Clinical research for GPNs

Research is about asking questions, gathering evidence and drawing a conclusion. Without it, we will have nothing more to offer our patients tomorrow than we do today. But is research the province solely of academics in ivory towers – or is it something that practice nurses can get involved in?

Our nursing role is underpinned by a plethora of evidence-based guidance to support best practice, fundamental to the standards of the NMC Code. We only have to look at how healthcare has changed since the birth of the NHS in 1948, and indeed how general practice nursing has changed in the last 30 years or so, to see the enormous clinical improvements and positive impact on health in that time. And it hasn’t just been a happy accident: the continuous advances in the care that we provide within the NHS are a result of continually evolving evidence – evidence that has been gained through innovation and research.

We are blessed with a whole library of guidance from a variety of sources, to support our day to day decisions, such as the National Institute for Health and Care Excellence (NICE), The Scottish Intercollegiate Guidelines Network (SIGN), National Travel Health Network and Centre (NaTHNaC), the Faculty of Sexual and Reproductive Health (FSRH) to name but a few. Furthermore, we are supported by local guidance and recommendations for best practice published in professional journals. Research also enhances the support available to patients through publications and online resources from organisations and registered charities heavily involved in research such as The British Heart Foundation, Crohn’s and Colitis UK and Epilepsy Action, among many others.

The advances we see in our daily clinical practice such as the range of inhaler devices we can offer patients; the processes in cervical screening; the dressings we choose for wound care and the options for diabetes medication we offer our patients – these have all come about through research. But who does this research? Does it feel like it’s out of our reach and it’s something that is only done ‘out there’ through Universities, regional hospitals, high profile charities or the big pharmaceutical companies? Or maybe you are already in a research-active practice and Primary Care Research is thoroughly embedded into your professional life?

THE STRUCTURE OF RESEARCH IN THE NHS

Research is at the heart of the NHS and is one of the seven key principles of the NHS Constitution for England.¹ Fully integrating research into the NHS is vital to continue to improve the health of our population, not just today but for future generations by improving the quality of the care we give and transforming the services we provide across our four nations. The National Institute for Health Research (NIHR), funded by the Department of Health and Social care, is the largest funder of health and care research in the UK, and its mission is to improve the health and wealth of the nation through research. In England, the NIHR Clinical Research Network, made up of 15 Local Clinical Research Networks (CRNs) across the country, provides the infrastructure to support the delivery of high-quality research within the NHS and that includes primary care. In 2018-19, the NIHR Network recruited 870,250 participants across over 6,000 high quality clinical research studies on the NIHR portfolio right across the whole of the NHS. The goal is to involve one million participants by 2023-24.^3,4

The NHS Long Term Plan, published in 2019, demonstrates the commitment by the NHS to research, and champions the outstanding capacity the UK has for innovation and research. In terms of the huge benefits to patients, the plan specifically highlights the consequences of such innovation and research, including:

• Earlier diagnosis
• Preventing ill-health
• Offering more effective treatments
• Better patient outcomes
• Faster recovery⁴

The UK Framework for Health and Social Care Research 2017, which sets out the principles of the management and conduct of good practice of health and social care research in the UK, defines research as: ‘the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods.’5 Research is about asking questions, gathering robust evidence and drawing a conclusion. Without asking these questions, we will have nothing more to offer our patients tomorrow than we do today.

RESEARCH IN PRIMARY CARE

The evidence base for primary care practice is building year upon year with an increasing number of studies delivered through general practice. In 2018-19, 160,146 patients were recruited to research studies in primary care, and that number is rising.⁶ These are studies where academics and primary care clinicians combine forces to implement relevant high quality cutting-edge research, studies which will ultimately have a significant impact on the care we provide our patients in the future through innovation. Research in primary care is growing – now that’s exciting.

