Acute care utilization for ambulatory care-sensitive conditions among publicly insured children.

BACKGROUND: Although characteristics of preventable hospitalizations for ambulatory care-sensitive conditions (ACSCs) have been described, less is known about patterns of emergency and other acute care utilization for ACSCs among children who are not hospitalized. We sought to describe patterns of utilization for ACSCs according to the initial site of care and to determine characteristics associated with seeking initial care in an acute care setting rather than in an office. A better understanding of the sequence of health care utilization for ACSCs may inform efforts to shift care for these common conditions to the medical home. METHODS: We performed a retrospective analysis of pediatric encounters for ACSCs between 2017 and 2019 using data from the IBM Watson MarketScan Medicaid database. The database includes insurance claims for Medicaid-insured children in 10 anonymized states. We assessed the initial sites of care for ACSC encounters, which were defined as either acute care settings (emergency or urgent care) or office-based settings. We used generalized estimating equations clustered on patient to identify associations between encounter characteristics and the initial site of care. RESULTS: Among 7,128,515 encounters for ACSCs, acute care settings were the initial site of care in 27.9%. Diagnoses with the greatest proportion of episodes presenting to acute care settings were urinary tract infection (52.0% of episodes) and pneumonia (44.6%). Encounters on the weekend (adjusted odds ratio [aOR] 6.30, 95% confidence interval [CI] 6.27-6.34 compared with weekday) and among children with capitated insurance (aOR 1.55, 95% CI 1.54-1.56 compared with fee for service) were associated with increased odds of seeking care first in an acute care setting. CONCLUSIONS: Acute care settings are the initial sites of care for more than one in four encounters for ACSCs among publicly insured children. Expanded access to primary care on weekends may shift care for ACSCs to the medical home.

Pharmacological agents for procedural sedation and analgesia in the emergency department and intensive care unit: a systematic review and network meta-analysis of randomised trials.

BACKGROUND: We aimed to evaluate the comparative effectiveness and safety of various i.v. pharmacologic agents used for procedural sedation and analgesia (PSA) in the emergency department (ED) and ICU. We performed a systematic review and network meta-analysis to enable direct and indirect comparisons between available medications. METHODS: We searched Medline, EMBASE, Cochrane, and PubMed from inception to 2 March 2023 for RCTs comparing two or more procedural sedation and analgesia medications in all patients (adults and children >30 days of age) requiring emergent procedures in the ED or ICU. We focused on the outcomes of sedation recovery time, patient satisfaction, and adverse events (AEs). We performed frequentist random-effects model network meta-analysis and used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to rate certainty in estimates. RESULTS: We included 82 RCTs (8105 patients, 78 conducted in the ED and four in the ICU) of which 52 studies included adults, 23 included children, and seven included both. Compared with midazolam-opioids, recovery time was shorter with propofol (mean difference 16.3 min, 95% confidence interval [CI] 8.4-24.3 fewer minutes; high certainty), and patient satisfaction was better with ketamine-propofol (mean difference 1.5 points, 95% CI 0.3-2.6 points, high certainty). Regarding AEs, compared with midazolam-opioids, respiratory AEs were less frequent with ketamine (relative risk [RR] 0.55, 95% CI 0.32-0.96; high certainty), gastrointestinal AEs were more common with ketamine-midazolam (RR 3.08, 95% CI 1.15-8.27; high certainty), and neurological AEs were more common with ketamine-propofol (RR 3.68, 95% CI 1.08-12.53; high certainty). CONCLUSION: When considering procedural sedation and analgesia in the ED and ICU, compared with midazolam-opioids, sedation recovery time is shorter with propofol, patient satisfaction is better with ketamine-propofol, and respiratory adverse events are less common with ketamine.

Evaluating Multiple Magnet Ingestion at 2 Large Canadian Pediatric Hospitals After Reintroduction to the US Marketplace.

OBJECTIVES: To determine the trend in incidence of pediatric magnet ingestions at 2 large Canadian tertiary pediatric hospitals after reintroduction of magnets to the US marketplace and to evaluate morbidity and mortality related to these ingestions. METHODS: This was a retrospective study performed in 2 tertiary care pediatric hospitals between 2004 and 2019. We reviewed the charts of all children who presented with a foreign body ingestion and included those with reported magnet ingestion. We characterized all events and compared the incidence rate before and after the US ban was overturned in 2016. Descriptive statistics were used to summarize our results. Incidence rate ratio was calculated using the total number of magnet ingestion cases and total emergency department visits normalized to 100,000 emergency department visits/year. RESULTS: We screened a total of 6586 ingestions and identified 192 patients with magnet ingestions. The period after the mandatory recall was compared with the period after the US ban revocation yielding an incidence rate ratio of 0.76 for all magnet ingestions ( P = 0.15) and 0.73 ( P = 0.34) for multiple magnet ingestions. There was, however, a graphical upward trend that immediately followed the US ban revocation. Sixty-nine patients (36%) were admitted to the hospital and 45 (23%) required a procedure to remove the magnet ingested. No deaths occurred. CONCLUSIONS: Our findings suggest that the overturning of the US ban did not lead to a significant increase in the incidence of rare earth magnet ingestion in 2 large tertiary pediatric hospitals in Canada despite noting a trend upwards.

