Validation of a Questionnaire to Delineate the Clinical Trial Nursing Roles in Korea.

Abstract

In clinical trials, research nurses play a particularly important role in promoting cancer care best practices. However, no Korean questionnaire has been developed to define the clinical trial nursing roles based on Good Clinical Practice standards. The aim of this study was to cross-culturally evaluate the reliability and validity of a Korean version of the Clinical Trials Nursing Questionnaire (CTNQ) among Korean clinical research nurses. Cross-cultural adaptation was performed, with forward and backward translation, a pilot test (linguistic validation), and a field test. Validation was performed by questioning 53 clinical research nurses who were working in clinical cancer centers at 5 tertiary university hospitals. The distribution of the item responses and internal consistency reliability were assessed using the ceiling and floor effects, Cronbach's α, and the item-total correlation. Construct validity was assessed using Spearman correlation analysis and principal-component factor analysis. The distributions of the item responses and the item-total correlation were generally appropriate. The Cronbach's α values for the frequency scale and the importance scale were 0.852 and 0.899, respectively. Eight sections of the Korean CTNQ were generally correlated with each other. The frequency subscale loaded on 1 factor, and the importance subscale loaded on 2 factors, with broadly similar factor loadings. The Korean version of the CTNQ is reliable, valid, and interchangeable with the original CTNQ. The Korean version of the CTNQ can be used to validly and reliably assess the clinical trial nursing roles in Korea.