For RCTs using time-to-event outcomes, non-blinded assessment overstated the hazard ratio by approximately 27%. For clinical trials that used measurement scale outcomes, non-blinded outcome assessment exaggerated effect size by 68% (6). For RCTs with binary outcomes, non-blinded outcome assessors generated odds ratios that, on average, were exaggerated by 36%. The studies included a range of conditions from angina to wound treatment to psychiatric disorders. Three types of RCTs were investigated: those with binary outcomes RCTs with measurement scale outcomes and RCTs with time-to-event outcomes. Hróbjartsson and colleagues produced three systematic reviews estimating the size of the impact of observer bias, by comparing estimates from studies in which outcome assessors were blinded to the intervention with those in which outcome assessors were not blinded. Observer bias may also occur if the researcher has a preconceived idea of what the blood pressure ought to be, leading to arbitrary adjustments of the readings. Clinicians measuring participants blood pressure using mercury sphygmomanometers have been found to round up, or down, readings to the nearest whole number. Observer bias has been repeatedly been documented in studies of blood pressure. However, if any part of the data collection process involves observation, observer bias can affect the measurement in the study. Randomized controlled trials are designed to provide the fairest test of an intervention. Observers might be somewhat conscious of their own biases about a study or may be unaware of factors influencing their decisions when recording study information. By recording subjective data, predispositions of the observer are likely to underpin observer biases. Observation of objective data, such as death, is at much lower risk of observer bias.īiases in recording objective data may result from inadequate training in the use of measurement devices or data sources or unchecked bad habits. Where subjective judgement is part of the observation, there is great potential for variability between observers, and some of these differences might be systematic and lead to bias. Colour change tests can be interpreted differently by different observers. Different observers might tend to round up or round down a measurement scale. For example, in the assessment of medical images, one observer might record an abnormality but another might not. Many healthcare observations are open to systematic variation. Parta’s Dictionary of Epidemiology gives the following definition: “Systematic difference between a true value and the value actually observed due to observer variation” and continues to describe observer variation. Observer bias is a type of detection bias that can affect assessment in observational and interventional studies.
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