Pediatric Acute Respiratory Distress Syndrome Severity and Health-Related Quality of Life Outcomes: Single-Center Retrospective Cohort, 2011-2017.

OBJECTIVES: To determine factors associated with health-related quality of life (HRQL) decline among pediatric acute respiratory distress syndrome (PARDS) survivors. DESIGN: Retrospective cohort study. SETTING: Academic children's hospital. PATIENTS: Three hundred fifteen children 1 month to 18 years old with an unplanned PICU admission from December 2011 to February 2017 enrolled in the hospital's Outcomes Assessment Program. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Pre-admission baseline and median 6-week post-discharge HRQL were assessed using the Pediatric Quality of Life Inventory or the Functional Status II-R. Patients meeting retrospectively applied Second Pediatric Acute Lung Injury Consensus Conference criteria for PARDS were identified, and PARDS severity was classified using binary (mild/moderate, severe) and trichotomous (mild, moderate, severe) categorization for noninvasive ventilation and invasive mechanical ventilation (IMV). PARDS occurred in 41 of 315 children (13.0%). Clinically important HRQL decline (≥ 4.5 points) occurred in 17 of 41 patients (41.5%) with PARDS and 64 of 274 without PARDS (23.4%). On multivariable generalized linear regression adjusted for age, baseline Pediatric Overall Performance Category, maximum nonrespiratory Pediatric Logistic Organ Dysfunction score, diagnosis, length of stay, and time to follow-up, PARDS was associated with HRQL decline (adjusted relative risk [aRR], 1.70; 95% CI, 1.03-2.77). Four-hour and maximum PARDS severity were the only factors associated with HRQL decline. HRQL decline occurred in five of 18 patients with mild PARDS at 4 hours, five of 13 with moderate PARDS (aRR 2.35 vs. no PARDS [95% CI, 1.01-5.50]), and seven of ten with severe PARDS (aRR 2.56 vs. no PARDS [95% CI, 1.45-4.53]). The area under the receiver operating characteristic curve for discrimination of HRQL decline for IMV patients was 0.79 (95% CI, 0.66-0.91) for binary and 0.80 (95% CI, 0.69-0.93) for trichotomous severity categorization. CONCLUSIONS: HRQL decline is common among children surviving PARDS, and risk of decline is associated with PARDS severity. HRQL decline from baseline may be an efficient and clinically meaningful endpoint to incorporate into PARDS clinical trials.

Social Determinants of Health and Health-Related Quality of Life following Pediatric Septic Shock: Secondary Analysis of the Life After Pediatric Sepsis Evaluation Dataset, 2014-2017.

OBJECTIVES: Social determinants of health (SDOH) are associated with disparities in disease severity and in-hospital outcomes among critically ill children. It is unknown whether SDOH are associated with later outcomes. We evaluated associations between SDOH measures and mortality, new functional morbidity, and health-related quality of life (HRQL) decline among children surviving septic shock. DESIGN: Secondary analysis of the Life After Pediatric Sepsis Evaluation (LAPSE) prospective cohort study was conducted between 2014 and 2017. SETTING: Twelve academic U.S. PICUs were involved in the study. PATIENTS: Children younger than 18 years with community-acquired septic shock were involved in the study. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We assessed associations between race, ethnicity, income, education, marital status, insurance, language, and home U.S. postal code with day 28 mortality, new functional morbidity at discharge per day 28, and HRQL decline using logistic regression. Of 389 patients, 32% (n = 98) of families had household income less than $50,000 per year. Median Pediatric Risk of Mortality (PRISM) score was 11 (interquartile range 6, 17). We found that English language and Area Deprivation Index less than 50th percentile were associated with higher PRISM scores. Mortality was 6.7% (n = 26), new functional morbidity occurred in 21.8% (n = 78) of patients, and HRQL decline by greater than 10% occurred in 31.0% of patients (n = 63). We failed to identify any association between SDOH measures and mortality, new functional morbidity, or HRQL decline. We are unable to exclude the possibility that annual household income greater than or equal to $50,000 was associated with up to 81% lesser odds of mortality and, in survivors, more than three-fold greater odds of HRQL decline by greater than 10%. CONCLUSIONS: In this secondary analysis of the 2014-2017 LAPSE dataset, we failed to identify any association between SDOH measures and in-hospital or postdischarge outcomes following pediatric septic shock. This finding may be reflective of the high illness severity and single disease (sepsis) of the cohort, with contribution of clinical factors to functional and HRQL outcomes predominating over prehospital and posthospital SDOH factors.

