Head trauma is a common chief complaint among children visiting

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Discussions in Surgery Validation of the Sainte-Justine Head Trauma Pathway for children younger than two years of age Sarah Spénard Serge Gouin, MDCM Marianne Beaudin, MD Jocelyn Gravel, MD, MSc Partial results of this study were presented at the International Conference on Emergency Medicine (Cape Town, South Africa) in April 2016, the Pediatric Academic Societies conference (Baltimore, USA) in May 2016 and the Canadian Association of Emergency Physicians conference (Québec, Canada) in June 2016. Accepted Dec. 6, 2017 Correspondence to: J. Gravel Section d Urgence, Département de Pédiatrie CHU Sainte-Justine 3175 Chemin Côte Sainte-Catherine Montréal QC H3T 1C5 graveljocelyn@hotmail.com DOI: 10.1503/cjs.013217 Summary The Sainte-Justine Head Trauma Pathway helps physicians decision-making in the evaluation of head in young children. We evaluated the pathway to identify clinically important tic brain injury (citbi) among children younger than two years who presented to a pediatric emergency department for a head. The primary outcome was citbi, defined as a TBI complicated by death, neurosurgery, intubation or hospitalization for more than one night. Among 2258 children, we reviewed the charts of all hospitalized children (n = 100) and a random sample of nonhospitalized children (n = 101) and found a citbi in 26 patients. The Sainte-Justine Head Trauma Pathway and the Pediatric Emergency Care Applied Research Network Pediatric Head Injury Prediction Rule both had a sensitivity of 96% (95% confidence interval 81% 100%). We found that the Sainte-Justine Head Trauma Pathway does not improve the identification of citbi among young children with head. Head is a common chief complaint among children visiting the emergency department (ED). The Pediatric Emergency Care Applied Research Network (PECARN) Head Injury Prediction Rule is the decision tool currently used in many institutions. 1 Its main limitation is that 33% of children younger than two years fall in the moderate-risk category, which entails the physician selecting further investigations based on various factors. 1 Identification of a skull would modify the management decisions of approximately half of Canadian pediatric emergency physicians. 2 In 2015, a new clinical decision rule was reported to identify children at risk of skull following head : the C-3PO rule. 3 Merging the C-3PO rule with the PECARN rule might facilitate the management of tic brain injury (TBI) in all children younger than two years while minimizing the limitations of each individual rule. With this aim in mind, the Sainte-Justine Head Trauma Pathway was proposed. Following its development, we aimed to measure the impact of the pathway in identifying children with clinically important TBI (citbi). We conducted a retrospective study of all children younger than two years with a chief complaint of head visiting our universityaffiliated pediatric hospital between 2013 and 2015. Children were dichotomized in two groups: all hospitalized children and a 5% random selection of all nonhospitalized children. We reviewed the complete medical chart of each eligible participant. Information was collected by a single coauthor (S.S.) using the standardized case report form, while a second coauthor (J.G.) evaluated a random sample of 5% of health records to assess data accuracy. We measured the interrater reliability using a κ score. The primary outcome was the presence of a citbi, defined as a TBI complicated by death, neurosurgery, intubation of more than 24 hours or hospitalization for more than one night. 1 Our primary analysis sought to determine the proportion of children with citbi that would have been accurately identified using the Sainte- 2018 Joule Inc. or its licensors Can J Surg, Vol. 61, No. 4, August 2018 283

