Full Text: Minimal Clinically Important Improvement and Patient Acceptable Symptom State for Subjective Outcome Measures in Rheumatic Disorders

Minimal Clinically Important Improvement and Patient Acceptable Symptom State for Subjective Outcome Measures in Rheumatic Disorders

FLORENCE TUBACH, PHILIPPE RAVAUD, DORCAS BEATON, MAARTEN BOERS, CLAIRE BOMBARDIER, DAVID T. FELSON, DESIREÉ van der HEIJDE, GEORGE WELLS, and MAXIME DOUGADOS

ABSTRACT.

The concepts of minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS) could help in interpreting results of trials involving patient-reported outcomes by translating the response at the group level (change in mean scores) into more clinically meaningful information by addressing the patient level as "therapeutic success (yes/no)." The aims of the special interest group (SIG) at OMERACT 8 were to discuss specific issues concerning the MCII and PASS concepts, especially the wording of the external anchor questions used to determine the MCII and PASS estimates, and to move toward a consensus for the cutoff values to use as the MCII and PASS in the different outcome criteria. The purpose of this SIG at OMERACT 8 was to inform participants of the MCII and PASS concepts and to agree on MCII and PASS values for pain, patient global assessment, and functional impairment. (J Rheumatol 2007;34:1188–93)

Key Indexing Terms:

MINIMAL CLINICALLY IMPORTANT DIFFERENCE
RESPONSE TO THERAPY
PATIENT ACCEPTABLE SYMPTOMATIC STATE
OUTCOME CRITERIA
PATIENT'S PERSPECTIVE

From the Département d'Epidémiologie, Biostatistique et Recherche Clinique, Hôpital Bichat, Paris, France; INSERM, U738; Université Paris 7 Denis Diderot; St. Michael's Hospital, Institute for Work and Health, University of Toronto, Toronto, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Arthritis Center, Boston University, Boston, Massachusetts, USA; Department of Rheumatology, University Hospital Maastricht, Maastricht, The Netherlands; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada; Department of Rheumatology B, Cochin Hospital, Paris, France and Université René Descartes, Paris 5.

Dr. Tubach obtained a EULAR/OMERACT Travel Bursary to attend the OMERACT 8 meeting.

F. Tubach, MD, INSERM, U738; AP-HP, Département d'Epidémiologie, Biostatistique et Recherche Clinique; Université Paris 7, UFR de médecine, Paris; P. Ravaud, MD, PhD, INSERM, AP-HP, Hôpital Bichat, Département d'Epidémiologie, Biostatistique et Recherche Clinique, Paris; D. Beaton, BScOT, PhD, St. Michael's Hospital, Institute for Work and Health, University of Toronto; M. Boers, MD, PhD, Professor of Clinical Epidemiology, Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam; C. Bombardier, MD, FRCPC, Institute of Medical Sciences, Institute for Work and Health, Faculty of Medicine, University of Toronto, Department of Medicine, Mount Sinai Hospital; D.T. Felson, MD, MPH, Professor, Clinical Epidemiology Research and Training Unit, Arthritis Center, Boston University; D.M. van der Heijde, MD, Professor of Rheumatology, Department of Rheumatology, University Hospital Maastricht; G.A. Wells, PhD, Professor, Department of Epidemiology and Community Medicine, University of Ottawa; M. Dougados, MD, Paris-Descartes University, Medicine Faculty; AP-HP, Department of Rheumatology B, Cochin Hospital, Paris.

Address reprint requests to Dr. F. Tubach, Département d'Epidémiologie, Biostatistique et Recherche Clinique, INSERM E0357, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France. E-mail:florence.tubach@bch.aphp.fr