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Original Research | 
Anita Kohli, MD; Sarah Kattakuzhy, MD; Sreetha Sidharthan, BS; Amy Nelson, RN; Mary McLaughlin, RN; Cassie Seamon, RN; Eleanor Wilson, MD; Eric G. Meissner, MD, PhD; Zayani Sims, BS; Rachel Silk, RN, MPH; Chloe Gross, RN; Elizabeth Akoth, RN, MS; Lydia Tang, MD; Angie Price, NP; Tim A. Jolley, RN; Benjamin Emmanuel, MPH; Michael Proschan, PhD; Gebeyehu Teferi, MD; Jose Chavez, MD; Stephen Abbott, MD; Anuoluwapo Osinusi, MD, MPH; Hongmei Mo, MD; Michael A. Polis, MD; Henry Masur, MD; and Shyam Kottilil, MD, PhD
Background:Treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals (DAAs) for 6 weeks achieves sustained virologic response (SVR) rates of 95% in some patients. If effective, shorter therapeutic courses could improve adherence and treatment costs. Objective:To determine factors predictive of SVR to 4 weeks of DAA treatment in patients with stage F0 to F2 liver fibrosis. Design:Open-label, nonrandomized, phase 2a trial. (Clinical Trials.gov: NCT01805882) Setting:Single-center. Patients:50 treatment-naive and predominantly African American patients with HCV genotype 1 infection and early-stage liver fibrosis were sequentially enrolled into 2 treatment groups. Intervention:25 participants received a 3-drug regimen consisting of ledipasvir and sofosbuvir plus GS-9451 for 4 weeks, and 25 received a 4-drug regimen consisting of ledipasvir, sofosbuvir, GS-9451, and GS-9669 for 4 weeks. Measurements:The primary efficacy end point was SVR12 (HCV RNA level below the lower limit of quantification at posttreatment week 12). Results:Forty percent (10 of 25) (95% CI, 21% to 61%) of patients in the 3-drug group and 20% (5 of 25) (CI, 7% to 41%) of those in the 4-drug group achieved SVR12. Exploratory analysis suggested that lower baseline HCV viral load, younger age, and HCV genotype 1b were associated with SVR12. Ten patients had baseline HCV variants conferring greater than 20-fold resistance in vitro to at least 1 study DAA; all had viral relapse. Forty-eight percent (12 of 25) of patients receiving the 3-drug regimen and 72% (18 of 25) of those receiving the 4-drug regimen had adverse events, most of which were mild. One participant was lost to follow-up. Limitation:Nonrandomized study design and small sample of patients with early-stage fibrosis. Conclusion:Combination DAA therapy with 3 or 4 drugs for 4 weeks was well-tolerated but resulted in limited cure rates. Primary Funding Source:National Institute of Allergy and Infectious Diseases, National Cancer Institute, and Clinical Center Intramural Program; supported in part by a cooperative research and development agreement between the National Institutes of Health and Gilead Sciences.
Topics: hepatitis c rna, antiviral agents, genotype, hepatitis c antibodies, viral load result, hepatitis c virus, sofosbuvir, hepatitis c virus genotype 1, ledipasvir, hepatitis c, chronic, safety, therapeutics, hepatitis c virus genotype determination, host (organism)
Original Research | 
Erica P. Gunderson, PhD, MPH, MS, RD; Shanta R. Hurston, MPA; Xian Ning, MS; Joan C. Lo, MD; Yvonne Crites, MD; David Walton, MD; Kathryn G. Dewey, PhD; Robert A. Azevedo, MD; Stephen Young, MD; Gary Fox, MD; Cathie C. Elmasian, MD; Nora Salvador, MD; Michael Lum, MD; Barbara Sternfeld, PhD; Charles P. Quesenberry Jr., PhD, for the Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy Investigators
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Background:Lactation improves glucose metabolism, but its role in preventing type 2 diabetes mellitus (DM) after gestational diabetes mellitus (GDM) remains uncertain. Objective:To evaluate lactation and the 2-year incidence of DM after GDM pregnancy. Design:Prospective, observational cohort of women with recent GDM. (ClinicalTrials.gov: NCT01967030) Setting:Integrated health care system. Participants:1035 women diagnosed with GDM who delivered singletons at 35 weeks' gestation or later and enrolled in the Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy from 2008 to 2011. Measurements:Three in-person research examinations from 6 to 9 weeks after delivery (baseline) and annual follow-up for 2 years that included 2-hour, 75-g oral glucose tolerance testing; anthropometry; and interviews. Multivariable Weibull regression models evaluated independent associations of lactation measures with incident DM adjusted for potential confounders. Results:Of 1010 women without diabetes at baseline, 959 (95%) were evaluated up to 2 years later; 113 (11.8%) developed incident DM. There were graded inverse associations for lactation intensity at baseline with incident DM and adjusted hazard ratios of 0.64, 0.54, and 0.46 for mostly formula or mixed/inconsistent, mostly lactation, and exclusive lactation versus exclusive formula feeding, respectively (P trend = 0.016). Time-dependent lactation duration showed graded inverse associations with incident DM and adjusted hazard ratios of 0.55, 0.50, and 0.43 for greater than 2 to 5 months, greater than 5 to 10 months, and greater than 10 months, respectively, versus 0 to 2 months (P trend = 0.007). Weight change slightly attenuated hazard ratios. Limitation:Randomized design is not feasible or desirable for clinical studies of lactation. Conclusion:Higher lactation intensity and longer duration were independently associated with lower 2-year incidences of DM after GDM pregnancy. Lactation may prevent DM after GDM delivery. Primary Funding Source:National Institute of Child Health and Human Development.
Topics: diabetes mellitus, type 2, gestational diabetes, lactation, follow-up, pregnancy, prospective studies, oral glucose tolerance
Original Research | 
Karen T. Tashima, MD; Laura M. Smeaton, MS; Carl J. Fichtenbaum, MD; Adriana Andrade, MD, MPH; Joseph J. Eron, MD; Rajesh T. Gandhi, MD; Victoria A. Johnson, MD; Karin L. Klingman, MD; Justin Ritz, MS; Sally Hodder, MD; Jorge L. Santana, MD; Timothy Wilkin, MD; Richard H. Haubrich, MD, on behalf of the A5241 Study Team
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Background:Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatment-experienced patients in the absence of data from randomized trials. Objective:To compare treatment success between participants who omit versus those who add NRTIs to an optimized antiretroviral regimen of 3 or more agents. Design:Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394) Setting:Outpatient HIV clinics. Participants:Treatment-experienced patients with HIV infection and viral resistance. Intervention:Open-label optimized regimens (not including NRTIs) were selected on the basis of treatment history and susceptibility testing. Participants were randomly assigned to omit or add NRTIs. Measurements:The primary efficacy outcome was regimen failure through 48 weeks using a noninferiority margin of 15%. The primary safety outcome was time to initial episode of a severe sign, symptom, or laboratory abnormality before discontinuation of NRTI assignment. Results:360 participants were randomly assigned, and 93% completed a 48-week visit. The cumulative probability of regimen failure was 29.8% in the omit-NRTIs group versus 25.9% in the add-NRTIs group (difference, 3.2 percentage points [95% CI, −6.1 to 12.5 percentage points]). No significant between-group differences were found in the primary safety end points or the proportion of participants with HIV RNA level less than 50 copies/mL. No deaths occurred in the omit-NRTIs group compared with 7 deaths in the add-NRTIs group. Limitation:Unblinded study design, and the study may not be applicable to resource-poor settings. Conclusion:Treatment-experienced patients with HIV infection starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. Primary Funding Sources:National Institute of Allergy and Infectious Diseases, Boehringer Ingelheim, Janssen, Merck, ViiV Healthcare, Roche, and Monogram Biosciences (LabCorp).
Topics: salvage therapy, anti-retroviral agents, nucleoside reverse transcriptase inhibitors, aids clinical trial group, hiv, antiretroviral therapy, highly active, adverse event, hiv-1
Topics: diabetes mellitus, type 2, gestational diabetes, lactation
Clinical Guidelines | 
Niteesh K. Choudhry, MD, PhD; Thomas D. Denberg, MD, PhD; Amir Qaseem, MD, PhD, MHA, for the Clinical Guidelines Committee of the American College of Physicians
Description:The discrepancy between health care spending and achieved outcomes in the United States has fueled efforts to identify and address situations where unnecessarily expensive therapies are used when less costly, equally effective options are available. The underuse of generic medications is an important example. Methods:A literature review was conducted to answer 5 questions about generic medications: 1) How commonly are brand-name medications used when a generic version is available? 2) How does the use of generic medications influence adherence? 3) What is the evidence that brand-name and generic medications have similar clinical effects? 4) What are the barriers to increasing the use of generic medications? 5) What strategies can be used to promote cost savings through greater generic medication use? This article was reviewed and approved by the American College of Physicians Clinical Guidelines Committee, whose members are physicians trained in internal medicine and its subspecialties and which includes experts in evidence synthesis. Best Practice Advice:Clinicians should prescribe generic medications, if possible, rather than more expensive brand-name medications.
