Delivery Room Resuscitation of Infants with Congenital Diaphragmatic Hernia: Lessons Learned through Video Review.

INTRODUCTION: Delivery room (DR) interventions for infants with congenital diaphragmatic hernia (CDH) are not well described. This study sought to describe timing and order of DR interventions and identify system factors impacting CDH DR resuscitations using a human factors framework. METHODS: Single center observational study of video recorded CDH DR resuscitations documenting timing and order of interventions. The team used the Systems Engineering Initiative for Patient Safety (SEIPS) model to identify system factors impacting DR resuscitations and time to invasive ventilation. RESULTS: We analyzed 31 video recorded CDH resuscitations. We observed variability in timing and order of resuscitation tasks. The 'Internal Environment' and 'Tasks' components of the SEIPS model were prominent factors affecting resuscitation efficiency; significant room and bed spatial constraints exist, and nurses have a significant task burden. Additionally, endotracheal tube preparation was a prominent barrier to timely invasive ventilation. CONCLUSION: Video review revealed variation in event timing and order during CDH resuscitations. Standardization of room set-up, equipment, and event order and reallocation of tasks facilitate more efficient intubation and ventilation, representing targets for CDH DR improvement initiatives. This work emphasizes the utility of rigorous human factors review to identify areas for improvement during DR resuscitation.

The Delivery Room Resuscitation of Infants with Congenital Diaphragmatic Hernia Treated with Fetoscopic Endoluminal Tracheal Occlusion: Beyond the Balloon.

INTRODUCTION: Randomized controlled trials found that fetoscopic endoluminal tracheal occlusion (FETO) resulted in increased fetal lung volume and improved survival for infants with isolated, severe left-sided congenital diaphragmatic hernia (CDH). The delivery room resuscitation of these infants is particularly unique, and the specific delivery room events are largely unknown. The objective of this study was to compare the delivery room resuscitation of infants treated with FETO to standard of care (SOC) and describe lessons learned. METHODS: Retrospective single-center cohort study of infants treated with FETO compared to infants who met FETO criteria during the same period but who received SOC. RESULTS: FETO infants were more likely to be born prematurely with 8/12 infants born <35 weeks gestational age compared to 3/35 SOC infants. There were 5 infants who required emergent balloon removal (2 ex utero intrapartum treatment and 3 tracheoscopic removal on placental bypass with delayed cord clamping) and 7 with prenatal balloon removal. Surfactant was administered in 6/12 FETO (50%) infants compared to 2/35 (6%) in the SOC group. Extracorporeal membrane oxygenation use was lower at 25% and survival was higher at 92% compared to 60% and 71% in the SOC infants, respectively. CONCLUSION: The delivery room resuscitation of infants treated with FETO requires thoughtful preparation with an experienced multidisciplinary team. Given increased survival, FETO should be offered to infants with severe isolated left-sided CDH, but only in high-volume centers with the experience and capability of removing the balloon, emergently if needed. The neonatal clinical team must be skilled in managing the unique postnatal physiology inherent to FETO where effective interdisciplinary teamwork is essential. Empiric and immediate surfactant administration should be considered in all FETO infants to lavage thick airway secretions, particularly those delivered <48 h after balloon removal.

Update on Management and Outcomes of Congenital Diaphragmatic Hernia.

Infants with congenital diaphragmatic hernia (CDH) benefit from comprehensive multidisciplinary teams that have experience in caring for the unique and complex issues associated with CDH. Despite prenatal referral to specialized high-volume centers, advanced ventilation strategies and pulmonary hypertension management, and extracorporeal membrane oxygenation, mortality and morbidity remain high. These infants have unique and complex issues that begin in fetal and infant life, but persist through adulthood. Here we will review the literature and share our clinical care pathway for neonatal care and follow up. While many advances have occurred in the past few decades, our work is just beginning to continue to improve the mortality, but also importantly the morbidity of CDH.

Identifying Gaps in Resuscitation Practices Across Level-IV Neonatal Intensive Care Units.

