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Summaries for Patients | 
Topics: hormone replacement therapy, cardiovascular diseases, menopause, hormone, women, coronary heart disease, symptom onset
Reviews | 
Mary Butler, PhD, MBA; Edward Ratner, MD; Ellen McCreedy, MPH; Nathan Shippee, PhD; and Robert L. Kane, MD
Advance care planning honors patients' goals and preferences for future care by creating a plan for when illness or injury impedes the ability to think or communicate about health decisions. Fewer than 50% of severely or terminally ill patients have an advance directive in their medical record, and physicians are accurate only about 65% of the time when predicting patient preferences for intensive care. Decision aids can support the advance care planning process by providing a structured approach to informing patients about care options and prompting them to document and communicate their preferences. This review, commissioned as a technical brief by the Agency for Healthcare Research and Quality Effective Health Care Program, provides a broad overview of current use of and research related to decision aids for adult advance care planning. Using interviews of key informants and a search of the gray and published literature from January 1990 to May 2014, the authors found that many decision aids are widely available but are not assessed in the empirical literature. The 16 published studies testing decision aids as interventions for adult advance care planning found that most are proprietary or not publicly available. Some are constructed for the general population, whereas others address disease-specific conditions that have more predictable end-of-life scenarios and, therefore, more discrete choices. New decision aids should be designed that are responsive to diverse philosophical perspectives and flexible enough to change as patients gain experience with their personal illness courses. Future efforts should include further research, training of advance care planning facilitators, dissemination and access, and tapping the potential opportunities that lie in social media or other technologies.
Topics: end-of-life care, terminal patient care, decision support techniques, terminally ill, terminal illness, advance care planning
Medicine and Public Issues | 
Neil M. Kirschner, PhD; Lois Snyder Sulmasy, JD; and Aaron S. Kesselheim, MD, JD, MPH
The Open Payments program is a government initiative through which financial relationships between applicable industries and covered physicians or teaching hospitals are publicly reported. The program does not assess these relationships but rather facilitates transparency and allows stakeholders to use this information in making informed decisions. This article outlines the program and its goals, reviews its requirements and when they go into effect, examines the implications for physicians and their patients, and makes recommendations to help physicians and teaching hospitals prepare for its implementation.
Topics: ethics, drug industry, health policy, medical industries, physician payments sunshine act, teaching hospitals
Recently revealed safety lapses in U.S. government facilities that work with deadly pathogens suggest that, despite efforts to protect us from bioterrorism as well as naturally occurring infectious diseases, there is another grave bioterror threat: the risk emanating from biocontainment laboratories themselves. This commentary discusses possible factors contributing to the safety lapses and strategies to prevent future incidents.
Topics: bioterrorism, containment of biohazards, biomedical research, laboratory biosafety level, biocontainment laboratories, laboratory
Original Research | 
S. Mitchell Harman, MD, PhD; Dennis M. Black, PhD; Frederick Naftolin, MD, DPhil; Eliot A. Brinton, MD; Matthew J. Budoff, MD; Marcelle I. Cedars, MD; Paul N. Hopkins, MD, MSPH; Rogerio A. Lobo, MD; JoAnn E. Manson, MD, DrPH; George R. Merriam, MD; Virginia M. Miller, PhD; Genevieve Neal-Perry, MD, PhD; Nanette Santoro, MD; Hugh S. Taylor, MD, PhD; Eric Vittinghoff, PhD; Mingzhu Yan, MD, PhD; and Howard N. Hodis, MD
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Background:Whether menopausal hormone therapy (MHT) protects against cardiovascular disease (CVD) remains unclear. Objective:To assess atherosclerosis progression and CVD risk factors after MHT initiated in early menopause. Design:Randomized, controlled trial. (ClinicalTrials.gov: NCT00154180) Setting:Nine U.S. academic centers. Participants:Healthy menopausal women aged 42 to 58 years between 6 and 36 months from last menses without prior CVD events who had a coronary artery calcium (CAC) score less than 50 Agatston units and had not received estrogen or lipid-lowering therapy for at least 90 days. Intervention:Oral conjugated equine estrogens (o-CEE), 0.45 mg/d, or transdermal 17β-estradiol (t-E2), 50 mcg/d, each with 200 mg of oral progesterone for 12 days per month, or placebo for 48 months. Measurements:Primary end point was annual change in carotid artery intima–media thickness (CIMT). Secondary end points included changes in markers of CVD risk. Results:Of 727 randomly assigned women, 89.3% had at least 1 follow-up CIMT and 79.8% had CIMT at 48 months. Mean CIMT increases of 0.007 mm/y were similar across groups. The percentages of participants in whom CAC score increased did not differ significantly across groups. No changes in blood pressure were observed with o-CEE or t-E2. Low- and high-density lipoprotein cholesterol levels improved and levels of C-reactive protein and sex hormone–binding globulin but not interleukin-6 increased with o-CEE. Insulin resistance decreased with t-E2. Serious adverse events did not differ by treatment. Limitation:Power to compare clinical events was insufficient. Conclusion:Four years of early MHT did not affect progression of atherosclerosis despite improving some markers of CVD risk. Primary Funding Source:Aurora Foundation.
Topics: hormone replacement therapy, cardiovascular diseases, menopause, cardiovascular disease risk factors, estrogen, diagnostic imaging, carotid intima-media thickness, coronary calcium score, follow-up, atherosclerosis
Reviews | 
Bram Rochwerg, MD; Waleed Alhazzani, MD; Anees Sindi, MD; Diane Heels-Ansdell, MSc; Lehana Thabane, PhD; Alison Fox-Robichaud, MD; Lawrence Mbuagbaw, MSc; Wojciech Szczeklik, MD; Fayez Alshamsi, MD; Sultan Altayyar, MD; Wang-Chun Ip, MD; Guowei Li, MSc; Michael Wang, MD; Anna Włudarczyk, MD; Qi Zhou, PhD; Gordon H. Guyatt, MD; Deborah J. Cook, MD; Roman Jaeschke, MD; and Djillali Annane, MD, PhD, for the Fluids in Sepsis and Septic Shock Group
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Background:Fluid resuscitation is the cornerstone of sepsis treatment. However, whether balanced or unbalanced crystalloids or natural or synthetic colloids confer a survival advantage is unclear. Purpose:To examine the effect of different resuscitative fluids on mortality in patients with sepsis. Data Sources:MEDLINE, EMBASE, ACP Journal Club, CINAHL, HealthSTAR, the Allied and Complementary Medicine Database, and the Cochrane Central Register of Controlled Trials through March 2014. Study Selection: Randomized trials that evaluated different resuscitative fluids in adult patients with sepsis or septic shock and death. No language restrictions were applied. Data Extraction:Two reviewers extracted data on study characteristics, methods, and outcomes. Risk of bias for individual studies and quality of evidence were assessed. Data Synthesis:14 studies (18 916 patients) were included with 15 direct comparisons. Network meta-analysis at the 4-node level showed higher mortality with starches than with crystalloids (high confidence) and lower mortality with albumin than with crystalloids (moderate confidence) or starches (moderate confidence). Network meta-analysis at the 6-node level showed lower mortality with albumin than with saline (moderate confidence) and low-molecular-weight starch (low confidence) and with balanced crystalloids than with saline (low confidence) and low- and high-molecular-weight starches (moderate confidence). Limitations:These trials were heterogeneous in case mix, fluids evaluated, duration of fluid exposure, and risk of bias. Imprecise estimates for several comparisons in this network meta-analysis contribute to low confidence in most estimates of effect. Conclusion:Among patients with sepsis, resuscitation with balanced crystalloids or albumin compared with other fluids seems to be associated with reduced mortality. Primary Funding Source:The Hamilton Chapter of the Canadian Intensive Care Foundation and the Critical Care Medicine Residency Program and Critical Care Division Alternate Funding Plan at McMaster University.
