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The Food and Drug Administration’s Role in Promoting Consistent Labels for Generic Drugs

from ArchInte - 01 Aug 14

The product information for a prescription drug—commonly called its label—is the full description of the drug’s indications for use, method of administration, warnings, contraindications, and potential adverse events. It is written by the manufacturer of the brand-name drug, approved by the US Food and Drug Administration (FDA), and published when the drug initially is marketed. As new effectiveness or safety information becomes available during the period of marketing exclusivity, the manufactu



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The Meaning of Brain Death A Different View

from ArchInte - 01 Aug 14

The recent case of Jahi McMath, a teenager in Oakland, California, was extensively publicized in the news media and led to prominent commentaries in medical journals on the meaning of brain death. McMath is a 14-year-old adolescent who in December 2013 experienced devastating neurological damage following complications from a tonsillectomy. McMath met criteria for the diagnosis of brain death. She continues, however, to receive mechanical ventilation, tube feedings, and supportive care at an und



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The Role of Copy-and-Paste in the Hospital Electronic Health Record

from ArchInte - 01 Aug 14

Before electronic health records: If you did not document it, you did not do it.





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Evidence-Based Evaluation for Allergies to Avoid Inappropriate Testing, Diagnosis, and Treatment

from ArchInte - 01 Aug 14

In the midst of an examination room cluttered with crayons, coloring books, and toys intended to pacify or bribe children during allergy skin testing, an anxious mother attended to her active 4-year-old son. A glance at the appointment book before walking into the room indicated that the reason for this new patient visit was “food allergies.” The interview began with the usual “why are you here” question. The mother’s response: she wanted to know what foods her son was really allergic to and wer



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Waiting for Words

from ArchInte - 01 Aug 14

She showed up on the afternoon of Christmas Eve to be seen as a new patient. She indicated that she had come at the insistence of her family. They were worried about her diabetes. She offered that over the previous decade she had seen more than 20 physicians. She said that her average glucose levels were usually 3 times normal and that, over the years, little progress had been made. After this report, she expressed minimal interest in further discussion and indicated that she just wanted new ins



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Effect of Patients’ Risks and Preferences on Health Gains With Plasma Glucose Level Lowering in Type 2 Diabetes Mellitus

from ArchInte - 01 Aug 14

ImportanceType 2 diabetes mellitus is common, and treatment to correct blood glucose levels is standard. However, treatment burden starts years before treatment benefits accrue. Because guidelines often ignore treatment burden, many patients with diabetes may be overtreated.ObjectiveTo examine how treatment burden affects the benefits of intensive vs moderate glycemic control in patients with type 2 diabetes.Design, Setting, and ParticipantsWe estimated the effects of hemoglobin A1c (HbA1c) redu



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Comparative Effectiveness of a Multifaceted Intervention to Improve Adherence to Annual Colorectal Cancer Screening in Community Health Centers A Randomized Clinical Trial

from ArchInte - 01 Aug 14

ImportanceColorectal cancer (CRC) screening rates are lower among Latinos and people living in poverty. Fecal occult blood testing (FOBT) is one recommended screening modality that may overcome cost and access barriers. However, the ability of FOBT to reduce CRC mortality depends on high rates of adherence to annual screening.ObjectiveTo determine whether a multifaceted intervention increases adherence to annual FOBT compared with usual care.Design, Setting, and ParticipantsPatient-level randomi



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Benefits and Risks of Anticoagulation Resumption Following Traumatic Brain Injury

from ArchInte - 01 Aug 14

ImportanceThe increased risk of hemorrhage associated with anticoagulant therapy following traumatic brain injury creates a serious dilemma for medical management of older patients: Should anticoagulant therapy be resumed after traumatic brain injury, and if so, when?ObjectiveTo estimate the risk of thrombotic and hemorrhagic events associated with warfarin therapy resumption following traumatic brain injury.Design, Setting, and ParticipantsRetrospective analysis of administrative claims data fo



