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Topics: obesity, physical activity, cardiovascular diseases, diabetes mellitus, cardiovascular disease risk factors, diabetes mellitus, type 2, diet, behavior therapy, counseling, preventive health services, lifestyle changes, health outcomes, changes in diet, healthy diet, diabetes prevention, cardiovascular disease prevention
Description:Update and refinement of the 2003 U.S. Preventive Services Task Force (USPSTF) recommendation on dietary counseling for adults with risk factors for cardiovascular disease (CVD). Methods:The USPSTF reviewed the evidence on whether primary care–relevant counseling interventions for a healthful diet and physical activity modify self-reported behaviors, intermediate physiologic outcomes, diabetes incidence, and cardiovascular morbidity or mortality in adults with CVD risk factors, as well as the adverse effects of counseling interventions. Population:This recommendation applies to adults aged 18 years or older in primary care settings who are overweight or obese and have known CVD risk factors (hypertension, dyslipidemia, impaired fasting glucose, or the metabolic syndrome). Recommendation:The USPSTF recommends offering or referring adults who are overweight or obese and have additional CVD risk factors to intensive behavioral counseling interventions to promote a healthful diet and physical activity for CVD prevention. (B recommendation)
Topics: diet, behavior therapy, preventive health services, lifestyle changes, health outcomes, changes in diet, healthy diet, diabetes prevention, cardiovascular disease prevention, physical activity, diabetes mellitus, cardiovascular disease risk factors, obesity, diabetes mellitus, type 2
Reviews | 
Jennifer S. Lin, MD, MCR; Elizabeth O'Connor, PhD; Corinne V. Evans, MPP; Caitlyn A. Senger, MPH; Maya G. Rowland, MPH; and Holly C. Groom, MPH
Includes: Supplemental Content
Background:Most Americans do not meet diet and physical activity recommendations despite known health benefits. Purpose:To systematically review the benefits and harms of lifestyle counseling interventions in persons with cardiovascular risk factors for the U.S. Preventive Services Task Force. Data Sources:MEDLINE, PsycINFO, the Database of Abstracts of Reviews of Effects, and the Cochrane Central Register of Controlled Trials (January 2001 to October 2013); experts; and existing systematic reviews. Study Selection:Two investigators independently reviewed 7218 abstracts and 553 articles against a set of inclusion and quality criteria. Data Extraction:Data from 74 trials were abstracted by one reviewer and checked by a second. Data Synthesis:At 12 to 24 months, intensive lifestyle counseling in persons selected for risk factors reduced total cholesterol levels by an average of 0.12 mmol/L (95% CI, 0.16 to 0.07 mmol/L) (4.48 mg/dL [CI, 6.36 to 2.59 mg/dL]), low-density lipoprotein cholesterol levels by 0.09 mmol/L (CI, 0.14 to 0.04 mmol/L) (3.43 mg/dL [CI, 5.37 to 1.49 mg/dL]), systolic blood pressure by 2.03 mm Hg (CI, 2.91 to 1.15 mm Hg), diastolic blood pressure by 1.38 mm Hg (CI, 1.92 to 0.83 mm Hg), fasting glucose levels by 0.12 mmol/L (CI, 0.18 to 0.05 mmol/L) (2.08 mg/dL [CI, 3.29 to 0.88 mg/dL]), diabetes incidence by a relative risk of 0.58 (CI, 0.37 to 0.89), and weight outcomes by a standardized mean difference of 0.25 (CI, 0.35 to 0.16). Behavioral changes in dietary intake and physical activity were generally concordant with changes in physiologic outcomes. Limitation:Sparse reporting of patient health outcomes, longer-term follow-up of outcomes, and harms. Conclusion:Intensive diet and physical activity behavioral counseling in persons with risk factors for cardiovascular disease resulted in consistent improvements across various important intermediate health outcomes up to 2 years. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: obesity, cardiovascular diseases, behavior therapy, counseling, preventive health services, lifestyle changes, changes in diet, healthy diet, diabetes prevention, cardiovascular disease prevention, cardiovascular disease risk factors, diet, diabetes mellitus, type 2, diabetes mellitus, health outcomes, physical activity
Ideas and Opinions | 
William A. Fischer II, MD; Noreen A. Hynes, MD, MPH; and Trish M. Perl, MD, MSc
The authors discuss how so many health care workers in West Africa could have become infected with Ebola virus disease despite the known effectiveness of barrier protection in blocking its transmission.
Topics: ebola virus, health personnel, hemorrhagic fever, ebola, personal protective equipment
Ideas and Opinions | 
Alison P. Galvani, PhD; Martial L. Ndeffo-Mbah, PhD; Natasha Wenzel, MPH; and James E. Childs, PhD
As an unprecedented Ebola epidemic continues to spread, the authors argue that vaccines not yet tested in humans should be deployed.
Topics: ebola virus, disease outbreaks, hemorrhagic fever, ebola, vaccination, epidemic, experimental treatment, ebola vaccines
Ideas and Opinions | 
Michael Klompas, MD, MPH; Daniel J. Diekema, MD; Neil O. Fishman, MD; and Deborah S. Yokoe, MD
On the basis of their review of evidence from prior Ebola outbreaks, the authors conclude that current recommendations from the Centers for Disease Control and Prevention to prevent transmission of the virus to health care workers are appropriate. They argue that additional measures, such as full-body hazardous material suits, may paradoxically increase the risk for transmission.
Topics: ebola virus, hemorrhagic fever, ebola, hospitals, protective clothing, infection prophylaxis
Ideas and Opinions | 
Carlos del Rio, MD; Aneesh K. Mehta, MD; G. Marshall Lyon III, MD; and Jeannette Guarner, MD
The possibility that a patient with Ebola hemorrhagic fever could travel to the United States has created unprecedented media coverage and widespread concern. It is important for clinicians to understand the epidemiology and pathogenesis of this once-obscure disease so they can serve as trusted experts to patients and the public.
Topics: epidemiology, ebola virus, disease outbreaks, hemorrhagic fever, ebola, epidemic, pathogenesis, epidemic control
Ideas and Opinions | 
Nancy Kass, ScD
Two U.S. aid workers with Ebola have been evacuated to the United States and treated with an extremely scarce and untested therapy. Given the hundreds of similarly stricken patients in Africa, whether it was ethical to single out the Americans for such heroic care is a matter of debate.
Topics: ethics, ebola virus, health personnel, hemorrhagic fever, ebola, public health medicine, epidemic, experimental treatment
Editorials | 
Dick Menzies, MD, MSc; and Timothy R. Sterling, MD
In this issue, Stagg and colleagues report a network meta-analysis that compares treatment regimens for Mycobacterium tuberculosis infection to identify which options provide the optimal balance of efficacy and tolerability. The editorialists discuss these findings and conclude that it is time to switch focus to short-course treatment with rifamycin-containing regimens for M. tuberculosis infection.
