Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma: A Prospective Cohort Study
The Relationship Between Family Socio-Cultural Level, Health Literacy, and Parental Demand for Computed Tomography in PECARN-Stratified Children Presenting With Minor Head Trauma: A Single-Centre Prospective Observational Cohort Study
Minor head trauma is one of the most frequent reasons for paediatric emergency department visits worldwide. The PECARN (Paediatric Emergency Care Applied Research Network) clinical decision rule stratifies children with minor head trauma into low-, intermediate-, and high-risk categories for clinically important traumatic brain injury (ciTBI) and provides evidence-based guidance on computed tomography (CT) ordering. Despite its high diagnostic accuracy, real-world CT utilisation frequently diverges from PECARN recommendations. Non-clinical family-level factors - including socio-cultural characteristics and health literacy - may drive part of this divergence, particularly through their influence on whether families explicitly request CT imaging.
This prospective observational cohort study will enrol 200 children with minor head trauma presenting to the emergency department of SBU Bursa Yuksek Ihtisas EAH, Bursa, Turkey. The primary aim is to determine whether family socio-cultural level (composite index incorporating education, occupation, income, and housing; scored 0-10) and health literacy (Newest Vital Sign-Turkish, NVS-TR) independently predict parental demand for CT imaging. Secondary aims include determining whether parental CT demand and family socio-cultural characteristics predict CT ordering by the treating physician, describing PECARN algorithm adherence patterns in this setting, and examining parental health-seeking behaviour at 7-day telephone follow-up.
Přehled studie
Postavení
Detailní popis
BACKGROUND: The PECARN rule classifies children with minor head trauma into three risk categories. Despite international validation, studies consistently document wide variation in CT utilisation. Turkey-specific data from Bursa and other centres confirm that fewer than half of cases are managed in strict accordance with PECARN guidance. Non-clinical drivers of this variation - including family socio-cultural level and health literacy - have not been systematically examined. Two mechanistic pathways are proposed: (1) families with lower health literacy or socio-cultural level may be more or less likely to explicitly request CT imaging; (2) physicians may respond to perceived family demand or anxiety in ways that are unrelated to clinical risk.
DESIGN: Single-centre prospective observational cohort study. Consecutive paediatric patients with minor head trauma (GCS 14-15, age under 18 years) are enrolled at SBU Bursa Yuksek Ihtisas EAH. The treating physician completes PECARN risk stratification and the CT decision field before the research coordinator's socio-cultural assessment is visible on the CRF, preventing information bias. Socio-cultural level is measured using a validated composite index (education 0-3, occupation 0-3, income 0-2, housing 0-2; total 0-10; Low 0-3, Mid 4-6, High 7-10). Health literacy is measured using the Newest Vital Sign-Turkish (NVS-TR; Cronbach alpha 0.720; cutoff >= 4 = adequate health literacy). Parental CT demand is documented using the CRF item "Did the family request CT?" (Yes/No/Not stated). PECARN adherence is classified as Adherent, Deviant, or Partial. Seven-day telephone follow-up captures ED re-presentation and new neurological symptoms.
SAMPLE SIZE: Powered on CT ordering (conservative proxy for CT demand) using a two-proportion z-test: p1 = 0.70 (low health literacy), p2 = 0.45 (adequate health literacy); alpha = 0.05 two-tailed; power = 80%. Required n = 138; adjusted for 15% loss to follow-up = 163; rounded to n = 200 to accommodate logistic regression (5 predictors, events per variable >= 15) and intermediate-risk subgroup analysis.
ANALYSIS: Primary - chi-squared test comparing parental CT request rates between low and high health literacy groups, stratified by PECARN risk category. Multivariable - two logistic regression models: Model A (parental CT demand as outcome) and Model B (CT ordering as outcome, including parental CT demand as predictor). Mediation - counterfactual causal mediation framework (Imai et al., 2010) testing whether parental CT demand mediates the effect of socio-cultural level on CT ordering, and whether NVS-TR mediates the effect of socio-cultural level on parental CT demand. Missing data - multiple imputation by chained equations (MICE; m = 20).
