Advertisement

Clinical trials: generalizability is much more than representativeness

  • Rafael Dal-Ré
    Correspondence
    Corresponding author. Phone: +34649410221
    Affiliations
    Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Avda Reyes Católicos 2, Madrid, E-28040, Spain
    Search for articles by this author
Published:April 18, 2020DOI:https://doi.org/10.1016/j.ejim.2020.04.008
      Recently, Anderson et al [
      • Anderson TS
      • Odden M
      • Penko J
      • et al.
      Generalizability of Clinical Trials supporting the 2017 American College of Cardiology/American Heart Association Blood Pressure Guideline.
      ] reported on the generalizability of trials supporting the 2017 American College of Cardiology/American Heart Association blood pressure guideline. They are correct when concluding that SPIRIT and ACCORD, the clinical trials underlying new treatment thresholds, were not representative for more than two-thirds of the target population. Yet, as the authors did [
      • Anderson TS
      • Odden M
      • Penko J
      • et al.
      Generalizability of Clinical Trials supporting the 2017 American College of Cardiology/American Heart Association Blood Pressure Guideline.
      ], in these two sentences two concepts have been used as if they were interchangeable: generalizability and representativeness.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to European Journal of Internal Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Anderson TS
        • Odden M
        • Penko J
        • et al.
        Generalizability of Clinical Trials supporting the 2017 American College of Cardiology/American Heart Association Blood Pressure Guideline.
        JAMA Intern Med. 2020 Mar 16; (Epub ahead of print)https://doi.org/10.1001/jamainternmed.2020.0051
        • International Epidemiology Association
        Porta M A dictionary of epidemiology. Oxford University Press, New York2014
        • Zwarenstein M
        • Treweek S
        • Gagnier JJ
        • et al.
        Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
        BMJ. 2008; 337 (a2390)
        • Dal-Ré R
        • Janiaud P
        • Ioannidis JPA
        Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic?.
        BMC Med. 2018; 16: 49
        • Loudon K
        • Treweek S
        • Sullivan F
        • Donnan P
        • Thorpe KE
        • Zwarenstein M
        The PRECIS-2 tool: designing trials that are fit for purpose.
        BMJ. 2015; 350 (h2147)
        • Dal-Ré R
        • Rosendaal F
        Efficacy and effectiveness: The wrong use of different terms.
        Eur J Intern Med. 2018; 54 (e17-8)