This study identifies that barriers and facilitators to specialist nurses inviting patients to participate in research are complex and interdependent. The five main themes show broad issues that appear to be important to specialist nurses, although individual views to the relative importance of barriers and facilitators across these themes varied. In order to contextualise these with previous research and consider implications for different stakeholders, the discussion is framed by the conceptual framework (Fig.
1).
Patient factors
Findings support previous research identifying that concerns about individual patient suitability are often barriers to healthcare professionals inviting patients to studies [
5,
7,
11‐
13,
26]. It is a common perception that such concerns of healthcare professionals are well-meaning but often misplaced, such ‘gatekeeping’ thus being potentially detrimental to both research success and patient autonomy [
28,
29]. Donovan and colleagues [
30] identified however that nurses may experience an uneasy role conflict between providing clinical care and inviting patients to participate in research. Our study supports this, as several participants expressed discomfort at broaching the subject of research if they considered it not in a patient’s best interests. This suggests, as recommended by Donovan and colleagues [
30], that specialised training and support for clinicians involved in research recruitment are required. Training in Good Clinical Practice (GCP) principles provides information relating to the legalities of obtaining informed consent, however does not usually address gatekeeping and related issues.
Conversely, several specialist nurses felt patient factors should not be barriers to inviting patients, agreeing that this diminished patient autonomy. Additionally, and in common with previous findings [
8], an understanding of potential benefits to patients could facilitate inviting research participation. This suggests that measures to highlight patient experiences of research are likely to be helpful, both by study teams and through broader initiatives. The
Research changed my life campaign within the NHS [
31], is an example of the latter, where patients across England share stories of how their lives were positively transformed by clinical research.
Research team factors
Research team behaviours, particularly relating to communication, and the quality of relationships between specialist nurses and research teams, appeared to influence barriers and facilitators across all five themes. Some of the links between these behaviours and the subsequent creation of a barrier or facilitator appear fairly obvious, such as failure to communicate the aims of a study leading to non-comprehension. However specialist nurses also gave examples of how these behaviours could have more subtle effects, for example that making efforts to provide clear and simple information could convey a sense of teamwork and hence increase motivation. Many previous studies have similarly identified research team conduct and relationships with clinicians as important to recruitment success [
5,
13]. These findings highlight that research teams should continuously reflect upon their behaviours, communication and relationships with clinicians in order to benefit from fruitful collaborations.
Participants were forthcoming with several examples of negative experiences of research team conduct. A notable feature of some previous studies is that researchers report making extensive efforts to communicate effectively with clinical teams, but still facing recruitment problems [
12,
32]. This raises the possibility that clinicians may be reluctant or unmotivated to express dissatisfaction or misunderstandings. Research teams should therefore encourage clinical collaborators to express their needs and give feedback, and promote honest and open communication.
Study factors
Previous research has identified that barriers to healthcare professionals inviting patients often result from concerns about research study interventions or randomisation processes [
12,
13]. These issues were however generally much less contentious to specialist nurses in this study, which could partly be explained by interviews focusing on general rather than study-specific issues.
The most important study-related factor appeared to be the nature of the invitation process, that is, the process specified by researchers to identify, approach and refer a patient to their study. The finding that a barrier to inviting patients is an excessively long-winded invitation process is supported by the literature, with many healthcare professionals preferring simple and quick recruitment procedures [
5]. Nonetheless, it was important to many of the specialist nurses in this study to give patients a reasonable amount of information about a study, and importantly, they were often willing and able to spend time doing so. Some previous studies have found that healthcare professionals require their time and effort over the entire invitation process to be minimised [
6,
12]. However, our findings suggest it may be counterproductive for research teams to attempt to reduce burden on specialist nurses by removing all responsibility for providing verbal study information to patients.
A significant barrier appeared to arise when specialist nurses felt they did not understand the study to their satisfaction, irrespective of its design or focus. This supports previous findings, for example Cvijovic and colleagues’ study, which found that pharmacists were reluctant to invite patients when they felt this could prompt questions they could not answer [
10]. Nonetheless, specialist nurses had differing requirements for levels of understanding, and varying levels of prior knowledge and experience to support their understanding. This suggests it could be useful for research teams to tailor the support provided to inviters to enhance understanding.
Individual (specialist nurse) factors
This study highlights important facilitators stemming from the attitudes, experience, skills and knowledge that specialist nurses bring to the invitation process.
Some specialist nurses held attitudes that they should not apply their own judgements about patient suitability for research studies. Similarly, some described strategies to invite patients in a manner that minimized anticipated negative emotions for patients, involving timing, interpersonal skills and the established clinical relationship. Holding these attitudes, and being willing and able to use these strategies, appeared to be important facilitators. This provides some new insights, as although it has been previously identified that certain clinicians feel all eligible patients should be invited to studies [
9,
13], these attitudes have been little explored. It would be beneficial to explore these attitudes and strategies in future research, in order to inform development of recruiter training as advocated by Donovan and colleagues [
30], and to support and encourage other clinicians inviting patients to studies.
Specialist nurses appeared to recognise and capitalise on facilitators within their roles because they regarded inviting patients to research as relevant and important. Finding ways to invoke similar positive attitudes in other clinicians could therefore be useful. As identified by previous studies [
5,
12], several participants felt that personal research knowledge and experience could invoke research appreciation. It is likely to therefore be useful to increase clinician exposure to and understanding of all aspects of research. Such measures may also support understanding of studies, further facilitating invitations. However, as some participants felt that research knowledge may increase their caution about inviting certain patients, any educational interventions should include consideration of gatekeeping issues.
Clinical setting factors
A positive research culture appeared to be an important facilitator to specialist nurses inviting patients to participate. Previous studies have found that positive organizational research cultures facilitate recruitment, provided that these result in sufficient provision of research infrastructure [
33], and that these values are communicated to staff [
7,
15]. The wider organisational research culture within NHS Trusts and clinical specialties was considered potentially influential by some participants. This supports the continuation of national initiatives to raise awareness of and promote involvement with research, for example the
Ok to ask campaign within the NHS [
34].
This study however highlights more strongly the importance of positive research cultures at the very local clinical team level, and provides some insights into how these may be achieved. Many examples of positive cultures appeared to have evolved within clinical teams according to local need and context, suggesting that encouraging local efforts to establish favourable research environments may be most successful. It may also be helpful to explore the development and features of established positive local research cultures in future research.
Strengths and limitations
Despite elements of convenience sampling, the final sample of specialist nurses represented a wide variety of clinical specialties and NHS Trusts, who had collective experience of inviting a variety of patient populations to numerous different research studies. This may increase the relevance of findings to a wide variety of other contexts. Nonetheless, more variation in clinical specialties, studies and Trusts may have further increased the range of perspectives obtained. Similarly, although data saturation was not a methodological aim of this study, new ideas continued to emerge during final interviews. This highlights that this study provides only limited insight into the perceptions of the wider population of specialist nurses.
All of the participants in this study expressed positivity towards research, and many had wider experience of research, meaning perceptions of specialist nurses who felt negatively or ambivalent were not obtained. These imbalances are very likely due to the sample being self-selecting, with participation in this study likely being most appealing to specialist nurses with an interest in research. While this is a limitation, several of the insights offered by this study relate to facilitators brought about by positive attitudes and research interest of specialist nurses, affording the opportunity to examine facilitators in more depth than many previous studies.
All participants were female and many had higher educational qualifications. This may again have limited the breadth of views obtained, however is likely reflective of the demographics of the specialist nurse workforce in the NHS.
A key strength of the data collection method is that the interviewer was not linked to the research studies or research teams discussed by participants, which may have encouraged participants to give more open and honest responses. The Framework data analysis method provided a clear audit trail to demonstrate how study findings developed from the original data [
35].
We could have strengthened the study by using an established theoretical framework to guide data collection and analysis. For example, the Theoretical Domains Framework (TDF) [
36,
37], would have enabled us to explore healthcare professional behaviour more systematically. The five themes our study has identified do seem to map well to five of the TDF domains. Assessing patient suitability resembles TDF’s
beliefs about consequences; team work shares similarities with s
ocial/professional role and identity, valuing research with
motivation and goals, invitation process with e
nvironmental context and resources, and understanding the study with k
nowledge and skills. Nonetheless, using the TDF during the study would have prompted us to ask additional questions relating to the other domains, which would likely have enriched the findings.
Some novel insights were offered by specialist nurses in this study. Certain issues may relate more to specialist nurses than other healthcare professionals, suggesting caution is necessary if applying findings beyond this professional group. Nevertheless, the detailed nature of the findings in this study aids those considering findings and recommendations to judge their wider applicability.