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

Abstract 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.

Even if their role is essential in clinical research, there exists no standardized, internationally agreed definition on the CRN role (Hastings et al., 2012). RNs struggle with their identity when becoming CRNs, trying to balance demands related to their responsibility for patient care and simultaneously following the study protocol. Adapting to the new role may create feelings of ambiguity and of being a novice again: to feel proficient takes time (Tinkler et al., 2018).

| BACKG ROU N D
CRNs not only manage many complex situations in their daily work but also see to several different tasks and demands associated with the role of being a clinical working RN versus a CRN. Various challenges associated with the transition to the new role as CRN include the use of new terminology and involvement in complex studies, which may create feelings of being a novice again and cause discomfort and moral distress (Höglund et al., 2010;Tinkler et al., 2018).
Developing and using standards for CRNs is something that may No such standards or approvals exist in Sweden, but in 2013 the Swedish government established a national committee and regional nodes for national coordination of clinical studies with a mission to support all research actors, including CRNs, with study support, education and consultancy (SOU 2013: 87). The purpose of the national coordination was to strengthen cooperation between health care, academia and industry in clinical studies. Since then, the regional nodes have given more attention to CRNs' role through both education and support from networks to improve the quality of clinical research. The lack of clear definitions and standards concerning professional competence and roles for CRNs is still a challenge, and there is a need for national consensus concerning the CRNs role, tasks and need of education.
The theoretical framework of this study is transition. According to Meleis et al. (2000), the mastery of the knowledge to perform a role is known as role clarification. A lack of role clarification can have a negative effect on role performance and relates to transitions, in this case from a RN to a CRN. The transitions between different professional roles and contexts are often complex and multidimensional and develop through phases (Meleis et al., 2000). How well the transition process proceeds, depends on personal, environmental and interpersonal resources (Young & Wilkersen, 2000).
In summary, there is a lack of studies of the Swedish CRN's role.
A better understanding of the role, tasks, competence and skills could potentially create better conditions for the transition to a CRN. Since there is a lack of consensus concerning the CRN's role, we need to investigate the tasks they are performing and if there are differences in frequency and their views of the importance of these work tasks. This knowledge is also important for international comparison as well as for the quality of clinical research and to inform the national, regional research nodes and healthcare organizations, which are expected to support and educate the CRNs.
The aim of this study was therefore to explore the role of CRNs in Sweden and the differences in competences and tasks, using the validated Clinical Trial Nursing Questionnaire -Swedish version (CTNQ-SWE).

| Design
A cross-sectional study was conducted and data were collected using the Swedish version of the CTNQ-SWE (Backman Lönn et al., 2019). This article adheres to the EQUATOR guidelines of reporting research using the STROBE checklist for observational research (Appendix S1), (Von Elm et al., 2008).

| Instrument
The CTNQ-SWE is a validated questionnaire based on the Clinical Trial Nursing Questionnaire (Ehrenberger & Lillington, 2004) and has previously been translated into Swedish as well as adapted to Swedish organizational settings and demographics. The Swedish version was tested for face and content validity as well as reliability (reproducibility) with test-retest procedures. Face and content validity was achieved by the bilingual expert and the expert panel, furthermore reliability analysis was made for comparing responses in frequency and importance scales. It resulted in Cronbach's alpha coefficient for frequency scale 0.97 and for importance scale 0.97.
Test-retest reliability/reproducibility, was made by a sample of The CTNQ-SWE contains 159 items in 10 sections (See Table 1).
Sections 1-8, with 120 items, examine the role components of clinical research that the CRNs are involved in.
Different areas of activities and responsibilities for the CRNs are rated for frequency (how often they perform the task/area) and for importance (how important they perceive the task/area for the practice of CRNs). A five-grade scale is used for: (a) the frequency of performing the activity (0, never, not part of my role; 1, once or twice; 2, occasionally when needed; 3, repeatedly, at various times; 4, extremely frequently) and (b) for the importance of the activity (0, not important; 1, somewhat important; 2, important; 3, moderately important; 4, very important). Section 9 contains 10 items concerning the professional nursing role perceptions. These answers are scored on a Likert scale, ranging from 1 (strongly agree) to 4 (strongly disagree) or the alternative response "not applicable to the role." While the original CTNQ includes three further sections: 10-12 with 24 items concerning the professional nursing role characteristics, organizational characteristics and demographic characteristics, the Swedish version has only one contextual section with 29 items concerning demographics, academic degree, certification level of experience in nursing and as CRN, employment status and work settings.

