此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年6月17日 更新者：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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
      • Bursa、土耳其（türkiye）
        • 招聘中
        • SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
        • 接触：
        • 首席研究员：
          • Zulfu Engindeniz, MD
        • 副研究员：
          • Mehmet Demir, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

取样方法

概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Parental Request for CT Head Imaging
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
CT Head Ordered
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bursa Yuksek Ihtisas Training and Research Hospital

调查人员

  • 首席研究员：Zulfi Engindeniz, MD、SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
  • 研究主任：Mehmet Demir, MD、SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年4月10日

初级完成 (估计的)

2026年7月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年6月12日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2024-TBEK-2024-04-16
  • 2024-TBEK 2024/04-16 (其他标识符：Institutional Ethics Committee, SBU Bursa Yuksek Ihtisas EAH)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

we have not decided where to share IPD

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