Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2025
Meaningful change threshold estimation for the non-small cell lung cancer symptom assessment questionnaire (NSCLC-SAQ): psychometric analysis from a phase 3 trial (LIBRETTO-431).
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 2 papers.
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.
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.
Who cites it
2 citing papers in PubMed.
- First-Line Selpercatinib or Chemotherapy and Pembrolizumab inThe New England journal of medicine · 2023Trial
- Patient-Reported Outcomes From LIBRETTO-431: First-Line Selpercatinib Versus Chemotherapy With Pembrolizumab inJTO clinical and research reports · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
purposeMeaningful change thresholds are important to help interpret patient-reported outcome scores. To date, meaningful within-patient change (MWPC) thresholds have only been proposed for NSCLC-SAQ total score. This study proposed clinically MWPC thresholds, and group-level minimal important change/difference (MIC/MID) thresholds for both improvement and worsening for the Non-Small Cell Lung Cancer- Symptom Assessment Questionnaire (NSCLC-SAQ) total and symptom scores.
methodsBlinded patient data (N = 246) from the Phase 3 LIBRETTO-431 clinical trial were used in a pre-specified meaningful change analysis. A combination of anchor- and supportive distribution-based methods were used to estimate the MWPC, MIC, and MID thresholds. Triangulation across anchor estimates was then performed using a correlation-weighted average to provide a single MWPC, MIC, and MID estimate for improvement and worsening.
resultsNSCLC-SAQ total score and symptom scores showed moderate to high correlations with various anchors (ranging from 0.306 to 0.890), with threshold estimates being provided from multiple anchors (except for cough). Triangulation suggested MWPC, MIC, and MID thresholds for improved total score were - 2.5, -3.5, and - 2.0, respectively. For worsening, the proposed thresholds were 2.0, 0.5, and 2.0, respectively. The MWPC, MIC, and MID thresholds for improved symptom scores ranged from - 0.5 to -1.5, and the worsening thresholds for symptom scores ranged from 0.5 to 1.0.
conclusionThis study provides the first worsening and improvement estimates of MWPC, MIC, and MID for NSCLC-SAQ total and symptom scores. The thresholds proposed in this study can be used to inform interpretation of NSCLC-SAQ scores in clinical trials.
Indexed as
Identifiers
39847268What OpenQuestion holds
Registered trials
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.