1. Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL™) scale
- Author
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Palle Jeppesen, S. Loth, Francisca Joly, Konstantinos C. Fragkos, J.P. Baxter, Bernard Messing, Alastair Forbes, P. Berghöfer, Marek Pertkiewicz, and H. Heinze
- Subjects
Adult ,Diarrhea ,Male ,Short Bowel Syndrome ,Gerontology ,medicine.medical_specialty ,Psychometrics ,Visual analogue scale ,Drug Resistance ,Critical Care and Intensive Care Medicine ,Severity of Illness Index ,Classical test theory ,Cost of Illness ,Double-Blind Method ,Gastrointestinal Agents ,Cronbach's alpha ,Quality of life ,Surveys and Questionnaires ,Activities of Daily Living ,Receptors, Glucagon ,medicine ,Humans ,Reliability (statistics) ,Aged ,Gastrointestinal agent ,Nutrition and Dietetics ,business.industry ,Reproducibility of Results ,Construct validity ,Middle Aged ,Recombinant Proteins ,humanities ,Gastrointestinal Tract ,Glucagon-Like Peptide-2 Receptor ,Quality of Life ,Physical therapy ,Female ,Peptides ,business - Abstract
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. © 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism.
- Published
- 2013