TITLE:
Developing Customized Evaluation Software for Clinical Trials: An Example with Obstructive Lung Diseases
AUTHORS:
Zhanqi Zhao, Barbara Vogt, Inéz Frerichs, Ullrich Müller-Lisse, Knut Möller
KEYWORDS:
Clinical Trial; Electrical Impedance Tomography; Pulmonary Function Test; Customized Software
JOURNAL NAME:
Engineering,
Vol.5 No.10B,
October
25,
2013
ABSTRACT: Corresponding customized software tool is usually
unavailable, which increases the time and workload for evaluating the results
of a clinical trial. In the present paper, we demonstrate the development
process of a customized software for one clinical trial on patients with
obstructive lung disease. Over hundred patients and volunteers as controlled
were included in the clinical trial. They were examined by spirometry and EIT
in a seated position during spontaneous tidal breathing. Subsequently, standard
vital capacity maneuver and forced full expiration maneuver were performed. In
order to evaluate the offline data, a customized software was
developed. The requirements of the software were defined by investigators. The
software was then tested on patients’ data and refined based on feedbacks of
the investigators. We finalized the customized software with analysis of various
disease-specific parameters and indices. Compared to the data process with
device specific programs and other commercial software, the customized software
is more flexible, user-friendly and extendable. As conclusion, customized
software simplifies the evaluation process distinctly and helps physicians to
focus on study design and result interpretation.