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PC-CRTU in Contact Issue 15 – Summer 2006 Welcome to the summer 2006 edition of the In-Contact newsletter. This year so far has been one of opportunities and expansion. As you may remember from the last newsletter, PCCRTU has been collaborating with colleagues in the development of ‘Topic Specific’ Local Research Networks (or LRNs) as part of the developing UK Clinical Research Network (UKCRN). Our collaborations have been successful in gaining funding for Topic Specific LRNs covering stroke, medicines for children and most recently primary care. These are in addition to previous and ongoing collaborations concerning mental health and cancer research. These new networks aim to improve the recruitment of patients to trials and other well designed studies and are in addition to the work of MidReC and the PC-CRTU that you will be familiar with. The key difference will be that the studies run through the new networks will originate nationally rather than locally as is the case for most of our current workload. The new networks provide both opportunities and risks. The major issue we are aware of is overload of practices. We hope to avoid this by helping to coordinate the various different networks ensuring that invitations to take part in research are shared out rather than bombarding some of you endlessly. New opportunities will arise, particularly perhaps in research areas where practices have had fewer chances to participate such as mental health or paediatrics. If any practices or individuals have a special interest in one of the ‘Topic Specific’ research areas we are involved in then please let us know and we can make sure that you are included in any mailshots etc. The recent research day in collaboration with Royal College of General Practitioners (West Midlands) and R & D for Birmingham and Solihull PCT Consortium proved to be a very successful day attended by over 150 delegates and packed with presentations, posters and workshops. Prof Colin Bradley from Cork gave an excellent key note ‘Robin Pinsent Memorial Lecture’ summarising research in and around the consultation. Plenary sessions were presented on ECG reading in primary care, continence in nursing homes and users’ views in the organisation of an STD clinic. City Hospital Postgraduate centre looked after us very well although some had difficulty getting out of the car park – apologies – caused by overzealous security. We are already planning next years event! Studies currently open to recruitment include: CP450 study (variability in response to warfarin); TASMINH2 study (RCT of self management in hypertension); Genetics: primary care pathways (evaluating a new service development) MMP9 study, evaluating the accuracy of a potential serum marker for colorectal cancer. Further information about all these studies are included within the newsletter. Dr Richard McManus Clinical Director, MidReC [email protected] Dr Sue Wilson Director, Research Support Facility [email protected] Supporting Primary Care Research in the West Midlands The Research Support Facility (RSF) is the research capacity building arm of the PC-CRTU. Following an independent review of activities, the RSF has made some changes to its support programme and introduced a new Pre Fellowship Award Scheme. Advice and support continues to be made available to individuals who need help in: - developing a research proposal - applying for funding - or with any stage of a research project. Training in research methods training is provided to complement the training programme of the Birmingham Research Training Collaborative. RSF training in 2006 is focussing primarily on encouraging research dissemination (writing for publication, conference presentation skills) and the use of software packages for analysing data. The Small Grants Scheme will continue (with some changes) to provide practitioners with small amounts of funding to undertake pilot or feasibility studies which have the potential to progress to larger studies with the potential to attract external grant funding. The Pre Fellowship Award Programme provides promising individuals with an opportunity to gain further research experience while developing an application for an externally funded research fellowship provided by such agencies as the Department of Health and the Research Councils. Awards are made on a part time or full time basis for up to two years. Further information is available on the website:www.pcpoh.bham.ac.uk/ primarycare/PC-CRTU/rsf.htm or by contacting Beverley Hancock, the RSF Manager. Email: [email protected] The resources of the RSF are available to any primary care researcher, from any professional group, working in the West Midlands. Research Support Facility In this edition… GP’s invitation to serve on the MidReC Management Group Bank Nurses required New Studies News from Cardiovascular Team, Screening Team, Mental Health Team Courses and Conferences

PC-CRTU in Contact - filecarpark–apologies–causedbyoverzealous security.Wearealreadyplanningnext yearsevent! Studies currently open to recruitment include: CP450study(variabilityinresponse

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PC-CRTU in ContactIssue 15 – Summer 2006

Welcome to the summer 2006 edition of the In-Contactnewsletter. This year so far has been one of opportunitiesand expansion.

As you may remember from the lastnewsletter, PCCRTU has been collaboratingwith colleagues in the development of‘Topic Specific’ Local Research Networks(or LRNs) as part of the developing UKClinical Research Network (UKCRN).Our collaborations have been successfulin gaining funding for Topic Specific LRNscovering stroke, medicines for childrenand most recently primary care. Theseare in addition to previous and ongoingcollaborations concerning mental healthand cancer research. These new networksaim to improve the recruitment of patientsto trials and other well designed studies andare in addition to the work of MidReC andthe PC-CRTU that you will be familiar with.The key difference will be that the studiesrun through the new networks will originatenationally rather than locally as is the casefor most of our current workload.

The new networks provide both opportunitiesand risks. The major issue we are aware of isoverload of practices. We hope to avoid thisby helping to coordinate the various differentnetworks ensuring that invitations to takepart in research are shared out rather thanbombarding some of you endlessly. Newopportunities will arise, particularly perhapsin research areas where practices have hadfewer chances to participate such as mentalhealth or paediatrics. If any practices orindividuals have a special interest in oneof the ‘Topic Specific’ research areas weare involved in then please let us know andwe can make sure that you are included inany mailshots etc.

The recent research day in collaboration withRoyal College of General Practitioners (WestMidlands) and R & D for Birmingham andSolihull PCT Consortium proved to be a verysuccessful day attended by over 150 delegatesand packed with presentations, posters andworkshops. Prof Colin Bradley from Cork gavean excellent key note ‘Robin Pinsent MemorialLecture’ summarising research in and aroundthe consultation. Plenary sessions werepresented on ECG reading in primary care,continence in nursing homes and users’ views inthe organisation of an STD clinic. City HospitalPostgraduate centre looked after us very wellalthough some had difficulty getting out of thecar park – apologies – caused by overzealoussecurity. We are already planning nextyears event!

