Search results for "informed consent"
showing 10 items of 109 documents
Prognosis of Patients Listed for a Heart Transplant During the Pretransplant Period: Does Diabetes Matter?
2013
Whether patients with advanced heart failure and diabetes mellitus (DM) should be listed for heart transplantation (HTx) remains controversial due to conflicting findings regarding their post-HTx survival (1–3). We studied HTx candidates with and without DM during the pre-HTx period, examining multiple waiting list outcomes. Patients were enrolled in the Waiting for a New Heart Study, a multisite observational study of 318 adult (≥18 years of age) patients (aged 53 ± 11 years; 18% female) who were newly listed for HTx with Eurotransplant between April 2005 and December 2006 (4). Informed consent and ethics approval were obtained (4). Characteristics at the time of listing included age, DM, …
Effectiveness of a digital dietary intervention program targeting young adults before parenthood: protocol for the PREPARED randomised controlled tri…
2021
IntroductionThe importance of preconception health for lifelong physical and mental health in the next generation has gained increasing recognition in recent years. Preconception paternal and maternal risk factors such as obesity and inadequate diet affect the metabolic and cardiovascular health of their offspring later in life. This highlights the importance of diet and dietary behaviour in the years before parenthood. In our project, PREPARED, we will evaluate the effectiveness of a digital intervention targeting young adults. Our primary aim is to improve participants’ preconception diet, and our secondary aim is to improve preconception quality of life and maternal and child perinatal o…
Onset of depressive symptomatology in a sample of university students
2018
The aim of the study was to evaluate depressive symptomatology within the student population of the University of Palermo (Italy). An anonymous online questionnaire was provided to the students of the University of Palermo. The first section investigated demographic and social data, while in the second section the QIDSSR16 (Quick Inventory of Depressive Symptomatology Self-Report) test was administered. 539 students (68.3% female) gave informed consent and completed the questionnaire. Considering as a dependent variable: Depressive symptomatology moderate-severe-very severe, the statistically significant independent variables associated are I don't live with my family (aOR 1.63, 95% CI 1.01…
Access to an online video enhances the consent process, increases knowledge, and decreases anxiety of caregivers with children scheduled for inguinal…
2019
Abstract Background There is limited time within the clinical workflow of most pediatric surgeons to obtain a comprehensive, well informed consent. This study evaluates whether ad-lib access to an online video on the consent dialogue enhances the consent process for inguinal hernia repair (IHR) in children. Methods The study was approved by the state ethics board. A 6-min video of a consent speech on IHR was produced and uploaded to a nonpublic online channel, explaining the condition, procedure, complications, and postoperative expectations. A total of 50 families were randomized to conventional, face-to-face consenting in clinic either with (intervention) or without (control) access to th…
Family perceptions of clinical research and the informed consent process in the ICU
2020
Abstract Purpose We investigated experiences of families who provide consent for research on behalf of a loved-one hospitalized in intensive care (ICU). Methods Multicentre, qualitative, descriptive study using semi-directive interviews in 3 ICUs. Eligible relatives were aged >18 years, and had provided informed consent for a clinical trial on behalf of a patient hospitalized in ICU. Interviews were conducted from 06/2018 to 06/2019 by a qualified sociologist, recorded and transcribed. Results Fifteen relatives were interviewed; average age 50.3 ± 15 years. All emphasized their interest in clinical research, seeing it as a duty. Involving their loved-one in research allowed them to find mea…
Impact of a program based in eating habits and physiotherapy on anthropometric parameters in patients with coronary artery disease: randomized contro…
2021
Abstract Funding Acknowledgements Type of funding sources: None. Introduction. On the one hand, physical training such as High intensity interval training (HIIT) and on the other, eating habits, it is often prescribed to patients with coronary artery disease (CAD). Nevertheless, the combination of HIIT and eating habits in CAD with percutaneous coronary intervention (PCI) there is no consensus on using a combined protocol of both. Purpose. The purpose of this study was to evaluate the impact of an HIIT program with eating habits, with a program based in HIIT, on anthropometric parameters in CAD patients with PCI. Methods. A randomized controlled trial was carried out in a hospital. 44 pati…
Protocol for developing a mental imagery intervention: a randomised controlled trial testing a novel implementation imagery e-health intervention to …
2019
IntroductionDrowning due to driving into floodwater accounts for a significant proportion of all deaths by drowning. Despite awareness campaigns such as ‘If it’s flooded, forget it’, people continue to drive into floodwater. This causes loss of life, risk to rescuers and damage to vehicles. The aim of this study was to develop and evaluate an online e-health intervention to promote safe driving behaviour during flood events.Methods and analysisThe study will use a 2×3 randomised controlled trial in which participants are randomised into one of two conditions: (1) education about the risks of driving into floodwater or (2) education about the risks of driving into floodwater plus a theory-ba…
The Norwegian childhood cancer biobank
2021
Background - The rapidly expanding era of “omics” research is highly dependent on the availability of quality-proven biological material, especially for rare conditions such as pediatric malignancies. Professional biobanks provide such material, focusing on standardized collection and handling procedures, distinctive quality measurements, traceability of storage conditions, and accessibility. For pediatric malignancies, traditional tumor biobanking is challenging due to the rareness and limited amount of tissue and blood samples. The higher molecular heterogeneity, lower mutation rates, and unique genomic landscapes, however, renders biobanking of this tissue even more crucial. Aim - The ai…
Qualitätssicherung in einer epidemiologischen Kohortenstudie: Durchführung von on-site Monitoring in gynäkologischen Arztpraxen
2014
Quality assurance is required for all relevant instruments and procedures in epidemiological studies just like for clinical trials. The structure and complexity of the monitoring was developed based on the monitoring in clinical trials and applied to an epidemiological cohort study on early detection of cervical cancer (MARZY Study). Analyses of the on-site monitoring in participating gynaecological practices during the baseline investigation of the MARZY cohort were presented. The baseline investigation of the MARZY study was conducted between 2005 and 2007 in the city of Mainz, the rural district of Mainz-Bingen and surrounding areas. Women, who were randomly selected via population regis…
The protection of the person in medical research in the Spanish law.
2002
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