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Validation of the PECARN clinical decision rule for children with minor head trauma: a French multicenter prospective study.

ABSTRACT: To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying children who are at very low risk of clinically-important traumatic brain injuries after minor head trauma has not been validated prospectively in an independent population. Our goal was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French pediatric population in multiple clinical settings.We conducted a multicenter, prospective, non-interventional cohort study of patients with minor head trauma who presented to three emergency departments in France. We enrolled patients younger than 16 years of age seeking a consultation within 24 h of head trauma with Glasgow Coma Scale scores of 14-15.During the study period, we included 1499 children of which 421 (28 %) were under 2 years of age, and 955 (64 %) were male. A cranial computed tomography (CT) scan was performed on 76 patients (5.1 %). Of the 1499 included patients, 9 children (0.6 %) had a clinically-important traumatic brain injury, and none were classified as very low risk by the PECARN rule. In our study, the sensitivity of this clinical decision rule was 100 % (95 % CI 66.4 to 100 %), the specificity was 69.9 % (95 % CI 67.5 to 72.2 %) and the negative predictive value was 100 % (95 % CI 99.7 to 100 %).Our study confirmed the good predictive performances of the PECARN clinical decision rule for minor head trauma in children. The PECARN rule performed similarly to our study and to its internal validation study.We conducted an external validation study of the PECARN clinical decision rule for the detection of clinically-important traumatic brain injuries in children with minor head trauma, according to the methodological standards. The PECARN rule successfully identified all patients with clinically-important traumatic brain injuries, with a limited use of CT scans. Conducting a broad validation study with a large cohort is a prerequisite to provide sufficient statistical power before authorizing its implementation and generalization.This study has been registered in ClinicalTrials.gov with identifier number: NCT02752711 on April 27, 2016.

SUBMITTER: Lorton F

PROVIDER: S-EPMC4973103 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Validation of the PECARN clinical decision rule for children with minor head trauma: a French multicenter prospective study.

Lorton F F Poullaouec C C Legallais E E Simon-Pimmel J J Chêne M A MA Leroy H H Roy M M Launay E E Gras-Le Guen C C

Scandinavian journal of trauma, resuscitation and emergency medicine 20160804

<h4>Background</h4>To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying children who are at very low risk of clinically-important traumatic brain injuries after minor head trauma has not been validated prospectively in an independent population. Our goal was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French pediatric population in multiple clinical settings.<h4>Methods</h4>We conducted a multicenter, prospective, non-i ...[more]

PMID: 27488722

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Project description:This study aims to evaluate the efficacy of the PECARN Rule (PR) in reducing radiological investigations in children with mild traumatic head injury in comparison with current clinical practice. A retrospective study was performed in our hospital between July 2015 and June 2020. Data of all children < 18 years of age admitted to the emergency department (ED), within 24 h after a head trauma with GCS ≥ 14, were analyzed. PECARN Rule was retrospectively applied to all patients. In total, 3832 patients were enrolled, 2613 patients ≥ 2 years and 1219 < 2 years. In the group of children ≥ 2 years, 10 presented clinically important traumatic brain injury (ciTBI) and were hospitalized, 7/10 underwent neurosurgery, and 3/10 clinical observation in the pediatric ward for more than 48 h. In children < 2 years, only 3 patients presented ciTBI, 2 underwent neurosurgery and 1 hospitalized. Applying the PR, no patient with ciTBI would have been discharged without an accurate diagnosis and we would have avoided 139 CT scans in patients ≥ 2 years, and 23 in those < 2 years of age (29% less).ConclusionWe demonstrated the safety and validity of the PR in our setting with 100% sensitivity in both age groups in identifying patients with ciTBI and theoretically in reducing performed CT scans by 29%. Therefore, in patients classified in the low-risk category, it is a duty not to expose the child to ionizing radiation.What is known• CT is the gold standard to identify intracranial pathology in children with head injury but CT imaging of head-injured children expose them to higher carcinogenic risk. • PECARN Rules support doctors in identifying children with ciTBI in order to reduce exposure to ionizing radiation.What is new• We demonstrate the safety and validity of the PR with 100% sensitivity in both age groups in identifying patients with ciTBI. • In our setting, the application of PECARN Rule would theoretically have allowed us to reduce the CT scan by 29%.

Project description:Study objectiveTo improve the efficiency and appropriateness of computed tomography (CT) use in children with minor head trauma, clinical prediction rules were derived and validated by the Pediatric Emergency Care Applied Research Network (PECARN). The objective of this study was to conduct a cost-effectiveness analysis comparing the PECARN traumatic brain injury prediction rules to usual care for selective CT use.MethodsWe used decision analytic modeling to project the outcomes, costs, and cost-effectiveness of applying the PECARN rules compared with usual care in a hypothetical cohort of 1,000 children with minor blunt head trauma. Clinical management was directed by level of risk as specified by the presence or absence of variables in the PECARN traumatic brain injury prediction rules. Immediate costs of care (diagnostic testing, treatment [not including clinician time], and hospital stay) were derived on single-center data. Quality-adjusted life-year losses related to the sequelae of clinically important traumatic brain injuries and to radiation-induced cancers, number of CT scans, number of radiation-induced cancers, number of missed clinically important traumatic brain injury, and total costs were evaluated.ResultsCompared with the usual care strategy, the PECARN strategy was projected to miss slightly more children with clinically important traumatic brain injuries (0.26 versus 0.02 per 1,000 children) but used fewer cranial CT scans (274 versus 353), resulted in fewer radiation-induced cancers (0.34 versus 0.45), cost less ($904,940 versus $954,420), and had lower net quality-adjusted life-year loss (-4.64 versus -5.79). Because the PECARN strategy was more effective (less quality-adjusted life-year loss) and less costly, it dominated the usual care strategy. Results were robust under sensitivity analyses.ConclusionApplication of the PECARN traumatic brain injury prediction rules for children with minor head trauma would lead to beneficial outcomes and more cost-effective care.

Project description:Blunt head trauma is a common cause of death and disability in children worldwide. Cranial computed tomography (CT), the reference standard for the diagnosis of traumatic brain injury (TBI), exposes children to ionizing radiation which has been linked to the development of brain tumors, leukemia, and other cancers. We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home.This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid, 'Head CT Choice', to a control group receiving usual care. The trial will be conducted at five diverse emergency departments (EDs) in Minnesota and California. Clinicians will be randomized to decision aid or usual care. Parents visiting the ED with children who are less than 18-years-old, have experienced blunt head trauma within 24 hours, and have one or two risk factors for clinically-important TBI (ciTBI) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment. We will measure the effect of Head CT Choice on: (1) parent knowledge regarding their child's risk of ciTBI, the available diagnostic options, and the risks of radiation exposure associated with a cranial CT scan (primary outcome); (2) parent engagement in the decision-making process; (3) the degree of conflict parents experience related to feeling uninformed; (4) patient and clinician satisfaction with the decision made; (5) the rate of ciTBI at seven days; (6) the proportion of patients in whom a cranial CT scan is obtained; and (7) seven-day healthcare utilization. To capture these outcomes, we will administer parent and clinician surveys immediately after each clinical encounter, obtain video recordings of parent-clinician discussions, administer parent healthcare utilization diaries, analyze hospital billing records, review the electronic medical record, and conduct telephone follow-up.This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes, safety, and healthcare utilization in parents of children with minor head trauma in five diverse EDs.ClinicalTrials.gov registration number: NCT02063087. Registration date February 13, 2014.

