Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL™) scale

Clin Nutr. 2013 Oct;32(5):789-96. doi: 10.1016/j.clnu.2012.12.001. Epub 2012 Dec 12.


Background & aims: 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.

Trial registration: NCT00798967.

Keywords: CTT; Classical test theory; Quality of life (QoL); RI; Responsiveness Index; Scale; Short bowel syndrome (SBS); VAS; Validation; Visual Analogue Scale.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Activities of Daily Living
  • Adult
  • Aged
  • Cost of Illness
  • Diarrhea / etiology
  • Diarrhea / prevention & control
  • Double-Blind Method
  • Drug Resistance
  • Female
  • Gastrointestinal Agents / therapeutic use
  • Gastrointestinal Tract / drug effects
  • Gastrointestinal Tract / physiopathology*
  • Glucagon-Like Peptide-2 Receptor
  • Humans
  • Male
  • Middle Aged
  • Peptides / therapeutic use
  • Psychometrics
  • Quality of Life*
  • Receptors, Glucagon / agonists
  • Recombinant Proteins / therapeutic use
  • Reproducibility of Results
  • Severity of Illness Index
  • Short Bowel Syndrome / drug therapy
  • Short Bowel Syndrome / physiopathology
  • Short Bowel Syndrome / therapy*
  • Surveys and Questionnaires


  • GLP2R protein, human
  • Gastrointestinal Agents
  • Glucagon-Like Peptide-2 Receptor
  • Peptides
  • Receptors, Glucagon
  • Recombinant Proteins
  • teduglutide

Associated data