Department of Psychiatry, Amsterdam UMC, Amsterdam, The Netherlands.
Amsterdam Neuroscience Research Institute, Amsterdam, The Netherlands.
Eur Psychiatry. 2024 Sep 20;67(1):e53. doi: 10.1192/j.eurpsy.2024.1768.
The change in symptoms necessary to be clinically relevant in obsessive-compulsive disorder (OCD) is currently unknown. In this study, we aimed to create an empirically validated threshold for clinical significance or minimal important difference (MID).
We analyzed individual participant data from short-term, double-blind, placebo-controlled registration trials of selective serotonin reuptake inhibitors in adult OCD patients. Data were collected from baseline to week 12. We used equipercentile linking to equate changes in the Clinical Global Impression (CGI) scale to changes in the Yale-Brown Obsessive-Compulsive Scale (YBOCS). We defined the MID as the YBOCS change linked to a CGI improvement of 3 (defined as "minimal improvement").
We included 7 trials with a total of 1216 patients. The CGI-scores and YBOCS were moderately to highly correlated. The MID corresponded to 4.9 YBOCS points (95% CI 4.4-5.4) for the full sample, or a 24% YBOCS-decrease compared to baseline. The MID varied with baseline severity, being lower in the group with mild symptoms and higher in the group with severe symptoms.
By linking the YBOCS to the CGI-I, this is the first study to propose an MID in OCD trials. Having a clearly defined MID can guide future clinical research and help interpretation of efficacy of existing interventions. Our results are clinician-based; however, there is further need for patient-reported outcomes as anchor to the YBOCS.
目前尚不清楚强迫症（OCD）中需要具有临床相关性的症状变化。在这项研究中，我们旨在创建一个经验验证的临床意义或最小重要差异（MID）阈值。
我们分析了来自成人 OCD 患者短期、双盲、安慰剂对照的选择性 5-羟色胺再摄取抑制剂注册试验的个体参与者数据。数据从基线收集到第 12 周。我们使用等百分位链接将临床总体印象量表（CGI）的变化与耶鲁-布朗强迫症量表（YBOCS）的变化进行匹配。我们将 MID 定义为与 CGI 改善 3 分相关的 YBOCS 变化（定义为“最小改善”）。
我们纳入了 7 项共纳入 1216 例患者的试验。CGI 评分和 YBOCS 之间存在中度至高度相关性。MID 对应于整个样本的 4.9 个 YBOCS 点（95%CI 4.4-5.4），或与基线相比 YBOCS 降低 24%。MID 随基线严重程度而变化，在症状较轻的组中较低，在症状较重的组中较高。
通过将 YBOCS 与 CGI-I 相关联，这是第一项在 OCD 试验中提出 MID 的研究。有一个明确定义的 MID 可以指导未来的临床研究，并有助于解释现有干预措施的疗效。我们的结果是基于临床医生的，但进一步需要患者报告的结果作为 YBOCS 的基准。
