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Stressor Scale for Clinical Research Coordinators: development and psychometric testing

Authors

  • Kazufumi Matsumoto,

    1. Kazufumi Matsumoto MS RN CCRP
      Clinical Research Coordinator
      Department of Clinical Trail Safety Management, Research Hospital, The Institute of Medical Science, The University of Tokyo, Japan
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  • Kumiko Sumino,

    1. Kumiko Sumino RN
      Clinical Research Coordinator
      Department of Clinical Trail Safety Management, Research Hospital, The Institute of Medical Science, The University of Tokyo, Japan
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  • Hiroki Fukahori,

    1. Hiroki Fukahori PhD RN
      Associate Professor
      Department of System Management in Nursing, Graduate School of Health Care Sciences, Tokyo Medical and Dental University, Japan
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  • Kazuyo Kitaoka,

    1. Kazuyo Kitaoka PhD RN
      Professor
      School of Nursing, Kanazawa Medical University, Ishikawa, Japan
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  • Kiyoko Kamibeppu,

    1. Kiyoko Kamibeppu PhD RN
      Associate Professor
      Department of Family Nursing, Graduate School of Medicine, The University of Tokyo, Japan
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  • Fumitaka Nagamura

    1. Fumitaka Nagamura MD PhD
      Associate Professor
      Department of Clinical Trail Safety Management, Research Hospital, The Institute of Medical Science, The University of Tokyo, Japan
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K. Matsumoto: e-mail: kmatsumoto-tky@umin.ac.jp

Abstract

matsumoto k., sumino k., fukahori h., kitaoka k., kamibeppu k. & nagamura f. (2012) Stressor Scale for Clinical Research Coordinators: development and psychometric testing. Journal of Advanced Nursing68(7), 1636–1645.

Abstract

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.

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