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Clinical Guidelines | 
Kirsten Bibbins-Domingo, PhD, MD, MAS, on behalf of the U.S. Preventive Services Task Force
Description:Update of the 2009 USPSTF recommendation on aspirin use to prevent cardiovascular disease (CVD) events and the 2007 recommendation on aspirin and nonsteroidal anti-inflammatory drug use to prevent colorectal cancer (CRC). Methods:The USPSTF reviewed 5 additional studies of aspirin for the primary prevention of CVD and several additional analyses of CRC follow-up data. The USPSTF also relied on commissioned systematic reviews of all-cause mortality and total cancer incidence and mortality and a comprehensive review of harms. The USPSTF then used a microsimulation model to systematically estimate the balance of benefits and harms. Population:This recommendation applies to adults aged 40 years or older without known CVD and without increased bleeding risk. Recommendation:The USPSTF recommends initiating low-dose aspirin use for the primary prevention of CVD and CRC in adults aged 50 to 59 years who have a 10% or greater 10-year CVD risk, are not at increased risk for bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years. (B recommendation)The decision to initiate low-dose aspirin use for the primary prevention of CVD and CRC in adults aged 60 to 69 years who have a 10% or greater 10-year CVD risk should be an individual one. Persons who are not at increased risk for bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years are more likely to benefit. Persons who place a higher value on the potential benefits than the potential harms may choose to initiate low-dose aspirin. (C recommendation)The current evidence is insufficient to assess the balance of benefits and harms of initiating aspirin use for the primary prevention of CVD and CRC in adults younger than 50 years. (I statement)The current evidence is insufficient to assess the balance of benefits and harms of initiating aspirin use for the primary prevention of CVD and CRC in adults aged 70 years or older. (I statement)
Topics: aspirin, cardiovascular diseases
Letters | 
Daniel S. Chertow, MD, MPH; Avindra Nath, MD; Anthony F. Suffredini, MD; Robert L. Danner, MD; Daniel S. Reich, MD, PhD; Rachel J. Bishop, MD; Richard W. Childs, MD; Andrew E. Arai, MD; Tara N. Palmore, MD; H. Clifford Lane, MD; Anthony S. Fauci, MD; and Richard T. Davey, MD
Medicine and Public Issues | 
Christine M. Durand, MD; Dorry Segev, MD, PhD; and Jeremy Sugarman, MD, MPH, MA
The HIV Organ Policy Equity (HOPE) Act now allows transplantation of organs from HIV-positive living and deceased donors to HIV-positive individuals with end-stage organ disease in the United States. Although clinical experience with such transplants is limited to a small number of deceased-donor kidney transplants from HIV-positive to HIV-positive persons in South Africa, unprecedented HIV-positive–to–HIV-positive liver transplantations and living-donor kidney transplantations are also now on the horizon. Initially, all HIV-positive–to–HIV-positive transplantations will occur under research protocols with safeguards and criteria mandated by the National Institutes of Health. Nevertheless, this historic change brings ethical opportunities and challenges. For HIV-positive individuals needing an organ transplant, issues of access, risk, and consent must be considered. For potential HIV-positive donors, there are additional ethical challenges of privacy, fairness, and the right to donate. Careful consideration of the ethical issues involved is critical to the safe and appropriate evaluation of this novel approach to transplantation.
Topics: hiv seropositivity, organ transplantation, donors, ethics, transplantation
Ideas and Opinions | 
Steven Joffe, MD, MPH; and David C. Magnus, PhD
In September 2015, sixteen federal agencies released a Notice of Proposed Rulemaking (NPRM) that outlined far-reaching changes to the Common Rule, the framework for all federally funded human subjects research. These are the first substantive alterations to the Rule in nearly 25 years. Although there are several worthwhile suggestions, on balance the NRPM seems more likely to be a hindrance than a help.
Topics: institutional review board, quality improvement
Editorials | 
Connie M. Ulrich, PhD, RN; and Christine Grady, PhD, RN
Registered nurses are integral members of health care teams in hospitals and other health care settings. They interact with many other individuals and are not immune to potential conflicts of interest within their work environments. Grundy and colleagues give us an opening glance at the personal narratives of nurse-industry relationships from nonprescribing practicing nurses.
Topics: nurses
Editorials | 
Seth S. Martin, MD, MHS; and Rani K. Hasan, MD, MHS
Zhang and colleagues have conducted a study-level meta-analysis that reports the pros and cons of implantation of an everolimus-eluting bioresorbable vascular scaffold (BVS) versus a current-generation, nonresorbable everolimus-eluting metallic stent in patients having percutaneous coronary intervention. The BVS is still in the early stages, and long-term postmarketing surveillance will be needed to ensure both safety and efficacy in broader populations.
