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Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma: A Prospective Cohort Study

12 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

200

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Turcja (Türkiye)
      • Bursa, Turcja (Türkiye)
        • Rekrutacyjny
        • SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
        • Kontakt:
        • Główny śledczy:
          • Zulfu Engindeniz, MD
        • Pod-śledczy:
          • Mehmet Demir, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Parental Request for CT Head Imaging
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
CT Head Ordered
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Śledczy

  • Główny śledczy: Zulfi Engindeniz, MD, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
  • Dyrektor Studium: Mehmet Demir, MD, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 kwietnia 2024

Zakończenie podstawowe (Szacowany)

1 lipca 2026

Ukończenie studiów (Szacowany)

1 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

12 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

17 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 czerwca 2026

Ostatnia weryfikacja

1 stycznia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

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NIEZDECYDOWANY

Opis planu IPD

we have not decided where to share IPD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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