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Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma

17. juni 2026 oppdatert av: Zulfı engındenız, Bursa Yuksek Ihtisas Training and Research Hospital

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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

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Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
      • Bursa, Tyrkia (Türkiye)
        • Rekruttering
        • SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zulfu Engindeniz, MD
        • Underetterforsker:
          • Mehmet Demir, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Consecutive paediatric patients (age under 18 years) presenting to the emergency department of SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi, a 1,200-bed tertiary referral and training hospital in Bursa, Turkey, with minor head trauma (GCS 14-15) within 24 hours of injury, accompanied by a parent or legal guardian. The ED serves a sociodemographically diverse urban and peri-urban catchment area and records approximately 170,000 adult and paediatric visits annually.

Beskrivelse

Inclusion Criteria:

  1. Age less than 18 years at time of emergency department presentation
  2. Presenting complaint of head trauma sustained within the preceding 24 hours
  3. Classified as minor head trauma at triage, defined as a Glasgow Coma Scale (GCS) score of 14 or 15 at initial assessment
  4. Accompanied by a parent or legal guardian with capacity to provide written informed consent

Exclusion Criteria:

  1. GCS score 13 or less at presentation (moderate or severe head injury)
  2. Transfer from another medical facility
  3. Head trauma sustained more than 24 hours before emergency department presentation
  4. Known coagulopathy, anticoagulant therapy, or bleeding disorder
  5. Ventriculoperitoneal shunt in situ
  6. Previous intracranial neurosurgery
  7. Pre-existing neurological disorder affecting GCS interpretation (e.g., cerebral palsy, developmental delay)
  8. Clinical suspicion of abusive head trauma (non-accidental injury) identified by the treating physician
  9. Concurrent multi-system trauma
  10. No accompanying parent or guardian available for consent and socio-cultural assessment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parental Request for CT Head Imaging
Tidsramme: At emergency department presentation (index visit, Day 0)
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.
At emergency department presentation (index visit, Day 0)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
CT Head Ordered
Tidsramme: At emergency department presentation (index visit, Day 0)
Binary outcome: CT head ordered (Yes) or not ordered (No) by the treating emergency physician following PECARN risk stratification and clinical assessment.
At emergency department presentation (index visit, Day 0)
PECARN Algorithm Adherence Category
Tidsramme: At emergency department presentation (index visit, Day 0)
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.
At emergency department presentation (index visit, Day 0)
Emergency Department Re-presentation Within 7 Days
Tidsramme: 7 days after index emergency department discharge
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.
7 days after index emergency department discharge
Clinically Important Traumatic Brain Injury (ciTBI)
Tidsramme: 7 days after emergency department presentation
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.
7 days after emergency department presentation
Physician-Assessed Parental Anxiety at Presentation
Tidsramme: At emergency department presentation (index visit, Day 0)
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.
At emergency department presentation (index visit, Day 0)

Samarbeidspartnere og etterforskere

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Sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Etterforskere

  • Hovedetterforsker: Zulfi Engindeniz, MD, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
  • Studieleder: Mehmet Demir, MD, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

10. april 2024

Primær fullføring (Antatt)

1. juli 2026

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

12. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2024-TBEK-2024-04-16
  • 2024-TBEK 2024/04-16 (Annen identifikator: Institutional Ethics Committee, SBU Bursa Yuksek Ihtisas EAH)

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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