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Outcome Event (outcome + event)
Selected AbstractsEnoxaparin vs heparin for prevention of deep-vein thrombosis in acute ischaemic stroke: a randomized, double-blind studyACTA NEUROLOGICA SCANDINAVICA, Issue 2 2002M. Hillbom Objectives , To compare the efficacy, safety, and overall risk,benefit profile of enoxaparin and unfractionated heparin (UFH) prophylaxis of venous thromboembolic complications in patients with acute ischaemic stroke. Methods , Patients with ischaemic stroke resulting in lower-limb paralysis lasting for at least 24 h and necessitating bedrest, were randomized within 48 h of the onset of stroke, and treated with enoxaparin (40 mg subcutaneously once daily) or UFH (5000 IU subcutaneously thrice daily) for 10 ± 2 days. Main outcome measures were deep-vein thrombosis, pulmonary embolism (PE), death from any cause, intracranial haemorrhage including haemorrhagic infarction, or any other major bleeding. Results , Outcome events occurred within 3 months of stroke in 40/106 patients treated with enoxaparin (37.7%) and 52/106 patients treated with UFH (49.1%, P =0.127). Fewer patients treated with enoxaparin (14, 13.2%) than with UFH (20, 18.9%) had evidence of haemorrhagic transformation of ischaemic stroke. Conclusions , Enoxaparin administered subcutaneously once daily was as safe and effective as subcutaneous UFH given thrice daily in the prevention of thromboembolic events in patients with lower limb paralysis caused by acute ischaemic stroke. [source] Elevated serum urate concentration independently predicts poor outcome following stroke in patients with diabetesDIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 1 2006Edward J. Newman Abstract Background Type 2 diabetes is a risk factor for stroke and confers increased risk of poor outcome and further vascular events following stroke. Hyperuricaemia occurs commonly in patients with type 2 diabetes, but its significance as a predictor of outcome following stroke is uncertain. We sought to investigate the prognostic significance of elevated serum urate concentration in diabetic subjects following stroke. Methods We studied a cohort of type 2 diabetes patients presenting to our unit with computed tomography-confirmed acute stroke. Fasting blood samples were drawn within 24 h of admission for urate concentration and standard battery of biochemistry and hematological tests. Information on age, stroke type, prior hypertension, smoking status, resolution time of symptoms and National Institutes of Health Stroke Score was collated. The main outcome event was time to myocardial infarction, recurrent stroke or vascular death, as defined in the CAPRIE trial. Stepwise proportional hazards regression was used to estimate the effect of the above variables on event-free survival following stroke. Results One hundred and forty patients were studied. Median follow-up duration was 974 days (IQR 163 to 1830 days). Sixty-four patients suffered an outcome event. Urate levels of greater than 0.42 mmol/L (p < 0.001) and an increasing NIHSS score (p < 0.001) independently predicted increased likelihood of suffering an event. Conclusion Elevated urate concentration is significantly and independently associated with increased risk of future vascular events in diabetic stroke patients. Further studies to elucidate the mechanism of this observation are required. Copyright © 2005 John Wiley & Sons, Ltd. [source] Meta-analysis: folic acid in the chemoprevention of colorectal adenomas and colorectal cancerALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2010C. CARROLL Aliment Pharmacol Ther,31, 708,718 Summary Background, Folic acid has been identified as a possible agent for the chemoprevention of colorectal cancer. Aim, To assess the effectiveness of folic acid in reducing the recurrence of adenomas (precursors of colorectal cancer) among populations with a history of adenomas and the incidence of colorectal cancer within average-risk populations. Methods, Systematic review of randomized controlled trials comparing folic acid alone, or with other agents, vs. placebo. Eight databases were searched for relevant trials. Meta-analysis was performed. Results, The literature search retrieved 3785 citations. Six studies met the inclusion criteria. Meta-analysis of three studies in individuals with a history of adenomas showed no statistically significant difference in the relative risk of adenoma recurrence (RR 0.93, P = 0.27). A sensitivity analysis of the two higher quality trials changed the direction of effect (RR 1.16, P = 0.11). Meta-analysis of three trials in general populations demonstrated no statistically significant effect on the relative risk of colorectal cancer (RR 1.13, P = 0.54). In all three analyses, outcome event rates were higher in individuals receiving folic acid. Conclusion, There is no evidence that folic acid is effective in the chemoprevention of colorectal adenomas or colorectal cancer for any population. [source] Semiparametric analysis of case series dataJOURNAL OF THE ROYAL STATISTICAL SOCIETY: SERIES C (APPLIED STATISTICS), Issue 5 2006C. P. Farrington Summary., The case series model for estimating the association between an age-dependent exposure and an outcome event requires information only on cases and implicitly adjusts for all age-independent multiplicative confounders, while allowing for an age-dependent base-line incidence. In the paper the model is presented in greater generality than hitherto, including more general discussion of its derivation, underlying assumptions, applicability, limitations and efficiency. A semiparametric version of the model is developed, in which the age-specific relative incidence is left unspecified. Modelling covariate effects and testing assumptions are discussed. The small sample performance of this model is studied in simulations. The methods are illustrated with several examples from epidemiology. [source] Reporting of minimum clinically important differences in surgical trialsANZ JOURNAL OF SURGERY, Issue 4 2009Irwin Kashani Background:, The minimum clinically important difference (MCID) is the smallest difference in outcome between the groups that would be of clinical interest. It influences the estimates that are made to determine the required sample side. The aim of this study was to explore the reporting of the MCID in surgical trials. Method:, Surgical trials that were published between January 1981 and December 2006 in five prestigious surgical journals were evaluated. Selected for study were trials that studied two groups and reported the main outcome event as a proportion. Results:, Only 21% (100/486) of the admissible surgical trials mentioned a value for the MCID when estimating the sample size. There was a trend, however, for compliance with these factors to increase during the study period. The present post-hoc calculations of the required sample size, which were based on the observed differences between the groups at the end of the study, suggested that one-third of the trials should have accrued at least fivefold the number of patients. Although reporting an estimate of the sample size was associated with the study of more patients (median sample size 145 vs 100), it was not associated with the reporting of more positive results, that is, 61% (95/155) versus 65% (214/331). Conclusion:, There has been an improvement in the proportion of surgical trials reporting formal estimates of sample size during the last three decades. But the construct of these estimates is often suspect because of a failure to provide realistic values for the MCID. [source] Lessons Learned from the Pediatric Heart Transplant StudyCONGENITAL HEART DISEASE, Issue 3 2006Daphne T. Hsu MD ABSTRACT The Pediatric Heart Transplant Study (PHTS) group was founded in 1991 as a voluntary, collaborative effort dedicated to the advancement of the science and treatment of children following listing for heart transplantation. Since 1993, the PHTS has collected data in an international, prospective, event-driven database that examines risk factors for outcome events following listing for transplantation. The events include transplantation, death, rejection, infection, malignancy, graft vasculopathy, and retransplantation. Over its 12 years of existence, the PHTS has made major contributions to the field of pediatric heart transplantation, especially in the areas of outcome analysis and risk factor assessment for death and other major morbidities after listing and after transplantation. The new challenges facing the PHTS include how to implement the practice of evidence-based medicine in the field of pediatric heart transplantation and how to support ongoing data collection and analysis to provide long-term outcomes as the PHTS subjects enter their second decade after transplantation. [source] Regular or "Super-Aspirins"?JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 4 2001A Review of Thienopyridines or Aspirin to Prevent Stroke PURPOSE: To review the evidence for the effectiveness and safety of the thienopyridines (ticlopidine and clopidogrel) compared with aspirin for the prevention of vascular events among patients at high risk of vascular disease. BACKGROUND: Atherosclerosis and resultant cardiovascular disease are important causes of morbidity and mortality in older people. In particular, atherosclerosis of the cerebral arteries can lead to transient ischemic attacks (TIAs) and stroke. Stroke ranks as the third-leading cause of death in the United States and in 1997 was responsible for over 150,000 fatalities.1 In addition to the mortality associated with this disease, stroke is also a leading source of long-term disability in survivors. Nearly 4.5 million stroke survivors are alive today,1 highlighting the fact that primary, but also secondary, prevention are extremely important for minimizing the complications of this illness. DATA SOURCES: Specialized trial registers of the Cochrane Stroke Group and the Antithrombotic Trialist's Collaboration, MEDLINE, and Embase were searched. Additional unpublished information and data were sought from Sanofi, the pharmaceutical company that developed and manufactures ticlopidine and clopidogrel, as well as the principal investigators of the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial,7 the largest of the trials identified. STUDY SELECTION CRITERIA: All unconfounded randomized trials comparing either ticlopidine or clopidogrel with aspirin among patients at high risk of vascular disease (those with symptoms of ischemia of the cerebral, coronary, or peripheral circulations) who were followed for at least 1 month for the recurrence of vascular events were included. DATA EXTRACTION: Data were extracted from four completed randomized trials completed in the past 20 years, which included 22,656 patients.7,10 Two authors independently extracted the data from these trials for the following information: the types of patients enrolled; the entry and exclusion criteria; the randomization method; the number of patients originally allocated to the treatment and