BACKGROUND: 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. AIMS: 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. METHODS: 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. RESULTS: 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 r > 0.90) with GCSI scores at 2-week follow-up. CONCLUSIONS: 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.
BACKGROUND: 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. AIMS: 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. METHODS: 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. RESULTS: Twelve gastroparesispatients, 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 r > 0.90) with GCSI scores at 2-week follow-up. CONCLUSIONS: 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.
Authors: H P Parkman; M Camilleri; G Farrugia; R W McCallum; A E Bharucha; E A Mayer; J F Tack; R Spiller; M Horowitz; A I Vinik; J J Galligan; P J Pasricha; B Kuo; L A Szarka; L Marciani; K Jones; C R Parrish; P Sandroni; T Abell; T Ordog; W Hasler; K L Koch; K Sanders; N J Norton; F Hamilton Journal: Neurogastroenterol Motil Date: 2009-12-09 Impact factor: 3.598
Authors: Michael D Crowell; Sarah B Umar; Brian E Lacy; Michael P Jones; John K DiBaise; Nicholas J Talley Journal: Dig Dis Sci Date: 2015-04-05 Impact factor: 3.199
Authors: John H Rodriguez; Ivy N Haskins; Andrew T Strong; Ryan L Plescia; Matthew T Allemang; Robert S Butler; Michael S Cline; Kevin El-Hayek; Jeffrey L Ponsky; Matthew D Kroh Journal: Surg Endosc Date: 2017-05-31 Impact factor: 4.584
Authors: Subhankar Chakraborty; Magnus Halland; Duane Burton; Anshuman Desai; Bridget Neja; Phillip Low; Wolfgang Singer; Michael Camilleri; Alan R Zinsmeister; Adil E Bharucha Journal: J Clin Endocrinol Metab Date: 2019-06-01 Impact factor: 5.958
Authors: Pankaj J Pasricha; Katherine P Yates; Irene Sarosiek; Richard W McCallum; Thomas L Abell; Kenneth L Koch; Linda Anh B Nguyen; William J Snape; William L Hasler; John O Clarke; Sameer Dhalla; Ellen M Stein; Linda A Lee; Laura A Miriel; Mark L Van Natta; Madhusudan Grover; Gianrico Farrugia; James Tonascia; Frank A Hamilton; Henry P Parkman Journal: Gastroenterology Date: 2017-10-28 Impact factor: 22.682