Search results for "Multicenter studies"
showing 10 items of 76 documents
High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol f…
2019
Background Noninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO2) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis. Methods We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial…
[Clinical audit of patients admitted to hospital in Spain due to exacerbation of COPD (AUDIPOC study): method and organisation].
2010
There is little information regarding the clinical management of hospital inpatients diagnosed with exacerbation of Chronic Obstructive Pulmonary Disease (COPD). AUDIPOC is a clinical audit dealing with the clinical management of COPD in Spain.To examine the adequacy and validity of the instruments used to measure the variables proposed by AUDIPOC Spain (Preliminary Study) and to verify the viability of AUDIPOC in a complex environment with hospitals of different sizes, resources, and organizational layout (Pilot Study).The Preliminary Study took place in 4 hospitals and studied 213 cases. The Pilot Study took place in 30 hospitals of 6 Autonomous Communities (i.e. Regions) and studied 1203…
Multicentre observational study on practice of prehospital management of hypotensive trauma patients: the SPITFIRE study protocol
2022
IntroductionMajor haemorrhage after injury is the leading cause of preventable death for trauma patients. Recent advancements in trauma care suggest damage control resuscitation (DCR) should start in the prehospital phase following major trauma. In Italy, Helicopter Emergency Medical Services (HEMS) assist the most complex injuries and deliver the most advanced interventions including DCR. The effect size of DCR delivered prehospitally on survival remains however unclear.Methods and analysisThis is an investigator-initiated, large, national, prospective, observational cohort study aiming to recruit >500 patients in haemorrhagic shock after major trauma. We aim at describing the current p…
The role of red yeast rice (RYR) supplementation in plasma cholesterol control: A review and expert opinion.
2019
1. Preamble : Hypercholesterolemia is a major risk factor for atherosclerotic cardiovascular disease (ASCVD) [1]. Increased levels of low density lipoprotein cholesterol (LDL-C) are associated with an increased risk of coronary heart disease (CHD) and many clinical trials have shown that reducing LDL-C levels significantly reduced the CHD and CVD risk [[2], [3], [4], [5]]. Thus LDL-C-lowering is the main approach for the management of cardiovascular disease. Current guidelines suggest LDL-C levels targets based on the individual CV risk; such targets can be achieved by several means, which include both lifestyle changes and pharmacological approaches [6], with statins being the cornerstone …
Relative validity of a semi-quantitative food-frequency questionnaire in an elderly Mediterranean population of Spain
2010
The aim of the present study was to assess reproducibility and relative validity of a self-administered FFQ used in the PREDIMED Study, a clinical trial for primary prevention of CVD by Mediterranean diet in a population at high cardiovascular risk. The FFQ was administered twice (FFQ1 and FFQ2) to explore reproducibility at 1 year. Four 3 d dietary records (DR) were used as reference to explore validity; participants therefore recorded their food intake over 12 d in the course of 1 year. The degree of misclassification in the FFQ was also evaluated by a contingency table of quintiles comparing the information from the FFQ2 and the DR. A total of 158 men and women (aged 55– 80 years) were a…
MASked-unconTrolled hypERtension management based on office BP or on ambulatory blood pressure measurement (MASTER) Study: a randomised controlled tr…
2018
Introduction Masked uncontrolled hypertension (MUCH) carries an increased risk of cardiovascular (CV) complications and can be identified through combined use of office (O) and ambulatory (A) blood pressure (BP) monitoring (M) in treated patients. However, it is still debated whether the information carried by ABPM should be considered for MUCH management. Aim of the MASked-unconTrolled hypERtension management based on OBP or on ambulatory blood pressure measurement (MASTER) Study is to assess the impact on outcome of MUCH management based on OBPM or ABPM. Methods and analysis MASTER is a 4-year prospective, randomised, open-label, blinded-endpoint investigation. A total of 1240 treated hyp…
Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized…
2019
There is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and tobacco consumption remains the most preventable risk factor involved. Developing new tools to motivate patients towards cessation of smoking is a high priority. Information on the motivational value of giving the lung age and prevention opportunities is unknown in this high-risk population. In the context of community care, screening and early detection of lung damage could potentially be used, together with mobile technology, in order to produce a prevention message, which may provi…
Chaînage de bases de données anonymisées pour les études épidémiologiques multicentriques nationales et internationales : proposition d'un algorithme…
2009
Background: Compiling individual records coming from different sources is very important for multicenter epidemiological studies; however, European directives and other national legislation concerning nominal data processing must be respected. These legal aspects can be satisfied by implementing mechanisms that allow anonymization of patient data (such as hashing techniques). Moreover, for security reasons, official recommendations suggest using different cryptographic keys in combination with a cryptographic hash function for each study. Unfortunately, this type of anonymization procedure is in contradiction with common requirements in public health and biomedical research because it becom…
Characteristics of liver cirrhosis in Italy: results from a multicenter national study.
2004
Abstract Background. In 1992, the characteristics of liver cirrhosis in Italy were assessed in a cross-sectional study among 1829 cirrhosis patients attending 21 tertiary centres. Aim. To evaluate the characteristics of cirrhosis patients 9 years later. Patients. A total of 2185 consecutive cirrhosis patients were enrolled over a 6-month period in 79 hospitals located throughout Italy, randomly selected by means of systematic cluster sampling. Results. The main agent associated with cirrhosis was hepatitis C virus, which was found in 69.9% of the patients and was the only etiologic factor in 51.1% of the patients. Hepatitis B surface antigen was present in the serum of 13.0% of the cases (i…
Improve hip fracture outcome in the elderly patient (iHOPE) : A study protocol for a pragmatic, multicentre randomised controlled trial to test the e…
2018
IntroductionHip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.Methods and analysisThe iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner aft…