Showing papers by "Paul P. Lee published in 2020"

Application of the Sight Outcomes Research Collaborative Ophthalmology Data Repository for Triaging Patients With Glaucoma and Clinic Appointments During Pandemics Such as COVID-19.

Abstract: Importance During the coronavirus disease 2019 (COVID-19) pandemic, eye care professionals caring for patients with sight-threatening diseases, such as glaucoma, have had to determine whether some patient appointments could safely get postponed, weighing the risk that the patient’s glaucoma could worsen during the interim vs the morbidity risk of acquiring COVID-19 while seeking ophthalmic care. They also need to prioritize appointment rescheduling during the ramp-up phase (when pandemic-associated service reductions are eased). Objective To describe a flexible and scalable scoring algorithm for patients with glaucoma that considers glaucoma severity and progression risk vs the presence of high-risk features for morbidity from COVID-19, using information from a large data repository. Design, Setting, and Participants In this cross-sectional study, patients with upcoming clinic appointments for glaucoma from March 16, 2020, to April 16, 2020, at an academic institution enrolled in the Sight Outcomes Research Collaborative (SOURCE) Ophthalmology Electronic Health Record Data Repository were identified. A risk stratification tool was developed that calculated a glaucoma severity and progression risk score and a COVID-19 morbidity risk score. These scores were summed to determine a total score for each patient. Main Outcomes and Measures Total scores and percentages of clinic appointments recommended for rescheduling. Results Among the 1034 patients with upcoming clinic appointments for glaucoma, the mean (SD) age was 66.7 (14.6) years. There were 575 women (55.6%), 733 White individuals (71%), and 160 Black individuals (15.5%). The mean (SD) glaucoma severity and progression risk score was 4.0 (14.4) points, the mean (SD) COVID-19 morbidity risk score was 27.2 (16.1) points, and the mean (SD) total score was 31.2 (21.4) points. During pandemic-associated reductions in services, using total score thresholds of 0, 25, and 50 points would identify 970 appointments (93.8%), 668 appointments (64.6%), and 275 appointments (26.6%), respectively, for postponement and rescheduling. The algorithm-generated total scores also helped prioritize appointment rescheduling during the ramp-up phase. Conclusions and Relevance A tool that considers the risk of underlying ophthalmic disease progression from delayed care receipt and the morbidity risk from COVID-19 exposure was developed and implemented, facilitating the triage of upcoming ophthalmic appointments. Comparable approaches for other ophthalmic and nonophthalmic care during the COVID-19 pandemic and similar crises may be created using this methodology.

Association of Individual-Level Factors With Visual Outcomes in Optic Neuritis: Secondary Analysis of a Randomized Clinical Trial

Abstract: Importance Using corticosteroids to treat acute demyelinating optic neuritis has been identified as an area for shared decision-making. However, no analysis exists to support personalized shared decision-making that considers long- and short-term treatment benefits. Objective To develop models of individual-level visual outcomes for patients with optic neuritis. Design, Setting, and Participants This secondary analysis of the Optic Neuritis Treatment Trial (ONTT), a randomized clinical trial, was performed at 14 academic eye centers and 1 large community eye center. Adults aged 18 to 46 years with incident acute unilateral optic neuritis within 8 days of vision loss onset were included. Data were collected from July 1988 to June 1991, downloaded on October 15, 2018, and analyzed from January 24, 2019, to February 20, 2020, using multivariable linear regression modeling. Exposures Intravenous corticosteroids vs placebo. Main Outcomes and Measures Visual acuity (VA) at 1 year. Secondary outcomes were 1-year contrast sensitivity (CS) and VA and CS at 15 and 30 days. Independent variables included age, sex, race, multiple sclerosis status, optic neuritis episodes in the fellow eye, vision symptoms (days), pain, optic disc swelling, viral illness, treatment group, and baseline VA or CS. Results Of the 455 participants, median age was 31.8 (interquartile range [IQR], 26.3-37.0) years; 350 (76.9%) were women; and 388 (85.3%) were white. For 410 participants (90.1%) with 1-year outcomes, median VA improved from 20/66 (IQR, 20/28-20/630) at enrollment to 20/17 (IQR, 20/14-20/21) at 1 year. Baseline VA was the primary variable associated with 1-year VA (regression coefficient, 0.056 [95% CI, 0.008-0.103];P = .02) if baseline VA was better than count fingers (CF). At 15 days, baseline VA and treatment status were associated with VA in those participants with baseline VA better than CF (regression coefficient, 0.305 [95% CI, 0.231-0.380];F = 9.42;P Conclusions and Relevance In this study, long-term VA was associated with severity of baseline vision loss. Early benefits with intravenous corticosteroid treatment were limited to participants with baseline VA better than CF. However, the early, temporary benefit of intravenous corticosteroids is of questionable clinical significance and should be weighed against potential harms.

