TABLE 1—

Comparison of Criterion Standard Research and Bad Outcome–Focused Quality Assurance (QA)

Characteristics of Criterion Standard Research (Randomized Controlled Trial)	Characteristics of Bad Outcome–Focused QA
The study assigns treatment to the patient.	The legitimate patient–physician relationship has determined a therapy for the patient's direct and immediate benefit. The study performed “after the fact of care” has no impact on therapy assignment.
The assignment of therapy is made randomly, permitted by clinical uncertainty (equipoise) as to whether the investigational drug, or an alternative or a placebo, is advantageous for the individual patient.	Therapeutic assignment is independent of the study and for the purpose of producing the best outcome, given the available medical knowledge.
A group is assigned “control status,” with the therapeutic intervention intentionally withheld to allow assessment of efficacy.	No control group is intentionally generated at the time of care delivery for the purpose of the study. A pseudocontrol group might be assembled after the fact, taking advantage of natural variation in clinical practice.
Therapy is delivered in a blinded fashion. Neither the investigator nor the patient knows to whom the active agent or placebo was given.	The physician and patient are both aware of the drugs administered, their side effects, and their putative utility.
Assessment of outcome is blinded to therapy for the purpose of establishing efficacy of the intervention.	Process that led to the known “bad outcome” is assessed for the purpose of discovering errors in practice compared with “community standard of practice.” Should errors in practice be found, corrective measures for the involved physicians and other health care workers will follow.
Society is the beneficiary. New knowledge developed is generalizable to other patient populations that will benefit.	Society is the beneficiary, since “dangerous doctors” will correct their errors or be denied access to patients. The index patient cannot be helped or harmed because this study assesses what led to the bad outcome, which cannot now be reversed. New generalizable medical knowledge is not an expected outcome of the review.