOS between the oritavancin group versus comparator (2.12 days versus 2.59 days; p = 0.097). The secondary endpoints revealed lower readmission rates associated with oritavancin treatment at 30 and 90 days; the average hospital cost was 5.9% lower for patients that received oritavancin. CONCLUSION: The results of this study demonstrate that oritavancin provides not only a single-dose alternative to multi-day therapies for skin and skin structure infections, but also a clinical and economic advantage compared to other antibiotic agents.

Clinical Benefit-Risk Assessment of Nivolumab 240 mg Every 2 Weeks in Chinese Patients With Advanced and Metastatic Solid Tumors.

Nivolumab 240 mg every 2 weeks is approved in China by the National Medical Product Agency for squamous cell carcinoma of the head and neck and gastric cancer, based on population pharmacokinetic (PPK) analyses and benefit-risk assessment of safety/efficacy in solid tumors, including Chinese and global populations. The aim of this assessment was to investigate exposure and risk for adverse events (AEs) with flat dosing compared with weight-based dosing. Nivolumab 240-mg and 3-mg/kg every-2-week exposures in Chinese patients were simulated using PPK modeling, and AEs in Chinese and pooled global populations were compared by dosing regimen, exposure, and weight. The 10-mg/kg every-2-week regimen was included because it is known to be well tolerated. Predicted nivolumab exposure in Chinese patients receiving 240 mg every 2 weeks was ∼25% higher versus 3 mg/kg every 2 weeks, but ∼60% lower versus 10 mg/kg every 2 weeks. Grade 3/4 AE incidence in Chinese patients receiving nivolumab 3 mg/kg every 2 weeks was similar with 240-mg every-2-week dosing and with patients from global populations treated with 3 or 10 mg/kg every 2 weeks. There was no trend toward increased AE incidence with high versus low nivolumab exposure or in global patients of varying body weight receiving 3 or 10 mg/kg every 2 weeks. Objective response rates were similar in Chinese and global patients with squamous and nonsquamous NSCLC. Results showed that benefit-risk profiles with nivolumab 240 mg every 2 weeks were similar to those of the 3-mg/kg every-2-week regimen in Chinese patients and global populations, providing an alternative treatment option to Chinese patients.