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Transforming Clinical Research to Meet Health Challenges

• 1 Office of the Director, National Institutes of Health, Bethesda, Maryland

The COVID-19 pandemic made “clinical trials” a household phrase, highlighting the critical value of clinical research in creating vaccines and treatments and demonstrating the need for large-scale, well-designed, and rapidly deployed clinical trials to address the public health emergency. As the largest public funder of clinical trials, the National Institutes of Health (NIH) launched a high-level effort to absorb the lessons of the pandemic and to assess and build on ongoing initiatives to improve efficiency, accountability, and transparency in clinical research.

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Wolinetz CD , Tabak LA. Transforming Clinical Research to Meet Health Challenges. JAMA. 2023;329(20):1740–1741. doi:10.1001/jama.2023.3964

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Respiratory viruses continue to circulate in Maryland, so masking remains strongly recommended when you visit Johns Hopkins Medicine clinical locations in Maryland. To protect your loved one, please do not visit if you are sick or have a COVID-19 positive test result. Get more resources on masking and COVID-19 precautions .

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Understanding Clinical Trials

Clinical research: what is it.

Your doctor may have said that you are eligible for a clinical trial, or you may have seen an ad for a clinical research study. What is clinical research, and is it right for you?

Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical research is different than laboratory research. It involves people who volunteer to help us better understand medicine and health. Lab research generally does not involve people — although it helps us learn which new ideas may help people.

Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.

At Johns Hopkins Medicine, we believe that clinical research is key to improve care for people in our community and around the world. Once you understand more about clinical research, you may appreciate why it’s important to participate — for yourself and the community.

What Are the Types of Clinical Research?

There are two main kinds of clinical research:

Observational Studies

Observational studies are studies that aim to identify and analyze patterns in medical data or in biological samples, such as tissue or blood provided by study participants.

Clinical Trials

Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people.

Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate. This will increase the chances that scientists and clinicians will develop treatments and procedures that are likely to be safe and work well in all people. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies is because of concerns about safety.

Both healthy people and those with diagnosed medical conditions can take part in clinical research. Participation is always completely voluntary, and participants can leave a study at any time for any reason.

“The only way medical advancements can be made is if people volunteer to participate in clinical research. The research participant is just as necessary as the researcher in this partnership to advance health care.” Liz Martinez, Johns Hopkins Medicine Research Participant Advocate

Types of Research Studies

Within the two main kinds of clinical research, there are many types of studies. They vary based on the study goals, participants and other factors.

Biospecimen studies

Healthy volunteer studies.

 Goals of Clinical Trials

Because every clinical trial is designed to answer one or more medical questions, different trials have different goals. Those goals include:

Treatment trials

Prevention trials, screening trials, phases of a clinical trial.

In general, a new drug needs to go through a series of four types of clinical trials. This helps researchers show that the medication is safe and effective. As a study moves through each phase, researchers learn more about a medication, including its risks and benefits.

Is the medication safe and what is the right dose?   Phase one trials involve small numbers of participants, often normal volunteers.

Does the new medication work and what are the side effects?   Phase two trials test the treatment or procedure on a larger number of participants. These participants usually have the condition or disease that the treatment is intended to remedy.

Is the new medication more effective than existing treatments?  Phase three trials have even more people enrolled. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, so that the new medication can be compared to that treatment.

Is the new medication effective and safe over the long term?   Phase four happens after the treatment or procedure has been approved. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.

“Johns Hopkins has a comprehensive system overseeing research that is audited by the FDA and the Association for Accreditation of Human Research Protection Programs to make certain all research participants voluntarily agreed to join a study and their safety was maximized.” Gail Daumit, M.D., M.H.S., Vice Dean for Clinical Investigation, Johns Hopkins University School of Medicine

Is It Safe to Participate in Clinical Research?

There are several steps in place to protect volunteers who take part in clinical research studies. Clinical Research is regulated by the federal government. In addition, the institutional review board (IRB) and Human Subjects Research Protection Program at each study location have many safeguards built in to each study to protect the safety and privacy of participants.

Clinical researchers are required by law to follow the safety rules outlined by each study's protocol. A protocol is a detailed plan of what researchers will do in during the study.

In the U.S., every study site's IRB — which is made up of both medical experts and members of the general public — must approve all clinical research. IRB members also review plans for all clinical studies. And, they make sure that research participants are protected from as much risk as possible.

Earning Your Trust

This was not always the case. Many people of color are wary of joining clinical research because of previous poor treatment of underrepresented minorities throughout the U.S. This includes medical research performed on enslaved people without their consent, or not giving treatment to Black men who participated in the Tuskegee Study of Untreated Syphilis in the Negro Male. Since the 1970s, numerous regulations have been in place to protect the rights of study participants.

Many clinical research studies are also supervised by a data and safety monitoring committee. This is a group made up of experts in the area being studied. These biomedical professionals regularly monitor clinical studies as they progress. If they discover or suspect any problems with a study, they immediately stop the trial. In addition, Johns Hopkins Medicine’s Research Participant Advocacy Group focuses on improving the experience of people who participate in clinical research.

Clinical research participants with concerns about anything related to the study they are taking part in should contact Johns Hopkins Medicine’s IRB or our Research Participant Advocacy Group .

Learn More About Clinical Research at Johns Hopkins Medicine

For information about clinical trial opportunities at Johns Hopkins Medicine, visit our trials site.

Video Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

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• Published: 29 August 2024

Federal funding shapes knowledge in clinical science

• Bunmi O. Olatunji 1 &
• Alexandra M. Adamis 1  

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Advances in clinical science often rely on federal funding, but an overly prescriptive funding agenda might limit the societal benefits of clinical research. Greater diversity in funding schemes is needed to ensure the highest clinical impact.

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Article Contents

Why we need a revolution in clinical research.

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Masud Husain, Why we need a revolution in clinical research, Brain , Volume 147, Issue 9, September 2024, Pages 2897–2898, https://doi.org/10.1093/brain/awae265

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We are at a pivotal moment for clinical research. In the UK, the system is fundamentally broken as recent reports have alluded to. 1 , 2 In other parts of the world too there are similar issues that are, at the very least, slowing down innovation and research. There are many factors that have been identified as contributing to this sad state of affairs in the UK. One important issue that has not attracted so much attention recently—though it was the subject of a report 3 in 2020—is the relationship between higher educational institutions (mostly universities) and healthcare providers (largely the National Health Service, NHS).

The vast majority of research activity in the UK occurs within the higher education sector, while most patient-related research such as clinical trials relies on NHS infrastructure. And this is where there is a massive disconnect. Each of these systems are huge, cumbersome behemoths, with their own local lumbering administrations focused on aims that are not aligned to the mission of producing rapid results in clinical research. In the university sector, the priorities of leaders are to keep the system financially afloat and minimize potential legal risks. Many institutions in the UK are on the cusp of fiscal ruin and so require grant and other research income to subsidize their existence. In the NHS on the other hand the aim is to cut waiting lists which, post pandemic and doctors’ industrial action, are now very lengthy, and to provide adequate service delivery. Making healthcare research effective and efficient is the last thing on the minds of the leadership of either sector.

But who can blame them? Surely, it’s difficult enough to run either a university or an NHS hospital? Indeed, this seems sufficient explanation—an adequate excuse—for some leaders of both these types of institution for the huge delays in getting any useful research done. Many teams are now waiting over a year to get their grant-funded research off the ground. Remarkably, some trials are failing because they never start, several years after the funding has been awarded. Material or data transfer agreements between universities; slothful legal reviews of contracts and agreements with third parties; calculating overheads to be charged; multiple reviews of research protocols by R&D departments; dragging of feet over costings independently for the university and hospital; sluggish reviews by research services; signing off contracts with the NHS; obtaining honorary contracts for non-clinical personnel; and many other procedures may take months, if not years, to complete. The system is both Byzantine and exasperating to navigate. No wonder that pharmaceutical companies are balking at initiating trials in the UK, their gaze turning instead to countries where they are more serious about getting things done sooner, not later. 1

So how do we get out of this mess? Given the narrow goals that the leaderships of universities and NHS hospitals have, we cannot expect a great deal more from them on this front— unless they are compelled to make changes. In the UK, when the National Institute for Health and Care Research (NIHR) was formed in 2006, many of us were under the impression that its mission really was to ‘create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public’. 4 Clearly though this just hasn’t happened. Otherwise, why the need for recent reports? 1 , 2

One of the key reasons for this failure (we cannot refer it to it as anything else) is the simple fact that universities and NHS infrastructure are not joined up. Many pretend to be, but it is obvious to anyone who works at even the best centres in the UK that this is a sham. At Oxford, one of the hospital networks calls itself the Oxford University Health NHS Foundation Trust, but there really is very little to suggest why ‘University’ should be in its title. The levels of duplication of work and contracting between the university and the hospital make a mockery of the concept of seamless integration between these institutions. It is the same elsewhere too. The result is a growing duopoly of administrations that negotiate with each other, waste time and slow the pace of progress. Even when a research proposal has been approved by a ‘joint’ R&D unit, there needs to be a costings agreement between university and NHS trust.

From a national perspective this makes little sense, either economically or for governance. We are in the bizarre situation where two sets of institution—universities and hospitals—both largely funded by taxpayers are independently setting their (growing) administrative staffs to scrutinize research protocols or haggle over costings on projects that are mostly funded by government or charities. It is even worse for multicentre studies when many different universities and NHS trusts each want a share of the pie. This has a hidden cost in numbers of people employed, researchers’ time dealing with paperwork, and an opportunity cost in terms of time taken to get studies off the ground. Furthermore, there is no incentive to do things better or faster. There is simply a parochial incentive to make money locally and mitigate risks locally . Until the day that universities and hospitals associated with them are compelled to work as one integrated unit, there is very little hope for change. We will be left in the current quagmire of structural indolence. And that is why we need a revolution. Writing more reports on the matter will not help.

It is interesting to reflect on the fact that it was also radical change that was necessary to bring medicine into the modern era—to make it based on observation, clinical examination and the scientific method—in the first place. From the confusing and sometimes bizarre practices that characterized medicine in the 18th century, there emerged a new way of doing things which came about within one generation and in perhaps one of the least advanced places in Europe for clinical science at that time: Paris. From being a backwater, the ‘Paris School of Medicine’ instigated such dramatic change that within 50 years it became the leading international centre for clinical practice, attracting physicians from around the world to learn about the ‘new medicine’. 5

The rise of scientific medicine in Paris depended on systematic correlation of physical examination findings on hundreds of patients with pathological findings at post-mortem; flexibility to revise diagnoses on the basis of these assessments; deployment of statistics, including data on mortality; and most of all on conducting this work and teaching it to medical students in hospitals. 5 What made this possible was reform. Before the French Revolution, control of medical care rested largely with the Church. With the reform of medical education that came after the Revolution, hospitals were centralized and their administration was overseen by the state. Fundamental changes in the way in which faculties of medicine were organized in France led the way for dramatic new ways of learning from patients and disseminating knowledge to clinicians. Medical education was transformed but it needed the convulsive change of a Revolution to make this happen. 6 It required top-down edicts to bring about change because there was no incentive for the old institutions to make those changes themselves.

We are now confronted with a similar problem. The old institutions—universities and hospitals—are used to doing things their way. There is no incentive for them to change unless the state or its organs of power intervene. In the UK, NIHR funds now support Biomedical Research Centres (BRCs) which supposedly cross universities and NHS hospital trusts, but in truth the fiscal support helps to prop up university research personnel with very little going to the NHS. Most importantly, the NIHR has not insisted on BRCs having joined up (i.e. single) integrated, university-NHS systems in place, or for seamless national transfer of approvals across sites without the need for new sets of contractual agreements. Nothing fundamental will change unless it or the new government compels this change. The pursuit of national interests requires national leadership to intervene; we can't rely on local, devolved institutions to make the obvious decisions that are required. This is why we need a revolution in healthcare research.