Nasal Suctioning Therapy Among Infants With Bronchiolitis Discharged Home From the Emergency Department: A Randomized Clinical Trial.

Importance: Although nasal suctioning is the most frequently used supportive management for bronchiolitis, its benefit remains unknown. Objective: To evaluate the effectiveness of enhanced vs minimal nasal suctioning in treating infants with bronchiolitis after discharge from the emergency department (ED). Design, Setting, and Participants: This single-blind, parallel-group, randomized clinical trial was conducted from March 6, 2020, to December 15, 2022, at 4 tertiary-care Canadian pediatric EDs. Participants included otherwise healthy infants aged 1 to 11 months with a diagnosis of bronchiolitis who were discharged home from the ED. Interventions: Participants were randomized to minimal suctioning via bulb or enhanced suctioning via a battery-operated device before feeding for 72 hours. Main Outcomes and Measures: The primary outcome was additional resource use, a composite of unscheduled revisits for bronchiolitis or use of additional suctioning devices for feeding and/or breathing concerns. Secondary outcomes included health care utilization, feeding and sleeping adequacy, and satisfaction. Results: Of 884 screened patients, 352 were excluded for criteria, 79 declined participation, 81 were otherwise excluded, 372 were randomized (185 to the minimal suction group and 187 to the enhanced suction group), and 367 (median [IQR] age, 4 [2-6] months; 221 boys [60.2%]) completed the trial (184 in the minimal suction and 183 in the enhanced suction group). Additional resource use occurred for 68 of 184 minimal suction participants (37.0%) vs 48 of 183 enhanced suction participants (26.2%) (absolute risk difference, 0.11; 95% CI, 0.01 to 0.20; P = .03). Unscheduled revisits occurred for 47 of 184 minimal suction participants (25.5%) vs 40 of 183 enhanced suction participants (21.9%) (absolute risk difference, 0.04; 95% CI, -0.05 to 0.12; P = .46). A total of 33 of 184 parents in the minimal suction group (17.9%) used additional suctioning devices vs 11 of 183 parents in the enhanced suction group (6.0%) (absolute risk difference, 0.12; 95% CI, 0.05 to 0.19; P < .001). No significant between-group differences were observed for all bronchiolitis revisits (absolute risk difference, 0.07; 95% CI, -0.02 to 0.16; P = .15), ED revisits (absolute risk difference, 0.04; 95% CI, -0.03 to 0.12; P = .30), parental care satisfaction (absolute risk difference, -0.02; 95% CI, -0.10 to 0.06; P = .70), and changes from baseline to 72 hours in normal feeding (difference in differences, 0.03; 95% CI, -0.10 to 0.17; P = .62), normal sleeping (difference in differences, 0.05; 95% CI, -0.08 to 0.18; P = .47), or normal parental sleeping (difference in differences, 0.10; 95% CI, -0.02 to 0.23; P = .09). Parents in the minimal suction group were less satisfied with the assigned device (62 of 184 [33.7%]) than parents in the enhanced suction group (145 of 183 [79.2%]) (risk difference, 0.45; 95% CI, 0.36 to 0.54; P < .001). Conclusions and Relevance: Compared with minimal suctioning, enhanced suctioning after ED discharge with bronchiolitis did not alter the disease course because there were no group differences in revisits or feeding and sleeping adequacy. Minimal suctioning resulted in higher use of nonassigned suctioning devices and lower parental satisfaction with the assigned device. Trial Registration: ClinicalTrials.gov Identifier: NCT03361371.

