Teresa F Allan

A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management

Background: The increase in numbers of patients receiving warfarin treatment has led to the development of alternative models of service delivery for oral anticoagulant monitoring. Patient self management for oral anticoagulation is a model new to the UK. This randomised trial was the first to compare routine primary care management of oral anticoagulation with patient self management. Aim: To test whether patient self management is as safe, in terms of clinical effectiveness, as primary care management within the UK, as assessed by therapeutic international normalised ratio (INR) control. Method: Patients receiving warfarin from six general practices who satisfied study entry criteria were eligible to enter the study. Eligible patients were randomised to either intervention (patient self management) or control (routine primary care management) for six months. The intervention comprised two training sessions of one to two hours duration. Patients were allowed to undertake patient self management on successful completion of training. INR testing was undertaken using a Coaguchek device and regular internal/external quality control tests were performed. Patients were advised to perform INR tests every two weeks, or weekly if a dose adjustment was made. Dosage adjustment was undertaken using a simple dosing algorithm. Results: Seventy eight of 206 (38%) patients were eligible for inclusion and, of these, 35 (45%) declined involvement or withdrew from the study. Altogether, 23 intervention and 26 control patients entered the study. There were no significant differences in INR control (per cent time in range: intervention, 74%; control, 77%). There were no serious adverse events in the intervention group, with one fatal retroperitoneal haemorrhage in the control group. Costs of patient self management were significantly greater than for routine care (£90 v £425/patient/year). Conclusion: These are the first UK data to demonstrate that patient self management is as safe as primary care management for a selected population. Further studies are needed to elucidate whether this model of care is suitable for a larger population.

A systematic review of the evidence supporting the use of priority dispatch of emergency ambulances

Objectives. Systematic reviews of the literature assist in the location, appraisal, and synthesis of available evidence. This systematic review aimed to 1) assess the existing literature evaluating the effect of the priority dispatch of emergency ambulances on clinical outcome and ambulance utilization and 2) assess the relative effectiveness of sources of literature relevant to prehospital care. Methods. Systematic review. The quality of each paper was assessed using a standardized seven-point scoring schedule. Sources used were: Medline, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), Bath Information & Data Services (BIDS), bibliographic searching, contacting researchers active in the field, and hand-searching relevant journals. Key words used were: “ambulance,” “prioritisation,” “dispatch,” and “triage.” Results. Three hundred twenty-six papers were identified: 64 (19.6%) were related to the prioritization of emergency ambulances, and only 20 (6.1%) contained original data. The overall quality of publications was poor, seven (35%) papers having a quality score ≥4. Only half were identified by electronic databases, 55% were identified by people working in the field, and two (10%) were identified by hand-searching (some papers were identified by more than one source). Two high-quality papers support the concept that criteria-based dispatch (CBD) improves clinical outcome; two other papers support CBDs role in improving ambulance utilization. Conclusions. There is very little evidence to support the effect of the prioritization of emergency ambulances on patient outcome. Electronic databases identify only approximately half of all relevant prehospital literature. Future systematic reviews in this area should use electronic databases, supplemented by contact with appropriate experts.

Gender as a variable in the assessment of final year degree‐level communication skills

Aim  To investigate possible bias due to gender combination of students, role players and examiners in a high‐stakes assessment.

Protocol for Birmingham Atrial Fibrillation Treatment of the Aged study (BAFTA): a randomised controlled trial of warfarin versus aspirin for stroke prevention in the management of atrial fibrillation in an elderly primary care population (ISRCTN89345269)

BackgroundAtrial fibrillation (AF) is an important independent risk factor for stroke. Randomised controlled trials have shown that this risk can be reduced substantially by treatment with warfarin or more modestly by treatment with aspirin. Existing trial data for the effectiveness of warfarin are drawn largely from studies in selected secondary care populations that under-represent the elderly.The Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study will provide evidence of the risks and benefits of warfarin versus aspirin for the prevention of stroke for older people with AF in a primary care setting.Study designA randomised controlled trial where older patients with AF are randomised to receive adjusted dose warfarin or aspirin. Patients will be followed up at three months post-randomisation, then at six monthly intervals there after for an average of three years by their general practitioner. Patients will also receive an annual health questionnaire.1240 patients will be recruited from over 200 practices in England. Patients must be aged 75 years or over and have AF. Patients will be excluded if they have a history of any of the following conditions: rheumatic heart disease; major non-traumatic haemorrhage; intra-cranial haemorrhage; oesophageal varices; active endoscopically proven peptic ulcer disease; allergic hypersensitivity to warfarin or aspirin; or terminal illness. Patients will also be excluded if the GP considers that there are clinical reasons to treat a patient with warfarin in preference to aspirin (or vice versa).The primary end-point is fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant arterial embolism. Secondary outcomes include major extra-cranial haemorrhage, death (all cause, vascular), hospital admissions (all cause, vascular), cognition, quality of life, disability and compliance with study medication.

A primary care evaluation of three near patient coagulometers.