Topics: generic drugs, proprietary drug, american college of physicians
Reviews | 
Sonali Paul, MD, MS; Akriti Saxena, MD; Norma Terrin, PhD; Kathleen Viveiros, MD; Ethan M. Balk, MD, MPH; and John B. Wong, MD
Background:Solid tumor chemotherapy regimens pose a risk for hepatitis B virus (HBV) reactivation, but screening and antiviral prophylaxis remains controversial because of insufficient evidence. Purpose:To determine the risk for HBV reactivation with and without antiviral prophylaxis and the effectiveness of prophylaxis in adults with solid tumors and chronic or resolved HBV infection. Data Sources:MEDLINE through 1 July 2015 and Web of Science, Cochrane Central Register of Controlled Trials, TOXNET, and Scopus through 1 March 2015. Study Selection:26 English-language observational studies and randomized, controlled trials in patients with chronic or resolved HBV receiving chemotherapy for solid tumors. Data Extraction:Study characteristics, quality, and risk of bias were assessed by 1 researcher and verified by another independent researcher. Data Synthesis:Random-effects model meta-analyses were used to estimate the risk and odds ratio (OR) of reactivation with versus without antiviral prophylaxis. Reactivation in chronic HBV without prophylaxis ranged from 4% to 68% (median, 25%) with substantial heterogeneity. Prophylaxis reduced the risk for HBV reactivation (OR, 0.12 [95% CI, 0.06 to 0.22]), HBV-related hepatitis (OR, 0.18 [CI, 0.10 to 0.32]), and chemotherapy interruption (OR, 0.10 [CI, 0.04 to 0.27]). In 3 studies of patients with resolved HBV infection, none received HBV prophylaxis and reactivation risk ranged from 0.3% to 9.0% Limitations:Significant heterogeneity in underlying study populations and treatment regimens, incomplete baseline data, possibility of publication bias, and limited study quality. Most studies were observational and from Asia. Conclusion:In patients with chronic HBV receiving solid tumor chemotherapy, the risk for HBV reactivation is similar to the risk with other types of immunosuppressive therapy. Results support HBV screening and antiviral prophylaxis before initiation of chemotherapy for solid tumors. Primary Funding Source:National Center for Advancing Translational Sciences and National Institutes of Health.
Topics: chemotherapy regimen, hepatitis b, chronic, hepatitis b virus, solid tumour, antiviral prophylaxis
Topics: patient compliance, generic drugs, treatment outcome
Original Research | 
Tianhua He, MD; Kan Li, MS; Mark S. Roberts, MD, MPP; Anne C. Spaulding, MD, MPH; Turgay Ayer, PhD; John J. Grefenstette, PhD; and Jagpreet Chhatwal, PhD
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Background:The prevalence of hepatitis C virus (HCV) in U.S. prisoners is high; however, HCV testing and treatment are rare. Infected inmates released back into society contribute to the spread of HCV in the general population. Routine hepatitis screening of inmates followed by new therapies may reduce ongoing HCV transmission. Objective:To evaluate the health and economic effect of HCV screening and treatment in prisons on the HCV epidemic in society. Design:Agent-based microsimulation model of HCV transmission and progression of HCV disease. Data Sources:Published literature. Target Population:Population in U.S. prisons and general community. Time Horizon:30 years. Perspective:Societal. Interventions:Risk-based and universal opt-out hepatitis C screening in prisons, followed by treatment in a portion of patients. Outcome Measures:Prevention of HCV transmission and associated disease in prisons and society, costs, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICER), and total prison budget. Results of Base-Case Analysis:Implementing risk-based and opt-out screening could diagnose 41 900 to 122 700 new HCV cases in prisons in the next 30 years. Compared with no screening, these scenarios could prevent 5500 to 12 700 new HCV infections caused by releasees, wherein about 90% of averted infections would have occurred outside of prisons. HCV screening could also prevent 4200 to 11 700 liver-related deaths. The ICERs of screening scenarios were $19 600 to $29 200/QALY, and the respective first-year prison budget was $900 to $1150 million. Prisons would require an additional 12.4% of their current health care budget to implement such interventions. Results of Sensitivity Analysis:Results were sensitive to the time horizon, and ICERs otherwise remained less than $50 000 per QALY. Limitation:Data on transmission network, reinfection rate, and opt-out HCV screening rate are lacking. Conclusions:Universal opt-out HCV screening in prisons is highly cost-effective and would reduce HCV transmission and HCV-associated diseases primarily in the outside community. Investing in U.S. prisons to manage hepatitis C is a strategic approach to address the current epidemic. Primary Funding Source:National Institutes of Health.
Topics: hepatitis c, hepatitis c virus, correctional facilities, hepatitis c screening
Medicine and Public Issues | 
Ezekiel J. Emanuel, MD; Peter A. Ubel, MD; Judd B. Kessler, PhD; Gregg Meyer, MD, MSc; Ralph W. Muller, MA; Amol S. Navathe, MD, PhD; Pankaj Patel, MD, MSc; Robert Pearl, MD; Meredith B. Rosenthal, PhD; Lee Sacks, MD; Aditi P. Sen, PhD; Paul Sherman, MD; and Kevin G. Volpp, MD, PhD
Behavioral economics provides insights about the development of effective incentives for physicians to deliver high-value care. It suggests that the structure and delivery of incentives can shape behavior, as can thoughtful design of the decision-making environment. This article discusses several principles of behavioral economics, including inertia, loss aversion, choice overload, and relative social ranking. Whereas these principles have been applied to motivate personal health decisions, retirement planning, and savings behavior, they have been largely ignored in the design of physician incentive programs. Applying these principles to physician incentives can improve their effectiveness through better alignment with performance goals. Anecdotal examples of successful incentive programs that apply behavioral economics principles are provided, even as the authors recognize that its application to the design of physician incentives is largely untested, and many outstanding questions exist. Application and rigorous evaluation of infrastructure changes and incentives are needed to design payment systems that incentivize high-quality, cost-conscious care.
Topics: incentives, behavioral economics
In this issue, Paul and colleagues' meta-analysis examined the risk for HBV reactivation with and without antiviral prophylaxis and its effectiveness in adults with solid tumors and chronic or resolved HBV infection. The editorialists discuss the findings and their implications for pretreatment HBV screening and prophylaxis.
Topics: chemotherapy regimen, hepatitis b, hepatitis b virus, solid tumour
Acute uncomplicated diverticulitis occurs in approximately 4% of patients with diverticulosis. Outpatient, acute care, and inpatient physicians all participate in their care. The American Gastroenterological Association (AGA) has developed a new guideline on this subject. This commentary discusses acute uncomplicated diverticulitis and the AGA's recommendations.
Topics: diverticulitis
Original Research | 
Karine R. Sahakyan, MD, PhD, MPH; Virend K. Somers, MD, PhD; Juan P. Rodriguez-Escudero, MD; David O. Hodge, MS; Rickey E. Carter, PhD; Ondrej Sochor, MD; Thais Coutinho, MD; Michael D. Jensen, MD; Véronique L. Roger, MD, MPH; Prachi Singh, PhD; and Francisco Lopez-Jimenez, MD, MS
Background:The relationship between central obesity and survival in community-dwelling adults with normal body mass index (BMI) is not well-known. Objective:To examine total and cardiovascular mortality risks associated with central obesity and normal BMI. Design:Stratified multistage probability design. Setting:NHANES III (Third National Health and Nutrition Examination Survey). Participants:15 184 adults (52.3% women) aged 18 to 90 years. Measurements:Multivariable Cox proportional hazards models were used to evaluate the relationship of obesity patterns defined by BMI and waist-to-hip ratio (WHR) and total and cardiovascular mortality risk after adjustment for confounding factors. Results:Persons with normal-weight central obesity had the worst long-term survival. For example, a man with a normal BMI (22 kg/m2) and central obesity had greater total mortality risk than one with similar BMI but no central obesity (hazard ratio [HR], 1.87 [95% CI, 1.53 to 2.29]), and this man had twice the mortality risk of participants who were overweight or obese according to BMI only (HR, 2.24 [CI, 1.52 to 3.32] and 2.42 [CI, 1.30 to 4.53], respectively). Women with normal-weight central obesity also had a higher mortality risk than those with similar BMI but no central obesity (HR, 1.48 [CI, 1.35 to 1.62]) and those who were obese according to BMI only (HR, 1.32 [CI, 1.15 to 1.51]). Expected survival estimates were consistently lower for those with central obesity when age and BMI were controlled for. Limitations:Body fat distribution was assessed based on anthropometric indicators alone. Information on comorbidities was collected by self-report. Conclusion:Normal-weight central obesity defined by WHR is associated with higher mortality than BMI-defined obesity, particularly in the absence of central fat distribution. Primary Funding Source:National Institutes of Health, American Heart Association, European Regional Development Fund, and Czech Ministry of Health.
