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In a double-blind randomized crossover clinical trial, Zuchinali and colleagues evaluated the acute effects of high-dose caffeine in 51 patients with heart failure with predominantly moderate-to-severe left ventricular systolic dysfunction, a population at increased risk for arrhythmic events. After 500 mg of caffeine administered over a 5-hour period, there was no statistically significant effect of caffeine ingestion on the frequency of ventricular or supraventricular ectopies, bigeminal cycles and episodes of non-sustained tachycardia at rest and during a symptom-limited physical exercise. Even in patients with higher levels of plasmatic caffeine, no proarrhythmic action was observed. Kelly and Granger provide the Invited Commentary.
Continuing Medical Education
In this randomized clinical trial, McCaul and colleagues assessed the influence of ultrasonography screening for abdominal aortic aneurysm (AAA) in men between ages 64 and 83 years on the mortality from AAA in Western Australia. Using the electoral roll to identify potential participants, 38 480 men were randomized, with 19 249 men invited for screening; overall, 12 203 men (63.4%) were enrolled. After 12.8 years of follow-up, there were 90 deaths from AAA in the invited group and 98 in the control group. The number needed to screen to prevent 1 death from AAA in 5 years was 4784 for men between ages 64 and 83 years and 3290 for men between ages 65 and 74 years. There were no meaningful differences in all-cause, cardiovascular, and other mortality risks. Lederle provides the Invited Commentary.
In this systematic review of 12 reports, Gardon and colleagues found that 2 reports that assessed the association of industry sponsorship with statistical significance of results found no association. The report that assessed effect sizes found that industry-sponsored studies reported smaller harmful effects than nonindustry-sponsored studies. A meta-analysis of 8 reports suggested that industry-sponsored studies were more likely to have favorable conclusions than nonindustry-sponsored studies. Although research conclusions are disseminated to the public, empirical evidence examining the association of sponsorship and results of nutrition research is vital to evaluating them for systematic reviews and dietary guidelines.
In this study, Levine and colleagues measured outpatient care quality over more than a decade (2002-2013) in a large, nationally representative study to determine if major efforts to improve the quality of outpatient care in the United States have been successful and found inconsistent improvement in overall care. Some areas improved, including provision of recommended medical treatments, recommended counseling, and avoidance of inappropriate cancer screening, while other areas declined, including avoidance of inappropriate antibiotic prescribing and avoidance of inappropriate medical treatments. Several areas demonstrated disappointingly low absolute rates, even when improvement occurred. In contrast, patient experience improved. Despite efforts, the clinical quality of outpatient care delivered to adults in the United States has not consistently improved. McGlynn and colleagues provide the Invited Commentary.
Author Audio Interview
In this study, Lortet-Tieulent and colleagues estimated the proportion of cancer deaths attributable to cigarette smoking by state in 2014 using relative risks for smoking-related cancers from large US prospective studies and state-specific smoking prevalence data from the Behavioral Risk Factor Surveillance System and found that the proportion of smoking-attributable cancer deaths varied substantially across states, ranging from 22% in Utah to 40% in Arkansas among men and 11% in Utah to 29% Kentucky among women. Cigarette smoking accounted for more than 30% of cancer deaths among men and 20% in women among almost every state underscoring the continued need for strengthening tobacco control programs and policies in each state and federally. Ribisl and colleagues provide the Invited Commentary.
Freedberg and colleagues examined patient pairs who were sequentially admitted to a given hospital bed and assessed whether receipt of antibiotics by the prior bed occupant associated with risk for Clostridium difficile infection (CDI) in subsequent patients in that bed. Receipt of antibiotics by prior patients was associated with a 22% relative increase in risk for CDI in subsequent patients who occupied the same bed. This relationship remained essentially unchanged after adjusting for traditional risk factors for CDI, and after excluding patient pairs in which the prior bed occupant developed CDI. These findings suggest that antibiotics can facilitate transmission of CDI via asymptomatically colonized patients and demonstrate how antibiotics can be a risk factor for CDI even in patients who do not themselves receive antibiotics.
The 2011 changes to the Centers for Medicare & Medicaid Services (CMS) reimbursement policy for hemodialysis and the US Food and Drug Administration (FDA) drug label for erythropoiesis-stimulating agents (ESAs) raised concerns of potential adverse effects on patients undergoing hemodialysis. The CMS and FDA initiated a collaboration to assess the effect of these changes. In this retrospective cohort study, Wang and colleagues included 69 718 US incident hemodialysis patients 66 years or older and covered by fee-for-service Medicare from 2008 to 2013. Compared with patients who initiated dialysis prior to the policy changes (January 2008 to December 2009), those who initiated dialysis after the changes (July 2011 to June 2013) experienced a similar risk of major adverse cardiovascular events, all-cause mortality, hospitalized congestive heart failure, and venous thromboembolism; but a significant reduction in risk of stroke; and a modest increase of blood transfusion.
Many investigational medicines never reach patients because they fail in phase 3 clinical trials. In this study, Hwang and colleagues assessed factors associated with regulatory approval, reasons for failure in phase 3 trials, and rates of trial results publication. Using public sources and commercial databases, investigational therapeutics that entered pivotal trials between 1998 and 2008 with follow-up through 2015 were identified, and it was found that 344 drugs (54%) failed in clinical development, while 230 (36%) were approved by the US Food and Drug Administration. Sixty-six drugs(10%) were approved in countries other than the United States but not in the United States. Results show that the majority of experimental products fail in late-stage trials due to efficacy or safety outcomes, but trial results frequently remain unpublished.
Highlights. JAMA Intern Med. 2016;176(12):1735–1737. doi:10.1001/jamainternmed.2015.4918
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