Topics: colloids, septicemia, starch, crystalloid, normal saline, fluid resuscitation, saline solution, albumin solution, crystalloid fluid replacement, colloid fluid replacement, systemic infection, albumins
Original Research | 
Timothy J. Henrich, MD; Emily Hanhauser, BS; Francisco M. Marty, MD; Michael N. Sirignano, BS; Sheila Keating, PhD; Tzong-Hae Lee, MD, PhD; Yvonne P. Robles, BA; Benjamin T. Davis, MD; Jonathan Z. Li, MD; Andrea Heisey, BS; Alison L. Hill, PhD; Michael P. Busch, MD, PhD; Philippe Armand, MD, PhD; Robert J. Soiffer, MD; Marcus Altfeld, MD, PhD; and Daniel R. Kuritzkes, MD
Background:It is unknown whether the reduction in HIV-1 reservoirs seen after allogeneic hematopoietic stem cell transplantation (HSCT) with susceptible donor cells is sufficient to achieve sustained HIV-1 remission. Objective:To characterize HIV-1 reservoirs in blood and tissues and perform analytic antiretroviral treatment interruptions to determine the potential for allogeneic HSCT to lead to sustained, antiretroviral-free HIV-1 remission. Design:Case report with characterization of HIV-1 reservoirs and immunity before and after antiretroviral interruption. Setting:Tertiary care center. Patients:Two men with HIV with undetectable HIV-1 after allogeneic HSCT for hematologic tumors. Measurements:Quantification of HIV-1 in various tissues after HSCT and the duration of antiretroviral-free HIV-1 remission after treatment interruption. Results:No HIV-1 was detected from peripheral blood or rectal mucosa before analytic treatment interruption. Plasma HIV-1 RNA and cell-associated HIV-1 DNA remained undetectable until 12 and 32 weeks after antiretroviral cessation. Both patients experienced rebound viremia within 2 weeks of the most recent negative viral load measurement and developed symptoms consistent with the acute retroviral syndrome. One patient developed new efavirenz resistance after reinitiation of antiretroviral therapy. Reinitiation of active therapy led to viral decay and resolution of symptoms in both patients. Limitation:The study only involved 2 patients. Conclusion:Allogeneic HSCT may lead to loss of detectable HIV-1 from blood and gut tissue and variable periods of antiretroviral-free HIV-1 remission, but viral rebound can occur despite a minimum 3-log10 reduction in reservoir size. Long-lived tissue reservoirs may have contributed to viral persistence. The definition of the nature and half-life of such reservoirs is essential to achieve durable antiretroviral-free HIV-1 remission. Primary Funding Source:Foundation for AIDS Research and National Institute of Allergy and Infectious Diseases.
Topics: hiv, hiv-1, hiv infection, anti-retroviral agents, allogeneic hematopoietic stem cell transplant, disease remission, hematopoietic stem cell transplantation, allogeneic stem cell transplant
Editorials | 
Sharon R. Lewin, FRACP, PhD
In 2 patients with HIV with undetectable virus years after hematopoietic stem cell transplantation, rebound viremia and acute retroviral syndrome occurred 12 and 32 weeks after stopping antiretroviral therapy. A “functional cure” of HIV infection remains elusive.
Topics: hiv, hematopoietic stem cell transplantation, hiv-1, allogeneic stem cell transplant, hiv infection, anti-retroviral agents, allogeneic hematopoietic stem cell transplant, disease remission
Optimal methods of fluid resuscitation for critically ill patients with sepsis are much debated. In this issue, Rochwerg and colleagues report a network meta-analysis that compares various strategies for fluid resuscitation in sepsis. The editorialist discusses the meta-analysis and raises unanswered questions about the role of crystalloid solutions in fluid resuscitation.
Topics: systemic infection, albumins, colloids, septicemia, starch, crystalloid, normal saline, fluid resuscitation, saline solution, albumin solution, crystalloid fluid replacement, colloid fluid replacement
The National Quality Forum recently convened an expert panel to make recommendations on whether to risk-adjust health care performance measures for patient sociodemographic factors in addition to clinical factors present at the initiation of care. This commentary discusses why the panel chose to recommend such adjustment and why the topic is so hotly debated.
