The content validity of the ANMS GCSI-DD in patients with idiopathic or diabetic gastroparesis

Revicki, Dennis A.; Lavoie, Sara; Speck, Rebecca M.; Puelles, Jorge; Kuo, Braden; Camilleri, Michael; Almansa, Cristina; Parkman, Henry P.

doi:10.1186/s41687-018-0081-2

Cited by 15 publications

(11 citation statements)

References 36 publications

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“…GCSI‐DD in particular was developed as a PRO endpoint for gastroparesis studies and clinical trials . It has been extensively validated and was determined to be easily understood by patients and to encompass the most important symptoms of gastroparesis.…”

Section: Discussionmentioning

confidence: 99%

Symptom variability throughout the day in patients with gastroparesis

Shahsavari

Jehangir

et al. 2019

Neurogastroenterology Motil

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Gastroparesis (Gp) is a chronic symptomatic motility disorder of the stomach manifested by delayed gastric emptying. 1 Despite delay of gastric emptying defining gastroparesis, poor correlation exists between symptoms and degree of gastric emptying. 2Recently, on evaluating studies using optimal gastric emptying test methodology, associations were seen between delayed gastric emptying with nausea, vomiting, abdominal pain, and early satiety/fullness. 3 Abstract Background: Symptoms of gastroparesis (Gp) can fluctuate at different times of the day. Our aims are (1) To characterize Gp symptom variability throughout the day and in relation to meals and (2) to compare the daily symptom variability in subtypes of Gp-diabetic gastroparesis (DGp) and idiopathic gastroparesis (IGp). Methods: Patients with Gp filled Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM) and completed a modified GCSI-DD seven times a day (GCSI-Throughout the Day [GCSI-TTD]; before and after meals, and before going to bed) over a 2-week period. Key Results: A total of 44 patients participated (86% females), including 29 (66%) with IGp, 13 (30%) with DGp, and 2 (4%) with postsurgical Gp. Using the GCSI-TTD, patients with Gp reported significant postprandial worsening of overall symptom severity, as well as severities of nausea, early satiety, stomach fullness, and abdominal pain. Patients also had progressive worsening of the overall symptom severity, early satiety, stomach fullness, and abdominal pain during the day; however, nausea severity did not differ during the day. Number of vomiting and retching episodes did not show significant variations postprandially or during the day. Patients with IGp had greater symptom severity throughout the day and greater postprandial increase in symptoms compared to patients with DGp. Conclusions and Inferences: Patients with Gp experience postprandial worsening of overall symptom severity, as well as severities of nausea, early satiety, stomach fullness, and abdominal pain. These symptoms also progressively worsen during the day, except for the severity of nausea which persists throughout the day. Understanding the symptom variability in patients with Gp throughout the day and postprandially may be useful in treatment of patients with Gp.

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Section: Discussionmentioning

confidence: 99%

Symptom variability throughout the day in patients with gastroparesis

Shahsavari

Jehangir

et al. 2019

Neurogastroenterology Motil

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“…This scale was based on the American Neurogastroenterology Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD), which has 5 questions rated on a 0-4 scale and has been previously validated in patients with idiopathic and diabetic gastroparesis. 12 Consistent with the GCSI-DD available through the Mapi Research Trust (Lyon, France) and the 2-week GCSI site-based questionnaire, the GCSDD allowed patients to select the category very mild, which is missing from the updated ANMS GCSI-DD.…”

Section: Assessmentsmentioning

confidence: 99%

“…The PAGI-SYM was developed to measure symptom severity for gastroparesis, functional dyspepsia, and gastroesophageal reflux disease. 12 The measure consists of 20 symptom severity items, which cover the following domains: nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, heartburn/regurgitation, and lower abdominal pain. The questionnaire uses a 0-5-point Likert scale from 0 (none) to 5 (very severe) and includes the GCSI.…”

Section: Supplementary Materialsmentioning

confidence: 99%

Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial

et al. 2021

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“…The GCSDD daily symptom diary asked patients to rate the worst occurrence of each cardinal symptom of gastroparesis in the past 24 hours on a 0 (no symptoms) to 5 (very severe) scale. This scale was based off of the ANMS GCSI-DD which has 5 questions rated on a 0-4 scale and has been previously validated in idiopathic and diabetic gastroparesis patients 15 . Consistent with the GCSI-DD available through the Mapi Research Trust (Lyon, France) and the 2-week GCSI site-based questionnaire, the GCSDD allowed patients to select the category "very mild" which is missing from the updated ANMS GCSI-DD.…”

Section: Assessmentsmentioning

confidence: 99%

Efficacy and Safety of Tradipitant in Diabetic and Idiopathic Gastroparesis: A Randomized, Placebo-Controlled Study

Carlin

Lieberman

Dahal

et al. 2020

Preprint

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Background and Aims: There is a high unmet need for the treatment of gastroparesis and studies of NK1-R antagonists suggest potential benefit in reducing the symptoms of nausea and vomiting. We hypothesized that tradipitant, an NK1-R antagonist, would be effective in treating patients with idiopathic or diabetic gastroparesis. Methods: In a randomized, double-blind, placebo-controlled study across 47 U.S. sites, 152 gastroparesis patients were randomized to receive oral 85mg BID tradipitant (n=77) or placebo (n=75) daily for four weeks. Symptoms were assessed using a daily symptom dairy, Gastroparesis Cardinal Symptom Index (GCSI), and other patient reported questionnaires. Results: Patients receiving tradipitant had a significant decrease in nausea score at Week 4 compared to placebo (-1.2 improvement vs -0.7, respectively, p=0.0099), and a significant increase in nausea-free days (28.8% increase on tradipitant vs 15.0% on placebo p=0.0160). Patients with both nausea and vomiting at baseline (n=101) showed an even greater decrease in nausea score (-1.4 improvement on tradipitant vs -0.4 on placebo p<0.0001) and an increase in nausea free days (32.3% improvement on tradipitant vs 7.6% on placebo p=0.0003). 32.9% of patients treated with tradipitant were nausea responders (average nausea score ≤ 1 at week 4) compared to 11.8% of patients on placebo (p=0.0013). 46.6% of patients treated with tradipitant had a greater than 1-point improvement in GCSI score compared to 23.5% of patients on placebo (p=0.0053). Conclusions: Tradipitant treatment resulted in statistically and clinically meaningful improvements in nausea and overall gastroparesis symptoms. These robust efficacy results suggest tradipitant has the potential to become a useful pharmacological treatment for gastroparesis.

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The content validity of the ANMS GCSI-DD in patients with idiopathic or diabetic gastroparesis

Cited by 15 publications

References 36 publications

Symptom variability throughout the day in patients with gastroparesis

Symptom variability throughout the day in patients with gastroparesis

Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial

Efficacy and Safety of Tradipitant in Diabetic and Idiopathic Gastroparesis: A Randomized, Placebo-Controlled Study

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