Justine Head Trauma Pathway and the PECARN rule. 1 For this analysis, participants were distributed in high-, moderate- and low-risk categories according to their baseline characteristics and radiological investigations. In a secondary analysis, results were extrapolated to the full population of all eligible children. We included all children admitted to hospital with a chief complaint of head in order to include all cases of citbi. This was expected to yield a sample of approximately 100 children and at least 20 children with a citbi. It was estimated that a random sample of 5% of nonhospitalized patients would need to be recruited to have at least 100 nonhospitalized patients. Our institutional review board approved the study, and we obtained a waiver of consent from the patients or their guardians for this project. Results During the study period, a total of 2258 children were eligible, including 101 children admitted to hospital. Table 1 shows baseline characteristics of participants. Among them, a citbi was reported in 26 participants. All children were hospitalized for more than 24 hours, three had a neurosurgical intervention (including one who was intubated for more than 24 hours), and an additional three were intubated for more than 24 hours. Figure 1 shows the distribution of the 201 participants according to the pathway and the PECARN rule alone. Both strategies showed a sensitivity of 96% (95% confidence interval 81% 100%) and specificities of approximately 41% (Table 2). Applying the distribution to the entire population would yield a rate of citbi in each risk category using the clinical pathway: approximately 33% in the high-risk category, 1% in the moderate-risk category and < 0.1% in the low-risk category for both the Sainte-Justine pathway and the PECARN rule (Figure 2). We evaluated 10 charts in duplicate to assess interrater reliability on the 10 baseline characteristics and items of the pathway. Among them, a perfect agreement was met for five characteristics. An intraclass correlation coefficient (ICC) between 80% and 99% was met for three characteristics, and an ICC less than 50% was calculated for two characteristics ( not acting normally and high velocity ). Discussion The Sainte-Justine Head Trauma Pathway allowed identification of more skull s than the PECARN rule, but it did not improve identification of citbi among young children. Local modifications to the PECARN rule have been suggested in various settings to ease adherence and satisfaction among physicians 4 or to improve diagnostic capacity. 5,6 The Sainte-Justine pathway was designed to help emergency physicians to stratify the risk among children at moderate risk for citbi according to the PECARN rule. Even if more than 33% of our sample still falls in the moderate-risk category, the inclusion of the C-3PO rule allows a better identification of skull, which could improve citbi diagnosis. To our knowledge, our study was the first to integrate skull radiography with the PECARN rule. Notably, use of bedside ultrasonography to detect pediatric skull s is a growing imaging modality for children at risk of skull. Therefore, incorporation of ultrasonography into a minor head decision rule is promising for diagnosis of skull s and warrants further investigation. Our study was limited by its small sample size, and the low frequency of citbi led to a large confidence interval, resulting in a lack of power in our results. Our study didn t collect information on previous medical experience and parental preference, which are clinical factors used by physicians when selecting further investigations Table 1. Baseline characteristics of study participants Characteristic Hospitalized, n = 101 Not hospitalized, n = 100 All not hospitalized, n = 2158 Age, mo, median (IQR) 6 (2 14) 10 (6 18) Age group, mo, % 1 2 29 4 8 3 11 36 54 46 > 11 36 42 46 Male sex, % 64 63 Falls, % Any fall 79 84 From his/her height 8 19 From 1 3 feet 46 48 From > 3 feet 25 17 Fall from arms of 24 2 a parent Fall on the stairs 7 14 Loss of 8 0 consciousness, % Head CT scan, % Not done 42 100 Normal 8 Not normal 50 Skull radiograph, % Not done 38 75 Normal 13 25 Not normal 50 Final disposition, % Hospitalized 100 0 Observation 19 then home Directly home 81 CT = computed tomography; IQR = interquartile range. 284 J can chir, Vol. 61, N o 4, août 2018

Discussions in Surgery A n = 26/201 n = 17/25 Clinical deterioration = Admission in Moderate risk n = 9/176 Occipital or parietal or temporal scalp hematoma n = 1/75 n = 8/101 Observation v. CT on the basis of other clinical factors including: Physician experience Multiple v. isolated findings Worsening symptoms or signs after emergency department observation Age < 3 months Parental preference B n = 26/201 n = 9/176 C3PO rule: 3 months or younger Parietal or occipital swelling/bump (n = 6/73) No (n = 2/26) Skull X-ray Large or depressed (n = 1/9) Simple (n = 3/38) n = 17/25 Clinical deterioration = Admission in n = 1/9 Highly consider CT scan Transfer to tertiary care setting if diastasis 4 mm or depressed 2 mm Ultrasound if diastasis 4 mm Observation 12 h post n = 5/129 (n = 4/57) n = 7/95 Observation 6 12h post recommended n = 1/72 ( ) Agitation, somnolence, repetitive questioning, slow response to verbal communication ( ) High-velocity injury Fig. 1. Distribution of the 201 participants according to (A) the Sainte-Justine Head Trauma Pathway and to (B) the Pediatric Emergency Care Applied Research Network (PECARN) Head Injury Prediction Rule. The numerators refer to the number of clinically important tic brain injuries (citbi). CT = computed tomography; GCS = Glasgow Coma Scale; LOC = loss of consciousness. Can J Surg, Vol. 61, No. 4, August 2018 285

A n = 26/2258 Glasgow score < 13 n = 17/46 Clinical deterioration = Admission in Moderate risk n = 9/2212 Occipital or parietal or temporal scalp hematoma n = 1/1370 n = 8/842 Observation v. CT on the basis of other clinical factors including: Physician experience Multiple v. isolated findings Worsening symptoms or signs after emergency department observation Age < 3 months Parental preference B n = 26/2258 n = 9/2212 C3PO rule: 3 months or younger Parietal or occipital swelling/bump (n = 6/443) No (n = 2/396) Skull X-ray Large or depressed (n = 1/9) Simple (n = 3/38) n = 17/46 Clinical deterioration = Admission in n = 1/9 Highly consider CT scan Transfer to tertiary care setting if diastasis 4 mm or depressed 2 mm Ultrasound if diastasis 4 mm Observation 12 h post n = 5/2165 (n = 4/715) n = 7/753 Observation 6 12h post recommended n = 1/1450 ( ) Agitation, somnolence, repetitive questioning, slow response to verbal communication ( ) High-velocity injury Fig. 2. Distribution of the full population (extrapolated) according to (A) the Sainte-Justine Head Trauma Pathway and to (B) the Pediatric Emergency Care Applied Research Network (PECARN) Head Injury Prediction Rule. The numerators refer to the number of clinically important tic brain injuries (citbi). CT = computed tomography; GCS = Glasgow Coma Scale; LOC = loss of consciousness. 286 J can chir, Vol. 61, N o 4, août 2018

