Clinical trial NCT06495073: Determining the MCID for the TOPICS-SF and PROMIS-10 in Older Patients That Suffered an Ischemic Stroke or TIA
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
TIA
Keywords: MCID
PROMIS-10
TOPICS-SF
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 125
Sex: ALL
Minimum age (years): 70
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MCID of the PROMIS-10
timeFrame: 4 weeks
measure: MCID of the TOPICS-SF
timeFrame: 4 weeks
Secondary outcomes:
measure: MCID of the mental health score of the PROMIS-10
timeFrame: 4 weeks
measure: MCID of the physical health score of the PROMIS-10
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG, locatie West
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
name: Renske van den Berg-Vos, Prof, dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
name: Nathalie van der Velde, Prof, dr
role: PRINCIPAL_INVESTIGATOR
References: