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Nick Freemantle

Publications and source records attributed to Nick Freemantle.

At least 37 records · Page 2Linked to original sources
PubMed2005

Cost-effectiveness of cardiac resynchronization therapy: results from the CARE-HF trial.

AIMS: Whilst the CArdiac REsynchronization in Heart Failure (CARE-HF) trial has shown that cardiac resynchronization therapy (CRT) leads to reduced morbidity and mortality, the cost-effectiveness of this therapy remains uncertain. The aim of this study was to evaluate the incremental cost per quality adjusted life year (QALY) gained and incremental cost per life year gained of CRT plus medical therapy compared to medical therapy alone. METHODS AND RESULTS: This prospective analysis based on intention to treat data from all patients enrolled in the CARE-HF trial at 82 clinical centres in 12 European countries. A total of 813 patients with New York Heart Association class III or IV heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony were randomized to CRT plus medical therapy (n = 409) vs. medical therapy alone (n = 404). During a mean follow-up of 29.4 months CRT was associated with increased costs (4316, 95% CI: 1327-7485), survival (0.10 years, 95% CI: -0.01-0.21), and QALYs (0.22, 95% CI: 0.13-0.32). The incremental cost-effectiveness ratio was 19 319 per QALY gained (95% CI: 5482-45 402) and 43 596 per life-year gained (95% CI: -146 236-223 849). These results were sensitive to the costs of the device, procedure, and hospitalization. CONCLUSION: Treatment with CRT appears cost-effective at the notional willingness to pay threshold of 29 400 (20,000 pounds sterlings) per QALY gained.

Adolescent↗
PubMed2005

Relation between mild renal dysfunction and outcomes after coronary artery bypass grafting.

BACKGROUND: Risk stratification algorithms for coronary artery bypass grafting (CABG) do not include a weighting for preoperative mild renal impairment defined as a serum creatinine 130 to 199 micromol/L (1.47 to 2.25 mg/dL), which may impact mortality and morbidity after CABG. METHODS AND RESULTS: We reviewed prospectively collected data between 1997 and 2004 on 4403 consecutive patients undergoing first-time isolated CABG with a preoperative serum creatinine <200 micromol/L (2.26 mg/dL)] in a single institution. The in-hospital mortality was 2.5% (112 of 4403), the need for new dialysis/hemofiltration was 1.3% (57 of 4403), and the stroke rate was 2.5% (108 of 4403). There were 458 patients with a serum creatinine 130 to 199 micromol/L or 1.47 to 2.25 mg/dL (mild renal dysfunction group) and 3945 patients with a serum creatinine <130 micromol/L (<1.47 mg/dL). Operative mortality was higher in the mild renal dysfunction group (2.1% versus 6.1%; P<0.001) and increased with increasing preoperative serum creatinine level. New dialysis/hemofiltration (0.8%versus 5.2%; P<0.001) and postoperative stroke (2.2% versus 5.0%; P<0.01) were also more common in the patients with mild renal impairment. Multivariate analysis adjusting for known risk factors confirmed preoperative mild renal impairment (creatinine 130 to 199 micromol/L or 1.47 to 2.25 mg/dL; odd ratio, 1.91; 95% CI, 1.18 to 3.03; P=0.007) or glomerular filtration rate estimates <60 mL/min per 1.73 m2, derived using the Cockroft-Gault formula, (odds ratio, 1.98; 95% CI, 1.16 to 3.48; P=0.015) as independent predictors of in-hospital mortality. Preoperative mild renal dysfunction adversely affected the 3-year survival probability after CABG (93% versus 81%; P<0.001). CONCLUSIONS: Mild renal dysfunction is an important predictor of outcome in terms of in-hospital mortality, morbidity, and midterm survival in patients undergoing CABG.

Aged↗
PubMed2005

Design of the BiRmingham Early Detection In untREated psyChosis Trial (REDIRECT): cluster randomised controlled trial of general practitioner education in detection of first episode psychosis [ISRCTN87898421].

BACKGROUND: Treatment delay in first episode psychosis is common. As general practitioners are the first point of contact for many individuals with first episode psychosis, they are well placed to detect the early symptoms and make urgent referrals to specialist secondary care services. However, early psychosis is often difficult to detect. The primary objective of the Redirect trial is to estimate whether an educational intervention targeted at general practitioners increases the general practitioner referral rate of young people with first episode psychosis to Early Intervention Services. METHODS/DESIGN: This paper describes the design of a stratified-cluster randomised controlled trial of an educational intervention on first episode psychosis in primary care. The primary outcome is the number of general practitioner referrals of young people with first episode psychosis to Early Intervention Services. Secondary outcomes are duration of untreated psychosis, time to recovery, use of the Mental Health Act, and general practitioner consultation rate. Young people with first episode psychosis referred to Early Intervention Services will be recruited over a two-year period from 1 March 2004. Seventy-eight out of 89 eligible general practices were recruited. The educational intervention has been implemented and evaluated by general practitioners. The education was well received and considered relevant to clinical practice by the general practitioners. DISCUSSION: The results suggest that the recruitment strategy and implementation of the educational intervention are feasible and acceptable in a primary care setting. The Redirect trial will provide robust information about the efficacy of an evidence-based complex educational intervention targeted at general practitioners on referral rates of young people with first episode psychosis to Early Intervention Services.

