Yaozhu J Chen, Karin S Coyne, Danielle Rodriguez, Andrea Schulz, Susanna Y Huh, Braden Kuo, Michael Camilleri, Jan Tack, Henry P Parkman
{"title":"美国神经胃肠病学与胃动力学会胃痉挛症状指数--每日日记（ANMS GCSI-DD）：特发性或糖尿病胃瘫患者的心理计量验证和有意义变化阈值。","authors":"Yaozhu J Chen, Karin S Coyne, Danielle Rodriguez, Andrea Schulz, Susanna Y Huh, Braden Kuo, Michael Camilleri, Jan Tack, Henry P Parkman","doi":"10.1111/nmo.14960","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) is a patient-reported outcome (PRO) instrument for gastroparesis. This study evaluated the psychometric properties of the ANMS GCSI-DD and determined a meaningful change threshold using the data from a phase 2b trial in adults with moderate-to-severe idiopathic or diabetic gastroparesis (DG).</p><p><strong>Methods: </strong>The psychometric properties of ANMS GCSI-DD were analyzed using other clinician- and patient-reported outcomes from 242 patients during the 12-week trial. Trial exit interviews were conducted in a cohort of 32 patients to capture their perspectives on meaningful change from the trial.</p><p><strong>Results: </strong>ANMS GCSI-DD demonstrated good performance: unidimensionality scores exhibited good fit; internal consistency reliability was >0.70; test-retest reliability was above 0.90, and convergent validity showed strong correlations (0.70-0.90) with overall severity rating and moderate correlations (0.30-0.70) with other outcomes. ANMS GCSI-DD scores discriminated among groups with varying severity of gastroparesis symptoms in known-groups validity (p < 0.001) and were responsive to symptom improvement. Triangulation of the quantitative anchor-based estimates of 0.9-1.4 category points as a meaningful change in the ANMS GCSI-DD composite score, and the qualitative exit interview findings of 0.5-1.5 as meaningful change, supports a one-point change on a five-point scale (0-4) as the meaningful change threshold.</p><p><strong>Conclusion: </strong>The ANMS GCSI-DD is a reliable and valid PRO instrument to employ in clinical development for patients with moderate-to-severe idiopathic or DG, and a one-point score change in the ANMS GCSI-DD composite score is recommended as a meaningful change threshold of symptom change.</p>","PeriodicalId":19123,"journal":{"name":"Neurogastroenterology and Motility","volume":" ","pages":"e14960"},"PeriodicalIF":3.5000,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD): Psychometric validation and meaningful change threshold in patients with idiopathic or diabetic gastroparesis.\",\"authors\":\"Yaozhu J Chen, Karin S Coyne, Danielle Rodriguez, Andrea Schulz, Susanna Y Huh, Braden Kuo, Michael Camilleri, Jan Tack, Henry P Parkman\",\"doi\":\"10.1111/nmo.14960\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) is a patient-reported outcome (PRO) instrument for gastroparesis. This study evaluated the psychometric properties of the ANMS GCSI-DD and determined a meaningful change threshold using the data from a phase 2b trial in adults with moderate-to-severe idiopathic or diabetic gastroparesis (DG).</p><p><strong>Methods: </strong>The psychometric properties of ANMS GCSI-DD were analyzed using other clinician- and patient-reported outcomes from 242 patients during the 12-week trial. Trial exit interviews were conducted in a cohort of 32 patients to capture their perspectives on meaningful change from the trial.</p><p><strong>Results: </strong>ANMS GCSI-DD demonstrated good performance: unidimensionality scores exhibited good fit; internal consistency reliability was >0.70; test-retest reliability was above 0.90, and convergent validity showed strong correlations (0.70-0.90) with overall severity rating and moderate correlations (0.30-0.70) with other outcomes. ANMS GCSI-DD scores discriminated among groups with varying severity of gastroparesis symptoms in known-groups validity (p < 0.001) and were responsive to symptom improvement. Triangulation of the quantitative anchor-based estimates of 0.9-1.4 category points as a meaningful change in the ANMS GCSI-DD composite score, and the qualitative exit interview findings of 0.5-1.5 as meaningful change, supports a one-point change on a five-point scale (0-4) as the meaningful change threshold.</p><p><strong>Conclusion: </strong>The ANMS GCSI-DD is a reliable and valid PRO instrument to employ in clinical development for patients with moderate-to-severe idiopathic or DG, and a one-point score change in the ANMS GCSI-DD composite score is recommended as a meaningful change threshold of symptom change.</p>\",\"PeriodicalId\":19123,\"journal\":{\"name\":\"Neurogastroenterology and Motility\",\"volume\":\" \",\"pages\":\"e14960\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2024-11-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neurogastroenterology and Motility\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/nmo.14960\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurogastroenterology and Motility","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/nmo.14960","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD): Psychometric validation and meaningful change threshold in patients with idiopathic or diabetic gastroparesis.
Introduction: The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) is a patient-reported outcome (PRO) instrument for gastroparesis. This study evaluated the psychometric properties of the ANMS GCSI-DD and determined a meaningful change threshold using the data from a phase 2b trial in adults with moderate-to-severe idiopathic or diabetic gastroparesis (DG).
Methods: The psychometric properties of ANMS GCSI-DD were analyzed using other clinician- and patient-reported outcomes from 242 patients during the 12-week trial. Trial exit interviews were conducted in a cohort of 32 patients to capture their perspectives on meaningful change from the trial.
Results: ANMS GCSI-DD demonstrated good performance: unidimensionality scores exhibited good fit; internal consistency reliability was >0.70; test-retest reliability was above 0.90, and convergent validity showed strong correlations (0.70-0.90) with overall severity rating and moderate correlations (0.30-0.70) with other outcomes. ANMS GCSI-DD scores discriminated among groups with varying severity of gastroparesis symptoms in known-groups validity (p < 0.001) and were responsive to symptom improvement. Triangulation of the quantitative anchor-based estimates of 0.9-1.4 category points as a meaningful change in the ANMS GCSI-DD composite score, and the qualitative exit interview findings of 0.5-1.5 as meaningful change, supports a one-point change on a five-point scale (0-4) as the meaningful change threshold.
Conclusion: The ANMS GCSI-DD is a reliable and valid PRO instrument to employ in clinical development for patients with moderate-to-severe idiopathic or DG, and a one-point score change in the ANMS GCSI-DD composite score is recommended as a meaningful change threshold of symptom change.
期刊介绍：
Neurogastroenterology & Motility (NMO) is the official Journal of the European Society of Neurogastroenterology & Motility (ESNM) and the American Neurogastroenterology and Motility Society (ANMS). It is edited by James Galligan, Albert Bredenoord, and Stephen Vanner. The editorial and peer review process is independent of the societies affiliated to the journal and publisher: Neither the ANMS, the ESNM or the Publisher have editorial decision-making power. Whenever these are relevant to the content being considered or published, the editors, journal management committee and editorial board declare their interests and affiliations.
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