Extracorporeal membrane oxygenation (ECMO) is deployed to support children with severe respiratory failure. Unlike neonatal and cardiac ECMO populations, childhood respiratory ECMO survivors are rarely studied as a distinct population, leading to gaps in our understanding of their experiences. This study aimed to describe the family and patient experiences and functional outcomes of childhood respiratory ECMO survivors. Retrospective, mixed-methods, single center cohort study of children who required ECMO for respiratory failure in the pediatric intensive care unit and survived to discharge from May 2014 to December 2020. Semi-structured interviews were conducted with parents, and functional assessments of children were conducted via Vineland Adaptive Behavior Scales, 3rd edition (VABS-3). Of 22 respiratory ECMO survivors, 15 (68%) were successfully contacted and 12 (55%) completed interviews. Median age was 7 years (IQR: 1-16) at cannulation and 12 years (IQR: 5-16) at interview. Interviews revealed the need for greater preparation before ECMO, and practitioner-led guidance and education during ECMO. Only 50% had a medical home. The magnitude of physical and psychological recovery was unexpected, and mental health needs continued after discharge. VABS-3 was assessed in 92% of participants and varied widely (median, 85, IQR: 74-107). Despite wide ranging outcomes, families shared difficulties surrounding rehabilitation, centralized care, and the emotional toll of their child's illness. Families desired additional support before, during, and after ECMO, particularly anticipatory guidance. Psychiatric needs were underestimated. Understanding the challenges faced by survivors and their parents will enable pediatric intensivists to better advise families through all phases of ECMO.

OBJECTIVE:To record the content and parental perceptions of family meetings in a Neonatal Intensive Care Unit (NICU) to improve existing frameworks for facilitating these meetings.STUDY DESIGN:A prospective, mixed-methods study. NICU family meetings were audio-recorded, transcribed, and analyzed by an iteratively derived coding framework until thematic saturation. We used descriptive statistics of parental post-meeting assessments.RESULTS:Qualitative analysis of 21 meetings identified both Communication Facilitators and Barriers. Facilitators included use of visual-aids and participation of social workers to clarify information for parents. Barriers included staff rarely eliciting parental comprehension (3 meetings) or concerns (5) before providing new information, resulting in 39% of parents reporting they didn't ask questions they wanted to ask. In 33% of meetings an important participant was absent.CONCLUSIONS:This novel qualitative and quantitative dataset of NICU family meetings highlights areas for improving communication. Attention to these components may improve parental perceptions of family meetings.

Given the burden of HIV and other sexually transmitted infections among adolescents who are legal minors, it is critical that they be included in biomedical sexual health trials to ensure that new prevention and treatment interventions are safe, effective, and acceptable for their use. However, adolescents are often not well represented in clinical trials. We provide an overview of the available evidence regarding adolescent and parent willingness for adolescents to participate in biomedical sexual health trials, parental involvement in the permission-consent process, management of differences and discord among adolescents and parents, and parental involvement throughout the study period. We also outline recommendations for current practice and areas for future research.

OBJECTIVES: To determine the impact of parental presence on the number and types of educational questions asked of and by medical trainees during PICU rounds. METHODS: An investigator joined bedside rounds in a 14-bed medical-surgical PICU on 20 weekdays between December 2016 and June 2017. For each patient, the investigator recorded the time devoted to education. Educational questions were recorded verbatim. Questions were categorized as “teaching” (senior team member to a trainee) or “learning” (trainee to a more senior team member) and by content (eg, physiology, imaging, prognosis). Two blinded investigators independently assigned codes to each educational question; discrepancies were resolved to the satisfaction of both. RESULTS: Data include 151 patient-specific rounding events, involving 92 patients. At least 1 parent attended the entirety of 59/151 rounding events (39%). There were no significant differences between the duration of education or the number of educational questions asked when parents were present (1 minute; 2 questions) versus absent (2 minutes; 2 questions). When parents were present, 20% questions were learning versus 25% when parents were absent. Zero percent of rounding events included ≥1 question about prognosis when parents were present versus 9% when absent (P = .02). There was no statistically significant difference in the frequency of questions related to complications of management or social factors. CONCLUSIONS: Parent participation in rounds did not impact the quantity of education during rounds but did impact the type of educational questions asked, specifically restricting the discussion of patient prognosis.

Background: Continuous positive airway pressure (CPAP) is a relatively low-cost technology which can improve outcome in neonatal and paediatric patients with respiratory distress. Prior work in a lower middle-income country demonstrated degradation of CPAP skills and knowledge after the initial training. Aims: To determine if a training-of-trainers (ToT) curriculum can decrease gaps in skills and knowledge between first-generation (trained by a United States physician and nurse) and second-generation healthcare providers (trained by local trainers) in Kenya, and to describe the usage pattern, outcome and safety in patients who received CPAP following the trainings. Methods: The first day of training entailed didactic and simulation sessions. On the second day participants were taught how to train others to use CPAP. First- and second-generation healthcare providers were tested on their skills and knowledge. Unpaired t-tests were used to test for equivalence. Prospective data on CPAP usage was collected following the initial trainings. Results: 37 first-generation healthcare providers (16 nurses; 21 physicians, medical/clinical officers) were trained as trainers and 40 second-generation healthcare providers (19 nurses, 21 physicians, medical/clinical officers) trained by first-generation healthcare providers were available for skills and knowledge testing. There were no statistically significant differences between first- and second-generation healthcare providers' skills (90%, 95% CI 87-93 vs 89%, 95% CI 86-92) or knowledge scores (91%, 95% CI 88-93 vs 90%, 95% CI 88-93). A total of 1111 patients were placed on CPAP mostly by nurses (61%), prematurity/acute respiratory distress syndrome was the most common indication, nasal injury/bleeding (2%) was the most common reported adverse event, and the overall mortality rate was 24%. Conclusion: The ToT model was successful, nurses initiated CPAP most commonly, prematurity with acute respiratory distress syndrome was the most common indication, and adverse events were uncommon.

Rationale: The decision whether to initiate or forgo long-term ventilation for children can be difficult and impactful. However, little has been published on the informational and decisional needs of families facing this decision. Objectives: To assess what families with children with chronic respiratory failure and life-limiting conditions need and want for informed decision-making. Methods: English- and Spanish-speaking parents who were facing (contemporaneous decision makers) or had previously faced (former decision makers) a decision regarding invasive or noninvasive long-term ventilation for their children were recruited using convenience sampling. Patients who were older and cognitively capable also were invited to participate. We performed semistructured interviews using an open-ended interview guide developed de novo to assess parents' decisional needs and experiences. Qualitative data analysis used a thematic approach based on framework analysis, and thematic saturation was a goal. Results: A sample of 44 parents and 2 patients from 43 families was interviewed. All contemporaneous decision makers (n = 28) favored or believed that they would choose long-term ventilation. Fifteen of 16 former decision makers chose long-term ventilation. Thematic saturation was achieved from the perspective of parents who favored or chose long-term ventilation. Four domains were identified: parents' emotional and psychological experiences with decision-making, parents' informational needs, parents' communication and decision support needs, and parents' views on the option not to initiate long-term ventilation. For most parents, making a decision regarding long-term ventilation was stressful, even though they articulated goals and values that could/did guide their decision-making. In general, parents wanted comprehensive information, including what life would be like at home for the child and the family. They wanted their medical providers to be honest, tactful, patient, and supportive. Parents reported that they felt being presented with the option not to initiate was acceptable. Conclusions: In this study, we identified specific informational and decision-making needs regarding long-term ventilation that parents facing decisions feel are important. These data suggest that providers should present families with comprehensive, balanced information on the impact of long-term ventilation and, when the child has a profoundly serious and life-limiting condition, explore the option not to initiate long-term ventilation.

OBJECTIVES To characterize the baseline level of emergency preparedness among families of technology-dependent children admitted to our PICU and to determine if an ICU-based planning intervention can sustainably improve families' disaster preparedness. METHODS A single-arm, survey-based study used to assess participants' preparedness to handle a 72-hour home power outage on the basis of a novel 8-point checklist. Parents of patients in the study completed the survey questions when their child was admitted to the PICU, discharged, or transferred from the PICU, after at least 2 weeks at home, and after at least 6 months at home. This study included a cohort of 50 children younger than18 years old who required daily use of at least 1 piece of qualifying electronic medical equipment at home and their custodial parents. The checklist surveyed was designed with the goals of maximizing care capacity at home during a power outage and planning for evacuation. Counseling and other resources were provided on the basis of item completion at admission assessment. RESULTS Patients' families completed a median of 3 items (range: 0-8; N = 50) at admission, 4 items (range: 1-8; n = 45) at discharge, and 7 items (range: 3-8; n = 37) at the 2-week follow-up and retained 7 items (range: 5-8; n = 29) at the 6-month follow-up. Completion rates were significantly higher at each follow-up time point compared with baseline (P < .001). CONCLUSIONS Families of technology-dependent children admitted to our PICU have significant disaster-preparedness needs, which can be addressed with an inpatient intervention.

