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1
Liberman, Robert P., Jane G. R. Musgrave, and Joe Langlois. "Taunton State Hospital, Massachusetts." American Journal of Psychiatry 160, no. 12 (December 2003): 2098. http://dx.doi.org/10.1176/appi.ajp.160.12.2098.
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Balducci, Patrick, Kendall Mongird, Di Wu, Dexin Wang, Vanshika Fotedar, and Robert Dahowski. "An Evaluation of the Economic and Resilience Benefits of a Microgrid in Northampton, Massachusetts." Energies 13, no. 18 (September 14, 2020): 4802. http://dx.doi.org/10.3390/en13184802.
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Recent developments and advances in distributed energy resource (DER) technologies make them valuable assets in microgrids. This paper presents an innovative evaluation framework for microgrid assets to capture economic benefits from various grid and behind-the-meter services in grid-connecting mode and resilience benefits in islanding mode. In particular, a linear programming formulation is used to model different services and DER operational constraints to determine the optimal DER dispatch to maximize economic benefits. For the resiliency analysis, a stochastic evaluation procedure is proposed to explicitly quantify the microgrid survivability against a random outage, considering uncertainties associated with photovoltaic (PV) generation, system load, and distributed generator failures. Optimal coordination strategies are developed to minimize unserved energy and improve system survivability, considering different levels of system connectedness. The proposed framework has been applied to evaluate a proposed microgrid in Northampton, Massachusetts that would link the Northampton Department of Public Works, Cooley Dickenson Hospital, and Smith Vocational Area High School. The findings of this analysis indicate that over a 20-year economic life, a 441 kW/441 kWh battery energy storage system, and 386 kW PV solar array can generate $2.5 million in present value benefits, yielding a 1.16 return on investment ratio. Results of this study also show that forming a microgrid generally improves system survivability, but the resilience performance of individual facilities varies depending on power-sharing strategies.
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Hua, May, Damon C. Scales, Zara Cooper, Ruxandra Pinto, Vivek Moitra, and Hannah Wunsch. "Impact of Public Reporting of 30-day Mortality on Timing of Death after Coronary Artery Bypass Graft Surgery." Anesthesiology 127, no. 6 (December 1, 2017): 953–60. http://dx.doi.org/10.1097/aln.0000000000001884.
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Abstract Background Recent reports have raised concerns that public reporting of 30-day mortality after cardiac surgery may delay decisions to withdraw life-sustaining therapies for some patients. The authors sought to examine whether timing of mortality after coronary artery bypass graft surgery significantly increases after day 30 in Massachusetts, a state that reports 30-day mortality. The authors used New York as a comparator state, which reports combined 30-day and all in-hospital mortality, irrespective of time since surgery. Methods The authors conducted a retrospective cohort study of patients who underwent coronary artery bypass graft surgery in hospitals in Massachusetts and New York between 2008 and 2013. The authors calculated the empiric daily hazard of in-hospital death without censoring on hospital discharge, and they used joinpoint regression to identify significant changes in the daily hazard over time. Results In Massachusetts and New York, 24,864 and 63,323 patients underwent coronary artery bypass graft surgery, respectively. In-hospital mortality was low, with 524 deaths (2.1%) in Massachusetts and 1,398 (2.2%) in New York. Joinpoint regression did not identify a change in the daily hazard of in-hospital death at day 30 or 31 in either state; significant joinpoints were identified on day 10 (95% CI, 7 to 15) for Massachusetts and days 2 (95% CI, 2 to 3) and 12 (95% CI, 8 to 15) for New York. Conclusions : In Massachusetts, a state with a long history of publicly reporting cardiac surgery outcomes at day 30, the authors found no evidence of increased mortality occurring immediately after day 30 for patients who underwent coronary artery bypass graft surgery. These findings suggest that delays in withdrawal of life-sustaining therapy do not routinely occur as an unintended consequence of this type of public reporting.
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Hague, Ashley Clare. "Recent Developments in Health Law: Civil Procedure: First Circuit Holds it Unreasonable to Hale Hospitals into Foreign Forums Simply for Accepting Out-of-State Patients — Harlow v. Children's Hospital." Journal of Law, Medicine & Ethics 34, no. 2 (2006): 467–69. http://dx.doi.org/10.1111/j.1748-720x.2006.00054.x.
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The United States Court of Appeals for the First Circuit recently upheld a United States District Court for the District of Maine Judge's decision to dismiss a Maine plaintiff's medical malpractice claim against a Massachusetts hospital defendant for want of personal jurisdiction over the hospital. The Court of Appeals found it unreasonable to hale hospitals into an out-of-state court merely because they accept out-of-state patients.Plaintiff Danielle Harlow is a Maine resident who suffered a stroke at the age of six while undergoing a medical procedure at Children's Hospital of Boston, Massachusetts (“Children's Hospital”). The stroke, allegedly caused by the Hospital's negligence, led to brain damage resulting in partial paralysis and cognitive and behavioral impairments. The procedure was supposed to treat Harlow's rapid heartbeat, a condition related to her Wolff-Parkinson-White Syndrome. Harlow's pediatrician in Maine recommended that she visit Children's Hospital in Boston to treat her arrhythmia.
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Mitra, Monika, Susan L. Parish, Karen M. Clements, Jianying Zhang, and Tiffany A. Moore Simas. "Antenatal Hospitalization Among U.S. Women With Intellectual and Developmental Disabilities: A Retrospective Cohort Study." American Journal on Intellectual and Developmental Disabilities 123, no. 5 (September 1, 2018): 399–411. http://dx.doi.org/10.1352/1944-7558-123.5.399.
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Abstract This population-based retrospective cohort study examines the prevalence of hospital utilization during pregnancy and the primary reason for antenatal hospital utilization among women with intellectual and developmental disabilities (IDD). Massachusetts residents with in-state deliveries that were ≥ 20 weeks gestational age were included via data from the 2002-2009 Massachusetts Pregnancy to Early Life Longitudinal Data System. Among women with IDD, 54.8% had at least one emergency department (ED) visit during pregnancy, compared to 23% of women without IDD. Women with IDD were more likely to have an antenatal ED visit, observational stays, and non-delivery hospital stays. This study highlights the need for further understanding of the health care needs of women with IDD during pregnancy.
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Noga, Patricia M., Anna Dermenchyan, Susan M. Grant, and Elizabeth B. Dowdell. "Developing Statewide Violence Prevention Programs in Health Care: An Exemplar From Massachusetts." Policy, Politics, & Nursing Practice 22, no. 2 (January 27, 2021): 156–64. http://dx.doi.org/10.1177/1527154420987180.
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Workplace violence is on the rise in health care. This problem contributes to medical errors, ineffective delivery of care, conflict and stress among health professionals, and demoralizing and unsafe work conditions. There is no specific federal statute that requires workplace violence protections, but several states have enacted legislation or regulations to protect health care workers. To address this problem in their state, the Massachusetts Health & Hospital Association developed an action plan to increase communication, policy development, and strategic protocols to decrease workplace violence. The purpose of this article is to report on the quality and safety improvement work that has been done statewide by the Massachusetts Health & Hospital Association and to provide a roadmap for other organizations and systems at the local, regional, or state level to replicate the improvement process.
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Bourque Kearin, Madeline. "‘As syllable from sound’: the sonic dimensions of confinement at the State Hospital for the Insane at Worcester, Massachusetts." History of Psychiatry 31, no. 1 (October 3, 2019): 67–82. http://dx.doi.org/10.1177/0957154x19879649.
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As the first state hospital in the USA, the Worcester State Hospital for the Insane at Worcester, Massachusetts (est. 1833), set a precedent for asylum design and administration that would be replicated across the country. Because the senses were believed to provide a direct conduit into a person’s mental state, the intended therapeutic force of the Worcester State Hospital resided in its particular command over sensory experience. In this paper, I examine how aurality was used as an instrument in the moral architecture of the asylum; how the sonic design of the asylum collided with the day-to-day logistics of institutional management; and the way that patients experienced and engaged with the resultant patterns of sound and silence.
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Haycock, Joel. "Comparative Suicide Rates in Different Types of Involuntary Confinement." Medicine, Science and the Law 33, no. 2 (April 1993): 128–36. http://dx.doi.org/10.1177/002580249303300208.
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In the past decade especially, a number of studies have appeared on suicide among court-involved persons, chiefly in jail and prison remand settings, and to a lesser degree among longer-term prisoners. Confinement is not everywhere equally suicidogenic, and the types of people who find themselves confined do not represent uniformly high risk groups. This article reports on rates of completed suicides over long periods of time in two very different US institutions operated by the Massachusetts Department of Correction: the Addiction Centre and its antecedent faculties (1886–1990); and the Defective Delinquent Department (1922–1971). For perspective, the paper compares suicide rates among its two populations to rates for other very distinctive institutions operated by the Massachusetts Department of Correction, the Bridgewater State Hospital and the Massachusetts Treatment Centre for Sexually Dangerous Persons. The results are remarkable for the rarity of suicide in three distinct populations—the Addiction Center, the Defective Delinquent Department and the Treatment Center for Sexually Dangerous Persons—but considerably higher rates in the State Hospital, a population often dismissed as “criminally insane.” The possible significance of these results for debates about “importation” versus “deprivation” explanations of custodial suicide is discussed.
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Gruber, Jonathan, and Robin McKnight. "Controlling Health Care Costs through Limited Network Insurance Plans: Evidence from Massachusetts State Employees." American Economic Journal: Economic Policy 8, no. 2 (May 1, 2016): 219–50. http://dx.doi.org/10.1257/pol.20140335.
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We investigate the impact of limited network insurance plans in the context of the Massachusetts Group Insurance Commission (GIC), the insurance plan for state employees. Our quasi-experimental analysis examines the introduction of a major financial incentive to choose limited network plans that affected a subset of GIC enrollees. We find that enrollees are very price sensitive in their decision to enroll in limited network plans. Those who switched spent almost 40 percent less on medical care. This reflects reductions in the quantity of services and prices paid per service. The spending reductions came from specialist and hospital care, while spending on primary care rose. (JEL G22, H75, I11, I13, J45)
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Joseph, Tiffany D. "What Health Care Reform Means for Immigrants: Comparing the Affordable Care Act and Massachusetts Health Reforms." Journal of Health Politics, Policy and Law 41, no. 1 (February 1, 2016): 101–16. http://dx.doi.org/10.1215/03616878-3445632.
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Abstract The 2010 Patient Protection and Affordable Care Act (ACA) was passed to provide more affordable health coverage to Americans beginning in 2014. Modeled after the 2006 Massachusetts health care reform, the ACA includes an individual mandate, Medicaid expansion, and health exchanges through which middle-income individuals can purchase coverage from private insurance companies. However, while the ACA provisions exclude all undocumented and some documented immigrants, Massachusetts uses state and hospital funds to extend coverage to these groups. This article examines the ACA reform using the Massachusetts reform as a comparative case study to outline how citizenship status influences individuals' coverage options under both policies. The article then briefly discusses other states that provide coverage to ACA-ineligible immigrants and the implications of uneven ACA implementation for immigrants and citizens nationwide.
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Loehrer, Andrew P., Zirui Song, Alex B. Haynes, David C. Chang, Matthew M. Hutter, and John T. Mullen. "Impact of Health Insurance Expansion on the Treatment of Colorectal Cancer." Journal of Clinical Oncology 34, no. 34 (December 1, 2016): 4110–15. http://dx.doi.org/10.1200/jco.2016.68.5701.
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Purpose Colorectal cancer is the third most common cancer and the third leading cause of cancer deaths in the United States. Lack of insurance coverage has been associated with more advanced disease at presentation, more emergent admissions at time of colectomy, and lower survival relative to privately insured patients. The 2006 Massachusetts health care reform serves as a unique natural experiment to assess the impact of insurance expansion on colorectal cancer care. Methods We used the Hospital Cost and Utilization Project State Inpatient Databases to identify patients with colorectal cancer with government-subsidized or self-pay (GSSP) or private insurance admitted to a hospital between 2001 and 2011 in Massachusetts (n = 17,499) and three control states (n = 144,253). Difference-in-differences models assessed the impact of the 2006 Massachusetts coverage expansion on resection of colorectal cancer, controlling for confounding factors and secular trends. Results Before the 2006 Massachusetts reform, government-subsidized or self-pay patients had significantly lower rates of resection for colorectal cancer compared with privately insured patients in both Massachusetts and the control states. The Massachusetts insurance expansion was associated with a 44% increased rate of resection (rate ratio = 1.44; 95% CI, 1.23 to 1.68; P < .001), a 6.21 percentage point decreased probability of emergent admission (95% CI, −11.88 to −0.54; P = .032), and an 8.13 percentage point increased probability of an elective admission (95% CI, 1.34 to 14.91; P = .019) compared with the control states. Conclusion The 2006 Massachusetts health care reform, a model for the Affordable Care Act, was associated with increased rates of resection and decreased probability of emergent resection for colorectal cancer. Our findings suggest that insurance expansion may help improve access to care for patients with colorectal cancer.
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Donohue, Jeffrey P. "Developing Issues Under the Massachusetts ‘Physician Profile’ Act." American Journal of Law & Medicine 23, no. 1 (1997): 115–58. http://dx.doi.org/10.1017/s0098858800010637.
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Massachusetts recently became the first state in the United States to publish physician malpractice histories and hospital disciplinary records. On August 9, 1996, Governor William F. Weld signed the Physician Profile Act (Profile Act or Act) into law, making “profiles” of the Commonwealth’s approximately twentyseven thousand doctors available to the public. Under the Act, the Massachusetts Board of Registration in Medicine (Board) provides information on physicians’ insurance plans, specialties, training, honors, and malpractice histories over a toll-free telephone number, through the Internet and on CD-ROM.The Act developed partially as a legislative response to a series of Boston Globe articles appearing in late 1994 which savaged the Board. Spotlighting a number of high-profile iatrogenic incidents, this highly charged series of articles, accompanied by a blistering editorial, alleged that some patients suffered substandard medical care at the hands of physicians who had been sued repeatedly for malpractice but never disciplined by the Board.
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McCormick, Danny, Srini Rao, Nancy Kressin, Rich Balaban, and Leah Zallman. "Impact of Social Factors on Hospital Readmissions at Massachusetts' Two Largest Safety Net Hospitals After State Health Reform." Journal of Health Care for the Poor and Underserved 30, no. 4 (2019): 1467–85. http://dx.doi.org/10.1353/hpu.2019.0092.
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Kang, Yu (Sunny), Huey-Ming Tzeng, and Ting Zhang. "Rural Disparities in Hospital Patient Satisfaction: Multilevel Analysis of the Massachusetts AHA, SID, and HCAHPS Data." Journal of Patient Experience 7, no. 4 (September 23, 2019): 607–14. http://dx.doi.org/10.1177/2374373519862933.
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Introduction: Hospital patient satisfaction has been a salient policy concern. We examined rurality’s impact on patient satisfaction measures. Methodology: We examined patients (age 50 and up) from 65 rural and urban hospitals in Massachusetts, using the merged data from 2007 American Hospital Association Annual Survey, State Inpatient Database and Survey of Patients’ Hospital Experiences, utilizing Hierarchical binary logistic regression analyses to examine the rural disparities in patient satisfaction measures. Results: Relative to the urban location, rurality reduced the likelihood of cleanliness of environment (odds ratio = 0.66, 95% confidence interval: [0.63-0.70]); but increased the likelihood of staff responsiveness and quietness. Compared to Caucasian counterparts, Hispanic patients were less likely to reside in a quiet hospital. Compared to other payments, Medicare or Medicaid coverage each reduced the likelihood of staff responsiveness and cleanliness. Compared to other diagnoses, depressive or psychosis disorders predicted smaller odds in responsiveness and cleanliness. Anxiety diagnosis reduced the likelihood of cleanness and quietness. At the facility level, higher registered nurse full-time equivalent (FTE)s or being a teaching hospital increased the likelihood of all measures. Conclusion: Relative to the urban counterparts, rural patients experienced lower likelihood of staff responsiveness after adjusting for other factors. Compared to Caucasian patients, Hispanic patients were less likely to reside in quiet hospital environment. Research is needed to further explore the basis of these disparities. Mental health diagnoses in depressive and psychosis disorders also called upon further studies in special care needs.
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Farland, L. V., J. E. Stern, C. L. Liu, H. Cabral, R. Knowlton, S. T. Gershman, H. Diop, and S. A. Missmer. "Cancer, subsequent subfertility, and fertility treatment: massachusetts deliveries linked to SART CORS, hospital stays, and the state cancer registry." Fertility and Sterility 110, no. 4 (September 2018): e15. http://dx.doi.org/10.1016/j.fertnstert.2018.07.061.
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Fagan, Karen A., Kamal K. Mubarak, Zeenat Safdar, Aaron Waxman, and Roham T. Zamanian. "Expanded Use of PAH Medications." Advances in Pulmonary Hypertension 7, no. 1 (January 1, 2008): 249–54. http://dx.doi.org/10.21693/1933-088x-7.1.249.
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This discussion was moderated by Karen A. Fagan, MD, Professor and Director, Division of Pulmonary Medicine, University of South Alabama College of Medicine, Mobile, Alabama. Panel members included Kamal K. Mubarak, MD, Assistant Professor of Medicine, Director, Pulmonary Hypertension Clinic, Wayne State University, Detroit, Michigan; Zeenat Safdar, MD, Assistant Professor of Medicine, Department of Medicine, Section of Pulmonary, Critical Care, and Sleep Medicine, Baylor College of Medicine, Houston, Texas; Aaron Waxman, MD, PhD, Associate Professor of Medicine, Harvard Medical School, Director, Pulmonary Vascular Disease Program and Pulmonary Critical Care Unit, Massachusetts General Hospital, Boston, Massachusetts; and Roham T. Zamanian, MD, Assistant Professor of Medicine, Director, Adult Pulmonary Hypertension Clinical Service, Vera Moulton Wall Center for Pulmonary Vascular Disease, Stanford University School of Medicine, Stanford, California.
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Wisor, Ronald L. "Community Care, Competition and Coercion: A Legal Perspective on Privatized Mental Health Care." American Journal of Law & Medicine 19, no. 1-2 (1993): 145–75. http://dx.doi.org/10.1017/s0098858800006699.
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Even as the Clinton administration considers an increased federal commitment to mental health care, delivery of such care remains fixed at the state level. In Massachusetts, state officials are privatizing mental health care on an unprecedented scale, an experiment that promises to provide better care at lower cost. This Note explores whether privatization can achieve that lofty goal, given a legal system that has made individual patient autonomy its preeminent value. The author concludes that wide-scale privatization and modern notions of self-determination can only coexist with a significant investment in the support services that are critical to the community tenure of former state hospital patients.
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Lan, F.-Y., C. A. Christophi, J. Buley, E. Iliaki, L. A. Bruno-Murtha, A. J. Sayah, and S. N. Kales. "Effects of universal masking on Massachusetts healthcare workers’ COVID-19 incidence." Occupational Medicine 70, no. 8 (October 21, 2020): 606–9. http://dx.doi.org/10.1093/occmed/kqaa179.
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Abstract Background Healthcare workers (HCWs) and other essential workers are at risk of occupational infection during the COVID-19 pandemic. Several infection control strategies have been implemented. Evidence shows that universal masking can mitigate COVID-19 infection, though existing research is limited by secular trend bias. Aims To investigate the effect of hospital universal masking on COVID-19 incidence among HCWs compared to the general population. Methods We compared the 7-day average incidence rates between a Massachusetts (USA) healthcare system and Massachusetts residents statewide. The study period was from 17 March (the date of first incident case in the healthcare system) to 6 May (the date Massachusetts implemented public masking). The healthcare system implemented universal masking on 26 March, we allotted a 5-day lag for effect onset and peak COVID-19 incidence in Massachusetts was 20 April. Thus, we categorized 17–31 March as the pre-intervention phase, 1–20 April the intervention phase and 21 April to 6 May the epidemic decline phase. Temporal incidence trends (i.e. 7-day average slopes) were compared using standardized coefficients from linear regression models. Results The standardized coefficients were similar between the healthcare system and the state in both the pre-intervention and epidemic decline phases. During the intervention phase, the healthcare system’s epidemic slope became negative (standardized β: −0.68, 95% CI: −1.06 to −0.31), while Massachusetts’ slope remained positive (standardized β: 0.99, 95% CI: 0.94 to 1.05). Conclusions Universal masking was associated with a decreasing COVID-19 incidence trend among HCWs, while the infection rate continued to rise in the surrounding community.
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Kwon, Dae-Jin, Hyelena Jeon, Keon Bong Oh, Sun-A. Ock, Gi-Sun Im, Sung-Soo Lee, Seok Ki Im, et al. "Generation of Leukemia Inhibitory Factor-Dependent Induced Pluripotent Stem Cells from the Massachusetts General Hospital Miniature Pig." BioMed Research International 2013 (2013): 1–11. http://dx.doi.org/10.1155/2013/140639.
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The generation and application of porcine induced pluripotent stem cells (iPSCs) may enable the testing for safety and efficacy of therapy in the field of human regenerative medicine. Here, the generation of iPSCs from the Massachusetts General Hospital miniature pig (MGH minipig) established for organ transplantation studies is reported. Fibroblasts were isolated from the skin of the ear of a 10-day-old MGH minipig and transduced with a cocktail of six human factors:POU5F1, NANOG, SOX2, C-MYC, KLF4,andLIN28. Two distinct types of iPSCs were generated that were positive for alkaline phosphatase activity, as well as the classical pluripotency markers:Oct4, Nanog, Sox2, and the surface marker Ssea-1. Only one of two porcine iPSC lines differentiated into three germ layers bothin vitroandin vivo. Western blot analysis showed that the porcine iPSCs were dependent on LIF or BMP-4 to sustain self-renewal and pluripotency. In conclusion, the results showed that human pluripotent factors could reprogram porcine ear fibroblasts into the pluripotent state. These cells may provide a useful source of cells that could be used for the treatment of degenerative and genetic diseases and agricultural research and application.
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CHO, Wonil. "The Relation Between Medical Care and Education in the Massachusetts State Hospital School for "Crippled Children" in the Early 20th Century." Japanese Journal of Special Education 41, no. 6 (2004): 641–49. http://dx.doi.org/10.6033/tokkyou.41.641.
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Gall, Kenneth P., Lynn Verhey, Jose Alonso, Joseph Castro, J. Michael Collier, William Chu, Inder Daftari, et al. "State of the Art? New proton medical facilities for the Massachusetts General Hospital and the University of California Davis Medical Center." Nuclear Instruments and Methods in Physics Research Section B: Beam Interactions with Materials and Atoms 79, no. 1-4 (June 1993): 881–84. http://dx.doi.org/10.1016/0168-583x(93)95490-v.
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Hackmann, Martin B., Jonathan T. Kolstad, and Amanda E. Kowalski. "Health Reform, Health Insurance, and Selection: Estimating Selection into Health Insurance Using the Massachusetts Health Reform." American Economic Review 102, no. 3 (May 1, 2012): 498–501. http://dx.doi.org/10.1257/aer.102.3.498.
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We implement an empirical test for selection into health insurance using changes in coverage induced by the introduction of mandated health insurance in Massachusetts. Our test examines changes in the cost of the newly insured relative to those who were insured prior to the reform. We find that counties with larger increases in insurance coverage over the reform period face the smallest increase in average hospital costs for the insured population, consistent with adverse selection into insurance before the reform. Additional results, incorporating cross-state variation and data on health measures, provide further evidence for adverse selection.
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Loehrer, Andrew P., David C. Chang, Zirui Song, and George J. Chang. "Health Reform and Utilization of High-Volume Hospitals for Complex Cancer Operations." Journal of Oncology Practice 14, no. 1 (January 2018): e42-e50. http://dx.doi.org/10.1200/jop.2017.025684.
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Purpose: Underinsured patients are less likely to receive complex cancer operations at hospitals with high surgical volumes (high-volume hospitals, or HVHs), which contributes to disparities in care. To date, the impact of insurance coverage expansion on site of complex cancer surgery remains unknown. Methods: Using the 2006 Massachusetts coverage expansion as a natural experiment, we searched the Hospital Cost and Utilization Project state inpatient databases for Massachusetts and control states (New York, New Jersey, and Florida) between 2001 and 2011 to evaluate changes in the utilization of HVHs for resections of bladder, esophageal, stomach, pancreatic, rectal, or lung cancer after the expansion of insurance coverage. We studied nonelderly, adult patients with private insurance and those with government-subsidized or self-pay (GSSP) coverage with a difference-in-differences framework. Results: We studied 11,687 patients in Massachusetts and 56,300 patients in control states. Compared with control states, the 2006 Massachusetts insurance expansion was associated with a 14% increased rate of surgical intervention for GSSP patients (incident rate ratio, 1.14; P = .015), but there was no significant change in the probability of GSSP patients undergoing surgery at an HVH (1.0 percentage-point increase; P = .710). The reform was associated with no change in the uninsured payer-mix at HVHs (0.6 percentage-point increase; P = .244) and with a 5.1 percentage-point decrease for the uninsured payer mix at low-volume hospitals ( P < .001). Conclusion: The 2006 Massachusetts insurance expansion, a model for the Affordable Care Act, was associated with increased rates of complex cancer operations and increased insurance coverage but with no change in utilization of HVH for complex cancer operations.