control groups; the method and duration of follow-up; the number of patients in each group lost to follow-up; information on compliance with the treatment allocated; the definitions of outcome events; the number of outcome events in each treatment group; and any method used for blinding patients, treating clinicians, and outcome assessors to treatment allocation. MAIN RESULTS: Four completed trials involving a total of 22,656 patients were identified. Aspirin was compared with ticlopidine in three trials (3,471 patients)8,10 and with clopidogrel in one trial (19,185 patients).7 A recent TIA or ischemic stroke was the qualifying event in 9,840 patients, a recent myocardial infarction in 6,302 patients, and symptomatic peripheral arterial disease in 6,514 patients. The average age of the patients was approximately 63, with approximately two-thirds of the patients being male and white. The duration of follow-up ranged from 12 to 40 months. CONCLUSIONS: This systematic review demonstrates that, compared with aspirin, thienopyridines are only modestly more effective in preventing serious vascular events in high-risk patients. For patients who are intolerant of, or allergic to aspirin, the available safety and efficacy data suggest that clopidogrel is an appropriate, but more-expensive, alternative antiplatelet drug. It appears safer than ticlopidine and as safe as aspirin but it should not replace aspirin as the first-choice antiplatelet agent for all patients. Further studies are necessary to determine which, if any, particular types of patients would benefit most and least from clopidogrel instead of aspirin. [source] Impact of training periods in the emergency department on the motivation of health care students to learnMEDICAL EDUCATION, Issue 5 2009Thierry Pelaccia Objectives, Motivation is one of the most important factors for learning and achievement. The perceived value of the task, perceptions of self-efficacy and beliefs about control of learning are the main determinants of motivation. They are highly influenced by the individual's personal history and especially by significant past experiences. We assessed the impact of training periods in the emergency department on the motivation of health care students to learn in the field of emergency medicine. Methods, A survey was conducted in 2008 with 112 undergraduate medical students and 201 undergraduate nursing students attending an emergency medicine academic programme. At the beginning of the course, the students completed an anonymous 26-item questionnaire to assess their motivational orientations. Results, Perceived task value was higher for students who had previously attended a training period in the emergency department (P = 0.002). Perceived self-efficacy was depressed when the respondent had been confronted with negative outcome events (P < 0.001). Control of learning beliefs was affected negatively in students who had attended a training period in the emergency department (P < 0.001). Conclusions, Motivation is a major contributor to the success of learning. Training periods in the emergency department can have positive and negative impacts on the learning motivation of medical and nursing students in the field of emergency medicine. Ideally, and in terms of increasing motivation, health care students should gain experiential learning in the emergency department before attending a corresponding academic course. During this period, tutors should provide appropriate supervision and feedback in order to support self-efficacy perception and learning control beliefs. [source] The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2006Andrew T. McAfee MD Abstract Purpose The purpose of this study was to compare incidence rates of hospitalization associated with rhabdomyolysis, myopathy, renal, or hepatic dysfunction, and of in-hospital death, between initiators of rosuvastatin and other statins. Methods This was a matched cohort study of statin initiators from the administrative database of a large health insurer in the US, during the first 6 months of rosuvastatin availability with up to 18 months of follow-up. All outcome events were verified by medical record review. Incidence rates, risk ratios, and associated 95% confidence intervals were estimated. Results From an initial pool of 12,217, 11,249 eligible rosuvastatin initiators were matched to 37,282 initiators of other statins. The incidence rate (IR) per 1000 person-years for rhabdomyolysis was 0.10 [0.00, 0.55] for rosuvastatin initiators (n,=,1) and 0.06 [0.01, 0.22] for other statin initiators (n,=,2), for a hazard ratio (HR) of 1.98 [0.18, 21.90]. The IR for myopathy was 0.20 [0.02, 0.71] for rosuvastatin initiators (n,=,2) and 0.00 [0.00, 0.09] for other statin initiators (n,=,0). The IR for renal dysfunction was 1.18 [0.61, 2.06] for rosuvastatin initiators (n,=,12) and 1.26 [0.91, 1.71] for other statin initiators (n,=,42), for a HR of 0.90 [0.47, 1.73]. The IR for hepatic dysfunction was 0.20 (0.02, 0.71) for rosuvastatin initiators (n,=,2) and 0.24 (0.10, 0.47) for other statin initiators (n,=,8), for a HR of 0.87 (0.18, 4.14). Conclusions This study found no difference between rosuvastatin and the other statins in the incidence of hospitalizations associated with renal or hepatic events, or death. The absolute incidence rates of rhabdomyolysis and myopathy were reassuringly low among all statin initiators but remain too small for firm conclusions to be drawn on any difference between the statins. Copyright © 2006 John Wiley & Sons, Ltd. [source] | ||||||||||