Adolescents, despite their disproportionate burden of disease, often are excluded from sexually transmitted infection and HIV biomedical prevention clinical trials. The 3 principles of the Belmont Report (justice, respect for persons, and beneficence, U.S. Department of Health and Human Services, 1979) can inform our understanding of the ethical imperative to include minors in these trials. Investigators and institutional review boards need to have an understanding of what constitutes no more than minimal risk, that is, what is part of adolescent well-child care. Although cognitive development extends into the young adult years, evidence suggests that in most situations research decision-making capacity of an older minor is similar to that of a young adult. Depending on the specifics of the study, parental involvement may range from parental consent while protecting confidentiality to adolescent self-consent with a waiver of parental consent. Regardless of the level of parental involvement, protection of adolescents enrolled in trials will require strategies that guard against the risk of accidental loss of confidentiality. We outline a number of ways in which pediatric psychologists can assist clinical trial investigators and institutional review boards to ethically recruit and enroll minors into biomedical prevention trials. Furthermore, a pediatric psychologist can contribute to needed research on adolescent decision making and parental involvement to develop more sophisticated approaches to involving minors in HIV and sexually transmitted infection biomedical clinical trials.

David Carpenter argues in favour of Internal Review Boards taking a virtue ethics approach to their reviews of research proposals. Carpenter views principle- and code-based approaches as in competition with virtue ethics, and he describes reliance on principles and codes as neither necessary nor sufficient. We agree with Carpenter’s thesis that a virtue ethics approach would be beneficial and even necessary for exemplary review of research proposals. We disagree with Carpenter, however, about the weight that should be given to principles and codes. We defend here our view that principles and regulations are indispensible to ethical review of research, in spite of the fact that principles often conflict with each other. In those situations, the reviewer’s virtue of practical wisdom is necessary to adjudicate between competing ethical claims.

Conducting clinical trials in resource-poor settings may contribute to local capacity building. We describe the perspectives of local research personnel regarding the impact of collaborating in a clinical trial in rural Ghana. Forty-six Ghanaian research personnel were eligible to complete an anonymous survey, and 35 (76%) participated. Of the 35 respondents, 32 (91%) agreed that future patients will benefit because the hospital was part of the study. All 35 respondents reported a personal benefit derived from study involvement, most commonly citing skills or knowledge gained. Of the 35 individuals, 21 reported one or more burdens, most commonly citing nonspecific research responsibilities. Our data support the hypothesis that participation in clinical trials can contribute to capacity building in district hospitals in a lower middle-income country.

OBJECTIVE:To explore parental opinions regarding opt-out consent for inpatient pediatric prospective observational research in the US.STUDY DESIGN:A series of handouts describing hypothetical observational research studies with opt-out consent were reviewed by parents of hospitalized children. A verbal survey explored parental opinions about the proposed consent process.RESULTS:A total of 166 parents reviewed the handout and completed the survey. Only 2/166 parents (1.2%) objected to the study described and another 10 (6.0%) cited concern about the privacy of their child's medical information. A total of 157 parents were asked "Is it okay to tell you about this kind of research using this handout?" - 116 (74%) responded positively, 19 (12%) responded negatively, and 21 (13%) made an indeterminate or neutral response. When parents were asked to recommend a specific consent approach for observational research, 86 (52%) chose an opt-in approach, 54 (33%) chose opt-out, and 25 (15%) chose "no consent needed". There were no significant associations between parental preferences and whether the child was admitted to the intensive care unit vs. pediatric ward, and no significant difference found based on type of handout reviewed (generic vs. study-specific).CONCLUSION:Few parents voiced objection to a hypothetical opt-out consent process for inpatient pediatric prospective observational research. When asked to recommend a specific consent approach, though, approximately half chose an opt-in approach. These data suggest that an opt-out consent process for observational inpatient research is likely to be acceptable to parents, but assessment of an opt-out consent process in a real-world setting is needed.

Pregnancy testing is often required for participation in clinical research, but little published literature addresses the special issues that arise when adolescents who are not legal adults (minor adolescents) are eligible to participate in such research. Below, we set forth a framework for how such testing should be managed, drawing on considerations of ethics, law, and adolescents’ developmental cognitive capacity to make decisions about research participation and medical care.

