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Clinical Guidelines | 
Amir Qaseem, MD, PhD, MHA; Devan Kansagara, MD, MCR; Mary Ann Forciea, MD; Molly Cooke, MD; Thomas D. Denberg, 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 chronic insomnia disorder in adults. Methods:This guideline is based on a systematic review of randomized, controlled trials published in English from 2004 through September 2015. Evaluated outcomes included global outcomes assessed by questionnaires, patient-reported sleep outcomes, and harms. The target audience for this guideline includes all clinicians, and the target patient population includes adults with chronic insomnia disorder. This guideline grades the evidence and recommendations by using the ACP grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Recommendation 1:ACP recommends that all adult patients receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia disorder. (Grade: strong recommendation, moderate-quality evidence) Recommendation 2:ACP recommends that clinicians use a shared decision-making approach, including a discussion of the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia disorder in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (Grade: weak recommendation, low-quality evidence)
Topics: pharmacotherapy, insomnia, chronic, insomnia, american college of physicians, sleep, elderly, clinical practice guideline
This issue includes systematic reviews on pharmacologic and psychological therapies to accompany new clinical practice guidelines for treatment of chronic insomnia from the American College of Physicians (ACP). The ACP recommends cognitive behavioral therapy for insomnia as first-line treatment. The editorialists discuss the barriers to its implementation in primary care.
Topics: insomnia, chronic, cognitive-behavioral therapy, insomnia
Reviews | 
Michelle Brasure, PhD, MSPH, MLIS; Erika Fuchs, MPH, PhD; Roderick MacDonald, MS; Victoria A. Nelson, MSc; Erin Koffel, PhD; Carin M. Olson, MD, MS; Imran S. Khawaja, MD; Susan Diem, MD, MPH; Maureen Carlyle, MPH; Timothy J. Wilt, MD, MPH; Jeannine Ouellette; Mary Butler, PhD; and Robert L. Kane, MD
Includes: Supplemental Content
Background:Psychological and behavioral interventions are frequently used for insomnia disorder. Purpose:To assess benefits and harms of psychological and behavioral interventions for insomnia disorder in adults. Data Sources:Ovid MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and PsycINFO through September 2015, supplemented with hand searching. Study Selection:Randomized, controlled trials of psychological or behavioral interventions that were published in English and enrolled adults with insomnia disorder lasting 4 or more weeks. Data Extraction:Data extraction by single investigator confirmed by a second reviewer; dual investigator assessment of risk of bias; consensus determination of strength of evidence. Data Synthesis:Sixty trials with low to moderate risk of bias compared psychological and behavioral interventions with inactive controls or other psychological and behavioral interventions. Cognitive behavioral therapy for insomnia (CBT-I) improved posttreatment global and most sleep outcomes, often compared with information or waitlist controls (moderate-strength evidence). Use of CBT-I improved several sleep outcomes in older adults (low- to moderate-strength evidence). Multicomponent behavioral therapy improved several sleep outcomes in older adults (low- to moderate-strength evidence). Stimulus control improved 1 or 2 sleep outcomes (low-strength evidence). Evidence for other comparisons and for harms was insufficient to permit conclusions. Limitations:A wide variety of comparisons limited the ability to pool data. Trials did not always report global outcomes and infrequently conducted remitter or responder analysis. Comparisons were often information or waitlist groups, and publication bias was possible. Conclusion:Use of CBT-I improves most outcomes compared with inactive controls. Multicomponent behavioral therapy and stimulus control may improve some sleep outcomes. Evidence on other outcomes, comparisons, and long-term efficacy were limited. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: behavior therapy, cognitive-behavioral therapy, sleep, insomnia, american college of physicians, clinical practice guideline, elderly
Topics: insomnia, chronic, insomnia, clinical practice guideline, american college of physicians, therapeutics
Original Research | 
Isuru Ranasinghe, MBChB, MMed, PhD; Craig S. Parzynski, MS; James V. Freeman, MD, MPH; Rachel P. Dreyer, PhD; Joseph S. Ross, MD, MHS; Joseph G. Akar, MD, PhD; Harlan M. Krumholz, MD, MS; and Jeptha P. Curtis, MD
