Na Zhu,1,* Ziyi Pan,2,* Tao Yang,2 Lu Yang,3 Xing Wang,2 Yousong Su,2 Xiaorui Yang,4 Yuru He,2 Haonan Zhang,2 Jing Liu,5 Jill K Murphy,5 Erin Michalak,5 Ping Sun,6 Yiru Fang,2,7,8 Raymond W Lam,5 Jun Chen2,8 

1Shanghai Pudong New Area Mental Health Center, Tongji University School of Medicine, Shanghai, People’s Republic of China; 2Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 3Department of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada; 4Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, People’s Republic of China; 5Interdisciplinary Health Program, St. Francis Xavier University, Antigonish, Nova Scotia, Canada; 6Qingdao Mental Health Center, Qingdao, People’s Republic of China; 7Department of Psychiatry & Affective Disorders Center, Ruijin Hospital, Shanghai, People’s Republic of China; 8Shanghai Key Laboratory of Psychotic Disorders, Shanghai, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Jun Chen, Email doctorcj2010@gmail.com Raymond W Lam, Email r.lam@ubc.ca

Background: Assessing adverse medication reactions can play a vital role in maximizing therapeutic outcomes by promoting the adherence and minimizing the cost of medication therapy in patients with major depressive disorder (MDD). Selecting a simple clinical tool that helps physicians assess and treat patients more effectively is necessary. The Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale has already been proven to be an effective measurement. This study aimed to identify the reliability and validity of the Chinese version of the FIBSER in MDD.
Methods: Patients who had been diagnosed with MDD according to the Diagnostic and Statistical Manual for Mental Disorders – Fifth Edition (DSM-5) were enrolled (n=105). The depressive symptoms and adverse medication reactions were assessed by using the Hamilton Depression Scale (HAMD), the Treatment Emergent Symptom Scale (TESS), and the Frequency, Intensity, and Burden of Side Effects Rating Scale (FIBSER). The psychometric analysis was conducted on the FIBSER.
Results: The Cronbach’s α coefficient for the FIBSER in patients with MDD ranged from 0.872 to 0.942. After four weeks, the test-retest reliability was evaluated with the intraclass correlation coefficient (ICC) ranging from 0.335 to 0.456. The parallel validity of the FIBSER was examined using Pearson’s correlation analysis, and r values ranged from 0.694 to 0.776 (P< 0.001), which indicated significantly moderate to high correlations between FIBSER and TESS.
Conclusion: The Chinese Version of the FIBSER demonstrates acceptable validity and internal consistency reliability, though test-retest reliability was low in this sample of major depressive disorder patients.

Keywords: major depressive disorder, reliability, validity, FIBSER, side effect