Skip to main content
Log in

Prognostic scores and design of clinical studies

  • Special Addendum—Part I
  • Published:
Infection Aims and scope Submit manuscript

Summary

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Spodick, D. H.: Randomized controlled clinical trials. The behavioral case. JAMA 247 (1982) 2258–2260.

    Article  PubMed  CAS  Google Scholar 

  2. Beahrs, O. H.: Clinical trials from the surgeon’s view. Cancer 65 (1990) 2383–2384.

    Article  PubMed  CAS  Google Scholar 

  3. Discussion Forum: Methodology of clinical trial in sepsis. Theor. Surg. 9 (1994) 10–67.

  4. Ohmann, C., Hau, T.: Prognostic indices in peritonitis. Hepato-gastroenterology 44 (1997) 937–946.

    PubMed  CAS  Google Scholar 

  5. Ohmann, C., Yang, Q., Hau, T., Wacha, H. andthe Peritonitis Study Group of the Surgical Infection Society Europe: Prognostic modelling in peritonitis. Eur. J. Surg. 163 (1997) 53–60.

    PubMed  CAS  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.

    PubMed  CAS  Google Scholar 

  7. Dominioni, L., Dionigi, R., Zanello, M., Chiarananda, M., Dionigi, R., Acquarolo, A., Ballabio, A., Sguotti, C.: Effects of high-dose IgG on survival of surgical patients with sepsis scores of 20 or greater. Arch. Surg. 126 (1991) 236–240.

    PubMed  CAS  Google Scholar 

  8. Hoogkamp-Korstanje, J. A. A.: Ciprofloxacin vs. cefotaxime regimens for the treatment of intraabdominal infections. Infection 28 (1995) 278–282.

    Article  Google Scholar 

  9. Solomkin, J. S., Dellinger, E. P., Christou, N. V., Busuttil, R. W.: Results of a multicenter trial comparing imipenem/cilastatin to tobramycin/clindamycin for anti-abdominal infections. Ann. Surg. 212 (1990) 581–591.

    Article  PubMed  CAS  Google 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 

  11. Hau, T., Ohmann, C., Wolmershäuser, A., Wacha, H., Yang, Q. for the Peritonitis Study Group of the Surgical Infection Society Europe: Planned relaparotomy vs relaparotomy on demand in the treatment of intraabdominal infections. Arch. Surg. 130 (1995) 1193–1197.

    PubMed  CAS  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.

    Article  PubMed  Google 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 

  14. Wittmann, D. H., Aprahamian, C., Bergstein, J. M.: Staged abdominal repair advanced diffuse peritonitis managed by planned multiple laparotomies utilizing zippers, slide fastener, and velcro analogue for temporary abdominal closure. World J. Surg. 14 (1990) 218–226.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Ohmann, C. Prognostic scores and design of clinical studies. Infection 26, 342–344 (1998). https://doi.org/10.1007/BF02962268

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02962268

Keywords

Navigation