Adolescent↗
PubMed2005

The effect of cardiac resynchronization on morbidity and mortality in heart failure.

BACKGROUND: Cardiac resynchronization reduces symptoms and improves left ventricular function in many patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony. We evaluated its effects on morbidity and mortality. METHODS: Patients with New York Heart Association class III or IV heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony who were receiving standard pharmacologic therapy were randomly assigned to receive medical therapy alone or with cardiac resynchronization. The primary end point was the time to death from any cause or an unplanned hospitalization for a major cardiovascular event. The principal secondary end point was death from any cause. RESULTS: A total of 813 patients were enrolled and followed for a mean of 29.4 months. The primary end point was reached by 159 patients in the cardiac-resynchronization group, as compared with 224 patients in the medical-therapy group (39 percent vs. 55 percent; hazard ratio, 0.63; 95 percent confidence interval, 0.51 to 0.77; P<0.001). There were 82 deaths in the cardiac-resynchronization group, as compared with 120 in the medical-therapy group (20 percent vs. 30 percent; hazard ratio 0.64; 95 percent confidence interval, 0.48 to 0.85; P<0.002). As compared with medical therapy, cardiac resynchronization reduced the interventricular mechanical delay, the end-systolic volume index, and the area of the mitral regurgitant jet; increased the left ventricular ejection fraction; and improved symptoms and the quality of life (P<0.01 for all comparisons). CONCLUSIONS: In patients with heart failure and cardiac dyssynchrony, cardiac resynchronization improves symptoms and the quality of life and reduces complications and the risk of death. These benefits are in addition to those afforded by standard pharmacologic therapy. The implantation of a cardiac-resynchronization device should routinely be considered in such patients.

Aged↗
PubMed2005

The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF study.

AIMS: To assess the quality of life of patients with heart failure, due to left ventricular dysfunction (NYHA class III or IV), taking optimal medical therapy using baseline quality of life assessments from the CArdiac REsynchronisation in Heart Failure (CARE-HF) trial, and to evaluate the appropriateness of using the EQ-5D in patients with heart failure. METHODS AND RESULTS: The quality of life of patients enrolled in CARE-HF was evaluated using the EQ-5D and Minnesota Living with Heart Failure Questionnaire. Response rates for the instruments were >90% and statistical modelling revealed an association between EQ-5D and Minnesota Living with Heart Failure scores. Heart failure is shown to have an important impact on all aspects of quality of life, but particularly on patients' mobility and usual activities, and leads to significant reductions in comparison with a representative sample of the UK population. CONCLUSIONS: The impact of heart failure varies amongst patients but the overall burden of disease appears to be comparable to other chronic conditions such as motor neurone or Parkinson's disease. The EQ-5D appears to be an acceptable valid measure for use in patients with heart failure although further evidence of the responsiveness of this measure in such patients is required.

Activities of Daily Living↗
PubMed2005

Highlighting the need for better patient care in stable angina: results of the international Angina Treatment Patterns (ATP) Survey in 7074 patients.

BACKGROUND: Stable angina is a growing problem worldwide. Diagnostic methods and treatment regimens are established but data on actual practice are sparse and pre-date current guidance. OBJECTIVES: To compare diagnosis and treatment information with guideline recommendations, and to assess impact on quality of life. METHODS: This international epidemiological survey recruited patients through primary and secondary care clinicians from China, Czech Republic, Greece, Hungary, Portugal, Russia and Slovak Republic. Participants experienced at least one episode of stable angina within the previous four weeks. Outcomes included use of diagnostic techniques, pharmacological treatments, surgical intervention, secondary prevention and quality of life. RESULTS: The study included 7074 patients, average age 63.3 (sd 10.3). Diagnosis of angina was most frequently as a result of chest pains (87.4%) with confirmation by resting ECG in only 54.9%. Advice regarding risk factors was frequently given although secondary prevention was often ineffective with 41% of treated hypertensives lacking effective control. 97% of patients were taking at least one of the primary therapies for stable angina recommended by the guidelines with rates of individual therapies varying greatly across countries. Quality of life was lowest in countries with low rates of surgical intervention and poor observance of guidelines on pharmaceutical therapy. CONCLUSION: Results show that the management of patients with stable angina does not meet recommended standards, although the appropriateness of these guidelines in poorer countries needs further investigation. Overall, the survey indicates that improved medical care and risk factor management would enhance prognosis and improve quality of life.

