Utility of accessible SARS-CoV-2 specific immunoassays in vaccinated adults with a history of advanced HIV infection.

Accessible SARS-CoV-2-specific immunoassays may inform clinical management in people with HIV, particularly in case of persisting immunodysfunction. We prospectively studied their application in vaccine recipients with HIV, purposely including participants with a history of advanced HIV infection. Participants received one (n = 250), two (n = 249) or three (n = 42) doses of the BNT162b2 vaccine. Adverse events were documented through questionnaires. Sample collection occurred pre-vaccination and a median of 4 weeks post-second dose and 14 weeks post-third dose. Anti-spike and anti-nucleocapsid antibodies were measured with the Roche Elecsys chemiluminescence immunoassays. Neutralising activity was evaluated using the GenScript cPass surrogate virus neutralisation test, following validation against a Plaque Reduction Neutralization Test. T-cell reactivity was assessed with the Roche SARS-CoV-2 IFNγ release assay. Primary vaccination (2 doses) was well tolerated and elicited measurable anti-spike antibodies in 202/206 (98.0%) participants. Anti-spike titres varied widely, influenced by previous SARS-CoV-2 exposure, ethnicity, intravenous drug use, CD4 counts and HIV viremia as independent predictors. A third vaccine dose significantly boosted anti-spike and neutralising responses, reducing variability. Anti-spike titres > 15 U/mL correlated with neutralising activity in 136/144 paired samples (94.4%). Three participants with detectable anti-S antibodies did not develop cPass neutralising responses post-third dose, yet displayed SARS-CoV-2 specific IFNγ responses. SARS-CoV-2 vaccination is well-tolerated and immunogenic in adults with HIV, with responses improving post-third dose. Anti-spike antibodies serve as a reliable indicator of neutralising activity. Discordances between anti-spike and neutralising responses were accompanied by detectable IFN-γ responses, underlining the complexity of the immune response in this population.

Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis.

INTRODUCTION: Progressive multifocal leukoencephalopathy (PML) was first described among patients affected by hematological or solid tumors. Following the human immunodeficiency virus (HIV) epidemic, people living with HIV have represented most cases for more than a decade. With the diffusion of highly active antiretroviral therapy, this group progressively decreased in favor of patients undergoing treatment with targeted therapy/immunomodulators. In this systematic review and meta-analysis, the objective was to assess which drugs are most frequently related to PML development, and report the incidence of drug-induced PML through a meta-analytic approach. METHODS: The electronic databases MEDLINE, EMBASE, ClinicalTrials.gov, Web of Science and the Canadian Agency for Drugs and Technologies in Health Database (CADTH) were searched up to May 10, 2022. Articles that reported the risk of PML development after treatment with immunomodulatory drugs, including patients of both sexes under the age of 80 years, affected by any pathology except HIV, primary immunodeficiencies or malignancies, were included in the review. The incidence of drug-induced PML was calculated based on PML cases and total number of patients observed per 100 persons and the observation time. Random-effect metanalyses were conducted for each drug reporting pooled incidence with 95% confidence intervals (CI) and median (interquartile range [IQR]) of the observation time. Heterogeneity was measured by I2 statistics. Publication bias was examined through funnel plots and Egger's test. RESULTS: A total of 103 studies were included in the systematic review. In our analysis, we found no includible study reporting cases of PML during the course of treatment with ocrelizumab, vedolizumab, abrilumab, ontamalimab, teriflunomide, daclizumab, inebilizumab, basiliximab, tacrolimus, belimumab, infliximab, firategrast, disulone, azathioprine or danazole. Dalfampridine, glatiramer acetate, dimethyl fumarate and fingolimod show a relatively safe profile, although some cases of PML have been reported. The meta-analysis showed an incidence of PML cases among patients undergoing rituximab treatment for multiple sclerosis (MS) of 0.01 cases/100 persons (95% CI - 0.08 to 0.09; I2 = 20.4%; p = 0.25) for a median observation period of 23.5 months (IQR 22.1-42.1). Treatment of MS with natalizumab carried a PML risk of 0.33 cases/100 persons (95% CI 0.29-0.37; I2 = 50%; p = 0.003) for a median observation period of 44.1 months (IQR 28.4-60) and a mean number of doses of 36.3 (standard deviation [SD] ± 20.7). When comparing data about patients treated with standard interval dosing (SID) and extended interval dosing (EID), the latter appears to carry a smaller risk of PML, that is, 0.08 cases/100 persons (95% CI 0.0-0.15) for EID versus 0.3 cases/100 persons (95% CI 0.25-0.34) for SID. CONCLUSIONS: A higher risk of drug-related PML in patients whose immune system is not additionally depressed by means of neoplasms, HIV or concomitant medications is found in the neurological field. This risk is higher in MS treatment, and specifically during long-term natalizumab therapy. While this drug is still routinely prescribed in this field, considering the efficacy in reducing MS relapses, in other areas it could play a smaller role, and be gradually replaced by other safer and more recently approved agents.

Utility of Liver Biopsy in the Diagnosis and Management of Possible Drug-Induced Liver Injury in Patients Receiving Antituberculosis Therapy: A Retrospective Study.

BACKGROUND: Drug-induced liver injury (DILI) secondary to ATT treatment (TB-DILI) is reported in 2-28% of patients. We present here a series of clinical cases of suspected DILI arising during antituberculosis treatment, studied with the aid of liver biopsy. METHODS: this was a retrospective descriptive study including 10 tuberculosis patients who underwent liver biopsy for suspected TB-DILI at the "Lazzaro Spallanzani" Institute from 2017 to 2022. RESULTS: Ten patients who underwent LB were extracted from the database and included in the retrospective study cohort. According to the clinical classification, eight patients had hepatocellular liver injury, one patient had cholestatic injury, and another had mixed-type injury. Histopathological diagnosis revealed liver damage due to DILI in 5/10 (50%) cases. In one case, liver biopsy showed necrotizing granulomatous hepatitis. CONCLUSIONS: Severe and persistent elevation of hepatic transaminases, hepatic cholestasis despite discontinuation of therapy, and other suspected hepatic conditions are indications for liver biopsy, which remains a valuable tool in the evaluation of selected tuberculosis patients with suspected DILI for many reasons. However, the decision to perform a liver biopsy should be based on clinical judgment, considering the benefits and risks of the procedure.

The Development and Validation of a Questionnaire to Investigate the Association Between Maternal Food Insecurity and Fetal Structural Anomalies: Delphi Procedure and Pilot Study.

INTRODUCTION: Food insecurity represents a public health issue that has been associated with poor birth outcomes. We describe the methodological steps followed to structure and validate a questionnaire, which has the potential to contribute to the planning and conduction of future studies investigating the possible association between maternal food insecurity and fetal structural anomalies. METHODS: We first conducted a literature review to structure and validate the questionnaire. Subsequently, we drafted the questionnaire based on the results of this review, further refined through two focus groups. Afterward, the questionnaire was submitted using the Delphi Method to a panel of experts for validation. We conducted a pilot study prior to recruiting the final sample. RESULTS: The questionnaire consisted of sections covering information about socio-demographic characteristics, women's health and lifestyle, pregnancy, and food security status. After the first Delphi round, the Content Validity Index (CVI) for each section ranged 0.81-0.85, while after the second round all items had a CVI of 1. The final version of the questionnaire, consisting of 87 items, was pilot tested among 20 participants. Cronbach's Alpha for each section resulted in values higher than 0.6. The response rate ranged from 78 to 100%. A situation of food security was present in 85% of the participants, while 5% were in a situation of mild food insecurity and 10% of moderate food insecurity. CONCLUSION: The questionnaire has appropriate measurement properties, and is an adequate instrument to evaluate the association between maternal food insecurity and fetal structural anomalies.

Knowledge, attitudes, and health status of childbearing age young women regarding preconception health - an Italian survey.