Design and rationale of the Post-Intensive Care Syndrome - paediatrics (PICS-p) Longitudinal Cohort Study.

INTRODUCTION: As paediatric intensive care unit (PICU) mortality declines, there is growing recognition of the morbidity experienced by children surviving critical illness and their families. A comprehensive understanding of the adverse physical, cognitive, emotional and social sequelae common to PICU survivors is limited, however, and the trajectory of recovery and risk factors for morbidity remain unknown. METHODS AND ANALYSIS: The Post-Intensive Care Syndrome - paediatrics Longitudinal Cohort Study will evaluate child and family outcomes over 2 years following PICU discharge and identify child and clinical factors associated with impaired outcomes. We will enrol 750 children from 30 US PICUs during their first PICU hospitalisation, including 500 case participants experiencing ≥3 days of intensive care that include critical care therapies (eg, mechanical ventilation, vasoactive infusions) and 250 age-matched, sex-matched and medical complexity-matched control participants experiencing a single night in the PICU with no intensive care therapies. Children, parents and siblings will complete surveys about health-related quality of life, physical function, cognitive status, emotional health and peer and family relationships at multiple time points from baseline recall through 2 years post-PICU discharge. We will compare outcomes and recovery trajectories of case participants to control participants, identify risk factors associated with poor outcomes and determine the emotional and social health consequences of paediatric critical illness on parents and siblings. ETHICS AND DISSEMINATION: This study has received ethical approval from the University of Pennsylvania Institutional Review Board (protocol #843844). Our overall objective is to characterise the ongoing impact of paediatric critical illness to guide development of interventions that optimise outcomes among children surviving critical illness and their families. Findings will be presented at key disciplinary meetings and in peer-reviewed publications at fixed data points. Published manuscripts will be added to our public study website to ensure findings are available to families, clinicians and researchers. TRIALS REGISTRATION NUMBER: NCT04967365.

Family Presence at the PICU Bedside: A Single-Center Retrospective Cohort Study.

OBJECTIVES: To determine factors associated with bedside family presence in the PICU and to understand how individual factors interact as barriers to family presence. DESIGN: Mixed methods study. SETTING: Tertiary children's hospital PICU. SUBJECTS: Five hundred twenty-three children of less than 18 years enrolled in the Seattle Children's Hospital Outcomes Assessment Program from 2011 to 2017. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Quantitative: Family was documented every 2 hours. Exposures included patient and illness characteristics and family demographic and socioeconomic characteristics. We used multivariable logistic regression to identify factors associated with presence of less than 80% and stratified results by self-reported race. Longer PICU length of stay (LOS), public insurance, and complex chronic conditions (C-CD) were associated with family presence of less than 80%. Self-reported race modified these associations; no factors were associated with lower bedside presence for White families, in contrast with multiple associations for non-White families including public insurance, C-CD, and longer LOS. Qualitative: Thematic analysis of social work notes for the 48 patients with family presence of less than 80% matched on age, LOS, and diagnosis to 48 patients with greater than or equal to 95% family presence. Three themes emerged: the primary caregiver's prior experiences with the hospital, relationships outside of the hospital, and additional stressors during the hospitalization affected bedside presence. CONCLUSIONS: We identified sociodemographic and illness factors associated with family bedside presence in the PICU. Self-reported race modified these associations, representing racism within healthcare. Family presence at the bedside may help identify families facing greater disparities in healthcare access.

Noninvasive Ventilation for Pediatric Acute Respiratory Distress Syndrome: Experience From the 2016/2017 Pediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology Prospective Cohort Study.

