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临床试验/NCT06495073
NCT06495073招募中不适用

Determining the Minimal Clinically Important Difference (MCID) for the TOPICS-SF and PROMIS-10 in Older Patients That Suffered an Ischemic Stroke or Transient Ischemic Attack (TIA), Using an Anchor-based Approach

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2024年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
2
主要终点
MCID of the PROMIS-10

研究概览

简要总结

Patient-related outcome measures (PROMs) play a crucial role in assessing patient outcomes in healthcare. Two of these PROMs are the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF) and Patient-Reported Outcomes Measurement Information System Global Health Short Form (PROMIS-10). The investigators aim to determine the Minimal Clinically Important Difference (MCID) for the TOPICS-SF and PROMIS-10 in older people that suffered an ischemic stroke or Transient Ischemic Attack (TIA), using an anchor-based method.

详细描述

Patient-related outcome measures (PROMs) play a crucial role in assessing patient outcomes in healthcare. Two of these PROMs are the TOPICS-Short Form (TOPICS-SF) and PROMIS Global Health-10 (PROMIS-10). The TOPICS-SF, a shortened version of the TOPICS MDS, is a 20-item survey used in geriatric medicine to collect data on daily functioning. The PROMIS-10, a 10-question survey, is a global measure of the mental and physical health of stroke survivors.

The Minimal Clinically Important Difference (MCID) for PROMs is used to determine the clinical significance of differences in patients' scores. The MCID is defined as "the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient's management".

MCID values vary across different populations. Despite the significance of MCID in interpreting PROM results, neither TOPICS-SF nor PROMIS-10 have established MCID values for the population of older adults that suffered a stroke.

One option to determine the MCID for these PROMs is a distribution-based method: this method compares the change in scores on the PROMS to statistical measures of spread of the data like the standard deviation. However, this approach may not always provide clinically relevant differences. A method that provides a more clinically meaningful MCID estimate is the anchor-based method.

With the anchor-based method, a specific question or "anchor" is chosen that is related to the concept being measured by the PROM. This anchor question typically asks participants about their perceived change in health or well-being over a specified period. For example, it might be a question like, "Has your physical health improved since ....?" The response options often include choices like "yes/no" or a range of improvement levels. The PROMs and the anchor questions are administered to the same group of participants, both before and after a specific time period. Based on the responses to the anchor question, participants are categorized into different groups like "improved" and "not improved". The MCID is then calculated using the predictive modeling approach. This technique uses statistical modeling techniques to analyze the relationship between changes in PROM scores and the categories established by the anchor question. The MCID value obtained through this process represents the minimum change in PROM scores that is considered clinically significant from the participant's perspective.

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
70 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • age = 70 years or older at the time of ischemic stroke or TIA;
  • inclusion within a week after diagnosis of ischemic stroke or TIA

排除标准

  • not speaking Dutch;
  • being unable to answer questions;
  • being unable or not willing to give written informed consent.

结局指标

主要结局

MCID of the PROMIS-10

时间窗: 4 weeks

The Minimal Clinically Important Difference (MCID) of the Patient-Reported Outcomes Measurement Information System Global Health Short Form(PROMIS-10) will be calculated using an achor-based approach. The PROMIS-10 has scores ranging from 10 to 50, where higher scores indicate better health status.

MCID of the TOPICS-SF

时间窗: 4 weeks

The Minimal Clinically Important Difference (MCID) of the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF) will be calculated using an achor-based approach. Of the TOPICS-SF, the investigators will use the questions regarding physical and psychological wellbeing (section D and E). These sections have combined scores ranging from 0 (worst) to 54 (best).

次要结局

  • MCID of the mental health score of the PROMIS-10(4 weeks)
  • MCID of the physical health score of the PROMIS-10(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. dr. Nathalie van der Velde

Full Professor Geriatric medicine (internal medicine), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam UMC, location AMC

研究点 (2)

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