Development, content validity, and cross‐cultural adaptation of a patient‐reported outcome measure for real‐time symptom assessment in irritable bowel syndrome

• DOI: 10.1111/nmo.13244
• Publication Date: 2017-11-06T06:32:50Z
• Authors: L. Vork; D. Keszthelyi; Z. Mujagic; J. W. Kruimel; C. Leue; I. Pontén; H. Törnblom; M. Simrén; A. Albu‐Soda; Q. Aziz; M. Corsetti; L. Holvoet; J. Tack; S. S. Rao; J. van Os; E. G. Quetglas; D. A. Drossman; A. A. M. Masclee
• Keywords: Cognitive interview; Prom; Content Validity; Patient-reported outcome; Interview

Abstract Background End‐of‐day questionnaires, which are considered the gold standard for assessing abdominal pain and other gastrointestinal ( GI ) symptoms in irritable bowel syndrome IBS ), influenced by recall ecological bias. The experience sampling method ESM is characterized random repeated assessments natural state environment of a subject, herewith overcomes these limitations. This report describes development patient‐reported outcome measure PROM based on principle, taking into account content validity cross‐cultural adaptation. Methods Focus group interviews with patients expert meetings international experts fields neurogastroenterology & motility were performed order to select items . Forward‐and‐back translation cognitive adapt instrument use different countries assure patients’ understanding final items. Key results revealed 42 items, categorized five domains: physical status, defecation, mood psychological factors, context environment, nutrition drug use. Experts reduced number 32 interviewing after resulted few slight adjustments regarding linguistic issues, but not Conclusions Inferences An ‐based , suitable momentary assessment symptom patterns was developed, will be implemented specifically designed smartphone application further validation multicenter setting follow.