OBJECTIVES: The worldwide practice and impact of noninvasive ventilation (NIV) in pediatric acute respiratory distress syndrome (PARDS) is unknown. We sought to describe NIV use and associated clinical outcomes in PARDS. DESIGN: Planned ancillary study to the 2016/2017 prospective Pediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology study. SETTING: One hundred five international PICUs. PATIENTS: Patients with newly diagnosed PARDS admitted during 10 study weeks. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Children were categorized by their respiratory support at PARDS diagnosis into NIV or invasive mechanical ventilation (IMV) groups. Of 708 subjects with PARDS, 160 patients (23%) received NIV at PARDS diagnosis (NIV group). NIV failure rate (defined as tracheal intubation or death) was 84 of 160 patients (53%). Higher nonrespiratory pediatric logistic organ dysfunction (PELOD-2) score, Pa o2 /F io2 was less than 100 at PARDS diagnosis, immunosuppression, and male sex were independently associated with NIV failure. NIV failure was 100% among patients with nonrespiratory PELOD-2 score greater than 2, Pa o2 /F io2 less than 100, and immunosuppression all present. Among patients with Pa o2 /F io2 greater than 100, children in the NIV group had shorter total duration of NIV and IMV, than the IMV at initial diagnosis group. We failed to identify associations between NIV use and PICU survival in a multivariable Cox regression analysis (hazard ratio 1.04 [95% CI, 0.61-1.80]) or mortality in a propensity score matched analysis ( p = 0.369). CONCLUSIONS: Use of NIV at PARDS diagnosis was associated with shorter exposure to IMV in children with mild to moderate hypoxemia. Even though risk of NIV failure was high in some children, we failed to identify greater hazard of mortality in these patients.

Predicting functional and quality-of-life outcomes following pediatric sepsis: performance of PRISM-III and PELOD-2.

BACKGROUND: Illness severity scores predict mortality following pediatric critical illness. Given declining PICU mortality, we assessed the ability of the Pediatric Risk of Mortality-III (PRISM) and Pediatric Logistic Organ Dysfunction-2 (PELOD) scores to predict morbidity outcomes. METHODS: Among 359 survivors <18 years in the Life After Pediatric Sepsis Evaluation multicenter prospective cohort study, we assessed functional morbidity at hospital discharge (Functional Status Scale increase ≥3 points from baseline) and health-related quality of life (HRQL; Pediatric Quality of Life Inventory or Functional Status II-R) deterioration >25% from baseline at 1, 3, 6, and 12 months post-admission. We determined discrimination of admission PRISM and admission, maximum, and cumulative 28-day PELOD with functional and HRQL morbidity at each timepoint. RESULTS: Cumulative PELOD provided the best discrimination of discharge functional morbidity (area under the receive operating characteristics curve [AUROC] 0.81, 95% CI 0.76-0.87) and 3-month HRQL deterioration (AUROC 0.71, 95% CI 0.61-0.81). Prediction was inferior for admission PRISM and PELOD and for 6- and 12-month HRQL assessments. CONCLUSIONS: Illness severity scores have a good prediction of early functional morbidity but a more limited ability to predict longer-term HRQL. Identification of factors beyond illness severity that contribute to HRQL outcomes may offer opportunities for intervention to improve outcomes. IMPACT: Illness severity scores are commonly used for mortality prediction and risk stratification in pediatric critical care research, quality improvement, and resource allocation algorithms. Prediction of morbidity rather than mortality may be beneficial given declining pediatric intensive care unit mortality. The PRISM and PELOD scores have moderate to good ability to predict new functional morbidity at hospital discharge following pediatric septic shock but limited ability to predict health-related quality of life outcomes in the year following PICU admission. Further research is needed to identify additional factors beyond illness severity that may impact post-discharge health-related quality of life.

Epidemiology of Intensive Care Admissions for Children in the US From 2001 to 2019.

