Designing a national pediatric critical care database: a Delphi consensus study.

PURPOSE: We sought to describe the processes undertaken for the systematic selection and consensus determination of the common data elements for inclusion in a national pediatric critical care database in Canada. METHODS: We conducted a multicentre Delphi consensus study of Canadian pediatric intensive care units (PICUs) participating in the creation of a national database. Participants were PICU health care professionals, allied health professionals, caregivers, and other stakeholders. A dedicated panel group created a baseline survey of data elements based on literature, current PICU databases, and expertise in the field. The survey was then used for a Delphi iterative consensus process over three rounds, conducted from March to June 2021. RESULTS: Of 86 invited participants, 68 (79%) engaged and agreed to participate as part of an expert panel. Panel participants were sent three rounds of the survey with response rates of 62 (91%), 61 (90%) and 55 (81%), respectively. After three rounds, 72 data elements were included from six domains, mostly reflecting clinical status and complex medical interventions received in the PICU. While race, gender, and home region were included by consensus, variables such as minority status, indigenous status, primary language, and ethnicity were not. CONCLUSION: We present the methodological framework used to select data elements by consensus for a national pediatric critical care database, with participation from a diverse stakeholder group of experts and caregivers from all PICUs in Canada. The selected core data elements will provide standardized and synthesized data for research, benchmarking, and quality improvement initiatives of critically ill children.

RéSUMé: OBJECTIF: Nous avons cherché à décrire les processus entrepris pour la sélection systématique et la détermination consensuelle des éléments de données communs à inclure dans une base de données nationale sur les soins intensifs pédiatriques au Canada. MéTHODE: Nous avons mené une étude multicentrique de consensus selon la méthode Delphi sur les unités de soins intensifs pédiatriques (USIP) canadiennes participant à la création d'une base de données nationale. Les personnes participant à l'étude étaient des professionnel·les de la santé de l'USIP, du personnel paramédical, des soignant·es et d'autres intervenant·es. Un groupe de travail spécialisé a créé une enquête de base des éléments de données sur la littérature, les bases de données actuelles portant sur les USIP et l'expertise dans le domaine. L'enquête a ensuite été utilisée pour créer un processus de consensus itératif Delphi sur trois cycles, mené de mars à juin 2021. RéSULTATS: Sur les 86 personnes invitées à participer, 68 (79 %) se sont engagées et ont accepté de participer à un groupe d'experts. Les membres du panel ont reçu trois rondes du sondage, avec des taux de réponse de 62 (91 %), 61 (90 %) et 55 (81 %), respectivement. Après trois cycles, 72 éléments de données provenant de six domaines ont été inclus, reflétant principalement l'état clinique et les interventions médicales complexes reçues à l'USIP. Alors que la race, le genre et la région d'origine ont été inclus par consensus, des variables telles que le statut de minorité, le statut d'autochtone, la langue principale parlée et l'origine ethnique ne l'ont pas été. CONCLUSION: Nous présentons le cadre méthodologique utilisé pour sélectionner des éléments de données consensuels destinés à une base de données nationale sur les soins intensifs pédiatriques, avec la participation d'un groupe diversifié d'expert·es et de soignant·es de toutes les USIP au Canada. Les éléments de données de base sélectionnés fourniront des données normalisées et synthétisées pour la recherche, l'analyse comparative et les initiatives d'amélioration de la qualité pour les enfants gravement malades.

The care of critically ill adults with COVID-19 in Ontario pediatric intensive care units.

PURPOSE: To describe and review the experience of two pediatric intensive care units (PICUs) in Ontario, Canada, adapting and providing care to critically ill adults during the COVID-19 pandemic. CLINICAL FEATURES: At a time of extreme pressure to adult intensive care unit (ICU) capacity, two PICUs provided care to critically ill adults with COVID-19 pneumonia. Substantial yet rapid planning was required to facilitate safe delivery of critical care to adult patients while maintaining PICU services, including thoughtful development of care pathways and patient selection. To prepare clinical staff, several communication strategies, knowledge translation, skill consolidation, and system-adaptation mechanisms were developed. There was iterative adaptation of operational processes, including staffing models, specialist consultation, and the pharmacy. Care provided by the interprofessional teams was reoriented as appropriate to the needs of critically ill adults in close collaboration with adult ICU teams. Forty-one adults were admitted to the two PICUs over a 12-week period. In total, 36 patients (88%) received invasive ventilation, eight patients (20%) were supported with venovenous extracorporeal membrane oxygenation, and six patients (15%) received continuous renal replacement therapy. Four died in the PICU during this period. Feedback from staff included anxiety around reorienting practice to the care of critically ill adults, physical exhaustion, and psychological distress. Importantly, staff also reported a renewed sense of purpose with participation in the program. CONCLUSION: Though challenging, the experience has provided opportunity to enhance collaboration with partner institutions and improve the care of older children and adolescents in the PICU.

