Extending the description of the clinical research nursing workforce.

Background: The role of Clinical Research Nurses across the globe has not been evaluated to identify similarities or differences among specific activities. Aims: This study's aims were to determine differences in Clinical Research Nurses most frequently performed activities, if these activities are reflective of those previously described in the literature, and job titles Clinical Research Nurses use to self-identify. Methods: An online cross-sectional survey distributed via snowball sampling through email, social media, and research nurses' networks included questions on frequency of activities performed and information related to job titles. Pearson's chi-square test is analyzed for associations between the groups. Results: Respondents returned 252 questionnaires, 233 were eligible for analysis. Research nurse activities performed internationally showed both similarities and differences. Any between country comparisons will be limited to the United States and the United Kingdom. The three most common tasks reported were recruitment 120 (51.5%), monitoring the research participant for potential adverse events 187 (80.2%) and providing nursing leadership within the interdisciplinary team 169 (72.5%). Conclusion: Considering the context and range of activities of the original Clinical Research Nursing Domain of Practice, broadening the framework to include the leadership domain will better serve as a foundation for the specialty practice.

Integrating Genomics into Oncology Practice.

OBJECTIVE: To discuss our clinical research hospital's experience in integrating genomics into nursing practice. DATA SOURCES: Published literature, national guidelines, and Web sites. CONCLUSION: Utilizing a program based on the Method for Introducing a New Competency toolkit and adapted competencies from the Essentials of Genetic and Genomic Nursing, the National Institutes of Health Clinical Center successfully integrated genomics into nursing practice and all major educational programs. IMPLICATIONS FOR NURSING PRACTICE: This experience provides an example for other nurses to integrate genetics/genomics into their practice settings.

Patient Acuity Related to Clinical Research: Concept Clarification and Literature Review.

In research settings, clinical and research requirements contribute to nursing workload, staffing decisions, and resource allocation. The aim of this article is to define patient acuity in the context of clinical research, or research intensity, and report available instruments to measure it. The design was based on Centre for Reviews and Dissemination recommendations, including defining search terms, developing inclusion and exclusion criteria, followed by abstract review by three members of the team, thorough reading of each article by two team members, and data extraction procedures, including a quality appraisal of each article. Few instruments were available to measure research intensity. Findings provide foundational work for conceptual clarity and tool development, both of which are necessary before workforce allocation based on research intensity can occur.

Developing Competency to Sustain Evidence-Based Practice.

Organizations must ensure that nursing care delivery is based on best evidence. This article describes how a clinical research hospital used a competency-based approach to structure the development and execution of a strategic plan and integrated evidence-based practice concepts into the activities of nurses at all levels. The article will also describe the process for developing and implementing the competency across our department including outcomes achieved.

Survey of nursing integration of genomics into nursing practice.

PURPOSE: Translating clinically valid genomic discoveries into practice is hinged not only on technologic advances, but also on nurses-the largest global contingent of health providers-acquiring requisite competencies to apply these discoveries in clinical care. The study aim was to assess practicing nurse attitudes, practices, receptivity, confidence, and competency of integrating genomics into nursing practice. DESIGN: A convenience sample of practicing nurses was recruited to complete an online survey that assessed domains from Roger's Diffusion of Innovations Theory and used family history utilization as the basis for competency assessment. METHODS: Results were tabulated and analyzed using descriptive statistical techniques. FINDINGS: Two-hundred-thirty-nine licensed registered nurses, 22 to 72 years of age, with a median of 20 years in practice, responded, for an overall response rate of 28%. Most were White (83%), female (92%), and held baccalaureate degrees (56%). Seventy-one percent considered genetics to be very important to nursing practice; however, 81% rated their understanding of the genetics of common diseases as poor or fair. Per-question response rates varied widely. Instrument assessment indicated that modifications were necessary to decrease respondent burden. CONCLUSIONS: Respondents' perceived genomic competency was inadequate, family history was not routinely utilized in care delivery, and the extent of family history varied widely. However, most nurses indicated interest in pursuing continuing genomic education. CLINICAL RELEVANCE: Findings from this study can lead to the development of targeted education that will facilitate optimal workforce preparation for the ongoing influx of genetics and genomics information, technologies, and targeted therapies into the healthcare arena. This pilot study provides a foundation on which to build the next step, which includes a national nursing workforce study.

Validating the clinical research nursing domain of practice.

