Nicholas Bellamy1, Marc Hochberg2, Florence Tubach3, Emilio Martin-Mola4, Hassane Awada5, Claire Bombardier6, Najia Hajjaj-Hassouni7, Isabelle Logeart8, Marco Matucci-Cerinic9, Mart van de Laar10, Désirée van der Heijde11, Maxime Dougados12. 1. University of Queensland School of Medicine, Brisbane, Queensland, Australia, and Royal Brisbane and Women's Hospital, Herston, Queensland, Australia. 2. University of Maryland School of Medicine, Baltimore. 3. Université Paris Diderot, Sorbonne Paris Cité, INSERM, UMR-S 1123, INSERM, CIC 1425-EC, UMR-S 1123, and AP-HP Hôpital Bichat, Paris, France. 4. Hospital Universitario La Paz and Universidad Autónoma Madrid, Madrid, Spain. 5. Saint Joseph University Hôtel-Dieu de France, Beirut, Lebanon. 6. University of Toronto, Toronto General Research Institute, Institute for Work and Health, and Mount Sinai Hospital, Toronto, Ontario, Canada. 7. Mohammed Vth Souissi University, CNRST, and Laboratory of Information and Research on Bone Diseases (LIRPOS-URAC 30), Rabat, Morocco, and El Ayachi Hospital and University Hospital, Salé, Morocco. 8. Pfizer, Paris, France. 9. Denothe Centre, University of Florence, Florence, Italy. 10. Arthritis Center Twente, Medisch Spectrum Twente, and University Twente, Enschede, The Netherlands. 11. Leiden University Medical Center, Leiden, The Netherlands. 12. Paris Descartes University, Cochin Hospital, AP-HP, INSERM (U1153), PRES Sorbonne Paris-Cité, Paris, France.
Abstract
OBJECTIVE: The ability to interpret scores from patient-reported outcome measures at the individual patient level depends on the availability of valid, clinically meaningful benchmarks of response and state attainment. The goal was to develop multinational estimates for minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS). METHODS: A multinational sample of patients with osteoarthritis (OA) was evaluated before and 4 weeks after treatment with nonsteroidal antiinflammatory drugs. Patients completed either the Western Ontario and McMaster Osteoarthritis Index (WOMAC) numerical rating scale 3.1 (hip and knee OA) or the Australian/Canadian Index (AUSCAN) numerical rating scale 3.1 (hand OA) before and after treatment. Patients rated the clinical importance of their response to treatment and their satisfaction with the health state achieved, from which multinational MCII and PASS estimates were calculated for both the WOMAC and AUSCAN indices. RESULTS: A total of 609 patients from 7 countries participated in the study. MCII and PASS estimates varied slightly by instrument and subscale. Absolute (percentage) change for MCII ranged 6-9 (10% to 17%) for WOMAC and 4-9 (8% to 15%) for AUSCAN. PASS estimates ranged 39-48 for WOMAC and 38-45 for AUSCAN. Some between-country variation was observed in MCII and PASS. CONCLUSION: Preliminary multinational estimates for MCII and PASS have been developed for several countries. Further research is required to evaluate the robustness, temporal consistency, and age- and sex-dependency of the preliminary estimates as well as their generalizability to other countries, languages, cultures, regions, and other condition-specific outcome measures.
OBJECTIVE: The ability to interpret scores from patient-reported outcome measures at the individual patient level depends on the availability of valid, clinically meaningful benchmarks of response and state attainment. The goal was to develop multinational estimates for minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS). METHODS: A multinational sample of patients with osteoarthritis (OA) was evaluated before and 4 weeks after treatment with nonsteroidal antiinflammatory drugs. Patients completed either the Western Ontario and McMaster Osteoarthritis Index (WOMAC) numerical rating scale 3.1 (hip and knee OA) or the Australian/Canadian Index (AUSCAN) numerical rating scale 3.1 (hand OA) before and after treatment. Patients rated the clinical importance of their response to treatment and their satisfaction with the health state achieved, from which multinational MCII and PASS estimates were calculated for both the WOMAC and AUSCAN indices. RESULTS: A total of 609 patients from 7 countries participated in the study. MCII and PASS estimates varied slightly by instrument and subscale. Absolute (percentage) change for MCII ranged 6-9 (10% to 17%) for WOMAC and 4-9 (8% to 15%) for AUSCAN. PASS estimates ranged 39-48 for WOMAC and 38-45 for AUSCAN. Some between-country variation was observed in MCII and PASS. CONCLUSION: Preliminary multinational estimates for MCII and PASS have been developed for several countries. Further research is required to evaluate the robustness, temporal consistency, and age- and sex-dependency of the preliminary estimates as well as their generalizability to other countries, languages, cultures, regions, and other condition-specific outcome measures.
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