EHR-Based Risk Factors With Prediction Models for Tinnitus Subtypes: A Multicenter Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,345
- 试验地点
- 1
- 主要终点
- Number of Patients in Each Tinnitus Subtype
研究概览
简要总结
Tinnitus affects an estimated 10-15% of the global population and can substantially impair quality of life, yet clinically actionable approaches for subtype identification and risk stratification remain limited. This multicenter, cross-sectional observational study will use de-identified electronic health record (EHR) data from three otolaryngology specialty hospitals in China to address these gaps. All extracted data will be de-identified with direct identifiers removed, and privacy safeguards will be implemented in accordance with institutional policies and applicable regulations to protect patient confidentiality.
详细描述
Using a prespecified, clinically informed framework, we will classify tinnitus into relevant subtypes, including somatosensory tinnitus, acute vs. chronic tinnitus, pulsatile tinnitus, and sudden hearing loss-related tinnitus. We will first describe the distribution of these subtypes and characterize their demographic, clinical, and laboratory profiles. We will then evaluate associations between candidate risk factors and subtype membership using multivariable analyses to quantify adjusted effects. Finally, we will develop and validate multivariable prediction models using both conventional statistical approaches and machine learning methods to support tinnitus subtype classification. Model performance will be assessed using discrimination, calibration, and clinical utility metrics. By integrating routine clinical data with biomarker information captured in real-world care, this study aims to provide evidence-based tools to improve tinnitus subtype diagnosis and enable more personalized clinical assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 95 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old;
- •Patients diagnosed with various types of tinnitus;
- •Patients with available electronic medical records, including demographic and clinical information.
排除标准
- •Patients with incomplete data;
- •Patients with severe neurological;
- •Patients with disorders that may confound tinnitus assessment.
结局指标
主要结局
Number of Patients in Each Tinnitus Subtype
时间窗: baseline
The number of participants classified into each predefined tinnitus subtype based on an integrated diagnosis clinical classification framework.
次要结局
- Adjusted odds ratios of risk factors associated with each tinnitus subtype(baseline)
- Accuracy of prediction models for identifying tinnitus subtype classification(baseline)
研究者
Hongsheng Tan
professor
Shanghai Jiao Tong University School of Medicine
