Development and Validity Assessment of a Self-evaluation Questionnaire for Functional Dyspepsia: A Multicenter Prospective Study in Korea

Kyoungwon Jung, Hye Kyung Jung, Joong Goo Kwon, Chung Hyun Tae, Ki Bae Bang, Jong Kyu Park, Ju Yup Lee, Cheol Min Shin, Jung Hwan Oh, Kyung Ho Song, Oh Young Lee, Myung Gyu Choi

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Background/Aims Patient-reported outcomes (PROs) are essential for clinical decision making, conduction of clinical research, and drug application acquisition in functional gastrointestinal disorders. The aim of this study is to develop a PRO instrument and to determine the respondents’ perception of the efficacy of therapeutic agents for functional dyspepsia (FD). Methods A self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) was developed and validated through a structured process. The 2-week reproducibility was evaluated, and the construct validity was assessed by correlating the scores of SEQ-DYSPEPSIA (including typical and major FD symptom subscales). Finally, the response to medication was assessed by comparing the changes after 4 weeks of treatment. Results A total of 193 Korean patients (age 48.5 ± 13.6 years, 69.4% women) completed the questionnaire. SEQ-DYSPEPSIA with 11 items had a good internal consistency (alpha = 0.770-0.905) and an acceptable test-retest reliability (intraclass correlation coefficient = 0.733-0.859). The self-evaluation questionnaire (SEQ)-major FD score highly correlated with the postprandial fullness/early satiety domain of the Patient Assessment of Gastrointestinal Symptom Severity Index (correlation coefficient r = 0.741, P < 0.001), Nepean Dyspepsia Index-Korean version (NDI-K) (r = 0.839, P < 0.001), and NDI-K quality of life (r = −0.275 to −0.344, P < 0.001). After medical treatment, decrease in the SEQ-typical FD and SEQ-major FD was significantly greater in the responder group than in non-responder group (P = 0.019 and P = 0.009, respectively). Conclusion This study suggests that the Korean version of SEQ-DYSPEPSIA has good reliability and validity, and can be a useful PRO measurement tool in patients with FD.

Original languageEnglish
Pages (from-to)111-120
Number of pages10
JournalJournal of Neurogastroenterology and Motility
Volume28
Issue number1
DOIs
StatePublished - Jan 2022

Bibliographical note

Funding Information:
Financial support: This research was supported by a grant of

Publisher Copyright:
© 2022 The Korean Society of Neurogastroenterology and Motility

Keywords

  • Dyspepsia
  • Patient outcome assessment
  • Surveys and questionnaires
  • Validation study

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