Targum Steven D, Catania Christopher J
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Contemp Clin Trials Commun. 2019 Jan 8;14:100317. doi: 10.1016/j.conctc.2019.100317. eCollection 2019 Jun.
Ratings surveillance is used in clinical trials to assure ratings reliability of site-based scores. One surveillance method employs audio-digital recordings of site-based clinician interviews to obtain remote, site-independent scores for assessment of paired scoring concordance and interview quality. We examined the utility of this surveillance strategy using paired site-independent scores derived from recorded site-based Montgomery-Asberg depression rating scale (MADRS) interviews obtained from patients with major depressive disorder (MDD) participating in 5 clinical trials. High correlations were noted between the 3736 paired site-based and site-independent scores across all visits. Some rater "outliers" were identified whose ratings performance improved following remediation. In 3 studies with available outcome data, the blinded remote ratings yielded a high predictive value (91.2%) for replicating treatment response rates. The magnitude of the total MADRS scores affected the directionality of paired scoring deviations in each of the 5 studies. Across all visits, site-based raters scored the more severe MADRS scores (≥30) higher than site-independent raters and the less severe MADRS scores (<20) lower than site-independent raters. Individual MADRS items were similarly affected by the directionality of symptom severity. This analysis affirms the utility of audio-digital recording of site-based interviews as a surveillance strategy for quality assurance (monitoring and remediation). In addition, the high predictive value of blinded remote ratings to replicate site-based treatment outcomes may be useful to affirm primary site-based results when there is a potential of functional unblinding. The use of remote ratings as a primary measure beyond its utility for quality assurance needs further exploration.
评分监测用于临床试验，以确保基于研究点的评分可靠性。一种监测方法是对基于研究点的临床医生访谈进行音频数字记录，以获得独立于研究点的远程评分，用于评估配对评分的一致性和访谈质量。我们使用从参与5项临床试验的重度抑郁症（MDD）患者的基于研究点的蒙哥马利-阿斯伯格抑郁评定量表（MADRS）访谈记录中得出的配对独立于研究点的评分，检验了这种监测策略的效用。在所有访视中，3736对基于研究点和独立于研究点的评分之间存在高度相关性。识别出了一些评分者“异常值”，其评分表现经过纠正后有所改善。在3项有可用结局数据的研究中，盲法远程评分对复制治疗反应率具有较高的预测价值（91.2%）。MADRS总分的大小影响了5项研究中每项研究配对评分偏差的方向。在所有访视中，基于研究点的评分者对更严重的MADRS评分（≥30）的评分高于独立于研究点的评分者，而对不太严重的MADRS评分（<20）的评分低于独立于研究点的评分者。MADRS各个项目同样受到症状严重程度方向的影响。该分析证实了对基于研究点的访谈进行音频数字记录作为质量保证（监测和纠正）监测策略的效用。此外，盲法远程评分对复制基于研究点的治疗结局具有较高的预测价值，当存在功能破盲的可能性时，这可能有助于确认基于研究点的主要结果。将远程评分用作超出其质量保证效用的主要测量方法需要进一步探索。
