Publications by authors named "Martha A Q Curley"

137 Publications

Enabling a learning healthcare system with automated computer protocols that produce replicable and personalized clinician actions.

J Am Med Inform Assoc 2021 Feb 16. Epub 2021 Feb 16.

Institute for Healthcare Improvement, Boston, Massachusetts, USA.

Clinical decision-making is based on knowledge, expertise, and authority, with clinicians approving almost every intervention-the starting point for delivery of "All the right care, but only the right care," an unachieved healthcare quality improvement goal. Unaided clinicians suffer from human cognitive limitations and biases when decisions are based only on their training, expertise, and experience. Electronic health records (EHRs) could improve healthcare with robust decision-support tools that reduce unwarranted variation of clinician decisions and actions. Current EHRs, focused on results review, documentation, and accounting, are awkward, time-consuming, and contribute to clinician stress and burnout. Decision-support tools could reduce clinician burden and enable replicable clinician decisions and actions that personalize patient care. Most current clinical decision-support tools or aids lack detail and neither reduce burden nor enable replicable actions. Clinicians must provide subjective interpretation and missing logic, thus introducing personal biases and mindless, unwarranted, variation from evidence-based practice. Replicability occurs when different clinicians, with the same patient information and context, come to the same decision and action. We propose a feasible subset of therapeutic decision-support tools based on credible clinical outcome evidence: computer protocols leading to replicable clinician actions (eActions). eActions enable different clinicians to make consistent decisions and actions when faced with the same patient input data. eActions embrace good everyday decision-making informed by evidence, experience, EHR data, and individual patient status. eActions can reduce unwarranted variation, increase quality of clinical care and research, reduce EHR noise, and could enable a learning healthcare system.
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http://dx.doi.org/10.1093/jamia/ocaa294DOI Listing
February 2021

The Impact of Preintubation Noninvasive Ventilation on Outcomes in Pediatric Acute Respiratory Distress Syndrome.

Crit Care Med 2021 Feb 15. Epub 2021 Feb 15.

Department of Pediatrics, Sacred Hearts Children's Hospital, Spokane, WA. Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI. Section of, Critical Care, Children's Hospital of Wisconsin, Milwaukee, WI. Department of Cardiology, Boston Children's Hospital, Boston, MA. Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL. Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA. Department of Pediatrics, Harvard Medical School, Boston, MA. Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA. Department of Anesthesia and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Research Institute, Children's Hospital of Philadelphia, Philadelphia, PA.

Objectives: There is evidence that noninvasive ventilation decreases the need for invasive mechanical ventilation. However, children with pediatric acute respiratory distress syndrome who fail noninvasive ventilation may have worse outcomes than those who are intubated without exposure to noninvasive ventilation. Our objective was to evaluate the impact of preintubation noninvasive ventilation on children with pediatric acute respiratory distress syndrome.

Design: Secondary analysis of data from the Randomized Evaluation of Sedation Titration for Respiratory Failure trial.

Setting: Thirty-one PICUs in the United States.

Patients: Children 2 weeks to 17 years old with pediatric acute respiratory distress syndrome receiving invasive mechanical ventilation, excluding those admitted with tracheostomies.

Interventions: None.

Measurements And Main Results: Of 2,427 subjects receiving invasive mechanical ventilation, preintubation noninvasive ventilation was used in 995 (41%). Compared with subjects without preintubation noninvasive ventilation use, subjects with preintubation noninvasive ventilation use were more likely to have a history of seizures (10% vs 8%; p = 0.04) or cancer (11% vs 6%; p < 0.001) and have moderate or severe pediatric acute respiratory distress syndrome by the end of their first full day of invasive mechanical ventilation (68% vs 60%; p < 0.001). Adjusting for age, severity of illness on PICU admission, and baseline functional status, preintubation noninvasive ventilation use resulted in longer invasive mechanical ventilation duration (median 7.0 vs 6.0 d), longer PICU (10.8 vs 8.9 d), and hospital (17 vs 14 d) lengths of stay, and higher 28-day (5% vs 4%) and 90-day (8% vs 5%) inhospital mortalities (all comparisons p < 0.001). Longer duration of noninvasive ventilation before intubation was associated with worse outcomes.

Conclusions: In children with pediatric acute respiratory distress syndrome, preintubation noninvasive ventilation use is associated with worse outcomes when compared with no preintubation noninvasive ventilation use. These data can be used to inform the design of clinical studies to evaluate best noninvasive ventilation practices in children with pediatric acute respiratory distress syndrome.
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http://dx.doi.org/10.1097/CCM.0000000000004819DOI Listing
February 2021

Nurses' Perceptions of Workload Burden in Pediatric Critical Care.

Am J Crit Care 2021 01;30(1):27-35

Martha A. Q. Curley is the Ruth M. Colket Endowed Chair in Pediatric Nursing, Department of Family and Community Health, School of Nursing, University of Pennsylvania, Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, and Research Institute, Children's Hospital of Philadelphia.

Background: Quantifying nurses' perceptions of workload burden when managing critically ill patients is essential for designing interventions to ease nurses' workday.

Objectives: To explore pediatric intensive care unit (PICU) nurses' perceptions of their workload when caring for critically ill patients and managing protocolized therapies.

Methods: This study was embedded in a multicenter randomized clinical trial where participants were assigned to receive either lower-target or higher-target glucose control. Nurses from 35 participating PICUs completed a baseline survey containing questions about their perceptions of PICU workload in general. They completed an intervention survey after caring for a study patient. Two workload measurement instruments, the Subjective Workload Assessment Technique (SWAT) and the National Aeronautics and Space Administration-Task Load Index (NASA-TLX), were embedded in these surveys.

Results: Baseline surveys were completed by 1476 PICU nurses, predominantly female with a bachelor's degree and a median (interquartile range) of 6 (3-11) years of nursing experience and 4 (2-9) years of PICU experience. Most nurses (65%) rated time burden as the most important component of their workload, followed by cognitive (22%) or psychological stress (13%) burden. Work performance was selected most often as contributing to workload, followed by cognitive demand, time pressure, effort, and physical demand. Intervention surveys were completed by 73% of enrolled participants (505 of 693). Nurses managing the lower glucose target group reported higher levels of workload burden as measured by the SWAT (P = .002) and NASA-TLX (P < .001).

Conclusions: This study describes the workload burden perceived by PICU nurses when managing critically ill patients in general and when managing protocolized therapies.
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http://dx.doi.org/10.4037/ajcc2021725DOI Listing
January 2021

Phenotypes and personalized medicine in the acute respiratory distress syndrome.

Intensive Care Med 2020 12 18;46(12):2136-2152. Epub 2020 Nov 18.

Department of Anesthesia, University of California San Francisco, San Francisco, CA, USA.

Although the acute respiratory distress syndrome (ARDS) is well defined by the development of acute hypoxemia, bilateral infiltrates and non-cardiogenic pulmonary edema, ARDS is heterogeneous in terms of clinical risk factors, physiology of lung injury, microbiology, and biology, potentially explaining why pharmacologic therapies have been mostly unsuccessful in treating ARDS. Identifying phenotypes of ARDS and integrating this information into patient selection for clinical trials may increase the chance for efficacy with new treatments. In this review, we focus on classifying ARDS by the associated clinical disorders, physiological data, and radiographic imaging. We consider biologic phenotypes, including plasma protein biomarkers, gene expression, and common causative microbiologic pathogens. We will also discuss the issue of focusing clinical trials on the patient's phase of lung injury, including prevention, administration of therapy during early acute lung injury, and treatment of established ARDS. A more in depth understanding of the interplay of these variables in ARDS should provide more success in designing and conducting clinical trials and achieving the goal of personalized medicine.
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http://dx.doi.org/10.1007/s00134-020-06296-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673253PMC
December 2020

Prevalence of ICU Delirium in Postoperative Pediatric Cardiac Surgery Patients.

Pediatr Crit Care Med 2021 Jan;22(1):68-78

University of California San Francisco, School of Nursing, San Francisco, CA.

Objectives: The objective of this study was to determine the prevalence of ICU delirium in children less than 18 years old that underwent cardiac surgery within the last 30 days. The secondary aim of the study was to identify risk factors associated with ICU delirium in postoperative pediatric cardiac surgical patients.

Design: A 1-day, multicenter point-prevalence study of delirium in pediatric postoperative cardiac surgery patients.

Setting: Twenty-seven pediatric cardiac and general critical care units caring for postoperative pediatric cardiac surgery patients in North America.

Patients: All children less than 18 years old hospitalized in the cardiac critical care units at 06:00 on a randomly selected, study day.

Interventions: Eligible children were screened for delirium using the Cornell Assessment of Pediatric Delirium by the study team in collaboration with the bedside nurse.

Measurement And Main Results: Overall, 181 patients were enrolled and 40% (n = 73) screened positive for delirium. There were no statistically significant differences in patient demographic information, severity of defect or surgical procedure, past medical history, or postoperative day between patients screening positive or negative for delirium. Our bivariate analysis found those patients screening positive had a longer duration of mechanical ventilation (12.8 vs 5.1 d; p = 0.02); required more vasoactive support (55% vs 26%; p = 0.0009); and had a higher number of invasive catheters (4 vs 3 catheters; p = 0.001). Delirium-positive patients received more total opioid exposure (1.80 vs 0.36 mg/kg/d of morphine equivalents; p < 0.001), did not have an ambulation or physical therapy schedule (p = 0.02), had not been out of bed in the previous 24 hours (p < 0.0002), and parents were not at the bedside at time of data collection (p = 0.008). In the mixed-effects logistic regression analysis of modifiable risk factors, the following variables were associated with a positive delirium screen: 1) pain score, per point increase (odds ratio, 1.3; 1.06-1.60); 2) total opioid exposure, per mg/kg/d increase (odds ratio, 1.35; 1.06-1.73); 3) SBS less than 0 (odds ratio, 4.01; 1.21-13.27); 4) pain medication or sedative administered in the previous 4 hours (odds ratio, 3.49; 1.32-9.28); 5) no progressive physical therapy or ambulation schedule in their medical record (odds ratio, 4.40; 1.41-13.68); and 6) parents not at bedside at time of data collection (odds ratio, 2.31; 1.01-5.31).

Conclusions: We found delirium to be a common problem after cardiac surgery with several important modifiable risk factors.
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http://dx.doi.org/10.1097/PCC.0000000000002591DOI Listing
January 2021

A Core Outcome Set for Pediatric Critical Care.

Crit Care Med 2020 Dec;48(12):1819-1828

1Department of Critical Care Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA. 2Department of Pediatrics, Critical Care Medicine, University of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO. 3Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA. 4Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT. 5Department of Molecular Biology, Princeton University, Princeton, NJ. 6Department of Pediatrics, Children's National Hospital, Washington, DC. 7Department of Pediatrics, Children's Hospital of Michigan, Detroit, MI. 8Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH. 9Department of Pediatrics, Mattel Children's Hospital, University of California Los Angeles, Los Angeles, CA. 10Department of Pediatrics, Benioff Children's Hospital, University of California, San Francisco, San Francisco, CA. 11Collaborative Pediatric Critical Care Research Network Family Collaborative, Great Falls, VA. 12Department of Paediatrics and Child Health, University of Cape Town, and Red Cross War Memorial Children's Hospital, Cape Town, South Africa. 13Department of Pediatrics, University of São Paulo, São Paulo, Brazil. 14Intensive Care Department of Paediatrics, The Royal Childrens Hospital, Melbourne, VIC, Australia. 15Departments of Pediatrics and Critical Care, McMaster University, Hamilton, ON, Canada. 16Department of Family and Community Health (Nursing), Anesthesiology and Critical Care (Perelman School of Medicine), University of Pennsylvania; Research Institute, Children's Hospital of Philadelphia, Philadelphia, PA. 17Department of Pediatric Critical Care, Hospital de Niños Dr R. Gutierrez, Buenos Aires, Argentina. 18Department of Pediatric Intensive Care, Istanbul University, Child Health Institute and Istanbul Faculty of Medicine, Istanbul, Turkey. 19Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA. 20Department of Paediatrics, Centrum Universiteit van Amsterdam, Amsterdam, The Netherlands. 21Department of Pediatric Subspecialities, KK Women's and Children's Hospital, Singapore. 22School of Nursing, Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, QLD, Australia. 23Children and Young People Health Research, School of Health Sciences, University of Nottingham and Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom. 24Department of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa. 25Department of Pediatrics, All India Institute of Medical Sciences, Chandigarh, India. 26Department of Neuropsychology, Kennedy Krieger Institute and Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD. 27Department of Pediatrics, University of Washington School of Medicine and Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA.

Objectives: More children are surviving critical illness but are at risk of residual or new health conditions. An evidence-informed and stakeholder-recommended core outcome set is lacking for pediatric critical care outcomes. Our objective was to create a multinational, multistakeholder-recommended pediatric critical care core outcome set for inclusion in clinical and research programs.

Design: A two-round modified Delphi electronic survey was conducted with 333 invited research, clinical, and family/advocate stakeholders. Stakeholders completing the first round were invited to participate in the second. Outcomes scoring greater than 69% "critical" and less than 15% "not important" advanced to round 2 with write-in outcomes considered. The Steering Committee held a virtual consensus conference to determine the final components.

Setting: Multinational survey.

Patients: Stakeholder participants from six continents representing clinicians, researchers, and family/advocates.

Measurements And Main Results: Overall response rates were 75% and 82% for each round. Participants voted on seven Global Domains and 45 Specific Outcomes in round 1, and six Global Domains and 30 Specific Outcomes in round 2. Using overall (three stakeholder groups combined) results, consensus was defined as outcomes scoring greater than 90% "critical" and less than 15% "not important" and were included in the final PICU core outcome set: four Global Domains (Cognitive, Emotional, Physical, and Overall Health) and four Specific Outcomes (Child Health-Related Quality of Life, Pain, Survival, and Communication). Families (n = 21) suggested additional critically important outcomes that did not meet consensus, which were included in the PICU core outcome set-extended.

Conclusions: The PICU core outcome set and PICU core outcome set-extended are multistakeholder-recommended resources for clinical and research programs that seek to improve outcomes for children with critical illness and their families.
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http://dx.doi.org/10.1097/CCM.0000000000004660DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785252PMC
December 2020

Are Mothers Certain About Their Perceptions of Recalled Infant Feeding History?

J Pediatr Health Care 2020 Oct 2. Epub 2020 Oct 2.

Introduction: Maternal recall of infant feeding, a potential measurement bias, is used to identify the relationship between mothers' own milk (MOM) feeding and subsequent health outcomes. This study describes maternal recall certainty of MOM feedings at four time periods.

Method: In this secondary analysis, mothers of children ages 4-36 months describe infants' MOM feeding and rate certainty of their recall.

Results: MOM was the first feeding for 78.5% of infants and received by 83% the first week, 85% the first month, and 62% the fourth month. Ratings of recall certainty were > 95% for each time period. Recall certainty was significantly different for four time periods (χ = 9.67, p = 0.02), with no two periods significantly different in post hoc analyses.

Discussion: Maternal recall certainty of infant feeding was high regardless of elapsed time. Measuring maternal recall certainty may be useful in clinical practice and studies linking MOM exposure to subsequent health outcomes.
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http://dx.doi.org/10.1016/j.pedhc.2020.09.002DOI Listing
October 2020

Medical Device-Related Pressure Injuries in Infants and Children.

J Wound Ostomy Continence Nurs 2020 Sep/Oct;47(5):459-469

Judith J. Stellar, MSN, CRNP, PPCNP-BC, CWOCN, Department of Nursing and General Surgery, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. Natalie R. Hasbani, MPH, Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts. Lindyce A. Kulik, PhD, RN, CWON, Cardiovascular Nursing Patient Services, Boston Children's Hospital, Boston, Massachusetts. Stacey S. Shelley, RN, DNP, Intermountain Healthcare, Salt Lake City, Utah. Sandy Quigley, RN, MSN, CPNP, CWOCN, Department of Nursing and Patient Care Services, Boston Children's Hospital, Boston, Massachusetts. David Wypij, PhD, Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. Martha A. Q. Curley, PhD, RN, FAAN, Department of Family and Community Health, School of Nursing, and Department of Anesthesia and Critical Care, Perelman School of Medicine, University of Pennsylvania and the Research Institute, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

Purpose: The purpose of this study was to describe medical device-related pressure injuries (MDRPIs) in hospitalized pediatric patients.

Design: A prospective, descriptive study.

Sample/subjects And Setting: The sample comprised 625 patients cared for in 8 US pediatric hospitals. Participants were aged preterm to 21 years, on bed rest for at least 24 hours, and had a medical device in place.

Methods: Two nursing teams, blinded to the other's assessments, worked in tandem to assess pressure injury risk, type of medical devices in use, and preventive interventions for each medical device. They also identified the presence, location, and stage of MDRPI. Subjects were observed up to 8 times over 4 weeks, or until discharge, whichever occurred first.

Results: Of 625 enrolled patients, 42 (7%) developed 1 or more MDRPIs. Two-thirds of patients with MDRPIs were younger than 8 years. Patients experiencing MDRPIs had higher acuity scores on hospital admission, were more frequently cognitively and/or functionally impaired, or were extreme in body mass index. Respiratory devices caused the most injuries (6.19/1000 device-days), followed by immobilizers (2.40/1000 device-days), gastric tubes (2.24/1000 device-days), and external monitoring devices (1.77/1000 device-days). Of the 6336 devices in place, 36% did not have an MDRPI preventive intervention in place. Clinical variables contributing to MDRPI development included intensive care unit care (odds ratio [OR] 8.9, 95% confidence interval [CI] 1.9-43.6), use of neuromuscular blockade (OR 3.7, 95% CI 1.7-7.8), and inotropic/vasopressor medications (OR 2.7, 95% CI 1.7-4.3). Multivariable analysis indicated that Braden QD scores alone predicted MDRPI development.

Conclusion: Medical devices are common in hospitalized infants and children and these medical devices place patients at risk for MDRPI.
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http://dx.doi.org/10.1097/WON.0000000000000683DOI Listing
September 2020

Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease.

Pediatrics 2020 09;146(3)

Department of Anesthesia and Critical Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

Objectives: To test the effect of a 4-month telehealth home monitoring program (REACH), layered on usual care, on postdischarge outcomes in parents of infants recovering from cardiac surgery and their infants.

Methods: Randomized trial of infants discharged from the hospital after cardiac surgery for congenital heart disease. Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers.

Results: From 2012 to 2016, 219 parent-infant dyads were enrolled; 109 were randomly assigned to the intervention group and 110 to the control group. At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215; = .61). The percentages of parents who met posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores were also not significantly different between the 2 groups (PTSD in the intervention group was 18% and was 18% in the control group; =.56; the mean Ulm Quality of Life Inventory for Parents in the intervention group was 71 andwas 70 in the control group; = .88). Infant growth in both groups was suboptimal (the mean weight-for-age scores were -1.1 in the intervention group and -1.2 in the control group; = .56), and more infants in the intervention group were readmitted to the hospital (66% in the intervention group versus 57% in the control group; < .001).

Conclusions: When added to usual care, the REACH intervention was not associated with an improvement in parent or infant outcomes. Four months after neonatal heart surgery, ∼20% of parents demonstrate PTSD symptoms. Suboptimal infant growth and hospital readmissions were common.
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http://dx.doi.org/10.1542/peds.2020-0531DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7461139PMC
September 2020

Association of Race and Ethnicity with Sedation Management in Pediatric Intensive Care.

Ann Am Thorac Soc 2021 01;18(1):93-102

School of Nursing and the Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; and.

Racial disparities in pain management have been previously reported for children receiving emergency care. To determine whether patient race or ethnicity is associated with the broader goal of pain management and sedation among pediatric patients mechanically ventilated for acute respiratory failure. Planned secondary analysis of RESTORE (Randomized Evaluation of Sedation Titration for Respiratory Failure). RESTORE, a cluster-randomized clinical trial conducted in 31 U.S. pediatric intensive care units, compared protocolized sedation management (intervention arm) with usual care (control arm). Participants included 2,271 children identified as non-Hispanic white (white,  = 1,233), non-Hispanic Black (Black,  = 502), or Hispanic of any race (Hispanic,  = 536). Within each treatment arm, neither opioid nor benzodiazepine selection, nor cumulative dosing, differed significantly among race and ethnicity groups. Black patients experienced fewer days with an episode of pain (compared with white patients in the control arm and with Hispanic patients in the intervention arm) and experienced less iatrogenic withdrawal syndrome (compared with white patients in either arm or with Hispanic patients in the intervention arm). The percentage of days awake and calm while intubated was not significantly different in pairwise comparisons by race and ethnicity groups in either the control arm (median: white, 75%; Black, 71%; Hispanic, 75%) or the intervention arm (white, 86%; Black, 88%; Hispanic, 85%). Across multiple measures, our study found scattered differences in sedation management among critically ill Black, Hispanic, and white children that did not consistently favor any group. However, racial disparities related to implicit bias cannot be completely ruled out.Clinical trial registered with clinicaltrials.gov (NCT00814099).
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http://dx.doi.org/10.1513/AnnalsATS.201912-872OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7780975PMC
January 2021

Nurse-Implemented Goal-Directed Strategy to Improve Pain and Sedation Management in a Pediatric Cardiac ICU.

Pediatr Crit Care Med 2020 12;21(12):1064-1070

Department of Cardiovascular and Critical Care Nursing Services, Boston Children's Hospital, Boston, MA.

Objectives: To assess the impact of a nurse-implemented goal-directed sedation strategy on patient care and nursing practice in a pediatric cardiac ICU.

Design: Quality improvement project with a pre-post interval measurement plan.

Setting: Thirty-one bed pediatric cardiac ICU in a freestanding tertiary care children's hospital.

Patients: Postoperative pediatric cardiac surgery patients.

Interventions: The implementation of cardiac-Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a nurse-implemented goal directed strategy to improve pain and sedation management in a pediatric cardiac ICU which included daily team discussion of the patient's trajectory of illness (acute, titration, or weaning phase), prescription of a sedation target score based on the patient's trajectory of illness, arousal assessments, and opioid and/or sedative titration. Withdrawal Assessment Scores were used to assess and manage iatrogenic withdrawal symptoms.

Measurements And Main Results: Data related to opioid and sedation use, pain and sedation scores, and the occurrence and management of iatrogenic withdrawal symptoms were reviewed on 1,243 patients during four separate time periods: one pre-implementation and three discontinuous post-implementation time intervals. Patient age and complexity were consistent across the data collection periods. Post-implementation opioids and benzodiazepines use was reduced about 50% without a concomitant increase in the use of other sedative classes. Few post-intervention patients were discharged from the pediatric cardiac ICU or to home on methadone (pediatric cardiac ICU: pre 19% to post 3%; hospital: pre 12% to post 1.3%). Documentation of pain, sedation, and withdrawal scores became more consistent and nurses reported satisfaction with their patient's comfort management.

Conclusions: The implementation of a nurse-driven goal-directed plan such as cardiac-RESTORE to manage pediatric cardiac ICU patient pain and sedation is possible, sustainable, and associated with reduced sedative and methadone use.
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http://dx.doi.org/10.1097/PCC.0000000000002505DOI Listing
December 2020

Association of patient weight status with plasma surfactant protein D, a biomarker of alveolar epithelial injury, in children with acute respiratory failure.

Pediatr Pulmonol 2020 10 7;55(10):2730-2736. Epub 2020 Aug 7.

Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.

Aims And Objectives: Alveolar epithelial injury is a key determinant of acute respiratory failure (ARF) severity. Plasma surfactant protein D (SP-D), a biomarker of alveolar epithelial injury, is lower in obese adults with ARF compared to their lean peers. We aimed to determine if children with ARF have similar variance in plasma SP-D associated with their weight status on admission.

Methods: Plasma SP-D was measured on days 0, 1, or 2 in children (1-18 years) with ARF enrolled in the genetic variation and biomarkers in children with acute lung injury and RESTORE studies. Weight classification (underweight, normal, overweight, and obese) was based on body mass index or weight-for-height z-scores. Associations between weight group and SP-D on each day were tested.

Results: Inclusion criteria were met in 212 subjects, 24% were obese. There were no differences among weight groups in SP-D levels on days 0 and 1. However, on day 2, there was a statistically significant linear trend for lower SP-D levels as weight increased in both the univariate analysis (P = .02) and when adjusting for age, ethnicity, and diagnosis of pediatric acute respiratory distress syndrome (P = .05).

Conclusions: Obesity was associated with lower plasma SP-D levels on day 2 of ARF. This finding may be explained by altered ARF pathogenesis in obese individuals or a reduced incidence of ventilator-induced lung injury.
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http://dx.doi.org/10.1002/ppul.24990DOI Listing
October 2020

Alone, the hardest part.

Intensive Care Med 2020 Oct 8;46(10):1974-1976. Epub 2020 Jun 8.

Department of Psychiatry, Boston Children's Hospital, Boston, USA.

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http://dx.doi.org/10.1007/s00134-020-06145-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276666PMC
October 2020

Study protocol for a multicentre longitudinal mixed methods study to explore the Outcomes of ChildrEn and fAmilies in the first year after paediatric Intensive Care: the OCEANIC study.

BMJ Open 2020 05 17;10(5):e038974. Epub 2020 May 17.

Children and Young People Health Research, School of Health Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK.

Introduction: Annually in the UK, 20 000 children become very ill or injured and need specialist care within a paediatric intensive care unit (PICU). Most children survive. However, some children and their families may experience problems after they have left the PICU including physical, functional and/or emotional problems. It is unknown which children and families experience such problems, when these occur or what causes them. The aim of this mixed-method longitudinal cohort study is to understand the physical, functional, emotional and social impact of children surviving PICU (aged: 1 month-17 years), their parents and siblings, during the first year after a PICU admission.

Methods And Analysis: A quantitative study involving 300 child survivors of PICU; 300 parents; and 150-300 siblings will collect data (using self-completion questionnaires) at baseline, PICU discharge, 1, 3, 6 and 12 months post-PICU discharge. Questionnaires will comprise validated and reliable instruments. Demographic data, PICU admission and treatment data, health-related quality of life, functional status, strengths and difficulties behaviour and post-traumatic stress symptoms will be collected from the child. Parent and sibling data will be collected on the impact of paediatric health conditions on the family's functioning capabilities, levels of anxiety and social impact of the child's PICU admission. Data will be analysed using descriptive and inferential statistics. Concurrently, an embedded qualitative study involving semistructured interviews with 24 enrolled families at 3 months and 9 months post-PICU discharge will be undertaken. Framework analysis will be used to analyse the qualitative data.

Ethics And Dissemination: The study has received ethical approval from the National Health Services Research Ethics Committee (Ref: 19/WM/0290) and full governance clearance. This will be the first UK study to comprehensively investigate physical, functional, emotional and social consequences of PICU survival in the first-year postdischarge.Clinical Trials Registration Number: ISRCTN28072812 [Pre-results].
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http://dx.doi.org/10.1136/bmjopen-2020-038974DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239532PMC
May 2020

Impact of Bilateral Infiltrates on Inflammatory Biomarker Levels and Clinical Outcomes of Children With Oxygenation Defect.

Crit Care Med 2020 Jun;48(6):e498-e504

Division of Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, MI.

Objectives: The 2015 definition for pediatric acute respiratory distress syndrome did not require the presence of bilateral infiltrates. We tested the hypothesis that pediatric patients meeting oxygenation criteria for pediatric acute respiratory distress syndrome but without bilateral infiltrates would have different inflammatory biomarker levels and clinical outcomes than those with bilateral infiltrates.

Design: Secondary analysis of a prospective cohort study.

Setting: Twenty-two PICUs.

Patients: Four-hundred forty-six patients age 2 weeks to 17 years intubated for respiratory failure with oxygenation index greater than or equal to 4 or oxygenation saturation index greater than or equal to 5 on the day of intubation or the day after.

Interventions: None.

