Development and psychometric evaluation of the Diabetic Gastroparesis Symptom Severity Diary.

ABSTRACT:

Background

Diabetic gastroparesis (DG) is defined as delayed gastric emptying with associated gastrointestinal symptoms, without mechanical obstruction. Patient-reported symptoms are critical for diagnosis and evaluation of treatment benefit in DG. The Diabetic Gastroparesis Symptom Severity Diary (DGSSD), a new patient-reported outcome measure, was developed for use in clinical trials to support product approval and labeling claims for DG treatments.

Materials and methods

Initial DGSSD development was based on a review of the existing instruments and qualitative research (focus groups and cognitive debriefing interviews) in 41 patients with DG. Psychometric evaluations (individual items and composite scores) were conducted using data from Phase IIa and IIb relamorelin clini

SUBMITTER: Fehnel S 

PROVIDER: S-EPMC6390855 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature