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Study End Points (study + end_point)
Selected AbstractsOlder patients' experiences of treatment for colorectal cancer: an analysis of functional status and service useEUROPEAN JOURNAL OF CANCER CARE, Issue 5 2004C. BAILEY msc, rgn Age and ageing are an important part of the context within which the care and treatment of people with cancer is provided. More information is needed about the effects of cancer treatment on the lives of older people following inpatient care. We conducted a 3-year study in which older people with colorectal cancer completed a detailed questionnaire on multidimensional function and service use before and after elective treatment. Here we present an analysis of changes in functional status and service use over the pre- to post-treatment period, and set out a detailed picture of older people's experiences before and after treatment. In total, 337 patients with colorectal adenocarcinoma aged 58,95 years were interviewed before treatment using the OARS Multidimensional Functional Assessment Questionnaire (OMFAQ), Rotterdam Symptom Checklist (RSCL) and a severity of morbidity score. Study end points were defined as post-treatment functional status, symptom distress, severity of morbidity and frequency of service use. Pre- and post-treatment data were compared using matched analyses. Logistic regression was used to assess associations between age and the main outcome measures, and frequency of service use after treatment was compared between age groups using the ,2 test. Overall, patients experienced both positive and negative outcomes following treatment. It was notable that patients aged ,,75 years showed improvement in only one of the principal outcome measures. Patterns of service use following treatment suggest that support at home is a key issue for patients. With the exception of nursing care, however, help at home is provided on a majority of occasions by families themselves. This raises important questions about how much preparation patients and families receive or would like before they leave hospital after treatment for cancer. A collaborative, family-centred approach to meeting people's needs is called for in the months following inpatient care. [source] Efficacy, pharmacodynamics, and safety of VX-702, a novel p38 MAPK inhibitor, in rheumatoid arthritis: Results of two randomized, double-blind, placebo-controlled clinical studies,ARTHRITIS & RHEUMATISM, Issue 5 2009Nemanja Damjanov Objective To assess the efficacy and safety of VX-702, a p38 MAPK inhibitor, in patients with active, moderate-to-severe rheumatoid arthritis (RA). Methods Two 12-week, double-blind, placebo-controlled studies of VX-702 were conducted in patients with active, moderate-to-severe RA. In the VeRA study, 313 patients received placebo or 2 daily doses of VX-702. In Study 304, 117 patients received placebo, daily VX-702, or twice weekly VX-702 in addition to concomitant methotrexate (MTX). Study end points included the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (an ACR20 response), ACR50 and ACR70 responses, changes in the serum levels of biomarkers of inflammation, and safety assessments. Results The numerically superior ACR20 response rates among patients receiving VX-702 compared with those receiving placebo in both studies did not reach pairwise statistical significance at the highest doses in either study. At week 12 in the VeRA study, ACR20 response rates were 40%, 36%, and 28% among patients receiving 10 mg of VX-702, 5 mg of VX-702, and placebo, respectively. In Study 304, the response rates were 40%, 44%, and 22% for patients receiving 10 mg VX-702 daily plus MTX, 10 mg VX-702 twice weekly plus MTX, and placebo, respectively. Reductions in the levels of C-reactive protein, soluble tumor necrosis factor receptor p55, and serum amyloid A were observed as early as week 1 in both studies, but these levels rapidly returned to baseline values by week 4. The overall frequency of adverse events was similar between the VX-702 and placebo groups. In the VeRA study, serious infections were more frequent in the VX-702 groups compared with the placebo group (2.4% versus 0%) but not in Study 304 (2.6% versus 4.9%). Conclusion The modest clinical efficacy plus the transient suppression of biomarkers of inflammation observed in this study suggest that p38 MAPK inhibition may not provide meaningful, sustained suppression of the chronic inflammation seen in RA. [source] Positive predictive value of ICD-9 codes 410 and 411 in the identification of cases of acute coronary syndromes in the Saskatchewan Hospital automated databasePHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2008Cristina Varas-Lorenzo MD Abstract Background Case definitions are essential to epidemiological research. Objectives To evaluate ICD-9 codes 410 and 411 to identify cases of acute coronary syndromes (ACS), and the clinical information availability in the administrative and hospital discharge records of Saskatchewan, Canada. Methods In the context of a safety cohort study, we identified hospitalisations with primary discharge codes 410 (2260) and 411 (799). We selected all records with code 411, and a random sample (200) with code 410. Based on information obtained by trained abstractors from hospital records, events were classified by two cardiologists as definite or possible according to adapted AHA/ESC criteria. The validity of 410 and 411 codes was assessed by calculating the positive predictive value (PPV). Completeness of the recorded information on risk factors and use of aspirin was explored. Results The PPVs of the codes 410 and 411 for ACS were 0.96 (95%CI: 0. 92,0.98) and 0.86 (95%CI: 0.83,0.88), respectively. The PPV of 410 for acute myocardial infarction (AMI) was 0.95 (95%CI: 0.91,0.98). The PPV of 411 was 0.73 (95%CI: 0.70,0.77) for primary unstable angina (UA) and 0.09 (95%CI: 0.07,0.11) for AMI. Hospital charts review revealed key information for clinical variables, smoking, obesity and use of aspirin at admission. Conclusions ICD-9 410 code has high PPV for AMI cases, likewise 411 for UA cases. Case validation remains important in epidemiological studies with administrative health databases. Given the pathophysiology of ACS, both AMI and UA might be used as study end points. In addition to code 410, we recommend the use of 411 plus validation. Copyright © 2008 John Wiley & Sons, Ltd. [source] Baseline Clinical Characteristics and Midterm Prognosis of STE-ACS and NSTE-ACS Patients with Normal Coronary ArteriesANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 1 2009Lukasz Mazurkiewicz M.D. Objective: We sought to compare clinical profiles and midterm prognosis of patients with normal coronary arteries presenting with ST-elevation ACS (STE-ACS) versus non-ST-elevation ACS (nSTE-ACS). Background: There are limited data regarding ACS in patients with normal coronary arteries, and especially clinical differences between ST-ACS and nSTE-ACS patients have not been evaluated sufficiently. Methods: The study group comprised 190 patients (mean age: 53.2 years, 63.1% males, 63.6% STE-ACS) presenting with ACS and normal coronary angiograms. The participants were evaluated in terms of 42 clinical variables. MACE [cardiac death (CD) and hospitalization for angina (HA)] were the study end points. Results: STE-ACS in comparison to nSTE-ACS patients were younger (P < 0.01), were more frequently males (P < 0.01), had more often infection prior to ACS (P < 0.01), higher hsCRP on admission (P < 0.01), and greater infarct size, measured by maximal troponin I (P < 0.01). By multivariate analysis in this subgroup, predictors of outcome were hsCRP (P = 0.03) and raised troponin I (P = 0.02). nSTE-ACS in comparison to STE-ACS patients were more obese (BMI, P < 0.01), had higher LDL cholesterol (P < 0.01), fasting glucose (P = 0.03). LDL cholesterol (P = 0.02) and fasting glucose (P = 0.03) emerged as independent predictors of outcome in these patients. Mean follow-up period was 25.4 months. STE-ACS patients had twice fewer MACE rate than nSTE-ACS patients [(1-CD, 12-HA; 11%) vs (1-CD, 16-HA; 25%), respectively, log rank P < 0.01]. Conclusions: STE-ACS and nSTE-ACS patients with normal coronary arteriography have different clinical profiles. In nSTE-ACS patients more pronounced metabolic abnormalities were identified, while in STE-ACS patients inflammatory background was more significant. [source] | ||||||||||