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).
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| Title: | 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). |
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| Authors: | Clarke, Nathan (AUTHOR), Worthy, Gill (AUTHOR), Payakachat, Nalin (AUTHOR), Gilligan, Adrienne M. (AUTHOR), Cocks, Kim (AUTHOR) |
| Source: | Quality of Life Research. Apr2025, Vol. 34 Issue 4, p1137-1146. 10p. |
| Subjects: | Non-small-cell lung carcinoma, Patient reported outcome measures, Symptoms, Health outcome assessment, Psychometrics, Clinical trials |
| Abstract: | Purpose: Meaningful 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. Methods: Blinded 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. Results: NSCLC-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. Conclusion: This 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. [ABSTRACT FROM AUTHOR] |
| Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 184382948 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Clarke%2C+Nathan%22">Clarke, Nathan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Worthy%2C+Gill%22">Worthy, Gill</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Payakachat%2C+Nalin%22">Payakachat, Nalin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gilligan%2C+Adrienne+M%2E%22">Gilligan, Adrienne M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cocks%2C+Kim%22">Cocks, Kim</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Quality+of+Life+Research%22">Quality of Life Research</searchLink>. Apr2025, Vol. 34 Issue 4, p1137-1146. 10p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Non-small-cell+lung+carcinoma%22">Non-small-cell lung carcinoma</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+reported+outcome+measures%22">Patient reported outcome measures</searchLink><br /><searchLink fieldCode="DE" term="%22Symptoms%22">Symptoms</searchLink><br /><searchLink fieldCode="DE" term="%22Health+outcome+assessment%22">Health outcome assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Psychometrics%22">Psychometrics</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Purpose: Meaningful 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. Methods: Blinded 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. Results: NSCLC-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. Conclusion: This 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. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=184382948 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s11136-025-03895-1 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 10 StartPage: 1137 Subjects: – SubjectFull: Non-small-cell lung carcinoma Type: general – SubjectFull: Patient reported outcome measures Type: general – SubjectFull: Symptoms Type: general – SubjectFull: Health outcome assessment Type: general – SubjectFull: Psychometrics Type: general – SubjectFull: Clinical trials Type: general Titles: – TitleFull: 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). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Clarke, Nathan – PersonEntity: Name: NameFull: Worthy, Gill – PersonEntity: Name: NameFull: Payakachat, Nalin – PersonEntity: Name: NameFull: Gilligan, Adrienne M. – PersonEntity: Name: NameFull: Cocks, Kim IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 04 Text: Apr2025 Type: published Y: 2025 Identifiers: – Type: issn-print Value: 09629343 Numbering: – Type: volume Value: 34 – Type: issue Value: 4 Titles: – TitleFull: Quality of Life Research Type: main |
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