Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy
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Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy Luis Prieto1, Hanne Thorsen2 and Kristian Juul*3 Address: 1Health Outcomes Consultant. C/ Rioja, 7. 28750 San Agustin de Guadalix, Spain, 2Institute of Public Health, Department of General Practice, University of Copenhagen, Denmark and 3Ostomy Division, Clinical Documentation Department, Coloplast A/S, Holtedam 1, DK-3050 Humlebæk, Denmark Email: Luis Prieto - [email protected]; Hanne Thorsen - [email protected]; Kristian Juul* - [email protected] * Corresponding author
Published: 12 October 2005 Health and Quality of Life Outcomes 2005, 3:62 62
doi:10.1186/1477-7525-3-
Received: 09 May 2005 Accepted: 12 October 2005
This article is available from: http://www.hqlo.com/content/3/1/62 © 2005 Prieto et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Stomaquality of lifedevelopmentvalidationreliabilityRasch analysis
Abstract Background: Quality of life of stoma patients is increasingly being addressed in clinical trials. However, the instruments used in the majority of these studies have not been validated specifically for stoma patients. The aim of this paper is to describe the development and validation of a qualityof-life instrument, "Stoma-QOL", specifically for patients with colostomy or ileostomy. Methods: Potential items were formulated in English on the basis of the results of a series of semistructured interviews with 169 adult stoma patients. The process resulted in a preliminary 37-item version, which was translated into French, German, Spanish and Danish, and administered repeatedly to 182 patients with colostomy or ileostomy. A psychometric selection of items was performed through Rasch Analysis. The measurement properties of the final questionnaire version were subsequently tested. Results: The 20 items in the final questionnaire covered four domains – sleep, sexual activity, relations to family and close friends, and social relations to other than family and close friends. These items were found to define a unidimensional variable according to Rasch specifications (Infit MNSQ < 1.3). Internal consistency reliability calculated as Cronbach's alpha was 0.92, i.e., highly reliable. Spearman's correlation coefficients of scores across times of administration was >0.88 (p < 0.01), indicating a high test-retest reliability. Item calibrations by country calculated as ICC were 0.81 (0.67–0.91 95% CI), confirming cross-cultural comparability across the European countries included in the study. Conclusion: Given the adequacy of the metric properties of the Stoma-QOL suggested by the psychometric analyses, this study confirms the suitability of the instrument in clinical practice and in clinical research.
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