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Ideas and Opinions | 
Matthew S. Simon, MD; Don Weiss, MD, MPH; and Roy M. Gulick, MD, MPH
Since August 2010, 22 cases of invasive meningococcal disease among men who have sex with men (MSM) have been reported to the New York City Department of Health and Mental Hygiene (NYC DOHMH). In Los Angeles, 4 cases of IMD among MSM have been reported since December 2012. The NYC DOHMH is recommending meningococcal vaccination for all NYC MSM who are HIV-positive or HIV-negative and have engaged in intimate contact with a man met through an online Web site, digital application, or at a bar or party.
Topics: men who have sex with men
Original Research | 
Walid F. Gellad, MD, MPH; Julie M. Donohue, PhD; Xinhua Zhao, PhD; Maria K. Mor, PhD; Carolyn T. Thorpe, PhD, MPH; Jeremy Smith, MPH; Chester B. Good, MD, MPH; Michael J. Fine, MD, MSc; and Nancy E. Morden, MD, MPH
Background:Medicare Part D and the U.S. Department of Veterans Affairs (VA) use different approaches to manage prescription drug benefits, with implications for spending. Medicare relies on private plans with distinct formularies, whereas the VA administers its own benefit using a national formulary. Objective:To compare overall and regional rates of brand-name drug use among older adults with diabetes in Medicare and the VA. Design:Retrospective cohort. Setting:Medicare and the VA, 2008. Patients:1 061 095 Medicare Part D beneficiaries and 510 485 veterans aged 65 years or older with diabetes. Measurements:Percentage of patients taking oral hypoglycemics, statins, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) who filled brand-name drug prescriptions and percentage of patients taking long-acting insulins who filled analogue prescriptions. Sociodemographic- and health status–adjusted hospital referral region (HRR) brand-name drug use was compared, and changes in spending were calculated if brand-name drug use in 1 system mirrored the other. Results:Brand-name drug use in Medicare was 2 to 3 times that in the VA: 35.3% versus 12.7% for oral hypoglycemics, 50.7% versus 18.2% for statins, 42.5% versus 20.8% for ACE inhibitors or ARBs, and 75.1% versus 27.0% for insulin analogues. Adjusted HRR-level brand-name statin use ranged (from the 5th to 95th percentiles) from 41.0% to 58.3% in Medicare and 6.2% to 38.2% in the VA. For each drug group, the 95th-percentile HRR in the VA had lower brand-name drug use than the 5th-percentile HRR in Medicare. Medicare spending in this population would have been $1.4 billion less if brand-name drug use matched that of the VA. Limitation:This analysis cannot fully describe the factors underlying differences in brand-name drug use. Conclusion:Medicare beneficiaries with diabetes use 2 to 3 times more brand-name drugs than a comparable group within the VA, at substantial excess cost. Primary Funding Source:U.S. Department of Veterans Affairs, National Institutes of Health, and Robert Wood Johnson Foundation.
Topics: statins, diabetes mellitus, type 2, medicare, veterans, insulin, prescription drug, medicare part d
Clinical Guidelines | 
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force*
Description:Update of the child abuse and neglect portion of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for family and intimate partner violence. Methods:The USPSTF commissioned a systematic review on interventions to prevent child maltreatment for children at risk, focusing on new studies and evidence gaps that were unresolved at the time of the 2004 recommendation. Beneficial outcomes considered include reduced exposure to maltreatment and reduced harms to physical or mental health or mortality. Population:This recommendation applies to children in the general U.S. population from newborn to age 18 years who do not have signs or symptoms of maltreatment. Recommendation:The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. (I statement)
Topics: advisory committees, primary health care, child abuse, neglect, united states preventive services task force, prevention
Ideas and Opinions | 
Robert Cook-Deegan, MD
This commentary reviews the events leading towards the Supreme Court decision anticipated in June 2013 regarding Myriad Genetics patents on the BRCA1 and BRCA2 genes. The Supreme Court appears poised to judge that Myriad's claims reached too far, however, to secure exclusive rights on naturally occurring DNA sequences. If so, those developing molecular diagnostics will have to comport with a new rule for U.S. patent jurisprudence: Yes, complementary DNA (cDNA) can be patented, but not genomic DNA.
Topics: dna, dna, complementary, genetics, patents, molecule
Letters | 
Yuehua Ke, PhD, MD; Yufei Wang, PhD, MD; Wenyi Zhang, MD; Liuyu Huang, PhD; and Zeliang Chen, PhD, MD
Topics: china, avian influenza, viruses, influenza a virus, h7n9 subtype
Ideas and Opinions | 
Anne M. Stack, MD
A physician involved in the care of the youngest victims of the 2010 Haiti earthquake and those of the April 2013 Boston bombings reflects on the differences in outcomes following disaster that are possible when well trained first responders are available.
