7321. The Anticipated Clinical and Economic Effects of 90-90-90 in South Africa.
作者: Rochelle P Walensky.;Ethan D Borre.;Linda-Gail Bekker.;Stephen C Resch.;Emily P Hyle.;Robin Wood.;Milton C Weinstein.;Andrea L Ciaranello.;Kenneth A Freedberg.;A David Paltiel.
来源: Ann Intern Med. 2016年165卷5期325-33页
The Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 global treatment target aims to achieve 73% virologic suppression among HIV-infected persons worldwide by 2020.
7322. The Effectiveness of Total Worker Health Interventions: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop.
作者: Cynthia Feltner.;Kristina Peterson.;Rachel Palmieri Weber.;Laurie Cluff.;Emmanuel Coker-Schwimmer.;Meera Viswanathan.;Kathleen N Lohr.
来源: Ann Intern Med. 2016年165卷4期262-9页
The Total Worker Health (TWH) program of the National Institute for Occupational Safety and Health aims to advance worker well-being by integrating injury and illness prevention efforts with work-related safety and health hazard efforts.
7323. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015.
作者: Dalia Deak.;Kevin Outterson.;John H Powers.;Aaron S Kesselheim.
来源: Ann Intern Med. 2016年165卷5期363-72页
A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information from company filings, press releases, and media reports. Four antibiotics were approved for acute bacterial skin and skin-structure infection. Seven had similar mechanisms of action to those of previously approved drugs. Six were initially developed by small to midsized companies, and 7 are currently marketed by 1 of 3 large companies. The drugs spent a median of 6.2 years in clinical trials (interquartile range [IQR], 5.4 to 8.8 years) and 8 months in FDA review (IQR, 7.5 to 8 months). The median number of patients enrolled in the pivotal trials was 666 (IQR, 553 to 739 patients; full range, 44 to 1005 patients), and median trial duration was 18 months (IQR, 15 to 22 months). Seven drugs were approved on the basis of pivotal trials evaluating noninferiority. One drug demonstrated superiority on an exploratory secondary end point, 2 showed decreased efficacy in patients with renal insufficiency, and 1 showed increased mortality compared with older drugs. Seven of the drugs are substantially more expensive than their trial comparators. Limitations are that future research may show benefit to patients, new drugs from older classes may show superior effectiveness in specific patient populations, and initial U.S. prices for each new antibiotic were obtained from public sources. Recently marketed antibiotics are more expensive but have been approved without evidence of clinical superiority.
7325. Public Reporting of Mortality Rates for Hospitalized Medicare Patients and Trends in Mortality for Reported Conditions.
Public reporting is seen as a powerful quality improvement tool, but data to support its efficacy are limited. The Centers for Medicare & Medicaid Services' Hospital Compare program initially reported process metrics only but started reporting mortality rates for acute myocardial infarction, heart failure, and pneumonia in 2008.
7326. Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease.
作者: Daniel B Mark.;Jerome J Federspiel.;Patricia A Cowper.;Kevin J Anstrom.;Udo Hoffmann.;Manesh R Patel.;Linda Davidson-Ray.;Melanie R Daniels.;Lawton S Cooper.;J David Knight.;Kerry L Lee.;Pamela S Douglas.; .
来源: Ann Intern Med. 2016年165卷2期94-102页
PROMISE (PROspective Multicenter Imaging Study for Evaluation of Chest Pain) found that initial use of at least 64-slice multidetector computed tomography angiography (CTA) versus functional diagnostic testing strategies did not improve clinical outcomes in stable symptomatic patients with suspected coronary artery disease (CAD) requiring noninvasive testing.
7327. Genomic Alteration-Driven Clinical Trial Designs in Oncology.
The established molecular heterogeneity of human cancers necessitates the development of new paradigms to serve as a reliable basis for precision medicine. The assumptions underlying some of the conventional approaches to clinical trial design and analysis are no longer appropriate because of the molecular heterogeneity of tumors of a given primary site. This article reviews some clinical trial designs that have been actively applied in the codevelopment of therapeutics and predictive biomarkers to inform their use in oncology. These include the enrichment design, the basket design, and the umbrella design. Oncology leads most other therapeutic areas in development of personalized or precision medicine. Personalized or precision medicine is practiced daily in oncology on the basis of tumor genomics and may evolve in other therapeutic areas as it has in oncology, rather than according to inherited polymorphisms as so often imagined. Consequently, some of the clinical trial designs described here may serve as a possible blueprint for therapeutic development in fields other than oncology.
7333. Yes, You Can: Physicians, Patients, and Firearms.
Physicians have unique opportunities to help prevent firearm violence. Concern has developed that federal and state laws or regulations prohibit physicians from asking or counseling patients about firearms and disclosing patient information about firearms to others, even when threats to health and safety may be involved. This is not the case. In this article, the authors explain the statutes in question, emphasizing that physicians may ask about firearms (with rare exceptions), may counsel about firearms as they do about other health matters, and may disclose information to third parties when necessary. The authors then review circumstances under which questions about firearms might be most appropriate if they are not asked routinely. Such circumstances include instances when the patient provides information or exhibits behavior suggesting an acutely increased risk for violence, whether to himself or others, or when the patient possesses other individual-level risk factors for violence, such as alcohol abuse. The article summarizes the literature on current physician practices in asking and counseling about firearms, which are done far less commonly than recommended. Barriers to engaging in those practices, the effectiveness of clinical efforts to prevent firearm-related injuries, and what patients think about such efforts and physicians who engage in them are discussed. Proceeding from the limited available evidence, the authors make specific recommendations on how physicians might counsel their patients to reduce their risk for firearm-related death or serious injury. Finally, the authors review the circumstances under which disclosure of patient information about firearms to third parties is supported by regulations implementing the Health Insurance Portability and Accountability Act.
7334. Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial.
作者: Chenchen Wang.;Christopher H Schmid.;Maura D Iversen.;William F Harvey.;Roger A Fielding.;Jeffrey B Driban.;Lori Lyn Price.;John B Wong.;Kieran F Reid.;Ramel Rones.;Timothy McAlindon.
来源: Ann Intern Med. 2016年165卷2期77-86页
Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis.
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