Clintara LLC, 505 Tremont Street, Boston, MA, 02116, USA.
Ann Gen Psychiatry. 2013 Jan 31;12(1):2. doi: 10.1186/1744-859X-12-2.
The clinical global impression of severity (CGI-S) scale is a frequently used rating instrument for the assessment of global severity of illness in Central Nervous System (CNS) trials. Although scoring guidelines have been proposed to anchor these scores, the collection of sufficient documentation to support the derived score is not part of any standardized interview procedure. It is self evident that the absence of a standardized, documentary format can affect inter-rater reliability and may adversely affect the accuracy of the resulting data.
We developed a structured interview guide for global impressions (SIGGI) and evaluated the instrument in a 2-visit study of ambulatory patients with Major Depressive Disorder (MDD) or schizophrenia. Blinded, site-independent raters listened to audio recorded SIGGI interviews administered by site-based CGI raters. We compared SIGGI-derived CGI-S scores between the two separate site-based raters and the site-independent raters.
We found significant intraclass correlations (p = 0.001) on all SIGGI-derived CGI-S scores between two separate site-based CGI raters with each other (r = 0.768) and with a blinded, site-independent rater (r = 0.748 and r = 0.706 respectively) and significant Pearson's correlations between CGI-S scores with all MADRS validity comparisons for MDD and PANSS comparisons for schizophrenia (p- 0.001 in all cases). Compared to site-based raters, the site-independent raters gave identical "dual" CGI-S scores to 67.6% and 68.2% of subjects at visit 1 and 77.1% at visit 2.
We suggest that the SIGGI may improve the inter-rater reliability and scoring precision of the CGI-S and have broad applicability in CNS clinical trials.
临床总体印象严重程度量表（CGI-S）是中枢神经系统（CNS）试验中评估整体疾病严重程度的常用评分工具。尽管已经提出了评分指南来确定这些评分，但收集足够的文件来支持得出的评分并不是任何标准化访谈程序的一部分。不言而喻，缺乏标准化的文件格式会影响评分者间的可靠性，并可能对得出的数据的准确性产生不利影响。
我们开发了一种用于总体印象的结构化访谈指南（SIGGI），并在一项门诊重度抑郁症（MDD）或精神分裂症患者的 2 访研究中评估了该工具。盲法、独立于地点的评分者收听由现场 CGI 评分者进行的音频记录的 SIGGI 访谈。我们比较了两个独立现场评分者与独立评分者之间的 SIGGI 衍生 CGI-S 评分。
我们发现，两个独立现场 CGI 评分者之间的所有 SIGGI 衍生 CGI-S 评分（r = 0.768）以及与盲法、独立地点评分者（r = 0.748 和 r = 0.706）之间均存在显著的组内相关性（p = 0.001），并且在所有情况下，MDD 的 CGI-S 评分与 MADRS 所有有效性比较以及精神分裂症的 PANSS 比较之间均存在显著的 Pearson 相关性（p < 0.001）。与现场评分者相比，独立评分者在第 1 访和第 2 访中分别有 67.6%和 68.2%的受试者和 77.1%的受试者给出了相同的“双重”CGI-S 评分。
我们建议，SIGGI 可能会提高 CGI-S 的评分者间可靠性和评分精度，并在 CNS 临床试验中具有广泛的适用性。