Project description:ObjectiveTo externally validate four commonly used rules in computed tomography (CT) for minor head injury.DesignProspective, multicentre cohort study.SettingThree university and six non-university hospitals in the Netherlands.ParticipantsConsecutive adult patients aged 16 years and over who presented with minor head injury at the emergency department with a Glasgow coma scale score of 13-15 between March 2015 and December 2016.Main outcome measuresThe primary outcome was any intracranial traumatic finding on CT; the secondary outcome was a potential neurosurgical lesion on CT, which was defined as an intracranial traumatic finding on CT that could lead to a neurosurgical intervention or death. The sensitivity, specificity, and clinical usefulness (defined as net proportional benefit, a weighted sum of true positive classifications) of the four CT decision rules. The rules included the CT in head injury patients (CHIP) rule, New Orleans criteria (NOC), Canadian CT head rule (CCHR), and National Institute for Health and Care Excellence (NICE) guideline for head injury.ResultsFor the primary analysis, only six centres that included patients with and without CT were selected. Of 4557 eligible patients who presented with minor head injury, 3742 (82%) received a CT scan; 384 (8%) had a intracranial traumatic finding on CT, and 74 (2%) had a potential neurosurgical lesion. The sensitivity for any intracranial traumatic finding on CT ranged from 73% (NICE) to 99% (NOC); specificity ranged from 4% (NOC) to 61% (NICE). Sensitivity for a potential neurosurgical lesion ranged between 85% (NICE) and 100% (NOC); specificity from 4% (NOC) to 59% (NICE). Clinical usefulness depended on thresholds for performing CT scanning: the NOC rule was preferable at a low threshold, the NICE rule was preferable at a higher threshold, whereas the CHIP rule was preferable for an intermediate threshold.ConclusionsApplication of the CHIP, NOC, CCHR, or NICE decision rules can lead to a wide variation in CT scanning among patients with minor head injury, resulting in many unnecessary CT scans and some missed intracranial traumatic findings. Until an existing decision rule has been updated, any of the four rules can be used for patients presenting minor head injuries at the emergency department. Use of the CHIP rule is recommended because it leads to a substantial reduction in CT scans while missing few potential neurosurgical lesions.

Project description:BackgroundCurrent management of children with minor head trauma (MHT) and intracranial injuries is not evidence-based and may place some children at risk of harm. Evidence-based electronic clinical decision support (CDS) for management of these children may improve patient safety and decrease resource use. To guide these efforts, we evaluated the sociotechnical environment impacting the implementation of electronic CDS, including workflow and communication, institutional culture, and hardware and software infrastructure, among other factors.MethodsBetween March and May, 2020 semi-structured qualitative focus group interviews were conducted to identify sociotechnical influences on CDS implementation. Physicians from neurosurgery, emergency medicine, critical care, and pediatric general surgery were included, along with information technology specialists. Participants were recruited from nine health centers in the United States. Focus group transcripts were coded and analyzed using thematic analysis. The final themes were then cross-referenced with previously defined sociotechnical dimensions.ResultsWe included 28 physicians and four information technology specialists in seven focus groups (median five participants per group). Five physicians were trainees and 10 had administrative leadership positions. Through inductive thematic analysis, we identified five primary themes: (1) clinical impact; (2) stakeholders and users; (3) tool content; (4) clinical practice integration; and (5) post-implementation evaluation measures. Participants generally supported using CDS to determine an appropriate level-of-care for these children. However, some had mixed feelings regarding how the tool could best be used by different specialties (e.g. use by neurosurgeons versus non-neurosurgeons). Feedback from the interviews helped refine the tool content and also highlighted potential technical and workflow barriers to address prior to implementation.ConclusionsWe identified key factors impacting the implementation of electronic CDS for children with MHT and intracranial injuries. These results have informed our implementation strategy and may also serve as a template for future efforts to implement health information technology in a multidisciplinary, emergency setting.

Project description:ImportanceThe Pediatric Emergency Care Applied Research Network prediction rules for minor head trauma identify children at very low, intermediate, and high risk of clinically important traumatic brain injuries (ciTBIs) and recommend no computed tomography (CT) for those at very low risk. However, the prediction rules provide little guidance in the choice of home observation or CT in children at intermediate risk for ciTBI.ObjectiveTo compare a decision aid with usual care in parents of children at intermediate risk for ciTBI.Design, settings, and participantsThis cluster randomized trial was conducted in 7 geographically diverse US emergency departments (EDs) from April 1, 2014, to September 30, 2016. Eligible participants were emergency clinicians, children ages 2 to 18 years with minor head trauma at intermediate risk for ciTBI, and their parents.InterventionsClinicians were randomly assigned (1:1 ratio) to shared decision-making facilitated by the Head CT Choice decision aid or to usual care.Main outcomes and measuresThe primary outcome, selected by parent stakeholders, was knowledge of their child's risk for ciTBI and the available diagnostic options. Secondary outcomes included decisional conflict, parental involvement in decision-making, the ED CT rate, 7-day health care utilization, and missed ciTBI.ResultsA total of 172 clinicians caring for 971 children (493 decision aid; 478 usual care) with minor head trauma at intermediate risk for ciTBI were enrolled. The patient mean (SD) age was 6.7 (7.1) years, 575 (59%) were male, and 253 (26%) were of nonwhite race. Parents in the decision aid arm compared with the usual care arm had greater knowledge (mean [SD] questions correct: 6.2 [2.0] vs 5.3 [2.0]; mean difference, 0.9; 95% CI, 0.6-1.3), had less decisional conflict (mean [SD] decisional conflict score, 14.8 [15.5] vs 19.2 [16.6]; mean difference, -4.4; 95% CI, -7.3 to -2.4), and were more involved in CT decision-making (observing patient involvement [OPTION] scores: mean [SD], 25.0 [8.5] vs 13.3 [6.5]; mean difference, 11.7; 95% CI, 9.6-13.9). Although the ED CT rate did not significantly differ (decision aid, 22% vs usual care, 24%; odds ratio, 0.81; 95% CI, 0.51-1.27), the mean number of imaging tests was lower in the decision aid arm 7 days after injury. No child had a missed ciTBI.Conclusions and relevanceUse of a decision aid in parents of children at intermediate risk of ciTBI increased parent knowledge, decreased decisional conflict, and increased involvement in decision-making. The intervention did not significantly reduce the ED CT rate but safely decreased health care utilization 7 days after injury.Trial registrationClinicalTrials.gov Identifier: NCT02063087.

