Evidence map›Paper›PMID 39585603›Full record

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

Myelofibrosis symptom assessment form total symptom score version 4.0: measurement properties from the MOMENTUM phase 3 study.

Christina Daskalopoulou, Boris Gorsh, Gerasimos Dumi, Samineh Deheshi, Chad Gwaltney, Jean Paty, Catherine Ellis, Jun Kawashima, Ruben Mesa

Abstract readClinical Trial, Phase III
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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Observational
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

9 authors.

Christina DaskalopoulouIQVIA, Athens, Greece. christina.daskalopoulou@iqvia.com.ORCID http://orcid.org/0000-0002-4328-2672
Boris GorshDaiichi Sankyo, Inc., Basking Ridge, NJ, USA.
Gerasimos DumiIQVIA, Athens, Greece.
Samineh DeheshiGSK plc, Philadelphia, PA, USA.
Chad GwaltneyGwaltney Consulting, Westerly, RI, USA.
Jean PatyIQVIA, New York, NY, USA.
Catherine EllisGSK plc, Philadelphia, PA, USA.
Jun KawashimaSierra Oncology, a GSK company, San Mateo, CA, USA.
Ruben MesaAtrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.

Funding

GSK GSK
6 · The paper itself

Abstract

purposeThe Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) comprises 7 common MF symptom items (fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, bone pain) and is the first patient-reported outcome (PRO) instrument designed to assess MF symptom burden. Given that information on the psychometric properties of this instrument has been limited, we sought to evaluate its measurement properties and validate its use in the phase 3 MOMENTUM trial.

methodsData were pooled to assess MFSAF item distribution, structural validity, reliability (test-retest and internal consistency), construct validity (convergent, divergent, and known-groups), and sensitivity to change. Other PRO measures included Patient Global Impression of Severity/Change (PGIS/PGIC), EORTC QLQ-C30, PROMIS Physical Function Short Form 10b, and ECOG performance status.

resultsParticipants (N = 195) showed high completion rates (> 93%) across 24 weeks. Moderate to strong Spearman correlation coefficients among items were mostly observed at baseline (range, 0.289-0.772) and week 24 (range, 0.391-0.829), which supported combining items into a multi-item scale and total score. Internal consistency (Cronbach's α, 0.877 at baseline and 0.903 at week 24) and test-retest reliability (intraclass correlation coefficient, > 0.829) were satisfactory across selected time intervals. Reliability was also supported by McDonald's omega (ω) coefficient (> 0.875). MFSAF moderately correlated with PRO measures of similar content, differentiated between PGIS and ECOG groups (P < .001), and was able to detect change over time.

conclusionsThe MFSAF v4.0 is a valid tool to assess MF symptom burden, supporting its use in future trials in similar populations.

Indexed as

Patient Reported Outcome MeasuresPrimary MyelofibrosisQuality of LifeSymptom AssessmentAdultAgedFemaleHumansMaleMiddle AgedPsychometricsReproducibility of ResultsSeverity of Illness IndexSurveys and QuestionnairesAnemiaMOMENTUMMyelofibrosisPatient-reported outcomesPsychometrics

Identifiers

PMID39585603
PMCPMC11919960

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Registered trials

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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.