Assessment of Nursing Workload and Complexity Associated with Oncology Clinical Trials: A Scoping Review.

OBJECTIVES: Clinical trials (CTs) play a crucial role in advancing medical knowledge and patient care but are increasingly complex and resource-intensive. This scoping review aims to explore the current approaches for evaluating workload (WL) in oncology CTs and identify tools for measuring clinical research nurses' WL. METHODS: The search was conducted through MEDLINE, Scopus, CINAHL, and COCHRANE databases and carried out through the framework developed by Arksey and O'Malley and revised by the Joanna Briggs Institute. Data extraction and synthesis were performed to analyze instruments used for WL assessment and their dimensions. RESULTS: Of the 1,005 records identified, 12 meet the inclusion criteria. The complexity and WL associated with CTs can be attributed to five main domains: (1) protocol, (2) single case, (3) data management, (4) regulatory, and (5) worker-related. These instruments varied in their approaches, scoring systems, and domains assessed. Notably, the protocol-related domain was prevalent across most instruments, highlighting its importance in WL evaluation. Furthermore, findings revealed a wide range of WL scores across different studies, emphasizing the complexity and variability in WL management within CTs. CONCLUSIONS: This scoping review underscores the importance of evaluating WL in CTs and provides insights into existing tools and approaches. Nurses, as integral members of clinical research teams, bear significant responsibilities in trial management, necessitating a balanced approach to WL allocation. Future research should focus on validating and standardizing assessment tools to optimize resource allocation and enhance research efficiency in CT centers. IMPLICATIONS FOR NURSING PRACTICE: Understanding WL dynamics in CTs is essential for nurses involved in research delivery. By utilizing validated WL assessment tools, nurses can advocate for appropriate staffing levels and promote efficient trial management, ultimately improving patient outcomes and research quality in CT settings.

Assessment of Nursing Faculty Members' Knowledge Toward Research: A Cross-Sectional Study.

Background and aim In the context of contributing to healthcare and the well-being of a nation and its communities, nursing research plays a vital role in advancing the discipline of nursing science. Nursing research is essential for improving the quality of nursing care. This study aims to examine the research knowledge level of faculty members at the College of Nursing, University of Raparin, Kurdistan Region, Iraq. Methods We conducted a cross-sectional study involving 43 nursing faculty members at the University of Raparin. The survey was distributed using convenience sampling in April 2024. Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 26.0 (released 2019, IBM Corp., Armonk, NY). Continuous variables were analyzed using mean and standard deviation, while categorical variables were analyzed using frequency and percentage distributions. The association between knowledge scores and demographics was tested using Mann-Whitney, Kruskal-Wallis, Chi-square, and post-hoc tests. Stepwise multiple regression analysis was used to determine the variables that influence the knowledge score. Significance was set at p < 0.05. Results A total of 43 participants were enrolled in this study. The mean age was 32.56 ± 4.75, with 69.8% of participants being male. In terms of educational attainment, 48.8% held master's degrees, 39.5% held bachelor's degrees, and only 11% possessed PhDs. The mean work experience was 5.40 ± 4.04 years, and the mean knowledge score toward research was 3.09 ± 1.97 out of 7. Demographic variables, such as age, marital status, and gender, showed no significant associations with knowledge levels (p > 0.05). However, significant associations were found for education level (p = 0.004) and years of experience (p = 0.011). In the stepwise regression analysis, we observed a significant positive correlation between the level of education and knowledge score (F =10.787, p = 0.002). However, variables, such as age, gender, marital status, years of experience, and participation in research courses, did not demonstrate statistical significance (p-values > 0.05). Conclusion This study highlights a significant lack of research expertise among nursing faculty members, emphasizing the urgent need for targeted interventions and instructional activities in nursing education programs. It is crucial to address this knowledge gap in order to support the professional growth of faculty members and promote the advancement of nursing research and evidence-based practice. Policymakers should also consider implementing mentorship programs that strategically pair less experienced faculty members with seasoned researchers. This initiative aims to cultivate a collaborative learning environment and enhance research skills.

Assessing the success of a research leadership programme for senior nurses and midwives: A mixed methods programme evaluation.