Introduction: Preconception health is a public health issue, concerning aspects that could have repercussions on pregnancy outcomes. Despite the importance, often there is a lack of knowledge, particularly among young women. This cross-sectional study aims to evaluate knowledge, attitudes and health status of young women regarding preconception health in the Italian context. Methods: From July 2020 until April 2021 a validated questionnaire (systematic review, Delphi procedure and pilot study) was administered to a sample of 340 women aged 18 to 25 years, without previous pregnancy and not planning it, attending secondary grade schools and universities. It collected information on knowledge, physical, sexual and mental health. T-test and analysis of variance (ANOVA) were used to determine a significant difference in knowledge mean score (KMS) among different groups. Results: KMS was 67.6% (SD = 18.1). Participants with Italian nationality, enrolled in a health-field university, with a full-time job, a family income higher than 35,000 €/year and teachers or health providers as information source, had a significantly higher KMS. Only 15.9% of women who saw a gynaecologist in the last year (47.7%) asked about preconception health. 56.5% knew that folic acid is effective in reducing the risk of neural tube defects, while 5.9% was taking it. 82.3% was living in stressing environment. Gender-based discrimination at work, school or family was felt by 25.1%, while 38.2% experienced at least one type of violence. Conclusions: Promoting preconception health by improving knowledge, attitudes and behaviours may be an impactful possibility to improve women's, children's, and communities' health.

The Role of Ultrasound in the Evaluation of Inguinal Lymph Nodes in Patients with Vulvar Cancer: A Systematic Review and Meta-Analysis.

OBJECTIVE: To determine the efficacy of ultrasound in assessing the inguinal lymph nodes in patients with vulvar cancer. METHODS: A systematic review of published research up to October 2020 that compares the results of ultrasound to determine groin node status with histology was conducted. All study types that reported primary data on the role of ultrasound in the evaluation of groin lymph nodes in vulvar cancer were included in the systematic review. Data retrieved from the included studies were pooled in random-effects meta-analyses. RESULTS: After the screening and selection process, eight articles were deemed pertinent for inclusion in the systematic review and meta-analysis. The random-effects model showed a pooled Se of 0.85 (95% CI: 0.81-0.89), Sp of 0.86 (95% CI: 0.81-0.91), PPV of 0.65 (95% CI: 0.54-0.79) and NPV of 0.92 (95% CI: 0.91-0.94). There was a pooled LR+ and LR- of 6.44 (95% CI: 3.72-11.4) and 0.20 (95% CI: 0.14-0.27), respectively. The pooled accuracy was 0.85 (95% CI: 0.80-0.91). CONCLUSIONS: Although the studies had small sample sizes, this review represents the best summary of the data so far. Ultrasound has revealed high sensitivity and high negative predictive value in the assessment of nodal status in vulvar cancer.

A comprehensive assessment of preconception health needs and interventions regarding women of childbearing age: a systematic review.

Background: This systematic review summarizes the preconception health needs of women in childbearing age, necessary to be addressed to have an eventual safe and healthy pregnancy. Methods: Web of Science, PubMed and Scopus were searched. We excluded studies involving women with reproductive system pathologies and referring to interconceptive or pregnancy period and non-empirical or only abstract studies. Two researchers independently performed the blind screening based on titles/abstracts and full-text and the quality assessment. Results: Four major domains resulted from the thematic analysis: knowledge, behaviors and attitudes, health status and access to healthcare services. The most examined topics were knowledge and awareness on preconception health, folic acid assumption, tobacco and alcohol consumption, physical activity and healthy diet. Conclusions: This review could assist healthcare professionals (physicians, nurses, midwives) in guiding tailored counselling to women to provide the adequate level of preconception care and act as a reference to policymakers.

Implementation level of best practice policies by Italian Government for healthier food environments: Healthy Food Environment Policy Index (Food-EPI).