O’Shaughnessy J . Commercial clinical trials in the UK: The Lord O’Shaughnessy review - final report. Accessed 13 August 2024. https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report

The Academy of Medical Sciences . Future-proofing UK health research: A people-centred, coordinated approach. https://acmedsci.ac.uk/file-download/23875189

The Academy of Medical Sciences . Transforming health through innovation: integrating the NHS and academia. https://acmedsci.ac.uk/file-download/23932583

Department of Health and Social Care . Best research for best health: a new national health research strategy. https://www.gov.uk/government/publications/best-research-for-best-health-a-new-national-health-research-strategy

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• Open access
• Published: 02 September 2024

Clinical supervisor’s experiences of peer group clinical supervision during COVID-19: a mixed methods study

• Owen Doody   ORCID: orcid.org/0000-0002-3708-1647 1 ,
• Kathleen Markey   ORCID: orcid.org/0000-0002-3024-0828 1 ,
• James Turner   ORCID: orcid.org/0000-0002-8360-1420 2 ,
• Claire O. Donnell   ORCID: orcid.org/0000-0003-2386-7048 1 &
• Louise Murphy   ORCID: orcid.org/0000-0003-2381-3963 1  

BMC Nursing volume  23 , Article number:  612 ( 2024 ) Cite this article

Metrics details

Providing positive and supportive environments for nurses and midwives working in ever-changing and complex healthcare services is paramount. Clinical supervision is one approach that nurtures and supports professional guidance, ethical practice, and personal development, which impacts positively on staff morale and standards of care delivery. In the context of this study, peer group clinical supervision provides allocated time to reflect and discuss care provided and facilitated by clinical supervisors who are at the same grade/level as the supervisees.

To explore the clinical supervisor’s experiences of peer group clinical supervision a mixed methods study design was utilised within Irish health services (midwifery, intellectual disability, general, mental health). The Manchester Clinical Supervision Scale was used to survey clinical supervisors ( n  = 36) and semi-structured interviews ( n  = 10) with clinical supervisors were conducted. Survey data were analysed through SPSS and interview data were analysed utilising content analysis. The qualitative and quantitative data’s reporting rigour was guided by the CROSS and SRQR guidelines.

Participants generally had a positive encounter when providing clinical supervision. They highly appreciated the value of clinical supervision and expressed a considerable degree of contentment with the supervision they provided to supervisees. The advantages of peer group clinical supervision encompass aspects related to self (such as confidence, leadership, personal development, and resilience), service and organisation (including a positive working environment, employee retention, and safety), and patient care (involving critical thinking and evaluation, patient safety, adherence to quality standards, and elevated levels of care).

There are many benefits of peer group clinical supervision at an individual, service, organisation, and patient level. Nevertheless, there is a need to address a lack of awareness and misconceptions surrounding clinical supervision to create an environment and culture conducive to realising its full potential. It is crucial that clinical supervision be accessible to nurses and midwives of all grades across all healthcare services, with national planning to address capacity and sustainability.

Peer Review reports

Within a dynamic healthcare system, nurses and midwives face growing demands, underscoring the necessity for ongoing personal and professional development. This is essential to improve the effectiveness and efficiency of care delivery for patients, families, and societies. Despite the increased emphasis on increasing the quality and safety of healthcare services and delivery, there is evidence highlighting declining standards of nursing and midwifery care [ 1 ]. The recent focus on re-affirming and re-committing to core values guiding nursing and midwifery practice is encouraging such as compassion, care and commitment [ 2 ], competence, communication, and courage [ 3 ]. However, imposing value statements in isolation is unlikely to change behaviours and greater consideration needs to be given to ways in which compassion, care, and commitment are nurtured and ultimately applied in daily practice. Furthermore, concerns have been raised about global staff shortages [ 4 ], the evidence suggesting several contributing factors such as poor workforce planning [ 5 ], job dissatisfaction [ 6 ], and healthcare migration [ 7 ]. Without adequate resources and staffing, compromising standards of care and threats to patient safety will be imminent therefore the importance of developing effective strategies for retaining competent registered nurses and midwives is paramount in today’s climate of increased staff shortages [ 4 ]. Clinical supervision serves as a means to facilitate these advancements and has been linked to heightened job satisfaction, enhanced staff retention, improved staff effectiveness, and effective clinical governance, by aiding in quality improvements, risk management, and heightened accountability [ 8 ].

Clinical supervision is a key component of professional practice and while the aim is largely known, there is no universally accepted definition of clinical supervision [ 8 ]. Clinical supervision is a structured process where clinicians are allowed protected time to reflect on their practice within a supportive environment and with the purpose of developing high-quality clinical care [ 9 ]. Recent literature published on clinical supervision [ 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 ] highlights the advantages and merits of clinical supervision. However, there are challenges also identified such as a lack of consensus regarding the meaning and goal, implementation issues, variations in approaches in its operationalisation, and an absence of research evidence on its effectiveness. Duration and experience in clinical supervision link to positive benefits [ 8 ], but there is little evidence of how clinical supervision altered individual behaviours and practices. This is reinforced by Kuhne et al., [ 15 ] who emphasise that satisfaction rather than effectiveness is more commonly examined. It is crucial to emphasise that reviews have pinpointed that clinical supervision lowers the risks of adverse patient outcomes [ 9 ] and demonstrates enhancements in the execution of certain care processes. Peer group clinical supervision is a form of clinical supervision whereby two or more practitioners engage in a supervision or consultation process to improve their professional practice [ 17 ]. There is limited evidence regarding peer group clinical supervision and research on the experiences of peer clinical supervision and stakeholders is needed [ 13 ]. In Ireland, peer group clinical supervision has been recommended and guidelines have been developed [ 18 ]. In the Irish context, peer clinical supervision is where both clinical supervisees and clinical supervisors are peers at the same level/grade. However, greater evidence is required to inform future decisions on the implementation of peer group clinical supervision and the purpose of this study is to explore clinical supervisors’ experiences of peer group clinical supervision. As the focus is on peer group supervisors and utilising mixed methods the experiences of the other stakeholders were investigated and reported separately.

A mixed methods approach was used (survey and semi-structured interviews) to capture clinical supervisor’s experiences of clinical supervision. The study adhered to the Consensus-Based Checklist for Reporting of Survey Studies guidelines [ 19 ] (Supplementary File S1 ) and Standards for Reporting Qualitative Research guidelines [ 20 ] (Supplementary File S2 ).

Participants

This study was conducted with participants who successfully completed a professionally credited award: clinical supervision module run by a university in Ireland (74 clinical supervisors across 5 programmes over 3 years). The specific selection criteria for participants were that they were registered nurses/midwives delivering peer group clinical supervision within the West region of Ireland. The specific exclusion criteria were as follows: (1) nurses and midwives who haven’t finished the clinical supervision module at the University, (2) newly appointed peer group clinical supervisors who have yet to establish their groups and initiate the delivery of peer group clinical supervision.

Measures and procedures

The Manchester Clinical Supervision Scale-26 was used to survey participants in February/March 2022 and measure the peer group clinical supervisors’ overall experiences of facilitating peer group clinical supervision. The Manchester Clinical Supervision Scale-26 is a validated 26-item self-report questionnaire with a Likert-type (1–5) scale ranging from strongly disagree (1) to strongly agree (5) [ 21 ]. The Manchester Clinical Supervision Scale-26 measures the efficiency of and satisfaction with supervision, to investigate the skills acquisition aspect of clinical supervision and its effect on the quality of clinical care [ 21 ]. The instrument consists of two main sections to measure three (normative, restorative, and formative) dimensions of clinical supervision utilising six sub-scales: (1) trust and rapport, (2) supervisor advice/support, (3) improved care/skills, (4) importance/value of clinical supervision, (5) finding time, (6) personal issues/reflections and a total score for the Manchester Clinical Supervision Scale-26 is also calculated. Section two consisted of the demographic section of the questionnaire and was tailored to include eight demographic questions concerning the supervisor’s demographics, supervisee characteristics, and characteristics of clinical supervision sessions. There were also two open field questions on the Manchester Clinical Supervision Scale-26 (model of clinical supervision used and any other comments about experience of peer group clinical supervision). The main question about participants’ experiences with peer clinical supervision was “What was your experience of peer clinical supervision?” This was gathered through individual semi-structured interviews lasting between 20 and 45 min, in March/April 2022 (Supplementary file 3 ).

Ethical considerations

Health service institutional review boards of two University hospitals approved this study (Ref: 091/19 and Ref: C.A. 2199). Participants were recruited after receiving a full explanation of the study’s purpose and procedure and all relevant information. Participants were aware of potential risks and benefits and could withdraw from the study, or the survey could be stopped at any time. Informed consent was recorded, and participant identities were protected by using a pseudonym to protect anonymity.

Data analysis method

Survey data was analysed using the data analysis software package Statistical Package for the Social Sciences, version 26 (SPSS Inc., Chicago, Il, USA). Descriptive analysis was undertaken to summarise responses to all items and categorical variables (nominal and ordinal) were analysed using frequencies to detail the number and percentage of responses to each question. Scores on the Manchester Clinical Supervision Scale-26 were reverse scored for 9 items (Q1-Q6, Q8, Q20,21) and total scores for each of the six sub-scales were calculated by adding the scores for each item. Raw scores for the individual sub-scales varied in range from 0 to 20 and these raw scores were then converted to percentages which were used in addition to the raw scores for each sub-scale to describe and summarise the results of the Manchester Clinical Supervision Scale-26. Cronbach’s alpha coefficient was undertaken with the 26 questions included within the Manchester Clinical Supervision Scale-26 and more importantly with each of the dimensions in the Manchester Clinical Supervision Scale-26. The open-ended questions on the Manchester Clinical Supervision Scale-26 and interviews were analysed using content analysis guided by Colorafi and Evans [ 22 ] and categories were generated using their eight steps, (1) creating a coding framework, (2) adding codes and memos, (3) applying the first level of coding, (4) categorising codes and applying the second level of coding, (5) revising and redefining the codes, (6) adding memos, (7) visualising data and (8) representing the data.

Research rigour

To ensure the validity and rigour of this study the researchers utilised the Manchester Clinical Supervision Scale-26 a recognised clinical supervision tool with good reliability and wide usage. Interviews were recorded, transcribed, and verified by four participants, data were collected until no new components appeared, data collection methods and analysis procedures were described, and the authors’ biases were minimised throughout the research process. The Manchester Clinical Supervision Scale-26 instrument internal consistency reliability was assessed which was overall good (α = 0.878) with individual subscale also good e.g., normative domain 0.765, restorative domain 0.864, and formative domain 0.900. Reporting rigour was demonstrated using the Consensus-Based Checklist for Reporting of Survey Studies guidelines [ 19 ] and Standards for Reporting Qualitative Research guidelines [ 20 ].

Quantitative data

Participant and clinical supervision characteristics.

Thirty-six of the fifty-two (69.2%) peer group clinical supervisors working across a particular region of Ireland responded to the Manchester Clinical Supervision Scale-26 survey online via Qualtrics. Table 1 identifies the demographics of the sample who were predominantly female (94.4%) with a mean age of 44.7 years (SD. 7.63).

Peer group clinical supervision session characteristics (Table  2 ) highlight over half of peer group clinical supervisors ( n  = 20, 55.6%) had been delivering peer group clinical supervision for less than one year and were mainly delivered to female supervisees ( n  = 28, 77.8%). Most peer group clinical supervision sessions took place monthly ( n  = 32, 88.9%) for 31–60 min ( n  = 27, 75%).

Manchester Clinical Supervision Scale-26 results

Participants generally viewed peer group clinical supervision as effective (Table  3 ), the total mean Manchester Clinical Supervision Scale-26 score among all peer group clinical supervisors was 76.47 (SD. 12.801) out of 104, Surpassing the clinical supervision threshold score of 73, which was established by the developers of the Manchester Clinical Supervision Scale-26 as the benchmark indicating proficient clinical supervision provision [ 21 ]. Of the three domains; normative, formative, and restorative, the restorative domain scored the highest (mean 28.56, SD. 6.67). The mean scores compare favourably to that of the Manchester Clinical Supervision Scale-26 benchmark data and suggest that the peer group clinical supervisors were satisfied with both the level of support, encouragement, and guidance they provided and the level of trust/rapport they had developed during the peer group clinical supervision sessions. 83.3% ( n  = 30) of peer group clinical supervisors reported being either very satisfied ( n  = 12, 33.3%) or moderately satisfied ( n  = 18, 50%) with the peer group clinical supervision they currently delivered. Within the peer group clinical supervisor’s supervisee related issues ( n  = 17, 47.2%), work environment-related issues ( n  = 16, 44.4%), staff-related issues ( n  = 15, 41.7%) were reported as the most frequent issues, with patient/client related issues being less frequent ( n  = 8, 22.2%). The most identified model used to facilitate peer group clinical supervision was the Proctors model ( n  = 8, 22.22%), which was followed by group ( n  = 2, 5.55%), peer ( n  = 2, 5.55%), and a combination of the seven-eyed model of clinical supervision and Proctors model ( n  = 1, 2.77%) with some not sure what model they used ( n  = 2, 5.553%) and 58.33% ( n  = 21) did not report what model they used.

