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Original Research | 
Gustaf Edgren, MD, PhD; Henrik Hjalgrim, MD, PhD, DrMedSci; Klaus Rostgaard, MSc; Paul Lambert, PhD; Agneta Wikman, MD, PhD; Rut Norda, MD, PhD; Kjell-Einar Titlestad, MD, PhD; Christian Erikstrup, MD, PhD; Henrik Ullum, MD, PhD; Mads Melbye, MD, DrMedSci; Michael P. Busch, MD, PhD; and Olof Nyrén, MD, PhD
Background:The aggregation of misfolded proteins in the brain occurs in several neurodegenerative disorders. Aberrant protein aggregation is inducible in rodents and primates by intracerebral inoculation. Possible transfusion transmission of neurodegenerative diseases has important public health implications. Objective:To investigate possible transfusion transmission of neurodegenerative disorders. Design:Retrospective cohort study. Setting:Nationwide registers of transfusions in Sweden and Denmark. Participants:1 465 845 patients who received transfusions between 1968 and 2012. Measurements:Multivariable Cox regression models were used to estimate hazard ratios for dementia of any type, Alzheimer disease, and Parkinson disease in patients receiving blood transfusions from donors who were later diagnosed with any of these diseases versus patients who received blood from healthy donors. Whether excess occurrence of neurodegenerative disease occurred among recipients of blood from a subset of donors was also investigated. As a positive control, transmission of chronic hepatitis before and after implementation of hepatitis C virus screening was assessed. Results:Among included patients, 2.9% received a transfusion from a donor diagnosed with one of the studied neurodegenerative diseases. No evidence of transmission of any of these diseases was found, regardless of approach. The hazard ratio for dementia in recipients of blood from donors with dementia versus recipients of blood from healthy donors was 1.04 (95% CI, 0.99 to 1.09). Corresponding estimates for Alzheimer disease and Parkinson disease were 0.99 (CI, 0.85 to 1.15) and 0.94 (CI, 0.78 to 1.14), respectively. Hepatitis transmission was detected before but not after implementation of hepatitis C virus screening. Limitation:Observational study design, underascertainment of the outcome, and possible insufficient statistical power. Conclusion:The data provide no evidence for the transmission of neurodegenerative diseases and suggest that if transmission does occur, it is rare. Primary Funding Source:Swedish Research Council, Swedish Heart-Lung Foundation, Swedish Society for Medical Research, and Danish Council for Independent Research.
Editorials | 
Michael J. Devlin, MD
The review by Brownley and colleagues summarizes the evidence on treatment for binge eating disorder, including psychotherapeutic and psychopharmacologic approaches developed since binge eating was first recognized as a clinical disorder. The editorialist notes that the article raises some fundamental questions: What are we to make of this “new” diagnosis, a disorder that did not formally exist for many of us during our education and training? Why has it come to light now? How should we approach our patients?
Original Research | 
Phillip O. Coffin, MD, MIA; Emily Behar, MA; Christopher Rowe, MPH; Glenn-Milo Santos, PhD, MPH; Diana Coffa, MD; Matthew Bald, MD; and Eric Vittinghoff, PhD
Background:Unintentional overdose involving opioid analgesics is a leading cause of injury-related death in the United States. Objective:To evaluate the feasibility and effect of implementing naloxone prescription to patients prescribed opioids for chronic pain. Design:2-year nonrandomized intervention study. Setting:6 safety-net primary care clinics in San Francisco, California. Participants:1985 adults receiving long-term opioid therapy for pain. Intervention:Providers and clinic staff were trained and supported in naloxone prescribing. Measurements:Outcomes were proportion of patients prescribed naloxone, opioid-related emergency department (ED) visits, and prescribed opioid dose based on chart review. Results:38.2% of 1985 patients receiving long-term opioids were prescribed naloxone. Patients prescribed higher doses of opioids and with an opioid-related ED visit in the past 12 months were independently more likely to be prescribed naloxone. Patients who received a naloxone prescription had 47% fewer opioid-related ED visits per month in the 6 months after receipt of the prescription (incidence rate ratio [IRR], 0.53 [95% CI, 0.34 to 0.83]; P = 0.005) and 63% fewer visits after 1 year (IRR, 0.37 [CI, 0.22 to 0.64]; P < 0.001) compared with patients who did not receive naloxone. There was no net change over time in opioid dose among those who received naloxone and those who did not (IRR, 1.03 [CI, 0.91 to 1.27]; P = 0.61). Limitation:Results are observational and may not be generalizable beyond safety-net settings. Conclusion:Naloxone can be coprescribed to primary care patients prescribed opioids for pain. When advised to offer naloxone to all patients receiving opioids, providers may prioritize those with established risk factors. Providing naloxone in primary care settings may have ancillary benefits, such as reducing opioid-related adverse events. Primary Funding Source:National Institutes of Health grant R21DA036776.
Coffin and colleagues report on the NOSE (Naloxone for Opioid Safety Evaluation) study, an evaluation of the implementation of overdose education and naloxone rescue kit prescriptions among patients in safety net community health centers treated with opioid therapy for chronic pain. The editorialists describe why this study is a critical step forward in integrating interventions to reduce opioid overdose into primary care settings.
Reviews | 
Kimberly A. Brownley, PhD; Nancy D. Berkman, PhD; Christine M. Peat, PhD; Kathleen N. Lohr, PhD; Katherine E. Cullen, BA; Carla M. Bann, PhD; and Cynthia M. Bulik, PhD
Includes: Supplemental Content
Background:The best treatment options for binge-eating disorder are unclear. Purpose:To summarize evidence about the benefits and harms of psychological and pharmacologic therapies for adults with binge-eating disorder. Data Sources:English-language publications in EMBASE, the Cochrane Library, Academic OneFile, CINAHL, and ClinicalTrials.gov through 18 November 2015, and in MEDLINE through 12 May 2016. Study Selection:9 waitlist-controlled psychological trials and 25 placebo-controlled trials that evaluated pharmacologic (n = 19) or combination (n = 6) treatment. All were randomized trials with low or medium risk of bias. Data Extraction:2 reviewers independently extracted trial data, assessed risk of bias, and graded strength of evidence. Data Synthesis:Therapist-led cognitive behavioral therapy, lisdexamfetamine, and second-generation antidepressants (SGAs) decreased binge-eating frequency and increased binge-eating abstinence (relative risk, 4.95 [95% CI, 3.06 to 8.00], 2.61 [CI, 2.04 to 3.33], and 1.67 [CI, 1.24 to 2.26], respectively). Lisdexamfetamine (mean difference [MD], −6.50 [CI, −8.82 to −4.18]) and SGAs (MD, −3.84 [CI, −6.55 to −1.13]) reduced binge-eating–related obsessions and compulsions, and SGAs reduced symptoms of depression (MD, −1.97 [CI, −3.67 to −0.28]). Headache, gastrointestinal upset, sleep disturbance, and sympathetic nervous system arousal occurred more frequently with lisdexamfetamine than placebo (relative risk range, 1.63 to 4.28). Other forms of cognitive behavioral therapy and topiramate also increased abstinence and reduced binge-eating frequency and related psychopathology. Topiramate reduced weight and increased sympathetic nervous system arousal, and lisdexamfetamine reduced weight and appetite. Limitations:Most study participants were overweight or obese white women aged 20 to 40 years. Many treatments were examined only in single studies. Outcomes were measured inconsistently across trials and rarely assessed beyond end of treatment. Conclusion:Cognitive behavioral therapy, lisdexamfetamine, SGAs, and topiramate reduced binge eating and related psychopathology, and lisdexamfetamine and topiramate reduced weight in adults with binge-eating disorder. Primary Funding Source:Agency for Healthcare Research and Quality.
