Pulmonary function testing was used in MRFIT to monitor the presence of airways disease and to assess changes in pulmonary function over time. The pulmonary function indices that were measured were FEV1, FVC, and MMEF, (FEF25-75). Quality control of technician training, equipment maintenance, data collection, and data measurement were essential to ensure that results, over time and from various clinics, could be compared. Based on the MRFIT experience, it is strongly recommended that centralized training in testing techniques and spirometer maintenance take place before a clinical trial begins, and periodically throughout a trial. Such training, combined with quality control follow-up, should prevent the loss of data due to inadequate spirometer maintenance and invalid testing procedures.

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http://dx.doi.org/10.1016/0197-2456(86)90167-4DOI Listing

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