RéSUMé: OBJECTIF: Nous avions pour objectif de décrire et examiner l'expérience de deux unités de soins intensifs pédiatriques (USIP) en Ontario, au Canada, qui se sont adaptées et ont fourni des soins aux adultes gravement malades pendant la pandémie de COVID-19. CARACTéRISTIQUES CLINIQUES: À l'époque où la capacité des unités de soins intensifs (USI) pour adultes était extrêmement sollicitée, deux USIP ont prodigué des soins à des adultes gravement malades souffrant de pneumonie liée à la COVID-19. Une planification substantielle mais rapide a été nécessaire pour faciliter la prestation sécuritaire de soins intensifs à une patientèle adulte tout en maintenant les services de l'USIP, y compris l'élaboration réfléchie des trajectoires de soins et la sélection de la patientèle. Pour préparer le personnel clinique, plusieurs stratégies de communication, d'application des connaissances, de consolidation des compétences et de mécanismes d'adaptation du système ont été élaborées. Il y a eu une adaptation progressive des processus opérationnels, y compris des modèles de dotation, des consultations de spécialistes et de la pharmacie. Les soins fournis par les équipes interprofessionnelles ont été réorientés en fonction des besoins des adultes gravement malades en étroite collaboration avec les équipes adultes de soins intensifs. Quarante et une personnes adultes ont été admises dans les deux unités de soins intensifs pédiatriques sur une période de 12 semaines. Au total, 36 adultes (88 %) ont bénéficié d'une ventilation invasive, huit personnes (20 %) ont reçu une oxygénation par membrane extracorporelle veino-veineuse, et six (15 %) ont reçu un traitement substitutif de l'insuffisance rénale en continu. Quatre personnes sont décédées à l'USIP au cours de cette période. Les commentaires du personnel comprenaient de l'anxiété liée à la réorientation de leur pratique vers des soins à des adultes gravement malades, l'épuisement physique et la détresse psychologique. Fait important, le personnel a également signalé un regain de motivation lié à la participation de leur USIP à ce programme. CONCLUSION: Bien que difficile, l'expérience a permis d'améliorer la collaboration avec les établissements partenaires et d'améliorer les soins aux enfants plus âgé·es et aux adolescent·es de l'USIP.

Efficacy of iGlarLixi in adults with type 2 diabetes inadequately controlled (glycated haemoglobin ≥8%, ≥64 mmol/mol) on two oral antidiabetes drugs: Post hoc analysis of the LixiLan-O randomized trial.

AIMS: To assess the efficacy and safety of iGlarLixi (the titratable fixed-ratio combination of insulin glargine 100 U/mL [iGlar] plus lixisenatide [Lixi]), in adults with type 2 diabetes (T2D) with glycated haemoglobin (HbA1c) levels ≥8% (≥64 mmol/mol). MATERIALS AND METHODS: The LixiLan-O study (NCT02058147) compared iGlarLixi with iGlar or Lixi in adults with T2D inadequately controlled on metformin ± a second oral antidiabetes drug (OAD). This exploratory analysis evaluated the LixiLan-O subgroup of participants with baseline HbA1c levels of ≥8% (≥64 mmol/mol) who were receiving metformin plus a second OAD at screening. RESULTS: The mean diabetes duration was 10.0 years, and the mean duration of second OAD use was 4.5 years. iGlarLixi demonstrated greater mean reductions from baseline in HbA1c and 2-hour postprandial glucose (PPG) compared with iGlar or Lixi (HbA1c -1.9% vs. -1.6% or -1.0% [-20 vs. -17 or -10 mmol/mol; 2-hour PPG -7.2 vs. -4.6 or -5.5 mmol/L). Greater proportions of participants achieved HbA1c <7% (<53 mmol/mol) with iGlarLixi versus iGlar or Lixi (67% vs. 51% or 18%), and the composite endpoints of HbA1c <7% (<53 mmol/mol) with no body weight gain (36% vs. 19% or 16%), and HbA1c <7% (<53 mmol/mol) with no body weight gain and no documented symptomatic hypoglycaemia (plasma glucose ≤3.9 mmol/L; 28% vs. 15% or 15%). The incidence rates of documented symptomatic hypoglycaemia were 29.0%, 27.9% and 12.1% for iGlarLixi, iGlar and Lixi, respectively. CONCLUSIONS: Adults with T2D and HbA1c ≥64 mmol/mol (≥8%) despite two OADs at screening achieved better glycaemic control with iGlarLixi versus iGlar or Lixi, without increased risk of hypoglycaemia versus iGlar.

Implementing a complex hospital innovation: conceptual underpinnings, program design and implementation of a complex innovation in an international multi-site hospital trial.

BACKGROUND: Designing implementation programs that effectively integrate complex healthcare innovations into complex settings is a fundamental aspect of knowledge translation. We describe the development of a conceptually grounded implementation program for a complex healthcare innovation and its subsequent application in pediatric hospital settings. METHODS: We conducted multiple case observations of the application of the Phased Reciprocal Implementation Synergy Model (PRISM) framework in the design and operationalization of an implementation program for a complex hospital wide innovation in pediatric hospital settings. RESULTS: PRISM informed the design and delivery of 10 international hospital wide implementations of the complex innovation, BedsidePEWS. Implementation and innovation specific goals, overarching implementation program design principles, and a phased-based, customizable, and context responsive implementation program including innovation specific tools and evaluation plans emerged from the experience. CONCLUSION: Theoretically grounded implementation approaches customized for organizational contexts are feasible for the adoption and integration of this complex hospital-wide innovation. Attention to the fitting of the innovation to local practices, setting, organizational culture and end-user preferences can be achieved while maintaining the integrity of the innovation.

