Clinical research nurses perspective 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.

Analysis of the Development Trend of Clinical Research Nurses in China Based On CiteSpace

Objective To reveal the development characteristics and trends of clinical research nurses in China and provide a reference for the training and employment of nursing talents. Methods Literature about clinical research nurses published from the year of database construction to 2020 were searched through the CNKI, Wanfang, Chinese Biomedical Literature (CBM) and Weipu (VIP) databases, and CiteSpace software was used to conduct a multidimensional analysis of the included literature. Results A total of 3,735 pieces of literature were retrieved, and after deduplication and screening, 199 pieces of literature were finally retained for this study. The practice and exploration of CRNs were regionalised, with varying degrees of development, and CRNs were at the forefront of development in oncology specialties. Conclusion It is important to continue to expand the breadth and depth of researchto promote the continuous development of China’s medical and health care to align with international standards.

Making ICU Research Happen: a Qualitative Descriptive Study About the Role of the Research Nurse in New Zealand Level III Intensive Care Units

<p>This study explored the role of the research nurse in New Zealand (NZ) Level III intensive care units (ICU). Little was known about this role in NZ prior to this study. A qualitative, descriptive approach, using semi-structured interviews was used. The study was conducted in six Level III ICUs throughout NZ, who employed a research nurse. Interviews were conducted with research nurses (n = 11), the doctors they work with (principal investigators) (n = 6) and nurse managers (n = 6) for the ICUs, and the findings were triangulated. The views across all ICUs and stakeholders were generally similar, with differences only being in some operational areas. This study found that the primary role of the research nurse was trial management, where they coordinated all elements of trial conduct. Almost half of the research nurses were also involved in trial design through their positions on management committees. Research nurses also played a vital role in patient and trial advocacy, and they bridged the knowledge gap by bringing research to staff nurses, patients and their families. The issue of consent for clinical trials in the ICU setting was significant, as this was a process which research nurses were very involved in. Consenting patients was a shared responsibility of research nurses and doctors. There was a perception that research nurses were senior nurses, but not necessarily because of their role in research. The majority of research nurses reported to a nursing line manager, and also had an informal accountability to the principal investigator (PI). Research nurses and PIs worked closely in the pursuit of rigorous research for ICU patients, and research nurses were highly regarded by PIs. This study provides clarity about the research nurse‟s role and showcases their key contribution in ensuring that NZ ICUs undertake high quality research, thus contributing to potential improvements for future patients‟ outcomes.</p>

Making ICU Research Happen: a Qualitative Descriptive Study About the Role of the Research Nurse in New Zealand Level III Intensive Care Units

<p>This study explored the role of the research nurse in New Zealand (NZ) Level III intensive care units (ICU). Little was known about this role in NZ prior to this study. A qualitative, descriptive approach, using semi-structured interviews was used. The study was conducted in six Level III ICUs throughout NZ, who employed a research nurse. Interviews were conducted with research nurses (n = 11), the doctors they work with (principal investigators) (n = 6) and nurse managers (n = 6) for the ICUs, and the findings were triangulated. The views across all ICUs and stakeholders were generally similar, with differences only being in some operational areas. This study found that the primary role of the research nurse was trial management, where they coordinated all elements of trial conduct. Almost half of the research nurses were also involved in trial design through their positions on management committees. Research nurses also played a vital role in patient and trial advocacy, and they bridged the knowledge gap by bringing research to staff nurses, patients and their families. The issue of consent for clinical trials in the ICU setting was significant, as this was a process which research nurses were very involved in. Consenting patients was a shared responsibility of research nurses and doctors. There was a perception that research nurses were senior nurses, but not necessarily because of their role in research. The majority of research nurses reported to a nursing line manager, and also had an informal accountability to the principal investigator (PI). Research nurses and PIs worked closely in the pursuit of rigorous research for ICU patients, and research nurses were highly regarded by PIs. This study provides clarity about the research nurse‟s role and showcases their key contribution in ensuring that NZ ICUs undertake high quality research, thus contributing to potential improvements for future patients‟ outcomes.</p>