AIM: To compare the reliability and relative costs of three international normalised ratio (INR) near patient tests. MATERIALS: Protime (ITC Technidyne), Coaguchek (Boehringer Mannheim), and TAS (Diagnostic Testing). METHODS: All patients attending one inner city general practice anticoagulation clinic were asked to participate, with two samples provided by patients not taking warfarin. A 5 ml sample of venous whole blood was taken from each patient and a drop immediately added to the prepared Coaguchek test strip followed by the Protime cuvette. The remainder was added to a citrated bottle. A drop of citrated blood was then placed on the TAS test card and the remainder sent to the reference laboratory for analysis. Parallel INR estimation was performed on the different near patient tests at each weekly anticoagulation clinic from July to December 1997. RESULTS: 19 patients receiving long term warfarin treatment provided 62 INR results. INR results ranged from 0.8-8.2 overall and 1.0-5.7 based on the laboratory method. Taking the laboratory method as the gold standard, 12/62 results were < 2.0 and 2/62 were > 4.5. There were no statistical or clinically significant differences between results from the three systems, although all near patient tests showed slightly higher mean readings than the laboratory, and 19-24% of tests would have resulted in different management decisions based on the machine used in comparison with the laboratory INR value. The cost of the near patient test systems varied substantially. CONCLUSIONS: All three near patient test systems are safe and efficient for producing acceptable and reproducible INR results within the therapeutic range in a primary care setting. All the systems were, however, subject to operator dependent variables at the time of blood letting. Adequate training in capillary blood sampling, specific use of the machines, and quality assurance procedures is therefore essential.

Hitting the mark: negotiated marking and performance factors in the communication skills element of the VOICE examination

Introduction  Communication skills assessment is complex. Standardised patient use is widespread, but anxiety exists around the use of role players as assessors of competence in high stakes examinations. This study measures the level of agreement between scoring examiners and role players, and considers their influence on each other. Examiner status and question choices are analysed as variables.

Closing the gap between what industry needs and what HE provides

The Economic and Social Science Research Council’s Innovation Agenda singled out “more innovation” as a key weapon for UK companies to outperform world competitors. This research explores this Innovation Agenda from an HE perspective, and reports on a study of a final year undergraduate course in Creative Management. Students, in syndicate groups, were asked to invent their own business idea. By simulating make‐believe situations in the classroom, we aimed to approximate feelings purportedly experienced by business managers as they innovate, such as “creative tension” and “strategic discomfort”. This article argues that preparedness for creative tension is now a necessity for business graduates. Additionally, it proposes that an awareness of discomfiting strategic effects of renewal is worthwhile. For example, how might students have coped with the shock to IBM during the demise of the computer mainframe market?

SMART: Self-Management of Anticoagulation, a Randomised Trial [ISRCTN19313375]

BackgroundOral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR). The development of reliable near patient testing (NPT) systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care.MethodThe study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics.DiscussionThe methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.

A Comparison of Bayesian and Maximum Likelihood Methods to Determine the Performance of a Point of Care Test for Helicobacter pylori in the Office Setting

Objective. Evaluations of point of care tests (PCT) are often hampered by a lack of appropriate gold standards. This study aimed to compare the results of a Bayesian statistical analysis and a maximum likelihood method to evaluate the performance of a PCT for Helicobacter pylori in primary care. Methods. The Helisal Rapid Blood Test (Cortecs Diagnostics) was performed in 311 patients from 6 primary care centers, and a concurrent venous sample was taken for 2 enzyme linked immunosorbent assays (ELISA) performed at the laboratory, blind to the PCT result. The Bayesian analysis was conducted using Markov Chain Monte Carlo methods (WinBUGS). The performance characteristics of the PCT and the 2 ELISA tests were estimated together with 95% credible intervals (95% CIs). Results. The estimate of prevalence of H. pylori in this population was 64% (95% CI, 59% to 70%), the sensitivity and specificity of the PCT were 89% (84% to 94%) and 84% (77% to 91%), respectively (likelihood ratios positive 5.6, negative 0.13). The equivalent maximum likelihood results were prevalence, 65%; sensitivity, 90%; and specificity, 83%. Conclusions. The Helisal Rapid Blood Test performed as well as laboratory-based ELISA tests in this cohort of patients. The Bayesian analysis and the maximum likelihood method gave similar results, the Bayesian method also simultaneously estimating 95% CIs.

Impact of a region-wide approach to improving systems for heart attack care: the West Midlands thrombolysis project.

Objective: To describe changes in delay to administration of thrombolytic therapy associated with a region-wide audit. Design: Observational study of patients admitted with suspected myocardial infarction (MI) based on continuous audit. Subjects: 18877 patients admitted to 23 hospitals with suspected MI between April 1995 and March 1998. Results: Of 11232 patients with a discharge diagnosis of definite MI, 8802 (46.6%) received thrombolytic therapy during hospitalisation, with 5155 patients eligible for treatment on admission to hospital on the basis of established indications. Call-to-needle time for those eligible for treatment on admission fell from median 105 min in the first year of the project to 85 min in year 3 (P<0.001), and door-to-needle time fell from 45 to 35 min (P<0.001). Forty percent of eligible patients were treated within the then current national standard of 90 min from time of call for help, with nearly 49% in the final year and 20% being treated within the new national standard of 60 min, by the third year. Conclusion: The proportion of eligible patients receiving thrombolysis within 1 h of the call for help doubled during the 3-year project but the majority of patients still wait longer than 60-min ‘call-to-needle’. New systems to reduce delays to administration of thrombolysis to within 60 min of call for help are required, including consideration of pre-hospital treatment.