Titre du document / Document title

Kwaliteit van een ongefinancierde multicentrische gerandomiseerde trial in niet-academische ziekenhuizen; een audit = Quality of a non-subsidised multicentre randomised trial in general hospitals; an audit

Auteur(s) / Author(s)

AUFENACKER Th. J. ; BANNENBERG J. ; GELDERE D. Uan ; SCHEIJDE E. ; JUTTMANN J. W. ; GOUMA D. J. ; SIMONS M. P. ;

Résumé / Abstract

Objective. To determine whether a randomised clinical trial in general hospitals can be performed in a reliable way without financial support. Design. Descriptive. Method. The trial involved I040 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. Conclusion. 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.

Revue / Journal Title

Nederlands tijdschrift voor geneeskunde   ISSN 0028-2162 

Source / Source

2006, vol. 150, n^o24, pp. 1337-1341 [5 page(s) (article)]

Langue / Language

Neerlandais

Editeur / Publisher

Bohn Stafleu Loghum, Houten, PAYS-BAS  (1857) (Revue)

Localisation / Location

INIST-CNRS, Cote INIST : 875, 35400014250188.0050