EP.WE.842Maintaining Recruitment to Surgical Trials during the Pandemic

Aims Recruitment to Randomised Controlled Trials (RCTs) has traditionally been the domain of Research Nurses. Due to the unprecedented pressures of the COVID pandemic, the majority of Research Nurses have been redeployed to other clinical roles, or those still working within research have had to focus on COVID-related projects. This has left existing surgical trials struggling to recruit. We report on our experience of engaging Specialist Nurses without a research background as well as Consultants and Trainees to support surgical research in these challenging circumstances. Method The Sunflower RCT was first opened to recruitment in August 2019 at our trust. The recruitment was led by single Research Nurse, but the delegation log included a range of Consultants, Trainees, and Specialist Nurses. Due to the COVID pandemic, recruitment was paused from March 2020 and restarted in July 2020. Data were collected on recruitment until January 2021. Results In the seven months before the recruitment pause, 80 patients were recruited (average 11 per month), with the highest proportion of recruits by the sole Research Nurse. Following the recruitment pause, a further 45 patients were recruited (average 7.5 per month). These patients were recruited by Consultants (20, 44%), Specialist Nurses (12, 27%), Trainees (7, 16%), Research Nurse (3, 7%) and postal consents (3, 7%). Conclusions We have demonstrated that surgical research activity can be maintained even with minimal Research Nurse recruitment by engaging all members of the surgical team, especially utilising Specialist Nurses, who may not commonly be approached for such a role.

Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial

Background Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we report the recruitment strategies and costs for the Trial for Healthy Relationship Initiatives in the Very Early years (THRIVE), an RCT evaluating two group-based parenting interventions for pregnant women. Methods THRIVE aimed to recruit 500 pregnant women with additional health and social care needs in Scotland between 2014 and 2018. Three recruitment strategies were employed: (1) referrals from a health or social care practitioner or voluntary/community organisation (practitioner-led referral), (2) direct engagement with potential participants by research staff (researcher-led recruitment) and (3) self-referral in response to study advertising (self-referral). The number of referrals and recruited participants from each strategy is reported along with the overall cost of recruitment. The impact of recruitment activities and the changes in maternity policy/context on recruitment throughout the study are examined. Results THRIVE received 973 referrals: 684 (70%) from practitioners (mainly specialist and general midwives), 273 (28%) from research nurses and 16 (2%) self-referrals. The time spent in antenatal clinics by research nurses each month was positively correlated with the number of referrals received (r = 0.57; p < 0.001). Changes in maternity policies and contexts were reflected in the number of referrals received each month, with both positive and negative impacts throughout the trial. Overall, 50% of referred women were recruited to the trial. Women referred via self-referral, THRIVE research nurses and specialist midwives were most likely to go on to be recruited (81%, 58% and 57%, respectively). Key contributors to recruitment included engaging key groups of referrers, establishing a large flexible workforce to enable recruitment activities to adapt to changes in context throughout the study and identifying the most appropriate setting to engage with potential participants. The overall cost of recruitment was £377 per randomised participant. Conclusions Recruitment resulted from a combination of all three strategies. Our reflections on the successes and challenges of these strategies highlight the need for recruitment strategies to be flexible to adapt to complex interventions and real-world challenges. These findings will inform future research in similar hard-to-reach populations. Trial registration International Standard Randomised Controlled Trials Number Registry ISRCTN21656568. Retrospectively registered on 28 February 2014

V10 The role of surgical trainees in recruiting to multicentre RCTs: an example from the Sunflower Study

Background The Sunflower Study aims to compare the effectiveness of expectant management and MRCP prior to laparoscopic cholecystectomy (LC) in patients at low or moderate risk of common bile duct stones. This is the largest surgical randomised controlled trial (RCT) in the UK and a secondary aim is to describe trainees’ contributions. Methods Participants are randomised to receive expectant management or MRCP in a 2:1 ratio. Over 13,500 patients from more than 50 UK hospitals are required over five years. Trainees’ contributions are documented as follows: total number signed up to the study; number enrolled in the NIHR associate PI scheme; and the number of patients approached and recruited. The proportion of ‘emergency’ and ‘elective’ patients recruited was also recorded. Results Sunflower has been open since February 2019 and 48 centres are currently participating. A total of 104 trainees have been actively involved and 34 are/have been enrolled in the associate PI scheme. To date, 3992 patients have been screened, by trainees (n = 719,18%), consultants (n = 439,11%) and research nurses (n = 2214,71%). 1996 patients have been recruited, 359(18%) of which by trainees, 319(16%) consultants and 1318(66%) research nurses. Of the recruited patients, 423 (21%) presented as emergencies, recruited by trainees (n = 169,40%), consultants (n = 59,14%) and research nurses (n = 195,46%). Conclusions Trainees have an important role to play in recruiting patients to multicentre surgical RCTs, in particular in emergency settings, which can help improve studies’ generalisability. The associate PI scheme seems to provide an extra incentive for trainees to be involved in an RCT.