Prognostic scores and design of clinical studies
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Randomized controlled clinical trials are the preferred scientific method and remain the vital bridge between basic science and improvements in health care according to general agreement. However, discussion has revealed various critical issues in the field of intraabdominal infection. Many of these critical points can be dealth with by prognostic scoring systems. In this paper the application areas for scores in clinical trials on intraabdominal infections are presented. These areas cover: assessment of severity of disease, definition of inclusion/exclusion criteria, analysis of comparability, adjustment for noncomparability, definition of end points and comparison of observed versus predicted outcome. The use of scoring systems in defining treatment policies is still experimental.
KeywordsControl Clinical Trial Intraabdominal Infection Randomize Control Clinical Trial Selective Decontamination Temporary Abdominal Closure
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- 3.Discussion Forum: Methodology of clinical trial in sepsis. Theor. Surg. 9 (1994) 10–67.Google Scholar
- 6.Gastinne, H., Wolff, M., Delatour, F., Faurisson, F., Chevet, S. andthe French Study Group on Selective Decontaminuation of the Digestive Tract: A controlled trial in intensive care units of selective decontamination of the digestive tract with non-absorbable antibiotics. N. Engl. J. Med. 326 (1992) 594–599.PubMedGoogle Scholar
- 10.Wittmann, D. H., Bansal, N., Bergstein, J. M., Wallace, J. R., Wittmann, M. M., Aprahamian, C.: Staged abdominal repair compares favorably with conventional operative therapy for intra-abdominal infections when adjusting for prognostic factors with a logistic model. Theor. Surg. 9 (1994) 201–207.Google Scholar
- 12.Nyström, P. O., Bax, R., Dellinger, E. P., Dominioni, L., Knaus, W. A., Meakins, S. L., Ohmann, C., Solomkin, J. C., Wacha, H., Wittmann, D. H.: Proposed definitions for diagnosis, severity scoring, stratification and outcome for trials on intraabdominal infection. World J. Surg. 14 (1990) 148–158.PubMedCrossRefGoogle Scholar
- 13.Pilz, G., Fateh-Moghadam, S., Viell, B., Bujdoso, O., Döring, G., Marget, W., Neumann, R., Werdan, K.: Supplement immunoglobin therapy in sepsis and septic shock—comparison of mortality under treatment with polyvalent i.v immunoglobin versus placebo. Protocol of a multicenter, randomized, prospective, double-blind trial. Theor. Surg. 8 (1993) 61–83.Google Scholar