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Systolic Blood Pressure Levels Among Adults With Hypertension and Incident Cardiovascular Events The Atherosclerosis Risk in Communities Study

from ArchInte - 01 Aug 14

ImportanceStudies document a progressive increase in heart disease risk as systolic blood pressure (SBP) rises above 115 mm Hg, but it is unknown whether an SBP lower than 120 mm Hg among adults with hypertension (HTN) lowers heart failure, stroke, and myocardial infarction risk.ObjectiveTo examine the risk of incident cardiovascular (CV) events among adults with HTN according to 3 SBP levels: 140 mm Hg or higher; 120 to 139 mm Hg; and a reference level of lower than 120 mm Hg.Design, Setting, a



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Statins and Physical Activity in Older Men The Osteoporotic Fractures in Men Study

from ArchInte - 01 Aug 14

ImportanceMuscle pain, fatigue, and weakness are common adverse effects of statin medications and may decrease physical activity in older men.ObjectiveTo determine whether statin use is associated with physical activity, longitudinally and cross-sectionally.Design, Setting, and ParticipantsMen participating in the Osteoporotic Fractures in Men Study (N?=?5994), a multicenter prospective cohort study of community-living men 65 years and older, enrolled between March 2000 and April 2002. Follow-up



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Survival and Functional Outcomes After Hip Fracture Among Nursing Home Residents

from ArchInte - 01 Aug 14

ImportanceLittle is known regarding outcomes after hip fracture among long-term nursing home residents.ObjectiveTo describe patterns and predictors of mortality and functional decline in activities of daily living (ADLs) among nursing home residents after hip fracture.Design, Setting, and ParticipantsRetrospective cohort study of 60?111 Medicare beneficiaries residing in nursing homes who were hospitalized with hip fractures between July 1, 2005, and June 30, 2009.Main Outcomes and MeasuresData



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Association of Marketing Interactions With Medical Trainees’ Knowledge About Evidence-Based Prescribing Results From a National Survey

from ArchInte - 01 Aug 14

ImportanceIn recent years, numerous US medical schools and academic medical centers have enacted policies preventing pharmaceutical sales representatives from interacting directly with students. Little is known about how pharmaceutical sales representatives affect trainees’ knowledge about pharmaceutical prescribing.ObjectiveTo determine whether there is an association between medical trainees’ interactions with pharmaceutical promotion and their preferences in medication use.Design, Setting, an



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Patient Engagement During Medical Visits and Smoking Cessation Counseling

from ArchInte - 01 Aug 14

ImportanceIncreased patient engagement with health and health care is considered crucial to increasing the quality of health care and patient self-management of health.ObjectiveTo examine whether patients with high levels of engagement during medical encounters are more likely to receive advice and counseling about smoking compared with less engaged patients.Design, Setting, and ParticipantsCross-sectional survey using multivariate regression analysis of 8656 current and retired autoworkers and



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5a-Reductase Inhibitors and Risk of High-Grade or Lethal Prostate Cancer

from ArchInte - 01 Aug 14

Importance5a-Reductase inhibitors (5ARIs) are widely used for benign prostatic hyperplasia despite controversy regarding potential risk of high-grade prostate cancer with use. Furthermore, the effect of 5ARIs on progression and prostate cancer death remains unclear.ObjectiveTo determine the association between 5ARI use and development of high-grade or lethal prostate cancer.Design, Setting, and ParticipantsProspective observational study of 38?058 men followed up for prostate cancer diagnosis an



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The Political Polarization of Physicians in the United States An Analysis of Campaign Contributions to Federal Elections, 1991 Through 2012

from ArchInte - 01 Aug 14

ImportanceFew current data are available regarding the political behavior of American physicians as the number of female physicians has increased and the number of solo practitioners has decreased.ObjectiveTo analyze campaign contributions that physicians made from the 1991 to 1992 through the 2011 to 2012 election cycles to Republican and Democratic candidates in presidential and congressional races and to partisan organizations, including party committees and super political action committees



