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临床试验/NCT07277790
NCT07277790已完成不适用

Predictive Value of Emergency Physician-coded Cincinnati Prehospital Stroke Scale Scores Based on Witness Reports and Their Association With Action Decision Time: A Cross-sectional Emergency Department Validation Study

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
235
试验地点
1
主要终点
Final Diagnosis

研究概览

简要总结

The Cincinnati Prehospital Stroke Scale (CPSS) is traditionally scored directly by a healthcare professional or a layperson who independently observes facial droop, arm weakness, and speech disturbance, constituting the primary CPSS score. In contrast, this study focuses on witness-derived secondary CPSS scoring, which is performed indirectly by an emergency physician who is blinded to the patient's physical examination findings and relies exclusively on symptom descriptions provided by witnesses of the patient's initial presentation.

This prospective analytical cross-sectional study aims to evaluate the predictive accuracy of secondary CPSS scores obtained by emergency physicians through structured interviews with witnesses of suspected stroke cases. Interrater reliability will be assessed between secondary CPSS scores independently assigned by a senior emergency medicine resident and an attending emergency physician based on witness-reported symptom descriptions. Secondary CPSS scores will then be compared with final neuroimaging diagnoses (CT/MRI), which will serve as the diagnostic gold standard. The study will also investigate the association between physician-coded secondary CPSS scores, witness demographic characteristics, and delays in seeking emergency medical care.

Research Questions

  1. Are witness-derived secondary CPSS scores, as assigned by an emergency physician, a valid tool for predicting ischemic stroke?
  2. Are witness-derived secondary CPSS scores of ≥1 associated with shorter recognition-to-action time (decision delay)?

Research Hypotheses

  1. Witness-derived secondary CPSS scores assigned by an emergency physician are a valid diagnostic tool for predicting ischemic stroke.
  2. Witness-derived secondary CPSS scores of ≥1 are associated with shorter recognition-to-action time.

A total of 235 stroke witnesses, including family members, friends, neighbors, or bystanders who observed the patient's initial symptoms and accompanied the patient to the emergency department with acute stroke or stroke-like symptoms, will be included. All eligible participants will provide written informed consent prior to enrollment. Witnesses will undergo a structured, physician-administered interview in which they will be asked to recall and describe the patient's first symptoms. Based solely on these reports, an emergency physician blinded to the patient's clinical examination will assign a secondary CPSS score focusing on facial droop, arm weakness, and speech impairment. Two investigators will independently score the secondary CPSS to enable interrater agreement analysis.

Participants will also provide demographic data and report three key time points: symptom recognition, decision to seek care, and arrival at the emergency department. These data will be used to calculate onset-to-door time (prehospital delay), recognition-to-action time (decision delay), and call-to-door time (transfer delay). Data collection and emergency care provision will be conducted by investigators independent of those performing secondary CPSS scoring to minimize bias.

详细描述

Study Design

  • Prospective, analytical, cross-sectional validation study
  • Conducted in the Emergency Department of a tertiary academic hospital in Türkiye Two phases
  1. Phase 1:

Interrater reliability assessment: Between a senior emergency medicine (EM) resident and an emergency medicine (EM) attending physician 2. Phase 2:

Predictive validity assessment The association between secondary CPSS scores, witness demographic characteristics, and decision delays

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Witnessing onset/discovery of stroke-like symptoms
  • Accompanying the patient to the ED
  • Being the individual who decided to call EMS or arrange transport
  • No cognitive impairment affecting communication
  • Not a healthcare professional
  • Patient requiring advanced neuroimaging (CT/MRI)
  • Provided written informed consent

排除标准

  • Age <18 years
  • Did not witness symptoms
  • Cognitive impairment limiting communication
  • Did not make the action decision
  • Healthcare professionals
  • Patients transferred with pre-confirmed stroke
  • Lack of consent or withdrawal
  • Missing/incomplete CPSS scoring items

结局指标

主要结局

Final Diagnosis

时间窗: At completion of diagnostic evaluation (ED visit)

Final diagnosis categorized as ischemic stroke, hemorrhagic stroke, or non-stroke, based on CT and/or MRI reports interpreted by independent radiologists.

Secondary CPSS Score

时间窗: During ED admission interview

Defined as the score indirectly derived from witness reports by an emergency physician who was blinded to the patient's physical examination and relied on the observations of individuals who witnessed the patient's initial symptoms. Physician-coded CPSS score derived from structured witness face-to-face interviews; assessed as a continuous variable (0-3) and dichotomized (≥1 vs 0).

次要结局

  • Decision Delay(Reported by the witness at ED arrival)
  • Witness Demographic Characteristics(Reported by the witness at ED arrival)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Betül Akbuğa Özel

Assistant Professor

Ankara City Hospital Bilkent

研究点 (1)

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