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N Engl J Med [journal]
- The Effect of Malpractice Reform on Emergency Department Care. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 16; 371(16):1518-1525.
Background Many believe that fear of malpractice lawsuits drives physicians to order otherwise unnecessary care and that legal reforms could reduce such wasteful spending. Emergency physicians practice in an information-poor, resource-rich environment that may lend itself to costly defensive practice. Three states, Texas (in 2003), Georgia (in 2005), and South Carolina (in 2005), enacted legislation that changed the malpractice standard for emergency care to gross negligence. We investigated whether these substantial reforms changed practice. Methods Using a 5% random sample of Medicare fee-for-service beneficiaries, we identified all emergency department visits to hospitals in the three reform states and in neighboring (control) states from 1997 through 2011. Using a quasi-experimental design, we compared patient-level outcomes, before and after legislation, in reform states and control states. We controlled for characteristics of the patients, time-invariant hospital characteristics, and temporal trends. Outcomes were policy-attributable changes in the use of computed tomography (CT) or magnetic resonance imaging (MRI), per-visit emergency department charges, and the rate of hospital admissions. Results For eight of the nine state-outcome combinations tested, no policy-attributable reduction in the intensity of care was detected. We found no reduction in the rates of CT or MRI utilization or hospital admission in any of the three reform states and no reduction in charges in Texas or South Carolina. In Georgia, reform was associated with a 3.6% reduction (95% confidence interval, 0.9 to 6.2) in per-visit emergency department charges. Conclusions Legislation that substantially changed the malpractice standard for emergency physicians in three states had little effect on the intensity of practice, as measured by imaging rates, average charges, or hospital admission rates. (Funded by the Veterans Affairs Office of Academic Affiliations and others.).
- Chimeric Antigen Receptor T Cells for Sustained Remissions in Leukemia. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 16; 371(16):1507-1517.
Background Relapsed acute lymphoblastic leukemia (ALL) is difficult to treat despite the availability of aggressive therapies. Chimeric antigen receptor-modified T cells targeting CD19 may overcome many limitations of conventional therapies and induce remission in patients with refractory disease. Methods We infused autologous T cells transduced with a CD19-directed chimeric antigen receptor (CTL019) lentiviral vector in patients with relapsed or refractory ALL at doses of 0.76×10(6) to 20.6×10(6) CTL019 cells per kilogram of body weight. Patients were monitored for a response, toxic effects, and the expansion and persistence of circulating CTL019 T cells. Results A total of 30 children and adults received CTL019. Complete remission was achieved in 27 patients (90%), including 2 patients with blinatumomab-refractory disease and 15 who had undergone stem-cell transplantation. CTL019 cells proliferated in vivo and were detectable in the blood, bone marrow, and cerebrospinal fluid of patients who had a response. Sustained remission was achieved with a 6-month event-free survival rate of 67% (95% confidence interval [CI], 51 to 88) and an overall survival rate of 78% (95% CI, 65 to 95). At 6 months, the probability that a patient would have persistence of CTL019 was 68% (95% CI, 50 to 92) and the probability that a patient would have relapse-free B-cell aplasia was 73% (95% CI, 57 to 94). All the patients had the cytokine-release syndrome. Severe cytokine-release syndrome, which developed in 27% of the patients, was associated with a higher disease burden before infusion and was effectively treated with the anti-interleukin-6 receptor antibody tocilizumab. Conclusions Chimeric antigen receptor-modified T-cell therapy against CD19 was effective in treating relapsed and refractory ALL. CTL019 was associated with a high remission rate, even among patients for whom stem-cell transplantation had failed, and durable remissions up to 24 months were observed. (Funded by Novartis and others; CART19 ClinicalTrials.gov numbers, NCT01626495 and NCT01029366 .).
- Achieving and Maintaining Polio Eradication - New Strategies. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 16; 371(16):1476-1479.
Given substantial progress against polio in Nigeria and the small number of polio cases identified elsewhere in Africa in recent months, it is now possible that the continent will be free of polio by the end of the year, though a few challenges remain.
- The New Diversity in Medical Education. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 16; 371(16):1474-1476.
In its latest formulation, diversity in medical education is a prerequisite for an optimal learning environment, where various ideas, opinions, and experiences create a breeding ground for innovative solutions to problems and a pathway to improved patient care.
- Diversity Dynamics - Challenges to a Representative U.S. Medical Workforce. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 16; 371(16):1471-1474.
Despite an increasingly diverse U.S. population, the overwhelming majority of medical school graduates continue to be white, and the number of black men completing medical school has been trending downward since 1997.
- The FDA, E-Cigarettes, and the Demise of Combusted Tobacco. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 16; 371(16):1469-1471.
The FDA has announced its intention to regulate e-cigarettes as tobacco products. As it moves forward, the agency, with help from tobacco-control advocates, state governments, and Congress, can drive a wedge between regulated clean-nicotine products and combustible cigarettes.
- Data Sharing, Year 1 - Access to Data from Industry-Sponsored Clinical Trials. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 15.
There has been considerable interest of late in increasing the transparency of clinical trials, including increasing access to the raw data from trials sponsored by the pharmaceutical industry.(1) Since May 2013, investigators have been able to request access to deidentified patient-level data from clinical trials sponsored by GlaxoSmithKline,(2) subject to review and oversight by an independent review panel (https://clinicalstudydatarequest.com/Default.aspx). As the members of this panel, we now have more than 12 months of experience with this initiative - and can report that it has been a productive and successful first step. The system was launched on May 7, 2013, and . . .
- Innovation in Health Care Leadership. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 15.
A growing demand for transparency has brought innovation in many areas of health care. In a video roundtable, three expert panels discuss the benefits and the challenges of these innovations, examining transparency in provider-driven quality data, in pricing, and in medical records.
- Ebola Virus Disease in the Democratic Republic of Congo. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 15.
Background The seventh reported outbreak of Ebola virus disease (EVD) in the equatorial African country of the Democratic Republic of Congo (DRC) began on July 26, 2014, as another large EVD epidemic continued to spread in West Africa. Simultaneous reports of EVD in equatorial and West Africa raised the question of whether the two outbreaks were linked. Methods We obtained data from patients in the DRC, using the standard World Health Organization clinical-investigation form for viral hemorrhagic fevers. Patients were classified as having suspected, probable, or confirmed EVD or a non-EVD illness. Blood samples were obtained for polymerase-chain-reaction-based diagnosis, viral isolation, sequencing, and phylogenetic analysis. Results The outbreak began in Inkanamongo village in the vicinity of Boende town in Équateur province and has been confined to that province. A total of 69 suspected, probable, or confirmed cases were reported between July 26 and October 7, 2014, including 8 cases among health care workers, with 49 deaths. As of October 7, there have been approximately six generations of cases of EVD since the outbreak began. The reported weekly case incidence peaked in the weeks of August 17 and 24 and has since fallen sharply. Genome sequencing revealed Ebola virus (EBOV, Zaire species) as the cause of this outbreak. A coding-complete genome sequence of EBOV that was isolated during this outbreak showed 99.2% identity with the most closely related variant from the 1995 outbreak in Kikwit in the DRC and 96.8% identity to EBOV variants that are currently circulating in West Africa. Conclusions The current EVD outbreak in the DRC has clinical and epidemiologic characteristics that are similar to those of previous EVD outbreaks in equatorial Africa. The causal agent is a local EBOV variant, and this outbreak has a zoonotic origin different from that in the 2014 epidemic in West Africa. (Funded by the Centre International de Recherches Médicales de Franceville and others.).
- National Health Spending in 2014 - Acceleration Delayed. [JOURNAL ARTICLE]
- N Engl J Med 2014 Oct 8.
On the basis of data from the Bureau of Economic Analysis (BEA), it was widely reported in May that U.S. health care spending during the first 3 months of 2014 grew at an annualized rate of about 10% relative to the previous quarter. It appeared, at that point, that the 5-year run of sub-4% growth that began in 2009 was ending with a double-digit bang. However, 2 months later, revised BEA data showed a dramatic change: first-quarter health spending had actually fallen at a 0.9% annual rate. The pronounced difference between these two estimates is highly influenced by the method . . .