在电子与纸质试验中的SPRUCE (SPRUCE) 试验:为部分随机的患者偏好研究的研究方案
Lara Philipps1, Stephanie Foster1, Deborah Gardiner1
1Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.
BMJ open
|September 21, 2023
概括
本研究评估了癌症试验中的电子患者报告结果 (ePRO) 与纸质问卷. 在瘤学临床试验中,正在评估ePRO收集的可接受性和数据完整性.
科学领域:
- 瘤学临床试验 临床试验
- 患者报告的结果.
- 医疗信息学 医疗信息学
背景情况:
- 患者报告的结果 (PRO) 在临床试验中至关重要.
- 目前,PRO数据由ICR-CTSU通过纸质问卷收集.
- 电子 PRO (ePRO) 收集可以提高数据质量和患者体验.
研究的目的:
- 调查ePRO在瘤学临床试验中的可接受性.
- 为了比较ePRO与纸质PRO的数据收集效率.
- 使用ePRO.评估患者和数据的完整性.
主要方法:
- 该SPRUCE协议 (电子与纸质基于患者报告的结果的试验中的研究) 是在患者的投入下开发的.
- 一个部分随机的患者偏好设计允许参与者选择或随机选择ePRO或纸质PRO.
- 主要目标是比较随机组中的ePRO和纸质PRO之间的回报率 (合规性),统计能力需要244名参与者.
主要成果:
- 这项研究旨在确定ICR-CTSU瘤学试验的参与者是否可以接受ePRO.
- 它将确定ePRO是否能够捕获与纸质PRO可比的完整PRO数据.
- 预计纸质PRO的合规率将达到90%.
结论:
- 该SPRUCE试验将为ePRO在癌症研究中的实施提供有价值的见解.
- 结果将为未来的战略提供信息,以便在临床试验中简化PRO数据收集.
- 该研究将评估数字健康工具在瘤学环境中的可行性和患者接受度.
相关概念视频
Methods of Documentation VII: EMR
855
Electronic Medical Records (EMRs) primarily center around electronically documenting patients' health information within a single healthcare organization or practice. They contain essential clinical data related to a patient's medical history, diagnoses, medications, treatment plans, lab results, and other pertinent information relevant to the specific encounter or episode of care. EMRs are designed to streamline documentation and workflow processes within individual healthcare...
855
Methods of Documentation II: POMR
982
The Problem-Oriented Medical Record (POMR) revolutionized medical record-keeping by introducing a systematic approach focusing on the patient's problems rather than merely listing symptoms. Dr. Lawrence Weed's introduction of this method in the 1960s marked a significant advancement in medical documentation. The POMR framework consists of four key components: the database, problem list, plan of care, and progress notes.
982
Study Designs in Epidemiology
262
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
262
Blind Procedures
10.6K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
10.6K
Types of Reports III: Telephone and Verbal Reports
764
Telephone and Verbal Reports in healthcare settings are two communication methods for conveying therapeutic instructions from healthcare providers to nurses or other healthcare staff.
Here's an overview of each type:
Telephone Orders
Here's an overview of each type:
Telephone Orders
764