Importance: Estimates of the number of US children receiving intensive care unit (ICU) care and ICU admission patterns over time are lacking. Objective: To determine how ICU admission patterns, use of critical care services, and the characteristics and outcomes of critically ill children have changed from 2001 to 2019. Design, Setting, and Participants: This population-based retrospective cohort study used data from the Healthcare Cost and Utilization Project's state inpatient databases from a total of 21 US states in 2001, 2004, 2010, 2016, and 2019. Hospitalized children aged 0 to 17 years, excluding newborns (during birth hospitalization), were included. Patients admitted to rehabilitation institutions or psychiatric hospitals were also excluded. Data were analyzed from July 2021 to December 2022. Exposures: Care in a nonneonatal ICU. Main Outcomes and Measures: From extracted patient data, International Classification of Diseases, Ninth Revision, Clinical Modification, and Tenth Revision, Clinical Modification, codes were used to identify diagnoses, comorbid conditions, organ failures, and mechanical ventilation. Generalized linear Poisson regression and the Cuzick test were used to evaluate trends. US Census data were used to generate age- and sex-adjusted national estimates of ICU admissions and costs. Results: Of 2 157 991 pediatric admissions, 275 656 (12.8%) included ICU care. The mean (SD) age was 6.43 (6.10) years; 121 894 individuals were female (44.2%), and 153 731 were male (55.8%). From 2001 to 2019, the prevalence of ICU care among hospitalized children increased from 10.6% to 15.5%. The percentage of ICU admissions in children's hospitals rose from 51.2% to 85.1% (relative risk [RR], 1.66; 95% CI, 1.64-1.68). The percentage of children admitted to an ICU with an underlying comorbidity increased from 46.2% to 57.0% (RR, 1.23; 95% CI, 1.22-1.25), and the percentage with preadmission technology dependence increased from 16.4% to 23.5% (RR, 1.44; 95% CI, 1.40-1.48). The prevalence of multiple organ dysfunction syndrome increased from 6.8% to 21.0% (RR, 3.12; 95% CI, 2.98-3.26), while mortality decreased from 2.5% to 1.8% (RR, 0.72; 95% CI, 0.66-0.79). Hospital length of stay increased by 0.96 days (95% CI, 0.73-1.18) for ICU admissions from 2001 to 2019. After inflation adjustment, total costs for a pediatric admission involving ICU care nearly doubled between 2001 and 2019. Nationally, an estimated 239 000 children were admitted to a US ICU in 2019, corresponding to $11.6 billion in hospital costs. Conclusions and Relevance: In this study, the prevalence of children receiving ICU care in the US increased, as did length of stay, technology use, and associated costs. The US health care system must be equipped to care for these children in the future.

Variation in tracheostomy placement and outcomes following pediatric trauma among adult, pediatric, and combined trauma centers.

BACKGROUND: Tracheostomy placement is much more common in adults than children following severe trauma. We evaluated whether tracheostomy rates and outcomes differ for pediatric patients treated at trauma centers that primarily care for children versus adults. METHODS: We conducted a retrospective cohort study of patients younger than 18 years in the National Trauma Data Bank from 2007 to 2016 treated at a Level I/II pediatric, adult, or combined adult/pediatric trauma center, ventilated >24 hours, and who survived to discharge. We used multivariable logistic regression adjusted for age, insurance, injury mechanism and body region, and Injury Severity Score to estimate the association between the three trauma center types and tracheostomy. We used augmented inverse probability weighting to model the likelihood of tracheostomy based on the propensity for treatment at a pediatric, adult, or combined trauma center, and estimated associations between trauma center type with length of stay and postdischarge care. RESULTS: Among 33,602 children, tracheostomies were performed in 4.2% of children in pediatric centers, 7.8% in combined centers (adjusted odds ratio [aOR], 1.47; 95% confidence interval [CI], 1.20-1.81), and 11.2% in adult centers (aOR, 1.81; 95% CI, 1.48-2.22). After propensity matching, the estimated average tracheostomy rate would be 62.9% higher (95% CI, 37.7-88.1%) at combined centers and 85.3% higher (56.6-113.9%) at adult centers relative to pediatric centers. Tracheostomy patients had longer hospital stay in pediatric centers than combined (-4.4 days, -7.4 to -1.3 days) or adult (-4.0 days, -7.2 to -0.9 days) centers, but fewer children required postdischarge inpatient care (70.1% pediatric vs. 81.3% combined [aOR, 2.11; 95% CI, 1.03-4.31] and 82.4% adult centers [aOR, 2.51; 95% CI, 1.31-4.83]). CONCLUSION: Children treated at pediatric trauma centers have lower likelihood of tracheostomy than children treated at combined adult/pediatric or adult centers independent of patient or injury characteristics. Better understanding of optimal indications for tracheostomy is necessary to improve processes of care for children treated throughout the pediatric trauma system. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level III.

