Maternal Vaccination and Risk of Hospitalization for Covid-19 among Infants.

BACKGROUND: Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (Covid-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal Covid-19 vaccination may confer protection against Covid-19 in infants. METHODS: We used a case-control test-negative design to assess the effectiveness of maternal vaccination during pregnancy against hospitalization for Covid-19 among infants younger than 6 months of age. Between July 1, 2021, and March 8, 2022, we enrolled infants hospitalized for Covid-19 (case infants) and infants hospitalized without Covid-19 (control infants) at 30 hospitals in 22 states. We estimated vaccine effectiveness by comparing the odds of full maternal vaccination (two doses of mRNA vaccine) among case infants and control infants during circulation of the B.1.617.2 (delta) variant (July 1, 2021, to December 18, 2021) and the B.1.1.259 (omicron) variant (December 19, 2021, to March 8, 2022). RESULTS: A total of 537 case infants (181 of whom had been admitted to a hospital during the delta period and 356 during the omicron period; median age, 2 months) and 512 control infants were enrolled and included in the analyses; 16% of the case infants and 29% of the control infants had been born to mothers who had been fully vaccinated against Covid-19 during pregnancy. Among the case infants, 113 (21%) received intensive care (64 [12%] received mechanical ventilation or vasoactive infusions). Two case infants died from Covid-19; neither infant's mother had been vaccinated during pregnancy. The effectiveness of maternal vaccination against hospitalization for Covid-19 among infants was 52% (95% confidence interval [CI], 33 to 65) overall, 80% (95% CI, 60 to 90) during the delta period, and 38% (95% CI, 8 to 58) during the omicron period. Effectiveness was 69% (95% CI, 50 to 80) when maternal vaccination occurred after 20 weeks of pregnancy and 38% (95% CI, 3 to 60) during the first 20 weeks of pregnancy. CONCLUSIONS: Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for Covid-19, including for critical illness, among infants younger than 6 months of age. (Funded by the Centers for Disease Control and Prevention.).

Effectiveness of BNT162b2 Vaccine against Critical Covid-19 in Adolescents.

BACKGROUND: The increasing incidence of pediatric hospitalizations associated with coronavirus disease 2019 (Covid-19) caused by the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the United States has offered an opportunity to assess the real-world effectiveness of the BNT162b2 messenger RNA vaccine in adolescents between 12 and 18 years of age. METHODS: We used a case-control, test-negative design to assess vaccine effectiveness against Covid-19 resulting in hospitalization, admission to an intensive care unit (ICU), the use of life-supporting interventions (mechanical ventilation, vasopressors, and extracorporeal membrane oxygenation), or death. Between July 1 and October 25, 2021, we screened admission logs for eligible case patients with laboratory-confirmed Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2) in case patients as compared with two hospital-based control groups: patients who had Covid-19-like symptoms but negative results on testing for SARS-CoV-2 (test-negative) and patients who did not have Covid-19-like symptoms (syndrome-negative). RESULTS: A total of 445 case patients and 777 controls were enrolled. Overall, 17 case patients (4%) and 282 controls (36%) had been fully vaccinated. Of the case patients, 180 (40%) were admitted to the ICU, and 127 (29%) required life support; only 2 patients in the ICU had been fully vaccinated. The overall effectiveness of the BNT162b2 vaccine against hospitalization for Covid-19 was 94% (95% confidence interval [CI], 90 to 96); the effectiveness was 95% (95% CI, 91 to 97) among test-negative controls and 94% (95% CI, 89 to 96) among syndrome-negative controls. The effectiveness was 98% against ICU admission and 98% against Covid-19 resulting in the receipt of life support. All 7 deaths occurred in patients who were unvaccinated. CONCLUSIONS: Among hospitalized adolescent patients, two doses of the BNT162b2 vaccine were highly effective against Covid-19-related hospitalization and ICU admission or the receipt of life support. (Funded by the Centers for Disease Control and Prevention.).

Durability of Original Monovalent mRNA Vaccine Effectiveness Against COVID-19 Omicron-Associated Hospitalization in Children and Adolescents - United States, 2021-2023.

Pediatric COVID-19 vaccination is effective in preventing COVID-19-related hospitalization, but duration of protection of the original monovalent vaccine during SARS-CoV-2 Omicron predominance merits evaluation, particularly given low coverage with updated COVID-19 vaccines. During December 19, 2021-October 29, 2023, the Overcoming COVID-19 Network evaluated vaccine effectiveness (VE) of ≥2 original monovalent COVID-19 mRNA vaccine doses against COVID-19-related hospitalization and critical illness among U.S. children and adolescents aged 5-18 years, using a case-control design. Too few children and adolescents received bivalent or updated monovalent vaccines to separately evaluate their effectiveness. Most case-patients (persons with a positive SARS-CoV-2 test result) were unvaccinated, despite the high frequency of reported underlying conditions associated with severe COVID-19. VE of the original monovalent vaccine against COVID-19-related hospitalizations was 52% (95% CI = 33%-66%) when the most recent dose was administered <120 days before hospitalization and 19% (95% CI = 2%-32%) if the interval was 120-364 days. VE of the original monovalent vaccine against COVID-19-related hospitalization was 31% (95% CI = 18%-43%) if the last dose was received any time within the previous year. VE against critical COVID-19-related illness, defined as receipt of noninvasive or invasive mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, and illness resulting in death, was 57% (95% CI = 21%-76%) when the most recent dose was received <120 days before hospitalization, 25% (95% CI = -9% to 49%) if it was received 120-364 days before hospitalization, and 38% (95% CI = 15%-55%) if the last dose was received any time within the previous year. VE was similar after excluding children and adolescents with documented immunocompromising conditions. Because of the low frequency of children who received updated COVID-19 vaccines and waning effectiveness of original monovalent doses, these data support CDC recommendations that all children and adolescents receive updated COVID-19 vaccines to protect against severe COVID-19.

Associations of Patient and Parent Characteristics With Parental Decision Regret in the PICU: A Secondary Analysis of the 2015-2017 Navigate Randomized Comparative Trial.

OBJECTIVES: To identify self-reported meaningful decisions made by parents in the PICU and to determine patient and parent characteristics associated with the development of parental decision regret, a measurable, self-reported outcome associated with psychologic morbidity. DESIGN: Secondary analysis of the Navigate randomized comparative trial (NCT02333396). SETTING: Two tertiary, academic PICUs. PATIENTS: Spanish- or English-speaking parents of PICU patients aged less than 18 years who were expected to remain in the PICU for greater than 24 hours from time of enrollment or who had a risk of mortality greater than 4% based on Pediatric Index of Mortality 2 score. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Between April 2015 and March 2017, 233 parents of 209 patients completed a survey 3-5 weeks post-PICU discharge which included the Decision Regret Scale (DRS), a 5-item, 5-point Likert scale tool scored from 0 (no regret) to 100 (maximum regret). Two hundred nine patient/parent dyads were analyzed. The decisions parents reported as most important were categorized as: procedure, respiratory support, medical management, parent-staff interactions and communication, symptom management, fluid/electrolytes/nutrition, and no decision. Fifty-one percent of parents had some decision regret (DRS > 0) with 19% scoring in the moderate-severe range (DRS 26-100). The mean DRS score was 12.7 (sd 18.1). Multivariable analysis showed that parental Hispanic ethnicity was associated with greater odds ratio (OR 3.12 [95% CI, 1.36-7.13]; p = 0.007) of mild regret. Being parents of a patient with an increased PICU length of stay (LOS) or underlying respiratory disease was associated with greater odds of moderate-severe regret (OR 1.03 [95% CI, 1.009-1.049]; p = 0.004 and OR 2.91 [95% CI, 1.22-6.94]; p = 0.02, respectively). CONCLUSIONS: Decision regret was experienced by half of PICU parents in the 2015-2017 Navigate study. The characteristics associated with decision regret (parental ethnicity, PICU LOS, and respiratory disease) are easily identifiable. Further study is needed to understand what contributes to regret in this population and what interventions could provide support and minimize the development of regret.

Challenges of Families of Patients Hospitalized in the PICU: A Preplanned Secondary Analysis From the Navigate Dataset.

OBJECTIVES: To describe challenges experienced by parents of children hospitalized in the PICU during PICU admission as reported by family navigators. DESIGN: A preplanned secondary analysis of open-response data coded via inductive qualitative approach from the Navigate randomized controlled trial (RCT) dataset (ID NCT02333396). SETTING: Two university-affiliated PICUs in the Midwestern United States as part of an RCT. PATIENTS: Two hundred twenty-four parents of 190 PICU patients. INTERVENTIONS: In 2015-2017, trained family navigators assessed and addressed parent needs, offered weekly family meetings, and provided post-PICU discharge parent check-ins as part of a study investigating the effectiveness of a communication support intervention ("PICU Supports"). MEASUREMENTS AND MAIN RESULTS: We analyzed qualitative data recorded by family navigators weekly across 338 encounters. Navigators described families' "biggest challenge," "communication challenges," and ways the team could better support the family. We used an inductive qualitative coding approach and a modified member-checking exercise. The most common difficulties included home life , hospitalization , and diagnosis distress (45.2%, 29.0%, and 17.2% of families, respectively). Navigators often identified that parents had co-occurring challenges. Communication was identified as a "biggest challenge" for 8% of families. Communication challenges included lack of information, team communication , and communication quality (7.0%, 4.8%, and 4.8% of families, respectively). Suggestions for improving care included better medical communication, listening, rapport, and resources. CONCLUSIONS: This study describes families' experiences and challenges assessed throughout the PICU stay. Family navigators reported families frequently experience stressors both internal and external to the hospital environment, and communication challenges between families and providers may be additional sources of distress. Further research should develop and assess interventions aimed at improving provider-family communication and reducing stressors outside the hospitalization itself, such as home life difficulties.

BNT162b2 mRNA Vaccination Against Coronavirus Disease 2019 is Associated With a Decreased Likelihood of Multisystem Inflammatory Syndrome in Children Aged 5-18 Years-United States, July 2021 - April 2022.

BACKGROUND: Multisystem inflammatory syndrome in children (MIS-C), linked to antecedent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, is associated with considerable morbidity. Prevention of SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19) by vaccination might also decrease MIS-C likelihood. METHODS: In a multicenter, case-control, public health investigation of children ages 5-18 years hospitalized from 1 July 2021 to 7 April 2022, we compared the odds of being fully vaccinated (2 doses of BNT162b2 vaccine ≥28 days before hospital admission) between MIS-C case-patients and hospital-based controls who tested negative for SARS-CoV-2. These associations were examined by age group, timing of vaccination, and periods of Delta and Omicron variant predominance using multivariable logistic regression. RESULTS: We compared 304 MIS-C case-patients (280 [92%] unvaccinated) with 502 controls (346 [69%] unvaccinated). MIS-C was associated with decreased likelihood of vaccination (adjusted OR [aOR]: .16; 95% CI: .10-.26), including among children ages 5-11 years (aOR: .22; 95% CI: .10-.52), ages 12-18 years (aOR: .10; 95% CI: .05-.19), and during the Delta (aOR: .06; 95% CI: .02-.15) and Omicron (aOR: .22; 95% CI: .11-.42) variant-predominant periods. This association persisted beyond 120 days after the second dose (aOR: .08; 95% CI: .03-.22) in 12-18-year-olds. Among all MIS-C case-patients, 187 (62%) required intensive care unit admission and 280 (92%) vaccine-eligible case-patients were unvaccinated. CONCLUSIONS: Vaccination with 2 doses of BNT162b2 is associated with reduced likelihood of MIS-C in children ages 5-18 years. Most vaccine-eligible hospitalized patients with MIS-C were unvaccinated.

Effectiveness of Maternal mRNA COVID-19 Vaccination During Pregnancy Against COVID-19-Associated Hospitalizations in Infants Aged <6 Months During SARS-CoV-2 Omicron Predominance - 20 States, March 9, 2022-May 31, 2023.

Infants aged <6 months are not eligible for COVID-19 vaccination. Vaccination during pregnancy has been associated with protection against infant COVID-19-related hospitalization. The Overcoming COVID-19 Network conducted a case-control study during March 9, 2022-May 31, 2023, to evaluate the effectiveness of maternal receipt of a COVID-19 vaccine dose (vaccine effectiveness [VE]) during pregnancy against COVID-19-related hospitalization in infants aged <6 months and a subset of infants aged <3 months. VE was calculated as (1 - adjusted odds ratio) x 100% among all infants aged <6 months and <3 months. Case-patients (infants hospitalized for COVID-19 outside of birth hospitalization and who had a positive SARS-CoV-2 test result) and control patients (infants hospitalized for COVID-19-like illness with a negative SARS-CoV-2 test result) were compared. Odds ratios were determined using multivariable logistic regression, comparing the odds of receipt of a maternal COVID-19 vaccine dose (completion of a 2-dose vaccination series or a third or higher dose) during pregnancy with maternal nonvaccination between case- and control patients. VE of maternal vaccination during pregnancy against COVID-19-related hospitalization was 35% (95% CI = 15%-51%) among infants aged <6 months and 54% (95% CI = 32%-68%) among infants aged <3 months. Intensive care unit admissions occurred in 23% of all case-patients, and invasive mechanical ventilation was more common among infants of unvaccinated (9%) compared with vaccinated mothers (1%) (p = 0.02). Maternal vaccination during pregnancy provides some protection against COVID-19-related hospitalizations among infants, particularly those aged <3 months. Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19.

