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Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR):… O’Brien, Claire; Bray, Emma P; Bryan, Stirling; Greenfield, Sheila M; Haque, M S; Hobbs, FD R; Jones, Miren I; Jowett, Sue; Kaambwa, Billingsley; Little, Paul; Mant, Jonathan; Penaloza, Cristina; Schwartz, Claire; Shackleford, Helen; Varghese, Jinu; Williams, Bryan; McManus, Richard J Mar 23, 2013

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STUDY PROTOCOL Open AccessTargets and self-management for the control ofblood pressure in stroke and at risk groups(TASMIN-SR): protocol for a randomisedcontrolled trialClaire O’Brien1, Emma P Bray1, Stirling Bryan2, Sheila M Greenfield1, M Sayeed Haque1, FD Richard Hobbs3,Miren I Jones1, Sue Jowett4, Billingsley Kaambwa4, Paul Little5, Jonathan Mant6, Cristina Penaloza4,Claire Schwartz1, Helen Shackleford1, Jinu Varghese1, Bryan Williams7 and Richard J McManus3*AbstractBackground: Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results inlower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated todate and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the addedvalue of self-management in high risk groups over and above usual care.Methods/Design: The targets and self-management for the control of blood pressure in stroke and at risk groups(TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronaryheart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will beindividually randomised to either usual care or self-management. The primary outcome of the trial will bedifference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP andcovariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related qualityof life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating theresults thereafter. A qualitative analysis will gain insights into patients’ views, experiences and decision makingprocesses.Discussion: The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to manyhundreds of thousands of individuals in the UK and beyond.Trial Registration: ISRCTN87171227Keywords: Hypertension, Self-management, Stroke, Diabetes, Coronary heart disease, Chronic kidney disease,Primary care* Correspondence: richard.mcmanus@phc.ox.ac.uk3Primary Care Health Sciences, NIHR School for Primary Care Research,University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford,OX2 6GG, UKFull list of author information is available at the end of the article© 2013 O’Brien et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.O’Brien et al. BMC Cardiovascular Disorders 2013, 13:21http://www.biomedcentral.com/1471-2261/13/21BackgroundThe potential benefit from optimal blood pressure (BP)lowering in patients at high cardiovascular risk followingstroke or TIA, coronary heart disease or with diabetes orCKD is large. The PROGRESS trial demonstrated thatblood pressure lowering is beneficial in reducing risk ofstroke amongst both hypertensive and non-hypertensiveindividuals with a history of stroke or TIA [1,2]. Forpeople with coronary heart disease, blood pressure low-ering has the same risk reduction as in those withoutcoronary heart disease however the higher absolute riskin CHD means that for a given blood pressure reductionthe absolute benefits are greater [3]. The HypertensionOptimal Treatment trial showed no difference in outcomefor diastolic blood pressure targets below 90mmHg, apartfrom in people with diabetes for whom the 80mmHg tar-get group did better. The blood pressure trialists collab-orative have shown similar relative risk reductions fromblood pressure lowering in diabetes compared to othergroups, again with higher absolute risk reductions. In sub-group analyses of the HOPE study, people with chronickidney disease (CKD) received equivalent benefit fromramipril as those without kidney disease [4].Guidelines for the various at risk groups vary in terms ofrecommendations for blood pressure lowering. The Na-tional Clinical Guideline for stroke [5] and the BritishHypertension Society (BHS) [6] recommend that unlessthere is bilateral carotid artery stenosis, the target bloodpressure for secondary prevention of stroke and TIAshould be 130/80mmHg. NICE guidelines for diabetes,suggest a lower blood pressure target than recommendedfor essential hypertension of 140/80mmHg (130/75mmHgin cases of proteinuria). For coronary heart disease, stand-ard blood pressure targets are recommended (≤ 140/90mmHg), and for chronic kidney disease NICE also recom-mend a target of 140/90 mmHg, unless there is accom-panying diabetes or proteinuria (ACR > 70 mg/mmol) inwhich case the target drops to 130/80 mmHg. The BHSguidelines however, suggest a target of <130/80 mmHg forstroke/ TIA, diabetes, CKD3 (without proteinuria), CHDand MI allowing uniformity across the range of high riskgroups [6].Data from national and international surveys suggestthat blood pressure control is sub-optimal [7]. Novel in-terventions are therefore needed to improve this and asmost blood pressure management is undertaken in pri-mary care, where hypertension is the commonest longterm condition seen by GPs, it is appropriate that inter-ventions are delivered in this setting. The TASMINH2trial [8,9] found that self-management of hypertensionresulted in significantly lower (5.4mmHg) systolic bloodpressure after one year compared to usual care. How-ever, the study included few people in high risk groupssuch as diabetes or CKD, in whom the effect sizeappeared to be smaller and included telemetry which isnot available in daily practice in the NHS.Self-management can encompass a wide range of be-haviours in addition to medication titration and moni-toring of symptoms, such as an individual’s ability tomanage physical, psychosocial and lifestyle behavioursrelated to chronic illness [10]. Self-efficacy, which is aperson’s confidence to be able to carry out behaviours toachieve a desired goal, has been found to be the stron-gest predictor of a person’s ability to change risky healthbehaviours by taking action, and an important character-istic for successful self-management [11]. It is unclearwhat the relationship is between self-monitoring ofblood pressure, self-efficacy and health behaviour modi-fication; it is possible that the self-monitoring aspectprovides feedback to the individual about their bloodpressure of which they would otherwise be unaware.This in turn may promote self-management of healthbehaviours in those with higher levels of self-efficacy.These behavioural aspects require further study.Therefore, the aim of this trial is to determine whetherthe benefits from blood pressure lowering observed inthe TASMINH2 trial will also be observed in a popula-tion of people at high cardiovascular risk without usingtelemetry and to assess further the mechanism behindany change in blood pressure observed. The TASMIN-SR trial sets out to investigate whether self-managementis effective and cost effective in people with stroke andother high risk conditions.Methods/DesignStudy aims, research questions, and outcomesThe primary aim of TASMIN-SR is to compare self-management with usual care in the control of hyperten-sion in patients with stroke and other at-risk conditions.The trial has four main research questions:1. Does self-management of blood pressure result inbetter control of blood pressure in people with strokeand other at-risk conditions compared to usual care?2. Is self-management of blood pressure in people withstroke and other at-risk conditions achievable inroutine practice and is it acceptable to patients?3. What is the relationship between self-managementof blood pressure, self-efficacy, lifestyle behaviours,patients’ attitude to health and health care and useof other self-care strategies in people with strokeand other at-risk conditions?4. Is self-management of blood pressure in people withstroke and other at-risk conditions cost effective?The primary outcome of the trial will be the differencein office systolic blood pressure (mmHg) at 12-monthfollow-up between intervention and control adjusted forO’Brien et al. BMC Cardiovascular Disorders 2013, 13:21 Page 2 of 8http://www.biomedcentral.com/1471-2261/13/21baseline blood pressure and co-variates. Secondary out-comes (also adjusted for baseline and co-variates) willinclude:– Difference in office SBP at 6-month follow-upbetween intervention and control– Difference in office DBP at 6 and 12-month follow-up between intervention and control– Percentage time in target BP range– Difference in pulse rate– Difference in self-management self-efficacy– Difference in lifestyle behaviours– Difference in health-related quality of life– Difference in BP measurement preference– Difference in anxiety– Difference in attitudes to health and healthcare– Difference in use of other self-managementstrategies– Reasons for non-participation– Adverse events (including cardiovascular events anddeath)– In addition there will be a qualitative analysis andhealth economic modelling.Study design and settingTASMIN-SR is a pragmatic, primary care based, un-blinded, randomised controlled trial (with embeddedeconomic and qualitative analyses) of self-managementof BP consisting of self-monitoring with self-titration ofanti-hypertensive medication in people with stroke andother at-risk conditions.Ethical considerationsEthical approval has been obtained from North West –Greater Manchester East ethics committee (reference: 10/H1013/60). Site specific R&D approval will be obtainedfrom the relevant Primary Care Trusts.Trial interventionsUsual care will consist of the participant seeing theirGeneral Practitioner (GP) and/or nurse for routine BPmeasurement and/or adjustment of medication at thediscretion of the health professional.Self-management will consist of self-monitoring of BPwith self-titration of medication following a predetermined3-step plan, dependant on the self-monitored BP readings.Blood pressure self-monitoringParticipants will be trained to self-monitor BP using anautomated sphygmomanometer. Patients will self-monitorBP for the first week of each month of the study, and willtake measurements in the morning. Two seated BP read-ings will be taken, with a five-minute rest period betweenthem. The second of these readings will be used todetermine if medication requires altering. Participants willbe provided with a guideline that contains simple colourcoded instructions. Very high or very low readings thatpersist when a third reading is taken five minutes after thesecond reading will require the participant to contact theirpractice for advice and potentially will need checking.Four or more above target readings in two consecutiveweeks of measurement will require a change in medica-tion. Readings within target range will simply require fur-ther monitoring the following month.Target blood pressureBlood pressure targets will be based on The BritishHypertension Society guidelines [6] and Joint British So-cieties Guidelines [12] that suggest that the BP for pa-tients with stroke/TIA, diabetes (in the absence ofproteinuria), CKD, CHD, and MI should be <130/80mmHg. The BHS suggest that for home monitoring thistarget should be adjusted by 10/5 mmHg, resulting in atarget of <120/75 mmHg [6].Communication of home readingsParticipants will complete a simple form each month torecord their daily BP readings and colour coding. Theseforms will be used to determine any action that is re-quired at the end of the measurement week, includingwhether a medication change is required. The form willbe printed on three-part non-carbon copy paper to allowone copy to be kept by the patient, one returned to theresearch team, and one posted to the GP should a medi-cation change be required. Reply paid envelopes will beprovided for this purpose. At follow-up, data from par-ticipants’ BP machines will be uploaded onto a databaseso that the research team has an electronic copy.Self-titration of medicationEach intervention patient will be given an individually tai-lored three-step management plan through which to ad-just medication according to measured BP. Each step willrepresent a single medication change (additional medica-tion or increased dose) that will be made following twoconsecutive months of raised readings. Medication choicewill remain at the discretion of the GP who will be pro-vided with an algorithm summarising the national clinicalguidelines for advice on hypertension. If patients use allthree steps of their management plan they will return totheir GP and an additional two-step plan will be devised.This will not be until at least eight months into the trial,assuming no very high or very low readings, so a three-step plan should be sufficient. Any additional monitoring(for instance blood tests or urinalysis) will be the responsi-bility, and at the discretion, of the GP.O’Brien et al. BMC Cardiovascular Disorders 2013, 13:21 Page 3 of 8http://www.biomedcentral.com/1471-2261/13/21Non-participationIncluded with the letter of invitation to take part in thetrial, will be a form for people to voluntarily returnshould they wish to decline the invitation. This will askfor basic demographic details as well as their reasons forwishing to decline.Study populationThe study population will comprise people with stroke/TIA, diabetes, CKD3, CABG, MI or angina, with poorlycontrolled hypertension managed in primary care. Eligi-bility criteria will be age above 35, have had a diagnosisof stroke/TIA, diabetes, CKD3, MI, angina, or CABG,and clinic blood pressure greater than 130/80. Exclusioncriteria will be inability to self-monitor (such as demen-tia or score of >10 on the short orientation memoryconcentration test), postural hypotension (systolic BPdrop > 20 mmHg), prescribed more than three anti-hypertensive medications, taking part in a current BPstudy or previously having taken part in TASMINH2[8], terminal disease, pregnant, BP not managed by GP,and acute cardiovascular event in the previous threemonths.Eligible patients will be identified from general prac-tices via the UK Primary Care Research Network.Trained practice nurses will identify potentially eligiblepatients by searching practice-based registers for pa-tients having a Read Code of stroke/TIA, diabetes,CKD3, Angina, CABG, or MI and whose last systolic BPmeasurement was greater than 145 mmHg (BP readingsare often lower when measured by research teams, so ahigher BP at invitation increases the likelihood of BPreadings falling within the suitable range [13].) GPs willbe asked to check the generated lists and remove pa-tients who have a terminal illness, are pregnant, or whoare thought to be unsuitable for the study.Participants who withdraw will not be replaced, butasked if they are prepared to continue to attend follow-up clinics.RandomisationPatients will be randomised to either usual care or self-management using an internet based system with tele-phone backup. Minimisation will be used to take intoaccount practice, gender, age, high risk group (CVD,diabetes, CKD3, CHD) and baseline BP.Study clinics and flow through studyAt baseline, all patients will attend a clinic at which thestudy will be explained, informed consent gained, height,weight, and BP measurements taken, and questionnairesregarding demographics, past medical history, BP meas-urement method preference, use of self-managementstrategies, attitudes to health and healthcare completed,and baseline economic data collected (Table 1). Measure-ment of blood pressure will use a validated automatedelectronic sphygmomanometer (BP TRU BPM 200; BPTRU Medical Devices; Coquitlam, BC, Canada) [14]. Afterfive minutes of rest, six seated blood pressure readings willbe taken at 1-minute intervals, of which the mean of the2nd and 3rd reading will comprise the primary outcome.Patients will then be randomised to either usual care orself-management. All patients will be given a diary to as-sess daily lifestyle behaviours and self-management self-efficacy which they will be asked to complete everyday forone week starting the first Monday of the month aftertheir baseline appointment. Patients randomised to usualcare will be asked to book an appointment for a routineblood pressure check and medication review with thestudy GP. Patients randomised to self-management will beasked to make an appointment with the research team fora training session on how to monitor their BP. Participantswill be asked to practice at home for a week beforereturning for a second training session covering the self-titration aspect of the intervention. If necessary, a thirdtraining session will be offered for additional support. Fol-lowing successful completion of the training, patients willTable 1 Data collection throughout the trialBaseline only:1 Demographic questions: including age, race, marital status,occupation, and education2 Duration of hypertension3 Past medical history4 Contraindications to anti-hypertensives5 Short orientation memory test [15]6 Height7 Joint pain questionnaire [16]Baseline and follow-up:1 New medical history (in last 6/12 months)2 Blood pressure (sitting plus standing at baseline)3 Current anti-hypertensive medications4 Weight5 Symptom section of the IPQ [17]6 Partners in health scale [18]7 Short-form of the State-Trait Anxiety Inventory [19]8 EQ-5D [20]9 Use of complementary and alternative medicine and self-tests [21]10 BP measurement preference11 Attitudes to health and healthcare [22]Lifestyle diaries1 Simple lifestyle indicator questionnaire (SLIQ) [23]2 The dietary quality score [24]3 Self-efficacy (adapted diabetes self-efficacy scale) [25]O’Brien et al. BMC Cardiovascular Disorders 2013, 13:21 Page 4 of 8http://www.biomedcentral.com/1471-2261/13/21be asked to make an appointment with the study GP attheir practice for a routine BP check and to devise a threestep titration plan for any potential medication changes.Patients who are unable to complete all aspects of thetraining will be given the option to self-monitor withoutself-titration of medications.Patients will be asked to attend two follow-up clinics at6- and 12-months post-randomisation. Each clinic will betimetabled for no more than one hour, during which pa-tients will have their BP and weight measured by the re-search team and will be asked to complete a questionnairesimilar to the one completed at baseline. At the 12 monthfollow up, participants will also be given a blank postcardand asked to write a few sentences about their experienceof the trial. Additionally, the research team will check thatpatients in the intervention arm are using the bloodpressure monitors correctly. Flow through the trial issummarised in Figure 1.Sample size considerationsA sample size of 243 people per group is required for90% power assuming a standard deviation of 17 mmHgPractice clinical system searches for potentially eligible participants:Age >35HypertensionDiagnosis of stroke/TIA, diabetes, CKD3, MI, angina, and/or CABGLast systolic BP measurement greater than 145 mmHgAntihypertensive treatment (  3 antihypertensive medications)GPs check patient list for personal knowledge ofpeople likely to be unsuitable:Terminally ill, pregnant, likely to be unable toself  manage, otherwise unsuitableBaseline Clinic: Explanation of study, baselinedata collection and randomisationIntervention grouptwo training sessionsControl groupMedication review withGPSelf  management planagreedMedication review withGPUsual CareSelf monitor for one weekeach monthSelf titrate medicationaccording to agreed planWeek 1Intervention vscontrolStudy EndPointsPrimary Carefollow upFollow up with GPdependent on selfmanagement algorithmFollow up as decidedby GP6 and 12 month follow upplus economic datacollection6 and 12 month follow upplus economic datacollectionFigure 1 Flow through the trial.O’Brien et al. BMC Cardiovascular Disorders 2013, 13:21 Page 5 of 8http://www.biomedcentral.com/1471-2261/13/21and a difference of at least 5 mmHg between interven-tion and control groups. This represents a clinically sig-nificant decrease in BP and is in line with the reductionobserved in TASMINH2 and would result in around20% reduction in stroke risk and 10% coronary heart dis-ease risk. Based on the follow-up in TASMINH andTASMINH2 self-monitoring trials, a 10% drop out rateduring follow-up is assumed, meaning