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Biomedical subjects

N Freemantle

Publications and source records attributed to N Freemantle.

At least 19 recordsLinked to original sources
PubMed2006

Cardiac resynchronisation for patients with heart failure due to left ventricular systolic dysfunction -- a systematic review and meta-analysis.

BACKGROUND: Randomised controlled trials generally suggest that cardiac resynchronisation improves outcomes in patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony. Our objective was to provide a valid synthesis of the effects of CRT on mortality, major morbidity, quality of life and implantation success rates. METHODS: Systematic overview and meta-analysis of randomised trials, both blinded and open, comparing cardiac resynchronisation with control. The primary outcome was all-cause mortality, and secondary outcomes included hospitalisation for worsening heart failure, quality of life and implantation success rates. RESULTS: We identified 8 randomised trials which included 3380 patients and observed a total of 524 deaths. Follow-up ranged from 1 month to a mean of 29.4 months. Most trials were of high quality, with centrally administered randomisation and few patients lost to follow-up. CRT reduced mortality in these trials (odds ratio 0.72, 95% CI 0.59 to 0.88). In addition CRT reduced hospitalisation for worsening heart failure (odds ratio 0.55, 95% CI 0.44 to 0.68) and improved quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (weighted mean difference -7.1, 95% CI -2.9 to -11.4). Implantation success rates in the trials were 87% or greater. CONCLUSION: Cardiac resynchronisation in patients with heart failure characterised by dyssynchrony substantially reduces all-cause mortality, major morbidity and improves quality of life.

Cardiac Output, Low↗
PubMed2005

Baseline characteristics of patients recruited into the CARE-HF study.

BACKGROUND: Cardiac resynchronization therapy (CRT) is a promising new treatment for patients with heart failure and cardiac dyssynchrony. The CARE-HF study is a morbidity/mortality trial designed to provide conclusive evidence of the effects of CRT in patients with moderate to severe heart failure. METHODS: A description of the baseline characteristics of patients randomised in the CARE-HF trial. RESULTS: 813 Patients with predominantly NYHA class III (94%) heart failure were randomised in 82 centres. Their mean age was 65 (interquartile range [IQR] 59 to 72) years, 34% were aged >70 years and 27% were women. Thirty-eight percent of the patients had ischaemic heart disease. Mean heart rate was adequately controlled at 70 (IQR 60 to 78) bpm consistent with the use of beta-blockers. Supine systolic blood pressure was low at 117 (IQR 105 to 130) mm Hg. Eighty-eight percent of patients had a QRS > or =150 ms. Mean LV ejection fraction was 26% (IQR 22 to 29) and end-diastolic dimension was 7.2 (IQR 6.4 to 7.8) cm. Ninety-four percent of patients were receiving loop diuretics, 95% an ACE inhibitor or angiotensin receptor blocker (ARB), 72% a beta-blocker and 56% were taking spironolactone. CONCLUSIONS: The patients enrolled in CARE-HF had moderately severe heart failure and cardiac dysfunction with evidence of cardiac dyssynchrony. The population appears at high risk of events despite pharmacological therapy and therefore appropriate for a trial of CRT.

Aged↗
PubMed2004

Use of implantable loop recorders in the diagnosis and management of syncope.

BACKGROUND: Syncope is a common, disabling symptom. The most useful data for diagnosing and managing syncope is the recording of physical parameters such as the ECG and blood pressure during a spontaneous event. Implantable loop recorders (ILR) provide an opportunity to record ECG data from a spontaneous event. The purpose of the Eastbourne Syncope Assessment Study (EaSyAS) was to investigate the impact of ILRs on an unselected population of syncopal patients presenting acutely to our institution. METHODS: All patients presenting acutely with recurrent, unexplained syncope over a 16-month period, were randomised after a basic clinical workup to receive the Reveal Plus ILR or conventional investigation. All patients were followed up for at least 6 months (mean 276+/-134 days) following randomisation. The primary outcome measure was time to ECG diagnosis. RESULTS: Four hundred twenty-one patients presented, 201 were eligible, median age 74 years (interquartile range 61-81 years), 54% female, with a median of three previous syncopes (IQ range 2-6). Thirty-three percent of ILR patients and 4% of conventional patients had an ECG diagnosis (hazard ratio 8.93, 95% CI 3.17-25.2, p < or = 0.0001). Introduction of ECG-directed therapy was quicker for ILR patients (hazard ratio 7.9, 95% CI 2.8-22.3, p < 0.0001). ILR patients had fewer post-randomisation investigations and fewer hospital days, resulting in a saving of costs, 406 UK pounds versus 1210 UK pounds (mean difference 809 UK pounds, 95% CI 123-2730 UK pounds). There was no difference in the number of subsequent syncopal episodes, mortality, or quality of life. CONCLUSIONS: LR significantly increased the rate of diagnosis in an unselected Western population with recurrent syncope. There was a significant decrease in the rates of hospitalisation and investigation in patients receiving an ILR.

Aged↗
PubMed2004

Use of health-related quality of life in prescribing research. Part 2: methodological considerations for the assessment of health-related quality of life in clinical trials.

This article aims to address key methodological issues that should be considered when assessing health-related quality of life (HRQoL) in a clinical trial. These include justification for the selection of HRQoL as a primary or secondary outcome and choice of an appropriate instrument to assess HRQoL, which meets basic psychometric properties. In addition we consider ways to minimize bias within the trial through optimization of compliance and timing of assessments.

Clinical Trials as Topic↗
PubMed2004

Educational outreach in diabetes to encourage practice nurses to use primary care hypertension and hyperlipidaemia guidelines (EDEN): a randomized controlled trial.

OBJECTIVE: To determine the effectiveness of specialist nurse delivered education in primary care to improve control of hypertension and hyperlipidaemia in patients with diabetes. DESIGN AND SETTING: Practice-level randomized controlled trial, Salford, England. SUBJECTS: From 44 practices, 10 303 subjects presenting in general practice with raised blood pressure (= 140/80 mmHg), raised total cholesterol (= 5.0 mmol/l) or both. INTERVENTIONS: Practices were randomized to receive either the intervention for hyperlipidaemia or for hypertension; practices acted as control for the intervention not received. Specialist nurses arranged a schedule of visits with general practitioners and general practice nurses, reminding them of diabetes protocols and clinical targets. They provided educational materials and protocols used in secondary care for nurse and doctor interventions including stepping up pharmacotherapy when necessary. Practices received a list of patients in their practice who were poorly controlled at their last annual review; new and recalled patients were targeted. OUTCOME MEASURES: At subsequent annual review, blood pressure and total cholesterol values were obtained from the Salford electronic diabetes register for patients from participating practices. RESULTS: Overall, specialist nurse-led educational outreach to primary care was associated with no improvement in patients achieving target after 1 year-odds ratio (OR): 1.03 (95% CI 0.95-1.11; P = 0.52). Similar results were achieved with hyperlipidaemia OR: 1.04 (95% CI 0.88-1.23; P = 0.62) and hypertension OR: 1.01 (95% CI 0.80-1.27; P = 0.93). CONCLUSION: This study provides evidence that the use of specialist nurses to perform educational outreach to improve target adherence to patients with diabetes in primary care is not effective.

Blood Pressure↗
PubMed2003

The EuroHeart Failure Survey programme--a survey on the quality of care among patients with heart failure in Europe. Part 2: treatment.