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Preoperative ß-Blocker Use in Coronary Artery Bypass Grafting Surgery National Database Analysis

from ArchInte - 01 Aug 14

ImportanceUse of preoperative ß-blockers has been associated with a reduction in perioperative mortality for patients undergoing coronary artery bypass grafting (CABG) surgery in observational research studies, which led to the adoption of preoperative ß-blocker therapy as a national quality standard.ObjectiveTo determine whether preoperative ß-blocker use within 24 hours of CABG surgery is associated with reduced perioperative mortality in a contemporary sample of patients.Design, Setting, and



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Genotype-Guided vs Clinical Dosing of Warfarin and Its Analogues Meta-analysis of Randomized Clinical Trials

from ArchInte - 01 Aug 14

ImportanceSignificant variations in dose requirements of warfarin and its analogues (acenocoumarol and phenprocoumon) make selecting the appropriate dose for an individual patient difficult. Genetic factors account for approximately one-third of the variation in dose requirement. The clinical usefulness of genotype-guided dosing of warfarin has been previously assessed in randomized clinical trials that were limited by lack of power and inconsistent results.ObjectiveTo compare genotype-guided in



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Cardiac Resynchronization Therapy in Women US Food and Drug Administration Meta-analysis of Patient-Level Data

from ArchInte - 01 Aug 14

ImportanceWomen were underrepresented in cardiac resynchronization therapy (CRT) trials for heart failure (making up about 20% of enrollees). Combining individual patient data from multiple clinical trials would enable assessment of CRT benefit in women.ObjectiveTo evaluate whether women with left bundle branch block (LBBB) benefit from CRT-defibrillators (CRT-D) at a shorter QRS duration than men with LBBB do.Design, Setting, and ParticipantsIndividual patient data were pooled from 3 CRT-D vs i



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Implementation of the Patient-Centered Medical Home in the Veterans Health Administration Associations With Patient Satisfaction, Quality of Care, Staff Burnout, and Hospital and Emergency Department

from ArchInte - 01 Aug 14

ImportanceIn 2010, the Veterans Health Administration (VHA) began implementing the patient-centered medical home (PCMH) model. The Patient Aligned Care Team (PACT) initiative aims to improve health outcomes through team-based care, improved access, and care management. To track progress and evaluate outcomes at all VHA primary care clinics, we developed and validated a method to assess PCMH implementation.ObjectivesTo create an index that measures the extent of PCMH implementation, describe vari



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Long-term Survival in Patients Undergoing Percutaneous Interventions With or Without Intracoronary Pressure Wire Guidance or Intracoronary Ultrasonographic Imaging A Large Cohort Study

from ArchInte - 01 Aug 14

ImportanceIntracoronary pressure wire–derived measurements of fractional flow reserve (FFR) and intravascular ultrasonography (IVUS) provide functional and anatomical information that can be used to guide coronary stent implantation. Although these devices are widely used and recommended by guidelines, limited data exist about their effect on clinical end points.ObjectiveTo determine the effect on long-term survival of using FFR and IVUS during percutaneous coronary intervention (PCI).Design and



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Buprenorphine Treatment for Hospitalized, Opioid-Dependent Patients A Randomized Clinical Trial

from ArchInte - 01 Aug 14

ImportanceBuprenorphine opioid agonist treatment (OAT) has established efficacy for treating opioid dependency among persons seeking addiction treatment. However, effectiveness for out-of-treatment, hospitalized patients is not known.ObjectiveTo determine whether buprenorphine administration during medical hospitalization and linkage to office-based buprenorphine OAT after discharge increase entry into office-based OAT, increase sustained engagement in OAT, and decrease illicit opioid use at 6 m



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Hypertrabeculation vs Left Ventricular Noncompaction on Echocardiogram A Reason to Restrict Athletic Participation?

from ArchInte - 01 Aug 14

ImportanceLeft ventricular noncompaction (LVNC) is a rare cause of progressive cardiomyopathy thought to result from incomplete myocardial development. It has been associated with an increased risk of sudden death, especially in those with a depressed left ventricular ejection fraction. Thus, the current recommendation for patients with this diagnosis is restriction from participation in competitive sports.ObservationsAn asymptomatic 18-year-old African American collegiate football player had a


 

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