Correlation Between Remote Symptom Reporting by Caregivers and Adverse Clinical Outcomes: Mixed Methods Study (Preprint)

Author:

Oakley-Girvan IngridORCID,Yunis ReemORCID,Fonda Stephanie JORCID,Longmire MichelleORCID,Veuthey Tess LORCID,Shieh JenniferORCID,Aghaee SaraORCID,Kubo AiORCID,Davis Sharon WORCID,Liu RaymondORCID,Neeman EladORCID

Abstract

BACKGROUND

Timely collection of patient-reported outcomes (PROs) decreases emergency department 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

The aim of this study is 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

We developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients’ electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events.

RESULTS

Participants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients’ hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (<i>P</i>&lt;.05), and hospice referrals (<i>P</i>=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (<i>P</i>=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (<i>P</i>=.03), 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 smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity.

Publisher

JMIR Publications Inc.

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