BACKGROUND: This work aims to identify policies implemented for healthy food environments in Italy within The Healthy Food Environment Policy Index (Food-EPI) project. METHODS: Food-EPI tool, which includes two components, thirteen domains and fifty good practice indicators, was adapted for the Italian context. Evidence for implementation was gathered and summarized for all fifty indicators from data sources such as governmental websites, non-government organizations publications and websites and via direct contact with Government officials. RESULTS: The highest level of evidence was found within five domains: food composition (2/2 indicators), labelling (3/4), promotion (4/5), provision (4/5) and leadership (5/5). The domains with less identified evidence were food prices (1/4), food in retail (0/4), trade and investment (0/2) and platforms and interaction (1/4). CONCLUSIONS: The evidence summarization and the upcoming stakeholders' meeting to rate the level of implementation for each indicator in Italy have the potential to improve Government commitment to shape healthier food environments.

Perceived knowledge, coping and diagnostic-therapeutic pathways of infertile couples trying to conceive: an Italian survey.

BACKGROUND: The last decades' increasing infertility risk factors have brought to a growing number of infertile couples. Knowledge regarding infertility and possible treatments is-however- poor, leading to difficulty in coping and understanding. Knowing infertile couples' perceptions and needs may help clinicians develop services that better address these needs. METHODS: This study aimed at assessing perceived knowledge, coping mechanisms and diagnostic-therapeutic pathways concerning infertility and Assisted Reproductive Technology (ART) in a sample of Italian infertile couples trying to conceive. In this cross-sectional study, 199 subjects aged 25-55 years old who had difficulties conceiving were asked to fill a questionnaire regarding infertility and ART perceived knowledge, coping and diagnostic-therapeutic pathways they had been through. RESULTS: The perceived knowledge score was 42.5%. Couples had difficulties understanding ART's success rate and the potential risks for the woman and fetus. Subjects from North of Italy, who were previously engaged in an ART procedure, those who had signed a written informed consent and were offered a specific counselling session had significantly higher mean score of perceived knowledge. Couples were handling the situation in a satisfactory way, supported also by their family, but the procedures, clinical examinations, therapies, medications, were considered complex and stressful by 66.5% of the respondents. CONCLUSIONS: Healthcare providers should consider the couples' previous experience with infertility, the important role of informed consent and personalized counselling sessions. Counselling for infertile couples should have a broader, comprehensive approach, integrating psychological, social, ethical support, as well as health literacy, taking into consideration the infertile couples' preferences and needs.

Community Initiatives to Promote Basic Life Support Implementation-A Scoping Review.

INTRODUCTION: Early intervention of bystanders (the first links of the chain of survival) have been shown to improve survival and good neurological outcomes of patients suffering out-of-hospital cardiac arrest (OHCA). Many initiatives have been implemented to increase the engagement of communities in early basic life support (BLS) and cardiopulmonary resuscitation (CPR), especially of lay people with no duty to respond. A better knowledge of the most effective initiatives might help improve survival and health system organization. Aim of the scoping review: To assess the impact of specific interventions involving lay communities on bystander BLS rates and other consistent clinical outcomes, and to identify relevant knowledge gaps. METHODS: This scoping review was part of the continuous evidence evaluation process of the International Liaison Committee on Resuscitation (ILCOR), and was performed following the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. We performed a literature search using the PubMed, EMBASE, and Cochrane databases until 1 February 2021. The screening process was conducted based on predefined inclusion/exclusion criteria, and for each included study, we performed data extraction focusing on the type of intervention implemented, and the impact of these interventions on the specific OHCAs outcomes. RESULTS: Our search strategy identified 19 eligible studies, originating mainly from the USA (47.4%) and Denmark (21%). The type of intervention included in 57.9% of cases was a community CPR training program, in 36.8% bundled interventions, and in 5.3% mass-media campaigns. The most commonly reported outcome for OHCAs was bystander CPR rate (94.7%), followed by survival to hospital discharge (36.8%), proportion of people trained (31.6%), survival to hospital discharge with good neurological outcome (21%), and Return of Spontaneous Circulation (10.5%). Community training programs and bundled interventions improved bystander CPR in most of the included studies. CONCLUSION: Based on the results of our scoping review, we identified the potential benefit of community initiatives, such as community training in BLS, even as part of bundled intervention, in order to improve bystander CPR rates and patient outcomes.

