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Original Research | 
Mildred K. Cho, PhD; David Magnus, PhD; Melissa Constantine, PhD, MPAff; Sandra Soo-Jin Lee, PhD; Maureen Kelley, PhD; Stephanie Alessi, JD; Diane Korngiebel, DPhil; Cyan James, PhD; Ellen Kuwana, MS; Thomas H. Gallagher, MD; Douglas Diekema, MD, MPH; Alexander M. Capron, LLB; Steven Joffe, MD, MPH; and Benjamin S. Wilfond, MD
Background:The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants. Objective:To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices. Design:Cross-sectional survey conducted in August 2014. Setting:Web-based questionnaire. Patients:1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290). Measurements:Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices. Results:97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%). Limitation:Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population. Conclusion:Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance. Primary Funding Source:National Center for Advancing Translational Sciences at the National Institutes of Health.
Topics: informed consent, attitude, cross-sectional studies, medical records review
In this issue, Cho and colleagues surveyed adults about research on medical ethics and found that most respondents were willing to participate in such research but preferred to be asked for permission first. The editorialist addresses this sensitive topic by emphasizing that research participants should have a voice in shaping the current regulatory system for clinical research.
Topics: ethics, informed consent, therapeutics, voice, clinical research, ethics, research, fear
Reviews | 
Shelley Selph, MD, MPH; Tracy Dana, MLS; Ian Blazina, MPH; Christina Bougatsos, MPH; Hetal Patel, MD; and Roger Chou, MD
Background:Screening for type 2 diabetes mellitus could lead to earlier identification and treatment of asymptomatic diabetes, impaired fasting glucose (IFG), or impaired glucose tolerance (IGT), potentially resulting in improved outcomes. Purpose:To update the 2008 U.S. Preventive Services Task Force review on diabetes screening in adults. Data Sources:Cochrane databases and MEDLINE (2007 through October 2014) and relevant studies from previous Task Force reviews. Study Selection: Randomized, controlled trials; controlled, observational studies; and systematic reviews. Data Extraction:Data were abstracted by 1 investigator and checked by a second; 2 investigators independently assessed study quality. Data Synthesis:In 2 trials, screening for diabetes was associated with no 10-year mortality benefit versus no screening (hazard ratio, 1.06 [95% CI, 0.90 to 1.25]). Sixteen trials consistently found that treatment of IFG or IGT was associated with delayed progression to diabetes. Most trials of treatment of IFG or IGT found no effects on all-cause or cardiovascular mortality, although lifestyle modification was associated with decreased risk for both outcomes after 23 years in 1 trial. For screen-detected diabetes, 1 trial found no effect of an intensive multifactorial intervention on risk for all-cause or cardiovascular mortality versus standard control. In diabetes that was not specifically screen-detected, 9 systematic reviews found that intensive glucose control did not reduce risk for all-cause or cardiovascular mortality and results for intensive blood pressure control were inconsistent. Limitation:The review was restricted to English-language articles, and few studies were conducted in screen-detected populations. Conclusion:Screening for diabetes did not improve mortality rates after 10 years of follow-up. More evidence is needed to determine the effectiveness of treatments for screen-detected diabetes. Treatment of IFG or IGT was associated with delayed progression to diabetes. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: diabetes mellitus, diabetes mellitus, type 2, impaired fasting glucose
In this issue, Selph and colleagues review evidence for screening for type 2 diabetes and prediabetes. The editorialists discuss the review and its implications for clinical practice.
Topics: hyperglycemia, diabetes prevention, diabetes mellitus, type 2, prediabetes
Ideas and Opinions | 
Andrew J. Vickers, DPhil; and David M. Kent, MD, CM, MSc
This commentary discusses the paradoxical finding that most patients are at below-average risk and can expect to experience less-than-average benefits from a treatment. This “Lake Wobegon effect,” the authors argue, can result in too many patients being screened, diagnosed, and treated.
Topics: therapeutics, lung cancer, overtreatment, smoking
Ideas and Opinions | 
Frank H. Bosch, MD, PhD; and David A. Fleming, MD, MA
In hospitals, physicians perform cardiopulmonary resuscitation (CPR) in hospitals repeatedly and reflexively. Too often CPR occurs regardless of prognosis, without knowing whether the patient desires CPR, and knowing that we may do harm. In this commentary, leaders of the European Federation of Internal Medicine and American College of Physicians remind physicians of the importance of discussing patient preferences for CPR and individual patient prognosis after CPR with hospitalized patients.
Topics: cardiopulmonary resuscitation
Background:Routine screening and supplementation for iron deficiency anemia (IDA) in asymptomatic, nonanemic pregnant women could improve maternal and infant health outcomes. Purpose:Update of a 2006 systematic review by the U.S. Preventive Services Task Force on screening and supplementation for IDA in pregnancy. Data Sources:MEDLINE and the Cochrane Library (1996 to August 2014) and reference lists of relevant systematic reviews to identify studies published since 1996. Study Selection:English-language trials and controlled observational studies about effectiveness of screening and routine supplementation for IDA in developed countries. Data Extraction:Data extraction and quality assessment confirmed and dual-rated by a second investigator using prespecified criteria. Data Synthesis:No study directly compared clinical outcomes or harms of screening or not screening pregnant women for IDA. Twelve supplementation trials were included, and no controlled observational studies met inclusion criteria. On the basis of 11 trials, routine maternal iron supplementation had inconsistent effects on rates of cesarean delivery, small size for gestational age, and low birthweight and no effect on maternal quality of life, gestational age, Apgar scores, preterm birth, or infant mortality. Twelve trials reported improvements in maternal hematologic indices, although not all were statistically significant. Pooled analysis of 4 trials resulted in a statistically significant difference in IDA incidence at term, favoring supplementation (risk ratio, 0.29 [95% CI, 0.17 to 0.49]; I2 = 0%). Maternal iron supplementation did not affect infant iron status at 6 months. Harms, none of which were serious or had long-term consequences, were inconsistently reported in 10 of the trials, with most finding no difference between groups. Limitations:Data from trials in countries with limited generalizability to U.S. populations were included. Studies were methodologically heterogeneous, and some were small and underpowered. Conclusion:There is inconclusive evidence that routine prenatal supplementation for IDA improves maternal or infant clinical health outcomes, but supplementation may improve maternal hematologic indices. Primary Funding Source:Agency for Healthcare Research and Quality.
Topics: pregnancy, iron, mothers
Original Research | 
Benjamin P. Linas, MD, MPH; Devra M. Barter, MS; Jake R. Morgan, MS; Mai T. Pho, MD, MPH; Jared A. Leff, MS; Bruce R. Schackman, PhD; C. Robert Horsburgh, MD, MUS; Sabrina A. Assoumou, MD, MPH; Joshua A. Salomon, PhD; Milton C. Weinstein, PhD; Kenneth A. Freedberg, MD, MSc; and Arthur Y. Kim, MD
Includes: Supplemental Content
Background:Chronic infection with hepatitis C virus (HCV) genotype 2 or 3 can be treated with sofosbuvir without interferon. Because sofosbuvir is costly, its benefits should be compared with the additional resources used. Objective:To estimate the cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the United States. Design:Monte Carlo simulation, including deterministic and probabilistic sensitivity analyses. Data Sources: Randomized trials, observational cohorts, and national health care spending surveys. Target Population:8 patient types defined by HCV genotype (2 vs. 3), treatment history (naive vs. experienced), and cirrhosis status (noncirrhotic vs. cirrhotic). Time Horizon:Lifetime. Perspective:Payer. Intervention:Sofosbuvir-based therapies, pegylated interferon–ribavirin, and no therapy. Outcome Measures:Discounted quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). Results of Base-Case Analysis:The ICER of sofosbuvir-based treatment was less than $100 000 per QALY in cirrhotic patients (genotype 2 or 3 and treatment-naive or treatment-experienced) and in treatment-experienced noncirrhotic patients but was greater than $200 000 per QALY in treatment-naive noncirrhotic patients. Results of Sensitivity Analysis:The ICER of sofosbuvir-based therapy for treatment-naive noncirrhotic patients with genotype 2 or 3 infection was less than $100 000 per QALY when the cost of sofosbuvir was reduced by approximately 40% and 60%, respectively. In probabilistic sensitivity analyses, cost-effectiveness conclusions were robust to uncertainty in treatment efficacy. Limitation:The analysis did not consider possible benefits of preventing HCV transmission. Conclusion:Sofosbuvir provides good value for money for treatment-experienced patients with HCV genotype 2 or 3 infection and those with cirrhosis. At their current cost, sofosbuvir-based regimens for treatment-naive noncirrhotic patients exceed willingness-to-pay thresholds commonly cited in the United States. Primary Funding Source:National Institute on Drug Abuse and National Institute of Allergy and Infectious Diseases.
Topics: ribavirin, sofosbuvir, peginterferon, hepatitis c virus, hepatitis c virus genotype 2, cost effectiveness, genotype
Editorials | 
Ohad Etzion, MD; and Marc G. Ghany, MD, MHSc
In this issue, Linas and colleagues estimate the cost-effectiveness of all-oral regimens compared with pegylated interferon–ribavirin or no therapy for hepatitis C virus (HCV) genotype 2 or 3 infection in the United States. The editorialists discuss the implications of the findings for future approaches to HCV treatment.
Topics: hepatitis c virus
New guidelines from the American Gastroenterological Association on the management of incidental pancreatic cysts recommend less aggressive evaluation than previous recommendations from other groups. The guidelines are needed because the rapid growth in the number of sensitive imaging studies has led to a marked increase in incidental pancreatic cysts. This commentary discusses lessons extending beyond pancreatic cysts about how physicians should consider diagnostic testing and what types of recommendations merit their attention.
Topics: pancreas, incidental findings
Ideas and Opinions | 
Giulio R. Romeo, MD; and Martin J. Abrahamson, MD
Each year, the American Diabetes Association's Standards of Medical Care in Diabetes provide comprehensive clinical practice recommendations for diabetes care, based on the latest available evidence. This commentary highlights 3 topics in the Standards of relevance to nonendocrinologists who care for patients with diabetes: ethnic differences in diabetes risk with different body mass indices, blood pressure targets, and individualization of diabetes treatment goals.
Topics: diabetes mellitus, patient-centered care, diabetes mellitus, type 2
Clinical Guidelines | 
Michael L. LeFevre, MD, MSPH, on behalf of the U.S. Preventive Services Task Force*
Description:Update of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for thyroid disease. Methods:The USPSTF reviewed the evidence on the benefits and harms of screening for subclinical and “overt” thyroid dysfunction without clinically obvious symptoms, as well as the effects of treatment on intermediate and final health outcomes. Population:This recommendation applies to nonpregnant, asymptomatic adults. Recommendation:The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for thyroid dysfunction in nonpregnant, asymptomatic adults. (I statement)
Topics: thyroid diseases, thyrotropin, early diagnosis, hypothyroidism, hyperthyroidism
Topics: thyroid diseases
Editorials | 
Anne R. Cappola, MD, ScM; and David S. Cooper, MD
In this issue, the U.S. Preventive Services Task Force concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for thyroid dysfunction in nonpregnant asymptomatic adults. The editorialists stress the urgent need for data to provide guidance on screening for thyroid dysfunction to assist clinicians in making the best decisions for their patients.
Topics: therapeutics, stalemate, subclinical thyroid disease, thyroid diseases
Original Research | 
Michael M. Mohareb, MD; Feng Qiu, MSc; Warren J. Cantor, MD; Kori J. Kingsbury, MSN, MPA; Dennis T. Ko, MD, MSc; and Harindra C. Wijeysundera, MD, PhD
Background:The use of invasive coronary angiography in stable ischemic heart disease (IHD) varies widely. Objective:To validate the 2012 appropriate use criteria for diagnostic catheterization (AUC) by examining the relationship between the appropriateness of cardiac catheterization in patients with suspected stable IHD and the proportion of patients with obstructive coronary artery disease (CAD) and subsequent revascularization. Design:Population-based, observational, multicenter cohort study. Setting:The Cardiac Care Network, a registry of all patients having elective angiography at 18 hospitals in Ontario, Canada, between 1 October 2008 and 30 September 2011. Patients:Persons without prior coronary revascularization or myocardial infarction who had angiography for suspected stable CAD. Measurements:Appropriateness scores were ascertained by using data collected at the time of the index angiography and were categorized as appropriate, inappropriate, or uncertain. Results:Among the final cohort of 48 336 patients, 58.2% of angiographic studies were classified as appropriate, 10.8% were classified as inappropriate, and 31.0% were classified as uncertain. Overall, 45.5% of patients had obstructive CAD. In patients with appropriate indications for angiography, 52.9% had obstructive CAD, with 40.0% undergoing revascularization. In those with inappropriate indications, 30.9% had obstructive CAD and 18.9% underwent revascularization; in those with uncertain indications, 36.7% had obstructive CAD and 25.9% had revascularization. Although more patients with appropriate indications had obstructive CAD and underwent revascularization (P < 0.001), a substantial proportion of those with inappropriate or uncertain indications had important coronary disease. Limitation:Data were not available on whether symptoms were atypical. Conclusion:Despite the association between appropriateness category and obstructive CAD, this study raises concerns about the ability of the AUC to guide clinical decision making. Primary Funding Source:Canadian Institutes of Health Research.
Topics: angina pectoris, angiogram, coronary angiography, cardiovascular stress test, exercise stress test, diagnosis, diagnostic imaging, revascularization, appropriateness, appropriate use, echocardiography, myocardial ischemia, catheterization, hospitals, coronary arteriosclerosis
In this issue, Mohareb and colleagues sought to validate the 2012 appropriate use criteria (AUC) for diagnostic catheterization. The editorialists discuss the opportunities and challenges of applying AUC to large data sets and urge physicians to embrace the opportunity for self-regulation that AUC offer to ensure that they remain advocates for patients and stewards of the health system.
Topics: social control, informal, appropriate use, diagnosis, catheterization
Ideas and Opinions | 
Neal Halsey, MD; and Daniel Salmon, PhD, MPH
Only a small portion of the U.S. population is susceptible to measles. However, international travel, vaccine refusal or delay, and rare vaccine failures combined with high social contacts allow this highly infectious virus to infect susceptible individuals of all ages. The recent measles outbreak in Disneyland is reflective of the increase in recent years of the number of parents declining to vaccinate their children. In addition, although great progress has been made in controlling measles globally, it has recently rebounded in many countries. Eradication of measles is possible but will take time, ramped-up efforts to ensure that eligible U.S. children are vaccinated, and greater international collaboration.
Topics: measles
Ideas and Opinions | 
Theodore G. Ganiats, MD
The chronic fatigue syndrome is often ignored or mismanaged by clinicians. The Institute of Medicine recently convened an expert committee to examine the evidence base for the condition, develop evidence-based clinical diagnostic criteria, and recommend whether new terminology should be adopted.
Topics: chronic fatigue syndrome, diagnosis
As the American College of Physicians celebrates its 100th anniversary in 2015, it is an appropriate time to reflect on the current challenges and opportunities that face internal medicine specialists and subspecialists, their patients, and American society. This commentary highlights 3 leading issues for internal medicine and for ACP as it enters its second century and strives to continue to meet the needs of internists and their patients.
Topics: internal medicine, job satisfaction, health care systems, health care cost containment, american college of physicians
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