AIMS: In 2018 the National Institute of Health and Care Research, United Kingdom, launched a 3-year Senior Nurse and Midwife Research Leader Programme to support nurse and midwifery research leaders to develop research capacity and capability within NHS organisations. We report the results of a service evaluation of the programme strengths, areas for improvement and achievement of programme aims. DESIGN: Partially mixed, concurrent mixed methods programme evaluation, including: (a) meeting evaluation (survey), (b) annual evaluation (survey) and (c) qualitative stakeholder interviews. METHODS: Survey results were quantitatively analysed using descriptive statistics. Interviews were audio-recorded, transcribed, deductively coded using elements within the logic model and analysed using the seven-stage framework analysis method. RESULTS: Satisfaction with the programme was high (75%). The main perceived benefit of the programme was being part of a network. Challenges included accessing learning resources, lack of opportunity to network and lack of clarity about the programme aims. Meetings were evaluated as relevant and helpful (mean 93%), thought-provoking (92%), inspiring (91%), at the appropriate level (91%) and aligned with the programme aims (90%). All meetings were ranked as highly beneficial by attendees (92%). Stakeholder feedback on the programme success reflected the importance of leadership, the programme design and content, 'connection and community' and communication with and about the cohort. Overall, the anticipated programme aims were met, evaluating well from both the perspective of those on the programme and the wider stakeholder group. There has been a lack of investment in schemes to support research leadership development for nurses/midwives. A novel programme to support nursing/midwifery research leadership was positively evaluated. The programme is a useful model to support future capacity and capability building for nurses/midwives. The work is reported with reference to the SQUIRE 2 and SRQR checklists. No patient or public contribution.

A global pilot comparative, cross-sectional study of clinical research nurses/research midwives: Definition, knowledge base, and communication skills related to the conduct of decentralized clinical trials.

Background: A gap in the literature exists pertaining to a global research nurse/research midwife resources and communication skill set necessary to engage with participants of diverse populations and geographic regions in the community or home-based conduct of decentralized clinical trials. Aims: An embedded mixed methods study was conducted to examine research nurse/research midwife knowledge base, experiences, and communication skill sets pertaining to decentralized trials across global regions engaged in remote research: the USA, Republic of Ireland, United Kingdom, and Australia. Methods: An online survey was deployed across international research nurse/research midwife stakeholder groups, collecting demographics, decentralized trial experience, barriers and facilitators to optimal trial conduct, and the self-perceived communication competence (SPCC) and interpersonal communication competence (IPCC) instruments. Results: 86 research nurses and research midwives completed the survey across all countries: The SPCC and IPCC results indicated increased clinical research experience significantly correlated with increased SPCC score (p < 0.05). Qualitative content analysis revealed five themes: (1) Implications for Role, (2) Safety and Wellbeing, (3) Training and Education, (4) Implications for Participants, and (5) Barriers and Facilitators. Conclusions: Common trends and observations across the global sample can inform decentralized trial resource allocation and policy pertaining to the research nurse/research midwife workforce. This study demonstrates shared cultural norms of research nursing and midwifery across varied regional clinical trial ecosystems.

Clinical research nurses perceive their role as being like the hub of a wheel without real power: Empirical qualitative research.

AIM: This study aimed to explore the experiences of being a clinical research nurse (CRN), in Sweden. DESIGN: A qualitative study analysing individual interview data. METHODS: Interviews with 10 participants were conducted in April 2017 and repeated with five participants in May 2022. A semi-structured interview guide was used to cover topics such as experiences of working in a new role and professional challenges related to the role. The transcribed interviews were analysed inductively using qualitative content analysis. RESULTS: The main theme revealed that the CRNs experienced their work role as being like a hub in a wheel, using an ethical compass, but without real power. The six themes identified showed that CRNs worked independently and relied on clinical experiences as nurses but needed more education. They not only had a sense of duty but also too large responsibilities. Furthermore, they viewed their work as valuable and important. However, they needed an accentuated ethical compass and were also affected by power relations that negatively impacted work. CONCLUSION: Working as a CRN means being in a central position and working independently, which requires diverse skills and competencies. CRNs, however, face and manage complex ethical and practical challenges without real power. They experience huge responsibilities but need education and acknowledgement, indicating a need for improvement. This is an important message to stakeholders and managers about the necessity of taking adequate action to support CRNs who are crucial resources in clinical research. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Education pathways and key tasks for research nurses in Europe, results from a VACCELERATE online survey.

