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The Potential Risks of Expedited Approval of Drugs for Acute Bacterial Infections

from ArchInte - 01 Sep 14

Each year, about 23?000 people in the United States die from antibiotic-resistant infections. For many of these infections, safe and effective treatments are lacking. To address this problem, the US Food and Drug Administration (FDA) has updated several expedited approval programs for new antibacterial therapies, some of which alter the evidentiary standard for drug approval. For instance, a drug may be eligible for “accelerated approval” if it “has an effect on a surrogate end point that is rea



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Controlling Costs by Expanding the Medicare Acute Care Episode Demonstration

from ArchInte - 01 Sep 14

Medicare’s Acute Care Episode (ACE) demonstration bundled hospital and physician payments for 37 inpatient cardiac and orthopedic procedures. This payment structure improved coordination between physicians and hospitals and motivated hospitals to negotiate lower prices with device manufacturers, in most instances saving money without evidence of stinting on care. The program should be expanded.



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Resuscitating Inpatient Clinical Clerkships A Medical Student Perspective

from ArchInte - 01 Sep 14

Inpatient clinical clerkships in the third year of medical school are the touchstones of traditional medical education in the United States and have remained so since they were originally suggested by Abraham Flexner in 1910. Historically, the third year is when a physician is forged from a student and when classroom experience is transformed into clinical acumen. It is a pivotal time for medical students to adapt to the work of the hospital and to revel in the responsibilities of patient care.



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Dual Therapy Difficulties in Angiotensin Blockade for Proteinuria A Teachable Moment

from ArchInte - 01 Sep 14

A man in his 60s with lymphoproliferative B-cell disorder, hypertension, and stage 3 chronic kidney disease (CKD) secondary to diabetic nephropathy presented for follow-up of his diabetic nephropathy.



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The Many Stories of My Mother’s Death

from ArchInte - 01 Sep 14

Of the many stories of my mother’s death, this one is the easiest to tell. “My mother had a good death. My mother died shortly after her beloved primary care physician, with tears in his eyes, removed the CPAP machine that kept her alive just long enough for us to gather at her bedside. My mother died to the sound of music. She died as we sang the songs that accompanied our family road trips and camping adventures more than 40 years before. We had no trouble remembering the words.”



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Next Time I’ll Ask

from ArchInte - 01 Sep 14

I knew I should have asked. My 82-year-old, “I’m fine” mother had struggled with a worsening upper respiratory tract infection and cough for 5 days. My sister and I finally convinced her to leave her home an hour north of us to spend a few days under our watchful eyes. As her cough and fever continued to worsen, my mother reluctantly agreed to go to the local hospital emergency department.



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Rescuing My Grandmothers

from ArchInte - 01 Sep 14

It was midway through internal medicine residency when a fellow resident turned to me and said, “I’m done with this medical torture.” I knew exactly how he felt. We had been working furiously to care for very sick, elderly patients in the intensive care unit, performing invasive procedures, carefully selecting medications, and sometimes ordering the use of physical restraints when patients became delirious and agitated. I had felt uneasy about this care when it seemed futile, but I had been too



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How I Was Prescribed an Unnecessary Antibiotic While Traveling to a Conference on Antibiotic Resistance

from ArchInte - 01 Sep 14

As a physician, I had always assumed that patients were the ones who pressured physicians for an unnecessary antibiotic prescription. I found out that this is not necessarily the case when I recently became ill while attending, ironically enough, an infectious disease conference on antibiotic-resistant bacteria sponsored by the US Department of Health and Human Services.



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Mourning the Need for So Many Handovers

from ArchInte - 01 Sep 14

As an internal medicine resident in the 1980s, I essentially lived in the hospital. On ward months, we were on an every-third-night rotation such that we woke up and went to sleep at home only 1 of every 3 days. On our on-call day we admitted patients all day and all night and spent the following day caring for our patients, often with minimal sleep. We had 1 day off each month, when the “swing day” fell on the weekend.



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Observational Modeling of Strict vs Conventional Blood Pressure Control in Patients With Chronic Kidney Disease

from ArchInte - 01 Sep 14

ImportanceThe effect of strict blood pressure control on clinical outcomes in patients with chronic kidney disease (CKD) is unclear.ObjectiveTo compare the outcomes associated with a treated systolic blood pressure (SBP) of less than 120 mm Hg vs those associated with the currently recommended SBP of less than 140 mm Hg in a national CKD database of US veterans.Design, Setting, and ParticipantsHistorical cohort study using a nationwide cohort of US veterans with prevalent CKD, estimated glomerul



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Physician Variation in Management of Low-Risk Prostate Cancer A Population-Based Cohort Study

from ArchInte - 01 Sep 14

ImportanceUp-front treatment of older men with low-risk prostate cancer can cause morbidity without clear survival benefit; however, most such patients receive treatment instead of observation. The impact of physicians on the management approach is uncertain.ObjectiveTo determine the impact of physicians on the management of low-risk prostate cancer with up-front treatment vs observation.Design, Setting, and ParticipantsRetrospective cohort of men 66 years and older with low-risk prostate cancer



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Fifteen-Year Survival Outcomes Following Primary Androgen-Deprivation Therapy for Localized Prostate Cancer

from ArchInte - 01 Sep 14

ImportanceOne in 6 American men will be diagnosed as having prostate cancer during their lifetime. Although there are no data to support the use of primary androgen-deprivation therapy (ADT) for early-stage prostate cancer, primary ADT has been widely used for localized prostate cancer, especially among older patients.ObjectiveTo determine the long-term survival impact of primary ADT in older men with localized (T1/T2) prostate cancer.Design, Setting, and ParticipantsThis was a population-based



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Use of Medical Consultants for Hospitalized Surgical Patients An Observational Cohort Study

from ArchInte - 01 Sep 14

ImportancePayments around episodes of inpatient surgery vary widely among hospitals. As payers move toward bundled payments, understanding sources of variation, including use of medical consultants, is important.ObjectiveTo describe the use of medical consultations for hospitalized surgical patients, factors associated with use, and practice variation across hospitals.Design, Setting, and ParticipantsObservational retrospective cohort study of fee-for-service Medicare patients undergoing colecto



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Morning Handover of On-Call Issues Opportunities for Improvement

from ArchInte - 01 Sep 14

ImportanceHandover is the process of transferring pertinent patient information and clinical responsibility between health care practitioners. Few studies have examined morning handover from the overnight trainee to the daytime team.ObjectiveTo characterize current morning handover practices in 2 academic medical centers by assessing the frequency of omissions of clinically important overnight issues during morning handover and identifying factors that influence the occurrence of such omissions.



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Trends in Use of Ezetimibe After the ENHANCE Trial, 2007 Through 2010

from ArchInte - 01 Sep 14

ImportanceResults from the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial, announced in January 2008, demonstrated that ezetimibe use lowered cholesterol levels but did not slow the progression of atherosclerosis.ObjectiveTo examine the association of this announcement with national patterns of ezetimibe prescribing, including medication initiation and discontinuation, as well as predictors of use.Design, Setting, and ParticipantsRetrospecti



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Comparative Outcomes of Catheter-Directed Thrombolysis Plus Anticoagulation vs Anticoagulation Alone to Treat Lower-Extremity Proximal Deep Vein Thrombosis

from ArchInte - 01 Sep 14

ImportanceThe role of catheter-directed thrombolysis (CDT) in the treatment of acute proximal deep vein thrombosis (DVT) is controversial, and the nationwide safety outcomes are unknown.ObjectivesThe primary objective was to compare in-hospital outcomes of CDT plus anticoagulation with those of anticoagulation alone. The secondary objective was to evaluate the temporal trends in the utilization and outcomes of CDT in the treatment of proximal DVT.Design, Setting, and ParticipantsObservational st



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Measuring the Effectiveness of Androgen-Deprivation Therapy for Prostate Cancer in the Medicare Population Adequate Data Are Neither the Same as Nor the Enemy of Perfect Data

from ArchInte - 01 Sep 14

In the late 1970s, investigators learned that androgen-deprivation therapy (ADT) decreased serum testosterone levels and, more importantly, reduced bone pain among men with prostate cancer. Whereas ADT demonstrated benefit in patients with metastatic disease and as an adjunct to radiation therapy in patients with locally advanced disease, its use at the organ-confined stage has never been supported by evidence or expert guidelines. Most importantly, randomized data have shown that immediate ADT



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Medical Consultation for Surgical Cases in the Era of Value-Based Care

from ArchInte - 01 Sep 14

Dr William Mason described the limitations of individual physician practice to provide the best care in the era of complex diagnostic and treatment algorithms in 1929. He explained medical consultation as a medium by which to secure ideas and the opinion of physicians with diverse medical expertise for patients segregated by specialized service units. An open and effective communication is necessary between surgeons and medical specialists for proper management of the patient with a complex medi



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Clinical Trials and the Right to Remain Silent

from ArchInte - 01 Sep 14

In this issue of JAMA Internal Medicine, Kernan et al chronicle Yale University’s experience responding to a subpoena for data from an ongoing, double-blind, placebo-controlled trial of pioglitazone. The subpoena arose from litigation brought by Sara J. Kincaid, who believed she had been injured by pioglitazone but who was not a clinical trial participant. Yale’s legal team was troubled because they believed that releasing the data would compromise the integrity of the trial and threaten the inv



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Litigation Seeking Access to Data From Ongoing Clinical Trials A Threat to Clinical Research

from ArchInte - 01 Sep 14

Researchers conducting randomized clinical trials may find themselves subject to legal subpoenas for interim data. When a subpoena demands premature disclosure of unblinded data, there is potential for damage to the scientific integrity and reputation of the on-going trial. We describe herein general issues raised by subpoenas for trial data and the particular case of a 2012 subpoena served on investigators from Yale University who were successful in winning reprieve from Connecticut Superior Co



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Validated Questionnaire vs Physicians’ Judgment to Estimate Preoperative Exercise Capacity

from ArchInte - 01 Sep 14

Assessment of exercise capacity is critical to preoperative evaluation. Practice guidelines recommend that patients proceed to noncardiac surgery without further testing if their exercise capacity exceeds 4 metabolic equivalent tasks (METs). This assumption that good exercise capacity indicates low perioperative risk is largely extrapolated from studies involving objective exercise testing. Clinical practice instead involves clinicians subjectively estimating exercise capacity by questioning pat



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Decision Making at the Time of ICD Generator Change Patients' Perspectives

from ArchInte - 01 Sep 14

There are increasing numbers of patients who are faced with implantable cardioverter-defibrillator (ICD) generators that are low in voltage and require replacement to remain functional. This is an ideal time to reevaluate health care goals and explore personal preferences regarding continuing ICD therapy. We aim herein to assess patient awareness that ICD generator replacement is optional, to gauge their understanding of the risks and benefits of ICD replacement, and to gain insight into their d



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The Challenge of Drug-Induced Aseptic Meningitis Revisited

from ArchInte - 01 Sep 14

Cases of drug-induced aseptic meningitis (DIAM) are likely underreported, and only a few reviews of the literature have been performed. We have updated (to February 2014) a previous review (1999) to identify newer agents associated with DIAM, as well as distinctive new features.



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Women’s Clinical Preventive Services in the United States Who Is Doing What?

from ArchInte - 01 Sep 14

A well-woman preventive care visit is a core service supported by the Human Resources and Services Administration, yet it is unclear which preventive services are provided by primary care physicians (PCPs) and which are provided by obstetrician/gynecologists (OB/GYNs). We examined patterns of selected age-appropriate preventive care visits across a woman’s lifespan, focusing on the wide range of preventive services provided to nonpregnant women.


 

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