Margaret McCabe is director of the Center for Pediatric Nursing Research and Evidence-Based Practice at the Children's Hospital of Philadelphia. Liza Behrens is a consultant at the Heilbrunn Family Center for Research Nursing at the Rockefeller University, New York, NY. Shaunagh Browning is director of the Office of Research Quality Assurance at Georgetown University, Washington, DC. Judith Vessey is the Lelia Holden Carroll Endowed Professor in Nursing at the William F. Connell School of Nursing, Boston College, Chestnut Hill, MA. Mary Jane Williams is the nurse manager of the clinical research unit at the University of Wisconsin Hospital and Clinics in Madison. The authors acknowledge Joseph G. Verbalis, MD, for his expert review of the manuscript during the writing process. Contact author: Margaret McCabe,
Am J Nurs. 2019 Aug;119(8):24-32. doi: 10.1097/01.NAJ.0000577324.10524.c9.
: Background: Clinical research nursing is an emerging specialty practice. Clinical research nurses (CRNs) work to make protocol-related care safe for the research subjects while simultaneously maintaining protocol fidelity. They must continuously balance the needs of the research subjects and the study requirements.
The purpose of this qualitative study was to describe CRNs' perceptions of the value of their role.
Two focus groups were conducted with a purposive sample of 18 CRNs. An interview guide consisting of eight open-ended items was used. Data analysis used critical elements from Krueger's systematic steps for analyzing focus group data.
Five major themes emerged from 168 coded statements contained within the focus group transcripts: comprehensive nursing care of research subjects, training and education of research subjects and staff, contributions to clinical science, unique combination of clinical and critical thinking skills, and CRN practice attributes. Subcategories were also identified. In general, participants felt strongly about the value they added.Clinical research nursing requires the use of a variety of abilities and skills, including critical thinking and problem solving, as well as clinical and research knowledge. The CRNs in this study described incorporating these and other elements into their practice, which they associated with their specialized role. The five themes that emerged help elucidate the importance and utility of including CRNs on research teams.
The unique combination of applied research knowledge and expert clinical skills sets the specialty of clinical research nursing apart. The study findings, in particular the five themes, provide an evidence-based framework that will be useful in the development of competencies for CRN specialty practice. In helping to bring research findings to bear on clinical care, the impact of CRNs' practice extends beyond the individual patient to larger patient populations.
背景：临床研究护理是一个新兴的专业实践领域。临床研究护士（CRN）致力于使与方案相关的护理对研究对象安全，同时保持方案的保真度。他们必须不断平衡研究对象的需求和研究要求。
本定性研究的目的是描述 CRN 对其角色价值的看法。
使用包含八个开放式问题的访谈指南，对 18 名 CRN 进行了两次焦点小组。使用 Krueger 系统分析焦点小组数据的步骤中的关键要素进行数据分析。
从焦点小组记录的 168 条编码陈述中出现了五个主要主题：研究对象的全面护理、研究对象和工作人员的培训和教育、对临床科学的贡献、临床和批判性思维技能的独特结合以及 CRN 实践属性。还确定了子类别。总的来说，参与者对他们所增加的价值有强烈的感受。临床研究护理需要运用各种能力和技能，包括批判性思维和解决问题的能力，以及临床和研究知识。本研究中的 CRN 描述了将这些能力和其他要素融入到他们的实践中，这与他们的专业角色有关。出现的五个主题有助于阐明在研究团队中纳入 CRN 的重要性和实用性。
应用研究知识和专家临床技能的独特结合使临床研究护理专业与众不同。特别是五项主题的研究结果提供了一个基于证据的框架，将有助于制定 CRN 专业实践的能力。通过帮助将研究结果应用于临床护理，CRN 实践的影响不仅限于个体患者，还延伸到更大的患者群体。
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