Evidence map›Paper›PMID 40933613›Full record

Trial reportNeuropsychiatric disease and treatment2025

Reliability and Validity of the Chinese Version of the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) in Patients with Major Depressive Disorder-a Cross-Cultural Adaptation Study.

Na Zhu, Ziyi Pan, Tao Yang, Lu Yang, Xing Wang, Yousong Su, Xiaorui Yang, Yuru He, Haonan Zhang, Jing Liu and 6 more

Abstract readCase ReportsClinical Trial
In one paragraph

Trial report in Neuropsychiatric disease and treatment, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Na Zhu *Shanghai Pudong New Area Mental Health Center, Tongji University School of Medicine, Shanghai, People's Republic of China.
Ziyi Pan *Clinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Tao YangClinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.ORCID 0000-0003-1472-7051
Lu YangDepartment of Community Health and Epidemiology, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.
Xing WangClinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Yousong SuClinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Xiaorui YangShanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, People's Republic of China.
Yuru HeClinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Haonan ZhangClinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Jing LiuInterdisciplinary Health Program, St. Francis Xavier University, Antigonish, Nova Scotia, Canada.
Jill K MurphyInterdisciplinary Health Program, St. Francis Xavier University, Antigonish, Nova Scotia, Canada.
Erin MichalakInterdisciplinary Health Program, St. Francis Xavier University, Antigonish, Nova Scotia, Canada.
Ping SunQingdao Mental Health Center, Qingdao, People's Republic of China.ORCID 0000-0003-1565-2872
Yiru FangClinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.ORCID 0000-0002-8748-9085
Raymond W LamInterdisciplinary Health Program, St. Francis Xavier University, Antigonish, Nova Scotia, Canada.ORCID 0000-0001-7142-4669
Jun ChenClinical Research Center, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.ORCID 0000-0002-3837-2761

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

FIBSERmajor depressive disorderreliabilityside effectvalidity

Identifiers

PMID40933613
PMCPMC12419203

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.