Survey open-ended question

‘Please enter any additional comments , which are related to your current experience of delivering Peer Group Clinical Supervision.’ There were 22 response comments to this question, which represented 61.1% of the 36 survey respondents, which were analysed using content analysis guided by Colorafi & Evans [ 22 ]. Three categories were generated. These included: personal value/benefit of peer group clinical supervision, challenges with facilitating peer group clinical supervision, and new to peer group clinical supervision.

The first category ‘personal value/benefit of peer group clinical supervision’ highlighted positive experiences of both receiving and providing peer group clinical supervision. Peer group clinical supervisors reported that they enjoyed the sessions and found them both worthwhile and beneficial for both the group and them as peer group clinical supervisors in terms of creating a trusted supportive group environment and motivation to develop. Peer group clinical supervision was highlighted as very important for the peer group clinical supervisors working lives and they hoped that there would be more uptake from all staff. One peer group clinical supervisor expressed that external clinical supervision was a ‘lifeline’ to shaping their supervisory journey to date.

The second category ‘challenges with facilitating peer group clinical supervision’, identified time constraints, lack of buy-in/support from management, staff shortages, lack of commitment by supervisees, and COVID-19 pandemic restrictions and related sick leave, as potential barriers to facilitating peer group clinical supervision. COVID-19 was perceived to have a negative impact on peer group clinical supervision sessions due to staff shortages, which resulted in difficulties for supervisees attending the sessions during work time. Peer group clinical supervisors felt that peer group clinical supervision was not supported by management and there was limited ‘buy-in’ at times. There was also a feeling expressed that peer group clinical supervision was in its infancy, as COVID-19 and its related restrictions impacted on this by either slowing down the process of commencing peer group clinical supervision in certain areas or having to move online. However, more recently improvements in managerial support and supervisee engagement with the peer group clinical supervision process are noted.

The final category ‘new to peer group clinical supervision’ highlighted that some peer group clinical supervisors were new to the process of providing peer group clinical supervision and some felt that this survey was not a true reflection of their experience of delivering peer group clinical supervision, as they were not fully established yet as clinical supervisors due to the impact of COVID-19. Peer group clinical supervisors identified that while they were new to providing peer group clinical supervision, they were enjoying it and that it was a learning curve for them.

Qualitative data

The qualitative phase explored peer group clinical supervisors’ ( n  = 10) own experiences of preparation received and experiences of being a peer group clinical supervisor. Three themes were identified through data analysis, building the foundations, enacting engagement and actions, and realities (Table  4 ).

Building the foundations

This theme highlights the importance of prior knowledge, awareness, and training but also the recruitment process and education in preparing peer group clinical supervisors.

Knowledge and awareness

Participant’s prior knowledge and awareness of peer group clinical supervision was mixed with some reporting having little or no knowledge of clinical supervision.

I’m 20 years plus trained as a nurse , and I had no awareness of clinical supervision beforehand , I really hadn’t got a clue what all of this was about , so it was a very new concept to me (Bernie) .

Others were excited about peer group clinical supervision and while they could see the need they were aware that there may be limited awareness of the value and process of clinical supervision among peers.

I find that there’s great enthusiasm and passion for clinical supervision as it’s a great support mechanism for staff in practice , however , there’s a lack of awareness of clinical supervision (Jane) .

Recruitment

Some participants highlighted that the recruitment process to become a peer group clinical supervisor was vague in some organisations with an unclear and non-transparent process evident where people were chosen by the organisation’s management rather than self-selecting interested parties.

It was just the way the training was put to the people , they were kind of nominated and told they were going and there was a lot of upset over that , so they ended up in some not going at all (Ailbhe) .

In addition, the recruitment process was seen as top loaded where senior grades of staff were chosen, and this limited staff nurse grade opportunities where there was a clear need for peer group clinical supervisors and support.

We haven’t got down to the ground level like you know we’ve done the directors , we’ve done the CNM3s the CNM2s we are at the CNM1s , so we need to get down to the staff nurse level so the nurses at the direct frontline are left out and aren’t receiving supervision because we don’t have them trained (Bernie) .

Training and education

Participants valued the training and education provided but there was a clear sense of ‘imposter syndrome’ for some peer group clinical supervisors starting out. Participants questioned their qualifications, training duration, and confidence to undertake the role of peer group clinical supervisor.

Because it is group supervision and I know that you know they say that we are qualified to do supervision and you know we’re now qualified clinical supervisors but I’m not sure that a three-month module qualifies you to be at the top of your game (Maria) .

Participants when engaged in the peer group clinical supervisor educational programme did find it beneficial and the true benefit was the actual re-engagement in education and published evidence along with the mix of nursing and midwifery practice areas.

I found it very beneficial , I mean I hadn’t been engaged in education here in a while , so it was great to be back in that field and you know with the literature that’s big (Claire) .

Enacting engagement and actions

This theme highlights the importance of forming the groups, getting a clear message out, setting the scene, and grounding the group.

Forming the groups

Recruitment for the group was of key importance to the peer group clinical supervisor and they all sent out a general invitation to form their group. Some supervisors used invitation letters or posters in addition to a general email and this was effective in recruiting supervisees.

You’re reaching out to people , I linked in with the ADoN and I put together a poster and circulated that I wasn’t ‘cherry picking , and I set up a meeting through Webex so people could get a sense of what it was if they were on the fence about it or unsure if it was for them (Karen) .

In forming the peer clinical supervision groups consideration needs to be given to the actual number of supervisees and participants reported four to six supervisees as ideal but that number can alter due to attendance.

The ideal is having five or six consistent people and that they all come on board and that you get the dynamics of the group and everything working (Claire) .

Getting a clear message out

Within the recruitment process, it was evident that there was a limited and often misguided understanding or perception of peer group clinical supervision.

Greater awareness of what actually clinical supervision is , people misjudge it as a supervision where someone is appraising you , when in fact it is more of a support mechanism , I think peer support is the key element that needs to be brought out (Jane) .

Given the lack of clarity and understanding regarding peer group clinical supervision, the participants felt strongly that further clarity is needed and that the focus needs to be on the support it offers to self, practice, and the profession.

Clinical supervision to me is clinical leadership (Jane) .

Setting the scene and grounding the group

In the initial phase of the group coming together the aspect of setting the scene and grounding the group was seen as important. A key aspect of this process was establishing the ground rules which not only set the boundaries and gave structure but also ensured the adoption of principles of trust, confidentiality, and safety.

We start with the ground rules , they give us structure it’s our contract setting out the commitment the expectation for us all , and the confidentiality as that’s so important to the trust and safety and building the relationships (Brid) .

Awareness of group dynamics is important in this process along with awareness of the group members (supervisees) as to their role and expectations.

I reiterate the role of each person in relation to confidentiality and the relationship that they would have with each other within the group and the group is very much aware that it is based on respect for each person’s point of view people may have a fear of contributing to the group and setting the ground rules is important (Jane) .

To ground the group, peer group clinical supervisors saw the importance of being present and allowing oneself to be in the room. This was evident in the time allocated at the start of each session to allow ‘grounding’ to occur in the form of techniques such as a short meditation, relaxation, or deep breathing.

At the start , I do a bit of relaxation and deep breathing , and I saw that with our own external supervisor how she settled us into place so very much about connecting with your body and you’ve arrived , then always come in with the contract in my first sentence , remember today you know we’re in a confidential space , of course , you can take away information , but the only information you will take from today is your own information and then the respect aspect (Mary Rose) .

This settling in and grounding was seen as necessary for people to feel comfortable and engage in the peer group clinical supervision process where they could focus, be open, converse, and be aware of their role and the role of peer group clinical supervision.

People have to be open, open about their practice and be willing to learn and this can only occur by sharing, clinical supervision gives us the space to do it in a space where we know we will be respected, and we can trust (Claire) .

This theme highlights the importance of the peer group clinical supervisors’ past experiences, delivering peer group clinical supervision sessions, responding to COVID-19, personal and professional development, and future opportunities.

Past experiences

Past experiences of peer group clinical supervisors were not always positive and for one participant this related to the lack of ground rules or focus of the sessions and the fact it was facilitated by a non-nurse.

In the past , I suppose I would have found it very frustrating as a participant because I just found that it was going round in circles , people moaning and you know it wasn’t very solution focused so I came from my situation where I was very frustrated with clinical supervision , it was facilitated by somebody that was non-nursing then it wasn’t very , there wasn’t the ground rules , it was very loose (Caroline) .

However, many did not have prior experience of peer group clinical supervision. Nonetheless, through the education and preparation received, there was a sense of commitment to embrace the concept, practice, and philosophy.

I did not really have any exposure or really much information on clinical supervision , but it has opened my eyes , and as one might say I am now a believer (Brid) .

Delivering peer group clinical supervision

In delivering peer group clinical supervision, participants felt supervisees were wary, as they did not know what peer group clinical supervision was, and they had focused more on the word supervision which was misleading to them. Nonetheless, the process was challenging, and buy-in was questioned at an individual and managerial level.

Buy-in wasn’t great I think now of course people will blame the pandemic , but this all happened before the pandemic , there didn’t seem to be you know , the same support from management that I would have expected so I kind of understood it in a way because then there wasn’t the same real respect from the practitioners either (Mary Rose) .

From the peer group clinical supervisor’s perspective, they were all novices in delivering/facilitating peer group clinical supervision sessions, and the support of the external clinical supervisors, and their own peer group clinical supervision sessions were invaluable along with a clinical supervision model.

Having supervision myself was key and something that is vital and needed , we all need to look at our practice and how we work it’s no good just facilitating others without being part of the process yourself but for me I would say the three principles of clinical supervision , you know the normative , formative and restorative , I keep hammering that home and bring that in regularly and revisit the contract and I have to do that often you know (Claire) .

All peer group clinical supervisors commented on the preparation for their peer group clinical supervision sessions and the importance of them having the right frame of mind and that often they needed to read over their course work and published evidence.

I want everybody to have a shared voice and you know that if one person , there is something that somebody feels very strongly and wants to talk about it that they e-mail in advance like we don’t have a set agenda but that’s agreed from the participant at the start (Caroline) .

To assist this, the peer group clinical supervisors noted the importance of their own peer group clinical supervision, the support of their peers, and external clinical supervisors. This preparation in an unpredictable situation can be difficult but drawing on one’s experience and the experience within the group can assist in navigating beyond unexpected situations.

I utilise the models of clinical supervision and this helps guide me , I am more of a facilitator of the group we are experts in our own area and our own role but you can only be an expert if you take the time to examine your practice and how you operate in your role (Brid) .

All clinical supervisors noted that the early sessions can be superficial, and the focus can be on other practice or management issues, but as time moves on and people become more engaged and involved it becomes easier as their understanding of supervision becomes clearer. In addition, there may be hesitancy and people may have difficulty opening up with certain people in the group and this is a reality that can put people off.

Initially there was so much managerial bashing and I think through supervision , I began to kind of think , I need the pillars of supervision , the governance , bringing more knowledge and it shifted everything in the room , trying to marry it with all the tensions that people have (Mary Rose) .

For some clinical supervisors, there were expected and unexpected challenges for them as clinical supervisors in terms of the discussions veering off course and expectations of their own ability.

The other big challenge is when they go off , how do you bring him back , you know when they veer off and you’re expected to be a peer , but you have to try and recoil that you have to get the balance with that right (Mary Rose) .

While peer group clinical supervision is accepted and seen as a valuable process by the peer group clinical supervisors, facilitating peer group supervision with people known to you can be difficult and may affect the process.

I’d love to supervise a group where I actually don’t know the people , I don’t know the dynamics within the group , and I’d love to see what it would be like in a group (Bernie) .

Of concern to clinical supervisors was the aspect of non-attendance and while there may be valid reasons such as COVID-19 the absence of a supervisee for several sessions can affect the group dynamics, especially if the supervisee has only engaged with early group sessions.