Measurements And Main Results: Patients with bilateral infiltrates, either on the day of intubation or within the following 2 days, were compared with children who never developed bilateral infiltrates. Two analyses were performed to test 1) whether bilateral infiltrates are associated with elevated interleukin-1 receptor antagonist or interleukin-8 and 2) whether bilateral infiltrates are associated with worse clinical outcomes. Patients with bilateral infiltrates more often had a primary diagnosis of pneumonia (41% vs 28%; p = 0.02) and less often asthma (8% vs 23%; p < 0.01). After controlling for age, gender, and primary diagnosis, interleukin-1 receptor antagonist was higher on study days 1 and 2 in patients with bilateral infiltrates. There was no difference in interleukin-8 levels. After adjusting for age, gender, Pediatric Risk of Mortality score, and severity of oxygenation defect, presence of bilateral infiltrates was associated with longer duration of mechanical ventilation in survivors (hazard ratio, 0.64; 95% CI, 0.49-0.82; p < 0.01); this association was independent of primary diagnosis. Overall mortality was 9%; mortality was higher in those without bilateral infiltrates (14% vs 8%; p = 0.04).

Conclusions: Children meeting pediatric acute respiratory distress syndrome oxygenation criteria with bilateral infiltrates on chest radiograph experience a more intense early inflammatory response. Bilateral infiltrates are associated with longer time on the ventilator independent of oxygenation defect severity.
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http://dx.doi.org/10.1097/CCM.0000000000004316DOI Listing
June 2020

Surfactant Protein D Is Associated With Severe Pediatric ARDS, Prolonged Ventilation, and Death in Children With Acute Respiratory Failure.

Chest 2020 Sep 8;158(3):1027-1035. Epub 2020 Apr 8.

Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Michigan, Ann Arbor, MI. Electronic address:

Background: Elevated surfactant protein D (SP-D) is a relatively specific indicator of lung injury and is associated with both acute and chronic lung disease in adults and respiratory distress syndrome in premature infants. The relationship between plasma SP-D and lung injury in children with acute respiratory failure is unclear.

Research Question: Is plasma SP-D associated with lung injury or outcome in children with acute respiratory failure?

Study Design And Methods: This was a prospective cohort study in children 2 weeks to 17 years of age with acute respiratory failure who participated in the BALI multi-center study. Analyses were done using SP-D levels in plasma from the first sample taken on either the day of intubation or one of the following 2 days. SP-D level was measured by enzyme-linked immunosorbent assay.

Results: Plasma samples from 350 patients were used in the analysis; 233 had pediatric ARDS (PARDS). SP-D levels varied across primary diagnoses (P < .001). Elevated SP-D levels were associated with severe PARDS after adjusting for age, pediatric risk of mortality III (PRISM-III), and primary diagnosis (OR = 1.02; CI = 1.01-1.04; P = .011). Multivariable analyses also indicated that elevated SP-D levels were associated with death (OR = 1.02; CI = 1.01-1.04; P = .004), duration of mechanical ventilation (P = .012), PICU length of stay (P = .019), and highest oxygenation index (P = .040). SP-D levels also correlated with age (r = 0.16, P = .002).

Interpretation: Elevated plasma SP-D levels are associated with severe PARDS and poor outcomes in children with acute respiratory failure. Future studies will determine whether SP-D can be used to predict the degree of lung injury or response to treatment and whether SP-D is useful in identifying PARDS endotypes.
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http://dx.doi.org/10.1016/j.chest.2020.03.041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478231PMC
September 2020

High-frequency oscillatory ventilation for PARDS: awaiting PROSPect.

Crit Care 2020 03 27;24(1):118. Epub 2020 Mar 27.

Family and Community Health, School of Nursing, Anesthesia and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

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http://dx.doi.org/10.1186/s13054-020-2829-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7099805PMC
March 2020

Defining a "Good Death" in the Pediatric Intensive Care Unit.

Am J Crit Care 2020 03;29(2):111-121

Martha A.Q. Curley is the Ruth M. Colket Endowed Chair in Pediatric Nursing, Children's Hospital of Philadelphia, and a professor, Department of Family and Community Health, School of Nursing and Department of Anesthesia and Critical Care, Perelman School of Medicine, University of Pennsylvania.

Background: Societal attitudes about end-of-life events are at odds with how, where, and when children die. In addition, parents' ideas about what constitutes a "good death" in a pediatric intensive care unit vary widely.

Objective: To synthesize parents' perspectives on end-of-life care in the pediatric intensive care unit in order to define the characteristics of a good death in this setting from the perspectives of parents.

Methods: A concept analysis was conducted of parents' views of a good death in the pediatric intensive care unit. Empirical studies of parents who had experienced their child's death in the inpatient setting were identified through database searches.

Results: The concept analysis allowed the definition of antecedents, attributes, and consequences of a good death. Empirical referents and exemplar cases of care of a dying child in the pediatric intensive care unit serve to further operationalize the concept.

Conclusions: Conceptual knowledge of what constitutes a good death from a parent's perspective may allow pediatric nurses to care for dying children in a way that promotes parents' coping with bereavement and continued bonds and memories of the deceased child. The proposed conceptual model synthesizes characteristics of a good death into actionable attributes to guide bedside nursing care of the dying child.
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http://dx.doi.org/10.4037/ajcc2020466DOI Listing
March 2020

A Phase II randomized controlled trial for lung and diaphragm protective ventilation (Real-time Effort Driven VENTilator management).

Contemp Clin Trials 2020 01 16;88:105893. Epub 2019 Nov 16.

Children's Hospital Los Angeles, Department of Anesthesiology and Critical Care, United States of America; University of Southern California, Keck School of Medicine, Department of Pediatrics, United States of America.

Lung Protective Mechanical Ventilation (MV) of critically ill adults and children is lifesaving but it may decrease diaphragm contraction and promote Ventilator Induced Diaphragm Dysfunction (VIDD). An ideal MV strategy would balance lung and diaphragm protection. Building off a Phase I pilot study, we are conducting a Phase II controlled clinical trial that seeks to understand the evolution of VIDD in critically ill children and test whether a novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can balance lung and diaphragm protective ventilation to reduce time on MV. REDvent systematically adjusts PEEP, FiO, inspiratory pressure, tidal volume and rate, and uses real-time measures from esophageal manometry to target normal levels of patient effort of breathing. This trial targets 276 children with pulmonary parenchymal disease. Patients are randomized to REDvent vs. usual care for the acute phase of MV (intubation to first Spontaneous Breathing Trial (SBT)). Patients in either group who fail their first SBT will be randomized to REDvent vs usual care for weaning phase management (interval from first SBT to passing SBT). The primary clinical outcome is length of weaning, with several mechanistic outcomes. Upon completion, this study will provide important information on the pathogenesis and timing of VIDD during MV in children and whether this computerized protocol targeting lung and diaphragm protection can lead to improvement in intermediate clinical outcomes. This will form the basis for a larger, Phase III multi-center study, powered for key clinical outcomes such as 28-day ventilator free days. Clinical Trials Registration: NCT03266016.
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http://dx.doi.org/10.1016/j.cct.2019.105893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6952541PMC
January 2020

Mother's Own Milk Feeding and Severity of Respiratory Illness in Acutely Ill Children: An Integrative Review.

J Pediatr Nurs 2020 Jan - Feb;50:5-13. Epub 2019 Oct 26.

Neonatal Intensive Care, Pediatrics, Women, Children and Family Nursing, Rush University Medical Chicago, IL USA. Electronic address:

Problem: Breastfed infants experience less severe infections while actively breastfeeding. However, little is known about whether a history of prior breastfeeding affects severity of illness. Therefore, the purpose of this integrative review was to examine the relationship between previous exposure to mother's own milk (MOM) feeding and severity of respiratory infectious illness in infants and children.

Eligibility Criteria: Studies meeting the following criteria were included: human subjects, term birth, ages 0-35 months at time of study, diagnosis of pneumonia, bronchiolitis or croup, MOM feeding, and statistical analyses reporting separate respiratory infectious illness outcomes when combined with other infections.

Sample: Twelve articles met eligibility criteria.

Results: Major findings were inconsistent definitions of both dose and exposure period of breastfeeding and the severity of illness. In particular, the severity of illness measure was limited by the use of proxy variables such as emergency room visits or hospitalizations that lacked reliability and validity. However, given this limitation, the data suggested that exclusive breastfeeding for four to six months was associated with reduced severity of illness as measured by frequency of visits to the primary care provider office, emergency department or hospitalization.

Conclusions: Future research in this area should incorporate reliable and valid measures of MOM dose and exposure period and severity of illness outcomes in the critically ill child.

Implications: Among many positive outcomes associated with breastfeeding, an additional talking point for encouragement of exclusive breastfeeding for four to six months may be protective against severe respiratory infectious illness after cessation of breastfeeding.
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http://dx.doi.org/10.1016/j.pedn.2019.09.020DOI Listing
December 2020

Nephrology in the Academic Intensive Care Unit: A Qualitative Study of Interdisciplinary Collaboration.

Am J Kidney Dis 2020 01 3;75(1):61-71. Epub 2019 Sep 3.

Department of Anesthesiology & Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Penn Center for Perioperative Outcomes Research and Transformation, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA.

Rationale & Objective: Collaboration between nephrology consultants and intensive care unit (ICU) teams is important in light of the high incidence of acute kidney injury in today's ICUs. Although there is considerable debate about how nephrology consultants and ICU teams should collaborate, communicative dynamics between the 2 parties remain poorly understood. This article describes interactions between nephrology consultants and ICU teams in the academic medical setting.

Study Design: Focused ethnography using semi-structured interviews and participant observation.

Setting & Participants: Purposive sampling was used to enroll nephrologists, nephrology fellows, and ICU practitioners across several roles collaborating in 3 ICUs (a medical ICU, a surgical ICU, and a cardiothoracic surgical ICU) of a large urban US academic medical center. Participant observation (150 hours) and semi-structured interviews (35) continued until theoretical saturation.

Analytical Approach: Interview and fieldnote transcripts were coded in an iterative team-based process. Explanation was developed using an abductive approach.

Results: Nephrology consultants and surgical ICU teams exhibited discordant preferences about the aggressiveness of renal replacement therapy based on different understandings of physiology, goals of care, and acuity. Collaborative difficulties resulting from this discordance led to nephrology consultants often serving as dialysis proceduralists rather than diagnosticians in surgical ICUs and to consultants sometimes choosing not to express disagreements about clinical care because of the belief that doing so would not lead to changes in the course of care.

Limitations: Aspects of this single-site study of an academic medical center may not be generalizable to other clinical settings and samples. Surgical team perspectives would provide further detail about nephrology consultation in surgical ICUs. The effects of findings on patient care were not examined.

Conclusions: Differences in approach between internal medicine-trained nephrologists and anesthesia- and surgery-trained intensivists and surgeons led to collaborative difficulties in surgical ICUs. These findings stress the need for medical teamwork research and intervention to address issues stemming from disciplinary siloing rooted in long-term socialization to different disciplinary practices.
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http://dx.doi.org/10.1053/j.ajkd.2019.05.030DOI Listing
January 2020

Effect of a Sedation Weaning Protocol on Safety and Medication Use among Hospitalized Children Post Critical Illness.

J Pediatr Nurs 2019 Nov - Dec;49:18-23. Epub 2019 Aug 27.

Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA, United States of America; Anesthesia and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; The Research Institute, Children's Hospital of Philadelphia, Philadelphia, PA, United States of America.

Background: Best practice guidelines for the safe and compassionate care of critically ill children necessitates the use of sedation to ensure adequate ventilation, patient safety and comfort. Prolonged use of sedation can result in tolerance, physical dependence and iatrogenic withdrawal syndrome if medications are weaned too quickly.

Problem: In the context of medication errors related to parent administration of outpatient sedation weans, we set out to improve the safety of children weaning from sedatives.

Methods: A retrospective analysis was completed. Quality improvement was guided by using Plan-Do-Study-Act cycles.

Interventions: An evidence-based post PICU sedation weaning guideline was created and implemented over time with ongoing education, and review of progress with staff members with pre-post evaluation.

Results: Post intervention, there were significant differences in the numbers of patients discharged on home weaning from both opioids and benzodiazepines (11%, n = 24/219 pre; 3%, n = 7/233 post; p < 0.005). The number of patients discharged with a methadone wean decreased (7%, n = 16/219 pre; 0%, 0/233 post; p = 0.03). Despite these differences, there were no significant differences in the median hospital length of stay (42 pre; 39 post; p = 0.35). Post implementation more children had mild to moderate symptoms of withdrawal (11% pre; 21% post; p < 0.005) as compared to pre-implementation, however, the percentage of severe symptoms remained consistently low (0.6% pre; 1% post; p = 0.11).

Conclusions: Implementation of an evidence-based post PICU weaning guideline significantly reduced the number of patients discharged on potentially dangerous medications with modest increases in mild-moderate symptoms of withdrawal and no significant change in length of stay or the incidence of severe symptoms of withdrawal.
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http://dx.doi.org/10.1016/j.pedn.2019.08.001DOI Listing
July 2020

Hospital-Acquired Pressure Injuries in Children With Congenital Heart Disease: Prevalence and Associated Factors.

Pediatr Crit Care Med 2019 11;20(11):1048-1056

Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA.

Objectives: To explore the prevalence, location, and clinical factors associated with hospital-acquired pressure injuries among pediatric patients with congenital heart disease.

Design: Secondary analysis of data from a multicenter prospective cohort study of pediatric pressure injury risk, including patients with congenital heart disease.

Setting: Eight acute care academic pediatric hospitals.

Patients: Patients were preterm to 21 years old with congenital heart disease and on bed rest for at least 24 hours after hospital admission with a medical device attached to or traversing the skin or mucous membrane.

Interventions: None.

Measurements And Main Results: Patients were evaluated for a maximum of eight observations during a 4-week period to identify Braden QD risk and pressure injury development. Hospital-acquired pressure injuries were staged according to the National Pressure Ulcer Advisory Panel guidelines. Stepwise logistic regression was used to explore risk factors associated with hospital-acquired pressure injuries development, accounting for site as a cluster variable using generalized estimating equations. Overall, 279 pediatric cardiac patients provided 919 observations (median, 2 per patient [interquartile range, 2-5 per patient]). Thirty-eight hospital-acquired pressure injuries occurred in 27 patients (9.7%). Most injuries (28/38 [74%]) were related to medical devices. The most common medical devices that caused injury were oxygen saturation probes. The remaining hospital-acquired pressure injuries were immobility-related pressure injuries (10/38 [26%]) located primarily on the buttock, sacrum, or coccyx (5/10 [50%]). In multivariable analyses, being non-Hispanic white (odds ratio, 3.54; 95% CI, 2.15-5.84), experiencing operating room time greater than 4 hours (odds ratio, 2.91; 95% CI, 1.13-7.49), having oxygen saturation levels less than 85% (odds ratio, 2.65; 95% CI, 1.01-6.96), and having worse Braden QD scores (odds ratio, 1.25 per 1 point increase; 95% CI, 1.17-1.34) were significantly associated with hospital-acquired pressure injuries development.

Conclusions: In this multicenter observational study of pediatric patients with congenital heart disease, we describe a hospital-acquired pressure injury prevalence of 9.7% with approximately 75% of injuries related to medical devices. These data can be used to inform practice and target interventions to decrease pressure injury risk and prevent pressure injuries in this vulnerable pediatric population.
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http://dx.doi.org/10.1097/PCC.0000000000002077DOI Listing
November 2019

Socioeconomic Status in Pediatric Health Research: A Scoping Review.

J Pediatr 2019 10 9;213:163-170. Epub 2019 Jul 9.

Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA; Department of Anesthesia and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Research Institute, Children's Hospital of Philadelphia, Philadelphia, PA.

Objective: To conduct a scoping review of the literature to describe current conceptualization and measurement of socioeconomic status in pediatric health research.

Study Design: Four databases were used to identify relevant studies, followed by selection and data extraction. Inclusion criteria for studies were the following: enrolled subjects <18 years old, included a health-related outcome, published from 1999 to 2018, and explicitly measured socioeconomic status (SES).

Results: Our literature search identified 1768 publications and 1627 unique records. After screening for duplication and relevance, 228 studies satisfied the inclusion criteria, with 75% (n = 170) published since 2009. There were 52 unique singular measures and an additional 20 composite measures. Income-related measures were used in 65% of studies (n = 147) and measures of education in 42% (n = 95). The majority of studies using census-derived variables or insurance status were conducted within the previous 10 years.

Conclusions: Pediatric studies use a variety of SES measures, which limits comparisons between studies. Few studies provide an evidenced-based rationale that connects the SES indicator to the health outcome, but the majority of studies do find a significant impact of SES on outcomes. SES should be comprehensively studied so that meaningful measures can be used to identify specific SES mechanisms that impact child health.
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http://dx.doi.org/10.1016/j.jpeds.2019.06.005DOI Listing
October 2019

Teamwork When Conducting Family Meetings: Concepts, Terminology, and the Importance of Team-Team Practices.

J Pain Symptom Manage 2019 08 30;58(2):336-343. Epub 2019 Apr 30.

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA; University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.

Family meetings, which bring together members of a seriously ill patient's family and the interprofessional team (IPT), have been widely recognized as promoting shared decision-making for hospitalized patients, particularly those in intensive care units. The planning and conducting of interprofessional family meetings are hampered, however, by a lack of clarity about who is doing what and when, which in turn can lead to inefficiencies and uncoordinated efforts. This article describes how members of the IPT interact with one another (what we have termed team-team practices), distinguishing these interactions from how the IPT engages directly with family members (team-family practices) in preparing for and conducting family meetings. Although most research and guidelines have focused on team-family practices that directly affect patient- and family-level outcomes (e.g., safety and satisfaction), team-team practices are needed to coordinate team contributions and optimize the skills of the diverse team. Team members' knowledge and attitudes also contribute to patient and family outcomes as well as team outcomes. Yet without attention to team-team practices before, during, and after a family meeting, the family-level outcomes are less likely to be achieved as are team well-being outcomes (e.g., reduced burnout and staff retention). Drawing upon team theory, we present a set of key concepts and corresponding terms that enable a more precise description of team-team practices and team-family practices, aiming to help with team training and evaluation and to enable future research of these distinct yet inter-related practices.
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http://dx.doi.org/10.1016/j.jpainsymman.2019.04.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6800049PMC
August 2019

Reappraisal of Ventilator-Free Days in Critical Care Research.

Am J Respir Crit Care Med 2019 10;200(7):828-836

Department of Pediatrics, University of Utah, Salt Lake City, Utah.

Ventilator-free days (VFDs) are a commonly reported composite outcome measure in acute respiratory distress syndrome trials. VFDs combine survival and duration of ventilation in a manner that summarizes the "net effect" of an intervention on these two outcomes. However, this combining of outcome measures makes VFDs difficult to understand and analyze, which contributes to imprecise interpretations. We discuss the strengths and limitations of VFDs and other "failure-free day" composites, and we provide a framework for when and how to use these outcome measures. We also provide a comprehensive discussion of the different analytic methods for analyzing and interpreting VFDs, including Student's tests and rank-sum tests, as well as competing risk regressions treating extubation as the primary outcome and death as the competing risk. Using simulations, we illustrate how the statistical test with optimal power depends on the relative contributions of mortality and ventilator duration on the composite effect size. Finally, we recommend a simple analysis and reporting framework using the competing risk approach, which provides clear information on the effect size of an intervention, a statistical test and measure of confidence with the ability to adjust for baseline factors and allow interim monitoring for trials. We emphasize that any approach to analyzing a composite outcome, including other "failure-free day" constructs, should also be accompanied by an examination of the components.
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http://dx.doi.org/10.1164/rccm.201810-2050CPDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6812447PMC
October 2019

Risk Factors for Functional Decline and Impaired Quality of Life after Pediatric Respiratory Failure.

Am J Respir Crit Care Med 2019 10;200(7):900-909

School of Nursing and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; and.

Poor outcomes of adults surviving critical illness are well documented, but data in children are limited. To identify factors associated with worse postdischarge function and health-related quality of life (HRQL) after pediatric acute respiratory failure. We assessed functional status at baseline, discharge, and 6 months after pediatric ICU discharge and HRQL 6 months after discharge in 2-week- to 17-year-olds mechanically ventilated for acute respiratory failure in the (Randomized Evaluation of Sedation Titration for Respiratory Failure) trial. We assessed HRQL via Infant and Toddler Quality of Life Questionnaire-97 (<2 yr old) or Pediatric Quality of Life Inventory (≥2 yr old). We categorized patients with normal baseline function as having impaired HRQL if scores were greater than 1 SD below mean norms for Infant and Toddler Quality of Life Questionnaire-97 growth and development or Pediatric Quality of Life Inventory total score. One-fifth ( = 192) of 949 patients declined in function from baseline to postdischarge; 20% (55/271) had impaired growth and development; 19% (64/343) had impaired HRQL. In multivariable analyses, decline in function was associated with baseline impaired function, prematurity, cancer, respiratory failure etiology, ventilation duration, and clonidine (odds ratio [OR] = 2.14; 95% confidence interval [CI] = 1.22-3.76). Independent predictors of impaired growth and development included methadone (OR = 2.27; 95% CI = 1.18-4.36) and inadequate pain management (OR = 2.94; 95% CI = 1.39-6.19). Impaired HRQL was associated with older age, non-white or Hispanic race, cancer, and inadequate sedation management (OR = 3.15; 95% CI = 1.74-5.72). Postdischarge morbidity after respiratory failure is common and associated with admission factors, exposure to critical care therapies, and pain and sedation management.
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http://dx.doi.org/10.1164/rccm.201810-1881OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6812438PMC
October 2019

A prospective investigation of interleukin-8 levels in pediatric acute respiratory failure and acute respiratory distress syndrome.

