JMIR Publications

ABSTRACT

Background:

Timely collection of patient-reported outcomes (PROs) decreases emergency room visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers’ reporting using similar clinical outcome assessments.

Objective:

To assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs), and if PROs were associated with future clinical events.

Methods:

Two iPhone applications were developed to collect PROs, one for cancer patients and one for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps (independently) for four weeks. Specific clinical events were obtained from the patients’ electronic health records up to six months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events.

Results:

Participants completed >96% of the planned PRO Common Terminology Criteria for Adverse Events (PRO-CTCAE) and Patient Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with hospitalizations/emergency department visits, grade 3-4 treatment related adverse events, dose reductions, and hospice referrals. PROMIS surveys completed by caregivers were associated with hospice referrals. PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality, while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks.

Conclusions:

In this study, caregivers and patients completed PROs using mobile apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity.