No false negative paradox in STEMI-NSTEMI diagnosis

Introduction

ST-segment elevation myocardial infarction (STEMI) diagnosis is based on a clinical presentation and ST-segment elevation (STE) in at least two consecutive leads. Despite being deeply rooted in both the literature and in current medical knowledge and having been pivotal in advancing reperfusion therapy for patients with acute myocardial infarction (MI), the diagnosis of STEMI presents a significant issue: What we, the authors, call the ‘no false negative paradox’. This paradox potentially makes it challenging to recognise a false negative diagnosis of STEMI and makes it difficult to appreciate the significance of an acute coronary occlusion (ACO) that could benefit from early reperfusion in door-to-needle or door-to-balloon times despite the absence of STE.1

This paradox stems from the incorporation bias and feedback sanction bias detailed in subsequent paragraphs. This is an opinion paper where the patient and the public were not involved.

The incorporation bias

In conducting diagnostic test accuracy studies, the selection of the population, index test and reference test prior to study execution is fundamental. However, a methodological problem arises when the index test and the reference test are identical or when they overlap which is known as ‘incorporation bias’.2 This bias falsely inflates the accuracy of the results of the study above their true value. During ACO, for someone to be considered ‘diseased’ (STEMI), the presence of parts of the definition of ‘diseased’ (STE) is mandatory. This makes ‘diseased’ and ‘positive’ almost the same causing sensitivity (the ability of a test to detect true positives among the diseased) to appear as 100% because the test is essentially comparing itself to a mirror. The problem is that a perfectly sensitive test has no false negatives. Because STE is part of both the test and the disease definition, the absence of …

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