%0 Journal Article
%T To whom do the results of the multicenter, randomized, controlled INSECT trial (ISRCTN 24023541) apply? - assessment of external validity
%A Lars Fischer
%A Hanns P Knaebel
%A Henriette Golcher
%A Thomas Bruckner
%A Markus K Diener
%A Jeannine Bachmann
%A Markus W B¨ąchler
%A Christoph M Seiler
%J BMC Surgery
%D 2012
%I BioMed Central
%R 10.1186/1471-2482-12-2
%X Existing evidence suggests that the transfer of results of randomized controlled trials into clinical practice may be limited. Potential reasons can be attributed to aspects of external validity. The aim of this study is to investigate issues related to the external validity of the INSECT trial.All participating surgical departments were categorized and the clinical and baseline characteristics of randomized patients were evaluated. In addition, demographic and clinical data of all screened and randomized patients at the Departments of Surgery in Heidelberg and Erlangen were analyzed.Twenty-five centers enrolled a total of 625 patients. These centers included eight primary, 11 secondary, and six tertiary care centers. The tertiary care centers enrolled the most patients (n = 237, 38%) followed by the primary care centers (n = 199, 32%) and the secondary care centers (n = 189 patients; 30%). The mean number and baseline data of randomized patients did not differ between the three types of care centers (p = 0.09). Overall, the treatment according to protocol was at least 92%. At the Department of Surgery, University of Heidelberg, 307 patients were screened and 60 out of 130 eligible patients were randomized. There were no differences in demographic and clinical baseline data between included and non-included patients. In Erlangen, 351 patients were screened and 57 out of 106 eligible patients randomized.Results of the INSECT trial are applicable to a broad spectrum of patients treated at different hospital levels.Incisional hernias of midline incisions are the most common long-term complication after major abdominal surgery with an incidence ranging from 5% - 24% [1]. Although randomized clinical trials (RCTs) and meta-analyses [2] have been performed in order to define optimal closure strategies, clinical uncertainty still has not been resolved.It has been shown that RCTs have average patient exclusion rates ranging from 73% to 97% [3]. This "selection" of patients
%U http://www.biomedcentral.com/1471-2482/12/2