Rationale Since subjects in clinical trials using paper reporting media have been shown to transcribe invented spirometry readings and to fill in diary cards erroneously, incompletely, and at invalid times (both retrospectively and prospectively), we have developed and tested electronic methods to capture data directly from spirometers and to force timely and complete entry of self reported outcome data in clinical research. Methods Handheld computers were programmed to accept symptom data only during the time periods specified in the protocol (morning and evening, each day). The handhelds also required complete, “in-range”, and legible values. An electronic spirometer and a physiological activity sensor were fitted with short-range (15 ft) wireless circuits to transmit data samples and timestamps directly to the handheld device for inspection, acceptance and integration into patient reported symptom scores. Results Subjects without computer expertise were able to complete daily diaries and to send both subjective and physiological data daily to a secure central computer. The system successfully prevented false and inappropriately timed data while delivering completion compliance in excess of 80% of the expected reports. Conclusions A portable electronic monitoring system can prevent commonly occurring errors in timing, accuracy, completeness and legibility of data provided by subjects in respiratory clinical research.
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