Evidence map›Paper›PMID 40120039›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2025

Determining minimal clinically important differences in ecological momentary assessment measures of fatigue in people with multiple sclerosis.

Sonia Sharma, Tiffany J Braley, Kevin N Alschuler, Dawn M Ehde, Anna L Kratz

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Sonia SharmaDepartment of Physical Medicine & Rehabilitation, University of Michigan, Michigan Medicine, Ann Arbor, MI, USA. soniasha@buffalo.edu.ORCID http://orcid.org/0000-0002-1887-7420
Tiffany J BraleyDepartment of Neurology, Division of Multiple Sclerosis and Clinical Neuroimmunology, University of Michigan, Michigan Medicine, Ann Arbor, MI, USA.
Kevin N AlschulerDepartment of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Dawn M EhdeDepartment of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Anna L KratzDepartment of Physical Medicine & Rehabilitation, University of Michigan, Michigan Medicine, Ann Arbor, MI, USA.

Funding

National Multiple Sclerosis Society MB-1706-27943National Multiple Sclerosis Society R-1803-30557Patient-Centered Outcomes Research Institute MS-1610-36980
6 · The paper itself

Abstract

purposeFatigue is a common debilitating symptom of multiple sclerosis (MS). Ecological momentary assessment (EMA) provides a more reliable and sensitive assessment of fatigue outcomes relative to traditional recall surveys; however, the minimal clinically important difference (MCID) for EMA fatigue outcomes has not been established.

methodsMCIDs for EMA fatigue intensity and fatigue interference (0-10 numerical rating scale) that were assessed as outcomes in a pragmatic randomized clinical trial of three fatigue interventions were determined using two statistical approaches. The Patient Global Impression of Change (PGIC) and the Modified Fatigue Impact Scale (MFIS) were used within the anchor-based approach, and standard deviations (SD) and standard error of measurements (SEM) were examined within the distribution-based approach.

resultsPre- and post-treatment EMA data from 336 individuals with MS (76.2% female, 71.1% relapsing-remitting MS, mean age 48.8 (± 11.7) years, mean duration of MS 12.2 (± 9.8) years) were included in the analysis. Percent complete EMA data (4 EMAs/day) for 7 days were comparable pre- and post-treatment for fatigue intensity and for fatigue interference. Using the PGIC and MFIS anchors, change in EMA scores averaged 0.94 and 1.04 for fatigue intensity and 0.62 and 1.04 for fatigue interference, respectively. The SD and SEM for EMA fatigue intensity were 0.75 and 1.19 and for EMA fatigue interference were 0.83 and 1.30, respectively.

conclusionCombining two approaches, our study contributes foundational information regarding meaningful change on EMA measures of fatigue, enabling effective use of EMA to assess fatigue treatment outcomes in a person-centered manner.

Indexed as

Ecological Momentary AssessmentFatigueMinimal Clinically Important DifferenceMultiple SclerosisAdultFemaleHumansMaleMiddle AgedQuality of LifeEcological momentary assessmentFatigueMinimal clinically important differencesMultiple sclerosis

Identifiers

PMID40120039
PMCPMC12119754

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.