Studies currently open to recruitment include: CP450 study (variability in responseto warfarin);

TASMINH2 study (RCT of self managementin hypertension);

Genetics: primary care pathways(evaluating a new service development)

MMP9 study, evaluating the accuracyof a potential serum marker forcolorectal cancer.

Further information about all these studiesare included within the newsletter.

Dr Richard McManusClinical Director, [email protected]

Dr Sue WilsonDirector, Research Support [email protected]

Supporting Primary CareResearch in theWest Midlands

The Research Support Facility (RSF) isthe research capacity building arm ofthe PC-CRTU. Following an independentreview of activities, the RSF has madesome changes to its support programmeand introduced a new Pre FellowshipAward Scheme.

Advice and support continues to bemade available to individuals whoneed help in:- developing a research proposal- applying for funding- or with any stage of a research project.

Training in research methods trainingis provided to complement the trainingprogramme of the Birmingham ResearchTraining Collaborative. RSF trainingin 2006 is focussing primarily onencouraging research dissemination(writing for publication, conferencepresentation skills) and the use ofsoftware packages for analysing data.

The Small Grants Scheme will continue(with some changes) to provide practitionerswith small amounts of funding to undertakepilot or feasibility studies which have thepotential to progress to larger studies withthe potential to attract external grant funding.

The Pre Fellowship Award Programmeprovides promising individuals with anopportunity to gain further researchexperience while developing an applicationfor an externally funded research fellowshipprovided by such agencies as theDepartment of Health and the ResearchCouncils. Awards are made on a part timeor full time basis for up to two years.

Further information is available on thewebsite:www.pcpoh.bham.ac.uk/primarycare/PC-CRTU/rsf.htm or bycontacting Beverley Hancock, the RSFManager. Email: [email protected]

The resources of the RSF are availableto any primary care researcher,from any professional group, workingin the West Midlands.

ResearchSupport Facility

In this edition…

GP’s invitation to serve on the MidReCManagement Group

Bank Nurses required New Studies News from Cardiovascular Team, Screening Team,Mental Health Team

Courses and Conferences

News from the Cardiovascular Team

The SCANAG trial examines the role ofnortriptyline, the old tricyclic antidepressant, instopping smoking. Nortriptyline is an effectivemedication for smoking cessation , as you canread in this Cochrane review(www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD000031/frame.html).What we examined in SCANAG was whetheradding two proven effective medicationstogether, nicotine replacement therapy (NRT)and nortriptyline would outperform NRT andplacebo. The trial recruited 901 participantsduring 2004–5, and the last follow up ofparticipants recruited in June 2005 is beingcompleted now, with big sighs of relief fromthe team. We will aim to publish this data assoon as possible, to get it out in time for theResearch Assessment Exercise (RAE). If youhave patients who want to stop smoking andhave tried ‘everything’, you could considerprescribing nortriptyline, building up to75mg/day over one to two weeks before theystop and for 6–12 weeks thereafter. Researchshows that having a track record of many failedquit attempts does not reduce a person’schances on their next go. So they (andyou as prescriber) should keep on going.

…..or St John’s WortOf course, people who have tried one wayoften (wrongly) ascribe their failure to thefailure of the method they used, in this casemedication, so new alternatives are welcome.Zyban (bupropion) and nortriptyline are bothantidepressants that help people stop smoking,whereas other antidepressants, including theSSRIs do not do so. St John’s Wort is aneffective antidepressant and might also work,and appears to work in rats who arewithdrawing from nicotine. In the SJW-C trial,funded by Cancer Research UK, we randomiseindividuals to St John’s Wort or placebo toexamine whether St John’s Wort can increasethe (short-term) quit rate. If participants fail toquit in the short-term, they are offered nicotine

replacement therapy and provided with supportto quit again. In addition, participants arerandomised to either chromium or placebo toexamine if chromium can prevent post-cessation weight gain, which is typically around0.3kg/week initially and about 5kg by the endof a year. Would you or your practice beinterested in taking part in this trial?Wewould write to smokers on your list, and wecould either train your nurse to administer thetrial, or use one of our Research Nurses if youhad an empty room. Your costs would becovered. If you are interested, contact AmandaParsons on 0121 414 8611.

… or the 3Ts studyThe uptake of cigarettes, the amount smoked,and the ability of people to give up is understrong genetic control with up to 70% of thevariance in people’s smoking habits explainedby genes. We can tell this from twin(monozygotic versus dizygotic) and adoptionstudies. We do not however, for the most part,know which genes are involved. However,findings are emerging related to variants insome neurotransmitter systems. For example,an opioid receptor gene variation calledOPRM1 has recently been linked to outcomesin attempts to stop smoking. People with thevariant Asp allele were shown to be more likelyto quit with more prolonged and higher dosesof NRT, whereas for individuals with the wildtype (ie more common) Asn variant, normaldose NRT was as effective as high dosetreatment. In our own data, people with thevariant were more likely to gain significantweight after stopping smoking. Such databegin to open the door to tailoring of treatmentto individuals.

There is a problem in preventative medicinewith genetic testing, however. We are oftenusing genetic tests to refine risk prediction, andwe want to use that refined risk prediction tomotivate people to make changes in their

behaviour to reduce the likelihood of futuredisease occurring. Emerging evidencesuggests that people see genetic feedbackabout risk as different to say, behaviouralfeedback. Thus, individuals tested and at highrisk because of their genotype do not see theconnection between the biologically revealedrisk, and the solution suggested, such asstopping smoking. Rather they see thatbiologically conferred risk requires biologicalsolutions, such as taking medication. In the 3Tsstudy, we have hypothesised that geneticfeedback will motivate increased adherence tonicotine replacement therapy as compared topsychological or behavioural feedback. In onearm then, individuals will undergo a genetictest for OPRM1 status. All participants will beprescribed a nicotine patch, and top-up oralnicotine replacement (gum, lozenge, microtab,or inhalator) with the dose determined bywhether they are Asp or Asn variant. Inthe other arm, individuals will undergo apsychological test for nicotine dependence,receive a patch, with the dose of top-uptreatment determined by high or low addictionscores. The smoking cessation support offeredis standard, and there is clear evidence thatcombinations of NRT are more effectivethan patch alone, and combination treatmenthas been licensed recently by the MHRA.Practices who want to take part would needto write to their list of registered smokersto invite them into the study and providea consulting room for use by our ResearchNurse. Your costs would be reimbursed.If you want to discuss this, please contactDr Paul Aveyard on 0121 414 8529.

Stopping smoking with SCANAG

There are forty ways to leave your lover, and about as many tostop smoking. In both cases, some ways work better than others.One of the aims of the department is to expand the list of ways tostop smoking.

This study aims to make the managementof warfarin therapy easier! By measuringenvironmental and genetic factors thatare known to influence INR, it is hopedto develop an algorithm for individualisedwarfarin dosing. Due to the increasingnumbers of patients in primary care beinganticoagulated, this is an important issue.

The potential benefits of this would include: improved safety of warfarin withreduced morbidity and mortality,

improvement in patient quality of life, improvement in the cost effectivenessof warfarin therapy and

improved uptake of warfarin,particularly for atrial fibrillation.

A cohort of 400 patients with Atrial Fibrillation(AF) are being recruited from about 100primary care practices within the WestMidlands, Warwickshire, Worcestershire andHertfordshire. Many thanks to all who haveresponded and are participating in this study.We have recruited 37 practices so far, of which25 are actively recruiting patients. We urgentlyneed to recruit more practices in order toachieve our target and with more practicesinvolved each has only to recruit about4 patients.

Training is offered locally within practices,and practices are reimbursed for GP andpractice nurse time spent on training, patientrecruitment and final data collection. Eachpatient makes just four visits over a six-month follow-up period, completing shortquestionnaires and providing blood samples.Data is collected via a secure online database.We can support practices by helping toidentify eligible patients and assisting withpatient visits.

For further information please contact:Dr Trini Closa LeónTel: 0121 414 2954Email: [email protected]

A prospective analysisof pharmacogenetic andenvironmental factors(CP 450 Study)

This major study has been funded by the BritishHeart Foundation and the Heart of Birminghamteaching PCT to establish, for the first time, thecommunity prevalence and severity of heartfailure amongst the South Asian and AfricanCaribbean communities.

To date, these communities have been eitherexcluded or under-represented in studies so thata population survey is needed. This will enablethe planning and delivery of cost-effectivetreatment within the wider community.

New studyHeart Failure amongst the minority ethnic communities inBirmingham: The E-ECHOES (Ethnic – EchocardiographicHeart of England Screening) Study

Individuals from these ethnic groups, aged 45years and above will be invited and screenedby researchers within general practices inthe Heart of Birmingham teaching PCT area.There is minimal workload for practices.

If you would like to know more aboutthis study please contactDr Paramjit GillTel: 0121 414 3758Email: [email protected]

TASMINH2 is a DH-funded RCT comparingself management of hypertension (self monitoringplus self titration of medication following pre-determined GP instructions) with normal care.We are pleased to report that the DH has justconfirmed an additional £300,000 of funding toallow incorporation of telemonitoring (sending BPresults to the research team and practices via aphone line) and a qualitative evaluation. We nowhope to start in the autumn and we will be looking

TASMINH 2 – An RCT ofPatient Self Managementof Hypertension

for 14–16 practices to recruit a total of 480patients (ie 30–35 patients with poorly controlledtreated hypertension per practice). If you havepreviously notified us that you would be interested,don’t worry, we haven’t forgotten you andwill be in touch soon. In the meantime anyoneelse potentially interested should contact:Emma VinceEmail: [email protected]

Variability inresponse towarfarin

Colposcopy is an important aspect of the NHScervical screening programme and is themeansof identifying pre-cancerous changes andimplementing any treatment required. Whilstthe effectiveness of treatment undercolposcopy is recognised and there have beena number of service developments in recentyears, such as the introduction of nursecolposcopy, there has been a limited amountof work that has addressed issues relating topatient’s preferences. Takinginto account patient’s preferences regardingthe delivery of the service may be important,not only in ensuring high satisfaction rates, butalso to reduce DNA rates and ensure womenattend follow-up appointments. In order toaddress these issues, this study aims to gainan insightinto the experience that patients have of thecolposcopy service. The investigation will

interview patients, from two Birminghamcolposcopy clinics (BirminghamWomen’sand City Hospital), about their experienceof colposcopy using qualitative in-depthinterviews. The outcome of the analysiswill be to determine the main factors patientsperceive to be important in their experienceof the colposcopy service. This informationwill be fed back to service providers and willalso be used to develop a questionnaire whichwill be sent to a larger, more representative,study population.

The study is currently in the interview stage,12 interviews have been conducted andinterviewing will continue until saturationoccurs which is anticipated this summer.

News from the Screening Team

Understanding the experience of colposcopy:A step towards service improvement

The CUBE trial is now completed and the teamare busy analysing the data. The first resultswill be presented at the Society for AcademicPrimary Care conference in July 2006, with fullpublications expected soon after. The CUBE teamwould like to thank all those involved in the CUBEstudy, for all their hard work and effort. Results willbe fed back in the next edition.

For any further information pleasecontact the Trial Administrator:Vivienne Tsimbilitel: 0121 414 3765Email: [email protected].

Self-testing is where a member of the publicbuys a test from a shop or over the Internet tosee if they may have a condition withoutinvolving a doctor, nurse or other healthprofessional. Examples include tests forchlamydia, prostate specific antigenand faecal occult blood. The range andaccessibility of self-tests has increaseddramatically over the last few years, butthere have been very few studies lookingat who is using self-tests and how or whythey are being used.

Last year, several general practices took partin a feasibility study about self-testing, fundedby Cancer Research UK. The focus was self-tests related to cancer, but preliminary resultssuggest that about 14% of people had usedany self-test (other than a test for pregnancyor high blood pressure) and that about 62%of people would use one in the future.

The Department of Primary Care and GeneralPractice at the University of Birmingham hasnow received funding from the Department ofHealth to carry out a full study looking at allself-tests. This study aims to get a preciseestimate of the prevalence of the use of anyself-test and determine factors that areassociated with using them.

The study has two stages. The first stageinvolves sending a short questionnaire aboutthe use of self-tests to people from generalpractice lists. A small number of respondentswill then be invited to discuss self-tests inan interview or focus group. A more detailedquestionnaire about why people use self-tests will then be designed and sent torespondents to the first questionnaire.

It is hoped that the outcomes from this studywill include recommendations about how to

improve the appropriate use of self-tests andalso health services, as well as information toprepare health professionals for people whoare using self-tests.

We will be approaching general practices inthe near future to ask them to take part in thisstudy. We would send the initialquestionnaire to samples of adults randomlyselectedfrom practice lists, excluding people whoit would be inappropriate for us to approach,for example because of a terminal illness,severe mental illness or recent bereavement.

If you are interested in collaborating withthis research, please contactAngela RyanTel: 0121 415 8015.Email: [email protected]

Use of medical self-tests by members of the public

CUBE

The BeST study is looking at thedevelopment of Cognitive BehaviouralTherapy (CBT) in patients with low backpain in a primary care setting. It is hopedthat this will empower patients to managetheir own back pain. We are collaboratingon this study with The Universityof Warwick.

The trial is a randomised controlled trialcomparing CBT with normal care, with allparticipants being given a copy of The BackBook. Patients are identified by read-codesearch and are contacted by letter explainingthe study. (All interested and eligible patientsare assessed by a Research Nurse). We areable to provide Research Nurse support tointerested practices to run the initial searchand also to assess the patients.

Two thirds of the patients will be randomisedto receive CBT in the form of 6 x 1.5 hoursessions (over a 6 week period).

We are now running the trial in Heart ofBirmingham and South Birmingham PCT’sand have so far randomised 30 patients. Weare still looking for further practices in these2 PCT’s to participate in the study, if youwould like more information please contact:Jo-Anne MilesTel: 0121 414 3323Email: [email protected]

The BeST Study(The Back Skills Training Trial)

The Rotavirus study is looking to estimate theburden of rotavirus in children aged under 5,including incidence rates, seasonal variationsand economic costs.

The study has now been running for 6 months in16 practices across Birmingham, we have beennotified of 228 patients and have found 13 positivecases of Rotavirus. We know that Rotavirus isseasonal and that technically the season has nowfinished but it is still very important to notify us ofany case of diarrhoea in the under 5 population.

We would like to thank all the participatingpractices and the Bank Nurses for their hardwork over the last 6 months.

Jo-Anne Miles

TheRotavirusIncidence Study

MMP9 UHBThis is a study to assess the value of a newblood test in improving the appropriateness ofurgent referrals to colorectal clinics. The studywill compare the MMP9 level of people whohave been referred to a colorectal clinic withthe results of examinations and investigationsundertaken at, or shortly after their clinic visit.If a high MMP9 level does identify peoplewith colorectal cancer or polyps, thetest could assist general practitionersin deciding which patients should bereferred urgently.

Our aim is to recruit around 1060 patientsand we have nearly achieved this target with acurrent total of 1,000 patients recruited to thestudy. We are now collecting outcomes anddata analysis will be completed by the endof the year.

For further information contact:Sally WarmingtonEmail: [email protected] Angela RyanEmail: [email protected]: 0121 414 8589.

MMP9 CR-UKThe aim of this study is to assess the accuracyand acceptability of MMP9 as a potentialscreening test for colorectal cancer. Allparticipating patients will provide a blood samplefor MMP9 estimation and have a colonoscopy(gold standard screening test for colorectalcancer). Comparison of MMP9 levels and thecolonoscopy results will establish the accuracyof the test. To achieve the end points of thestudy 700 colonoscopies will be undertakenand to date 182 have been performed.

General practices agreeing to participatewith the study are essential to the processof patient recruitment. The first phase of practicerecruitment is complete and 11 practices areinvolved in the study. However we aim to recruita total of 29 practices within travelling distanceof the QE.

Any other practices interested inparticipating should contact either:Dr Sue Wilson, [email protected] Redman, [email protected] Colbourne, [email protected]: 0121 414 2688

MMP9MMP9 Studies

Increased levels of MMP9 have been found in the bloodof people with colorectal cancer and polyps. Two ongoingstudies (MMP9 UHB and MMP9 CR-UK) aim to establishthe accuracy of MMP9 and determine whether it will beof value in increasing the proportion of colorectal cancersdiagnosed at an early stage of disease.

This multi-centre study funded by the HealthTechnology Assessment (HTA), is asking thequestion – what is the utility of Liver FunctionTest (LFT) abnormalities in predicting riskof serious treatable disease? The aimis to develop an algorithm to inform GPdecision-making within the consultation.

Patients with abnormal LFT’s detected duringroutine consultation will (after consent ofcourse), undergo extensive investigations

including further blood tests, and anultrasound of their liver. All results willthen be fed back to the GP with furtherfollow-up if indicated.

We have four practices local to UHB currentlytaking part. If you would like to take part orwant further information, please contact:Louise Bentham,BALLETS Study Coordinator (Birmingham)[email protected]

Birmingham And Lambeth LiverEvaluation Testing Strategies –BALLETS Study

The aim of this service development initiative isto develop and evaluate patient pathways forthe identification of patients at risk of aninherited cardiac, endocrine or renal condition.Six general practitioners (GPs) from the Heartof Birmingham teaching PCT (HOBtPCT) arecurrently participating in this initiative and haveimplemented the model patient pathways.Three practices have implemented the reactivepatient pathways and are displaying postersabout the service. One GP has implementedthe proactive pathway and is targeting newpatients registering with the practice, and a fifthpractice is monitoring patient-initiated interestand demand for genetic services. During thenext 3 months we will be evaluating thepathways in each of these practices andinviting patients that enter the pathways totake part in telephone interviews and completeanxiety, worry and satisfaction questionnaires.

We would like to recruit a further 2HOBtPCT practices to implement theproactive pathways. A number of focusgroups and interviews have been conductedwith primary care health professionals toexplore attitudes towards primary careprovision of genetics services for commoncardiac, renal and endocrine genetic disorders.During August and September 2006 we willbe offering primary care health professionalsthe opportunity to express their opinionsregarding the expansion of their role andparticipate in interviews and focus groups.

If you would like to participate inthis service development initiativeby implementing patient pathwaysor taking part in a focus group orinterview, please contact Debbie McCahonon 0121 414 2957 for more information.

Development of patient pathways toidentify risk of genetic disorder inprimary care

We know that at least 6 million peopleconsult their GP with sore throat eachyear costing an estimated £25 million inconsultations and a further £6–12 millionwith prescribing and complication costs takeninto account. Antibiotic resistance is still amajor threat to public health and the key isto reduce use for those that will not benefit.

We are looking to strengthen the evidencebase (and therefore improve patient care) forthe treatment of sore throats and so will beasking practices to recruit patients whoconsult with a sore throat. One study(DESCARTES – MRC funded) is evaluating

management decisions in the treatmentof sore throat. The other study (PRISM –Department of Health HTA Programmefunded) will test the accuracy and utilityof near patient testing for streptococcalantigen in the diagnosis and treatmentof people with sore throat.

We will be writing to invite practices toparticipate in the near future but if youwould like to know more about eitherstudy now please contact:Ros SalterTel: 0121 414 6505Email: [email protected]

Another unanswered questionfor General Practice!

PC-CRTU in collaboration with six universities will belaunching two sore throat studies during the coming autumnand winter months.

News from the Screening Teamcontinued

The Specialist Workers for Older People (SWOP)service was introduced by Heart of Birminghamteaching Primary Care Trust in December 2004.The scheme provides a case management servicefor vulnerable older people. It aims to help peopleto: avoid unnecessary hospital admissions; remainindependent in their own homes; and to improvequality of life. Eligible people are assigned a SWOPworker who co-ordinates all aspects of their care,including health, social and housing needs.

An evaluation of the SWOP scheme wascompleted by the University of Birmingham inMay 2006 and was carried out in two parts: a‘before and after’ study and a user satisfactionsurvey. The evaluation concluded that the service isvery successful. Multiple hospital admissions werereduced, as were the number of home visits carriedout by Primary Care practitioners. The UserSatisfaction survey found high levels of satisfactionwith the service, demonstrating the value of theservice to patients.

If you have any queries about the SpecialistWorkers for Older People scheme, pleasecontact Kate Fletcher on 0121 414 8091.

Evaluation of theSpecialist Workers forOlder People service.

Nominations to serve on MidReCManagement Group

Nominations are sought for aGP representative toserve on the MidReC Management Group (for a threeyear period). Meetings are held quarterly and practicesare re-imbursed on an annual basis for time out ofpractice and travel. Members of the ManagementGroup are eligible to be Trustees of the MidReCCharitable Trust.

If you would like to nominate yourself or a colleague,or would like further information about the MidReCManagement Group, please contact:

Mrs Sheila BaileyMidReC AdministratorDepartment of Primary Care and General PracticePrimary Care Clinical Research and Trials UnitThe University of BirminghamPrimary Care Clinical Sciences BuildingEdgbaston, Birmingham B15 2TTor fax to: 0121 414 2282

Closing date for receipt of nominations is NoonFriday 1 September 2006.

Nominations to serve onMidReC Management Group

Completed studiesEDEN: The EDEN project is due to close inJuly 2006. The research has involved over300 interviews with Early InterventionService (EIS) health professionals, servicesusers and families focussing on theimplementation and impact of new serviceson the care of young people with firstepisode psychosis. Reports and papers arecurrently being prepared for the Departmentof Health and peer reviewed journals.Contact details: Helen RogersEmail: [email protected]

Studies in progressNATIONAL EDEN: National EDEN (fundedby the Department of Health and the MentalHealth Research Network, £1.64 million2005-9) is now underway evaluating multipleaspects of EIS across England. This studyinvolves collaboration with the Universities ofCambridge, Bristol and Manchester and isled by Professor Helen Lester and ProfessorMax Birchwood at The University ofBirmingham.Contact details: Natasha PosnerEmail: [email protected]

REDIRECT: This randomised controlled trialaims to evaluate the effect of GP educationon the referral of young people with firstepisode psychosis to EIS. We are now

recruiting patients in over 100 practices inthe Heart of Birmingham and EastBirmingham PCT. The primary care trainingmaterials to help GPs diagnose youngpeople presenting with early symptoms offirst episode psychosis are now being usedroutinely by early intervention services inNew Zealand, The Netherlands and Canada.We are still looking to recruit practicesfor this study!Contact details: Lynda TaitEmail: [email protected]

Other successesWe’re delighted to say that one of the papersfrom the Mental Health Team has beenawarded the RCGP/BOOTS PAPER OFTHE YEAR for 2006. The winning paperProviding primary care for people withserious mental illness: a focus group studywas published in the British Medical Journalin 2005. The first author, Professor HelenLester, has also been awarded the John Fryaward 2006 by the RCGP.

Dr Elizabeth England has now takenup a prestigious National ResearcherDevelopment Award and will be evaluatingthe commissioning of Early InterventionServices across the West Midlands fromthe perspective of PCTs and StrategicHealth Authorities.

News from the MentalHealth Team

In 2005/06 the Mental Health Team continued toconsolidate existing research studies and disseminatecompleted work nationally and internationally. The teamalso developed a significant policy focus; with the teamlead Helen Lester (recently promoted to Professor)leading the expert panel that reviewed the Quality andOutcomes Framework in the GP contract. The teamcontributed to reports in a number of significant areasof mental health and primary care including depression,anxiety and dementia. These reports were presentedto the national negotiators and helped to informchanges to the GP contract that affect the care ofpatients across the UK.

