The Affordable Care Act was passed in 2010 to great controversy as it sought to implement comprehensive reforms to improve access, affordability, and funding of healthcare in the United States. In this special communication, the President of the United States reviews publically available government data from 1963 to 2016 to characterize the impact of this legislation. There has been a 43% decrease in the uninsured rate from 16.0% in 2010 to 9.1% in 2015, as well as a decreased proportion of nonelderly adults able to afford healthcare by 5.5%. The law enacted changes in healthcare financing, and now 30% of Medicare payments are given through alternative payment models including bundled payments and accountable care organizations. There have been significant changes to the American healthcare system with the passage of the Affordable Care Act.
With the focus on personalized medicine and tailoring therapy towards the particular genotype of malignancies, clinical trialists have thought about how to perform clinical trials on genetically heterogeneous diseases. In the I-SPY 2 phase 2, multicenter adaptive randomized trial, investigators studied the effect of the addition of neratinib (a tyrosine kinase targeting Her2) and a combination of veliparib (a poly(ADP-ribose polymerase inhibitor)-carboplatin to treat clinical stage II or III breast cancer. Patients were classified into 8 subcategories depending on HER2 status, genetic profile, and biomarker subtype assay and randomized to different treatment regimens with adaptive randomization in which more participants were randomized to treatment regimens with higher confidence of improved efficacy. In the comparison of veliparib-carboplatin vs. standard therapy in triple-negative breast cancer, the pathological complete response was 51% vs. 26%, which is thought to predict an 88% probability of success in phase 3 trial. In the comparison of neratinib vs. control in HER2-positive PR-negative breast cancer, the pathological complete response was 56% vs. 33%, which was thought to predict an 79% probability of success in phase 3 trial. Further review investigation of this clinical trial approach will tell whether this method of rapidly investigate multiple therapeutics can lead to more approved therapeutics for breast cancer.
Previous studies have suggested improved life-expectancy and symptom management in patients with co-management of palliative care specialists along with oncologists for malignant breast cancer. There is significant psychological distress for family and caretakers of patients with chronic critical illness. In this multicenter randomized trial, patients requiring 7 or more days of mechanical ventilation were randomized to family meetings conducted either by ICU teams (standard care) or structured family meetings by palliative care specialists to evaluate medium and long term outcomes. In this study, 312 surrogate decision makers completed the study, however there was no statistically significant difference in anxiety or depressive symptoms as measured by Hospital Anxiety and Depression Scale symptom score (12.2 vs. 11.4, p = 0.34). Posttrauamtic stress disorder symptoms were higher in the intervention group (25.9 vs. 21.3, p = 0.0495). There was no difference in patient preferences, patient length of stay, or 90-day survival rate. This study does not lean evidence to routine involvement of palliative care specialists in patients with chronic critical illness.
Prognostic Value of Cardiovascular Magnetic Resonance and Single-Photon Emission Computed Tomography in Suspected Coronary Heart Disease: Long-Term Follow-up of a Prospective, Diagnostic Accuracy Cohort Study
Cardiovascular magnetic resonance (CMR) imaging and single-photon emission computed tomography (SPECT) are both noninvasive methods to evaluate patients with suspected coronary artery disease. The CE-MARC trial is a single center, prospective cohort trial evaluating the efficacy of CMR to identify coronary artery disease and evaluate the incidence of major adverse cardiovascular events (cardiovascular death, acute coronary syndrome, unscheduled hospitalization or catheterization for cardiovascular cause). 752 recruited patients had 4 year follow-up, of which 628 underwent both CMR and SPECT as well as coronary angiogram. 104 (16.6%) of patients had a major adverse cardiovascular events, with strong predictive value of events based on abnormal SPECT findings (HR 1.62, 95% CI 1.11 to 2.38, p = 0.014) and abnormal CMR findings (HR 2.77, 95% CI 1.85 to 4.16, p < 0.001). Both imaging modalities prognosticate future cardiovascular outcomes and can help determine the need for percutaneous coronary intervention.
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