Identifying outcomes and outcome measures in neonatal family-centered care trials: a systematic review.

BACKGROUND: A wide range of outcomes for infants and parents has been reported in clinical trials testing FCC interventions. This systematic review aimed to identify outcomes, outcome measures, and time-points reported in experimental studies testing FCC interventions in neonatal care units. METHODS: This review included experimental studies investigating FCC interventions in neonatal settings. Database searches were conducted in MEDLINE, EMBASE, CINAHL, Cochrane, PsycINFO, Scopus, JBI, Lilacs, and SciELO, completed in December 2022 and updated in November 2023. Critical appraisal was performed using the JBI checklist for randomized controlled trials, and a narrative synthesis process was used. Outcomes were categorized into the Comet Taxonomy core areas. RESULTS: The search identified 8787 papers; 42 studies were included in the analysis. Totally, 60 outcomes were identified: 42 infant and 18 parents' outcomes. Outcomes were clustered into 12 domains for infants and five domains for parents and measured by 97 outcome measures. The included studies reported 25 and 27 different time-points for infants and parents, respectively. CONCLUSION: This review of studies testing FCC interventions identified heterogeneity and inconsistency of outcomes, outcome measures, and time-points measuring the outcomes. Developing a core outcome set for FCC studies is warranted to benchmark the evidence and identify best-practices. IMPACT: This systematic review identified inconsistency of outcomes, outcome measures, and time-points reported in quantitative studies testing family-centered care interventions in neonatal care settings. The lack of standardized outcomes and outcome measures reported in clinical trials makes it difficult to synthesize data to provide conclusive recommendations. This systematic review will contribute to the development of a core outcome set for research testing family-centered care interventions in neonatal care settings.

[Process for the Implementation of Evidence-Based Parenteral Nutrition in German Perinatal Centres - Outcomes of a Multidisciplinary Network]. / Prozess zur Implementierung Evidenzbasierter Parenteraler Ernährung in Deutschen Perinatalzentren ­ Ergebnisse eines Multidisziplinären Netzwerks.

INTRODUCTION: Parenteral nutrition, usually indicated for preterm infants with a birthweight<1500 g and sick newborns, enables the supply with critical nutrients. As a high degree of therapy safety is required, a European guideline provides recommendations for safe therapy procedures. The present project aimed to evaluate the implementation of the European guideline in German perinatal centers and to identify possible barriers that impede its implementation. A further goal was to develop solution approaches to overcome possible barriers. METHODS AND RESULTS: A multidisciplinary cooperation conducted an online survey questioning the current implementation procedures of the European guideline among pediatricians and hospital pharmacists. Results show barriers in the provisioning process of parenteral nutrition that hinder a guideline-compliant implementation in practice. Based on results of this survey, an expert network developed an interactive toolkit with simplified guideline recommendations, guideline-compliant advice for practice, best-practice examples, forms, and handouts. It seeks to encourage critical reflection of routine processes and provides concrete solutions to overcome barriers in practice. CONCLUSION: The current procedures related to parenteral nutrition deviate from guideline recommendations. The developed toolkit provides practice-oriented support aiming to enhance the guideline-compliant implementation of parenteral nutrition in perinatal centers.

Women's viewpoints on egg freezing in Austria: an online Q-methodology study.

BACKGROUND: Egg freezing has emerged as a technology of assisted reproductive medicine that allows women to plan for the anticipated loss of fertility and hence to preserve the option to conceive with their own eggs. The technology is surrounded by value-conflicts and is subject to ongoing discussions. This study aims at contributing to the empirical-ethical debate by exploring women's viewpoints on egg freezing in Austria, where egg freezing for social reasons is currently not allowed. METHODS: Q-methodology was used to identify prevailing viewpoints on egg freezing. 46 female participants ranked a set of 40 statements onto a 9-column forced choice ranking grid according to the level of agreement. Participants were asked to explain their ranking in a follow-up survey. By-person factor analysis was used to identify distinct viewpoints which were interpreted using both the quantitative and the qualitative data. RESULTS: Three distinct viewpoints were identified: (1) "women should decide for themselves", (2) "we should accept nature but change policy", and (3) "we need an informed societal debate". These viewpoints provide insights into how biomedical innovations such as egg freezing are perceived by women in Austria and illustrate the normative tensions regarding such innovations. CONCLUSIONS: Acknowledging the different prioritizations of values regarding assisted reproductive technologies is important to better understand the underlying normative tensions in a country where egg freezing for social reasons is currently not allowed. The study adds new empirical insights to the ongoing debate by outlining and discussing viewpoints of those directly affected: women. Following up on the lay persons perspective is particularly important in the context of future biomedical innovations that may challenge established norms and create new tensions. It therefore also adds to the societal debate and supports evidence-informed policy making in that regard.

Correction: Geiger et al. Reassessing and Extending the European Standards of Care for Newborn Health: How to Keep Reference Standards in Line with Current Evidence. Children 2024, 11, 179.

In the original publication [...].

Reassessing and Extending the European Standards of Care for Newborn Health: How to Keep Reference Standards in Line with Current Evidence.

The European Standards of Care for Newborn Health (ESCNH) were launched in 2018. After three years, the first standards were reassessed and revised to align with current evidence. Moreover, new standards regarding emerging topics were developed. The aim of this paper is to outline the approach adopted for reassessing, revising and developing new standards for the ESCNH. We established a systematic approach to reassess the ESCNH including a public and an expert consultation. The public consultation was open to all stakeholders for feedback whereas the expert consultation followed a targeted consultation method. For developing new standards, a similar process to the original development was implemented. Overall, 20 standards were reassessed and six standards were developed. For the revision process, 23 experts were involved in the targeted consultation method and 253 questionnaires were completed via the open consultation. We demonstrated a systematic approach to update and extend reference standards, which can be applied by other developers of standards. Thereby, we highlighted that including a public and an expert consultation is crucial to improve quality and to ensure that all stakeholder perspectives are integrated.

ResQ Family: Respiratory Syncytial Virus (RSV) Infection in Infants and Quality of Life of Families-Study Protocol of a Multi-Country Family Cohort Study.

(1) Respiratory syncytial virus (RSV) infection in infants not only affects the child itself, but also their families. Nevertheless, information on the overall impact is scarce. A comprehensive caregiver-specific approach covering essential (health) dimensions and relevant stakeholders was initiated under the ResQ Family study conducted in Germany, France, Italy and Sweden. The primary objective is to investigate the health-related quality of life of parents and/or caregivers of children (<24 months) hospitalised for RSV. (2) Each participant completes an online questionnaire disseminated via social media and printed material in hospitals. Using the PedsQLTM FIM as well as further self-designed questions, parent and patient characteristics as well as potential stressors and preventive factors are recorded at baseline and after six weeks. Multivariate regression models with health-related quality of life as main outcome parameter will be conducted. (3) The study is currently in the recruitment process. A full analysis will be performed once the data collection phase is complete. First results are to be expected in late 2023. (4) Publishing the results in the form of scientific papers but also non-scientific (information) material will help us raise awareness for RSV and the importance of prevention among healthcare professionals, patient representatives and decision-makers.

Parents' experiences regarding neonatal care during the COVID-19 pandemic: country-specific findings of a multinational survey.

OBJECTIVES: The COVID-19 pandemic has disrupted healthcare systems, challenging neonatal care provision globally. Curtailed visitation policies are known to negatively affect the medical and emotional care of sick, preterm and low birth weight infants, compromising the achievement of the 2030 Development Agenda. Focusing on infant and family-centred developmental care (IFCDC), we explored parents' experiences of the disruptions affecting newborns in need of special or intensive care during the first year of the pandemic. DESIGN: Cross-sectional study using an electronic, web-based questionnaire. SETTING: Multicountry online-survey. METHODS: Data were collected between August and November 2020 using a pretested online, multilingual questionnaire. The target group consisted of parents of preterm, sick or low birth weight infants born during the first year of the COVID-19 pandemic and who received special/intensive care. The analysis followed a descriptive quantitative approach. RESULTS: In total, 1148 participants from 12 countries (Australia, Brazil, Canada, China, France, Italy, Mexico, New Zealand, Poland, Sweden, Turkey and Ukraine) were eligible for analysis. We identified significant country-specific differences, showing that the application of IFCDC is less prone to disruptions in some countries than in others. For example, parental presence was affected: 27% of the total respondents indicated that no one was allowed to be present with the infant receiving special/intensive care. In Australia, Canada, France, New Zealand and Sweden, both the mother and the father (in more than 90% of cases) were allowed access to the newborn, whereas participants indicated that no one was allowed to be present in China (52%), Poland (39%), Turkey (49%) and Ukraine (32%). CONCLUSIONS: The application of IFCDC during the COVID-19 pandemic differs between countries. There is an urgent need to reconsider separation policies and to strengthen the IFCDC approach worldwide to ensure that the 2030 Development Agenda is achieved.

