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Original Research | 
Joann G. Elmore, MD, MPH; Heidi D. Nelson, MD, MPH; Margaret S. Pepe, PhD; Gary M. Longton, MS; Anna N.A. Tosteson, ScD; Berta Geller, EdD; Tracy Onega, PhD; Patricia A. Carney, PhD; Sara L. Jackson, MD, MPH; Kimberly H. Allison, MD; and Donald L. Weaver, MD
Background:The effect of physician diagnostic variability on accuracy at a population level depends on the prevalence of diagnoses. Objective:To estimate how diagnostic variability affects accuracy from the perspective of a U.S. woman aged 50 to 59 years having a breast biopsy. Design:Applied probability using Bayes' theorem. Setting:B-Path (Breast Pathology) Study comparing pathologists' interpretations of a single biopsy slide versus a reference consensus interpretation from 3 experts. Participants:115 practicing pathologists (6900 total interpretations from 240 distinct cases). Measurements:A single representative slide from each of the 240 cases was used to estimate the proportion of biopsies with a diagnosis that would be verified if the same slide were interpreted by a reference group of 3 expert pathologists. Probabilities of confirmation (predictive values) were estimated using B-Path Study results and prevalence of biopsy diagnoses for women aged 50 to 59 years in the Breast Cancer Surveillance Consortium. Results:Overall, if 1 representative slide were used per case, 92.3% (95% CI, 91.4% to 93.1%) of breast biopsy diagnoses would be verified by reference consensus diagnoses, with 4.6% (CI, 3.9% to 5.3%) overinterpreted and 3.2% (CI, 2.7% to 3.6%) underinterpreted. Verification of invasive breast cancer and benign without atypia diagnoses is highly probable; estimated predictive values were 97.7% (CI, 96.5% to 98.7%) and 97.1% (CI, 96.7% to 97.4%), respectively. Verification is less probable for atypia (53.6% overinterpreted and 8.6% underinterpreted) and ductal carcinoma in situ (DCIS) (18.5% overinterpreted and 11.8% underinterpreted). Limitations:Estimates are based on a testing situation with 1 slide used per case and without access to second opinions. Population-adjusted estimates may differ for women from other age groups, unscreened women, or women in different practice settings. Conclusion:This analysis, based on interpretation of a single breast biopsy slide per case, predicts a low likelihood that a diagnosis of atypia or DCIS would be verified by a reference consensus diagnosis. This diagnostic grey zone should be considered in clinical management decisions in patients with these diagnoses. Primary Funding Source:National Cancer Institute.
Topics: ductal carcinoma in situ, biopsy of breast, consensus, atypical, breast, biopsy, breast cancer, invasive
Original Research | 
Nicola Lindson-Hawley, PhD; Miriam Banting, MSc; Robert West, PhD; Susan Michie, DPhil; Bethany Shinkins, DPhil; and Paul Aveyard, PhD
Background:Most smoking cessation guidelines advise quitting abruptly. However, many quit attempts involve gradual cessation. If gradual cessation is as successful, smokers can be advised to quit either way. Objective:To examine the success of quitting smoking by gradual compared with abrupt quitting. Design:Randomized, controlled noninferiority trial. (International Standardized Randomized Controlled Trial Number Register: ISRCTN22526020) Setting:Primary care clinics in England. Participants:697 adult smokers with tobacco addiction. Intervention:Participants quit smoking abruptly or reduced smoking gradually by 75% in the 2 weeks before quitting. Both groups received behavioral support from nurses and used nicotine replacement before and after quit day. Measurements:The primary outcome measure was prolonged validated abstinence from smoking 4 weeks after quit day. The secondary outcome was prolonged, validated, 6-month abstinence. Results:At 4 weeks, 39.2% (95% CI, 34.0% to 44.4%) of the participants in the gradual-cessation group were abstinent compared with 49.0% (CI, 43.8% to 54.2%) in the abrupt-cessation group (relative risk, 0.80 [CI, 0.66 to 0.93]). At 6 months, 15.5% (CI, 12.0% to 19.7%) of the participants in the gradual-cessation group were abstinent compared with 22.0% (CI, 18.0% to 26.6%) in the abrupt-cessation group (relative risk, 0.71 [CI, 0.46 to 0.91]). Participants who preferred gradual cessation were significantly less likely to be abstinent at 4 weeks than those who preferred abrupt cessation (38.3% vs 52.2%; P = 0.007). Limitations:Blinding was impossible. Most participants were white. Conclusion:Quitting smoking abruptly is more likely to lead to lasting abstinence than cutting down first, even for smokers who initially prefer to quit by gradual reduction. Primary Funding Source:British Heart Foundation.
Topics: smoking, smoking cessation, nurses, cigarettes, adverse event
Original Research | 
Sara Y. Tartof, PhD; Lei Qian, PhD; Gunter K. Rieg, MD; Kalvin C. Yu, MD; Lina S. Sy, MPH; Hung Fu Tseng, PhD; Rulin C. Hechter, MD, PhD; and Steven J. Jacobsen, MD, PhD
Background:Despite recommendations to vaccinate surgical inpatients against influenza, vaccination rates remain low in this population, due in part to concerns about potential negative effects on postsurgical care. Objective:To evaluate whether influenza vaccination in the perioperative period increases health care utilization and evaluations for postsurgical infection after discharge. Design:Retrospective cohort study. Setting:Members of Kaiser Permanente Southern California. Participants:Patients aged 6 months or older who had inpatient surgery with admission and discharge between 1 September and 31 March from 2010 to 2013. Measurements:All influenza vaccinations administered between 1 August and 30 April in the 2010–2011, 2011–2012, and 2012–2013 influenza seasons. Outcomes included rates of outpatient visits, readmission, emergency department (ED) visits, fever (temperature ≥38.0 °C), and clinical laboratory evaluations for infection (urine culture, complete blood count, blood culture, and wound culture) in the 7 days after discharge. Results:Of the 42 777 surgeries included in adjusted analyses, vaccine was administered during hospitalization in 6420. No differences were detected between the vaccinated and unvaccinated groups in risk for inpatient visits (rate ratio [RR], 1.12 [95% CI, 0.96 to 1.32]), ED visits (RR, 1.07 [CI, 0.96 to 1.20]), postdischarge fever (RR, 1.00 [CI, 0.76 to 1.31]), or clinical evaluations for infection (RR, 1.06 [CI, 0.99 to 1.13]). A marginal increase in risk for outpatient visits (RR, 1.05 [CI, 1.00 to 1.10]; P = 0.032) was found. Limitation:The study did not distinguish between planned and unplanned readmissions or outpatient visits. Conclusion:No strong evidence of increased risk for adverse outcomes was found in comparisons of patients who received influenza vaccine during a surgical hospitalization and those who did not. The data support the recommendation to vaccinate surgical inpatients against influenza. Primary Funding Source:Centers for Disease Control and Prevention.
Topics: influenza, influenza virus vaccine, inpatient, vaccination, safety, vaccines
Summaries for Patients | 
Topics: smoking, self-mutilation by cutting
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.
Ideas and Opinions | 
Evan M. Bloch, MD, MS; Matthew S. Simon, MD, MS; and Beth H. Shaz, MD
Thirty years ago, the recognition that HIV was transmitted through transfusion led to sweeping changes in the procurement, testing, and regulation of the blood supply. Transmission of pathogens, including hepatitis C virus, West Nile virus, and HIV, via transfusion has now been virtually eliminated. However, the authors argue that in 2016, new economic challenges and the emergence of global pathogens, such as Zika virus, call for new investments in blood bank infrastructure and testing technologies, as well as improved collaboration among stakeholders.