OBJECTIVE: This study aimed to describe resuscitation practices in level-IV neonatal intensive care units (NICUs) and identify possible areas of improvement. STUDY DESIGN: This study was a cross-sectional cohort survey and conducted at the Level-IV NICUs of Children's Hospital Neonatal Consortium (CHNC). The survey was developed with consensus from resuscitation and education experts in the CHNC and pilot tested. An electronic survey was sent to individual site sponsors to determine unit demographics, resuscitation team composition, and resuscitation-related clinical practices. RESULTS: Of the sites surveyed, 33 of 34 sites responded. Unit average daily census ranged from less than 30 to greater than 100, with the majority (72%) of the sites between 30 and 75 patients. A designated code response team was utilized in 18% of NICUs, only 30% assigned roles before or during codes. The Neonatal Resuscitation Program (NRP) was the exclusive algorithm used during codes in 61% of NICUs, and 34% used a combination of NRP and the Pediatric Advanced Life Support (PALS). Most (81%) of the sites required neonatal attendings to maintain NRP training. A third of sites (36%) lacked protocols for high-acuity events. A code review process existed in 76% of participating NICUs, but only 9% of centers enter code data into a national database. CONCLUSION: There is variability among units regarding designated code team presence and composition, resuscitation algorithm, protocols for high-acuity events, and event review. These inconsistencies in resuscitation teams and practices provide an opportunity for standardization and, ultimately, improved resuscitation performance. Resources, education, and efforts could be directed to these areas to potentially impact future neonatal outcomes of the complex patients cared for in level-IV NICUs. KEY POINTS: · Resuscitation practice is variable in level-IV NICUs.. · Resuscitation algorithm training is not uniform. · Standardized protocols for high-acuity low-occurrence (HALO) events are lacking.

Comparison of a dichotomous versus trichotomous checklist for neonatal intubation.

BACKGROUND: To compare validity evidence for dichotomous and trichotomous versions of a neonatal intubation (NI) procedural skills checklist. METHODS: NI skills checklists were developed utilizing an existing framework. Experts were trained on scoring using dichotomous and trichotomous checklists, and rated recordings of 23 providers performing simulated NI. Videolaryngoscope recordings of glottic exposure were evaluated using Cormack-Lehane (CL) and Percent of Glottic Opening scales. Internal consistency and reliability of both checklists were analyzed, and correlations between checklist scores, airway visualization, entrustable professional activities (EPA), and global skills assessment (GSA) were calculated. RESULTS: During rater training, raters gave significantly higher scores on better provider performance in standardized videos (both p < 0.001). When utilized to evaluate study participants' simulated NI attempts, both dichotomous and trichotomous checklist scores demonstrated very good internal consistency (Cronbach's alpha 0.868 and 0.840, respectively). Inter-rater reliability was higher for dichotomous than trichotomous checklists [Fleiss kappa of 0.642 and 0.576, respectively (p < 0.001)]. Sum checklist scores were significantly different among providers in different disciplines (p < 0.001, dichotomous and trichotomous). Sum dichotomous checklist scores correlated more strongly than trichotomous scores with GSA and CL grades. Sum dichotomous and trichotomous checklist scores correlated similarly well with EPA. CONCLUSIONS: Neither dichotomous or trichotomous checklist was superior in discriminating provider NI skill when compared to GSA, EPA, or airway visualization assessment. Sum scores from dichotomous checklists may provide sufficient information to assess procedural competence, but trichotomous checklists may permit more granular feedback to learners and educators. The checklist selected may vary with assessment needs.

Single-Center Comparison of Outcomes Following Cardiac Surgery in Low Birth Weight and Standard Birth Weight Neonates.

OBJECTIVE: To compare outcomes between low birth weight (LBW; <2.5 kg) and standard birth weight neonates undergoing cardiac surgery. STUDY DESIGN: A single-center retrospective study of neonates undergoing cardiac surgery with cardiopulmonary bypass from 2012 to 2018. LBW neonates were 1:2 propensity score-matched to standard birth weight neonates (n = 93 to n = 186) using clinical characteristics. The primary and secondary outcomes were survival to hospital discharge and postoperative complications, respectively. After matching, regression analyses were conducted to compare outcomes. RESULTS: The LBW group had a higher proportion of premature neonates than the standard birth weight group (60% vs 8%; P < .01) and were less likely to survive to hospital discharge (88% vs 95%; OR, 0.39; 95% CI, 0.15-0.97). There was no difference in unplanned cardiac reoperations or catheter-based interventions, cardiac arrest, extracorporeal membrane oxygenation, infection, and end-organ complications between the groups. Among LBW infants, survival was improved at weight >2 kg. CONCLUSIONS: LBW is a risk factor for decreased survival. LBW neonates weighing >2 kg have survival comparable to those weighing >2.5 kg.

