Common Quality Improvement Methodologies Including the Model for Improvement, Lean, and Six Sigma.

This article reviews several common quality improvement methodologies, including the Model for Improvement, Lean, and Six Sigma. We demonstrate how these methods are based on a similar improvement science foundation. We describe the tools used to understand problems in the context of systems and the mechanisms to learn and build knowledge, using specific examples from the neonatology and pediatric literature. We conclude with a discussion on the importance of the human side of change in quality improvement, including team formation and culture.

Characteristics and Outcomes in Preterm Infants with Extubation Failure in the First Week of Life.

OBJECTIVE: This study aimed to evaluate characteristics and outcomes in preterm infants with extubation failures in their first week of life. STUDY DESIGN: Retrospective chart review of infants born between 24 and 27 weeks' gestational age at the Sharp Mary Birch Hospital for Women and Newborns between January 2014 and December 2020 who had an extubation attempt within the first 7 days of life. Infants that were successfully extubated were compared with those who required reintubation in the first 7 days. Maternal and neonatal outcome measures were analyzed. RESULTS: A total of 215 extremely preterm infants had an extubation attempt in the first 7 days of life. Forty-six infants (21.4%) failed extubation and were reintubated within the first 7 days. Infants who failed extubation had a lower pH (p < 0.01), increased base deficit (p < 0.01), and more surfactant doses prior to first extubation (p < 0.01). Birth weight, Apgar scores, antenatal steroid doses, and maternal risk factors such as preeclampsia, chorioamnionitis, and duration of ruptured membranes were not different between success and failure groups. Rates of moderate to large patent ductus arteriosus (p < 0.01), severe intraventricular hemorrhage (p < 0.01), posthemorrhagic hydrocephalus (p < 0.05), periventricular leukomalacia (p < 0.01), and retinopathy of prematurity stage 3 or greater (p < 0.05) were higher in the failure group. CONCLUSION: In this cohort of extremely preterm infants that failed extubation in the first week of life, there were as increased risk of multiple morbidities. Base deficit, pH, and number of surfactant doses prior to first extubation may be useful tools in predicting which infants are likely to have early extubation success, but this needs prospective study. KEY POINTS: · Predicting extubation readiness in preterm infants remains challenging.. · Extubation failure is associated with multiple neonatal morbidities.. · Infant clinical characteristics may help predict extubation failure..

Caffeine and Less Invasive Surfactant Administration for Respiratory Distress Syndrome of the Newborn.

BACKGROUND: Management strategies for preterm neonates with respiratory distress syndrome include early initiation of continuous positive airway pressure (CPAP) and titration of fractional inspired oxygen and may include the use of less invasive surfactant administration (LISA) to avoid the need for endotracheal intubation. This randomized trial investigated whether early administration of caffeine and LISA would decrease the need for endotracheal intubation in the first 72 hours of life (HoL) compared with caffeine and CPAP alone. METHODS: Eligible neonates born at 24 weeks 0 days to 29 weeks 6 days of gestational age were randomly assigned to receive intravenous caffeine in the first 2 HoL followed by surfactant administration via the LISA method (intervention) or caffeine followed by CPAP (control). The primary outcome was the frequency of neonates requiring endotracheal intubation or meeting respiratory failure criteria between groups (caffeine and LISA vs. caffeine and CPAP) within the first 72 HoL. Multivariable logistic regression modeling was used to adjust for gestational age strata in normally distributed primary and secondary outcomes. RESULTS: Enrollment occurred between January 2020 and December 2022. Endotracheal intubation or meeting respiratory failure criteria within the first 72 HoL occurred in 21 (23%) of 92 neonates randomly assigned to receive caffeine and LISA compared with 47 (53%) of 88 neonates in the caffeine and CPAP group (odds ratio, 0.258; 95% confidence interval, 0.136 to 0.490; P<0.001), which remained significant after adjusting for gestational age strata (odds ratio, 0.227; 95% confidence interval, 0.112 to 0.460; P<0.001). Adverse events were similar between groups, except bronchopulmonary dysplasia, which occurred in 26% of the LISA group and 39% of the control group (P=0.049). CONCLUSIONS: In preterm neonates supported with CPAP, early caffeine and LISA resulted in a lower frequency of endotracheal intubation within the first 72 HoL. (Funded by Chiesi USA; ClinicalTrials.gov number, NCT04209946.)

Multicentre, randomised trial of preterm infants receiving caffeine and less invasive surfactant administration compared with caffeine and early continuous positive airway pressure (CaLI trial): study protocol.

INTRODUCTION: Respiratory distress syndrome (RDS) or surfactant deficiency occurs primarily in premature infants resulting in composite outcomes of death or bronchopulmonary dysplasia. Initial management strategies for preterm infants with RDS includes early initiation of continuous positive airway pressure (CPAP) and titration of fractional inspired oxygen (FiO2), and may include the use of less invasive surfactant administration (LISA) to avoid the need for mechanical ventilation. In order to optimise success of non-invasive support, the use of early caffeine therapy may be critical to the success of LISA. The objective of our trial is to evaluate whether infants that receive early caffeine, CPAP and surfactant via the LISA method compared with infants that receive caffeine and CPAP alone, have a decreased need for invasive mechanical ventilation in the first 72 hours of life. METHODS AND ANALYSIS: CaLI is an unblinded multicentre, randomised controlled, trial of 180 preterm infants (24+0-29+6 weeks corrected GA). Criteria for intubation/treatment failure will follow guidelines for the management of RDS, including: (1) CPAP level of 6-8 cmH20 and FiO2 >0.40 required to maintain saturations 90%-95% for 2 hours after randomisation; (2) a pH of 7.15 or less or a paCO2 >65 mm Hg on any (2) blood gases (arterial/capillary/or venous) at least 2 hours after randomisation and in the first 72 hours of life; (3) continued apnoea/bradycardia/desaturation events despite nasal intermittent minute ventilation mode of ventilation. Infants will be randomised by 1 hour of life and caffeine/LISA treatments administered by 2 hour of life. Caffeine will be administered prior to surfactant in the LISA arm and before 2 hours of life in the control arm. ETHICS AND DISSEMINATION: Chiesi Farmaceutici, S.p.A is the sponsor of CaLI. Ethical approval has been obtained. Results will be submitted for publication in peer reviewed journals. TRIAL REGISTRATION NUMBER: www.Clinicaltrials.gov: NCT04209946; Pre-results.

Improving the Resident Educational Experience in a Level IV Neonatal/Infant Intensive Care Unit.

The neonatal/infant intensive care unit (N/IICU) at the Children's Hospital of Philadelphia is a 98-bed, level IV unit through which second-year pediatric residents rotate monthly. We developed a quality improvement project to improve the resident educational experience using goal setting. Primary objectives were to increase resident educational goal identification to 65% and goal achievement to 85% by June 2017. Secondary objectives were to (1) increase in-person feedback from fellows and/or attendings to 90% by June 2017 and (2) sustain improvements through June 2018. METHODS: The quality improvement team developed a driver diagram and administered a baseline survey to 48 residents who had rotated through the N/IICU in the 18 months before the project. Plan-Do-Study-Act cycles targeted project awareness and trialing of 3 different methods to elicit goals and track feedback, from July 2016 through June 2018. RESULTS: The baseline survey response rate was 52% (n = 25). Among 60 rotating residents, the median resident-reported rate of goal achievement increased from 37.5% to 50%, and residents receiving in-person feedback increased from 25% to 50%. Of the 63% (n = 38) of residents who participated in data collection, goal identification and achievement increased from 38% to 100% between academic year 2016 and academic year 2017, and in-person feedback increased from 24% to 82%. CONCLUSIONS: Instituting a goal-setting framework for residents during their N/IICU rotation increased goal achievement and in-person feedback. Consistent resident participation in postrotation data collection made measuring project outcomes challenging. These data support goal-oriented learning as an approach to enhance learner engagement and improve goal achievement.

Reducing Variation in the Management of Apnea of Prematurity in the Intensive Care Nursery.

