Abstract
Background: The patient acceptable symptom state (PASS) is the value beyond which patients can consider themselves well. This concept can help in interpreting results of clinical trials.
Objective: To determine the PASS estimate for patients with knee and hip osteoarthritis (OA) by assessing pain, patient's global assessment of disease activity, and functional impairment.
Methods: A 4 week prospective multicentre cohort study of 1362 outpatients with knee or hip OA was carried out. Data on assessment of pain and patient's global assessment of disease, measured on visual analogue scales, and functional impairment, measured on the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) function subscale, were collected at baseline and final visits. The patients assessed their satisfaction with their current state at the final visit. An anchoring method based on the patient's opinion was used.
Results: For patients with knee and hip OA, the estimates of PASS were, respectively, 32.3 and 35.0 mm for pain, 32.0 and 34.6 mm for patient global assessment of disease activity, and 31.0 and 34.4 points for WOMAC function score. The PASS varied moderately across the tertiles of baseline scores but not across age, disease duration, or sex.
Conclusion: The use of PASS in clinical trials would provide more meaningful results expressed as a proportion of patients in an acceptable symptom state.
Full Text
The Full Text of this article is available as a PDF (78.4 KB).
Figure 1.
Aspects of the cumulative distribution function used to determine the PASS (pain scores in patients with knee OA). Among patients considering their state as satisfactory, 75% assessed their pain score at final visit below 32.3 mm on a 0–100 mm VAS (which is the PASS limit). Among patients considering their state as unsatisfactory, only 25% assessed their pain score at final visit below 32.3 on a 0–100 mm VAS.
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Altman R., Alarcón G., Appelrouth D., Bloch D., Borenstein D., Brandt K., Brown C., Cooke T. D., Daniel W., Feldman D. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505–514. doi: 10.1002/art.1780340502. [DOI] [PubMed] [Google Scholar]
- Altman R., Asch E., Bloch D., Bole G., Borenstein D., Brandt K., Christy W., Cooke T. D., Greenwald R., Hochberg M. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039–1049. doi: 10.1002/art.1780290816. [DOI] [PubMed] [Google Scholar]
- Beaton D. E., Bombardier C., Katz J. N., Wright J. G. A taxonomy for responsiveness. J Clin Epidemiol. 2001 Dec;54(12):1204–1217. doi: 10.1016/s0895-4356(01)00407-3. [DOI] [PubMed] [Google Scholar]
- Bellamy N., Kirwan J., Boers M., Brooks P., Strand V., Tugwell P., Altman R., Brandt K., Dougados M., Lequesne M. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol. 1997 Apr;24(4):799–802. [PubMed] [Google Scholar]
- Bodian C. A., Freedman G., Hossain S., Eisenkraft J. B., Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356–1361. doi: 10.1097/00000542-200112000-00013. [DOI] [PubMed] [Google Scholar]
- Boers Maarten, Anderson Jennifer J., Felson David T. Deriving an operational definition of low disease activity state in rheumatoid arthritis. J Rheumatol. 2003 May;30(5):1112–1114. [PubMed] [Google Scholar]
- Jaeschke R., Singer J., Guyatt G. H. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407–415. doi: 10.1016/0197-2456(89)90005-6. [DOI] [PubMed] [Google Scholar]
- Juniper E. F., Guyatt G. H., Willan A., Griffith L. E. Determining a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol. 1994 Jan;47(1):81–87. doi: 10.1016/0895-4356(94)90036-1. [DOI] [PubMed] [Google Scholar]
- Saag Kenneth G. OMERACT 6 brings new perspectives to rheumatology measurement research. J Rheumatol. 2003 Apr;30(4):639–641. [PubMed] [Google Scholar]
- Tubach F., Ravaud P., Baron G., Falissard B., Logeart I., Bellamy N., Bombardier C., Felson D., Hochberg M., van der Heijde D. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2004 Jun 18;64(1):29–33. doi: 10.1136/ard.2004.022905. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Wells George, Anderson Jennifer, Boers Maarten, Felson David, Heiberg Turid, Hewlett Sarah, Johnson Kent, Kirwan John, Lassere Marissa, Robinson Vivian. MCID/Low Disease Activity State Workshop: summary, recommendations, and research agenda. J Rheumatol. 2003 May;30(5):1115–1118. [PubMed] [Google Scholar]
- Wells George, Boers Maarten, Shea Beverley, Anderson Jennifer, Felson David, Johnson Kent, Kirwan John, Lassere Marissa, Robinson Vivian, Simon Lee. MCID/Low Disease Activity State Workshop: low disease activity state in rheumatoid arthritis. J Rheumatol. 2003 May;30(5):1110–1111. [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.