People with moderate/severe depressionshould be treated with an antidepressant andthe NICE guidelines recommend an SSRI asthe first line treatment. These work well for manypeople but not all people respond. GenPod isan innovative research study, funded by theMRC, investigating two possible explanations.

Genes or severityThe genes we inherit may affect response toSSRIs. Studies investigating polymorphism in thepromoter region of the gene which encodes theserotonin transporter suggest that the long formis functionally more active than the short. It maybe that patients who are homozygous for theshort form are those who fail to respond toSSRIs. Alternatively, the severity of the illness maybe the controlling factor. Doctors have observedthat patients with more severe depression dobetter on the older tricyclic antidepressants,which block the re-uptake of serotonin andnoradrenaline. Low levels of noradrenaline areassociated with severe depressive episodes.It is possible that specific noradrenalinereuptake inhibitors (NaRIs) will be moreeffective for these patients.

SSRIs or NARIsWe know that both SSRIs and NARIs areequally effective, but we don’t know which onewill be more effective for whom. GenPod willaddress this question, helping GPs to targettreatment and prescribe the most appropriateantidepressant for each patient. As well asachieving significant savings to the healthservice in time and money, this project will alsobenefit the patient by speeding recovery.

GenPod is being carried out by the Universityof Bristol and University of Birmingham.We are asking GPs to identify patients whomthey feel would benefit from treatment with anantidepressant. There are over 25 participatingpractices in the Birmingham area and over 300patients have been recruited into the trial.

If you would like to be one of the participatingpractices or find out more about the study,please contactProfessor Helen LesterTel: 0121 414 2684Email: [email protected]

Antidepressants:hitting the target

Background: Almost 35,000 people arediagnosed with bowel cancer each year inthe UK and 16,000 people die from thisdisease every year, making it the secondmost common cause of cancer death inthe UK. The public health impact andavailability of suitable methods fordiagnosing and treating bowel cancermake it a suitable condition for screening.A bowel cancer screening programme willbe phased in throughout the UK withnational coverage planned by 2010. Theprogramme will screen men and womenaged 50–69 using faecal occult bloodtesting (FOBt). A pilot study has indicatedthat national screening is feasible in theUK, however, the uptake rates were onlyaround 60%.

This cross-sectional questionnaire surveyaimed to investigate the acceptability ofsampling for FOBt in a large community

sample by: (1) investigating whether theacceptability of FOBt varied with differentmethods of sampling and (2) investigatingwhether the acceptability of FOBt varied withlevel of experience of FOBt.

Participants: Population sample of 1,300participants aged 50–69 from two generalpractices in South Birmingham PCT area.Those known to have colorectal cancer or anyother patients the GP deemed unsuitable tobe sent a questionnaire were excluded.

Methods: Postal questionnaire asking aboutsocio-demographics and the acceptability,practical issues and previous experience ofFOBt. The acceptability of three differentmethods of FOBt sampling were assessed:(1) a sterile transport swab; this samplingmethod is currently not in use; (2) the hema-screen card that will be used in the nationalscreening roll-out; (3) the faecal specimen

pot that is currently used in general practiceand secondary care.

Results: The participation rate was 63%.The idea of FOBt in general was highlyacceptable, but acceptability rates fellsignificantly when the actual samplingmethods were described. The swab wasrated significantly more acceptable than thecard or the pot (p<0.0005). The swab wasrated as the best method by 56% ofresponders, then the pot (22%), and card(7%). FOBt acceptability did not vary withprevious experience of FOBt.

Conclusions: The acceptability of FOBtvaried by the sampling method. To increasethe uptake of screening, new methods offaecal sampling should be designed, testedand compared.

This year we were pleased to have an intercalated student (medical students who take a year out of their studies to complete a

research degree) undertake a project based in primary care. We are especially grateful to Dr. Coward (The Kings Norton Surgery)

and Dr. Kelly (Yardley Wood Health Centre) for allowing their practices to participate in the project.

Title: Different faecal sampling methods alter the acceptabilityof faecal occult blood testing in screening for colorectal cancer:a cross sectional survey in a general practice population.

For more information, please contact Richard Ellis (medical student) c/o Dr Sue Wilson, email: [email protected]

Anticoagulation Courses aimed at GeneralPractitioners, Nurses, Pharmacists,Bio-MedicalScientists and other Health Care Professionals.

Accredited Oral Anticoagulation ManagementA three-day course providing the knowledge and skills necessary foreffective management of oral anticoagulation in primary care. Includessix months post-course clinical supervision.

Patient Self-Testing / Management (PSM)A one-day event that defines the content of a patient educationprogramme and provides guidelines for health professionals.

Oral Anticoagulation Management - Update DayFor continued professional development and to keep up to date withcurrent issues.

For further details or to reserve a place, please contact Deborah Bird:Email: [email protected] www.anticoagulation.org.uk

Health and OpportunityStrength and Directionin Primary Care Research27-28 November 2006The Adelphi Hotel, Liverpool

The UK Federation of Primary Care ResearchOrganisations is the collective body for primarycare research and development organisationsin the United Kingdom.

The infrastructure for primary care research ischanging and researchers need to make themost of opportunities to pursue the goal ofBest Health, the focus of the new nationalresearch strategy. The key strength of primarycare research is contributing to Best Health byproducing evidence about new treatments,better services and the development ofpractitioners.

This year’s Annual Conference embracesthese dual themes of Health and Opportunityand will focus on the strengths of primary careresearch and demonstrate how researcherscan meet the challenges and new directionscreated by change.

Outline Programme Plenary Sessions Papers, posters and workshops Research Interest Groups Annual General Meeting of theUK Federation of Primary CareResearch Organisations

Conference dinner

Keynote Speakers will include: Professor Janet Darbyshire Professor Martin Roland Dr Lucy McCloughan Dr Mark Gabbay

Information about the programme andspeakers will be available on the website asarrangements progress: www.ukf-pcro.org

Call for abstractsProposals are invited for papers, posterpresentations and workshops on primary careresearch, research capacity development andresearch policy and practice. Closing date forsubmission of abstracts is July 31st.