Topics: obesity, cardiovascular death, mortality, body mass index procedure
Original Research | 
Gregory T. Everson, MD; William J. Towner, MD; Mitchell N. Davis, DO; David L. Wyles, MD; Ronald G. Nahass, MD; Paul J. Thuluvath, MD; Kyle Etzkorn, MD; Federico Hinestrosa, MD; Myron Tong, MD, PhD; Mordechai Rabinovitz, MD; John McNally, PhD; Diana M. Brainard, MD; Lingling Han, PhD; Brian Doehle, PhD; John G. McHutchison, MD; Timothy Morgan, MD; Raymond T. Chung, MD; and Tram T. Tran, MD
Background:Effective, pangenotypic treatments for hepatitis C virus (HCV) infection are needed. Objective:To assess the safety and efficacy of sofosbuvir with velpatasvir in patients infected with HCV genotypes 1 to 6. Design:Randomized, phase 2, open-label study. (ClinicalTrials.gov: NCT01858766) Setting:48 U.S. sites. Patients:377 treatment-naive noncirrhotic patients. In part A, patients infected with HCV genotypes 1 to 6 were randomly assigned to sofosbuvir, 400 mg, with velpatasvir, 25 or 100 mg, for 12 weeks. In part B, patients with genotype 1 or 2 HCV infection were randomly assigned to sofosbuvir, 400 mg, and velpatasvir, 25 or 100 mg, with or without ribavirin for 8 weeks. Measurements:Sustained virologic response at 12 weeks (SVR12). Results:In part A, SVR12 rates were 96% (26 of 27) with velpatasvir, 25 mg, and 100% (28 of 28) with velpatasvir, 100 mg, for genotype 1; 93% (25 of 27) in both groups for genotype 3; and 96% (22 of 23) with velpatasvir, 25 mg, and 95% (21 of 22) with velpatasvir, 100 mg, for genotypes 2, 4, 5, and 6. In part B, for genotype 1, SVR12 rates were 87% (26 of 30) with velpatasvir, 25 mg; 83% (25 of 30) with velpatasvir, 25 mg, plus ribavirin; 90% (26 of 29) with velpatasvir, 100 mg; and 81% (25 of 31) with velpatasvir, 100 mg, plus ribavirin. For genotype 2, SVR12 rates were 77% (20 of 26) with velpatasvir, 25 mg; 88% (22 of 25) with velpatasvir, 25 mg, plus ribavirin; 88% (23 of 26) with velpatasvir, 100 mg; and 88% (23 of 26) with velpatasvir, 100 mg, plus ribavirin. Adverse events included fatigue (21%), headache (20%), and nausea (12%). One patient committed suicide. Limitation:The study was Open-label, no inferential statistics were planned, and sample sizes were small. Conclusion:Twelve weeks of sofosbuvir, 400 mg, and velpatasvir, 100 mg, was well-tolerated and resulted in high SVR in patients infected with HCV genotypes 1 to 6. Primary Funding Source:Gilead Sciences.
