JMIR Publications

ABSTRACT

Background:

The evaluation of electronic patient reported outcomes (ePROs) is increasingly being used in clinical studies with cancer patients and enables structured and standardized data collection in patients' everyday lives (real-world evidence). Recent studies also indicate a medical benefit of ePROs for patients, but so far there have been few studies or analyses that focus on this aspect.

Objective:

Our aim of the current analysis was to determine whether the use of the consilium careTM app (now mediduxTM) for structured and regular self-assessment of side effects by ePRO had a recognizable effect on incidences of unplanned consultations and hospitalizations of cancer patients (different entities) compared to a control group from the real-world care setting without app-usage. To analyze this, the incidences of unplanned consultations and hospitalizations of cancer patients using the consilium careTM app (“consilum group") that were recorded by the treating physicians as part of the PRO study were compared retrospectively to corresponding data of a comparable cancer patient population collected at two Swiss oncology centers during standard-of-care treatment.

Methods:

Cancer patients in the PRO study (178 included in this analysis) receiving systemic therapy in a (neo-)adjuvant or non-curative setting performed self-assessment of side effects via the consilium careTM app over an observational period of 90 days. In this period, unplanned (emergency) consultations and hospitalizations were documented by the participating physicians. The incidence of these events was compared with retrospective data from a matched cancer patient cohort obtained from two Swiss tumor centers.

Results:

Both patient groups were comparable in terms of age and gender ratio, as well as the distribution of cancer entities and AJCC stages. 139 patients from each group were treated with chemotherapy and 39 with other therapies. Looking at all patients, no significant difference in events per patient was found between the app-using group and the control group (odds ratio 0.742). However, a positive effect was found in a particular subgroup of cancer patients (139 each) who had received chemotherapy; i.e., the incidence of emergency consultations and hospitalizations per patient was reduced when using the consilium careTM app. The calculated odds ratio of 0.53 is equivalent to a halving of the risk for patients in the “consilium” group and suggests a highly clinically relevant effect that is significant at a two-sided 10% level (p = 0.075, Fisher's Exact Test).

Conclusions:

A comparison of unplanned consultations and hospitalizations from the PRO study with retrospective data from a comparable cancer patient cohort suggests a positive effect of regular app-based ePROs. These data are to be verified in the ongoing randomized PRO2 study (NCT05425550). Clinical Trial: ClinicalTrials.gov registration identifier NCT03578731