Vertebral fracture assessment (VFA) with a densitometer predicts future fractures in elderly women unselected for osteoporosis.

Low radiation dose imaging of the lateral spine acquired with a bone densitometer for vertebral fracture assessment (VFA) has great potential for clinical use. We have undertaken an evaluation of VFA in a prospective population cohort of elderly women to examine the prevalence of vertebral fractures, their ability to predict incident fractures, and their use in targeting therapy. Women (n = 5157) >or=75 yr of age living in the general community in the United Kingdom underwent posteroanterior and lateral imaging of the spine (T(4)-L(4)) with a densitometer (Hologic QDR4500A) at entry to a randomized, double-blind, controlled trial of 800 mg oral clodronate (Bonefos) or matching placebo daily over 3 yr. The women were identified from general practice registers and recruited by letter of invitation regardless of skeletal status. The proportion of vertebrae interpretable varied from 98.2% at T(12) to 57.1% at T(4), with >92% interpretable at levels between T(8) and L(3). As judged by BMD at the total hip, 19.6% of the women had osteoporosis, and the prevalence of vertebral fracture was 14.5%. Women with one or more vertebral fractures had a relative risk (RR) for incident osteoporotic fractures of 2.01 (95% CI, 1.64-2.47). The RR for hip fractures was 2.29 (95% CI, 1.63-3.21). After adjustment for age, femoral neck BMD, weight, and treatment, the RR was 1.50 (95% CI, 1.21-1.86) for osteoporotic fractures, with similar results for hip fractures (RR, 1.41; 95% CI, 0.99-2.02). For women with two or more vertebral fractures, the adjusted RRs were 1.97 (95% CI, 1.24-2.72) and 1.86 (95% CI, 1.14-3.03) for osteoporotic and hip fractures, respectively. We conclude that VFA can frequently detect vertebral fractures in a population cohort of elderly women. These fractures, like radiographic fractures, predict future clinical fractures independent of age, weight, and BMD. Having multiple vertebral fractures was associated with greater risk of incident osteoporotic fractures and hip fractures.

Prevalence of ECG abnormalities in an international survey of patients with suspected or confirmed heart failure at death or discharge.

BACKGROUND: Most patients suspected of having heart failure (HF) will get a 12-lead electrocardiogram (ECG) but its utility for excluding HF or assisting in its management has rarely been investigated. METHODS: The EuroHeart Failure survey identified 11,327 patients hospitalised with a suspected diagnosis of HF from 115 hospitals in 24 countries. ECGs were obtained from 9315 patients, of whom 5934 had cardiac imaging tests. The utility of the ECG was assessed for excluding or diagnosing major structural heart disease (MSHD) or major left ventricular systolic dysfunction (MLVSD) and for therapeutic decision making. FINDINGS: MSHD was present in 70% and MLVSD in 54% of patients overall but in only 21% and 5%, respectively, if the ECG was entirely normal. However, <2% of patients had a normal ECG. No single ECG characteristic identified a probability <25% of MSHD or <20% of MLVSD. Patients with QRS width >or=120 ms or anterior pathological Q-waves had a probability >80% of MSHD and >70% of MLVSD. Diagnostic models suggested that electrocardiographic criteria alone were not accurate for the diagnosis or exclusion of important heart disease in this population. However, 2468 patients (42%) had an electrocardiographic finding that should be used to guide the choice of therapy. CONCLUSIONS: A normal ECG is rare in patients with suspected HF but has limited diagnostic value in this setting. The ECG has an important role in guiding therapy.

Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial.

OBJECTIVE: to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents. DESIGN: randomised controlled trial of clinical medication review by a pharmacist against usual care. SETTING: sixty-five care homes for the elderly in Leeds, UK. PARTICIPANTS: a total of 661 residents aged 65+ years on one or more medicines. INTERVENTION: clinical medication review by a pharmacist with patient and clinical records. Recommendations to general practitioner for approval and implementation. Control patients received usual general practitioner care. MAIN OUTCOME MEASURES: primary: number of changes in medication per participant. Secondary: number and cost of repeat medicines per participant; medication review rate; mortality, falls, hospital admissions, general practitioner consultations, Barthel index, Standardised Mini-Mental State Examination (SMMSE). RESULTS: the pharmacist reviewed 315/331 (95.2%) patients in 6 months. A total of 62/330 (18.8%) control patients were reviewed by their general practitioner. The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group (P < 0.0001). There were respectively 0.8 and 1.3 falls per patient (P < 0.0001). There was no significant difference for GP consultations per patient (means 2.9 and 2.8 in 6 months, P = 0.5), hospitalisations (means 0.2 and 0.3, P = 0.11), deaths (51/331 and 48/330, P = 0.81), Barthel score (9.8 and 9.3, P = 0.06), SMMSE score (13.9 and 13.8, P = 0.62), number and cost of drugs per patient (6.7 and 6.9, P = 0.5) (pounds sterling 42.24 and pounds sterling 42.94 per 28 days). A total of 75.6% (565/747) of pharmacist recommendations were accepted by the general practitioner; and 76.6% (433/565) of accepted recommendations were implemented. CONCLUSIONS: general practitioners do not review most care home patients' medication. A clinical pharmacist can review them and make recommendations that are usually accepted. This leads to substantial change in patients' medication regimens without change in drug costs. There is a reduction in the number of falls. There is no significant change in consultations, hospitalisation, mortality, SMMSE or Barthel scores.

Do shock absorbing insoles in recruits undertaking high levels of physical activity reduce lower limb injury? A randomized controlled trial.