Topics: hepatitis c, genotype, hepatitis c virus, therapy naive, sofosbuvir, ribavirin
Original Research | 
Stephen Pianko, MD, PhD; Steven L. Flamm, MD; Mitchell L. Shiffman, MD; Sonal Kumar, MD; Simone I. Strasser, MD; Gregory J. Dore, MD; John McNally, PhD; Diana M. Brainard, MD; Lingling Han, PhD; Brian Doehle, PhD; Erik Mogalian, PhD; John G. McHutchison, MD; Mordechai Rabinovitz, MD; William J. Towner, MD; Edward J. Gane, MD; Catherine A.M. Stedman, MD; K. Rajender Reddy, MD; and Stuart K. Roberts, MD
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Background:Effective treatment options are needed for patients with genotype 1 or 3 hepatitis C virus (HCV) infection in whom previous therapy has failed. Objective:To assess the efficacy and safety of sofosbuvir plus velpatasvir, with and without ribavirin, in treatment-experienced patients. Design:Randomized, phase 2, open-label study. (ClinicalTrials.gov: NCT01909804) Setting:58 sites in Australia, New Zealand, and the United States. Patients:Treatment-experienced adults with genotype 3 HCV infection without cirrhosis (cohort 1) and with compensated cirrhosis (cohort 2) and patients with genotype 1 HCV infection that was unsuccessfully treated with a protease inhibitor with peginterferon and ribavirin (50% could have compensated cirrhosis) (cohort 3). Intervention:All patients received 12 weeks of treatment that included 400 mg of sofosbuvir once daily. Patients in each cohort were randomly assigned to 25 mg of velpatasvir once daily with or without ribavirin or 100 mg of velpatasvir once daily with or without ribavirin. Measurements:Proportion of patients with sustained virologic response at week 12 after treatment (SVR12). Results:In cohort 1, SVR12 rates were 85% with 25 mg of velpatasvir, 96% with 25 mg of velpatasvir plus ribavirin, 100% with 100 mg of velpatasvir, and 100% with 100 mg of velpatasvir plus ribavirin. In cohort 2, SVR12 rates were 58% with 25 mg of velpatasvir, 84% with 25 mg of velpatasvir plus ribavirin, 88% with 100 mg of velpatasvir, and 96% with 100 mg of velpatasvir plus ribavirin. In cohort 3, SVR12 rates were 100% with 25 mg of velpatasvir, 97% with 25 mg of velpatasvir plus ribavirin, 100% with 100 mg of velpatasvir, and 96% with 100 mg of velpatasvir plus ribavirin. The most common adverse events were headache, fatigue, and nausea. Limitation:Treatment assignments were not blinded, and no inferential statistics were planned. Conclusion:Treatment with 400 mg of sofosbuvir plus 100 mg of velpatasvir for 12 weeks was well-tolerated and highly effective in treatment-experienced patients with genotype 1 or 3 HCV infection. Primary Funding Source:Gilead Sciences.
Topics: hepatitis c, genotype, sofosbuvir, ribavirin, combined modality therapy, liver cirrhosis
In this issue, Sahakyan and colleagues examine data from a large cohort and compare the total and cardiovascular mortality risks for various combinations of BMI and WHR categories. The editorialist reviews their results and asserts that clinicians must look beyond BMI when assessing adiposity to better determine persons at greater risk for cardiovascular disease.
Topics: obesity
Summaries for Patients | 
Topics: obesity, mortality
As physicians seek innovative practice models, one that is gaining ground is for practices to contract with patients to pay directly for some or all services—often called cash-only, retainer, boutique, concierge, or direct primary care or specialty care practices.Such descriptions do not reflect the variability found in practices. For the purposes of this paper, the American College of Physicians (ACP) defines a direct patient contracting practice (DPCP) as any practice that directly contracts with patients to pay out-of-pocket for some or all of the services provided by the practice, in lieu of or in addition to traditional insurance arrangements, and/or charges an administrative fee to patients, sometimes called a retainer or concierge fee, often in return for a promise of more personalized and accessible care. This definition encompasses the practice types previously described.The move to DPCPs is based on the premise that access and quality of care will be improved without third-party payers imposing themselves between the patient and the physician. Yet concerns have been raised that DPCPs may cause access issues for patients that cannot afford to pay directly for care.This ACP position paper, initiated and written by its Medical Practice and Quality Committee and approved by the Board of Regents on 25 July 2015, assesses the impact of DPCPs on access, cost, and quality; discusses principles from the ACP Ethics Manual, Sixth Edition, that should apply to all practice types; and makes recommendations to mitigate any adverse effect on underserved patients.
