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Objective: Antibiotic prophylaxis reduces infection risk following transrectal prostate biopsy. Studies in countries with high antibiotic resistance show that fosfomycin, given an hour or more before biopsy, has equal or better outcomes than ciprofloxacin. This study aimed to evaluate if fosfomycin, administered immediately before biopsy, is as effective as ciprofloxacin in Sweden, where antibiotic resistance is low.

Material and Methods: A randomised, non-inferiority study of different antibiotic prophylactic regimes, including men undergoing transrectal prostate biopsy, was conducted. A total of 3448 patients were planned to be included. Primary outcome was hospitalisation due to urinary tract infection (UTI) within 14 days. Men without risk factors for infection received either fosfomycin or ciprofloxacin immediately before biopsy. Patients with risk factors received additional doses post-biopsy.

Results: The study was stopped by the safety board after enrolment of 42 men. Four of 20 men (25%) in the fosfomycin group were hospitalised due to UTI, including two with positive blood cultures for Pseudomonas, whereas no hospitalisations (0%) occurred in the ciprofloxacin group. The main limitation was the small sample size.

Conclusion: Fosfomycin administered immediately before biopsy was not supported by this study. The results may be skewed by the high incidence of Pseudomonas infections.

Level of evidence: 2

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.

Background: Clinical research studies are important for the developmentof new treatments in healthcare. The quality of clinical research relies on the competence, skills, and knowledge of the research team. Clinical research nurses (CRNs) are important members of clinical research teams as they are responsible for various tasks specified in study procedures. Internationally, nurses have been engaged as CRNs in in many areas of medicine, such as oncological research, for several decades. However, there is a lack of consensus concerning their professional role and a clear work description is lacking. In Sweden, nurses are becoming increasingly involved in research as CRNs, yet the CRN role is undefined as there is no Swedish national competence description that could guide CRNs’ work tasks, requirements for education, and management of ethical issues. Furthermore, the processof becoming a CRN is not understood. Increasing international research into the CRN role has shown that the role differs between countries.There is a lack of Swedish studies, including studies of the process of transitioning from being a registered nurse (RN) to a CRN. Since consensus is lacking concerning the CRN role in Sweden, we need to explore it further and examine how nursing perspectives are influencing it. The overall aim of this thesis was therefore to explore the professional role of CRNs in Sweden and the transition of RNs to being CRNs.

Methods: Both quantitative (studies I and II) and qualitative (studies III and IV) methods were used. The analyses are based on data from questionnaires and individual interviews of CRNs in Sweden. In study I, descriptive statistics and test–retest analyses were used to analyze the validity and reliability of the translated CTNQ-SWE. In study II, descriptive statistics and one-way ANOVA were used to analyze reported work tasks, perceptions, and differences between groups of CRNs. In studies III and IV, qualitative content analysis according to Graneheimet al., (2004) was used to analyze the transition, i.e., becoming and being a CRN.

Results: CRNs perform new and diverse work tasks and are often involved throughout the study process, with the greatest activity in data management and the actual conducting and evaluation of clinical studies (e.g., scheduling and performing procedures and tests according to the research protocols). There is seldom any work description or competence framework to guide nurses through the transition to the CRN role, placing them in an uncertain position where they must struggle to adaptiv to their new role and work tasks. To perform these new work activities, CRNs need more support as well as education in research procedures, regulations, and ethics. During the transition, CRNs improve their knowledge of research, regulations, and ethics and increase their experience of clinical research practice and collaboration in networks. They also learn and develop from dealing with challenging situations, such as the informed consent process. Furthermore, problem solving, study requirements, and ethical reasoning are emphasized as challenging. When passing through the different phases of transition to the CRN role, the nurses achieve expanded competence, change didentity, and growing confidence as informal leaders. CRNs also advocate for patient rights and mentor others involved in research, but they simultaneously lack acknowledgement and a formal leadership role.

Conclusions and clinical implications: This thesis provides important insights into the CRN role in Sweden. It highlights the transition of RNs to becoming CRNs as well as their experiences of working as and becoming CRNs. The thesis reports that CRNs, overall, seem to be satisfied with their work, but some of their experiences highlight that skills, education, and organizational structures require improvement; forexample, appropriate introduction and support are required during the transition to the CRN role. Ethical challenges call for ongoing discussion in research teams. One conclusion is that CRNs’ competences and tasks need to be clarified. Developing clear competence pathways for nurses to become CRNs, including mentorship and support, could be one way of acknowledging CRNs’ important work, thereby creating a better outlook for high-quality clinical research procedures. Making the CRN professional title more homogeneous nationally and internationally would make comparisons easier. This would clarify CRNs’ work tasks and role in Sweden and extend the nursing perspective on ethics. This thesis adds to a slowly growing body of literature on the CRN role and is relevant to both practitioners and policymakers. Additionally, it illustrates a need to develop both educational and mentoring support aswell as career pathways for RNs to become CRNs, which could improve the quality of clinical research in Sweden.

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.

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.

Aim and objectives: To translate the Clinical Trial Nursing Questionnaire (CTNQ) into Swedish and test it for face and content validity as well as internal consistency and reproducibility using test–retest procedures.

Introduction/Background: In many countries, as in Sweden, a registered nurse can be involved in research by becoming a clinical research nurse. The clinical research nurse plays a pivotal role in clinical studies as a part of the research team. Scales have been developed and used with the objective to clarify the role of clinical research nurses: one of them is the CTNQ.

Methods: A quantitative cross-sectional design with a test–retest procedure was applied to validate the translated questionnaire. By using a snowball sampling method, relevant participants were identified and 49 registered nurses working in the field of research as clinical research nurses answered the questionnaire on two occasions. An expert panel of three clinical research nurses evaluated the questionnaire for face and content validity. The STROBE checklist for observational research has been followed for presenting the research (see File S1).

Results: Face and content validity was agreed upon in the expert panel group. Tests for internal consistency of the CTNQ was calculated and showed a high Cronbach's alpha for both the frequency and importance subscales. The test–retest correlation analysis (reproducibility) also revealed a high correlation coefficient for both subscales.

Conclusion: The CTNQ-SWE is a valid and robust instrument in a Swedish version. The instrument can be of importance in assessing the role of clinical research nurses in Sweden in future studies.

Relevance to clinical practice: Use of the CTNQ-SWE in future research can be of value for clarification and professional development of the clinical research nurse role in Sweden. The further use of the CTNQ in Sweden can be of value in understanding the process where licensed nurses make a transition into becoming a clinical research nurse, and to identify needs for customised education.