In Contact Spring 2016

Clinical Research Network

Working Together for Better Health Launch of the new RCGP Ready® website CTU merger

Delivering research to make patients, and the NHS, better 2 In Contact

Hello, goodbye

Clinical Research Network West Midlands Dear colleagues, Scientific Advisor for the Department of Health during an event hosted by the British On the 10th February 2016 the National Medical Association in London. Community Institute for Health Research published its Pharmacy continues to play a key role in raising 100th research summary. The research awareness of research and they are contributing featured, showed that engaging clinicians and towards recruitment to the TIME study, healthcare organisations in research is linked to which is comparing evening dosing of usual improvements in the delivery of healthcare. The antihypertensive therapy with conventional paper published in the BMJ Open by Boaz and morning dose. colleagues, found that most of the improved healthcare performances related to processes We showcased Commercial Research to of care (ie, following best practice according GP practices in November and new practices to guidelines) and outcomes for patients now receive regular invitations to participate in (ie, better survival). industry research. This has led to GP practices now being involved in cardiovascular and The NHS has a duty to promote research dermatitis research. In February, we hosted our and innovation, which aims to improve patient inaugural event for research site initiative (RSI)

Max Feltham outcomes. The commissioning system promotes practices at Cricket Ground. The and supports participation by NHS organisations event was attended by GPs and Practice and NHS patients in clinical research. Managers from 50 practices and we presented Your GP practice and community pharmacy research findings from the Primary Care Patient can be supported by the clinical research Safety Toolkit and the Weigh 2 Go study. networks (CRN) to meet benchmarking Furthermore, GP practices had an opportunity standards for delivery of research to time and to learn more about a new study that is Contents target recruitment levels. NHS organisations investigating the effects of web support for that have deliberately integrated the research exercise referral schemes. The general feedback Welcome 2 function into their structures demonstrate how was very positive and we will organise a similar News 3 research engagement can, among other factors, annual RSI event for our community pharmacies. New studies 4 contribute to improved healthcare performance. Current studies 5 Our team of primary care research facilitators In this final paragraph, I would like to take the In follow up 9 and nurses are dedicated to support high-quality opportunity to announce that I am moving away Study findings 10 clinical research in your GP practice and from the Clinical Research Network on 30 April. Study Updates 12 community pharmacy. Working as the Research Manager over the Courses 13 past three years to lead the team based at Research Design Service 14 We are delighted to welcome three new the University of to deliver Primary Keep In Contact 15 members to our CRN: Primary Care delivery Care research in your GP practice, community team. Sue Read has taken up the role as Senior pharmacy and care home has been enjoyable Research Nurse for Primary Care and will lead and fulfilling. Together we recruited 9,000 our team of six Research Nurses who are participants into clinical research, where we aim embedded across Birmingham and The Black to improve the delivery of healthcare and make Country. Furthermore, she can offer support and patients better. This figure excludes patients who advice to your practice nurse on how to deliver were recruited into secondary care studies after research in your surgery. Marie Crook and being initially identified in primary care, so our Georgi Dotchin have joined our Research impact has been even greater. Recruiting this Facilitator team and have already started number of patients requires the support of so conducting practice visits for the All-HEART, many people and I hope I get an opportunity to HEAT and IMPRESS-AF studies. say ‘thank you’ to all the Primary Healthcare providers involved in research over the coming I am pleased to announce that Kaldeep Singh, months. I wish you all the very best for the future. Community Pharmacy Champion for the West Midlands, received a national award for their Dr Max Feltham contribution to the development of an innovative Research Manager – Primary Care model for commercial research recruitment. NIHR Clinical Research Network: West Midlands Kaldeep received his award from the Chief News 3

News Notification of CTU merger

We wish to inform you that the Primary Care methodological research across a wide range Clinical Research and Trials Unit (PC-CRTU) of disease areas in both primary and secondary combined with Birmingham Clinical Trials Unit care settings. BCTU has specialist statistical, (BCTU) in April this year to form a new BCTU, methodological, trial management, research with Professor Peter Brocklehurst taking over governance, quality assurance and computing directorship of the new unit mid-2016. The new expertise, who currently oversee the design, unit is now one of the largest and most effective setup, coordination, analysis and reporting of the clinical trials units in the UK, undertaking high Unit’s clinical trial research. BCTU will continue to quality late phase clinical trials, diagnostic and work with the CRN: West Midlands to facilitate test evaluation studies, systematic reviews and primary care research.

Launch of the new RCGP Research Ready® website

The RCGP Research Ready® programme has How do I register to become Research Access is completely free for every practice now been running for approximately ten years. Ready® Accredited? joining the Research Ready® programme (and April saw the launch of the newly developed Practices register via a three-step process is priced at £300 to non-accredited practices). programme and website. Previously, practices on the website: may have focused on the quality badge element More details can be found at: www.rcgp.org.uk/ of the programme; from now on, the programme 1. Provide practice information (eg, contact learning/online-learning/ole/rcgp-research-ready. will seek to provide greater support in the details, research interests) aspx development and implementation of primary 2. Complete a short assessment, establishing care research projects. A prime example of this ‘research competency’ Further Information is the online RCGP eLearning Research Ready® 3. Pay an administration fee*: £100 for one year’s More details on the Research Ready programme package (see below for further details). accreditation; £250 for three years’ accreditation can be found on the RCGP website: www.rcgp.org.uk/researchready. The programme has two principal aims: FREE eLearning research course Launched alongside the new system is an online *Please note that practices within Birmingham n To make available a ‘quality badge’, signalling eLearning research course designed for all GP and Black Country that are part of the Research to interested parties – eg, Care Quality practice staff, both clinical and non-clinical, who Site Initiative (RSI) Scheme receive funding for Commission (CQC), National Institute for may have involvement in research projects. The Research Ready® accreditation. For further Health Research (NIHR), potential research online training package covers diverse aspects information on the RSI scheme and how your project participants – that accredited GP of primary healthcare, and offers a full package practice could join, please contact Sheila Bailey practices are cognisant of meeting current based on Research Ready®. ([email protected]) or 0121 414 7956. UK research standards/requirements The four modules cover: (ie, ‘readiness’ to undertake research) n Becoming ‘research ready’ n To give information, guidance and support n Obtaining informed consent to staff at GP practices in order to improve n Assessing project feasibility awareness of standards/requirements and how n Data management to meet them, as well as practical guidance in designing and delivering research projects

Accredited practices will join the RCGP’s largest network – around 1,000 practices, covering 14% of the UK’s patient population. Updates on research opportunities from the Clinical Research Network (CRN), RCGP and partner organisations are communicated regularly, on a local, regional and national basis, allowing for enhanced integration, communication and co-operation. 4 In Contact

The Clinical Research Ambassador Group – Valuing Patient and Public involvement in research

Improved care and better outcomes are strongly knowledge and experiences to provide an Learn More associated with research active organisations. alternative perspective on the array of research Tel: 0121 424 2966 At the Heart of NHS Foundation Trust topics we are involved with in the Trust. Email: [email protected] (HEFT), we have a commitment to ensure This can ensure the research methods and Twitter: @CRAGHEFT research is an integral part of the clinical care outcomes are important and relevant to the that is provided to our patients. As part of this public and patient’s needs. commitment, we have a research Patient and Public Involvement (PPI) group called The CRAG was formed in 2012 for people who Clinical Research Ambassador Group (CRAG) have an interest in research to meet, through in order to engage with patients, carers and meetings and events held at the trust, to discuss, members of the public to enable them to voice inform and update on research within the Trust. their opinions and offer their perspective on Membership of the group is open to anyone the research we do at HEFT. within the HEFT catchment area and the level of involvement is up to the individual. This can Public involvement in research is essential vary from being involved with designing research to enable us to gather a different perspective projects to ensuring research questions being and outlook on the research we do within the asked are understandable and relevant to Trust. It allows us to draw on others personal the public.

New Study – PIC Study REACT: REtirement in ACTion study

Please note that this study attracts patient population. The REACT intervention is a Remuneration: accruals and would therefore meet study 12-month programme with a strong social n Based on recruitment of 32 patients either: commitment for RSI practices. An opportunity element. It starts as a centre-based exercise £664 or £315 (Docmail option) for your practice to be involved in a major programme, but adds support for gradually study to help older people stay fitter and ‘translating’ exercise and physical activity The target number of participants is 768 across live independently for longer. into participants’ day-to-day lives. It will be all the trial centres (Bath, Bristol, Birmingham delivered in community centres when low-cost and Devon) with the aim of recruiting around 32 REACT (REtirement in ACTion) is a new daytime capacity is available. Sessions will be patients per practice (dependent on list size). intervention study aimed at improving mobility organised as group activities (15 per group) and maintaining independence in older with individually tailored elements, and will For the pilot study, we are looking to recruit people, using an exercise-based rehabilitation include cardiovascular, strength, co-ordination practices from the , , programme. REACT is based on the LIFE and flexibility/balance exercises. Increased daily and Oscott areas. The main trial conducted in the USA where the study walking will also be encouraged and social study is planned to commence Autumn 2016. intervention was found to reduce the incidence engagement and enjoyment will be prioritised. of major mobility limitation in older adults. Learn More REACT will adapt the LIFE study intervention What is involved for practices? Sheila Bailey/Marie Crook to ascertain whether it is an effective and n Search GP database Research Facilitator, CRN: Primary Care cost-effective approach to reducing mobility- n GP to check the list Tel: 0121 414 7956 or 0121 414 6270 related disability in older adults in a UK setting. n Mail-out to eligible patients Fax: 0121 414 6571 n Follow-up mailing to non-responders Email: [email protected] or REACT will recruit sedentary, community living, if recruitment targets not met [email protected] older persons aged 65 and over, with functional limitations (ie, who are at risk of major mobility Patients will respond direct to the REACT is funded by the National Institute limitations), but who are still ambulatory. The study team based at the University for Health Research Public Health Research aim is to target a non-disabled, but at-risk of Birmingham. Programme. In Contact 5

Current Studies – Site Studies

Treatment in Morning Versus Evening (TIME) Study

Funded by British Heart Foundation, the main There are study posters available in order objective is to determine if anti-hypertensive to bring it to the attention of anti-hypertensive therapy taken in the evening has improved patients. Interested patients register themselves cardiovascular outcome compared with more on the study secure website: conventional morning dosing. The study is trying www.timestudy.co.uk to recruit approximately 10,000 patients from across the UK in order to find an answer to a They will confirm consent and enter their clinically important question. personal details. All study management is done by emails between study team and the patient Patients diagnosed and treated for hypertension with information being updated online. The study (all forms) with at least one antihypertensive documents are available on the TIME website: drug, aged ≥18 and having a valid email address www.timestudy.co.uk/GPRegistration.aspx are randomised into two groups where one group takes the treatment in the morning and the Learn More other group in the evening. Moreover, the study Anu Krishna also regularly monitors and records the number Research Facilitator, CRN: Primary Care, of heart-attacks, strokes and vascular deaths Tel: 0121 414 6643 from each group. Email: [email protected]

Practices will be asked to conduct a search to identify potentially eligible patients and the patient list will be checked by GP for exclusions. Patient invitation letters will be sent out using DOCMAIL.

Global Anticoagulant Registry in the FIELD (GARFIELD-AF)

GARFIELD-AF is an ongoing observational, GARFIELD-AF is now recruiting to the fifth multicentre, international registry of newly and final cohort and recruitment is expected diagnosed atrial fibrillation patients with at to end in July 2016. The UK continues to be least one additional, investigator determined a leading recruiter to GARFIELD-AF with risk factor for stroke. The aim of the study is 3,567 UK participants enrolled to date. to evaluate the management and outcomes of patients with newly diagnosed non-valvular Thank you to all the practices that are AF at risk of stroke. The registry aims to enrol participating in GARFIELD-AF. 55,000 patients at more than 1,000 sites in 50 countries. Learn More Stacy Edwards Enrolment is taking place in five independent, Tel: 0121 415 8204 sequential cohorts and patients are followed up Email: [email protected] for a minimum of two years. UK participants are recruited in primary care with the University of Birmingham as the recruiting centre. 6 In Contact

Current Studies – Site Studies

FAST

Febuxostat versus Allopurinol Streamlined Trial.

The trial will evaluate the long term It is expected that each participating GP cardiovascular safety profile of febuxostat in practice will recruit a minimum of 6 patients comparison with allopurinol in patients aged 60 per practice. years or older with chronic hyperuricaemia in conditions where urate disposition has already Practice Remuneration occurred. Eligible patients will be randomly Each practice will receive £500 search fee allocated to either febuxostat or allopurinol for the initial practice database search, plus treatment. The study research nurses, or local £5 per month per patient for follow-up data. network nurses, will follow-up the patients for an average of 3 years. The trial aims to recruit Learn More 5,706 patients. Beth Hinks Research Facilitator, CRN: Primary Care Practice Involvement Tel: 0121 414 8545 Practices will be asked to: Email: [email protected] n Nominate a Lead GP to undertake Good Clinical Practice Training (can be provided as part of the trial) n Search GP database for eligible patients n Nominate Lead GP to review the patient list and remove unsuitable patients n Nominate Lead GP to report any Serious Adverse Events via the FAST Web portal or by contacting the study centre

ACCU-RATE

How accurate are home blood pressure monitors used by patients?

‘Accu-rate’ is a NIHR funded cross sectional Eligible patients on the hypertension register n Mail-out of a study invitation letter survey that aims to determine whether patients’ who currently self monitor with either a wrist n Receipt of monitors (frontline staff) own blood pressure monitoring equipment is or upper arm blood pressure monitor will be n Room hire sufficiently accurate to be integrated into invited to attend device accuracy sessions at daily practice. their own practices. Using standard calibration Learn More equipment and following a standard testing Siobhan Milner It will ascertain which digital blood pressure procedure as recommended by the British Project Officer monitors are currently used by patients, how Hypertension Society, each monitor will be Tel: 0121 414 2954 well they perform, and whether there is any tested over a range of pressures. Machines Fax: 0121 414 8616 evidence of decreasing accuracy over time with a difference in pressure of ≤3mmHg at Email: [email protected] or with greater usage. all levels will pass. Each patient will receive individual feedback for their monitor. We would like to invite interested practices to contact us to take part. The additional Trial participation involves: workload is minimal. Service support costs n Identification and screening of eligible will be reimbursed to cover recruitment. patients using the hypertension register Patients will be recruited from 8 practices (health care professional) across Birmingham. In Contact 7

Current Studies – Site Studies

Validation of home blood pressure monitors in patients with atrial fibrillation

This research aims to determine if automatic monitors in patients with AF to assess contact us to take part or for further blood pressure (BP) monitors, already their accuracy in this population, including information. The additional workload is independently validated to take measurements additional analysis of the minimum number minimal and service support costs to cover in the home environment and shown to be of measurements required before we can be time recruiting patients will be reimbursed. amongst the most accurate in the general confident in the accuracy of the obtained BP population, can be reliably used in patients values for AF patients. Devices will be validated Study participation involves: with Atrial Fibrillation (AF). against standardised protocols to ensure Identification and screening of eligible patients consistent and reliable assessment. Mail-out of study invitation letter No automatic BP monitors are currently validated for use in AF. If monitors are shown Eligible patients, recorded as having Learn More to take accurate blood pressure readings in permanent chronic AF, will be invited to Dr James Hodgkinson patients with AF, the use of home BP participate. The validation studies will follow Tel: 0121 414 8842 monitoring could be recommended in this the standard British Hypertension Society Email: [email protected] high risk group to improve the effectiveness (BHS) and European Society of Hypertension of hypertension diagnosis and management. International Protocol (ESH-IP) protocols, and Home BP monitoring allows many more BP will take place in the NIHR Wellcome Trust readings to be taken, and therefore might help Clinical Research Facility in Birmingham, which provide a more accurate picture of the true is accredited by the BHS as a site for monitor underlying BP levels in AF patients. validation, and where validation studies are regularly conducted. The proposed research will assess the potential of home BP monitoring in AF through We are looking to recruit up to 10 practices, validation studies of different home BP and would like to invite interested practices to

Current Studies – PIC Studies

Brains in Transition Study

It is possible to identify young people at risk the transition from being at risk for psychosis Learn More for psychotic illnesses such as schizophrenia to the development of a psychotic illness, and Brains in Transition (BrIT) team through a combination of symptoms and determine if those changes can be used to Tel: 07934996686/0121 414 4937 personal or family history. Around 20% of such predict outcome and improve early detection. Email: [email protected] people develop psychosis within 12 months of or being identified. There are differences in the Participation in the study involves assessments Anu Krishna brains of at risk cases when compared to of symptoms and functioning, as well as brain Research Facilitator, CRN: Primary Care similar participants not at risk and these scans (MRI). Participants are followed for one Tel: 0121 414 6643 differences get greater with the onset of year and receive £20 in recognition of their Email: [email protected] psychotic illness. We don’t yet know, however, time and expenses each time they take part. when in the progression these changes occur. They may come before (and somehow cause) GP practices taking part will be eligible to the increase in symptoms, implying that trying receive payment via service support costs to to prevent these brain changes could prevent cover the time spent identifying and mailing the illness. The Brains in Transition (BrIT) study out to eligible patients. GP practices will be (funded by the Medical Research Council) will informed in writing of a patient’s participation investigate the course of brain changes across in the study. 8 In Contact

Current studies – PIC Studies

Early treatment of Atrial fibrillation for Stroke Trial

We would like to invite you to take part in an to prevent strokes and other cardiovascular Learn More exciting European study which is seeking to complications. Earlier treatment may involve Beth Hinks improve cardiovascular outcomes for patients the use of anti-arrhythmic medicines as well Research Facilitator, CRN: Primary Care with newly diagnosed Atrial Fibrillation (AF). as AF ablation. All treatments selected will Tel: 0121 414 8545 comply with usual NHS guidance/technology Email: [email protected] This is a Patient Identification Centre (PIC) appraisals and patient preferences will be study so we are simply inviting you to identify discussed and agreed. potential patients who can be invited to take part in the study. In Birmingham, the study Patients will be randomly assigned to receive is based around 2 secondary care sites; either usual care or early rhythm control, and City Hospital and University Hospital followed up for a minimum of three years. Birmingham. Professor Paulus Kirchhof, Participants will have their travel expenses Chair in Cardiovascular Medicine, Clinical reimbursed. Recruitment to the study is and Experimental Medicine, University of currently due to end in 2016. Birmingham, is the International Principal Investigator. Practices will be remunerated for their involvement in the study. The study will compare the usual treatment of AF with a management that uses early rhythm control therapy on top of usual care to explore whether earlier rhythm control has the potential