One of the ones that couldn’t attend because of COVID and whatever , but she’s coming to the next one and I just feel there’s a lot of issues in her area and I suppose I’m mindful that I don’t want that sort of thing to seep in , so I suppose it’s just for me just to keep reiterating the ground rules and the boundaries , that’s something I just have to manage as a facilitator , but what if they don’t attend how far will the group have progressed before she attends (Caroline) .

Responding to COVID-19

The advent of COVID-19 forced peer group clinical supervisors to find alternative means of providing peer group clinical supervision sessions which saw the move from face-to-face to online sessions. The online transition was seen as seamless for many established groups while others struggled to deliver sessions.

With COVID we did online for us it was fine because we were already formed (Corina) .

While the transition may have been positive many clinical supervisors came across issues because they were using an online format that would not be present in the face-to-face session.

We did have a session where somebody was in the main office and they have a really loud booming voice and they were saying stuff that was not appropriate to say outside of clinical supervision and I was like are you in the office can you lower it down a bit can you put your headphones on (Maria) .

However, two peer group clinical supervisors ceased or hasted the progress of rolling out peer group clinical supervision sessions mainly due to redeployment and staff availability.

With COVID it just had to be canceled here , it’s just the whole thing was canceled so it was very , very difficult for people (Mary Rose) .

It was clear from clinical supervisors that online sessions were appropriate but that they felt they were only appropriate for existing established groups that have had the opportunity to build relationships, develop trust, embed the ground rules, and create the space for open communication and once established a combined approach would be appropriate.

Since we weren’t as established as a group , not everybody knew each other it would be difficult to establish that so we would hold off/reschedule , obviously COVID is a major one but also I suppose if you have an established group now , and again , you could go to a remote one , but I felt like since we weren’t established as a group it would be difficult to develop it in that way (Karen) .

Within practice COVID-19 took priority and other aspects such as peer group clinical supervision moved lower down on the priority list for managers but not for the clinical supervisors even where redeployment occurred.

With COVID all the practical side , if one of the managers is dealing with an outbreak , they won’t be attending clinical supervision , because that has to be prioritised , whereas we’ve prioritised clinical supervision (Maria) .

The valuing of peer group clinical supervision was seen as important by clinical supervisors, and they saw it as particularly needed during COVID-19 as staff were dealing with many personal and professional issues.

During the height of COVID , we had to take a bit of a break for four months as things were so demanding at work for people but then I realised that clinical supervision was needed and started back up and they all wanted to come back (Brid) .

Having peer group clinical supervision during COVID-19 supported staff and enabled the group to form supportive relationships.

COVID has impacted over the last two years in every shape and they needed the supervision and the opportunity to have a safe supportive space and it gelled the group I think as we all were there for each other (Claire) .

While COVID-19 posed many challenges it also afforded clinical supervisors and supervisees the opportunity for change and to consider alternative means of running peer group clinical supervision sessions. This change resulted in online delivery and in reflecting on both forms of delivery (face-to-face and online) clinical supervisors saw the benefit in both. Face-to-face was seen as being needed to form the group and then the group could move online once the group was established with an occasional periodic face-to-face session to maintain motivation commitment and reinforce relationships and support.

Online formats can be effective if the group is already established or the group has gone through the storming and forming phase and the ground rules have been set and trust built , then I don’t see any problem with a blended online version of clinical supervision , and I think it will be effective (Jane) .

Personal and professional development

Growth and development were evident from peer group clinical supervisors’ experiences and this growth and development occurred at a personal, professional, and patient/client level. This development also produced an awakening and valuing of one’s passion for self and their profession.

I suppose clinical supervision is about development I can see a lot of development for me and my supervisees , you know personally and professionally , it’s the support really , clinical supervision can reinvigorate it’s very exciting and a great opportunity for nursing to support each other and in care provision (Claire) .

A key to the peer group clinical supervisor’s development was the aspect of transferable skills and the confidence they gained in fulfilling their role.

All of these skills that you learn are transferable and I am a better manager because of clinical supervision (Maria) .

The confidence and skills gained translated into the clinical supervisor’s own practice as a clinical practitioner and clinical supervisor but they were also realistic in predicting the impact on others.

I have empowered my staff , I empower them to use their voice and I give my supervisees a voice and hope they take that with them (Corina) .

Fundamental to the development process was the impact on care itself and while this cannot always be measured or identified, the clinical supervisors could see that care and support of the individual practitioner (supervisee) translated into better care for the patient/client.

Care is only as good as the person delivering it and what they know , how they function and what energy and passion they have , and clinical supervision gives the person support to begin to understand their practice and how and why they do things in a certain way and when they do that they can begin to question and even change their way of doing something (Brid) .

Future opportunities

Based on the clinical supervisor’s experiences there was a clear need identified regarding valuing and embedded peer group clinical supervision within nursing/midwifery practice.

There has to be an emphasis placed on supervision it needs to be part of the fabric of a service and valued by all in that service , we should be asking why is it not available if it’s not there but there is some work first on promoting it and people knowing what it actually is and address the misconceptions (Claire) .

While such valuing and buy-in are important, it is not to say that all staff need to have peer group clinical supervision so as to allow for personal choice. In addition, to value peer group clinical supervision it needs to be evident across all staffing grades and one could question where the best starting point is.

While we should not mandate that all staff do clinical supervision it should become embedded within practice more and I suppose really to become part of our custom and practice and be across all levels of staff (Brid) .

When peer group clinical supervision is embedded within practice then it should be custom and practice, where it is included in all staff orientations and is nationally driven.

I suppose we need to be driving it forward at the coal face at induction , at orientation and any development for the future will have to be driven by the NMPDUs or nationally (Ailbhe) .

A formalised process needs to address the release of peer group clinical supervisors but also the necessity to consider the number of peer group clinical supervisors at a particular grade.

The issue is release and the timeframe as they have a group but they also have their external supervision so you have to really work out how much time you’re talking about (Maria) .

Vital within the process of peer group clinical supervision is receiving peer group clinical supervision and peer support and this needs to underpin good peer group clinical supervision practice.

Receiving peer group supervision helps me , there are times where I would doubt myself , it’s good to have the other group that I can go to and put it out there to my own group and say , look at this , this is what we did , or this is what came up and this is how (Bernie) .

For future roll out to staff nurse/midwife grade resourcing needs to be considered as peer group clinical supervisors who were managers could see the impact of having several peer group clinical supervisors in their practice area may have on care delivery.

Facilitating groups is an issue and needs to be looked at in terms of the bigger picture because while I might be able to do a second group the question is how I would be supported and released to do so (Maria) .

While there was ambiguity regarding peer group clinical supervision there was an awareness of other disciplines availing of peer group clinical supervision, raising questions about the equality of supports available for all disciplines.

I always heard other disciplines like social workers would always have been very good saying I can’t meet you I have supervision that day and I used to think my God what’s this fabulous hour that these disciplines are getting and as a nursing staff it just wasn’t there and available (Bernie) .

To address this equity issue and the aspect of low numbers of certain grades an interdisciplinary approach within nursing and midwifery could be used or a broader interdisciplinary approach across all healthcare professionals. An interdisciplinary or across-services approach was seen as potentially fruitful.

I think the value of interprofessional or interdisciplinary learning is key it addresses problem-solving from different perspectives that mix within the group is important for cross-fertilisation and embedding the learning and developing the experience for each participant within the group (Jane) .

As we move beyond COVID-19 and into the future there is a need to actively promote peer group clinical supervision and this would clarify what peer group clinical supervision actually is, its uptake and stimulate interest.

I’d say it’s like promoting vaccinations if you could do a roadshow with people , I think that would be very beneficial , and to launch it , like you have a launch an official launch behind it (Mary Rose) .

The advantages of peer group clinical supervision highlighted in this study pertain to self-enhancement (confidence, leadership, personal development, resilience), organisational and service-related aspects (positive work environment, staff retention, safety), and professional patient care (critical thinking and evaluation, patient safety, adherence to quality standards, elevated care standards). These findings align with broader literature that acknowledges various areas, including self-confidence and facilitation [ 23 ], leadership [ 24 ], personal development [ 25 ], resilience [ 26 ], positive/supportive working environment [ 27 ], staff retention [ 28 ], sense of safety [ 29 ], critical thinking and evaluation [ 30 ], patient safety [ 31 ], quality standards [ 32 ] and increased standards of care [ 33 ].

In this study, peer group clinical supervision appeared to contribute to the alleviation of stress and anxiety. Participants recognised the significance of these sessions, where they could openly discuss and reflect on professional situations both emotionally and rationally. Central to these discussions was the creation of a safe, trustworthy, and collegial environment, aligning with evidence in the literature [ 34 ]. Clinical supervision provided a platform to share resources (information, knowledge, and skills) and address issues while offering mutual support [ 35 ]. The emergence of COVID-19 has stressed the significance of peer group clinical supervision and support for the nursing/midwifery workforce [ 36 ], highlighting the need to help nurses/midwifes preserve their well-being and participate in collaborative problem-solving. COVID-19 impacted and disrupted clinical supervision frequency, duration and access [ 37 ]. What was evident during COVID-19 was the stress and need for support for staff and given the restorative or supportive functions of clinical supervision it is a mechanism of support. However, clinical supervisors need support themselves to be able to better meet the supervisee’s needs [ 38 ].

The value of peer group clinical supervision in nurturing a conducive working environment cannot be overstated, as it indorses the understanding and adherence to workplace policies by empowering supervisees to understand the importance and rationale behind these policies [ 39 ]. This becomes vital in a continuously changing healthcare landscape, where guidelines and policies may be subject to change, especially in response to situations such as COVID-19. In an era characterised by international workforce mobility and a shortage of healthcare professionals, a supportive and positive working environment through the provision of peer group clinical supervision can positively influence staff retention [ 40 ], enhance job satisfaction [ 41 ], and mitigate burnout [ 42 ]. A critical aspect of the peer group clinical supervision process concerns providing staff the opportunity to reflect, step back, problem-solve and generate solutions. This, in turn, ensures critical thinking and evaluation within clinical supervision, focusing on understanding the issues and context, and problem-solving to draw constructive lessons for the future [ 30 ]. Research has determined a link between clinical supervision and improvements in the quality and standards of care [ 31 ]. Therefore, peer group clinical supervision plays a critical role in enhancing patient safety by nurturing improved communication among staff, facilitating reflection, promoting greater self-awareness, promoting the exchange of ideas, problem-solving, and facilitating collective learning from shared experiences.

Starting a group arose as a foundational aspect emphasised in this study. The creation of the environment through establishing ground rules, building relationships, fostering trust, displaying respect, and upholding confidentiality was evident. Vital to this process is the recruitment of clinical supervisees and deciding the suitable group size, with a specific emphasis on addressing individuals’ inclination to engage, their knowledge and understanding of peer group clinical supervision, and dissipating any lack of awareness or misconceptions regarding peer group supervision. Furthermore, the educational training of peer group clinical supervisors and the support from external clinical supervisors played a vital role in the rollout and formation of peer group clinical supervision. The evidence stresses the significance of an open and safe environment, wherein supervisees feel secure and trust their supervisor. In such an environment, they can effectively reflect on practice and related issues [ 41 ]. This study emphasises that the effectiveness of peer group supervision is more influenced by the process than the content. Clinical supervisors utilised the process to structure their sessions, fostering energy and interest to support their peers and cultivate new insights. For peer group clinical supervision to be effective, regularity is essential. Meetings should be scheduled in advance, allocate protected time, and take place in a private space [ 35 ]. While it is widely acknowledged that clinical supervisors need to be experts in their professional field to be credible, this study highlights that the crucial aspects of supervision lie in the quality of the relationship with the supervisor. The clinical supervisor should be supportive, caring, open, collaborative, sensitive, flexible, helpful, non-judgmental, and focused on tacit knowledge, experiential learning, and providing real-time feedback.

Critical to the success of peer group clinical supervision is the endorsement and support from management, considering the organisational culture and attitudes towards the practice of clinical supervision as an essential factor [ 43 ]. This support and buy-in are necessary at both the management and individual levels [ 28 ]. The primary obstacles to effective supervision often revolve around a lack of time and heavy workloads [ 44 ]. Clinical supervisors frequently struggle to find time amidst busy environments, impacting the flexibility and quality of the sessions [ 45 ]. Time constraints also limit the opportunity for reflection within clinical supervision sessions, leaving supervisees feeling compelled to resolve issues on their own without adequate support [ 45 ]. Nevertheless, time-related challenges are not unexpected, prompting a crucial question about the value placed on clinical supervision and its integration into the culture and fabric of the organisation or profession to make it a customary practice. Learning from experiences like those during the COVID-19 pandemic has introduced alternative ways of working, and the use of technology (such as Zoom, Microsoft Teams, Skype) may serve as a means to address time, resource, and travel issues associated with clinical supervision.

Despite clinical supervision having a long international history, persistent misconceptions require attention. Some of these include not considering clinical supervision a priority [ 46 ], perceiving it as a luxury [ 41 ], deeming it self-indulgent [ 47 ], or viewing it as mere casual conversation during work hours [ 48 ]. A significant challenge lies in the lack of a shared understanding regarding the role and purpose of clinical supervision, with past perceptions associating it with surveillance and being monitored [ 48 ]. These negative connotations often result in a lack of engagement [ 41 ]. Without encouragement and recognition of the importance of clinical supervision from management or the organisation, it is unlikely to become embedded in the organisational culture, impeding its normalisation [ 39 ].

In this study, some peer group clinical supervisors expressed feelings of being impostors and believed they lacked the knowledge, skills, and training to effectively fulfil their roles. While a deficiency in skills and competence are possible obstacles to providing effective clinical supervision [ 49 ], the peer group clinical supervisors in this study did not report such issues. Instead, their concerns were more about questioning their ability to function in the role of a peer group clinical supervisor, especially after a brief training program. The literature acknowledges a lack of training where clinical supervisors may feel unprepared and ill-equipped for their role [ 41 ]. To address these challenges, clinical supervisors need to be well-versed in professional guidelines and ethical standards, have clear roles, and understand the scope of practice and responsibilities associated with being a clinical supervisor [ 41 ].

The support provided by external clinical supervisors and the peer group clinical supervision sessions played a pivotal role in helping peer group clinical supervisors ease into their roles, gain experiential learning, and enhance their facilitation skills within a supportive structure. Educating clinical supervisors is an investment, but it should not be a one-time occurrence. Ongoing external clinical supervision for clinical supervisors [ 50 ] and continuous professional development [ 51 ] are crucial, as they contribute to the likelihood of clinical supervisors remaining in their roles. However, it is important to interpret the results of this study with caution due to the small sample size in the survey. Generalising the study results should be approached with care, particularly as the study was limited to two regions in Ireland. However, the addition of qualitative data in this mixed-methods study may have helped offset this limitation.

This study highlights the numerous advantages of peer group clinical supervision at individual, service, organisational, and patient/client levels. Success hinges on addressing the initial lack of awareness and misconceptions about peer group clinical supervision by creating the right environment and establishing ground rules. To unlock the full potential of peer group clinical supervision, it is imperative to secure management and organisational support for staff release. More crucially, there is a need for valuing and integrating peer group clinical supervision into nursing and midwifery education and practice. Making peer group clinical supervision accessible to all grades of nurses and midwives across various healthcare services is essential, necessitating strategic planning to tackle capacity and sustainability challenges.

Data availability

Data are available from the corresponding author upon request owing to privacy or ethical restrictions.

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Acknowledgements

The research team would like to thank all participants for their collaboration, the HSE steering group members and Carmel Hoey, NMPDU Director, HSE West Mid West, Dr Patrick Glackin, NMPD Area Director, HSE West, Annette Cuddy, Director, Centre of Nurse and Midwifery Education Mayo/Roscommon; Ms Ruth Hoban, Assistant Director of Nursing and Midwifery (Prescribing), HSE West; Ms Annette Connolly, NMPD Officer, NMPDU HSE West Mid West.

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OD: Conceptualization, Methodology, Formal analysis, Investigation, Writing - Original Draft, Writing - Review & Editing, Project administration, Funding acquisition. COD: Methodology, Formal analysis, Investigation, Writing - Original Draft, Writing - Review & Editing, Funding acquisition. KM: Methodology, Formal analysis, Investigation, Writing - Original Draft, Writing - Review & Editing, Funding acquisition. JT: Methodology, Formal analysis, Writing - Original Draft, Writing - Review & Editing. LM: Methodology, Formal analysis, Investigation, Writing - Original Draft, Writing - Review & Editing, Funding acquisition.

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This study was approved by two health service institutional review boards University Hospital Limerick (Ref: 091/19) and Galway University Hospitals (Ref: C.A. 2199). The study was conducted in accordance with the principles of the Declaration of Helsinki and all study details were fully disclosed to participants, who were assured of the voluntary nature of participation and withdrawal. The study questionnaires were coded, and identities were not disclosed to guarantee participants’ anonymity and all participants provided written informed consent before interviews.

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Doody, O., Markey, K., Turner, J. et al. Clinical supervisor’s experiences of peer group clinical supervision during COVID-19: a mixed methods study. BMC Nurs 23 , 612 (2024). https://doi.org/10.1186/s12912-024-02283-3

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A Perspective on Possible Applications of Artificial Intelligence to the Clinical Trial Workforce

Blog September 4, 2024

Clinical trials provide the scientific foundation for justifying the safety and efficacy of drugs, biologics, and devices—but are laborious, expensive, and risky. Only 10% of drugs entering clinical trials receive U.S. Food and Drug Administration (FDA) approval, while common reasons for trial failure include poor patient selection, recruitment challenges, and complex study designs.{1} The pharmaceutical industry has begun leveraging artificial intelligence (AI) to streamline numerous aspects of drug development from identification of novel drug targets to clinical trial design.{2} Moreover, AI is being leveraged to predict clinical parameters ranging from disease onset to mortality, drug-target connections, and drug repositioning suggestions.

In response, the FDA is devising an ongoing regulatory framework that will consider feedback from various stakeholders within drug development to spur innovation, while promoting patient safety.{3} The clinical research professionals working behind the scenes play a vital role in the drug development process, yet face administrative burden, burnout, and high turnover rates that all adversely impact clinical trial quality and the safety of new therapies.{4}   For instance, a little more than half of the U.S. clinical trial workforce reported burnout since the 2020 COVID-19 pandemic.{4}

AI could be leveraged to reduce the administrative burden associated with laborious, site-specific documents to provide research teams more time to conduct high-priority tasks such as identifying, screening, and enrolling patients. For instance, AI could analyze a clinical study protocol in PDF format and generate a series of documents, forms, and templates to aid with study execution based on insights and similarities drawn from a database of similar protocols. Such documents could include study-specific checklists, guides, and notes to assist the clinical team in conducting a study more efficiently.

Furthermore, machine learning tools could build protocol-specific electronic case report forms for data capture using existing protocols and databases to establish a new electronic data capture (EDC) database. This could generate EDC builds faster than traditional teams that could then be reviewed by data management teams for discrepancies. Clinical study report (CSR) generation can also benefit from AI-assisted product information management by producing initial draft shells of a clinical study report based on each individual protocol’s specifications. Automating this task alone will garner significant time savings at end of study by expediting submissions to, and ultimately approvals from, drug authorities.

However, implementation of AI models to clinical trials presents risks that must be considered since sensitive patient data and sponsor proprietary information are involved. Potential risks include incorrect data computation resulting in protocol deviations; data breaches that may disclose confidential information; and various legal and ethical implications pertaining to data privacy and compliance with country-specific regulations—such as General Data Protection Regulation in the European Union and the Health Insurance Portability and Accountability Act in the United States.

Addressing these risks must include a multi-disciplinary approach that involves legal experts and experienced AI developers to create a robust core that will protect patients while encouraging new innovations in clinical trials. With strong data encryption and access controls/monitoring, an AI model would need to ensure that data are encrypted when being transferred between systems. Including an additional security measure can safeguard clinical trial data. Implementing access to the AI model should be rigorous to ensure that only authorized clinical trial team members can access the system. Continuous monitoring of access logs can assist in detecting and preventing unauthorized access to the AI model.

AI will profoundly impact numerous industries, and clinical research is no exception to this technological shift. Industry leaders have focused on utilizing AI to improve clinical trial design, patient recruitment, and data quality. For instance, a recent study focused on the implementation of an AI tool called Trial Pathfinder, using real-world data (RWD) to simulate data for non-small cell lung cancer. This then allowed the AI tool to learn both clinical protocols and patient RWD.{5}

While these approaches are undoubtedly important, another area requiring attention involves actual trial operations. We believe that technology should also be used to reduce the burden on study teams, whether at a clinical trial site, contract research organization, or study sponsor. Using an AI system to generate study- and site-level documents, in addition to building an electronic database to automatically create CSRs, would contribute to delivering lifesaving therapies to patient populations faster.

Submitted as independent authors by Justin Scott Brathwaite, PMP, CCRP; Lindsey Haroun; Daniel Goldstein, MSN, RN, CCRP; Erin Dowgiallo; Karah Hogue; John Seeley, MBA

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding Sources

• Van Norman GA. 2016. Drugs, devices, and the FDA: Part 1. JACC Basic to Transl Sci 1(3):170–9. https://doi.org/10.1016/j.jacbts.2016.03.002
• Bhatt A. 2021. Artificial intelligence in managing clinical trial design and conduct: man and machine still on the learning curve? Perspect Clin Res 12(1):1. https://doi.org/10.4103/picr.picr_312_20
• U.S. Food and Drug Administration. Center for Drug Evaluation and Research. 2023. Artificial intelligence and machine learning (AI/ML) for drug development. https://www.fda.gov/science-research/science-and-research-special-topics/artificial-intelligence-and-machine-learning-aiml-drug-development
• Causey M. 2021. Burnout threatens to undermine clinical trial workforce productivity. ACRP Blog . https://acrpnet.org/2021/09/burnout-threatens-to-undermine-clinical-trial-workforce-productivity/
• Zhang B, Zhang L, Chen J, Jin Z, Liu S, Zhang S. 2023. Harnessing artificial intelligence to improve clinical trial design. Commun Med 3(1). https://doi.org/10.1038/s43856-023-00425-3

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University Hospitals Excels at the Forefront of Artificial Intelligence and Healthcare, Enhancing Clinical Outcomes, Research, and Administrative Functions

August 28, 2024

By UH R&E Institute Team

UH Research & Educations Update | September 2024

Artificial intelligence (AI), the transformative data-driven technology that emulates human brain power, is revolutionizing the healthcare landscape, rapidly advancing diagnostic precision and treatment, and streamlining administrative tasks to enable more patient-centered care.

Propelled by immense high-quality data systems and analytics, AI empowers medical decision making, helping physicians and other care providers triage and treat patients in a timelier and effective manner, while maximizing opportunities to individualize treatment plans, amplify the precise cellular and diagnostic information available to care providers, and improve clinical outcomes.

“Big data inputs potentially allow us to be more accurate in identifying biomarkers for disease, radiologic and pathologic diagnoses, and personalized treatments,” says Daniel Simon, MD , President of Academic & External Affairs and Chief Scientific Officer and the Ernie and Patti Novak Distinguished Chair in Health Care Leadership for University Hospitals. “The volume of information is so vast that you need tools of big data, such as AI, for accurate analyses and definitive diagnostic and treatment recommendations.”

A Powerful Tool Reshaping the Healthcare Landscape

With AI-powered technology, physicians can better determine if a particular treatment will help a patient, or if the potential risks and side effects exceed the clinical benefit. For instance, at University Hospitals a combination of imaging for coronary artery calcium scoring and AI-guided methodologies is used to more precisely identify patients with a high cardiovascular disease risk who will most benefit from preventive therapies, such as statins and aspirin (i.e., 10-year risk of cardiovascular death, heart attack or stroke >7.5%). Classifying and treating patients according to quantified risk minimizes the potential for overtreatment based on guideline cut points.

AI platforms can also expedite the treatment of disease by specific genomic and cellular characteristics. For example, sequencing cancer patient genomic profiling with AI-assisted technologies readily hones in on mutations for which there might be a targeted or genetic therapy a patient might benefit from.

At a time when healthcare organizations across the country are challenged by workforce shortages, AI systems offer assistance and solutions for working faster, more efficiently, including built-in safety mechanisms that alert physicians and care providers to a change in a patient’s medical condition, says Dr. Simon. For example, machine learning algorithms and AI tools can track a patient’s blood pressure and heart and respiratory rates to warn medical staff when a patient is at risk of developing sepsis, prompting timely fluid resuscitation and antibiotic therapy to improve survival and limit complications.

