Evidence map›Paper›PMID 40866741›Full record

ArticleThe patient2026

Patient-Reported Side Effect Bother: Understanding the Value of the Baseline Report.

Jessica Roydhouse, Monique Breslin, Anne Zola, Ethan Basch, Melanie Calvert, David Cella, Mary Lou Smith, Gita Thanarajasingam, John Devin Peipert

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The patient, 2026. 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

9 authors.

Jessica RoydhouseMenzies Institute for Medical Research, University of Tasmania, 15-17 Liverpool Street, Hobart, TAS, 7000, Australia. jessica.roydhouse@utas.edu.au.ORCID 0000-0002-8025-5841
Monique BreslinMenzies Institute for Medical Research, University of Tasmania, 15-17 Liverpool Street, Hobart, TAS, 7000, Australia.
Anne ZolaKellogg School of Management, Northwestern University, Evanston, IL, USA.
Ethan BaschUniversity of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Melanie CalvertCentre for Patient-Reported Outcomes Research, Birmingham Health Partners Centre for Regulatory Science and Innovation, National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre and NIHR Blood and Transplant Research Unit in Precision Cellular Therapeutics, University of Birmingham, Edgbaston, Birmingham, UK.
David CellaFeinberg School of Medicine, Northwestern University, Evanston, IL, USA.
Mary Lou SmithResearch Advocacy Network, Plano, TX, USA.
Gita ThanarajasingamDivision of Hematology, Mayo Clinic, Rochester, MN, USA.
John Devin PeipertCentre for Patient-Reported Outcomes Research, Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Edgbaston, Birmingham, UK.

Funding

FDA HHS 75F40121C00162
6 · The paper itself

Abstract

aimPatient-perceived treatment tolerability can affect patient ability and willingness to remain on therapy. We sought to examine completion rates for a single item of overall side effect bother at baseline and at the first on-treatment assessment, the association between this item with other patient-reported outcomes (PROs) and the odds of early discontinuation due to clinician-assessed adverse events or reasons other than disease progression.

methodsData were from three commercial cancer trials in solid tumours, focusing on the safety population. The GP5 item from the Functional Assessment of Cancer Therapy (FACT) was used for side effect bother. Other PROs included items on specific symptoms, functional impacts and global health status, all drawn from validated measures. Descriptive statistics were used for completion rates, and correlation and logistic regression analyses were used to examine associations. GP5 was dichotomised as 0-1 ('low') versus 2-4 ('high').

resultsCompletion rates were at or above 90% at baseline for all items. GP5 completion rates were 5% lower than completion rates for other items (89.8% versus 94.9%) at baseline, but this was not seen after baseline. Among patients with non-missing baseline GP5, 11.8-15.7% of cancer treatment-naïve patients reported high bother, compared with 23.9% of treatment-experienced patients. Patients with high bother at baseline had higher odds of early discontinuation compared with those with low bother, but this was not statistically significant after covariate adjustment.

conclusionsContinued collection of the GP5 item and concomitant work aiming to understand reasons for missingness as well as interpretation is important for evaluating tolerability in cancer trials.

Indexed as

Antineoplastic AgentsNeoplasmsPatient Reported Outcome MeasuresAdultAgedFemaleHumansMaleMiddle AgedSurveys and QuestionnairesAntineoplastic Agents

Identifiers

PMID40866741
PMCPMC12789233

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.