ArticleCurrent therapeutic research, clinical and experimental2021
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire: Psychometric Performance and Regulatory Qualification of a Novel Patient-Reported Symptom Measure.
Article in Current therapeutic research, clinical and experimental, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07631299 (Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer), which is not on this map. Cited by 11 papers.
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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.
Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer (NSCLC)
Who cites it
11 citing papers in PubMed.
- 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).Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Trial
- 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.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Trial
- Developing a fit-for-purpose composite symptom score as a symptom burden endpoint for clinical trials in patients with malignant pleural mesothelioma.Scientific reports · 2024Trial
- Are we reporting well enough? A systematic survey of missing data in patient-reported outcomes from non-small cell lung cancer randomized trials.Health and quality of life outcomes · 2026Article
- Patient-Reported Symptoms and Quality of Life With Sacituzumab Govitecan Versus Docetaxel in Metastatic NSCLC: The Phase 3, Randomized EVOKE-01 Trial.JTO clinical and research reports · 2026Article
- Assessment of patient-reported symptom and psychological distress after neoadjuvant chemo-immunotherapy and lung resection for non-small cell lung cancer.Interdisciplinary cardiovascular and thoracic surgery · 2026Article
- Intelligence Architectures and Machine Learning Applications in Contemporary Spine Care.Bioengineering (Basel, Switzerland) · 2025Review
- Patient-Reported Outcomes From LIBRETTO-431: First-Line Selpercatinib Versus Chemotherapy With Pembrolizumab inJTO clinical and research reports · 2025Article
- Osimertinib-chemotherapy synergy inTranslational cancer research · 2025Article
- Comparing patient global impression of severity and patient global impression of change to evaluate test-retest reliability of depression, non-small cell lung cancer, and asthma measures.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Article
- Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): Measurement Properties and Estimated Clinically Meaningful Thresholds From a Phase 3 Study.JTO clinical and research reports · 2022Article
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7 authors.
Funding
Abstract
backgroundThe Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) was developed to incorporate the patient's perspective into evaluation of clinical benefit in advanced non-small cell lung cancer trials and meet regulatory expectations for doing so. Qualitative evidence supported 7 items covering 5 symptom concepts.
objectiveThis study evaluated measurement properties of the NSCLC-SAQ's items, overall scale, and total score.
methodsIn this observational cross-sectional study, a purposive sample of patients with clinician-diagnosed advanced non-small cell lung cancer, initiating or undergoing treatment, provided sociodemographic information and completed the NSCLC-SAQ, National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lung Symptom Index (FLSI-17), and a Patient Global Impression of Severity item. Rasch analyses, factor analyses, and assessments of construct validity and reliability were completed.
resultsThe 152 participants had a mean age of 64 years, 57% were women, and 87% where White. The majority were Stage IV (83%), 51% had an Eastern Cooperative Oncology Group performance status of 1 (32% performance status 0 and 17% performance status 2), and 33% were treatment naïve. Rasch analyses showed ordered thresholds for response options. Factor analyses demonstrated that items could be combined for a total score. Internal consistency (Cronbach α = 0.78) and test-retest reliability (intraclass correlation coefficient = 0.87) were quite satisfactory. NSCLC-SAQ total score correlation was 0.83 with the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lung Symptom Index-17. The NSCLC-SAQ was able to differentiate between symptom severity levels and performance status (both
conclusionsThe NSCLC-SAQ generated highly reliable scores with substantial evidence of construct validity. The Food and Drug Administration's qualification supports the NSCLC-SAQ as a measure of symptoms in drug development. Further evaluation is needed on its longitudinal measurement properties and interepretation of meaningful within-patient score change. (Curr Ther Res Clin Exp. 2021; 82:XXX-XXX).
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