Original Research | 
John N. Mafi, MD, MPH; Christina C. Wee, MD, MPH; Roger B. Davis, ScD; and Bruce E. Landon, MD, MBA, MSc
Background:Many physicians believe that advanced practice clinicians (APCs [nurse practitioners and physician assistants]) provide care of relatively lower value. Objective:To compare use of low-value services among U.S. APCs and physicians. Design:Service use after primary care visits was evaluated for 3 conditions after adjustment for patient and provider characteristics and year. Patients with guideline-based red flags were excluded and analyses stratified by office- versus hospital-based visits, acute versus nonacute presentations, and whether clinicians self-identified as the patient's primary care provider (PCP). Setting:National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS), 1997 to 2011. Patients:Patients presenting with upper respiratory infections (URIs), back pain, or headache. Measurements:Use of guideline-discordant antibiotics (for URIs), radiography (for URIs and back pain), computed tomography (CT) or magnetic resonance imaging (MRI) (for headache and back pain), and referrals to other physicians (for all 3 conditions). Results:12 170 physician and 473 APC office-based visits and 13 359 physician and 2947 APC hospital-based visits were identified. Although office-based clinicians saw similar patients, hospital-based APCs saw younger patients (mean age, 42.6 vs. 45.0 years; P < 0.001), and practiced in urban settings less frequently (49.7% vs. 81.7% of visits; P < 0.001) than hospital-based physicians. Unadjusted and adjusted results revealed that APCs ordered antibiotics, CT or MRI, radiography, and referrals as often as physicians in both settings. Stratification suggested that self-identified PCP APCs ordered more services than PCP physicians in the hospital-based setting. Limitation:NHAMCS reflects hospital-based APC care; NAMCS samples physician practices and likely underrepresents office-based APCs. Conclusion:APCs and physicians provided an equivalent amount of low-value health services, dispelling physicians' perceptions that APCs provide lower-value care than physicians for these common conditions. Primary Funding Source:U.S. Health Services and Research Administration, Ryoichi Sasakawa Fellowship Fund, and National Institutes of Health.
Topics: antibiotics, primary care physicians, atrial premature complexes, hospitals, primary health care, low-value services, back pain, magnetic resonance imaging, headache, diagnostic radiologic examination, patient referral, nurse practitioner, physician assistant
Reviews | 
J. Morgan Freiman, MD; Trang M. Tran, BA; Samuel G. Schumacher, MSc, PhD; Laura F. White, PhD; Stefano Ongarello, PhD; Jennifer Cohn, MD, MPH; Philippa J. Easterbrook, MD, MPH; Benjamin P. Linas, MD, MPH; and Claudia M. Denkinger, MD, PhD
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Background:Diagnosis of chronic hepatitis C virus (HCV) infection requires both a positive HCV antibody screen and confirmatory nucleic acid testing (NAT). Testing for hepatitis C virus core antigen (HCVcAg) is a potential alternative to NAT. Purpose:To evaluate the accuracy of diagnosis of active HCV infection among adults and children for 5 HCVcAg tests compared with NAT. Data Sources:EMBASE, PubMed, Web of Science, Scopus, and Cochrane Database of Systematic Reviews from 1990 through 31 March 2016. Study Selection:Case–control, cross-sectional, cohort, or randomized trials that compared any of 5 HCVcAg tests with an NAT reference standard. Data Extraction:2 independent reviewers extracted data and assessed quality using an adapted QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) tool. Data Synthesis:44 studies evaluated 5 index tests. Studies for the Abbott ARCHITECT HCV Ag assay had the highest quality, whereas those for the Ortho HCV Ag enzyme-linked immunosorbent assay (ELISA) had the lowest quality. From bivariate analyses, the sensitivity and specificity of the assays were as follows: Abbott ARCHITECT, 93.4% (95% CI, 90.1% to 96.4%) and 98.8% (CI, 97.4% to 99.5%); Ortho ELISA, 93.2% (CI, 81.6% to 97.7%) and 99.2% (CI, 87.9% to 100%); and Hunan Jynda Bioengineering Group HCV Ag ELISA, 59.5% (CI, 46.0% to 71.7%) and 82.9% (CI, 58.6% to 94.3%). Insufficient data were available for a meta-analysis about the Fujirebio Lumipulse Ortho HCV Ag and Eiken Lumispot HCV Ag assays. In 3 quantitative studies using Abbott ARCHITECT, HCVcAg correlated closely with HCV RNA levels greater than 3000 IU/mL. Limitations:Insufficient data were available on covariates, such as HIV or hepatitis B virus status, for subgroup analyses. Few studies reported genotypes of isolates, and data for genotypes 4, 5, and 6 were scant. Most studies were conducted in high-resource settings and reference laboratories. Conclusion:The HCVcAg assays with signal amplification have high sensitivity, high specificity, and good correlation with HCV RNA levels greater than 3000 IU/mL and have the potential to replace NAT in settings with high HCV prevalence. Primary Funding Source:National Institutes of Health.
Topics: enzyme-linked immunosorbent assay, hepatitis c, antigens, hepatitis c virus, nucleic acid amplification tests
In this issue, Mafi and colleagues seek insights on the role of nurse practitioners and physician assistants in the delivery of high-quality, cost-effective primary care, focusing on care of patients with upper respiratory infections, back pain, and headache. The editorialist is surprised that differences in low-value care did not differ between advanced practice clinicians and physicians. However, he believes that substantive questions remain on how to assure the ready availability of the deep clinical competencies required for correct diagnosis and management of patients who are, or prove to be, more medically complex.
Topics: primary health care, atrial premature complexes
Original Research | 
Kenneth Cusi, MD; Beverly Orsak, RN; Fernando Bril, MD; Romina Lomonaco, MD; Joan Hecht, RN; Carolina Ortiz-Lopez, MD; Fermin Tio, MD; Jean Hardies, PhD; Celia Darland, RD; Nicolas Musi, MD; Amy Webb, MD; and Paola Portillo-Sanchez, MD
Background:The metabolic defects of nonalcoholic steatohepatitis (NASH) and prediabetes or type 2 diabetes mellitus (T2DM) seem to be specifically targeted by pioglitazone. However, information about its long-term use in this population is limited. Objective:To determine the efficacy and safety of long-term pioglitazone treatment in patients with NASH and prediabetes or T2DM. Design:Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT00994682) Setting:University hospital. Participants:Patients (n = 101) with prediabetes or T2DM and biopsy-proven NASH were recruited from the general population and outpatient clinics. Intervention:All patients were prescribed a hypocaloric diet (500–kcal/d deficit from weight-maintaining caloric intake) and then randomly assigned to pioglitazone, 45 mg/d, or placebo for 18 months, followed by an 18-month open-label phase with pioglitazone treatment. Measurements:The primary outcome was a reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (in 2 histologic categories) without worsening of fibrosis. Secondary outcomes included other histologic outcomes, hepatic triglyceride content measured by magnetic resonance and proton spectroscopy, and metabolic parameters. Results:Among patients randomly assigned to pioglitazone, 58% achieved the primary outcome (treatment difference, 41 percentage points [95% CI, 23 to 59 percentage points]) and 51% had resolution of NASH (treatment difference, 32 percentage points [CI, 13 to 51 percentage points]) (P < 0.001 for each). Pioglitazone treatment also was associated with improvement in individual histologic scores, including the fibrosis score (treatment difference, −0.5 [CI, −0.9 to 0.0]; P = 0.039); reduced hepatic triglyceride content from 19% to 7% (treatment difference, −7 percentage points [CI, −10 to −4 percentage points]; P < 0.001); and improved adipose tissue, hepatic, and muscle insulin sensitivity (P < 0.001 vs. placebo for all). All 18-month metabolic and histologic improvements persisted over 36 months of therapy. The overall rate of adverse events did not differ between groups, although weight gain was greater with pioglitazone (2.5 kg vs. placebo). Limitation:Single-center study. Conclusion:Long-term pioglitazone treatment is safe and effective in patients with prediabetes or T2DM and NASH. Primary Funding Source:Burroughs Wellcome Fund and American Diabetes Association.
