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Broadshires as Clinical Research Centre

Introduction

 

At Broadshires Health Centre we pride ourselves on participation in medical research, in particular studies approved by the Thames Valley Primary Care Research Network, and run by the Universities of Oxford, Cambridge, Bristol, Birmingham, Southampton or Nottingham.

You may be one of the many patients who have taken the opportunity to get involved in this clinical research. This web site will give periodic updates, and highlight when preliminary results are available. Once study findings have been published in peer-reviewed journals we will offer a brief lay summary and provide web links to where the completed study findings can be accessed.

You can find out more about research carried out in UK general practice by looking at the website of the University of Oxford’s Department of Primary Care Health Sciences at www.primarycare.ox.ac.uk

Since 2010, over 400 patients at Broadshires have participated in the 19 studies summarised below.

 

Completed studies at Broadshires Health Centre

 

AIRS study (Autoinflation Randomised Study)

This study is investigating whether children with ‘glue ear’ can be helped by blowing up a specially adapted balloon called an Otovent. 320 children aged 4-11 were recruited (35 from Broadshires), and results are due to be published in Autumn 2013.

 

CAPS (Children and Persistent Cough Study)

This study looked at how often two types of bacterial infection (whooping cough and another infection called Mycoplasma pneumoniae) were found in school aged children who saw their doctor or nurse with a persistent cough (defined here as a cough that would not go away after 2 weeks). The study recruited 302 children from 22 general practices in Thames Valley, including 32 children from Broadshires.

More than 90% of children had been vaccinated against whooping cough as babies and more than 80% had had their pre-school booster vaccination. But evidence of recent whooping cough infection was found in 56 (18%) children.  Mycoplasma pneumoniae was found in 32 (10%) children.

These findings show that both these infections are important causes of persistent cough in children and that whooping cough can still be found in children who have been vaccinated.  These findings also emphasise the importance of vaccinating pregnant women against whooping cough so that their babies will have some protection in those vulnerable first 8 weeks of life before their first vaccinations.

 

Frequent HbAiC

This study involved people with Type 2 Diabetes and was designed to find out how soon after a change of medication there is a change in the widely used blood test, ‘HbA1C’, which is used to monitor how well diabetes is controlled. The aim was to find out how quickly HbA1c changes and how long we should wait before making further medication changes. A total of 101 participants were recruited to the study (14 from Broadshires), The results showed that most people can be re-tested after just 8 weeks so in the case of people wanting to gain rapid control of their diabetes, medications can be adjusted after this length of time instead of waiting longer. Longer waits may however be appropriate if people want to change their lifestyle in such a way as to improve their diabetes control ( by weight loss and exercising). More about the results can be seen at: 

 

 

HyBet (Hypertension Bluetooth Measurement in Primary Care)

This study involving 240 patients recruited from 4 Oxfordshire practices (128 people from Broadshires) seeks to establish how best to diagnose Hypertension (persistent high blood pressure). We asked people with suspected Hypertension to measure their own blood pressure at home using a suitable automated monitoring advice that transmitted all its recordings to a website using ‘Bluetooth’ technology. They did this twice daily for one month. At the end of the month patients wore an ‘ambulatory’ blood pressure recording device for 24 hours. Results from the two approaches were compared and showed that just 5 days self monitoring gives equally useful information and is generally more acceptable to patients than the wearing of an ‘ambulatory’ monitor for 24 hours. It is hoped these results will be incorporated into updated national recommendations produced by the National Institute of Clinical Excellence (NICE)

 

MAC (Montelukast for Adults with Persistent Cough)

This study looked at whether a medicine called montelukast, which is already used to treat asthma, could also be used to treat adults with a persistent cough brought on by a cold or chest infection.  People who took part in the study were tested for whooping cough, and treated with either montelukast or placebo tablets for up to four weeks using a study design known as a double-blind, randomised, placebo controlled trial (see separate explanation). This is the best way to determine whether a treatment really does help people or not.

276 patients from 25 general practices across Thames Valley and South West England took part in the study, including 33 patients from Broadshires.  The study did not find montelukast made any difference to persistent cough. What we did find was that whooping cough was common in adults with persistent cough, with 70 patients (25%) testing positive for whooping cough. Some good news is that in around half of patients the cough will almost completely settle two weeks after initial presentation in primary care.

The published findings are available at

 

PRIMIT (A Primary care trial of a website based infection control intervention to modify Influenza-like Illness and Respiratory Tract Infection Transmission)

This UK–wide study looks at the impact of people accessing a specially designed website giving advice on how to limit the spread of the common cold and flu like germs from one person to another. The aim is to see whether a website like this could help reduce the spread of infection in the event of a pandemic flu outbreak. The study has recruited 16,000 adults across the UK  (90 from Broadshires) during the winters of 2011 and 2012. Participants were randomised to use of website advice or no advice. Randomisation means the participants were allocated by chance alone to either the website (the ‘intervention) or to no special advice (the ‘control’), as this is the best way to find out if the intervention is truly effective. Currently the records of those participants are being examined to establish the consultation rates for infections, and any complications.

 

RCT2 (Randomised Controlled pilot Trial of corticosteroid injection for shoulder pain

This study was looking at how much benefit people might get from having an injection of steroid plus local anaesthetic, or simply a local anaesthetic injection into a painful shoulder if the pain is due to soft tissue injury ( rotator cuff tendonopathy or adhesive capsulitis). 40 patients (6 from Broadshires) took part in a preliminary phase of the study assessing whether patients and their doctors found this comparison acceptable and achievable (a so-called ‘feasibility study’).  A study involving this number of patients is too small to draw any definite conclusions over whether one injection is more effective than the other, but has successfully been used to plan a larger study.

 

 

Ongoing Studies at Broadshires

 

BUMP (pilot study of self- monitoring of blood pressure in pregnancy)

This study is looking at how pregnant women who have risk factors for developing high blood pressure and even ‘toxaemia’ (also known as pre-eclampsia or PET) might be helped by provision of home blood pressure recording equipment alongside the regular ante-natal checks they already receive from their midwife or GP. Pregnant women in the study are carrying out blood pressure readings three times a week, morning and evening. Their blood pressure results are recorded automatically, and shared with their GPs and midwives. The results of this preliminary ‘feasibility’ study will be used to ensure the best possible design of a larger trial to see if home blood pressure measurement enhances early and accurate detection of conditions which pose some risk to mother and baby.

 

COPD-EDGE(Self management and Support Programme for COPD)

This study explores whether people with Chronic Obstructive Pulmonary Disease (COPD) might find their condition easier to manage using a mobile health application. Study participants are provided for 6 months with a small hand held computer and a device placed on the finger called a oximeter used for a daily assessment of oxygen levels, heart rate and breathing rate. They are encouraged to answer some questions about their condition daily and to use educational information about COPD available on the computer. Participants are interviewed before and after to 6 month period to find out the impact on their self confidence and well-being, and if they agree, their carers may be interviewed also.

 

3Cplus ( cough complications cohort plus study)

This study is looking at whether a new technique for rapid identification of germs collected on throat swabs offers an accurate tool to help clinicians know the cause and likely severity of chest infections. The study is also looking at whether any particular symptoms, physical features or measurements help a clinician know which patients with a cough are likely to develop complications. The aim is to find a test which provides such rapid and accurate results it could help clinicians choose the best antibiotics for people with proven bacterial infections and, equally importantly, avoid antibiotics when they are unlikely to be helpful.

 

EXPERT (Experience of a health website evaluated in a research study)

This study is looking at which of two online sources of support is most helpful for smokers wanting to quit. One form of support is online videos of people reporting their experience of quitting (Patient Experience information). The other is a website giving information based solely on facts and figures and discussed by medical professionals. The study is using a newly developed method for assessing the impact of these on line resources to compare which helps best with motivation to stop smoking.  A related study is making a similar comparison to assess which form of information helps people with asthma self-manage their condition. The results of this study should help throw light on when and how the NHS should provide online information based on patient experiences.

 

HEAT (Helicobacter eradication to prevent ulcer n

Bleeding in aspirin user)

31 patients from Broadshires have participated in this study which will involve 120,000 patients across the UK. Its aim is to establish whether identification and eradication of a specific stomach infection (called Helicobacter pylori) reduces the occasional occurrence of gastrointestinal bleeding in patients taking low dose aspirin for the prevention of heart attacks and strokes.

