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Quality of Life Research

05-12-2024

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

Auteurs: Carrie R. Houts, Andrea Savord, Molly J. Gardner, Maria Mattera, John Devin Peipert, Trishala Agrawal, Mahadi Baig, Praveen Barala, Joshua Bauml, Brooke Diorio, Angela Girvin, Jan Sermon, Sujay Shah, Monica Withelder, Honeylet Wortman-Vayn, Julia Schuchard

Gepubliceerd in: Quality of Life Research

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Abstract

Purpose

Physical 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).

Methods

Data 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.

Results

Both 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.

Conclusions

This 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.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Voetnoten
1
Full qualification package for the NSCLC-SAQ is available for review at https://​fda.​force.​com/​ddt/​s/​ddt-project?​ddtprojectid=​6.
 
2
While the PROMIS PF-SF 8c was administered in both PAPILLON and MARIPOSA-2, the psychometric work presented here uses only the PAPILLON dataset for the PROMIS PF-SF 8c, as those data were available before MARIPOSA-2. The NSCLC-SAQ was only administered in MARIPOSA-2.
 
3
Clarke et al. [21] examined patients with locally advanced or metastatic RET fusion positive, non-squamous NSCLC receiving the study intervention as first-line treatment.
 
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Metagegevens
Titel
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
Auteurs
Carrie R. Houts
Andrea Savord
Molly J. Gardner
Maria Mattera
John Devin Peipert
Trishala Agrawal
Mahadi Baig
Praveen Barala
Joshua Bauml
Brooke Diorio
Angela Girvin
Jan Sermon
Sujay Shah
Monica Withelder
Honeylet Wortman-Vayn
Julia Schuchard
Publicatiedatum
05-12-2024
Uitgeverij
Springer New York
Gepubliceerd in
Quality of Life Research
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-024-03846-2