Detection of adverse drug reactions in a clinical trial using two types of questioning.
Two methods of assessing adverse drug effects-an open-ended question versus a checklist-were compared in a clinical study involving 515 patients being treated with bacampicillin for gonorrhea. Results indicate that adverse reactions are reported more frequently if a checklist is used. However, it was also observed that more serious side effects are usually reported in response to an open-ended question rather than a checklist. Thus it was concluded that the optimal procedure for assessing adverse reactions is to record responses to both an open-ended question and a checklist.
D000667:Ampicillin / Q000009:adverse effects / Q000031:analogs & derivatives*; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011795:Surveys and Questionnaires
D000900:Anti-Bacterial Agents; D000667:Ampicillin; C011674:bacampicillin