PMID- 34012411 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210522 IS - 1664-0640 (Print) IS - 1664-0640 (Electronic) IS - 1664-0640 (Linking) VI - 12 DP - 2021 TI - 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. PG - 653916 LID - 10.3389/fpsyt.2021.653916 [doi] LID - 653916 AB - 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. CI - Copyright (c) 2021 Si, Shi, Sun, Zhang and Zhang. FAU - Si, Tianmei AU - Si T AD - Peking University Sixth Hospital (Institute of Mental Health), Beijing, China. AD - NHC Key Laboratory of Mental Health (Peking University) & National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China. FAU - Shi, Chuan AU - Shi C AD - Peking University Sixth Hospital (Institute of Mental Health), Beijing, China. AD - NHC Key Laboratory of Mental Health (Peking University) & National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China. FAU - Sun, Ling AU - Sun L AD - Tianjin Anding Hospital, Tianjin, China. FAU - Zhang, Yilong AU - Zhang Y AD - Xian Janssen Pharmaceuticals, Beijing, China. FAU - Zhang, Lili AU - Zhang L AD - Xian Janssen Pharmaceuticals, Beijing, China. LA - eng PT - Journal Article DEP - 20210503 PL - Switzerland TA - Front Psychiatry JT - Frontiers in psychiatry JID - 101545006 PMC - PMC8126618 OTO - NOTNLM OT - clinical global impression-severity scale OT - minimum clinically important difference OT - personal and social performance OT - positive and negative syndrome scale OT - schizophrenia COIS- YZ and LZ were employees of Xian Janssen Pharmaceuticals at the time during which the work was undertaken. This work is a post-hoc analysis of a Xian Janssen sponsored phase 3 study R0776477-SCH-3034. The remaining authors declare that the research was conducted in the absence of any other commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2021/05/21 06:00 MHDA- 2021/05/21 06:01 PMCR- 2021/05/03 CRDT- 2021/05/20 06:40 PHST- 2021/01/15 00:00 [received] PHST- 2021/03/29 00:00 [accepted] PHST- 2021/05/20 06:40 [entrez] PHST- 2021/05/21 06:00 [pubmed] PHST- 2021/05/21 06:01 [medline] PHST- 2021/05/03 00:00 [pmc-release] AID - 10.3389/fpsyt.2021.653916 [doi] PST - epublish SO - Front Psychiatry. 2021 May 3;12:653916. doi: 10.3389/fpsyt.2021.653916. eCollection 2021.