dc.contributor.author | Kolotkin, Ronette Loganzo | |
dc.contributor.author | Williams, Valerie S L | |
dc.contributor.author | von Huth Smith, Lisa | |
dc.contributor.author | Meincke, Henrik H | |
dc.contributor.author | Qin, Shanshan | |
dc.contributor.author | Williams, Nicole | |
dc.contributor.author | Fehnel, Sheri E | |
dc.date.accessioned | 2021-10-18T09:15:24Z | |
dc.date.available | 2021-10-18T09:15:24Z | |
dc.date.created | 2021-07-28T09:11:00Z | |
dc.date.issued | 2021 | |
dc.identifier.citation | Kolotkin, R. L., Williams, V. S. L., von Huth Smith, L., Meincke, H. H., Qin, S., Williams, N., & Fehnel, S. E. (2021). Confirmatory psychometric evaluations of the Impact of Weight on Quality of Life–Lite Clinical Trials Version (IWQOL‐Lite‐CT). Clinical Obesity, 11(5), e12477. | en_US |
dc.identifier.issn | 1758-8103 | |
dc.identifier.uri | https://hdl.handle.net/11250/2823612 | |
dc.description.abstract | The Impact of Weight on Quality of Life–Lite Clinical Trials Version (IWQOL-Lite-CT) was developed to assess weight-related physical and psychosocial functioning in the context of clinical trials. Data from two pivotal trials of once-weekly subcutaneous semaglutide for the purpose of weight management (NCT03548935 and NCT03552757) were analysed to confirm the structure, reliability, validity, and responsiveness of the IWQOL-Lite-CT and evaluate the magnitude of meaningful within-patient change in patients with overweight or obesity, with and without type 2 diabetes. Factor analyses and inter-item correlations confirmed the IWQOL-Lite-CT structure and scoring algorithm. Each composite score (physical, physical function, psychosocial, and total) demonstrated excellent internal consistency (Cronbach's alphas ≥ 0.82) and test–retest reliability (intraclass correlation coefficients ≥ 0.85) in both trials. Patterns of cross-sectional and longitudinal construct validity correlations were generally consistent with hypotheses. Each of the IWQOL-Lite-CT composites was able to discriminate between known groups. Effect sizes and paired t tests comparing IWQOL-Lite-CT scores at baseline and Week 68 were statistically significant for all composites in both trials (P < 0.0001), providing strong support for the ability to detect change. Results of anchor-based analyses supported responder thresholds ranging from 13.5 to 16.6 across composite scores. The IWQOL-Lite-CT, a comprehensive assessment of weight-related functioning from the patient perspective, is appropriate for use in clinical trials evaluating the efficacy of new treatments for weight management. | en_US |
dc.language.iso | eng | en_US |
dc.publisher | Wiley | en_US |
dc.rights | Navngivelse 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/deed.no | * |
dc.title | Confirmatory psychometric evaluations of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) | en_US |
dc.type | Peer reviewed | en_US |
dc.type | Journal article | en_US |
dc.description.version | publishedVersion | en_US |
dc.rights.holder | © 2021 Novo Nordisk | en_US |
dc.subject.nsi | VDP::Medisinske Fag: 700::Helsefag: 800 | en_US |
dc.source.volume | 11 | en_US |
dc.source.journal | Clinical Obesity | en_US |
dc.source.issue | 5 | en_US |
dc.identifier.doi | 10.1111/cob.12477 | |
dc.identifier.cristin | 1922844 | |
dc.source.articlenumber | e12477 | en_US |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 1 | |