Feres Magda, Retamal-Valdes Belen, Faveri Marcelo, Duarte Poliana, Shibli Jamil, Soares Geisla Mary Silva, Miranda Tamires, Teles Flavia, Goodson Max, Hasturk Hatice, Van Dyke Thomas, Ehmke Benjamin, Eickholz Peter, Schlagenhauf Ulrich, Meyle Joerg, Koch Raphael, Kocher Thomas, Hoffmann Thomas, Kim Ti-Sun, Kaner Dogan, Figueiredo Luciene Cristina, Doyle Helio
Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil; Email
Department of Periodontology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.
J Int Acad Periodontol. 2020 Apr 1;22(2):41-53.
The selection of proper outcome measures is a critical step in clinical research. Most randomized clinical trials (RCTs) assessing the effects of initial anti-infective periodontal therapies use surrogate outcomes as primary outcome variables, such as mean changes in probing depth (PD) or in clinical attachment. However, these parameters do not reflect disease remission/control at patient level, which has led to subjective interpretations of the data from RCTs and Systematic Reviews. Based on a comprehensive analysis of 724 patients from USA, Germany and Brazil treated for periodontitis, this paper suggests that the clinical endpoint of "≤4 sites with PD≥5mm" is effective in determining disease remission/control after active periodontal treatment and therefore, may represent a pertinent endpoint for applying the treat-to-target concept in RCTs. Furthermore, regression models showed that the presence of >10% and >20% sites with bleeding on probing in the mouth post-treatment increases the risk of a patient leaving the endpoint from 1-2 years (OR=3.5 and 8.7, respectively). Researchers are encouraged to present results on this outcome when reporting their trials, as this will allow for an objective comparison across studies and facilitate systematic reviews, and consequently, the extrapolation of data from research to clinical practice.
选择合适的结局指标是临床研究中的关键一步。大多数评估初始抗感染牙周治疗效果的随机临床试验（RCT）使用替代结局作为主要结局变量，如探诊深度（PD）或临床附着的平均变化。然而，这些参数并不能反映患者层面的疾病缓解/控制情况，这导致了对RCT和系统评价数据的主观解读。基于对来自美国、德国和巴西的724例牙周炎患者的综合分析，本文表明“≤4个位点PD≥5mm”这一临床终点在确定积极牙周治疗后疾病的缓解/控制方面是有效的，因此，可能代表了在RCT中应用治疗至目标概念的相关终点。此外，回归模型显示，治疗后口腔内探诊出血位点>10%和>20%会增加患者在1 - 2年内未达到终点的风险（OR分别为3.5和8.7）。鼓励研究人员在报告试验时展示该结局的结果，因为这将允许对各项研究进行客观比较，并促进系统评价，从而便于将研究数据外推至临床实践。
