Serious adverse events
Nurses in the catheter lab, coronary care unit (CCU) and
cardiology wards had a vital role in data collection.
Importantly, their documentation of care was integral to
the capture of potential adverse events. Although the
study team trawled clinical records, it was gratifying that
busy nursing teams often took the time to specifically flag
any concerns.
The aim of HEAT-PPCI was to learn more about the
most effective treatment for a high-risk STEMI population.
It was inevitable, therefore, that patients would experience
serious adverse events (SAEs), such as reinfarction,
bleeding, stroke and, unfortunately, death. Each SAE was
reviewed by two adjudicators independent of each other
and not involved in the care of the patient. One of the
research nurses developed an innovative system to allow
the creation of electronic adjudication ‘packs’ in writable
portable document format (pdf) files. Each adjudicator
would receive anonymised and blinded clinical information
from which consensus was eventually reached. This use of
electronic adjudication provided both clarity and efficiency
by completely negating the need for time-consuming
searches of clinical records.