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[临床研究中的系统误差:全面调查]

[Systematic errors in clinical studies : A comprehensive survey].

作者信息

Golder W A

机构信息

, 23 rue de l'Oriflamme, 84000, Avignon, Frankreich.

出版信息

Z Rheumatol. 2017 Feb;76(1):71-82. doi: 10.1007/s00393-016-0253-5.

DOI:10.1007/s00393-016-0253-5
PMID:28083633
Abstract

Systematic errors and related phenomena represent an intrinsic challenge to the quality of clinical research. As a consequence even otherwise methodologically demanding studies may produce results that systematically differ from the true values. Systematic errors relating to investigative medicine are divided into six groups according to their affiliation with the consecutive chronological sections of the study. Bias can occur in preliminary literature research in the field, specifying the study design and selecting the study sample, measuring exposure and outcome, analyzing the data, interpreting the analyses and publishing the results. The most important systematic errors that concern diagnostic and interventional studies are created by access to the data of previous tests, calculated study design, preselection of the participants, comparison with non-contemporaneous controls, antedating the time of diagnosis and overdiagnosis of slowly progressive forms of diseases examined. Checking the measured values often leads to a mosaic of several biases with one being more or less dominant. Even by exercising due care in the preparation and performance of the study, the majority of distortions cannot be eliminated but only diminished. It is essential to consider each detected bias as a potential full or partial argument in support of an observed correlation. The control of systematic errors and related phenomena is both a significant element of the discussion of the study report and a key element for assessment of its scientific value.

摘要

系统误差及相关现象是临床研究质量面临的固有挑战。因此,即使是其他方面对方法要求很高的研究,其结果也可能与真实值存在系统性差异。与调查医学相关的系统误差根据其与研究连续时间阶段的关联分为六组。在该领域的初步文献研究、确定研究设计和选择研究样本、测量暴露因素和结果、分析数据、解释分析结果以及发表研究结果等过程中都可能出现偏倚。与诊断性和干预性研究相关的最重要的系统误差是由获取先前检查的数据、计算得出的研究设计、参与者的预先选择、与非同期对照进行比较、提前诊断时间以及对所研究的缓慢进展性疾病形式的过度诊断所造成的。对测量值进行核查往往会导致多种偏倚交织在一起,其中一种偏倚或多或少占主导地位。即使在研究的准备和实施过程中格外小心,大多数偏差也无法消除,只能减少。必须将每一个检测到的偏倚视为支持所观察到的相关性的潜在完整或部分论据。对系统误差及相关现象的控制既是研究报告讨论的重要内容,也是评估其科学价值的关键因素。

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