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Teres, Daniel, Keith Boyd, John Rapoport, Martin Strosberg, Robert Baker, and Stanley Lemeshow. "The Impact of Legislation Requiring DNR Orders: New York State Compared with Neighboring States." Journal of Intensive Care Medicine 11, no. 6 (November 1996): 335–42. http://dx.doi.org/10.1177/088506669601100605.
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Decisions to place limitations on the care of patients are complex, and they often involve physicians, other medical professionals, patients, or a surrogate decision-maker, family members, and others. In 1988, the Joint Commission on Accreditation of Health Care Organizations (JCAHO) and the New York State government adopted two different approaches to this complex issue of do-not-resuscitate (DNR) orders: one involved professional self-regulation, whereas the other mandated a standardized procedure requiring completion of legal documents. This study examines the impact of these two different approaches to writing of DNR orders for adult intensive care unit (ICU) patients on utilization and resulting length of stay. The study used three data bases. One is from a larger study designed to update the Mortality Probability Model (MPM), a measure of severity of illness for ICU patients. This data base includes consecutive admissions to the adult ICUs of four hospitals in the northeastern United States. The second is a similar data base from the European-North American Study of Severity Systems (ENAS), and it includes 20 hospitals. The third data base, a 1991 national survey of ICUs by the Society of Critical Care Medicine (SCCM), lists characteristics of patients in ICUs in the United States on a specific day. Logistic regression was used to analyze the first two data bases; the percentage of patients in New York with DNR orders was calculated for each of the three data bases and compared with patients in neighboring states. Length of ICU and hospital stay was measured in the first two data sets. In the MPM data, 14.4% of medical patients in New York had a DNR order written at the time of ICU discharge, compared with 198% of medical patients in Massachusetts; and 4.3% of New York surgical patients had a DNR order written at the time of ICU discharge, compared with 8.3% of surgical patients in Massachusetts. In the ENAS data, 7.4% of New York nonoperative patients has a DNR order in place within 24 hours, compared with 8.4% of such patients in the other states; and 1.0% of New York operative patients had DNR orders, compared with 3–5% of operative patients from other states. Logistic regression revealed that a New York patient was less likely to have a DNR order written than a patient located in one of the other states studied. Data from the SCCM survey demonstrated that the New York percentage of patients with “no CPR” orders was 5.50%, compared with a percentage of 6.87% in other states. With few exceptions, these differences between New York and surrounding states did not have an impact on hospital length of stay. During the period studied following implementation of New York's DNR Law, utilization of DNR orders in New York State was significantly lower than neighboring states. This decreased utilization, however, did not effect hospital utilization as measured through length of stay and ICU admissions.
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Wilkinson, Joanne, Emily Lauer, Nechama W. Greenwood, Karen M. Freund, and Amy K. Rosen. "Evaluating Representativeness and Cancer Screening Outcomes in a State Department of Developmental Services Database." Intellectual and Developmental Disabilities 52, no. 2 (April 1, 2014): 136–46. http://dx.doi.org/10.1352/1934-9556-52.2.136.
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Abstract Though it is widely recognized that people with intellectual and developmental disabilities (IDD) face significant health disparities, the comprehensive data sets needed for population-level health surveillance of people with IDD are lacking. This paucity of data makes it difficult to track and accurately describe health differences, improvements, and changes in access. Many states maintain administrative health databases that, to date, have not been widely used for research purposes. In order to evaluate the feasibility of using administrative databases for research purposes, the authors attempted to validate Massachusetts' administrative health database by comparing it to a large safety net hospital system's patient data regarding cancer screening, and to the state's service enrollment tables. The authors found variable representativeness overall; the sub-population of adults who live in 24-hr supported residences were better represented than adults who live independently or with family members. They also found a fairly low false negative rate for cancer screening data as compared with the “gold standard” of hospital records. Despite some limitations, these results suggest that state-level administrative databases may represent an exciting new avenue for health research. These results should lend context to efforts to study cancer and health screening variables using administrative databases. The present study methods may also have utility to researchers in other states for critically evaluating other state IDD service databases. This type of evaluation can assist researchers in contextualizing their data, and in tailoring their research questions to the abilities and limitations of this kind of database.
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Rubin, Samuel, Jacqueline A. Wulu, Heather A. Edwards, Robert W. Dolan, David M. Brams, and Bharat B. Yarlagadda. "The Impact of MassPAT on Opioid Prescribing Patterns for Otolaryngology Surgeries." Otolaryngology–Head and Neck Surgery 164, no. 4 (February 16, 2021): 781–87. http://dx.doi.org/10.1177/0194599820987454.
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Objective Determine whether opioid prescriber patterns have changed for tonsillectomy, parotidectomy, and thyroidectomy after implementation of the Massachusetts Prescription Awareness Tool (MassPAT). Study Design Retrospective cohort study. Setting Single-center tertiary care hospital. Methods Patients were included if they received tonsillectomy, parotidectomy, or thyroid surgery at Lahey Hospital and Medical Center (Burlington, Massachusetts) between October 1, 2015, and October 1, 2019. Prescribing patterns were compared prior to implementation of MassPAT, October 1, 2015, to October 14, 2016, to postimplementation of MassPAT, October 15, 2016, to October 1, 2019. Quantity of opioids prescribed was described using total morphine milligram equivalents (MME). Data were analyzed using univariate analysis, multivariate analysis, and trend line using line of best fit. Results A total of 737 subjects were included in the study. There was a downward trend in the quantity of opioids prescribed for all 3 surgeries during the study period. There was a significant difference in the quantity of opioids prescribed pre- and postimplementation of MassPAT for tonsillectomy (647.70 ± 218.50 MME vs 474.60 ± 185.90 MME, P < .001), parotidectomy (241.20 ± 57.66 MME vs 156.70 ± 72.99 MME, P < .001), and thyroidectomy (171.20 ± 93.77 MME vs 108.50 ± 63.84 MME, P < .001). There was also a decrease in the number of patients who did not receive opioids for thyroidectomy pre- and post-MassPAT (7.56% vs 24.14%). Conclusion We have demonstrated that there is an association with state drug monitoring programs and decrease in the amount of opioids prescribed for acute postoperative pain control for common otolaryngology surgeries.
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Yamamoto, Ayae, Lillian Gelberg, Yusuke Tsugawa, Gerald Kominski, and Jack Needleman. "4269 Frequent emergency department use among homeless individuals seen in emergent care: High risks of opioid-related diagnoses and adverse health services utilization outcomes." Journal of Clinical and Translational Science 4, s1 (June 2020): 133. http://dx.doi.org/10.1017/cts.2020.394.
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OBJECTIVES/GOALS: Using multi-state discharge data, to identify predictors of frequent emergency department (ED) use among the homeless patients seen in emergent care, and to compare frequent versus less frequent homeless ED users for their risk of serious health services utilization outcomes. METHODS/STUDY POPULATION: Based on the State Emergency Department Database and the State Inpatient Database, homeless individuals (n = 88,541) who made at least one ED visit in four states (Florida, Maryland, Massachusetts, and New York) in 2014. In this retrospective cross-sectional analysis, patient-level demographic and clinical factors were assessed as predictors for increased ED use. Risks of opioid overdose, opioid-related hospital admission/ED visit, in-hospital mortality, mechanical ventilation, and number of hospitalizations were compared between individuals with 4 or more vs. 2-3 vs. 1 ED visit(s), adjusting for potential confounders including hospital fixed effects (allowing for within hospital comparisons). RESULTS/ANTICIPATED RESULTS: Higher rates of ED use were associated with Medicare coverage <65; primary diagnosis of alcohol abuse, asthma, or abdominal pain; and co-morbidity of alcohol abuse, psychoses, or chronic pulmonary disease. Individuals with ≥4 visits had significantly higher adjusted risk of opioid overdose (3.7% vs. 1.2% vs. 1.0%), opioid-related hospitalizations/ED visits (17.9% vs. 8.5% vs. 6.6%), mechanical ventilation (9.8% vs. 7.0% vs. 4.7%), and greater # of hospitalizations (3.2 vs. 1.3 vs. 0.8) compared to individuals with 2-3 or 1 ED visit. Individuals with ≥4 and 2-3 ED visits had similar but increased risks of in-hospital mortality compared to individuals with 1 ED visit (2.8% vs. 2.8% vs. 2.3%). DISCUSSION/SIGNIFICANCE OF IMPACT: Homeless patients who were high ED users were more likely to be hospitalized and have other adverse outcomes. These findings encourage targeted interventions (i.e. housing) for the high-utilizer homeless population to reduce the burden of serious outcomes and costs for the patient and society.
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Dahlin, Constance, Joshua Nyambose, Gail Merriam, and Cherline Gene. "Promoting palliative care access to persons with cancer: A model for mapping statewide services." Journal of Clinical Oncology 33, no. 29_suppl (October 10, 2015): 127. http://dx.doi.org/10.1200/jco.2015.33.29_suppl.127.
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127 Background: The CDC comprehensive cancer initiatives value comprehensive quality care within its mission and program development. Currently, over 75% of hospitals in the United States have palliative care services for cancer patients (CAPC 2011). In order to promote access to quality palliative care in the community outside the hospital, an evaluation is essential. The CDC model of comprehensive cancer care and prevention control structure is an appropriate mechanism to perform such an evaluation. From 2014-2015, the Massachusetts Comprehensive Cancer and Prevention Control Network Palliative Care Workgroup performed a survey to hospitals, home health agencies, hospices, long term care facilities, and community providers to determine palliative care services available to cancer patients across the state. Methods: Using the National Consensus Project for Quality Palliative Care Clinical Practice Guidelines, a robust palliative survey tool was created by the Massachusetts Comprehensive Cancer and Prevention Control Palliative Care Workgroup. It was individualized to each of the following settings - hospitals, home health organizations, hospices, skilled nursing facilities, and community health agencies. Follow-up telephonic key informant interviews regarding palliative care services were conducted within the various settings, service organizations, and insurers. Results: The results of qualitative and quantitative data will be concluded in August. Initial results reveal significant disparities in access to palliative care across by geography and setting of care. Hospices and hospitals had the most access to palliative care services. Long term care settings and community health settings had the least access. Conclusions: Data reveals disparities in palliative care access within Massachusetts by geography, race, and setting of cancer care. This data will serve as the basis of regional networks to promote better access to palliative care for cancer patients across all settings. It is hoped this evaluation process will serve as a model for other states to perform a similar evaluation.
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Ullah, Amin, Sadaqat ur Rehman, Shanshan Tu, Raja Majid Mehmood, Fawad, and Muhammad Ehatisham-ul-haq. "A Hybrid Deep CNN Model for Abnormal Arrhythmia Detection Based on Cardiac ECG Signal." Sensors 21, no. 3 (February 1, 2021): 951. http://dx.doi.org/10.3390/s21030951.
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Electrocardiogram (ECG) signals play a vital role in diagnosing and monitoring patients suffering from various cardiovascular diseases (CVDs). This research aims to develop a robust algorithm that can accurately classify the electrocardiogram signal even in the presence of environmental noise. A one-dimensional convolutional neural network (CNN) with two convolutional layers, two down-sampling layers, and a fully connected layer is proposed in this work. The same 1D data was transformed into two-dimensional (2D) images to improve the model’s classification accuracy. Then, we applied the 2D CNN model consisting of input and output layers, three 2D-convolutional layers, three down-sampling layers, and a fully connected layer. The classification accuracy of 97.38% and 99.02% is achieved with the proposed 1D and 2D model when tested on the publicly available Massachusetts Institute of Technology-Beth Israel Hospital (MIT-BIH) arrhythmia database. Both proposed 1D and 2D CNN models outperformed the corresponding state-of-the-art classification algorithms for the same data, which validates the proposed models’ effectiveness.
