1,720,979 research outputs found
Three scenarios illustrating ethical concerns when considering bariatric surgery in obese adolescents with Prader-Willi syndrome.
No full textPrader-Willi syndrome (PWS) is one of the 25 syndromic
forms of obesity, in which patients present—in addition
to different degrees of obesity—intellectual disability,
endocrine disturbs, hyperphagia and/or other signs of
hypothalamic dysfunction. In front of a severe/extreme
obesity and the failure of non-invasive
treatments,
bariatric surgery is proposed as a therapeutic option.
The complexity of the clinical condition, which could
affect the long-term
effects of bariatric surgery, and the
frequent association with a mild to severe intellectual
disability raise some ethical concerns in the treatment
of obese PWS adolescents. This article analyses these
issues referring to the principles of healthcare ethics:
beneficence/non-maleficence
(proportionality of
treatments; minimisation of risks); respect of autonomy;
justice. Based on these principles, three hypothetical
scenarios are defined: (1) obese PWS adolescent,
capable of making an autonomous decision; (2) obese
PWS adolescent with a severe intellectual disability,
whose parents agree with bariatric surgery; (3) obese
PWS adolescent with a life-threatening
condition and
a severe intellectual disability, whose parents do not
agree with bariatric surgery. The currently available
evidence on efficacy and safety of bariatric surgery in
PWS adolescents with extreme or severe obesity and
the lack of adequate long-term
follow-up
suggests
great caution even in a very life-threatening
condition.
Clinicians must always obtain a full IQ assessment of
patients by psychologists. A multidisciplinary team is
needed to analyse the clinical, psychological, social and
ethical aspects and organise support for patient and
parents, involving also the hospital ethical committee or,if necessary, legal authorities
Implementing carrier screening for cystic fibrosis outside the clinic: ethical analysis in the light of the personalist view
Get PDFBackground. Cystic Fibrosis (CF) is an autosomal recessive genetic disease. Two models for screening CF are normally used: newborn screening and population-based CF carrier screening. In turn, there are three main models of population-based CF carrier screening: prenatal carrier screening, preconception carrier screening, and carrier screening outside clinical settings. Aim. To evaluate, in the light of the personalist view, the use of carrier screenings for CF outside the clinic, i.e. in non-clinical settings, such as school and workplaces.Methods. Analysis has been carried out according to the “Perso-nalist approach” (also called “Triangular model”), an ethical method for performing ethical analysis within HTA process. It includes factual, anthropological and ethical data in a ‘‘triangular’’ normative reflection process.Findings. Implementing carrier screening for cystic fibrosis outside the clinical settings allows acquisition of knowledge for informing reproductive choices, that can be considered as valuable; benefit-risk ratio seems to be not much favorable; autonomous and responsible decisions can be taken only under certain conditions; economic ad-vantage is difficult to determine; therefore, from a personalist view, implementing carrier screenings outside the clinic seems not to be ethically justified. Conclusion. In accordance with the personalist perspective, public health programs providing carrier screenings outside the clinic should not be implemented
Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review
Get PDFBACKGROUND: Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. OBJECTIVE: We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. METHODS: We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. RESULTS: A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies' populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. CONCLUSIONS: Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979.sponsorship: This research was funded by KU Leuven and by the European Network Staff Exchange for Integrating Precision Health in the Health Care Systems project (Marie Sklodowska-Curie Research and Innovation Staff Exchange No. 823995). Pascal Borry is funded through a European Union's Horizon 2020 research and innovation programme under grant agreement No. 825903 (euCanShare). (KU Leuven, European Network Staff Exchange for Integrating Precision Health in the Health Care Systems project (Marie Sklodowska-Curie Research and Innovation Staff Exchange)|823995, European Union|825903, Marie Curie Actions (MSCA)|823995)status: Publishe
Knowledge And Attitudes Of Women Diagnosed With Oncological Pathology Towards Fertility Preservation: Preliminary Data
No full textKnowledge And Attitudes of Women Diagnosed with Oncological Pathology Towards Fertility Preservation: Preliminary Dat
Socio-psychological distress, violence, and food insecurity in women undergoing gynecological examinations: insights from a cross-sectional study of an Italian Tertiary Clinic
Get PDFBackground: The reality of gynecological patients represents a distinct subgroup of the population in which social and psychological distress can coexist alongside the burden of the disease. “Unmet social needs,” including social distress, which encompasses gender and family violence, abuse, unemployment, and food insecurity, are now widely recognized as critical determinants of health. Some studies have examined the social needs experienced by patients with gynecological disorders, but primarily in gynecologic oncology patients. Objective: This study aims to assess the prevalence of socio-psychological distress, experiences of violence, and food insecurity in patients attending a tertiary outpatient gynecological clinic. Data were collected using a tailored open-ended questionnaire administered by trained volunteers. Study design: This is a prospective cross-sectional study. An ad-hoc questionnaire, validated through the Delphi methodology, was administered to all women attending the Gynaecological Outpatient Clinic at Fondazione Policlinico A. Gemelli IRCCS in Rome, Italy, from March to November 2023. Their responses were analyzed focusing on self-reported socio-psychological distress, violence experienced and food insecurity. Inferential analysis was provided to evaluate the possible association with socioeconomic distress and clinical characteristics of patients. Multivariable logistic regression models