Topics: explosions, face, hospitals, inpatient, nurses, pediatrics, wounds and injuries, mass casualty setting
Reviews | 
Lois Donovan, MD; Lisa Hartling, PhD; Melanie Muise, MA; Alyssa Guthrie, MSSc; Ben Vandermeer, MSc; and Donna M. Dryden, PhD
Background:A 50-g oral glucose challenge test (OGCT) is a widely accepted screening test for gestational diabetes mellitus (GDM), but other options are being considered. Purpose:To systematically review the test characteristics of various screening methods for GDM across a range of recommended diagnostic glucose thresholds. Data Sources:15 electronic databases from 1995 to May 2012, reference lists, Web sites of relevant organizations, and gray literature. Study Selection:Two reviewers independently identified English-language prospective studies that compared any screening test for GDM with any reference standard. Data Extraction:One reviewer extracted and a second reviewer verified data from 51 cohort studies. Two reviewers independently assessed methodological quality. Data Synthesis:The sensitivity, specificity, and positive and negative likelihood ratios for the OGCT at a threshold of 7.8 mmol/L (140 mg/dL) were 70% to 88%, 69% to 89%, 2.6 to 6.5, and 0.16 to 0.33, respectively. At a threshold of 7.2 mmol/L (130 mg/dL), the test characteristics were 88% to 99%, 66% to 77%, 2.7 to 4.2, and 0.02 to 0.14, respectively. For a fasting plasma glucose threshold of 4.7 mmol/L (85 mg/dL), they were 87%, 52%, 1.8, and 0.25, respectively. Glycated hemoglobin level had poorer test characteristics than fasting plasma glucose level or the OGCT. No studies compared the OGCT with International Association of the Diabetes and Pregnancy Study Groups (IADPSG) diagnostic criteria. Limitations:The lack of a gold standard for confirming GDM limits comparisons. Few data exist for screening tests before 24 weeks' gestation. Conclusion:The OGCT and fasting plasma glucose level (at a threshold of 4.7 mmol/L [85 mg/dL]) by 24 weeks' gestation are good at identifying women who do not have GDM. The OGCT is better at identifying women who have GDM. The OGCT has not been validated for the IADPSG diagnostic criteria. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: gestational diabetes, advisory committees, screening test, prevention
Reviews | 
Lisa Hartling, PhD; Donna M. Dryden, PhD; Alyssa Guthrie, MSSc; Melanie Muise, MA; Ben Vandermeer, MSc; and Lois Donovan, MD
Background:Outcomes of treating gestational diabetes mellitus (GDM) are not well-established. Purpose:To summarize evidence about the maternal and neonatal benefits and harms of treating GDM. Data Sources:15 electronic databases from 1995 to May 2012, gray literature, Web sites of relevant organizations, trial registries, and reference lists. Study Selection:English-language randomized, controlled trials (n = 5) and cohort studies (n = 6) of women without known preexisting diabetes. Data Extraction:One reviewer extracted data, and a second reviewer verified them. Two reviewers independently assessed methodological quality and evaluated strength of evidence for primary outcomes by using a Grading of Recommendations Assessment, Development and Evaluation approach. Data Synthesis:All studies compared diet modification, glucose monitoring, and insulin as needed with no treatment. Women who were treated had more prenatal visits than those in control groups. Moderate evidence showed fewer cases of preeclampsia, shoulder dystocia, and macrosomia in the treated group. Evidence was insufficient for maternal weight gain and birth injury. Low evidence showed no difference between groups for neonatal hypoglycemia. Evidence was insufficient for long-term metabolic outcomes among offspring. No difference was found for cesarean delivery (low evidence), induction of labor (insufficient evidence), small-for-gestational-age neonates (moderate evidence), or admission to a neonatal intensive care unit (low evidence). Limitations:Evidence is low or insufficient for many outcomes of greatest clinical importance. The strongest evidence supports reductions in intermediate outcomes; however, other factors (for example, maternal weight and gestational weight gain) may impart greater risk than GDM, particularly when glucose levels are modestly elevated. Conclusion:Treating GDM results in less preeclampsia, shoulder dystocia, and macrosomia; however, current evidence does not show an effect on neonatal hypoglycemia or future poor metabolic outcomes. There is little evidence of short-term harm of treating GDM other than an increased demand for services. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: diabetes mellitus, type 2, glucose, gestational diabetes, advisory committees, mothers, united states national institutes of health, women, shoulder dystocia, prevention
Ideas and Opinions | 
Robert P. Kocher, MD; and Ezekiel J. Emanuel, MD, PhD
The Affordable Care Act made preliminary efforts to collect and disseminate data on health care price and quality in the United States. This commentary proposes that all data on price, utilization, and quality needs to be publicly available to achieve a health care system that delivers high value.
Topics: pregnancy, coronary artery bypass surgery, chronic obstructive airway disease, congestive heart failure, diabetes mellitus, type 2, community acquired pneumonia, decision making, fees and charges, government, health services, hospitalization, hospitals, laboratory techniques and procedures, medicare, organ transplantation, privacy, surgical procedures, operative, hip replacement arthroplasty, knee replacement arthroplasty, medical coding, health care systems, risk aversion, robotic prostatectomy, healthcare payer
Original Research | 
Mark S. Sulkowski, MD; Kenneth E. Sherman, MD, PhD; Douglas T. Dieterich, MD; Mohammad Bsharat, PhD; Lisa Mahnke, MD, PhD; Jürgen K. Rockstroh, MD; Shahin Gharakhanian, MD, DPH; Scott McCallister, MD; Joshua Henshaw, PhD; Pierre-Marie Girard, MD, PhD; Bambang Adiwijaya, PhD; Varun Garg, PhD; Raymond A. Rubin, MD; Nathalie Adda, MD; and Vincent Soriano, MD, PhD
Background:Telaprevir (TVR) plus peginterferon-α2a (PEG-IFN-α2a) and ribavirin substantially increases treatment efficacy for genotype 1 chronic hepatitis C virus (HCV) infection versus PEG-IFN-α2a–ribavirin alone. Its safety and efficacy in patients with HCV and HIV-1 are unknown. Objective:To assess the safety and efficacy of TVR plus PEG-IFN-α2a–ribavirin in patients with genotype 1 HCV and HIV-1 and evaluate pharmacokinetics of TVR and antiretrovirals during coadministration. Design:Phase 2a, randomized, double-blind, placebo-controlled study. (ClinicalTrials.gov: NCT00983853) Setting:16 international multicenter sites. Patients:62 patients with HCV genotype 1 and HIV-1 who were HCV treatment–naive and taking 0 or 1 of 2 antiretroviral regimens were randomly assigned to TVR plus PEG-IFN-α2a–ribavirin or placebo plus PEG-IFN-α2a–ribavirin for 12 weeks, plus 36 weeks of PEG-IFN-α2a–ribavirin. Measurements:HCV RNA concentrations. Results:Pruritus, headache, nausea, rash, and dizziness were higher with TVR plus PEG-IFN-α2a–ribavirin during the first 12 weeks. Serious adverse events occurred in 5% (2 in 38) of those receiving TVR plus PEG-IFN-α2a–ribavirin and 0% (0 in 22) of those receiving placebo plus PEG-IFN-α2a–ribavirin; the same number in both groups discontinued treatment due to adverse events. Sustained virologic response occurred in 74% (28 in 38) of patients receiving TVR plus PEG-IFN-α2a–ribavirin and 45% (10 in 22) of patients receiving placebo plus PEG-IFN-α2a–ribavirin. Rapid HCV suppression was seen with TVR plus PEG-IFN-α2a–ribavirin (68% [26 in 38 patients] vs. 0% [0 in 22 patients] undetectable HCV RNA levels by week 4). Two patients had on-treatment HCV breakthrough with TVR-resistant variants. Patients treated with antiretroviral drugs had no HIV breakthroughs; antiretroviral exposure was not substantially modified by TVR. Limitation:Small sample size and appreciable dropout rate. Conclusion:In patients with HCV and HIV-1, more adverse events occurred with TVR versus placebo plus PEG-IFN-α2a–ribavirin; these were similar in nature and severity to those in patients with HCV treated with TVR. With or without concomitant antiretrovirals, sustained virologic response rates were higher in patients treated with TVR versus placebo plus PEG-IFN-α2a–ribavirin. Primary Funding Source:Vertex Pharmaceuticals and Janssen Pharmaceuticals.
Topics: hiv, hepatitis c, chronic, hepatitis c rna, combined modality therapy, genotype, ribavirin, infection, viruses, hepatitis c virus, anti-retroviral agents, telaprevir
Ideas and Opinions | 
Allen Frances, MD
The American Psychiatric Association has released the long-awaited fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This commentary notes that the DSM-5 “introduced several high-prevalence diagnoses at the fuzzy boundary with normality” and recommends that “physicians … use the DSM-5 cautiously, if at all.”
