JMIR Publications

ABSTRACT

Background:

Patient Reported Outcomes (PROs) are known to improve care delivery. Among PROs, adverse effects (AEs) of treatments represent an important source of information for doctors. Nowadays, mHealth technologies allow symptoms self-reporting, but the terminology used to report AEs is still a challenge.

Objective:

Although a widely-used, validated patient-oriented terminology exists, namely the PRO-CTCAE, in this paper we motivate and describe the creation of a new one, as part of the CAPABLE EU project.

Methods:

NIH developed PRO-CTACE as the patient-oriented companion of the CTCAE, which is instead doctor-oriented. While suitable for other purposes, PRO-CTACE shows some weaknesses in completeness and precision when used for continuous home patient monitoring and decision support. Thus, we developed a new terminology, intended to be as accessible to patients as PRO-CTACE, but at the same time able to convey more useful and exploitable information. By involving patients and care teams, we started from CTCAE, and through a multi-step approach, we reduced and adapted the AE list for a mobile app.

Results:

We obtained a list of 124 AEs (49 expressed as “present/absent”, 77 associated with four “description levels”). A mapping between the description levels and the original CTCAE grades enables running the decision support system embedded in CAPABLE. The proposed terminology was evaluated within a clinical pilot study involving 86 patients observed for at least 6 months.

Conclusions:

To support our claim on the need of a more complete terminology, we observed that patients reported 24 unique AEs that are not included in the PRO-CTCAE. We also observed that patients used only once the “Other” option to specify a symptom. Finally, through the mapping of our terminology to the CTCAE, we demonstrated that it was possible to trigger decision support rules coherent with clinical practice guidelines. Clinical Trial: CAPABLE was tested within a clinical pilot study that took place in three clinical centers, two in Italy and one in The Netherlands in 2023 (clinicaltrials.gov IDs: NCT06161233 and NCT05827289).