Emergency department visits and hospital admissions for suicidal ideation, self-poisoning and self-harm among adolescents in Canada during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic had profound effects on the mental wellbeing of adolescents. We sought to evaluate pandemic-related changes in health care use for suicidal ideation, self-poisoning and self-harm. METHODS: We obtained data from the Canadian Institute for Health Information on emergency department visits and hospital admissions from April 2015 to March 2022 among adolescents aged 10-18 years in Canada. We calculated the quarterly percentage of emergency department visits and hospital admissions for a composite outcome comprising suicidal ideation, self-poisoning and self-harm relative to all-cause emergency department visits and hospital admissions. We used interrupted time-series methods to compare changes in levels and trends of these outcomes between the prepandemic (Apr. 1, 2015-Mar. 1, 2020) and pandemic (Apr. 1, 2020-Mar. 31, 2022) periods. RESULTS: The average quarterly percentage of emergency department visits for suicidal ideation, self-poisoning and self-harm relative to all-cause emergency department visits was 2.30% during the prepandemic period and 3.52% during the pandemic period. The level (0.08%, 95% confidence interval [CI] -0.79% to 0.95%) or trend (0.07% per quarter, 95% CI -0.14% to 0.28%) of this percentage did not change significantly between periods. The average quarterly percentage of hospital admissions for the composite outcome relative to all-cause admissions was 7.18% during the prepandemic period and 8.96% during the pandemic period. This percentage showed no significant change in level (-0.70%, 95% CI -1.90% to 0.50%), but did show a significantly increasing trend (0.36% per quarter; 95% 0.07% to 0.65%) during the pandemic versus prepandemic periods, specifically among females aged 10-14 years (0.76% per quarter, 95% CI 0.22% to 1.30%) and females aged 15-18 years (0.56% per quarter, 95% CI 0.31% to 0.81%). INTERPRETATION: The quarterly change in the percentage of hospital admissions for suicidal ideation, self-poisoning and self-harm increased among adolescent females in Canada during the first 2 years of the COVID-19 pandemic. This underscores the need to promote public health policies that mitigate the impact of the pandemic on adolescent mental health.

Prevalence and characterization of food insecurity in a Canadian paediatric emergency department.

Objectives: Food insecurity (FI) is associated with a number of adverse child health outcomes and increased emergency department (ED) use. The COVID-19 pandemic exacerbated the financial hardship faced by many families. We sought to determine the prevalence of FI among children with ED visits, compare this to pre-pandemic rates, and describe associated risk factors. Methods: From September to December 2021, families presenting to a Canadian paediatric ED were asked to complete a survey screening for FI along with health and demographic information. Results were compared to data collected in 2012. Multivariable logistic regression was used to measure associations with FI. Results: In 2021, 26% (n = 173/665) of families identified as food insecure compared to 22.7% in 2012 (n = 146/644) a difference of 3.3% (95% CI [-1.4%, 8.1%]). In multivariable analysis, greater number of children in the home (OR 1.19, 95% CI [1.01, 1.41]), financial strain from medical expenses (OR 5.31, 95% CI [3.45, 8.18]), and a lack of primary care access (OR 1.27, 95% CI [1.08, 1.51]) were independent predictors of FI. Less than half of families with FI reported use of food charity, most commonly food banks, while one-quarter received help from family or friends. Families experiencing FI expressed a preference for support through free or low-cost meals and financial assistance with medical expenses. Conclusion: More than one in four families attending a paediatric ED screened positive for FI. Future research is needed to examine the effect of support interventions for families assessed in medical care facilities including financial support for those with chronic medical conditions.

Comparative Effectiveness of Ketorolac Dosing Strategies for Emergency Department Patients With Acute Pain.

STUDY OBJECTIVES: Ketorolac is a commonly used nonopioid parenteral analgesic for treating emergency department (ED) patients with acute pain. Our systematic review aims to summarize the available evidence by comparing the efficacy and safety of differing ketorolac dosing strategies for acute pain relief in the ED. METHODS: The review was registered on PROSPERO (CRD42022310062). We searched MEDLINE, PubMed, EMBASE, and unpublished sources from inception through December 9, 2022. We included randomized control trials of patients presenting with acute pain to the ED, comparing ketorolac doses less than 30 mg (low dose) to ketorolac doses more than or equal to 30 mg (high dose) for the outcomes of pain scores after treatment need for rescue analgesia, and incidence of adverse events. We excluded patients in non-ED settings, including postoperative settings. We extracted data independently and in duplicate and pooled them using a random-effects model. We assessed the risk of bias using the Cochrane Risk of Bias 2 tool and the overall certainty of the evidence for each outcome using the Grading Recommendations Assessment, Development, and Evaluation approach. RESULTS: This review included 5 randomized controlled trials (n=627 patients). Low-dose parenteral ketorolac (15 to 20 mg), as compared to high-dose ketorolac (≥30 mg), probably has no effect on pain scores (mean difference 0.05 mm lower on 100 mm visual analog scale, 95% confidence interval [CI] -4.91 mm to +5.01 mm; moderate certainty). Further, low-dose ketorolac at 10 mg may have no effect on pain scores compared to high-dose ketorolac (mean difference 1.58 mm lower on 100 mm visual analog scale, 95% CI -8.86 mm to +5.71 mm; low certainty). Low-dose ketorolac may increase the need for rescue analgesia (risk ratio 1.27, 95% CI 0.86 to 1.87; low certainty) and may have no difference on rates of adverse events (risk ratio 0.84, 95% CI 0.54 to 1.33; low certainty). CONCLUSION: In adult ED patients with acute pain, parenteral ketorolac given at doses of 10 mg to 20 mg is probably as effective in relieving pain as doses of 30 mg or higher. Low-dose ketorolac may have no effect on adverse events, but these patients may require more rescue analgesia. This evidence is limited by imprecision and is not generalizable to children or those at higher risk of adverse events.

Interpretable Skin Cancer Classification based on Incremental Domain Knowledge Learning.

The recent advances in artificial intelligence have led to the rapid development of computer-aided skin cancer diagnosis applications that perform on par with dermatologists. However, the black-box nature of such applications makes it difficult for physicians to trust the predicted decisions, subsequently preventing the proliferation of such applications in the clinical workflow. In this work, we aim to address this challenge by developing an interpretable skin cancer diagnosis approach using clinical images. Accordingly, a skin cancer diagnosis model consolidated with two interpretability methods is developed. The first interpretability method integrates skin cancer diagnosis domain knowledge, characterized by a skin lesion taxonomy, into model development, whereas the other method focuses on visualizing the decision-making process by highlighting the dominant of interest regions of skin lesion images. The proposed model is trained and validated on clinical images since the latter are easily obtainable by non-specialist healthcare providers. The results demonstrate the effectiveness of incorporating lesion taxonomy in improving model classification accuracy, where our model can predict the skin lesion origin as melanocytic or non-melanocytic with an accuracy of 87%, predict lesion malignancy with 77% accuracy, and provide disease diagnosis with an accuracy of 71%. In addition, the implemented interpretability methods assist understand the model's decision-making process and detecting misdiagnoses. This work is a step toward achieving interpretability in skin cancer diagnosis using clinical images. The developed approach can assist general practitioners to make an early diagnosis, thus reducing the redundant referrals that expert dermatologists receive for further investigations.

Insulin Infusion Dosing in Pediatric Diabetic Ketoacidosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

In children with diabetic ketoacidosis (DKA), insulin infusions are the mainstay of treatment; however, optimal dosing remains unclear. Our objective was to compare the efficacy and safety of different insulin infusion doses for the treatment of pediatric DKA. DATA SOURCES: We searched MEDLINE, EMBASE, PubMed, and Cochrane from inception to April 1, 2022. STUDY SELECTION: We included randomized controlled trials (RCTs) of children with DKA comparing intravenous insulin infusion administered at 0.05 units/kg/hr (low dose) versus 0.1 units/kg/hr (standard dose). DATA EXTRACTION: We extracted data independently and in duplicate and pooled using a random effects model. We assessed the overall certainty of evidence for each outcome using the Grading Recommendations Assessment, Development and Evaluation approach. DATA SYNTHESIS: We included four RCTs (n = 190 participants). In children with DKA, low-dose compared with standard-dose insulin infusion probably has no effect on time to resolution of hyperglycemia (mean difference [MD], 0.22 hr fewer; 95% CI, 1.19 hr fewer to 0.75 hr more; moderate certainty), or time to resolution of acidosis (MD, 0.61 hr more; 95% CI, 1.81 hr fewer to 3.02 hr more; moderate certainty). Low-dose insulin infusion probably decreases the incidence of hypokalemia (relative risk [RR], 0.65; 95% CI, 0.47-0.89; moderate certainty) and hypoglycemia (RR, 0.37; 95% CI, 0.15-0.80; moderate certainty), but may have no effect on rate of change of blood glucose (MD, 0.42 mmol/L/hr slower; 95% CI, 1 mmol/L/hr slower to 0.18 mmol/L/hr faster; low certainty). CONCLUSIONS: In children with DKA, the use of low-dose insulin infusion is probably as efficacious as standard-dose insulin, and probably reduces treatment-related adverse events. Imprecision limited the certainty in the outcomes of interest, and the generalizability of the results is limited by all studies being performed in a single country.

Ambulatory follow-up among publicly insured children discharged from the emergency department.

