Stressor Scale for Clinical Research Coordinators: Development and psychometric testing

Aim. This article is a report of the development and psychometric testing of the Stressor Scale for Clinical Research Coordinators. Background. Job stress is viewed as a situation where working conditions interact with individual worker characteristics and result in disruption of psychological or physiological homeostasis. Clinical research coordinators, also known as research nurses, are professionals who play a central role in clinical trials. They face various problems associated with their responsibilities; however, few studies have reported on their stress. To manage their stress, it is necessary to identify the sources of stress (i.e. stressors). Method. The 56-item preliminary instrument was developed based on literature review and expert discussions. A total of 589 clinical research coordinators in 186 hospitals in Japan were surveyed in 2011. Statistical analyses on construct and concurrent validity, internal consistency, and test-retest reliability were performed. Results. A six-factor solution with 23 items was selected using exploratory factor analysis: 'quantitative workload', 'conflict with investigators', 'ambiguity of work', 'conflict with other clinical research coordinators and with supervisors', 'demands from an affiliate other than the hospital', and 'difficulty in caring for trial participants'. Confirmatory factor analysis affirmed construct validity, with a demonstrated acceptable fit between the factor structure and the observed data. All factors had significant correlations with burnout and psychological distress, which indicated acceptable concurrent validity. Cronbach's alpha coefficients ranged from 0·73-0·82. Intra-class correlation coefficients indicated almost satisfactory test-retest reliability. Conclusion. Our new instrument has acceptable validity and reliability for evaluating job stressors for clinical research coordinators.