Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. Weather dependent nasal erythema in reindeer (Rangifer tarandus)

A short cut review was carried out to establish whether nasal erythema in a reindeer might be a useful navigational aid on Christmas Eve. From a search of nine papers, five presented evidence relevant to the question. The author, date and country of publication, "subjects" studied, study type, relevant outcomes, results and study weaknesses of these papers are presented in table 3. The clinical bottom line is that a reindeer with a red nose at rest at the North Pole would not inspire confidence.     

Phase II multi-step planning methods in oncology: comparison, recommendations and potential applications

Phase II clinical trials in oncology are commonly used to determine whether a new treatment has a sufficient response rate to be compared with the best standard therapy in phase III. The multi-step planning methods such as Fleming's procedure and the triangular test adapted for phase II trials were elaborated to terminate phase II trials early. We compared these methods considering a fixed number of steps (4 or 5) on their statistical properties: overall type II error and observed type II error, average number of subjects necessary to conclude, probability to conclude at each step and maximum number of subjects necessary to conclude. Fleming's procedure has an actual power similar to the theoretical power for low to high response rate. In contrast, triangular test has an actual power different from the theoretical power in a few situations: it was very high in case of a very low minimum response rate and very low (<20%) in case of a very high minimum response rate (>80%). In these situations, Fleming's procedure and triangular test were not compared and triangular test cannot be recommended. For intermediate response rate, triangular test required a lower average number of subjects to conclude, a larger number of subjects at each step and thus a larger maximum number of subjects. It provided a larger probability to conclude during the first steps. These advantages should be balanced with the risk to have to include a larger number of patients. Multi-step methods, when correctly used are useful for cytotoxic development when response rate is the end point. They can also be used in trials where toxicity is the end point, and could be of great interest for cytostatic development for example with biological surrogate endpoints. An example using real phase II data is also presented.     

Preventing tomorrow's sudden cardiac death today: part II: Translating sudden cardiac death risk assessment strategies into practice and policy

Although current evidence supporting a more precise strategy for identifying patients at highest risk for sudden cardiac death (SCD) is sparse, strategies for translating existing and future evidence into clinical practice and policy are needed today. A great many unanswered questions exist. Examples include the following: At what level of risk for SCD should we pursue further testing or therapy? How should clinical strategies ethically and economically balance alternative outcomes? How can we best translate optimal strategies into clinical practice so as to prevent tomorrow's SCDs? On July 20 and 21, 2006, a group of individuals with expertise in clinical cardiovascular medicine, biostatistics, economics, and health policy was joined by government (Food and Drug Administration; Centers for Medicare and Medicaid Services; National Heart, Lung, and Blood Institute; Agency for Healthcare Research and Quality), professional societies (Heart Rhythm Society), and industry to discuss strategies for risk assessment and prevention of SCD. The meeting was organized by the Duke Center for the Prevention of Sudden Cardiac Death and the Duke Clinical Research Institute. This article, the second of 2 documents, summarizes the policy discussions of that meeting, discusses an analytic framework for evaluating the risks and benefits associated with SCD prevention and risk stratification, and addresses the translation of SCD risk assessment strategies into practice and policy.     

Improving influenza vaccine distribution in preparation for an H1N1 influenza pandemic: lessons from the field

Vaccine distribution is an essential component of any healthcare organization's pandemic influenza plan. Variables surrounding distribution in these circumstances are often difficult to anticipate and require careful consideration. The 2009 H1N1 influenza pandemic provided organizations with an opportunity to test current models and overall organizational readiness for the next influenza pandemic. This article describes the experiences at a large, midwestern, multispecialty medical system in responding to the unique circumstances surrounding distribution of the 2009 H1N1 influenza vaccine. We discuss challenges, variables to consider when choosing a vaccine distribution model, institutional response, and lessons learned.     

Effects of prolonged worm storage on the viability of <Emphasis Type="Italic">Echinostoma caproni</Emphasis> eggs

This study examined the effects of long-term worm storage on the viability of Echinostoma caproni eggs. Gravid adults (referred to as worm carcasses or WCs) were maintained in Locke's 1:1 at 4 degrees C for 2, 4, 6, 8, 10, and 12 months prior to use. When used, about 100 eggs at each time interval were tested for viability by embryonating them at either 22 +/- 1 degrees C for 14 days or 28 degrees C for 10 days in artificial spring water. Viability was determined by detecting fully developed miracidia in the eggs or miracidia in the cultures at the above-mentioned time periods. There was a high percentage of fully developed eggs from WCs stored in Locke's 1:1 at 4 degrees C for 2 and 4 months, 92% and 71%, respectively. Beyond these times, there was a marked decline in egg viability. We suggest that WCs should not be stored for longer than 4 months in Locke's 1:1 at 4 degrees C to obtain optimal embryonation and hatching of E. caproni.     

A Critical Analysis of Orthotopic Bladder Substitutes in Adult Patients with Bladder Cancer: Is There a Perfect Solution?

Context

Orthotopic bladder substitute (OBS) has been popularized over the past 2 decades as a diversion following radical cystectomy for invasive bladder cancer. Various reports, mostly single-center experiences, are published on patients with OBS.

Objective

This study reviews the literature regarding indications, postoperative care, complications, quality-of-life measures, as well as functional and oncologic outcomes that have been published on patients with OBS.

Evidence acquisition

An English-language literature review of the Medline database (1990 to January 2010) of published data on patients with OBS following radical cystectomy for bladder cancer was undertaken. Articles that included surgery for noncancer etiology were excluded.

Evidence synthesis

Indications and patient selection criteria have significantly widened over the past 2 decades. Comparable oncologic data have been reported between patients with OBS versus other diversions. Secondary urethral tumors seem less common in patients with OBS compared with those with conduits or continent cutaneous diversions. Durable daytime and nocturnal continence is achieved in 85–90% and 60–80%, respectively. Continence is inferior in elderly patients with OBS. Urinary retention remains significant in the female patients, ranging from 25% to 50%. Complications including electrolyte disturbances, altered sensorium and drug metabolism, mucus retention, rupture, urinary tract infections, and upper tract deterioration are reviewed.

Conclusions

Indications for OBS following radical cystectomy in patients with invasive bladder cancer have significantly widened over the past 2 decades. An OBS should be offered to both male and female patients in the absence of contraindications. Good long-term functional and oncologic outcomes can be achieved in patients with OBS treated in high-volume institutions by experienced surgeons with specific knowledge in the field. Preoperative patient information, patient selection, surgical techniques, and careful postoperative follow-up are the cornerstones to achieve good long-term results.