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Green, Jeremy. "Stem cells, lineage and plasticity of the differentiated state: a one-day symposium sponsored by Massachusetts General Hospital, Harvard Cutaneous Biology Research Center, held Friday, May 17, 1996." Biochimica et Biophysica Acta (BBA) - Reviews on Cancer 1288, no. 2 (October 1996): R9—R11. http://dx.doi.org/10.1016/0304-419x(96)00026-1.
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Refaai, Majed A., Phan N. Nguyen, Thora S. Steffensen, Richard J. Evans, Joanne E. Cluette-Brown, and Michael Laposata. "Liver and Adipose Tissue Fatty Acid Ethyl Esters Obtained at Autopsy Are Postmortem Markers for Premortem Ethanol Intake." Clinical Chemistry 48, no. 1 (January 1, 2002): 77–83. http://dx.doi.org/10.1093/clinchem/48.1.77.
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Abstract Background: Fatty acid ethyl esters (FAEEs) are nonoxidative ethanol metabolites that have been implicated as mediators of alcohol-induced organ damage. FAEEs are detectable in the blood after ethanol ingestion, and on that basis have been proposed as markers of ethanol intake. Because blood is not always available at autopsy, in this study we quantified FAEEs in human liver and adipose tissue as potential postmortem markers of premortem ethanol intake. Methods: Twenty-four sets of samples were collected at the Massachusetts State Medical Examiner’s Office, and 7 sets of samples were obtained from the Pathology Department of Massachusetts General Hospital. Samples of liver and adipose tissue were collected at autopsy, and FAEEs were isolated and quantified from these organs as mass per gram of wet weight. Postmortem analysis of blood involved assessment for ethanol and other drugs. Results: The study shows a substantial difference in FAEE concentrations in liver and adipose tissue of patients with detectable blood ethanol at the time of autopsy vs those with no detectable blood ethanol, who were either chronic alcoholics or social drinkers. In addition, a specific FAEE, ethyl arachidonate, was found at concentrations >200 pmol/g almost exclusively in the liver and adipose tissue of individuals with detectable blood ethanol at the time of death, providing an additional FAEE-related marker for prior ethanol intake. Conclusions: The mass of FAEEs in liver and adipose tissue and the presence of ethyl arachidonate can serve as postmortem markers of premortem ethanol intake when no blood sample can be obtained.
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McDade, Theodore P., Jillian K. Smith, Zeling Chau, Elan R. Witkowski, James K. West, and Jennifer F. Tseng. "Inequal benefits from regionalization of cancer care: The pancreatic cancer surgery paradigm." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 4059. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.4059.
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4059 Background: Regionalization has been proposed for high-level care, including multidisciplinary cancer treatment and complex procedures. Pancreatic resections can serve as a marker for both. Using Massachusetts Division of Health Care Finance and Policy (DHCFP) data, we investigated regionalization of surgery for pancreatic cancer (PCa), its potential effect on perioperative outcomes, and disparities in access to high-volume PCa surgery centers. Methods: Using MA DHCFP Hospital Inpatient Discharge Data, 2005-2009, 10,524 discharges for PCa were identified, of which 746 were associated with pancreatic resection. Discharges with missing or out-of-state residence were excluded (n=704). Using geodetic methods and ZIP codes, center-to-center distances were calculated between patient (pt) and treating hospital. Median ZIP income was estimated from 2009 census data. High volume hospitals (4 of 25 performing pancreatic resections in MA) were defined using Leapfrog Criteria (> 11 per year (87th percentile for MA). Chi-square and logistic regression analyses were performed using SAS software. Results: Median age was 65. Pts were predominantly White (87.2%), with median ZIP income of $54,677. Pts travelled in-state up to 112 miles (median 15.4), with the majority resected at high volume hospitals (76%). Median length of stay (LOS) was 8.0 days, with LOS>1 week associated with low volume hospitals (p=0.0002). Of 14 in-hospital deaths, 7 were at low volume hospitals (4.14% of 169 pts) compared to 7 at high volume hospitals (1.31% of 535 pts) (p=0.0214). Predictors of shorter travel distance were: Black race (OR 4.45 (95% CI 1.66-11.93)), operation at low volume hospital (OR 2.62 (95% CI 1.81-3.77), and increased age (per year) (OR 1.02 (95% CI 1.00-1.03), but not sex or median income. Conclusions: Using MA statewide discharge data, regionalization of pancreatic cancer surgery to high-volume, better-outcome centers is seen to be occurring. However, it is not uniform, and disparities exist between groups of cancer pts that do and do not travel for their care. In the current era of scrutiny on cost, quality, and access to cancer care, further study into predictors of pts receiving optimal care is warranted.
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Lewandrowski, Kent, Kimberly Gregory, and Donna Macmillan. "Assuring Quality in Point-of-Care Testing: Evolution of Technologies, Informatics, and Program Management." Archives of Pathology & Laboratory Medicine 135, no. 11 (November 1, 2011): 1405–14. http://dx.doi.org/10.5858/arpa.2011-0157-ra.
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Context.—Managing the quality of point-of-care testing (POCT) is a continuing challenge. Advances in testing technologies and the development of specialized informatics for POCT have greatly improved the ability of hospitals to manage their POCT program. Objectives.—To present the evolving role of technology improvement, informatics, and program management as the key developments to ensure the quality of POCT. Data Sources.—This presentation is based on a review of the literature and on our experiences with POCT at the Massachusetts General Hospital (Boston). Conclusions.—Federal and state regulations, along with accreditation standards developed by the College of American Pathologists and The Joint Commission, have established guidelines for the performance of POCT and have provided a strong incentive to improve the quality of testing. Many instruments for POCT have incorporated advanced design features to prevent analytic and operator errors. This, along with the development of connectivity standards and specialized data management software, has enabled remote review of test data and electronic flow of information to hospital information systems. However, documentation of manually performed, visually read tests remains problematic and some POCT devices do not have adequate safeguards to prevent significant errors. In the past 2 decades the structure of a successful POCT management program has been defined, emphasizing the role of POCT managers working in conjunction with a pathology-based medical director. The critical skill set of POCT managers has also been identified. The POCT manager is now recognized as a true specialist in laboratory medicine.
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Lee, H. H., L. Faundez, C. Yarbrough, C. W. Lewis, and A. T. LoSasso. "Patterns in Pediatric Dental Surgery under General Anesthesia across 7 State Medicaid Programs." JDR Clinical & Translational Research 5, no. 4 (February 10, 2020): 358–65. http://dx.doi.org/10.1177/2380084420906114.
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Objectives: Children’s access to dental general anesthesia (DGA) is limited, with highly variable wait times. Access factors occur at the levels of facility, dental provider, and anesthesia provider. It is unknown if these factors also influence utilization of dental surgery. We characterized patterns in DGA utilization by system, provider, population, and individual disease levels to explain variation. Methods: We conducted a cross-sectional analysis of Medicaid-enrolled children (≤9 y) who received DGA in Massachusetts, Maryland, Texas, Connecticut, Washington, Illinois, and Florida from 2011 to 2012. DGA events were characterized by the place of service, measures of disease burden, average reimbursements for dental provider and anesthesia provider, and average total expenditures. Results: A total of 10,149,793 children met study eligibility criteria. States with similar patterns of caries-related visits, such as Illinois (16% of Medicaid enrollees had a caries-related claim) and Washington (22%), had different DGA rates (1% and 17%, respectively). Reimbursement rates for dental providers, DGA services, and nonhospital places of services did not consistently align in states with higher DGA rates. Surgical extraction rates, as a proxy for the most severe disease, exceeded 75% in Maryland, which had the lowest DGA rate (0.3%) Conclusions: Variation in DGA rates across states was not explained by reimbursements rates (provider, DGA services, place of service) or population or individual level of caries burden. Efforts to evaluate and alter utilization of DGA should consider factors such as dental and anesthesia provider capacity, health facility capacity (hospital vs. ambulatory surgery center vs. office), and population- and individual-level disease burden. Our negative findings suggest the presence of other social determinants of oral health that influence utilization of services (e.g., race/ethnicity, language preference, immigration status, policy and budget goals), which should be explored. Our findings also raise the specter that variation in surgical rates may represent instances of unmet needs or overtreatment. Knowledge Transfer Statement: The results of this study can be used by clinicians and policy makers as they address policy and clinical interventions to influence children with severe caries. Interventions to change utilization of surgical services on a population level may need to include state-specific factors that extend beyond reimbursement, disease burden, anesthesia provider type, or facility type.
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Miyawaki, Atsushi, Dhruv Khullar, and Yusuke Tsugawa. "Processes of care and outcomes for homeless patients hospitalised for cardiovascular conditions at safety-net versus non-safety-net hospitals: cross-sectional study." BMJ Open 11, no. 4 (April 2021): e046959. http://dx.doi.org/10.1136/bmjopen-2020-046959.
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ObjectivesEvidence suggests that homeless patients experience worse quality of care and poorer health outcomes across a range of medical conditions. It remains unclear, however, whether differences in care delivery at safety-net versus non-safety-net hospitals explain these disparities. We aimed to investigate whether homeless versus non-homeless adults hospitalised for cardiovascular conditions (acute myocardial infarction (AMI) and stroke) experience differences in care delivery and health outcomes at safety-net versus non-safety-net hospitals.DesignCross-sectional study.SettingData including all hospital admissions in four states (Florida, Massachusetts, Maryland, and New York) in 2014.ParticipantsWe analysed 167 105 adults aged 18 years or older hospitalised for cardiovascular conditions (age mean=64.5 years; 75 361 (45.1%) women; 2123 (1.3%) homeless hospitalisations) discharged from 348 hospitals.Outcome measuresRisk-adjusted diagnostic and therapeutic procedure and in-hospital mortality, after adjusting for patient characteristics and state and quarter fixed effects.ResultsAt safety-net hospitals, homeless adults hospitalised for AMI were less likely to receive coronary angiogram (adjusted OR (aOR), 0.42; 95% CI, 0.36 to 0.50; p<0.001), percutaneous coronary intervention (aOR, 0.52; 95% CI, 0.44 to 0.62; p<0.001) and coronary artery bypass graft (aOR, 0.43; 95% CI, 0.26 to 0.71; p<0.01) compared with non-homeless adults. Homeless patients treated for strokes at safety-net hospitals were less likely to receive cerebral arteriography (aOR, 0.23; 95% CI, 0.16 to 0.34; p<0.001), but were as likely to receive thrombolysis therapy. At non-safety-net hospitals, we found no evidence that the probability of receiving these procedures differed between homeless and non-homeless adults hospitalised for AMI or stroke. Finally, there were no differences in in-hospital mortality rates for homeless versus non-homeless patients at either safety-net or non-safety-net hospitals.ConclusionDisparities in receipt of diagnostic and therapeutic procedures for homeless patients with cardiovascular conditions were observed only at safety-net hospitals. However, we found no evidence that these differences influenced in-hospital mortality markedly.
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Alexeevich, Andreev Alexander, and Anton Petrovich Ostroushko. "Harvey Williams Cushing - founder of anesthetic monitoring, pioneer of neurosurgery (to the 150th of birthday." Journal of Experimental and Clinical Surgery 12, no. 1 (March 2, 2019): 84. http://dx.doi.org/10.18499/2070-478x-2019-12-1-84-84.
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Harvey Williams Cushing (1869–1939) graduated from Yale College and Harvard Medical School, and worked at the Massachusetts General Hospital of Boston. He created the first anesthesia card, introduced the term “regional anesthesia” into medical practice, described the Cushing triad, and in 1901, the second in the world, performed a successful operation on the pituitary gland for acromegaly. In 1910, he accepted the offer to become the head of the department of surgery at Harvard Medical School and the chief surgeon at Peter Benton Brigham Hospital, located on the campus. In 1933, Cushing moved to Yale, where from 1933 to 1937. was a professor of neurology. In the US, Harvey Williams Cushing is honored as a pioneer of neurosurgery and the greatest neurosurgeon in world history. Cushing developed and improved the technique of many neurosurgical operations, proved the right to the very existence of intracranial surgery as a separate medical specialty. In 1939, he was honored to become an Honorary Member of the Royal Medical College in London. Harvey Williams Cushing died on October 7, 1939 from myocardial infarction. He was awarded honorary degrees in nine American and thirteen European universities; several state orders and medals; as well as many different awards and prizes. Harvey Williams Cushing was a member of the American Philosophical Society, the National Academy of Natural Sciences, and the American Academy of Humanities and Natural Sciences, a foreign member of the Royal Society of London, and also an honorary member of about seventy medical, surgical, and scientific communities in Europe, USA, South America and india.