Topics: stent, heart, bioresorbable vascular scaffold
Original Research | 
Michael W. Yeh, MD; Hui Zhou, PhD; Annette L. Adams, PhD; Philip H.G. Ituarte, PhD, MPH; Ning Li, PhD; In-Lu Amy Liu, MS; and Philip I. Haigh, MD
Background:The comparative effectiveness of surgical and medical treatments on fracture risk in primary hyperparathyroidism (PHPT) is unknown. Objective:To measure the relationship of parathyroidectomy and bisphosphonates with skeletal outcomes in patients with PHPT. Design:Retrospective cohort study. Setting:An integrated health care delivery system. Participants:All enrollees with biochemically confirmed PHPT from 1995 to 2010. Measurements:Bone mineral density (BMD) changes and fracture rate. Results:In 2013 patients with serial bone density examinations, total hip BMD increased transiently in women with parathyroidectomy (4.2% at <2 years) and bisphosphonates (3.6% at <2 years) and declined progressively in both women and men without these treatments (−6.6% and −7.6%, respectively, at >8 years). In 6272 patients followed for fracture, the absolute risk for hip fracture at 10 years was 20.4 events per 1000 patients who had parathyroidectomy and 85.5 events per 1000 patients treated with bisphosphonates compared with 55.9 events per 1000 patients without these treatments. The risk for any fracture at 10 years was 156.8 events per 1000 patients who had parathyroidectomy and 302.5 events per 1000 patients treated with bisphosphonates compared with 206.1 events per 1000 patients without these treatments. In analyses stratified by baseline BMD status, parathyroidectomy was associated with reduced fracture risk in both osteopenic and osteoporotic patients, whereas bisphosphonates were associated with increased fracture risk in these patients. Parathyroidectomy was associated with fracture risk reduction in patients regardless of whether they satisfied criteria from consensus guidelines for surgery. Limitation:Retrospective study design and nonrandom treatment assignment. Conclusion:Parathyroidectomy was associated with reduced fracture risk, and bisphosphonate treatment was not superior to observation. Primary Funding Source:National Institute on Aging.
Topics: bisphosphonates, fracture, parathyroidectomy, hyperparathyroidism, primary, osteoporotic fracture risk, hip fractures
Original Research | 
Adrian Reuben, MBBS; Holly Tillman, MS; Robert J. Fontana, MD; Timothy Davern, MD; Brendan McGuire, MD; R. Todd Stravitz, MD; Valerie Durkalski, PhD; Anne M. Larson, MD; Iris Liou, MD; Oren Fix, MD; Michael Schilsky, MD; Timothy McCashland, MD; J. Eileen Hay, MBBS; Natalie Murray, MD; Obaid S. Shaikh, MD; Daniel Ganger, MD; Atif Zaman, MD; Steven B. Han, MD; Raymond T. Chung, MD; Alastair Smith, MB, ChB; Robert Brown, MD; Jeffrey Crippin, MD; M. Edwyn Harrison, MD; David Koch, MD; Santiago Munoz, MD; K. Rajender Reddy, MD; Lorenzo Rossaro, MD; Raj Satyanarayana, MD; Tarek Hassanein, MD; A. James Hanje, MD; Jody Olson, MD; Ram Subramanian, MD; Constantine Karvellas, MD; Bilal Hameed, MD; Averell H. Sherker, MD; Patricia Robuck, PhD; and William M. Lee, MD
Background:Acute liver failure (ALF) is a rare syndrome of severe, rapid-onset hepatic dysfunction without prior advanced liver disease that is associated with high morbidity and mortality. Intensive care and liver transplantation provide support and rescue, respectively. Objective:To determine whether changes in causes, disease severity, treatment, or 21-day outcomes have occurred in recent years among adult patients with ALF referred to U.S. tertiary care centers. Design:Prospective observational cohort study. (ClinicalTrials .gov: NCT00518440) Setting:31 liver disease and transplant centers in the United States. Patients:Consecutively enrolled patients–without prior advanced liver disease–with ALF (n = 2070). Measurements:Clinical features, treatment, and 21-day outcomes were compared over time annually for trends and were also stratified into two 8-year periods (1998 to 2005 and 2006 to 2013). Results:Overall clinical characteristics, disease severity, and distribution of causes remained similar throughout the study period. The 21-day survival rates increased between the two 8-year periods (overall, 67.1% vs. 75.3%; transplant-free survival [TFS], 45.1% vs. 56.2%; posttransplantation survival, 88.3% vs. 96.3% [P < 0.010 for each]). Reductions in red blood cell infusions (44.3% vs. 27.6%), plasma infusions (65.2% vs. 47.1%), mechanical ventilation (65.7% vs. 56.1%), and vasopressors (34.9% vs. 27.8%) were observed, as well as increased use of N-acetylcysteine (48.9% vs. 69.3% overall; 15.8% vs. 49.4% [P < 0.001] in patients with ALF not due to acetaminophen toxicity). When examined longitudinally, overall survival and TFS increased throughout the 16-year period. Limitations:The duration of enrollment, the number of patients enrolled, and possibly the approaches to care varied among participating sites. The results may not be generalizable beyond such specialized centers. Conclusion:Although characteristics and severity of ALF changed little over 16 years, overall survival and TFS improved significantly. The effects of specific changes in intensive care practice on survival warrant further study. Primary Funding Source:National Institutes of Health.
