Development of a Measure to Delineate the Clinical Trials Nursing Role

Heidi E. Ehrenberger

Linda Lillington

ONF 2004, 31(3), E64-E68. DOI: 10.1188/04.ONF.E64-E68

Purpose/Objectives: To identify the significant dimensions of the clinical trials nursing role and to construct a reliable and valid survey instrument to reflect these dimensions.

Design: Methodologic survey.

Setting/Sample: The judge panel consisted of six national nurse experts. The focus group sample was comprised of 24 clinical research nurses from the West, Northeast, and Great Lakes regions of the United States and five research nurses from Canada. The sample for instrument testing consisted of 40 oncology clinical research nurses from the Southeast.

Methods: Several strategies were used to develop the Clinical Trials Nursing Questionnaire (CTNQ): literature review, conceptualization of the subscales, development of items for each subscale, development of the tool, expert judge panel evaluation, focus group testing, administration of the tool, and psychometric analysis of the results.

Main Research Variables: Frequency and importance of clinical trials nursing activities.

Findings: Content validity was established at 0.95. The alpha reliability coefficient was 0.92 for the frequency scale and 0.95 for the importance scale. A two-week test-retest reliability of 0.88 was obtained for the frequency scale and 0.92 for the importance scale. The final CTNQ contained 12 sections with 154 items.

Conclusions: The CTNQ has acceptable content validity, internal consistency, and stability reliability. This instrument is promising for the assessment of the research nurse role, and its use in further research is appropriate.

Implications for Nursing: A valid and reliable measure can be used to delineate the subspecialty of clinical trials nursing, thus providing a better understanding of how nursing professionals contribute to the cancer research enterprise.

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    Bowen, K., & Rice, L. (1998). Who is a clinical research nurse? Establishing guidelines and standards of practice for a growing profession. Research Nurse, 4(4), 1-4.

    Brant, J.M. (1996). Standards of oncology nursing practice. Pittsburgh, PA: Oncology Nursing Society.

    Burns, N., & Grove, S.K. (1997). The practice of nursing research: Conduct, critique, and utilization (3rd ed.). Philadelphia: W.B. Saunders.

    Crosby, F., Ventura, M., & Feldman, J. (1989). Examination of a survey methodology: Dillman's total design method. Nursing Research, 38, 56-58.

    Ehrenberger, H.E., Lillington, L., Bacon, M., Burks, K., Ward, K., & Zimmerman, J. (2003). The development of a virtual work group of the Oncology Nursing Society Clinical Trials Nurses Special Interest Group: Keys to productivity [Abstract 237]. Oncology Nursing Forum, 30(2 Suppl.), 166.

    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (1996). Guidance for industry: E6 good clinical practice: Consolidated guidance. Retrieved April 10, 2003, from

    Irvine, D., Sidani, S., & McGillis-Hall, L. (1998). Finding value in nursing care: A framework for quality improvement and clinical evaluation. Nursing Economics, 16, 110-116.

    Joshi, T.G., & Ehrenberger, H.E. (2001). Cancer clinical trials in the new millennium: Novel challenges and opportunities for oncology nursing. Clinical Journal of Oncology Nursing, 5, 147-152.

    Klimaszewski, A., Aikin, J., Bacon, M., Distasio, S., Ehrenberger, H., & Ford, B. (2000). Manual for clinical trials nursing. Pittsburgh, PA: Oncology Nursing Society.

    Lynn, M.R. (1986). Determination and quantification of content validity. Nursing Research, 35, 382-385.

    Mishel, M.H. (1998). Methodological studies: Instrument development. In P.J. Brink & M.J. Wood (Eds.)Advanced design in nursing research (pp. 235-286). Thousand Oaks, CA: Sage.

    Mueller, M. (2001). From delegation to specialization: Nurses and clinical trial co-ordination. Nursing Inquiry, 8, 182-190.

    Oncology Nursing Society. (1997). Statement on the scope and standards of advanced practice in oncology nursing (2nd ed.). Pittsburgh, PA: Author.

    Oncology Nursing Society. (1998). Cancer research and cancer clinical trials [Position statement]. Oncology Nursing Forum, 25, 973-974.

    Sidani, S., & Irvine, D. (1999). A conceptual framework for evaluating the nurse practitioner role in acute care settings. Journal of Advanced Nursing, 30, 58-66.

    Waltz, C.F., Strickland, O.L., & Lenz, E.R. (1991). Measurement in nursing research. Philadelphia: F.A. Davis.