The conference will be of particular interest to: Researchers at all levels of expertise Research teams Research networks, research organisationsand RDSUs

Academic departments involved in primarycare research

Primary Care Trusts and Consortia

Conference Fees £180 (non residential) for two daysattendance. Accommodation at an additionalcost is available (please state on bookingform).

£120 for one day attendance

Please note that there is a discount of £15on the conference fees provided you quoteMidReC or RSF member on the booking form.

Further InformationFor information on how to submit anabstract, more details on the programmeor to make a booking, please visit thewebsite: www.ukf-pcro.org

9th Annual Conference of the UK Federationof Primary Care Research Organisations

Other clinical basedcourses on offer from theDepartment of PrimaryCare and General Practice.

Birmingham AnticoagulationProgram for Primary Care.The practical tool foranticoagulant management.

Diabetes ManagementOffers accredited certification andvalidation of competencies for all thoseinvolved in diabetes care in the community.Includes post-course clinical supervision.More details are available atwww.diabetes-courses.co.uk

Dermatology TrainingA five-day course providing a concise and systematic understanding ofdermatological knowledge and its application in clinical practice. Offeringaccredited certification, this event provides skills to manage dermatologyproblems presented in the community.

The validated warfarin dosing tool (CDSS).Written by The Department of Primary Care & General Practice,University of Birmingham, BAP-PC has been used for facilitatinganticoagulant dose adjustment in Primary Care over the past sevenyears. The calculation of a suggested anticoagulant dose from a patient’sINR is based upon a validated and published equation for calculatingwarfarin dosage.

Features – The basic package offers:100 patient licence, 12 months FREE technical support, Easily managedclinics, Approved dosing & recall functions, Comprehensive audit facility,Stand-alone or network capability. Trial version available on request.

BAP-PC provides advice on warfarin dose and recall date calculation.It relies on the user applying clinical judgement. It is NOT a substitutefor that clinical judgement.

For further info contact Jonathan BettsTel: 0121 414 2283 Email: [email protected]

The Cardiovascular Team are running a studylooking at the pharmacogenetics of warfarin.We require nurses to visit participatingpractices to carry out study visits. These willinvolve the collection of blood samples,review of patient notes and entering dataonto a secure online database.

The nurses are required to be experiencedusing the vacutainer venepuncture systemand to be able to input data onto computer.

Training will be provided by the study teamand payment will be made on a per visitbasis. If you are interested in registering forour Nurse Bank, please complete theavailability form below and return to:

Mrs Ros SalterMidReCDepartment of Primary Care& General PracticePrimary Care Clinical Sciences BuildingEdgbaston, Birmingham B15 2TT

or fax to: (0121) 414 2282

Alternatively if you are interested in findingout more about the Nurse Bank, pleasecontact Ros SalterTel: (0121) 414 6505Email: [email protected]

Bank Nurses required

MidReC runs a Nurse Bank to assist with data collection for our studies. All work is on anad-hoc sessional basis and can be fitted around existing practice commitments. Hours areflexible to suit both practices and patients. We are looking for registered nurses to complementour existing Nurse Bank.

Surname: ________________________________________ Forenames: _________________________________________ Initials ____________

Address: ________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________

________________________________________________________________ Postcode:______________________________________________

Contact telephone numbers (please tick box to indicate which number you would prefer us to contact you on)

Home No: _____________________________ Mobile No: __________________________

Practice No: ___________________________

Email address: ____________________________________________________________________

From time to time our studies require researchers that can converse in different languages. If you are fluent in more than one

language please let us know:

Availability form

Please tick box as appropriate

I am willing to do clinical work, ie ECG’s, blood taking (and my registration is up to date).

I am willing to do note searching and non-clinical work

I can work for the bank at the following times:

Mon:__________ Tues: ___________ Wed: ___________ Thurs:___________ Fri:__________

Please state which areas you are willing to travel to: ________________________________________________________________________

________________________________________________________________________________________________________________________

BAFTA aims to determine whether Aspirin orWarfarin is the best form of stroke preventionin people who are aged 75 years and over whohave a diagnosis of atrial fibrillation. Over 300practices throughout England and Wales aretaking part, and they managed to recruit 973patients into the study – exceeding our 930target! Recruitment ended in December2004 and follow up will finish at the endof September 2006.

Once again we would like to thank everyone fortheir hard work – without it we would not havebeen able to recruit such an amazing numberof patients. We’d also like to remind you tokeep sending us the follow up information,as it is really important that we continue tofollow up as many of the recruited patientsas possible. Kate Fletcher – 0121 414 8091.

The following abstract is taken from a paper byVictoria Hurley, Research Fellow, which wasaccepted for publication by the InternationalJournal of Cardiology. The full article will beavailable later in the year. Many morepublications are anticipated following finalanalysis. You will of course be kept fully

Birmingham Atrial Fibrillation Treatmentof the Aged (BAFTA) study publication.

Would your practice liketo take part in this project?

It has been funded by the NHS ServiceDelivery and Organisation R & D Programmeand will determine what pattern of servicedelivery will best meet the needs of people

What is the optimum model of service deliveryfor Transient Ischaemic Attack (TIA)?

who have had a TIA. Four different patternsof service provision will be assessed: currentpractice; enhanced primary care services;a ‘999’ service and a rapid access neuro-vascular clinic. A mathematical model willbe used to predict how many strokes willbe prevented by each of these services andat what cost.

I am interested in taking part in the ‘What is the optimum model of service delivery forTransient Ischaemic Attack?’ project. Please send me further details.

Name: ___________________________________________________________________________

Surgery: __________________________________________________________________________

Surgery Address: __________________________________________________________________

_________________________________________________________________________________

Telephone Number:___________________________ Fax Number: __________________________

informed. If you have any questions, pleasecontact Dr Jonathan Mant on 0121 414 8582.

