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Topics: advisory committees, primary health care, drug usage, united states preventive services task force, prevention
Reviews | 
Carrie D. Patnode, PhD, MPH; Elizabeth O'Connor, PhD; Maya Rowland, MPH; Brittany U. Burda, MPH; Leslie A. Perdue, MPH; and Evelyn P. Whitlock, MD, MPH
Background:Drug use among youths is associated with negative health and social consequences. Even infrequent use increases the risk for serious adverse events by increasing risk-taking behaviors in intoxicated or impaired persons. Purpose:To systematically review the benefits and harms of primary care–relevant interventions designed to prevent or reduce illicit drug use or the nonmedical use of prescription drugs among youths. Data Sources:PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through 4 June 2013; MEDLINE through 31 August 2013; and manual searches of reference lists and gray literature. Study Selection:Two investigators independently reviewed 2253 abstracts and 144 full-text articles. English-language trials of primary care–relevant behavioral interventions that reported drug use, health outcomes, or harms were included. Data Extraction:One investigator abstracted data from good- and fair-quality trials into prespecified evidence tables, and a second investigator checked these data. Data Synthesis:Six trials were included, 4 of which examined the effect of the intervention on a health or social outcome. One trial found no effect of the intervention on marijuana-related consequences or driving under the influence of marijuana; 3 trials generally found no reduction in depressed mood at 12 or 24 months. Four of the 5 trials assessing self-reported marijuana use found statistically significant differences favoring the intervention group participants (such as a between-group difference of 0.10 to 0.17 use occasions in the past month). Three trials also reported positive outcomes in nonmedical prescription drug use occasions. Limitations:The body of evidence was small, and there were heterogeneous measures of outcomes of limited clinical applicability. Trials primarily included adolescents with little or no substance use. Conclusion:Evidence is inadequate on the benefits of primary care–relevant behavioral interventions in reducing self-reported illicit and pharmaceutical drug use among adolescents. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: drug abuse, behavior therapy, primary health care, prevention, pharmacy (field), advisory committees, drug usage, computers
Reviews | 
Jennifer S. Lin, MD, MCR; Elizabeth O'Connor, PhD; Rebecca C. Rossom, MD, MCR; Leslie A. Perdue, MPH; and Elizabeth Eckstrom, MD, MPH
Includes: Supplemental Content
Background:Earlier identification of cognitive impairment may reduce patient and caregiver morbidity. Purpose:To systematically review the diagnostic accuracy of brief cognitive screening instruments and the benefits and harms of pharmacologic and nonpharmacologic interventions for early cognitive impairment. Data Sources:MEDLINE, PsycINFO, and the Cochrane Central Register of Controlled Trials through December 2012; systematic reviews; clinical trial registries; and experts. Study Selection:English-language studies of fair to good quality, primary care–feasible screening instruments, and treatments aimed at persons with mild cognitive impairment or mild to moderate dementia. Data Extraction:Dual quality assessment and abstraction of relevant study details. Data Synthesis:The Mini-Mental State Examination (k = 25) is the most thoroughly studied instrument but is not available for use without cost. Publicly available instruments with adequate test performance to detect dementia include the Clock Drawing Test (k = 7), Mini-Cog (k = 4), Memory Impairment Screen (k = 5), Abbreviated Mental Test (k = 4), Short Portable Mental Status Questionnaire (k = 4), Free and Cued Selective Reminding Test (k = 2), 7-Minute Screen (k = 2), and Informant Questionnaire on Cognitive Decline in the Elderly (k = 5). Medications approved by the U.S. Food and Drug Administration for Alzheimer disease (k = 58) and caregiver interventions (k = 59) show a small benefit of uncertain clinical importance for patients and their caregivers. Small benefits are also limited by common adverse effects of acetylcholinesterase inhibitors and limited availability of complex caregiver interventions. Although promising, cognitive stimulation (k = 6) and exercise (k = 10) have limited evidence to support their use in persons with mild to moderate dementia or mild cognitive impairment. Limitation:Limited studies in persons with dementia other than Alzheimer disease and sparse reporting of important health outcomes. Conclusion:Brief instruments to screen for cognitive impairment can adequately detect dementia, but there is no empirical evidence that screening improves decision making. Whether interventions for patients or their caregivers have a clinically significant effect in persons with earlier detected cognitive impairment is still unclear. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: caregiver, diagnosis, cognitive impairment, elderly, minimal cognitive impairment, dementia, prevention, advisory committees, cognitive ability
Clinical Guidelines | 
Amir Qaseem, MD, PhD, MHA; Jon-Erik C. Holty, MD, MS; Douglas K. Owens, MD, MS; Paul Dallas, MD; Melissa Starkey, PhD; Paul Shekelle, MD, PhD, for the Clinical Guidelines Committee of the American College of Physicians
Description: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the management of obstructive sleep apnea (OSA) in adults. Methods: This guideline is based on published literature from 1966 to September 2010 that was identified by using MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews. A supplemental MEDLINE search identified additional articles through October 2012. Searches were limited to English-language publications. The clinical outcomes evaluated for this guideline included cardiovascular disease (such as heart failure, hypertension, stroke, and myocardial infarction), type 2 diabetes, death, sleep study measures (such as the Apnea–Hypopnea Index), measures of cardiovascular status (such as blood pressure), measures of diabetes status (such as hemoglobin A1c levels), and quality of life. This guideline grades the evidence and recommendations using ACP's clinical practice guidelines grading system. Recommendation 1:ACP recommends that all overweight and obese patients diagnosed with OSA should be encouraged to lose weight. (Grade: strong recommendation; low-quality evidence) Recommendation 2:ACP recommends continuous positive airway pressure treatment as initial therapy for patients diagnosed with OSA. (Grade: strong recommendation; moderate-quality evidence) Recommendation 3:ACP recommends mandibular advancement devices as an alternative therapy to continuous positive airway pressure treatment for patients diagnosed with OSA who prefer mandibular advancement devices or for those with adverse effects associated with continuous positive airway pressure treatment. (Grade: weak recommendation; low-quality evidence)
Topics: continuous positive airway pressure
Clinical Guidelines | 
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force*
Description:Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation on the use of medications for breast cancer risk reduction. Methods:The USPSTF reviewed evidence on the effectiveness, adverse effects, and subgroup variations of medications to reduce the risk for breast cancer—specifically, the selective estrogen receptor modulators tamoxifen and raloxifene. The USPSTF also reviewed a meta-analysis of placebo-controlled trials to understand the relative benefits and harms of tamoxifen and raloxifene. Population:This recommendation applies to asymptomatic women aged 35 years or older without a prior diagnosis of breast cancer, ductal carcinoma in situ, or lobular carcinoma in situ. Recommendation:The USPSTF recommends that clinicians engage in shared, informed decision making with women who are at increased risk for breast cancer about medications to reduce their risk. For women who are at increased risk for breast cancer and at low risk for adverse medication effects, clinicians should offer to prescribe risk-reducing medications, such as tamoxifen or raloxifene. (B recommendation) The USPSTF recommends against the routine use of medications, such as tamoxifen or raloxifene, for risk reduction of primary breast cancer in women who are not at increased risk for breast cancer. (D recommendation)
Topics: raloxifene, tamoxifen, women, breast cancer, risk reduction, united states preventive services task force, breast cancer risk, prevention
Original Research | 
Katherine A. Moon, MPH; Eliseo Guallar, MD, DrPH; Jason G. Umans, MD, PhD; Richard B. Devereux, MD; Lyle G. Best, MD; Kevin A. Francesconi, PhD; Walter Goessler, PhD; Jonathan Pollak, MPP; Ellen K. Silbergeld, PhD; Barbara V. Howard, PhD; and Ana Navas-Acien, MD, PhD
Includes: Supplemental Content
Background:Long-term exposure to high levels of arsenic is associated with increased risk for cardiovascular disease, whereas risk from long-term exposure to low to moderate arsenic levels (<100 µg/L in drinking water) is unclear. Objective:To evaluate the association between long-term exposure to low to moderate arsenic levels and incident cardiovascular disease. Design:Prospective cohort study. Setting:The Strong Heart Study baseline visit between 1989 and 1991, with follow-up through 2008. Patients:3575 American Indian men and women aged 45 to 74 years living in Arizona, Oklahoma, and North and South Dakota. Measurements:The sum of inorganic and methylated arsenic species in urine at baseline was used as a biomarker of long-term arsenic exposure. Outcomes were incident fatal and nonfatal cardiovascular disease. Results:A total of 1184 participants developed fatal and nonfatal cardiovascular disease. When the highest- and lowest-quartile arsenic concentrations (>15.7 vs. <5.8 µg/g creatinine) were compared, the hazard ratios for cardiovascular disease, coronary heart disease, and stroke mortality after adjustment for sociodemographic factors, smoking, body mass index, and lipid levels were 1.65 (95% CI, 1.20 to 2.27; P for trend < 0.001), 1.71 (CI, 1.19 to 2.44; P for trend < 0.001), and 3.03 (CI, 1.08 to 8.50; P for trend = 0.061), respectively. The corresponding hazard ratios for incident cardiovascular disease, coronary heart disease, and stroke were 1.32 (CI, 1.09 to 1.59; P for trend = 0.002), 1.30 (CI, 1.04 to 1.62; P for trend = 0.006), and 1.47 (CI, 0.97 to 2.21; P for trend = 0.032), respectively. These associations varied by study region and were attenuated after further adjustment for diabetes, hypertension, and kidney disease measures. Limitations:Direct measurement of individual arsenic levels in drinking water was unavailable. Conclusion:Long-term exposure to low to moderate arsenic levels was associated with cardiovascular disease incidence and mortality. Primary Funding Source:National Heart, Lung, and Blood Institute and National Institute of Environmental Health Sciences.
Topics: cardiovascular diseases, arsenic, urinary tract
Editorials | 
Yu Chen, PhD; and Margaret R. Karagas, PhD
In this issue, Moon and colleagues report results from the Strong Heart Study, documenting an association between urinary arsenic levels and cardiovascular disease. The editorialists discuss the study and pose questions about the effect of this common exposure not only from water but from foods, such as grains, and about populations in which arsenic exposure presents the highest risks.
Topics: cardiovascular diseases, arsenic
Ideas and Opinions | 
Erik W. Gunderson, MD
Synthetic cannabinoid use has increased in the United States, and the consequences are dangerous. This commentary discusses the difficulties associated with regulating its use and the need for research to aid efforts to slow the trend.
Topics: cannabinoid, designer drugs
Ideas and Opinions | 
Miguel A. Hernán, MD; Sonia Hernández-Díaz, MD; and James M. Robins, MD
Authors of this commentary posit that randomized trials with long follow-up duration are similar to observational studies and that “intention-to-treat” analysis of such studies may be inadequate. They instead propose use of g-methods to adjust for postrandomization confounding and selection bias in trials.
Topics: hormone replacement therapy, follow-up, endocrine therapy, intention to treat, prevention, zidovudine, breast cancer, pneumonia, pneumocystis carinii, prognostic factors, progestins, therapeutics, estrogen, toxic effect
Ideas and Opinions | 
Michael B. Steinberg, MD, MPH; and Cristine D. Delnevo, PhD, MPH
Tobacco use remains the leading cause of preventable death in the United States, and the goal of comprehensive tobacco control is to reduce its harm to society. A critical aspect of tobacco control is to prevent young people from ever becoming smokers. Toward this aim, New York City has proposed to increase the legal age of sale for tobacco products from 18 to 21 years. This commentary discusses this proposal and other efforts to reduce smoking among young people.
Topics: smoking, tobacco
Clinical Guidelines | 
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force†
Includes: Supplemental Content
Description:Update of the 2003 U.S. Preventive Services Task Force (USPSTF) recommendation on primary care interventions to prevent tobacco use in children and adolescents. Methods:The USPSTF reviewed the evidence on the effectiveness of primary care interventions on the rates of initiation or cessation of tobacco use in children and adolescents and on health outcomes, such as respiratory health, dental and oral health, and adult smoking. The USPSTF also reviewed the evidence on the potential harms of these interventions. Population:This recommendation applies to school-aged children and adolescents. The USPSTF has issued a separate recommendation statement on tobacco use counseling in adults and pregnant women. Recommendation:The USPSTF recommends that primary care clinicians provide interventions, including education or brief counseling, to prevent initiation of tobacco use in school-aged children and adolescents.
Topics: smoking, advisory committees, primary health care, tobacco use, prevention, united states preventive services task force
Topics: advisory committees, primary health care, tobacco use, prevention
Ideas and Opinions | 
Jeremy Sugarman, MD, MPH, MA
Mounting evidence is fueling excitement over the possibility of curing HIV infection. Research aimed at eliminating the need for continuous antiretroviral therapy includes approaches ranging from bone marrow transplantation, to aggressive early treatment of HIV infection, to withdrawal of antiretroviral therapy to permit the killing of HIV in biological reservoirs. This commentary discusses the complex ethical issues associated with such research.
Topics: hiv, ethics
Clinical Guidelines | 
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force*
Includes: Supplemental Content
Description:Update of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for glaucoma. Methods:The USPSTF reviewed evidence on the benefits and harms of screening for glaucoma and of medical and surgical treatment of early glaucoma. Beneficial outcomes of interest included improved vision-related quality of life and reduced progression of early asymptomatic glaucoma to vision-related impairment. The USPSTF also considered evidence on the accuracy of glaucoma screening tests. Population:This recommendation applies to adults who do not have vision symptoms and are seen in a primary care setting. Recommendation:The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for primary open-angle glaucoma in adults. (I statement)
Topics: glaucoma, prevention, united states preventive services task force, advisory committees
Topics: glaucoma, advisory committees, prevention
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: diabetes mellitus, type 2, medicare, veterans, prescription drug, medicare part d, statins, insulin
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, patents, molecule, dna, complementary, genetics
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: combined modality therapy, genotype, ribavirin, infection, viruses, hepatitis c virus, anti-retroviral agents, telaprevir, hiv, hepatitis c, chronic, hepatitis c rna
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
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