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The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-beta-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 x 10(6) IU (30 micrograms) of IFN-beta-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0-3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-beta-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

In this pilot study hypnosis was used in an attempt to provide evidence of a psychogenic component of pseudo-epileptic seizures. The criterion for psychogenesis was the reversal of the amnesia, which is often present in epileptic- and pseudo-epileptic seizures. The technique has been validated by a semi-blind referral of cases for analysis after the clinician had been able to make a firm diagnosis based on electro-encephalic corroboration of the nature of the seizure. In eight out of nine patients (of the original 13 patients, three patients dropped out and one patient was not evaluable), the experimental diagnosis corresponded with the clinical diagnosis. As pseudo-epileptic seizures can be characterized by their dissociative nature, a reasonable hypothesis is that patients with pseudo-epileptic seizures are more responsive to hypnosis than patients with epileptic seizures. Measurements of hypnotizability among seven patients with epileptic seizures and six patients with pseudo-epileptic seizures supported this supposition.

We report an unusual case of an emphysematous prostatic abscess. Prostatic abscess is a difficult clinical diagnosis associated with lower urinary tract symptomatology and frequently diabetes mellitus. Computerized axial tomography and transrectal or transurethral ultrasonography can assist in making a specific diagnosis. Definitive treatment is complete surgical drainage, which is achieved by transurethral resection of the prostate. Wide spectrum, adjuvant antibiotic therapy should be given to assure coverage of anaerobic bacteria.

A cost-effective urinalysis test strategy, employing screening dipstick analysis with sediment microscopy performed on urines positive for leukocyte esterase, nitrite, protein, or blood, is evaluated. Screening urine culture is done when greater than or equal to 5 WBC/HPF, greater than 10 bacteria/HPF, or yeasts are found on sediment microscopy. Predictive value, sensitivity, and specificity of the test strategy in predicting significant bacteriuria is compared with sediment microscopy, Gram staining of uncentrifuged urine and leukocyte chamber counting. Employment of the test protocol for routine urine specimens would decrease sediment microscopy by 49%, while effectively screening for significant bacteriuria with a sensitivity of 88.9% and predictive value of a negative result of 98.8%.