Determining the MCID for the TOPICS-SF and PROMIS-10 in Older Patients That Suffered an Ischemic Stroke or TIA (CONSIDER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; TIA
• Intervention / Treatment: Other: PROMIS-10 and TOPICS-SF

Detailed Description

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.

The investigators aim to determine the MCID for the TOPICS-SF and PROMIS-10 in people aged 70 or older that suffered an ischemic stroke or Transient Ischemic Attack (TIA), using an anchor-based method, to determine the clinical significance of differences in participant' scores.

This will be achieved through a prospective cohort study with no intervention. Participants will complete questionnaires at two time points: initially after providing informed consent during their hospital visit for diagnostic evaluation of the TIA or ischemic stroke, and then again four weeks later (with a two-week window, allowing for a range of two to six weeks). At the first time point, participants will complete the PROMIS-10 and elements D and E of the TOPICS-SF, which assess functional limitations and psychological well-being. At the second time point, participants will answer the same questions along with three additional anchor questions. The MCID for the PROMIS-10 and TOPICS-SF will be calculated using prognostic modeling techniques.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Susanna R Prins, MSc; Phone Number: 0031 20 566 9111; Email: s.r.prins@amsterdamumc.nl
• Study Contact Backup: Name: Birgit A Damoiseaux-Volman,, PhD; Phone Number: 0031 20 566 9111; Email: b.a.damoiseaux@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam UMC, locatie AMC
      • Contact: Susanna R Prins, MSc; Phone Number: 0031 20 566 9111; Email: s.r.prins@amsterdamumc.nl
    • Amsterdam, Noord-Holland, Netherlands, 1061 AE
      • Not yet recruiting
      • OLVG, locatie West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The patient population consists of older (>=70 yrs) patients with a recent acute ischemic stroke or TIA who are admitted to or Amsterdam UMC location AMC or the OLVG West hospital, or visit the outpatient clinic or emergency department of one of these hospitals for diagnostic evaluation. Diagnosis of ischemic stroke or TIA will be left to the discretion of the neurologist.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MCID of the PROMIS-10	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.	4 weeks
MCID of the TOPICS-SF	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).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MCID of the mental health score of the PROMIS-10	Since the Patient-Reported Outcomes Measurement Information System Global Health Short Form(PROMIS-10) provides subscales for mental health (ranging from 4 to 20 points, higher scores indicating better mental health), as well as a global measure of the health related quality of life, the investigators will try to calculate the The Minimal Clinically Important Difference (MCID) for the mental health subscale.	4 weeks
MCID of the physical health score of the PROMIS-10	Since the Patient-Reported Outcomes Measurement Information System Global Health Short Form(PROMIS-10) provides subscales for physical health (ranging from 4 to 20 points, higher scores indicating better physical health), as well as a global measure of the health related quality of life, the investigators will try to calculate the The Minimal Clinically Important Difference (MCID) for the physical health subscale.	4 weeks

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Renske van den Berg-Vos, Prof, dr., Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Principal Investigator: Nathalie van der Velde, Prof, dr, Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: MCID; PROMIS-10; TOPICS-SF
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: 2023.0822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The CONSIDER database can be requested by other researchers. These requests will be reviewed according the requirements for sharing CONSIDER data.
• IPD Sharing Time Frame: After data-collection/analysis.

IPD Sharing Access Criteria

privacy laws of the Netherlands, including policy of NFU and AmsterdamUMC must be followed:

• data will be shared anonymously
• data can only be used to study the research question for which participants signed the ICF
• data will not be shared for commercial purposes.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No