Selecting a Subset Based on the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Patient-Reported Symptom Monitoring in Lung Cancer Treatment: Mixed Methods Study

JMIR Cancer. 2021 Sep 14;7(3):e26574. doi: 10.2196/26574.

Abstract

Background: The Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item library covers a wide range of symptoms relevant to oncology care. There is a need to select a subset of items relevant to specific patient populations to enable the implementation of PRO-CTCAE-based symptom monitoring in clinical practice.

Objective: The aim of this study is to develop a PRO-CTCAE-based subset relevant to patients with lung cancer that can be used for monitoring during multidisciplinary clinical practice.

Methods: The PRO-CTCAE-based subset for patients with lung cancer was generated using a mixed methods approach based on the European Organization for Research and Treatment of Cancer guidelines for developing questionnaires, comprising a literature review and semistructured interviews with both patients with lung cancer and health care practitioners (HCPs). Both patients and HCPs were queried on the relevance and impact of all PRO-CTCAE items. The results were summarized, and after a final round of expert review, a selection of clinically relevant items for patients with lung cancer was made.

Results: A heterogeneous group of patients with lung cancer (n=25) from different treatment modalities and HCPs (n=22) participated in the study. A final list of eight relevant PRO-CTCAE items was created: decreased appetite, cough, shortness of breath, fatigue, constipation, nausea, sadness, and pain (general).

Conclusions: On the basis of the literature and both professional and patient input, a subset of PRO-CTCAE items has been identified for use in patients with lung cancer in clinical practice. Future work is needed to confirm the validity and effectiveness of this PRO-CTCAE-based lung cancer subset internationally and in real-world clinical practice settings.

Keywords: PRO-CTCAE; PROM; lung cancer; patient-reported outcomes; side effects; symptomatic adverse events.