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PubMedDate not supplied

Sample size calculations in randomised trials: mandatory and mystical.

Investigators should properly calculate sample sizes before the start of their randomised trials and adequately describe the details in their published report. In these a-priori calculations, determining the effect size to detect--eg, event rates in treatment and control groups--reflects inherently subjective clinical judgments. Furthermore, these judgments greatly affect sample size calculations. We question the branding of trials as unethical on the basis of an imprecise sample size calculation process. So-called underpowered trials might be acceptable if investigators use methodological rigor to eliminate bias, properly report to avoid misinterpretation, and always publish results to avert publication bias. Some shift of emphasis from a fixation on sample size to a focus on methodological quality would yield more trials with less bias. Unbiased trials with imprecise results trump no results at all. Clinicians and patients deserve guidance now.

Randomized Controlled Trials as Topic↗
PubMed2002

A comparison of the antimicrobial activity of meropenem and selected broad-spectrum antimicrobials tested against multi-drug resistant Gram-negative bacilli including bacteraemic Salmonella spp.: initial studies for the MYSTIC programme in India.

The evolution in India of multi-drug resistant pathogens possessing extended-spectrum beta-lactamases (ESBLs) threatens to compromise the clinical utility of third-generation cephalosporins and monobactams. Using selected resistant strains from a recent Indian 10 centre surveillance study that measured the prevailing incidence of resistance to beta-lactam antibiotics, the potential clinical utility of meropenem was assessed against nine other antimicrobial agents. A total of 212 Gram-negative bacilli were tested, of which 125 were confirmed by reference methods to be ESBL-producers. Meropenem was the most active of the test antimicrobials against these strains and the rank order of susceptibility was meropenem (99.1% susceptible) > piperacillin/tazobactam (76.9%) > ciprofloxacin (42.5%) > aminoglycosides (34.4-39.6%) = other beta-lactams (30.0-39.6%). Of the tested strains only two (Acinetobacter spp. and Pseudomonas putida) showed an intermediate susceptibility (8 mg/l) to meropenem. Of the 57 tested strains of Salmonella spp., three had an ESBL phenotype, confirmed two of the strains. This study confirms the high levels of resistance to beta-lactams agents in India reported elsewhere and also demonstrates, for Escherichia coli and Klebsiella spp., high levels of co-resistance between the tested beta-lactam agents and ciprofloxacin and the aminoglycosides, gentamicin and tobramycin. However, carbapenems such as meropenem, remain a therapeutic option.

Anti-Bacterial Agents↗
PubMed2006

blaVIM-2 and blaVIM-7 carbapenemase-producing Pseudomonas aeruginosa isolates detected in a tertiary care medical center in the United States: report from the MYSTIC program.

Two Pseudomonas aeruginosa strains resistant to beta-lactams, fluoroquinolones, aminoglycosides, tetracyclines, and carbapenems and susceptible only to polymyxin B (MIC <or= 2 microg/ml) were identified as part of the Meropenem Yearly Susceptibility Test Information Collection program. Metallo-beta-lactamase screening tests were positive, PCR yielded products with blaVIM primers, and sequence analysis revealed blaVIM-7 and blaVIM-2. The isolates had distinct ribotype and pulsed-field gel electorphoresis patterns and appeared independently, remote in time and location, at the same cancer center.

Academic Medical Centers↗
PubMed2005

The mystical effects of dermatological vehicles.

Topical treatment of the skin is as old as the evolution of man. Instinctively, we try to treat a skin injury or irritation with cooling or soothing substances. Even animals lick their wounds, trusting instinctively in the healing power of saliva. When did this archaic pattern of treatment take the gigantic leap from folk medicine to modern drug therapy? This text illustrates the evolution of topical dermatological vehicles, their application (guidelines) and future use. In particular, a phenomenon that has so far been ignored in product development and clinical testing is the vehicle metamorphosis. In clinical and experimental situations, most dermatological vehicles undergo considerable changes after they have been removed from the primary container and are applied to the skin. Subsequently, the initial structural matrix, and the quantitative composition of the vehicle, will most likely change during and after the mechanical shear associated with application of the product and/or evaporation of ingredients. This natural, but highly dynamic process will generate mini-environments for the active moiety that are difficult to predict and that are crucial to the fate of the active moiety. Despite the reasonable wishes of formulators, clinicians, patients and customers, there are still no universal vehicles. Each drug, at each concentration, requires a different vehicle for optimized therapy. Stability and compatibility of excipients and active moiety are crucial for any commercially available pharmaceutical or cosmetic formulation, together with local and systemic safety of all components. Nonetheless, more diverse and molecularly complex classes of new dermatological vehicles are continuously being researched and refined. The scientific progress has been remarkable when one considers the simple emulsion mixtures that were commonplace in dermatological therapy and still persist to this day in commercial products. It is to be hoped that the result of these research endeavors will be the emergence of more innovative topical formulations, applying engineered bioavailability control systems, with broader applications in topical therapeutic and cosmetic vehicles.

Administration, Cutaneous↗