Development and Item Selection of the Inflammatory Bowel Disease Patient-reported Outcomes Scale Based on Theories of Traditional Chinese Medicine

Abstract

Background The prevalence of inflammatory bowel disease (IBD) increases annually in China. The integrated traditional Chinese and western medicine is helpful to alleviate and control symptoms of IBD. Quality of life (QoL) is an important index to evaluate the clinical efficacy of IBD. However, there are few studies about IBD patient-reported outcomes (PROs) based on TCM theories. Objective To determine the framework and items, and then use them to develop the IBD PROs scale using TCM theories. Methods Under the guidance of the TCM theory of "body and mind harmony, and man's adaptation to his total environment" , literature review, core-group discussion and expert consultation were carried out. The conceptual framework and item pool of the draft of an IBD PROs scale were developed, then the corresponding items were determined, forming the draft of the IBD PROs scale. Then the draft scale was pre-tested in IBD patients treated in Department of Spleen and Stomach Diseases, the First Affiliated Hospital of Guangzhou University of Chinese Medicine from January to June 2021. The dispersion tendency, Cronbach's α and correlation analysis were used for further item selection. Results The final IBD PROs scale is composed of two domains: body and mind harmony (12 body-related items, and 9 mind-related items) and man's adaptation to his total environment (6 items) . Conclusion The IBD PROs scale developed based on theories of TCM could be used to evaluate the QoL of IBD patients. But further clinical research is still needed to verify its reliability and validity.

Keywords

• inflammatory bowel disease|patient-reported outcomes|tcm theories|quality of life|item selection|construction of scale