在为血液性恶性瘤治疗的患者中,患者报告的身体功能的纵向图形
Gita Thanarajasingam1, Vishal Bhatnagar2, Brie N Noble3
1Division of Hematology, Mayo Clinic, 200 First Street SW, Rochester, MN, USA. thanarajasingam.gita@mayo.edu.
BMC medical research methodology
|August 8, 2025
概括
这项研究开发和可视化了患者报告的癌症临床试验的身体功能 (PF) 数据. 这些方法和可视化得到了患者,临床医生和FDA利益相关方的好评.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 美国食品和药物管理局 (FDA) 在癌症临床试验中发布了有关患者报告结果 (PRO) 的指导,包括癌症临床试验中的身体功能 (PF).
- 开发有效的分析方法和可视化PF数据对于评估治疗耐受性至关重要.
研究的目的:
- 在癌症患者中开发和可视化患者报告的身体功能 (PF) 数据.
- 在临床试验中创建PF终点的分析方法和图形表示.
主要方法:
- 对患者报告的耐受性终点应用了一个估计和框架.
- 从临床医生,统计学家和FDA利益相关者那里收集了代反,使用了三个血液恶性瘤试验数据集.
- 图形方法包括堆叠的条形图,线图,饼图,蛋糕图和布图,同时考虑PRO完成率和可访问性.
主要成果:
- 采用了各种可视化技术,包括堆叠条形图,线图和布图.
- 利益相关者的反表明他们更喜欢堆叠的条形图和线图,共识赞成布图而不是饼图.
- 患者反强调了需要图形来传达群体级趋势和个人患者数据的需求.
结论:
- 患者报告的身体功能对于评估癌症治疗耐受性至关重要.
- 为PF开发的数据摘要和可视化得到了患者,临床医生和FDA利益相关方的积极欢迎.
- 需要进一步的研究,以系统地评估这些分析和可视化方法在不同利益相关者的解释性.
相关概念视频
02:20Longitudinal Research
12.5K
Sometimes we want to see how people change over time, as in studies of human development and lifespan. When we test the same group of individuals repeatedly over an extended period of time, we are conducting longitudinal research. Longitudinal research is a research design in which data-gathering is administered repeatedly over an extended period of time. For example, we may survey a group of individuals about their dietary habits at age 20, retest them a decade later at age 30, and then again...
12.5K
01:21Cancer Survival Analysis
455
Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...
455
01:26Longitudinal Studies
247
Longitudinal studies are also widely used in other medical and social science fields. For instance, in cardiovascular research, they can monitor patients' health over decades to identify risk factors for heart disease, such as high cholesterol or smoking, and evaluate the long-term effectiveness of preventive measures. Similarly, in mental health studies, researchers might follow individuals from adolescence into adulthood to understand the development and progression of conditions like...
247
01:22Bone Marrow Sampling and Transplants
500
Bone marrow transplant is a potential cure for several diseases, including cancer and specific genetic disorders. Notably, this procedure is applicable for patients suffering from aplastic anemia, certain types of leukemia, severe combined immunodeficiency disease (SCID), Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, thalassemia, sickle-cell disease, and certain cancers.
The transplant begins with high doses of chemotherapy and radiation treatment, which aim to destroy...
The transplant begins with high doses of chemotherapy and radiation treatment, which aim to destroy...
500