Topics: antitubercular agents, isoniazid, mycobacterium tuberculosis, tuberculosis, rifamycins, latent tuberculosis, hepatotoxicity
Reviews | 
Erin D. Michos, MD, MHS; Lisa M. Wilson, ScM; Hsin-Chieh Yeh, PhD; Zackary Berger, MD, PhD; Catalina Suarez-Cuervo, MD; Sylvie R. Stacy, MD; and Eric B. Bass, MD, MPH
Includes: Supplemental Content
Background:Clinicians face uncertainty about the prognostic value of troponin testing in patients with chronic kidney disease (CKD) without suspected acute coronary syndrome (ACS). Purpose:To systematically review the literature on troponin testing in patients with CKD without ACS. Data Sources:MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through May 2014. Study Selection:Studies examining elevated versus normal troponin levels in patients with CKD without ACS. Data Extraction:Paired reviewers selected articles for inclusion, extracted data, and graded strength of evidence (SOE). Meta-analyses were conducted when studies had sufficient homogeneity of key variables. Data Synthesis:Ninety-eight studies met inclusion criteria. Elevated troponin levels were associated with all-cause and cardiovascular mortality among patients receiving dialysis (moderate SOE). Pooled hazard ratios (HRs) for all-cause mortality from studies that adjusted for age and coronary artery disease or a risk equivalent were 3.0 (95% CI, 2.4 to 4.3) for troponin T and 2.7 (CI, 1.9 to 4.6) for troponin I. The pooled adjusted HRs for cardiovascular mortality were 3.3 (CI, 1.8 to 5.4) for troponin T and 4.2 (CI, 2.0 to 9.2) for troponin I. Findings were similar for patients with CKD who were not receiving dialysis, but there were fewer studies. No study tested treatment strategies by troponin cut points. Limitation:Studies were heterogeneous regarding assays, troponin cut points, covariate adjustment, and follow-up. Conclusion:In patients with CKD without suspected ACS, elevated troponin levels were associated with worse prognosis. Future studies should focus on whether this biomarker is more appropriate than clinical models for reclassifying risk of patients with CKD and whether such classification can help guide treatment in those at highest risk for death. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: acute coronary syndromes, troponin, hemodialysis, kidney failure, chronic, troponin t, dialysis procedure, troponin i, cardiovascular death, cardiac troponin measurement
Reviews | 
Sylvie R. Stacy, MD, MPH*; Catalina Suarez-Cuervo, MD*; Zackary Berger, MD, PhD; Lisa M. Wilson, ScM; Hsin-Chieh Yeh, PhD; Eric B. Bass, MD, MPH; and Erin D. Michos, MD, MHS
Background:Patients with chronic kidney disease (CKD) have high prevalence of elevated serum troponin levels, which makes diagnosis of acute coronary syndrome (ACS) challenging. Purpose:To evaluate the utility of troponin in ACS diagnosis, treatment, and prognosis among patients with CKD. Data Sources:MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through May 2014. Study Selection:Studies examining elevated versus normal troponin levels in terms of their diagnostic performance in detection of ACS, effect on ACS management strategies, and prognostic value for mortality or cardiovascular events after ACS among patients with CKD. Data Extraction:Paired reviewers selected articles for inclusion, extracted data, and graded strength of evidence (SOE). Data Synthesis:Twenty-three studies met inclusion criteria. The sensitivity of troponin T for ACS diagnosis ranged from 71% to 100%, and specificity ranged from 31% to 86% (6 studies; low SOE). The sensitivity and specificity of troponin I ranged from 43% to 94% and from 48% to 100%, respectively (8 studies; low SOE). No studies examined how troponin levels affect management strategies. Twelve studies analyzed prognostic value. Elevated levels of troponin I or troponin T were associated with higher risk for short-term death and cardiac events (low SOE). A similar trend was observed for long-term mortality with troponin I (low SOE), but less evidence was found for long-term cardiac events for troponin I and long-term outcomes for troponin T (insufficient SOE). Patients with advanced CKD tended to have worse prognoses with elevated troponin I levels than those without them (moderate SOE). Limitation:Studies were heterogeneous in design and in ACS definitions and adjudication methods. Conclusion:In patients with CKD and suspected ACS, troponin levels can aid in identifying those with a poor prognosis, but the diagnostic utility is limited by varying estimates of sensitivity and specificity. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: troponin, hemodialysis, kidney failure, chronic, dialysis procedure, cardiovascular death, cardiac troponin measurement, troponin i, acute coronary syndromes, troponin t
Ideas and Opinions | 
Linda S. Kinsinger, MD, MPH; David Atkins, MD, MPH; Dawn Provenzale, MD, MS; Charles Anderson, MD, PhD; and Robert Petzel, MD
Whether community lung cancer screening programs will result in benefits and harms similar to those in a clinical trial is unknown. As policymakers debate about whether to adopt widespread screening or await further data, the Veterans Health Administration is initiating a demonstration project to assess initial experience in implementing a screening program at select sites and will assess the results to inform whether, and how, to proceed with broader implementation.
