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.

National health system cuts and triage decisions during the COVID-19 pandemic in Italy and Spain: ethical implications.

In this paper, we analyse the most important documents establishing the criteria for the treatment and exclusion of COVID-19 patients, especially in regard to the giving of respiratory support, in Italy and Spain. These documents reflect a tension that stems from limited healthcare resources which are insufficient to save lives that, under normal conditions, could have been saved, or at least could have received the best possible treatment. First, we analyse the healthcare systems of these two countries before the spread of the virus, both of which have seen decreases in the number of intensive care beds and have been marked by financial cuts during the last ten years. It is a fact that a greater number of people, especially those over 70 years of age, have been left without respiratory support treatment, and therefore, there have been a greater number of deaths. It is also a fact that there has been a higher infection rate among healthcare professionals due to the delay in the management of protective measures and the inability to provide adequate care for those in nursing homes, as recognised by WHO. In the context of this health emergency, healthcare professionals have suffered a real 'moral distress' because, knowing first-hand the causes of the limitation of resources, they have had to put triage protocols into practice. Finally, we set forth a series of concrete ethical proposals with which to face the successive waves of COVID-19 infection, as well as other future pandemics.

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.

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.

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.

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.

Adjuvanted influenza vaccine for the Italian elderly in the 2018/19 season: an updated health technology assessment.

BACKGROUND: The elderly, defined here as subjects aged ≥ 65 years, are among at-risk subjects for whom annual influenza vaccination is recommended. For the 2018/19 season, three vaccine types are available for the elderly in Italy: trivalent inactivated vaccine (TIV), adjuvanted TIV (aTIV) and quadrivalent inactivated vaccines (QIV). No health technology assessment (HTA) of seasonal influenza vaccination in the elderly has previously been conducted in Italy. METHODS: An HTA was conducted in 2017 to analyze the burden of influenza illness, the characteristics, efficacy, safety and cost-effectiveness of available vaccines and the related organizational and ethical implications. This was then contextualized to the 2018/19 influenza season. Comprehensive literature reviews/analyses were performed and a static mathematical model developed in order to address the above issues. RESULTS: In Italy, influenza is usually less common in the elderly than in other age-classes, but the burden of disease is the highest; >10% of infected elderly subjects develop complications, and about 90% of all influenza-related deaths occur in this age-class. All available vaccines are effective, safe and acceptable from an ethical standpoint. However, aTIV has proved more immunogenic and effective in the elderly. Furthermore, from the third payer's perspective, aTIV is highly cost-effective and cost-saving in comparison with TIV and QIV, respectively. Nevertheless, vaccination coverage needs to be improved. CONCLUSIONS: According to this HTA, aTIV appeared the vaccine of choice in the elderly. HTA should be reapplied whenever new relevant data become available.

Diet and lifestyles of young women of childbearing age: an Italian survey.

BACKGROUND: Daily lifestyles play a pivotal role in influencing the preconception health of women in their childbearing years. The aim of this cross-sectional study is to delineate, within the Italian context, the lifestyles of young women of childbearing age, that may have repercussions on their preconception health. METHODS: From July 2020 until April 2021, an anonymous online questionnaire was administered to a sample of 340 women aged 18-25 years attending secondary grade schools and universities in Italy. RESULTS: Over the course of the preceding three days, 90.29% of women had meat, 45.59% had fish. 28.24%, 38.82% and 18.53% of women reported tobacco, alcohol and drugs consumption, respectively. The mean amount of folic acid taken through foods consumed was 341 µg/day. Only 53.53% of women did sports. Smokers were more frequently consuming alcohol and drugs. Women who never did sports, were more likely to use drugs. CONCLUSIONS: Young women in our sample had suboptimal dietary habits. It is imperative to advocate for policies and interventions that endorse healthy dietary patterns and physical activity, improve knowledge and discourage young women from smoking, alcohol consumption and drug use.

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.

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 New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment.

BACKGROUND: The elderly, commonly defined as subjects aged ≥65 years, are among the at-risk subjects recommended for annual influenza vaccination in European countries. Currently, two new vaccines are available for this population: the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) and the high-dose quadrivalent influenza vaccine (hdQIV). Their multidimensional assessment might maximize the results in terms of achievable health benefits. Therefore, we carried out a Health Technology Assessment (HTA) of the aQIV by adopting a multidisciplinary policy-oriented approach to evaluate clinical, economic, organizational, and ethical implications for the Italian elderly. METHODS: A HTA was conducted in 2020 to analyze influenza burden; characteristics, efficacy, and safety of aQIV and other available vaccines for the elderly; cost-effectiveness of aQIV; and related organizational and ethical implications. Comprehensive literature reviews/analyses were performed, and a transmission model was developed in order to address the above issues. RESULTS: In Italy, the influenza burden on the elderly is high and from 77.7% to 96.1% of influenza-related deaths occur in the elderly. All available vaccines are effective and safe; however, aQIV, such as the adjuvanted trivalent influenza vaccine (aTIV), has proved more immunogenic and effective in the elderly. From the third payer's perspective, but also from the societal one, the use of aQIV in comparison with egg-based standard QIV (eQIV) in the elderly population is cost-effective. The appropriateness of the use of available vaccines as well as citizens' knowledge and attitudes remain a challenge for a successful vaccination campaign. CONCLUSIONS: The results of this project provide decision-makers with important evidence on the aQIV and support with scientific evidence on the appropriate use of vaccines in the elderly.