Angina Pectoris↗
PubMed2005

Clinical trials update from the American Heart Association meeting: ACORN-CSD, primary care trial of chronic disease management, PEACE, CREATE, SHIELD, A-HeFT, GEMINI, vitamin E meta-analysis, ESCAPE, CARP, and SCD-HeFT cost-effectiveness study.

This article provides information and a commentary on landmark trials presented at the American Heart Association meeting held in November 2004, relevant to the pathophysiology, prevention, and treatment of heart failure. An open trial of the ACORN Cardiac Support Device (CSD) showed encouraging preliminary results in patients with severe heart failure. The PEACE (Prevention of Events with Angiotensin-Converting Enzyme inhibition) study supports data from previous studies showing that ACE inhibitors reduce vascular events in patients at increased risk. The CREATE (clinical trial of metabolic modulation in acute MI treatment evaluation) study of patients with acute myocardial infarction (MI) showed no mortality benefit of a glucose/insulin/potassium regimen, but treatment with reviparin reduced the incidence of death, MI, or stroke. Azimilide was not associated with a significant reduction in shocks, but reduced the shocks or episodes of markedly symptomatic ventricular tachycardia terminated by pacing in the SHIELD (Shock Inhibition Evaluation with Azimilide) study. The addition of isosorbide dinitrate plus hydralazine to standard therapy improved survival in black heart failure patients in the A-HeFT (African-American Heart Failure Trial) study. In an investigation of hypertensive patients with diabetes, carvedilol had fewer adverse effects on diabetic control than metoprolol. A meta-analysis of high-dose vitamin E supplementation suggested an association with increased mortality. The ESCAPE (Evaluation Study of CHF and Pulmonary Artery Catheterisation Effectiveness) study showed no benefit of pulmonary artery catheterisation over clinical management in patients with severe heart failure. Routine prophylactic coronary revascularisation for stable coronary disease prior to major vascular surgery showed no benefit in the CARP (Coronary Artery Revascularization Prophylaxis) study. Analysis of data from SCD-HeFT supports the cost-effectiveness of ICDs in heart failure, although overall cost implications may be prohibitive.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed2005

The diagnosis of heart failure in European primary care: The IMPROVEMENT Programme survey of perception and practice.

OBJECTIVE: To examine European primary care physicians (PCPs) views on diagnosis of heart failure and compare perceptions with actual practice. DESIGN: Semi-structured PCP interviews and case note review on a random sample of heart failure patients. PARTICIPANTS: 1363 primary care physicians from 14 countries and 11,062 patient notes. MAIN OUTCOME MEASURES: Perceptions of PCPs compared to actual performance in heart failure (HF) diagnosis. RESULTS: Over 50% of patients with HF were above 70 years of age. Most subjects presented with typical clinical symptoms and objective signs of HF. In 50% of cases, HF was mainly diagnosed by PCPs. New York Heart Association classification was used by 50% of physicians. Electrocardiogram and chest X-ray were the most used diagnostic tests (90% and 84% respectively). PCPs considered echocardiography as having low diagnostic value, with only 48% routine usage. However, in actual practice echocardiography was used in 82% of diagnoses. Systolic dysfunction was observed in 51% HF subjects, but only 50% of physicians would differentiate systolic from diastolic heart failure. CONCLUSIONS: There was low use of NYHA classification (which denotes symptom severity) and differentiation between systolic and diastolic causes (which determines treatment strategies).

Adult↗
PubMed2005

Clinical trials update from the American College of Cardiology meeting: CARE-HF and the remission of heart failure, Women's Health Study, TNT, COMPASS-HF, VERITAS, CANPAP, PEECH and PREMIER.

This article provides information and a commentary on landmark trials presented at the American College of Cardiology meeting held in March 2005, relevant to the pathophysiology, prevention and treatment of heart failure. All reports should be considered as preliminary data, as analyses may change in the final publication. CARE-HF showed that Cardiac Re-synchronisation Therapy, administered in addition to expert pharmacological management, reduced all cause mortality and CV hospitalisation in patients with moderate or severe heart failure and cardiac dyssynchrony. The Women's Health Study showed no benefit of vitamin E supplementation or aspirin in the primary prevention of CV disease. The TNT study showed that reducing LDL cholesterol to levels lower than currently recommended, produced a 22% reduction in the incidence of major cardiovascular events. In COMPASS, an implantable device that continuously monitors intra-cardiac pressures was shown to be safe and to improve care in patients with chronic heart failure. Tezosentan failed to show benefit in patients with acute heart failure in the VERITAS study. The CANPAP study failed to show a benefit of continuous positive airway pressure on mortality and heart transplantation in heart failure patients with central sleep apnoea. EECP therapy improved exercise capacity but had no effect on peak VO2 in heart failure patients in the PEECH study. In the PREMIER study the matrix metalloproteinase inhibitor PG-116800 failed to prevent LV remodelling following myocardial infarction.