Topics: veterans, lung cancer, lung cancer screening, low-dose spiral ct
Reviews | 
Helen R. Stagg, PhD*; Dominik Zenner, MD*; Ross J. Harris, MSc; Laura Muñoz, MD; Marc C. Lipman, MD; and Ibrahim Abubakar, MBBS, PhD
Includes: Supplemental Content
Background:Effective treatment of latent tuberculosis infection (LTBI) is an important component of tuberculosis (TB) elimination programs. Promising new regimens that may be more effective are being introduced. As few regimens can be directly compared, network meta-analyses, which allow indirect comparisons to be made, strengthen conclusions. Purpose:To determine the most efficacious regimen for preventing active TB with the lowest likelihood of adverse events in order to inform LTBI treatment policies. Data Sources:PubMed, EMBASE, and Web of Science to the end of January 2014; clinical trial registries; and conference abstracts. Study Selection:Randomized, controlled trials that evaluated human LTBI treatment and recorded at least one of two prespecified end points (preventing active TB or hepatotoxicity), without language or date restrictions. Data Extraction:Data from eligible studies were independently extracted by 2 investigators according to a standard protocol. Data Synthesis:Of the 1516 articles identified, 53 studies met the inclusion criteria. Data on 15 regimens were available; of 105 possible comparisons, 42 (40%) were compared directly. Compared with placebo, isoniazid for 6 months (odds ratio [OR], 0.64 [95% credible interval {CrI}, 0.48 to 0.83]) or 12 months or longer (OR, 0.52 [CrI, 0.41 to 0.66]), rifampicin for 3 to 4 months (OR, 0.41 [CrI, 0.18 to 0.86]), rifapentine-isoniazid (OR, 0.61 [CrI, 0.29 to 1.22]), and rifampicin-isoniazid (OR, 0.52 [CrI, 0.34 to 0.79]) were efficacious within the network. Limitations:The risk of bias was unclear for many studies across various domains. Evidence was sparse for some comparisons, particularly hepatotoxicity. Conclusion:Comparison of different LTBI treatment regimens showed that therapies containing rifamycin for 3 months or more were efficacious at preventing active TB, potentially more so than isoniazid alone. Regimens containing rifamycin may be effective alternatives to isoniazid monotherapy. Primary Funding Source:None.
Topics: antitubercular agents, isoniazid, mycobacterium tuberculosis, tuberculosis, rifamycins, latent tuberculosis, hepatotoxicity
Editorials | 
William G. Kussmaul III, MD; and Ashwini R. Sehgal, MD
In this issue, Michos, Stacy, and colleagues report 2 systematic reviews that address the challenges of using troponin levels to diagnose cardiac disease in patients with chronic kidney disease. The editorialists discuss these findings and view them as a solid base for future research to optimize the renal and cardiac outcomes of patients with chronic kidney disease.
Topics: acute coronary syndromes, troponin, hemodialysis, kidney failure, chronic, dialysis procedure, troponin i, cardiovascular death, cardiac troponin measurement, troponin t
Ideas and Opinions | 
Scott H. Podolsky, MD
Two American missionary workers infected with the deadly Ebola virus have been administered a combination of preformed monoclonal antibodies directed against the virus and previously demonstrated to work only in monkeys. This commentary discusses the history of serotherapy in the United States and what lessons we can learn from it.
Topics: ebola virus, monoclonal antibodies, hemorrhagic fever, ebola, serotherapy
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
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
Includes: Supplemental Content
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
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