title: (Unlearned) lessons from John Graunt and Kenneth Rothman: a "CLASSic" example.
abstract: This commentary reviews the work of John Graunt and Kenneth J. Rothman on statistical significance and the need for prespecification of study end points. The authors argue that it is dangerous to substitute oversimplifications based exclusively on whether a result has reached statistical significance for a rational process of causal inference. An example is given based on the Celecoxib Long-term Arthritis Safety Study.
authors.affiliation: Drug Safety Surveillance, Pfizer Inc, Peapack, New Jersey 07977, USA. felix.m.arellano@pfizer.com
authors.forename: Felix M
authors.initials: FM
authors.lastname: Arellano
authors.forename: Jordi
authors.initials: J
authors.lastname: Castellsague
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D004812:Epidemiologic Methods; D015340:Epidemiologic Research Design; D006801:Humans; D010437:Peptic Ulcer / Q000139:chemically induced; D016032:Randomized Controlled Trials as Topic
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal