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https://www.readbyqxmd.com/read/28720112/association-of-the-fda-amendment-act-with-trial-registration-publication-and-outcome-reporting
#1
REVIEW
Adam T Phillips, Nihar R Desai, Harlan M Krumholz, Constance X Zou, Jennifer E Miller, Joseph S Ross
BACKGROUND: Selective clinical trial publication and outcome reporting has the potential to bias the medical literature. The 2007 Food and Drug Administration (FDA) Amendment Act (FDAAA) mandated clinical trial registration and outcome reporting on ClinicalTrials.gov, a publicly accessible trial registry. METHODS: Using publicly available data from ClinicalTrials.gov, FDA documents, and PubMed, we determined registration, publication, and reporting of findings for all efficacy trials supporting FDA approval of new drugs for cardiovascular disease and diabetes between 2005 and 2014, before and after the FDAAA...
July 18, 2017: Trials
https://www.readbyqxmd.com/read/28719692/association-of-changing-hospital-readmission-rates-with-mortality-rates-after-hospital-discharge
#2
Kumar Dharmarajan, Yongfei Wang, Zhenqiu Lin, Sharon-Lise T Normand, Joseph S Ross, Leora I Horwitz, Nihar R Desai, Lisa G Suter, Elizabeth E Drye, Susannah M Bernheim, Harlan M Krumholz
Importance: The Affordable Care Act has led to US national reductions in hospital 30-day readmission rates for heart failure (HF), acute myocardial infarction (AMI), and pneumonia. Whether readmission reductions have had the unintended consequence of increasing mortality after hospitalization is unknown. Objective: To examine the correlation of paired trends in hospital 30-day readmission rates and hospital 30-day mortality rates after discharge. Design, Setting, and Participants: Retrospective study of Medicare fee-for-service beneficiaries aged 65 years or older hospitalized with HF, AMI, or pneumonia from January 1, 2008, through December 31, 2014...
July 18, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28710296/priorities-for-cardiovascular-outcomes-research-a-report-of-the-national-heart-lung-and-blood-institute-s-centers-for-cardiovascular-outcomes-research-working-group
#3
REVIEW
Prateeti Khazanie, Harlan M Krumholz, Catarina I Kiefe, Nancy R Kressin, Barbara Wells, Tracy Y Wang, Eric D Peterson
The Centers for Cardiovascular Outcomes Research (CCORs) held a meeting to review how cardiovascular outcomes research had evolved in the decade since the National Heart, Lung, and Blood Institute 2004 working group report and to consider future directions. The conference involved representatives from governmental agencies, outcomes research thought leaders, and public and private healthcare partners. The main purposes of this meeting were to (1) advance collaborative high-yield, high-impact outcomes research; (2) identify priorities and barriers to important cardiovascular outcomes research; and (3) define future needs for the field...
July 2017: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/28705865/with-great-power-comes-great-responsibility-big-data-research-from-the-national-inpatient-sample
#4
Rohan Khera, Harlan M Krumholz
No abstract text is available yet for this article.
July 2017: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/28697251/hemoglobin-a1c-as-a-surrogate-for-clinical-outcomes-in-diabetes-studies-reply
#5
Kasia J Lipska, Harlan M Krumholz
No abstract text is available yet for this article.
July 11, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28685482/hospital-readmissions-among-commercially-insured-and-medicare-advantage-beneficiaries-with-diabetes-and-the-impact-of-severe-hypoglycemic-and-hyperglycemic-events
#6
Rozalina G McCoy, Kasia J Lipska, Jeph Herrin, Molly M Jeffery, Harlan M Krumholz, Nilay D Shah
BACKGROUND: Hospital readmission is common among patients with diabetes. Some readmissions, particularly for hypoglycemia and hyperglycemia, may be avoidable with better care transitions and post-discharge management. OBJECTIVE: To ascertain the most common reasons and risk factors for readmission among adults with diabetes, with specific consideration of severe dysglycemia. DESIGN: Retrospective analysis of data from the OptumLabs Data Warehouse, an administrative data set of commercially insured and Medicare Advantage beneficiaries across the U...
July 6, 2017: Journal of General Internal Medicine
https://www.readbyqxmd.com/read/28677976/interconnection-of-key-microbial-functional-genes-for-enhanced-benzo-a-pyrene-biodegradation-in-sediments-by-microbial-electrochemistry
#7
Zaisheng Yan, Yuhong He, Haiyuan Cai, Joy D Van Nostrand, Zhili He, Jizhong Zhou, Lee R Krumholz, He-Long Jiang
Sediment microbial fuel cells (SMFCs) can stimulate the degradation of polycyclic aromatic hydrocarbons in sediments, but the mechanism of this process is poorly understood at the microbial functional gene level. Here, the use of SMFC resulted in 92% benzo[a]pyrene (BaP) removal over 970 days relative to 54% in the controls. Sediment functions, microbial community structure, and network interactions were dramatically altered by the SMFC employment. Functional gene analysis showed that c-type cytochrome genes for electron transfer, aromatic degradation genes, and extracellular ligninolytic enzymes involved in lignin degradation were significantly enriched in bulk sediments during SMFC operation...
