Evidence map›Paper›PMID 34634139›Full record

ArticleCancer2022

Floor and ceiling effects in the EORTC QLQ-C30 Physical Functioning Subscale among patients with advanced or metastatic breast cancer.

Meena N Murugappan, Bellinda L King-Kallimanis, Christina Mangir, Lynn Howie, Vishal Bhatnagar, Julia A Beaver, Ethan M Basch, Sydney R Henson, Paul G Kluetz

Abstract read
In one paragraph

Article in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  7. Quality of care experience- aged care consumers (QCE-ACC) in residential aged care: an assessment of construct validity.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
  8. Trajectory of quality of life among patients with cancer at the end of life: a longitudinal survey study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Meena N MurugappanOffice of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.ORCID 0000-0001-7865-3931
Bellinda L King-KallimanisOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
Christina MangirAssociation of Community Cancer Centers, Rockville, Maryland.
Lynn HowiePardee Hospital, University of North Carolina Health, Hendersonville, North Carolina.
Vishal BhatnagarOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
Julia A BeaverOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
Ethan M BaschLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.ORCID 0000-0003-3813-9318
Sydney R HensonLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
Paul G KluetzOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.

Funding

UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
NCI NIH HHS UG1 CA233373Oak Ridge Institute for Science and EducationPatient-Centered Outcomes Research Institute IHS-1511-33392
6 · The paper itself

Abstract

backgroundThe European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 Physical Functioning subscale is a widely used patient-reported outcome measure that quantifies cancer patients' physical functioning. Strong floor/ceiling effects can affect a scale's sensitivity to change. The aim of this study was to characterize floor/ceiling effects of the physical functioning domain in patients with advanced/metastatic breast cancer enrolled in commercial clinical trials and a community-based trial.

methodsThe clinical trial cohort comprised patients from 5 registrational trials submitted to the Food and Drug Administration for review (2010-2017). The community cohort comprised a subgroup of patients from the Alliance Patient Reported Outcomes to Enhance Cancer Treatment (PRO-TECT) trial. The distribution of patient responses to Physical Functioning items and the summed score were assessed at the baseline and 3-month follow-up for both cohorts. Descriptive statistics were used to determine floor/ceiling effects at the item and scale levels.

resultsThe clinical trial cohort and the community cohort consisted of 2407 and 178 patients, respectively. Twenty-four percent or more of the respondents reported "not at all" for having trouble/needing help with each Physical Functioning item across both cohorts and measurement time points. Fourteen to twenty percent of the patients scored perfectly (100 of 100) on the Physical Functioning subscale summary measure (where higher scores indicated better physical functioning) across both cohorts and time points.

conclusionsMinor floor effects and notable ceiling effects were found at the item and scale levels of the Physical Functioning subscale, regardless of cohort, and this creates some uncertainty about its ability to detect changes in physical functioning among high-functioning patients. Investigators may consider adding additional high-functioning items from the EORTC's item library to more accurately describe the impact of anticancer treatment on patients' physical functioning.

Indexed as

Breast NeoplasmsQuality of LifeFemaleHumansPatient Reported Outcome MeasuresSurveys and Questionnairesbreast neoplasmsEuropean Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)patient-reported outcome measuresphysical functioningquality of life

Identifiers

PMID34634139
PMCPMC9923627

What OpenQuestion holds

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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.