Topics: pioglitazone, diabetes mellitus, type 2, liver, steatohepatitis, non-alcoholic, prediabetes
In this issue, Cusi and colleagues present the results of a randomized trial that evaluated pioglitazone for the treatment of patients with nonalcoholic steatohepatitis (NASH) and type 2 diabetes. The editorialists note that NASH is associated with substantial morbidity and mortality, particularly in patients with diabetes. Yet, many patients are unable to achieve or sustain the amount of weight loss that has been shown to improve outcomes. The editorialists believe that pharmacologic therapies such as pioglitazone are welcome additions to the therapeutic armamentarium for NASH.
Topics: diabetes mellitus, pioglitazone, diabetes mellitus, type 2, steatohepatitis, non-alcoholic
Topics: pioglitazone, diabetes mellitus, type 2, steatohepatitis, non-alcoholic, prediabetes
Original Research | 
Torsten Dahlén, MD; Gustaf Edgren, MD, PhD; Mats Lambe, MD, PhD; Martin Höglund, MD, PhD; Magnus Björkholm, MD, PhD; Fredrik Sandin, MSc; Anders Själander, MD, PhD; Johan Richter, MD, PhD; Ulla Olsson-Strömberg, MD, PhD; Lotta Ohm, MD, PhD; Magnus Bäck, MD, PhD; Leif Stenke, MD, PhD, on behalf of the Swedish CML Group and the Swedish CML Register Group
Background:Tyrosine kinase inhibitors (TKIs) have increased survival dramatically for patients with chronic myeloid leukemia (CML), but continuous administration of these drugs may elicit long-term toxicity. Objective:To investigate the incidence of vascular events in patients with CML treated with first- and second-generation TKIs. Design:Retrospective cohort study using nationwide population-based registries. Setting:Sweden. Patients:All patients diagnosed with chronic-phase CML in Sweden from 2002 to 2012 and treated with a TKI, and 5 age- and sex-matched control individuals per patient. Measurements:Relative risks, expressed as incidence rate ratios comparing patients with control individuals, were calculated. Events per 1000 person-years were assessed in interdrug comparisons. Results:896 patients, 94.4% with documented TKI treatment, were followed for a median of 4.2 years. There were 54 arterial and 20 venous events in the CML cohort, corresponding to relative risks of 1.5 (95% CI, 1.1 to 2.1) and 2.0 (CI, 1.2 to 3.3), respectively. The event rate for myocardial infarction was higher in patients treated with nilotinib or dasatinib (29 and 19 per 1000 person-years, respectively) than in those receiving imatinib (8 per 1000 person-years), although data are limited and the CIs were wide and overlapped. Among 31 patients treated with a TKI who had myocardial infarction, 26 (84%) had at least 1 major cardiac risk factor diagnosed before the event occurred. Limitations:Patients may have been exposed to multiple TKIs. Data on second- and third-generation TKIs were limited. Conclusion:An increased risk for arterial and venous vascular events was seen in patients with CML treated with a TKI. Further study is needed to determine whether the risk for myocardial infarction increases with second-generation drugs. Primary Funding Source:No external funding.
