If Nothing Goes Wrong, Is Everything All Right? Interpreting Zero Numerators.¶
Hanley, J. A. (1983). If Nothing Goes Wrong, Is Everything All Right? Interpreting Zero Numerators. JAMA, 249(13), 1743-1745.
Cited by¶
2 citations across 2 artifacts.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Absence Of Evidence Vs Evidence Of Absence
- In drug and vaccine safety, a rare event observed zero times in N patients only constrains the true rate to roughly below 3/N, and that constraint depends on N, on exposure duration, and on the ascertainment apparatus, so "no signal" is not by itself evidence of safety.
This sourceDerives the rule of three: zero events in N observations bounds the true rate at roughly 3/N, the bound on which the worked drug-safety figures rest.
- In drug and vaccine safety, a rare event observed zero times in N patients only constrains the true rate to roughly below 3/N, and that constraint depends on N, on exposure duration, and on the ascertainment apparatus, so "no signal" is not by itself evidence of safety.
- Empirical No-Failure Anchor
- With zero events observed in n independent units, the one-sided ninety-five-percent upper bound on the underlying rate is approximately three divided by n, so ten clean units remain consistent with a failure rate near thirty percent while a hundred clean units narrow it to roughly three; the anchor level is identical in both cases and the claim differs by an order of magnitude.
This sourceDerives the rule of three, under which zero events in n units leaves rates up to roughly three over n consistent with the observation, and tabulates 0 of 10 as excluding only rates above about 26 percent.
- With zero events observed in n independent units, the one-sided ninety-five-percent upper bound on the underlying rate is approximately three divided by n, so ten clean units remain consistent with a failure rate near thirty percent while a hundred clean units narrow it to roughly three; the anchor level is identical in both cases and the claim differs by an order of magnitude.
Verification¶
Does it exist? Confirmed. This work's DOI resolves to a registered record, which fixes its identity. That is all it fixes.
Does it back the claim? Not recorded. Neither this nor any other of the 2 citations of this work carries a recorded support check.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
See how references were verified.
Links previously used in the corpus¶
Before the registry existed this work was also linked 1 other way.
Registry ID ref:05a2367976b7 · see in the full table