25. Adverse events
What to write
Any adverse events from performing the index test or the reference standard.
Explanation
Not all medical tests are equally safe, and in this, they do not differ from many other medical interventions.1,2 The testing procedure can lead to complications, such as perforations with endoscopy, contrast allergic reactions in CT imaging or claustrophobia with MRI scanning.
Measuring and reporting of adverse events in studies of diagnostic accuracy will provide additional information to clinicians, who may be reluctant to use them if they produce severe or frequent adverse events. Actual application of a test in clinical practice will not just be guided by the test's accuracy, but by several other dimensions as well, including feasibility and safety. This also applies to the reference standard.
In the example, the authors distinguished between ‘significant’ and ‘minor’ adverse events, and explicitly reported how often these were observed.
Example
‘No significant adverse events occurred as a result of colonoscopy. Four (2%) patients had minor bleeding in association with polypectomy that was controlled endoscopically. Other minor adverse events are noted in the appendix’.3
Training
The UK EQUATOR Centre runs training on how to write using reporting guidelines.
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