EXAMINER Project Structure

EXAMINER was developed in two general phases. Phase One emphasized battery development and lasted two years. Phase Two focused on data collection.

Phase One

Phase 1 emphasized battery development and lasted two years. In the first year of Phase 1, the UCSF team was built, and a website was created to facilitate communication to NIH and the public. The literature on executive functioning was extensively reviewed by the UCSF team and posted on the website. A team of external advisers was created, with the first advisory meeting taking place in San Francisco on April 24, 2006. Finally, the advisers and experts in the field were surveyed on what they felt were the highest priorities for battery development. Priorities identified by the NINDS, the external advisers, and the survey of experts were to:

  1. have a brief (30–40 minute) battery designed for clinical trials with alternate forms and a single composite score;
  2. create a menu of tasks from which investigators can select to meet specific research goals;
  3. use non-copyrighted tasks that NIH could distribute freely; and
  4. validate the battery by demonstrating a relationship with real-world markers.

During Phase 1’s second year, attention shifted toward defining the conceptual framework for the EXAMINER battery, selecting extant executive paradigms from the research and clinical literature, and developing novel tasks. Extensive piloting was undertaken at UCSF and UC-Davis (Dan Mungas, PI), and tasks were continually revised. Record forms, test stimuli, software for computerized tasks, and training materials were created. Translation of test materials was carried out by a professional translation service with back translation. Traditional neuropsychological measures like Trail-Making, Stroop Interference, WAIS-III Digit Symbol, D-KEFS Design Fluency, and Wide Range Achievement Test-III Reading subtest were added to the battery as control measures. The Frontal Systems Behavior Scale™ (FrsBe) and the Behavior Rating Inventory of Executive Function®(BRIEF), copyrighted informant-based questionnaires, were added as measures of day-to-day executive functioning and behavior. Concurrently, the information technology team began work on a web-based data management system for use during the data collection phase. Finally, subcontract sites for data collection were identified, and the contracts and grants process was initiated to enable sites to begin data collection in January 2008.

Phase Two

Phase 2 focused on data collection. It was initially designed for two years and a third year was later added, allowing EXAMINER to exceed its original recruitment goals. Several different approaches to data reduction were piloted, and item response theory was ultimately selected as the best method for generating a smaller set of meaningful scores with ready application to research and clinical trials settings.