The vaccine against COVID-19 and institutional trust.

Major public and private laboratories have entered into a race to find an effective Covid-19 vaccine. When that vaccine arrives, the governments will have to implement vaccination programs to achieve the necessary immunization levels to prevent the disease transmission. In this context, the ethical dilemma of compulsory vaccination vs. voluntary vaccination will be raised. Underlying this dilemma, lies the problem of the ethical models on which the political decisions of governments in matters of health are based. The article proposes and argues the need to base health policy decisions on an ethical "first person" model, based on responsibility, that allows us to move from a normative ethic to an ethic of responsible behavior. This change in the ethical model, together with certain proposals for political action, will help us to restore institutional trust so that the necessary levels of collective immunity against Covid-19 can be achieved through the voluntary vaccination of the citizens.

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.

The vaccine against COVID-19 and institutional trust. / La vacuna frente a la COVID-19 y la confianza institucional.

Major public and private laboratories have entered into a race to find an effective COVID-19 vaccine. When that vaccine arrives, the governments will have to implement vaccination programs to achieve the necessary immunization levels to prevent the disease transmission. In this context, the ethical dilemma of compulsory vaccination vs. voluntary vaccination will be raised. Underlying this dilemma, lies the problem of the ethical models on which the political decisions of governments in matters of health are based. The article proposes and argues the need to base health policy decisions on an ethical «first person¼ model, based on responsibility, that allows us to move from a normative ethic to an ethic of responsible behavior. This change in the ethical model, together with certain proposals for political action, will help us to restore institutional trust so that the necessary levels of collective immunity against COVID-19 can be achieved through the voluntary vaccination of the citizens.

The therapeutic proportionality standard: a new content for the best interests standard.

The standard of the patient's best interests is the main bioethical standard used in the decision-making process that involves incompetent patients (i.e. neonatology, pediatric patients and incompetent adults). This standard has been widely criticized as being self-destructive, individualistic, vague, unknown, dangerous and open to abuse. With the purpose of defending it, several reforms of this standard have been proposed, especially in the pediatric field. We propose a redefinition of the standard based on two concepts: 1) medical futility as a negative criterion, and 2) the principle of proportionality as a positive criterion. Our work includes a new relationship between concepts in classical moral theology (i.e. ordinary / extraordinary; proportionate / disproportionate) applied to the bioethics of life-sustaining treatments for incompetent patients.

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.

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.

Strengthening the Evidence-Based Approach to Guiding Effective Influenza Vaccination Policies.

The availability of several effective and safe vaccines enables health systems to counteract annual influenza epidemics. However, the criteria of appropriateness and sustainability require that each citizen should receive the right vaccine. The value of each vaccine can be assessed within well-known frameworks, such as the Health Technology Assessment (HTA), a step that is fundamental to the process of allocating resources to vaccination strategies. The paper describes how HTA has been incorporated as an evidence-based tool to support the definition of Italian vaccination strategies, reports the results of the HTA report on the most recently available influenza vaccine in Italy (cell-based quadrivalent vaccine (QIVc)-Flucelvax® Tetra) and elaborates on current and future recommendations in the field of influenza vaccination. Recommendations issued by the Italian Ministry of Health foster the appropriate use of influenza vaccines from 2018-2019 onwards. Evidence of the value of newly available vaccines will hopefully support future decisions and promote the appropriate use of these vaccines on the basis of the characteristics of the target population. However, the success of influenza vaccination will also depend on citizens' empowerment and engagement in the decision-making process.

[A Case of Uterine Rupture during Pregnancy]. / Un Caso de Rotura Uterina durante el Embarazo.

The article presents a rare case of uterine rupture at the 19th week of gestation, in the presence of a scar after a caesarean section practiced two years earlier. The fetus was pulled out alive, but given the gestational age, died within a few minutes. The uterus was preserved, but the woman was advised to proceed with tubal ligation and, in any case, to absolutely avoid a new pregnancy. The literature on uterine rupture is examined focusing on the problem of uterine rupture resulting after a caesarean section, analyzing the possibility of monitoring the risk of rupture through ultrasound evaluation. Finally, the article conducts a moral analysis of the case in the light of catholic moral, questioning in particular the acceptability of a hysterectomy under certain conditions. The illegitimacy of direct sterilization is reaffirmed, that is to say, an intervention whose purpose is the impediment of procreation, but it is emphasized that direct sterilization cannot occur when it comes to the moral certainty that that uterus, because of its conditions , cannot carry on a pregnancy until the viability of the fetus. In fact, an intervention that affects a uterus that is objectively incapable of carrying out its natural function cannot be qualified as anti-procreative.