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纵向临床试验中附着丧失测量的可靠性

Reliability of attachment loss measurements in a longitudinal clinical trial.

作者信息

Best A M, Burmeister J A, Gunsolley J C, Brooks C N, Schenkein H A

机构信息

Clinical Research Center for Periodontal Diseases, School of Dentistry, Virginia Commonwealth University, Richmond.

出版信息

J Clin Periodontol. 1990 Sep;17(8):564-9.

PMID:2212086
Abstract

In order to appropriately carry out a longitudinal assessment of periodontal attachment loss in individuals with untreated periodontitis, reliable criteria for determining "real" changes in attachment level (AL) are required. In the present study, 25 subjects were to be examined every 2 months for up to 2 years to determine changes in AL and to relate clinical and laboratory criteria to such changes. Trained examiners for the study underwent calibration trials to determine inter-examiner and intra-examiner reliability both before the study and at intervals during the study. It was found that AL measurements were in agreement within 2 mm more than 95% of the time. The calibration trials provided an estimate of the error in attachment loss measurements, since no "real" attachment loss had occurred. From estimates of measurement error, the probability of false positive changes were determined. It was found that acceptable false positive rates (less than 5%) could be achieved if 2 examiners each detected 3 mm change at a given site or if 2 examiners each detected 2 mm change at a site and verified that this change persisted at a subsequent examination. The results of the longitudinal trial were then compared to the probability estimates calculated from the calibration trials. It was found that probabilities of AL changes detected during the longitudinal trial for less stringent conditions than described above (e.g., single examiner, 2 examiners unconfirmed) were similar to to previously estimated false positive rates.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

为了对未经治疗的牙周炎患者的牙周附着丧失进行恰当的纵向评估,需要可靠的标准来确定附着水平(AL)的“真实”变化。在本研究中,25名受试者每2个月接受一次检查,为期2年,以确定AL的变化,并将临床和实验室标准与这些变化相关联。参与该研究的经过培训的检查者在研究前以及研究期间每隔一段时间进行校准试验,以确定检查者间和检查者内的可靠性。结果发现,超过95%的时间里,AL测量值在2毫米范围内一致。由于没有发生“真实”的附着丧失,校准试验提供了附着丧失测量误差的估计值。根据测量误差的估计值,确定了假阳性变化的概率。结果发现,如果两名检查者在给定部位均检测到3毫米的变化,或者两名检查者在一个部位均检测到2毫米的变化并在后续检查中证实该变化持续存在,那么可以实现可接受的假阳性率(小于5%)。然后将纵向试验的结果与校准试验计算出的概率估计值进行比较。结果发现,在纵向试验中检测到的AL变化概率,对于比上述情况更宽松的条件(例如,单一检查者、两名检查者未确认),与先前估计的假阳性率相似。(摘要截短至250字)

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