Evidence map›Paper›PMID 38937473›Full record

Trial reportScientific reports2024

Developing a fit-for-purpose composite symptom score as a symptom burden endpoint for clinical trials in patients with malignant pleural mesothelioma.

Charles S Cleeland, Karen N Keating, Brian Cuffel, Cem Elbi, Jonathan M Siegel, Christoph Gerlinger, Tara Symonds, Jeff A Sloan, Amylou C Dueck, Andrew Bottomley and 3 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Patient symptoms, confidence, and adherence during the first 8 weeks of targeted oral anticancer agent treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  7. Article
  8. Defining critical symptom parameters for an ePRO-based management pathway during systemic treatment for advanced upper gastrointestinal cancer: a longitudinal study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
  9. Article
  10. Patient-reported outcomes after CAR T-cell therapy in patients with hematological malignancies.Hematology. American Society of Hematology. Education Program · 2024
    Review
  11. 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

13 authors.

Charles S CleelandDepartment of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-1460-6527
Karen N KeatingBayer HealthCare Pharmaceuticals, Whippany, NJ, USA.ORCID 0000-0001-6993-3114
Brian CuffelBayer HealthCare Pharmaceuticals, Whippany, NJ, USA.ORCID 0000-0003-0205-0530
Cem ElbiBayer HealthCare Pharmaceuticals, Whippany, NJ, USA.ORCID 0000-0002-1327-3476
Jonathan M SiegelBayer HealthCare Pharmaceuticals, Whippany, NJ, USA.ORCID 0000-0001-6477-4281
Christoph GerlingerBayer AG, Berlin, Germany.ORCID 0000-0003-4538-6413
Tara SymondsClinical Outcomes Solutions, Folkestone, Kent, UK.
Jeff A SloanDivision of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-3393-2387
Amylou C DueckSection of Biostatistics, Division of Health Sciences Research, Mayo Clinic, Phoenix, AZ, USA.ORCID 0000-0002-9912-1085
Andrew BottomleyQuality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.ORCID 0000-0002-3067-5207
Xin Shelley WangDepartment of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0003-2348-8005
Loretta A WilliamsDepartment of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0003-2788-657X
Tito R MendozaDepartment of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. tito.mendoza@nih.gov.ORCID 0000-0001-8122-5233

Funding

Office of Patient-Centered Outcomes Research (OPCORe)ZIDBC012078 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI MENDOZA, TITO · 2023 to 2025
$3.6M
6 · The paper itself

Abstract

We developed a composite symptom score (CSS) representing disease-related symptom burden over time in patients with malignant pleural mesothelioma (MPM). Longitudinal data were collected from an open-label Phase IIB study in which 239 patients completed the validated MD Anderson Symptom Inventory for MPM (MDASI-MPM). A blinded, independent review committee of external patient-reported outcomes experts advised on MDASI-MPM symptoms to include in the CSS. Through iterative analyses of potential symptom-item combinations, 5 MPM symptoms (pain, fatigue, shortness of breath, muscle weakness, coughing) were selected. The CSS correlated strongly with the full MDASI-MPM symptom set (0.92-0.94) and the Lung Cancer Symptom Scale-Mesothelioma (0.79-0.87) at each co-administration of the scales. The CSS also had good sensitivity to worsening disease and global quality-of-life ratings. The MDASI-MPM CSS can be used as an outcome in MPM clinical trials, including in responder analyses and at the individual patient level. It is brief enough to administer frequently, including electronically, to better capture symptom trajectories during and after a trial and in clinical practice. As a single score, the CSS addresses multiplicity issues that can arise when several symptoms increase due to worsening disease. Our process can be adapted to produce a CSS for other advanced-cancer trials.

Indexed as

Mesothelioma, MalignantPleural NeoplasmsQuality of LifeAgedFatigueFemaleHumansLongitudinal StudiesLung NeoplasmsMaleMesotheliomaMiddle AgedPatient Reported Outcome MeasuresSeverity of Illness IndexSymptom AssessmentSymptom Burden

Identifiers

PMID38937473
PMCPMC11211485

What OpenQuestion holds

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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.