July 14, 2017: Environmental Science & Technology
https://www.readbyqxmd.com/read/28662045/describing-the-performance-of-u-s-hospitals-by-applying-big-data-analytics
#8
Nicholas S Downing, Alexander Cloninger, Arjun K Venkatesh, Angela Hsieh, Elizabeth E Drye, Ronald R Coifman, Harlan M Krumholz
Public reporting of measures of hospital performance is an important component of quality improvement efforts in many countries. However, it can be challenging to provide an overall characterization of hospital performance because there are many measures of quality. In the United States, the Centers for Medicare and Medicaid Services reports over 100 measures that describe various domains of hospital quality, such as outcomes, the patient experience and whether established processes of care are followed. Although individual quality measures provide important insight, it is challenging to understand hospital performance as characterized by multiple quality measures...
2017: PloS One
https://www.readbyqxmd.com/read/28645937/quality-of-care-in-chinese-hospitals-processes-and-outcomes-after-st-segment-elevation-myocardial-infarction
#9
Nicholas S Downing, Yongfei Wang, Kumar Dharmarajan, Sudhakar V Nuti, Karthik Murugiah, Xue Du, Xin Zheng, Xi Li, Jing Li, Frederick A Masoudi, John A Spertus, Lixin Jiang, Harlan M Krumholz
BACKGROUND: China has gaps in the quality of care provided to patients with ST-elevation myocardial infarction, but little is known about how quality varies between hospitals. METHODS AND RESULTS: Using nationally representative data from the China PEACE-Retrospective AMI Study, we characterized the quality of care for ST-elevation myocardial infarction at the hospital level and examined variation between hospitals. Two summary measures were used to describe the overall quality of care at each hospital and to characterize variations in quality between hospitals in 2001, 2006, and 2011...
June 23, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28643207/parental-depressive-symptoms-as-a-predictor-of-outcome-in-the-treatment-of-child-depression
#10
Dikla Eckshtain, Lauren Krumholz Marchette, Jessica Schleider, John R Weisz
Child depression is an impairing condition for which psychotherapies have shown modest effects. Parental depression is a risk factor for development of child depression and might also be negatively associated with child depression treatment outcomes. To explore this possibility, we analyzed data from a study in which children were treated for depression after parental depressive symptoms had been assessed at baseline. Among children treated for depression in a randomized controlled trial, we identified 31 who had child- and parent-report pre- and post-treatment data on child symptoms and parent-report of pre-treatment parental depressive symptoms...
June 23, 2017: Journal of Abnormal Child Psychology
https://www.readbyqxmd.com/read/28634181/outcomes-after-observation-stays-among-older-adult-medicare-beneficiaries-in-the-usa-retrospective-cohort-study
#11
Kumar Dharmarajan, Li Qin, Maggie Bierlein, Jennie E S Choi, Zhenqiu Lin, Nihar R Desai, Erica S Spatz, Harlan M Krumholz, Arjun K Venkatesh
Objective To characterize rates and trends over time of emergency department treatment-and-discharge stays, repeat observation stays, inpatient stays, any hospital revisit, and death within 30 days of discharge from observation stays.Design Retrospective cohort study.Setting 4750 hospitals in the USA.Participants Nationally representative sample of Medicare fee for service beneficiaries aged 65 or over discharged after 363 037 index observation stays, 2 540 000 index emergency department treatment-and-discharge stays, and 2 667 525 index inpatient stays from 2006-11...
June 20, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28611187/comparing-outcomes-of-coronary-artery-bypass-grafting-among-large-teaching-and-urban-hospitals-in-china-and-the-united-states
#12
Zhe Zheng, Heng Zhang, Xin Yuan, Chenfei Rao, Yan Zhao, Yun Wang, Sharon-Lise Normand, Harlan M Krumholz, Shengshou Hu
BACKGROUND: Coronary artery disease is prevalent in China, with concomitant increases in the volume of coronary artery bypass grafting (CABG). The present study aims to compare CABG-related outcomes between China and the United States among large teaching and urban hospitals. METHODS AND RESULTS: Observational analysis of patients aged ≥18 years, discharged from acute-care, large teaching and urban hospitals in China and the United States after hospitalization for an isolated CABG surgery...
June 2017: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/28593267/national-trends-in-use-and-outcomes-of-pulmonary-artery-catheters-among-medicare-beneficiaries-1999-2013
#13
Kevin Ikuta, Yun Wang, Austin Robinson, Tariq Ahmad, Harlan M Krumholz, Nihar R Desai
Importance: Recent studies have observed an increase in the rate of pulmonary artery catheter (PAC) use in heart failure admissions. Little is known about the national trends in other previously common indications for PAC placement, PAC use overall, or outcomes associated with PAC placement. Objective: To determine national trends in PAC use overall as well as across sociodemographic groups and key clinical conditions, including acute myocardial infarction, heart failure, and respiratory failure...
June 7, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/28569419/regulating-drivers-with-epilepsy-in-maryland-results-of-the-application-of-a-united-states-consensus-guideline
#14
Brandy B Ma, John Bloch, Allan Krumholz, Jennifer L Hopp, Perry J Foreman, Carl A Soderstrom, Mary A Scottino, Martha Matsumoto, Gregory L Krauss
OBJECTIVE: Driving regulations for people with seizures vary widely throughout the United States and the world. Maryland updated their guidelines in 2003 to reflect those of a U.S. consensus guideline requiring a minimum 3-month seizure-free period as well as an individual risk assessment by a Medical Advisory Board (MAB). This retrospective study provides the first analysis of outcomes after the implementation of the consensus guidelines and an assessment of their predictive validity through longitudinal outcome data...
June 1, 2017: Epilepsia
https://www.readbyqxmd.com/read/28559399/heterogeneity-in-early-responses-in-allhat-antihypertensive-and-lipid-lowering-treatment-to-prevent-heart-attack-trial
#15
Sanket S Dhruva, Chenxi Huang, Erica S Spatz, Andreas C Coppi, Frederick Warner, Shu-Xia Li, Haiqun Lin, Xiao Xu, Curt D Furberg, Barry R Davis, Sara L Pressel, Ronald R Coifman, Harlan M Krumholz
Randomized trials of hypertension have seldom examined heterogeneity in response to treatments over time and the implications for cardiovascular outcomes. Understanding this heterogeneity, however, is a necessary step toward personalizing antihypertensive therapy. We applied trajectory-based modeling to data on 39 763 study participants of the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) to identify distinct patterns of systolic blood pressure (SBP) response to randomized medications during the first 6 months of the trial...
July 2017: Hypertension
https://www.readbyqxmd.com/read/28548291/practitioner-review-empirical-evolution-of-youth-psychotherapy-toward-transdiagnostic-approaches
#16
REVIEW
Lauren Krumholz Marchette, John R Weisz
BACKGROUND: Psychotherapy for children and adolescents (herein, 'youths') has grown more precise and focused over the decades, shifting toward empirically supported treatments standardized via therapist manuals. The manuals have increasingly emphasized precise targeting of single disorders or problems, or homogenous clusters. These focal treatments represent a valuable advance, with intervention benefit documented in hundreds of studies. However, relatively few of these treatments are widely used in everyday clinical practice, and their level of benefit may not be ideal, particularly in practice contexts and when compared to usual clinical care...
May 26, 2017: Journal of Child Psychology and Psychiatry, and Allied Disciplines
https://www.readbyqxmd.com/read/28516505/associations-between-nursing-home-performance-and-hospital-30-day-readmissions-for-acute-myocardial-infarction-heart-failure-and-pneumonia-at-the-healthcare-community-level-in-the-united-states
#17
Michelle M Pandolfi, Yun Wang, Ann Spenard, Florence Johnson, Alice Bonner, Shih-Yieh Ho, Timothy Elwell, Anila Bakullari, Deron Galusha, Erica Leifheit-Limson, Judith H Lichtman, Harlan M Krumholz
OBJECTIVES: To evaluate community-specific nursing home performance with community-specific hospital 30-day readmissions for Medicare patients discharged with acute myocardial infarction, heart failure or pneumonia. DESIGN: Cross-sectional study using 2009-2012 hospital risk-standardised 30-day readmission data for Medicare fee-for-service patients hospitalised for all three conditions and nursing home performance data from the Centers for Medicare & Medicaid Services Five-Star Quality Rating System...
May 17, 2017: International Journal of Older People Nursing
https://www.readbyqxmd.com/read/28506980/sex-differences-in-trajectories-of-risk-after-rehospitalization-for-heart-failure-acute-myocardial-infarction-or-pneumonia
#18
Rachel P Dreyer, Kumar Dharmarajan, Angela F Hsieh, John Welsh, Li Qin, Harlan M Krumholz
BACKGROUND: Women have an increased risk of rehospitalization in the immediate postdischarge period; however, few studies have determined how readmission risk dynamically changes on a day-to-day basis over the full year after hospitalization by sex and how these differences compare with the risk for mortality. METHODS AND RESULTS: We identified >3 000 000 hospitalizations of patients with a principal discharge diagnosis of heart failure, acute myocardial infarction, or pneumonia and estimated sex differences in the daily risk of rehospitalization/death 1 year after discharge from a population of Medicare fee-for-service beneficiaries aged 65 years and older...
May 2017: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/28493548/time-for-a-new-approach-to-studying-older-people-with-ischemic-heart-disease
#19
EDITORIAL
John A Dodson, Sarwat I Chaudhry, Harlan M Krumholz
No abstract text is available yet for this article.
May 11, 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28492899/postmarket-safety-events-among-novel-therapeutics-approved-by-the-us-food-and-drug-administration-between-2001-and-2010
#20
Nicholas S Downing, Nilay D Shah, Jenerius A Aminawung, Alison M Pease, Jean-David Zeitoun, Harlan M Krumholz, Joseph S Ross
Importance: Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making. Objectives: To characterize the frequency of postmarket safety events among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic characteristics known at the time of FDA approval were associated with increased risk...
May 9, 2017: JAMA: the Journal of the American Medical Association
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