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                                            • Perinatal Care at the threshold of viability

                                            Perinatal Care at the threshold of viability

                                            Nicu-fotolia-106055878-m
                                            Research area: High tech medicine


                                            Part I Resource planning for Neonatal Care Units: clinical outcomes and resource needs
                                            Part II (Good) Practice Models to handle Ethical, Organizational, and Social Challenges

                                            Duration: May 2017 – November 2017
                                            Suggested by: Representatives of federal states

                                            Publications:
                                            LBI-HTA Project report No. 97a: https://eprints.aihta.at/1146/
                                            LBI-HTA Project report No. 97b: https://eprints.aihta.at/1148/

                                            Language: English (with German summary)

                                            Background:
                                            Due to medical advances in neonatal intensive care, the survival rate of extremely preterm infants has increased in the last two decades, whereby infants born after the 22 week of gestation have a chance for survival. However, the outcomes of extremely early born (defined as week 22 +0 days until 25 + 6 days of gestation) are still poor with high rates of mortality and morbidity. Apart from additional treatment efforts for preterm infants, the rising number of survivors increases the resource needs and costs for care and support at neonatal care units. These organizational and financial consequences need to be accounted and planned for when allocating health care budgets.

                                            Aim:
                                            The aim of this project is to provide a decision support for resource planning of neonatal intensive care units in Austria.

                                            Part I: We aim to provide evidence on the clinical outcomes of extremely preterm infants as well as insights into the resources needed in neonatal care units (NICU) for the provision of adequate care for preterm infants, to inform health care planning.

                                            Part II: We aim to provide information on “good practice” models of decision-making procedures (choosing between active vs palliative treatments), the social factors that serve as the basis for making the decision whether to prolong life (parents’ age, educational background, or socio-economic status) and the ethical challenges with interventions at the threshold of viability. Furthermore, we aim to consult experts from Neonatal Intensive Care Units (NICUs) in the Austrian health care context.

                                            Research questions:

                                            Part I: Resource planning for Neonatal Care Units: clinical outcomes and resource needs

                                            1. What are the clinical outcome parameters of children born in the 22, 23, 24, and 25 week?

                                            2. What resources are needed in neonatal care units for the provision of adequate care for preterm infants to inform health care planning?

                                            PICO: (Inclusion criteria)

                                            Population

                                            Extremely preterm infants (born before week 26: 22 + 0 – 25 +6)

                                            Intervention

                                            Active treatment: Surfactant therapy, tracheal intubation, ventilatory support (CPAP, bag-mask ventilation, mechanical ventilation) parenteral nutrition, epinephrine (or other adrenaline), chest compression

                                            Comparators

                                            No intervention, palliative care, Preterm infants >26 weeks of gestation

                                            Outcomes

                                            1. Clinical Outcomes:
                                            • General survival
                                            • Survival without impairment
                                            • Survival with cognitive impairment
                                            1. Resource needs
                                            • doctor to patient ratio (per gestation week)
                                            • nurse to patient ratio (per gestation week)
                                            • median length of stay at NICU (compared to non-preterm, compared to born > 26 week of gestation)

                                            Setting

                                            Neonatal care units

                                            Study type

                                            Clinical Outcomes: Systematic reviews, meta-analyses, HTA assessments

                                            Resource needs: no study limitation

                                            Publication period

                                            Clinical Outcomes: 2013-2017

                                            Resource needs: 2007-2017

                                            Languages

                                            German/English


                                            Methods

                                            To answer research question 1) we will systematically review the current literature on clinical outcomes of survival and survival without impairment in relation to gestation week (week 22+ 0 until 25+6) by analysing and updating evidence from recent systematic reviews.

                                            This report will not assess costs of resource needs, costs of interventions. Furthermore, we will not assess comparative effectiveness and safety of individual interventions.

                                            Research questions Part II: (Good) Practice Models to handle Ethical, Organizational, and Social Challenges 

                                            1. What are the “good practice” models in the decision-making procedures (between active vs palliative treatments) that are currently implemented?
                                            2. Are there social factors that serve as the basis for the decision to prolong life (such as parents’ age, educational background, or socio-economic status)?
                                            3. How are the social and ethical challenges at the threshold of viability being handled in Austrian NICUs?

                                            MIP (methodology, issue, participants): (Inclusion criteria)

                                            Methodology

                                            Include empirical studies. Both quantitative and qualitative studies - surveys, in-depth interviews, questionnaires, etc.

                                            Issue

                                            Limit of viability, threshold of viability, border of viability, children born at 22 to 25 week of gestation, extremely preterm birth, gestational age 22+0 to 25+6, end of life treatment, “best practice”/”good practice” models of decision-making, social factors, ethics, ethical/moral challenges/dilemmas

                                            Participants

                                            parents, doctors (physicians), ethical council, ethical committee

                                            Setting

                                            Neo-natal intensive care units (NICU)

                                            Publication period

                                            1990-2017

                                            Languages

                                            German/English

                                             

                                            Methods:

                                            Part II of the project will be answered by mixed methods.

                                            To answer research questions 1) and 2), a systematic search in six databases (Medline via Ovid, PubMed, Embase, The Cochrane Library, CRD, CINAHL) will be performed and complemented by a hand search to review information on “good practice” models of NICU decision-making procedures and social factors that influence the related decision-making.

                                            To answer research question 3), interviews with Austrian NICU experts will be conducted and followed by a critical review using the EUnetHTA additional assessment elements checklist.

                                            Time schedule: to be finished until November 2017

                                            Period

                                            Task

                                            April/ May

                                            Scoping

                                            May

                                            Literature search, hand search

                                            June

                                            Literature selection, contacting interview participants

                                            July

                                            Literature analysis, data extraction (Part I and II),

                                            July- August

                                            Conducting of interviews (July/August) and interview transcription and analyses

                                            September

                                            Drafting of the report

                                            October

                                            Internal review and external review

                                            November

                                            Finalizing, layout

                                             

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