Topics: liver failure, acute, liver transplantation, transplantation, acetylcysteine, vasoconstrictor agents, acetaminophen, trend
Background:The mainstay for addressing conflicts of interest in health care is disclosure of personal financial ties to industry. However, this approach fails to capture the complexity of industry interactions that are built into clinical practice. Further, the policy climate focuses on physicians and traditional pharmaceutical marketing. Objective:To describe industry activities targeted at registered nurses. Design:Qualitative, ethnographic study conducted from January 2012 to October 2014. Setting:Four acute care hospitals in a western U.S. city. Participants:A purposive sample of 72 participants with direct experience with industry, including staff nurses, administrators, and industry and supply chain professionals. Measurements:Fieldwork, including observations (102 hours), semistructured in-depth interviews (n = 51), focus groups (n = 4), and documents analysis. Results:Nurses' reported financial relationships with industry were similar to those reported by prescribers. However, nurses reported that their most significant interactions with industry occurred in daily practice. The current policy environment rendered these interactions invisible, leaving nurses with little guidance to ensure that the boundary between service and sales remained intact. Limitations:This study could not determine the frequency or prevalence of nurse–industry interactions. The sample is not representative. Conclusion:Nurse–industry interactions may be common and influential, but they remain invisible in the current policy climate. Although some aspects of these interactions may be beneficial, others may pose financial risks to hospitals or safety risks to patients. Disclosure strategies alone do not provide health professionals with adequate support to manage day-to-day interactions. Management of industry interactions must include guidance for nurses. Primary Funding Source:Agency for Healthcare Research and Quality; Canadian Institutes of Health Research; and University of California, San Francisco.
Topics: nurses, marketing
Reviews | 
Xin-Lin Zhang, MD; Li Zhu, MD; Zhong-Hai Wei, MD; Qing-Qing Zhu, MD; Jian-Zhong Qiao, MM; Qing Dai, MM; Wei Huang, MD; Xiao-Hong Li, MD; Jun Xie, MD; Li-Na Kang, MD; Lian Wang, MD; and Biao Xu, MD, PhD
Includes: Supplemental Content
Background:Theoretically, the everolimus-eluting bioresorbable vascular scaffold (BVS) could eliminate stent thrombosis and improve outcomes in patients having percutaneous coronary intervention. Purpose:To estimate the incidence of stent thrombosis after BVS implantation and to compare the efficacy and safety of BVSs versus everolimus-eluting metallic stents (EESs) in adults having percutaneous coronary intervention. Data Sources:PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 20 January 2016. Study Selection:6 randomized, controlled trials and 38 observational studies, each involving at least 40 patients with BVS implantation. Data Extraction:Two reviewers independently extracted study data and evaluated study risk of bias. Data Synthesis:The pooled incidence of definite or probable stent thrombosis after BVS implantation was 1.5 events per 100 patient-years (PYs) (95% CI, 1.2 to 2.0 events per 100 PYs) (126 events during 8508 PYs). Six randomized trials that directly compared BVSs with EESs showed a non–statistically significant increased risk for stent thrombosis (odds ratio [OR], 2.05 [CI, 0.95 to 4.43]; P = 0.067) and myocardial infarction (OR, 1.38 [CI, 0.98 to 1.95]; P = 0.064) with BVSs. The 6 observational studies that compared BVSs with EESs showed increased risk for stent thrombosis (OR, 2.32 [CI, 1.06 to 5.07]; P = 0.035) and myocardial infarction (OR, 2.09 [CI, 1.23 to 3.55]; P = 0.007) with BVSs. The relative rates of all-cause and cardiac death, revascularization, and target lesion failure were similar for BVSs and EESs. Limitation:Scarce comparative data, no published data from large trials with long-term follow-up, and limited quality and incomplete reporting of observational studies. Conclusion:Compared with EESs, BVSs do not eliminate and might increase risks for stent thrombosis and myocardial infarction in adults having percutaneous coronary intervention. Results of large trials with long-term follow-up are critically needed to establish the safety or at least the noninferiority of BVSs compared with EESs. Primary Funding Source:None.
