title: Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL™) scale.
abstract: OBJECTIVE
  Subjects with short bowel syndrome (SBS) have impaired quality of life (QoL). No disease-specific instrument has been available to measure treatment-induced changes in QoL over time. Therefore, the aim was to develop and validate an SBS-specific QoL scale.
  
  
  METHODS
  Classical test theory and Food and Drug Administration (FDA) guidance were applied for development and validation of the SBS-QoL™. Procedures included item generation and raw scale construction. Factor analysis, construct validity and internal consistency were assessed in a non-interventional observation, test re-test reliability and responsiveness in a randomised clinical study.
  
  
  RESULTS
  The SBS-QoL™ comprises 17 items including two subscales. Subjects assessed the scale as easy to handle and comprehensible. Good construct validity was shown by comparison with the Home Parenteral Nutrition-Quality Of Life questionnaire as an external scale, which yielded moderately high correlation (r ≥ 0.7). High internal consistency was demonstrated (Cronbach's alpha: 0.94). Also the test re-test reliability was high (r ≥ 0.95), indicating reliable reproducibility of results. The Responsiveness Index (1.84) indicated the ability of the scale to detect changes in QoL over time.
  
  
  CONCLUSIONS
  The SBS-QoL™ is an easy to handle and comprehensible SBS-specific subject-reported QoL scale. It is valid, reliable and sensitive with excellent psychometric characteristics to measure treatment-induced changes in QoL over time in subjects with SBS.
authors.affiliation: Medical Scientific Strategy, Takeda GmbH, Byk-Gulden-Str. 2, 78467 Konstanz, Germany. Electronic address: peter.berghoefer@takeda.com.
authors.forename: P
authors.initials: P
authors.lastname: Berghöfer
authors.forename: K C
authors.initials: KC
authors.lastname: Fragkos
authors.forename: J P
authors.initials: JP
authors.lastname: Baxter
authors.forename: A
authors.initials: A
authors.lastname: Forbes
authors.forename: F
authors.initials: F
authors.lastname: Joly
authors.forename: H
authors.initials: H
authors.lastname: Heinze
authors.forename: S
authors.initials: S
authors.lastname: Loth
authors.forename: M
authors.initials: M
authors.lastname: Pertkiewicz
authors.forename: B
authors.initials: B
authors.lastname: Messing
authors.forename: P B
authors.initials: PB
authors.lastname: Jeppesen
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D017281:Cost of Illness; D003967:Diarrhea / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D041981:Gastrointestinal Tract / Q000187:drug effects / Q000503:physiopathology*; D000067758:Glucagon-Like Peptide-2 Receptor; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use; D011594:Psychometrics; D011788:Quality of Life; D018027:Receptors, Glucagon / Q000819:agonists; D011994:Recombinant Proteins / Q000627:therapeutic use; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D012778:Short Bowel Syndrome / Q000188:drug therapy / Q000503:physiopathology / Q000628:therapy*; D011795:Surveys and Questionnaires
chemical_list: C578749:GLP2R protein, human; D005765:Gastrointestinal Agents; D000067758:Glucagon-Like Peptide-2 Receptor; D010455:Peptides; D018027:Receptors, Glucagon; D011994:Recombinant Proteins; C494910:teduglutide