BACKGROUND: While children discharged from the emergency department (ED) are frequently advised to follow up with ambulatory care providers, the extent to which this occurs is unknown. We sought to characterize the proportion of publicly insured children who have an ambulatory visit following ED discharge, identify factors associated with ambulatory follow-up, and evaluate the association of ambulatory follow-up with subsequent hospital-based health care utilization. METHODS: We performed a cross-sectional study of pediatric (<18 years) encounters during 2019 included in the IBM Watson Medicaid MarketScan claims database from seven U.S. states. Our primary outcome was an ambulatory follow-up visit within 7 days of ED discharge. Secondary outcomes were 7-day ED return visits and hospitalizations. Logistic regression and Cox proportional hazards were used for multivariable modeling. RESULTS: We included 1,408,406 index ED encounters (median age 5 years, IQR 2-10 years), for which a 7-day ambulatory visit occurred in 280,602 (19.9%). Conditions with the highest proportion of 7-day ambulatory follow-up included seizures (36.4%); allergic, immunologic, and rheumatologic diseases (24.6%); other gastrointestinal diseases (24.5%); and fever (24.1%). Ambulatory follow-up was associated with younger age, Hispanic ethnicity, weekend ED discharge, ambulatory encounters prior to the ED visit, and diagnostic testing performed during the ED encounter. Ambulatory follow-up was inversely associated with Black race and ambulatory care-sensitive or complex chronic conditions. In Cox models, ambulatory follow-up was associated with a higher hazard ratio (HR) of subsequent ED return (HR range 1.32-1.65) visit and hospitalization (HR range 3.10-4.03). CONCLUSIONS: One-fifth of children discharged from the ED have an ambulatory visit within 7 days, which varied by patient characteristics and diagnoses. Children with ambulatory follow-up have a greater subsequent health care utilization, including subsequent ED visit and/or hospitalization. These findings identify the need to further research the role and costs associated with routine post-ED visit follow-up.

Novel care pathway to optimise antimicrobial prescribing for uncomplicated community-acquired pneumonia: study protocol for a prospective before-after cohort study in the emergency department of a tertiary care Canadian children's hospital.

INTRODUCTION: Evidence-based recommendations for paediatric community-acquired pneumonia (CAP) diagnosis and management are needed. Uncomplicated CAP is often caused by respiratory viruses, especially in younger children; these episodes self-resolve without antibiotic treatment. Unfortunately, there are no clinical criteria that reliably discriminate between viral and bacterial disease, and so the majority of children diagnosed with CAP are given antibiotics-even though these will often not help and may cause harm. We have developed a novel care pathway that incorporates point-of-care biomarkers, radiographic patterns, microbiological testing and targeted follow-up. The primary study objective is to determine if the care pathway will be associated with less antimicrobial prescribing. METHODS AND ANALYSIS: A prospective, before-after, study. Previously well children aged≥6 months presenting to a paediatric emergency department (ED) that have at least one respiratory symptom/sign, receive chest radiography, and are diagnosed with CAP by the ED physician will be eligible. Those with medical comorbidities, recently diagnosed pulmonary infection, or ongoing fever after≥4 days of antimicrobial therapy will be excluded. In the control (before) phase, eligible participants will be managed as per the standard of care. In the intervention (after) phase, eligible participants will be managed as per the novel care pathway. The primary outcome will be the proportion of participants in each phase who receive antimicrobial treatment for CAP. The secondary outcomes include: clinical cure; re-presentation to the ED; hospitalisation; time to resolution of symptoms; drug adverse events; caregiver satisfaction; child absenteeism from daycare/school; and caregiver absenteeism from work. ETHICS AND DISSEMINATION: All study documentation has been approved by the Hamilton Integrated Research Ethics Board and informed consent will be obtained from all participants. Data from this study will be presented at major conferences and published in peer-reviewed publications to facilitate collaborations with networks of clinicians experienced in the dissemination of clinical guidelines. TRIAL REGISTRATION NUMBER: NCT05114161.

Canadian Anaphylaxis Network-Predicting Recurrence after Emergency Presentation for Allergic REaction (CAN-PREPARE): a prospective, cohort study protocol.

INTRODUCTION: Anaphylaxis is a severe, potentially fatal multiorgan system manifestation of an allergic reaction. The highest incidence of anaphylaxis is in children and adolescents. Biphasic anaphylaxis (BA) is defined as the recurrence of allergic symptoms after resolution of an initial reaction. It has been reported to occur in 10%-20% of cases within 1-48 hours from the onset of the initial reaction. The dilemma for physicians is determining which patients with resolved anaphylaxis should be observed for BA and for how long. Guidelines for duration of postanaphylaxis monitoring vary, are based on limited evidence and can have unintended negative impacts on patient safety, quality of life and healthcare resources. The objectives of this study are to derive a prognostic model for BA and to develop a risk-scoring system that informs disposition decisions of children who present to emergency departments (ED) with anaphylaxis. METHODS AND ANALYSIS: This prospective multicentre cohort study will enrol 1682 patients from seven paediatric EDs that are members of the Paediatric Emergency Research Canada network. We will enrol patients younger than 18 years of age with an allergic reaction meeting anaphylaxis diagnostic criteria. Trained ED research assistants will screen, obtain consent and prospectively collect study data. Research assistants will follow patients during their ED visit and ascertain, in conjunction with the medical team, if the patient develops BA. A standardised follow-up survey conducted following study enrolment will determine if a biphasic reaction occurred after ED disposition. Model development will conform to the broad principles of the PROGRESS (Prognosis Research Strategy) framework and reporting will follow the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis Statement. ETHICS AND DISSEMINATION: Ethics approval has been received from all participating centres. Our dissemination plan focuses on informing clinicians, policy makers and parents of the results through publication in peer-reviewed journals and broadcasting on multiple media platforms. TRIAL REGISTRATION NUMBER: NCT05135377.

Kiwifruit and Kiwifruit Extracts for Treatment of Constipation: A Systematic Review and Meta-Analysis.

Introduction: This systematic review aimed to summarize evidence to determine the effectiveness of kiwifruit or kiwifruit extracts in the treatment of constipation. Methods: Electronic databases were searched from inception to May 2022 without any age or language limitations. Eligible studies enrolled participants with constipation who were randomized to receive kiwifruit or kiwifruit extracts vs. any nonkiwifruit control. Standardized mean difference (SMD) and mean difference (MD) with confidence intervals (CI) were determined for the following outcomes: frequency of spontaneous bowel movements (SBM), abdominal pain and straining, as well as stool type as determined by the Bristol Stool Scale (BSS). The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to rate the certainty of evidence. Our review was registered on PROSPERO (CRD42021239397). Results: Seven RCTs, including 399 participants (82% female; mean age: 42 years (SD 14.6)), were included. Compared with placebo (n = 95), kiwifruit extracts might increase the weekly frequency of SBM (MD: 1.36; 95% CI: -0.44, 3.16) with low certainty of evidence; moreover, it had an uncertain effect on BSS (SMD: 1.54; 95% CI: -1.33, 4.41) with very low certainty of evidence. Additionally, compared with placebo (n = 119), kiwifruit or its extracts reduced abdominal pain (SMD: -1.44, 95% CI -2.83, -1.66) with moderate certainty of the evidence and improved frequency of straining (SMD: -0.29; 95% CI: -1.03, 0.47). Compared with psyllium, kiwifruit may increase the weekly frequency of SBM (MD: 1.01; 95% CI: -0.02, 2.04) with moderate certainty evidence, and may increase the value on the BSS (indicating softer stools) (MD: 0.63; 95% CI: 0.01, 1.25)with low certainty of evidence. Compared to placebo, kiwifruit-encapsulated extracts may result in an increase in minor adverse events (relative risk: 4.58; 95% CI: 0.79, 26.4). Conclusions: Among individuals with constipation, there is an overall low certainty of evidence indicating that kiwifruit may increase SBM when compared to placebo or psyllium. Although overall results are promising, establishing the role of kiwifruit in constipation requires large, methodologically rigorous trials. Protocol Registration: PROSPERO registration number CRD42021239397.

Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study.

INTRODUCTION: Patient engagement in healthcare research is a necessity to ensure that research objectives align with priorities, outcomes and needs of the population under study, and to facilitate ease of implementation and adoption of findings. In clinical trials, there is an increasing focus on patient engagement during the planning and conduct of clinical trials due to the potential for ethical and methodological benefits. As patient engagement in clinical trials increases, there is a need to evaluate the approaches of these activities to contribute evidence on what is most appropriate and successful. The purpose of this study is to evaluate patient engagement processes and the activities of patient partners during and after a paediatric mental healthcare trial. METHODS AND ANALYSIS: Using a mixed-methods study design, we will evaluate patient partners' engagement activities across set time-points during the trial and after trial completion. In this study, the term 'patient partner' is inclusive of two groups of people with lived experience: (1) caregivers (parents, formal/informal caregivers and family), and (2) youth (aged 15-24 years). Engagement will be evaluated using the participant and project questionnaires of the Public and Patient Engagement Evaluation Tool (PPEET), followed sequentially by semi-structured interviews. Quantitative data from the PPEET questionnaire will be analysed and reported using descriptive statistics. Data from open-ended questions from the PPEET questionnaires and semi-structured interviews will be analysed using thematic analysis. ETHICS AND DISSEMINATION: Approval from Athabasca University Research Ethics Board will be obtained for this project. Findings will be disseminated at both academic and public venues whether in-person or online, and using platforms that are caregiver and youth friendly. TRIAL REGISTRATION NUMBER: NCT04902391.

An Innovative Model of Pediatric Emergency Department Mental Health Care: Protocol for a Multicenter Type 1 Effectiveness-Implementation Cluster Randomized Trial.

