We are actively supporting clinical research studies within primary care.
The NHS Constitution states that Research is a core function of the NHS. Clinical Research is a major driver of innovation and central to NHS practice for maintaining and developing high standards of patient care. Ultimately, clinical research means patients get access to new treatments, interventions and medicines. Investment in research means better, more cost effective care for patients.
National Institute for Health Research
In 2006, the Department of Health set up The National Institute for Health Research (NIHR) to improve the health and wealth of the nation through Research. The NIHR Clinical Research Network (CRN) was introduced to provide the infrastructure to the NHS to allow high quality research to be set up and delivered efficiently and effectively.
Mulberry House and St Denys Surgeries are part of a network of local practices participating in research activities under the banner of CRN Wessex. To find out more about the work of the NIHR Clinical Research Network go to www.crn.nihr.ac.uk
What is Primary Care Research?
The CRN Primary Care speciality works in collaboration with researchers and primary care practitioners such as GPs', practice nurses, pharmacists and dentists to promote the successful delivery of research studies in the NHS. A wide range of research studies are supported which look at:
- Promoting a healthier lifestyle
- Disease diagnosis and prevention
- Management of long-term illnesses such as diabetes or hypertension
- Prevention of future ill-health
- Treating common conditions such as tonsillitis or influenza
What are the Benefits of GP practices taking part in research?
- It offers patients access to new treatments
- It brings new dimension to practice and added skills to those involved
- It provides national gold standard training for research
- It offers mentorship and support to those involved in research within practice
How can you help and take part?
There are various ways a patient can become involved in studies at Mulberry House and St Denys Surgeries.
- A doctor or nurse may talk to you about a particular study and ask whether you would be interested in participating
- You may be sent information through the post if we feel you may be a suitable participant
- You may read information about a current study in the patient waiting room or on the surgery website and wish to take part by contacting your GP or the Research Nurse
All clinical research carried out at our surgeries is thoroughly checked and approved by ethical committees thus ensuring it is appropriate and safe to perform. Your participation is entirely voluntary and can be withdrawn by yourself at any time without any explanation required.
You are under no obligation to participate in any research project
Your care and your relationship with your doctor will not be affected in any way if you decided not to take part in a research study
You will always receive clear information about what taking part in a research study would involve. You will have the opportunity to ask questions and obtain further details about a study.
If you do agree to take part in a study, you will be asked to sign a consent form. This will clearly state which parts of your notes (if any) may be looked at for the purposes of the research study. Nobody from outside this practice will be given your contact details or have access to your medical records without your prior consent.
Research Training - Good Clinical Practice for Research in Primary Care
A key requirement for anyone involved in the conduct of Clinical Research is Good Clinical Practice for Research (GCP) training.
Good Clinical Practice (GCP) is the international guideline and standard to which all NHS research is conducted.
Why do you need Research Training?
Everyone involved in the conduct of clinical research must have the necessary training and education in order to ensure they are competent to carry out their duties and responsibilities.
This is a requirement of the Research Governance Framework for Health and Social Care 2005. This policy covers all research within the NHS in England, and in law, for those people working on clinical trials.
The Principles of GCP states that: "Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s)" (2.8, E6 Guidelines for Good Clinical Practice)
GCP Trained Staff at Mulberry House and St Denys Surgeries
Dr Miyuru Amarapala (Research Lead)
Dr Richard Barnes (Acting Research Lead)
Philippa Larard-Young (Research Advanced Nurse Practitioner)
Emma Wiltshire, Practice Manager
Helen Rodwell, Medicine Manager
Rachel Eynon, Practice Nurse
Current Research Studies
ANTLER is an individually randomised double blind placebo controlled trial that will recruit patients who have taken antidepressants for at least 9 months but are now well enough to consider stopping the treatment.
Eligible participants will be taking either citalopram 20mg, sertraline 100mg, fluoxetine 20mg or mirtazapine 30mg per day. In the Trial, Patients will either continue to use the active drugs for 12 months or be allocated to placebo group, where the antidepressant medication will be tapered over 2 months to reduce withdrawal effects.
The results will provide clearer, evidence based guidance as to the effectiveness of long term maintenance antidepressant treatment, allowing doctors to give better advice to people who have taken antidepressants for some time.
The research is being organised by University College London in collaboration with the University of Bristol, Southampton and the Hull York Medical School. It is funded by The NHS National Institute for Health Research (NIHR) HTA. The study is also supported by the NIHR Clinical Research Networks.
This study aims explores attitudes, preferences and behaviours of people on antidepressants for more than two years. The study is a postal questionnaire and interviews with primary care patients.
Although chest infections are one on the most common infections managed in children seen in primary care, there have been no placebo controlled trials to show what effect antibiotics have. Over prescribing of antibiotics will cause the bacteria to become resistant which will likely lead in the future to serious infections in children becoming untreatable from ‘superbugs’. This study will provide evidence to inform the management of chest infections in children.
The study will run as a clinical trial for children whose parents have consented to their child being randomised and as an observational study for parents who do not. Children, aged 6 months to 12 years, with chest infections, defined as an acute cough as the predominant symptom, will be randomised to either get amoxicillin or not get amoxicillin for 1 week, to see whether antibiotics make any difference to symptom severity or the duration of the illness.