Topics: leukemia, myelocytic, chronic, protein-tyrosine kinase inhibitor, cardiovascular event, adverse event, cardiovascular system, therapeutics
Original Research | 
Mark S. Lachs, MD, MPH; Jeanne A. Teresi, EdD, PhD; Mildred Ramirez, PhD; Kimberly van Haitsma, PhD; Stephanie Silver, MPH; Joseph P. Eimicke, MS; Gabriel Boratgis, MPH; Gail Sukha, BA; Jian Kong, MS; Alexandra M. Besas, RN; Maria Reyes Luna, AS; and Karl A. Pillemer, PhD
Includes: Supplemental Content
Background:Resident-to-resident elder mistreatment (R-REM) in nursing homes can cause physical and psychological injury and death, yet its prevalence remains unknown. Objective:To estimate the prevalence of physical, verbal, and sexual R-REM in nursing home residents and subgroups. Design:1-month observational prevalence study. Setting:5 urban and 5 suburban New York state nursing homes. Participants:2011 residents in 10 facilities randomly selected on the basis of size and location; 83% of facilities and 84% of eligible residents participated. Measurements:R-REM was identified through resident interviews, staff interviews, shift coupons, observation, chart review, and accident or incident reports. Results:407 of 2011 residents experienced at least 1 R-REM event; the total 1-month prevalence was 20.2% (95% CI, 18.1% to 22.5%). The most common forms were verbal (9.1% [CI, 7.7% to 10.8%]), other (such as invasion of privacy or menacing gestures) (5.3% [CI, 4.4% to 6.4%]), physical (5.2% [CI, 4.1% to 6.5%]), and sexual (0.6% [CI, 0.3% to 1.1%]). Several clinical and contextual factors (for example, lower versus severe levels of cognitive impairment, residing on a dementia unit, and higher nurse aide caseload) were associated with higher estimated rates of R-REM. Limitations:Most facilities were relatively large. All R-REM cases may not have been detected; resident and staff reporting may be subject to recall bias. Conclusion:R-REM in nursing homes is highly prevalent. Verbal R-REM is most common, but physical mistreatment also occurs frequently. Because R-REM can cause injury or death, strategies are urgently needed to better understand its causes so that prevention strategies can be developed. Primary Funding Source:National Institute on Aging.
Topics: internship and residency, nursing homes, medical residencies, elder abuse
Ideas and Opinions | 
Michael Klompas, MD, MPH; and Chanu Rhee, MD, MPH
In 2015, the Centers for Medicare & Medicaid Services began requiring hospitals to report their adherence to treatment bundles for patients with sepsis. The reporting rules are rigid and onerous and may not always reflect best clinical care for all patients. The authors of this article describe what they think might be done about the situation.
Topics: systemic infection, health care financing administration, septicemia, hospitals
Lachs and colleagues examine the prevalence and correlates of resident-to-resident elder mistreatment among 2011 residents in 10 New York state nursing homes from 2009 to 2013. The editorialist discusses the results of the study and calls for strategies to engage the collective efforts of federal and state government agencies, health care facilities, and social service and health professional organizations to better prevent, screen for, monitor, and manage elder abuse in nursing homes.
Topics: elder abuse, nursing homes, medical residencies, internship and residency
Research and Reporting Methods | 
Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS; Eugene Zheng, BA; Tony Tse, PhD; and Deborah A. Zarin, MD
Background:Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. Purpose:To validate results posted on ClinicalTrials.gov against publicly available U.S. Food and Drug Administration (FDA) reviews on Drugs@FDA. Data Sources:ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical and statistical reviews). Study Selection:100 parallel-group, randomized trials for new drug approvals (January 2013 to July 2014) with results posted on ClinicalTrials.gov (15 March 2015). Data Extraction:2 assessors extracted, and another verified, the trial design, primary and secondary outcomes, adverse events, and deaths. Results:Most trials were phase 3 (90%), double-blind (92%), and placebo-controlled (73%) and involved 32 drugs from 24 companies. Of 137 primary outcomes identified from ClinicalTrials.gov, 134 (98%) had corresponding data at Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results. Most differences were nominal (that is, relative difference <10%). Primary outcome results in 14 trials could not be validated. Of 1927 secondary outcomes from ClinicalTrials.gov, Drugs@FDA mentioned 1061 (55%) and included results data for 367 (19%). Of 96 trials with 1 or more serious adverse events in either source, 14 could be compared and 7 had discordant numbers of persons experiencing the adverse events. Of 62 trials with 1 or more deaths in either source, 25 could be compared and 17 were discordant. Limitation:Unknown generalizability to uncontrolled or crossover trial results. Conclusion:Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half the secondary outcomes, as well as serious events and deaths, could not be validated because Drugs@FDA includes only “key outcomes” for regulatory decision making and frequently includes only adverse event results aggregated across multiple trials. Primary Funding Source:National Library of Medicine.
Topics: drug approval, united states food and drug administration, adverse event, specimen collection
Letters | 
Katrice D. Cain, MA; Bindu R. Sehgal, MD; Kenneth E. Covinsky, MD, MPH; David C. Kaelber, MD, PhD, MPH; and Ashwini R. Sehgal, MD
Original Research | 
Ga Eun Park, MD; Jae-Hoon Ko, MD; Kyong Ran Peck, MD, PhD; Ji Yeon Lee, MD; Ji Yong Lee, MD; Sun Young Cho, MD; Young Eun Ha, MD; Cheol-In Kang, MD, PhD; Ji-Man Kang, MD; Yae-Jean Kim, MD, PhD; Hee Jae Huh, MD, PhD; Chang-Seok Ki, MD, PhD; Nam Yong Lee, MD, PhD; Jun Haeng Lee, MD, PhD; Ik Joon Jo, MD, PhD; Byeong-Ho Jeong, MD; Gee Young Suh, MD, PhD; Jinkyeong Park, MD; Chi Ryang Chung, MD, PhD; Jae-Hoon Song, MD, PhD; and Doo Ryeon Chung, MD, PhD
Background:In 2015, a large outbreak of Middle East respiratory syndrome (MERS) occurred in the Republic of Korea. Half of the cases were associated with a tertiary care university hospital. Objective:To document the outbreak and successful control measures. Design:Descriptive study. Setting:A 1950-bed tertiary care university hospital. Patients:92 patients with laboratory-confirmed MERS and 9793 exposed persons. Measurements:Description of the outbreak, including a timeline, and evaluation of the effectiveness of the control measures. Results:During the outbreak, 92 laboratory-confirmed MERS cases were associated with a large tertiary care hospital, 82 of which originated from unprotected exposure to 1 secondary patient. Contact tracing and monitoring exposed patients and assigned health care workers were at the core of the control measures in the outbreak. Nontargeted screening measures, including body temperature screening among employees and visitors at hospital gates, monitoring patients for MERS-related symptoms, chest radiographic screening, and employee symptom monitoring, did not detect additional patients with MERS without existing transmission links. All in-hospital transmissions originated from 3 patients with MERS who also had pneumonia and productive cough. Limitations:This was a retrospective single-center study. Statistical analysis could not be done. Because this MERS outbreak originated from a superspreader, effective control measures could differ in endemic areas or in other settings. Conclusion:Control strategies for MERS outbreaks should focus on tracing contacts of persons with epidemiologic links. Adjusting levels of quarantine and personal protective equipment according to the assumed infectivity of each patient with MERS may be appropriate. Primary Funding Source:Samsung Biomedical Research Institute.
