[Quality of a non-subsidised multicentre randomised trial in non-academic hospitals; an audit].
OBJECTIVE
To determine whether a randomised clinical trial in general hospitals can be performed in a reliable way without financial support.


METHODS
Descriptive.


METHODS
The trial involved 1040 patients in whom an inguinal hernia had been corrected with a propylene mat in the period 1998-2003. They were randomised to either a single dose of prophylactic antibiotics or a placebo. The primary outcome measure was 'wound infection during the 3 months after the operation'. The audit concerned 98 patients, chosen at random, for whom 3 investigators from an independent bureau collected data from the patient charts and study forms during 3 clinic visits in the period 2000-2003. Whether various quality criteria had been fulfilled was assessed on the basis of these data.


RESULTS
In all 4 participating clinics, approval of the medical ethics assessment committees had been obtained. The trial protocol corresponded to the consent form. A proper informed consent was obtained from 63/98 patients (64%). The last (third) follow-up was missed in 23/98 patients (23%). During the trial, the patients who had missed this follow-up were contacted by telephone, which succeeded in 98%. The status and trial forms had been filled out completely and correctly with regard to the peroperative randomisation forms in 90% of the cases and with regard to the follow-up in 75% of the cases. The trial protocol was adhered to on almost every point.


CONCLUSIONS
The data collection in the studied, not financed trial was adequate, probably as a result of the relatively simple questions posed, the easily determinable outcome measure and the efforts expended above and beyond the protocol.
Aufenacker
Th J
TJ
Onze Lieve Vrouwe Gasthuis, afd Chirurgie, Amsterdam. aufenacker@hetnet.nl
Bannenberg
J
J
van Geldere
D
D
Scheijde
E
E
Juttmann
J W
JW
Gouma
D J
DJ
Simons
M P
MP
D019072:Antibiotic Prophylaxis; D032962:Consent Forms; D005260:Female; D005500:Follow-Up Studies; D006552:Hernia, Inguinal / Q000601:surgery; D006769:Hospitals, General / Q000592:standards; D006801:Humans; D008297:Male; D008485:Medical Audit; D009426:Netherlands; D016032:Randomized Controlled Trials as Topic / Q000191:economics* / Q000592:standards*; D013530:Surgical Wound Infection / Q000453:epidemiology* / Q000517:prevention & control*