Simulation in Neonatal-Perinatal Medicine Fellowship Programs.

OBJECTIVE: This study aimed to investigate the use of simulation in neonatal-perinatal medicine (NPM) fellowship programs. STUDY DESIGN: This was a cross-sectional survey of program directors (PDs) and simulation educators in Accreditation Council for Graduate Medical Education (ACGME) accredited NPM fellowship programs. RESULTS: Responses were received from 59 PDs and 52 simulation educators, representing 60% of accredited programs. Of responding programs, 97% used simulation, which most commonly included neonatal resuscitation (94%) and procedural skills (94%) training. The time and scope of simulation use varied significantly. The majority of fellows (51%) received ≤20 hours of simulation during training. The majority of PDs (63%) wanted fellows to receive >20 hours of simulation. Barriers to simulation included lack of faculty time, experience, funding, and curriculum. CONCLUSION: While the majority of fellowship programs use simulation, the time and scope of fellow exposure to simulation experiences are limited. The creation of a standardized simulation curriculum may address identified barriers to simulation.

Team Stress and Adverse Events during Neonatal Tracheal Intubations: A Report from NEAR4NEOS.

OBJECTIVE: This study aimed to examine the association between team stress level and adverse tracheal intubation (TI)-associated events during neonatal intubations. STUDY DESIGN: TIs from 10 academic neonatal intensive care units were analyzed. Team stress level was rated immediately after TI using a 7-point Likert scale (1 = high stress). Associations among team stress, adverse TI-associated events, and TI characteristics were evaluated. RESULT: In this study, 208 of 2,009 TIs (10%) had high stress levels (score < 4). Oxygenation failure, hemodynamic instability, and family presence were associated with high stress level. Video laryngoscopy and premedication were associated with lower stress levels. High stress level TIs were associated with adverse TI-associated event rates (31 vs. 16%, p < 0.001), which remained significant after adjusting for potential confounders including patient, provider, and practice factors associated with high stress (odds ratio: 1.90, 96% confidence interval: 1.36-2.67, p < 0.001). CONCLUSION: High team stress levels during TI were more frequently reported among TIs with adverse events.

Implementation of an Innovative, Multiunit, Postevent Debriefing Program in a Children's Hospital.

BACKGROUND: Postevent debriefing has been associated with improved resuscitation outcomes and is recommended by the American Heart Association and the American Academy of Pediatrics to improve clinical performance. OBJECTIVE: Despite the benefits of postevent debriefing, published debriefing programs have focused on single areas within a hospital. We are unaware of any hospital-wide debriefing programs implemented in a pediatric setting. METHODS: We established a multidisciplinary, interprofessional debriefing collaborative at the Children's Hospital of Philadelphia to implement postevent debriefings in multiple areas of the hospital. The collaborative created a standardized debriefing form to capture data about the postevent debriefings. RESULTS: From July 23, 2015 to December 31, 2017, the emergency department performed 153 debriefings (18%) for 850 resuscitations. The neonatal intensive care unit conducted 10 debriefings (9%) for 107 resuscitations, and the pediatric intensive care unit performed 5 debriefings (7%) for 73 resuscitations. CONCLUSIONS: Several departments at the Children's Hospital of Philadelphia have incorporated hot and cold debriefings into their clinical practice as part of their continuous quality improvement programs. By disseminating the tools and lessons learned from the implementation process, the collaborative hopes that other institutions will benefit from their lessons learned to successfully create their own debriefing programs. Widespread adoption of debriefing programs will enable a more scientific approach to studying the outcomes of debriefing.

Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit.

The effect of video laryngoscopy on adverse events during neonatal tracheal intubation is unknown. In this single site retrospective cohort study, video laryngoscopy was independently associated with decreased risk for adverse events during neonatal intubation.

Association between video laryngoscopy characteristics and successful neonatal tracheal intubation: a prospective study.