Topics: communicable diseases, emerging, safety, transfusion
Editorials | 
Gabriela S. Ferreira, MD; and Michael B. Steinberg, MD, MPH
Most smoking cessation guidelines advise patients to stop abruptly on a set quit date. In this week's Annals, Lindson-Hawley and colleagues' randomized, controlled noninferiority trial found that abrupt cessation was more effective than gradual reduction. The editorialists believe that these findings call into question whether clinicians should encourage the practice of gradual reduction before a quit date in smokers who are ready to quit.
Topics: smoking cessation, smoking
Original Research | 
Casey Crump, MD, PhD; Jan Sundquist, MD, PhD; Marilyn A. Winkleby, PhD; Weiva Sieh, MD, PhD; and Kristina Sundquist, MD, PhD
Background:Early-life physical fitness has rarely been examined in relation to type 2 diabetes mellitus (DM) in adulthood because of the lengthy follow-up required. Elucidation of modifiable risk factors at young ages may help facilitate earlier and more effective interventions. Objective:To examine aerobic capacity and muscle strength at age 18 years in relation to risk for type 2 DM in adulthood. Design:National cohort study. Setting:Sweden. Participants:1 534 425 military conscripts from 1969 to 1997 (97% to 98% of all men aged 18 years nationwide) without prior type 2 DM. Measurements:Aerobic capacity and muscle strength (measured in watts and newtons per kilogram of body weight, respectively) were examined in relation to type 2 DM identified from outpatient and inpatient diagnoses from 1987 to 2012 (maximum age, 62 years). Results:34 008 men were diagnosed with type 2 DM in 39.4 million person-years of follow-up. Low aerobic capacity and muscle strength were independently associated with increased risk for type 2 DM. The absolute difference in cumulative incidence of type 2 DM between the lowest and highest tertiles of both aerobic capacity and strength was 0.22% at 20 years of follow-up (95% CI, 0.20% to 0.25%), 0.76% at 30 years (CI, 0.71% to 0.81%), and 3.97% at 40 years (CI, 3.87% to 4.06%). Overall, the combination of low aerobic capacity and muscle strength was associated with a 3-fold risk for type 2 DM (adjusted hazard ratio, 3.07 [CI, 2.88 to 3.27]; P < 0.001), with a positive additive interaction (P < 0.001). These associations were seen even among men with normal body mass index. Limitation:This cohort did not include women and did not measure physical fitness at older ages. Conclusion:In this large cohort of Swedish male military conscripts, low aerobic capacity and muscle strength at age 18 years were associated with increased long-term risk for type 2 DM, even among those with normal body mass index. Primary Funding Source:National Institutes of Health.
Topics: diabetes mellitus, type 2, military personnel, physical fitness, muscle strength, aerobic capacity
In this week's Annals, Crump and colleagues document the largest known study to show an inverse association between objectively measured cardiorespiratory and muscular fitness and risk for incident type 2 diabetes mellitus (DM). The editorialist discusses how this study fills an important research gap by demonstrating a strong inverse association between physical fitness at a young age and risk for type 2 DM, independent of weight status. The enhancement of fitness through habitual physical activity should be recommended as a front-line therapy to address the burden of type 2 DM.
Topics: physical fitness, diabetes mellitus, type 2, risk reduction
Topics: physical fitness, diabetes mellitus, type 2
Physicians increasingly practice as employees of large organizations; therefore, they may often report to managers who are not physicians. These managers may not share physicians' professional values and may believe that practices learned in business school apply to all organizations, including hospitals. This commentary discusses how clauses in the contracts that physicians sign with their employers or that their employers sign with third parties may be part of a growing class of subtle restrictions on employed physicians' professionalism and autonomy.
Topics: professionalism, employer, hospitals
Letters | 
Sean O'Loghlen, MD, BSc(Hons); Grayson J. Hall, MD; Nadil Zeiadin, MD; Laura Milne, MD; and Benedetto Mussari, MD
Clinicians usually can identify the cause of unilateral lower extremity swelling, but even experienced clinicians can be misled by rare causes of this condition. This case report describes unilateral lower extremity swelling that can be mistaken for deep venous thrombosis.
Two states, Oregon and California, now allow pharmacists to prescribe and dispense oral hormonal birth control, which some see as a step toward improved access. However, a prescription is still required in these cases. In this commentary, the Chief Executive Officer of the American Congress of Obstetricians and Gynecologists describes how pharmacist prescription simply exchanges one barrier for another and why over-the-counter availability of oral contraceptives would be a better strategy for increasing access to safe, effective birth control.
Topics: oral contraceptives, contraceptive methods, pharmacist, drugs, non-prescription
Letters | 
Vincent Mallet, MD, PhD; Rebecca Sberro-Soussan, MD; Anais Vallet-Pichard, MD; Anne-Marie Roque-Afonso, MD, PhD; and Stanislas Pol, MD, PhD
Ideas and Opinions | 
Federico Costa, PhD; Manoel Sarno, MD, PhD; Ricardo Khouri, PhD; Bruno de Paulo Freitas, MD; Isadora Siqueira, MD, PhD; Guilherme S. Ribeiro, MD, PhD; Hugo C. Ribeiro, MD; Gubio S. Campos, PhD; Luiz C. Alcântara, PhD; Mitermayer G. Reis, MD, PhD; Scott C. Weaver, PhD; Nikos Vasilakis, PhD; Albert I. Ko, MD; and Antonio Raimundo Almeida, MD
From July to September 2015, several months after the introduction of Zika virus into northeastern Brazil, obstetricians noticed an increased number of fetuses with congenital malformations during ultrasound screening. By October, the number of newborns with microcephaly had increased significantly in this area. Microcephaly has now risen in other regions along with the spread of Zika virus. To date, more than 4000 cases have been reported.
Topics: zika virus, zika virus disease, microcephaly
Letters | 
Rodrigo Mendirichaga, MD; Rhanderson Cardoso, MD; Daniel Garcia, MD; Marian Calfa, MD; and Victor Soto, MD
Ideas and Opinions | 
Michael J. Barry, MD; and Peter C. Albertsen, MD
A recently proposed quality measure, “Non-Recommended PSA-Based Screening,” has generated considerable debate. It would be one of the first U.S. quality metrics to focus on the delivery of too much rather than too little care. The authors discuss their concerns about the proposed measure.
Topics: prostate-specific antigen screening
Ideas and Opinions | 
Eduardo Ortiz, MD, MPH; and Paul A. James, MD
SPRINT (Systolic Blood Pressure Intervention Trial), a randomized trial that compared aggressive treatment to a target systolic blood pressure (BP) less than 120 mm Hg with a target less than 140 mm Hg in patients with increased cardiovascular risk, found a 25% relative risk reduction in cardiovascular events. The authors discuss why they believe that the small absolute benefit seen in SPRINT does not provide convincing evidence that large segments of the population should be treated with additional drugs to a systolic BP goal less than 120 mm Hg, especially when the adverse events, costs, and burden of such treatment are considered.
Topics: blood pressure, judgment, therapeutics, cardiovascular disease risk factors, systolic blood pressure
Letters | 
Shinichiro Ohshimo, MD, PhD; Takuma Sadamori, MD, PhD; and Koichi Tanigawa, MD, PhD
It is difficult to describe the sounds of breathing, especially when different types of sound are present at the same time. The authors propose the use of an electronic stethoscope with innovative software to solve this problem and use videos to illustrate its possibilities.
Ideas and Opinions | 
Katherine E. Warren, BA; Shirli Tay, BA; and Leana S. Wen, MD, MSc
The U.S. Alcohol and Tobacco Tax and Trade Bureau recently approved a formulation of powdered alcohol for sale. The authors discuss the paucity of data available on the safety of this product, its potential harms on an individual and public health basis, and how local advocacy led to a ban of its sale and distribution in Baltimore, Maryland.
Topics: ethanol
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