Topics: risk adjustment, socioeconomic factors, poverty, patient characteristics, performance measures, hospitals, patient readmission
Letters | 
Charlene A. Wong, MD; David A. Asch, MD, MBA; Cjloe M. Vinoya, BS; Carol A. Ford, MD; Tom Baker, JD; Robert Town, PhD; and Raina M. Merchant, MD, MSHP
Topics: decision support systems, internet, patient protection and affordable care act, consumer preference, usability testing, health insurance exchanges
Reviews | 
Daniel E. Jonas, MD, MPH; Cynthia Feltner, MD, MPH; Halle R. Amick, MSPH; Stacey Sheridan, MD, MPH; Zhi-Jie Zheng, MD, MPH, PhD; Daniel J. Watford, MD, MPH; Jamie L. Carter, MD, MPH; Cassandra J. Rowe, MPH; and Russell Harris, MD, MPH
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Background:Approximately 10% of ischemic strokes are caused by carotid artery stenosis (CAS). Estimated prevalence of asymptomatic CAS is 1%. Purpose:To evaluate evidence on screening and treating asymptomatic adults for CAS. Data Sources:MEDLINE, the Cochrane Library, EMBASE, and trial registries through September 2013; MEDLINE through March 2014 for trials. Study Selection:Good- or fair-quality trials of screening, carotid endarterectomy (CEA), or stenting compared with medical therapy or of intensification of medical therapy; systematic reviews; multi-institution studies reporting harms; and externally validated risk-stratification tools. Data Extraction:Dual extraction and quality assessment. Data Synthesis:No trials compared screening with no screening or stenting with medical therapy or assessed intensification of medical therapy, and no externally validated, reliable risk-stratification tools were found. Given the specificity of ultrasonography (range, 88% to 94% for CAS of ≥50% to ≥70%), its use in low-prevalence populations would yield many false-positive results. Absolute reduction of nonperioperative strokes was 5.5% (95% CI, 3.9% to 7.0%; 3 trials with 5223 participants) over approximately 5 years for CEA compared with medical therapy. The 30-day rates of stroke or death after CEA in trials and cohort studies were 2.4% (CI, 1.7% to 3.1%; 6 trials; n = 3435) and 3.3% (CI, 2.7% to 3.9%; 7 studies; n = 17 474), respectively. Other harms of interventions include myocardial infarction, nerve injury, and hematoma. Limitations:Trials may have overestimated benefits and used highly selected surgeons. Medical therapy used in trials was outdated, and stroke rates have declined in recent decades. Harms may have been underreported. Conclusion:Current evidence does not establish incremental overall benefit of CEA, stenting, or intensification of medical therapy. Potential for overall benefit is limited by low prevalence and harms. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: carotid stenosis, ischemic stroke, screening
The U.S. Preventive Services Task Force recommends against screening for asymptomatic carotid artery stenosis. However, such screenings are offered throughout the United States. The editorialist discusses the recommendations and warns potential consumers of these services to be aware that the test is unlikely to prevent them from having a stroke.
Topics: carotid stenosis, ischemic stroke, screening
Clinical Guidelines | 
Michael L. LeFevre, MD, MSPH, on behalf of the U.S. Preventive Services Task Force*
Description:Update of the 2007 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for carotid artery stenosis. Methods:The USPSTF commissioned a systematic review to synthesize the evidence on the accuracy of screening tests, externally validated risk stratification tools, the benefits of treatment of asymptomatic carotid artery stenosis with carotid endarterectomy (CEA) or carotid angioplasty and stenting (CAAS), the benefits from medications added to current standard medical therapy, and the harms of screening and treatment with CEA or CAAS. Population:This recommendation applies to adults without a history of transient ischemic attack, stroke, or other neurologic signs or symptoms. Recommendation:The USPSTF recommends against screening for asymptomatic carotid artery stenosis in the general adult population. (D recommendation)
Topics: carotid stenosis, screening, ischemic stroke
Topics: carotid stenosis, ischemic stroke, screening
Topics: abdominal aortic aneurysm, preventive health services, united states preventive services task force
Clinical Guidelines | 
Michael L. LeFevre, MD, MSPH, on behalf of the U.S. Preventive Services Task Force*
