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.

Tianmei Si,Yilong Zhang,Ling Sun,Chuan Shi,Lili Zhang

doi:10.3389/fpsyt.2021.653916

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.

Highlights

Schizophrenia is a psychiatric disorder with a lifetime prevalence of 0.3–0.66%
This study estimated the value of minimum clinically important difference (MCID) for the Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance (PSP) in patients with acutely exacerbated schizophrenia, which is a widely used measure of symptoms and functions in schizophrenia
The current study, a post hoc analysis of data from a study conducted on Chinese patients, revealed significant differences in PANSS and PSP changes from baseline to 8 weeks using flexible doses (3–12 mg/day) of paliperidone-extended release (pali-ER)

Summary

Introduction

Schizophrenia is a psychiatric disorder with a lifetime prevalence of 0.3–0.66%. It can lead to a considerable psychosocial dysfunction [1] and can influence the quality of life of patients significantly, resulting in the need for assistance in meeting basic living needs [1, 2]. The Positive and Negative Syndrome Scale (PANSS) and the Personal and Social Performance (PSP) assessment are reliable tools for assessing the symptoms and functional outcomes in the acute and stable stages of schizophrenia [3]. PANSS is the most widely used standardized scale for assessing symptom severity in schizophrenia [4]. It has been used as an outcome measure in a multitude of treatment. The PSP scale was designed to measure and distinguish between specific domains of functioning and includes specific criteria for rating the severity of dysfunction, in addition to incorporating psychopathologic aspects of behavior. PANSS and PSP are based on summary rating scores and lack a gold standard to interpret results. Clinicians must rely on the experience with individual patients and populations to interpret PANSS scores and the clinical significance of various degrees of change [5]

Objectives

Methods

Results

Conclusion