Myeloproliferative neoplasms treated with hydroxyurea, pegylated interferon alpha-2A or ruxolitinib: clinicohematologic responses, quality-of-life changes and safety in the real-world setting

Abstract: Introduction: Real-world data of responses, quality-of-life (QOL) changes and adverse events in patients with myeloproliferative neoplasms (MPN) on conventional therapy (hydroxyurea ± anagrelide),

Insights Into Eye Care Practice During COVID-19.

Abstract: 2020 Started as a year of celebration for the tremendous advances in ophthalmology that would make the promise of 20/20 visual acuity a reality for more people worldwide. Yet, our conventional perspectives have changed owing to changes following the coronavirus disease 2019 (COVID-19) pandemic on societies around the world, its disparate outcomes in Black and older individuals in the US, and the changes in eye care practices that were associated with steps designed to control the spread of the virus. With the known and unknown risks of COVID-19 to patients and to health care teams, the predictions of multiple models, and the experience of overwhelmed hospital systems in Wuhan, China, and Northern Italy, the US Centers for Disease Control and Prevention and the American Academy of Ophthalmology1 recommended in mid-March 2020 that physicians, including ophthalmologists, limit in-person care to urgent and emergent patients while assuming use of appropriate personal protective equipment. This heightened concern was paralleled by patient fears, with the perception that many were opting to not pursue care for even urgent or emergent ophthalmic concerns. The cumulative effect of these delays on visual outcomes is not yet known, although it is estimated that there was a nearly 80% initial decrease in ophthalmology visits2 and that as of mid-June there was still a cumulative decrease in ophthalmology visits of 40%.3 Minimizing further loss of vision and its effect on patients and populations obviously requires the resumption of more regular eye care. We would benefit from a thorough understanding of how to ramp up eye care, both to describe lessons learned from COVID-19 and for insights relevant to potential future pandemics. In this issue of JAMA Ophthalmology, Starr et al4 provide data related to these issues by exploring practice patterns for common ocular complaints among comprehensive ophthalmology practices in the US during the initial phase of the COVID-19 pandemic in North America. Using a prepared but not validated script, the authors made telephone calls with simulated patient requests for cataract surgery evaluation, routine refraction, and new-onset flashes and floaters (posterior vitreous detachment) roughly 6 weeks after the initial shutdown in most regions of the country and during a time (April 29 and 30, 2020) when many parts of the US were actively opening or preparing to open their practices to patients beyond urgent and emergent patients. Among 40 private and 20 university comprehensive ophthalmology practices from 4 regions in the US, private practices were more likely to schedule all patients (not just those with urgent complaints), had shorter wait times for appointments for cataract surgery evaluations, and were more likely to be available to evaluate patients with flashes and floaters. University practices were more likely to mention preparations to limit the spread of COVID-19. It might be helpful to know if there was a relationship, if any, of the various parameters used to track the virus, including the various total cases, cases per capita, percent positivity rate, hospitalizations, ventilator use, and deaths, which can vary not only by state over time, but also by county. This study provides insight with point estimates into how different practices in different environments and regions implemented changes in patient care to adapt to COVID-19. It is reassuring to see that most practices (60% of private and 85% of university practices) adhered to the recommendations of the Centers for Disease Control and Prevention, state governments, the American Academy of Ophthalmology, and other professional organizations. Fifteen of 60 practices (35% of private and 5% of university practices) were open to scheduling all patients at the time the study was conducted in late April. Four comprehensive practices were closed (5% of private and 10% of university practices), although the confidence of how that estimate relates to the universe of US practices is not provided. It would be interesting to further explore these variations in practice openings and availability. In this sample of practices, the only regional difference detected was that practices in the South were more likely to schedule patients for all services and to see cataract surgery patients sooner. It is noteworthy that appointments for issues other than posterior vitreous detachment symptoms were being scheduled well into the future, meaning it is likely that, as the authors noted, practices were compliant with the recommendations of the American Academy of Ophthalmology and Centers for Disease Control and Prevention by scheduling nonurgent concerns for dates when they believed it would be more appropriate to return to providing more routine eye care. On the other hand, one notable finding was that many practices did not offer an appointment for patients with new onset of symptoms of posterior vitreous detachment. Referring patients to the emergency department in this situation only shifted the responsibility to another colleague while potentially exposing the patient and the colleague(s) to the risks of contracting or transmitting COVID-19 in an emergency department setting. As noted by the authors, there are many reasons why this may have been the case, but it would be important for practices to assess ways of enhancing their response to this situation in the future. The authors also found that 17.5% of private practices and 15% of university centers were offering telemedicine services, although the effect of these services on outcomes currently is unknown. It was unclear if the frequency of telemedicine visits was due to the nature of the scenarios presented in this study (refractive error, cataract evaluation, and possible posterior vitreous detachment) or if there were alternative explanations. If it is indeed the case that many practices were not offering any form of telemedicine, this is consistent with data that Woodward et al5 reported, demonstrating that most Related article Insights Into Eye Care Practice During COVID-19 Invited Commentary