Discussions in Surgery Table 2. Accuracy in identification of patients using Sainte-Justine Pathway and PECARN rule Sainte-Justine Pathway PECARN rule Variable Moderate risk Total Moderate risk Total Study sample citbi 18 7 1 26 17 8 1 26 No citbi 16 88 71 175 8 93 74 175 Total 34 95 72 201 25 101 75 201 Sensitivity (95% CI), % 96 (81 99) 96 (81 99) Specificity (95% CI), % 41 (33 48) 42 (35 50) Positive predictive value (95% CI), % 19 (17 22) 19 (17 22) Negative predictive value (95% CI), % 99 (91 100) 99 (91 100) Positive likelihood ratio (95% CI) 1.6 (1.4 1.9) 1.6 (1.4 1.9) Negative likelihood ratio (95% CI) 0.09 (0.01 0.65) 0.09 (0.01 0.65) All population citbi (% of risk category) 18 (0.33) 7 1 (0.0007) 26 17 (0.37) 8 1 (0.0007) 26 (0.01) (0.01) No citbi 37 746 1449 2232 29 834 1369 2232 Total 55 753 1450 2258 46 842 1370 2258 Sensitivity (95% CI), % 96 (80 100) 96 (80 100) Specificity (95% CI), % 65 (63 67) 61 (59 63) Positive predictive value (95% CI), % 3.0 (2.7 3.3) 2.8 (2.3 3.3) Negative predictive value (95% CI), % 99.9 (9.59 99.9) 99.9 (9.59 99.9) Positive likelihood ratio (95% CI) 2.7 (2.4 3.0) 2.5 (2.3 2.7) Negative likelihood ratio (95% CI) 0.06 (0.01 0.40) 0.06 (0.1 0.4) CI = confidence interval; citbi = clinically important tic brain injury; PECARN = Pediatric Emergency Care Applied Research Network. in patients at moderate risk for citbi. Finally, our study was conducted in a single tertiary care pediatric hospital. Before incorporating the Sainte-Justine Head Trauma Pathway into local practice, it should be validated in a multicentre prospective cohort. Conclusion The Sainte-Justine Head Trauma Pathway effectively identifies children younger than two years at risk for citbi following head while effectively triaging children at low risk. However, while improving skull detection, the pathway was not a better screening tool than the PECARN rule to identify children at risk for citbi. Affiliations: From the Université de Montréal, Montréal, Que. (Spénard, Gouin, Beaudin, Gravel); the Department of Pediatrics, Division of Pediatric Emergency Medicine, CHU Sainte-Justine, Université de Montréal, Montréal, Que. (Gouin, Gravel); and the Department of Surgery, Division of Pediatric Surgery, CHU Sainte-Justine, Université de Montréal, Montréal, Que. (Beaudin). Competing interests: None declared. Contributors: All authors contributed substantially to the conception, writing and revision of this article and approved the final version for publication. References 1. Kuppermann N, Holmes JF, Dayan PS, et al. Identification of children at very low risk of clinically-important brain injuries after head : a prospective cohort study. Lancet 2009;374:1160-70. 2. Carriere B, Clement K, Gravel J. Variation in the use of skull radiographs by emergency physicians in young children with minor head. CJEM 2014;16:281-7. 3. Gravel J, Gouin S, Chalut D, et al. A clinical decision rule to identify skull among young children with isolated head. CMAJ 2015;187:1202-8. 4. Bressan S, Romanato S, Mion T, et al. Implementation of adapted PECARN decision rule for children with minor head injury in the pediatric emergency department. Acad Emerg Med 2012;19:801-7. 5. Bressan S, Daverio M, Martinolli F, et al. The use of handheld nearinfrared device (Infrascanner) for detecting intracranial haemorrhages in children with minor head injury. Childs Nerv Syst 2013;e-pub online. 6. Simon-Pimmel J, Lorton F, Guiziou N, et al. Serum S100beta neuroprotein reduces use of cranial computed tomography in children after minor head. Shock 2015;44:410-6. Can J Surg, Vol. 61, No. 4, August 2018 287