Abstract
BackgroundQuality of life (QoL) is increasingly recognized as an important outcome measure in clinical trials. The Canadian Hemophilia Outcomes-Kids Life Assessment Tool (CHO-KLAT) shows promise for use in China.ObjectiveTo adapt the CHO-KLAT version 2.0 for use in clinical trials in China.MethodsForward and back translations of the CHO-KLAT2.0 were completed in 2008. Between October 2009 and June 2010, a series of 3 focus groups were held with 20 boys and 31 parents in rural and urban China to elicit additional concepts, important to their QoL, for the Chinese CHO-KLAT2.0. All of the items identified by boys and parents were reviewed by a group of experts, resulting in a Chinese version of the CHO-KLAT2.0. This version underwent a detailed cognitive debriefing process between October 2010 and June 2011. Thirteen patient-parent pairs participated in this cognitive debriefing process until a stable and clearly understood Chinese version of the CHO-KLAT2.0 was obtained.ResultsThe initial back translation of the Chinese CHO-KLAT2.0 was slightly discrepant from the original English version on 12 items. These were all successfully adjudicated. The focus groups identified 9 new items that formed an add-on Socio-Economic Context (SEC) module for China. Linguistic improvements were made after the 2nd, 5th, 7th and 13th cognitive debriefings pairs and affected a total of 18 items. The result was a 35 item CHO-KLAT2.0 and a SEC module in Simplified Chinese, both of which have good content validity.ConclusionThis detailed process proved to be extremely valuable in ensuring the items were accurately interpreted by Chinese boys with hemophilia ages ≤18 years. The need for the additional SEC module highlighted the different context that currently exists in China with regard to hemophilia care as compared to many Western countries, and will be important in tracking progress within both rural and urban China over time. Changes based on the cognitive debriefings suggest that expert verbatim translation alone is not sufficient. The Chinese version of the CHO-KLAT2.0 is well understood by boys with hemophilia in China. Next steps will be to test its construct validity and reliability in boys with hemophilia in China.
Highlights
Quality of life (QoL) is increasingly recognized as an important outcome measure in clinical trials
The need for the additional Socio-Economic Context (SEC) module highlighted the different context that currently exists in China with regard to hemophilia care as compared to many Western countries, and will be important in tracking progress within both rural and urban China over time
These focus groups were led by a psychiatrist at Beijing Children’s Hospital (JZ) whose first language was Chinese and who was experienced in the management of persons with hemophilia in China
Summary
Quality of life (QoL) is increasingly recognized as an important outcome measure in clinical trials. Over the last 2 decades there has been significant improvement in hemophilia care in China promoted by the World Federation of Hemophilia (WFH), beginning in 1993. The development of WFH twinning programs with leading Canadian hemophilia treatment centers began in. Recent literature indicates that 90% of boys in China over the age of 6 years have significant joint arthropathy, [3] which may reflect a gap in access to treatment. Hemophilia treatment centers are beginning to be developed in many cities. These are based on the comprehensive hemophilia care model. The recent changes in management of hemophilia in China present a unique opportunity to study the impact of factor replacement therapy and enhanced hemophilia care on the quality of life of boys with hemophilia
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
