Desenvolvimento e validação de aplicativo assistencial para predição de pré-eclâmpsia no primeiro trimestre gestacional (11+0 a 13+6 semanas)

Abstract

Introduction: Preeclampsia (PE) is a disease of great clinical and social relevance; and to study its prediction is a challenge for contemporary obstetrics. Developing an assistance app with an algorithm to predict PE will facilitate the individualized risk evaluation process, furthering clinical decision in adequate time, and will serve as an investigation resource, promoting the implementation of interventional therapies in a timely manner. Objectives: To develop and validate an assistance app to predict preeclampsia during the pregnancy’s 1st trimester (11+0 to 13+6 weeks). Methods: The study was developed in two phases: 1) Technological development (development of PREApp®) from the following steps: scope definition, planning, production, and implementation. This phase elapsed from June 2018 to January 2020; and 2) PREApp® validation which took place between February and March 2020 involving 19 researchers/ teachers, and professionals from the following fields: obstetrics, high-risk pregnancy, preeclampsia and cardiology, and information technology/communication/ computer sciences. For this purpose, we used a questionnaire related to the expert’s profile and his/her professional trajectory, an instrument to assess PREApp® for clinical experts and another one for technical experts, and the System Usability Scale. The Exact Binomial Distribution Test was performed, considering significance levels of p>0,05 and a proportion of 0,80 concordance to estimate the statistical reliability of the CVI (content validity index). The study was approved by the Research Ethics Committees under number 3,835,900/2020. Results: The PREApp® was developed in Wordpress, based on PHP, with MySQL database, and four months were required to develop the first version adding up to one year and eight months to the final version. PREApp® was validated by 19 experts, of which 11 were clinicians and 8 technicians, and indicated a global CVI of 1.00 and 0.99, respectively, and p>0.05, ensuring the validity of the technology created and the agreement between the judges. As for usability, it was classified as excellent, with a total score of 91.1. Conclusion: The PREApp® can be used in clinical practice to screen women’s risk in developing PE in the first trimester of pregnancy (11+0 - 13+6), since the combination of MC+MAP (maternal characteristics + mean arterial blood pressure) in a prediction system is valid, presents good usability, and reaches the objectives intended. Safe screening favors early diagnosis, the implementation of timely therapeutic approaches, and the reduction of maternal and fetal morbidity and mortality. Thus, the study will contribute to improve maternal mortality indicators in Brazil in order to reach this Sustainable Development Goal.