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Mogasala, Nagendra, Sumana Devata, Anthony Perissinotti, and Dale Bixby. "Clinical Availability of All-Trans Retinoic Acid (ATRA) for Patients with Suspected Acute Promyelocytic Leukemia – Why National Guidelines May Not be Followed." Blood 124, no. 21 (December 6, 2014): 2297. http://dx.doi.org/10.1182/blood.v124.21.2297.2297.
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Abstract Background: All-Trans Retinoic Acid (ATRA, Tretinoin, Vesinoid, Teva Pharmaceuticals Industries, North Wales, PA) serves as a uniform backbone in the care and management of patients with acute promyelocytic leukemia (APL). While first investigated as a salvage therapy for patients with relapsed or refractory disease, current National Comprehensive Cancer Network (NCCN) and European LeukemiaNet (ELN) guidelines call for its early use in patients suspected of having APL even prior to the genetic confirmation of the disease. Because ATRA can significantly mitigate disseminated intravascular coagulopathy (DIC), one of the early complications of APL, the NCCN and ELN guidelines support the prescription of ATRA as soon as there is a clinical suspicion of the diagnosis. As a regional referral center for the care of patients with advanced myeloid malignancies, we receive numerous requests for the transfer of care for patients suspected of having APL. Yet many of the referring centers have not instituted treatment with ATRA, typically due to a lack of access to the medication in the referring hospital’s formulary. Therefore, we conducted an exploratory analysis of the clinical availability of ATRA for patients with a suspected diagnosis of APL and also to explore the potential hurdles limiting the availability of this drug. Methods: We divided the United States into six geographical regions: Northwest, Southwest, Central, Southeast, Northeast, and the Great Lakes. A state from each of these regions was selected (Washington, Arizona, Missouri, Georgia, Massachusetts, and Michigan). To select the 120 hospitals, an online hospital directory – American Hospital Directory (ahd.com) was utilized. We went to each state’s specific hospital list page and assigned a number to all hospitals with a bed capacity of greater than 100. We then entered these numbers into a random number generator and selected the first 20 hospitals to be generated (excluding repeats). We then asked the following set of questions to the inpatient pharmacist of the hospital: 1. Does your hospital treat Acute Leukemia or do they refer to other hospitals; 2. Do you have All Trans Retinoic Acid (oral) – 10 mg tablets on the formulary or available in stock as a non-formulary request; 3. If no, why not. Results: Based upon the responses we received, ATRA was available in less than half of the hospitals queried (46%) (Table 1). There were no identifiable differences in the percentages based upon hospital size (inpatient beds) or academic versus non-academic status of the hospital. Interestingly, of the hospitals that refer to other institutions for the care of their leukemia patients, only 19% (8/43) had ATRA on their formulary or available in stock as a non-formulary request that could act as a bridge prior to the transfer. The analysis identified three common barriers to the availability of ATRA in these hospitals including: a) that it has not been recently requested by a physician and therefore was not available, b) the inpatient pharmacist had never heard of the drug, and c) that the hospital relied on associated hospitals or cancer centers to provide the drug to the patient. Table 1 Clinical Availability of All-Trans Retinoic Acid in Participating Hospitals Region State Percentage of Hospitals Possessing ATRA Northwest Washington 65% Southwest Arizona 45% Midwest Missouri 35% Great Lakes Michigan 58% Southeast Georgia 35% Northeast Massachusetts 40% Conclusion: While national guidelines support the rapid introduction of ATRA as soon as there is a morphologic consideration for APL, the majority of hospitals caring for these patients can not rapidly institute therapy due to a lack of availability of the medication. Moreover, only 19% (8/43) of hospitals that we studied that refer patients to tertiary care centers can provide ATRA as a bridge prior to their transfer. While much has been written about the early 30-day mortality seen in patients with APL, we can not specifically comment on the impact of these findings on the rates of mortality of APL patients treated in hospitals without ready access to ATRA versus those with the medication available on formulary. However, we propose that these findings should spur an investigation of this possibility together with a call by hematologists nationwide to their formulary committees to ensure that this lifesaving medication is available to patients in as timely a manner as possible. Disclosures Off Label Use: All Trans Retinoic Acid (ATRA) is indicated for the use in patients with acute promyelocytic leukemia (APL) who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline based chemotherapy is contraindicated. We will be discussing the availability of ATRA for the use in patients with newly diagnosed APL..
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Kandala, Rajesh N. V. P. S., Ravindra Dhuli, Paweł Pławiak, Ganesh R. Naik, Hossein Moeinzadeh, Gaetano D. Gargiulo, and Suryanarayana Gunnam. "Towards Real-Time Heartbeat Classification: Evaluation of Nonlinear Morphological Features and Voting Method." Sensors 19, no. 23 (November 21, 2019): 5079. http://dx.doi.org/10.3390/s19235079.
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Abnormal heart rhythms are one of the significant health concerns worldwide. The current state-of-the-art to recognize and classify abnormal heartbeats is manually performed by visual inspection by an expert practitioner. This is not just a tedious task; it is also error prone and, because it is performed, post-recordings may add unnecessary delay to the care. The real key to the fight to cardiac diseases is real-time detection that triggers prompt action. The biggest hurdle to real-time detection is represented by the rare occurrences of abnormal heartbeats and even more are some rare typologies that are not fully represented in signal datasets; the latter is what makes it difficult for doctors and algorithms to recognize them. This work presents an automated heartbeat classification based on nonlinear morphological features and a voting scheme suitable for rare heartbeat morphologies. Although the algorithm is designed and tested on a computer, it is intended ultimately to run on a portable i.e., field-programmable gate array (FPGA) devices. Our algorithm tested on Massachusetts Institute of Technology- Beth Israel Hospital(MIT-BIH) database as per Association for the Advancement of Medical Instrumentation(AAMI) recommendations. The simulation results show the superiority of the proposed method, especially in predicting minority groups: the fusion and unknown classes with 90.4% and 100%.
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McManus, Michael L., and Urbano L. França. "Availability of Inpatient Pediatric Surgery in the United States." Anesthesiology 134, no. 6 (April 8, 2021): 852–61. http://dx.doi.org/10.1097/aln.0000000000003766.
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Background In 2015, the American College of Surgeons began its Children’s Surgery Verification Quality Improvement Program, promulgating standards intended to promote regionalization and improve pediatric surgical care. It was hypothesized that pediatric surgical care was already highly regionalized and concentrated before implementation of the program. This study aimed to demonstrate this by describing the sites and volume of nonambulatory pediatric surgery. Methods A two-part, retrospective, cross-sectional analysis was performed. First, six all-encounter state inpatient data sets (Arkansas, Florida, Kentucky, Maryland, and New York from the Healthcare Cost and Utilization Project and Massachusetts from the Center for Health Information) were used to evaluate all procedures performed within specific hospitals in 2014. Next, a national sample data set (2016 Kids’ Inpatient Database) was used to determine the generalizability of the single state results. All acute care hospital admissions for patients less than 18 yr of age were included to describe the nature and location of all surgical procedures therein by patient age, surgical specialty, procedure type, and hospital service breadth. Results Within the six study states, there were 713 hospitals, of which 635 (89.1%) admitted patients less than 18 yr old, and 516 (72.4%) reported pediatric procedures. Among these, there were 9 specialty hospitals and 39 hospitals with services comparable to independent children’s hospitals. Of 153,587 procedures among 1,065,655 pediatric admissions, 127,869 (83.3%) took place within these 48 centers. This fraction decreased with age (89.9% of patients less than 2 yr old and 68.5% of 15- to 17-yr-olds), varied slightly by specialty, and was similar across states. Outside of specialized centers, teenagers accounted for 47.4% of all procedures. Within the national data sample, the concentration was similar: 8.7% (328 of 3,777) of all hospitals admitting children were responsible for 90.1% (793,905 of 881,049) of all procedures, with little regional variation. Conclusions Before the American College of Surgeons Children’s Surgery Verification Quality Improvement Program, the vast majority of pediatric nonambulatory surgeries were already confined to a small subset of high-capability and specialty centers. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New
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Kabraji, Sheheryar Kairas, Xavier Sole, Ying Huang, Clyde Bango, Michaela Bowden, Aditya Bardia, Dennis Sgroi, Massimo Loda, and Sridhar Ramaswamy. "Persistence of AKT1 low quiescent cancer cells after neoadjuvant chemotherapy in triple negative breast cancer patients." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 11579. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.11579.
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11579 Background: The mechanisms that allow triple negative breast cancer (TNBC) tumors to survive neoadjuvant chemotherapy (NACT) are incompletely understood. Evidence suggests that proliferative heterogeneity may contribute to primary chemotherapy resistance in patients with localized triple negative breast cancer. However, the detailed characterization of a drug-resistant cancer cell state in residual TNBC tissue after NACT has remained elusive. AKT1lowquiescent cancer cells (QCCs) are a quiescent, epigenetically plastic, and chemotherapy resistant subpopulation initially identified in experimental cancer models. Here, we asked whether AKT1low QCCs actually exist in primary tumors from patients with TNBC and persist after treatment with NACT. Methods: We identified QCCs in primary and metastatic human breast tumors using automated, quantitative, immunofluorescence microscopy coupled with computational and statistical analysis. We obtained pre-treatment biopsy, post-treatment mastectomy, and metastatic specimens from a retrospective cohort of TNBC patients treated with neoadjuvant chemotherapy at Massachusetts General Hospital (n = 25). Using automated quantitative immunofluorescence microscopy, QCCs were identified as AKTlow / H3K9me2low / HES1high cancer cells using prespecified immunofluorescence intensity thresholds. QCCs were represented as 2D and 3D digital tumor maps and QCC percentage (QCC-P) and QCC cluster index (QCC-CI) were determined for each sample. Results: We found that QCCs exist as non-random and heterogeneously distributed clusters within primary tumors. In addition, these QCC clusters are enriched after treatment with multi-agent, multi-cycle, neoadjuvant chemotherapy in both residual primary tumors as well as nodal and distant metastases in patients with triple negative breast cancer. Conclusions: Together, these data qualify QCCs as a non-genetic mechanism of chemotherapy resistance in triple negative breast cancer patients that warrants further study.
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Liu, Feifan, Richeek Pradhan, Emily Druhl, Elaine Freund, Weisong Liu, Brian C. Sauer, Fran Cunningham, Adam J. Gordon, Celena B. Peters, and Hong Yu. "Learning to detect and understand drug discontinuation events from clinical narratives." Journal of the American Medical Informatics Association 26, no. 10 (April 29, 2019): 943–51. http://dx.doi.org/10.1093/jamia/ocz048.
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Abstract Objective Identifying drug discontinuation (DDC) events and understanding their reasons are important for medication management and drug safety surveillance. Structured data resources are often incomplete and lack reason information. In this article, we assessed the ability of natural language processing (NLP) systems to unlock DDC information from clinical narratives automatically. Materials and Methods We collected 1867 de-identified providers’ notes from the University of Massachusetts Medical School hospital electronic health record system. Then 2 human experts chart reviewed those clinical notes to annotate DDC events and their reasons. Using the annotated data, we developed and evaluated NLP systems to automatically identify drug discontinuations and reasons at the sentence level using a novel semantic enrichment-based vector representation (SEVR) method for enhanced feature representation. Results Our SEVR-based NLP system achieved the best performance of 0.785 (AUC-ROC) for detecting discontinuation events and 0.745 (AUC-ROC) for identifying reasons when testing this highly imbalanced data, outperforming 2 state-of-the-art non–SEVR-based models. Compared with a rule-based baseline system for discontinuation detection, our system improved the sensitivity significantly (57.75% vs 18.31%, absolute value) while retaining a high specificity of 99.25%, leading to a significant improvement in AUC-ROC by 32.83% (absolute value). Conclusion Experiments have shown that a high-performance NLP system can be developed to automatically identify DDCs and their reasons from providers’ notes. The SEVR model effectively improved the system performance showing better generalization and robustness on unseen test data. Our work is an important step toward identifying reasons for drug discontinuation that will inform drug safety surveillance and pharmacovigilance.