HI-Light

Vitiligo affects around 0.5-1% of the b) To assess whether combination of NB-UVB All the research activities are taking place in world’s population. Current clinical guidelines light therapy with potent TCS is better than Royal Wolverhampton Hospital NHS Trust recommend the use of potent or super potent either treatment used alone for the treatment (Adults), Birmingham Children’s Hospital topical corticosteroids (TCS), topical calcineurin of early and limited non-segmental vitiligo. (Children) and Solihull Hospital (Adults and inhibitors, or narrowband UVB light therapy Children). (NB-UVB) for the first line treatment of vitiligo. The sponsor of the study is University of Nottingham, the study is funded by NIHR Health Patients choose the research site based A Cochrane systematic review of ‘Interventions Technology Assessment Ref 12/24/02 and on their convenience. for vitiligo’ was last updated in 2010; one Chief Investigator is Dr Jonathan Batchelor, of the main conclusions of the update was Consultant Dermatologist, The University Learn More that combination treatments seem to be more of Nottingham. Anu Krishna effective than mono-therapies in treating vitiligo Research Facilitator, CRN: Primary Care but the trial evidence supporting their use is The HI-Light trial is a multi-centre double-blind, Tel: 0121 414 6643 currently limited. 3-arm randomised controlled trial (RCT) Fax: 0121 414 6571 comparing potent topical corticosteroid to home Email: [email protected] The trial’s objectives are to assess the based light therapy using hand-held devices, effectiveness of TCS and home based NB-UVB and to a combination of the two treatments. therapy for the treatment of patients with early or limited non-segmental vitiligo, used as Participants will receive up to 9 months of mono-therapy and in combination for up to treatment. There will be 2 initial assessments at nine months. the hospital on consecutive days, then a 3, 6 and 9 month assessment at the hospital – which a) To assess whether NB-UVB light therapy will be mainly answering questions, then follow is better than potent TCS for the treatment of up questionnaires at 12,15,18 and 21 months early and limited non-segmental vitiligo. In Contact 9

Current studies – PIC Studies

Would you like to take part in National Research into COPD?

A randomised, double-blind placebo There are study posters available to display in We would be very grateful for your support controlled trial of the effectiveness of low your practice to provide information about the and involvement in this study. dose oral theophylline as an adjunct to study to patients. Patients who agree to take inhaled corticosteroids (ICS) in preventing part in the study will attend three research Learn More exacerbations of chronic obstructive pulmonary clinics at the Queen Elizabeth Hospital, Anu Krishna disease (COPD). Birmingham (their travel expenses will be Research Facilitator, CRN: Primary Care reimbursed at £10 per visit). They will also Tel: 0121 414 6643 The study is trying to determine the clinical receive three telephone contacts from the Email: [email protected] effectiveness and cost-effectiveness of adding study team and be asked to complete some low dose theophylline to ICS therapy in patients questionnaires. with COPD. Its objective is to improve the quality of life of COPD patients and to reduce Participating patients may benefit from a the burden of COPD on the NHS. possible reduction in COPD exacerbations and reduced hospital admissions as well as receiving Practices will be asked to conduct a search assessments (health outcome and spirometry) to identify potentially eligible patients and the by a hospital based specialist respiratory team. patient list will be checked by the GP for any Practices will benefit from receiving study and exclusions. Patient invitation letters will then spirometry data for any of their patients taking be sent out from the practice inviting eligible part in the study which can be used to meet patients to take part in the study. QOF targets.

In Follow Up

TASMINH 4

Recruitment to the TASMINH 4 trial has now We really do appreciate the efforts that finished and, in total, 1,181 patients were colleagues are taking to see participants recruited to the study nationally. Patient and keep them engaged with the study. follow up will continue until February 2017. What is the TASMINH 4 trial? The study team would like to say a huge ‘thank This research is a patient randomised you’ to staff at all the 28 practices in our region controlled trial to evaluate the management that have helped to recruit patients and made of hypertension in primary care using self the study such a success. Currently, our follow monitored blood pressure values, with or Learn More up response to 6 month follow-up clinics without tele-monitoring, compared to that using Siobhan Milner averages 83%. This response rate represents clinic monitored blood pressure. It will also Project Officer a lot of hard work from all the surgeries and consider the effect of self-monitoring and Tel: 0121 414 2954 researchers involved in the study and we would tele-monitoring on adherence, side effects, Fax: 0121 414 8616 like to extend our sincere thanks and gratitude. quality of life, adverse events and costs. Email: [email protected] 10 In Contact

Study Findings If you want to quit smoking, do it now

Smokers who try to cut down the amount they smoke before stopping are less likely to quit than those who choose to quit all in one go, Oxford University researchers have found. Their study is published in journal Annals of Internal Medicine.

Most experts say that people should give up At four weeks, 39% of the gradual cessation study many people cannot imagine being able in one go, but most people who smoke seem to group had kept off tobacco, compared to 49% to stop completely. For these people it is much try to stop by gradually reducing the amount they of the abrupt cessation group, meaning that better to attempt to cut down their smoking smoke before stopping. This research helps the abrupt group were 25% more likely to quit. than do nothing at all and we should increase to answer the questions ‘Which approach is The difference between the groups began support for gradual cessation to increase their better?’, and ‘Are both as likely to help people on quit day, when more of the abrupt group chances of succeeding.’ quit in the short and long term?’ attempted to quit (defined as having at least 24 hours with no tobacco), compared to the Mike Knapton, Associate Medical Director at Dr Nicola Lindson-Hawley from the Nuffield gradual cessation group. the British Heart Foundation, which funded the Department of Primary Care Health Sciences led study, said: ‘This study shows that the most the research. She explained: ‘We recruited 697 Dr Lindson-Hawley said: ‘The difference in quit effective way to quit smoking is to stop all at smokers who had chosen to stop smoking. They attempts seemed to arise because people once, rather than gradually reducing the number were split into two groups. One group – the struggled to cut down. It provided them with of cigarettes. This BHF funded research also ‘abrupt cessation’ group – set a quit day and an extra thing to do, which may have put them highlights just how crucial it is that smokers stopped all smoking on that day. The second off quitting altogether. If people actually made have access to advice and support from NHS group – the ‘gradual cessation’ group – set a quit attempt then the success rate was equal smoking cessation services. a quit day but gradually reduced their tobacco across groups. We also found that more people use in the two weeks leading up to that date. preferred the idea of quitting gradually than ‘Quitting smoking is the single best thing ‘Both groups had advice and support and access abruptly; however, regardless of what they you can do for your heart health which is why to nicotine patches and nicotine replacement thought, they were still more likely to quit in we successfully encouraged thousands of therapy, like nicotine gum or mouth spray.’ the abrupt group. smokers to quit for good this No Smoking Day, Once quit day had passed, volunteers were Wednesday March 9th. Setting a date, today, assessed weekly for the next four weeks, and ‘It is important to note that these results were to ditch the cigarettes is the best start towards after six months. As well as asking them about found in people who wanted to quit soon and a smoke free life.’ how they were doing, the researchers measured who were receiving counselling support and the amount of carbon monoxide they were using nicotine replacement therapy. For these The paper, Gradual versus Abrupt Smoking breathing out – an objective way to check people the best advice appears to be to pick a Cessation, is published in journal Annals of whether people were actually sticking to day and stop smoking completely on that day. Internal Medicine on Tuesday 15 March their quit plan. However, as we found that at the start of the (DOI: 10.7326/M14-2805). In Contact 11

Study Findings

Flu jabs ‘more effective in morning’

Morning flu jabs provoke a stronger immune It is not clear exactly what the critical difference response than those given in the afternoon, between the morning and afternoon immune a study shows. system is.

The trial at 24 doctors’ practices found people Levels of immune messengers called cytokines, vaccinated before lunch produced the most the stress hormone cortisol and sex hormones defensive antibodies. – all of which affect the immune system – fluctuate in a daily rhythm. The University of Birmingham team suggested immunising people in tune with the body’s And individual white blood cells also have their natural rhythm could be a cheap way to own internal clocks that alter their activity too. save lives. ‘Major gain’ Experts said the study may mark the dawn of Andrew Loudon and David Ray, a pair of body making use of ‘the body clock in the clinic’. clock professors at the University of Manchester, Our internal clock alters our alertness, mood, told the BBC News website ‘This may be the physical strength and even the risk of a heart dawn of the body clock in the clinic. attack in a daily rhythm. This is a most interesting study, and is And our immune system also waxes and wanes among the first to show how the body clock through the day. can be used to make healthcare interventions more effective.’ The trial looked at 276 healthy people, aged over 65, getting the flu jab before the 2011, ‘There have been major advances in 2012 and 2013 flu seasons. understanding how the body clock can regulate immunity in laboratory animals, but very little They were vaccinated either in a morning of that exciting science has led to changes session (9.00 – 11.00am) or an afternoon in healthcare.’ appointment (1.00 – 5.00pm). ‘This study shows that a simple intervention, One month later, patients vaccinated in giving the same vaccine at a different time of the morning had produced significantly more day, can result in a major gain in effectiveness.’ antibodies against two of the three flu strains in the jab. However, other vaccines stimulate the immune system in different ways so it is too simple to Similar antibody levels were produced for conclude that all immunisation should take place the third strain, the results in the journal before lunch. Vaccine showed. There have been some suggestions that Dr Anna Phillips, one of the researchers from the hepatitis B vaccination may be more effective University of Birmingham, said the results were in the afternoon. meaningful and doctors should ‘definitely’ think about performing flu jabs in the morning. But the concept of timing medicine to the body clock – the field of chronotherapy – is powerful She told the BBC News website: ‘A lot of and is also showing promise in treating cancer surgeries just try and fit in vaccination anyway and rheumatoid arthritis. so it’s not going to risk any patient, it’s not going to cost anything and even if we’re wrong you’ve BBC News website 26th April 2016 nothing to lose by doing this.

