Krause Karolin R, Lee Alina, Shan Di, Cost Katherine Tombeau, Hawke Lisa D, Cheung Amy H, Cleverley Kristin, de Oliveira Claire, Quinlan-Davidson Meaghen, Moretti Myla E, Henderson Jo L, Ma Clement, Szatmari Peter
Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Centre for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Paris, France.
BMJ Ment Health. 2025 Jan 22;28(1):e301425. doi: 10.1136/bmjment-2024-301425.
Evidence-based mental health requires patient-relevant outcome data, but many indicators lack clinical meaning and fail to consider youth perceptions. The minimally important change (MIC) indicator designates change as meaningful to patients, yet is rarely reported in youth mental health trials.
This study aimed to establish MIC thresholds for two patient-reported outcome measures (PROMs), the Columbia Impairment Scale (CIS) and the Strengths and Difficulties Questionnaire (SDQ), using different estimation methods.
A sample of 247 youths (14-17 years) completed the CIS and SDQ at baseline and at 6 months in a youth mental health and substance use trial. At 6 months, youths also reported perceived change. Three anchor-based (mean change, receiver operating characteristic analysis, predictive modelling) and three distribution-based methods (0.5 SD, measurement error, smallest detectable change) were compared.
Different methods yielded varying MIC thresholds. Predictive modelling provided the most precise anchor-based MIC: -2.6 points (95% CI -3.6, -1.6) for the CIS and -1.7 points (95% CI -2.2, -1.2) for the SDQ, indicating that score improvements of 12% for the CIS and 8% for the SDQ may be perceived as 'important' by youths. However, correlations between change score and anchor were below 0.5 for both measures, indicating suboptimal anchor credibility. Stronger correlations between the anchor and T2 PROM scores compared with T1 scores suggest the presence of recall bias. All MIC estimates were smaller than the smallest detectable change.
Predictive modelling offers the most precise MIC, but limited anchor credibility suggests careful anchor calibration is necessary.
Clinicians may consider the MIC CI as indicative of meaningful change when discussing treatment impact with patients.
NCT02836080.
循证心理健康需要与患者相关的结局数据，但许多指标缺乏临床意义，且未考虑青少年的看法。最小重要变化（MIC）指标将对患者有意义的变化进行了界定，但在青少年心理健康试验中很少被报告。
本研究旨在使用不同的估计方法，为两项患者报告结局测量工具（PROMs），即哥伦比亚损伤量表（CIS）和优势与困难问卷（SDQ），确定MIC阈值。
在一项青少年心理健康与物质使用试验中，247名年龄在14至17岁的青少年样本在基线时以及6个月时完成了CIS和SDQ。在6个月时，青少年还报告了感知到的变化。比较了三种基于锚定的方法（平均变化、受试者工作特征分析、预测模型）和三种基于分布的方法（0.5标准差、测量误差、最小可检测变化）。
不同方法得出了不同的MIC阈值。预测模型提供了最精确的基于锚定的MIC：CIS为-2.6分（95%CI -3.6，-1.6），SDQ为-1.7分（95%CI -2.2，-1.2），这表明CIS得分提高12%以及SDQ得分提高8%可能被青少年视为“重要”。然而，两项测量中变化得分与锚定之间的相关性均低于0.5，表明锚定可信度欠佳。与T1得分相比，锚定与T2 PROM得分之间更强的相关性表明存在回忆偏差。所有MIC估计值均小于最小可检测变化。
预测模型提供了最精确的MIC，但有限的锚定可信度表明需要仔细校准锚定。
临床医生在与患者讨论治疗效果时，可将MIC CI视为有意义变化的指标。
NCT02836080。