Description:Update of the 2005 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for abdominal aortic aneurysm (AAA). Methods:The USPSTF commissioned a systematic review that assessed the evidence on the benefits and harms of screening for AAA and strategies for managing small (3.0 to 5.4 cm) screen-detected AAAs. Population:These recommendations apply to asymptomatic adults aged 50 years or older. Recommendation:The USPSTF recommends 1-time screening for AAA with ultrasonography in men aged 65 to 75 years who have ever smoked. (B recommendation) The USPSTF recommends that clinicians selectively offer screening for AAA in men aged 65 to 75 years who have never smoked. (C recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for AAA in women aged 65 to 75 years who have ever smoked. (I statement) The USPSTF recommends against routine screening for AAA in women who have never smoked. (D recommendation)
Topics: abdominal aortic aneurysm, ultrasonography, mortality, american academy of arts and sciences, ruptured abdominal aortic aneurysm, rupture
Medicine and Public Issues | 
Michelle K. Koltov, MPH; and Nitin S. Damle, MD
The U.S. health care system is in the midst of transforming from a fee-for-service system to a value-based system that delivers high-quality and cost-effective care. Quality reporting programs and increasing transparency of performance are meant to encourage physicians and hospitals to invest in improving the delivery of care. In 2006, the Centers for Medicare & Medicaid Services implemented the Physician Quality Reporting System (PQRS). The PQRS is an incentive and penalty payment program for eligible professionals who report data on quality measures for covered professional services furnished to Medicare beneficiaries. The program gives eligible professionals the opportunity to assess the quality of care they are providing to their patients and compare their performance on a given measure with their peers. This article discusses the history of PQRS, the 2014 PQRS, and how it affects other quality programs.
Topics: physician quality reporting system, health policy
On 30 April 2014, the Medicare Evidence Development & Coverage Advisory Committee convened to weigh the evidence for low-dose computed tomography (LDCT) screening for lung cancer. Many were shocked by the outcome: a vote of low confidence about whether the benefits of LDCT screening would outweigh harms among Medicare beneficiaries in a community setting. This commentary discusses potential strategies to implement lung cancer screening with LDCT in a responsible manner that avoids overzealous screening.
Topics: lung cancer screening, low-dose spiral ct
Reviews | 
Devan Kansagara, MD, MCR; Joel Papak, MD; Amirala S. Pasha, DO, MS; Maya O'Neil, PhD; Michele Freeman, MPH; Rose Relevo, MLIS, MS; Ana Quiñones, PhD; Makalapua Motu'apuaka, BS; and Janice H. Jou, MD, MHS
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Background:Guidelines recommend routine screening for hepatocellular carcinoma (HCC) in high-risk patients, but the strength of evidence supporting these recommendations is unclear. Purpose:To review the benefits and harms of HCC screening in patients with chronic liver disease. Data Sources:MEDLINE, PsycINFO, and ClinicalTrials.gov from inception to April 2014; Cochrane databases to June 2013; reference lists; and technical advisors. Study Selection:English-language trials and observational studies comparing screening versus no screening, studies of harms, and trials comparing different screening intervals. Data Extraction:Mortality and adverse events were the outcomes of interest. Individual-study quality and the overall strength of evidence were dual-reviewed using published criteria. Data Synthesis:Of 13 801 citations, 22 studies met inclusion criteria. The overall strength of evidence on the effects of screening was very low. One large trial found decreased HCC mortality with periodic ultrasonographic screening (rate ratio, 0.63 [95% CI, 0.41 to 0.98]), but the study was limited by methodological flaws. Another trial in patients with hepatitis B found no survival benefit with periodic α-fetoprotein screening. In 18 observational studies, screened patients had earlier-stage HCC than clinically diagnosed patients, but lead- and length-time bias confounded the effects on mortality. Two trials found no survival differences between shorter (3- to 4-month) and longer (6- to 12-month) screening intervals. Harms of screening were not well-studied. Limitations:Only English-language studies were included. The evidence base is limited by methodological issues and a paucity of trials. Conclusion:There is very-low-strength evidence about the effects of HCC screening on mortality in patients with chronic liver disease. Screening tests can identify early-stage HCC, but whether systematic screening leads to a survival advantage over clinical diagnosis is uncertain. Primary Funding Source:U.S. Department of Veterans Affairs Quality Enhancement Research Initiative.
Topics: carcinoma, hepatocellular, hepatitis b, chronic, hepatitis b virus, liver disease, chronic, liver cancer screening, mortality, liver cirrhosis
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