EXAMINER
The EXAMINER test battery was developed to reliably and validly assess executive function for clinical research and trials.

User Manual

The NIH EXAMINER User Manual for the original computer-based EXAMINER battery includes information about scoring, test administration, and data analysis.

Project Goal

The goal of the EXAMINER project was to develop a neuropsychological test battery to reliably and validly assess domains of executive function (often defined as the ability to engage in goal-oriented behavior) for clinical investigations and clinical trials that would be adaptable to a wide range of ages and disorders and capture real-life social and executive deficits. Data collection targets were established with this goal in mind by the EXAMINER advisory panel, NINDS focus groups, NINDS Project Officer and the UCSF team. Piloting and ongoing data collection were conducted utilizing the large research infrastructure at UCSF and in collaboration with nine remote sites to represent a full range of geographic regions, ethnic groups, age groups and diagnostic disorders. The project lasted five years, from December 2006 through 2010.

Our battery of executive tests was modeled to encompass the attributes described below:

  1. Modular. Executive functioning encompasses multiple domains of behavior, such as generation, set-shifting, working memory, inhibition, concept formation and social behavior. A valid measure of executive functions should assess all of these domains. Separate modules offering the ability to quantify each of the relevant domains should be available to researchers to use separately or collectively, depending on the researcher’s needs.
  2. Modifiable. Any standard battery of executive tasks must be flexible enough to be adapted to a range of experimental and clinical situations.
  3. Efficient. To be maximally useful, an executive function battery will need to provide reliable and valid test data in as brief a period as possible.
  4. Applicable to a broad range of subjects in terms of age and ethnicity. An unbiased measure should be equally sensitive to change in individuals from different age and ethnic groups.
  5. Psychometrically robust. Good psychometric properties, including measured reliability and relationships with frontal lobe injury or real-world behavior, are a key element for measures designed for clinical trials.

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 1

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 2

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.

A central goal of the EXAMINER project was to develop a battery that could reliably and validly assess executive functions across a wide range of ages and disorders. Data collection targets were established with this goal in mind by the EXAMINER advisory panel, NINDS focus groups, NINDS Project Officer, and the UCSF team. Piloting and ongoing data collection were conducted utilizing the large research infrastructure at UCSF and in collaboration with nine remote sites to represent a full range of geographic regions, ethnic groups, age groups and diagnostic disorders.

Subjects & Sites

Subject inclusion criteria

All participants were ages 3–90 years old and spoke fluent English and/or Spanish. Participants assessed included normal controls and subjects with one of the following neurological conditions or neurodegenerative disorders:

  • Attention deficit hyperactive disorder (ADHD)
  • Alzheimer’s disease (AD)
  • Focal lesions
  • Behavioral variant frontotemporal dementia (bvFTD)
  • Huntington’s disease (HD)
  • Mild cognitive impairment
  • Amnestic and executive subtypes (MCI-exec)
  • Multiple sclerosis (MS)
  • Parkinson’s disease (PD)
  • Progressive supranuclear palsy (PSP)
  • Sickle-cell anemia
  • Traumatic brain injury (TBI)
  • Very low birth weight (VLBW)
  • Current medication likely to affect CNS functions (e.g., benzodiazepines, antidepressants, lithium, and/or neuroleptics in the phenothiazine and haloperidol families)

Subject exclusion criteria

Participants were excluded if they had the following:

  • Current alcohol abuse or dependence
  • Current drug abuse
  • Psychiatric disorder (apart from those specified in diagnostic groups of interest)
  • B12 deficiency or another metabolic syndrome
  • Hypothyroidism (i.e., TSH>150% of normal)
  • Known HIV
  • Renal failure
  • Respiratory failure (i.e., requiring oxygen)
  • Significant systemic medical illnesses (e.g., deteriorating cardiovascular disease)

Participating Sites

Ten nationwide sites completed the field tests:

  1. The Memory and Aging Center at the University of California, San Francisco (PI: Joel Kramer, PsyD)
  2. Boston Children’s Hospital Department of Neurology (PI: Celiane Rey-Casserly, PhD)
  3. Case Western Reserve University Rainbow Hospital (PI: H. Gerry Taylor, PhD)
  4. The Developmental Cognitive Neuroscience Laboratory at the University of Nebraska-Lincoln (PI: Kimberly Espy, PhD)
  5. The Mayo Clinic Alzheimer’s Disease Research Center (PI: Glenn Smith, PhD)
  6. The University of California, Berkeley’s Helen Wills Neuroscience Institute (PI: Robert Knight, MD)
  7. The University of California, Davis Department of Neurology (PI: Dan Mungas, PhD) ensured psychometric validity between the English and Spanish language instruments
  8. The University of Iowa (PI: Daniel Tranel, PhD)
  9. The University of South Carolina Neuropsychology and Human Development Lab (PI: Jeffrey Schatz, PhD)
  10. The University of Texas Southwestern Medical Center Ramon Diaz-Arrastia, MD, PhD)