Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: Results from a prospective multinational study

Authors

  • F. Tubach,

    Corresponding author
    1. INSERM, Université Paris Diderot, and AP-HP, Hôpital Bichat, Paris, France
    • Département d'Epidémiologie et Recherche Clinique, Hôpital Bichat, 46 Rue Henri Huchard, Secteur Claude Bernard, 75877 Paris Cedex 18, France
    Search for more papers by this author
  • P. Ravaud,

    1. INSERM, Université Paris Descartes, and AP-HP, Hôpital Hôtel-Dieu, Paris, France
    Search for more papers by this author
    • Dr. Ravaud has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Merck, Sharp, & Dohme.

  • E. Martin-Mola,

    1. Hospital Universitario La Paz and Universidad Autónoma Madrid, Madrid, Spain
    Search for more papers by this author
  • H. Awada,

    1. Hôpital Hôtel-Dieu, Paris, France
    2. Saint Joseph University, Beirut, Lebanon
    Search for more papers by this author
    • Dr. Awada has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Ipsen and Novartis.

  • N. Bellamy,

    1. Centre of National Research on Disability and Rehabilitation Medicine and University of Queensland, Queensland, Australia
    Search for more papers by this author
  • C. Bombardier,

    1. University of Toronto, Toronto General Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada
    Search for more papers by this author
    • Dr. Bombardier holds a Pfizer Research Chair and a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care.

    • Dr. Bombardier has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott Canada, AstraZeneca, BioGen, Pfizer, Merck (Schering), and Janssen (Merck), (more than $10,000) from Abbott International, and served on the advisory boards for Bristol Myers Squibb, Pfizer, Pfizer (Wyeth), Merck (Schering), Janssen (Merck), and Takeda.

  • D. T. Felson,

    1. Boston University School of Medicine, Boston, Massachusetts
    Search for more papers by this author
  • N. Hajjaj-Hassouni,

    1. El Ayachi Hospital, Salé, Morocco
    Search for more papers by this author
  • M. Hochberg,

    1. University of Maryland School of Medicine, Baltimore
    Search for more papers by this author
    • Dr. Hochberg has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Covidien, Eli Lilly, EMD Serono, Merck, Genentech, VCB, Theralogix, and Teva Pharmaceuticals, and (more than $10,000 each) from Bioiberica, NicOx, and Pfizer.

  • I. Logeart,

    1. Merck Sharp & Dohme, Paris, France
    Current affiliation:
    1. Pfizer SAS, Paris, France
    Search for more papers by this author
  • M. Matucci-Cerinic,

    1. Denothe Centre, University of Florence, Florence, Italy
    Search for more papers by this author
    • Dr. Matucci-Cerinic has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Bristol Myers Squibb, Pfizer, and Actelion.

  • M. van de Laar,

    1. Medisch Spectrum Twente and University Twente, Enschede, The Netherlands
    Search for more papers by this author
  • D. van der Heijde,

    1. Leiden University Medical Center, Leiden, The Netherlands
    Search for more papers by this author
    • Dr. van der Heijde has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Centocor, Chugai, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering Plough, UCB, and Wyeth.

  • M. Dougados

    1. Paris-Descartes University and AP-HP, Cochin Hospital, Paris, France
    Search for more papers by this author
    • Dr. Dougados has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Merck.


Abstract

Objective

To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries.

Methods

We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4-week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0–100 score.

Results

For the whole sample, the estimated MCII values for absolute change at 4 weeks were −17 (95% confidence interval [95% CI] −18, −15) for pain; −15 (95% CI −16, −14) for patient global assessment; −12 (95% CI −13, −11) for functional disability assessment; and −14 (95% CI −15, −14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients).

Conclusion

This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria.

Ancillary