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临床试验/NCT06649591
NCT06649591进行中(未招募)不适用

A Survey Based Study Assessing the Feasibility of Using Standardized Clinical Vignettes to Aid in Medical Decision in Patients with Malignant Brain Tumors

Tufts Medical Center1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2017年7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)
入组人数
225
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

Nearly 23,000 adults are diagnosed with primary central nervous system (CNS) malignancy yearly. An additional 200,000 adults are diagnosed with brain metastasis. There are significant variations in CNS tumor treatment. However, due to significant heterogeneity in patient baseline factors, identifying unwarranted variation is challenging. Ghogawala et al have previously demonstrated that, among patients undergoing surgical treatment of cervical myelopathy and lumbar degenerative spinal disease, an expert panel consisting of surgeon experts can identify variations in proposed surgical procedure and demonstrated superior patient outcomes when the surgery performed matched the procedure recommended by expert consensus. Expert panel surveys have not previously been used to identify variations in care among patients with CNS malignancy.

The primary aim is to determine whether patient outcomes are superior when treatment aligns with recommendations made by a clinical expert neurosurgical panel. The study also seek to identify patient factors that predispose to variability in care. Our long-term aim is to determine whether predictive artificial learning algorithms can achieve the same outcomes, or better, as clinical expert panels, but with greater efficiency and greater capacity to be available for more patients. The investigators hypothesize that:

  • When a team of 10 medical experts has greater than 80% consensus regarding optimal treatment and when the doctor and patient select that specific treatment, the outcome is superior than when a patient and doctor select an alternative procedure.
  • When a team of 10 medical experts has greater than 80% consensus regarding optimal treatment, the structured data used by the experts can be processed and trained by computing algorithms to predict the pattern recognized by the experts - i.e. - the computer can predict how an expert panel would vote.

Procedures include the following:

  1. Chart review portion of study: Patients will be identified from case logs of the principal investigators from July 2017 through July 2023. Data will be collected retrospectively and will include age, non-identifier demographics, diagnosis details, operative/treatment characteristics, post-treatment characteristics, and follow-up characteristics. Images reviewed will include pre and post-treatment MRIs obtained as part of routine care. Data will be abstracted from the medical record (Epic/Soarian and PACS) and recorded in an excel database.

  2. Survey portion of study: De-identified structured radiographic data and a brief clinical vignette without patient identifiers will be uploaded to Acesis Healthcare Process Optimization Platform (http://www.acesis.com/our-platform). A survey will be generated by Acesis and emailed to the subject experts/participants. This portion is prospective.

  3. Cohort definitions:

  4. Patients will be assigned to either "expert-treatment consensus" or "no expert-treatment consensus" arms based on whether greater than 80% consensus is achieved

  5. Patients will be assigned to either "Expert consensus-aligned" or "Expert consensus - unaligned" arms based on whether expert survey results match actual treatment given.

  6. Data will then be analyzed using appropriate packages with SAS statistical analysis software. Survival analysis will be performed to determine whether consensus predicts improved progression free survival (PFS).

  7. The structured and de-identified radiographic images used by the experts in surveys will be used for training and development of an AI algorithm. The aim of this portion of the study is to determine whether standardized and structured imaging can be used to train an algorithm to predict whether expert consensus is achieved and the recommended treatment.

详细描述

  1. Statistical analysis plan:
  1. this document provides the details of statistical analyses planned for the EC-AIM Brain study.
  2. Objective of this study:

i. The primary objective is to determine whether patients whose treatment aligns with expert consensus have a superior outcome to those who treatment does not align with expert consensus.

  1. This will be determined with a primary endpoint of progression free survival (alive and without tumor growth at last follow up).
  2. This will be tested with the log-rank test for equality of survival curves (EC/aligned vs EC/unaligned).
  1. Abbreviations:

研究设计

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

入排标准

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

入选标准

  • consecutive patients treated at a single center between April 2018 and July 2023 for malignant brain tumors, including glioma, metastasis, and lymphoma.

排除标准

  • Patients without available MRI dicom images
  • Patients with other CNS malignancies
  • Patients with multiply recurrent gliomas undergoing treatment for primarily palliative purposes
  • Patients younger than 18 years old

结局指标

主要结局

Overall Survival

时间窗: Through study completion, an average of 2 years

Patients alive at last follow up through study completion, an average of 2 years

次要结局

  • Progression free survival(Through study completion, an average of two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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