BACKGROUND:Despite calls for a controlled organ donation after circulatory death (cDCD) consent process that is more rigorous, consistent, and transparent, little is known about the cDCD consent processes utilized by U.S. hospitals. The objective of this research was to describe the cDCD consent policies of U.S. transplant hospitals, including consent for antemortem interventions (AMI), in order to inform the development of a more rigorous and sound consent process. METHODS:Cross-sectional study data of cDCD policies of U.S. transplant hospitals were collected between July 2013 and October 2014. Respondents submitted their policies for investigator review and/or completed a 25-item Web-based survey describing their hospital's cDCD and AMI policies. There were 209 U.S. adult transplant hospitals identified through the Organ Procurement and Transplantation Network (OPTN). RESULTS:One hundred responses were received, representing 48% of all 209 U.S. transplant hospitals and 60% of the 168 transplant centers with an identified knowledgeable informant. In 79 policies (79%), organ procurement organization representatives (OPOs) are given sole responsibility for obtaining signed cDCD consent. Thirty-four policies (34%) give OPOs the responsibility for obtaining written AMI consent, 13 policies give it to treating physicians, and 6 policies state that AMI consent must be obtained collaboratively. Treating physicians have no delineated responsibilities in the cDCD and AMI consent process in 70 (70%) and 58 (58%) policies, respectively. We observed wide variability in the acceptability of first-person authorization (FPA) for cDCD and AMI; FPA was rejected as evidence of consent for cDCD and AMI in 7 and 11 policies, respectively. CONCLUSIONS:The cDCD consent policies of U.S. transplant hospitals are highly variable and inconsistent in addressing key aspects of the consent process. The major policy differences observed raise questions about what constitutes a sound and comprehensive cDCD consent policy.

Objectives: Seeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit. Design: Prospective cohort study. Setting: Five ICUs within a tertiary care hospital. Patients: Newly admitted ICU patients 18 years old or older. Interventions: We administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed. Measurements and Main Results: One hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question “Did we make the right choice in waiting until now to ask your consent?” three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%). Conclusions: Most patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.

Background: In low-income and middle-income countries, invasive mechanical ventilation is often not available for children at risk of death from respiratory failure. We aimed to determine if continuous positive airway pressure (CPAP), a form of non-invasive ventilation, decreases all-cause mortality in children with undifferentiated respiratory distress in Ghana. Methods: This open-label, cluster, crossover trial was done in two Ghanaian non-tertiary hospitals where invasive mechanical ventilation is not routinely available. Eligible participants were children aged from 1 month to 5 years with a respiratory rate of more than 50 breaths per min in children 1–12 months old, or more than 40 breaths per min in children older than 12 months, and use of accessory muscles or nasal flaring. CPAP machines were allocated to one hospital during each study block, while the other hospital served as the control site. The initial intervention site was randomly chosen using a coin toss. 5 cm of water pressure was delivered via CPAP nasal prongs. The primary outcome measure was all-cause mortality rate at 2 weeks after enrolment in patients for whom data were available after 2 weeks. We also did post-hoc regression analysis and subgroup analysis of children by malaria status, oxygen saturation, and age. This study is registered with ClinicalTrials.gov, number NCT01839474. Findings: Between Jan 20, 2014, and Dec 5, 2015, 2200 children were enrolled: 1025 at the intervention site and 1175 at the control site. Final analysis included 1021 patients in the CPAP group and 1160 patients in the control group. 2 weeks after enrolment, 26 (3%) of 1021 patients in the CPAP group, and 44 (4%) of 1160 patients in the control group, had died (relative risk [RR] of mortality 0·67, 95% CI 0·42–1·08; p=0·11). In children younger than 1 year, all-cause mortality was ten (3%) of 374 patients in the CPAP group, and 24 (7%) of 359 patients in the control group (RR 0·40, 0·19–0·82; p=0·01). After adjustment for study site, time, and clinically important variables, the odds ratio for 2-week mortality in the CPAP group versus the control group was 0·4 in children aged up to 6 months, 0·5 for children aged 12 months, 0·7 for children aged 24 months, and 1·0 for those aged 36 months. 28 patients (3%) in the CPAP group and 24 patients (2%) in the control group had CPAP-related adverse events, such as vomiting, aspiration, and nasal, skin, or eye trauma. No serious adverse events were observed. Interpretation: In the unadjusted analysis the use of CPAP did not decrease all-cause 2-week mortality in children 1 month to 5 years of age with undifferentiated respiratory distress. After adjustment for study site, time, and clinically important variables, 2-week mortality in the CPAP group versus the control group was significantly decreased in children 1 year of age and younger. CPAP is safe and improves respiratory rate in a non-tertiary setting in a lower-middle-income country. Funding: General Electric Foundation.

Rationale: The decision of whether to initiate or forgo long-term ventilation (LTV) for children with life-limiting conditions can be complex and impactful. Providers are responsible for helping families to understand the consequences of their options and guiding them through shared decision-making, but little has been published on how to do this.Objectives: To assess how directors of pediatric home ventilation programs facilitate shared decision-making with families facing decisions of whether to initiate or forgo LTV for their children with life-limiting conditions. In addition, to assess directors’ perspectives on these families’ decisional needs.Methods: Purposeful recruiting of directors/codirectors of pediatric home ventilation programs at children’s hospitals was used. We performed semistructured interviews using an open-ended interview guide developed de novo to assess their approach to informed, shared decision-making around LTV and their perspectives on these decisions. Qualitative data analysis was conducted using a thematic approach based on framework analysis in which thematic saturation was achieved.Results: A sample of 15 experienced physician directors across North America was interviewed. All (15/15) inform families of the potential benefits and burdens/risks of LTV for the child and of the option to forgo LTV. All stress to families the physical, emotional, and social impact of caring for a child using LTV on the family; 12 directors also highlight the financial impact. All recommend that decision-making around LTV should be interdisciplinary, initiated early, and not rushed; nine described their approach as guided by the family’s goals for the child and their family. All recommend that providers be transparent, candid, active listeners, and supportive. All directors believe that the family’s decision should be respected, but vary in the extent to which they recommend an option to families. They described barriers to decision-making that stem from families, providers, and other sources.Conclusions: As providers who follow children using LTV, directors of pediatric home ventilation programs have perspectives regarding the decisional needs of these families and how to meet them that can help inform and shape the practices of other providers who assist families facing this decision.

Institutional review boards have a dual goal: first, to protect the rights and welfare of human research subjects, and second, to support and facilitate the conduct of valuable research. In striving to achieve these goals, IRBs must often consider conflicting interests. In the discussion below, we characterize research oversight as having three elements: (i) research regulations, which establish a minimum acceptable standard for research conduct; (ii) ethical principles, which help us identify and define relevant ethical issues; and (iii) virtue ethics, which guides the prioritization of relevant issues. We describe specific ways in which the lessons of virtue ethics suggest revisions to the IRB structure and review process, the education and training of IRB members, and the appropriate limits of regulations in research ethics oversight.

Copyright © 2016 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

We describe a pragmatic training-of-trainers program for the use of continuous positive airway pressure (CPAP) for neonatal and pediatric patients. The program is designed for medical professionals working in low-and middle-income countries and involves 2 days of in-class training followed by 1 day of in-service training. The program was created after training in Cambodia, Ghana, Honduras, Kenya and Rwanda and addresses the issues of resource availability, cultural context and local buy-in and partnership in low-and middle-income countries. We hope others will use the training program to increase knowledge and use of CPAP with the ultimate goal of improving neonatal and pediatric survival globally.

Introduction: Child maltreatment is prevalent globally. In Papua New Guinea (PNG), child maltreatment remains an under-reported problem.Methods: As part of a 10 month prospective observational study conducted at Modilon Hospital in PNG, we investigated the burden of child maltreatment in the form of sexual abuse, physical abuse and neglect, leading to hospitalization in children <= 14 years.Results: Of 1061 screened admissions, 107 (10%) fulfilled the definition of child maltreatment. The in-hospital admission prevalence of sexual abuse was 5.7% [60 of 1061; 95% confidence interval (CI): 4.4-7.3]. Neglect accounted for 3.4% (36 of 1061; 95% CI: 2.4-4.7) of admissions, while physical abuse accounted for 1.0% (11 of 1061; 95% CI: 0.6-1.9). Mortality was highest in the neglected group, with severe acute malnutrition accounting for 89% of deaths.Conclusion: Improved awareness, establishment of appropriate channels for addressing child maltreatment and enforcement of child protection laws in PNG and other epidemiologically similar settings are urgently needed.