ETHICS: Approved by the Institutional Ethics Committee of SBU Bursa Yuksek Ihtisas EAH (Protocol 2024-TBEK 2024/04-16; 05 April 2024). Written informed consent obtained from parent/guardian; verbal assent from children aged 8 and older. No financial compensation. No external funding.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Zulfi Engindeniz, MD
- Telefonní číslo: +905334169101
- E-mail: zengindeniz@gmail.com
Studijní místa
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Bursa, Turecko (Türkiye)
- Nábor
- SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
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Kontakt:
- Zulfu Engindeniz, MD
- Telefonní číslo: +905334169101
- E-mail: zengindeniz@gmail.com
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Vrchní vyšetřovatel:
- Zulfu Engindeniz, MD
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Dílčí vyšetřovatel:
- Mehmet Demir, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Age less than 18 years at time of emergency department presentation
- Presenting complaint of head trauma sustained within the preceding 24 hours
- Classified as minor head trauma at triage, defined as a Glasgow Coma Scale (GCS) score of 14 or 15 at initial assessment
- Accompanied by a parent or legal guardian with capacity to provide written informed consent
Exclusion Criteria:
- GCS score 13 or less at presentation (moderate or severe head injury)
- Transfer from another medical facility
- Head trauma sustained more than 24 hours before emergency department presentation
- Known coagulopathy, anticoagulant therapy, or bleeding disorder
- Ventriculoperitoneal shunt in situ
- Previous intracranial neurosurgery
- Pre-existing neurological disorder affecting GCS interpretation (e.g., cerebral palsy, developmental delay)
- Clinical suspicion of abusive head trauma (non-accidental injury) identified by the treating physician
- Concurrent multi-system trauma
- No accompanying parent or guardian available for consent and socio-cultural assessment
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Children with minor head trauma
Consecutive patients aged under 18 years presenting to the emergency department with minor head trauma (GCS 14-15) within 24 hours of injury, accompanied by a parent or legal guardian able to provide written informed consent.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Parental Request for CT Head Imaging
Časové okno: At emergency department presentation (index visit, Day 0)
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Explicit verbal request by the accompanying parent or guardian for CT head to be performed, documented by the treating physician at the time of PECARN risk assessment (recorded as Yes / No / Not stated).
Operationalised as any affirmative parental request for CT regardless of the physician's independent clinical assessment.
Responses of Not stated will be handled as missing data and imputed under the MICE procedure.
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At emergency department presentation (index visit, Day 0)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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CT Head Ordered
Časové okno: At emergency department presentation (index visit, Day 0)
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Binary outcome: CT head ordered (Yes) or not ordered (No) by the treating emergency physician following PECARN risk stratification and clinical assessment.
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At emergency department presentation (index visit, Day 0)
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PECARN Algorithm Adherence Category
Časové okno: At emergency department presentation (index visit, Day 0)
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Three-category prospective classification assigned by the treating physician.
Adherent: management matched PECARN guidance for the assigned risk category (CT in high-risk; CT or observation in intermediate-risk; no CT in low-risk).
Deviant: management discordant with PECARN (CT ordered in a low-risk patient [unnecessary CT], or CT withheld in a high-risk patient [missed CT]).
Partial: applicable exclusively to intermediate-risk patients in whom structured observation was bypassed and CT ordered immediately without a preceding observation phase.
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At emergency department presentation (index visit, Day 0)
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Emergency Department Re-presentation Within 7 Days
Časové okno: 7 days after index emergency department discharge
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Re-attendance at any emergency department within 7 days of the index visit, as determined by structured telephone follow-up conducted at 7 days post-discharge by the research coordinator.
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7 days after index emergency department discharge
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Clinically Important Traumatic Brain Injury (ciTBI)
Časové okno: 7 days after emergency department presentation
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ciTBI defined as any of the following attributable to traumatic brain injury: death; neurosurgical intervention; intubation for more than 24 hours; or hospital admission for at least two nights.
Identified either on index CT or reported at 7-day telephone follow-up.
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7 days after emergency department presentation
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Physician-Assessed Parental Anxiety at Presentation
Časové okno: At emergency department presentation (index visit, Day 0)
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Parental anxiety level as assessed by the treating physician using a 10-point visual analogue scale (0 = not anxious at all; 10 = maximally anxious), completed at the time of clinical assessment.
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At emergency department presentation (index visit, Day 0)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Zulfi Engindeniz, MD, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
- Ředitel studie: Mehmet Demir, MD, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
Publikace a užitečné odkazy
Obecné publikace
- Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14.
- Ratcliffe N, Newport R. The Effect of Visual, Spatial and Temporal Manipulations on Embodiment and Action. Front Hum Neurosci. 2017 May 4;11:227. doi: 10.3389/fnhum.2017.00227. eCollection 2017.
- Sahiner IT, Akpinar Z, Demir O, et al. Validity and reliability of the Turkish version of the Newest Vital Sign. J Community Health. 2020.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2024-TBEK-2024-04-16
- 2024-TBEK 2024/04-16 (Jiný identifikátor: Institutional Ethics Committee, SBU Bursa Yuksek Ihtisas EAH)
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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