Effectiveness of premixed insulin to achieve glycaemic control in type 2 diabetes: A retrospective UK cohort study.

AIM: To investigate the effectiveness of premixed insulin for achieving glycaemic outcomes in clinical practice in the UK. MATERIALS AND METHODS: Electronic medical record data from The Health Improvement Network database were captured for adults with type 2 diabetes (T2D) uncontrolled (HbA1c ≥9%) on two or more oral antihyperglycaemic drugs (OADs) initiating premixed insulin. Effectiveness of premixed insulin was assessed by the probability and incidence of achieving glycaemic outcomes (target HbA1c <7.5% [<58 mmol/mol] and a ≥1% or ≥2% HbA1c reduction) over 24 months. RESULTS: Data from 974 participants (mean age 62 years; 56% male; 52% obese or extremely obese; mean HbA1c 11.3% [100 mmol/mol]; hypertension 64%, dyslipidaemia 23% and nephropathy 21%) were analysed. The probability of achieving HbA1c <7.5% was highest during months 3-6 (18.2%), while the cumulative probability of achieving this target plateaued between months 15-24 (15.7%-16.0%). Incidence of achieving all glycaemic outcomes plateaued after 12 months and differed by baseline HbA1c, but not OAD use. Factors affecting some glycaemic outcomes included a body mass index >40 kg/m2 and co-morbidities including nephropathy and stroke. CONCLUSIONS: In people with uncontrolled T2D (HbA1c ≥9%), glycaemic outcome achievement on premixed insulin was low at 6 months with little additional clinical benefit beyond 12 months, suggesting a high unmet need for early, timely treatment changes with more effective, simpler therapies.

Effects of hospital funding reform on wait times for hip fracture surgery: a population-based interrupted time-series analysis.

BACKGROUND: Health care funding reforms are being used worldwide to improve system performance but may invoke unintended consequences. We assessed the effects of introducing a targeted hospital funding model, based on fixed price and volume, for hip fractures. We hypothesized the policy change was associated with reduction in wait times for hip fracture surgery, increase in wait times for non-hip fracture surgery, and increase in the incidence of after-hours hip fracture surgery. METHODS: This was a population-based, interrupted time series analysis of 49,097 surgeries for hip fractures, 10,474 for ankle fractures, 1,594 for tibial plateau fractures, and 40,898 for appendectomy at all hospitals in Ontario, Canada between April 2012 and March 2017. We used segmented regression analysis of interrupted monthly time series data to evaluate the impact of funding reform enacted April 1, 2014 on wait time for hip fracture repair (from hospital presentation to surgery) and after-hours provision of surgery (occurring between 1700 and 0700 h). To assess potential adverse consequences of the reform, we also evaluated two control procedures, ankle and tibial plateau fracture surgery. Appendectomy served as a non-orthopedic tracer for assessment of secular trends. RESULTS: The difference (95 % confidence interval) between the actual mean wait time and the predicted rate had the policy change not occurred was - 0.46 h (-3.94 h, 3.03 h) for hip fractures, 1.46 h (-3.58 h, 6.50 h) for ankle fractures, -3.22 h (-39.39 h, 32.95 h) for tibial plateau fractures, and 0.33 h (-0.57 h, 1.24 h) for appendectomy (Figure 1; Table 3). The difference (95 % confidence interval) between the actual and predicted percentage of surgeries performed after-hours - 0.90 % (-3.91 %, 2.11 %) for hip fractures, -3.54 % (-11.25 %, 4.16 %) for ankle fractures, 7.09 % (-7.97 %, 22.14 %) for tibial plateau fractures, and 1.07 % (-2.45 %, 4.59 %) for appendectomy. CONCLUSIONS: We found no significant effects of a targeted hospital funding model based on fixed price and volume on wait times or the provision of after-hours surgery. Other approaches for improving hip fracture wait times may be worth pursuing instead of funding reform.

Moral Distress of Clinicians in Canadian Pediatric and Neonatal ICUs.

