Development and validation of the WEll-being and Satisfaction of CAREgivers of Children with Diabetes Questionnaire (WE-

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Development and validation of the WEll-being and Satisfaction of CAREgivers of Children with Diabetes Questionnaire (WE-CARE) Joseph C Cappelleri*1, Robert A Gerber1, Teresa Quattrin2,3, Rosemarie Deutschmann4, Xuemei Luo1, Robert Arbuckle5 and Linda Abetz5 Address: 1Pfizer Global Research and Development, Groton, CT, USA, 2Women's and Children's Hospital of Buffalo, Buffalo, NY, USA, 3State University of New York, Buffalo, NY, USA, 4Deutschmann and Company, Mt. Sheridan, Australia and 5Mapi Values, Bollington, UK Email: Joseph C Cappelleri* - [email protected]; Robert A Gerber - [email protected]; Teresa Quattrin - [email protected]; Rosemarie Deutschmann - [email protected]; Xuemei Luo - [email protected]; Robert Arbuckle - [email protected]; Linda Abetz - [email protected] * Corresponding author

Published: 18 January 2008 Health and Quality of Life Outcomes 2008, 6:3

doi:10.1186/1477-7525-6-3

Received: 5 June 2007 Accepted: 18 January 2008

This article is available from: http://www.hqlo.com/content/6/1/3 © 2008 Cappelleri 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.

Abstract Background: This study was designed to develop a diabetes-specific questionnaire on parents' quality of life and satisfaction with their child's diabetes treatment, the WEll-being and Satisfaction of CAREgivers of Children with Diabetes Questionnaire, and to conduct psychometric validation of the WE-CARE. Methods: Parents of 116 children aged 6 to 11 years were enrolled in the United States. Children had type 1 diabetes mellitus for > 1 year, had been treated with subcutaneous insulin for ≥ 2 months, and had a recent glycosylated hemoglobin (HbA1C) measurement. Recruiting clinicians provided clinical information on the children. Over a two-week period, parents completed WECARE (initial 68 items) and two other questionnaires (the 36-item Short Form of the Medical Outcomes Study and the 50-item Child Health Questionnaire-Parent Form) twice. Results: A literature review and one-on-one interview with caregivers and pediatricians led to the development of a draft questionnaire consisting of 68 items. Factor analysis suggested retention of 37 of the 68 initial items grouped into four multi-item scales (Psychosocial Well-being, Ease of Insulin Use, Treatment Satisfaction, and Acceptance of Insulin Administration as well as a Total Score). The four multi-item domains of WE-CARE were found to be psychometrically robust – they had negligible floor and ceiling effects, excellent internal consistency and test-retest reliability, high item-discriminant validity and good concurrent, divergent, known-group and clinical validity. Moderate interscale correlations among the four WE-CARE domains indicated that the concepts