PURPOSE/OBJECTIVES: To develop and validate a taxonomy for the domain of clinical research nursing. DESIGN: Survey. SETTING: Clinical research settings in the United States. SAMPLE: A purposefully selected expert panel of 22 nurses who were actively practicing or supervising in a clinical research environment. METHODS: A study team consisting of nurses with experience in clinical research synthesized peer-reviewed articles, academic curricula, professional guidelines, position descriptions, and expert opinion. Using the Delphi technique, three rounds of surveys were conducted to validate the taxonomy. The three sequential questionnaires were completed over five months. MAIN RESEARCH VARIABLES: Activities performed by nurses in a clinical research setting. FINDINGS: A taxonomy for clinical research nursing was validated with five dimensions and 52 activities: Clinical Practice (4 activities), Study Management (23 activities), Care Coordination and Continuity (10 activities), Human Subjects Protection (6 activities), and Contributing to the Science (9 activities). CONCLUSIONS: This study validated activities for direct care providers and nurses with the primary focus of research coordination. The findings identify a variety of activities that are unique to nurses in a clinical research setting. IMPLICATIONS FOR NURSING: Nurses play an integral role in the clinical research enterprise. Validating a taxonomy for the specialty of clinical research nursing allows for roles to be compared across settings, competency requirements to be defined, and nursing organizations to be guided in the development of specialty certification.

Defining clinical research nursing practice: results of a role delineation study.

Clinical research nursing is a specialty nursing practice focused on the care of research subjects and implementation of clinical research. A five-dimensional model (Clinical Practice [CP], Study Management, Care Coordination and Continuity, Contributing to the Science [CS], Human Subjects Protection) has been validated nationally to represent the domain of clinical research nursing practice. The purpose of this study was to describe the frequency and importance of activities within each dimension as performed by nurses in clinical research and to describe differences between roles. One thousand and four nurses from the NIH Intramural Campus in Bethesda, Maryland, were invited to participate in an anonymous web-based survey. Participants (N = 412) were predominantly female (90%) with ≥11 years research experience (70%). Two hundred eighty-eight respondents (70%) identified themselves as clinical research nurses (CRNs) and 74 (18%) as research nurse coordinators (RNCs). CP activities were reported most frequent and important whereas CS activities were least frequent and important. CRN and RNC activity frequency differed across all dimensions (p < 0.001) with CRNs reporting significantly higher levels of CP activities and significantly lower levels in other dimensions. Delineating specialty activities and practice across roles enhances the understanding of nurses' role in clinical research and provides groundwork for role-based training.

Evaluating a hybrid web-based basic genetics course for health professionals.

Health professionals, particularly nurses, continue to struggle with the expanding role of genetics information in the care of their patients. This paper describes an evaluation study of the effectiveness of a hybrid basic genetics course for healthcare professionals combining web-based learning with traditional face-to-face instructional techniques. A multidisciplinary group from the National Institutes of Health (NIH) created "Basic Genetics Education for Healthcare Providers" (BGEHCP). This program combined 7 web-based self-education modules with monthly traditional face-to-face lectures by genetics experts. The course was pilot tested by 186 healthcare providers from various disciplines with 69% (n=129) of the class registrants enrolling in a pre-post evaluation trial. Outcome measures included critical thinking knowledge items and a Web-based Learning Environment Inventory (WEBLEI). Results indicated a significant (p<0.001) change in knowledge scores. WEBLEI scores indicated program effectiveness particularly in the area of convenience, access and the course structure and design. Although significant increases in overall knowledge scores were achieved, scores in content areas surrounding genetic risk identification and ethical issues regarding genetic testing reflected continued gaps in knowledge. Web-based genetics education may help overcome genetics knowledge deficits by providing access for health professionals with diverse schedules in a variety of national and international settings.

Monoclonal antibodies and side-effect management.

Monoclonal antibodies are increasingly becoming a standard part of clinical cancer treatment. Eight monoclonal antibodies are approved by the Food and Drug Administration for the treatment of cancer in the United States. Oncology nurses are expected to be familiar with these agents, their indications, and their adverse effects, to provide appropriate care and symptom management to patients receiving these agents, and to adequately educate patients and families about these treatments and their specific and overlapping side effects. Monoclonal antibody mechanisms of action and indications, infusion guidelines, and symptom management are outlined in this article.

Patient intensity in an ambulatory oncology research center: step forward for the field of ambulatory care--part III.

Nursing leaders in ambulatory care need to objectively quantify patient intensity to balance patient care needs and nursing resources. The day-to-day application of the Ambulatory Intensity System (AIS) is illustrated in this final article of a three-part series that reviewed current literature on acuity/intensity tools, and described the development of an AIS system to objectively quantify the nursing care.

Patient intensity in an ambulatory oncology research center: A step forward for the field of ambulatory care--Part II.

Nursing leaders in ambulatory care need to objectively quantify patient intensity to balance patient care needs and nursing resources. In this three-part series, current literature on acuity/intensity tools will be reviewed, and the development of an Ambulatory Intensity System (AIS) to objectively quantify nursing care will be described. In this article, the ongoing implementation of the system, its incorporation into the organization's established computerized appointment system, reliability measures, and related performance improvement activities will be discussed.

Patient intensity in an ambulatory oncology research center: a step forward for the field of ambulatory care.

Nursing leaders in ambulatory care need to objectively quantify patient intensity to balance patient care needs and nursing resources. In this three-part series the current literature on acuity/intensity tools will be reviewed, and the development of an Ambulatory Intensity System (AIS) to objectively quantify the nursing care will be described.