Advertisement

Effect measure for quantitative endpoints: Statistical versus clinical significance, or “how large the scale is?”

  • Cristian Baicus
    Correspondence
    Corresponding author. Tel.: +40 788302355 (mobile); fax: +40 213180657.
    Affiliations
    Clinica de Medicina Interna, and Réseau d'Epidémiologie Clinique International Francophone (RECIF), Spitalul Colentina, Soseaua Stefan cel Mare 19–21, Sector 2, 21125 Bucharest, Romania
    Search for articles by this author
  • Simona Caraiola
    Affiliations
    Clinica de Medicina Interna, and Réseau d'Epidémiologie Clinique International Francophone (RECIF), Spitalul Colentina, Soseaua Stefan cel Mare 19–21, Sector 2, 21125 Bucharest, Romania
    Search for articles by this author
Published:November 21, 2008DOI:https://doi.org/10.1016/j.ejim.2008.10.002
      Frequently when a study finds a statistical significance for the difference between treatment and placebo, the scientific society of the respective specialty introduces this new treatment in its guidelines [
      • Baicus C.
      • Chivu R.
      Drug politics — economic viewpoint of a practitioner.
      ], leaving apart the intense promotion by the pharmaceutical industry. However, we must always ask ourselves if the differences detected in continuous variables-endpoints with the tested treatment is clinically important. In order to do this, we need to know at least how large is the scale and how clinically significant is the treatment effect.

      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

        • Baicus C.
        • Chivu R.
        Drug politics — economic viewpoint of a practitioner.
        Rev Med Chir Soc Med Nat Iasi. 2004; 108 ([French]): 674-678
        • Bookman A.A.
        • Williams K.S.
        • Shainhouse J.Z.
        Effect of a topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: a randomized controlled trial.
        CMAJ. 2004; 171: 333-338
      1. Topical Diclofenac Improved Pain and Physical Function with No Systemic Side Effects in Primary Osteoarthritis of the Knee. Ann Cranney, Siobhan O'Donnell (Commentators). EBM 2005; 10:81.

        • Mazieres B.
        • Rouanet S.
        • Guillon Y.
        • Scarsi C.
        • Reiner V.
        Topical ketoprofen patch in the treatment of tendinitis: a randomized, double blind, placebo controlled study.
        J Rheumatol. 2005; 8: 1563-1570
        • Calverley P.
        • Pauwels R.
        • Vestbo J.
        • Jones P.
        • Pride N.
        • Gulsvik A.
        • et al.
        for the TRISTAN (TRial of Inhaled STeroids ANd long-acting β2 agonists) study group. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial.
        Lancet. 2003; 361: 449-456
        • Jaeschke R.
        • Singer J.
        • Guyatt G.H.
        Measurement of health status. ascertaining the minimal clinically important difference.
        Cont Clin Trials. 1989; 10: 407-415
        • Walters S.J.
        • Brazier J.E.
        What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D.
        Health Qual Life Outcomes. 2003; 11: 4
        • Norman G.R.
        • Sloan J.A.
        • Wyrwich K.W.
        Interpretation of changes in health related quality of life: the remarkable universality of half a standard deviation.
        Med Care. 2003; 41: 582-592
        • Angst F.
        • Aeschlimann A.
        • Stucki G.
        Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities.
        Arthritis Rheum. 2001; 45: 384-391
        • Jones P.W.
        Interpreting thresholds for a clinically significant change in health status in asthma and COPD.
        Eur Respir J. 2002; 19: 398-404