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Am. J. Respir. Crit. Care Med., Volume 162, Number 6, December 2000, 2134-2138

Design Strategies for Longitudinal Spirometry Studies
Study Duration and Measurement Frequency

MEI-LIN WANG, ERDOGAN GUNEL, and EDWARD L. PETSONK

Division of Respiratory Disease Studies, National Institute for Occupational Safety and Health (NIOSH), Morgantown; Section of Pulmonary and Critical Care Medicine, West Virginia University School of Medicine, Morgantown; and Department of Statistics, West Virginia University, Morgantown, West Virginia

Measuring the longitudinal change in FEV1 is useful for assessing the adverse effects of respiratory exposures and pulmonary diseases. Investigators seek to estimate the "true" mean FEV1 slope (µbeta ) of an infinite population. The difference between the estimated mean FEV1 slope (^µ beta ) and the true mean slope, resulting from biological variation and measurement errors, can be minimized by increasing the number of subjects (N), years of follow-up (D), or the frequency of measurements (P). We defined maximum error emax such that P[|<A><AC>μ</AC><AC>ˇ</AC></A>beta  - µbeta | =< emax] = 0.95, and thus emax is one-half the width of the 95% confidence interval for µbeta . We computed the values of emax on the basis of actual data obtained from 160 coal miners and working nonminers who had completed 11 spirometry measurements, using recommended equipment and procedures, at 6-mo intervals over 5 yr. Individual 5-yr FEV1 slopes (Delta FEV1) were calculated by linear regression. For a range of values of N, D, and P, tables are provided for emax, the magnitude of detectable differences in Delta FEV1 between two groups, and the recommended number of subjects needed in each of two groups to reliably detect the anticipated differences in Delta FEV1. The tables provide unique guidance for investigators in selecting among various study design options.




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