AIM: This article aims to provide a comprehensive overview of the educational pathways and responsibilities of research nurses in Europe, particularly focusing on their essential role in conducting research in clinical settings, including clinical trials, while adhering to ethical and regulatory standards. BACKGROUND: Research nurses play a crucial role in clinical research settings, especially in clinical trials, ensuring adherence to ethical and regulatory standards. Understanding their educational pathways and responsibilities is essential for promoting consistency and quality in research practices across Europe. DESIGN: Between October and November 2022, relevant European nursing education authorities, including those focused on research nursing, were contacted to participate in an online cross-sectional survey. The survey aimed to gather information about research nurse education and training in their respective countries. METHODS: The study followed a cross-sectional design. Contacts were made with European nursing education authorities based on recommendations from the VACCELERATE National Coordinators and the VACCELERATE Site Network. Participating organizations were invited to complete an online survey regarding research nurse education in their countries. RESULTS: Responses were obtained from 37 European countries, a response rate of 74%. The most common terms used to refer to nurses involved in clinical trials and epidemiological studies were "study nurse" (62%) and "clinical research nurse" and "research nurse" (43% each). The requirements to become a research nurse varied across countries, with a nursing degree necessary in 87% of countries and Good Clinical Practice (GCP) courses mandatory in 81%. Local providers of research nurse courses existed in 84% of countries, coordinated by online organisations (51%) or universities/hospitals (46%). The most common tasks assigned to research nurses were the administration of investigational medicinal products (from 78% in observational studies to 89% in phase IV trials) and blood sample processing (84% in phase II and IV trials). CONCLUSIONS: This study provides valuable insights into research nurse education and tasks in European countries. It highlights the need for standardisation to enhance consistency and quality of training across Europe.

Enhancing competency of clinical research nurses: A comprehensive training and evaluation framework.

The Sun et al's training program for clinical research nurses (CRNs) in the World Journal of Clinical Cases is a comprehensive and scientific approach. It includes structured frameworks for CRN training, aiming to improve CRN competency. This program emphasizes practical abilities, updates training content, and improves evaluation methods. The cultivation of CRN talents focuses on enhancing the training system, establishing a multifaceted evaluation framework, and continuously refining the training programs. Regular feedback and evaluation are essential to improve CRNs' competency in practical settings.

Starting a career in research nursing during a global pandemic.

In the spring of 2020, two nurses (KR and AJ) commenced their research nurse careers amid the SARS-Cov-2 (COVID-19) global pandemic. This reflective article discusses their experiences of beginning a clinical research nursing career, presented as a case study of their learning journey, rather than detailing the randomised controlled trial they delivered via GP practices. The main study compared standard care to nurse-led management of irritable bowel syndrome, the details of which will be published separately. The article identifies three overarching concepts: 'Green as grass, keen as mustard', 'Spires and steeples', and 'Down the rabbit hole'. The article offers insight from the two nurses for other professionals contemplating a career in research.

Enhancing the clinical research workforce: a collaborative approach with human resources.

Jobs for clinical research professionals (CRPs) have grown increasingly complex over the past 20+ years. This is due largely to additional administrative burden for investigators, study teams, sponsors, Clinical Research Organizations (CROs), and sites, particularly Academic Medical Centers (AMCs). Furthermore, National Institutes of Health (NIH) has reduced capacity to effectively fund research recognizing this is dependent on the overall congressional budget, which creates greater pressure for clinician scientists to secure external support. It is widely known clinical research will continue to become increasingly more complex for clinician scientists. This manuscript explores adoption of a clinical research competency-based job classification framework from the Joint Task Force for Clinical Trial Competency (JTFCTC) across several AMCs and the role of Human Resources (HR) in facilitating this process. This collaboration focuses on fostering successful projects tied to the business case in order to address equity and improve support for the clinical research enterprise.

