ITEM 20.  Report any adverse events from performing the index tests or the reference standard.

Example

A mean period of 15 min was sufficient for full investigation of the uterine cavity. The mean tolerance on a pain scale range of 0 to 10 was 1. However, sonohysterography has not been tolerated once (indication of pain to 10). The patient had pelvic pains that were regressive with phosphoglucinol and after 20 min of rest in decubitus position. Only one complication was recorded during the subsequent 3 days, an endometritis in a patient with unbalanced diabetes. Ampicilen antibiotic treatment was efficient permitting a complete recovery.[1]

Not all tests are safe. Measuring and reporting of adverse events in studies of diagnostic accuracy can provide additional information about the clinical usefulness of a particular test. The requirement to report adverse events applies equally to diagnostic research and research of treatments.[2]

It can also be important to learn about the invasiveness and risks of the reference standard used. For example, if in the evaluation of the positive results of hemocult screening, colonscopy, sigmoidscopy, and double contrast barium enema were to be used, one might expect complications (perforation or hemorrhage) once in 300-900 subjects investigated.[3]

The example comes from the first part of the results section of a study of sonohysterography for the diagnosis of intrauterine abnormalities, with histopathology and clinical outcome as the composite reference standard.

References