OBJECTIVE: To identify associations between procedural characteristics and success of neonatal tracheal intubation (NTI) using video laryngoscopy (VL). DESIGN: Prospective single-centre observational study. SETTING: Quaternary neonatal intensive care unit. PATIENTS: Infants requiring NTI at the Children's Hospital of Philadelphia. INTERVENTIONS: VL NTI recordings were evaluated to assess 11 observable procedural characteristics hypothesised to be associated with VL NTI success. These characteristics included measures of procedural time and performance, glottic exposure and position, and laryngoscope blade tip location. MAIN OUTCOME MEASURE: VL NTI attempt success. RESULTS: A total of 109 patients underwent 109 intubation encounters with 164 intubation attempts. The first attempt success rate was 65%, and the overall encounter success rate was 100%. Successful VL NTI attempts were associated with shorter procedural duration (36 s vs 60 s, p<0.001) and improved Cormack-Lehane grade (63% grade I vs 49% grade II, p<0.001) compared with unsuccessful NTIs. Other factors more common in successful NTI attempts than unsuccessful attempts were laryngoscope blade placement to lift the epiglottis (45% vs 29%, p=0.002), fewer tracheal tube manoeuvres (3 vs 8, p<0.001) and a left-sided or non-visualised tongue location (76% vs 56%, p=0.009). CONCLUSION: We identified procedural characteristics visible on the VL screen that are associated with NTI procedural success. Study results may improve how VL is used to teach and perform neonatal intubation.

Association between video laryngoscopy characteristics and successful neonatal tracheal intubation: a prospective study.

OBJECTIVE: To identify associations between procedural characteristics and success of neonatal tracheal intubation (NTI) using video laryngoscopy (VL). DESIGN: Prospective single-centre observational study. SETTING: Quaternary neonatal intensive care unit. PATIENTS: Infants requiring NTI at the Children's Hospital of Philadelphia. INTERVENTIONS: VL NTI recordings were evaluated to assess 11 observable procedural characteristics hypothesised to be associated with VL NTI success. These characteristics included measures of procedural time and performance, glottic exposure and position, and laryngoscope blade tip location. MAIN OUTCOME MEASURE: VL NTI attempt success. RESULTS: A total of 109 patients underwent 109 intubation encounters with 164 intubation attempts. The first attempt success rate was 65%, and the overall encounter success rate was 100%. Successful VL NTI attempts were associated with shorter procedural duration (36 s vs 60 s, p<0.001) and improved Cormack-Lehane grade (63% grade I vs 49% grade II, p<0.001) compared with unsuccessful NTIs. Other factors more common in successful NTI attempts than unsuccessful attempts were laryngoscope blade placement to lift the epiglottis (45% vs 29%, p=0.002), fewer tracheal tube manoeuvres (3 vs 8, p<0.001) and a left-sided or non-visualised tongue location (76% vs 56%, p=0.009). CONCLUSION: We identified procedural characteristics visible on the VL screen that are associated with NTI procedural success. Study results may improve how VL is used to teach and perform neonatal intubation.

Association between initial ventilation mode and hospital outcomes for severe congenital diaphragmatic hernia.

OBJECTIVE: To determine the association between initial delivery room (DR) ventilator (conventional mechanical ventilation [CMV] versus high frequency oscillatory ventilation [HFOV] and hospital outcomes for infants with severe congenital diaphragmatic hernia (CDH). STUDY DESIGN: Quasi-experimental design before/after introducing a clinical protocol promoting HFOV. The primary outcome was first blood gas parameters. Secondary outcomes included serial blood gas assessments, ECMO, survival, duration of ventilation, and length of hospitalization. RESULTS: First pH and CO2 were more favorable in the HFOV group (n = 75) than CMV group (n = 85), median (interquartile range (IQR)) pH 7.18 (7.03, 7.24) vs. 7.05 (6.93, 7.17), adjusted p-value < 0.001; median CO2 62.0 (46.0, 82.0) vs 85.9 (59.0, 103.0), adjusted p-value < 0.001. ECMO, survival, duration of ventilation, and length of hospitalization did not differ between groups in adjusted analysis. CONCLUSION: Among infants with severe CDH, initial DR HFOV was associated with improved early gas exchange with no adverse differences in hospital outcomes.

Considerations on the Use of Neonatal and Pediatric Resuscitation Guidelines for Hospitalized Neonates and Infants: On Behalf of the American Heart Association Emergency Cardiovascular Care Committee and the American Academy of Pediatrics.