BACKGROUND: Premature infants have bradycardia and/or desaturation events due to apnea of prematurity that resolve as the infants mature. Despite American Academy of Pediatrics guidelines recommending a standard "event-free" period before discharge, length of observation in our Intensive Care Nursery was variable. By June 2018, for infants born <36 weeks' gestation in the Intensive Care Nursery, we aimed to standardize time to discharge after the last documented event at 5 days, when the baseline mean was 3.6 days (range 0-6 days). METHODS: A quality-improvement team used the Model for Improvement. Plan-do-study-act cycles improved nursing documentation of events and standardized discharge criteria after consensus on operational definitions. The outcome measure was days to discharge after last documented event. Process measures included percentage of events documented completely and correctly in the electronic medical record. Balancing measure was length of stay after 36 weeks' corrected gestational age. We used statistical process control. RESULTS: The baseline event watch ranged from 0 to 6 days. After defining significant events, documentation expectations, and consensus on a 5-day "watch" before discharge, the event watch range narrowed with a mean that shifted from 3.6 to 4.8 days on X-bar S statistical process control chart. Completeness of documentation increased from 38% to 63%, and documentation of significant events increased from 38% to 88%. Length of stay after 36 weeks' corrected gestational age was unchanged, and nursing satisfaction improved. CONCLUSIONS: We found decreasing variation in the management of apnea of prematurity while simultaneously improving staff satisfaction. Next steps include revising electronic medical record flowsheets and spread to network NICUs.

Quality improvement methods - Part II.

To solve complex problems in healthcare, providers need the will to make change, well thought-out or evidence-based ideas, and a quality improvement methodology for executing those ideas. This review will focus on specific elements of execution. A previous review by Picarillo (1) discussed the Model for Improvement, process maps, Pareto charts, Ishikawa diagrams, and driver diagrams. Here, Lean/Six Sigma (LSS) is introduced as an additional methodology for quality improvement (QI), including a selected discussion of some associated LSS tools. Specifically, the Failure Modes and Effects Analysis (FMEA) will be reviewed in more detail. This is a tool to proactively identify possible errors in processes of care, prioritize those which may have the biggest impact if they reached the patient, and develop action plans to address them. Finally, Planned Experimentation is presented as a mechanism to organize your testing strategy for ideas for change. Having an understanding of the concepts in this review and that by Picarillo (1) will provide a sound foundation in the methodology and tools needed to address quality problems in healthcare.

Methemoglobinemia in an Infant After Sclerotherapy With High-Dose Doxycycline.

Methemoglobinemia occurs when the heme moiety of hemoglobin (Hb) is oxidized from the ferrous to ferric state, leading to impairments in oxygen transport and delivery. Methemoglobinemia is rare in pediatric patients but has been described in the setting of congenital abnormalities in the Hb structure, inherited enzyme deficiencies, oxidative Hb injury in response to illness, and oxidative Hb injury due to toxicants. We present a 1-week-old infant born with a cervical lymphangioma who developed persistent desaturations that were unresponsive to oxygen after sclerotherapy with doxycycline. Arterial blood gas revealed a high Pao2 despite low saturations being found on pulse oximetry and a methemoglobin level that was found to be elevated. Further sclerotherapy was discontinued, the saturations eventually normalized, and the methemoglobin level decreased. This is a novel report of sclerotherapy with doxycycline associated with the development of methemoglobinemia.

Thiol-Epoxy "Click" Chemistry to Engineer Cytocompatible PEG-Based Hydrogel for siRNA-Mediated Osteogenesis of hMSCs.

Thiol-epoxy "click" chemistry is employed for the first time to engineer a new cytocompatible PEG-based hydrogel system in aqueous media with the ability to encapsulate human mesenchymal stem cells (hMSCs) and control their fate for tissue regeneration. Cells were easily encapsulated into the hydrogels and exhibited high cell viability over 4 weeks of culture regardless of the presence of siRNA, complexed with polyethylenimine (PEI) in the form of siRNA/PEI nanocomplexes, indicating the biocompatibility of the developed hydrogel. Loading pro-osteogenic siNoggin in the hydrogel significantly enhanced the osteogenesis of encapsulated hMSCs, demonstrating the potential application of this system in tissue engineering.

Characteristics Associated With Preferences for Parent-Centered Decision Making in Neonatal Intensive Care.

Importance: Little is known about how characteristics of particular clinical decisions influence decision-making preferences by patients or their surrogates. A better understanding of the factors underlying preferences is essential to improve the quality of shared decision making. Objective: To identify the characteristics of particular decisions that are associated with parents' preferences for family- vs medical team-centered decision making across the spectrum of clinical decisions that arise in the neonatal intensive care unit (NICU). Design, Setting, and Participants: This cross-sectional survey assessed parents' preferences for parent- vs medical team-centered decision making across 16 clinical decisions, along with parents' assessments of 7 characteristics of those decisions. Respondents included 136 parents of infants in 1 of 3 academically affiliated hospital NICUs in Philadelphia, Pennsylvania, from January 7 to July 8, 2016. Respondents represented a wide range of educational levels, employment status, and household income but were predominantly female (109 [80.1%]), white (68 [50.0%]) or African American (53 [39.0%]), and married (81 of 132 responding [61.4%]). Main Outcomes and Measures: Preferences for parent-centered decision making. For each decision characteristic (eg, urgency), multivariable analyses tested whether middle and high levels of that characteristic (compared with low levels) were associated with a preference for parent-centered decision making, resulting in 2 odds ratios (ORs) per decision characteristic. Results: Among the 136 respondents (109 women [80.1%] and 27 men [19.9%]; median age, 30 years [range, 18-43 years]), preferences for parent-centered decision making were positively associated with decisions that involved big-picture goals (middle OR, 2.01 [99% CI, 0.83-4.86]; high OR, 3.38 [99% CI, 1.48-7.75]) and that had the potential to harm the infant (middle OR, 1.32 [99% CI, 0.84-2.08]; high OR, 2.62 [99% CI, 1.67-4.11]). In contrast, preferences for parent-centered decision making were inversely associated with the following 4 decision characteristics: technical decisions (middle OR, 0.82 [99% CI, 0.45-1.52]; high OR, 0.48 [99% CI, 0.25-0.93]), the potential to benefit the infant (middle OR, 0.42 [99% CI, 0.16-1.05]; high OR, 0.21 [99% CI, 0.08-0.52]), requires medical expertise (middle OR, 0.48 [99% CI, 0.22-1.05]; high OR, 0.21 [99% CI, 0.10-0.48]), and a high level of urgency (middle OR, 0.47 [99% CI, 0.24-0.92]; high OR, 0.42 [99% CI, 0.22-0.83]). Conclusions and Relevance: Preferences for parent-centered vs medical team-centered decision making among parents of infants in the NICU may vary systematically by the characteristics of particular clinical decisions. Incorporating this variation into shared decision making and endorsing models that allow parents to cede control to physicians in appropriate clinical circumstances might improve the quality and outcomes of medical decisions.

Characterization of Spirituality in Maternal-Child Caregivers.

OBJECTIVE: To characterize spiritual beliefs and support provided by maternal-child staff at three academic hospitals. BACKGROUND: Parents in neonatal intensive care units (NICUs) believe that addressing spirituality is important. The spiritual beliefs and the support provided by NICU staff are currently unknown. METHODS: This prospective study surveyed all maternal-child staff (NICU and Obstetrics): physicians, neonatal nurse practitioners, physician assistants, nurses, respiratory therapists, and social workers. Two validated tools were used: Spiritual Involvement and Beliefs Scale (SIBS) and Spiritual Care Inventory (SCI); SIBS assesses spiritual beliefs and practices, SCI assesses the perception of spiritual care that one provides. Demographic information, including self-identified religious affiliation, was collected. RESULTS: Respondents of 406 completed surveys were mostly nurses, female, white, and Christian. SIBS scores ranged between 21 and 136. Higher SIBS score was associated with Christian religion (p = 0.001) and African American (p = 0.003) and Asian (p = 0.017) race, when controlling for site, age, gender, education, role in the NICU, and years in practice. A high SCI score was also associated with Christian religion (p = 0.01). There was a trend toward an association between SCI and older age (p = 0.051). There was an association between a high SIBS score and higher ratings on both SCI subscales used. DISCUSSION: There is a wide range in spirituality and perceived spiritual support among maternal-child staff. This may coincide with the spiritual needs of families in the NICU.

A curious case of anti-D antibody titer.

RhD alloimmunization remains a threat to 1% of the 10% of RhD-negative women in the United States who are giving birth to RhD-positive fetuses despite routine antenatal and postpartum administration of Rh(o)D immune globulin (RhIG). This report examines the clinical course of an RhD-negative woman who developed a high anti-D antibody titer during her pregnancy while carrying an RhD-positive female fetus yet had a negative antibody screen at the time she gave birth. Although she delivered a healthy newborn unaffected by hemolytic disease, subsequent pregnancies will be treated as though she is RhD alloimmunized. The discussion below includes possible causes for the abrupt rise in this woman's anti-D antibody titer, a review of the complex Rh system and cellular anamnestic response, and current fetal surveillance for hemolytic disease of the fetus and newborn.