Czobor Pál, Sebe Barbara, Acsai Károly, Barabássy Ágota, Laszlovszky István, Németh György, Furukawa Toshi A, Leucht Stefan
Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary.
Global Medical Division, Gedeon Richter Plc, Budapest, Hungary.
Front Psychiatry. 2022 Apr 25;13:816339. doi: 10.3389/fpsyt.2022.816339. eCollection 2022.
Minimum clinically important difference (MCID) is a measure that defines the minimum amount of change in an objective score of a clinical test that must be reached for that change to be clinically noticeable. We aimed to find the MCID for patients with predominantly negative symptoms of schizophrenia at its earliest occurrence.
Data of a 26-week long, double-blind study with 454 patients [Positive and Negative Symptom Scale Negative Factor Score (PANSS-FSNS) ≥24, Positive and Negative Symptom Scale Positive Factor Score (PANSS-FSPS) ≤ 19] treated with cariprazine 4.5 mg/d or risperidone 4 mg/d were analyzed. The Clinical Global Impression-Improvement scale was used to quantify minimum improvement (CGI-I = 3) and no clinical change (CGI-I = 4) on the PANSS-FSNS, and the MCID was estimated with the following methods: as the mean PANSS-FSNS changes corresponding to the first instance of minimal improvement across all visits (MCID); as the difference between the PANSS-FSNS change associated with the first instance and the PANSS-FSNS changes associated with the last recorded clinically unchanged status across all visits (MCID); with the effect size approach (MCID); as the Youden Index based cut-off value between no clinical change and minimal improvement (MCID); as the relative likelihood of minimal improvement (MCID).
The MCID and MCID resulted in, respectively, a 3.8-point (18.5%) and a 1.5-point (7.3%) decrease from baseline severity on the PANSS-FSNS. Greater values were required for the MCID at later evaluation times. The cut-off between minimum improvement and no clinical change defined by the Youden Index was a-3-point (15%) change in the PANSS-FSNS. The effect size approach indicated the 1.5-point difference between minimally improved and unchanged patients to be a medium effect (ES = 0.6).
Applying different methods led to different results, ranging between 7.3 and 18.5% improvement from the baseline for the MCID at its earliest occurrence in patients with predominantly negative symptoms of schizophrenia.
最小临床重要差异（MCID）是一种衡量指标，用于定义临床测试客观评分中必须达到的最小变化量，以使该变化在临床上可被察觉。我们旨在找出精神分裂症以阴性症状为主的患者在疾病最早出现时的MCID。
分析了一项为期26周的双盲研究数据，该研究纳入了454例患者[阳性和阴性症状量表阴性因子得分（PANSS - FSNS）≥24，阳性和阴性症状量表阳性因子得分（PANSS - FSPS）≤19]，这些患者接受4.5毫克/天的卡立哌嗪或4毫克/天的利培酮治疗。使用临床总体印象改善量表来量化PANSS - FSNS上的最小改善（CGI - I = 3）和无临床变化（CGI - I = 4），并采用以下方法估计MCID：作为对应于所有访视中最小改善首次出现时的平均PANSS - FSNS变化（MCID）；作为与首次出现相关的PANSS - FSNS变化与所有访视中最后记录的临床无变化状态相关的PANSS - FSNS变化之间的差值（MCID）；采用效应量法（MCID）；作为无临床变化和最小改善之间基于约登指数的临界值（MCID）；作为最小改善的相对可能性（MCID）。
MCID和MCID分别导致PANSS - FSNS从基线严重程度下降3.8分（18.5%）和1.5分（7.3%）。在后期评估时间，MCID需要更大的值。约登指数定义的最小改善与无临床变化之间的临界值是PANSS - FSNS变化-3分（15%）。效应量法表明，最小改善患者与未改善患者之间1.5分的差异为中等效应（ES = 0.6）。
应用不同方法会导致不同结果，对于以阴性症状为主的精神分裂症患者，在疾病最早出现时，MCID从基线的改善幅度在7.3%至18.5%之间。
