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IMPORTANCE: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. OBJECTIVE: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. INTERVENTIONS: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. RESULTS: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of −2.0% (1-sided 97.5% CI, −∞ to 1.2%; P

OBJECTIVES: This study sought to determine if percutaneous coronary intervention (PCI) prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease would produce noninferior clinical results when compared with no PCI (control arm). BACKGROUND: PCI in patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice. METHODS: Patients with severe symptomatic aortic stenosis and significant coronary artery disease with Canadian Cardiovascular Society class ≤2 angina were randomly assigned to receive PCI or no PCI prior to TAVR. The primary endpoint was a composite of all-cause death or rehospitalization at 1 year. Noninferiority testing (prespecified margin of 7.5%) was performed in the intention-to-treat population. RESULTS: At 17 centers, 235 patients underwent randomization. At 1 year, the primary composite endpoint occurred in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm. The requirement for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067). On analysis of the as-treated population, the difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050). Mortality was 16 (13.4%) in the PCI arm and 14 (12.1%) in the no-PCI arm. At 1 year, there was no evidence of a difference in the rates of stroke, myocardial infarction, or acute kidney injury, with higher rates of any bleed in the PCI arm (P = 0.021). CONCLUSIONS: Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding. (Assessing the Effects of Stenting in Significant Coronary Artery Disease Prior to Transcatheter Aortic Valve Implantation; ISRCTN75836930).

An increase in development on many of the Gulf Islands, coupled with changing precipitation patterns due to an altered climate, has led to increased pressures on fresh water resources from already highly vulnerable island aquifers. With a growing demand for the existing and increasingly scarce water resources available, an increase to density on each island in the Islands Trust Area is emerging as the number one concern and priority for the land use authority vis-à-vis subdivision regulations, and affordable housing opportunities. Overlapping regional jurisdictions create further regulatory challenges to this issue. Regional Districts, Islands Trust, and Island Health (the regional health authority for Vancouver Island and the Gulf Islands area), for example, all have various roles to play in a complex governance structure under the auspices of the province of British Columbia (BC). In the interest of ensuring access to a reliable supply of fresh water into the future, a collaborative and cross-jurisdictional policy approach is needed in order to address alternatives to the increased extraction of water from identified vulnerable aquifers in the region. Rainwater harvesting (RWH) could be part of the solution to this issue. This paper explores the framework of statute, policy, regulation, governing RWH in the Islands Trust Area to better understand whether barriers or gaps exist in the overall regulatory ecosystem that could be addressed in order to better facilitate the implementation of RWH as part of climate change adaptation efforts. Thesis submitted to the Faculty of Social Sciences, Vancouver Island University in partial fulfillment of the requirements for the degree of Master of Community Planning. https://viurrspace.ca/bitstream/handle/10613/24452/CoxThesis.pdf?sequence=3

No matter what the context, all rational efforts directed at monitoring or improving business outcomes are reliant on data obtained via measurements that are never perfect. In the industrial context, the most widely used approach to quantifying and communicating the limitations of a measurement is the Gage R&R study, popularized by the Auto Industry Action Group (AIAG) of the American Society for Quality. Although ubiquitous in current practice, this approach carries with it some difficulties in interpretation that actually limit its usefulness. In 2006 Don Wheeler developed an alternative approach that removes these limitations, but this has yet to see mainstream adoption. This paper briefly reviews Wheeler's critique of the Gage R&R study, and using a specific example, shows the benefit of the alternative approach in the hope of its fostering wider adoption.