Clofarabine, cytarabine, and mitoxantrone in refractory/relapsed acute myeloid leukemia: High response rates and effective bridge to allogeneic hematopoietic stem cell transplantation.

Abstract: Clofarabine is active in refractory/relapsed acute myeloid leukemia (AML). In this phase 2 study, we treated 18- to 65-year-old AML patients refractory to first-line 3 + 7 daunorubicin/cytarabine induction or relapsing after 3 + 7 induction and high-dose cytarabine consolidation, with clofarabine (30 mg/m2 /d, Days 1-5), cytarabine (750 mg/m2 /d, Days 1-5), and mitoxantrone (12 mg/m2 /d, Days 3-5) (CLAM). Patients achieving remission received up to two consolidation cycles of 50% CLAM, with eligible cases bridged to allogeneic hematopoietic stem cell transplantation (allo-HSCT). The mutational profile of a 69-gene panel was evaluated. Twenty-six men and 26 women at a median age of 46 (22-65) years were treated. The overall response rate after the first cycle of CLAM was 90.4% (complete remission, CR: 69.2%; CR with incomplete hematologic recovery, CRi: 21.2%). Twenty-two CR/CRi patients underwent allo-HSCT. The 2-year overall survival (OS), relapse-free survival (RFS), and event-free survival (EFS) were 65.8%, 45.7%, and 40.2%, respectively. Multivariate analyses showed that superior OS was associated with CR after CLAM (P = .005) and allo-HSCT (P = .005), and superior RFS and EFS were associated with allo-HSCT (P < .001). Remarkably, CR after CLAM and allo-HSCT resulted in 2-year OS of 84.3% and 90%, respectively. Karyotypic aberrations and genetic mutations did not influence responses or survivals. Grade 3/4 neutropenia/thrombocytopenia and grade 3 febrile neutropenia occurred in all cases. Other nonhematologic toxicities were mild and uncommon. There was no treatment-related mortality and the performance of allo-HSCT was not compromised. Clofarabine, cytarabine, and mitoxantrone was highly effective and safe in refractory/relapsed AML. This study was registered at ClinicalTrials.gov (NCT02686593).

B Cell Subsets and Cellular Signatures and Disease Relapse in Lupus Nephritis.

Abstract: Introduction Renal relapses adversely affect the long-term outcomes of patients with lupus nephritis (LN), but the pathogenic mechanisms remain elusive. B cell signatures of miR-148a, BACH1, BACH2, and PAX5 expression are relevant to the regulation of B lymphocyte homeostasis. It is unknown whether B cell signature is related to the relapse of LN. Methods We compared B lymphocyte subsets and cellular signatures during disease quiescence between LN patients with multiple relapses (MR, ≥3 LN relapses within 36 months) and those with no relapse (NR). Also, circulating B lymphocytes were isolated from treatment-naive patients with active LN and treated with antagomir-148a in vitro to investigate the relationship between miR-148a, BACH1, BACH2, and PAX5. Results MR patients (n = 19), when compared with NR (n = 14), showed significantly lower percentage of circulating naive B cells and higher memory B cell-to-naive B cell ratio. MR patients also showed higher miR-148a levels in sera and B cells, and lower BACH1, BACH2, and PAX5 expression in naive and memory B cells. Antagomir-148a upregulated BACH1, BACH2, and PAX5 expression, and reduced B cell proliferation upon stimulation, in naive and memory B cells isolated from treatment-naive active LN patients. Conclusion Altered B cell subsets and cellular signatures of miR-148a, BACH1, BACH2, and PAX5 may be associated with distinct patient phenotypes related to the risk of LN relapse.