OBJECTIVES: To assess the benefits, if any, of the use of shock absorbing insoles in reducing lower limb injury among Air Force recruits, and to assess the differences, if any, in the efficacy of two commonly available shock absorbing insoles. DESIGN: Randomized controlled trial. SETTING: RAF Halton, UK. Site of all basic training for RAF personnel. PARTICIPANTS: 1205 recruits participating in basic training between 17 September 2003 and 7 April 2004. INTERVENTIONS: Participants were randomized to receive either standard issue Saran non-shock absorbing insoles, or shock absorbing Sorbothane or Poron insoles, on a 1:1:1 basis. MAIN OUTCOME MEASURES: The primary outcome measure was withdrawal from training for lower limb injury. The two primary comparisons were shock absorbing insole versus non-shock absorbing insole, and Sorbothane versus Poron (comparison of different shock absorbing insoles). Secondary outcomes were medical withdrawals for reasons other than those qualifying for the primary outcome measure. RESULTS: When comparing the non-shock absorbing insole to the shock absorbing insoles 72/401 participants (18.0%) allocated to Saran insoles were removed from training because of a qualifying lower limb injury, compared with 149/804 (18.5%) allocated to the shock absorbing insole (Sorbothane or Poron), odds ratio 1.04 (95% CI 0.75 to 1.44; P=0.87). When comparing the two shock absorbing insole 73/421 participants (17.3%) randomized to Sorbothane were removed from training because of a qualifying lower limb injury, compared with 76/383 for Poron (19.8%), odds ratio 0.85 (95% CI 0.58 to 1.23; P=0.37). CONCLUSIONS: Similar rates of lower limb injuries were observed for all insoles (shock absorbing and non-shock absorbing) in the trial. The trial provides no support for a change in policy to the use of shock absorbing insoles for military recruits.

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).

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.

Relation of sex, age and concomitant diseases to drug prescription for heart failure in primary care in Europe.

AIM: To study the role of sex, age and concomitant diseases for prescription of cardiovascular drugs among patients with heart failure cared for in the community. METHODS AND RESULTS: In 15 European countries, a survey was conducted during 1999 and 2000 among 1363 primary care physicians who included 8256 patients with symptoms of heart failure. Predictors of drug prescription were assessed with multivariate logistic regression. Overall prescription rates for ACE-inhibitors/angiotensin receptor blockers (ACE-I/ARB), beta-blockers, digitalis, diuretics and oral anticoagulants were 69%, 30%, 41%, 75% and 18%. Women had no reduced likelihood to receive ACE-I/ARB and beta-blockers (odds ratio [OR]=0.96 [95% CI 0.87-1.06] and 1.02 [0.92-1.13], respectively), but prescription of oral anticoagulants was decreased (OR=0.74, 95% CI 0.65-0.84). Compared to patients <65 years of age, ACE-I/ARB prescription did not materially decline up to 75-85 years (R=0.91, 95% CI 0.81-1.04), whereas beta-blocker prescription was already significantly decreased in this age category (OR=0.49, 95% CI 0.43-0.56). There was no general under-prescription of evidence-based cardiovascular drugs in patients with concomitant diseases. CONCLUSIONS: Among heart failure patients cared for in the community advanced age strongly predicts decreased prescription of beta-blockers. Female sex and comorbidity is not associated with a consistent underutilization of evidence-based cardiovascular drugs.

Composite outcomes in randomized trials: greater precision but with greater uncertainty?

Composite outcomes, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency. However, such measures may prove challenging for the interpretation of results. In this article, we examine the use of composite outcomes in major clinical trials, assess the arguments for and against them, and provide guidance on their application and reporting. To assess incidence and quality of reporting, we systematically reviewed the use of composite end points in clinical trials in Annals of Internal Medicine, BMJ, Circulation, Clinical Infectious Diseases, Journal of the American College of Cardiology, JAMA, Lancet, New England Journal of Medicine, and Stroke from 1997 through 2001 using a sensitive search strategy. We selected for review 167 original reports of randomized trials (with a total of 300 276 patients) that included a composite primary outcome that incorporated all-cause mortality. Sixty-three trials (38%) were neutral both for the primary end point and the mortality component. Sixty trials (36%) reported significant results for the primary outcome measure but not for the mortality component. Only 6 trials (4%) were significant for the mortality component but not for the primary composite outcome, whereas 19 trials (11%) were significant for both. Twenty-two trials (13%) were inadequately reported. Our review suggests that reporting of composite outcomes is generally inadequate, implying that the results apply to the individual components of the composite outcome rather than only to the overall composite. Current guidelines for the undertaking and reporting of clinical trials could be revised to reflect the common use of composite outcomes in clinical trials.

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.

What is the place of beta-blockade in patients who have experienced a myocardial infarction with preserved left ventricular function? Evidence and (mis)interpretation.

Beta blockers have long been used in patients who have experienced a myocardial infarction. However, many new therapies are available for this patient group, and as a result, the current role of beta blockers may have become uncertain. In this article we address a series of questions related to the important and continuing role of beta blockade after myocardial infarction.

Beta-blockers for heart failure.

This is the protocol for a review and there is no abstract. The objectives are as follows: Our objective is to appraise the effectiveness of beta blockers in patients with heart failure. Our protocol defined main outcome is all cause mortality. The specific a priori defined aims are to examine: the effectiveness of beta blockers in all trials of patients with heart failure, and examine the importance of the presence or absence of ischaemic cardiomyopathy in patients included in trials and vasodilator properties of beta blocking agents used. We will also examine the predictive value of left ventricular function, age, use of angiotensin converting enzyme inhibitors and New York Heart Association Class (NYHA), and the rate of discontinuation of therapy due to treatment. There are a number of important ongoing trials for which data will become available in the next few years. Thus a systematic review which may be updated regularly is required to provide an up to date synthesis of the available data in this increasingly important area.