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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)
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)
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 Tuberculosis (TB) is associated with anti-tumor necrosis factor (anti-TNF) monoclonal antibody (mAb) therapy, but whether this association is drug-specific remains a concern. Our objective was to describe cases of TB associated with anti-TNF mAb therapy, identify risk factors, and estimate the incidence. METHODS We conducted an incidence study(More)
BACKGROUND Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and(More)
The fear-avoidance beliefs of patients with subacute low back pain (LBP) considered at risk for chronic disabling LBP are not well known. The objectives of this cross-sectional descriptive survey, conducted in secondary care practice, were to assess fear-avoidance beliefs about back pain in patients with subacute LBP and to seek an association between(More)
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)