Comorbidity assessment using the Index of Coexistent Diseases in a multicenter clinical trial
Comorbidity assessment using the Index of Coexistent Diseases in a multicenter clinical trial
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DOI：
10.1046/j.1523-1755.2001.00954.x
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发表时间：
2001-10-01
影响因子：
19.6
通讯作者：
Levey, AS
中科院分区：
文献类型：
--
作者：
Miskulin, DC;Athienites, NV;Levey, AS
背景血液透析（HEMO）研究是一项多中心试验，旨在确定血液透析剂量和膜通量是否影响生存率。合并症也是生存的重要决定因素，因此，需要一种准确可靠的方法来评估合并症。在HEMO研究中，使用共存疾病指数（ICED）在基线和每年评估合并症。我们描述了仪器。其在HEMO研究中的实施，以及试验中前1000名随机患者的合并症评估结果。ICED在两个量表中汇总了19种医疗状况和11种身体损伤的存在和严重程度：疾病严重程度指数（IDS）和身体损伤指数（IPI）。最终ICED评分由IDS和IPI峰值评分相结合的算法确定。ICED的范围从0到3，反映了严重程度的增加。对15个临床中心的研究人员进行了培训，以更新和提取透析病历中的数据。数据的可用性，结构效度的措施，和措施的可靠性是足够的，99.8%和60.6%的患者有共病的条件，至少一个IDS或IPI类别，分别。按ICED节段划分的患者分布为0例（02%）、1例（34.9%）。2例（31.2%），3例（33.7%）。在多变量分析中，以下因素与更严重的合并症显著相关：年龄较大、糖尿病和其他肾病原因、教育水平较低、就业状况（失业和退休）、透析持续时间较长和血清肌酐较低。在调整其他因素后，各临床中心的合并症严重程度存在显著差异。该模型的R-2为25.3%，表明ICED中的很大一部分变化不能由这些因素解释。我们的结论是，在透析患者的多中心临床试验中，使用ICED进行合并症评估是可行的。透析患者中存在大量合并症负担，这不能很好地用肾脏疾病的原因、人口统计学和社会经济因素以及常见的临床和实验室测量来解释。在病例组合调整中，这些变量不应被视为共病条件的替代品。合并症评估有助于描述样本人群，提高治疗效果的精确度，并可能用作结局测量。
Background. The Hemodialysis (HEMO) Study is a multicenter trial designed to determine whether hemodialysis dose and membrane flux affect survival. Comorbid conditions are also important determinants of survival, and thus, an accurate and reliable method to assess comorbidity was required. Comorbidity was being assessed at baseline and annually in the HEMO Study using the Index of Coexistent Disease (ICED). We describe the instrument. its implementation in the HEMO Study, and the results of comorbidity assessment in the first 1000 randomized patients in the trial.Methods. The ICED aggregated the presence and severity of 19 medical conditions and 11 physical impairments within two scales: the Index of Disease Severity (IDS) and the Index of Physical Impairment (IPI). The final ICED score was determined by an algorithm combining the peak scores for the IDS and IPI. The range of the ICED was from 0 to 3, reflecting increasing severity.Results. Study personnel at 15 clinical centers were trained to update and abstract data from the dialysis medical records. Availability of data, measures of construct validity, and measures of reliability were adequate; 99.8% and 60.6% of patients had comorbid conditions in at least one IDS or IPI category, respectively. The distribution of patients by ICED level was 0 (02%), 1 (34.9%). 2 (31.2%), and 3 (33.7%). In multivariable analysis, the following factors were significantly associated with more severe comorbidity: older age, diabetes and other causes of renal disease, a lower level of education, employment status (unemployed and retired), longer duration of dialysis, and lower serum creatinine. There was a significant variation in the severity of comorbidity among clinical centers after adjustment for other factors. The R-2 of the model was 25.3%, indicating that a substantial proportion of the variation in the ICED was not explained by these factors.Conclusions. We conclude that comorbidity assessment using the ICED is feasible in multicenter clinical trials of dialysis patients. There is a large burden of comorbidity in dialysis patients, which is not well explained by the cause of renal disease, demographic, and socioeconomic factors and common clinical and laboratory measurements. These variables should not be considered substitutes for comorbid conditions in case-mix adjustment. Comorbidity assessment is useful to describe the sample population, to improve the precision of the treatment effect, and to use possibly as an outcome measurement.