Annals of Internal Medicine - recientes
Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus–Infected Donors to Noninfected Recipients An Open-Label Nonrandomized Trial17/4/2018
Durand CM, Bowring MG, Brown DM, et al.
Background:Given the high mortality rate for patients with end-stage kidney disease receiving dialysis and the efficacy and safety of hepatitis C virus (HCV) treatments, discarded kidneys from HCV-infected donors may be a neglected public health resource.
Objective:To determine the tolerability and feasibility of using direct-acting antivirals (DAAs) as prophylaxis before and after kidney transplantation from HCV-infected donors to non–HCV-infected recipients (that is, HCV D+/R− transplantation).
Design:Open-label nonrandomized trial. (ClinicalTrials.gov: NCT02781649)
Participants:10 HCV D+/R− kidney transplant candidates older than 50 years with no available living donors.
Intervention:Transplantation of kidneys from deceased donors aged 13 to 50 years with positive HCV RNA and HCV antibody test results. All recipients received a dose of grazoprevir (GZR), 100 mg, and elbasvir (EBR), 50 mg, immediately before transplantation. Recipients of kidneys from donors with genotype 1 infection continued receiving GZR–EBR for 12 weeks after transplantation; those receiving organs from donors with genotype 2 or 3 infection had sofosbuvir, 400 mg, added to GZR–EBR for 12 weeks of triple therapy.
Measurements:The primary safety outcome was the incidence of adverse events related to GZR–EBR treatment. The primary efficacy outcome was the proportion of recipients with an HCV RNA level below the lower limit of quantification 12 weeks after prophylaxis.
Results:Among 10 HCV D+/R− transplant recipients, no treatment-related adverse events occurred, and HCV RNA was not detected in any recipient 12 weeks after treatment.
Limitation:Nonrandomized study design and a small number of patients.
Conclusion:Pre- and posttransplantation HCV treatment was safe and prevented chronic HCV infection in HCV D+/R– kidney transplant recipients. If confirmed in larger studies, this strategy should markedly expand organ options and reduce mortality for kidney transplant candidates without HCV infection.
Primary Funding Source:Merck Sharp & Dohme.
Trends in Racial/Ethnic and Nativity Disparities in Cardiovascular Health Among Adults Without Prevalent Cardiovascular Disease in the United States, 1988 to 201417/4/2018
Brown AF, Liang L, Vassar SD, et al.
Background:Trends in cardiovascular disparities are poorly understood, even as diversity increases in the United States.
Objective:To examine U.S. trends in racial/ethnic and nativity disparities in cardiovascular health.
Design:Repeated cross-sectional study.
Setting:NHANES (National Health and Nutrition Examination Survey), 1988 to 2014.
Participants:Adults aged 25 years or older who did not report cardiovascular disease.
Measurements:Racial/ethnic, nativity, and period differences in Life's Simple 7 (LS7) health factors and behaviors (blood pressure, cholesterol, hemoglobin A1c, body mass index, physical activity, diet, and smoking) and optimal composite scores for cardiovascular health (LS7 score ≥10).
Results:Rates of optimal cardiovascular health remain below 40% among whites, 25% among Mexican Americans, and 15% among African Americans. Disparities in optimal cardiovascular health between whites and African Americans persisted but decreased over time. In 1988 to 1994, the percentage of African Americans with optimal LS7 scores was 22.8 percentage points (95% CI, 19.3 to 26.4 percentage points) lower than that of whites in persons aged 25 to 44 years and 8.0 percentage points (CI, 6.4 to 9.7 percentage points) lower in those aged 65 years or older. By 2011 to 2014, differences decreased to 10.6 percentage points (CI, 7.4 to 13.9 percentage points) and 3.8 percentage points (CI, 2.5 to 5.0 percentage points), respectively. Disparities in optimal LS7 scores between whites and Mexican Americans were smaller but also decreased. These decreases were due to reductions in optimal cardiovascular health among whites over all age groups and periods: Between 1988 to 1994 and 2011 to 2014, the percentage of whites with optimal cardiovascular health decreased 15.3 percentage points (CI, 11.1 to 19.4 percentage points) for those aged 25 to 44 years and 4.6 percentage points (CI, 2.7 to 6.5 percentage points) for those aged 65 years or older.
Limitation:Only whites, African Americans, and Mexican Americans were studied.
Conclusion:Cardiovascular health has declined in the United States, racial/ethnic and nativity disparities persist, and decreased disparities seem to be due to worsening cardiovascular health among whites rather than gains among African Americans and Mexican Americans. Multifaceted interventions are needed to address declining population health and persistent health disparities.
Primary Funding Source:National Institute of Neurological Disorders and Stroke and National Center for Advancing Translational Sciences of the National Institutes of Health.
Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients A Randomized Controlled Trial17/4/2018
Miller DP, Jr., Denizard-Thompson N, Weaver KE, et al.
Background:Screening for colorectal cancer (CRC) reduces mortality, yet more than one third of age-eligible Americans are unscreened.
Objective:To examine the effect of a digital health intervention, Mobile Patient Technology for Health–CRC (mPATH-CRC), on rates of CRC screening.
Design:Randomized clinical trial. (ClinicalTrials.gov: NCT02088333)
Setting:6 community-based primary care practices.
Participants:450 patients (223 in the mPATH-CRC group and 227 in usual care) scheduled for a primary care visit and due for routine CRC screening.
Intervention:An iPad application that displays a CRC screening decision aid, lets patients order their own screening tests, and sends automated follow-up electronic messages to support patients.
Measurements:The primary outcome was chart-verified completion of CRC screening within 24 weeks. Secondary outcomes were ability to state a screening preference, intention to receive screening, screening discussions, and orders for screening tests. All outcome assessors were blinded to randomization.
Results:Baseline characteristics were similar between groups; 37% of participants had limited health literacy, and 53% had annual incomes less than $20 000. Screening was completed by 30% of mPATH-CRC participants and 15% of those receiving usual care (logistic regression odds ratio, 2.5 [95% CI, 1.6 to 4.0]). Compared with usual care, more mPATH-CRC participants could state a screening preference, planned to be screened within 6 months, discussed screening with their provider, and had a screening test ordered. Half of mPATH-CRC participants (53%; 118 of 223) “self-ordered” a test via the program.
Limitation:Participants were English speakers in a single health care system.
Conclusion:A digital health intervention that allows patients to self-order tests can increase CRC screening. Future research should identify methods for implementing similar interventions in clinical care.
Primary Funding Source:National Cancer Institute.
Evidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1) A Systematic Review17/4/2018
Pepper DJ, Jaswal D, Sun J, et al.
This article has been corrected. To see what has changed, please read the Letter to the Editor and the authors' response. The original version (PDF) is appended to this article as a Supplement.
Background:The Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), the sepsis performance measure introduced in 2015 by the Centers for Medicare & Medicaid Services (CMS), requires the reporting of up to 5 hemodynamic interventions, as many as 141 tasks, and 3 hours to document for a single patient.
Purpose:To evaluate whether moderate- or high-level evidence shows that use of the 2015 SEP-1 or its hemodynamic interventions improves survival in adults with sepsis.
Data Sources:PubMed, Embase, Scopus, Web of Science, and ClinicalTrials.gov from inception to 28 November 2017 with no language restrictions.
Study Selection:Randomized and observational studies of death among adults with sepsis who received versus those who did not receive either the entire SEP-1 bundle or 1 or more SEP-1 hemodynamic interventions, including serial lactate measurements; a fluid infusion of 30 mL/kg of body weight; and assessment of volume status and tissue perfusion with a focused examination, bedside cardiovascular ultrasonography, or fluid responsiveness testing.
Data Extraction:Two investigators independently extracted study data and assessed each study's risk of bias; 4 authors rated level of evidence by consensus using CMS criteria published in 2013. High- or moderate-level evidence required studies to have no confounders and low risk of bias.
Data Synthesis:Of 56 563 references, 20 studies (18 reports) met inclusion criteria. One single-center observational study reported lower in-hospital mortality after implementation of the SEP-1 bundle. Sixteen studies (2 randomized and 14 observational) reported increased survival with serial lactate measurements or 30-mL/kg fluid infusions. None of the 17 studies were free of confounders or at low risk of bias. In 3 randomized trials, fluid responsiveness testing did not alter survival.
Limitations:Few trials, poor-quality and confounded studies, and no studies (with survival outcomes) of the focused examination or bedside cardiovascular ultrasonography. Use of the 2015 version of SEP-1 and 2013 version of CMS evidence criteria, both of which were updated in 2017.
Conclusion:No high- or moderate-level evidence shows that SEP-1 or its hemodynamic interventions improve survival in adults with sepsis.
Primary Funding Source:National Institutes of Health. (PROSPERO: CRD42016052716)
Hemoglobin A 1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians17/4/2018
Qaseem A, Wilt TJ, Kansagara D, et al.
Description:The American College of Physicians developed this guidance statement to guide clinicians in selecting targets for pharmacologic treatment of type 2 diabetes.
Methods:The National Guideline Clearinghouse and the Guidelines International Network library were searched (May 2017) for national guidelines, published in English, that addressed hemoglobin A1c (HbA1c) targets for treating type 2 diabetes in nonpregnant outpatient adults. The authors identified guidelines from the National Institute for Health and Care Excellence and the Institute for Clinical Systems Improvement. In addition, 4 commonly used guidelines were reviewed, from the American Association of Clinical Endocrinologists and American College of Endocrinology, the American Diabetes Association, the Scottish Intercollegiate Guidelines Network, and the U.S. Department of Veterans Affairs and Department of Defense. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the guidelines.
Guidance Statement 1:Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of benefits and harms of pharmacotherapy, patients' preferences, patients' general health and life expectancy, treatment burden, and costs of care.
Guidance Statement 2:Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes.
Guidance Statement 3:Clinicians should consider deintensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%.
Guidance Statement 4:Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 years or older), residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage kidney disease, or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population.
Addressing Social Determinants to Improve Patient Care and Promote Health Equity: An American College of Physicians Position Paper17/4/2018
Daniel H, Bornstein SS, Kane GC, et al.
Social determinants of health are nonmedical factors that can affect a person's overall health and health outcomes. Where a person is born and the social conditions they are born into can affect their risk factors for premature death and their life expectancy. In this position paper, the American College of Physicians acknowledges the role of social determinants in health, examines the complexities associated with them, and offers recommendations on better integration of social determinants into the health care system while highlighting the need to address systemic issues hindering health equity.
Delbanco S, Delbanco T.
With patients and clinicians confronting daunting uncertainties in health care, arguments rage about quality, costs, and how to improve the lives of both those who seek and those who provide care. In light of rapidly evolving health information technologies, the authors anticipate that widespread societal movement toward greater transparency will spur important advances.
Teutsch SM, Naimi TS.
More than 10 000 alcohol-related driving fatalities occur each year. To identify ways of reinvigorating efforts to stem these tragic events, the National Highway Traffic Safety Administration asked the National Academies of Sciences, Engineering, and Medicine to form a committee to rigorously study the problem and make recommendations. This commentary highlights those recommendations.
The Short-Lived Epidemic of Botulism From Commercially Canned Foods in the United States, 1919 to 192517/4/2018
In 1919, three deadly outbreaks of botulism caused by consumption of canned olives packed in California captured national headlines. In all of the outbreaks, which occurred in separate locales, unsuspecting people died after consuming tainted food during a banquet or family meal. The press's sensational portrayal of canned food as hazardous aroused alarm among consumers at a time when commercial canning was becoming more common. Intent on restoring the image of their product as safe and wholesome, canning industry leaders funded a “botulism commission” of scientific experts in 1919 to investigate how to systematically eliminate the threat of botulism that had imperiled their business. The commissioners identified the scientific reasons for the outbreaks, and on the basis of their findings, the California Department of Public Health issued explicit recommendations for sterilization procedures intended to ensure safety. However, the department did not mandate inspections for all canneries. When commercially packed fruits and vegetables continued to cause botulism, industry leaders voluntarily backed a cannery inspection act to legally require all California canners to possess appropriate equipment and follow scientifically validated sterilization procedures. After the California legislature approved the act in 1925, canneries were inspected, regulations were enforced, and no further outbreaks occurred.This botulism epidemic is an example of a disease outbreak that was controlled when business interests became aligned with public health goals. The press's portrayal of afflicted persons as innocent victims and worthy citizens galvanized businessmen to implement safeguards to protect consumers from botulism intoxication. To preserve their customer base and salvage their corporations, leaders of the canning industry acknowledged the public health threat of their unregulated procedures and acted on the recommendations of scientists.
Disparities in cardiovascular health remain pervasive in the United States, with higher mortality in blacks than whites. Brown and colleagues' report showed a narrowing of the black–white gap in cardiovascular health. The editorialist notes that while this result seems encouraging, the report adds an unexpected but important wrinkle to the health disparities saga.
Mehta SJ, Asch DA.
Miller and colleagues report the results of a randomized trial of an iPad-based decision aid and patient self-ordering intervention that achieved a 30% colorectal cancer screening rate, compared with 15% among control patients. The editorialists speculate on what aspect of the intervention might account for the effect observed and how an even more effective intervention could be designed.
Kress JP, Hall JB.
Regulatory agencies evaluate hospitals' care of patients with sepsis according to their completion of the SEP-1 performance measure. Pepper and colleagues found that evidence is lacking to support a survival benefit of SEP-1 or its hemodynamic interventions. The editorialists discuss this study's importance in light of the many hours it may require for clinicians to comply with SEP-1's documentation requirements.
Himmelstein DU, Woolhandler S.
The American College of Physicians position paper focuses on deteriorating social determinants of health. The editorialists note that the paper highlights many social determinants that underlie health inequities but omits others, such as mass incarceration and inequities in power.
Woolhandler S, Himmelstein DU.
Prorok PC, Miller AB.
Autier P, Boyle P.
Luh JY, Finkelstein SE, Michalski JM, et al.
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