Chronic kidney disease (CKD) affects around 10% of the UK population. It is linked with increasing age and is more common in people with other illnesses such as hypertension, diabetes mellitus, obesity and primary renal disorders. Of interest to this study, CKD is a major contributor to cardiovascular disease, with CKD patients showing a greater incidence of heart failure and sudden cardiac death. Conventional treatments for cardiovascular disease have been disappointing in CKD patients. There are also limited treatment options to prevent further decline in kidney function.
Established drugs called aldosterone receptor antagonists reduce deaths in patients with heart disease. There is also evidence that these drugs may reduce kidney damage attributed to circulating aldosterone. In order to answer the research question, we will conduct a prospective randomised open blinded endpoint (PROBE) trial using a low dose of the aldosterone receptor antagonist, spironolactone.
Patients with more advanced (stage 3B) CKD will be randomised into two groups. One group will be given current standard care. The other group will receive this same care along with a low dose of spironolactone. Patients will be followed up for 156 weeks and again at 5 years.
We aim to establish whether the group receiving spironolactone need less frequent hospital admissions for cardiovascular disease and experience fewer deaths, and whether there are other beneficial cardiovascular and kidney function blood tests taken. An important aspect of these tests will include the safety of spironolactone.
CLASP 4 - RENEWED
This study aims to develop a cost-effective web-based intervention to improve the quality of life and long term prospects through secondary prevention of cancer. The intervention will provide patients who have finished primary treatments for breast, colon and prostate cancer with self-management support for a healthy lifestyle and improved mood that will increase their quality of life and hopefully assist in preventing the recurrence of cancer.
Acute chest infections are common and antibiotics are often prescribed despite them having limited impact on the symptoms. Finding a safe and effective way to control the symptoms associated with a chest infection, particularly cough, could help reduce antibiotic use. There is evidence, based on traditional use, to suggest that a herbal extract called pelargonium, could help control chest infection symptoms. We would like to know whether the herbal extract, pelargonium, could be an alternative to antibiotics. This feasibility study will not answer this question but will help us to plan a large full-scale trial.
This non-commercial research project is recruiting adults between 18-25 years of age with mental health problems including: depression, attention deficit/hyperactivity disorder (ADHD) and alcohol use disorder. The STRATIFY study is investigating the effects of psychiatric comorbidity. It will help elucidate the neural and genetic basis of mental disorders and will lay the groundwork for development of treatments that target specific pathological processes across mental disorders rather than being limited to traditional psychiatric diagnostic categories. This will be explored using cognitive, behavioural, clinical, neuroimaging and genetic data. The project is being run jointly by the University of Southampton and Kings College London.
Our colleagues in Health Psychology have developed an intervention, to help doctors and nurses in general practice to check if older adults who live at home are at risk of malnutrition. They can then offer support to those who need it. Our intervention, called ‘Eat well, feel well, stay well’, includes MUST (the Malnutrition Universal Screening Tool), booklets and other materials for older adults, and a support tool for health professionals. The support tool includes guidance about when to see patients and when to use oral nutritional supplements.
In the study, we aim to assess the feasibility and acceptability of the intervention. We will compare two versions of the intervention. One is a brief intervention with MUST screening, patient booklets and follow-up; the other is a stepped care intervention. This means that patients will have the brief intervention plus oral nutritional supplements (ONS) for short spells when they are unwell. We will also follow a group of patients who have the usual care that is provided by their doctors’ surgery. We will assess outcomes including change in eating patterns, weight and quality of life. We will also compare patients and health professionals’ experiences of being in these three different groups. The results of the feasibility study will help us to design a full trial.
Past Research Studies
This research aims to help patients manage short-term (acute) fatigue - one of the most intrusive but often hidden symptoms - and to better understand and predict which patients with acute fatigue go on to develop Chronic Fatigue (lasting 6 months or more) or Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME).
The CEDAR study aims to investigate the clinical and cost effectiveness of anaesthetic ear drops in reducing antibiotic consumption and ear pain in children presenting to their GP with acute otitis media (ear infection).
In a previous study the research team looked at how acceptable a traditional mindfulness ‘short-course’ was to help patients with asthma. Patients liked mindfulness and felt it helped how they felt about their asthma, but attendance was low (perhaps because of the commitment of attending a weekly group). We want to see if ‘Headspace’, an online mindfulness-based ‘programme’ (app and website), can help. The Headspace programme takes 30 days of 10-minute practices that can be done whenever it’s convenient.
In this feasibility study we will mainly be looking at how many people want to take part, how many go on to take part and how many complete the process, but we will also look at how much mindfulness could help improve quality of life for people with asthma.
Questionnaires measuring mood and quality-of-life in 80 patients with asthma, will be used before and after using Headspace. Change in these patients will be compared to a control group of 40 patients who will receive their usual care from their GP team. Headspace have allowed free access to their intervention for everyone in the study (although the control group will only be given access after follow-up).
We will also call some participants to ask about their experiences of Headspace and the study, and how they think Headspace (and mindfulness more broadly) could help their asthma. This study will help us design an online programme specifically for people with asthma, to improve their quality of life beyond that offered by ‘pharmacological’ treatments such as new medication types, that we will test in a larger trial in the future.
The study aims to look at the genetic factors that determine genetic susceptibility in thin people (BMI <18kg/m2).