Between 0.25% and 3% of admissions to the NICU, PICU, and PCICU receive cardiopulmonary resuscitation (CPR). Most CPR events occur in patients <1 year old. The incidence of CPR is 10 times higher in the NICU than at birth. Therefore, optimizing the approach to CPR in hospitalized neonates and infants is important. At birth, the resuscitation of newborns is performed according to neonatal resuscitation guidelines. In older infants and children, resuscitation is performed according to pediatric resuscitation guidelines. Neonatal and pediatric guidelines differ in several important ways. There are no published recommendations to guide the transition from neonatal to pediatric guidelines. Therefore, hospitalized neonates and infants can be resuscitated using neonatal guidelines, pediatric guidelines, or a hybrid approach. This report summarizes the current neonatal and pediatric resuscitation guidelines, considers how to apply them to hospitalized neonates and infants, and identifies knowledge gaps and future priorities. The lack of strong scientific data makes it impossible to provide definitive recommendations on when to transition from neonatal to pediatric resuscitation guidelines. Therefore, it is up to health care teams and institutions to decide if neonatal or pediatric guidelines are the best choice in a given location or situation, considering local circumstances, health care team preferences, and resource limitations.

A clinical consensus guideline for nutrition in infants with congenital diaphragmatic hernia from birth through discharge.

OBJECTIVE: To develop a consensus guideline to meet nutritional challenges faced by infants with congenital diaphragmatic hernia (CDH). STUDY DESIGN: The CDH Focus Group utilized a modified Delphi method to develop these clinical consensus guidelines (CCG). Topic leaders drafted recommendations after literature review and group discussion. Each recommendation was sent to focus group members via a REDCap survey tool, and members scored on a Likert scale of 0-100. A score of > 85 with no more than 25% outliers was designated a priori as demonstrating consensus among the group. RESULTS: In the first survey 24/25 recommendations received a median score > 90 and after discussion and second round of surveys all 25 recommendations received a median score of 100. CONCLUSIONS: We present a consensus evidence-based framework for managing parenteral and enteral nutrition, somatic growth, gastroesophageal reflux disease, chylothorax, and long-term follow-up of infants with CDH.

Videolaryngoscopy versus direct laryngoscopy in simulated pediatric intubation.

STUDY OBJECTIVE: We determine whether videolaryngoscopy results in a higher prevalence of first-attempt intubation success and improved glottic visualization than direct laryngoscopy when performed by pediatric emergency medicine providers in simulated patients. METHODS: This was a cross-sectional study at a single institution. Fellows and faculty in pediatric emergency medicine were invited to participate. Each subject performed intubations on 3 simulators (newborn, infant, adult), using a videolaryngoscope; each simulator was intubated by each subject with and without use of video. Primary outcome was first-attempt intubation success; secondary outcome was percentage of glottic opening score (POGO). RESULTS: Twenty-six participants performed 156 intubations; complete data were available for 148 intubations. First-attempt success in the neonate was 88%; in the infant, 79%; and in the adult, 60%. In the adult simulator, videolaryngoscopy use showed a first-attempt success in 81% of subjects compared with 39% with direct laryngoscopy (difference 43%; 95% confidence interval [CI] 18% to 67%). There was no difference in first-attempt success rates between videolaryngoscopy and direct laryngoscopy in the newborn or infant simulators. Videolaryngoscopy use led to increased POGO scores in all 3 simulators, with a difference of 25% (95% CI 2% to 48%) in newborn simulators, 23% (95% CI 2% to 48%) in infant simulators, and 42% (95% CI 18% to 66%) in adult simulators. CONCLUSION: Videolaryngoscopy was associated with greater first-attempt success during intubation by pediatric emergency physicians on an adult simulator. POGO score was significantly improved in all 3 simulators with videolaryngoscopy.

Assessment of technique during pediatric direct laryngoscopy and tracheal intubation: a simulation-based study.