The value and limitations of using predetermined criteria in decision making for maternal-fetal interventions.

Maternal-fetal interventions-such as prenatal fetal myelomeningocele (MMC) repair-are at the forefront of clinical innovation within maternal-fetal medicine, pediatric surgery, and neonatology. Many centers determine eligibility for innovative procedures using pre-determined inclusion and exclusion criteria based on seminal studies, for example, the "Management of Myelomeningocele Study" for prenatal MMC repair. What if a person's clinical presentation does not conform to predetermined criteria for maternal-fetal intervention? Does changing criteria on a case-by-case basis (i.e., ad hoc) constitute an innovation in practice and flexible personalized care or transgression of commonly held standards with potential negative consequences? We outline principle-based, bioethically justified answers to these questions using fetal MMC repair as an example. We pay special attention to the historical origins of inclusion and exclusion criteria, risks and benefits to the pregnant person and the fetus, and team dynamics. We include recommendations for maternal-fetal centers facing these questions.

A Qualitative Study of Nurses' Perspectives on Neonatologist Continuity of Care.

BACKGROUND: Families and staff in neonatal intensive care units (NICUs) value continuity of care (COC), though definitions, delivery, and impacts of COC are incompletely described. Previously, we used parental perspectives to define and build a conceptual model of COC provided by neonatologists. Nursing perspectives about COC remain unclear. PURPOSE: To describe nursing perspectives on neonatologist COC and revise our conceptual model with neonatal nurse input. METHODS: This was a qualitative study interviewing NICU nurses. The investigators analyzed transcripts with directed content analysis guided by an existing framework of neonatologist COC. Codes were categorized according to previously described COC components, impact on infants and families, and improvements for neonatologist COC. New codes were identified, including impact on nurses, and codes were classified into themes. RESULTS: From 15 nurses, 5 themes emerged: (1) nurses validated parental definitions and benefits of COC; (2) communication is nurses' most valued component of COC; (3) neonatologist COC impact on nurses; (4) factors that modulate the delivery of and need for COC; (5) conflict between the need for COC and the need for change. Suggested improvement strategies included optimizing staffing and transition processes, utilizing clinical guidelines, and enhancing communication at all levels. Our adapted conceptual model describes variables associated with COC. IMPLICATIONS FOR PRACTICE AND RESEARCH: Interdisciplinary NICU teams need to develop systematic strategies tailored to their unit's and patients' needs that promote COC, focused to improve parent-clinician communication and among clinicians. Our conceptual model can help future investigators develop targeted interventions to improve COC.

A Scoping Review on the Concept of Physician Caring.

BACKGROUND: Physicians' interest in the health and well-being of their patients is a tenet of medical practice. Physicians' ability to act upon this interest by caring for and about their patients is central to high-quality clinical medicine and may affect burnout. To date, a strong theoretical and empirical understanding of physician caring does not exist. To establish a practical, evidence-based approach to improve health care delivery and potentially address physician burnout, we sought to identify and synthesize existing conceptual models, frameworks, and definitions of physician caring. METHODS: We performed a scoping review on physician caring. In November 2019 and September 2020, we searched PubMed MEDLINE, Embase, PsycINFO, CINAHL, and CENTRAL Register of Controlled Trials to identify conceptual models, frameworks, and definitions of physician caring. Eligible articles involved discussion or study of care or caring among medical practitioners. We created a content summary and performed thematic analysis of extracted data. RESULTS: Of 11,776 articles, we reviewed the full text of 297 articles; 61 articles met inclusion criteria. Commonly identified concepts referenced Peabody's "secret of care" and the ethics of care. In bioethics, caring is described as a virtue. Contradictions exist among concepts of caring, such as whether caring is an attitude, emotion, or behavior, and the role of relationship development. Thematic analysis of all concepts and definitions identified six aspects of physician caring: (1) relational aspects, (2) technical aspects, (3) physician attitudes and characteristics, (4) agency, (5) reciprocity, and (6) physician self-care. DISCUSSION: Caring is instrumental to clinical medicine. However, scientific understanding of what constitutes caring from physicians is limited by contradictions across concepts. A unifying concept of physician caring does not yet exist. This review proposes six aspects of physician caring which can be used to develop evidence-based approaches to improve health care delivery and potentially mitigate physician burnout.

Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12-18 Years - United States, July-December 2021.

Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5),§ and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe COVID-19 (6). Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design¶ among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to SARS-CoV-2 B.1.617.2 (Delta) variant predominance. Patients with MIS-C (case-patients) and two groups of hospitalized controls matched to case-patients were evaluated: test-negative controls had at least one COVID-19-like symptom and negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) or antigen-based assay results, and syndrome-negative controls were hospitalized patients without COVID-19-like illness. Among 102 MIS-C case-patients and 181 hospitalized controls, estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% (95% CI = 78%-97%). All 38 MIS-C patients requiring life support were unvaccinated. Receipt of 2 doses of the Pfizer-BioNTech vaccine is associated with a high level of protection against MIS-C in persons aged 12-18 years, highlighting the importance of vaccination among all eligible children.

Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19-Associated Hospitalization in Infants Aged <6 Months - 17 States, July 2021-January 2022.

COVID-19 vaccination is recommended for persons who are pregnant, breastfeeding, trying to get pregnant now, or who might become pregnant in the future, to protect them from COVID-19.§ Infants are at risk for life-threatening complications from COVID-19, including acute respiratory failure (1). Evidence from other vaccine-preventable diseases suggests that maternal immunization can provide protection to infants, especially during the high-risk first 6 months of life, through passive transplacental antibody transfer (2). Recent studies of COVID-19 vaccination during pregnancy suggest the possibility of transplacental transfer of SARS-CoV-2-specific antibodies that might provide protection to infants (3-5); however, no epidemiologic evidence currently exists for the protective benefits of maternal immunization during pregnancy against COVID-19 in infants. The Overcoming COVID-19 network conducted a test-negative, case-control study at 20 pediatric hospitals in 17 states during July 1, 2021-January 17, 2022, to assess effectiveness of maternal completion of a 2-dose primary mRNA COVID-19 vaccination series during pregnancy against COVID-19 hospitalization in infants. Among 379 hospitalized infants aged <6 months (176 with COVID-19 [case-infants] and 203 without COVID-19 [control-infants]), the median age was 2 months, 21% had at least one underlying medical condition, and 22% of case- and control-infants were born premature (<37 weeks gestation). Effectiveness of maternal vaccination during pregnancy against COVID-19 hospitalization in infants aged <6 months was 61% (95% CI = 31%-78%). Completion of a 2-dose mRNA COVID-19 vaccination series during pregnancy might help prevent COVID-19 hospitalization among infants aged <6 months.

Family Outcomes After the Pediatric Intensive Care Unit: A Scoping Review.

BACKGROUND: Intensivists are increasingly attuned to the postdischarge outcomes experienced by families because patient recovery and family outcomes are interdependent after childhood critical illness. In this scoping review of international contemporary literature, we describe the evidence of family effects and functioning postpediatric intensive care unit (PICU) as well as outcome measures used to identify strengths and weaknesses in the literature. METHODS: We reviewed all articles published between 1970 and 2017 in PubMed, Embase, PsycINFO, Cumulative Index of Nursing and Allied Health Literature (CINAHL), or the Cochrane Controlled Trials Registry. Our search used a combination of terms for the concept of "critical care/illness" combined with additional terms for the prespecified domains of social, cognitive, emotional, physical, health-related quality of life (HRQL), and family functioning. RESULTS: We identified 71 articles reporting on the postPICU experience of more than 2400 parents and 3600 families of PICU survivors in 8 countries. These articles used 101 different metrics to assess the various aspects of family outcomes; 34 articles also included open-ended interviews. Overall, most families experienced significant disruption in at least five out of six of our family outcomes subdomains, with themes of decline in mental health, physical health, family cohesion, and family finances identified. Almost all articles represented relatively small, single-center, or disease-specific observational studies. There was a disproportionate representation of families of higher socioeconomic status (SES) and Caucasian race, and there was much more data about mothers compared to fathers. There was also very limited information regarding outcomes for siblings and extended family members after a child's PICU stay. CONCLUSIONS: Significant opportunities remain for research exploring family functioning after PICU discharge. We recommend that future work include more diverse populations with respect to the critically ill child as well as family characteristics, include more intervention studies, and enrich existing knowledge about outcomes for siblings and extended family.