Topics: hospitals, middle east respiratory syndrome, disease outbreaks, korea, infectious disease contact tracing, diagnostic radiologic examination
Original Research | 
Andrew Anglemyer, PhD; Matthew L. Miller, MS; Samuel Buttrey, PhD; and Lyn Whitaker, PhD
Background:Suicide prevention programs have become ubiquitous among military units; identifying temporal trends and nonclinical factors associated with the chosen suicide methods may help improve suicide prevention strategies. Objective:To calculate suicide rates of active duty military personnel and identify those who are at risk for firearm-specific suicide. Design:Retrospective cohort study. Setting:Military units in the United States. Patients:All active duty enlisted U.S. military personnel from 2005 to 2011. Measurements:Suicide rates per 100 000 were calculated for each branch. Adjusted odds ratios for firearm-specific suicide were calculated with 95% CIs. Results:1455 military personnel committed suicide from 2005 to 2011. From 2006 to 2011, the rates were highest among army personnel (19.13 to 29.44 cases per 100 000). Among suicides with a known cause of death, 62% were attributed to firearms. The results of this study also suggest that among army personnel or marines who committed suicide, those with infantry or special operations job classifications were more likely than those in noninfantry positions to use a firearm. Limitations:Results are generalizable only to enlisted personnel and reflect only stateside suicides. Data regarding previous psychiatric illness, deployment history, and firearms ownership were lacking. Conclusion:These results may help inform policymakers and advisors about differences in risks of suicide and violent suicide among the armed services and may help guide efforts to prevent self-harm within the military. Primary Funding Source:None.
Topics: military personnel, suicide, firearms
Reviews | 
Giuseppe Gargiulo, MD; Anna Sannino, MD; Davide Capodanno, MD, PhD; Marco Barbanti, MD; Sergio Buccheri, MD; Cinzia Perrino, MD, PhD; Piera Capranzano, MD; Ciro Indolfi, MD, PhD; Bruno Trimarco, MD; Corrado Tamburino, MD, PhD; and Giovanni Esposito, MD, PhD
Includes: Supplemental Content
Purpose:To compare clinical outcomes, including early (≤30-day) and midterm (≤1-year) mortality, in adults with severe aortic stenosis undergoing either transapical aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). Data Sources:MEDLINE, Cochrane, and Scopus databases (without language restrictions) from April 2002 to 5 April 2016; multiple registries and Web sites; scientific meeting presentations. Study Selection:Five randomized trials and 31 observational matched studies comparing mortality outcomes after TAVI or SAVR. Data Extraction:Two investigators independently extracted study data and rated risk of bias. Data Synthesis:A total of 16 638 patients were analyzed. Overall, there was no statistically significant difference between TAVI and SAVR in early (odds ratio [OR], 1.01 [95% CI, 0.81 to 1.26]) or midterm (OR, 0.96 [CI, 0.81 to 1.14]) all-cause mortality. Analyses restricted to trials (early: OR, 0.80 [CI, 0.51 to 1.25]; midterm: OR, 0.90 [CI, 0.64 to 1.26]) were inconclusive, with wide CIs, whereas analyses of matched studies were similar to the overall results. Transfemoral TAVI provided mortality benefits over SAVR in trials. Analyses restricted to studies of patients at low to intermediate risk showed statistically nonsignificant reductions in early (OR, 0.67 [CI, 0.42 to 1.07]) and midterm (OR, 0.91 [CI, 0.67 to 1.23]) mortality with TAVI. Incidence of periprocedural myocardial infarction, major bleeding, acute kidney injury, and new-onset atrial fibrillation was lower with TAVI, but risk for pacemaker implantation, vascular complications, and paravalvular leak increased. Overall, there was a statistically nonsignificant increased risk in long-term (2- to 5-year) all-cause mortality with TAVI (OR, 1.28 [CI, 0.97 to 1.69]), whereas long-term mortality outcomes in patients at low to intermediate risk were inconclusive, with wide CIs (OR, 1.06 [CI, 0.59 to 1.91]). Limitation:The number of trials was limited, and study designs and patient characteristics were heterogeneous. Conclusion:Compared with SAVR, TAVI may have similar or better early and midterm outcomes for adults with aortic stenosis, including those at low to intermediate risk. Primary Funding Source:None.
Topics: aortic valve replacement, transcatheter aortic-valve implantation
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