Evidence map›Paper›PMID 39440720›Full record

Observational studyClinical trials (London, England)2025

Statistical properties of items and summary scores from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE

Carolyn Mead-Harvey, Ethan Basch, Lauren J Rogak, Blake T Langlais, Gita Thanarajasingam, Brenda F Ginos, Minji K Lee, Claire Yee, Sandra A Mitchell, Lori M Minasian and 5 more

Registry-linked trialAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Clinical trials (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02158637 (Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events), which is not on this 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.

NCT02158637 completednot on this map

Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

TypeobservationalSponsorMayo ClinicRan2010 to 2017Enrolled1,100ConditionsCancer
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

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

15 authors.

Carolyn Mead-HarveyDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
Ethan BaschUNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.ORCID 0000-0003-3813-9318
Lauren J RogakDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.ORCID 0009-0009-9430-2256
Blake T LanglaisDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
Gita ThanarajasingamDivision of Hematology, Mayo Clinic, Rochester, MN, USA.
Brenda F GinosDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
Minji K LeeDepartment of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.
Claire YeeDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.
Sandra A MitchellNational Cancer Institute, Rockville, MD, USA.
Lori M MinasianNational Cancer Institute, Rockville, MD, USA.
Tito R MendozaNational Cancer Institute, Rockville, MD, USA.
Antonia V BennettUNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.ORCID 0000-0002-8968-4511
Deborah SchragMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Amylou C DueckDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.ORCID 0000-0002-9912-1085
Gina L MazzaDepartment of Quantitative Health Sciences, Mayo Clinic, Scottsdale, AZ, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Analyzing and Interpreting PRO-CTCAE with CTCAE and Other Clinical Data to Characterize Drug TolerabilityU01CA233046 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BASCH, ETHAN M., DUECK, AMYLOU CONSTANCE · 2018 to 2023
$3.0M
NCI NIH HHS HHSN261200800043CNCI NIH HHS P30 CA008748NCI NIH HHS U01 CA233046
6 · The paper itself

Abstract

BACKGROUND/

aimsThe Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE

methodsUsing data from the PRO-CTCAE validation study (NCT02158637), prevalence, means, and standard deviations of PRO-CTCAE items, composite scores, and mean and maximum scores across attributes (frequency, severity, and/or interference) of symptomatic adverse events were calculated. For each adverse event, correlations and agreement between attributes, correlations between attributes and composite scores, and correlations between composite, mean, and maximum scores were estimated.

resultsPRO-CTCAE items were completed by 899 patients with various cancer types. Most patients reported experiencing one or more adverse events, with the most prevalent being fatigue (87.7%), sad/unhappy feelings (66.0%), anxiety (63.6%), pain (63.2%), insomnia (61.8%), and dry mouth (60.0%). Attributes were moderately to strongly correlated within an adverse event (

conclusionsResults provide evidence for PRO-CTCAE administration and reporting recommendations that the full complement of attributes be administered for each adverse event, and that attributes as well as summary scores be reported.

Indexed as

Antineoplastic AgentsDrug-Related Side Effects and Adverse ReactionsNeoplasmsPatient Reported Outcome MeasuresAdultAgedFemaleHumansMaleMiddle AgedAntineoplastic Agentsadverse eventscancerPatient-reported outcomesPRO-CTCAE®symptomstolerability

Identifiers

PMID39440720
PMCPMC11986086

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Registered trials

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.