Crit Care 2019 04 17;23(1):128. Epub 2019 Apr 17.

Division of Pediatric Critical Care Medicine, Department of Pediatrics and Communicable Diseases, University of Michigan, 1500 East Medical Center Dr, F6790/5243, Ann Arbor, MI, 48109, USA.

Background: The association of plasma interleukin-8 (IL-8), or IL-8 genetic variants, with pediatric acute respiratory distress syndrome (PARDS) in children with acute respiratory failure at risk for PARDS has not been examined. The purpose of this study was to examine the association of early and sequential measurement of plasma IL-8 and/or its genetic variants with development of PARDS and other clinical outcomes in mechanically ventilated children with acute respiratory failure.

Methods: This was a prospective cohort study of children 2 weeks to 17 years of age with acute airways and/or parenchymal lung disease done in 22 pediatric intensive care units participating in the multi-center clinical trial, Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE). Plasma IL-8 levels were measured within 24 h of consent and 24 and 48 h later. DNA was purified from whole blood, and IL-8 single nucleotide polymorphisms, rs4073, rs2227306, and rs2227307, were genotyped.

Results: Five hundred forty-nine patients were enrolled; 480 had blood sampling. Plasma IL-8 levels ranged widely from 4 to 7373 pg/mL. Highest IL-8 levels were observed on the day of intubation with subsequent tapering. Levels of IL-8 varied significantly across primary diagnoses with the highest levels occurring in patients with sepsis and the lowest levels in those with asthma. Plasma IL-8 was strongly correlated with oxygenation defect and severity of illness. IL-8 was consistently higher in PARDS patients compared to those without PARDS; levels were 4-12 fold higher in non-survivors compared to survivors. On multivariable analysis, IL-8 was independently associated with death, duration of mechanical ventilation, and PICU length of stay on all days measured, but was not associated with PARDS development. There was no association between the IL-8 single nucleotide polymorphisms, rs4073, rs2227306, and rs2227307, and PARDS development or plasma IL-8 level.

Conclusions: When measured sequentially, plasma IL-8 was robustly associated with multiple, relevant clinical outcomes including mortality, but was not associated with PARDS development. The wide range of plasma IL-8 levels exhibited in this cohort suggests that further study into the heterogeneity of this patient population and its impact on individual responses to PARDS treatment is warranted.
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http://dx.doi.org/10.1186/s13054-019-2342-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6471952PMC
April 2019

Morphine Dose Optimization in Critically Ill Pediatric Patients With Acute Respiratory Failure: A Population Pharmacokinetic-Pharmacogenomic Study.

Crit Care Med 2019 06;47(6):e485-e494

Metrum Research Group, Tariffville, CT.

Objective: To develop a pharmacokinetic-pharmacogenomic population model of morphine in critically ill children with acute respiratory failure.

Design: Prospective pharmacokinetic-pharmacogenomic observational study.

Setting: Thirteen PICUs across the United States.

Patients: Pediatric subjects (n = 66) mechanically ventilated for acute respiratory failure, weight greater than or equal to 7 kg, receiving morphine and/or midazolam continuous infusions.

Interventions: Serial blood sampling for drug quantification and a single blood collection for genomic evaluation.

Measurements And Main Results: Concentrations of morphine, the two main metabolites, morphine-3-glucuronide and morphine-6-glucuronide, were quantified by high-performance liquid chromatography tandem mass spectrometry/mass spectroscopy. Subjects were genotyped using the Illumina HumanOmniExpress genome-wide single nucleotide polymorphism chip. Nonlinear mixed-effects modeling was performed to develop the pharmacokinetic-pharmacogenomic model. A two-compartment model with linear elimination and two individual compartments for metabolites best describe morphine disposition in this population. Our analysis demonstrates that body weight and postmenstrual age are relevant predictors of pharmacokinetic parameters of morphine and its metabolites. Furthermore, our research shows that a duration of mechanical ventilation greater than or equal to 10 days reduces metabolite formation and elimination upwards of 30%. However, due to the small sample size and relative heterogeneity of the population, no heritable factors associated with uridine diphosphate glucuronyl transferase 2B7 metabolism of morphine were identified.

Conclusions: The results provide a better understanding of the disposition of morphine and its metabolites in critically ill children with acute respiratory failure requiring mechanical ventilation due to nonheritable factors. It also provides the groundwork for developing additional studies to investigate the role of heritable factors.
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http://dx.doi.org/10.1097/CCM.0000000000003741DOI Listing
June 2019

Midazolam Dose Optimization in Critically Ill Pediatric Patients With Acute Respiratory Failure: A Population Pharmacokinetic-Pharmacogenomic Study.

Crit Care Med 2019 04;47(4):e301-e309

Metrum Research Group, Tariffville, CT.

Objectives: To develop a pharmacokinetic-pharmacogenomic population model of midazolam in critically ill children with primary respiratory failure.

Design: Prospective pharmacokinetic-pharmacogenomic observational study.

Setting: Thirteen PICUs across the United States.

Patients: Pediatric subjects mechanically ventilated for acute respiratory failure, weight greater than or equal to 7 kg, receiving morphine and/or midazolam continuous infusions.

Interventions: Serial blood sampling for drug quantification and a single blood collection for genomic evaluation.

Measurements And Main Results: Concentrations of midazolam, the 1' (1`-hydroxymidazolam metabolite) and 4' (4`-hydroxymidazolam metabolite) hydroxyl, and the 1' and 4' glucuronide metabolites were measured. Subjects were genotyped using the Illumina HumanOmniExpress genome-wide single nucleotide polymorphism chip. Nonlinear mixed effects modeling was performed to develop the pharmacokinetic-pharmacogenomic model. Body weight, age, hepatic and renal functions, and the UGT2B7 rs62298861 polymorphism are relevant predictors of midazolam pharmacokinetic variables. The estimated midazolam clearance was 0.61 L/min/70kg. Time to reach 50% complete mature midazolam and 1`-hydroxymidazolam metabolite/4`-hydroxymidazolam metabolite clearances was 1.0 and 0.97 years postmenstrual age. The final model suggested a decrease in midazolam clearance with increase in alanine transaminase and a lower clearance of the glucuronide metabolites with a renal dysfunction. In the pharmacogenomic analysis, rs62298861 and rs28365062 in the UGT2B7 gene were in high linkage disequilibrium. Minor alleles were associated with a higher 1`-hydroxymidazolam metabolite clearance in Caucasians. In the pharmacokinetic-pharmacogenomic model, clearance was expected to increase by 10% in heterozygous and 20% in homozygous for the minor allele with respect to homozygous for the major allele.

Conclusions: This work leveraged available knowledge on nonheritable and heritable factors affecting midazolam pharmacokinetic in pediatric subjects with primary respiratory failure requiring mechanical ventilation, providing the basis for a future implementation of an individual-based approach to sedation.
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http://dx.doi.org/10.1097/CCM.0000000000003638DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6432942PMC
April 2019