Executive Summary of the Second International Guidelines for the Diagnosis and Management of Pediatric Acute Respiratory Distress Syndrome (PALICC-2).

OBJECTIVES: We sought to update our 2015 work in the Second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) guidelines for the diagnosis and management of pediatric acute respiratory distress syndrome (PARDS), considering new evidence and topic areas that were not previously addressed. DESIGN: International consensus conference series involving 52 multidisciplinary international content experts in PARDS and four methodology experts from 15 countries, using consensus conference methodology, and implementation science. SETTING: Not applicable. PATIENTS: Patients with or at risk for PARDS. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Eleven subgroups conducted systematic or scoping reviews addressing 11 topic areas: 1) definition, incidence, and epidemiology; 2) pathobiology, severity, and risk stratification; 3) ventilatory support; 4) pulmonary-specific ancillary treatment; 5) nonpulmonary treatment; 6) monitoring; 7) noninvasive respiratory support; 8) extracorporeal support; 9) morbidity and long-term outcomes; 10) clinical informatics and data science; and 11) resource-limited settings. The search included MEDLINE, EMBASE, and CINAHL Complete (EBSCOhost) and was updated in March 2022. Grading of Recommendations, Assessment, Development, and Evaluation methodology was used to summarize evidence and develop the recommendations, which were discussed and voted on by all PALICC-2 experts. There were 146 recommendations and statements, including: 34 recommendations for clinical practice; 112 consensus-based statements with 18 on PARDS definition, 55 on good practice, seven on policy, and 32 on research. All recommendations and statements had agreement greater than 80%. CONCLUSIONS: PALICC-2 recommendations and consensus-based statements should facilitate the implementation and adherence to the best clinical practice in patients with PARDS. These results will also inform the development of future programs of research that are crucially needed to provide stronger evidence to guide the pediatric critical care teams managing these patients.

Defining Pediatric Chronic Critical Illness: A Scoping Review.

OBJECTIVES: Children with chronic critical illness (CCI) are hypothesized to be a high-risk patient population with persistent multiple organ dysfunction and functional morbidities resulting in recurrent or prolonged critical care; however, it is unclear how CCI should be defined. The aim of this scoping review was to evaluate the existing literature for case definitions of pediatric CCI and case definitions of prolonged PICU admission and to explore the methodologies used to derive these definitions. DATA SOURCES: Four electronic databases (Ovid Medline, Embase, CINAHL, and Web of Science) from inception to March 3, 2021. STUDY SELECTION: We included studies that provided a specific case definition for CCI or prolonged PICU admission. Crowdsourcing was used to screen citations independently and in duplicate. A machine-learning algorithm was developed and validated using 6,284 citations assessed in duplicate by trained crowd reviewers. A hybrid of crowdsourcing and machine-learning methods was used to complete the remaining citation screening. DATA EXTRACTION: We extracted details of case definitions, study demographics, participant characteristics, and outcomes assessed. DATA SYNTHESIS: Sixty-seven studies were included. Twelve studies (18%) provided a definition for CCI that included concepts of PICU length of stay (n = 12), medical complexity or chronic conditions (n = 9), recurrent admissions (n = 9), technology dependence (n = 5), and uncertain prognosis (n = 1). Definitions were commonly referenced from another source (n = 6) or opinion-based (n = 5). The remaining 55 studies (82%) provided a definition for prolonged PICU admission, most frequently greater than or equal to 14 (n = 11) or greater than or equal to 28 days (n = 10). Most of these definitions were derived by investigator opinion (n = 24) or statistical method (n = 18). CONCLUSIONS: Pediatric CCI has been variably defined with regard to the concepts of patient complexity and chronicity of critical illness. A consensus definition is needed to advance this emerging and important area of pediatric critical care research.

Outcomes of Children Surviving Pediatric Acute Respiratory Distress Syndrome: From the Second Pediatric Acute Lung Injury Consensus Conference.

OBJECTIVES: To summarize the evidence for the Second Pediatric Acute Lung Injury Consensus Conference-2 (PALICC-2) recommendations for assessment of outcomes among patients surviving pediatric acute respiratory distress syndrome (PARDS). DATA SOURCES: MEDLINE (Ovid), Embase (Elsevier), and CINAHL Complete (EBSCOhost). STUDY SELECTION: We conducted a scoping review to identify studies evaluating outcomes following PARDS. We included studies of survivors of PARDS, acute respiratory failure with a high proportion of PARDS patients, or other critical illnesses if PARDS-specific outcomes could be extracted. DATA EXTRACTION: Title/abstract review, full-text review, and data extraction using a standardized data collection form. DATA SYNTHESIS: The Grading of Recommendations Assessment, Development and Evaluation approach was used to identify and summarize evidence and develop recommendations. Of 8,037 abstracts screened, we identified 20 articles for inclusion. Morbidity following PARDS was common and affected multiple domains of pulmonary and nonpulmonary function. There was insufficient evidence to generate any evidence-based recommendations. We generated eight good practice statements and five research statements. A panel of 52 experts discussed each proposed good practice statement and research statement, and the agreement rate was measured with an online voting process. Good practice statements describe the approach to clinical outcome assessment, assessment of pulmonary outcomes of children surviving PARDS, and assessment of nonpulmonary outcomes of children surviving PARDS including health-related quality of life and physical, neurocognitive, emotional, family, and social functioning. The five research statements relate to assessment of patient preillness status, use of postdischarge endpoints for clinical trials, the association between short-term and longer term outcomes, the trajectory of recovery following PARDS, and practices to optimize follow-up. CONCLUSIONS: There is increasing evidence that children are at risk for impairments across a range of pulmonary and nonpulmonary health domains following hospitalization for PARDS. The results of this extensive scoping review and consensus conference involving experts in PARDS research, clinical care, and outcomes assessment provide guidance to clinicians and researchers on postdischarge follow-up to optimize the long-term health of patients surviving PARDS.

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.

Association of Illness Severity With Family Outcomes Following Pediatric Septic Shock.

It is unknown which families are at risk for poor outcomes following a child's critical illness. OBJECTIVES: To evaluate if pediatric septic shock severity is associated with caregiver distress and family dysfunction throughout the year postadmission and if caregiver outcomes are associated with child health-related quality of life (HRQL). DESIGN SETTING AND PARTICIPANTS: Secondary analysis of the Life After Pediatric Sepsis Evaluation prospective cohort study among children less than 18 years old with community-acquired septic shock requiring vasoactive-inotropic support and invasive or noninvasive ventilation in 12 academic U.S. PICUs. MAIN OUTCOMES AND MEASURES: Caregivers reported personal psychologic distress (Brief Symptom Inventory), family functioning (Family Assessment Device), and child HRQL (Pediatric Quality of Life Inventory, Functional Status II-Revised) at baseline and 1, 3, 6, and 12 months following PICU admission. RESULTS: Among 276 caregivers, psychologic distress prevalence initially decreased then rose to 15.3%, whereas prevalence of family dysfunction increased steadily to 30.9% at 12 months. On multivariable logistic regression adjusting for patient age, medical complexity, and immunosuppression, higher Pediatric Risk of Mortality and vasoactive-inotropic scores and longer PICU and hospital stay were associated with greater caregiver distress at 1 month. Higher Pediatric Logistic Organ Dysfunction (PELOD) score, longer ventilation, and longer PICU stay were associated with lower odds of family dysfunction at 1, 3, and 6 months (average PELOD vs new 6-mo dysfunction: odds ratio [OR], 0.73 [95% CI, 0.55-0.96]). Caregiver distress was associated with child HRQL decline from baseline to 1 month (OR, 2.92 [1.27-6.75]), 3 months (OR, 2.34 [1.01-5.42]), and 12 months (OR, 3.94 [1.54-10.06]). CONCLUSIONS AND RELEVANCE: Family dysfunction becomes increasingly prevalent over the year following pediatric septic shock and is less likely following higher severity illness. Caregiver psychologic distress is associated with worse child HRQL. Both patients and families may benefit from ongoing psychosocial support following survival from pediatric septic shock.

A Clinician's Guide to Conducting Research on Causal Effects.

Surgeons are uniquely poised to conduct research to improve patient care, yet a gap often exists between the clinician's desire to guide patient care with causal evidence and having adequate training necessary to produce causal evidence. This guide aims to address this gap by providing clinically relevant examples to illustrate necessary assumptions required for clinical research to produce causal estimates.