@article{3146429,
    title = "Patients included in randomised controlled trials do not represent those
seen in clinical practice: focus on antimicrobial agents",
    author = "Falagas, Matthew E. and Vouloumanou, Evridiki K. and Sgouros, and Konstantinos and Athanasiou, Stavros and Peppas, George and Siempos, and Ilias I.",
    journal = "International Journal of Antimicrobial Agents",
    year = "2010",
    volume = "36",
    number = "1",
    pages = "1-13",
    publisher = "ELSEVIER SCIENCE BV",
    issn = "0924-8579",
    doi = "10.1016/j.ijantimicag.2010.03.020",
    keywords = "Evidence-based medicine; External validity",
    abstract = "Clinicians rely on the findings of randomised controlled trials (RCTs)
to formulate clinical decisions regarding individual patients. We
examined whether patients included in RCTs focusing on antimicrobial
agents are representative of those encountered in real-life clinical
situations. 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. In total, 30
trials (17 referring to respiratory tract, 5 to skin and soft-tissue, 4
to intra-abdominal, 2 to gynaecological and 2 to bloodstream infections)
were included in the 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, it was observed that the above-mentioned patient
populations differ considerably. In conclusion, 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. (C) 2010 Elsevier B.V. and the
International Society of Chemotherapy. All rights reserved."
}