Evidence map›Paper›PMID 40048089›Full record

ArticleJournal of patient-reported outcomes2025

Mapping immune checkpoint inhibitor side effects to item libraries for use in real-time side effect monitoring systems.

Julia Lai-Kwon, Michael Jefford, Stephanie Best, Iris Zhang, David Cella, Claire Piccinin, Bryce B Reeve, Claudia Rutherford

Abstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Mapping the EORTC item library to the World Health Organization international classification of functioning, disability and health: a content analysis.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
    Article
  2. Review
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

8 authors.

Julia Lai-KwonDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. Julia.Lai-Kwon@petermac.org.ORCID http://orcid.org/0000-0002-5388-1695
Michael JeffordDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Stephanie BestDepartment of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
Iris ZhangDepartment of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
David CellaDepartment of Medical Social Sciences and Robert H. Lurie Comprehensive Cancer Centre, Northwestern, Chicago, IL, USA.
Claire PiccininQuality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.
Bryce B ReeveDepartment of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
Claudia RutherfordSydney Quality of Life Office, Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

Funding

Western and Central Melbourne Integrated Cancer Service Not applicable
6 · The paper itself

Abstract

backgroundMonitoring for the side effects of novel therapies using patient-reported outcomes (PROs) is critical for ensuring patient safety. Existing static patient-reported outcome measures may not provide adequate coverage of novel side effects. Item libraries provide a flexible approach to monitoring for side effects using customized item lists, but the ideal process for matching side effects to items sourced from multiple item libraries is yet to be established. We sought to develop a pragmatic process for mapping side effects to items from three major item libraries using immune checkpoint inhibitor (ICI) side effects as an example.

methodsUsing a consumer- and clinician-driven list of 36 ICI side effects, two authors independently mapped side effects to Common Terminology Criteria for Adverse Event (CTCAE) terms, and then to three item libraries: the Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), the European Organisation for Research and Treatment of Cancer (EORTC) Item Library, and the Functional Assessment of Chronic Illness Therapy (FACIT) searchable library. The rates of inter-rater agreement were recorded. Following item collation from the item libraries, we devised criteria for selecting the optimal item for each side effect for inclusion in a future electronic PRO system based on guidance from the above groups.

resultsAll 36 side effects mapped to at least one CTCAE term, with eight mapping to more than one term. Twenty-three side effects mapped to at least one PRO-CTCAE term, 35 side effects mapped to at least one EORTC item, and 31 side effects mapped to at least one FACIT item. The inter-rater agreement rate was 100% (PRO-CTCAE), 83% (EORTC) and 75% (FACIT). Pre-determined criteria were applied to select the optimal item for each side effect from the three item libraries, producing a final 61-item list.

conclusionUsing ICI side effects as an example, we developed a pragmatic approach to creating customized item lists from three major item libraries to monitor for side effects of novel therapies in routine care. This process highlighted the challenges of using item libraries and priorities for future work to improve their usability.

Indexed as

Drug-Related Side Effects and Adverse ReactionsImmune Checkpoint InhibitorsPatient Reported Outcome MeasuresAdverse Drug Reaction Reporting SystemsHumansNeoplasmsImmune Checkpoint InhibitorsDigital healthImmune checkpoint inhibitorsImmunotherapyItem librariesItem listsPatient-reported outcomesSymptom monitoring

Identifiers

PMID40048089
PMCPMC11885683

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.