Randomized open-label trial of intravenous brivaracetam versus lorazepam for acute treatment of increased seizure activity.

Objective: The objective of the present trial was to assess efficacy and safety of intravenous (IV) brivaracetam (BRV) vs. lorazepam (LZP) in patients with epilepsy undergoing evaluation in an epilepsy monitoring unit (EMU) who experienced seizures requiring acute treatment.

Methods: This was a phase 2, open-label, randomized, active-control, proof-of-concept trial (EP0087; NCT03021018).

Lessons in Medical Record Abstraction from the Prostate, Lung, Colorectal, and Ovarian (PLCO) National Screening Trial.

The most rigorous and accurate approach to evaluating clinical events in cancer screening studies is to use data obtained through medical record abstraction (MRA). Although MRA is complex, the particulars of the procedure-such as the specific training and quality assurance processes, challenges of implementation, and other factors that influence the quality of abstraction--are usually not described in reports of studies that employed the technique. In this paper, we present the details of MRA activities used in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, which used MRA to determine primary and secondary outcomes and collect data on other clinical events.

A randomized, controlled, dose-ranging study investigating single doses of GW406381, naproxen sodium, or placebo in patients with acute pain after third molar tooth extraction.

Objectives: To evaluate the efficacy and tolerability of 4 doses of GW406381, a cyclooxygenase-2 inhibitor, compared with placebo in a standard model of acute inflammatory pain.

Methods: This randomized, double-blind, placebo-controlled, single-center study compared single doses of GW406381 (10 to 70 mg) or naproxen sodium 550 mg with placebo in patients after extraction of 2 or more partially bony impacted third molar teeth. A total of 300 patients were randomized (50 per group).

Validation of the revised Patient Perception of Migraine Questionnaire: measuring satisfaction with acute migraine treatment.

Objective: To evaluate the psychometric properties of the revised Patient Perception of Migraine Questionnaire (PPMQ-R), which measures satisfaction with migraine treatment.

Background: The original version of the PPMQ was developed prior to the introduction of newer migraine treatments, which may have attributes that influence treatment satisfaction.

Methods: Literature review, patient focus groups, and one-on-one patient interviews guided revisions to the original PPMQ.