A Core Outcome Measurement Set for Pediatric Critical Care.

OBJECTIVES: To identify a PICU Core Outcome Measurement Set (PICU COMS), a set of measures that can be used to evaluate the PICU Core Outcome Set (PICU COS) domains in PICU patients and their families. DESIGN: A modified Delphi consensus process. SETTING: Four webinars attended by PICU physicians and nurses, pediatric surgeons, rehabilitation physicians, and scientists with expertise in PICU clinical care or research ( n = 35). Attendees were from eight countries and convened from the Pediatric Acute Lung Injury and Sepsis Investigators Pediatric Outcomes STudies after PICU Investigators and the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network PICU COS Investigators. SUBJECTS: Measures to assess outcome domains of the PICU COS are as follows: cognitive, emotional, overall (including health-related quality of life), physical, and family health. Measures evaluating social health were also considered. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Measures were classified as general or additional based on generalizability across PICU populations, feasibility, and relevance to specific COS domains. Measures with high consensus, defined as 80% agreement for inclusion, were selected for the PICU COMS. Among 140 candidate measures, 24 were delineated as general (broadly applicable) and, of these, 10 achieved consensus for inclusion in the COMS (7 patient-oriented and 3 family-oriented). Six of the seven patient measures were applicable to the broadest range of patients, diagnoses, and developmental abilities. All were validated in pediatric populations and have normative pediatric data. Twenty additional measures focusing on specific populations or in-depth evaluation of a COS subdomain also met consensus for inclusion as COMS additional measures. CONCLUSIONS: The PICU COMS delineates measures to evaluate domains in the PICU COS and facilitates comparability across future research studies to characterize PICU survivorship and enable interventional studies to target long-term outcomes after critical illness.

Evaluation of Organ Dysfunction Scores for Allocation of Scarce Resources in Critically Ill Children and Adults During a Healthcare Crisis.

OBJECTIVES: When healthcare systems are overwhelmed, accurate assessments of patients' predicted mortality risks are needed to ensure effective allocation of scarce resources. Organ dysfunction scores can serve this essential role, but their evaluation in this context has been limited so far. In this study, we sought to assess the performance of three organ dysfunction scores in both critically ill adults and children at clinically relevant mortality thresholds and timeframes for resource allocation and compare it with two published prioritization schemas. DESIGN: Retrospective observational cohort study. SETTING: Three large academic medical centers in the United States. PATIENTS: Critically ill adults and children. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We calculated the daily Sequential Organ Failure Assessment score in adults and the Pediatric Logistic Organ Dysfunction 2 score and the Pediatric Sequential Organ Failure Assessment score in children. There were 49,290 (11.6% mortality) and 19,983 children (2.5% mortality) included in the analysis. Both the Sequential Organ Failure Assessment and Pediatric Sequential Organ Failure Assessment scores had adequate discrimination across relevant timeframes and adequate distribution across relevant mortality thresholds. Additionally, we found that the only published state prioritization schema that includes pediatric and adult patients had poor alignment of mortality risks, giving adults a systematic advantage over children. CONCLUSIONS: In the largest analysis of organ dysfunction scores in a general population of critically ill adults and children to date, we found that both the Sequential Organ Failure Assessment and Pediatric Sequential Organ Failure Assessment scores had adequate performance across relevant mortality thresholds and timeframes for resource allocation. Published prioritization schemas that include both pediatric and adult patients may put children at a disadvantage. Furthermore, the distribution of patient and mortality risk in the published schemas may not adequately stratify patients for some high-stakes allocation decisions. This information may be useful to bioethicists, healthcare leaders, and policy makers who are developing resource allocation policies for critically ill patients.

Parent and Physician Report of Discussions About Prognosis for Critically Ill Children.

