The Ethics and Practice of Periviability Care.

Since the 1960s, the gestational age at which premature infants typically survive has decreased by approximately one week per decade [...].

Overdiagnosis of Newborn Hyperbilirubinemia: A Natural Experiment in Quality Improvement Fundamentals.

Two hospitals noted increased newborn hyperbilirubinemia coinciding with an undisclosed total serum bilirubin (TSB) assay change. Clinicians rapidly applied quality improvement methodologies to ascertain increased jaundice evaluations, readmissions, and possible safety issues. Methods: In January 2020, 2 hospitals (A and B) transitioned to a new method of measuring TSB using a new clinical chemistry analyzer (Siemens Atellica CH), which measured TSB by vanadate oxidase assay instead of the previous diazo assay. Five affiliated hospitals (C-G) continued to utilize the diazo assay. This natural experiment led to a comparison of data across the 7 hospitals. We analyzed: (1) TSB levels, (2) hospital hyperbilirubinemia readmissions, and (3) paired TSB measurements comparing the diazo assay and vanadate oxidase method. Results: Compared to the 2019 baseline, Hospitals A and B had a significant increase in TSBs ≥17.0 mg/dl and TSBs ≥20 mg/dl in 2020; Hospitals C-G did not. Readmissions for phototherapy significantly increased in hospitals A and B in 2020 compared to 2019. Paired blood samples showed bias-elevated TSBs by vanadate assay compared to the diazo method. By 2021, the laboratory resumed processing TSB samples by diazo assay, and the frequency of elevated TSBs and hyperbilirubinemia readmissions returned to 2019 levels. Conclusions: Factitious TSB elevation related to an assay change significantly increased newborn hyperbilirubinemia evaluations and phototherapy readmissions. Imbedded quality improvement methodologies of careful structure, process, and outcomes review hastened resolution.

Discontinuation of Car Seat Tolerance Screening and Postdischarge Adverse Outcomes in Infants Born Preterm.

OBJECTIVE: To study the association between discontinuing predischarge car seat tolerance screening (CSTS) with 30-day postdischarge adverse outcomes in infants born preterm. STUDY DESIGN: Retrospective cohort study involving all infants born preterm from 2010 through 2021 who survived to discharge to home in a 14-hospital integrated health care system. The exposure was discontinuation of CSTS. The primary outcome was a composite rate of death, 911 call-triggered transports, or readmissions associated with diagnostic codes of respiratory disorders, apnea, apparent life-threatening event, or brief resolved unexplained events within 30 days of discharge. Outcomes of infants born in the periods of CSTS and after discontinuation were compared. RESULTS: Twelve of 14 hospitals initially utilized CSTS and contributed patients to the CSTS period; 71.4% of neonatal intensive care unit (NICU) patients and 26.9% of non-NICU infants were screened. All hospitals participated in the discontinuation period; 0.1% was screened. Rates of the unadjusted primary outcome were 1.02% in infants in the CSTS period (n = 21 122) and 1.06% after discontinuation (n = 20 142) (P = .76). The aOR (95% CI) was 0.95 (0.75, 1.19). Statistically insignificant differences between periods were observed in components of the primary outcome, gestational age strata, NICU admission status groups, and other secondary analyses. CONCLUSIONS: Discontinuation of CSTS in a large integrated health care network was not associated with a change in 30-day postdischarge adverse outcomes. CSTS's value as a standard predischarge assessment deserves further evaluation.

Extremely premature birth bioethical decision-making supported by dialogics and pragmatism.

Moral values in healthcare range widely between interest groups and are principally subjective. Disagreements diminish dialogue and marginalize alternative viewpoints. Extremely premature births exemplify how discord becomes unproductive when conflicts of interest, cultural misunderstanding, constrained evidence review, and peculiar hierarchy compete without the balance of objective standards of reason. Accepting uncertainty, distributing risk fairly, and humbly acknowledging therapeutic limits are honorable traits, not relativism, and especially crucial in our world of constrained resources. We think dialogics engender a mutual understanding that: i) transitions beliefs beyond bias, ii) moves conflict toward pragmatism (i.e., the truth of any position is verified by subsequent experience), and iii) recognizes value pluralism (i.e., human values are irreducibly diverse, conflicting, and ultimately incommensurable). This article provides a clear and useful Point-Counterpoint of extreme prematurity controversies, an objective neurodevelopmental outcomes table, and a dialogics exemplar to cultivate shared empathetic comprehension, not to create sides from which to choose. It is our goal to bridge the understanding gap within and between physicians and bioethicists. Dialogics accept competing relational interests as human nature, recognizing that ultimate solutions satisfactory to all are illusory, because every choice has downside. Nurturing a collective consciousness via dialogics and pragmatism is congenial to integrating objective evidence review and subjective moral-cultural sentiments, and is that rarest of ethical constructs, a means and an end.

The Triple Aim Quality Improvement Gold Standard Illustrated as Extremely Premature Infant Care.

OBJECTIVES: The Triple Aim is widely regarded as the quality improvement gold standard that enhances population health, lowers costs, and betters individual care. There have been no large-scale, sustained demonstrations of such improvement in healthcare. Illustrating the Triple Aim using relevant extremely premature infant outcomes might highlight interwoven proficiency and efficiency complexities that impede sustained value progress. STUDY DESIGN: Ten long-term collaborating neonatal intensive care units (NICU) in the Vermont Oxford Network calculated the Triple Aim in 230/7 to 276/7-week infants using three surrogate measures: (1) population health/x-axis-eight major morbidity rates as a composite, risk-adjusted metric; (2) cost/y-axis-total hospital length of stay; and (3) individual care/z-axis-mortality, then illustrated this relationship as a sphere within a three-dimensional cube. RESULTS: Three thousand seven hundred six infants born between January 1, 2014 and December 31, 2019, with mean (standard deviation) gestational age of 25.7 (1.4) weeks and birth weight of 803 (208) grams were analyzed. Triple Aim three-axis cube positions varied inconsistently comparing NICUs. Each NICUs' sphere illustrated mixed x- and z-axis movement (clinical proficiency), and y-axis movement (cost efficiency). No NICU demonstrated the theoretically ideal Triple Aim improvement in all three axes. Backward movement in at least one axis occurred in eight NICUs. The whole-group Triple Aim sphere moved forward along the x-axis (better morbidities metric), but moved backward in the y-axis length of stay and z-axis mortality measurements. CONCLUSION: Illustrating the Triple Aim gold standard as extreme prematurity outcomes reveals complexities inherent to simultaneous attempts at improving interwoven quality and cost outcomes. Lack of progress using relevant Triple Aim parameters from our well-established collaboration highlights the difficulties prioritizing competing outcomes, variable potentially-better-practice applications amongst NICUs, unmeasured biologic interactions, and obscured cultural-environmental contexts that all likely affect care. Triple Aim excellence, if even remotely possible, will necessitate scalable, evidence-based methodologies, pragmatism regarding inevitable trade-offs, and wise constrained-resource decisions. KEY POINTS: · The Triple Aim gold standard is elusive. There is no demonstration of sustained, large-scale success in healthcare and our quality improvement network has previously published benchmark extreme prematuritymorbidity improvements.. · Extreme prematurity outcomes illustrated as the Triple Aim show uneven results in relevant surrogate parameters and Triple Aim achievement, if even possible, will necessitate evidence-based methodologies that are scalable.. · Pragmatism, inevitable trade-offs, and wise constrained-resource decisions are required for Triple Aim success..

Change in neurodevelopmental outcomes for extremely premature infants over time: a systematic review and meta-analysis.

OBJECTIVE: Survival rates of extremely premature infants are rising, but changes in neurodevelopmental impairment (NDI) rates are unclear. Our objective was to perform a systematic review of intrainstitutional variability of NDI over time. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Ovid MEDLINE, Embase, PubMed, Cochrane Library and Google Scholar. STUDY SELECTION: Study eligibility: (1) at least two discrete cohorts of infants born <27 weeks' gestation or <1000 g birth weight, (2) one cohort born after 1990 and at least one subsequent cohort of similar gestational age, (3) all cohorts cared for within the same Neonatal Intensive Care Unit(s) (NICU) and (4) neurodevelopmental outcomes at 18-36 months corrected age. MAIN OUTCOME: Change in NDI rates. Quality, validity and bias were assessed using Grading of Recommendations, Assessment, Development, and Evaluation and Quality in Prognosis Studies guidelines. RESULTS: Of 203 publications, 15 were eligible, including 13 229 infants. At the first time point, average NDI rate across study groups weighted by sample size was 41.0% (95% CI 34.0% to 48.0%). The average change in NDI between time points was -3.3% (95% CI -8·8% to 2.2%). For each added week of gestation at birth, the rate of NDI declined by 9.7% (95% CI 6.2% to 13.3%). Most studies exhibited moderate-severe bias in at least one domain, especially attrition rates. CONCLUSIONS: When comparing discrete same-centre cohorts over time, there was no significant change in NDI rates in infants born <27 weeks' gestation or <1000 g. Higher survival rates unaccompanied by improvement in neurodevelopment highlight urgency for renewed focus on the causes of NDI and evidence-based strategies to reduce brain injury.

Do small baby units improve extremely premature infant outcomes?

Increasing numbers of neonatal intensive care units have formed small baby units or small baby teams with the intention to optimize care of extremely premature infants. Considerable time, energy, and resources are required to develop and sustain complex quality improvement constructs, so legitimate questions about effectiveness, unintended consequences, and lost opportunity costs warrant scrutiny. The small baby unit literature is diminutive. Errors of chance, bias, and confounding secondary to insufficient definitions of process and outcome metrics, overlapping quality improvement projects, and limited cost analyses restrict firm conclusions. Well-established quality improvement methodologies such as evidence-based guidelines, standardized variability reduction using measurement-and-adjust techniques, family-integrated focus, and developmentally sensitive care, reliably improve outcomes for all-sized premature infants. There is not compelling published evidence that adding specialized small baby units or designated teams for extremely premature infants further enhances short- or long-term health if robust quality improvement fundamentals are already imbedded within local culture.

Sustained quality improvement collaboration and composite morbidity reduction in extremely low gestational age newborns.

AIM: Continuous quality improvement has failed to consistently reduce morbidities in extremely low gestational age newborns 23-27 weeks. 10 Vermont Oxford Network NICUs describe a novel, sustained collaboration for progress. METHODS: We emphasised a) commitment to inter-NICU trust with face-to-face meetings, site visits, teleconferences, scrutiny of quality improvement methodology, b) transparent process and outcomes sharing, c) evidence-based formulation of an orchestrated testing matrix to select potentially better practices, d) family integration, e) benchmarking with a composite mortality-morbidity score (Benefit Metric). RESULTS: A total of 4709 infants, mean (SD) gestational age 25.8 (1.4) weeks, admitted to 10 NICUs 1.01.2010 to 12.31.2016. The orchestrated matrix offered 45 potentially better practices; NICUs implemented mean 29 (range 19-40). There was widespread adoption of delivery room, respiratory care and infection prevention practices, but no uniform pattern. Our Benefit Metric was significantly greater than the Vermont Oxford Network all seven years (p < 0.001). Six major morbidities decreased, two significantly (p < 0.05), mortality unchanged (14%). 34% of survivors had no morbidities, 35% just one. CONCLUSION: Cultivating trust, transparent outcomes sharing, and tailored, potentially better practice selection is associated with encouraging improvement in 23- to 27-week survival without morbidity. Our outcomes are objective but the optimal implementation pathway to sustain progress remains murky, reflective of NICUs as complex adaptive networks.

Aletheia-20 unconcealed observations from quality improvement and evidence-based medicine.

Quality improvement (QI) and evidence-based medicine (EBM) activities ideally generate value (benefit/cost). Physicians and hospitals vary in ability to demonstrate efficiency despite common methodology available to all. Based upon our 60-some years of combined QI and EBM experience, we suggest reasoned consideration of meta-cognition-thinking about thinking. How do we observe, analyze, intuit, then share observations and learning with collaborative networks? The Greek word aletheia denotes disclosure of the essence of an object or event as its genuine nature, "unhidden, revealed, unconcealed". Aletheia is authenticity, not a claim or opinion, not an argument or hypothesis, nor an intervention-based assertion. QI and EBM have crucial features obscured by the lure and distraction of technology, economic conflicts, and inherent self-interests. We offer 20 QI and EBM observations in the spirit of aletheia. Enhancing the well-being of children is the foundation of a civilized society, a journey needful of shared QI understanding.

Using a composite morbidity score and cultural survey to explore characteristics of high proficiency neonatal intensive care units.

