Kolb Hubert, Martin Stephan, Lodwig Volker, Heinemann Lutz, Scherbaum Werner A, Schneider Berthold
Hagedorn Research Institute, Gentofte, Denmark.
J Diabetes Sci Technol. 2009 Nov 1;3(6):1507-15. doi: 10.1177/193229680900300633.
In the German multicenter, retrospective cohort study (ROSSO), those patients with type 2 diabetes who performed self-monitoring of blood glucose (SMBG) had a better long-term clinical outcome. We analyzed whether confounders accounted for the lower rate of clinical events in the SMBG cohort.
ROSSO followed 3268 persons from diagnosis of type 2 diabetes for a mean of 6.5 years. Data were retrieved from patient files of randomly contacted primary care practices.
In total, more than 60 potential confounders were documented, including nondisease-associated parameters such as patient's health insurance, marital status, habitation, and characteristics of diabetes centers. There were only modest differences for these parameters between groups with versus without SMBG, and multiple adjustments did not weaken the association of SMBG use with better outcome (odds ratio 0.65, 95% confidence interval 0.53-0.81, p < .001). This was also true for subgroups of patients defined by type of antidiabetes treatment. Propensity score analysis confirmed the association of SMBG use with outcome. Using key baseline parameters, 813 matching pairs of patients were identified. The analysis again showed a better long-term outcome in the SMBG group (hazard ratio 0.67 p = .004).
An influence of nonrecognized confounders on better outcome in the SMBG group is rendered improbable by similar results obtained with adjustments for disease-associated or disease-independent parameters, by the analysis of patient subgroups, by propensity score analysis and by performing a matched-pair analysis. The higher flexibility in pharmacological antidiabetes treatment regimens in the SMBG cohort suggests a different attitude of treating physicians and patients in association with SMBG.
在德国的多中心回顾性队列研究(ROSSO)中,那些进行血糖自我监测(SMBG)的2型糖尿病患者具有更好的长期临床结局。我们分析了混杂因素是否可解释SMBG队列中较低的临床事件发生率。
ROSSO对3268例2型糖尿病确诊患者进行了平均6.5年的随访。数据从随机联系的初级保健机构的患者档案中获取。
总共记录了60多个潜在混杂因素,包括与疾病无关的参数,如患者的健康保险、婚姻状况、居住情况以及糖尿病中心的特征。在进行SMBG和未进行SMBG的组之间,这些参数仅有适度差异,多次调整并未削弱SMBG使用与更好结局之间的关联(优势比0.65,95%置信区间0.53 - 0.81,p <.001)。对于按抗糖尿病治疗类型定义的患者亚组也是如此。倾向评分分析证实了SMBG使用与结局之间的关联。利用关键基线参数,确定了813对匹配患者。分析再次显示SMBG组有更好的长期结局(风险比0.67,p =.004)。
通过对疾病相关或疾病无关参数进行调整、对患者亚组进行分析、倾向评分分析以及进行配对分析所获得的相似结果,使得未被识别的混杂因素对SMBG组更好结局产生影响的可能性不大。SMBG队列中抗糖尿病药物治疗方案具有更高的灵活性,这表明治疗医生和患者在SMBG方面持有不同态度。