OBJECTIVE: To quantify moral distress in neonatal ICU and PICU clinicians and to identify associated factors. DESIGN: A national cross-sectional survey of clinicians working in an neonatal ICU or PICU. Moral distress was assessed with the Moral Distress Scale-Revised and by self-rating. Depersonalization was assessed on the subscale of the Maslach Burnout Inventory. Respondents reported their attendance at each of six hospital supports that may serve to mitigate moral distress in frontline staff. Analyses compared outcomes across respondent characteristics and hierarchical linear regression evaluated individual, ICU, hospital, and regional effects. SETTING: Eligible ICUs were PICUs and level-3 neonatal ICUs in Canada. SUBJECTS: Eligible participants had worked in the participating ICU for more than 3 months. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We identified 54 eligible ICUs from 31 hospitals. Forty-nine Canadian neonatal ICUs and PICUs (91%) contributed 2,852 complete responses for a 45.2% response rate. Most respondents were nurses (64.9%) or from a neonatal ICU (66.5%). The median and interquartile range Moral Distress Scale-Revised were 79 (52-113); 997 respondents (34.2%) had Moral Distress Scale-Revised scores greater than or equal to 100, and 234 respondents (8.3%) strongly agreed that work caused them significant moral distress. Nurses had a median (interquartile range) Moral Distress Scale-Revised score of 85 (57-121), 19 points higher than physicians and 8 points higher than respiratory therapists (p < 0.0001). Moral Distress Scale-Revised scores increased from 53 (35-79) for those working in ICU less than 1 year to 83 (54-120) in those working in ICU more than 30 years (p < 0.0001); 22.5% reported high degrees of depersonalization, which was associated with moral distress (p < 0.0001). Variability in Moral Distress Scale-Revised scores was explained by individual-level (92%), hospital-level (5%), and ICU-level effects (1%). Frequency of participation in potentially mitigating hospital supports had small effects (< 10 points) on mean Moral Distress Scale-Revised scores. CONCLUSIONS: Moral distress is common in clinicians working in ICUs for children. Addressing moral distress will require interventions tailored to individuals in higher-risk groups.

Moral distress: Developing strategies from experience.

BACKGROUND: Moral distress was first described by Jameton in 1984, and has been defined as distress experienced by an individual when they are unable to carry out what they believe to be the right course of action because of real or perceived constraints on that action. This complex phenomenon has been studied extensively among healthcare providers, and intensive care professionals in particular report high levels of moral distress. This distress has been associated with provider burnout and associated consequences such as job attrition, with potential impacts on patient and family care. There is a paucity of literature exploring how middle and late career healthcare providers experience and cope with moral distress. OBJECTIVES: We explore the experience of moral distress and the strategies and resources invoked to mitigate that distress in mid- and late-career healthcare providers practicing in paediatric intensive care, in order to identify ways in which the work environment can build a culture of moral resilience. RESEARCH DESIGN: An exploratory, qualitative quality improvement project utilizing focus group and semi-structured interviews with pediatric intensive care front-line providers. PARTICIPANTS: Mid-and-later career (10 + years in practice) pediatric intensive care front line providers in a tertiary pediatric hospital. RESEARCH CONTEXT: This work focuses on paediatric intensive care providers in a single critical care unit, in order to explore the site-specific perspectives of health care providers in that context with respect to moral distress coping strategies. ETHICAL CONSIDERATIONS: The study was approved by the Quality Management Office at the institution; consent was obtained from participants, and no identifying data was included in this project. FINDINGS: Participants endorsed perspective-building and described strategies for positive adaptation including; active, reflective and structured supports. Participants articulated interest in enhanced and accessible formal supports. DISCUSSION: Findings in this study resonate with the current literature in healthcare provider moral distress, and exposed ways in which the work environment could support a culture of moral resilience. Avenues are described for the management and mitigation of moral distress in this setting. CONCLUSION: This exploratory work lays the groundwork for interventions that facilitate personal growth and meaning in the midst of moral crises in critical care practice.

Once daily long-acting beta2-agonists and long-acting muscarinic antagonists in a combined inhaler versus placebo for chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a respiratory condition causing accumulation of mucus in the airways, cough, and breathlessness; the disease is progressive and is the fourth most common cause of death worldwide. Current treatment strategies for COPD are multi-modal and aim to reduce morbidity and mortality and increase patients' quality of life by slowing disease progression and preventing exacerbations. Fixed-dose combinations (FDCs) of a long-acting beta2-agonist (LABA) plus a long-acting muscarinic antagonist (LAMA) delivered via a single inhaler are approved by regulatory authorities in the USA, Europe, and Japan for the treatment of COPD. Several LABA/LAMA FDCs are available and recent meta-analyses have clarified their utility versus their mono-components in COPD. Evaluation of the efficacy and safety of once-daily LABA/LAMA FDCs versus placebo will facilitate the comparison of different FDCs in future network meta-analyses. OBJECTIVES: We assessed the evidence for once-daily LABA/LAMA combinations (delivered in a single inhaler) versus placebo on clinically meaningful outcomes in patients with stable COPD. SEARCH METHODS: We identified trials from Cochrane Airways' Specialised Register (CASR) and also conducted a search of the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization International Clinical Trials Registry Platform (apps.who.int/trialsearch). We searched CASR and trial registries from their inception to 3 December 2018; we imposed no restriction on language of publication. SELECTION CRITERIA: We included parallel-group and cross-over randomised controlled trials (RCTs) comparing once-daily LABA/LAMA FDC versus placebo. We included studies reported as full-text, those published as abstract only, and unpublished data. We excluded very short-term trials with a duration of less than 3 weeks. We included adults (≥ 40 years old) with a diagnosis of stable COPD. We included studies that allowed participants to continue using their ICS during the trial as long as the ICS was not part of the randomised treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results to determine included studies, extracted data on prespecified outcomes of interest, and assessed the risk of bias of included studies; we resolved disagreements by discussion with a third review author. Where possible, we used a random-effects model to meta-analyse extracted data. We rated all outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) system and presented results in 'Summary of findings' tables. MAIN RESULTS: We identified and included 22 RCTs randomly assigning 8641 people with COPD to either once-daily LABA/LAMA FDC (6252 participants) or placebo (3819 participants); nine studies had a cross-over design. Studies had a duration of between three and 52 weeks (median 12 weeks). The mean age of participants across the included studies ranged from 59 to 65 years and in 21 of 22 studies, participants had GOLD stage II or III COPD. Concomitant inhaled corticosteroid (ICS) use was permitted in all of the included studies (where stated); across the included studies, between 28% to 58% of participants were using ICS at baseline. Six studies evaluated the once-daily combination of IND/GLY (110/50 µg), seven studies evaluated TIO/OLO (2.5/5 or 5/5 µg), eight studies evaluated UMEC/VI (62.5/5, 125/25 or 500/25 µg) and one study evaluated ACD/FOR (200/6, 200/12 or 200/18 µg); all LABA/LAMA combinations were compared with placebo.The risk of bias was generally considered to be low or unknown (insufficient detail provided), with only one study per domain considered to have a high risk of bias except for the domain 'other bias' which was determined to be at high risk of bias in four studies (in three studies, disease severity was greater at baseline in participants receiving LABA/LAMA compared with participants receiving placebo, which would be expected to shift the treatment effect in favour of placebo).Compared to the placebo, the pooled results for the primary outcomes for the once-daily LABA/LAMA arm were as follows: all-cause mortality, OR 1.88 (95% CI 0.81 to 4.36, low-certainty evidence); all-cause serious adverse events (SAEs), OR 1.06 (95% CI 0.88 to 1.28, high-certainty evidence); acute exacerbations of COPD (AECOPD), OR 0.53 (95% CI 0.36 to 0.78, moderate-certainty evidence); adjusted St George's Respiratory Questionnaire (SGRQ) score, MD -4.08 (95% CI -4.80 to -3.36, high-certainty evidence); proportion of SGRQ responders, OR 1.75 (95% CI 1.54 to 1.99). Compared with placebo, the pooled results for the secondary outcomes for the once-daily LABA/LAMA arm were as follows: adjusted trough forced expiratory volume in one second (FEV1), MD 0.20 L (95% CI 0.19 to 0.21, moderate-certainty evidence); adjusted peak FEV1, MD 0.31 L (95% CI 0.29 to 0.32, moderate-certainty evidence); and all-cause AEs, OR 0.95 (95% CI 0.86 to 1.04; high-certainty evidence). No studies reported data for the 6-minute walk test. The results were generally consistent across subgroups for different LABA/LAMA combinations and doses. AUTHORS' CONCLUSIONS: Compared with placebo, once-daily LABA/LAMA (either IND/GLY, UMEC/VI or TIO/OLO) via a combination inhaler is associated with a clinically significant improvement in lung function and health-related quality of life in patients with mild-to-moderate COPD; UMEC/VI appears to reduce the rate of exacerbations in this population. These conclusions are supported by moderate or high certainty evidence based on studies with an observation period of up to one year.

Out of sync: a Shared Mental Models perspective on policy implementation in healthcare.

The impact of policy ambiguity on implementation is a perennial concern in policy circles. The degree of ambiguity of policy goals and the means to achieve them influences the likelihood that a policy will be uniformly understood and implemented across implementation sites. We argue that the application of institutional and organisational theories to policy implementation must be supplemented by a socio-cognitive lens in which stakeholders' interpretations of policy are investigated and compared. We borrow the concept of 'Shared Mental Models' from the literature on industrial psychology to examine the microprocesses of policy implementation. Drawing from interviews with 45 key informants involved in the implementation of a hospital funding reform, known as Quality-Based Procedures in Ontario, Canada, we identify divergent mental models and explain how these divergences may have affected implementation and change management. We close with considerations for future research and practice.

Logistics of Withdrawal of Life-Sustaining Therapies in PICU.

OBJECTIVES: To describe practical considerations and approaches to best practices for end-of-life care for critically ill children and families in the PICU. DATA SOURCES: Literature review, personal experience, and expert opinion. STUDY SELECTION: A sampling of the foundational and current evidence related to the withdrawal of life-sustaining therapies in the context of childhood critical illness and injury was accessed. DATA EXTRACTION: Moderated by the authors and supported by lived experience. DATA SYNTHESIS: Narrative review and experiential reflection. CONCLUSIONS: Consequences of childhood death in the PICU extend beyond the events of dying and death. In the context of withdrawal of life-sustaining therapies, achieving a quality death is impactful both in the immediate and in the longer term for family and for the team. An individualized approach to withdrawal of life-sustaining therapies that is informed by empiric and practical knowledge will ensure best care of the child and support the emotional well-being of child, family, and the team. Adherence to the principles of holistic and compassionate end-of-life care and an ongoing commitment to provide the best possible experience for withdrawal of life-sustaining therapies can achieve optimal end-of-life care in the most challenging of circumstances.

