This is a cross-sectional study aiming to understand the early characteristics and background of bone health impairment in clinically well children with Fontan circulation.

We enrolled 10 clinically well children with Fontan palliation (operated >5 years before study entrance, Tanner stage ≤3, age 12.1 ± 1.77 years, 7 males) and 11 healthy controls (age 12.0 ± 1.45 years, 9 males) at two children’s hospitals. All patients underwent peripheral quantitative CT. For the Fontan group, we obtained clinical characteristics, NYHA class, cardiac index by MRI, dual x-ray absorptiometry, and biochemical studies. Linear regression was used to compare radius and tibia peripheral quantitative CT measures between Fontan patients and controls.

All Fontan patients were clinically well (NYHA class 1 or 2, cardiac index 4.85 ± 1.51 L/min/m2) and without significant comorbidities. Adjusted trabecular bone mineral density, cortical thickness, and bone strength index at the radius were significantly decreased in Fontan patients compared to controls with mean differences −30.13 mg/cm3 (p = 0.041), −0.31 mm (p = 0.043), and −6.65 mg2/mm4 (p = 0.036), respectively. No differences were found for tibial measures. In Fontan patients, the mean height-adjusted lumbar bone mineral density and total body less head z scores were −0.46 ± 1.1 and −0.63 ± 1.1, respectively, which are below the average, but within normal range for age and sex.

In a clinically well Fontan cohort, we found significant bone deficits by peripheral quantitative CT in the radius but not the tibia, suggesting non-weight-bearing bones may be more vulnerable to the unique haemodynamics of the Fontan circulation.

The U.S. Food and Drug Administration (FDA) traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.

To develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.

In 2016-2017, we convened a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.

The team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.

The development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation.

Inpatient length of stay (LOS) has been used as a measure of hospital quality and efficiency. Patients with Clostridium difficile infections (CDI) have longer LOS.

To describe the relationship between hospital CDI incidence and the LOS of patients without CDI.

Retrospective cohort analysis.

We predicted average LOS for patients without CDI at both the hospital and patient level using hospital CDI incidence. We also controlled for hospital characteristics (eg, bed size) and patient characteristics (eg, comorbidities, age).

Healthcare Cost and Utilization Project Nationwide Inpatient Sample, 2009–2011.

The Nationwide Inpatient Sample includes patients from a 20% sample of all nonfederal US hospitals.

Inpatient LOS was significantly longer (P<.001) at hospitals with greater CDI incidence at both the hospital and individual level. At a hospital level, a percentage point increase in the CDI incidence rate was associated with more than an additional day’s stay (between 1.19 and 1.61 days). At the individual level, controlling for all observable variables, a percentage point increase in the CDI incidence rate at their hospital was also associated with longer LOS (between 0.6 and 1.05 additional days). Hospital CDI incidence had a larger impact on LOS than many other commonly used predictors of LOS.

CDI rates are a predictor of LOS in patients without CDI at an individual and institutional level. CDI rates are easy to measure and report and thus may provide an important marker for hospital efficiency and/or quality.

Infect. Control Hosp. Epidemiol. 2016;37(4):404–410