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Preliminary piloting and validation of a questionnaire identifying basic clinical skills practised by research nurses

14 February 2019
Volume 28 · Issue 3

Abstract

Clinical research nurses (CRNs) need to be competent in both clinical and research skills. In the past 10 years there has been increasing focus on developing the research competencies of CRNs. Employers, however, use the nurses' registered status as a proxy measure of clinical competence to perform their duties. The true extent of what clinical skills are practised by CRNs in a large NHS trust is unclear and there is a lack of validated measures to obtain this information. By using a mixed-methods approach of questionnaire and semi-structured interview, we aimed to pilot and validate a questionnaire to identify CRNs' self-reported confidence with clinical skills.

The UK Clinical Research Collaboration (UKCRC) defines the clinical research nurse (CRN) as ‘a nurse who is employed principally to undertake research within the clinical environment’ (UKCRC Sub-committee for Nurses in Clinical Research, 2007: 32). The role was formalised in 1977 when the Royal College of Nursing (RCN) published its guidance on research ethics for CRNs (RCN, 2009: 2). This has led to nurses carrying out their own and others' projects, and undertaking all elements of the research journey, including:

  • Collecting data
  • Writing and reviewing research protocols
  • Commissioning research.
  • The CRN is not the same as a ‘nurse researcher’; whereas a CRN works on projects related to patient care and treatment, the nurse researcher is generally part of an academic career path allowing the nurse to undertake postgraduate educational qualifications (Jones, 2015).

    CRNs play a vital role in the research team, ensuring a study's success, as they are experts in combining patient care with the research process (Mori et al, 2007). A CRN's expertise can include being a:

  • Data collector
  • Laboratory technician
  • Counsellor
  • Mediator
  • Expert—according to the needs of a particular study.
  • Despite the extensive nature of the role of the CRN, individuals often have to learn on the job with little supervision or guidance (Stephens-Lloyd, 2004; Calvin-Naylor et al, 2017).

    The Competency Framework for Clinical Research Nurses (Competency Working Group, 2011), an initiative supported by the National Institute for Health Research and the RCN, was published in December 2008 and revised in October 2011. This provides the basis for establishing the training and development needs for research staff. Although the framework focuses heavily on research competencies, there is little mention of clinical competencies. It does, however, state that:

    ‘The competencies presented in this document focus only on those skills unique to the role of CRNs. Clinical skills are assessed through different processes.’

    Competency Working Group, 2011: 8

    However, these processes are not clear. The Competency Working Group (2011) recognised the complexities of the role, which make it challenging to provide a one-size-fits-all competency model for CRNs, but the framework offers a useful starting point for developing local competency guidelines.

    This potential for decay of clinical skills among CRNs is increasingly recognised across the medical, nursing and allied health professions (Maehle et al, 2017). A major concern for managers is that, while the role of the CRN is expanding and CRNs take on more research activity, they are doing less clinical work. Consequently, they are becoming deskilled, suffering from skill fade/decay and become less competent in carrying out clinical tasks. CRN managers therefore face a challenge with the training and development of their CRNs when the true extent of clinical skills practised is unknown.

    It is the experience of the authors of this article that, within the NHS, CRNs have clinical experience, that basic clinical skills have been mastered and that they are competent to carry out tasks such as measuring temperature, pulse, respiration and oxygen levels, performing an electrocardiogram, cannulation, and venepuncture and administering specific treatments. However, to date, no research has been found to support this assumption. It is therefore unsurprising that there are no known measures to identify what clinical skills are believed to be essential to the CRN role and, as such, it is difficult for research managers to ensure relevant training is provided and competence is appropriately reviewed. This study aimed to develop a questionnaire that could be used to establish what clinical skills are practised by CRNs.

    Method

    A mixed-methods approach using a questionnaire and semi-structured interview was adopted in order to capture specific information relating to clinical skills and CRNs' views about clinical competency. The use of these two methods allowed complementary data to be gathered. The questionnaire provided information on what skills are being used, as well as reliability of responses. The face validity and acceptability of the tool was explored via the interviews.