Ovarian Reserve after Chemotherapy in Breast Cancer: A Systematic Review and Meta-Analysis.

Background: Worldwide, breast cancer (BC) is the most common malignancy in the female population. In recent years, its diagnosis in young women has increased, together with a growing desire to become pregnant later in life. Although there is evidence about the detrimental effect of chemotherapy (CT) on the menses cycle, a practical tool to measure ovarian reserve is still missing. Recently, anti-Mullerian hormone (AMH) has been considered a good surrogate for ovarian reserve. The main objective of this paper is to evaluate the effect of CT on AMH value. METHODS: A systematic review and meta-analysis were conducted on the PubMed and Scopus electronic databases on articles retrieved from inception until February 2021. Trials evaluating ovarian reserves before and after CT in BC were included. We excluded case reports, case-series with fewer than ten patients, reviews (narrative or systematic), communications and perspectives. Studies in languages other than English or with polycystic ovarian syndrome (PCOS) patients were also excluded. AMH reduction was the main endpoint. Egger's and Begg's tests were used to assess the risk of publication bias. RESULTS: Eighteen trials were included from the 833 examined. A statistically significant decline in serum AMH concentration was found after CT, persisting even after years, with an overall reduction of -1.97 (95% CI: -3.12, -0.82). No significant differences in ovarian reserve loss were found in the BRCA1/2 mutation carriers compared to wild-type patients. CONCLUSIONS: Although this study has some limitations, including publication bias, failure to stratify the results by some important factors and low to medium quality of the studies included, this metanalysis demonstrates that the level of AMH markedly falls after CT in BC patients, corresponding to a reduction in ovarian reserve. These findings should be routinely discussed during oncofertility counseling and used to guide fertility preservation choices in young women before starting treatment.

Development and validation of a questionnaire to assess Unaccompanied Migrant Minors' needs (AEGIS-Q).

BACKGROUND: While many studies focus on specific aspects of Unaccompanied Migrant Minors' (UMMs) health, especially mental well-being, there is a lack of tools comprehensively assessing their needs. To fill this gap, we developed and validated a questionnaire to thoroughly assess unAccompaniEd miGrant mInorS' physical, psychological, legal, spiritual, social and educational needs (AEGIS-Q). METHODS: This work consisted of three stages. The first one involved an extensive literature review. Given the results of the review, a first draft of the questionnaire was developed and submitted to a panel of experts for validation (Delphi method-second stage). During the third stage, the final version of the questionnaire was pilot-tested in a sample of 18 UMMs. RESULTS: The questionnaire, drafted based on the results of the review, consisted of sections covering personal data, migration profile, physical health needs and access to healthcare, psychological needs, legal needs, spiritual needs and educational and social needs of UMMs. After two Delphi rounds, the final version of the questionnaire, consisting of 83 questions, was structured. The pilot study had a response rate of 89-100%. We found substantial reliability for most of the sections in the questionnaire, including physical health (α=0.652), legal (α=0.781), and educational and social (α=0.614) needs. The questions regarding psychological needs had very high reliability (α=0.860). CONCLUSIONS: The questionnaire offers a useful sharable tool to assess and monitor UMMs' needs, helping the reception system to better know and meet their needs and implement the taking in charge.

Intrafamilial communication of hereditary breast and ovarian cancer genetic information in Italian women: towards a personalised approach.

