Towards a Clinical Trial Protocol to Evaluate Health Information Systems: Evaluation of a Computerized System for Monitoring Tuberculosis from a Patient Perspective in Brazil.

Assessment of health information systems consider different aspects of the system itself. They focus or on the professional who will use the software or on its usability or on the software engineering metrics or on financial and managerial issues. The existent approaches are very resources consuming, disconnected, and not standardized. As the software becomes more critical in the health organizations and in patients, becoming used as a medical device or a medicine, there is an urgency to identify tools and methods that can be applied in the development process. The present work is one of the steps of a broader study to identify standardized protocols to evaluate the health information systems as medicines and medical devices are evaluated by clinical trials. The goal of the present work was to evaluate the effect of the introduction of an information system for monitoring tuberculosis treatment (SISTB) in a Brazilian municipality from the patients' perspective. The Patient Satisfaction Questionnaire and the Hospital Consumer Assessment of Healthcare Providers and Systems were answered by the patients before and after the SISTB introduction, for comparison. Patients from an outpatient clinic, formed the control group, that is, at this site was not implanted the SISTB. Descriptive statistics and mixed effects model were used for data analysis. Eighty-eight interviews were conducted in the study. The questionnaire's results presented better averages after the system introduction but were not considered statistically significant. Therefore, it was not possible to associate system implantation with improved patient satisfaction. The HIS evaluation need be complete, the technical and managerial evaluation, the safety, the impact on the professionals and direct and/or indirect impact on patients are important. Developing the right tools and methods that can evaluate the software in its entirety, from the beginning of the development cycle with a normalized scale, are needed.

Impact assessment on patients' satisfaction and healthcare professionals' commitment of software supporting Directly Observed Treatment, Short-course: A protocol proposal.

Doctors, nurses, and other healthcare professionals use software that affects the patients. Directly Observed Treatment, Short-course is the name given to the tuberculosis control strategy recommended by the World Health Organization. The main goal of this work is to propose a protocol for evaluating the impact of healthcare software supporting Directly Observed Treatment, Short-course on patients, healthcare professionals, and services. The proposed protocol consists of a set of instruments and steps. The instruments are reliable and validated existing questionnaires to be applied before and after using the software tool. The literature points out the need for standards on the software assessment. This is particularly critical when software affects patients directly. The present protocol is a universal tool to assess the impact of software used to support the fight against the tragedy of tuberculosis where a rigorous evaluation of IT in healthcare is highly recommended and of great importance.