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Background  The chronic kidney disease (CKD) is a worldwide critical problem, especially in developing countries. CKD patients usually begin their treatment in advanced stages, which requires dialysis and kidney transplantation, and consequently, affects mortality rates. This issue is faced by a mobile health (mHealth) application (app) that aims to assist the early diagnosis and self-monitoring of the disease progression.    Methods  A user-centered design (UCD) approach involving health professionals (nurse and nephrologists) and target users guided the development process of the app between 2012 and 2016. In-depth interviews and prototyping were conducted along with healthcare professionals throughout the requirements elicitation process. Elicited requirements were translated into a native mHealth app targeting the Android platform. Afterward, the Cohen’s Kappa coefficient statistics was applied to evaluate the agreement between the app and three nephrologists who analyzed test results collected from 60 medical records. Finally, eight users tested the app and were interviewed about usability and user perceptions.    Results  A mHealth app was designed to assist the CKD early diagnosis and self-monitoring considering quality attributes such as safety, effectiveness, and usability. A global Kappa value of 0.7119 showed a substantial degree of agreement between the app and three nephrologists. Results of face-to-face interviews with target users indicated a good user satisfaction. However, the task of CKD self-monitoring proved difficult because most of the users did not fully understand the meaning of specific biomarkers (e.g., creatinine).    Conclusion  The UCD approach provided mechanisms to develop the app based on the real needs of users. Even with no perfect Kappa degree of agreement, results are satisfactory because it aims to refer patients to nephrologists in early stages, where they may confirm the CKD diagnosis.

Design and evaluation of a mobile application to assist the self-monitoring of the chronic kidney disease in developing countries