Genomic testing expansion is accompanied by an increasing need for genetic counselling and intrafamilial communication. Genetic counselling can play an important role in facilitating intrafamilial communication and relationships. We conducted a cross-sectional, multicenter study including 252 Italian women, using a questionnaire divided in two sections, the first one to be filled after the pre-test counselling and the second after receiving BRCA test results. We assessed the factors influencing intrafamilial disclosure of genetic information for hereditary breast and ovarian cancer, family members with whom probands are more prone to share genetic information, and the perceived understanding of information received by counselees during genetic counselling. Women were accompanied to the counselling more often by their husband/partner. Among those with a positive BRCA test result, 49% intended to communicate it to their offspring and 27% to their husband/partner. Younger women, those living with their husband/partner, and those who described family communication as open/profound and spontaneous/sincere had a higher probability of being accompanied during genetic counselling and discuss about it with relatives. Spontaneous/sincere or open/profound family communication and joyful/happy familial relationships were associated with the decision to undergo genetic testing as a responsibility towards relatives. Women had a good understanding of counselling contents (mean score 9.27 in a scale 1-10). Genetic counselling providers should consider that genetic information disclosure does not depend only on the clarity of the information provided, but also on pre-existing intrafamilial communication and relationships, family structure and marital status, indicating the need for a personalised approach accounting for these factors.

Association of maternal food insecurity before and during pregnancy with fetal structural anomalies: A multicenter case-control study protocol.

BACKGROUND: Food insecurity, an issue also affecting developed countries, is associated with different negative outcomes. Particularly in pregnant women, a vulnerable population group, it has a double burden, as it affects both the woman and her child. Food insecurity has been associated with low birth weight and shorter gestational age, but there is less evidence on the association with fetal structural anomalies. AIM: To fill this gap, a study will be conducted to examine if pregnant women in a condition of food insecurity have a higher risk for fetal structural anomalies. METHODS: A case-control study will be conducted in three centers. Cases will be pregnant women (>18 years old) diagnosed with a fetal structural anomaly during the prenatal ultrasound examination of the II-III trimester, while controls will be pregnant women (>18 years old) with a negative result for fetal structural anomaly at the II-III trimester prenatal ultrasound examination. The exposure of interest will be food insecurity during the last 12 months, measured using the validated Household Food Insecurity Access Scale. A dedicated questionnaire will be given to women after they sign the informed consent form. SUMMARY: Finding a positive association between food insecurity in pregnant women and fetal structural anomalies could be the first step towards screening for it among pregnant women and designing policies that could mitigate this condition. Lowering food insecurity could prevent a certain number of fetal structural anomalies, leading to fewer negative pregnancy outcomes and health problems during childhood and adulthood.

How health systems approached respiratory viral pandemics over time: a systematic review.

BACKGROUND: Several healthcare systems facing respiratory viral infections outbreaks, like COVID-19, have not been prepared to manage them. Public health mitigation solutions ranging from isolation of infected or suspected cases to implementation of national lockdowns have proven their effectiveness for the outbreak's control. However, the adjustment of public health measures is crucial during transition phases to avoid new outbreaks. To address the need for designing evidence-based strategies, we performed a systematic review to identify healthcare systems interventions, experiences and recommendations that have been used to manage different respiratory viral infections outbreaks in the past. METHODS: PubMed, Web of Science, Scopus and Cochrane were searched to retrieve eligible studies of any study design, published in English until 17 April 2020. Double-blinded screening process was conducted by titles/abstracts and subsequently eligible full texts were read and pertinent data were extracted. When applicable, quality assessment was conducted for the included articles. We performed a narrative synthesis of each implemented public health approaches. RESULTS: We included a total of 24 articles addressing the public health approaches implemented for respiratory viral infections outbreaks for COVID-19, influenza A H1N1, MERS and severe acute respiratory syndrome . The identified approaches are ascribable to two main categories: healthcare system strategies and healthcare provider interventions. The key components of an effective response on respiratory viral outbreaks included the implementation of evidence-based contextual policies, intrahospital management actions, community healthcare facilities, non-pharmaceutical interventions, enhanced surveillance, workplace preventive measures, mental health interventions and communication plans. CONCLUSION: The identified healthcare system strategies applied worldwide to face epidemics or pandemics are a useful knowledge base to inform decision-makers about control measures to be used in the transition phases of COVID-19 and beyond.

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.

BACKGROUND: 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.

Three scenarios illustrating ethical concerns when considering bariatric surgery in obese adolescents with Prader-Willi syndrome.

Prader-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.

Prevalence and correlates of food insecurity among children in high-income European countries. A systematic review.

BACKGROUND: 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.