Topics: diagnosis, psychiatric
Topics: alcohol abuse, advisory committees, behavior therapy, prevention
Clinical Guidelines | 
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force*
Description:Update of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening and behavioral counseling interventions in primary care to reduce alcohol misuse. Methods:The USPSTF reviewed new evidence on the effectiveness of screening for alcohol misuse for improving health outcomes, the accuracy of various screening approaches, the effectiveness of various behavioral counseling interventions for improving intermediate or long-term health outcomes, the harms of screening and behavioral counseling interventions, and influences from the health care system that promote or detract from effective screening and counseling interventions for alcohol misuse. Population:These recommendations apply to adolescents aged 12 to 17 years and adults aged 18 years or older. These recommendations do not apply to persons who are actively seeking evaluation or treatment for alcohol misuse. Recommendation:The USPSTF recommends that clinicians screen adults aged 18 years or older for alcohol misuse and provide persons engaged in risky or hazardous drinking with brief behavioral counseling interventions to reduce alcohol misuse. (Grade B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening and behavioral counseling interventions in primary care settings to reduce alcohol misuse in adolescents. (I statement)
Topics: alcohol abuse, advisory committees, behavior therapy, primary health care, united states preventive services task force, prevention
Ideas and Opinions | 
Andrew T. Pavia, MD
On 31 March 2013, Chinese public health authorities notified the World Health Organization of the isolation of influenza A(H7N9) virus from 3 critically ill adults. This avian influenza virus had never before been detected in humans, and its association with severe disease shocked experts. This commentary asks whether we should be concerned and whether we are fully prepared for a pandemic.
Topics: anxiety, influenza, influenzavirus a, influenza a virus, h7n9 subtype
Editorials | 
Moupali Das, MD, MPH; and Paul Volberding, MD
The updated U.S. Preventive Services Task Force recommendations converge with those from the Centers for Disease Control and Prevention. The editorialists comment on the Task Force recommendations and see them as informing the roadmap to the elusive end to AIDS.
Topics: vision, hiv screen, consensus
Clinical Guidelines | 
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force*
Includes: Supplemental Content
Description:Update of the 2005 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for HIV. Methods:The USPSTF reviewed new evidence on the effectiveness of treatments in HIV-infected persons with CD4 counts greater than 0.200 × 109 cells/L; effects of screening, counseling, and antiretroviral therapy (ART) use on risky behaviors and HIV transmission risk; and long-term cardiovascular harms of ART. Population:These recommendations apply to adolescents, adults, and pregnant women. Recommendation:The USPSTF recommends that clinicians screen adolescents and adults aged 15 to 65 years for HIV infection. Younger adolescents and older adults who are at increased risk should also be screened. (Grade A recommendation) The USPSTF recommends that clinicians screen all pregnant women for HIV, including those who present in labor who are untested and whose HIV status is unknown. (Grade A recommendation)
Topics: hiv, advisory committees, cd4 count determination procedure, hiv seropositivity, hiv infection, hiv screen, united states preventive services task force, prevention
Topics: advisory committees, hiv screen, prevention
Ideas and Opinions | 
Alasdair Conn, MD
We thought it would be a normal Marathon Monday at Massachusetts General Hospital. The Boston Marathon is always held on the third Monday in April and is a public holiday—Patriots Day. The hospital normally expects to receive about 15 to 20 marathon runners with hyponatremia and dehydration, many more are treated at the medical tents along the route of the marathon. For many this is a day that Bostonians look forward to as the unofficial start of spring.
Topics: dehydration, disasters, explosions, hospitals, operating room, disasters and emergency preparedness
Ideas and Opinions | 
Deborah Cotton, MD, MPH, Deputy Editor
The Boston health care war had really stepped up at the end of winter. The hospitals were competing furiously for us to be their patients. Their ads boasted: “Individual Care/Global Impact,” “Human First,” “Exceptional Care Without Exception.” They told us we should choose them because they were big, because they were small, because they alone could transplant faces, because they knew our neighborhoods, because they performed true miracles every day. And then it was a Perfect Spring Day and the Marathon was in full swing. Many of the runners were nurses. Many of the runners were doctors. Many were EMTs and health policy experts and insurance executives and legislators and some were even hospital CEOs. When the finish line exploded, the nurses and doctors and EMTs all ran to help and we could not tell them apart if we tried.
Topics: care of intensive care unit patient, health policy, hospitals, insurance carriers, nurses, money
Updates | 
Atul Deodhar, MD
This Update summarizes studies published in 2012 that the authors consider highly relevant to the practice of rheumatology. Topics include treatment of rheumatologic disease, pharmacoepidemiology, diagnostic testing, and new practice guidelines.
Topics: arthritis, gout, anti-inflammatory agents, non-steroidal, rheumatology, infection, guidelines, rituximab
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