a sample of 270per group will need to be randomised, a total of 540 pa-tients altogether. Should the drop-out rate be higherthan TASMINH2, for instance 20%, the study wouldhave more than 85% power.RecruitmentPatients will be recruited over an eight month period.Based on practice-based pilot searches, it is estimatedthat in a practice with an average size of 6000 patients,2.5% will be eligible for invitation. Previous experiencefrom the TASMINH2 trial suggests that approximately30% of invited patients will attend baseline clinics, andof these 50% will be eligible [8]. A minimum of 25 prac-tices will be needed in order to recruit the requirednumber of participants (approximately 22 patients perpractice being randomised) but many more will be avail-able if necessary.Statistical analysisThe primary analysis will include all available partici-pants, i.e. all of those with complete data from follow-up,and will be performed at the end of the trial after all datahas been collected. A mixed model analysis will be usedto examine differences between intervention and controlsystolic BP at twelve months, adjusting for practice (as arandom effect), baseline BP, gender, and high risk group.Planned sub group analyses will be of older vs younger(65 as threshold), males vs females, better controlled atbaseline vs worse controlled at baseline (threshold 145systolic), the different risk groups and deprivation. Sensi-tivity analyses will examine the potential effect of missingdata. These will include multiple imputation, replace-ment of missing data by the most recent previous dataor by the mean of the series. Any deviation from the ori-ginal statistical plan will be described in the final reportand publications.Economic analysisThe economic analysis will be in two parts. The first partis a cost-effectiveness analysis conducted alongside therandomised clinical trial (trial-based analysis). An eco-nomic evaluation will compare the strategy of self-management of blood pressure in at-risk patients to thestrategy of usual care. Primary outcome will be expressedin terms of the cost per additional 1 mm Hg reduction inoffice SBP from baseline to 12 months. Use of utility-based outcomes (EQ-5D) will allow a secondary outcometo be the cost per quality-adjusted life year (QALY) gainedover the same 12 months period. The results for bothoutcomes will be expressed in terms of incremental cost-effectiveness ratios (ICERs). NHS resource use will includehospital and GP consultations, medications, referrals,equipment and training. Intervention costs, includingequipment and training, will be collected by the researchteam. All other resource use data will be collected frompractice computer systems by the research team at followup visits. Cost data will be derived from sources such asthe British National Formulary (BNF), the National Sched-ule for Reference Costs and the Unit Costs of Health andSocial Care (PSSRU) [26].The second part will be a model-based cost-effectivenessanalysis, building on the trial-based analysis and using pub-lished data on long-term outcomes and costs. The modelwill estimate the long-term cost-effectiveness of self-management of blood pressure in people with stroke andother at- risk conditions in terms of cost per QALY gained.The model type and structure will be informed byreviewing modelling studies which consider outcomes afterstroke and other at-risk conditions. Experts within theteam will advise on the final structure of the model. Coststo be included in the model will be for self-management(from the trial based analysis), hospital stays, readmissionsand long-term care for stroke and other cardiovascularoutcomes related to level of disability and discharge destin-ation. Resource use will be determined from the trial andestimates from the literature. Unit costs will be collectedfrom published sources (National Schedule for ReferenceCosts and the PSSRU) [26]. Outcomes will be in the formof survival and quality of life and will use data collectedfrom the trial and literature on quality of life after stroke.The model will be run over remaining patient lifetime, withcosts and benefits discounted at a rate of 3.5%. The analysiswill be conducted from an NHS perspective. Extensive de-terministic sensitivity analysis will be undertaken to assessthe impact of changing the values of key parameters. Foreach important model parameter, we will determine apoint estimate and construct a probability distributionaround that estimate. Probabilistic sensitivity analyses willbe conducted to deal with uncertainty in model parametersand cost-acceptability curves presented.Qualitative sub studyThis part of the study aims to gain insight into patients’decision making processes regarding whether to seekprofessional advice, whether to make a medicationchange, or any concerns they may have.Open commentsEach month, on an open-comment section of the BPmeasurement record, intervention patients will be askedO’Brien et al. BMC Cardiovascular Disorders 2013, 13:21 Page 6 of 8http://www.biomedcentral.com/1471-2261/13/21to