    Ethical issues

    Ethical approval was obtained from the University of West of England ethics committee.

    Sample selection

    The potential research population included all professionals working under the banner of ‘clinical research nurse’ employed in a clinical research role. There were approximately 120 CRNs employed within the recruiting trust. As a pilot study, 15 participants randomly selected using a random number generator (Stat Trek) (https://tinyurl.com/76rtja8) were invited by email to complete an online survey twice, with a gap of 2 weeks between administrations. According to Connelly (2008), extant literature suggests that a pilot study sample should be 10% of the potential population; 15 people were approached to allow for people to decline the invitation.

    Not all participants completed the online questionnaire twice; however, those who did were asked if they were willing to participate in a follow-up interview.

    Data collection

    There were two phases to the data collection. First, the development and administration of an online questionnaire and, second, interviews. The method of developing the questionnaire is presented below, followed by that of the interview schedule. This mirrors the pattern experienced by the participants.

    Developing the questionnaire

    The questionnaire was developed using pre-existing knowledge of clinical skills that registered nurses in one NHS trust are known to practise. This was independently assessed by the lead CRN of a large acute NHS trust and by members of the trust training and development department. Demographic data were collected in the first section of the questionnaire (Table 1).


    Questionnaire Directorate Job title Pay band Full time/part time
    Administration 1 (n=14) MedicalSurgicalMusculoskeletalNeuroscienceCore clinical 12641 Clinical research nurseSenior research nurseNurseOther 7304 Band 7Band 6Band 5 653 Part timeFull time 86
    Administration 2 (n=8) MedicalMusculoskeletalNeuroscienceCore clinical 1421 Clinical research nurseSenior research nurseNurseOther 4022 Band 7Band 6Band 5 431 Part timeFull time 35

    The list of clinical competencies were grouped into four distinct subscales, each relating to the level of expertise required to perform the skill. The four subscales were ‘basic’, ‘intermediate’, ‘advanced’ and ‘clinically specific’. The categorising of the skills was undertaken by the hospital trust's training department and was informed by the trust protocols.

    Fourteen skills were categorised as basic, seven as intermediate and two as advanced (Table 2). Clinically specific skills, such as those in oncology (administration of intravenous cytotoxic medication, care of the peripherally inserted central catheters (PICC line), and patient education on the effects of chemotherapy) and those in renal (care of the Hickman line, haemodialysis) were included and respondents were given an opportunity to add other clinically specific skills relevant to their practice.


    Skill Weekly Monthly 1–2 times a year Never Total N No response Skills Spearman's rho
    Basic skills
    Monitoring blood pressure 4 3 3 2 12 1 0.976
    Monitor pulse 4 3 3 2 12 1 0.976
    Monitor temperature 4 3 1 4 12 1 0.813
    Monitor respiration 4 3 2 2 11 2 0.813
    Measure oxygen saturation levels 3 3 2 4 12 1 0.802
    Administer oxygen therapy 1 2 2 6 11 2 0.885
    Administer oral medication 1 2 3 5 11 2 0.733
    Administer subcutaneous injections 1 2 2 6 11 2 0.932
    Administer intravenous medication 0 2 2 7 11 2 0.741
    Urinalysis 2 3 0 6 11 2 1.000
    Administer enteral feeds 0 0 2 9 11 2 0.655
    Female catheterisation 0 0 1 10 11 2 0.488
    Wound care 0 1 3 7 11 2 1.000
    Specimen collection 3 2 0 6 11 2 0.842
    Intermediate skills
    Male catheterisation 0 0 3 8 11 2 -0.218
    ECG monitoring 2 4 0 5 11 2 1.000
    Venepuncture 4 2 1 4 11 2 0.753
    Cannulation 1 1 1 8 11 2 1.000
    Bandaging 0 2 2 7 11 2 0.843
    Care of a central line 0 0 0 10 10 3 1.000
    Patient education on how to self-medicate 2 2 3 4 11 2 0.891
    Advanced skills
    Taking full medical history 3 1 1 6 11 2 0.958
    Non-medical prescriber 1 0 0 10 11 2 0.843

    Respondents were asked to rate their level of confidence, frequency of applying the skill and how essential to their role they considered each skill was. This was done using each skill on standardised formats. The responses for how confident the CRN was in performing the skill included ‘not at all’, ‘moderately’ or ‘very’. To rate how frequently a skill was applied, the choices were ‘weekly’, ‘monthly’, ‘one or two times a year’ or ‘never’; and to establish whether respondents thought that the skill was essential to the role the response options were either ‘not at all’, ‘moderately’ or ‘very’. Responses were assigned value, and each individual's responses within each skill category (basic, intermediate, advanced) were added to result in an overall score for each category.

    Development of the interview guide

    A semi-structured interview schedule was constructed to focus the discussion on user experience of completing the questionnaire and to ensure the acceptability of the content to the CRNs. The researcher invited respondents who completed the questionnaire twice (n=8) to a face-to-face interview. Five questionnaire respondents agreed to participate in an interview, but owing to clinical commitments interviews with only three CRNs were undertaken.

    Data analysis

    Questionnaire

    SPSS for Windows version 19 was used to analyse the questionnaire responses.

    Establishing reliability requires that a questionnaire is both stable and internally consistent (Bryman, 2008). To assess stability, individuals' responses to each administration of the questionnaire were compared using Spearman's rank correlation coefficient (rho) (p); an acceptable level of correlation was set at 0.8 (Oppenheim, 1992). This analysis was undertaken with each skill and for overall scores.

    The internal consistency of each of the scales was assessed by means of Cronbach's alpha coefficient.

    Interview

    Relational content analysis was undertaken with the transcriptions from the three interviews (Kaid, 1989).

    Results

    Section one of the questionnaire explored demographic data (Table 1). Of the 15 people invited to take part in this pilot study, 14 responded to the first administration of the questionnaire. One of the 14 respondents did not complete the full questionnaire and their data was removed from analysis, leaving a sample of 13. Eight respondents completed the questionnaire a second time, but one only completed section one and therefore their data were not used in the validation process. The seven people who did not complete the questionnaire on the second occasion volunteered reasons such as: work/time demands, and the need to have access to a computer to complete the questionnaire.

    Questionnaires

    Table 2 shows the frequency of the performance of clinical skills. A test-retest administration of the online questionnaire was conducted with seven complete datasets. The correlations for each skill were calculated for both confidence and essential nature of the skill to the role of the CRN.

    The correlations for confidence in basic skills were satisfactory, with only enteral feeding and female catheterisation scoring below 0.7 (Table 2). For intermediate skills, the correlation was good except for male catheterisation, which yielded a negative correlation (-0.218). Spearman's rho for most other basic and intermediate skills was > 0.8. The advanced skills correlated very well, with scores greater than 0.8.

    The correlation for the essential nature of the skills revealed similar results, with only enteral feeding and female catheterisation scoring < 0.7 for the basic skills. Administration of oral and intravenous medication scored in the 0.7–0.8 range. With regards to the intermediate skills, male catheterisation revealed a negative correlation, -0.218 again, with venepuncture correlating at 0.753. Spearman's rho for all other basic and intermediate skills was > 0.8. The advanced skills correlated well (> 0.8).

    The internal consistency of each subscale and the full scale was assessed by means of Cronbach's alpha coefficient. Coefficients obtained for confidence were 0.979 for the basic skills subscale and 0.904 for the intermediate skills subscale (n=13). Coefficients for the essential nature of skills were 0.976 for basic skills and 0.899 for intermediate skills. The full scale reached a Cronbach's alpha of 0.952.

    Scales for respondents' attitudes about confidence and the essential nature of the skills were evaluated. At least 12 respondents were ‘moderately’ or ‘very’ confident about performing basic skills; however, 6 lacked confidence (‘not at all’ response) in some basic skills (Table 3). Similarly, overall, at least 6 respondents were confident about performing intermediate skills (Table 4).


    Answer options Not at all Moderately Very No response Total n
    Basic skills
    Monitor blood pressure 1 0 12 0 13
    Monitor pulse 1 0 12 0 13
    Monitor temperature 1 0 12 0 13
    Monitor respiration 1 0 12 0 13
    Measure oxygen saturation levels 1 0 12 0 13
    Administer oxygen therapy 1 4 8 0 13
    Administer oral medication 1 1 10 1 13
    Administer subcutaneous medication 1 5 7 0 13
    Administer intravenous medication 2 3 8 0 13
    Urinalysis 1 1 11 0 13
    Administer enteral feeds 6 3 4 0 13
    Female catheterisation 6 5 2 0 13
    Wound care 2 6 5 0 13
    Specimen collection 1 4 8 0 13
    Intermediate skills
    Male catheterisation 7 3 2 1 13
    ECG monitoring 3 4 6 0 13
    Venepuncture 1 2 10 0 13
    Cannulation 6 5 2 0 13
    Bandaging 3 5 5 0 13
    Care of a central line 7 1 5 0 13
    Patient education on how to self-medicate 2 4 7 0 13
    Advanced skills
    Taking full medical history 4 6 3 0 13
    Non-medical prescriber 12 0 1 0 13

    Skills Not confident Neutral Confident Total
    Basic 4 0 9 13
    Intermediate 4 3 6 13

    At least 7 respondents considered that many of the basic skills were ‘moderately’ or ‘very’ essential to their role (Table 5). For the intermediate skills, the pattern was more mixed; the majority of respondents reported male catheterisation and care of a central line as ‘not at all’ necessary, with just over half highly valuing the ability to perform venepuncture (Table 5).


    Skills Not at all Moderately Very No response Total n
    Basic skills
    Monitoring blood pressure 3 1 7 2 13
    Monitor pulse 3 1 7 2 13
    Monitor temperature 3 1 7 2 13
    Monitor respiration 3 1 7 2 13
    Measure oxygen saturation levels 4 0 7 2 13
    Administer oxygen therapy 5 4 2 2 13
    Administer oral medication 4 2 5 2 13
    Administer subcutaneous medication 4 5 2 2 13
    Administer intravenous medication 5 5 1 2 13
    Urinalysis 4 4 3 2 13
    Administer enteral feeds 9 2 0 2 13
    Female catheterisation 10 1 0 2 13
    Wound care 7 3 1 2 13
    Specimen collection 4 1 6 2 13
    Intermediate skills
    Male catheterisation 9 1 0 3 13
    ECG monitoring 4 2 5 2 13
    Venepuncture 2 1 7 3 13
    Cannulation 4 4 3 2 13
    Bandaging 7 3 1 2 13
    Care of a central line 9 0 2 2 13
    Patient education on how to self-medicate 3 2 6 2 13
    Advanced skills
    Taking full medical history 3 3 5 2 13
    Non-medical prescriber 6 4 1 2 13

    Quantative interview

    All interviewees reported that the questionnaire questions and content were appropriate to their role as CRNs and that using an electronic format to deliver the questionnaire was positive. However, communication skills were identified as an important skill that should have been included in the questionnaire.

    Interviewee 1 did not consider some of the basic skills as essential (‘not at all’ answer) to her role. She confirmed that she was not confident in performing them. However, she did not think that she required any further relevant training because she did not use these skills often enough.

    Interviewee 2 reported being ‘moderately’ to ‘very’ confident in all basic skills in the questionnaire. She thought that these skills were ‘moderately’ to ‘very’ essential to her role and she did not require any further training on basic and intermediate skills.

    Interviewee 3 demonstrated in his responses that some basic skills are not essential (‘not at all’ response) to his role; he reported not being competent in these skills but did not feel that he required further training.

    An advanced skill such as obtaining a medical history was identified by interviewees 1 and 2 as essential to the role of the CRN. They reported having received training in this skill, used this skill regularly and felt confident about performing it. Interviewee 2 added that she was also a non-medical prescriber but did not think that this skill was essential to her role.

    Interviewee 1 said it was important to be clinically updated because research nurses may be called upon at any time to support their colleagues in the wards. She expressed her personal concern that she has been off the wards for a long period and would not feel confident at present if asked to work in the clinical environment. Interviewee 3, however, thought that, although he did not feel confident in practising some skills, further training for skills that are not frequently used would not be beneficial.

    Discussion

    Clinical research nurse managers are challenged with training and developing CRNs and improving the effectiveness of the future CRN workforce. The Competency Working Group (2011) has developed competency frameworks to facilitate this; however, the clinical skills of CRN roles are hard to define due to the variety of the research projects on which they are employed to work (Competency Working Group, 2011). A validated tool could be used as part of personal skills' reflection or as part of an annual appraisal. This could identify which clinical skills are essential to the role of the individual CRN. The tool would support research managers in monitoring competence and providing appropriate training.

    This project developed a short pragmatic tool to assess which clinical skills are used by CRNs and their frequency of use. This tool, in combination with an individual CRN's project role within a given research project, could ensure the enhanced maintenance of both clinical and research skills.

    The results from piloting indicate that the questionnaire has strong face validity and, despite the small number of participants, it showed good levels of reliability and is therefore worth further development. The combination of the results of the repeat administration and the alpha coefficients indicates that the questionnaire satisfies conditions for adequate reliability (Spector, 1992; Oppenheim, 1992).

    This present study in part builds on work by Gordon (2008) who suggested that there is a need to take a closer look at the specific roles, competencies and daily activities of those nurses whose specialist skills involve conducting research in a general sense, according to clinical trials' protocols. A comprehensive document detailing these responsibilities and the competence required to perform these duties at individual levels would be extremely useful in the management and support of the CRN and could be supported by the measure developed in the current research. A document such as this, alongside one detailing the measures developed in the current research, could be used to clearly define what clinical skills are central to the role of the CRN, and how competence is achieved. However, at present it is difficult for the CRN to justify the development of new skills, or for employers to structure their services to facilitate competence maintenance and development, because they do not have the tools to identify competency fade, they cannot plan and budget for ongoing training.

    Although the main aim of this project was to develop a questionnaire, the results show differences in opinion about the relevance to practise of some clinical skills, even with the small sample size. Although there is a debate about sample size in relation to establishing reliability, it is generally accepted that a relatively large sample size is not needed for this purpose (Bonett, 2002). In this context it can also be noted that, despite the small sample size, Cronbach's alpha for each of the two subscales that addressed the essential nature and confidence in performing basic skills was good, and the test-retest coefficients were only slightly less than optimum (Oppenheim, 1992). It can be argued that the piloting and validation of the scale has gone some way to establishing its robustness, although it is recognised that further validation work is required across medical fields and organisations. It should also be noted that this is the first research of its kind, and the findings have implications for the management and training of CRNs; however, further research in this area is required.

    Conclusion

    It has been possible to design a questionnaire that can identify clinical competencies that are central to the role of the CRN, as well as individual development needs. This can assist research managers to support CRNs to achieve an appropriate optimum level of competence and to function safely and confidently in their role.

    The questionnaire can provide a tool that CRNs could use to monitor and reflect on their confidence regarding the included skills, and to facilitate discussion with line managers regarding their ongoing training and development needs. In the long term, this may help CRNs progress to advanced practitioners, which is essential in today's NHS (Department of Health, 2006).

    KEY POINTS

  • The clinical research nurse plays a vital role in the research team's successful delivery of a project
  • Maintaining clinical competencies may be challenging for the clinical research nurse
  • There are currently no measures to determine which clinical competencies are needed, or if they are practised by the clinical research nurse
  • A brief measure of clinical competencies for clinical research nurses has been developed
  • CPD reflective questions

  • Think about the essential clinical skills required to carry out your role
  • Consider how often you practise these skills; how would you evidence reaching competence in them?
  • Think about how clinical research nurses could maintain their competence in basic skills if these skills are not practised regularly
  • Consider the challenges clinical research nurses face that may lead to them becoming clinically deskilled