Between "Medical" and "Social" Egg Freezing : A Comparative Analysis of Regulatory Frameworks in Austria, Germany, Israel, and the Netherlands.

Egg freezing has led to heated debates in healthcare policy and bioethics. A crucial issue in this context concerns the distinction between "medical" and "social" egg freezing (MEF and SEF)-contrasting objections to bio-medicalization with claims for oversimplification. Yet such categorization remains a criterion for regulation. This paper aims to explore the "regulatory boundary-work" around the "medical"-"social" distinction in different egg freezing regulations. Based on systematic documents' analysis we present a cross-national comparison of the way the "medical"-"social" differentiation finds expression in regulatory frameworks in Austria, Germany, Israel, and the Netherlands. Findings are organized along two emerging themes: (1) the definition of MEF and its distinctiveness-highlighting regulatory differences in the clarity of the definition and in the medical indications used for creating it (less clear in Austria and Germany, detailed in Israel and the Netherlands); and (2) hierarchy of medical over social motivations reflected in usage and funding regulations. Blurred demarcation lines between "medical" and "social" are further discussed as representing a paradoxical inclusion of SEF while offering new insights into the complexity and normativity of this distinction. Finally, we draw conclusions for policymaking and the bioethical debate, also concerning the related cryopolitical aspects.

Unveiling the controversy on egg freezing in The Netherlands: A Q-methodology study on women's viewpoints.

Preserving the option to conceive through egg freezing (oocyte cryopreservation) is surrounded by value conflicts and diverse viewpoints, particularly when non-medical or so-called 'social' reasons are involved. The debate is controversial and shaped by normative perceptions of the life course, including concepts regarding reproductive ageing, gender, motherhood and biomedicalization. To unravel the controversy and systematically identify the variety of viewpoints on egg freezing, a Q-methodology study was conducted in The Netherlands between December 2018 and October 2019. Thirty-four women of reproductive age participated in the study. They ranked 40 statements according to their level of agreement, and explained their ranking during follow-up interviews. Data were analysed using by-person factor analysis and interpreted using both quantitative and qualitative data. Four viewpoints, of which the fourth was bipolar, were identified: (1) cautious about egg freezing technology; (2) my body, my choice; (3) egg freezing is unnatural; and (4) have children and have them early. The distinct viewpoints illustrate different prioritizations of values and normative dimensions of biomedical innovations. By knowing more about the prevalent opinions on egg freezing and the surrounding controversy, policy makers and practitioners can make better informed decisions in terms of promoting and providing patient-centred infertility care. The findings furthermore stimulate continuing scholarly work on egg freezing and other innovations in reproductive medicine which may continue to disrupt normative standards.

Neonatal care during the COVID-19 pandemic - a global survey of parents' experiences regarding infant and family-centred developmental care.

BACKGROUND: The COVID-19 pandemic restrictions affect provision and quality of neonatal care. This global study explores parents' experiences regarding the impact of the restrictions on key characteristics of infant and family-centred developmental care (IFCDC) during the first year of the pandemic. METHODS: For this cross-sectional study, a pre-tested online survey with 52 questions and translated into 23 languages was used to collect data between August and November 2020. Parents of sick or preterm infants born during the pandemic and receiving special/intensive care were eligible for participation. Data analysis included descriptive statistics and statistical testing based on different levels of restrictive measures. FINDINGS: In total, 2103 participants from 56 countries provided interpretable data. Fifty-two percent of respondents were not allowed to have another person present during birth. Percentages increased with the extent of restrictions in the respondents' country of residence (p = 0·002). Twenty-one percent of total respondents indicated that no-one was allowed to be present with the infant receiving special/intensive care. The frequency (p < 0·001) and duration (p = 0·001) of permitted presence largely depended on the extent of restrictions. The more restrictive the policy measures were, the more the respondents worried about the pandemic situation during pregnancy and after birth. INTERPRETATION: COVID-19 related restrictions severely challenged evidence-based cornerstones of IFCDC, such as separating parents/ legal guardians and their newborns. Our findings must therefore be considered by public health experts and policy makers alike to reduce unnecessary suffering, calling for a zero separation policy. FUNDING: EFCNI received an earmarked donation by Novartis Pharma AG in support of this study.