Caring for Parents After the Death of a Child.

OBJECTIVES: To describe the health outcomes of bereaved parents and identify practical strategies for critical care providers as they support and provide anticipatory guidance to bereaved parents. DATA SOURCES: PubMed and PsycInfo databases with search terms of bereavement, grief, with parent and pediatric or child complimented by personal experience and knowledge. STUDY SELECTION: We sought studies describing parental health outcomes and needs of bereaved parents after the death of their child. DATA SYNTHESIS: A narrative literature review was performed and framed from the perspective of PICU providers who care for bereaved parents. We aimed to describe experiences of grief and short- and long-term consequences and approaches to the care of parents and families in the immediate period and in the months after the death of a child. CONCLUSIONS: The death of a child is a traumatic experience that can put parents at risk for adverse mental and physical health during bereavement. Health professionals working in PICUs can benefit from knowing these risks to best support bereaved parents, both during their child's hospitalization and in the early postdeath period. The bereavement experience of parents is an adaptive process, and ongoing professional support may be required for vulnerable families. After the child's hospitalization and death, a bereavement follow-up meeting with PICU physician(s) and staff may allow parents to gain additional information, emotional support, and provide an opportunity for parents to give feedback on their experiences.

Organ Donation Following Neurologic and Circulatory Determination of Death.

OBJECTIVES: To describe important considerations during the process of caring for critically ill children who may be potential organ donors and supporting the family during the death of their child. DESIGN: Literature review and expert commentary. MEASUREMENT AND MAIN RESULTS: Medical literature focusing on pediatric donation, best pediatric donation practices, donor management, and factors influencing donation were reviewed. Additional pediatric data were obtained and reviewed from the U.S. Organ Procurement and Transplantation Network. Achieving successful organ donation requires the coordinated efforts of the critical care team, organ donation organization, and transplant team to effectively manage a potential donor and recover suitable organs for transplantation. Collaboration between these teams is essential to ensure that all potential organs are recovered in optimal condition, to reduce death and morbidity in children on transplantation waiting lists as well as fulfilling the family's wishes for their dying child to become a donor. CONCLUSIONS: Organ donation is an important component of end-of-life care and can help the healing process for families and medical staff following the death of a child. The process of pediatric organ donation requires healthcare providers to actively work to preserve the option of donation before the death of the child and ensure donation occurs after consent/authorization has been obtained from the family. Medical management of the pediatric organ donor requires the expertise of a multidisciplinary medical team skilled in the unique needs of caring for children after neurologic determination of death and those who become donors following circulatory death after withdrawal of life-sustaining medical therapies.

Care for Dying Children and Their Families in the PICU: Promoting Clinician Education, Support, and Resilience.

OBJECTIVES: To describe the consequences of workplace stressors on healthcare clinicians in PICU, and strategies for personal well-being, and professional effectiveness in providing high-quality end-of-life care. DATA SOURCES: Literature review, clinical experience, and expert opinion. STUDY SELECTION: A sampling of foundational and current evidence was accessed. DATA SYNTHESIS: Narrative review and experiential reflection. CONCLUSIONS: The well-being of healthcare clinicians in the PICU influences the day-to-day quality and effectiveness of patient care, team functioning, and the retention of skilled individuals in the PICU workforce. End-of-life care, including decision making, can be complicated. Both are major stressors for PICU staff that can lead to adverse personal and professional consequences. Overresponsiveness to routine stressors may be seen in those with moral distress, and underresponsiveness may be seen in those with compassion fatigue or burnout. Ideally, all healthcare professionals in PICU can rise to the day-to-day workplace challenges-responding in an adaptive, effective manner. Strategies to proactively increase resilience and well-being include self-awareness, self-care, situational awareness, and education to increase confidence and skills for providing end-of-life care. Reactive strategies include case conferences, prebriefings in ongoing preidentified situations, debriefings, and other postevent meetings. Nurturing a culture of practice that acknowledges the emotional impacts of pediatric critical care work and celebrates the shared experiences of families and clinicians to build resilient, effective, and professionally fulfilled healthcare professionals thus enabling the provision of high-quality end-of-life care for children and their families.

When a Child Dies in the PICU Despite Ongoing Life Support.

