Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study.

OBJECTIVE: Patients with ANCA-associated vasculitis (AAV) experience high levels of fatigue, despite disease remission. This study assessed the feasibility and acceptability of a definitive randomized controlled trial of a behavioural-based physical activity intervention to support fatigue self-management in AAV patients. METHODS: AAV patients in disease remission with fatigue (Multidimensional Fatigue Inventory-20 general fatigue domain ≥14) were randomly allocated to intervention or standard care in this single-centre open-label randomized controlled feasibility study. The intervention lasted 12 weeks and comprised eight face-to-face physical activity sessions with a facilitator and 12 weekly telephone calls. Participants were encouraged to monitor their physical activity using a tracker device (Fitbit). Standard care involved sign-posting to fatigue websites. The primary outcome was feasibility of a phase III trial assessed against three stop/go traffic light criteria, (recruitment, intervention adherence and study withdrawal). A qualitative study assessed participant views about the intervention. RESULTS: A total of 248 patients were screened and 134 were eligible to participate (54%). Stop/go criteria were amber for recruitment; 43/134 (32%, 95% CI: 24, 40) eligible participants randomized, amber for adherence; 73% of participants attended all eight physical activity sessions, but only 11/22 (50%, 95% CI: 29, 71%) completed the intervention as per the intended schedule, and green for study withdrawal; 2/43 participants withdrew before 24 weeks (5%, 95% CI: 0, 11). Qualitative results suggested the intervention was acceptable. CONCLUSION: This study suggests a behavioural-based physical activity intervention targeting fatigue self-management was acceptable to patients with AAV, although recruitment and protocol adherence will need modification prior to a definitive trial. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN11929227.

A randomised controlled trial of extended anticoagulation treatment versus standard treatment for the prevention of recurrent venous thromboembolism (VTE) and post-thrombotic syndrome in patients being treated for a first episode of unprovoked VTE (the ExACT study).

Venous thromboembolism (VTE) is prevalent and impactful, with a risk of death, morbidity and recurrence. Post-thrombotic syndrome (PTS) is a common consequence and associated with impaired quality of life (QoL). The ExACT study was a non-blinded, prospective, multicentred randomised controlled trial comparing extended versus limited duration anticoagulation following a first unprovoked VTE (proximal deep vein thrombosis or pulmonary embolism). Adults were eligible if they had completed ≥3 months anticoagulation (remaining anticoagulated). The primary outcome was time to first recurrent VTE from randomisation. The secondary outcomes included PTS severity, bleeding, QoL and D-dimers. Two-hundred and eighty-one patients were recruited, randomised and followed up for 24 months (mean age 63, male:female 2:1). There was a significant reduction in recurrent VTE for patients receiving extended anticoagulation [2·75 vs. 13·54 events/100 patient years, adjusted hazard ratio (aHR) 0·20 (95% confidence interval (CI): 0·09 to 0·46, P < 0·001)] with a non-significant increase in major bleeding [3·54 vs. 1·18 events/100 patient years, aHR 2·99 (95% CI: 0·81-11·05, P = 0·10)]. Outcomes of PTS and QoL were no different between groups. D-dimer results (on anticoagulation) did not predict VTE recurrence. In conclusion, extended anticoagulation reduced VTE recurrence but did not reduce PTS or improve QoL and was associated with a non-significant increase in bleeding. Results also suggest very limited clinical utility of D-dimer testing on anticoagulated patients.

Prevention of excessive hypothermia in infants with hypoxic ischemic encephalopathy prior to admission to a quaternary care center: a neonatal outreach educational project.

OBJECTIVE: Excessive hypothermia is common in infants that receive passive cooling for hypoxic ischemic encephalopathy (HIE). Our goal was to reduce the number of infants with admission temperature <33 °C from 33% to less than 10% by December 2017. METHODS: Outcome measures included the number of infants with admission temperature <33 °C and number of infants with temperature within therapeutic range. Interventions included implementation of passive cooling guidelines and outreach education to birth hospitals and transport team. We used statistical process control chart to compare outcomes over a 3 year period. RESULTS: The number of infants with admission temperature <33 °C decreased from 33.3% to 5.5% (p = 0.013). The number of infants with admission temperature within target range for hypothermia therapy increased from 61.1% to 77.7% (p = 0.014). Balancing measures and complications remained unchanged. CONCLUSION: Implementation of passive cooling guidelines and outreach education led to significant decrease in excessive hypothermia in infants with HIE.

Treatment of fatigue with physical activity and behavioural change support in vasculitis: study protocol for an open-label randomised controlled feasibility study.

INTRODUCTION: Fatigue is a major cause of morbidity, limiting quality of life, in patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The aetiology of fatigue is multifactorial; biological and psychosocial mediators, such as sleep deprivation, pain and anxiety and depression, are important and may be improved by increasing physical activity. Current self-management advice is based on expert opinion and is poorly adhered to. This study aims to investigate the feasibility of increasing physical activity using a programme of direct contact and telephone support, to provide patient education, encourage behaviour self-monitoring and the development of an individual change plan with defined goals and feedback to treat fatigue compared with standard of care to inform the design of a large randomised controlled trial to test the efficacy and cost effectiveness of this programme. METHODS AND ANALYSIS: Patients with AAV and significant levels of fatigue (patient self-report using multidimensional fatigue index score questionnaire ≥14) will be randomised in a 1:1 ratio to the physical activity programme supported by behavioural change techniques or standard of care. The intervention programme will consist of 8 visits of supervised activity sessions and 12 telephone support calls over 12 weeks with the aim of increasing physical activity to the level advised by government guidelines. Assessment visits will be performed at baseline, 12, 24 and 52 weeks. The study will assess the feasibility of recruitment, retention, the acceptability, adherence and safety of the intervention, and collect data on various assessment tools to inform the design of a large definitive trial. A nested qualitative study will explore patient experience of the trial through focus groups or interviews. ETHICS AND DISSEMINATION: All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, patient networks and academic publications. TRIAL REGISTRATION NUMBER: ISRCTN11929227.

Cost-effectiveness analysis of use of a polypill versus usual care or best practice for primary prevention in people at high risk of cardiovascular disease.

BACKGROUND: Clinical trials suggest that use of fixed-dose combination therapy ('polypills') can improve adherence to medication and control of risk factors of people at high risk of cardiovascular disease (CVD) compared to usual care, but cost-effectiveness is unknown. OBJECTIVE: To determine whether a polypill is cost-effective compared to usual care and optimal guideline-recommended treatment for primary prevention in people already on statins and/or blood pressure lowering therapy. METHODS: A Markov model was developed to perform a cost-utility analysis with a one year time cycle and a 10 year time horizon to compare the polypill with usual care and optimal implementation of NICE Guidelines, using patient level data from a retrospective cross-sectional study. The model was run for ten age (40 years+) and gender-specific sub-groups on treatment for raised CVD risk with no history of CVD. Published sources were used to estimate impact of different treatment strategies on risk of CVD events. RESULTS: A polypill strategy was potentially cost-effective compared to other strategies for most sub-groups ranging from dominance to up to £18,811 per QALY depending on patient sub-group. Optimal implementation of guidelines was most cost-effective for women aged 40-49 and men aged 75+. Results were sensitive to polypill cost, and if the annual cost was less than £150, this approach was cost-effective compared to the other strategies. CONCLUSIONS: For most people already on treatment to modify CVD risk, a polypill strategy may be cost-effective compared with optimising treatment as per guidelines or their current care, as long as the polypill cost is sufficiently low.

Exploring demand reduction through design, durability and 'usership' of fashion clothes.

Global planetary boundaries confer limits to production and consumption of material goods. They also confer an obligation to experiment, as individuals and collectively as society, with less-materially-intensive, but no less exuberant, ways of living. This paper takes up this mantle and explores materials demand reduction through a focus on design, fashion garments and the universal, everyday activity of wearing clothes. It takes as its starting point the design of longer-lasting products, a widely favoured strategy for increasing materials efficiency and reducing materials demand in many sectors, including fashion. Drawing on scholarship in the field of design for sustainability and ethnographic research conducted in 16 locations in nine countries about already-existing practices of intensive use and maintenance of clothing, this paper critiques the effectiveness of durability strategies to reduce the amount of materials used. It argues for an update in the familiar preference within sustainability debates for the 'techno-fix' to explore instead resourceful use of materials as emerging from human actions and relationships with material goods. It suggests that, while facilitated by design, technology and engineering, opportunities to reduce materials demand begin in individual and collective practices, which, in turn, have dynamic implications for use of materials.This article is part of the themed issue 'Material demand reduction'.

Cost-effectiveness analysis of different systolic blood pressure targets for people with a history of stroke or transient ischaemic attack: Economic analysis of the PAST-BP study.

BACKGROUND: The PAST-BP trial found that using a lower systolic blood pressure target (<130 mmHg or lower versus <140 mmHg) in a primary care population with prevalent cerebrovascular disease was associated with a small additional reduction in blood pressure (2.9 mmHg). OBJECTIVES: To determine the cost effectiveness of an intensive systolic blood pressure target (<130 mmHg or lower) compared with a standard target (<140 mmHg) in people with a history of stroke or transient ischaemic attack on general practice stroke/transient ischaemic attack registers in England. METHODS: A Markov model with a one-year time cycle and a 30-year time horizon was used to estimate the cost per quality-adjusted life year of an intensive target versus a standard target. Individual patient level data were used from the PAST-BP trial with regard to change in blood pressure and numbers of primary care consultations over a 12-month period. Published sources were used to estimate life expectancy and risks of cardiovascular events and their associated costs and utilities. RESULTS: In the base-case results, aiming for an intensive blood pressure target was dominant, with the incremental lifetime costs being £169 lower per patient than for the standard blood pressure target with a 0.08 quality-adjusted life year gain. This was robust to sensitivity analyses, unless intensive blood pressure lowering reduced quality of life by 2% or more. CONCLUSION: Aiming for a systolic blood pressure target of <130 mmHg or lower is cost effective in people who have had a stroke/transient ischaemic attack in the community, but it is difficult to separate out the impact of the lower target from the impact of more active management of blood pressure.

Different systolic blood pressure targets for people with history of stroke or transient ischaemic attack: PAST-BP (Prevention After Stroke--Blood Pressure) randomised controlled trial.

OBJECTIVE: To assess whether using intensive blood pressure targets leads to lower blood pressure in a community population of people with prevalent cerebrovascular disease. DESIGN: Open label randomised controlled trial. SETTING: 99 general practices in England, with participants recruited in 2009-11. PARTICIPANTS: People with a history of stroke or transient ischaemic attack whose systolic blood pressure was 125 mm Hg or above. INTERVENTIONS: Intensive systolic blood pressure target (<130 mm Hg or 10 mm Hg reduction from baseline if this was <140 mm Hg) or standard target (<140 mm Hg). Apart from the different target, patients in both arms were actively managed in the same way with regular reviews by the primary care team. MAIN OUTCOME MEASURE: Change in systolic blood pressure between baseline and 12 months. RESULTS: 529 patients (mean age 72) were enrolled, 266 to the intensive target arm and 263 to the standard target arm, of whom 379 were included in the primary analysis (182 (68%) intensive arm; 197 (75%) standard arm). 84 patients withdrew from the study during the follow-up period (52 intensive arm; 32 standard arm). Mean systolic blood pressure dropped by 16.1 mm Hg to 127.4 mm Hg in the intensive target arm and by 12.8 mm Hg to 129.4 mm Hg in the standard arm (difference between groups 2.9 (95% confidence interval 0.2 to 5.7) mm Hg; P=0.03). CONCLUSIONS: Aiming for target below 130 mm Hg rather than 140 mm Hg for systolic blood pressure in people with cerebrovascular disease in primary care led to a small additional reduction in blood pressure. Active management of systolic blood pressure in this population using a <140 mm Hg target led to a clinically important reduction in blood pressure.Trial registration Current Controlled Trials ISRCTN29062286.

A feasibility study to inform the design of a randomised controlled trial to identify the most clinically effective and cost-effective length of Anticoagulation with Low-molecular-weight heparin In the treatment of Cancer-Associated Thrombosis (ALICAT).

BACKGROUND: Venous thromboembolism is common in cancer patients and requires anticoagulation with low-molecular-weight heparin (LMWH). Current data recommend LMWH for anticoagulation as far as 6 months, yet guidelines recommend LMWH beyond 6 months in patients who have ongoing or active cancer. This recommendation, based on expert consensus, has not been evaluated in a clinical study. OBJECTIVES: (1) To identify the most clinically and cost-effective length of anticoagulation with LMWH in the treatment of cancer-associated thrombosis (CAT); (2) to identify practicalities of conducting a full randomised controlled trial (RCT) with regard to recruitment, retention and outcome measurement; and (3) to explore the barriers for progressing to a full RCT. DESIGN: The Anticoagulation with Low-molecular-weight heparin In the treatment of Cancer-Associated Thrombosis (ALICAT) trial is a randomised, multicentre, feasibility mixed-methods study with three components: (1) a RCT comparing ongoing LMWH treatment for CAT with cessation of LMWH at 6 months' treatment (current licensed practice) in patients with locally advanced or metastatic cancer, consulted in three clinical settings (haematology outpatients, oncology outpatients and primary care); (2) a nested qualitative study, including focus groups with clinicians to investigate attitudes for recruiting to the study and identify the challenges of progressing to a full RCT, and semistructured interviews with patients and relatives to explore their attitudes towards participating in the study, and potential barriers and concerns to participation; and (3) a UK-wide survey exercise to develop a classification and enumeration system for the CAT models and pathways of care. SETTING: A haematology outpatients department, an oncology outpatients department and primary care. PARTICIPANTS: Patients with ongoing active or metastatic cancer who have received 6 months of LMWH for CAT. INTERVENTIONS: Ongoing LMWH treatment for CAT versus cessation of LMWH at 6 months' treatment in patients with locally advanced or metastatic cancer. MAIN OUTCOME MEASURES: (i) The number of eligible patients over 12 months; (ii) the number of recruited patients over 12 months (target recruitment rate of 30% of eligible patients); and (iii) the proportion of randomised participants with recurrent venous thromboembolisms (VTEs) during follow-up. RESULTS: Following several delays in setting up the RCT component of the study, 5 out of 32 eligible patients consented to be randomised to the RCT suggesting progression to a full RCT was not feasible. Reasons for non-consenting were primarily based on a fixed preference for continuing or discontinuing treatment after 6 months of anticoagulation, and a fear of randomisation to their non-preferred option. Views were largely influenced by patients' initial experience of CAT. Focus groups with clinicians revealed that they would be reticent to recruit to such a study as they had fixed views of best management despite the lack of evidence. Patient pathway modelling suggested that there is a broad heterogeneity of practice with respect to CAT management and co-ordination, with no consensus on which specialty should best manage such cases. CONCLUSIONS: The results of the RCT reflect recruitment from the oncology site only and provide no recruitment data from haematology centres. However, it is unlikely that these other sites would have access to more eligible patients. The management of cancer-associated thrombosis beyond 6 months will remain a clinical challenge. As it is unlikely that a prospective study will successfully recruit, other strategies to accrue relevant data are necessary. Currently the LONGHEVA (Long-term treatment for cancer patients with deep-venous thrombosis or pulmonary embolism) registry is in development to prospectively evaluate this important and common clinical scenario. STUDY REGISTRATION: This study is registered as clinical trials.gov number NCT01817257 and International Standard Randomised Controlled Trial Number (ISRCTN) 37913976. FUNDING DETAILS: Funding for the ALICAT trial was provided by the Health Technology Assessment programme (10/145/01) in response to a themed funding call. The study was designed in accordance with the initial funding brief and feedback from the review process.

