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BACKGROUND Cardiac resynchronization therapy (CRT) improves quality of life (QoL) when measured 3 to 6 months after implantation, but whether these effects are sustained is unknown. The CArdiac Resynchronisation-Heart Failure study is the only long-term randomized trial of CRT with repeated measures of QoL. METHODS Quality of life was measured at baseline(More)
AIMS To assess the quality of life of patients with heart failure, due to left ventricular dysfunction (NYHA class III or IV), taking optimal medical therapy using baseline quality of life assessments from the CArdiac REsynchronisation in Heart Failure (CARE-HF) trial, and to evaluate the appropriateness of using the EQ-5D in patients with heart failure. (More)
Composite outcomes, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency. However, such measures may prove challenging for the interpretation of results. In this article, we examine the use of composite outcomes in major clinical trials,(More)
OBJECTIVE Assess the existing evidence on the clinical effectiveness of wound-edge protection devices (WEPDs) in reducing the surgical site infection (SSI) rate in patients undergoing open abdominal surgery. BACKGROUND Surgical site infections are a common postoperative complication associated with considerable morbidity, extended hospital stay, increased(More)
AIMS Cardiac resynchronization therapy (CRT-P) is an effective treatment for patients with heart failure and cardiac dyssynchrony with moderate or severe symptoms despite pharmacological therapy. The addition of an implantable cardioverter-defibrillator (ICD) function may further reduce the risk of sudden death. We assessed the cost-effectiveness of CRT-P(More)
Clinicians, regulatory authorities, and pharmaceutical companies increasingly recognize the importance of assessing the patient's perspective on the impact of disease and its treatment on their health-related quality of life (HRQoL). This article describes the importance of assessing HRQoL, particularly in patients with chronic disease, provides examples of(More)
Cardiac resynchronization therapy (CRT) is a new therapeutic approach for a selected group of patients with symptomatic heart failure (NYHA functional class III-IV) despite optimal medical therapy, due to dilated cardiomyopathy of any etiology (left ventricular ejection fraction < or = 35% and left ventricular end-diastolic diameter > or = 55 mm), who(More)
Patient-reported outcomes (PROs), such as symptoms, health-related quality of life (HRQOL), or patient perceived health status, are reported directly by the patient and are powerful tools to inform patients, clinicians, and policy-makers about morbidity and 'patient suffering', especially in chronic diseases. Patient-reported outcomes provide information on(More)
To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs. A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership.(More)
OBJECTIVE To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery. DESIGN Multicentre observer blinded randomised controlled trial. PARTICIPANTS Patients undergoing laparotomy at 21 UK hospitals. INTERVENTIONS Standard care or the use of a wound edge protection device during(More)