AI Applications Multiply Amid Key Collaborations

“The heart of AI, what makes it so exciting, not only for healthcare, but for all other sectors, is the fact that it will automate many tasks that are repetitive or time consuming,” says Leonardo Kayat Bittencourt, MD, PhD , and Vice Chair of Innovation in the Department of Radiology . In medicine, AI will expedite a standard of care that is dependable, says Dr. Kayat Bittencourt, adding, “Almost everything we, human providers, do in healthcare can be helped and augmented by AI.”

Already, use of AI technologies has grown significantly throughout University Hospitals, across a range of clinical specialties and conditions. They are being used in the diagnosis and treatment of conditions such as pulmonary embolism, aortic dissection, vertebral compression fracture, and pneumothorax according to Dr. Kayat Bittencourt. Likewise, AI systems are helping physicians make treatment decisions in men with prostate cancer. They are also enabling radiologists to more quickly and accurately diagnose bone fractures in the emergency room and assist ophthalmologists striving to more precisely diagnose patients.

Strategic collaborations and partnerships with national and global industry have increased opportunities for research, innovation, and clinical applications across University Hospitals. In June, the health system announced the deployment of a comprehensive AI platform, Aidoc aiOS™, across the entire enterprise , including 13 hospitals and dozens of outpatient locations. This significantly advances AI system integration to enhance clinical outcomes and streamline workflow, providing access to 17 FDA-cleared AI algorithms.

In 2022, University Hospitals launched the Radiology AI and Diagnostic Innovation Collaborative, or RadiCLE , to advance the science of teaching, research discoveries, and clinical adoption of radiology AI, while also serving as a revenue stream for the radiology department and University Hospitals through collaboration with outside entities. This leverages the system’s wealth of data, advanced applications, diverse Northeast Ohio population, and world-class radiologists and specialists, to further advance the development and application of AI. The RadiCLE program is directed by Dr. Kayat Bittencourt, and the team includes a Program Manager, a Data Lead and a community of AI Clinical Champions composed of UH radiology faculty and a diverse representation of healthcare providers, trainees, and medical students.

Earlier this summer, the Department of Radiology at UH was designated an American College of Radiology® (ACR®) Recognized Center for Healthcare-AI (ARCH-AI). ARCH-AI is the first national artificial intelligence quality assurance program for radiology facilities nationwide. Becoming an ARCH-AI distinguishes University Hospitals as a leading-edge program in the adoption of best practices for the use of artificial intelligence technologies in radiology, affirming its position at the forefront of AI in

“The UH Department of Radiology is fortunate to have a team of world-renowned radiologists and informatics experts who are highly engaged in with the adoption and early-stage (AI) technologies, and they help drive us forward in their own areas of expertise,” says Donna Plecha, MD , Chair, Department of Radiology, Ida and Irwin Haber and Wei-Shen Chin, MD, Chair in Radiology, Co-Director, Diagnostic Institute, University Hospitals Cleveland Medical Center and Professor of Radiology, Professor of Pathology, Case Western Reserve University School of Medicine.

In addition to clinical applications, AI systems within University Hospitals are being used to magnify research opportunities. In 2023, the health system unveiled a collaboration with Premier Inc.’s PINC AI™ Applied Sciences (PAS) to advance clinical research, real-world evidence generation, and explore the development of new solutions, interventions and other novel healthcare initiatives using data-fueled AI platforms.

“Leveraging our combined data and research expertise will enable reduced research timelines, clinical care pathway development and testing, early disease intervention and help drive innovations in clinical, quality and operational effectiveness,” said Dr. Peter Pronovost , Chief Clinical Transformation Officer and Chief Quality Officer, University Hospitals.

Responsible Use of AI will Enable Continued Growth

Those integrally involved in the proliferation of AI throughout University Hospitals are quick to note the technology’s powerful capabilities, but equally mindful that the most powerful tool in medicine is an empathetic human touch. As use of AI in healthcare grows, physicians will remain the drivers of personalized, patient-centered care. Rather than replace physicians, AI will simply augment their capacity to treat patients, with vastly informed clinical judgement, in the most responsive, safest, and effective manner, says Dr. Simon.

“This is AI-assisted, AI-facilitated” care, Dr. Simon explains. “AI is a powerful tool that is enabling caregivers and health systems to be more responsive, accurate, effective and timely.”

To ensure patient privacy ample precautions are taken to remove patient-specific identifiers from the data used to develop AI systems, according to Dr. Simon. Strict data oversight at University Hospitals and HIPAA (Health Insurance Portability and Accountability Act) regulations require that any data provided to construct large data sets for AI systems be de-identified.

Moving forward, AI healthcare applications will undoubtedly proliferate, with greater capabilities and integration of comprehensive patient data to fully reflect heterogeneous patient populations, something University Hospitals is well positioned to do, given the diversity of patients it serves in Cleveland.

When it comes to future AI growth and identifying meaningful healthcare applications, “It is now widely accepted that AI is unlikely to fully replace us humans. However, humans that ethically embrace AI, and allow themselves to be augmented and be better for our patients, will certainly replace those who refuse to do so,” says Dr. Kayat Bittencourt.

Tags: AI , Radiology , Research

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Clinical research nursing and factors influencing success: a qualitative study describing the interplay between individual and organisational leadership influences and their impact on the delivery of clinical research in healthcare

Linda tinkler.

Trust Lead, Nursing, Midwifery and AHP Research, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK

Lisa Robinson

Consultant Allied Health Professional, Major Trauma Rehabillitation Department, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK

Clinical research delivery is a term increasingly used to describe the work undertaken to implement studies which explore and test prevention, diagnosis and treatment in healthcare. Such studies range from multi-site clinical trials to single site observational projects. Whilst widely acknowledged as fundamental to effective healthcare, clinical research is complex to deliver and is met with challenges in the busy clinical environment. The perceptions and experiences of Clinical Research Nurses, whose work is central to this agenda, have emerged as important, yet frequently overlooked insights in relation to the potential success of research delivery. Increased understanding of these insights is essential to address the barriers and maximise facilitators to success in clinical research.

To better understand how the perceptions and experiences of Clinical Research Nurses relate to potential for success in research delivery.

Seven focus groups and two one-to-one interviews (27 participants) were conducted in a large tertiary North East England National Health Service Foundation Trust between March and June 2017.

Clinical Research Nurses’ described perceptions and experiences of working to co-ordinate and deliver a range of research as individuals, within their teams, throughout the wider organisation, and beyond. Two key elements situated within an overarching theme of leadership emerged as likely to impact on how successfully they were able to practise:

• the individual (self-leadership).

• the organisation (leadership culture).

Conclusions

The framework emerging from this study illustrates a complex interplay between personal attributes and organisational culture, mediated by national strategies and targets associated with the clinical research agenda. When situated within the concept of leadership, it broadens the potential for understanding the underlying issues and increases the range of possible support mechanisms to improve experiences for Clinical Research Nurses. Framing the challenges in this way contributes new knowledge to the dialogue surrounding clinical research delivery.

Introduction

The successful delivery of clinical research is fundamental to enabling continuous improvements in health ( Cooksey, 2006 ; Department of Health, 2017 ). Research-active organisations report better patient outcomes and research activity and engagement at all organisational levels is fundamental to high-quality care provision. The Care Quality Commission (CQC) now enables NHS organisations to showcase research engagement as part of its inspection programme ( CQC, 2017 ; Ozdemir, 2015 ).

Trial recruitment challenges are relevant to the entire healthcare community and increasingly cited in the literature ( Adams et al., 2015 ; Donovan et al., 2014a , b , 2016 ; Elliot et al., 2017 ). The Clinical Research Nurse (CRNurse) workforce is a key element of successful research delivery and an integral part of the research journey for patients. The perceptions and experiences of their role and the content and context of their work are emerging as an important marker in understanding the complexities of trial delivery ( Adams et al., 2015 ; Gibbs and Lowton, 2012 ; Hamer, 2017 ; Hill, 2018; Jones, 2017 ; Kunhunny and Salmon, 2017 ; MacArthur et al., 2014; Tinkler et al., 2018 ; Whitehouse and Smith, 2018 ).

Previous research from our team explored the role and the ethical perceptions of Clinical Research Nurses (CRNurses) specifically in relation to their roles, undertaking study recruitment and the informed consent process ( Tinkler et al., 2018 ). The findings emerging from that study identified numerous factors that could adversely impact on successful research delivery. Factors included a range of intrinsic and extrinsic issues, such as role transition and the conflict between core clinical values and perceived pressure to recruit. Altered relationships with multidisciplinary colleagues and perceptions of how the CRNurses were viewed by the wider organisation led to reduced morale and contributed to staff turnover. Kunhunny and Salmon (2017) reported similar findings in relation to issues undermining the professional identity of CRNurses and role-related challenges. The work of Whitehouse and Smith (2018 ) has highlighted the need for clearer CRNurse strategies and structure, and further research into professional identity, understanding of the role by multi-professional team members and work to increase the evidence base regarding the role and impact.

The recent National Institute for Health Research (NIHR) CRNurse strategy has further highlighted the need for visible leaders in clinical research nursing along with the imperative to demonstrate the impact of the CRNurse in the patient journey. The International Association of Clinical Research Nurses (IACRN) embodies similar aims through their Scope and Standards of Practice ( American Nurses Association and International Association of Clinical Research Nursing, 2016 ). As such clinical research nursing is recognised as specialty nursing practice by the American Nurses Association, though this status is not the case in the UK.

With increasing interest and expertise emerging in this area, there is an opportunity to influence policy and practice in relation to the CRNurse role, whilst contributing to the dialogue on trial recruitment challenges through a focus on self-leadership and organisational culture ( Jones, 2017 ; Whitehouse and Smith, 2018 ).

Methodology

A qualitative study design used focus groups as the primary method of data collection. Focus groups maximise the benefit of group interaction and generate data that highlight underlying factors influencing the feelings, attitudes and behaviour of participants ( Kitzinger, 2006 ; Krueger and Casey, 2015 ). Focus groups were also chosen due to their time effectiveness for busy clinical staff. One-to-one interviews were added approximately one month into data collection in response to requests from potential participants. The lead author (LT) adopted a constructivist approach, facilitating participants to share their experiences, focusing on enablers and barriers to their practice as CRNurses, in a supportive, confidential environment ( Mills and Birks, 2014 ).

Sample/participants

The host organisation for this study is one of the largest NHS foundation trusts in the UK, with a sustained successful track record in clinical research delivery; 108 CRNurses were employed by the organisation at the time of study recruitment. These individuals were invited to participate, via email of the participant information sheet (PIS) from team leaders. The email invited potential participants to opt in by returning an expression of interest form via email to LT. The email stated that involvement was voluntary and that a decision not to take part would not affect subsequent interactions or relationships with the researcher or the organisation. Participants were given up to four weeks to decide on participation and were free to ask questions prior to making a decision. LT attended organisational meetings to present the study and its background, however participants were not known to LT prior to study commencement.

Data collection

Data were collected during the working week between March and June 2017. Focus groups were conducted at one hospital site, utilising two dedicated meeting rooms situated away from the clinical area to reduce interruptions. One-to-one interviews were conducted at a venue of the participants’ choice in the workplace. Each focus group comprised of between two and seven participants and lasted approximately two hours. Interviews lasted approximately one hour and 30 minutes. All interviews and focus groups were digitally audio-recorded with participants’ consent and transcribed verbatim by an independent transcriber approved by the study sponsor. LT, an adult nurse qualified to Masters’ Level, with 14 years’ clinical experience, (nine of these in designated research roles) moderated all focus groups and interviews. Open-ended questioning was supported by a topic guide ( Table 1 ).

Topic guide.

Data analysis

Data were analysed systematically by LT using an inductive approach which incorporated thematic analysis ( Braun and Clarke, 2006 ) supported by NVivo 11 qualitative data analysis software. Thematic analysis enabled an iterative process of engagement with the data through familiarisation by repeatedly listening to recordings and comparing with transcripts, generating initial codes and organizing data excerpts within NVivo, searching for and identifying themes, reviewing, defining and naming themes, before producing the final report.

Although they did not emerge as a useful strategy for increasing participation, the semi-structured interviews confirmed the themes generated by the focus groups and proved to be a valuable source of data triangulation ( Carter et al., 2014 ).

A high level of consensus was reached by the third focus group. Although data saturation may have occurred, data collection continued until everyone who had expressed an interest in participating had been given the opportunity to share their views. No new themes emerged in the subsequent data collection.

