Development and content validity of a gastroparesis cardinal symptom index daily diary
Autor: | Dennis A. Revicki, N. J. Norton, Michael Camilleri, Andrew Palsgrove, B. Kuo, Lindsey Murray, Henry P. Parkman |
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Rok vydání: | 2009 |
Předmět: |
Adult
Male medicine.medical_specialty Gastroparesis Daily diary Severity of Illness Index Disability Evaluation Surveys and Questionnaires Content validity Medicine Humans Pharmacology (medical) In patient Hepatology Recall business.industry Gastroenterology Middle Aged Patient recall medicine.disease Surgery Gastric Emptying Research Design Mental Recall Physical therapy Female business Follow-Up Studies |
Zdroj: | Alimentary pharmacologytherapeutics. 30(6) |
ISSN: | 1365-2036 |
Popis: | The Gastroparesis Cardinal Symptom Index (GCSI) is a patient-reported outcome for gastroparesis using a two-week recall period. To minimize potential patient recall effects, a daily diary version of the GCSI (GCSI-DD) was developed.To evaluate the content validity of GCSI-DD for the symptoms in patients with documented gastroparesis, to capture symptom variability over time and to compare responses of this GCSI-DD to the original GCSI.In gastroparesis adults with delayed gastric emptying, cognitive debriefing interviews were conducted to elicit their perspective on relevant symptoms of gastroparesis and relevant recall periods and to evaluate patient understanding of GCSI-DD. Patients completed the GCSI-DD daily over a 2-week period and completed the GCSI at baseline and the 2-week follow-up visit.Twelve gastroparesis patients, of whom five were diabetic and nine women, reported nausea (100%), vomiting (100%), stomach fullness (75%), bloating (58%) and loss of appetite (50%) were important symptoms. All patients understood diary instructions and item content and reported that the diary captured their gastroparesis symptom experience; 83% considered response scales adequate. There was significant daily variability in GCSI-DD scores. Mean GCSI-DD subscale and total scores over 2 weeks correlated strongly (all r0.90) with GCSI scores at 2-week follow-up.The GCSI-DD includes symptoms relevant to patients with gastroparesis, captures daily variability of those symptoms and has psychometric properties consistent with a good patient-reported outcome endpoint for gastroparesis clinical trials. |
Databáze: | OpenAIRE |
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