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Area of Science:

  • Infectious Diseases
  • Clinical Trials
  • Public Health

Background:

  • External validity of randomized controlled trials (RCTs) is crucial, especially in infectious diseases.
  • Limited research exists on the external validity of RCTs for uncomplicated urinary tract infections (UTIs).

Purpose of the Study:

  • To evaluate the external validity of a prior investigator-initiated trial on UTI treatment.
  • To compare characteristics and outcomes of patients included versus excluded from the original UTI RCT.

Main Methods:

  • Compared 127 women included in a UTI RCT with 110 women screened but excluded, all from Israel.
  • Primary outcome: emergency department visits leading to hospitalization within 28 days.
  • Secondary outcomes: clinical and microbiological failure rates.

Main Results:

  • Excluded patients had a significantly higher rate of initial hospitalization (13.6% vs. 3.1%, p=0.003).
  • Clinical and microbiological failure rates were substantially higher in included patients (26% vs. 1.8%, p<0.001 and 7.9% vs. 0%, p=0.003, respectively).
  • Reasons for exclusion included recruitment difficulties and recent antibiotic use.

Conclusions:

  • The excluded patient group did not represent a more complicated population than those included.
  • Collecting data on excluded patients is vital for understanding RCT generalizability.
  • Findings underscore the importance of comprehensive data collection in clinical trials.