Development and validation of the self-report symptom inventory of immune-related adverse events in patients with lung cancer

Author(s)
Author(s)
Fan, T.
Zhu, S.
Wang, H.
Dong, Y.
Zhou, Y.
Song, Y.
Pan, S.
Wu, Q.
Li, Y.
Han, Y.
Date Issued
2024
Publisher
Elsevier
Journal
Asia-Pacific Journal of Oncology Nursing
Volume
11
Issue
12
Abstract
Objective This study aims to develop and validate the Self-Report Symptom Inventory of immune-related Adverse Events in Patients with Lung Cancer (SRSI-irAEs-LC) to allow for systematic assessment of symptomatic irAEs in patients with lung cancer treated with programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors (ICIs). Methods A sequential two-phase mixed-methods study was conducted. In phase I, a draft version of the SRSI-irAEs-LC was constructed through item generation and draft inventory construction. Delphi expert consultation, cognitive interviews and a pilot study were conducted to evaluate the content validity and refine the scale. In phase II, psychometric testing was performed on 512 patients with lung cancer treated with PD-1/PD-L1 ICIs using item analysis, exploratory factor analysis (EFA), confirmatory factor analysis (CFA), criterion validity, discriminant validity, and reliability evaluations. Results Through 5 sequential steps in phase I, the preliminary version of the SRSI-irAEs-LC comprised 10 dimensions with 41 items. Through EFA, the final version of the SRSI-irAEs-LC included 8 dimensions and 26 items that explained 62.33% of the variance. The CFA model showed that the 8-factor model fitted the data well. Good criteria validity and known-groups discriminant validity were demonstrated. Cronbach's alpha, split-half reliability, and test-retest reliability of the scale were 0.824, 0.725, and 0.851, respectively. Conclusions Preliminarily, the SRSI-irAEs-LC is a valid and reliable instrument for assessing symptomatic irAEs in patients with lung cancer treated with PD-1/PD-L1 ICIs. Further research is needed to confirm its generalizability to a broader population as well as its validity and reliability.
URI
DOI
SFU Affiliated Publication
Yes
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