Over the past decade, visits to American and Canadian emergency departments (EDs) for child and youth mental health care have increased substantially.1,2 Acute mental health crises can occur as a result of a variety of concerns, including those that are life threatening (eg, suicide attempts), pose safety concerns (eg, suicidal intentions, aggressive behaviors, alcohol and other drug use), and are physically distressing to the child or youth (eg, panic attacks). ED health care providers play a vital role in assessing the safety and well-being of the child or youth and referring them to services for ongoing care.3,4 During the ED visit, assessment and care should pinpoint risks, inform treatment, and consider family needs and preferences as part of a patient-centered approach. Yet, this approach to care is not widely adopted in EDs. Most EDs do not require the use of pediatric-specific mental health tools to guide assessments or have patient-centered procedures in place to guide the care of patients with mental health emergencies.5-7 Our team believes these limitations have led to the provision of acute mental health care that can lack sufficient quality and efficiency. This study protocol describes a trial designed to evaluate if a novel mental health care bundle that was co-designed with parents and youth results in greater improvements in the well-being of children and youth 30 days after seeking ED care for mental health and/or substance misuse concerns compared with existing care protocols. We hypothesize that the bundle will positively impact child and youth well-being, while also providing cost-effective health care system benefits.

Probiotics in Critical Illness: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

OBJECTIVES: To determine the safety and efficacy of probiotics or synbiotics on morbidity and mortality in critically ill adults and children. DATA SOURCES: We searched MEDLINE, EMBASE, CENTRAL, and unpublished sources from inception to May 4, 2021. STUDY SELECTION: We performed a systematic search for randomized controlled trials (RCTs) that compared enteral probiotics or synbiotics to placebo or no treatment in critically ill patients. We screened studies independently and in duplicate. DATA EXTRACTION: Independent reviewers extracted data in duplicate. A random-effects model was used to pool data. We assessed the overall certainty of evidence for each outcome using the Grading Recommendations Assessment, Development, and Evaluation approach. DATA SYNTHESIS: Sixty-five RCTs enrolled 8,483 patients. Probiotics may reduce ventilator-associated pneumonia (VAP) (relative risk [RR], 0.72; 95% CI, 0.59 to 0.89 and risk difference [RD], 6.9% reduction; 95% CI, 2.7-10.2% fewer; low certainty), healthcare-associated pneumonia (HAP) (RR, 0.70; 95% CI, 0.55-0.89; RD, 5.5% reduction; 95% CI, 8.2-2.0% fewer; low certainty), ICU length of stay (LOS) (mean difference [MD], 1.38 days fewer; 95% CI, 0.57-2.19 d fewer; low certainty), hospital LOS (MD, 2.21 d fewer; 95% CI, 1.18-3.24 d fewer; low certainty), and duration of invasive mechanical ventilation (MD, 2.53 d fewer; 95% CI, 1.31-3.74 d fewer; low certainty). Probiotics probably have no effect on mortality (RR, 0.95; 95% CI, 0.87-1.04 and RD, 1.1% reduction; 95% CI, 2.8% reduction to 0.8% increase; moderate certainty). Post hoc sensitivity analyses without high risk of bias studies negated the effect of probiotics on VAP, HAP, and hospital LOS. CONCLUSIONS: Low certainty RCT evidence suggests that probiotics or synbiotics during critical illness may reduce VAP, HAP, ICU and hospital LOS but probably have no effect on mortality.

Intravenous ketorolac versus morphine in children presenting with suspected appendicitis: a pilot single-centre non-inferiority randomised controlled trial.

OBJECTIVES: Despite a lack of evidence demonstrating superiority to non-steroidal anti-inflammatory drugs, like ketorolac, that are associated with lower risk of harms, opioids remain the most prescribed analgesic for acute abdominal pain. In this pilot trial, we will assess the feasibility of a definitive trial comparing ketorolac with morphine in children with suspected appendicitis. We hypothesise that our study will be feasible based on a 40% consent rate. METHODS AND ANALYSIS: A single-centre, non-inferiority, blinded (participant, clinician, investigators and outcome assessors), double-dummy randomised controlled trial of children aged 6-17 years presenting to a paediatric emergency department with ≤5 days of moderate to severe abdominal pain (≥5 on a Verbal Numerical Rating Scale) and are investigated for appendicitis. We will use variable randomised blocks of 4-6 and allocate participants in 1:1 ratio to receive either intravenous (IV) ketorolac 0.5 mg/kg+IV morphine placebo or IV morphine 0.1 mg/kg+IV ketorolac placebo. Analgesic co-intervention will be limited to acetaminophen (commonly used as first-line therapy). Participants in both groups will be allowed rescue therapy (morphine 0.5 mg/kg) within 60 min of our intervention. Our primary feasibility outcome is the proportion of eligible patients approached who provide informed consent and are enrolled in our trial. Our threshold for feasibility will be to achieve a ≥40% consent rate, and we will enrol 100 participants into our pilot trial. ETHICS AND DISSEMINATION: Our study has received full approval by the Hamilton integrated Research Ethics Board. We will disseminate our study findings at national and international paediatric research conferences to garner interest and engage sites for a future multicentre definitive trial. TRIAL REGISTRATION: NCT04528563, Pre-results.

Leveraging Artificial Intelligence to Improve the Diversity of Dermatological Skin Color Pathology: Protocol for an Algorithm Development and Validation Study.

BACKGROUND: The paucity of dark skin images in dermatological textbooks and atlases is a reflection of racial injustice in medicine. The underrepresentation of dark skin images makes diagnosing skin pathology in people of color challenging. For conditions such as skin cancer, in which early diagnosis makes a difference between life and death, people of color have worse prognoses and lower survival rates than people with lighter skin tones as a result of delayed or incorrect diagnoses. Recent advances in artificial intelligence, such as deep learning, offer a potential solution that can be achieved by diversifying the mostly light-skin image repositories through generating images for darker skin tones. Thus, facilitating the development of inclusive cancer early diagnosis systems that are trained and tested on diverse images that truly represent human skin tones. OBJECTIVE: We aim to develop and evaluate an artificial intelligence-based skin cancer early detection system for all skin tones using clinical images. METHODS: This study consists of four phases: (1) Publicly available skin image repositories will be analyzed to quantify the underrepresentation of darker skin tones, (2) Images will be generated for the underrepresented skin tones, (3) Generated images will be extensively evaluated for realism and disease presentation with quantitative image quality assessment as well as qualitative human expert and nonexpert ratings, and (4) The images will be utilized with available light-skin images to develop a robust skin cancer early detection model. RESULTS: This study started in September 2020. The first phase of quantifying the underrepresentation of darker skin tones was completed in March 2021. The second phase of generating the images is in progress and will be completed by March 2022. The third phase is expected to be completed by May 2022, and the final phase is expected to be completed by September 2022. CONCLUSIONS: This work is the first step toward expanding skin tone diversity in existing image databases to address the current gap in the underrepresentation of darker skin tones. Once validated, the image bank will be a valuable resource that can potentially be utilized in physician education and in research applications. Furthermore, generated images are expected to improve the generalizability of skin cancer detection. When completed, the model will assist family physicians and general practitioners in evaluating skin lesion severity and in efficient triaging for referral to expert dermatologists. In addition, the model can assist dermatologists in diagnosing skin lesions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34896.

An Advanced Nursing Directive for Children With Suspected Appendicitis: Protocol for a Quality Improvement Feasibility Study.

BACKGROUND: Pediatric appendicitis accounts for an estimated 7% to 10% of abdominal pain cases in the emergency department (ED). The diagnosis is time-consuming, and the investigative process depends on physician assessment, resulting in delays in diagnosis and therapeutic management. The utility of an advanced nursing directive (AND) to expedite this process is unclear and needs further exploration. OBJECTIVE: This study aims to describe key components of ED flow in patients with suspected appendicitis seen at a pediatric ED and pilot a directive that allows ED nurses to perform an order set that includes blood work, urine tests, analgesics, fluids, and an abdominal-pelvis ultrasound prior to physician assessment. METHODS: This study involves conducting a retrospective chart review alongside a quality improvement initiative to compare key ED flow metrics before and after AND implementation. Primary outcome measures include median time from ED triage assessment to ultrasound completion, analgesia administration, blood work results, and time to disposition (consult or discharge), alongside other key ED flow metrics for suspected appendicitis. Secondary outcomes will involve patient and caretaker satisfaction surveys. Descriptive statistics will be used to summarize the data. For differences in proportions, a chi-square test will be used. The Student t test will be used for continuous variables. A variable-controlled run chart will be performed to assess impact on ED flow metrics. Patient and family satisfaction surveys are administered immediately after the directive encounter and 7 days afterward. RESULTS: There are currently 3900 patients who have been screened, 344 patients who have been enrolled, and 90 patients who have received the medical directive since implementation in June 2020. Interim results on reduction of time to diagnostic and therapeutic ED flow parameters and satisfaction surveys are expected to be published in February 2022. The final study endpoint will be in June 2022. CONCLUSIONS: This study proposes a novel protocol for improving the diagnosis and treatment of suspected pediatric appendicitis through implementation of an evidence-based AND. This model may provide a standardized, international pathway for management of common pediatric and adult emergencies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/33158.