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Cited by 10Schizophrenia research and treatmentStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of Life

Assessment of the Minimum Clinically Important Difference in Symptoms and Functions of Patients With Acute Schizophrenia: A Post hoc Analysis of an Open-Label, Single-Arm Multicenter Study

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Si, Tianmei, Shi, Chuan, Sun, Ling, Zhang, Yilong, Zhang, Lili·2021·Frontiers in Psychiatry
DOI 10.3389/fpsyt.2021.653916PMC PMC8126618
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Abstract

The purpose of this study was to evaluate the application of the minimum clinically important difference (MCID) concept to clinical results in Chinese patients with acutely exacerbated schizophrenia. The original study was an 8-week, open-label, single-arm, multicenter study of flexible doses of paliperidone-extended release (pali-ER) in Chinese patients with acutely exacerbated schizophrenia. This is a post hoc analysis to determine the MCID value of PANSS, PSP and evaluate the responsiveness of each outcome measurements in the acute phase of schizophrenia. The responsiveness of the four measurements (PANSS, PANSS reduction rate, PSP, CGI-S) was analyzed. Four hundred ninety nine patients completed the 8-week follow-up and were finally used for this post hoc analysis. The MCID calculated by different approaches varied from 14.02 to 31.50 for PANSS, 15.14 to 42.79% for PANSS reduction rate, and 7.62 to 13.13% for PSP. In addition, the improvement of the CGI-S owned the highest responsiveness of the four outcome measurements. The threshold value of MCID for schizophrenia patients was determined by choice of the assessment method to an extent. In addition, the CGI-S score appeared to be the most valid and responsive measure of effectiveness for the acute phase of schizophrenia when take the treatment satisfaction of patients as anchor.

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Cited by

Sorted by citations

Authors
Si, T., Shi, C., Sun, L., Zhang, Y., & Zhang, L.
Affiliations
  • Peking University (CN)
  • Tianjin Anding Hospital (CN)
  • Xian Janssen Pharmaceutical Ltd. (China) (CN)
Corresponding author
Zhang, Lili
ORCID
Venue
Frontiers in Psychiatry
Publisher
Frontiers Media SA
Published
2021-05-03
Volume
12
Pages
653916-653916
ISSN
1664-0640 (ISSN-L)
DOI
10.3389/fpsyt.2021.653916
PMC
PMC8126618
OpenAlex
W3157862832
Cited by
10
References
1
Citations by year
2026: 1 · 2025: 4 · 2024: 2 · 2023: 1 · 2022: 2
FWCI
0.90
Type
journal article
Language
en
Open access
Licence
Locations
  • Frontiers in Psychiatry (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Greater South Information System
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Keywords
minimal clinically important difference, acute schizophrenia, paliperidone extended-release, PANSS, patient satisfaction scale, outcome measure responsiveness, Chinese patients, antipsychotic drugs

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