Dr. Chen and colleagues in the Fay W. Boozman College of Public Health at the University of Arkansas for Medical Sciences compared the financial performance between Delta hospitals and non-Delta hospitals (namely, other hospitals in the nation) from 2008 through 2014 that were covered before and after the implementation of the HRRP and HVBP programs. The financial performance was measured by using the operating margin (profitability from patient care) and total margin (profitability from patient care and non-patient care)
Before the implementation of the HRRP and HVBP programs, Delta hospitals had weaker financial performance than non-Delta hospitals but their differences were not statistically significant. After the implementation of the HRRP and HVBP programs, the gap in financial performance between Delta and non-Delta hospitals became wider and significant. The unadjusted operating margin for Delta hospitals was about -4.0% in 2011 and continuously fell to -10.4% in 2014, while the unadjusted operating margin for non-Delta hospitals was about 0.1% in 2011 and dropped to -1.5% in 2014. The unadjusted total margin for Delta hospitals significantly fell from 3.6% in 2012 to 1.1% in 2013 and reached 0.2% in 2014, while the unadjusted total margin for non-Delta hospitals remained about 5.3% from 2012 through 2014. After adjusting hospital and community characteristics, the difference in financial performance between Delta and non-Delta remained significant.
(more…)MedicalResearch.com Interview with: Hawkins C. Gay, MD, MPH Resident Physician, Internal Medicine Feinberg School of Medicine Northwestern University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The National Academy of Medicine and other leading institutions have highlighted clinical trial data sharing as an important initiative for enhancing trust in the clinical research enterprise. More recently, the International Committee of Medical Journal Editors stipulated that manuscripts published in their journals must clearly state plans for data sharing in the trial’s registration, and the National Institutes of Health now requires a data sharing plan as part of new grant applications. Many clinical trialists rightly debate the costs and time required to curate their data into a format that is usable by third part data analysts. Similarly, there has been debate about the most efficient platforms from which to distribute this data, and different models exist, including governmental (NIH BioLINCC), commercial (ClinicalStudyDataRequest.com), and academic (Yale Open Access Data Project [YODA]) platforms. Our study sought to explore these questions by conducting a reproduction analysis of the Thermocool Smarttouch Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial (NCT01385202), which is the only cardiovascular clinical trial available through the YODA platform. Reproduction analyses represent a fundamental approach for and outcome from data sharing but are uncommonly performed even though results change more than one-quarter of the time in reproduction analyses. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. The time from our initial proposal submission to YODA and the final analysis completion was 11 months. Freedom from atrial arrhythmias at 12 months post-procedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the two analyses. We could not reproduce all analyses that were conducted in the primary study report; specifically, the analyses relating to contact force range and regression models. The primary reason for non-reproducibility was missing or un-locatable data in the analyzable dataset. (more…)