Development of a measure to delineate the clinical trials nursing role.
OBJECTIVE
To identify the significant dimensions of the clinical trials nursing role and to construct a reliable and valid survey instrument to reflect these dimensions.


METHODS
Methodologic survey.


METHODS
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.


METHODS
Frequency and importance of clinical trials nursing activities.


RESULTS
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.


CONCLUSIONS
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.
Ehrenberger
Heidi E
HE
College of Nursing at the University of Tennessee in Knoxville, USA. ehrenber@umich.edu
Lillington
Linda
L
D002986:Clinical Trials as Topic / Q000451:nursing*; D017144:Focus Groups; D016294:Models, Nursing; D024802:Nurse's Role; D015399:Nursing Research / Q000295:instrumentation* / Q000592:standards*; D009859:Oncology Nursing / Q000592:standards*; D011159:Population Surveillance / Q000379:methods; D015203:Reproducibility of Results; D012956:Societies, Nursing; D011795:Surveys and Questionnaires / Q000592:standards*; D014481:United States