 

HOLDFAST (A multicentre ethnographic study of unplanned hospital admission for heart failure)

This is a study of the medical and social reasons why patients with severe heart failure often have unplanned hospital admissions. A researcher keeps in close contact with participants in this study to try and track exactly what happens and, it is hoped, how medical and social services could be improved.

 

OxValve

In this study, patients over 65 years of age are invited for a heart scan (echocardiogram) to see if they have unsuspected malfunction of any one of the heart’s four valves (Valvular Heart Disease or VHD). The aim is to establish how common is VHD, what genes may cause it, and what happens over the long term. The study will include 3500 Oxfordshire patients, and to date at least 200 Broadshires have had an echocardiogram and a chance to discuss any unexpected findings with a specialist.

 

PD Exercise (longer-term exercise interventions in people with Parkinson's Disease

This study is looking at the effect of a 6 month exercise programme (walking, gym-based and home hand-writing exercises) on mobility, fitness, health and well-being in people with Parkinson's Disease

 

POWeR2 (Positive Online Weight Reduction)

This study is looking at whether a specially developed advisory internet site together with email reminders helps weight loss in people who are obese (as defined by a Body Mass Index > 30), and people who are overweight (BMI > 28) and have an additional risk factor such as high blood pressure, high cholesterol or diabetes. It is a randomised controlled study so participants will be allocated by chance to either having access to the website and being monitored by a research nurse, or simply being monitored by the research nurse. At the end of the study all participants will be allowed access to the website.

 

STILTS2 (study of common and rare genetic variants associated with thinness)

This study is looking at adults aged 18-65 years who are otherwise well but unusually thin (Body Mass Index < 8) to find out about genes that contribute to thinness. DNA samples collected using a saliva test kit will be used to measure the frequency of common and rare gene variations. Comparison of gene frequencies in thin people with frequencies in normal weight people and people with severe obesity (information already gathered by this research team) should enable identification of genes which make thinness more likely. This might provide insights into the regulation of body weight and in time help the development of rational approaches to the prevention and treatment of weight disorders.

 

TOAST ( Treatment Options without Antibiotics for Sore Throat)

This study looks at whether a single dose of a powerful steroid called dexamethasone might provide effective and safe symptom relief for people with a recently developed sore throat of the kind thought unlikely to benefit from antibiotics. It is a ‘double-blind, randomised placebo-controlled trial’ (see separate explanation below) as this is the best way to determine whether a treatment really does help people or not.  Participants will be given a tablet containing either steroid or placebo, will then have their progress assessed by answering a text enquiry 24 and 48 hours after taking the medication, and will keep a symptom diary for one week.

 

YDX (Young Adult-onset Diabetes)

This study looks at the types and causes of diabetes in relatively young adults. People whose diabetes was diagnosed between the ages of 18 and 45 are invited to have some detailed blood tests and physical measurements.  Diabetes developing in adulthood is usually assumed to be 'Type 2' Diabetes but the researchers are carrying out tests of antibodies which will reveal if person has 'Type 1' Diabetes, and genetic testing which can show if a person has one of the rare inherited forms of diabetes. This information can sometimes lead to better treatments for a study participant's diabetes. If many people are found to need re-classification of their diabetes the study may influence how young adults with diabetes are tested in future.

 

What is a double-blind, randomized, placebo controlled study?

This is considered the best way to determine whether a treatment really does help people or not.  Trial participants are given either the treatment being investigated or a placebo. A placebo is a treatment with no active ingredient which is made to look like the treatment being tested. By comparing people s responses to the placebo and to the treatment being tested, researchers can tell whether the treatment is having any real benefit, rather than patients simply feeling better because something is being done . Whether a trial participant receives the treatment being tested, or a placebo is determined by randomisation meaning by chance and not by choice. Double blinding means that neither the GP nor the patient knows which has been given, and only the scientists analysing the results will have this information.  If participants want to find out which they were given this is generally possible at the end of the study once results have been published.

This video  explains randomised controlled trials in  language understandable to non-scientists:

 

 



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