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


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 nonresponder 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.

SUBMITTER: Jung K 

PROVIDER: S-EPMC8748857 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Jung Kyoungwon K   Jung Hye-Kyung HK   Kwon Joong Goo JG   Tae Chung Hyun CH   Bang Ki Bae KB   Park Jong Kyu JK   Lee Ju Yup JY   Shin Cheol Min CM   Oh Jung Hwan JH   Song Kyung Ho KH   Lee Oh Young OY   Choi Myung-Gyu MG  

Journal of neurogastroenterology and motility 20220101 1


<h4>Background/aims</h4>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).<h4>Methods</h4>A self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) was developed and validated through a structure  ...[more]

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