What fraction of hospital ulcer patients is eligible for prospective drug trials?
Data of all 397 gastric ulcer patients diagnosed and treated at Jorvi Hospital, Finland, during 1980-1984 were collected and the outcome followed up for 5-7 years. The commonly used exclusion criteria of prospective drug trials were applied to this series. Only 29% of patients would have been eligible for a trial. The excluded patients were older, their ulcer was larger and more proximally located. Nearly all major complications of gastric ulcer disease leading to surgery (bleeding, perforation, obstruction) and deaths due to gastric ulcer disease appeared in the excluded group. Exclusion criteria may profoundly affect the selection of patients and the results. When many patients are excluded the applicability of results to the whole material is questionable.
Kääriäinen
I
I
Jorvi Hospital, Espoo, Finland.
Sipponen
P
P
Siurala
M
M
D002986:Clinical Trials as Topic; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000473:pathology