Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2001 Jun;233(6):859-66.
doi: 10.1097/00000658-200106000-00017.

Prospective randomized trials affect the outcomes of intraabdominal infection

J I Merlino  1 , M A Malangoni, C M Smith, R L Lange
Affiliations
Comparative Study

Prospective randomized trials affect the outcomes of intraabdominal infection

J I Merlino et al. Ann Surg. 2001 Jun.

Abstract

Objective: To compare the characteristics and outcomes of patients with intraabdominal infections enrolled in prospective randomized trials (PRTs) with those of a cohort of patients not enrolled in a trial.

Summary background data: Prospective randomized trials are the gold standard for the evaluation of new treatments. Patients are screened using rigorous eligibility criteria and sometimes are excluded from PRTs because of associated medical conditions or more severe illness. However, the effect that the exclusion of these patients has on the applicability of clinical trial outcomes has not been defined.

Methods: One hundred sixty-eight adults with intraabdominal infection were treated at a single institution during 7 years. Fifty-three patients were enrolled in four PRTs comparing various antibiotic regimens for treatment; 115 were not enrolled. Patient characteristics and outcomes of these two groups were compared.

Results: Patients with infections from appendicitis (n = 68) had a low severity of illness and similar outcomes in both groups. These patients and those for whom a concurrent PRT was unavailable were excluded from subsequent analysis. Eighty-eight patients (42 PRT, 46 not enrolled) with serious infection remained for analysis. Patients enrolled in PRTs were younger, had less severe illness, had a decreased length of stay, a lower incidence of antibiotic resistance, and less frequent extraabdominal infections than those not enrolled in a trial. Patients enrolled in PRTs were more likely to be cured and were less likely to die. Logistic regression analysis demonstrated that cure was associated with a lower initial severity of illness, absence of antibiotic resistance, and participation in a PRT.

Conclusions: Patients with intraabdominal infection enrolled in PRTs have an increased likelihood of cure and survival. This is due in part to a lower incidence of antibiotic resistance, which may reflect improved drug selection. Patients not enrolled in PRTs are at greater risk for treatment failure and death because of concomitant illness. Outcomes from PRTs may not be applicable to all patients with intraabdominal infections.

PubMed Disclaimer

Figures

None
Figure 1. Outline for selection of patients with serious intraabdominal infections. PRT, prospective randomized trial.
See this image and copyright information in PMC

References

    1. Bull JP. The historical development of clinical therapeutic trials. J Chron Dis 1959; 10: 218–248. - PubMed
    1. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials, 3d ed. New York: Springer-Verlag; 1998.
    1. Leber P. The future of controlled clinical trials: is there an alternative to the randomized controlled trial? Psychol Bull 1991; 27: 3–8. - PubMed
    1. Preventative Services Task Force. Guide to clinical preventative services: Report of the U.S. Preventative Services Task Force, 2d ed. Baltimore: Williams & Wilkins; 1996.
    1. Piantadosi S. Clinical trials: a methodologic perspective. New York: John Wiley & Sons; 1997.

Publication types

MeSH terms

Substances