Evidence map›Paper›PMID 41422214›Full record

ArticleBMC medical informatics and decision making2025

ProAE: an R package for graphical tools and standardized analysis of patient-reported outcomes and adverse events data.

Blake Langlais, Brie Noble, Briant Fruth, Mia Truman, Gina L Mazza, Brenda Ginos, Carolyn Mead-Harvey, Minji Lee, Claire Yee, Lauren Rogak and 6 more

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In one paragraph

Article in BMC medical informatics and decision making, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Blake LanglaisMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Brie NobleMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Briant FruthMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Mia TrumanMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Gina L MazzaMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Brenda GinosMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Carolyn Mead-HarveyMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Minji LeeMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Claire YeeMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Lauren RogakMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Eric MeekMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA.
Allison M DealUNC Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
John Devin PeipertCentre for Patient-Reported Outcomes Research, Department of Applied Health Sciences, University of Birmingham, Birmingham, UK.
Gita ThanarajasingamMayo Clinic, Department of Hematology, Mayo Clinic, Rochester, MN, USA.
Ethan BaschUNC Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
Amylou C DueckMayo Clinic, Department of Quantitative Health Sciences, Division of Biostatistics and Clinical Trials, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA. dueck.amylou@mayo.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatient-reported symptomatic adverse events (AE) are increasingly collected in oncology clinical trials to characterize treatment tolerability and inform clinical decision making using the Patient-Reported Outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®). Although there are numerous analysis methods and graphical approaches used for PRO-CTCAE data, the current PRO literature is limited in unified reporting and graphical approaches as well as public-facing analysis tools.

resultsCollaborative efforts from the Standardization Working Group of the National Cancer Institute Cancer Treatment Tolerability Consortium worked to develop the R package, ProAE. Testing and validation of widely used methods were implemented in the R package and deployed to various open-source outlets including the Comprehensive R Archive Network (CRAN).

conclusionProAE is a free and publicly available collection of standardized statistical analysis tools for PRO-CTCAE and other PRO data used in patient care and research. The ProAE package provides oncology researchers with an efficient and modern means to apply the published analysis approaches, including hypothesis testing, descriptive and inferential tables, and longitudinal graphics, without the need for costly software or licensing.

Indexed as

Drug-Related Side Effects and Adverse ReactionsPatient Reported Outcome MeasuresSoftwareHumansNeoplasmsCancer clinical trialsPRO-CTCAEStatistical programmingSymptomatic adverse eventTolerabilityToxicity

Identifiers

PMID41422214
PMCPMC12831245

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LicenceCC BY-NC-ND
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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.