Search results for "Secondary outcome"
showing 5 items of 5 documents
Standardising clinical outcomes measures for adult clinical trials in Fabry disease: A global Delphi consensus.
2021
International audience; Background: Recent years have witnessed a considerable increase in clinical trials of new investigational agents for Fabry disease (FD). Several trials investigating different agents are currently in progress; however, lack of standardisation results in challenges to interpretation and comparison. To facilitate the standardisation of investigational programs, we have developed a common framework for future clinical trials in FD.Methods and findings: A broad consensus regarding clinical outcomes and ways to measure them was obtained via the Delphi methodology. 35 FD clinical experts from 4 continents, representing 3389 FD patients, participated in 3 rounds of Delphi p…
Customised products for orbital wall reconstruction: a systematic review
2021
Abstract The purpose of this systematic review was to critically analyze the recent literature to present the state of the art in customized reconstruction of orbital fractures. Three electronic databases and manual search approaches were used to identify relevant articles. Only studies with a controlled clinical study design were included. Primary outcome was defined as the status of recovery (complete/partial functional and esthetic disturbances). The benefit of intra-surgical navigation should be described. Secondary outcome was defined as the time of surgery, post-surgical events and hospitalization. A total of eight studies out of 552 records identified met the inclusion criteria. Post…
Controlled trial for long-term low-dose erythromycin after sinus surgery for chronic rhinosinusitis
2014
Objectives/Hypothesis The efficacy of macrolides in chronic rhinosinusitis (CRS) is still under controversy. To date, only two double-blind, placebo-controlled studies have been published with differing results. None of these studies investigated the possible benefit of macrolides in the postoperative period. We conducted an investigator-initiated clinical trial using 250-mg erythromycin once a day over a period of 3 months, beginning the administration of either erythromycin or placebo 2 weeks after a surgical intervention for CRS. Study Design Randomized double-blind, placebo-controlled trial. Methods The concentrations of eosinophilic cationic protein (ECP) and myeloperoxidase in nasal s…
Students' satisfaction and perceived impact on knowledge, attitudes and skills after a 2-day course in scientific writing: a prospective longitudinal…
2018
OBJECTIVES: This study aimed to determine students' satisfaction with a 2-day course on scientific writing in health sciences and to assess their perceptions of the long-term impact on their knowledge, attitudes and skills. SETTING: 27 iterations of a 2-day course on writing and publishing scientific articles in health sciences. PARTICIPANTS: 741 students attending the 27 courses. DESIGN: Prospective longitudinal study. PRIMARY AND SECONDARY OUTCOME MEASURES: Immediately after each course, students completed a first questionnaire, rating their satisfaction with different aspects of the classroom sessions on a Likert scale (0-5). Approximately 2 years after the course, students completed a f…
A Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for Laypeople: The MANI-CPR T…
2021
Background Compression-only cardiopulmonary resuscitation (CPR) is a suggested technique for laypeople facing out-of-hospital cardiac arrest (OHCA). However, it is difficult performing high-quality CPR until emergency medical services arrival with this technique. We aimed to verify whether incorporating intentional interruptions of different frequency and duration increases laypeople's CPR quality during an 8-minute scenario compared with compression-only CPR. Methods We performed a multicenter randomized manikin study selecting participants from 2154 consecutive laypeople who followed a basic life support/automatic external defibrillation course. People who achieved high-quality CPR in 1-m…