write down their description of any action they took,whether it followed protocol or not, their decision mak-ing process, and their thoughts and feelings associatedwith the decision making. Similarly, the postcards partic-ipants will be given at the end of the study provide a fur-ther opportunity for open comment about the trial. Thisapproach is useful for capturing aspects of a patient’s ex-perience of a study or an intervention which may other-wise not be documented [27]. The open comments willbe analysed by content analysis using both quantitative(e.g. number of times a word/phrase mentioned) andqualitative (e.g. examples of participants’ own words toreflect emerging themes) techniques. Concepts identifiedwill be integrated into themes providing a structure forpresentation of findings.DiscussionThe results of the trial will be directly applicable to pri-mary care in the UK. If successful, self-management ofblood pressure in people with stroke and other high riskconditions would be applicable to many hundreds ofthousands of individuals in the UK and beyond.It is anticipated that the potential risks of this studyare low and similar to those associated with usual care.Particular issues are potential increased anxiety whenpatients find excessively high or low blood pressurereadings, or as a result of self-titration. The patientguideline will advise contact with the supervising phys-ician or nurse for a blood pressure check and furthermanagement if required. Training of participants willcover repeated measurements in the case of high or lowreadings and a helpline will be available should partici-pants or clinical staff require advice over and above thatprovided in the guideline. The study GP will have con-trol over prescription of all medications within the study,and will make changes to prescriptions as required. Par-ticipants will be advised to attend their GPs should theyexperience an adverse event thought to be due to theirparticipation in the trial.Competing interestsRJM has received equipment for research purposes from Omron and LloydsHealthcare. FDRH has received limited research support in terms of bloodpressure devices from Microlife and BpTRU. All other authors declare thatthey have no conflicts of interest.Authors’ contributionsRJM conceived the study and in collaboration with JM, SB and FDRH gainedthe funding. The protocol was developed by the trial investigators groupcomprising all the authors. The first draft of this paper was written by COwith RM and subsequently edited and approved by all co-authors. Allauthors read and approved the final manuscript.Article summaryThis is the protocol for a randomised controlled trial comparing self-management of blood pressure (BP) with usual care in people with previousstroke, coronary heart disease, diabetes or chronic kidney disease.The primary research question is: does self-management of blood pressureresult in better control of blood pressure in people with stroke and other at-risk conditions compared to usual care?AcknowledgementsThanks are due to Amanda Davies and Fran Palmer for administrative workon the project and to Roger Holder, Head of Statistics in Primary Care inBirmingham who was the original trial statistician before handing over toMSH.The trial is funded by an NIHR programme grant, an NIHR national schoolprimary care trial development grant, and by an NIHR career developmentfellowship awarded to Prof RJ McManus, the Chief Investigator. Servicesupport costs are administered through the Primary Care Research Networkand collaborating Comprehensive Local Research Networks. ProfessorsHobbs, Little and Williams are NIHR Senior Investigators.This article presents independent research commissioned by the NationalInstitute for Health Research (NIHR) under a Programme Grant for AppliedResearch (RP-PG-0606-1153). The views expressed in this publication arethose of the authors and not necessarily those of the NHS, the NIHR or theDepartment of Health.Author details1Primary Care Clinical Sciences, NIHR School for Primary Care Research,University of Birmingham, Edgbaston, Birmingham B15 2TT, UK. 2Centre forClinical Epidemiology and Evaluation, Vancouver Coastal Health ResearchInstitute, and School of Population and Public Health, University of BritishColumbia, Vancouver, BC, Canada. 3Primary Care Health Sciences, NIHRSchool for Primary Care Research, University of Oxford, Radcliffe ObservatoryQuarter, Woodstock Road, Oxford, OX2 6GG, UK. 4Health Economics Unit,School of Health and Population Sciences, University of Birmingham,Edgbaston, Birmingham B15 2TT, UK. 5School of Medicine, University ofSouthampton, University Road, Southampton SO17 1BJ, UK. 6Primary CareUnit, Institute of Public Health, University of Cambridge, Forvie Site, RobinsonWay, Cambridge, Cambridgeshire CB1 8RN, UK. 7Institute of CardiovascularSciences, University College London, 170 Tottenham Court Road, LondonW1T 7HA, UK.Received: 31 January 2013 Accepted: 13 March 2013Published: 23 March 2013References1. 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