LT’s experience as a CRNurse and her developing knowledge and expertise in this area has contributed to the development of concepts, subsequently informing the study design and conduct. These experiences have stimulated a strong commitment to objectively exploring the subject and have subsequently fostered a level of trust and credibility with participants, meaning they were comfortable with LT’s motivations as a researcher. Data verification was sought from LR, via regular discussions throughout the data collection and analysis process.

A post-data-collection feedback workshop was undertaken to present results and provide opportunities for staff to discuss their implications and plan actions. This was well attended by original participants, other CRNurses who were unable to contribute to the original data collection and allied health professionals with an interest in the work. Outputs from the workshop confirmed the themes emerging were an accurate and relevant reflection of the content of sessions, and it emerged that they were also reflective of experiences of those who were not present at data collection, adding further validity to the themes.

Of the 108 staff invited, 47 responded to the initial email invitation: 27 went on to participate, through seven focus groups and two one-to-one interviews. Non-participation resulted from work pressures, sickness, annual leave, leaving post or conflicting patient visits. Focus groups and interviews comprised of CRNurses working in a variety of practice settings across the organisation, from ward-like clinical research units to independent specialty teams operating out of offices.

The framework presented in Figure 1 illustrates the complex interplay between personal attributes, organisational culture, national priorities and strategic direction in clinical research delivery. Preliminary data analysis generated over 80 initial ‘nodes’ within NVivo. These were refined, combined and eventually translated into two overarching themes and seven sub-themes:

• 1. The individual:
•   1.1. prior experience and personal attributes;
•   1.2. the patient;
•   1.3. the role.
• 2. The organisation
•   2.1. communication;
•   2.2. feeding the machine;
•   2.3. structure and teams;
•   2.4. the reality.

Theoretical framework.

These themes and subthemes form the basis of our presentation of the qualitative findings. We will demonstrate how a focus on leadership at an individual and organisational level has the potential to enhance our understanding of the experiences of the CRNurse, shifting the emphasis towards the development of support strategies to overcome the challenges associated with clinical research delivery.

The individual

Experiences of the CRNurse role are impacted by the individual in the post. Intrinsic individual factors may explain why some CRNurses react differently to others with the challenges and complexity of the role.

I think for some people, their personality is better to deal with that [negativity from other staff] in research … other staff might not be as resilient to put up with things like that. It’s another stress in the day isn’t it I suppose … (IP2)

Prior experience and personal attributes

The importance of ‘know-how’ was debated. Narratives varied depending on whether participants had prior experiences of delivering research or knowledge of the CRNurse role. Prior knowledge of the specialty, or familiarity with staff in that area made a difference.

it probably makes the job a little bit easier initially if you know a little of the terminology about the specialty. Maybe know some of the doctors, or some of the team already. (P6FG1)

It was agreed that experience of delivering research is hard to come by and this is often the main element of know-how in the role that needs to be developed for the new CRNurse. However, if the CRNurse is coming into post as a research novice and also picking up an unfamiliar clinical specialty, this is particularly challenging. One participant (P3FG7) described this as ‘coming in with two hands [tied] behind your back’.

There was a lack of uniformity in the approach to inductions across the teams. As this became apparent it led to various debates with mixed views about what was important and how it should be developed. This suggests role transition and induction is critically important.

I have been in this post a year and have only just got to feel like I’m starting to get a handle on it. There’s still lots I don’t know … (P1FG7)

Despite the challenges described, participants recognised the value of their role and were keen to express the positive elements that they feel are little known.

And actually, it’s a privilege isn’t it, and I didn’t realise, the privilege, and actually, these patients want to be here … I enjoy coming to work so much more … I didn’t think that would have been as big a thing to me. I just thought it would be a job, I feel if people knew this, more people would want to work in research. (P7 FG1)

The patient

The nurse–patient relationship was a prominent and positive element of individual narratives, providing them with familiarity with previous nursing roles, as well as a close holistic nurse-patient relationship.

You feel you are doing something good towards improving nursing and treatments for patients which is why a lot of patients seem to want to be on studies and I think that it feels good to be able to contribute to that. (IP2)

CRNurses consistently described themselves as advocates for patients. Although this sometimes led to conflict with medical PIs, they expressed a clear vision of their role and positive contribution to the patient pathway. They described knowing instinctively when it was or was not appropriate to approach patients. Experiences of receiving informed consent and conducting research in areas where there were little or no other treatment options left were discussed. Whilst posing challenges around timing, appropriateness of approach and patient priorities during difficult times, CRNs felt offering hope through research participation was important.

Maybe it’s like a, you know that gut feeling isn’t it. It’s hard to describe … We’ve had patients that have signed up for an early phase study and yes, they understood the information and signed the consent form but talking to them, I was like, this patient doesn’t want to do this study. And then I had to go back to the consultant and say, this is just not sitting right with me … (P1FG5)

Some CRNurses described a reduction in patient contact resulting from moving into a research post, however this was not the case in every area.

I personally don’t have as much contact with patients and people have found that quite challenging and they still want to keep their hand in and in some studies you do, you have a lot of contact but some you don’t, and I think that is probably one of the biggest things you have to find out straightaway that you are not going to be over bothered by the amount of contact that you have with patients. (P3FG5)

CRNurses described the positives of having time to spend with patients. They sympathised with their non-research counterparts expressing how limited quality time with patients can be in areas outside of research.

I think that is the main thing that I get from the job, especially the older population, I love just going and chatting to them. Having the time, whereas normally when I’m on the ward you can’t because there’s either a buzzer or someone wants tablets, there is always something going on. (P4FG5)

The range of ways CRNurses deal with the role as individuals depends on numerous factors. This impacts on experiences, thoughts, mind-set, job satisfaction and intention to remain in post. The consensus was that the CRNurse should feel positive about the specialty they are practising in and the job itself should be intrinsically motivating. If this is not the case it can impact on morale and mind-set, ultimately affecting study delivery.

Factors such as the type of study, its design, sponsor and complexity were important and there was a mixture of opinions about the value of commercial versus academic research. Some participants preferred commercial studies:

I love commercial studies … I just feel it is a lot more professional, I feel they are run better, I feel like the protocols are more in depth, more detailed, I feel like academic protocols are rushed to a degree. I’m not saying that academic you know, there’s a place for it. But as a nurse, when I get an academic study, I’m like oh, nightmare. (P7FG1)

Others preferred academic work, and expressed frustration at aspects of commercial trial delivery:

I think commercially … when they’re writing them, they have no idea what happens in clinical practice … I think generally they don’t consider that there’s clinical things going on, everything just has to be done, they’re very narrow-thinkers. (P4FG1)

Individual capacity and capability were debated, along with the challenges of measuring workload, intensity, and when to decline studies. There was agreement that what one person may find challenging and exciting, another may find stressful and overwhelming. The support received in day-to-day practice varied, and a feeling of responsibility and lack of ability to hand over caused tension for some. Some individuals valued the autonomy and associated ownership of their studies, including a sense of achievement in delivering it successfully.

That’s what I found really difficult coming to the role. Knowing that there wasn’t another shift coming after me … knowing that there is not another team coming on after, you know, and having to get everything organised weeks in advance, like really forward planning for your patients. I found that really difficult. And managing my own time is, difficult. (P1FG5)

There was a passion for attracting others into CRNurse roles, and participants debated how to inspire others to consider trying research nursing. There was an appetite to raise awareness of the role with other nurses to help them understand the role. Offering student placements was particularly positive for those who had the opportunity to do so, recognising the value of the opportunity to inspire the next generation.

it’s about being quite outgoing and upfront about what you are doing and talking to people and just getting integrated … I think, you know, they’re introducing students into research I think that might help as well. (P4FG1)

The organisation

There was an understanding that healthcare is complex, with numerous priorities and strategies that CRNurse teams and individuals contribute to. In research these can sometimes feel more complex because of the increased number of external stakeholders, and the link to other national priorities.

Communication

Communication discussions focused on dialogue between the CRNurse and the Medical PI.

I think some of them do it because they maybe feel they should do be doing it, rather than actually being enthusiastic about it. The consultant we are talking about, I don’t know why they chose the two studies because they’re not interested in them really. It is almost like a pain. You are a nuisance, to ask them to sign this, or see the patient. (P1FG4)

Communication was discussed in relation to the individual teams, external study teams and the wider organisation.

I tried to go to one of those specialist nurse groups and I felt absolutely out of place. And I thought, well I shouldn’t, because we should be here but I did feel I didn’t belong there really … I don’t know I think I was probably the only CRNurse. (P1FG4)

Internal meetings and the tone of communication was raised by the majority of participants.

It’s about perspective, we can come out of a meeting and feel that we’ve been absolutely flogged because we are not meeting targets, but then you look and we are at the top … It’s not reflected in the culture, it’s just ‘duf duf duf’ [gestures towards pressure]. (P1FG6)

Feeding the machine

One message that was clearly identified throughout the study was around funding and targets. ‘Feeding the machine’ was a poignant description to make sense of the challenges the CRNurse workforce experiences, with messages of reduced funding and the pressure to deliver every study successfully to time and target.

It is, it’s all about targets isn’t it – meeting targets and if you don’t then heaven help you. (P2FG6)

Concerns around job security were shared. These were identified as a new feeling in comparison to working on a ward, as discussions about funding repeatedly linked patient recruitment to funding for posts.

But you also get told well numbers are jobs. So, we need to keep our accruals up or we lose funding and then that will be somebody leaving. You know, you do get told that. (P1FG4)

Despite such observations, some teams admitted to enjoying, even thriving on a little healthy competition.

I must admit, I think I am a little bit target driven. I quite enjoy it to an extent actually … they are not such a bad thing because there is something to aim for … (P1FG6)

Structure and teams

Structure and team working impacted on experiences. Working across specialties was described as less positive than a focused approach. Participants acknowledged that this was necessary to enable effective delivery of the wide range of studies across different clinical areas in the context of a limited research delivery workforce. They also recognised the resulting opportunities to enhance skills development and the potential to support colleagues in other teams, though this approach to working introduced competing priorities.

You were just trying to spread yourself too thinly … you were working with different PI’s who wanted to see patients on the same day at the same time and you couldn’t … (P1FG3)

Those working in areas with limited contact with their clinical counterparts felt isolated, describing the challenges of motivating teams to support their roles.

So I think we are a product of our own success in that we have managed to successfully separate research and deliver research in parallel to the clinical service, but it’s not embedded in the clinical service because you’ve got a whole separate research department and so the clinical staff can now think oh no that’s for the research department … (P1FG6)

Those who were more embedded clinically either through where they were based geographically or through their specific role, reported more positive experiences.

I prefer and I would suggest the reason I get so much out of my job is because I feel part of the directorate, the clinical directorate … I like being part of that … (IP)

The reality

The reality of operating within the organisation varied across the teams and individuals. Visibility and awareness of the role outside of research was linked with communication, structures and teams, and it also linked back to individual attributes.

I think a lot of people don’t know what we do and don’t understand that all the current drives that research should be an option for all patients and that it’s actually good for patients and it can benefit them … I think they don’t realise that being nicer to us and allowing us to get access to the patients would actually be them supporting their patients … (IP)

Access to space and facilities varied across the teams.

I mean one of the pressures we have at the minute is that we do not have a designated area to see our patients so we go down to out-patients and you are not stressing about whether the patient’s going to go in [the study] or not you are stressing about whether you are going to have a room. (P1FG3)

Others described a feeling of isolation in terms of where they were based geographically, and a struggle to be accepted into the clinical areas they needed to access to be able to undertake their patient visits.

We are the last in the pecking order of who needs to see. When I am waiting to see somebody in clinic … the dietician is free now so they will just pinch them. So I will wait, and they will come out of the dietician and the psychologist is waiting … and then before you know it you’ve been waiting there an hour to see somebody, and they want to go then because they’ve been there for that long [laughs]. Because there was nowhere for you to go and you always felt the clinical need to go and see somebody was greater than yours. (P3FG5)

There was talk of emotional labour, making an extra effort to be welcomed into the area or allowed space to practise.

I’ve gone back to being a second class citizen in the Trust, so I feel that quite a lot, I feel like I have to justify what I do. (P6FG1)

There were excellent examples of work going on to raise awareness and visibility of the CRNurse contribution to the patient pathway. Posters, information boards, staff presentations, research champions and linking in with multi-disciplinary meetings were described. These activities and the impact of them weren’t shared widely, and those attending the focus groups seemed to learn from the experience, taking practical strategies away with them to try.

On each ward there’s somebody allocated, and they will come to a meeting so many times a year where we tell them a little bit about research, about things we have to do and a bit about the studies that again is relevant to their ward … There’s posters on every ward, again it’s a directorate thing, they want very much to integrate research and the directorate stuff … (P4FG1)

The findings illustrated above indicate a complex blend of factors with the potential to impact on successful research delivery. These factors arise from a combination of interplay between the personal attributes of CRNurses, their experiences and behaviours and how they are impacted by and can equally impact on organisational culture and national priorities. This combination of factors and a focus on self-leadership and organisational culture has the potential to contribute to the dialogue on challenges in clinical research delivery and should be considered by policy makers and organisational leads.

The King’s Fund (2011) acknowledges high levels of complexity and debate related to the many definitions of leadership and its impact.

Historically, leadership has been described and interpreted in a positive manner:

Leadership is interpersonal influence, exercised in a situation, and directed, through the communication process, toward the attainment of a specified goal or goals ( Tannenbaum et al., 1961 ).

In its most basic form, however, leadership is derived from individual approaches to influencing, in order to modify the behaviours of others towards a specific goal, agenda or outcome. Zalenik (1992) captures the essence of leadership as follows:

Leadership requires using power to influence the thoughts and actions of other people.

An increased focus on leadership in recent years, has led to improved awareness of how individual behaviours can impact on performance and experiences, ultimately translating into the quality of outcomes, whether for individual consumers or businesses as a whole ( Blanchard, 2010 ; Goleman, 2013 ; Kouzes and Posner, 2012 ; Sinek, 2014 ; Yukl, 2013 ).

The findings from the present study describe intrinsic feelings, perceptions and motivators that have the potential to impact on actions and reactions to events, pressures and expectations placed on individuals to varying degrees. These intrinsic factors are often described through psychological trait theory, which is reported to influence how we act in addition to situational factors such as learned behaviours, lived experiences and social interactions. This results in what is described as self-leadership ( Goleman, 2013 ; Northouse, 2013 ).

Trait theory historically indicates that the majority of intrinsic characteristics are relatively fixed, with limited scope for development; however, behavioural research has increasingly identified that individuals have the capacity for development and change through increased self-awareness ( Northouse, 2013 ). Increased self-awareness, understanding the relevance of prior experiences and knowledge, in addition to greater awareness of the CRNurse role prior to being appointed, could assist in recruitment and selection for posts, improve experiences of role transition and enhance performance within the role.

The suggestion that some nurses are more suited to research delivery posts than others and the individual nature of how one person’s ability to ‘cope’ with the complexities of the role differ to another, relate to the concept of resilience. This is the subject of increasing debate in healthcare at present. Whilst implementing strategies to enhance personal resilience may assist individuals in dealing with the challenges they face, the very concept of resilience is argued to foster a submissive mindset, placing responsibility for coping with adversity in the hands of the individual rather than enabling action to explore the core of the issues and identify what support is required ( Traynor, 2017 , 2018 ).

Intrinsic issues are also associated with professional identity; a broad term emerging from our previous study, described as a continuing process of development affected by numerous social interactions and environmental factors ( Franco and Tavares, 2013 ; Workman and Pickard, 2008 ). A positive professional identity is fundamental to performance, impacting on patient care, job satisfaction and decisions to remain in a particular post ( Cowin et al., 2008 ; Kunhunny and Salmon, 2017 ). Professional identity in clinical research nursing is under-researched, and the results of this study suggest a positive, embedded organisational research culture, is a key mediator of a positive professional identity.

The experiences described by participants in relation to organisational challenges, indicate an increasing level of discomfort with the current target-based culture in research delivery, and whilst CRNurses were able to articulate the relevance of targets, they were negatively impacted by the focus on funding linked to those targets. This left them feeling there was limited focus on improved patient outcomes and the value and benefit of research participation for patients.

The Nuffield Trust (2015 ) identified funding crises, NHS management and culture, and the effectiveness of performance targets as priorities for the Government to address. Re-connecting with the core NHS workforce to improve engagement and empowerment, and implementing successful workforce development and planning, were also key priorities, however, growing workloads and staff shortages underline the current pressure on the NHS workforce, impacting staff morale ( The King’s Fund, 2017 ).

Whilst the research arena has historically been less affected by funding crises, the issues described above are increasingly evident, and equally important, and the majority of participants acknowledged this. Difficulties meeting trial recruitment targets, combined with the threat of funding reductions based on reduced activity, may have affected the morale of CRNurses ( Tinkler et al., 2018 ). Reduced morale across the NHS may also have potentially contributed to disconnection between CRNurse teams and their wider organisational colleagues.

Organisational and team-focused research predominates the healthcare leadership literature, with a focus on collective and multilevel models to define the most effective approaches to leadership (Yukl, 2013; MacPhee et al., 2013 ). Increased performance and safer care are synonymous with satisfied and contented teams and a recent shift in leadership culture within the NHS has identified increasingly that a top-down approach results in disengaged staff, ultimately leading to poorer standards of care ( The King’s Fund, 2011 , 2012 ; Turnbull James, 2011 ; West, 2012 ). Turnbull James (2011) also identified that it is vital to engage and empower staff to recognise the importance of their unique contribution in the provision of high-quality care. This is as important in research delivery as any other sphere of healthcare delivery.

Healthcare priorities are driven by various national and government strategies influencing and directing every element of practice. The NIHR was established in the UK through one such government strategy ( Department of Health, 2006 ). The seven high-level objectives (HLOs) from the NIHR influence practice and performance in research delivery in the UK. The general tone of these HLOs is about increasing numbers of patients into studies and reducing the time taken to achieve this. The core foundations of these high-level objectives are with patients in mind, in being able to prevent ill health, improve diagnosis and offer better treatments more readily ( NHS England, 2014 , 2016 ). Funding is also a key foundation of the HLOs aimed at improving the UK’s reputation as a setting for research ( Department of Health, 2017 ; NHS England, 2013 ). As identified by the participants in this study, the tone of the message from national strategies and how those messages are translated into practice have the potential to affect organisational culture, which mediates individual experiences as professionals operating at the frontline.

‘The NHS Long Term Plan’, launched in January of 2019 articulates the clear necessity for change in the health service, including a commitment to release pressure at the frontline whilst capitalising on the medical advances we currently benefit from. The plan commits to increased funding to support staff whilst continuing to sustain and further develop a vibrant life sciences sector ( NHS England, 2019a ).

The subsequent launch of ‘The NHS Interim People Plan’ built on the commitments of this through dedicating a strategy to improving the leadership culture, tackling the nursing workforce challenges we currently see and making the NHS the best place to work ( NHS England, 2019b ). By harnessing the recommendations in this plan there is scope to further influence the Clinical Research Nursing agenda through improving awareness and attitudes towards research, whilst working to address some of the unhelpful behaviours that have impacted on relationships, experiences and productivity in the research area.

The framework and results presented in this paper provide a valuable contribution to the evidence base in this under-represented area, with the potential to influence policy and practice in relation to clinical research delivery. It highlights the numerous factors that have the potential to impact on the practice of CRNurses and introduces how they may subsequently affect how well research is delivered. Themes emerging from this piece of work build on previous work and confirm that there is transferability between areas of practice and types of organisation.

A focus on self-leadership and organisational culture, whilst positioning the discussion within the context of the wider health service and national priorities provides a context for the issues described and shifts dialogue towards increased focus on approaches to communication, awareness, visibility and support mechanisms to inform policy and practice and overcome challenges associated with clinical research delivery.

The challenges described also suggest there is further engagement work to do to improve understanding of the importance of the CRNurse role in the patient pathway. Within its recently launched CRNurse strategy (2017–20), clear recognition of CRNurses, and their unique role in the delivery of quality clinical research care was identified as key to achieving the NIHR mission. Increasing the understanding of the experiences and perceptions of the CRNurse is essential to address the barriers to research delivery and increase awareness and understanding of the role of the CRNurse and associated challenges.

The following key points have been generated from this study:

• This study contributes to the increasing literature indicating that work to deliver research in the clinical environment is complex and that CRNursing roles are often poorly understood outside of research delivery teams
• Exploring the experiences and perceptions of CRNurses is increasingly highlighting important and inherently complex factors related to successful research delivery. This approach should be further developed to fully understand the issues and influence policy in relation to organisation of the workforce
• This study adds new knowledge in relation to the finding that research delivery relies on a complex, multi-faceted range of factors originating from individual clinical research nurses and the organisations in which they operate. This is mediated by the context of national drivers and strategies influencing their work and this should be considered in relation to the wider NHS workforce
• The concept of leadership is a useful frame in which to situate the challenges associated with clinical research delivery. This has the potential to facilitate a broader dialogue on the subject and increases the potential for developing appropriate support mechanisms to address the barriers, whilst maximising the facilitators to clinical research delivery

Limitations

Although data were collected in a single organisation the findings were consistent with previous and other emerging research.

It became apparent during the recruitment process that the agreed approach to sampling staff had not been followed by all team leads. Some expressed discomfort with the email approach and therefore did not send emails to their teams. Instead they made Participant Information Leaflets available to staff through placing them at the nurses’ station. At this time, it is not possible to say with certainty whether all CRNurses were given the opportunity to participate, or whether they felt able to do so confidentially, due to this unforeseen change to the sampling process.

Key points for policy, practice and/or research

• Consideration should be given to the relevance of strategies to increase personal resilience and consider where these may assist in addressing the challenges identified.
• Work should be undertaken to improve the induction process and more broadly improve the organisational support offered to CRNurses in the delivery of their roles.
• The utility of the target-based culture in the NHS should be explored further, more specifically in relation to where this may be impacting on clinical research delivery roles.
• Further exploration of the utility of the NIHR HLOs should be considered, including how they may be adapted to reduce the focus on recruitment to time and target and include metrics measuring the impact of research, dissemination and knowledge transfer and real impact on health inequalities and unwarranted variations in care.
• The interface between the CRNurse role and their multiprofessional colleagues from the perspective of those colleagues could be investigated to enable enhanced understanding of their needs in relation to supporting the delivery of research and the opportunities for patients in their care to participate in research.

Acknowledgements

The lead author would like to thank Aileen Burn, Matron for Clinical Research Delivery at Newcastle upon Tyne Hospitals NHS Foundation Trust.

Linda Tinkler is the Trust Lead for Nursing, Midwifery and Allied Health Professionals Research at Newcastle upon Tyne Hospitals NHS Foundation Trust. Linda's role involves leading and implementing research specific strategies, policies and initiatives on behalf of the Executive Chief Nurse team. This includes building research capacity and capability to enable staff in the NMAHP disciplines to develop along the research continuum from research awareness to research leadership. Linda's own research interests include leadership culture in the NHS and the interface between Clinical Research Delivery and Clinical Practice. She is currently undertaking a PhD through a Royal College of Nursing Strategic Research Alliance with the University of Sheffield, is a Florence Nightingale Leadership Scholar and an NIHR 70@70 Senior Nurse Research Leader.

Lisa Robinson is currently employed as Consultant Allied Health Professional – Major Trauma Rehabilitation. Her clinical and research interests are informed by four key areas: improving healthcare organization and delivery; improving patient experience and outcomes; advancing complex interventions research methods in a rehabilitation setting; and workforce development and professional learning in the nursing, midwifery and allied health professions, with a particular emphasis on building research capacity and capability.

Contributor Information

Linda Tinkler, Trust Lead, Nursing, Midwifery and AHP Research, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.

Lisa Robinson, Consultant Allied Health Professional, Major Trauma Rehabillitation Department, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK.

Declaration of conflicting interest

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The study was assessed and approved through the UK Health Research Authority (HRA: 17/HRA/0125), and capacity and capability to participate was confirmed by the sponsor/host organisation. The study did not require full Research Ethics Committee approval due to the involvement of NHS staff members only. Participants provided written informed consent prior to data collection.

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Study funding was awarded to the lead author through a competitive process by Newcastle upon Tyne Hospitals NHS Foundation Trust, utilising NIHR Research Capability Funding (Ref. No. 1617-039).

Linda Tinkler https://orcid.org/0000-0003-3052-0640

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