{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:43:52Z","timestamp":1785545032050,"version":"3.56.0"},"reference-count":44,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Mhealth Uhealth"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec sec-type=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Adverse events (AEs) related to cancer treatment represent a valuable source of information that can be used to adjust therapy for individual patients. The National Institutes of Health developed the Common Terminology Criteria for Adverse Events (CTCAE), a comprehensive standardized terminology for health care providers to consistently report AEs during patient visits. Mobile health technologies, in principle, also allow AEs to be self-reported by patients in between visits; however, the terminology poses challenges for them, both in selecting the correct symptom to report and in rating its severity. The National Institutes of Health developed the Patient-Reported Outcomes\u2013CTACE as the patient-oriented\n                      <jats:italic>companion<\/jats:italic>\n                      of the CTCAE. However, it shows some weaknesses in completeness and precision when used for continuous home patient monitoring and for decision support.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"objective\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The aim of this paper is to propose a new terminology for reporting AEs that is easy for patients to use while also being clinically meaningful for health care providers and easily exploitable by decision support systems. Moreover, we aim to demonstrate its implementation and validation within the CAPABLE (Cancer Patients Better Life Experience) EU project.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The development of the new terminology starts from the CTCAE, which includes a comprehensive list of signs and symptoms along with guidance for accurately grading their severity. Through a multistep, participatory approach involving both patients and health care providers, we reduced and adapted the AE list for patient-oriented apps. During the CAPABLE project, the proposed terminology was integrated into a mobile app and evaluated within a clinical pilot study involving 86 patients who were monitored through the app for at least 6 months, and a control cohort of 133 patients monitored using standard care practices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The final terminology includes 124 AEs, 49 expressed as \u201cpresent or absent,\u201d and 77 associated with 4 description levels. A mapping between the description levels and the original CTCAE grades enables running the decision support system embedded in the CAPABLE app. The pilot study demonstrated that the majority of the patients used the symptoms reporting functionality, sharing also 24 unique AEs that are not present in the Patient-Reported Outcomes\u2013CTCAE. Symptoms reported using the proposed terminology allowed the enactment of the clinical practice guidelines included in the CAPABLE decision support tool, triggering 11 distinct recommendations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The results obtained from the clinical study support our claim regarding the need for a novel terminology for the self-reporting of AEs, characterized by ease of use, completeness, and clinical meaningfulness. Finally, by mapping our terminology to the CTCAE, we demonstrated that it is possible to exploit self-reported data to trigger decision support rules consistent with clinical practice guidelines.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/65504","type":"journal-article","created":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T13:35:09Z","timestamp":1761744909000},"page":"e65504-e65504","source":"Crossref","is-referenced-by-count":0,"title":["Obtaining Patient-Reported Outcome Data via a Home Patient Monitoring App: Development, Implementation, and Validation of Novel Interface 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