Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy

Health and Quality of Life Outcomes

Kristian Juul²  Hanne Thorsen³  Luis Prieto¹ 

[1] Health Outcomes Consultant. C/ Rioja, 7. 28750 San Agustin de Guadalix, Spain;Ostomy Division, Clinical Documentation Department, Coloplast A/S, Holtedam 1, DK-3050 Humlebæk, Denmark;Institute of Public Health, Department of General Practice, University of Copenhagen, Denmark

关键词: Rasch analysis;    reliability;    validation;    development;    quality of life;    Stoma;   

Others  :  1219261
DOI  :  10.1186/1477-7525-3-62

 received in 2005-05-09, accepted in 2005-10-12,  发布年份 2005

【 摘 要 】

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 quality-of-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 semi-structured 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.

【 授权许可】

   
2005 Prieto et al; licensee BioMed Central Ltd.

【 图 表 】

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Figure 2.

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