Topics: ethics, patient evaluation, fees and charges, income, insurance, primary health care, diphenylcyclopropenone, american college of physicians, money, physician-patient relations, health insurance
Background:Studies in patients with acute coronary syndrome (ACS) undergoing invasive management showed conflicting conclusions regarding the effect of access site on outcomes. Purpose:To summarize evidence from recent, high-quality trials that compared clinical outcomes occurring with radial versus femoral access in invasively managed adults with ACS. Data Sources:English-language publications in MEDLINE, EMBASE, and Cochrane databases between January 1990 and August 2015. Study Selection:Randomized trials of radial versus femoral access in invasively managed patients with ACS. Data Extraction:Two investigators independently extracted the study data and rated the risk of bias. Data Synthesis:Of 17 identified randomized trials, 4 were high-quality multicenter trials that in total involved 17 133 patients. Pooled data from the 4 trials showed that radial access reduced death (relative risk [RR], 0.73 [95% CI, 0.59 to 0.90]; P = 0.003), major adverse coronary events (RR, 0.86 [CI, 0.75 to 0.98]; P = 0.025), and major bleeding (RR, 0.57 [CI, 0.37 to 0.88]; P = 0.011). Radial procedures lasted slightly longer (standardized mean difference, 0.11 minute) and had higher risk for access-site crossover (6.3% versus 1.7%) than did femoral procedures. Limitations:Heterogeneity in outcomes definitions and potential treatment modifiers across studies, including operator experience in radial procedures and concurrent anticoagulant regimens. Conclusions:Compared with femoral access, radial access reduces mortality, major coronary adverse events, and major bleeding in patients with ACS undergoing invasive management. Primary funding sources:No external funding. (PROSPERO: CRD42015022031)
Topics: acute coronary syndromes, st-segment elevation mi, hemorrhage, site of access, rifle-steacs trial, myocardial infarction, heterogeneity, st segment elevation, percutaneous coronary intervention
Editorials | 
Michael P. Savage, MD; David L. Fischman, MD; and Nicholas J. Ruggiero, MD
In this issue, Andò and Capodanno report a meta-analysis of randomized trials comparing radial and femoral artery access in patients with acute coronary syndromes (ACS). The editorialists comment on the strength and limitations of the evidence on vascular access during invasive interventions for ACS. They conclude that, although it is time for U.S. cardiologists to increase their utilization of the radial approach, patients are best served by operators who are facile with both approaches.
Topics: percutaneous coronary intervention, radial artery
Reviews | 
Ethan M. Balk, MD, MPH; Amy Earley, BS; Esther E. Avendano, BA; and Gowri Raman, MD, MS
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Background:Silicone gel breast implants were removed from the U.S. market for cosmetic use in 1992 owing to safety concerns. They were reintroduced in 2006, with a call for improved surveillance of clinical outcomes. Purpose:To systematically review the literature regarding specific long-term health outcomes in women with silicone gel breast implants, including cancer; connective tissue, rheumatologic, and autoimmune diseases; neurologic diseases; reproductive issues, including lactation; offspring issues; and mental health issues (depression and suicide). Data Sources:MEDLINE, EMBASE, and Ovid Healthstar (inception through 30 June 2015), and the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (through the first quarter of 2015). Study Selection:4 researchers double-screened articles for longitudinal studies that compared women with and without breast implants and reported long-term health outcomes of interest. Data Extraction:4 researchers extracted data on participant and implant characteristics, analytic methods, and results. Data Synthesis:32 studies (in 58 publications) met eligibility criteria. Random-effects model meta-analyses of effect sizes were conducted when feasible. For most outcomes, there was at most only a single adequately adjusted study, which usually found no significant associations. There were possible associations with decreased risk for primary breast and endometrial cancers and increased risks for lung cancer, rheumatoid arthritis, Sjögren syndrome, and Raynaud syndrome. There was limited evidence on or no association between breast implants and other outcomes. Limitation:The evidence was most frequently not specific to silicone gel implants, and studies were rarely adequately adjusted for potential confounders. Conclusion:The evidence remains inconclusive about any association between silicone gel implants and long-term health outcomes. Better evidence is needed from existing large studies, which can be reanalyzed to clarify the strength of associations between silicone gel implants and health outcomes. Primary Funding Source:The Plastic Surgery Foundation.
Topics: silicone gels, breast implants, cancer, health outcomes
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