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J Patient Rep Outcomes. 2018 Dec 13;2(1):61. doi: 10.1186/s41687-018-0081-2.

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

Author information

1
Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, MD, 20814, USA. dennis.revicki@evidera.com.
2
Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, MD, 20814, USA.
3
Takeda Pharmaceuticals, 61 Aldwych, London, WC2B 4AE, UK.
4
Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
5
Mayo Clinic, 200, 1st Street SW, Rochester, MN, 55905, USA.
6
Takeda Pharmaceuticals, 35 Lansdowne Street, Cambridge, MA, 02139, USA.
7
Temple University Hospital, 3401 N Broad Street, #1003, Philadelphia, PA, 19140, USA.

Abstract

BACKGROUND:

The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) was developed to meet Food and Drug Administration (FDA) recommendations for patient-reported outcome (PRO) endpoints in gastroparesis studies, including therapeutic trials. The current version of the ANMS GCSI-DD contains five items pertaining to nausea, early satiety, post-prandial fullness, upper abdominal pain, and vomiting. The specific aims of this study were to determine if the appropriate symptoms are included in the ANMS GCSI-DD and to assess the content validity in patients with idiopathic (IG) and diabetic gastroparesis (DG).

METHODS:

Patients diagnosed with IG or DG were recruited by five clinical sites in the United States for a cross-sectional, qualitative study involving one-on-one in-person concept elicitation and cognitive debriefing interviews. Concept elicitation included open-ended questions to elicit patients' symptoms and impacts of gastroparesis, while cognitive debriefing was designed to assess the comprehensiveness of the ANMS GCSI-DD and clarity of the instructions, items, and response scales. The interviews were audio-recorded and transcribed. Transcripts were analyzed using a content analysis approach with ATLAS.ti.

RESULTS:

Of 25 patients interviewed, 15 (60%) had IG and 10 (40%) DG. Mean age of the sample was 42.3 years (range: 20-70 years), and most patients were female (n = 19, 76%) and white (n = 19, 76%). During concept elicitation, patients endorsed the following signs and symptoms as relevant and important to their condition: early satiety (n = 25, 100%), post-prandial fullness (n = 25, 100%), nausea (n = 22, 88%), upper abdominal pain (n = 18, 72%), vomiting (n = 15, 60%), and bloating (n = 11, 44%). Many patients (n = 20, 80%) experienced day-to-day symptom change. During cognitive debriefing, patients confirmed the ANMS GCSI-DD content was comprehensive and reflective of their gastroparesis experience. Patients could easily select a response option and describe how they arrived at their answers. Overall, patients found the instrument's instructions, recall period, items, and response options clear and understandable.

CONCLUSIONS:

The ANMS GCSI-DD was easily understood, found to contain the most important symptoms for patients with IG and DG, and no changes were recommended. Results support the content validity of the ANMS GCSI-DD for clinical trials and clinical care among IG or DG patients.

KEYWORDS:

Content validity; Gastroparesis; HRQL; Patient-reported outcome; Qualitative; Symptoms

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