Project description:BackgroundUnnecessary diagnostic imaging leads to higher costs, longer emergency department stays, and increased patient exposure to ionizing radiation. We sought to prospectively derive and validate two decision instruments (DIs) for selective chest computed tomography (CT) in adult blunt trauma patients.Methods and findingsFrom September 2011 to May 2014, we prospectively enrolled blunt trauma patients over 14 y of age presenting to eight US, urban level 1 trauma centers in this observational study. During the derivation phase, physicians recorded the presence or absence of 14 clinical criteria before viewing chest imaging results. We determined injury outcomes by CT radiology readings and categorized injuries as major or minor according to an expert-panel-derived clinical classification scheme. We then employed recursive partitioning to derive two DIs: Chest CT-All maximized sensitivity for all injuries, and Chest CT-Major maximized sensitivity for only major thoracic injuries (while increasing specificity). In the validation phase, we employed similar methodology to prospectively test the performance of both DIs. We enrolled 11,477 patients-6,002 patients in the derivation phase and 5,475 patients in the validation phase. The derived Chest CT-All DI consisted of (1) abnormal chest X-ray, (2) rapid deceleration mechanism, (3) distracting injury, (4) chest wall tenderness, (5) sternal tenderness, (6) thoracic spine tenderness, and (7) scapular tenderness. The Chest CT-Major DI had the same criteria without rapid deceleration mechanism. In the validation phase, Chest CT-All had a sensitivity of 99.2% (95% CI 95.4%-100%), a specificity of 20.8% (95% CI 19.2%-22.4%), and a negative predictive value (NPV) of 99.8% (95% CI 98.9%-100%) for major injury, and a sensitivity of 95.4% (95% CI 93.6%-96.9%), a specificity of 25.5% (95% CI 23.5%-27.5%), and a NPV of 93.9% (95% CI 91.5%-95.8%) for either major or minor injury. Chest CT-Major had a sensitivity of 99.2% (95% CI 95.4%-100%), a specificity of 31.7% (95% CI 29.9%-33.5%), and a NPV of 99.9% (95% CI 99.3%-100%) for major injury and a sensitivity of 90.7% (95% CI 88.3%-92.8%), a specificity of 37.9% (95% CI 35.8%-40.1%), and a NPV of 91.8% (95% CI 89.7%-93.6%) for either major or minor injury. Regarding the limitations of our work, some clinicians may disagree with our injury classification and sensitivity thresholds for injury detection.ConclusionsWe prospectively derived and validated two DIs (Chest CT-All and Chest CT-Major) that identify blunt trauma patients with clinically significant thoracic injuries with high sensitivity, allowing for a safe reduction of approximately 25%-37% of unnecessary chest CTs. Trauma evaluation protocols that incorporate these DIs may decrease unnecessary costs and radiation exposure in the disproportionately young trauma population.

Dataset Information

Validation of the PECARN clinical decision rule for children with minor head trauma: a French multicenter prospective study.

Publications

Validation of the PECARN clinical decision rule for children with minor head trauma: a French multicenter prospective study.

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