Caroline J. Doré

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The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a(More)
PURPOSE To determine whether adding shear-wave (SW) elastographic features could improve accuracy of ultrasonographic (US) assessment of breast masses. MATERIALS AND METHODS From September 2008 to September 2010, 958 women consented to repeat standard breast US supplemented by quantitative SW elastographic examination in this prospective multicenter(More)
BACKGROUND Diet influences the prevalence of coronary heart disease (CHD). Insulin sensitivity and concentrations of HDL cholesterol, two metabolic predictors of CHD, are also influenced by diet. Dietary carbohydrates with a high glycaemic index cause a high postprandial glucose and insulin response, and are associated with decreased insulin sensitivity and(More)
BACKGROUND The purpose of this study was to determine the cerebrovascular risk stratification potential of baseline degree of stenosis, clinical features, and ultrasonic plaque characteristics in patients with asymptomatic internal carotid artery (ICA) stenosis. METHODS This was a prospective, multicenter, cohort study of patients undergoing medical(More)
BACKGROUND Hepatic steatosis is associated with obesity and type II diabetes. Proton magnetic resonance spectroscopy (1H MRS) is a non-invasive method for measurement of tissue fat content, including intrahepatocellular lipids (IHCL) and intramyocellular lipids (IMCL). PATIENTS AND METHODS We used 1H MRS and whole body magnetic resonance imaging (MRI) to(More)
INTRODUCTION Combinations of disease-modifying anti-rheumatic drugs (DMARDs) are increasingly used to treat rheumatoid arthritis (RA). Early trials showed their toxicity while recent trials suggest superior efficacy. Trials of DMARD combinations have enrolled different types of patient (early or established RA), used different designs (step-up, parallel or(More)
Colony-forming units of Mycobacterium tuberculosis in sputum were counted at 2-day intervals in 100 patients treated with 22 regimens of isoniazid, rifampin, pyrazinamide, ethambutol, or streptomycin, given alone or in combinations. The exponential fall in colony-forming units was measured by linear regression coefficients of the log counts during the(More)
Autoregulation of blood flow in response to changes in perfusion pressure is known to occur in a number of tissues including the human retina. Defective autoregulation may play a part in the pathophysiology of several retinal diseases. Laser Doppler velocimetry has been used to study retinal blood flow. Technically superior measurements are obtained from(More)
Twenty-one with symptomatic cervical spondylosis or nonspecific neck pain were given an amnesic dose of diazepam before manipulation of the cervical spine. Eighteen patients served as controls and also received diazepam but no manipulation. Results were obtained in a randomized, double-blind fashion. Statements of outcome by patients and mean visual analog(More)
STUDY DESIGN This was a multicenter, factorial, randomized, controlled trial on the postoperative management of spinal surgery patients, with randomization stratified by surgeon and operative procedure. OBJECTIVE This study sought to determine whether the functional outcome of two common spinal operations could be improved by a program of postoperative(More)