OBJECTIVES: Parents value clear communication with PICU clinicians about possible patient and family outcomes (prognostic conversations). We describe PICU parent and attending physician reports and agreement regarding the occurrence of prognostic conversations. We queried parents and physicians about prognostic conversation content, which healthcare providers had prognostic conversations, and whether parents wanted more prognostic information. DESIGN: Prospective cross-sectional survey study. SETTING: University-based 40-bed PICU. PARTICIPANTS: Parents and attending physicians of PICU patients with multiple organ dysfunction within 24 hours of PICU admission. INTERVENTIONS: Surveys administered to parents and attending PICU physicians 5-10 days after PICU admission. MEASUREMENTS AND MAIN RESULTS: Surveys asked parents and physicians to report the occurrence of prognostic conversations related to PICU length of stay, risk of PICU mortality, and anticipated post-PICU physical, neurologic, and psychologic morbidities for patients and post-PICU psychologic morbidities for parents. Of 101 participants, 87 parents and 83 physicians reported having prognostic conversations. Overall concordance between parents and physicians was fair (Kappa = 0.22). Parents and physicians most commonly reported prognostic conversations about PICU length of stay (67.3% and 63.3%, respectively) and patient post-PICU physical morbidity (n = 48; 48.5% and n = 45; 44.5% respectively). Conversations reported less often by parents and physicians were about patient post-PICU psychologic morbidity (n = 13; 12.9% and n = 20; 19.8%, respectively). Per parent report, bedside nurses and physicians provided most prognostic information. Chaplains (n = 14; 50%) and social workers (n = 17; 60%) were more involved in conversations regarding parent psychologic morbidities. Most commonly, parents requested more information about length of stay and their child's physical morbidities. Parents less frequently wanted information about their own psychologic morbidities. CONCLUSIONS: Most parents and physicians report having prognostic conversations, primarily about length of stay and post-ICU physical morbidities. Concordance between parents and physicians is suboptimal. Future studies should evaluate prognostic conversations at other timepoints, how information is delivered, and how these conversations impact the PICU experience.

Parental Perspectives on Neonatologist Continuity of Care.

BACKGROUND: Continuity of care (COC) is highly regarded; however, data about benefits are mixed. Little is known about components, parental views, or the value COC may provide to neonatal intensive care unit (NICU) infants and families. PURPOSE: To describe parents' perspectives on definitions, reasons they value, and suggested improvements regarding COC provided by neonatologists. METHODS: We performed a qualitative study of in-person, semistructured interviews with parents of NICU infants hospitalized for 28 days or more. We analyzed interview transcripts using content analysis, identifying codes of parental experiences, expressed value, and improvement ideas related to neonatologist COC, and categorizing emerging themes. RESULTS: Fifteen families (15 mothers and 2 fathers) described 4 themes about COC: (1) longitudinal neonatologists: gaining experience with infants and building relationships with parents over time; (2) background knowledge: knowing infants' clinical history and current condition; (3) care plans: establishing patient-centered goals and management plans; and (4) communication: demonstrating consistent communication and messaging. Parents described benefits of COC as decreasing knowledge gaps, advancing clinical progress, and decreasing parental stress. Suggested improvement strategies included optimizing staffing and sign-out/transition processes, utilizing clinical guidelines, and enhancing communication. Using parent input and existing literature, we developed a definition and conceptual framework of COC. IMPLICATIONS FOR PRACTICE: NICUs should promote practices that enhance COC. Parental suggestions can help direct improvement efforts. IMPLICATIONS FOR RESEARCH: Our COC definition and conceptual framework can guide development of research and quality improvement projects. Future studies should investigate nursing perspectives on NICU COC and the impact of COC on infant and family outcomes.

Association Between Resilience and Psychological Morbidity in Parents of Critically Ill Children.

OBJECTIVE: To determine whether parental resilience, measured at ICU admission, is associated with parent-reported symptoms of depression, anxiety, posttraumatic stress, and satisfaction with ICU care 3-5 weeks following ICU discharge. DESIGN: Planned prospective, observational study nested in a randomized comparative trial. SETTING: PICUs and cardiac ICUs in two, free-standing metropolitan area children's hospitals. PARTICIPANTS: English- and Spanish-speaking parents whose children were younger than 18 years old and had anticipated ICU stay of greater than 24 hours or Pediatric Index of Mortality score of greater than or equal to 4 at the time of consent. All ICU admissions were screened for inclusion. Of 4,251 admissions reviewed, 1,360 were eligible. Five hundred families were approached and 382 enrolled. Two hundred thirty-two parents from 210 families with complete data were included in analysis. INTERVENTIONS: All participating parents completed the Connor-Davidson Resilience Scale at the time of consent and outcome measures 3-5 weeks after ICU discharge. MEASUREMENTS AND MAIN RESULTS: All parents completed the Patient-Reported Outcome Measurement Information System Short Forms 8a for Depression and Anxiety, Impact of Event Scale-Revised for posttraumatic stress, and Pediatric Family Satisfaction-ICU 24 for parental satisfaction 3-5 weeks after ICU discharge. Higher parental resilience was associated with fewer symptoms of depression, anxiety, and posttraumatic stress in the final model (all p < 0.0001). Shorter length of stay, early mechanical ventilation, Latino ethnicity, and lower illness severity (both objective and parental perceptions) were associated with less morbidity in some or all measured mental health outcomes. CONCLUSIONS: Higher parental resilience is associated with fewer reported symptoms of anxiety, depression, and posttraumatic stress 3-5 weeks after ICU discharge. Parental resilience may impact parental post-ICU psychological morbidity. Measuring parental resilience could be one approach to identify parents at risk for post-ICU psychological morbidity. Future research into the impact of interventions designed to boost parental resilience is warranted.