BACKGROUND: National surveys suggest that treatment of heart failure in daily practice differs from guidelines and is characterized by underuse of recommended medications. Accordingly, the Euro Heart Failure Survey was conducted to ascertain how patients hospitalized for heart failure are managed in Europe and if national variations occur in the treatment of this condition. METHODS: The survey screened discharge summaries of 11304 patients over a 6-week period in 115 hospitals from 24 countries belonging to the ESC to study their medical treatment. RESULTS: Diuretics (mainly loop diuretics) were prescribed in 86.9% followed by ACE inhibitors (61.8%), beta-blockers (36.9%), cardiac glycosides (35.7%), nitrates (32.1%), calcium channel blockers (21.2%) and spironolactone (20.5%). 44.6% of the population used four or more different drugs. Only 17.2% were under the combination of diuretic, ACE inhibitors and beta-blockers. Important local variations were found in the rate of prescription of ACE inhibitors and particularly beta-blockers. Daily dosage of ACE inhibitors and particularly of beta-blockers was on average below the recommended target dose. Modelling-analysis of the prescription of treatments indicated that the aetiology of heart failure, age, co-morbid factors and type of hospital ward influenced the rate of prescription. Age <70 years, male gender and ischaemic aetiology were associated with an increased odds ratio for receiving an ACE inhibitor. Prescription of ACE inhibitors was also greater in diabetic patients and in patients with low ejection fraction (<40%) and lower in patients with renal dysfunction. The odds ratio for receiving a beta-blocker was reduced in patients >70 years, in patients with respiratory disease and increased in cardiology wards, in ischaemic heart failure and in male subjects. Prescription of cardiac glycosides was significantly increased in patients with supraventricular tachycardia/atrial fibrillation. Finally, the rate of prescription of antithrombotic agents was increased in the presence of supraventricular arrhythmia, ischaemic heart disease, male subjects but was decreased in patients over 70. CONCLUSION: Our results suggest that the prescription of recommended medications including ACE inhibitors and beta-blockers remains limited and that the daily dosage remains low, particularly for beta-blockers. The survey also identifies several important factors including age, gender, type of hospital ward, co morbid factors which influence the prescription of heart failure medication at discharge.

Adrenergic beta-Antagonists↗
PubMed2003

The EuroHeart Failure survey programme-- a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis.

BACKGROUND: The European Society of Cardiology (ESC) has published guidelines for the investigation of patients with suspected heart failure and, if the diagnosis is proven, their subsequent management. Hospitalisation provides a key point of care at which time diagnosis and treatment may be refined to improve outcome for a group of patients with a high morbidity and mortality. However, little international data exists to describe the features and management of such patients. Accordingly, the EuroHeart Failure survey was conducted to ascertain if appropriate tests were being performed with which to confirm or refute a diagnosis of heart failure and how this influenced subsequent management. METHODS: The survey screened consecutive deaths and discharges during 2000-2001 predominantly from medical wards over a 6-week period in 115 hospitals from 24 countries belonging to the ESC, to identify patients with known or suspected heart failure. RESULTS: A total of 46788 deaths and discharges were screened from which 11327 (24%) patients were enrolled with suspected or confirmed heart failure. Forty-seven percent of those enrolled were women. Fifty-one percent of women and 30% of men were aged >75 years. Eighty-three percent of patients had a diagnosis of heart failure made on or prior to the index admission. Heart failure was the principal reason for admission in 40%. The great majority of patients (>90%) had had an ECG, chest X-ray, haemoglobin and electrolytes measured as recommended in ESC guidelines, but only 66% had ever had an echocardiogram. Left ventricular ejection fraction had been measured in 57% of men and 41% of women, usually by echocardiography (84%) and was <40% in 51% of men but only in 28% of women. Forty-five percent of women and 22% of men were reported to have normal left ventricular systolic function by qualitative echocardiographic assessment. A substantial proportion of patients had alternative explanations for heart failure other than left ventricular systolic or diastolic dysfunction, including valve disease. Within 12 weeks of discharge, 24% of patients had been readmitted. A total of 1408 of 10434 (13.5%) patients died between admission and 12 weeks follow-up. CONCLUSIONS: Known or suspected heart failure comprises a large proportion of admissions to medical wards and such patients are at high risk of early readmission and death. Many of the basic investigations recommended by the ESC were usually carried out, although it is not clear whether this was by design or part of a general routine for all patients being admitted regardless of diagnosis. The investigation most specific for patients with suspected heart failure (echocardiography) was performed less frequently, suggesting that the diagnosis of heart failure is still relatively neglected. Most men but a minority of women who underwent investigation of cardiac function had evidence of moderate or severe left ventricular dysfunction, the main target of current advances in the treatment of heart failure. Considerable diagnostic uncertainty remains for many patients with suspected heart failure, even after echocardiography, which must be resolved in order to target existing and new therapies and services effectively.