Investigation and analysis of the current status of clinical research nurses / 中国临床药理学与治疗学

AIM: To investigate and analyze the current situation and needs of clinical research nurses in China, in order to provide scientific basis for constructing a training system for research nurses, promoting standardized training, and achieving standardized management for them. METHODS:A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China. The contents of the questionnaire mainly included the general information, professional experience and work content of the research nurses, the sense of accomplishment and training needs of clinical trial work. RESULTS: Among the 102 research nurses surveyed, 92.15% have a bachelor's degree or above; 53.92% of those have intermediate or higher professional titles; 74.51% of them are part-time research nurse. Among professional experiences, 19.61% have more than 10 years of clinical trial experience; 47.06%, 40.20%, and 21.17% of surveyed research nurses were authorized to participate in clinical trial drug management, sample management, and quality control; 70.59% of research nurses have a high sense of achievement in their daily work. In terms of education and training needs, clinical trial related laws and regulations, standardized training for clinical trial protocol implementation, and good clinical practice (GCP) are the three most important aspects. CONCLUSION: Clinical research nurses in China have a relatively high level of education and nursing experience, but there is still a large gap in the amount of professional full-time clinical research nurses in China. Due to the rapid development of innovative drugs and devices, as well as the urgent need to improve the clinical research system, it is necessary to establish a training, assessment, and evaluation system for research nurses that is in line with China's national conditions in order to improve the professional level of research nurses, and improve the quantity and quality of clinical trial research on innovative drugs and devices in China.

Expert consensus on clinical research nurse management in China.

Objective: With the rising number of clinical trials conducted in China, the role of Clinical Research Nurses (CRNs) within clinical trial organizations has become increasingly crucial. However, in the absence of industry guidelines, the management of CRNs lacks clarity. This study aims to address this gap by establishing a consensus on CRN management. Methods: The IACRN-Shanghai Chapter assembled a panel of experts to develop a consensus on the management of clinical research nurses. This consensus was formulated through an extensive literature review, expert evaluations, and collaborative conference discussions. Results: The consensus document offers a comprehensive professional definition of CRNs and provides detailed insights into their management. It covers aspects such as job settings, qualifications, responsibilities, training, assessment, workload management, staffing allocation, performance evaluation, and career progression. Conclusions: Establishing a professional definition for CRNs creates a standardized reference point for clinical trial institutions to effectively manage these professionals. Consistency in CRNs' roles, training, staffing, and corresponding assessments is essential for promoting their sustainable and healthy development within the field of clinical research.

Clinical research nurse predictions of trial failure, recruitment and retention: a case for their early inclusion in trial design.

BACKGROUND: Clinical research nurses are a key part of the clinical trial team but typically get involved later in the trial, usually during recruitment. The purpose of our study was to establish if CRNs who read the trial protocol can predict the performance of the trial. METHODS: We randomly selected 18 trial protocols with three statuses, terminated, withdrawn, and completed, from ClinicalTrials.gov, between 2014 and 2018 inclusive. We gave the protocols to five CRNs, asked them to make a judgement and provide a reason for that judgement (via a 12-item questionnaire) on the status of the trial (terminated, withdrawn or completed), if the trial met its recruitment target, if it recruited on time, and if it retained its participants. We also asked if it was likely a CRN was involved in the design of the trial. The CRNs were blinded to the study outcomes, did not receive any training on how to read a protocol and were prohibited from using/abstained from using the internet while completing the task. RESULTS: Twenty-three questionnaires on 23 trial protocols (18 different trials) were completed by 5 CRNs. The CRNs correctly predicted the trial status 48%, 95% CI: 29-67% (11/23) of the time; successful/unsuccessful recruitment 74%, 95% CI: 54-87% (17/23) of the time; on-time recruitment 70%, 95% CI: 49-84% (16/23) of the time; and participant retention 52%, 95% CI: 33-71% (12/23). CRNs identified 100% (sensitivity) of sites that hit their target and 63%, 95% CI: 36-84% (specificity) of sites that missed their target. CONCLUSIONS: CRNs are very good judges of trial recruitment and site performance issues and are a vital part of the clinical trial team. Taken with the ESP (Estimating Site Performance) study, we have made a strong case for broadening the trial team at the trial design stage. Early engagement of a broad skillset can potentially offset problems of recruitment, retention and trial failure.

The role of advanced clinical practitioners in clinical research.