A cross-sectional study of hypertension inan elderly population (75yrs and over) withatrial fibrillation: secondary analysis of datafrom the Birmingham Atrial Fibrillation in theAged (BAFTA) randomised controlled trial.

Introduction: Atrial fibrillation (AF) andhypertension are two common conditionsin the elderly, associated with significantmorbidity and mortality. Little information iscurrently available regarding the epidemiologyof hypertension in elderly patients with AF inprimary care.

Subjects and Methods: A secondary analysisof data from the Birmingham Atrial FibrillationTreatment of the Aged (BAFTA) study,a randomised controlled trial of themanagement of AF in a general practicepopulation. The study population comprisedpatients aged 75 and over with ECGconfirmed AF. Blood pressure wasrecorded in the general practice surgery ontwo occasions using standardised methods.

History of hypertension was sought fromthe GP medical records and from askingthe patient.

Results: 3059 subjects had ECG confirmedAF. The prevalence of a diagnosis ofhypertension in this group was 57.5%.The mean systolic blood pressure (SBP)was 141mmHg (standard deviation, SD.21mmHg) in men and 144mmHg (SD.22mmHg) in women. The mean diastolicblood pressure (DBP) was 79mmHg (SD.12mmHg) in men and 80 mmHg in women(SD 12mmHg). The mean SBP was slightlylower than that of the general populationaged 75 and over, but the mean DBP wassignificantly higher in patients in AF (by 8mmHg). Among the patients with a diagnosisof hypertension, 86.5% were on bloodpressure lowering medications.

Conclusions: Hypertension is more commonlydiagnosed in older patients with AF than in thegeneral population. The mean SBP is slightlylower, but the mean DBP substantially higherin older patients in AF, compared to thegeneral population.

We need to send questionnaires to patientswho have had a recent TIA to find out theirpreferences. The workload for practices willbe minimal.

For further details please contact Dr JonathanMant or Kate Fletcher on 0121 414 8582, orcomplete and return this form.

Please return form to:Kate FletcherDepartment of Primary Care andGeneral PracticePrimary Care Clinical Sciences BuildingUniversity of BirminghamEdgbastonB15 2TT

or fax: 0121 414 3759

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PC-CRTU CONTACTSRichard Hobbs DirectorRichard McManus Clinical DirectorSue Wilson Trials DirectorRos Salter R&D Manager

Andrea Roalfe StatisticianMiren Jones Research FellowBeverley Hancock Research andTraining FacilitatorJo-Anne Miles Research Co-ordinatorDarren Douglas IT Co-ordinatorSheila Bailey AdministratorJuliet Ralphs Finance OfficerVanessa Currie Secretary

The Department of Primary Careand General PracticeUniversity of BirminghamPrimary Care Clinical Sciences BuildingEdgbaston, Birmingham B15 2TTTel: 0121 414 2845Fax: 0121 414 2282www.pcpoh.bham.ac.uk/primarycare/PC-CRTU/index.htm

This study was primarily concerned with investigating therelationships between exercise participation and menopausalsymptoms in women aged 46–55 years. A secondary aim ofthis study was to examine factors associated with the use ofcomplementary medicine and non-pharmacological interventions(including exercise) in symptomatic menopausal women andthese results are reported below.

News from the Exercise andMenopause Study (EAMS).

Results from completed studies

AbstractBackground: Many women are seekingalternatives to Hormone Replacement Therapyincluding complementary and alternativemedicine (CAM), including non-pharmacologicalinterventions (NPI), to alleviate symptoms. Theprevalence and perceived effectiveness of CAMand NPI for ameliorating menopausal symptomsis not widely known and factors likely to predictCAM and NPI utilisation for menopausalsymptom management have not beencomprehensively documented.

Objectives: The objectives of this study were to:(1) determine the prevalence of using CAM andNPI for menopausal symptoms; (2) describe theperceived effectiveness of CAM and NPI forsymptom management; and (3) investigatelifestyle and demographic factors associatedwith CAM/NPI use among menopausal womenwith vasomotor symptoms.

Methods: Women aged 46-55 years wererecruited via six socio-economically diversegeneral practices. Participants completed apostal questionnaire that contained items relatingto demographics, lifestyle factors, weight, height,exercise behaviour, menopausal status,vasomotor symptoms and utilisation andperceived effectiveness of a range of CAM/NPIfor symptom management.

Results: Of 1206 women who responded, 563were symptomatic. The most commonly usedCAM/NPI for symptom management werediet/nutrition (44.3%), exercise/yoga (41.5%),relaxation/stress management (27.4%) andhomeopathic/naturopathic remedies (25.4%).Of women who used these interventions, largeproportions reported them to be helpful.The characteristics that were independentlyassociated with use of CAM/NPI wereWhite ethnicity, being physically activeand not smoking.

Conclusions: Many menopausal symptomaticwomen are using a wide range of CAM/NPIand report these to be effective, particularlythose who are White, physically active and donot smoke.

The full reference for this study is as follows;Daley AJ, MacArthur C, McManus R, Stokes-Lampard H, Wilson S, Roalfe A, Mutrie N.Factors associated with the use ofcomplementary medicine and non-pharmacological interventions in symptomaticmenopausal women.Climacteric in press.

For further details please contact:Dr Amanda DaleyTel: 0121 414 3762.Email: [email protected])

Introductory Practitioner Course

This course has been running at The Universityof Birmingham for three successful years andis available via two routes; accredited andnon-accredited.

The aim of the course is to:1. Equip participants with some CBT methodsto use in their routine clinical work

2. Act as a knowledge and skills foundation forthose who wish to subsequently gain furtherformal CB Therapist qualifications.

Current fees are: Non accredited version, £520 Accredited version, £750(NB. Fee includes marking of assignments)

Postgraduate Diploma in CognitiveBehaviour Therapy

The diploma is now in its third year and we willshortly be advertising for the next intake, whichwill be January 2007. If you are interested andwould like further information, please contact us.

For further information and application formplease contact:Helen DuffyTel: 0121 414 7609Email: [email protected]

Cognitive BehaviourTherapy Programme