跳至主要内容
临床试验/NCT06961253
NCT06961253进行中(未招募)不适用

External Validation of Ten Prediction Models With Low Risk of Bias for 30-day Mortality Following Hip Fracture: A Focus on Predictive Performance and Clinical Applicability

JointResearch1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
3,500
试验地点
1
主要终点
30-day mortality

研究概览

简要总结

This study aims to externally validate ten existing prediction models with a low risk of bias for 30-day mortality following hip fracture. Data will be collected from the Dutch Hip Fracture Audit (DHFA) and supplemented with structured and unstructured data extracted through text mining using CTcue. Approximately 35 clinical variables will be used, including factors consistently associated with short-term mortality. The primary outcome is all-cause mortality within 30 days after hip fracture. Predictive performance will be assessed through discrimination (AUC), explained variance (R²), and calibration analysis. Clinical usefulness will be evaluated using Net Benefit and Decision Curve Analysis. This study seeks to identify models with strong predictive performance and practical applicability to support shared decision-making between clinicians and patients.

详细描述

Hip fractures are a major health concern, especially among older adults, and are associated with substantial morbidity, mortality, and healthcare costs. While surgical intervention is standard practice for most patients, a growing number of cases require careful consideration of operative versus non-operative management based on individual risk profiles and patient preferences.

Several prediction models have been developed to estimate the risk of short-term mortality after hip fracture, but many have shown only moderate predictive performance or lacked clinical applicability. In 2024, a systematic review identified ten models with a low risk of bias, based on methodological criteria such as adequate sample size, proper handling of missing data, internal validation, and assessment of calibration.

This study aims to externally validate these ten prediction models using data from the Dutch Hip Fracture Audit (DHFA) combined with additional structured and unstructured clinical information extracted through CTcue, a text-mining software tool. Approximately 35 variables, including key preoperative factors such as age, sex, ASA score, institutionalization, and metastatic cancer, will be analyzed. Missing data will be addressed through multiple imputation.

The primary outcome is 30-day all-cause mortality following a hip fracture. Validation of the models will involve evaluation of predictive performance through discrimination (area under the curve [AUC]), explained variance (R²), and calibration curves. The DeLong test will be used to statistically compare model AUCs. Clinical usefulness will be assessed by calculating Net Benefit and conducting Decision Curve Analysis.

By rigorously validating these models in a large, real-world cohort, the study aims to identify which models offer both strong predictive accuracy and practical feasibility for supporting shared decision-making between clinicians and patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • •Patients admitted to OLVG between January 1, 2016, and March 1, 2024, with a diagnosis of hip fracture; and/or.
  • •Patients who underwent surgery at OLVG between January 1, 2016, and March 1, 2024, with an indication of hip fracture; and.
  • •Availability of independent predictor variables for at least one of the selected prediction models in the medical record.

排除标准

  • •Patients with unknown 30-day follow-up mortality status.
  • •Patients with periprosthetic fractures (fractures around an existing hip prosthesis) at the time of presentation.
  • •Patients aged under 18 years at the time of hip fracture.
  • •Patients who declined the use of their medical data for research purposes.

结局指标

主要结局

30-day mortality

时间窗: 30 days post-fracture

Occurrence of death from any cause within 30 days following hip fracture diagnosis or hospital admission. Mortality status (yes/no) will be determined based on hospital records and confirmed via the Dutch national population registry (Basisregistratie Personen, BRP).

次要结局

  • Discriminative Ability (AUC)(30 days post-fracture)

研究者

发起方
JointResearch
申办方类型
Other
责任方
Sponsor

研究点 (1)

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