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Publications

Journal Article Epublish

PubMed: 39641008 DOI: 10.1016/j.apjon.2024.100603

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

Asia Pac J Oncol Nurs 11(12):100603

Authors: Tiantian Fan, Siying Zhu, Hong Wang, Yan Dong, Ying Zhou, Yalan Song, Shan Pan, Qiujuan Wu, Graeme Drummond Smith, Yumei Li, Yuan Han

Affiliations

  • Thoracic Surgery Area Three, Guangzhou Institute of Cancer Research, The Affiliated Cancer Hospital, Guangzhou Medical University, Guangzhou, China.
  • School of Nursing, Guangzhou Medical University, Guangzhou, China.
  • Nursing Department, Guangzhou Institute of Cancer Research, The Affiliated Cancer Hospital, Guangzhou Medical University, Guangzhou, China.
  • Internal Medicine Oncology, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
  • Internal Medicine Oncology, The Fifth Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
  • S.K. Yee School of Health Sciences, Saint Francis University, Hong Kong, China.

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 , 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.

MeSH

Lung, Neoplasms, Drug-Related Side Effects And Adverse Reactions, Lung Neoplasms, Self Report