OBJECTIVES: This study aimed to assess the feasibility of characterizing direct laryngoscopy (DL) and tracheal intubation (TI) technique based on videographic review and to determine the association between technical aspects of DL and TI with successful completion of intubation. METHODS: Physicians in pediatrics, emergency medicine, pediatric emergency, pediatric critical care, and neonatology performed TI on simulators (newborn, infant, and adult). A video laryngoscope was used without a display (ie, as a direct laryngoscope), and video recordings were reviewed. A scoring instrument characterized technical aspects of DL and TI; outcomes related to procedural performance were recorded. Interrater reliability of the instrument was assessed by weighted κ; collinearity was assessed by a correlation matrix. Univariate analysis determined technical aspects of DL and TI associated with outcomes. RESULTS: Seventy-three subjects performed 206 intubations. Significant differences existed between simulators with respect to the first-attempt success (newborn, 63%; infant, 80%; adult, 42%; P < 0.001), laryngoscopy time (27 seconds vs 31 seconds vs 42 seconds, P < 0.001), and percentage of glottic opening score (68% vs 65% vs 35%, P < 0.001). Interrater reliability for the instrument was good (κ = 0.68); no significant collinearity existed between data points. Position of the tip of the laryngoscope blade in the vallecula and under the proximal epiglottis was associated with improved first-attempt success. CONCLUSIONS: Pediatric intubation technique can be reliably assessed using videography and video laryngoscopy. Future studies should examine video-based characterization of DL and TI technique in real patients outside the operating room, as well as whether technical aspects of intubation are associated with improved outcomes.

Respiratory function after birth in infants with congenital diaphragmatic hernia.

OBJECTIVE: To characterise the transitional pulmonary physiology of infants with congenital diaphragmatic hernia (CDH) using measures of expiratory tidal volume (TV) and end-tidal carbon dioxide (ETCO2). DESIGN: Prospective single-centre observational study. SETTING: Quaternary neonatal intensive care unit. PATIENTS: Infants with an antenatal diagnosis of CDH born at the Children's Hospital of Philadelphia. INTERVENTIONS: TV and ETCO2 were simultaneously recorded using a respiratory function monitor (RFM) during invasive positive pressure ventilation immediately after birth. MAIN OUTCOME MEASURES: TV per birth weight and ETCO2 values were summarised for each minute after birth. Subgroups of interest were defined by liver position (thoracic vs abdominal) and extracorporeal membrane oxygenation (ECMO) treatment. RESULTS: RFM data were available for 50 infants from intubation until a median (IQR) of 9 (7-14) min after birth. TV and ETCO2 values increased for the first 10 min after birth, but intersubject values were heterogeneous. TVs were overall lower and ETCO2 values higher in infants with an intrathoracic liver and infants who were ultimately treated with ECMO. On hospital discharge, survival was 88% (n=43) and 34% (n=17) of infants were treated with ECMO. CONCLUSION: Respiratory function immediately after birth is heterogeneous for infants with CDH. Lung aeration, as evidenced by expired TV and ETCO2, appears to be ongoing throughout the first 10 min after birth during invasive positive pressure ventilation. Close attention to expired TV and ETCO2 levels by 10 min after birth may provide an opportunity to optimise and individualise ventilatory support for this high-risk population.

Setting an Agenda: Results of a Consensus Process on Research Directions in Distance Simulation.

BACKGROUND: The COVID-19 pandemic forced rapid implementation and refinement of distance simulation methodologies in which participants and/or facilitators are not physically colocated. A review of the distance simulation literature showed that heterogeneity in many areas (including nomenclature, methodology, and outcomes) limited the ability to identify best practice. In April 2020, the Healthcare Distance Simulation Collaboration was formed with the goal of addressing these issues. The aim of this study was to identify future research priorities in the field of distance simulation using data derived from this summit. METHODS: This study analyzed textual data gathered during the consensus process conducted at the inaugural Healthcare Distance Simulation Summit to explore participant perceptions of the most pressing research questions regarding distance simulation. Participants discussed education and patient safety standards, simulation facilitators and barriers, and research priorities. Data were qualitatively analyzed using an explicitly constructivist thematic analysis approach, resulting in the creation of a theoretical framework. RESULTS: Our sample included 302 participants who represented 29 countries. We identified 42 codes clustered within 4 themes concerning key areas in which further research into distance simulation is needed: (1) safety and acceptability, (2) educational/foundational considerations, (3) impact, and (4) areas of ongoing exploration. Within each theme, pertinent research questions were identified and categorized. CONCLUSIONS: Distance simulation presents several challenges and opportunities. Research around best practices, including educational foundation and psychological safety, are especially important as is the need to determine outcomes and long-term effects of this emerging field.