Patients included in randomized controlled trials do not represent those seen in clinical practice

Abstract number: P1544

Falagas M., Vouloumanou E., Sgouros C., Athanasiou S., Peppas G., Siempos I.

Objective: Clinicians rely on findings of randomized controlled trials (RCTs) to formulate clinical decisions regarding individual patients. To examine whether patients included in RCTs are representative of those encountered in real life clinical situations.

Methods: PubMed was searched for RCTs referring to the field of infectious diseases. Data regarding the exclusion criteria of the identified RCTs were extracted and critically evaluated.

Results: Thirty trials (seventeen referring to respiratory tract, five to skin and soft tissue, four to intra-abdominal, two to gynecologic, and two to bloodstream infections) were included in our study. All retrieved RCTs reported extensive exclusion criteria. After comparing in a qualitative manner (based on our clinical experience) the eligible patient population in the identified RCTs with the respective population that would be encountered in general practice, we noted that the abovementioned patient populations differ considerably.

Conclusions: RCTs in the field of infectious diseases use extensive and stringent exclusion criteria; a fact that may lead to considerable difference between the patient populations of RCTs and those viewed in clinical practice. The application of the findings of RCTs to the care of individual patients should be performed cautiously.

Session Details

Date: 10/04/2010
Time: 00:00-00:00
Session name: Abstracts 20th European Congress of Clinical Microbiology and Infectious Diseases
Location: Vienna, Austria, 10 - 13 April 2010
Presentation type:
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