[Systematic errors in clinical studies : A comprehensive survey]

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.

Keywords: Bias; Blinding; Clinical study; Randomization; Sources of error.