title: [Development and validation of QPD 32, a specific questionnaire for measuring the quality of life of patients with peptic ulcer].
abstract: Drugs need to be evaluated both in terms of efficacy, safety and regarding the patient's perception of his own health status. For these reasons, sensible, reliable and patient-oriented instruments are needed, besides the methodologies for evaluation of drug efficacy and safety. Such instruments substantially evaluate Health related Quality of Life (HrQoL). Concerning gastric acid hypersecretion few papers are available, based on HrQoL questionnaires, both general and specific. A research project led us to develop through patients and physicians involvement, a specific instrument to evaluate HrQoL as to the various aspects of the peptic disease. The project started in 1993 through a series of 4 focus groups with gastroenterologists and patients, followed by the preparation of a questionnaire named QPD48. Such instrument was psychometrically validated through a study named Herqules 1, involving 176 gastroenterologists and 1774 patients. The psychometric analysis on QPD48 led to the re-issue of a questionnaire named QPD32 with Chronbach's alfa equal to 0.91, based on 3 factor-referenced subscales evaluating pain, induced anxiety, constrained daily living and awareness of symptoms and agents. Concerning the concurrent validity a one-way analysis of variance showed highly significant differences associated with attack frequency with substantial effect sizes ranging from 0.46 to 1.27 of a standard deviation in the full scale. QPD 32 is patent protected and will be used in clinical trials.
authors.affiliation: Medical Department Glaxo SpA, Verona.
authors.forename: G
authors.initials: G
authors.lastname: De Carli
authors.forename: S H
authors.initials: SH
authors.lastname: Irvine
authors.forename: F
authors.initials: F
authors.lastname: Arpinelli
authors.forename: F
authors.initials: F
authors.lastname: Bamfi
authors.forename: A
authors.initials: A
authors.lastname: Olivieri
authors.forename: G
authors.initials: G
authors.lastname: Recchia
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000523:psychology; D010437:Peptic Ulcer / Q000523:psychology; D011594:Psychometrics; D011788:Quality of Life; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires
vernacular_title: Sviluppo e validazione di un questionario specifico per la misurazione della qualità della vita nei pazienti con malattia peptica: QPD 32.