for predicting outcomes were performed including those parameters that were statistically significant at univariable analysis (p value <.05). Results: A total of 408 women were included in the study. One hundred and fifty-two (37.2%) reported socio-psychological distress, 136 (33.3%) violence, and 60 (14.7%) food insecurity. Independent risk factors for socio-psychological distress included oncological conditions (OR: 3.76, 95% CI: 1.55–9.11), chronic conditions (OR: 2.22, 95% CI: 1.38–3.57), economic difficulties (OR: 3.91, 95% CI: 2.20–6.93), and experiencing violence (OR: 4.65, 95% CI: 2.83–7.65). Independent risk factors for violence were benign gynecological conditions (OR: 1.95, 95% CI: 1.02–3.74), alcohol use (OR: 1.88, 95% CI: 1.16–3.04), economic difficulties (OR: 1.72, 95% CI: 1.02–2.90), and experiencing food insecurity (OR: 1.92, 95% CI: 1.03–3.59). The only independent risk factor for food insecurity was having economic difficulties (OR: 6.01, 95% CI: 3.06–11.81). Conclusion: Socio-psychological distress and experiences of violence were found to be prevalent in over one-third of the population studied. Identified risk factors include the type of gynecological condition, economic hardship, and food insecurity. These findings underscore the urgent need for the development of comprehensive social support systems to assist women with gynecological conditions. While integrated clinical and social support programs remain underdeveloped in some countries, trained volunteers can serve as a valuable interim resource, complementing but not replacing the essential role of professional social and psychological services
Health Technology Assessment and Ethics Health
Get PDFA trend or a useful tool? HTA (Health Technology Assessment) was born in the 70s as a tool to support decision makers in the health sector and has been quickly developing since, also with the creation of specialized international agencies (e.g. Health Technology Assessment International – HTAi; International Network of Assessment Agencies of health technologies - INAHTA). What is HTA? It is the “systematic evaluation of the properties and effects of a health technology, which addresses the direct and expected effects of this technology, as well as its indirect and unintended consequences, and aims primarily to inform decision-makers on health technologies”. The approach is interdisciplinary, because HTA summarizes information on medical, social, economic and ethical issues, and methods of evaluation can be different. Since of its born, ethics has been considered a key element in HTA, even if there is still not an agreement on “why” and “how” ethics should be integrated in HTA. This difficulty is not new and it mainly due to the narrowing of HTA to economic analysis. In 2004, ten Have has listed some potential reasons of this situation: a) Existing approaches for ethical inquiry are not suitable for HTA; b) Technologies are often considered by HTA producers as being value-free; c) The only questions perceived as relevant in an HTA are technical and economical ones; d) Value issues may be acknowledged to be present at all levels in HTA, but ethics is not needed to address these issues; e) It is practically difficult to integrate ethical considerations in HTA; f) HTA experts are not trained to make ethical assessments and there is too little expertise on ethics and HTA; g. Limited resources available to conduct ethical analyses
Prevalence and correlates of food insecurity among children in high-income European countries. A systematic review.
Get PDFBackground. In Europe, there is not routinely collected data on children’s food insecurity.
Indirect data show that food insecurity is on the rise in Europe, which may have a
great impact on children’s health.
Methods. Considering that, we systematically reviewed any evidence coming from European
countries in the last 10 years that reported the prevalence and correlates of food
insecurity among children, intending to serve as a starting point for policymakers and
guidelines.
Results. We report worrying prevalence rates of food insecurity among children from 9
studies. There is a lack of evidence regarding this issue in many EU countries, especially
Eastern Europe. Hence, the need for increased attention towards food insecurity among
children in European countries.
Conclusions. Achieving food security means designing targeted policies and interventions,
both at a national and EU level. Policymakers and governments should make the
appropriate efforts to deliver food security as a public good
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Role of artificial intelligence applied to ultrasound in gynecology oncology: A systematic review
Get PDFThe aim of this paper was to explore the role of artificial intelligence (AI) applied to ultrasound imaging in gynecology oncology. Web of Science, PubMed, and Scopus databases were searched. All studies were imported to RAYYAN QCRI software. The overall quality of the included studies was assessed using QUADAS-AI tool. Fifty studies were included, of these 37/50 (74.0%) on ovarian masses or ovarian cancer, 5/50 (10.0%) on endometrial cancer, 5/50 (10.0%) on cervical cancer, and 3/50 (6.0%) on other malignancies. Most studies were at high risk of bias for subject selection (i.e., sample size, source, or scanner model were not specified; data were not derived from open-source datasets; imaging preprocessing was not performed) and index test (AI models was not externally validated) and at low risk of bias for reference standard (i.e., the reference standard correctly classified the target condition) and workflow (i.e., the time between index test and reference standard was reasonable). Most studies presented machine learning models (33/50, 66.0%) for the diagnosis and histopathological correlation of ovarian masses, while others focused on automatic segmentation, reproducibility of radiomics features, improvement of image quality, prediction of therapy resistance, progression-free survival, and genetic mutation. The current evidence supports the role of AI as a complementary clinical and research tool in diagnosis, patient stratification, and prediction of histopathological correlation in gynecological malignancies. For example, the high performance of AI models to discriminate between benign and malignant ovarian masses or to predict their specific histology can improve the diagnostic accuracy of imaging methods
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