Translation and validation of the Clinical Trial Nursing Questionnaire in Swedish-A first step to clarify the clinical research nurse role in Sweden.

Abstract

To translate the Clinical Trial Nursing Questionnaire (CTNQ) into Swedish and test it for face and content validity as well as internal consistency and reproducibility using test-retest procedures. In many countries, as in Sweden, a registered nurse can be involved in research by becoming a clinical research nurse. The clinical research nurse plays a pivotal role in clinical studies as a part of the research team. Scales have been developed and used with the objective to clarify the role of clinical research nurses: one of them is the CTNQ. A quantitative cross-sectional design with a test-retest procedure was applied to validate the translated questionnaire. By using a snowball sampling method, relevant participants were identified and 49 registered nurses working in the field of research as clinical research nurses answered the questionnaire on two occasions. An expert panel of three clinical research nurses evaluated the questionnaire for face and content validity. The STROBE checklist for observational research has been followed for presenting the research (see File S1). Face and content validity was agreed upon in the expert panel group. Tests for internal consistency of the CTNQ was calculated and showed a high Cronbach's alpha for both the frequency and importance subscales. The test-retest correlation analysis (reproducibility) also revealed a high correlation coefficient for both subscales. The CTNQ-SWE is a valid and robust instrument in a Swedish version. The instrument can be of importance in assessing the role of clinical research nurses in Sweden in future studies. Use of the CTNQ-SWE in future research can be of value for clarification and professional development of the clinical research nurse role in Sweden. The further use of the CTNQ in Sweden can be of value in understanding the process where licensed nurses make a transition into becoming a clinical research nurse, and to identify needs for customised education.