Background:Long-term nonfatal outcomes after implantable cardioverter-defibrillator (ICD) placement are poorly defined. Objective:To determine the long-term risk for ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications, and to assess associated patient and device characteristics. Design:Observational cohort study of ICD implantations from the National Cardiovascular Data Registry ICD registry linked with Medicare fee-for-service claims data. Setting:1437 U.S. hospitals. Patients:114 484 patients aged 65 years or older (mean, 74.8 years [SD, 6.2]; 72.4% male) receiving an ICD for the first time from 2006 to 2010 (single-chamber, 19.8%; dual-chamber, 41.3%; cardiac resynchronization therapy with a defibrillator [CRT-D], 38.9%). Measurements:Rate and cumulative incidence of ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications. Results:During a median follow-up of 2.7 years (interquartile range, 1.8 to 3.9 years), 40 072 patients died, representing 12.6 (95% CI, 12.5 to 12.7) deaths per 100 patient-years of follow-up. When the risk for death was accounted for, there were 6.1 (CI, 6.0 to 6.2) ICD-related complications per 100 patient-years that required reoperation or hospitalization and 3.9 (CI, 3.8 to 4.0) reoperations per 100 patient-years for reasons other than complications. Overall, 10 patients had complications or reoperation per 100 patient-years of follow-up. Younger age at implantation (65 to 69 vs. >85 years) (hazard ratio [HR], 1.55 [CI, 1.43 to 1.69]), receipt of a CRT-D device (HR, 1.38 [CI, 1.31 to 1.45]) versus a single-chamber device, female sex (HR, 1.16 [CI, 1.12 to 1.21]), and black race (HR, 1.14 [CI, 1.05 to 1.23]) were associated with the greatest increased risks for ICD-related complications. Limitation:The analysis was limited to Medicare fee-for-service patients aged 65 years or older. Conclusion:Patients have a high rate of device-related complications and reoperation for other causes after ICD implantation. Risks of ICD implantation and strategies to reduce them should be actively considered before implantation. Primary Funding Source:American College of Cardiology Foundation's National Cardiovascular Data Registry.
Topics: implantable defibrillators, repeat surgery, implantable defibrillator insertion
Position Papers | 
Renee Butkus, BA; Susan Lane, MD; Alwin F. Steinmann, MD; Kelly J. Caverzagie, MD; Thomas G. Tape, MD; Susan T. Hingle, MD; Darilyn V. Moyer, MD, and the Alliance for Academic Internal Medicine and American College of Physicians Graduate Medical Education Task Forces, for the Health and Public Policy Committee of the American College of Physicians
In this position paper, the Alliance for Academic Internal Medicine and the American College of Physicians examine the state of graduate medical education (GME) financing in the United States and recent proposals to reform GME funding. They make a series of recommendations to reform the current funding system to better align GME with the needs of the nation's health care workforce. These recommendations include using Medicare GME funds to meet policy goals and to ensure an adequate supply of physicians, a proper specialty mix, and appropriate training sites; spreading the costs of financing GME across the health care system; evaluating the true cost of training a resident and establishing a single per-resident amount; increasing transparency and innovation; and ensuring that primary care residents receive training in well-functioning ambulatory settings that are financially supported for their training roles.
Topics: education, medical, graduate, internship and residency
Reviews | 
Kathryn B. Anderson, MD, PhD; Stephen J. Thomas, MD; and Timothy P. Endy, MD, MPH
Zika virus (ZIKV) is yet another arbovirus that is rapidly emerging on a global scale, on the heels of a chikungunya epidemic in the Americas that began in 2013. A ZIKV epidemic that began in Brazil in 2015 has now spread rapidly to more than 30 countries in the Americas and the Caribbean, infecting more than 2 million inhabitants. This epidemic currently continues unabated. The explosive nature of recent outbreaks and concerning links to Guillain–Barré syndrome and microcephaly are incompletely understood. Also unknown is the relative importance of sexual transmission of ZIKV and asymptomatic ZIKV infections to the overall burden of transmission. The limited understanding of ZIKV presents an enormous challenge for responses to this rapidly emerging threat to human health. This article reviews the existing literature on ZIKV and proposes critical questions for vaccine development and other areas of needed research.
