Validation of the Leuven Postprandial Distress Scale, a questionnaire for symptom assessment in the functional dyspepsia/postprandial distress syndrome

Autor:	Florencia Carbone, Michael P. Jones, Tim Vanuytsel, Lieselot Holvoet, L. Van Oudenhove, Jan Tack, A. Vandenberghe
Rok vydání:	2016
Předmět:	Adult Male medicine.medical_specialty Gastrointestinal Diseases Severity of Illness Index 03 medical and health sciences 0302 clinical medicine Double-Blind Method Surveys and Questionnaires Severity of illness Content validity medicine Humans Pharmacology (medical) Dyspepsia Aged Hepatology business.industry Gastroenterology Reproducibility of Results Construct validity Syndrome Middle Aged Itopride Postprandial Period Distress Postprandial Convergent validity 030220 oncology & carcinogenesis Scale (social sciences) Physical therapy Female 030211 gastroenterology & hepatology Symptom Assessment business medicine.drug
Zdroj:	Alimentary Pharmacology & Therapeutics. 44:989-1001
ISSN:	0269-2813
Popis:	SummaryBackground A validated patient-reported outcome instrument is lacking for the functional dyspepsia/postprandial distress syndrome. Aim To validate the Leuven Postprandial Distress Scale (LPDS). Methods The LPDS diary, comprising eight symptoms with verbal descriptors rated for severity (0–4), was derived from focus groups and cognitive debriefing. It was used in a 2-week run-in, 8-week double-blind placebo-controlled trial of itopride 100 mg t.d.s. Results in 60 patients, with concealed treatment allocation, were used to analyse LPDS content validity, consistency, reliability and responsiveness. Patients also filled out Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM), Nepean Dyspepsia Index, overall treatment evaluation and overall symptom severity questionnaires. Construct validity was evaluated by known-group analyses and by correlating LPDS with these additional questionnaires. Minimum Clinically Important Difference was determined from threshold changes in anchor questionnaires. Results Symptom patterns and factor analysis identified three cardinal symptoms of postprandial distress syndrome (early satiation, postprandial fullness, upper abdominal bloating), whose mean intensities generate weekly LPDS scores. Known-groups analysis showed large-effect-size differences in LPDS scores (Cohen's d = 2.16). Strong correlations (r > 0.57) between LPDS scores and relevant anchors at baseline indicate good convergent validity. Internal consistency of LPDS was good (α > 0.85) with high inter-item correlations (0.67–0.76), and test–retest reliability (r = 0.85). Changes in LPDS scores were highly convergent with changes in overall treatment evaluation, overall symptom severity and PAGI-SYM (r > 0.52). minimum clinically important difference analysis generated thresholds of 0.4-0.6. Conclusions The Leuven Postprandial Distress Scale, which is supported by the European Medicines Agency, is a sensitive and reliable patient-reported outcome instrument to assess symptoms in the functional dyspepsia/postprandial distress syndrome.
Databáze:	OpenAIRE
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