Aged↗
PubMed2003

The heart failure revascularisation trial (HEART): rationale, design and methodology.

BACKGROUND: Most patients with heart failure due to left ventricular systolic dysfunction (LVSD) secondary to coronary artery disease (CAD) have evidence of myocardium in jeopardy (reversible ischaemia and/or stunning hibernation). It is not known whether revascularisation in such cases is safe or beneficial. AIMS: To determine whether revascularisation will improve the survival of patients with LVSD and heart failure secondary to CAD and myocardium in jeopardy. METHODS: This is a randomised controlled trial comparing revascularisation or not, in addition to optimal medical therapy with ACE inhibitors, beta-blockers, aldosterone antagonists and an anti-thrombotic agent. Patients must have heart failure requiring treatment with diuretics, a left ventricular ejection fraction <35% and evidence of coronary disease. Myocardial viability and ischaemia are assessed by a broad range of techniques including stress echocardiography and nuclear imaging. All imaging tests are reviewed in core laboratories to ensure uniform reporting. Any conventional revascularisation technique is permitted. The primary outcome measure is all cause mortality. Symptoms, quality of life and health economic issues will also be explored. Assuming an annual mortality of 10% in the control group and allowing for substantial cross-over rates, a study of 800 patients followed for 5 years has 80% power with an alpha of 0.05 (two-sided) to show a 25% reduction in mortality with revascularisation. RESULTS: At the time of writing 180 patients have been screened for inclusion, 111 have consented to participate and 70 have been randomised. The results of viability testing are awaited in 22 patients. Twenty-six patients had been investigated for myocardial viability and/or by angiography prior to consent, as part of the routine practice in that cardiology department. Of 68 patients who have completed assessment only after consent, 47 (69%) were included. The principal reason for drop-out between consent and randomisation was lack of evidence of myocardial ischaemia or hibernation. CONCLUSION: The HEART trial will help to determine whether investigation of myocardial ischaemia and/or viability with a view to revascularisation should become part of the routine care of patients with heart failure due to LVSD and CAD.

Coronary Artery Disease↗
PubMed2003

Use of health-related quality of life in prescribing research. Part 1: why evaluate health-related quality of life?

Clinicians, regulatory authorities, and pharmaceutical companies increasingly recognize the importance of assessing the patient's perspective on the impact of disease and its treatment on their health-related quality of life (HRQoL). This article describes the importance of assessing HRQoL, particularly in patients with chronic disease, provides examples of the different types of instrument available for measuring HRQoL and considers how such assessment can aid medical-decision making. In addition we consider the potential role of HRQoL assessment in routine clinical practice, and its use in licensing and health technology appraisal.

Adolescent↗
PubMed2002

Management of heart failure in primary care (the IMPROVEMENT of Heart Failure Programme): an international survey.

BACKGROUND: Heart failure is a prevalent condition that is generally treated in primary care. The aim of this study was to assess how primary-care physicians think that heart failure should be managed, how they implement their knowledge, and whether differences exist in practice between countries. METHODS: The survey was undertaken in 15 countries that had membership of the European Society of Cardiology (ESC) between Sept 1, 1999, and May 31, 2000. Primary-care physicians' knowledge and perceptions about the management of heart failure were assessed with a perception survey and how a representative sample of patients was managed with an actual practice survey. FINDINGS: 1363 physicians provided data for 11062 patients, of whom 54% were older than 70 years and 45% were women. 82% of patients had had an echocardiogram but only 51% of these showed left ventricular systolic dysfunction. Ischaemic heart disease, hypertension, diabetes mellitus, atrial fibrillation, and major valve disease were all common. Physicians gave roughly equal priority to improvement of symptoms and prognosis. Most were aware of the benefits of ACE inhibitors and beta blockers. 60% of patients were prescribed ACE inhibitors, 34% beta blockers but only 20% received these drugs in combination. Doses given were about 50% of targets suggested in the ESC guidelines. If systolic dysfunction was documented, ACE inhibitors were more likely and beta blockers less likely to be prescribed than when there was no evidence of systolic dysfunction. INTERPRETATION: Results from this survey suggest that most patients with heart failure are appropriately investigated, although this finding might be as a result of high rates of hospital admissions. However, treatment seems to be less than optimum, and there are substantial variations in practice between countries. The inconsistencies between physicians' knowledge and the treatment that they deliver suggests that improved organisation of care for heart failure is required.