General practice is the first point of contact for the majority of patients – the ‘front door’ of the NHS. In England, over 300 million consultations are provided in general practice each year.⁷ This means there is a huge pool of potential participants throughout the country to invite to take part in research. So what sort of research is actually being undertaken in in our practices? Essentially, it focuses on the following main areas:

• Promoting healthier lifestyles
• Improving diagnosis
• Managing long term conditions
• Preventing future ill-health
• Treating common conditions
• Preventing disease

Studies that address these areas are conducted in many ways. It may be quantitative research, a study that seeks to prove a hypothesis and collects data in a structured and pre-defined manner. On the other hand, the researchers may be seeking to prove an understanding of experience through qualitative research, such as how it feels for a patient to live with a life-limiting illness. The study may require the participant to complete questionnaires, undertake cognitive testing or carry out online activities. It may be that the researchers are observing lifestyle behaviour. Alternatively, a patient enrolled on to a study may be participating in a clinical drug trial (Clinical Trials of Investigational Medicinal Products [CTIMPS]), taking part in an innovative invasive procedure or even undergoing genetic testing. Researchers may be looking at a specific disease area, a particular aspect of a long term condition or diagnosis, or they may wish to recruit ‘healthy volunteers’. Again, patient involvement will vary depending on the type of study – it may be just a one-off visit to the practice or completing a paper or online questionnaire at home or, at the other end of the scale, it may be a study requiring several visits to the practice research team over a number of years.

Practice nurses are in a prime position to be directly involved in research within their practices. Research is a speciality that complements the GPN’s professional work. It enables the development of new skills and opportunities, and gives GPNs exposure to the latest ideas and evidence to support clinical decision-making, and allows us to be a part of future change in the NHS.

GOOD CLINICAL PRACTICE

So, what training do we need to do to enable us to embark on research within our practice? Three words: Good Clinical Practice (GCP). Crucial to any research is the protection of the rights and dignity of the people – the participants – who take part. The Declaration of Helsinki of 1964 is considered the cornerstone document on human ethics and forms the basis of the ethical principles that underline Good Clinical Practice Guidelines for Research.⁸ The International Conference on Harmonisation Good Clinical Practice Guideline (ICH GCP) is the ‘international ethical, scientific and practical standard to which all clinical research is conducted’.⁸ The fundamental ethical principles of GCP are to ensure that the rights, safety and wellbeing of research participants are safeguarded above the interest of science and society, and that the quality of the data is scientifically sound and reliable. All studies should be conducted in compliance with the study protocol – the document that describes every step of how the trial is conducted – which has received ethical and regulatory approval, and in accordance with the relevant legislation and statutory regulations.⁵ The protocol ensures the integrity and quality of the study is maintained and that all data collected are handled and stored in such a way to allow for accurate reporting, interpretation and verification. Health professionals involved in any clinical trial must therefore be competent to undertake the specific tasks involved. GCP training, and the application and compliance of its principles, therefore underpins the conduct of all research (Box 1).

PATIENT INVOLVEMENT IN RESEARCH

Patients may be involved in research through specific invitations for a particular study from their practice or a research study team, or they may access studies directly through the NIHR ‘Be Part of Research’ initiative, or via organisations such as Asthma UK, Diabetes UK and Join Dementia Research (Box 2). Promoting research opportunities in your practice creates a research-positive ethos and awareness, as well as encouraging patients to think about becoming involved. Using ‘Research Active’ posters, advertising research on waiting room digital displays and offering leaflets are all ways of getting the research message across.

Patients who meet the specific criteria for a particular study and who would like to take part need to give their consent to do so. Informed consent is the process of learning all the key facts about a study before the patient is able to decide whether or not they wish to participate. Giving consent must be within GCP principles and essentially a potential participant must:

• Be fully informed as to the nature of the study and what they are consenting to
• Understand that taking part in a research study is entirely voluntary
• Be given the opportunity to ask questions about the study
• Know what personal information is going to be used and how it is going to be accessed, stored and kept safe within GDPR principles
• Have the capacity to give consent
• Be aware that giving consent is a continuing process throughout the study, and
• Understand that they have the right to withdraw from the study at any time without recrimination.

Patients who chose to take part in research do so for many reasons (Box 3). The NIHR Patient Research Experience Survey monitors the feedback from patients who have taken part in research. The response is hugely positive, with 90% of patients who responded to the NIHR last year reporting that they had a positive experience of taking part in research.⁹ Clearly, participants enjoy the research process.

CHOOSING STUDIES

GPNs new to research may wonder where to begin. If your practice is keen to embark on research, the Local Clinical Research Network for each region will provide support and guidance and is your first port of call. They will advise which studies are currently open for recruitment and the funding structure involved. It is vital that as a Research Nurse you have a supportive team around you, from the GP who will take on the Principal Investigator role and lead the delivery of the study within the practice, through to administrative staff and reception teams who will support the whole process. Research is absolutely a team effort and everyone needs to play their part. There are many aspects to consider when choosing a study for your practice:

• Is it suitable for your patient demographic?
• Is it feasible and can you recruit patients?
• What is the practice involvement?
• What does the study entail?
• What type of study is it – for example is it postal, observational, interventional, commercial?
• What is the recruitment target?
• Is there any benefit to patients?
• How long does the study go on for?
• What support would you need?
• How much interest is there within your practice?
• What are the financial benefits?

Consider the structure and team members you have in place at your practice, how you can engage them in research, and decide whether a study is right for where you work and whether or not it is feasible. It is abundantly important for GPNS to establish what support is available to implement research in practice to ensure that studies are delivered to time and target.

GENERAL PRACTICE NURSES AND RESEARCH

There are often misconceptions and misunderstandings about what research in general practice actually entails. Research isn’t audit or undertaking a survey or evaluation of a process. It can be incorrectly seen as data processing or undertaking systematic reviews. Far from it. The role of a research nurse allows greater autonomy and responsibility; it develops relationships with the clinical research community and extends knowledge into specialist areas. GPNs who undertake research need to have a complete understanding of the research process and its application to each study, a determination to meet targets and have meticulous attention to detail. Communication, as ever, is absolutely key. Patient relationships are enhanced – research brings with it a different focus with the shared goal of seeking to improve future patient care. By embedding research into primary care, the GPN’s clinical and research roles can work together.

Undertaking research inevitably competes for our time and resources in our everyday practice but by doing so we are exposed to the latest evidence to support our clinical decisions and it challenges our practice and approach to the delivery of care. As NHS employees, we all have a shared responsibility to be part of research. Without high quality clinical research, without evidence to support our practice, without innovation, the NHS and the service and the care we provide for our patients is unable to grow. What better than to be at the grass roots of this research, this evidence, and to leave a legacy for our patients not just today but for future generations?

REFERENCES

1. Department of Health & Social Care. Guidance: The NHS Constitution for England. Updated 14 October 2015. https://www.gov.uk/government/publications/the-nhs-constitution-for-england/the-nhs-constitution-for-england

2. National Institute for Health Research. Our mission and strategic work streams. Not dated. https://www.nihr.ac.uk/about-us/

3. National Institute for Health Research. News: number of participants in NIHR-supported research exceeds one million for the first time. 22 October 2019. https://www.nihr.ac.uk/news/number-of-participants-in-nihr-supported-research-exceeds-one-million-for-the-first-time/22543

4. The NHS Long Term Plan; January 2019. https://www.longtermplan.nhs.uk/wp-content/uploads/2019/08/nhs-long-term-plan-version-1.2.pdf

5. Health Research Authority. UK Policy Framework for Health and Social Care Research; Updated March 2018. https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

6. National Institute for Health Research. Primary Care. https://www.nihr.ac.uk/explore-nihr/specialties/primary-care.htm

7. NHS. Next steps on the NHS five year forward view; 31 March 2017. www.england.nhs.uk/publication/next-steps-on-the-nhs-five-year-forward-view/

8. Good Clinical Practice (GCP) Reference Guide 2016 Version 3.1; August 2016. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf

9. National Institute for Health Research. Research participant experience survey; 2019. https://www.nihr.ac.uk/patients-carers-and-the-public/i-want-to-learn-about-research/research-participant-experience-survey.htm