Development of a measure to delineate the clinical trials nursing role.

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.