Aged↗
PubMed2002

Using effectiveness studies for prescribing research, part 1.

The process of evaluating pharmaceuticals has become highly conceptualized in contrast to the lack of formal rules for assessing effects of interventions on practice. We argue that clinical audit is a key factor prior to instigating an intervention and that randomized controlled evaluations are preferable. We discuss the need for small-scale experiments prior to full trials to validate the underlying concept of an intervention with the recognition that different approaches may be necessary. This includes open rather than blind assessments and greater emphasis on qualitative issues during development of interventions followed by quantitative appraisal of their impact.

Clinical Trials as Topic↗
PubMed2002

Using effectiveness studies for prescribing research, part 2.

Trials that consider the effects of interventions on prescribing behaviour amongst clinicians often have complex design implications resulting in data that has inherent hierarchical structure. It follows that both experimental design and analysis plans must account for this structure and thus results should be considered in terms of clinician behaviour rather than individual patient response. We describe this change in perspective and the necessity for using statistical techniques that allow incorporation of potential confounding effects. We also discuss the appropriateness of some specific outcomes in relation to these trials.

Clinical Trials as Topic↗
PubMed2001

When is it cost-effective to change the behavior of health professionals?

Because of the workings of health care systems, new, important, and cost-effective treatments sometimes do not become routine care while well-marketed products of equivocal value achieve widespread adoption. Should policymakers attempt to influence clinical behavior and correct for these inefficiencies? Implementation methods achieve a certain level of behavioral change but cost money to enact. These factors can be combined with the cost-effectiveness of treatments to estimate an overall policy cost-effectiveness. In general, policy cost-effectiveness is always less attractive than treatment cost-effectiveness. Consequently trying to improve the uptake of underused cost-effective care or reduce the overuse of new and expensive treatments may not always make economic sense. In this article, we present a method for calculating policy cost-effectiveness and illustrate it with examples from a recent trial, conducted during 1997 and 1998, of educational outreach by community pharmacists to influence physician prescribing in England.

Cost-Benefit Analysis↗
PubMed2001

Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice.

OBJECTIVE: To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice. DESIGN: Randomised controlled trial of clinical medication review by a pharmacist against normal general practice review. SETTING: Four general practices. PARTICIPANTS: 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community. INTERVENTION: Patients were invited to a consultation at which the pharmacist reviewed their medical conditions and current treatment. MAIN OUTCOME MEASURES: Number of changes to repeat prescriptions over one year, drug costs, and use of healthcare services. RESULTS: 590 (97%) patients in the intervention group were reviewed compared with 233 (44%) in the control group. Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions (mean number of changes per patient 2.2 v 1.9; difference=0.31, 95% confidence interval 0.06 to 0.57; P=0.02). Monthly drug costs rose in both groups over the year, but the rise was less in the intervention group (mean difference 4.72 pound sterling per 28 days, - 7.04 pound sterling to - 2.41 pound sterling); equivalent to 61 pound sterling per patient a year. Intervention patients had a smaller rise in the number of drugs prescribed (0.2 v 0.4; mean difference -0.2, -0.4 to -0.1). There was no evidence that review of treatment by the pharmacist affected practice consultation rates, outpatient consultations, hospital admissions, or death rate. CONCLUSIONS: A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs. Such review results in significant changes in patients' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners.

Aged↗