ABSTRACT
Sister to the Chiroptera crown-clade, the 50 million year old Vielasia sigei is suggested to have used laryngeal echolocation based on morphometric analyses. We discuss how Vielasia's discovery influences our understanding of the evolution of echolocation in bats and the insights fossils provide to the lives of extinct species.
ABSTRACT
Currently, ALS clinical trials require large sample size and the participation of many clinical evaluators to perform the outcome measure. High variability due to testers, instruments, or patients performance errors may result in systematic bias or random error leading to erroneous or uninterpretable results. Consequently, a quality control system that aims to produce high quality data in terms of reproducibility and accuracy to ensure reliability of the primary outcome measure is essential. In this paper we report our experience in preparing and executing a prospective quality control system that was implemented in conjunction with a large multicenter, multinational randomized placebo-controlled phase III clinical trial in ALS. We have shown that a prospective quality control system is highly effective to ensure inter- and intra-rater reliability of vital capacity as a primary outcome measure during the entire trial.
Subject(s)
Amyotrophic Lateral Sclerosis/physiopathology , Outcome Assessment, Health Care/standards , Quality Control , Vital Capacity/physiology , Amyotrophic Lateral Sclerosis/therapy , Clinical Trials, Phase III as Topic/methods , Humans , Outcome Assessment, Health Care/methods , Prospective Studies , Randomized Controlled Trials as Topic , Reproducibility of Results , Sensitivity and Specificity , Statistics as Topic , Treatment OutcomeABSTRACT
BACKGROUND: Disease management programs (DMPs) are developed to address the high morbi-mortality and costs of congestive heart failure (CHF). Most studies have focused on intensive programs in academic centers. Washington County Hospital (WCH) in Hagerstown, MD, the primary reference to a semirural county, established a CHF DMP in 2001 with standardized documentation of screening and participation. Linkage to electronic records and state vital statistics enabled examination of the CHF population including individuals participating and those ineligible for the program. METHODS: All WCH inpatients with CHF International Classification of Diseases, Ninth Revision code in any position of the hospital list discharged alive. RESULTS: Of 4,545 consecutive CHF admissions, only 10% enrolled and of those only 52.2% made a call. Enrollment in the program was related to: age (OR 0.64 per decade older, 95% CI 0.58-0.70), CHF as the main reason for admission (OR 3.58, 95% CI 2.4-4.8), previous admission for CHF (OR 1.14, 95% CI 1.09-1.2), and shorter hospital stay (OR 0.94 per day longer, 95% CI 0.87-0.99). Among DMP participants mortality rates were lowest in the first month (80/1000 person-years) and increased subsequently. The opposite mortality trend occurred in nonenrolled groups with mortality in the first month of 814 per 1000 person-years in refusers and even higher in ineligible (1569/1000 person-years). This difference remained significant after adjustment. Re-admission rates were lower among participants who called consistently (adjusted incidence rate ratio 0.62, 95% CI 0.52-0.77). CONCLUSION: Only a small and highly select group participated in a low-intensity DMP for CHF in a community-based hospital. Design of DMPs should incorporate these strong selective factors to maximize program impact.
