The aims of this study were to (1) identify and categorize study eligibility criteria concepts used in cancer nursing randomized controlled trials and (2) determine the extent to which a previously identified set of study eligibility criteria, based primarily on medical randomized controlled trials, were represented in cancer nursing randomized controlled trials. A total of 145 articles of cancer nursing randomized controlled trials indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature and published in English from 1986 to 2010 were screened, and 114 were eligible. Directed content analysis was conducted until data saturation was achieved. Forty-three concepts categorized into eight domains were extracted from 49 articles published in 27 different journals. Most of the concepts identified were related to health status, treatment, and demographics domains. Although many concepts matched to the previously identified study eligibility concepts based on medical research, new concepts may need to be added to fully represent cancer nursing research. This study provides a solid foundation for future study of mapping the concepts to existing standardized terminologies to identify which systems can be adopted. Nursing researchers can use these eligibility criteria concepts as a guideline in structuring the eligibility criteria for their studies.
Author Affiliations: College of Nursing, University of Utah, Salt Lake City (Drs Guo, Sward, Beck, and Wong); School of Nursing, University of Maryland, Baltimore (Dr Staggers); and Biomedical Informatics, University of Utah, Salt Lake City (Dr Frey).
This study was supported by a research award in 2011 from the Gamma Rho Chapter of Sigma Theta Tau International at University of Utah.
The authors have disclosed that they have no significant relationship with, or financial interest in, any commercial companies pertaining to this article.
Corresponding author: Jia-Wen Guo, PhD, RN, 2000 East 10 South, Salt Lake City, UT 84112 ( Jia-Wen.Guo@nurs.utah.edu).
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