To the Editor: Dr Casarett and colleagues1 tackled an important issue in modern medicine.
Quality improvement initiatives are key strategies in ensuring accountability
in health care. While it is appropriate that the QI movement itself be held
accountable, draconian restrictions that could cripple the continued growth
and development of QI are unnecessary and unwise.
Widespread adoption and use of the authors' criteria would result not
only in severe curtailment of QI initiatives in most settings but would also
inundate and render useless the IRB system of accountability for research
in clinical settings. The second proposed criterion—whether a QI initiative
imposes additional risks or burdens beyond the standard of practice to make
results generalizable—seems reasonable to us. It is the first proposed
criterion—whether the majority of patients who "participate" would benefit
from the knowledge to be gained—that is problematic. We believe the
critical question to be asked about a QI initiative is whether the patients
being studied will be harmed by the effort.
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