Cardiac Pacing, Artificial↗
PubMed2005

The development and implementation of an educational intervention on first episode psychosis for primary care.

INTRODUCTION: This paper describes the development and implementation of an educational intervention to help general practitioners (GPs) recognise young people with first episode psychosis. METHOD: The Medical Research Council complex interventions framework was used to guide the development of the intervention. The theoretical phase included a literature review of previous educational interventions in primary care and consideration of the literature on attitude formation and change, and the relationship between attitudes and behaviour. The modelling phase included focus groups with GPs and service users, and a training needs analysis questionnaire administered to GPs. The 2-stage intervention consisted of a video featuring role-plays of primary care consultations, GP-led discussion and discussion with early intervention service users. The acceptability and utility of the educational programme was evaluated using a 5-point Likert scale questionnaire administered at the end of each session. RESULTS: General practitioners from each of the 39 intervention practices participated in the initial session and from 27 practices in the booster session. Information about symptoms and signs of first episode psychosis was the most valued aspect of the initial session. The booster session was also well received, with GPs valuing the opportunity to gain insight into first episode psychosis from users. CONCLUSIONS: This paper adds a pragmatic description to the literature on the development of educational interventions in primary care. The Medical Research Council framework helped to identify and clarify component parts of the intervention and how the active components may relate to the expected outcome of behaviour change.

Adolescent↗
PubMed2005

Real-world trials to answer real-world questions.

Currently, there is a discrepancy between clinical trials designed to assess the efficacy and safety of a new medication under investigation and the real-life questions that need to be addressed regarding the clinical use of the medication by patients, healthcare professionals and society. The data necessary to obtain regulatory approval may be of limited relevance to policy makers when calculating economic parameters such as value for money or cost effectiveness. 'Real-world' studies examine questions relevant to health policy and reimbursement. There are many different forms of clinical trials, but in designing trials incorporating realistic budget impact estimates the important issue is to ensure we are asking a sensible question and attempting to answer it with an appropriate experimental design. As an example, a real-world trial currently underway that examines scenarios of introducing inhaled insulin into clinical practice is described.

Clinical Trials as Topic↗
PubMed2005

Specialist nurse-led clinics to improve control of hypertension and hyperlipidemia in diabetes: economic analysis of the SPLINT trial.

OBJECTIVE: To determine the cost-effectiveness of specialist nurse-led clinics provided to improve lipid and blood pressure control in diabetic patients receiving hospital-based care. RESEARCH DESIGN AND METHODS: A policy of targeting improved care through specialist nurse-led clinics is evaluated using a novel method, linking the cost-effectiveness of antihypertensive and lipid-lowering treatments with the cost and level of behavioral change achieved by the specialist nurse-led clinics. Treatment cost-effectiveness is modeled from the U.K. Prospective Diabetes Study and Heart Protection Study treatment trials, whereas specialist nurse-led clinics are evaluated using the Specialist Nurse-Led Clinics to Improve Control of Hypertension and Hyperlipidemia in Diabetes (SPLINT) trial. RESULTS: Good lipid and blood pressure control are cost-effective treatment goals for patients with diabetes. Modeling findings from treatment trials, blood pressure lowering is estimated to be cost saving and life prolonging (-1,400 dollars/quality-adjusted life-year [QALY]), whereas lipid-lowering is estimated to be highly cost-effective (8,230 dollars/QALY). Investing in nurse-led clinics to help achieve these benefits imposes an addition on treatment cost-effectiveness leading to higher estimates: 4,020 dollars/QALY and 19,950 dollars/QALY, respectively. For both clinics combined, the estimated cost-effectiveness is 9,070 dollars/QALY. Using an acceptability threshold of 50,000 dollars/QALY, the likelihood that blood pressure-lowering clinics are cost-effective is 77%, lipid clinics 99%, and combined clinics 83%. CONCLUSIONS: A method is described for evaluating the cost-effectiveness of policies to change patient uptake of health care. Such policies are less attractive than treatment cost-effectiveness (which implies cost-less self-implementation). However, specialist nurse-led clinics, as an adjunct to hospital-based diabetic care, combining both lipid and blood pressure control, appear effective and likely to provide excellent value for money.

Blood Glucose↗