Advanced clinical practitioners (ACPs) contribute immensely to patient care, so there is consequently a need to develop and create a sustainable environment for advanced clinical practice in clinical research. To achieve this it is necessary to evaluate the current challenges to enable stakeholders and policymakers to take the appropriate measures in safeguarding the future of advanced clinical practice in clinical research. The ACP workforce presents an opportunity to enhance access to clinical research. This article looks at the role of ACPs in clinical research and significant developmental milestones. The challenges of ACPs in clinical research are discussed, with an analysis of the needed interventions within the UK context. Strategies aimed at increasing the utilisation of the larger ACP workforce in clinical research are proposed.

Clinical nurses' understanding of the role of the clinical research nurse in the renal unit.

Clinical research nurses (CRNs) have been recognised as drivers of success in the conduct of clinical research and clinical trials. However, despite its popularity as a career option, the CRN role is unclear and misunderstood by most clinical nurses. A survey questionnaire was developed and distributed to clinical nurses in the renal unit of a large London hospital to ascertain their understanding of the role of the CRN. Although about 90% of clinical colleagues believed that research was beneficial to patients, a significant proportion (40%) misunderstood the role and 60% were found to have limited or basic understanding. Lack of communication between the CRN and clinical nurses, and research information dissemination emerged as the major contributing factors for this. Developing an approach to address this issue to bridge the gap between these two key nursing specialties is pivotal not only to increase research output but also to augment research awareness and improve working relationships.

Clinical research nurses, perspectives on recruitment challenges and lessons learnt from a large multi-site observational study.

Background: Recruitment of large numbers of study participants within a designated time frame for multi-site clinical research studies is a significant challenge faced by researchers. If a study does not manage to recruit targeted number of participants, it could have a significant impact on the statistical significance of the research. Purpose: This paper highlights the challenges of recruitment for a large multi-site UK-based tuberculosis observational study 'PREDICT'. Methods: It uses a case-study analysis from the research nurses, perspective, and descriptive information retrieved from non-recruitment log forms to understand reasons for potential recruits not participating. Results: Some of the main challenges to recruitment included patients not attending their clinic appointments, time required to obtain site-specific permissions and courier timings for blood sample collection. This paper also outlines key reasons for potential recruits who did not participate. Some of the common barriers to participation for non-recruited participants were work and family commitments, additional blood tests and language barriers. Conclusion: Successful strategies which were implemented to overcome some of the challenges during the study are presented. This paper, therefore, aims to present the challenges faced, lessons learnt and successful strategies implemented to inform the planning of similar longitudinal studies of this scale in future.

Exploring nurses' experiences of caring for patients participating in cancer clinical trials.

AIMS: Drawing on the experiences of cancer research nurses (CRNs) from the Cancer Research UK Excellence in Research Programme, this article aims to provide an insight into managing cancer patients' expectations of participating in clinical trials. It also outlines what CRNs consider are the key elements when supporting patients through side-effect management. METHOD: Through group work and discussions, CRNs' reflective experiences were captured by workshop facilitators around three topics by exploring nurses' experiences of caring for patients participating in cancer clinical trials. Reflective CRN experiences for each of the three topics were reviewed and themes were developed by the author, who also facilitated this workshop. RESULTS: Developing relationships, patient education and effective communication were all identified as important factors when helping to manage patient expectations and aid side-effect management. CONCLUSION: The findings, based on CRN experiences, give an understanding of aspects of the role that nurses have within cancer clinical trials, what patient expectations of clinical trial are and strategies on how best to support patients within this area of nursing.

[The Role and Function of Clinical Research Nurses in Anti-tumor Drug Clinical Trials for Lung Cancer Patients].

Clinical trials of anti-tumor drugs is not only the important way to develop new drugs, but also the most advanced treatment methods for malignant tumors, bringing survival benefits to patients. There are a large number of new anti-tumor drug clinical trials for lung cancer patients, covering a wide variety of anti-tumor drugs, and with rapid progress and high efficiency of clinical transformation. These trials could not be carried out successfully without the joint efforts of the research team, in which the research nurses also played a role that should not be underestimated. Combined with the work content of clinical research nurses, this paper introduced the post management, role function, core competence and career development prospect of clinical research nurses in the process of carrying out clinical trial of lung cancer drugs in detail. In order to provide reference for more medical institutions to carry out related work, and promote the further development of clinical research nurses to standardization and specialization.
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Transitioning to the clinical research nurse role - A qualitative descriptive study.

BACKGROUND: Studies have reported on the important role of the clinical research nurse in clinical studies. Yet, there is no international consensus about the role's competencies and tasks. Furthermore, the literature offers a little description of the career pathway from a ward-based registered nurse to a clinical research nurse. More knowledge about this specific role could benefit the nursing profession as well as increase the quality of clinical research. AIM: The aim of the study was to explore Swedish registered nurses' experiences transitioning into the clinical research nurse role. DESIGN: The study had a qualitative design. Data were collected via semi-structured interviews. Inductive qualitative content analysis was employed. METHODS: Ten participants (i.e., clinical research nurses) were interviewed in the spring of 2017. A semi-structured interview guide was used to address the transition into the clinical research nurse role, experience working in a new role, experience of ethical dilemmas and experience of organizational and professional issues related to the role. The interviews were analysed inductively using qualitative content analysis. RESULTS: The registered nurses described experiencing reality shock when they became clinical research nurses; that is, it was a challenging and transforming experience. The main theme, a challenging transition, was developed from the four subthemes highlighting that it defied their previous nursing role. They experienced an unclear professional identity, extended professional mandate, increased professional status and growing ethical consciousness in their new role. CONCLUSION: The results highlight that registered nurses who became clinical research nurses had needs that were both distinct from and overlapped with those of their former professional role as registered nurses. To avoid reality shocks, the development of clear competence pathways for nurses to become clinical research nurses, including introduction, mentorship and continued support, is necessary. Making their professional title more homogeneous, nationally and internationally, would facilitate role identification and comparisons in research.

Clarifying the role of clinical research nurses working in Sweden, using the Clinical Trial Nursing Questionnaire - Swedish version.

AIM: To explore the role of CRNs in Sweden and differences in competences and tasks, using the Clinical Trial Nursing Questionnaire - Swedish version (CTNQ-SWE). DESIGN: A cross-sectional survey. METHODS: Participants were identified through strategic sampling. Data were analysed by descriptive and comparative statistics. RESULTS: The respondents were experienced nurses who felt proficient in their role, they felt more acceptance by the principal investigators than by nursing colleagues. A majority of CRNs are involved in all procedures specified in the CTNQ-SWE. The most often performed tasks, also rated as the most important by the CRNs, concerned informed consent and management of investigational products. The education was often informal: with a lack of job descriptions and professional development plans. Need of formal specialist education was expressed. CONCLUSIONS: Knowledge about the role description can be used by clinical research enterprise internationally and healthcare organizations aiming to support CRNs in their role.

Moral distress in clinical research nurses.

Background: Clinical research nurses experience unique challenges in the context of their role that can lead to conflict and moral distress. Although examined in many areas, moral distress has not been studied in clinical research nurses.Research aim: The aim of this study was to examine moral distress in clinical research nurses and the relationship between moral distress scores and demographic characteristics of clinical research nurses.Research design: This was a descriptive quantitative study to measure moral distress in clinical research nurses using the Measure of Moral Distress - Healthcare Professionals (MMD-HP) administered electronically. Demographic data were also collected.Participants and research context: Registered nurses working in the clinical research nurse role (N = 322) were recruited through use of social media, emails, digital flyers, and snowball recruitment. Data was analyzed using SPSS. Pearson's correlation, independent t-test, and one-way ANOVA were performed to explore differences among the demographic variables.Ethical considerations: This study was approved by the Institutional Review Board at Texas Woman's University. A consent statement was included, and completion of the questionnaire was construed as consent.Findings/results: Analysis revealed a mean overall moral distress score of 79.58 (SD = 64.27) and median of 67, with a range of 0-354. Moral distress scores were negatively correlated with clinical research nurse age (r = 0-.156, p < 0.05). Reliability of the MMD-HP was demonstrated with a Cronbach's alpha of 0.93.Conclusions: The findings demonstrate that clinical research nurses do experience moral distress and revealed a wide range of scores. Further research is necessary to determine potential patient impact due to moral distress and to develop processes to minimize moral distress in the clinical research setting. This study was conducted during the COVID-19 pandemic, and the digital recruitment methods proved effective in recruiting a wide range of clinical research nurses, both nationally and internationally.