National Institute of Neurological Disorders and Stroke Common Data Element Project – approach and methods

Abstract

• Create easily accessible tools for investigators to collect study data. These tools should be especially helpful to new investigators and others working with limited budgets.• Encourage focused and simplified data collection to reduce burden on investigators and practice-based clinicians to facilitate their participation in clinical research.• Improve data quality while controlling cost by providing uniform data descriptions and tools across NINDS-funded clinical studies.The anticipated benefits of the CDE Project include accelerating study start up and facilitating data sharing and aggregation. The standard definitions, measures, and templates should help researchers more rapidly assemble their data collection materials. When studies which have used the CDEs are complete, less effort should be required to transform the data into a common format for aggregation and to perform meta-analyses, as much of the data are defined the same way.

Longitudinal Assessment of Blood Cholinesterase Activities Over 2 Consecutive Years Among Latino Nonfarmworkers and Pesticide-Exposed Farmworkers in North Carolina

“…Data were collected from these study participants on lifetime and current exposure using a published instrument. 27 The results establish that our intended differences in pesticide exposure between the groups are reflected in their reports of work and living environments. 28 Genetic variability may affect cholinesterase activities, 29 as well as pesticide metabolism.…”

Common data elements for clinical research in mitochondrial disease: a National Institute for Neurological Disorders and Stroke project

“…The Common Data Element (CDE) project began in 2005 as part of an initiative by the National Institute of Neurological Disorders and Stroke (NINDS) to assist NINDS-funded investigators in the collection of neuroscientific clinical trial research data in a standardized and consistent fashion (Grinnon et al 2012). The CDEs are content standards that can be applied to various data collection models and are intended to be dynamic and evolve over time, as indicated by research advances.…”

“…The goals of the NINDS CDE Project are to: 1) Disseminate standards for data collection from participants enrolled in neurological disease studies; 2) Create easily accessible tools for investigators to 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64collect study data. These tools should be especially helpful to new investigators and others working with limited budgets; 3) Encourage focused and simplified data collection to reduce burden on investigators and practice-based clinicians to facilitate their participation in clinical research; 4) Improve data quality while controlling cost by providing uniform data descriptions and tools across NINDS-funded clinical studies (Grinnon et al 2012). As the CDEs were being developed, the number of clinical trials for patients with mitochondrial disease also rose, highlighting the value and urgency of such tools to be developed.…”

Olfactory Function in Latino Farmworkers

“…This measure was based on items selected from the National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (http://www.commondataelements.ninds.nih.gov/PD.aspx#tab=Data_Standards). 18 Participants were asked about 13 residential and occupational pesticide exposures (e.g., residence located within ¼ mile of farm fields, different types of pesticides used in residence, employment as pesticide applicator, employment in farming and other pesticide-exposing industries) for up to 7 age periods (0 to 17 years, 18 to 25 years, 26 to 35 years, 36 to 45 years, 46 to 55 years, 56 to 65 years, 66 years or older). The positive responses were given a value of 1 and were summed, providing a measure with the values 0 to 13 for each age period.…”