BACKGROUND: Continuous quality improvement (CQI) collaboration has not eliminated the morbidity variability seen among neonatal intensive care units (NICUs). Factors other than inconstant application of potentially better practices (PBPs) might explain divergent proficiency. OBJECTIVE: Measure a composite morbidity score and determine whether cultural, environmental and cognitive factors distinguish high proficiency from lower proficiency NICUs. DESIGN/METHODS: Retrospective analysis using a risk-adjusted composite morbidity score (Benefit Metric) and cultural survey focusing on very low birth weight (VLBW) infants from 39 NICUs, years 2000-2014. The Benefit Metric and yearly variance from the group mean was rank-ordered by NICU. A comprehensive survey was completed by each NICU exploring whether morbidity variance correlated with CQI methodology, cultural, environmental and/or cognitive characteristics. RESULTS: 58 272 VLBW infants were included, mean (SD) age 28.2 (3.0) weeks, birth weight 1031 (301) g. The 39 NICU groups' Benefit Metric improved 40%, from 80 in 2000 to 112 in 2014 (P<0.001). 14 NICUs had composite morbidity scores significantly better than the group, 16 did not differ and 9 scored below the group mean. The 14 highest performing NICUs were characterised by more effective team work, superior morale, greater problem-solving expectations of providers, enhanced learning opportunities, knowledge of CQI fundamentals and more generous staffing. CONCLUSION: Cultural, environmental and cognitive characteristics vary among NICUs perhaps more than traditional CQI methodology and PBPs, possibly explaining the inconstancy of VLBW infant morbidity reduction efforts. High proficiency NICUs foster spirited team work and camaraderie, sustained learning opportunities and support of favourable staffing that allows problem solving and widespread involvement in CQI activities.

Extremely premature birth, informed written consent, and the Greek ideal of sophrosyne.

Most extremely premature infants die in the intensive care unit or suffer significant neurologic impairment. Many therapies result in unhealthy consequences, and the emotional and financial turmoil for families warrant reappraisal of our motives. Shared decision-making and informed consent in preference-sensitive conditions imply the family: (a) understands the medical problem, (b) grasps the risks and benefits of each therapy, (c) has the opportunity to ask questions and reflect upon options, (d) knows their values and preferences are understood, and (e) accepts or declines therapies without judgment or penalty. Mandatory resuscitation of premature infants or inflexible palliative comfort care policies are inconsistent with the principles of informed consent and shared decision-making. Physicians should emulate the Greek ideal of sophrosyne-virtue inherent to balance, reasoned limits, freedom but restraint, and humility. Informed choice is fundamental to liberty; evidence-based periviability guidelines and decision aids bolstered by structured informed consent ensure process integrity.

A risk-adjusted, composite outcomes score and resource utilization metrics for very low-birth-weight infants.

IMPORTANCE: It is difficult for neonatal intensive care units (NICUs) to determine the overall efficacy of multiple continuous quality improvement (CQI) projects aimed at reducing very low-birth-weight (VLBW) infant morbidities. It is challenging to know whether a NICU is becoming more proficient, and it is not usually apparent whether concurrent resource use is changing. OBJECTIVE: To develop a risk-adjusted composite score of the major morbidities in VLBW infants and a companion metric that accounts for resource use to enhance the ability to measure overall progress in CQI and to identify proficient NICUs. DESIGN, SETTING, AND PARTICIPANTS: This retrospective investigation used individual patient-level demographic and outcomes data from 8 NICUs who were long term CQI collaborators within the Vermont Oxford Network, a large international quality improvement organization dedicated to improving the care of premature infants. Study participants were infants who weighed 401 to 1500 g born from January 1, 2000, through December 31, 2011, at each of the 8 participating NICUs. MAIN OUTCOMES AND MEASURES: Risk-adjusted, composite VLBW infant morbidity and resource utilization score. RESULTS: A total of 15,961 infants (mean [SD] gestational age, 28.2 [3.0] weeks; mean [SD] birth weight, 1020 [306] g) were analyzed. Concurrent with multiple shared CQI projects over 12 years, the group benefit metric improved 38% from 80 in 2000 to 110 in 2011 (P < .001). The entire member VON benefit metric improved 28% from 72 in 2000 to 92 in 2011 (P < .001). The group value metric improved 25% from 1.2 in 2000 to 1.5 in 2011 (P < .001). The entire member VON value metric improved 18% from 1.1 in 2000 to 1.3 in 2011 (P < .001). Significant inter-NICU variation in both composite scores was noted in the 8 member CQI group. Hospital length of stay increased in the 8 NICUs 64 to 71 days (P <.001), and a similar increase was noted in the entire member VON, 65 to 68 days (P < .001). CONCLUSIONS AND RELEVANCE: We have created the first, to our knowledge, web-based tool for NICUs to calculate their own composite morbidity and resource utilization scores that estimate NICU CQI proficiency. In our structured group CQI over 12 years, both metrics revealed significant improvement, but increases in length of stay (resource use) blunted value improvement. Why some NICUs improve their scores more successfully than others remains a crucial challenge. Future CQI efforts should explore strategies that cost-efficiently reduce intertwined VLBW infant morbidities, emphasizing whole cultures of proficient care rather than the traditional emphasis on single-morbidity reduction.

Delayed umbilical cord clamping in premature neonates.

