风险评分概况：一种描述参与临床研究人群风险的新方法。

The Risk Score Profile: a novel approach to characterising the risk of populations enrolled in clinical studies.

作者信息

Morrow David A, Antman Elliott M, Murphy Sabina A, Assmann Susan F, Giugliano Robert P, Cannon Christopher P, Michael Gibson C, McCabe Carolyn H, Barron Hal V, Van De Werf Frans, Braunwald Eugene

机构信息

TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.

出版信息

Eur Heart J. 2004 Jul;25(13):1139-45. doi: 10.1016/j.ehj.2004.04.036.

DOI:10.1016/j.ehj.2004.04.036

PMID:15231372

Abstract

AIMS

Interpreting the results and practice implications of clinical studies requires accurate characterisation of the baseline risk of the population. We evaluated the Thrombolysis in Myocardial Infarction (TIMI) risk score for STEMI as a tool to describe and compare the risk profile of populations enrolled in three clinical trials (InTIME-II, ASSENT-2 and MAGIC) and the National Registry of Myocardial Infarction.

METHODS AND RESULTS

The risk score was calculated for each patient (N=121,085) and the frequency distribution plotted for each population. The Risk Score Profiles were compared using the Kolmogorov-Smirnov test. The Risk Score Profile demonstrated a striking concordance between the baseline risk of patients in InTIME-II and ASSENT-2 (median scores in each= 3[1,4], P=0.11). In contrast, the distributions in MAGIC (designed to enroll high risk) and NRMI (registry) were shifted significantly toward higher risk (median scores=4[3,5] for MAGIC and 4[2,6] in NRMI, P < 0.0001 for each vs. InTIME-II). A graded relationship between the risk score and mortality was evident in each study (P<0.0001).

CONCLUSIONS

The frequency distribution of the TIMI Risk Score, or similar tools for risk assessment, may be used to quantify and readily compare the risk profile of populations enrolled in clinical studies.

摘要

目的

解读临床研究的结果及实践意义需要准确描述人群的基线风险。我们评估了ST段抬高型心肌梗死的心肌梗死溶栓（TIMI）风险评分，将其作为一种工具，用于描述和比较三项临床试验（InTIME-II、ASSENT-2和MAGIC）以及国家心肌梗死注册研究中所纳入人群的风险特征。

方法与结果

计算了每位患者（N = 121,085）的风险评分，并绘制了各人群的频率分布。使用柯尔莫哥洛夫-斯米尔诺夫检验比较风险评分概况。风险评分概况显示InTIME-II和ASSENT-2患者的基线风险之间存在显著一致性（每组中位数评分 = 3[1,4]，P = 0.11）。相比之下，MAGIC（旨在纳入高风险患者）和NRMI（注册研究）中的分布显著向更高风险偏移（MAGIC的中位数评分为4[3,5]，NRMI为4[2,6]，与InTIME-II相比，每组P < 0.0001）。在每项研究中，风险评分与死亡率之间均存在分级关系（P < 0.0001）。