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Rentz, Dorene M., Kathryn V. Papp, Danielle V. Mayblyum, Justin S. Sanchez, Hannah Klein, William Souillard-Mandar, Reisa A. Sperling, and Keith A. Johnson. "Association of Digital Clock Drawing With PET Amyloid and Tau Pathology in Normal Older Adults." Neurology 96, no. 14 (February 15, 2021): e1844-e1854. http://dx.doi.org/10.1212/wnl.0000000000011697.
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ObjectiveTo determine whether a digital clock-drawing test, DCTclock, improves upon standard cognitive assessments for discriminating diagnostic groups and for detecting biomarker evidence of amyloid and tau pathology in clinically normal older adults (CN).MethodsParticipants from the Harvard Aging Brain Study and the PET laboratory at Massachusetts General Hospital were recruited to undergo the DCTclock, standard neuropsychological assessments including the Preclinical Alzheimer Cognitive Composite (PACC), and amyloid/tau PET imaging. Receiver operating curve analyses were used to assess diagnostic and biomarker discriminability. Logistic regression and partial correlations were used to assess DCTclock performance in relation to PACC and PET biomarkers.ResultsA total of 300 participants were studied. Among the 264 CN participants, 143 had amyloid and tau PET imaging (Clinical Dementia Rating [CDR] 0, Mini-Mental State Examination [MMSE] 28.9 ± 1.2). An additional 36 participants with a diagnosis of mild cognitive impairment or early Alzheimer dementia (CDR 0.5, MMSE 25.2 ± 3.9) were added to assess diagnostic discriminability. DCTclock showed excellent discrimination between diagnostic groups (area under the receiver operating characteristic curve 0.86). Among CN participants with biomarkers, the DCTclock summary score and spatial reasoning subscores were associated with greater amyloid and tau burden and showed better discrimination (Cohen d = 0.76) between Aβ± groups than the PACC (d = 0.30).ConclusionDCTclock discriminates between diagnostic groups and improves upon traditional cognitive tests for detecting biomarkers of amyloid and tau pathology in CN older adults. The validation of such digitized measures has the potential of providing an efficient tool for detecting early cognitive changes along the AD trajectory.Classification of EvidenceThis study provides Class II evidence that DCTclock results were associated with amyloid and tau burden in CN older adults.
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Mitchell, J. M., K. R. Meehan, J. Kong, and K. A. Schulman. "Access to bone marrow transplantation for leukemia and lymphoma: the role of sociodemographic factors." Journal of Clinical Oncology 15, no. 7 (July 1997): 2644–51. http://dx.doi.org/10.1200/jco.1997.15.7.2644.
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PURPOSE Use of bone marrow transplantation (BMT), a complex, costly treatment for many forms of cancers, has increased significantly in recent years. The increasingly competitive health care marketplace raises concerns about patient access to costly medical procedures such as BMT. We attempted to evaluate patient access to BMT for the treatment of leukemias and lymphomas. METHODS We analyzed inpatient hospital discharge data from four states (California, Maryland, Massachusetts, and New York) for 2 years (1988 and 1991) to examine whether the use of BMT for patients with either leukemia or lymphoma varies by sociodemographic characteristics and insurance coverage. We developed a sorting algorithm to collapse the discharge data into patient level records. We used logistic regression to analyze the odds of receiving a BMT stratified by disease type (leukemia or lymphoma). RESULTS After controlling for other factors, black patients with leukemia are 51% to 53% as likely as whites, while black patients with lymphoma are 34% to 45% as likely as white patients to undergo a BMT (P < .05). Medicaid, self-pay patients, and Health Maintenance Organization (HMO) enrollees with either leukemia or lymphoma are significantly less likely to undergo a BMT compared with patients with private insurance. Younger patients are significantly more predisposed to undergo a BMT than older patients. The odds of receiving a BMT have increased over time, but the rates of increase vary by state. Consistent with clinical expectations, the relative odds of BMT vary significantly by type of leukemia or lymphoma. CONCLUSION Substantial variation exists in access to BMT for patients with either leukemia or lymphoma. Black patients, those enrolled in HMOs, those covered by Medicaid, and self-pay patients were less likely to receive a BMT when admitted for either leukemia or lymphoma. These findings raise concerns about access to cancer treatments for patients in the current health care system.
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Ganglberger, Wolfgang, Parimala Velpula Krishnamurthy, Abigail Bucklin, Ryan Tesh, Madalena Da Silva Cardoso, Haoqi Sun, Noor Adra, et al. "666 Sleep Architecture in the Intensive Care Unit As Revealed via Breathing and Heart Rate Variability." Sleep 44, Supplement_2 (May 1, 2021): A260—A261. http://dx.doi.org/10.1093/sleep/zsab072.664.
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Abstract Introduction Sleep in the intensive care unit (ICU) is difficult to measure by conventional polysomnography. We investigated the feasibility of assessing sleep state from readily available ICU signals: heart rate variability (HRV) from electrocardiography and breathing from a wearable respiratory band. We compared findings with an age and sex matched sleep laboratory group. Methods As part of a clinical trial, 102 adult non-ventilated patients in three ICUs in the Massachusetts General Hospital wore a respiratory band. Both heart rate variability (RR-intervals) from ECG, and breathing (respiratory effort waveforms) data for up to seven days per patient were obtained. 220 age- and sex-matched subjects from a sleep lab cohort who wore the same respiratory effort band and ECG were selected for comparison. We staged sleep from the HRV and breathing data using previously published deep neural network models. We defined discordant sleep epochs as those where HRV- and breathing-based models disagreed. Agreement was computed for the following pairs: (R,R),(N1,N1),(N2,N2),(N3,N3),(N1,W),(N1,N2),(N2,N3). Results Demographics: Mean(STD) age: ICU 68(9), sleeplab 68(9); BMI: ICU 27(6), sleeplab 31(6); ICU 40% female, sleeplab 44% female; race: ICU%:Sleeplab% 90:69 White, 5:4 Black, 2:7 Asian. 34% of ICU-subjects were in a medical ICU, 66% in a surgical ICU. Mean total sleep duration in the ICU was 8.9 hours (4.5h concordant, 4.4h discordant sleep). We observed increased amounts of discordant sleep in the ICU compared with the sleeplab cohort (4.4h vs. 1h, p<0.01). We found different REM sleep distributions (p<0.01) with reduced median (10% vs. 20%) but elevated 90% quantile (45% vs. 26%), elevated N1(%) (41% vs. 26%, p<0.05), reduced N2(%) (19 vs. 44, p<0.01), and reduced N2+N3(%) (34 vs. 59, p<0.05). We further observed higher mean respiratory rate (17.4 vs. 15.9 breaths per minute, p<0.01), lower inter-breath-intervals (3.9 vs. 4.7 seconds per breath, p<0.01), and more breathing variability than in sleeplab AHI<5 group but less than in AHI>15 group. Conclusion HRV and respiratory-based measures can assess sleep in the ICU. The findings of increased discordant sleep in the ICU might stem from limitations of the models, fundamental changes in sleep biology during critical illness, pharmaceutical drugs, sleep fragmentation, and/or associated pathology in the ICU. Support (if any):
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Fogerty, Annemarie E., and Walter Dzik. "Gestational Thrombocytopenia: Insights into Mechanism from 3730 Pregnancies." Blood 134, Supplement_1 (November 13, 2019): 1092. http://dx.doi.org/10.1182/blood-2019-126045.
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Introduction: Gestational thrombocytopenia (GT) is one of the most common hematologic disorders of young adults, observed in approximately 10% of pregnancies worldwide. Despite its prevalence, the cause of GT is not known. To gain insight into the potential mechanisms underlying GT, we analyzed clinical and laboratory features of the 3,730 pregnancies delivered at the Massachusetts General Hospital in 2017. Methods: Patients were identified and their clinical data were extracted from a standardized obstetric database. Results of 25,131 complete blood counts (CBCs) were obtained directly from the hospital laboratory record. CBCs obtained prior to pregnancy were removed from analysis. GT was defined as women with at least one recorded platelet count of <150K at any time during day -100 to the day of the delivery (day 0). For CBCs obtained on day 0, the medical record was reviewed to ensure that only platelet counts prior to parturition were used to categorize the patient. Controls included all other patients with platelet counts >150K during the final 100 days antepartum. For both GT and controls, women with an ICD-9 code for pre-eclampsia, antiphospholipid antibody syndrome, ITP, SLE, HIV, HCV, or HBV were excluded (n=29), as were women with a platelet count <50K (n=6) at any time during the pregnancy. This method resulted in 3,695 deliveries available for analysis. Comparisons of GT versus controls used the chi-square test for categorical data, t-test for parametric data, and Wilcoxon test for non-parametric data. Results: Of 3,695 deliveries, we identified 453 (12%) as GT and 3,242 as controls. For each stage of pregnancy, the CBC closest to delivery was selected, yielding 13,792 total CBCs for analysis (Figure 1). Of particular importance, the average percent decline in platelet count between trimester 1 and day 0 was 25.7% in women with GT versus 16.9% in the controls (p<0.0001). The decline in platelet count in both groups is much greater than the decline observed in hemoglobin (Hb) between trimester 1 and day 0: 1.1% decline in GT and 3.0% decline in controls. As shown in Table 1, the mean platelet volume (MPV) increased during pregnancy in both groups, with GT patients having a significantly higher MPV compared with controls in each trimester and at delivery (p<0.0001). Among 51 GT women with >1 CBC result post-partum, analysis revealed a greater than two-fold rise in platelet count within the first 7 days. The mean increases in platelet count compared with day 0 were: 100% on day 1, 117% on day 2, 142% on day 3, 159% on day 4, 187% on day 5, 214% on day 6, and 226% on day 7. Clinical and demographic data for the 2 groups are shown in Table 1. There was no significant difference between GT and controls in maternal age, gestational weeks at delivery, gravida, race, blood type, weight gain, mode of delivery, type of anesthesia, estimated blood loss, transfusions, rates of neonatal demise, APGAR scores, neonatal height or weight. A higher percentage of GT patients (9.1%, n=41) were given antenatal steroids versus controls (5.7%, n=186) (p=0.0059). There were more twin pregnancies among the GT group (5.1%, n=23) versus controls (2.9%, n=95) (p=0.015). Conclusions: Based on this retrospective analysis of 3695 pregnancies, GT is confirmed as a common hematologic disorder, occurring in 12% of pregnancies in this series. The significantly greater percent-decline in platelets during pregnancy in women with GT compared with controls suggests that GT is a distinct pathophysiology, and not that all pregnancies result in a similar degree of platelet decline with GT women simply starting at a lower platelet count. The data also argue against hemodilution as the etiology for GT given the relative stability in Hb compared with platelet decline throughout gestation in both groups and given the lack of significant difference in maternal weight gain between GTs and controls. The rapid doubling in platelet count within 7 days of delivery argues against an autoimmune mechanism, which would not likely demonstrate such spontaneous recovery kinetics. The progressive and statistically significant increase in MPV in women with GT compared with controls would be consistent with a high platelet turnover state in affected women, which may be exaggerated in pregnancy by increased blood flow sheer rates. Exploring causes for an increased rate of platelet turnover in GT as a component of the responsible mechanism merits further investigation. Disclosures No relevant conflicts of interest to declare.
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Hollenhorst, Marie A., and David J. Kuter. "Markers of Autoimmunity in Immune Thrombocytopenia: Prevalence and Prognostic Significance." Blood 128, no. 22 (December 2, 2016): 1363. http://dx.doi.org/10.1182/blood.v128.22.1363.1363.
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Abstract Background: Immune thrombocytopenia (ITP) is an acquired thrombocytopenia resulting from autoantibodies against platelets. Prior studies have suggested an increased prevalence of autoimmune markers in patients with ITP, even in the absence of another overt autoimmune illness. Clinical experience has suggested that there may be an association between autoimmune markers and poor outcomes in ITP but current guidelines do not encourage routine testing in ITP patients. The goal of this retrospective chart review was to investigate the prevalence of autoimmune markers and to determine if there is an association between autoimmune marker positivity and thrombosis or remission rates in patients with ITP. Methods: This was a retrospective chart review study of ITP patients who presented to one practice at Massachusetts General Hospital where a series of autoimmune markers were routinely evaluated at the time or diagnosis or referral. Included in the analysis were all patients with ITP according to ASH 2011 criteria who presented to this clinic between 1995 and 2014 and had at least one of the following autoimmune markers measured: antinuclear antibody (ANA), direct antiglobulin test (DAT), anti-thyroid peroxidase antibody (anti-ThyPeroxAb), anticardiolipin (ACL) IgM, ACL IgG, rheumatoid factor (RF), and lupus anticoagulant (LAC). Remission status was assessed at the most recent follow-up visit. Remission was defined as a platelet count greater than 30 x 109/L in a patient who was off all medications for ITP and never had a splenectomy. Patients not fulfilling both of these criteria at the most recent follow-up visit were counted as not being in remission. Thrombosis was assessed by review of the patient's radiology studies and the most recent Hematology note and included deep venous thrombosis, pulmonary embolism, embolic stroke, or lower extremity arterial embolism. Results: 169 ITP patients were identified between 1995 and 2014 who met ASH criteria for ITP and had testing for autoimmune markers. The mean age at initial evaluation was 49 years and mean duration of follow-up was 6 years. 60% of the patients were female. There is a high rate of autoimmune marker positivity in this population (Table 1). The most prevalent autoimmune markers were ANA (66%), anti-ThyPeroxAb (31%), and DAT (28%). In those subjects where all three of these tests were performed, there was significant overlap of the positive markers; out of 51 patients who had at least one positive marker, 55% had more than one positive autoimmune marker. 11% of the patients had a documented thrombosis, and 51% of the 166 patients for whom remission status was able to be ascertained achieved remission. Of the autoimmune marker tests, only the presence of anti-ThyPeroxAb was statistically significantly associated with lower remission rates, with 61% of anti-ThyPeroxAb negative patients achieving remission compared with 39% of anti-ThyPeroxAb positive patients (p = 0.04). Positive ANA and LAC were both highly statistically significantly associated with an increased rate of thrombosis (Table 2). Patients with a positive ANA had a 17% rate of thrombosis compared with 0% in patients with a negative ANA (p = 0.002). Patients with a positive LAC had a 50% rate of thrombosis compared with 11% in patients with a negative LAC (p = 0.001). Conclusions: These results suggest that ITP is a state of immune dysregulation that extends beyond antiplatelet antibodies. Routine measurement of anti-ThyPeroxAb, ANA, and LAC may be helpful in assessing the risk for remission and thrombosis and should be considered for inclusion in future ITP treatment guidelines. Table 1 Table 1. Disclosures Kuter: Genzyme: Consultancy; ONO: Consultancy; GlaxoSmithKline: Consultancy; 3SBios: Consultancy; Shionogi: Consultancy; MedImmune: Consultancy; CRICO: Other: Paid expert testimony; Eisai: Consultancy; Pfizer: Consultancy; Rigel: Consultancy, Research Funding; Syntimmune: Consultancy; Bristol-Myers Squibb: Research Funding; Protalex: Research Funding; Shire: Consultancy; Amgen: Consultancy, Paid expert testimony.
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Nakagawa, Akito, Ferrari Michele, Chen Liu, Lorenzo Berra, Elizabeth S. Klings, Martin K. Safo, Donald B. Bloch, Osheiza Abdulmalik, and Warren M. Zapol. "Development of a Triazolyldisulfide Compound That Increases the Affinity of Hemoglobin for Oxygen and Reduces Hypoxic Sickling of Sickle Cells." Blood 128, no. 22 (December 2, 2016): 3642. http://dx.doi.org/10.1182/blood.v128.22.3642.3642.
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Abstract Introduction: In patients with sickle cell disease,during a vasoocclusive crisis, deoxygenated sickle hemoglobin (HbS) polymerizes forming fibers of HbS in red blood cells (SS RBCs). HbS fibers distort SS RBCs, causing microvascular occlusion, increased thrombosis and inflammation, and severe pain for patients. Increasing the affinity of Hb for oxygen reduces sickling of SS RBCs, because oxygenated HbS does not form polymers. It has been reported that modification of the thiol group of Hb β-Cys93 increases Hb's affinity for oxygen by destabilizing the T-state and stabilizing the R-state. In addition, modification of HbS β-Cys93 might prevent interaction between HbS molecules and thereby reduce sickling. Herein we report a novel triazolyldisulfide compound (4,4'-Di(1,2,3-triazolyl)disulfide, designated "TD-3"), which increases the affinity of Hb for oxygen and reduces the sickling of hypoxic human SS RBCs in vitro. Intravenous administration of TD-3 to mice increases the affinity of murine Hb for oxygen. The effects of TD-3 on the affinity of Hb for oxygen may be a result of interaction with HbA-Cys93. Methods: TD-3 hydrate was dissolved in a mixture of Dulbecco's phosphate buffered saline and 30% polyethylene glycol 400. The oxygen dissociation curve (ODC) of Hb was measured at 37°C (pH 7.3) using a HEMOX analyzer. The partial oxygen pressure at which 50% of Hb is oxygenated was determined as P50 from the ODC and the P50 was used to assess the affinity of Hb for oxygen. SS whole blood was incubated with TD-3 (Hb tetramer/TD-3 = 1/1 mol/mol) for 10 min at 37°C and the P50 of TD-3 treated RBCs was determined. To evaluate the ability of TD-3 to reduce sickling in vitro, SS RBCs (Hct ≈ 20%) were incubated with TD-3 in a gas mixture of 4% oxygen and 96% nitrogen and the percentage of sickled RBCs was determined after incubation. To determine the effect of TD-3 on time-dependent change of P50 in vitro, normal human whole blood (Hct ≈ 45-50%) was incubated with TD-3 (Hb tetramer/TD-3 = 1/1 mol/mol) for 10 min and 8 h at 37°C. At both times, the P50 of RBCs was determined. To determine the effect of TD-3 on the time-dependent change of P50 in vivo, TD-3 (100 mg/kg) was administered intravenously to C57BL/6 mice and the P50 of murine Hb was determined (as hemolysate) before, and 1 and 24 h after TD-3 treatment. As a first step to investigate the mechanism of action of TD-3, normal adult hemoglobin (HbA) was treated with N-ethylmaleimide (NEM) to block HbA β-Cys93 and the P50 of NEM-treated HbA was determined. Either HbA or NEM-treated HbA was incubated with TD-3 at 37°C for 10 min (Hb tetramer/TD-3 = 1/6 mol/mol). After the incubation, the P50 of HbA and NEM-treated HbA was determined. Results: Incubation of TD-3 with SS RBCs reduced the P50 of SS RBCs from 29 mmHg to 24 mmHg. Incubation of SS RBCs with TD-3 (2 mM) in 4% oxygen decreased the percentage of sickled RBCs from 94% (without TD-3) to 22%. The P50 of TD-3-treated human normal RBCs was decreased from 25 mmHg (prior to adding TD-3) to 21 mmHg at 10 min. At 8 h, the P50 of TD-3-treated human normal RBCs was the same as that of RBCs treated with vehicle alone. The P50 of TD-3-treated murine Hb was reduced from 21 mmHg (before treatment with TD-3) to 18 mmHg at 1 h. At 24 h, the P50 of TD-3-treated murine Hb was the same as that of mice treated with vehicle alone. At 24 h, all of the mice that were treated with either TD-3 or vehicle alone were alive and appeared normal. Treatment of HbA with NEM reduced the P50 from 17 mmHg to 8 mmHg. Incubation of TD-3 with either HbA or NEM-treated HbA reduced the P50 of HbA from 17 mmHg to 4 mmHg, but did not alter the P50 of NEM treated HbA (8 mmHg). Conclusions: 4,4'-Di(1,2,3-triazolyl)disulfide (TD-3) increased the affinity of human normal and SS RBCs for oxygen and reduced the sickling of hypoxic human SS RBCs in vitro. Administration of TD-3 to healthy mice increased the affinity of murine Hb for oxygen and the compound was well tolerated by the mice. The effect of TD-3 on the affinity of HbA for oxygen was impaired by blocking the thiol group of HbA β-Cys93 with NEM, suggesting that the mechanism by which TD-3 increases the affinity of Hb for oxygen and reduces sickling may be through interaction with Hb β-Cys93. Our data demonstrate that TD-3 has the potential to prevent and treat sickle cell disease. Disclosures Nakagawa: Massachusetts General Hospital: Patents & Royalties: MGH filed a patent application on the use of heteroaryl disulfide compounds including TD-3 to increase the oxygen-binding affinity of hemoglobin and treat sickle cell disease and other uses of these compounds. The patent hasn't issued or licensed yet.. Zapol:Massachusetts General Hospital: Patents & Royalties: MGH filed a patent application on the use of heteroaryl disulfide compounds including TD-3 to increase the oxygen-binding affinity of hemoglobin and treat sickle cell disease and other uses of these compounds. The patent hasn't issued or licensed yet..
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Jonczyk, Michael, Ilse M. Schol, Philipp Tratnig-Frankl, Alexandre G. Lellouch, Dicken S. C. Ko, and Curtis L. Cetrulo. "3281 Management of Acute Rejection in Penile Allotransplantation." Journal of Clinical and Translational Science 3, s1 (March 2019): 15–16. http://dx.doi.org/10.1017/cts.2019.38.
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OBJECTIVES/SPECIFIC AIMS: Objective: To summarize the diagnosis and management of two acute rejection (AR) episodes in the first penis transplant patient in the U.S. Background: Vascularized composite allotransplantation (VCA) has been utilized for state-of-the-art reconstruction of devastating craniofacial defects, limb loss, and recently, severe genitourinary defects. To date, more than 200 VCA’s have been performed, of which four successful penis transplants have been achieved worldwide (Two in the U.S.). However, despite the technical success of VCAs in general, acute rejection episodes remain a significant postoperative management problem, with 80-85% experiencing at least one episode in the first-year post-transplantation. The incorporation of skin in VCAs, which is highly immunogenic, allows early visible recognition of rejection but requires prompt management to prevent allograft failure as well as the progression of chronic rejection, which has been associated with the frequency of acute rejection episodes in preclinical models. We present the first report of acute rejection in a penile allograft. AR episodes in VCA typically manifest with erythema of the allograft skin and/or maculopapular lesions that can be either patchy, focal or diffuse. Histopathologic assessment is essential for diagnosis and management. The Banff classification of histopathologic criteria for degree of AR is most commonly utilized to direct clinical management. METHODS/STUDY POPULATION: We reviewed the clinical course of the first American patient who underwent penis transplantation at Massachusetts General Hospital in 2016. Postoperatively, routine clinical and chemical assessment (immunosuppression levels, routine blood work) was performed, with increased frequency during AR episodes. Skin punch biopsies were obtained during (suspected) AR episodes, analyzed and graded according to the Banff 2007 classification of rejection of skin-containing composite allografts. Histopathologic tissue assessment included CD3, C4d, CD4/8, CD20 FOXP3 and cellular infiltration (hyper keratinization, lymphocytic infiltrate, dermal erosion, macrophage, eosinophilia, T-cell infiltration) and epidermal or perivascular fibrosis. RESULTS/ANTICIPATED RESULTS: The patient is a 65-year-old male with history of penile carcinoma requiring subtotal penectomy in 2012. He is currently 30-months post penile transplantation (as of 11/15/2018). First Rejection Episode: At 28 days post-transplantation, the patient noted induration, swelling and erythema of the allograft, which was diagnosed as AR clinically (Image 1A). Biopsy showed a Banff Grade III AR, with focal keratinocyte apoptosis with lymphocytic infiltration in epidermis and arteriolar endothelialitis with perivascular inflammation. Initially this episode was treated for 2 days with 2 pulse doses of methylprednisolone (500mg/d IV) with clinical improvement. However, recurrent allograft erythema was observed on postoperative day 32 and an acute rejection grade III according the Banff classification was confirmed by a second biopsy that demonstrated epidermal perivascular lymphocytic infiltrates, spongiosis and dyskeratosis, deep dermis focal lymphocytic infiltrates and focal infiltrates in arterioles as well as endothelialitis in venules. Donor specific antibodies and C4d were negative. CD3+ T cells were present in the epidermis and perivascular space. This was treated with anti-thymocyte globulin (thymoglobulin) course for 4 days (1.5mg/kg/day IV) and 3 more pulse doses of methylprednisolone (500mg/d IV.), followed by a prednisone (250mg/d) taper to baseline. This resulted in complete resolution of AR. Second Rejection Episode: At 10.8 months post VCA the patient presented with penile erythema and scrotal swelling suggestive of AR and received three doses of methylprednisolone (day 1: 500mg/d IV, day 2: 1000mg/d IV and day 3: 500mg/d IV respectively) followed by increased baseline prednisone (10mg PO daily; increased dose compared to previous AR episode). A skin biopsy confirmed Banff Grade III AR. Compared to the previous biopsy, this biopsy demonstrated an increased density of lymphocytic inflammation of the dermis with endarteritis. Prominent involvement of epidermis and adnexal structures corresponding to acute T-cell mediated rejection was also observed (Figure 1). Donor specific antibodies and C4d were again negative. Three doses of ATG (1.5mg/kg/day IV) were administered. In addition, tacrolimus was increased and local tacrolimus (1% ointment) treatment was begun. Clinical signs of rejection improved and repeat biopsy showed dramatic histopathological improvement. Current maintenance immunosuppressive regimen consists of tacrolimus, sirolimus, prednisone, mycophenolic mofetil acid (MMF), rapamycin, and tacrolimus ointment, with no new clinical or histopathological signs of rejection (Image 1B). DISCUSSION/SIGNIFICANCE OF IMPACT: We report the first described case of acute T-cell mediated rejection in penile transplantation. These rejection episodes demonstrated that, even on stringent immunosuppressive regimens, severe acute rejection episodes in VCA may still occur. Edema and acute induration preceded the development of erythema in our cases, representing a harbinger for the more severe grade of rejection that eventually developed. Our experience was consistent with other VCAs in that donor specific antibodies did not develop, despite a severe Banff Grade. Consistent use of topical calcineurin inhibitor based immunosuppression on the allograft skin may be helpful in warding off future episodes, as our patient has been rejection free now for 18 months. To date, no histologic signs of chronic rejection were present on 2-year protocol surveillance biopsy. We have added rapamycin to the current drug regimen, with concurrent reduction of tacrolimus dosing for renal protection, which has been demonstrated in cardiac transplantation to deter the intimal hyperplasia/vasculopathy associated with chronic rejection.