Patients' views about taking a polypill to manage cardiovascular risk: a qualitative study in primary care.

BACKGROUND: A 'polypill' containing a combination of antihypertensives and statins could prevent up to 80% of cardiovascular disease (CVD) events. AIM: To investigate patients' opinions about the use of a polypill for CVD prevention. DESIGN AND SETTING: Qualitative study of 17 patients from seven primary care practices in Birmingham, UK. METHOD: Patients were recruited through purposive sampling to maximise variation of characteristics. Semi-structured interviews were conducted with responders. Results were analysed and reported using a qualitative description approach. RESULTS: Patients expressed concerns that polypill prescription for primary prevention simply on the basis of age was unnecessary and would lead to side effects, despite recognising potential benefits. For high-risk patients, or for secondary prevention, a polypill was deemed more acceptable, but was still felt to require regular monitoring of blood pressure and cholesterol. CONCLUSION: Patients were sceptical about the role of a polypill as a 'blanket' approach. If a population strategy offering a polypill to all people over a certain age was to be implemented, it would need to be supported by patient education.

Visceral leishmaniasis and immunocompromise as a risk factor for the development of visceral leishmaniasis: a changing pattern at the hospital for tropical diseases, london.

METHODS AND PRINCIPAL FINDINGS: A retrospective study of imported VL to the HTD, London including patients diagnosed and/or managed at the HTD between January 1995 and July 2013. We analyse patient demographics, risk factors for developing VL, diagnosis, investigation, management and outcome. Twenty-eight patients were treated for VL at the HTD over an 18 year period. The median age at VL diagnosis was 44 years (range 4-87 years) with a male to female ratio of 2:1. Most patients were British and acquired their infection in the Mediterranean basin. The median time from first symptom to diagnosis was six months with a range of 1-12 months and diagnosis included microscopic visualisation of leishmania amastigotes, positive serological tests (DAT and k39 antibody) or identification of leishmania DNA. Nineteen patients had some form of immunocompromise and this has increased proportionally compared to previously described data. Within the immunocompromised group, the ratio of those with autoimmune disease has increased. Immunocompromised patients had lower cure and higher relapse rates. CONCLUSIONS: The rise of VL in patients with immunocompromise secondary to autoimmune disease on immunomodulatory drugs presents new diagnostic and therapeutic challenges. VL should be a differential diagnosis in immunocompromised patients with pyrexia of unknown origin returning from travel in leishmania endemic areas.

Prevalence and costs of treating uncomplicated stage 1 hypertension in primary care: a cross-sectional analysis.

BACKGROUND: Treatment for uncomplicated stage 1 hypertension is recommended in most international guidelines but there is little evidence to indicate that therapy is beneficial. AIM: To estimate the prevalence of this condition in an untreated population and the potential costs of initiating therapy in such patients. DESIGN AND SETTING: Cross-sectional study of anonymised patient records in 19 general practices in the West Midlands, UK. METHOD: Data relating to patient demographics, existing cardiovascular disease (CVD), and risk factors (blood pressure and cholesterol) were extracted from patient records. Patients with a blood pressure of 140/90-159/99 mmHg, no CVD, and <20% 10-year cardiovascular risk were classified as having uncomplicated stage 1 hypertension. Missing data were imputed. The prevalence of untreated, uncomplicated stage 1 hypertension was estimated using descriptive statistics and extrapolated using national data. The cost of achieving blood pressure control in this population was examined in a cost-impact analysis using published costs from previous studies. RESULTS: Of the 34 975 patients (aged 40-74 years) in this study, untreated, uncomplicated stage 1 hypertension was present in 2867 individuals (8.2%, 95% confidence interval [CI] = 7.9 to 8.5). This is equivalent to 1 892 519 patients in England and Wales, for whom the additional cost of controlling blood pressure, according to guidelines, was estimated at £106-229 million per annum, depending on the health professional delivering care. CONCLUSION: Untreated, uncomplicated stage 1 hypertension is relatively common, affecting 1 in 12 patients aged 40-74 years in primary care. Current international guidelines and pay-for-performance targets, if followed, will incur significant costs for a patient benefit that is debatable.

Warfarin versus aspirin for prevention of cognitive decline in atrial fibrillation: randomized controlled trial (Birmingham Atrial Fibrillation Treatment of the Aged Study).

BACKGROUND AND PURPOSE: Atrial fibrillation is associated with decline of cognitive function. Observational evidence suggests that anticoagulation might protect against this decline. We report the first randomized controlled trial evidence on the effect of anticoagulation on cognitive function in elderly patients with atrial fibrillation. METHODS: A total of 973 patients aged≥75 years with atrial fibrillation were recruited from primary care and randomly assigned to warfarin (n=488; target international normalized ratio, 2-3) or aspirin (n=485; 75 mg/d). Neither participants nor investigators were masked to group assignment. Follow-up was for a mean of 2.7 years (SD, 1.2). Cognitive outcome was assessed using the Mini-Mental State Examination at 9-, 21-, and 33-month follow-up. Participants who had a stroke were censored from the analysis, which was by intention to treat with imputation for missing data. RESULTS: There was no difference between mean Mini-Mental State Examination scores in people assigned to warfarin or aspirin at 9 or 21 months. At 33-month follow-up, there was a nonsignificant difference of 0.56 in favor of warfarin that decreased to 0.49 (95% confidence interval, -0.01 to 0.98) after imputation. CONCLUSIONS: We found no evidence that anticoagulation confers clinically important protection over aspirin against cognitive decline as measured by the Mini-Mental State Examination in atrial fibrillation in the first 33 months of treatment other than that provided by preventing clinical stroke. CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Unique identifier: ISRCTN89345269.

Missed opportunities in prevention of cardiovascular disease in primary care: a cross-sectional study.

BACKGROUND: Screening cardiovascular disease (CVD) risk is an important part of CVD prevention. The success of screening is dependent on the rigour with which treatments are subsequently prescribed. AIM To establish the extent to which treatment conforms to guidelines. DESIGN AND SETTING: Cross-sectional study of anonymised patient records from 19 general practices in the UK. METHOD: Data relating to patient characteristics, including CVD risk factors, risk score and prescribed medication were extracted. CVD risk (thus eligibility for cholesterol and blood pressure-lowering treatment) was calculated using the Framingham equation. Guideline adherence was defined with descriptive statistics and comparisons by age, sex and disease were made using χ(2) tests. RESULTS: Of the 34 975 patients (aged 40-74 years) included in this study, 2550 (7%) patients had existing CVD and 12 349 (35%) had a calculable CVD risk or were on treatment. CVD risk was formally assessed in 8390 (24%) patients. Approximately 7929 (64%) patients eligible for primary prevention therapy were being treated appropriately for their CVD risk. Guideline adherence was higher in younger patients (6284 [69%] aged 40-64 years versus 1645 [50%] aged 65-74 years, P<0.001) and in females (4334 [69%] females versus 3595 [59%] males, P<0.001). There was no difference in guideline adherence between patients where CVD risk had been recorded and those where CVD was calculable. Guideline adherence in patients with existing CVD was highest in patients with ischaemic heart disease (866 [ischaemic heart disease], 52%, versus 288 [stroke], 46%, versus 276 [other CVD], 39%; P<0.001). CONCLUSION: There is scope for improvement in assessment and treatment for prevention of CVD in clinical practice. Increasing the uptake of evidence-based treatments would improve the cost-effectiveness of CVD risk screening programmes.

Attending coroner's court: a practical guide.

It will happen to many of us during our medical careers. We will receive a summons to give evidence at a coroner's inquest, and the nerves will start to run riot.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

BACKGROUND: People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? METHODS/DESIGN: This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. DISCUSSION: This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. TRIAL REGISTRATION: ISRCTN62019087.