Nurses in clinical trials: perceptions of impact on the research enterprise.

Background: Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the protocol and quality care for participants. Aims: The purpose of this study was to describe Clinical Research Nurses' experiences in clinical trials, educational preparation, and career pathways, to gain a deeper understanding of clinical research nursing contributions to the clinical research enterprise. Methods: An internet-based survey was conducted to collect demographic data and free text responses to four open-ended queries related to the experience of nurses working in clinical trials research, educational preparation, and role pathways. Qualitative content analysis was used to analyze free text responses. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy's Quality Caring Model of relationship centered professional encounters. Results: Forty clinical research nurses responded to the open-ended questions with themes related to dual fidelity to study participants and protocols, relationships and nursing care, interdisciplinary team membership and contributing to science, emerging from the data. Gaps in educational preparation and professional pathways were identified. Conclusion: This study provides insights to unique clinical research nurse practice contributions in the clinical trial research enterprise within a context of Duffy's Quality Caring Model.

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.

Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-severe Pain Following Abdominoplasty.

BACKGROUND: A nanocrystal intravenous (IV) formulation of meloxicam is being studied with the aim of providing postoperative analgesia. METHODS: This randomized, multicenter, double-blind, placebo-controlled trial evaluated meloxicam IV 30 mg or placebo (≤ 3 doses) in 219 subjects undergoing abdominoplasty. The primary endpoint was the summed pain intensity difference over 24 hours postdose (SPID24). RESULTS: Meloxicam IV-treated subjects had a statistically significant reduction in the least squares mean of SPID24 compared with placebo-treated subjects (-4,262.1 versus -3,535.7; P = 0.0145). Meloxicam IV was associated with statistically significant differences over placebo on several other secondary endpoints, including other SPID intervals (ie, SPID12, SPID48, and SPID24-48), achievement of perceptible pain relief, the proportion of subjects with a ≥ 30% improvement in the first 24 hours, and Patient Global Assessment of pain at hour 48. Meloxicam IV was also associated with a reduction in the number of subjects receiving opioid rescue medication during hours 24-48 and the total number of doses of opioid rescue analgesia. Meloxicam IV was generally well tolerated, with the numbers and frequencies of adverse events similar to that of the placebo group. There was no evidence of an increased risk of adverse events commonly associated with nonsteroidal anti-inflammatory drugs including bleeding, thrombotic, cardiovascular, renal, hepatic, cardiovascular, injection site, and wound healing events. CONCLUSION: Meloxicam IV provided sustained pain relief and generally was well tolerated in subjects with moderate-to-severe pain following abdominoplasty.

Efficacy and Safety of Intravenous Meloxicam in Patients With Moderate-to-Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-controlled Trial.

OBJECTIVE: To evaluate the analgesic efficacy and safety of a novel intravenous (IV) formulation of meloxicam (30 mg) in patients with moderate-to-severe pain following a standardized, unilateral bunionectomy with first metatarsal osteotomy and internal fixation. MATERIALS AND METHODS: Patients who met the criteria for moderate-to-severe postoperative pain were randomized to receive bolus injections of meloxicam IV 30 mg (n=100) or placebo (n=101) administered once daily. The primary efficacy endpoint was the Summed Pain Intensity Difference over 48 hours (SPID48). Secondary efficacy endpoints included sum of time-weighted pain intensity differences (SPID) values at other timepoints/intervals, time to first use of rescue analgesia, and number of rescue doses taken. Safety assessments included the incidence of adverse events (AEs), physical examinations, laboratory tests, 12-lead electrocardiography, and wound healing. RESULTS: Patients randomized to meloxicam IV 30 mg exhibited a statistically significant difference in SPID48 versus the placebo group (P=0.0034). Statistically significant differences favoring meloxicam IV over placebo were also observed for secondary efficacy endpoints, including SPID at other times/intervals (SPID6: P=0.0153; SPID12: P=0.0053; SPID24: P=0.0084; and SPID24-48: P=0.0050) and first use of rescue medication (P=0.0076). Safety findings indicated that meloxicam IV 30 mg was generally well tolerated; no serious AEs or bleeding events were observed. Most AEs were assessed by the investigator to be mild in intensity, and no patients discontinued due to AEs. There were no meaningful differences between the study groups in vital signs, electrocardiographic findings, or laboratory assessments. In most cases, investigators found that wound healing followed a normal course and mean wound-healing satisfaction scores were similar for meloxicam IV 30 mg and placebo. DISCUSSION: Meloxicam IV doses of 30 mg provided effective pain relief when administered once daily by bolus injection to patients with moderate-to-severe pain following bunionectomy, and had an acceptable safety profile.

Frequency of use of complementary and alternative medicine in women with breast cancer.

PURPOSE/OBJECTIVES: To estimate the frequency of use of complementary and alternative medicine (CAM) therapies among women diagnosed with breast cancer and to identify demographic and clinical factors associated with CAM use in these patients. DESIGN: A descriptive, cross-sectional survey. SAMPLE: A convenience sample of 105 predominantly Caucasian women (mean age = 59 years) with a diagnosis of breast cancer was recruited from the Tampa Bay area and a rural midwestern area. METHODS: Utilizing the "Use of Complementary Therapies Survey," frequency of CAM use was calculated for 33 individual therapies listed on the survey and among three survey-defined subscales of CAM therapies (i.e., diet and nutritional supplements, stress-reducing techniques, and traditional and ethnic medicines). MAIN RESEARCH VARIABLES: Use of CAM therapies and types of treatment in women with breast cancer. FINDINGS: Among diet and nutritional supplements, 64% of all participants reported regular use of vitamins and minerals and 33% regularly used antioxidants, herbs, and health foods. Among stress-reducing techniques, 49% of all participants regularly used prayer and spiritual healing, followed by support groups (37%) and humor or laughter therapy (21%). Traditional and ethnic medicine therapies rarely were used with the exception of massage, which 27% of all participants used at least once after diagnosis. More frequent CAM use was observed among study participants who had undergone previous chemotherapy treatment and those with more than a high school education. Also, being less satisfied with their primary physician was associated with patients' more frequent CAM use. CONCLUSIONS: CAM use is increasing among women with breast cancer, and frequency of specific use according to type of CAM is higher than what has been reported in other studies. Use increased in patients who had undergone chemotherapy and in those with a high school education. IMPLICATIONS FOR NURSING: Oncology nurses are in a key position to identify what treatments patients are using and implement CAM therapies that can be helpful to relieve patient symptoms related to treatment and psychological distress.

The impact of osteoporosis continuing education on nurses' knowledge and attitudes.

BACKGROUND: Osteoporosis has rapidly evolved into a severe health threat to Americans and a major public health problem. The increasing incidence of this disease and related fractures mandates that continuing education include osteoporosis content to ensure nurses provide competent education and care. An osteoporosis educational program was presented to nurses as part of a continuing education symposium on women's health issues. The program was tested to determine its effectiveness in augmenting the osteoporosis-related knowledge and attitudes of nurses. METHOD: Eighty-one RNs with educational levels varying from associate degrees to doctorates attended the continuing education program. Sixty-three of the program participants completed pretest and posttest measures. FINDINGS: The educational program significantly increased osteoporosis knowledge in this cohort of nurses. Additionally, nurses indicated they were more likely to pay attention to their own bone health as a result of attending the program. CONCLUSION: Results of this study reinforce the need for osteoporosis-related continuing education.