Customized evaluation software for clinical trials: An example on pulmonary function test with electrical impedance tomography

Evaluating the results of a clinical trial is often time consuming and tedious, since a corresponding customized software tool is usually unavailable. In the present paper, we report an example of customized software for one clinical trial on patients with obstructive lung disease and demonstrate the development of the software for batching EIT data (EIT: electrical impedance tomography). Patients included in the clinical trial were examined by spirometry and EIT in a seated position during spontaneous tidal breathing. Subsequently, a standard vital capacity maneuver and a forced full expiration maneuver were performed. A customized software was developed for offline data analysis. The investigators defined the requirements of the software and discussed them with the software developers. The software was then tested on patients' data and refined based on feedbacks of the investigators. Compared to the data process with device specific programs and other commercial software, the customized software includes analysis of various disease-specific parameters and indices; it is more flexible, user-friendly and extendable. As conclusion, customized software simplify the evaluation process distinctly and help physicians to focus on study design and result interpretation.