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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses

Published on: August 30, 2018

Patients included in randomised controlled trials do not represent those seen in clinical practice: focus on

Matthew E Falagas1, Evridiki K Vouloumanou, Konstantinos Sgouros

  • 1Alfa Institute of Biomedical Sciences (AIBS), 9 Neapoleos Street, 151 23 Marousi, Athens, Greece. m.falagas@aibs.gr

International Journal of Antimicrobial Agents
|May 14, 2010
PubMed

Insights

Randomised controlled trials (RCTs) for infectious diseases often exclude many patients seen in clinical practice due to strict criteria. This limits the generalizability of RCT findings to real-world patient care.

Area of Science:

  • Infectious Diseases
  • Clinical Trials
  • Evidence-Based Medicine

Background:

  • Clinicians depend on randomised controlled trials (RCTs) for treatment decisions.
  • The representativeness of RCT participants compared to general patient populations is crucial for evidence-based practice.

Purpose of the Study:

  • To assess if patients in antimicrobial agent RCTs reflect those in real-life clinical settings.
  • To evaluate the exclusion criteria used in infectious disease RCTs.

Main Methods:

  • A PubMed search identified RCTs in infectious diseases.
  • Exclusion criteria from 30 selected RCTs were extracted and analyzed.
  • Qualitative comparison of RCT-eligible patients versus general practice patients was performed.

Main Results:

  • Thirty RCTs (respiratory, skin, abdominal, gynaecological, bloodstream infections) were included.
  • All identified RCTs utilized extensive exclusion criteria.
  • Significant differences were observed between RCT populations and general clinical practice populations.

Conclusions:

  • Infectious disease RCTs frequently employ stringent exclusion criteria.
  • These criteria can create a substantial divergence between trial participants and patients in clinical practice.
  • Caution is advised when applying RCT findings to individual patient care.

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