A Randomized Comparative Trial to Evaluate a PICU Navigator-Based Parent Support Intervention.

OBJECTIVES: Communication breakdowns in PICUs contribute to inadequate parent support and poor post-PICU parent outcomes. No interventions supporting communication have demonstrated improvements in parental satisfaction or psychologic morbidity. We compared parent-reported outcomes from parents receiving a navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure. DESIGN: Patient-level, randomized trial. SETTING: Two university-based, tertiary-care children's hospital PICUs. PARTICIPANTS: Parents of patients requiring more than 24 hours in the PICU. INTERVENTIONS: PICU Supports included adding a trained navigator to the patient's healthcare team. Trained navigators met with parents and team members to assess and address communication, decision-making, emotional, informational, and discharge or end-of-life care needs; offered weekly family meetings; and did a post-PICU discharge parent check-in. The comparator arm received an informational brochure providing information about PICU procedures, terms, and healthcare providers. MEASUREMENTS AND MAIN RESULTS: The primary outcome was percentage of "excellent" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge. Secondary outcomes included parental psychologic and physical morbidity and perceptions of team communication. We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure. Fifty-seven percent (216/382) completed the 3-5 weeks post-PICU discharge survey. The mean percentage of excellent responses to the Pediatric Family Satisfaction in the ICU 24 decision-making items was 60.4% for PICU Supports versus 56.1% for the brochure (estimate, 3.57; SE, 4.53; 95% CI, -5.77 to 12.90; p = 0.44). Differences in secondary outcomes were not statistically significant. Most parents (91.1%; 113/124) described PICU Supports as "extremely" or "somewhat" helpful. CONCLUSIONS: Parents who received PICU Supports rated the intervention positively. Differences in decision-making satisfaction scores between those receiving PICU Supports and a brochure were not statistically significant. Interventions like PICU Supports should be evaluated in larger studies employing enhanced recruitment and retention of subjects.

Patient and Family Engagement During Treatment Decisions in an ICU: A Discourse Analysis of the Electronic Health Record.

OBJECTIVES: Shared decision-making is recommended for critically ill adults who face major, preference-sensitive treatment decisions. Yet, little is known about when and how patients and families are engaged in treatment decision-making over the longitudinal course of a critical illness. We sought to characterize patterns of treatment decision-making by evaluating clinician discourse in the electronic health record of critically ill adults who develop chronic critical illness or die in an ICU. DESIGN, SETTING, AND PATIENTS: We conducted qualitative content analysis of the electronic health record of 52 adult patients, admitted to a medical ICU in a tertiary medical center from January 1, 2016, to December 31, 2016. We included patients who met a consensus definition of chronic critical illness (26 patients) and a matched sample who died or transitioned to hospice care in the ICU before developing chronic critical illness (26 patients). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Characterization of clinician decision-making discourse documented during the course of an ICU stay. Clinician decision-making discourse in the electronic health record followed a single, consistent pattern across both groups. Initial decisions about admission to the ICU focused on specific interventions that can only be provided in an ICU environment (intervention-focused decisions). Following admission, the documented rationale for additional treatments was guided by physiologic abnormalities (physiology-centered decisions). Clinician discourse transitioned to documented engagement of patients and families in decision-making when treatments failed to achieve specified physiologic goals. The phrase "goals of care" is common in the electronic health record and is used to indicate poor prognosis, to describe conflict with families, and to provide rationale for treatment limitations. CONCLUSIONS: Clinician discourse in the electronic health record reveals that patient physiology strongly guides treatment decision-making throughout the longitudinal course of critical illness. Documentation of patient and family engagement in treatment decision-making is limited until available medical treatments fail to achieve physiologic goals.