Topics: myocardial infarction, erythema chronicum migrans, follow-up, safety, everolimus, metallic stents, revascularization, stent thrombosis, bioresorbable vascular scaffold, heart
Letters | 
Yalçin Velibey, MD; Tolga S. Guvenc, MD; Murat Ugur, MD; Ozge Guzelburc, MD; and Mehmet Eren, MD
Position Papers | 
Hilary Daniel, BS, for the Health and Public Policy Committee of the American College of Physicians
This American College of Physicians position paper, initiated and written by its Health and Public Policy Committee and approved by the Board of Regents on 16 February 2016, reports policy recommendations from the American College of Physicians to address the escalating costs of prescription drugs in the United States. Prescription drugs play an important part in treating and preventing disease. However, the United States often pays more for some prescription drugs than other developed countries, and the high price and increasing costs associated with prescription medication is a major concern for patients, physicians, and payers. Pharmaceutical companies have considerable flexibility in how they price drugs, and the costs that payers and patients see are dependent on how payers are able to negotiate discounts or rebates. Beyond setting list prices are issues of regulatory approval, patents and intellectual property, assessment of value and cost-effectiveness, and health plan drug benefits. These issues are linked, and comprehensive efforts will be needed to affect how drugs are priced in the United States.
Topics: prescriptions, drug, prescription drug, formulary, pharmaceutical company, american college of physicians
Letters | 
Kalyan C. Mantripragada, MD, MPH; Sophia Fircanis Rizk, MD; John L. Reagan, MD; and Mark LeGolvan, MD
Ideas and Opinions | 
Shmuel Shoham, MD; Annukka A.R. Antar, MD, PhD; Paul G. Auwaerter, MD, MBA; Christine M. Durand, MD; Mark S. Sulkowski, MD; and Deborah J. Cotton, MD, MPH
Prevention of antimicrobial shortages is a fundamental aspect of keeping patients free of harm. When shortages of these drugs are coupled with the dynamics of serious infections, the results can be catastrophic. The authors discuss possible incentives, programs, and regulation that could help to combat the problem.
Topics: antimicrobials
Ideas and Opinions | 
Evan M. Bloch, MD, MS; Matthew S. Simon, MD, MS; and Beth H. Shaz, MD
Thirty years ago, the recognition that HIV was transmitted through transfusion led to sweeping changes in the procurement, testing, and regulation of the blood supply. Transmission of pathogens, including hepatitis C virus, West Nile virus, and HIV, via transfusion has now been virtually eliminated. However, the authors argue that in 2016, new economic challenges and the emergence of global pathogens, such as Zika virus, call for new investments in blood bank infrastructure and testing technologies, as well as improved collaboration among stakeholders.
Topics: communicable diseases, emerging, safety, transfusion
Letters | 
Caroline M. Lee, MD, PhD; Jason D. Lee, MD, PhD; Lisa D. Hobson-Webb, MD; Richard S. Bedlack, MD, PhD; and Joseph K. Salama, MD
This case report describes an alternative approach for treating thymoma-associated myasthenia gravis.
Letters | 
Sean O'Loghlen, MD, BSc(Hons); Grayson J. Hall, MD; Nadil Zeiadin, MD; Laura Milne, MD; and Benedetto Mussari, MD
Clinicians usually can identify the cause of unilateral lower extremity swelling, but even experienced clinicians can be misled by rare causes of this condition. This case report describes unilateral lower extremity swelling that can be mistaken for deep venous thrombosis.
Physicians increasingly practice as employees of large organizations; therefore, they may often report to managers who are not physicians. These managers may not share physicians' professional values and may believe that practices learned in business school apply to all organizations, including hospitals. This commentary discusses how clauses in the contracts that physicians sign with their employers or that their employers sign with third parties may be part of a growing class of subtle restrictions on employed physicians' professionalism and autonomy.
Topics: professionalism, employer, hospitals
Two states, Oregon and California, now allow pharmacists to prescribe and dispense oral hormonal birth control, which some see as a step toward improved access. However, a prescription is still required in these cases. In this commentary, the Chief Executive Officer of the American Congress of Obstetricians and Gynecologists describes how pharmacist prescription simply exchanges one barrier for another and why over-the-counter availability of oral contraceptives would be a better strategy for increasing access to safe, effective birth control.
Topics: oral contraceptives, contraceptive methods, pharmacist, drugs, non-prescription
Letters | 
Vincent Mallet, MD, PhD; Rebecca Sberro-Soussan, MD; Anais Vallet-Pichard, MD; Anne-Marie Roque-Afonso, MD, PhD; and Stanislas Pol, MD, PhD
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