Standardized neurological, behavioral measures to aid clinical research
Unveiled in September 2012, the NIH Toolbox for Assessment of Behavioral and Neurological Function  provides common, standardized measurements that will make it easier to pool data and compare results among studies, particularly in large-scale research such as epidemiological studies or clinical trials. It will also make neurological and behavioral assessment faster and cheaper. The intent is to produce economies of time and cost in these types of studies by allowing richer data collection without creating undue burden for study participants.
Six years in the making, the NIH Toolbox seeks to arm investigators with standard sets of instruments to assess cognitive, sensory, motor, and emotional function in U.S. study participants between the ages of 3 and 85. It includes 45 brief, royalty-free measures in English and Spanish that evaluate functions as diverse as language, memory, executive function, vision, smell, pain, strength, movement, and psychological well-being. The entire battery can be administered in 2 hours—a shorter time than for many comparable instruments—reducing the burden on both researchers and participants.
Dr. Molly Wagster, chief of the Behavioral and Systems Neuroscience Branch in NIA’s Division of Neuroscience, helped lead the team of 250-plus scientists and staff from 13 NIH Institutes, Centers, and Offices and nearly 100 academic institutions that developed the NIH Toolbox. The principal investigator was Dr. Richard Gershon, associate professor and vice chair for research at Northwestern University’s Department of Medical Social Sciences.
“When the idea for this project was first brought forward, we saw the tremendous value in designing a toolbox of standardized measures for neurological and behavioral research,” said NIA Director Dr. Richard J. Hodes. “It is designed to fulfill a unique need for a battery of online and royalty-free measures in this area, a resource especially important for the increasing numbers of large-scale epidemiological studies or clinical trials.”
Training to administer the NIH Toolbox measures is available for intramural and extramural scientists through a free e-learning module at www.nihtoolbox.org , a website that also includes the instruments, training manuals, and videos. Following the conference, Northwestern University held 3 days of hands-on training.
The NIH Toolbox addresses a common issue in scientific research—the difficulty of comparing results of studies using different outcome measures for similar functions, like cognition. “There’s been little uniformity in measures. This hinders our ability to interpret data and to share and integrate study results,” Dr. Wagster said. The NIH Toolbox gives researchers a “common currency” for measuring neural and behavioral health and will be particularly useful for large-scale research such as large longitudinal studies, epidemiological studies, prevention studies, and intervention trials, Dr. Wagster added.
NIH scientists also noted that they are particularly interested in feedback about the use of these assessments in patient populations. It might be possible to build on these assessments so they can be used for patients with health disorders ranging from schizophrenia to Parkinson’s.
The NIH Toolbox team evaluated more than 1,400 instruments for possible use in the batteries. In many instances, already-existing instruments were included in the NIH Toolbox if they met a number of criteria: available for people over a wide age range; royalty-free; brief and easy to use; psychometrically sound; and applicable in a variety of settings and populations, including people with disabilities, very young children, and Spanish speakers. Most existing instruments did not meet all of these requirements and had to be modified or expanded to meet the NIH Toolbox criteria.
Where necessary, novel instruments were created. “If we developed an instrument from scratch, we went out of our way to develop it against whatever was the gold standard in that area,” Dr. Gershon said. A rigorous process of field testing and validation was performed in more than 16,000 people. Norming was conducted in almost 4,900 people of different ages, races, and economic status.
The NIH Toolbox is a project of the NIH Blueprint for Neuroscience Research, a trans-NIH initiative that pools funding and resources to accelerate research on the nervous system. For more information about the NIH Toolbox, go to www.nihtoolbox.org .