A Contemporary Framework Update for Today's School Nursing Landscape: Introducing the School Nursing Practice Framework™.

School nursing is a unique nursing specialty that benefits from a practice framework that aids school nurses in explaining and accomplishing their role. In 2016, the NASN debuted its Framework for 21st Century School Nursing Practice™, which has shaped school nursing practice as well as education, leadership, research, and collaboration with stakeholders. However, practice frameworks are not meant to remain the same indefinitely. Therefore, NASN evaluated and updated the Framework to ensure its continued alignment with the education and healthcare landscape. The purpose of this article is to share the history of the Framework for 21st Century School Nursing Practice™ development, provide the rationale for the update, and discuss the strategic process NASN used to update its Framework now entitled the School Nursing Practice Framework™.

Medical-surgical nurses' EBP beliefs and competencies.

BACKGROUND: The lack of evidence-based practice (EBP) knowledge and inability to implement EBP among nurses is a major barrier to quality nursing care. The literature shows that nurses highly value the use of EBP, however, they lack necessary EBP competencies. Although medical-surgical nurses were included in studies examining cross-sections of the nursing workforce, no studies exist specifically investigating their EBP beliefs and EBP competencies. AIMS: The purpose of this study was to describe medical-surgical nurses' self-reported EBP beliefs and competencies. METHOD: A descriptive, cross-sectional design employing survey methodology was used. RESULTS: A total of 1,709 medical-surgical nurses participated for a response rate of 13%. The findings revealed that medical-surgical nurses had positive beliefs about EBP. However, they rated themselves competent in only 2 EBP competencies of 24. Medical-surgical nurses working in units or organizations that had a special designation such as Academy of Medical-Surgical Nurses Premier Recognition in the Specialty of Med-Surg (AMSN PRISM; p = .001) or Pathway to Excellence (p = .006) reported greater EBP competency scores. Also, nurses educated at the master's level or higher had better EBP competency scores (p < .0001). LINKING EVIDENCE TO ACTION: Medical-surgical nurses need support at the personal and organizational levels to improve their EBP competence and increase uptake of EBP in their practice. Therefore, individual nurses must reflect on their EBP competence level and pursue opportunities to develop these essential attributes. Leaders must also create practice environments where EBP is valued, and barriers to EBP implementation are eliminated. Faculty in prelicensure and graduate programs should integrate EBP into their curricula and assess students' EBP competencies.

Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials.

BACKGROUND/AIMS: Numerous reasons have been identified for why U.S.-based principal investigators choose to not continue participating in FDA-regulated trials. However, unexplored are reasons why a substantial number of principal investigators, facing the same challenges, remain engaged in clinical research. This study aimed to both describe barriers and identify factors that contribute to active investigators' success in conducting multiple FDA-regulated trials. METHODS: We conducted qualitative in-depth interviews (IDIs) with "active" multi-trial investigators. Interviews focused on investigators' experiences with FDA-regulated drug trials, challenges faced, and factors contributing to success. Investigators also reflected on previously identified barriers and shared advice for new investigators. Narratives were analyzed using applied thematic analysis. RESULTS: We interviewed 23 experienced investigators, representing a variety of backgrounds. Most reported that demonstrated ability to conduct a trial led to being approached again by sponsors. Investigators cited infrastructure, staff support, advance planning, and personal qualities as key factors in successfully conducting multiple trials. Nearly all cited difficulties related to trial finances. Three-quarters pointed to challenges with patient recruitment; others described challenges related to data and safety reporting and to the time that trial implementation takes away from other activities. Aspiring investigators were advised to engage in research-specific training and seek out mentorship opportunities. CONCLUSION: Investigators in our sample faced many of the same challenges identified in previous research, yet they had evolved strategies to overcome them. The amount and type of support to which investigators have access may represent a crucial difference between "active" investigators and principal investigators who leave FDA-regulated trials.

Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative.

The Clinical Trials Transformation Initiative (CTTI) Strengthening the Investigator Community Project was prompted by the need to understand the reasons for high rates of turnover among investigators who lead US Food and Administration-regulated clinical trials at research sites. Because investigator knowledge and experience directly affect the quality and ultimate success of clinical trials, investigator turnover has important implications for the research enterprise, as well as the patients and other stakeholders who depend on the outcomes of clinical research. The CTTI project team used findings from both quantitative and qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to delineate key concerns faced by investigators and recommend practical, action-based solutions. The recommendations focus on strengthening four key categories of site-based research activity: developing site-based research infrastructure and staff, optimizing trial execution and conduct, improving site budget development and contract negotiations, and discovering opportunities for conducting additional trials.

Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database.

BACKGROUND: High turnover rates among clinical trial investigators contribute to inefficiency, instability, and increased costs for the clinical research enterprise; however, factors contributing to investigator turnover have not been well characterized. METHODS: Using information from the U.S. Food and Drug Administration's Bioresearch Monitoring Information System (BMIS), we examined trends in the overall clinical investigator workforce and within specific "phenotypes" as well as differences by investigator location (U.S.-based vs. non-U.S.-based). We identified unique investigators within the database, stratifying them into one of three "phenotypes": those with one Form FDA1572 submission across the study interval ("one-and-done"); those with two or more submissions but with substantial intervals between trials ("stop-and-go"); and those with two or more submissions and continuous involvement in multiple trials ("stayers"). RESULTS: Of the 172,453 unique investigators who submitted a Form FDA 1572 during the study interval (1999-2015), 85,455 were classified as "one-and-done" investigators; 21,768 as "stop-and-go" investigators; and 65,231 as "stayer" investigators. The total number of investigators declined across the study interval. Among all subgroups, only "one-and-done" investigators showed growth across the study period, largely driven by increases in non-U.S.-based investigators. "Stop-and-go" investigators showed declines for both U.S.-based and non-U.S.-based investigators, as did "stayers," who showed the largest absolute and proportional declines of all subgroups. CONCLUSIONS: From 1999 to 2015, investigators submitting a Form FDA 1572 to the BMIS database declined by approximately one-third and the proportion of investigators involved in only one trial increased, signaling potential adverse trends in the clinical investigator workforce. Strategies for sustaining investigator engagement warrant further exploration.

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial.

Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA) Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs) decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as "one-and-done." Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1) workload balance (balancing trial implementation with other work obligations and opportunities) (63.8%); 2) time requirements (time to initiate and implement trial; investigator and staff time) (63.4%); and 3) data and safety reporting (56.5%). Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly "one-and-done." Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.