You are here:
FINAL REPORT: NATIONAL CHILDREN'S STUDY (NCS) ESTIMATING SUBJECT BURDEN FOR POTENTIAL NCS MEASUREMENTS
Citation:
MENDOLA, P. AND D. K. WAGENER. FINAL REPORT: NATIONAL CHILDREN'S STUDY (NCS) ESTIMATING SUBJECT BURDEN FOR POTENTIAL NCS MEASUREMENTS. U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-05/010, 2005.
Impact/Purpose:
To better understand the participant burden of environmental exposures among children
Description:
Purpose The National Children's Study (NCS), a large longitudinal cohort study of environmental exposures among children, is currently in the planning stage. Prior to enrollment of 100,000 pregnant women across the United Sates for this study, a better understanding of the participant burden involved is essential. Due to the number and range of hypotheses being tested in the NCS, the families participating could face some significant burdens. Even though individually the burden associated with specific measurements are not very taxing, the subject's effort increases with multiple measurements. Currently, research in the area of participant burden is limited. The purpose of this work assignment (WA) was to: " Develop a definition of participant burden, " Provide the U.S. EPA with an Excel spreadsheet, i.e., the burden database, that can be used to calculate burden under a number of scenarios, Begin compiling estimates of burden for specific measurements from a list provided by EPA in the spreadsheet, and Provide suggestions on strategies that can be used to increase or decrease participant burden. 1.2 Specific Objectives The main objectives of this work assignment were to: (1) Develop a quantitative method with the following characteristics: Develop a quantitative method of calculating participant burden that could be used for the following calculations: o Total visit-specific burden for specific participants, o Total hypothesis-related burden for specific participants, o Total hypothesis-related burden by specific visit,
1
o Hypothesis-related burden by specific participant for specific visits, Assessment method-specific burden for specific participant, and Assessment method-specific burden for specific visit. " Develop a quantitative method that would accommodate: Acceptability of assessment by the participant, A different testing pattern for people with a disability, and Sub-study burden estimation. (2) Develop a database in the form of an MS Excel spreadsheet that:" Includes information relevant to all the measurements, visits, participants, and hypotheses in the list provided by EPA, " Contains notes regarding sources of burden estimates, and " Includes example calculations of burden estimates.
2