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AIMS To identify the characteristics, treatment, and outcomes of contemporary patients with valvular heart disease (VHD) in Europe, and to examine adherence to guidelines. METHODS AND RESULTS The Euro Heart Survey on VHD was conducted from April to July 2001 in 92 centres from 25 countries; it included prospectively 5001 adults with moderate to severe(More)
AIMS To analyse decision-making in elderly patients with severe, symptomatic aortic stenosis (AS). METHODS AND RESULTS In the Euro Heart Survey on valvular heart disease, 216 patients aged > or =75 had severe AS (valve area < or =0.6 cm(2)/m(2) body surface area or mean gradient > or =50 mmHg) and angina or New York Heart Association class III or IV.(More)
OBJECTIVE To develop a disease activity index for patients with primary Sjögren's syndrome (SS): the European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI). METHODS Thirty-nine SS experts participated in an international collaboration, promoted by EULAR, to develop the ESSDAI. Experts identified 12 organ-specific(More)
Adequate reporting of randomized, controlled trials (RCTs) is necessary to allow accurate critical appraisal of the validity and applicability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem by improving the reporting of RCTs. However, some specific(More)
OBJECTIVES To assess quality of reporting of sample size calculation, ascertain accuracy of calculations, and determine the relevance of assumptions made when calculating sample size in randomised controlled trials. DESIGN Review. DATA SOURCES We searched MEDLINE for all primary reports of two arm parallel group randomised controlled trials of(More)
BACKGROUND Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard) methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of(More)
for the RATIO group Mod les et m thodes de l valuation th rapeutique des maladies chroniques 1 è é 'é é INSERM : U738 , Universit Paris-Diderot-Paris VII é , Facult de m decine Paris 7 16, Rue Henri Huchard 75018 Paris,FR é é D partement d pid miologie, biostatistique et recherche clinique 2 é 'é é Abstract Background
BACKGROUND The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration-approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals. METHODS AND(More)
Patterns of leukoaraiosis were analyzed on both T2-weighted fast fluid-attenuated inversion-recovery and 3D T1-weighted sequences in 23 community-dwelling older subjects with mild cognitive impairment. Mobility assessment had allowed their classification into higher and lower mobility groups (P<0.0001). Lower mobility appeared correlated with frontal(More)
BACKGROUND Previous studies indicate that in published reports, trial results can be distorted by the use of "spin" (specific reporting strategies, intentional or unintentional, emphasizing the beneficial effect of the experimental treatment). We aimed to (1) evaluate the presence of "spin" in press releases and associated media coverage; and (2) evaluate(More)