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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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