OBJECTIVE: Delayed umbilical cord clamping is reported to increase neonatal blood volume. We estimated the clinical outcomes in premature neonates who had delayed umbilical cord clamping compared with a similar group who had early umbilical cord clamping. METHODS: This was a before-after investigation comparing early umbilical cord clamping with delayed umbilical cord clamping (45 seconds) in two groups of singleton neonates, very low birth weight (VLBW) (401-1,500 g) and low birth weight (LBW) (greater than 1,500 g but less than 35 weeks gestation). Neonates were excluded from delayed umbilical cord clamping if they needed immediate major resuscitation. Primary outcomes were provision of delivery room resuscitation, hematocrit, red cell transfusions, and the principle Vermont Oxford Network outcomes. RESULTS: In VLBW neonates (77 delayed umbilical cord clamping, birth weight [mean±standard deviation] 1,099±266 g; 77 early umbilical cord clamping 1,058±289 g), delayed umbilical cord clamping was associated with less delivery room resuscitation, higher Apgar scores at 1 minute, and higher hematocrit. Delayed umbilical cord clamping was not associated with significant differences in the overall transfusion rate, peak bilirubin, any of the principle Vermont Oxford Network outcomes, or mortality. In LBW neonates (172 delayed umbilical cord clamping, birth weight [mean±standard deviation] 2,159±384 g; 172 early umbilical cord clamping 2,203±447 g), delayed umbilical cord clamping was associated with higher hematocrit and was not associated with a change in delivery room resuscitation or Apgar scores or with changes in the transfusion rate or peak bilirubin. Regression analysis showed increasing gestational age and birth weight and delayed umbilical cord clamping were the best predictors of higher hematocrit and less delivery room resuscitation. CONCLUSION: Delayed umbilical cord clamping can safely be performed in singleton premature neonates and is associated with a higher hematocrit, less delivery room resuscitation, and no significant changes in neonatal morbidities. LEVEL OF EVIDENCE: II.

NICU practices and outcomes associated with 9 years of quality improvement collaboratives.

OBJECTIVE: Quality improvement collaboratives (QICs) can improve short-term outcomes, but few have examined their long-term results. This study evaluated the changes in treatment practices and outcomes associated with participation in multiple sequential QICs. DESIGN AND METHODS: This retrospective, 9-year, pre-post study of very low birth weight infants, we assessed treatment and outcomes from the 8 NICUs of the Reduce Lung Injury (ReLI) group of a QIC sponsored by the Vermont Oxford Network (VON). We analyzed data from 1998 (pre-ReLI), 2001 (last ReLI year), and 2006 (5 years after ReLI) by using univariate and multiple regression. RESULTS: A total of 4065 very low birth weight infants were treated in ReLI NICUs in 1998, 2001, and 2006. From 1998 to 2006, the ReLI group decreased delivery room intubation (70% vs 52%; adjusted odds ratio [aOR]: 0.2 [95% confidence interval (CI): 0.2-0.3]; P < .001), conventional ventilation (75% vs 62%; aOR: 0.3 [95% CI: 0.2-0.4]; P < .001), and postnatal steroids for BPD (35% vs 10%; aOR: 0.09 [95% CI: 0.07-0.1]; P < .001). They increased the use of nasal continuous positive airway pressure (57% vs 78%; aOR: 3.3 [95% CI: 2.7-3.9]; P < .001). BPD-free survival remained unchanged (68% vs 66%; aOR: 0.9 [95% CI: 0.7-1.1]; P = .16), the BPD rate increased (25% vs 29%; aOR: 1.3 [95% CI: 1.1-1.6]; P = .017), survival to discharge increased (90% vs 93%; aOR: 1.5 [95% CI: 1.1-2.2]; P < .001), and nosocomial infections decreased (18% vs 15%; aOR: 0.8 [95% CI: 0.6-0.99]; P = .045). CONCLUSIONS: Participation in VON-sponsored QICs was associated with sustained implementation of potentially better respiratory practices, increased survival, and reduced nosocomial infections. The BPD-free survival rate did not change, and the BPD rate increased. Implemented changes endured for at least 5 years after the QIC.

Caring for the pregnant woman presenting at periviable gestation: acknowledging the ambiguity and uncertainty.

Counseling the periviable pregnant woman presenting at the edge of viability can often be confusing for the patient and frustrating for the clinician. Although neonatal survival rates have improved dramatically over the last few decades, severe morbidity is still common. This is further complicated by the fact that the information provided to the parents regarding the outcomes may not be up to date or completely accurate. The counseling is also frequently influenced by personal beliefs and biases of the medical staff. An evidence-based approach may improve the experience for both the expectant parents and the health care team.