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External validity of randomized controlled trials in COPD.

Justin Travers1, Suzanne Marsh, Brent Caldwell

  • 1Medical Research Institute of New Zealand, Wellington, New Zealand.

Respiratory Medicine
|November 23, 2006
PubMed
Summary
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Most randomized controlled trials (RCTs) for chronic obstructive pulmonary disease (COPD) may not reflect real-world patient populations. Over 90% of treated COPD patients in the community would not meet eligibility criteria for these major drug trials.

Area of Science:

  • Pulmonary Medicine
  • Clinical Trials
  • Epidemiology

Background:

  • Chronic obstructive pulmonary disease (COPD) is a complex, heterogeneous condition with diverse clinical phenotypes.
  • Variability in disease presentation (emphysema, chronic bronchitis, bronchospasm, small airways inflammation) complicates the generalizability of clinical trial findings.
  • Difficulty exists in determining the applicability of evidence from randomized controlled trials (RCTs) to individual patients with COPD.

Purpose of the Study:

  • To estimate the proportion of community-dwelling COPD patients eligible for inclusion in major COPD RCTs.
  • To assess the external validity of RCTs informing current COPD treatment guidelines.

Main Methods:

  • A community-based respiratory health survey was conducted using a postal questionnaire and pulmonary function tests on 3500 randomly selected adults aged 25-75 years.

Related Experiment Videos

  • COPD was diagnosed based on post-bronchodilator spirometry.
  • Eligibility criteria from 18 major COPD RCTs, referenced in Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, were applied to surveyed subjects.

    • Main Results:

    • Of 749 respondents completing the survey, 117 had COPD.
    • A median of only 5% (range 0-20%) of all COPD subjects met the inclusion criteria for major RCTs.
    • Among COPD patients receiving treatment, a median of 5% (range 0-9%) met the inclusion criteria for these trials.

    Conclusions:

    • Major COPD RCTs underpinning GOLD treatment guidelines may possess limited external validity.
    • A significant majority (over 90%) of treated COPD patients in the community were receiving medication based on RCTs for which they were ineligible.
    • Findings highlight a potential disconnect between clinical trial populations and the broader COPD patient population encountered in clinical practice.