Quantitative Assessment of Statistical Reviews of Patient Safety Research Articles.

OBJECTIVES: For 8.5 consecutive years, all patient safety articles of a journal underwent statistical review before publication. We sought to establish the prevalence of statistical themes in the statistical reviews, consideration of contemporary statistical methods, and their associations with time to journal receipt of authors' revision. METHODS: An initial set of statistical themes was created using the statistical editor's notes. For example, for the statistical theme of "CONSORT checklist," the search term needed was "CONSORT." A complete (exhaustive) list of additional themes was obtained inductively. RESULTS: Among the 273 subsequent reviews for manuscripts that were ultimately accepted, the number of paragraphs that included a theme of a statistical method was only weakly associated with longer revision times (Kendall τ = 0.139 ± 0.039, P = 0.0004). Among the total 3274 paragraphs of statistical reviews, 72.2% did not include a theme of a statistical method (e.g., the editor instead asked the authors to clarify what statistical method had been used) (95% confidence interval [CI] = 70.6%-73.7%, P < 0.0001 versus 50%).Among the 207 manuscripts with a review that included a statistical method, 47.3% included a contemporary topic (e.g., generalized pivotal methods) (95% CI = 40.4%-54.4%). However, among the 911 corresponding paragraphs of statistical review comments, only 16.0% included a contemporary theme (95% CI = 13.7%-18.6%). CONCLUSIONS: The revised versions of patient safety articles, which are eventually to be accepted for publication, have many statistical limitations especially in the reporting (writing) of basic statistical methods and results. The results suggest a need for education of patient safety investigators to include statistical writing.

Complete heart block with diastolic heart failure and pulmonary edema secondary to enlarging previously diagnosed thrombosed aneurysm of sinus of valsalva in a patient with history of autosomal dominant polycystic kidney disease.

Autosomal dominant polycystic kidney disease (ADPKD) is associated with vascular aneurysms that can affect any part of the vascular tree, like ascending aorta or coronary arteries. Sinus of Valsalva is known as an anatomical dilation at the root of aorta above the aortic valve and very few cases show aneurysm at that site in patients with ADPKD. Sinus of Valsalva aneurysm (SVA) can present with rupture and acute heart failure and infective endocarditis or could be asymptomatic accidentally discovered during cardiac catheterization. We report a case of a 76-year-old male with a unique constellation of cardiovascular anomalies associated with ADPKD. Patient was previously diagnosed with aneurysms affecting ascending aorta, sinus of Valsalva, and coronary arteries. Several years later, he came with complete heart block which was discovered later to be secondary to enlargement of his previously diagnosed thrombosed SVA. His case was complicated with acute heart failure and pulmonary edema. Conclusion. Patients with ADPKD can present with extrarenal manifestations. In our case, aneurysm at sinus of Valsalva was progressively enlarging and presented with complete heart block.

Determination and maintenance of DE minimis risk for migration of residual tritium (3H) from the 1969 Project Rulison nuclear test to nearby hydraulically fractured natural gas wells.

The Project Rulison underground nuclear test was a proof-of-concept experiment that was conducted under the Plowshare Program in 1969 in the Williams Fork Formation of the Piceance Basin in west-central Colorado. Today, commercial production of natural gas is possible from low permeability, natural gas bearing formations like that of the Williams Fork Formation using modern hydraulic fracturing techniques. With natural gas exploration and production active in the Project Rulison area, this human health risk assessment was performed in order to add a human health perspective for site stewardship. Tritium (H) is the radionuclide of concern with respect to potential induced migration from the test cavity leading to subsequent exposure during gas-flaring activities. This analysis assumes gas flaring would occur for up to 30 d and produce atmospheric H activity concentrations either as low as 2.2 × 10 Bq m (6 × 10 pCi m) from the minimum detectable activity concentration in produced water or as high as 20.7 Bq m (560 pCi m), which equals the highest atmospheric measurement reported during gas-flaring operations conducted at the time of Project Rulison. The lifetime morbidity (fatal and nonfatal) cancer risks calculated for adults (residents and workers) and children (residents) from inhalation and dermal exposures to such activity concentrations are all below 1 × 10 and considered de minimis. The implications for monitoring production water for conforming health-protective, risk-based action levels also are examined.

How clean is clean enough? Recent developments in response to threats posed by chemical and biological warfare agents.

Recent terrorist events underscore the urgent need to develop a comprehensive set of health-protective cleanup standards and effective decontamination technologies for use in the restoration of civilian facilities. Accurate scientific information remains limited in the area of biological warfare agents. However, new guidelines and calculated cleanup values are emerging for initial re-entry and long-term reoccupation following use of chemical warfare agents. This article addresses airborne, soil, and surface exposures following release of G-type chemical warfare agents and VX. Cleanup goals should be tailored to the type of population that may be exposed, potential exposure times, and other scenario-specific considerations. Three different airborne concentrations are proposed for cleanup of public sector facilities. One value is recommended for initial re-entry; a more conservative value is recommended for long-term monitoring and increased public confidence; and a third, even more conservative concentration represents essentially a no-effect level for round-the-clock airborne exposure. Health-based cleanup levels are provided for contaminated residential and industrial soil. Results are presented on the outcome of a preliminary risk assessment to determine safe surface levels (e.g., walls, floors, and handrails) for cleanup after exposure to the G agents and VX. Because specific cleanup criteria for most biological warfare agents remain problematic, recommendations are made for filling the knowledge gaps.