OBJECTIVES: Gastroparesis is a condition involving delayed gastric emptying when no mechanical obstruction is present. The ANMS GCSI-DD was developed to meet FDA recommendations for use as Patient Reported Outcome (PRO) endpoints in gastroparesis studies, including therapeutic trials. The purpose of this study was to determine if the appropriate symptoms are included in the instrument and to assess the content validity of the revised ANMS GCSI-DD in idiopathic (IG) and diabetic gastroparesis (DG) patients.

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 software.

RESULTS: Of 25 patients interviewed, 15 (60%) had IG and 10 (40%) DG. Consistent with other gastroparesis studies, mean age was 42.3 years (range: 20-70 years), and most patients were female (n=19, 76%) and Caucasian (n=19, 76%). 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%). Patients confirmed that the ANMS GCSI-DD content was comprehensive and reflective of their gastroparesis experience. Overall, patients found the instrument’s instructions, recall period, items, and response options clear and easy to understand.

CONCLUSIONS: Based on patient feedback, no changes to the ANMS GCSI-DD were recommended. The study results provide evidence supporting the content validity of the ANMS GCSI-DD for clinical trials and clinical care among IG or DG patients.