Evidence map›Paper›PMID 39636512›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2025

Patient-reported outcomes in non-small cell lung cancer: psychometric evaluation of the PROMIS PF-SF 8c and NSCLC-SAQ in two phase 3 clinical trials.

Carrie R Houts, Andrea Savord, Molly J Gardner, Maria Mattera, John Devin Peipert, Trishala Agrawal, Mahadi Baig, Praveen Barala, Joshua Bauml, Brooke Diorio and 6 more

Abstract readClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2025. 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

16 authors.

Carrie R HoutsVector Psychometric Group, LLC, Chapel Hill, NC, USA.ORCID http://orcid.org/0000-0003-1233-9389
Andrea SavordVector Psychometric Group, LLC, Chapel Hill, NC, USA.
Molly J GardnerVector Psychometric Group, LLC, Chapel Hill, NC, USA.
Maria MatteraPatient-Reported Outcome Consortium, Critical Path Institute (C-Path), Tucson, AZ, USA.
John Devin PeipertFeinberg School of Medicine, Northwestern University, Evanston, IL, USA.
Trishala AgrawalJanssen Global Services, LLC, Horsham, PA, USA.
Mahadi BaigJanssen Global Services, LLC, Horsham, PA, USA.
Praveen BaralaJanssen Research and Development, LLC, Spring House, PA, USA.
Joshua BaumlJanssen Global Services, LLC, Horsham, PA, USA.
Brooke DiorioJanssen Research and Development, Titusville, NJ, USA.
Angela GirvinJanssen Global Services, LLC, Horsham, PA, USA.
Jan SermonJanssen Pharmaceutica NV, Beerse, Belgium.
Sujay ShahJanssen Research and Development, LLC, Spring House, PA, USA.
Monica WithelderJanssen Research and Development, LLC, Malvern, PA, USA.
Honeylet Wortman-VaynJanssen Global Services, LLC, Raritan, NJ, USA.
Julia SchuchardJanssen Global Services, LLC, Horsham, PA, USA. JSchucha@its.jnj.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePhysical functioning and symptom severity are important factors in the experience of people with living with non-small cell lung cancer (NSCLC). This study evaluates the reliability, validity, and meaningful within-person change (MWPC) thresholds of 2 patient-reported outcome (PRO) measures in NSCLC: the Patient-Reported Outcomes Measurement Information System (PROMIS®) Physical Function (PF) short form (SF) 8c and the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ).

methodsData came from 2 Phase 3 clinical trials among people living with NSCLC. PROMIS PF-SF analyses included data from 300 participants in the PAPILLON trial, and NSCLC-SAQ analyses included 615 participants in the MARIPOSA 2 trial. Prespecified expected relationships between target PRO measures and relevant study variables were used to evaluate validity evidence. Additionally, MWPC thresholds were estimated using anchor- and distribution-based analyses.

resultsBoth PRO measures exhibited adequate internal consistency for clinical trial use. All examined correlations with reference variables and score differences between clinically meaningful groups conformed to expectations for both measures. Estimated thresholds for meaningful worsening were a decrease of 6-7 points on the PROMIS PF-SF and an increase of 2-3 points on NSCLC-SAQ.

conclusionsThis study is the first to examine longitudinal measurement properties of PROMIS PF-SF and investigates thresholds for meaningful change on the PROMIS PF-SF and NSCLC-SAQ measures. Results support the validity of these measures in NSCLC and aid the interpretation of clinically meaningful change in scores over time.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsPatient Reported Outcome MeasuresQuality of LifeAdultAgedFemaleHumansMaleMiddle AgedPsychometricsReproducibility of ResultsSurveys and QuestionnairesMeaningful within person changeNon-small cell lung cancerNSCLC-SAQPatient reported outcomePROMIS PF-SF

Identifiers

PMID39636512

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.