OBJECTIVES: To examine the circumstance of death in the PICU in the setting of ongoing curative or life-prolonging goals. DATA SOURCES: Multidisciplinary author group, international expert opinion, and use of current literature. DATA SYNTHESIS: We describe three common clinical scenarios when curative or life-prolonging goals of care are pursued despite a high likelihood of death. We explore the challenges to providing high-quality end-of-life care in this setting. We describe possible perspectives of families and ICU clinicians facing these circumstances to aid in our understanding of these complex deaths. Finally, we offer suggestions of how PICU clinicians might improve the care of children at the end of life in this setting. CONCLUSIONS: Merging curative interventions and optimal end-of-life care is possible, important, and can be enabled when clinicians use creativity, explore possibilities, remain open minded, and maintain flexibility in the provision of critical care medicine. When faced with real and perceived barriers in providing optimal end-of-life care, particularly when curative goals of care are prioritized despite a very poor prognosis, tensions and conflict may arise. Through an intentional exploration of self and others' perspectives, values, and goals, and working toward finding commonality in order to align with each other, conflict in end-of-life care may lessen, allowing the central focus to remain on providing optimal support for the dying child and their family.

Standardising costs or standardising care? Qualitative evaluation of the implementation and impact of a hospital funding reform in Ontario, Canada.

BACKGROUND: Since 2011, the Government of Ontario, Canada, has phased in hospital funding reforms hoping to encourage standardised, evidence-based clinical care processes to both improve patient outcomes and reduce system costs. One aspect of the reform - quality-based procedures (QBPs) - replaced some of each hospital's global budget with a pre-set price per episode of care for patients with specific diagnoses or procedures. The QBP initiative included publication and dissemination of a handbook for each of these diagnoses or procedures, developed by an expert technical group. Each handbook was intended to guide hospitals in reducing inappropriate variation in patient care and cost by specifying an evidence-based episode of care pathway. We explored whether, how and why hospitals implemented these episode of care pathways in response to this initiative. METHODS: We interviewed key informants at three levels in the healthcare system, namely individuals who conceived and designed the QBP policy, individuals and organisations supporting QBP adoption, and leaders in five case-study hospitals responsible for QBP implementation. Analysis involved an inductive approach, incorporating framework analysis to generate descriptive and explanatory themes from data. RESULTS: The 46 key informants described variable implementation of best practice episode of care pathways across QBPs and across hospitals. Handbooks outlining evidence-based clinical pathways did not address specific barriers to change for different QBPs nor differences in hospitals' capacity to manage change. Hospitals sometimes found it easier to focus on containing and standardising costs of care than on implementing standardised care processes that adhered to best clinical practices. CONCLUSION: Implementation of QBPs in Ontario's hospitals depended on the interplay between three factors, namely complexity of changes required, internal capacity for organisational change, and availability and appropriateness of targeted external facilitators and supports to manage change. Variation in these factors across QBPs and hospitals suggests the need for more tailored and flexible implementation supports designed to fit all elements of the policy, rather than one-size-fits-all handbooks alone. Without such supports, hospitals may enact quick fixes aimed mainly at preserving budgets, rather than pursue evidence- and value-based changes in care management. Overestimating hospitals' change management capacity increases the risk of implementation failure.

Effect of a Pediatric Early Warning System on All-Cause Mortality in Hospitalized Pediatric Patients: The EPOCH Randomized Clinical Trial.

Importance: There is limited evidence that the use of severity of illness scores in pediatric patients can facilitate timely admission to the intensive care unit or improve patient outcomes. Objective: To determine the effect of the Bedside Paediatric Early Warning System (BedsidePEWS) on all-cause hospital mortality and late admission to the intensive care unit (ICU), cardiac arrest, and ICU resource use. Design, Setting, and Participants: A multicenter cluster randomized trial of 21 hospitals located in 7 countries (Belgium, Canada, England, Ireland, Italy, New Zealand, and the Netherlands) that provided inpatient pediatric care for infants (gestational age ≥37 weeks) to teenagers (aged ≤18 years). Participating hospitals had continuous physician staffing and subspecialized pediatric services. Patient enrollment began on February 28, 2011, and ended on June 21, 2015. Follow-up ended on July 19, 2015. Interventions: The BedsidePEWS intervention (10 hospitals) was compared with usual care (no severity of illness score; 11 hospitals). Main Outcomes and Measures: The primary outcome was all-cause hospital mortality. The secondary outcome was a significant clinical deterioration event, which was defined as a composite outcome reflecting late ICU admission. Regression analyses accounted for hospital-level clustering and baseline rates. Results: Among 144 539 patient discharges at 21 randomized hospitals, there were 559 443 patient-days and 144 539 patients (100%) completed the trial. All-cause hospital mortality was 1.93 per 1000 patient discharges at hospitals with BedsidePEWS and 1.56 per 1000 patient discharges at hospitals with usual care (adjusted between-group rate difference, 0.01 [95% CI, -0.80 to 0.81 per 1000 patient discharges]; adjusted odds ratio, 1.01 [95% CI, 0.61 to 1.69]; P = .96). Significant clinical deterioration events occurred during 0.50 per 1000 patient-days at hospitals with BedsidePEWS vs 0.84 per 1000 patient-days at hospitals with usual care (adjusted between-group rate difference, -0.34 [95% CI, -0.73 to 0.05 per 1000 patient-days]; adjusted rate ratio, 0.77 [95% CI, 0.61 to 0.97]; P = .03). Conclusions and Relevance: Implementation of the Bedside Paediatric Early Warning System compared with usual care did not significantly decrease all-cause mortality among hospitalized pediatric patients. These findings do not support the use of this system to reduce mortality. Trial Registration: clinicaltrials.gov Identifier: NCT01260831.

Moral Distress in PICU and Neonatal ICU Practitioners: A Cross-Sectional Evaluation.

OBJECTIVES: To measure the level of moral distress in PICU and neonatal ICU health practitioners, and to describe the relationship of moral distress with demographic factors, burnout, and uncertainty. DESIGN: Cross-sectional survey. SETTING: A large pediatric tertiary care center. SUBJECTS: Neonatal ICU and PICU health practitioners with at least 3 months of ICU experience. INTERVENTIONS: A 41-item questionnaire examining moral distress, burnout, and uncertainty. MEASUREMENTS AND MAIN RESULTS: The main outcome was moral distress measured with the Revised Moral Distress Scale. Secondary outcomes were frequency and intensity Revised Moral Distress Scale subscores, burnout measured with the Maslach Burnout Inventory depersonalization subscale, and uncertainty measured with questions adapted from Mishel's Parent Perception of Uncertainty Scale. Linear regression models were used to examine associations between participant characteristics and the measures of moral distress, burnout, and uncertainty. Two-hundred six analyzable surveys were returned. The median Revised Moral Distress Scale score was 96.5 (interquartile range, 69-133), and 58% of respondents reported significant work-related moral distress. Revised Moral Distress Scale items involving end-of-life care and communication scored highest. Moral distress was positively associated with burnout (r = 0.27; p < 0.001) and uncertainty (r = 0.04; p = 0.008) and inversely associated with perceived hospital supportiveness (r = 0.18; p < 0.001). Nurses reported higher moral distress intensity than physicians (Revised Moral Distress Scale intensity subscores: 57.3 vs 44.7; p = 0.002). In nurses only, moral distress was positively associated with increasing years of ICU experience (p = 0.02) and uncertainty about whether their care was of benefit (r = 0.11; p < 0.001) and inversely associated with uncertainty about a child's prognosis (r = 0.03; p = 0.03). CONCLUSIONS: In this single-center, cross-sectional study, we found that moral distress is present in PICU and neonatal ICU health practitioners and is correlated with burnout, uncertainty, and feeling unsupported.

Pediatric Critical Care Nursing Research Priorities-Initiating International Dialogue.

OBJECTIVE: To identify and prioritize research questions of concern to the practice of pediatric critical care nursing practice. DESIGN: One-day consensus conference. By using a conceptual framework by Benner et al describing domains of practice in critical care nursing, nine international nurse researchers presented state-of-the-art lectures. Each identified knowledge gaps in their assigned practice domain and then poised three research questions to fill that gap. Then, meeting participants prioritized the proposed research questions using an interactive multivoting process. SETTING: Seventh World Congress on Pediatric Intensive and Critical Care in Istanbul, Turkey. PARTICIPANTS: Pediatric critical care nurses and nurse scientists attending the open consensus meeting. INTERVENTIONS: Systematic review, gap analysis, and interactive multivoting. MEASUREMENTS AND MAIN RESULTS: The participants prioritized 27 nursing research questions in nine content domains. The top four research questions were 1) identifying nursing interventions that directly impact the child and family's experience during the withdrawal of life support, 2) evaluating the long-term psychosocial impact of a child's critical illness on family outcomes, 3) articulating core nursing competencies that prevent unstable situations from deteriorating into crises, and 4) describing the level of nursing education and experience in pediatric critical care that has a protective effect on the mortality and morbidity of critically ill children. CONCLUSIONS: The consensus meeting was effective in organizing pediatric critical care nursing knowledge, identifying knowledge gaps and in prioritizing nursing research initiatives that could be used to advance nursing science across world regions.

Nurses' views of factors affecting sleep for hospitalized children and their families: A focus group study.

Light, noise, and interruptions from hospital staff lead to frequent awakenings and detrimental changes to sleep quantity and quality for children who are hospitalized and their parents who stay with them overnight. An understanding of nurses' views on how care affects sleep for the hospitalized child and parent is crucial to the development of strategies to decrease sleep disturbance in hospital. The purpose of this descriptive qualitative study was to gain an understanding of nurses' views on their role in and influence on sleep for families; perceived barriers and facilitators of patient and parent sleep at night; strategies nurses use to preserve sleep; the distribution, between parent and nurse, of care for the child at night; views of the parent as a recipient of nursing care at night; and the nature of interactions between nurses and families at night. Thirty registered nurses from general pediatric and critical care units participated in one of four semi-structured focus groups. Four main influences on sleep were identified: child factors; environmental factors; nurse-parent interaction factors; and nursing care factors. Some of these restricted nurses' ability to optimize sleep, but many factors were amenable to intervention. Balancing strategies to preserve sleep with the provision of nursing assessment and intervention was challenging and complicated by the difficult nature of work outside of usual waking hours. Nurses highlighted the need for formal policy and mentoring related to provision of nursing care at night in pediatric settings.