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Chen, Evan C., Shuli Li, Ann-Kathrin Eisfeld, Marlise R. Luskin, Alice S. Mims, Daniel Jones, Joseph H. Antin, et al. "Outcomes of IDH1- and IDH2-Mutated AML Patients Undergoing Allogeneic Hematopoietic Cell Transplantation." Blood 136, Supplement 1 (November 5, 2020): 2–3. http://dx.doi.org/10.1182/blood-2020-140353.
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Background: Allogeneic hematopoietic cell transplant (HCT) is a potentially curative approach for eligible patients with acute myeloid leukemia (AML). The 5-year overall survival (OS) for AML patients (pts) following HCT is approximately 40-50%. However, data regarding outcomes for pts with certain molecular subtypes of AML are lacking. Of particular interest are post-HCT outcomes of pts with targetable mutations such as FLT3, IDH1, or IDH2, given the potential role of maintenance targeted therapy in the post-HCT setting. We conducted a retrospective, multi-institutional study describing outcomes for IDH1- or IDH2-mutated AML pts following HCT. Methods: We performed retrospective data collection, using institutional databases, at three academic sites (Massachusetts General Hospital, Dana Farber Cancer Institute, and Ohio State University). We identified pts >18 years of age with a diagnosis of IDH1- or IDH2-mutated AML who underwent allogeneic HCT from 2010 to 2019. Data collected included pt age, sex, mutational and cytogenetic profile, treatment received prior to HCT, marrow response prior to HCT, stem cell source, HCT conditioning regimen, graft-versus-host disease (GVHD) prophylaxis, and time of relapse, death, or last known follow-up. IDH mutational status was assessed using next generation sequencing prior to HCT. Time to event endpoints are analyzed using the Kaplan Meier method for OS and progression-free survival (PFS), or the Gray method in a competing risk setting for time to relapse and non-relapse mortality (NRM). Proportional hazard cox models and competing risk regression models were used to test difference between groups while adjusting for other covariates. Results: In total, 117 pts with IDH1- or IDH2-mutated AML who received allogeneic HCT were identified. An IDH1 mutation was identified in 35 patients (pts) while an IDH2 mutation was found in 81 pts (Table 1). One pt had both IDH1 and IDH2 mutations and he was not included in subsequent univariate and multivariate analyses. The most commonly co-occurring mutations among all patients were DNMT3A (35%), NPM1 (32%), FLT3-ITD (14%), ASXL1 (10%), and TP53 (3%). 50 pts (43%) were >65 years old (range 27-74), and 60 (51%) were male. 12 pts (10%) had favorable-risk, 70 pts (60%) had intermediate-risk, and 21 pts (18%) had adverse-risk AML by ELN cytogenetic criteria; data were unavailable for 14 patients (12%). 112 pts (96%) achieved CR/CRi prior to HCT. 76 pts (65%) received reduced intensity and 40 (34%) underwent myeloablative conditioning (Table 1); data were unavailable for 1 patient (0.9%). 36 pts (31%) received an IDH inhibitor before HCT and 3 (2.6%) received an IDH inhibitor as maintenance therapy after HCT. Following HCT, 18 pts (15%) experienced grade 2-4 acute GVHD and 44 (38%) experienced chronic GVHD requiring systemic treatment. With a median follow-up of 23 months for surviving pts, the 1-year PFS and OS for the IDH1-mutated cohort was 74% (95% CI 55%-85%) and 76% (95% CI 58%-87%), respectively, and the 2-year PFS and OS was 55% (95% CI 35%-71%) and 73% (95% CI 55%-85%), respectively (Figure 1). With a median follow-up of 26 months for surviving pts, the 1-year PFS and OS for the IDH2-mutated cohort was 58% (95% CI 47%-68%) and 72% (95% CI 61%-81%), respectively, and the 2-year PFS and OS was 52% (95% CI 40%-63%) and 60% (95% CI 48%-70%), respectively (Figure 1). The 2-year cumulative incidence of relapse and NRM was 36.1% (95% CI 19.0%-53.6%) and 9.1% (95% CI 2.2%-22.0%), respectively, for the IDH1-mutated cohort, and 29.8% (95% CI 19.9%-40.4%) and 18.0% (95% CI 10.3%-27.3%), respectively, for the IDH2-mutated cohort. On multivariate analysis of OS, there was no statistically significant association with older age, higher-risk disease, absence of pre-HCT CR/CRi, use of reduced intensity conditioning, or IDH mutation. Conclusion: This is the first multi-institutional retrospective study to characterize outcomes of IDH1- or IDH2-mutated AML patients undergoing allogeneic HCT. We report important benchmarks of relapse, disease-free, and overall survival that will inform interpretation of ongoing and future clinical trials investigating the benefit of maintenance IDH1 and IDH2 inhibitor therapy in the post-HCT setting. Disclosures Eisfeld: Karyopharm: Current Employment, Current equity holder in publicly-traded company; Vigeo Therapeutics: Consultancy. Mims:Novartis: Speakers Bureau; Agios: Consultancy; Leukemia and Lymphoma Society: Other: Senior Medical Director for Beat AML Study; Abbvie: Membership on an entity's Board of Directors or advisory committees; Kura Oncology: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Other: Data Safety Monitoring Board; Syndax Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees. Jones:Pharmacyclics LLC, an AbbVie Company: Patents & Royalties: and other intellectual property, Research Funding. Cutler:Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kadmon: Consultancy, Membership on an entity's Board of Directors or advisory committees; Jazz: Consultancy, Membership on an entity's Board of Directors or advisory committees; Medsenic: Consultancy, Membership on an entity's Board of Directors or advisory committees; Generon: Consultancy, Membership on an entity's Board of Directors or advisory committees; Mesoblast: Consultancy, Membership on an entity's Board of Directors or advisory committees. Koreth:Amgen: Consultancy; Moderna Therapeutics: Consultancy; Biolojic Design Inc: Consultancy; EMD Serono: Consultancy; Equillium: Consultancy; Clinigen: Other; Miltenyi: Other: Research Support; BMS: Other: Research Support; Cugene: Membership on an entity's Board of Directors or advisory committees; Therakos: Membership on an entity's Board of Directors or advisory committees; Regeneron: Other: Research Support. Defilipp:Incyte: Research Funding; Regimmune: Research Funding; Syndax Pharmaceuticals: Consultancy. Soiffer:Celgene: Membership on an entity's Board of Directors or advisory committees; Rheos Therapeutics: Consultancy; Juno: Membership on an entity's Board of Directors or advisory committees; alexion: Consultancy; Be the Match/ National Marrow Donor Program: Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy; Cugene: Consultancy; Precision Bioscience: Consultancy; Kiadis: Membership on an entity's Board of Directors or advisory committees; VOR Biopharma: Consultancy; Mana Therapeutics: Consultancy; Novartis: Consultancy. Chen:AbbVie: Other: Data and Safety Monitoring Board Member; Equillium: Other: Data and Safety Monitoring Board Member; Takeda: Consultancy; Incyte Corporation: Consultancy; Magenta: Consultancy; Kiadis: Consultancy; Actinium: Other: Data and Safety Monitoring Board Member. Fathi:PTC Therapeutics: Consultancy; Daiichi Sankyo: Consultancy; Abbvie: Consultancy; Takeda: Consultancy, Research Funding; Trillium: Consultancy; Forty Seven: Consultancy; Novartis: Consultancy; Amphivena: Consultancy; Astellas: Consultancy; BMS/Celgene: Consultancy, Research Funding; Kite: Consultancy; Trovagene: Consultancy; Boston Biomedical: Consultancy; Kura Oncology: Consultancy; Blueprint: Consultancy; Jazz: Consultancy; Pfizer: Consultancy; Newlink Genetics: Consultancy; Agios: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Amgen: Consultancy.
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Confino, Edmond, Richard H. Demir, Jan Friberg, and Norbert Gleicher. "Does cyclic human chorionic gonadotropin secretion indicate embryo loss in in vitro fertilization?*†‡*The International Collaborators for this study were Benjamin G. Brackett, M.D., Ph.D., The University of Georgia College of Veterinary Medicine, Atlanta, Georgia, USA, Jairo Garcia, M.D., Suheil Muasher, M.D., Anibal A. Acosta, M.D., Mason C. Andrews, M.D., Gary Hodgen, Ph.D., Zev Rosenwaks, M.D., Georgeanna Seegar Jones, M.D., Howard W. Jones, Jr., M.D., Eastern Virginia Medical School, Norfolk, Virginia, USA, Robert H. Glass, M.D., Mary C. Martin, M.D., Pramila Dandekar, M.SC., University of California, San Francisco, California, USA, Vesselko Grizelj, M.D., Ph.D., University Medical School of Zagreb, Zagreb, Yugoslavia, George Henry, M.D., Jon Van Blerkom, M.D., Barbara J. Corn, R.N., Reproductive Genetics, In Vitro, P.C., Denver, Colorado, USA, Aarne Koskimies, M.D., Markku Seppala, M.D., Helsinki University Central Hospital, Helsinki, Finland, David Magyar, M.D., Robert J. Sokol, M.D., Patricia A. Rogus, R.N., Hutzel Hospital, Wayne State University, Detroit, Michigan, USA, H.W. Michelmann, M.D., L. Mettler, M.D., Universitats Frauenklinik, Kiel, German Federal Republic, Jean Parinaud, Ph.D., Georges Pontonnier, M.D., Institut National de la Sante et de la Recherche Medicale, Toulouse, France, E. van Roosendaal, M.D., R. Schoysman, M.D., Academisch Zeikenhuis Vrije Universiteit, Brussels, Belgium, Melvin Taymor, M.D., Beth Israel Hospital and Harvard Medical School, Boston, Massachusetts, USA, Raimund Winter, M.D., Geburtshilfliche Gynakologische Universitatsklinik Graz, Austria, Richard J. Worley, M.D., William R. Keye, Jr., M.D., University of Utah Medical Center, Salt Lake City, Utah, USA, John L. Yovich, M.D., University of Western Australia, Subiaco, Perth, Western Australia, Australia.†Supported by the Foundation for Reproductive Medicine, Inc., Chicago, Illinois.‡Presented in part in Future Aspects in Human In Vitro Fertilization Congress, Vienna, Austria, April 2 to 4, 1986, and the Forty-Second Annual Meeting of The American Fertility Society and the Eighteenth Annual Meeting of The Canadian Fertility and Andrology Society, Toronto, Canada, September 27 to October 2, 1986." Fertility and Sterility 46, no. 5 (November 1986): 897–902. http://dx.doi.org/10.1016/s0015-0282(16)49831-6.
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