Evidence map›Paper›PMID 39990686›Full record

ArticleFrontiers in oncology2025

Psychometric properties and meaningful change thresholds for the QOL-E instrument in patients with myelodysplastic neoplasms.

Esther Natalie Oliva, Shien Guo, Jennifer Lord-Bessen, Aylin Yucel, Roberto Latagliata, Massimo Breccia, Giuseppe A Palumbo, Grazia Sanpaolo, Marta Riva, Valeria Santini and 4 more

Abstract read
In one paragraph

Article in Frontiers in oncology, 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

14 authors.

Esther Natalie OlivaHematology Unit, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy.
Shien GuoEvidera, Waltham, MA, United States.
Jennifer Lord-BessenBristol Myers Squibb, Lawrence, NJ, United States.
Aylin YucelBristol Myers Squibb, Lawrence, NJ, United States.
Roberto LatagliataHematology Unit, Belcolle Hospital, Viterbo, Italy.
Massimo BrecciaHematology, Department of Translational and Precision Medicine, Az. Policlinico Umberto I-Sapienza University, Rome, Italy.
Giuseppe A PalumboDepartment of Medical, Surgical Sciences and Advanced Technologies "GF Ingrassia", University of Catania, Catania, Italy.
Grazia SanpaoloDepartment of Hematology and Stem Cell Transplantation Unit, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.
Marta RivaDepartment of Hematology and Oncology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Valeria SantiniMDS Unit, Hematology, DMSC, University of Florence, AOUC, Florence, Italy.
Uwe PlatzbeckerMedical Clinic and Policlinic 1, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany.
Guillermo Garcia-ManeroDepartment of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Pierre FenauxService d'Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, Paris, France.
Christopher G PelligraEvidera, Atlanta, GA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Myelodysplastic neoplasms (MDS) are characterized by ineffective hematopoiesis, peripheral blood cytopenias, and an increased risk of progression to acute myeloid leukemia. One of the main treatment goals is improving quality of life (QoL), particularly for patients with lower-risk MDS (LR-MDS) who may live longer with compromised QoL. The QOL-E Methods: Data from four clinical trials in MDS (MEDALIST, DARB-MDS, EQoL-MDS, and RevMDS trials) were used to assess construct validity, reliability, and responsiveness. The QOL-E was validated by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and clinical outcomes. It contains 29 items with the first two items assessing the patient's general well-being and the 27 remaining items grouped into six domain scores: physical well-being (QOL-FIS), functional well-being (QOL-FUN), social/family well-being (QOL-SOC), sexual well-being (QOL-SEX), fatigue (QOL-FAT), and MDS-specific disturbances (QOL-MDSS). Additionally, meaningful within-patient change (MWPC) thresholds were determined for the domains and summary scores of the QOL-E using anchor-based analyses, supported by distribution-based analyses. Results: A total of 458 patients were included in the analyses. The QOL-E domain/summary scores demonstrated acceptable convergent/divergent and known-groups validity. Test-retest reliability and internal consistency was confirmed with intraclass correlation coefficients and Cronbach alpha exceeding 0.70 across most QOL-E domains/summary scores. The QOL-E domains/summary scores, except for QOL-SEX, had an adequate ability to detect change from baseline to Week 24. MWPC thresholds were proposed for all other domains and summary scores. Conclusion: The study results demonstrate that the QOL-E is generally fit for purpose to assess treatment effects in populations with LR-MDS and the proposed MWPC thresholds can be used to assess within-patient treatment effect on PROs, as assessed by the QOL-E, in future studies.

Indexed as

clinically meaningful changeshealth-related quality of lifemyelodysplastic neoplasmsmyelodysplastic syndromespatient-reported outcomespsychometric analysisQOL-E

Identifiers

PMID39990686
PMCPMC11842348

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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.