Massachusetts General Hospital, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA.
J Atten Disord. 2022 Mar;26(5):696-705. doi: 10.1177/10870547211020073. Epub 2021 Jun 4.
The Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior-Revised assess early morning (BSFQ, PREMB-R AM subscale) and late afternoon/evening (PREMB-R PM subscale) functional impairment in children with ADHD. Clinically meaningful improvements were identified and applied to a trial of delayed-release and extended-release methylphenidate (DR/ER-MPH) in children with ADHD (NCT02520388) to determine if the statistically-determined improvements in functional impairment were also clinically meaningful.
Clinically meaningful improvements in BSFQ/PREMB-R were established post hoc by receiver operating characteristics curves, using anchors of Clinical Global Impression-Improvement (CGI-I) = 1 and CGI-I ≤ 2. Percentages of participants achieving these thresholds were calculated.
Thresholds for CGI-I = 1/CGI-I ≤ 2, respectively, were 27/20 (BSFQ), 5/3 (PREMB-R AM), and 9/5 (PREMB-R PM)-point decreases. More children achieved clinically meaningful improvements with DR/ER-MPH versus placebo (all < .05).
DR/ER-MPH increased proportions of children achieving clinically meaningful improvements in BSFQ and PREMB-R.
《上学前功能问卷和家长评定的早晚行为修订版》评估了 ADHD 儿童的清晨（BSFQ、PREMB-R AM 子量表）和傍晚/晚上（PREMB-R PM 子量表）的功能障碍。确定了有临床意义的改善，并应用于 ADHD 儿童的延迟释放和延长释放哌甲酯（DR/ER-MPH）试验（NCT02520388），以确定功能障碍的统计学改善是否也具有临床意义。
使用临床总体印象改善（CGI-I）= 1 和 CGI-I ≤ 2 的锚定，通过受试者工作特征曲线事后确定 BSFQ/PREMB-R 的有临床意义的改善。计算达到这些阈值的参与者比例。
CGI-I = 1/CGI-I ≤ 2 的阈值分别为 27/20（BSFQ）、5/3（PREMB-R AM）和 9/5（PREMB-R PM）点降低。与安慰剂相比，更多的儿童接受 DR/ER-MPH 治疗后取得了有临床意义的改善（均<.05）。
DR/ER-MPH 增加了在 BSFQ 和 PREMB-R 中达到有临床意义改善的儿童比例。
