IN 2007 I joined a GP surgery in Dudley already established in teaching and training, and as a young partner I was keen to bring something new to the practice. We regularly received a newsletter from the local Clinical Research Network (CRN) hosted at the University of Birmingham, detailing research studies being run in primary care and recruiting GP practices to take part. The CRN is part of the National Institute of Health Research (NIHR), which is considered the ‘research arm’ of the NHS.
I contacted the CRN for further information and we were visited by two of their ‘research facilitators’ who explained what was involved and provided us with details of studies considered suitable for a practice with no research experience. We felt that getting involved in primary care research could benefit the practice by giving our patients the opportunity to partake in research relevant to them, which could potentially bring about benefits to their care.
We were encouraged to undertake training in Good Clinical Practice (GCP), which is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected, and is a requirement of the Research Governance Framework for Health and Social Care (2005) which covers all research in the NHS in England. The NIHR offers GCP training either as a face-to-face workshop, or as an online module.
The first study we joined was the 3C cough study which recruited patients presenting with an acute cough. The study involved asking a few questions about presenting symptoms, recording a detailed examination, and then undertaking a follow-up ‘notes review’ which was conducted by our practice nurse or healthcare assistant one month after initial attendance, detailing what had happened to the patient in the interim (e.g. recovered, admitted, referred, died or not returned).
Within a few weeks we were up and running with the study and the partners and GP registrars were recruiting patients into the trial. With an autumn start, the timing was perfect and our acute cough presentations generated practice income in the region of £30 per patient recruited. By the end of the recruitment period we had consented 117 patients, second highest in the West Midlands, and the study team reached their 30,000 recruit target overall.
The patients enjoyed being given a little extra time in consultations and asked more detailed questions, and the staff felt increasingly skilled in managing this particular clinical area.
So we took on other studies involving conditions including cancer, atrial fibrillation, chronic obstructive pulmonary disease (COPD), gout, heart disease, Helicobacter pylori infection and smoking cessation. Taking part in these studies meant that some of our patients were given access to novel treatments and received more intensive monitoring and review, as well as accessing additional support in managing their chronic conditions and generally enjoying the ‘altruism’ of giving something back to the NHS. As clinicians, we valued learning more about the conditions, gaining an understanding of how research is carried out and being able to add something different into our annual appraisal documentation. Income generated from our involvement was invested back into the practice, allowing for additional staff training and support.
The support that we received from our local CRN team was fantastic, and they would frequently pre-select us, knowing that we would recruit well into their studies. We subsequently completed the Royal College of General Practitioners’ (RCGP) Research Ready accreditation, which is a framework to ensure practices run research in accordance with correct clinical and legal frameworks (including contacting indemnity providers to ensure this is in place, and notifying the Information Commissioner’s Office).
Our participation also paid off in our Care Quality Commission (CQC) practice inspection, where we were able to demonstrate how research benefited patients and contributed to continuous quality improvement (QI). For example, the FAST study (Febuoxstat versus Allopurinol Streamline Trial) improved the management of our patients with gout by optimising urate-lowering therapy for them. Another study, the ‘TargetCOPD2’ trial, invited current and ex-smokers into the practice for lung function testing, resulting in a rise in recorded COPD prevalence with the associated benefits for patients previously not known to be suffering from the condition – the so-called ‘missing millions’. We achieved an overall ‘outstanding’ rating from the CQC, with specific mention of our research activity in the report.
Several years on from that first study, we now participate in approximately five studies per year and have just taken on our first commercial research study, partnering with a major pharmaceutical company. The work required in a commerical study is more detailed and intensive and, again, the support we have recieived from the CRN has been invaluable.
Fortunately we have not experienced any difficulties with our research activity, but we have been careful to ensure that our clinical coding and records are kept up-to-date, and we screen every list of patients generated by the research ‘searches’ to ensure we don’t contact anyone recently bereaved or with a recent significant diagnosis, where it may be felt inappropriate to invite them at this particular time.
Many practices have also been concerned about the impact of the General Data Protection Regulation (GDPR) and how this may affect the way in which patients are invited into studies. Is individual patient consent now required to participate? The Health Research Authority (HRA) are due to issue further specific guidance on this, but it is hoped that very little will change in practice and patients can be recruited as before. Article 9 of the GDPR provides exemptions for research carried out in the public health interest, or in helping the NHS carry out its statutory duty to ‘inform patients of research studies in which they may be eligible to participate’ (NHS Constitution 2015). Practices are encouraged to use posters, leaflets and notices on their website and new patient forms to inform patients that the practice is ‘research active’ and where they can find out more information about what this means, and how to ‘opt out’ should they wish to (NHS Digital’s national data opt-out system came into effect 25 May).
I now work directly for the CRN as a Primary Care Research Lead and have clinical oversight of delivery of research studies taking place in Birmingham and the Black Country. About 45 per cent of our GP surgeries are ‘research active’, and with more GPs taking on portfolio roles and looking for other interests, research delivery can provide opportunities. The CRN is adapting its support model for primary care, taking account of changes such as the formation of large super-partnerships, federations, vanguards and other ‘new care models’. Working at scale is likely to have benefits for research activity in primary care, hopefully giving more patients the opportunity to be involved in research studies.
Involvement with research benefits patients, doctors and other practice staff and is generally very easy to undertake with limited time resource and the support of a local CRN team. It’s also academically satisfying and provides relief from the demands of the day job – and, on the whole, patients are happy to take part.
Dr David Shukla is a GP Partner at Eve Hill Medical Practice in Dudley, Clinical Research Specialty Lead for Primary Care in the West Midlands and Clinical Research Fellow at the University of Birmingham’s Institute for Applied Health Research