| Data collection
Since no Swedish register of a number of RNs working as CRNs exists, we did not know how many CRNs in total were eligible. Therefore, a request for email addresses of CRNs along with an invitation for participation was sent to all regions/county councils; LIF (Läkemedelsindustriföreningen, a trade association for the researchbased pharmaceutical industry); municipalities responsible for health care and research; national and regional nodes for clinical research; and lastly, the trade union for nurses. The study information was also shared through networks on LinkedIn. This resulted in a total of 591 email addresses representing potential participants. Eligible with educational backgrounds other than nurses, and who worked as clinical research assistants, were excluded. The strategic sampling process striving to reach all eligible CRNs in Sweden, is described in Figure 1.
The total study population (n = 591 email addresses) was invited to fill in the CTNQ-SWE through a personal email link. The study information highlighted that the study concerned only those who were RNs working as CRNs. Ten persons who responded that they did not work as a CRNs were excluded. Reminders were sent out on three occasions, after 14 days, 1 and 3 months. Of the 581 potential participants, 156 people answered the questionnaire.
Additionally, after 6 months, as an attempt to reach out to more participants, a public online link invitation was sent out to the regional nodes for distribution in their networks, that is, strategic sampling in two steps. Information about how many people in total were reached by the regional nodes in this step is lacking, but it resulted in only five additional responses from new participants.
In total, 161 participants (28%) finally answered and sent back the CTNQ-SWE (see Figure 1). The participant information is presented in Table 2.

| Data analysis
Data were analysed using SPSS Statistics version 23 and SPSS version 25 (SPSS Inc., Chicago, IL, USA). All items were analysed descriptively, and mean values and standard deviations are presented for sections 1 to 9 in Tables 3 and 4.
We investigated the association between the task frequency and rated importance, as well as an association with other variables such as level of education and number of years as a CRN. Differences between groups of experience in the CRN role were evaluated using analysis of variance -ANOVA test. To examine the relationship between the performed tasks and the number of years working as CRN, one-way ANOVA was applied (Appendix S2). Games Howell post hoc test was used for pairwise comparison between the groups within each item. The level of statistical significance adopted was p < 0.05.

| RE SULTS
The majority of the participants were women representing various regions of Sweden. Their current work titles differed, such as RN, RN with specialist functions, specialist nurse, CRN and project or study coordinator. They worked full (47%) or part-time (53%) as a CRN.
Fewer than half (44%) stated that a job description was available.
Only a fourth of the respondents stated that they had a professional development plan drawn up. Their education was mostly described as informal (n = 137), and the majority reported that they had taken the initiative to attend courses by themselves, such as ethics in research, Many (n = 118), though, reported that they had attended one to five research courses the previous year; a few (n = 9) had attended six courses or more. Some CRNs (n = 34) reported that they had not attended any course during the last year. Many also highlighted the need for improved education, and if a specialist education to become a CRN existed, a majority (n = 124) would attend it.
The CRNs reported that they were involved in pre-study activities, study implementation and evaluation to various degrees. As shown in Figure 2, the most frequently performed activities concerned informed consent and managing the investigational products, which also were rated as most important by the CRNs. In general, the participants rated the importance of activities higher than the frequencies. Protocol planning and assessment were less frequently performed and rated as less important. The most and least frequently performed study tasks are presented in Table 3. The CRNs reported that they were often involved in practical work with inclusion, case report forms and study logs but seldom in budget issues, ethics applications and reporting of the results. In Table 4, the items assessed to be most and least important are listed.

| Protocol assessment
The result showed that the activities concerning the assessment of protocol under development were performed less frequently in comparison to the activities in other sections. These activities are related to identifying concerns about the study design with the focus on the well-being and security of the study patients. Assessing study budget and economics were seldom an activity for the CRNs and were also viewed as less important.

| Protocol planning
Participating in study initiation meetings and determining that all required documents were in place before study start were the activities the CRNs performed most frequently. They were very seldom involved in preparing documents for the Ethics Review Committee.

| Subject recruitment
In recruiting and screening potential study patients, the most frequent activities were related to maintaining screening logs and monitoring for correct inclusion. This was also graded with high importance. They seldom developed recruitment materials such as print materials and websites. Developing study-related documents was something they also scored as of the lowest importance.

| Informed consent process
Regarding the process of informed consent, securing written consent before participation in the study was the most frequent and important activity. Assessing the goals and purposes of the study patients in participating was rated with low frequency and low importance in their role as CRNs.

| Investigational product
Regarding the investigational product, activities concerned with handling, ordering, accurately documenting and administering the study drugs, and maintaining accountability for the investigational product, were rated most frequently performed as well as most important.

| Data management
Among activities related to managing data in all forms, such as source data and records for collecting study data, and being a part of audits and inspections, the most frequently performed activity concerned entering data into case report forms and confirming its accuracy, that is, that data were input correctly, while preparing final written reports for the ethical review authority or for sponsors, was an activity they seldom performed.

| Professional nursing role performance
This section related to how the CRNs performed activities based on their professional role, the most frequent activities concerning performance appraisals of their own practice and role performance in relation to peers or supervisor, identifying areas of strength and areas for further development. The lowest frequent activity concerned identifying clinical problems of research, something they performed only once or twice a year or occasionally.

| Professional nursing role perception
In this section, the analysis showed that the CRNs strongly agreed or agreed (78.9%) that they felt competent and secure in their role. They also strongly agreed/agreed on having good communication with study patients and their families (97.5%) as well having good communication with healthcare personnel and the research team (94.4%).
Approximately 98% strongly agreed or agreed that their work as a CRN was independent. In terms of acceptance of the role by colleagues, they reported high acceptance from the physicians (88.2%) but lower acceptance by other nurses not working as CRNs (55.9%).

| Tasks related to the CRNs' work experience
Comparisons were made to identify differences between groups, that is, reported tasks and years of work experience as a CRN; see Appendix S1. Post hoc tests of sections and individual items (data not shown) showed that more experienced CRNs conducted some tasks more frequently than less experienced ones. Highly experienced CRNs (>15 years of experience) more often worked with all investigational product tasks, such as educating study patients, than did less experienced nurses (<10 years of experience). Regarding the frequency of implementation and evaluation and frequency of professional nursing role performance, post hoc tests could not find significant differences between the groups.

| DISCUSS ION
This study is the first scientific report on the tasks of CRNs in

F I G U R E 2 Frequency and importance of activities related to the role of the 161 Swedish CRNs
Oncology Group (COG) in the United States and Canada, but results from Catania et al. (2012) indicated that Italian CRNs seldom were involved in the consent process. We found that CRNs in Sweden reported a broader involvement in the entire study procedure than the Italian CRNs, who mostly were involved in the practical tasks in clinical study implementation (Catania et al., 2012).

AUTH O R CO NTR I B UTI O N S
The authors confirm contribution to the paper as follows; icmje.org/recom menda tions/)]: • substantial contributions to conception and design, acquisition of data or analysis and interpretation of data; • drafting the article or revising it critically for important intellectual content.

ACK N OWLED G EM ENT
Thanks to the CRNs in Sweden who patiently answered the questionnaire.

CO N FLI C T O F I NTE R E S T
The authors declare that there is no conflict of interest.

DATA AVA I L A B I L I T Y S TAT E M E N T
Data available on request due to privacy/ethical restrictions. The data that support the findings of this study are not publicly available since the data consists of information that could compromise research participants' privacy and consent.

E TH I C A L A PPROVA L
The study followed the ethical principles of the Declaration of Helsinki (1996) and was approved by the regional Ethics Review Authority (Dno: 2017/67-31). All participants were given written information about the study by email, attached with a personal link to the questionnaire. The study information stated that participation was voluntary and that the result would be presented in group level, with contact information to the researcher if they had any questions or felt a need for more details. Instead of signing an informed consent, it was explained at the front page of the online web-questionnaire that they consented to participation by completing the questionnaire. No conflicts of interest have been identified.