‘I think it’s fantastic, the idea of an intervention this easy to do and free is unheard of in terms of trying to change NHS practice.’ 12 In Contact

Study Updates The Million Women Study A national study of women’s health. It is nearly 20 years since we started Hormone replacement therapy (HRT), oral active, increasing its frequency does not seem to recruiting UK women to participate in contraceptives, and cancers of the ovary and confer further reduction in risks. It has also been the Million Women Study. With continued the endometrium thought that participation in social activities may funding from the Medical Research Council MWS investigators combined efforts with prevent heart disease. In the MWS, those who and Cancer Research UK, the study is other scientists in a global collaboration. HRT use participated in social activities were more likely providing answers to many questions relating increases the risk of ovarian cancer, with use for to be non-smokers, physically active, and have to women’s health. We are most grateful to five years from around age 50 years associated better self-rated health, which largely explained our participants and collaborators for their with about one extra ovarian cancer per 1,000 why they had a lower risk of heart disease than continued support. users. In contrast, oral contraceptive use gives those who do not engage in social activities. long-term protection against endometrial cancer, Armstrong ME, et al. Circulation 2015;131:721; Million Women Study (MWS) investigations and oral contraceptives may have prevented Floud S, et al. Eur J Prev Cardiol 2015 (E-pub). published in scientific journals since 200,000 cases worldwide in the last ten years October 2014 alone. Beral V, et al. Lancet 2015;385:1835; Risk factors for dementia Information provided by the MWS participants Allen N, et al. Lancet Oncol 2015;16:1061. A new area of research for the study is dementia. has been instrumental in our research to help With such a large, long-term study we hope to clarify some of the uncertainties about risk factors Risk factors for ‘rare’ cancers add to what is known about lifestyle risk factors. for cancers and vascular disease in women, and Our investigations into less common cancers provide novel insights into potential causes of suggest that oestrogen-only HRT use is Blood samples and genetic studies these diseases. Summaries of all published associated with increased risks of brain tumours, We continue to collect blood samples for some studies are available on the study website but the risks are small (two extra cases per women in the study, for genetic studies of breast (www.millionwomenstudy.org), but here 10,000 users over five years). We also identified cancer and of vascular disease. are a number of our recent findings: factors associated with increased risk of anal cancer, including smoking, and a history of We would like to say a big ‘thank you’ to cervical precancer. Benson VS, et al. Int J Cancer all the practices that have participated in 2015;136:2369; Coffey K, et al. Br J Cancer the study and for continuing to support 2015;112:1568. the Network.

Determinants of heart disease and stroke Learn More Physical activity is known to be beneficial to Lynden Guiver health. We found that at moderate levels, Email: [email protected]. Million Women Study investigators and staff at the it was associated with lower risks of heart disease Study website: www.millionwomenstudy.org Cancer Epidemiology Unit, University of Oxford. and stroke; but among women who were already

ExACT – Extended anticoagulation treatment for VTE: a randomised trial Funded as part of an NIHR programme grant.

Recruitment to the ExACT study has now This suggests that some patients We are also looking at the cost effectiveness finished. The study team would like to say a should continue anticoagulation long-term. of continuing oral anticoagulation treatment big ‘thank you’ to Doctors and Staff at all the However, currently we are unable to for these patients. practices that have helped to recruit patients identify this population. and make the study such a success. For those of you who are already involved: Aim of trial n We will be in contact as usual to organise In total, 281 patients have been recruited to To investigate whether extending anticoagulation rooms for follow up visits the study and patient follow up continues until treatment beyond 3–6 months, for patients with a n Please contact the study team on 0121 414 February 2017. first unprovoked proximal DVT or PE reduces the 3354 if an ExACT patient experiences any recurrence rate. adverse events Background to trial Venous thromboembolism (VTE) is common with Trial Intervention There is a reimbursement for these services. an incidence of approximately 1 per 1,000 per Patients are randomised to either continue annum. It is associated with significant mortality or discontinue oral anticoagulation and will Learn More and morbidity, including post-thrombotic be followed up every six months for two years. Sheriden Bevan syndrome (PTS). The annual recurrence rate We will be looking at D-dimer levels (a product Tel 0121 414 3354 following a first VTE is approximately 10% per present in the blood after a blood clot), the Email: [email protected] annum irrespective of the duration of development of PTS and associated quality anticoagulation therapy. of life. In Contact 13

Courses/Training Getting to Hospital at a Single Stroke

A free training initiative will be launched an online e-learning module and face-to-face It revealed that 20% of stroke patients called to help GP receptionists recognise the training events. The project has been their GP, rather than an ambulance, at the symptoms of stroke and TIA (transient developed by Dr Liz Bates, GP and NIHR onset of symptoms. After a successful pilot, ischaemic attack). Clinical Lecturer in Primary Care, in response the training will be launched later this year. to the RECEPTS study carried out at the ‘Getting to Hospital at a Single Stroke’ offers University and published in the British Journal More details: http://mymds.bham.ac.uk/ two complementary ways to access training: of General Practice, last June. eStroke/

University Accredited Courses 2016

The Institute of Applied Health Research at the University of Birmingham is pleased to introduce some new courses in 2016.

Lung Cancer Study Day We are also continuing to offer the following Monday 27 June courses over the spring and summer: This one day course is aimed at GPs and medical trainees with an interest in lung cancer, but is Learning objectives suitable for any healthcare professional regularly n Aetiology and epidemiology of thrombosis managing lung cancer patients. The course will n Symptoms and signs of DVT and PE cover diagnosis and management of all stages of n Guidelines for treatment of thrombosis disease through a combination of lectures and n How to set up community management facilitated discussion of case studies. of DVT and PE n NICE guidelines for VTE prophylaxis and Learning objectives what can be done in primary care n How to diagnose lung cancer n Surgery for lung cancer Anticoagulation Management in Primary n The essentials of chemotherapy and Care (MSc module) An Introduction to Oral radiotherapy for lung cancer 13–15 June Anticoagulation Management n Understanding palliative care for lung n This course enables autonomous practice in 21 June cancer and dying at home dealing with fundamental and more complex This course is targeted at nurses, and aims problems in oral anticoagulation management. to provide an overview of the management Anticoagulation Masterclass for Nurses n An understanding of the theory of oral anticoagulation. Tuesday 28 June underpinning anticoagulation management This study day has been designed for n An understanding of the pharmacology Learning objectives nurses working with people receiving oral of vitamin K antagonists and the relevant n A knowledge of the principles of anticoagulants who wish to advance their medication, side effects, antidotes, anticoagulation therapy, indication knowledge and skills in using vitamin K interactions and dosing for use, side effects and interactions antagonists (eg, warfarin) and direct oral n A knowledge of the management of n A knowledge of the principles of point anticoagulants (DOACs). It is a practical and anticoagulation and prevention of of care, INR testing & quality assurance clinically focused course, including lectures complications on the basis of current n A knowledge of the professional guidelines and workshops, making use of examples guidelines and existing research evidence for management of oral anticoagulation, to show how to resolve complex problems. n An understanding of the requirements audit procedures & protocol development The course will help you further develop and of clinical governance for anticoagulation enhance your skills and clinical knowledge for management, eg, developing/ Learn More management of anticoagulation, and enable adapting and applying audit tools with Amy Partleton you to translate evidence into everyday practice performance indicators Tel: 0121 414 2677 for the benefit of patients. Email: [email protected] 14 In Contact

Clinical Research Network Research Design Service West Midlands West Midlands

What is RDS WM? How can RDS WM help me?

RDS WM exists to provide help to people RDS WM can advise on all aspects of the preparing research proposals for submission to preparing grant applications, eg: peer-reviewed funding competitions for applied o Formulating research questions health or social care research. RDS WM o Building an appropriate research team essentially consists of a team of methodologists o How to apply for our public involvement based in universities and the NHS across the fund scheme West Midlands, able to advise and provide o Designing a study practical support when you are developing o Appropriate methodologies for quantitative your grant application. As RDS WM is funded research, eg, statistical issues, health by the NIHR for this purpose, such help is economics provided free of charge. o Appropriate methodologies for qualitative research, eg, sampling, analytical strategies Who can use the RDS? o Identifying suitable funding sources o Regulatory issues We support a broad range of people, including: o Writing lay summaries o Doctors, nurses and allied health o Identifying the resources required for professionals a successful project o Patients and service users o Academics and NHS and social care Advice and support is best provided managers face-to-face. RDS WM staff will be happy to meet with you at a convenient time and place to

For more information on RDS WM please contact discuss your research. It is preferable to contact Melanie Guthrie on 0121 414 8533 or us at an early stage to discuss your ideas. [email protected] www.wm-rds.bham.ac.uk In Contact 15

Clinical Research Network West Midlands

Keep In Contact

Interested in taking part in research? We’d like to hear from you. n You will always be able to choose your practice’s level of involvement. n You will be remunerated for practice time spent on research.

Contact details:

Name:

Job title:

Practice address:

Postcode:

Practice code:

Email:

Your email address will only be used to send you details of studies being undertaken by the CRN Primary Care.

Clinical Research Network: Primary Care is part of the National Institute for Health Research (NIHR). Only studies which have been independently peer-reviewed and funded through national competition; and commercial research asking relevant questions will be adopted onto the NIHR Portfolio of studies.

You can:

Fax back this form to 0121 414 2282 or Email the details above to [email protected] or Phone us on 0800 085 4229 for further information.

Alternatively, send the completed form to our postal address, as detailed on the back page. Primary Care University of Birmingham CRN: Primary Care, Murray Learning Centre, Edgbaston, Birmingham B15 2TT

Visit our website www.birmingham.ac.uk/crn-wm

General Enquiries Tel: 0121 414 8843 Fax: 0121 414 2282

Randomisation Service We now offer a telephone randomisation service for studies. Contact us for further details on 0800 6946943

Edgbaston, Birmingham, B15 2TT, www.birmingham.ac.uk 13083 © University of Birmingham 2016. Printed on a recycled grade paper containing 100% post-consumer waste.