Topics: microcephaly, epidemic, narrative review, zika virus, vaccine development, viruses, dengue fever, americas
Original Research | 
Cora L. Bernard, MS; Margaret L. Brandeau, PhD; Keith Humphreys, PhD; Eran Bendavid, MD, MS; Mark Holodniy, MD; Christopher Weyant, MS; Douglas K. Owens, MD, MS; and Jeremy D. Goldhaber-Fiebert, PhD
Includes: Supplemental Content
Background:The total population health benefits and costs of HIV preexposure prophylaxis (PrEP) for people who inject drugs (PWID) in the United States are unclear. Objective:To evaluate the cost-effectiveness and optimal delivery conditions of PrEP for PWID. Design:Empirically calibrated dynamic compartmental model. Data Sources:Published literature and expert opinion. Target Population:Adult U.S. PWID. Time Horizon:20 years and lifetime. Intervention:PrEP alone, PrEP with frequent screening (PrEP+screen), and PrEP+screen with enhanced provision of antiretroviral therapy (ART) for individuals who become infected (PrEP+screen+ART). All scenarios are considered at 25% coverage. Outcome Measures:Infections averted, deaths averted, change in HIV prevalence, discounted costs (in 2015 U.S. dollars), discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Results of Base-Case Analysis:PrEP+screen+ART dominates other strategies, averting 26 700 infections and reducing HIV prevalence among PWID by 14% compared with the status quo. Achieving these benefits costs $253 000/QALY gained. At current drug prices, total expenditures for PrEP+screen+ART could be as high as $44 billion over 20 years. Results of Sensitivity Analysis:Cost-effectiveness of the intervention is linear in the annual cost of PrEP and is dependent on PrEP drug adherence, individual transmission risks, and community HIV prevalence. Limitations:Data on risk stratification and achievable PrEP efficacy levels for U.S. PWID are limited. Conclusion:PrEP with frequent screening and prompt treatment for those who become infected can reduce HIV burden among PWID and provide health benefits for the entire U.S. population, but, at current drug prices, it remains an expensive intervention both in absolute terms and in cost per QALY gained. Primary Funding Source:Grant R01-DA15612 from the National Institute on Drug Abuse.
Topics: hiv, cost effectiveness, pre-exposure prophylaxis
Reviews | 
Nancy Greer, PhD; Jennifer Bolduc, PharmD; Eric Geurkink, PharmD; Thomas Rector, PhD, PharmD; Kimberly Olson, MD; Eva Koeller, BA; Roderick MacDonald, MS; and Timothy J. Wilt, MD, MPH
Includes: Supplemental Content
Background:Increased involvement of pharmacists in patient care may increase access to health care and improve patient outcomes. Purpose:To determine the effectiveness and harms of pharmacist-led chronic disease management for community-dwelling adults. Data Sources:MEDLINE, Cochrane Library, CINAHL, and International Pharmaceutical Abstracts from 1995 through February 2016, and reference lists of systematic reviews and included studies. Study Selection:65 patient populations in 63 studies conducted in the United States and of any design reported outcomes of pharmacist-led chronic disease management versus a comparator for community-dwelling adults in the United States. Studies set in retail pharmacies were excluded. Data Extraction:Data extraction done by a single investigator was confirmed by a second investigator; risk of bias was assessed by 2 investigators; and strength of evidence was determined by consensus. Data Synthesis:Pharmacist-led care was associated with similar numbers of office visits, urgent care or emergency department visits, and hospitalizations (moderate-strength evidence) and medication adherence (low-strength evidence) compared with usual care (typically continuing a prestudy visit schedule). Pharmacist-led care increased the number or dose of medications received and improved study-selected glycemic, blood pressure, and lipid goal attainment (moderate-strength evidence). Mortality and clinical events were similar (low-strength evidence). Evidence on patient satisfaction was mixed and insufficient. The reporting of harms was limited. Limitations:Interventions were heterogeneous. Studies were typically short-term and designed to assess physiologic intermediate outcomes rather than clinical events. Reporting of many clinical outcomes of interest was limited, and often they were not the study-defined primary end points. Conclusion:Pharmacist-led chronic disease management was associated with effects similar to those of usual care for resource utilization and may improve physiologic goal attainment. Further research is needed to determine whether increased medication utilization and goal attainment improve clinical outcomes. Primary Funding Source:Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative.
Topics: chronic disease, pharmacist, hospitalization
The results of Bernard and colleagues' study bring to light several key points with regard to PrEP for PWID, one of which is the staggering financial resources that would be required of a PrEP for PwID initiative. However, that the United States is immersed in a scourging opioid crisis is clear. Deaths due to overdose in 2014 eclipsed the number of deaths at the peak of the HIV epidemic. As a result, now is the time to be maximally efficient with HIV prevention resources to ensure their greatest impact.
Topics: hiv, opioid analgesics, overdose, hiv infection, opioids, pre-exposure prophylaxis, hiv prevention
Research and Reporting Methods | 
Wei Duan-Porter, MD, PhD; Karen M. Goldstein, MD, MSPH; Jennifer R. McDuffie, PhD, MPH; Jaime M. Hughes, MPH, MSW; Megan E.B. Clowse, MD, MPH; Ruth S. Klap, PhD; Varsha Masilamani, MBBS; Nancy M. Allen LaPointe, PharmD, MHS; Avishek Nagi, MS; Jennifer M. Gierisch, PhD, MPH; and John W. Williams Jr., MD, MHSc
Systematic reviews (SRs) have the potential to contribute uniquely to the evaluation of sex and gender differences (termed “sex effects”). This article describes the reporting of sex effects by SRs on interventions for depression, type 2 diabetes mellitus, and chronic pain conditions (chronic low back pain, knee osteoarthritis, and fibromyalgia). It includes SRs published since 1 October 2009 that evaluate medications, behavioral interventions, exercise, quality improvement, and some condition-specific treatments. The reporting of sex effects by primary randomized, controlled trials is also examined. Of 313 eligible SRs (86 for depression, 159 for type 2 diabetes mellitus, and 68 for chronic pain), few (n = 29) reported sex effects. Most SRs reporting sex effects used metaregression, whereas 9 SRs used subgroup analysis or individual-patient data meta-analysis. The proportion of SRs reporting the sex distribution of primary studies varied from a low of 31% (n = 8) for low back pain to a high of 68% (n = 23) for fibromyalgia. Primary randomized, controlled trials also infrequently reported sex effects, and most lacked an adequate sample size to examine them. Therefore, all SRs should report the proportion of women enrolled in primary studies and evaluate sex effects using appropriate methods whenever power is adequate.
Topics: diabetes mellitus, diabetes mellitus, type 2, depressive disorders, chronic pain, russell-silver syndrome, somatostatin receptor scintigraphy, chronic low back pain
Ideas and Opinions | 
Gillian J. Buckley, PhD, MPH; and Brian L. Strom, MD, MPH
Highlighting recent findings of a National Academies of Sciences, Engineering, and Medicine report, this commentary addresses the feasibility of eliminating hepatitis B and C in the United States.
Topics: hepatitis b, rare diseases
Letters | 
Daniel S. Chertow, MD, MPH; Avindra Nath, MD; Anthony F. Suffredini, MD; Robert L. Danner, MD; Daniel S. Reich, MD, PhD; Rachel J. Bishop, MD; Richard W. Childs, MD; Andrew E. Arai, MD; Tara N. Palmore, MD; H. Clifford Lane, MD; Anthony S. Fauci, MD; and Richard T. Davey, MD
Ideas and Opinions | 
Steven Joffe, MD, MPH; and David C. Magnus, PhD
In September 2015, sixteen federal agencies released a Notice of Proposed Rulemaking (NPRM) that outlined far-reaching changes to the Common Rule, the framework for all federally funded human subjects research. These are the first substantive alterations to the Rule in nearly 25 years. Although there are several worthwhile suggestions, on balance the NRPM seems more likely to be a hindrance than a help.
Topics: institutional review board, quality improvement
Medicine and Public Issues | 
Christine M. Durand, MD; Dorry Segev, MD, PhD; and Jeremy Sugarman, MD, MPH, MA
The HIV Organ Policy Equity (HOPE) Act now allows transplantation of organs from HIV-positive living and deceased donors to HIV-positive individuals with end-stage organ disease in the United States. Although clinical experience with such transplants is limited to a small number of deceased-donor kidney transplants from HIV-positive to HIV-positive persons in South Africa, unprecedented HIV-positive–to–HIV-positive liver transplantations and living-donor kidney transplantations are also now on the horizon. Initially, all HIV-positive–to–HIV-positive transplantations will occur under research protocols with safeguards and criteria mandated by the National Institutes of Health. Nevertheless, this historic change brings ethical opportunities and challenges. For HIV-positive individuals needing an organ transplant, issues of access, risk, and consent must be considered. For potential HIV-positive donors, there are additional ethical challenges of privacy, fairness, and the right to donate. Careful consideration of the ethical issues involved is critical to the safe and appropriate evaluation of this novel approach to transplantation.
Topics: hiv seropositivity, organ transplantation, donors, ethics, transplantation
Letters | 
Yalçin Velibey, MD; Tolga S. Guvenc, MD; Murat Ugur, MD; Ozge Guzelburc, MD; and Mehmet Eren, MD
Position Papers | 
Hilary Daniel, BS, for the Health and Public Policy Committee of the American College of Physicians
This American College of Physicians position paper, initiated and written by its Health and Public Policy Committee and approved by the Board of Regents on 16 February 2016, reports policy recommendations from the American College of Physicians to address the escalating costs of prescription drugs in the United States. Prescription drugs play an important part in treating and preventing disease. However, the United States often pays more for some prescription drugs than other developed countries, and the high price and increasing costs associated with prescription medication is a major concern for patients, physicians, and payers. Pharmaceutical companies have considerable flexibility in how they price drugs, and the costs that payers and patients see are dependent on how payers are able to negotiate discounts or rebates. Beyond setting list prices are issues of regulatory approval, patents and intellectual property, assessment of value and cost-effectiveness, and health plan drug benefits. These issues are linked, and comprehensive efforts will be needed to affect how drugs are priced in the United States.
Topics: prescriptions, drug, prescription drug, formulary, pharmaceutical company, american college of physicians
Ideas and Opinions | 
Shmuel Shoham, MD; Annukka A.R. Antar, MD, PhD; Paul G. Auwaerter, MD, MBA; Christine M. Durand, MD; Mark S. Sulkowski, MD; and Deborah J. Cotton, MD, MPH
Prevention of antimicrobial shortages is a fundamental aspect of keeping patients free of harm. When shortages of these drugs are coupled with the dynamics of serious infections, the results can be catastrophic. The authors discuss possible incentives, programs, and regulation that could help to combat the problem.
Topics: antimicrobials
Letters | 
Kalyan C. Mantripragada, MD, MPH; Sophia Fircanis Rizk, MD; John L. Reagan, MD; and Mark LeGolvan, MD
Letters | 
Caroline M. Lee, MD, PhD; Jason D. Lee, MD, PhD; Lisa D. Hobson-Webb, MD; Richard S. Bedlack, MD, PhD; and Joseph K. Salama, MD
This case report describes an alternative approach for treating thymoma-associated myasthenia gravis.
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