The minimal important difference in obsessive-compulsive disorder: An analysis of double-blind SSRI trials in adults.

IF 7.2 2区医学 Q1 PSYCHIATRY European Psychiatry Pub Date : 2024-09-20 DOI:10.1192/j.eurpsy.2024.1768

Sem E Cohen, Jasper B Zantvoord, Taina K Mattila, Bram W C Storosum, Anthonius de Boer, Damiaan Denys

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Abstract

Background: 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).

Methods: 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").

Results: 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.

Conclusions: 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.

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强迫症的最小重要差异：成人双盲 SSRI 试验分析。

背景：目前尚不清楚强迫症（OCD）临床相关症状的必要变化。在这项研究中，我们的目标是为临床意义或最小重要差异（MID）设定一个经验验证的阈值：我们分析了选择性 5-羟色胺再摄取抑制剂在成年强迫症患者中进行的短期、双盲、安慰剂对照注册试验的个体参与者数据。数据收集时间为基线至第 12 周。我们使用等位联系将临床总体印象量表（CGI）的变化等同于耶鲁-布朗强迫症量表（YBOCS）的变化。我们将 MID 定义为与 CGI 改善 3（定义为 "最小改善"）相关的 YBOCS 变化：结果：我们纳入了 7 项试验，共有 1216 名患者参加。CGI评分和YBOCS呈中度至高度相关。在全部样本中，MID相当于4.9个YBOCS点（95% CI 4.4-5.4），或与基线相比YBOCS下降24%。MID随基线严重程度而变化，症状轻微组的MID较低，症状严重组的MID较高：通过将YBOCS与CGI-I联系起来，这是第一项在强迫症试验中提出MID的研究。明确定义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。我们的研究结果以临床医生为基础；但是，还需要患者报告的结果作为 YBOCS 的锚。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Psychiatry 医学-精神病学

CiteScore

8.50

自引率

3.80%

发文量

2338

审稿时长

4.5 weeks

期刊介绍： European Psychiatry, the official journal of the European Psychiatric Association, is dedicated to sharing cutting-edge research, policy updates, and fostering dialogue among clinicians, researchers, and patient advocates in the fields of psychiatry, mental health, behavioral science, and neuroscience. This peer-reviewed, Open Access journal strives to publish the latest advancements across various mental health issues, including diagnostic and treatment breakthroughs, as well as advancements in understanding the biological foundations of mental, behavioral, and cognitive functions in both clinical and general population studies.