Impact of the joint space width measurement method on the design of knee osteoarthritis studies.

Aged; Female; Humans; Knee Joint/anatomy & histology/pathology/radiography; Male; Middle Aged; Observer Variation; Osteoarthritis, Knee/drug therapy/pathology; Radiographic Image Interpretation, Computer-Assisted; Reproducibility of Results; Research Design; Sensitivity and Specificity

Abstract :

[en] BACKGROUND AND AIMS: Recent guidelines recommend measurement of articular loss over several years, determined by conventional X-rays, as the principal outcome measure in clinical trials of potential structure-modifying drugs in osteoarthritis (OA). The aim of this study was to assess the impact of the joint space width measurement method on sample size calculation in knee OA studies. METHODS: Standard knee X-rays were taken in 212 patients with knee OA at baseline and after 3 years of follow-up. Mean joint space width (JSW) was measured with an in-house computer-assisted method. Minimum JSW, measured with a graduated magnifying lens, was taken as external standard. After calculation of the intra- and inter-observer reproducibility of the JSW, sensitivity to change was assessed using the standardized response mean (SRM). The number of patients needed to identify a mean significant difference of 0.5 mm in joint space narrowing between the placebo and the treated group, after 3 years of follow-up, was then calculated. RESULTS: JSW measured with the computer-assisted technique showed better intra- and inter-observer reproducibility than when using the magnifying lens. JSW values measured with our computer-assisted method were significantly correlated with JSW values obtained using the magnifying lens (r=0.87, p<0.001). The SRM were 0.44 and 0.40 for the computer-assisted method and magnifying lens, respectively. The number of patients needed was 131 per group using the computer-assisted method, and 104 using the magnifying lens. CONCLUSIONS: Our method of measurement of JSW may be of potential use in longitudinal studies evaluating the effect of structure-modifying drugs in OA, due to its high level of precision and efficiency. However, although sensitivity to change is markedly better with the digitized method compared with the graduated magnifying lens, we recommend the measurement of mean and minimum JSW in structure-modifying OA trials.

Disciplines :

General & internal medicine
Public health, health care sciences & services

Author, co-author :

Bruyère, Olivier ; Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique

Henrotin, Yves ; Université de Liège - ULiège > Département des sciences de la motricité > Unité de recherche sur l'os et le cartillage (U.R.O.C.) - Didactique des sciences de la santé - Pathologie générale et physiopathologie

Honore, Aline

Rovati, Lucio C

Seidel, Laurence ; Centre Hospitalier Universitaire de Liège - CHU > Non budgétaires

Dardenne, Charles-Bernard ; Centre Hospitalier Universitaire de Liège - CHU > Urgences

Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique

Language :

English

Title :

Impact of the joint space width measurement method on the design of knee osteoarthritis studies.

Publication date :

April 2003

Journal title :

Aging Clinical and Experimental Research

ISSN :

1594-0667

eISSN :

1720-8319

Publisher :

Editrice Kurtis SRL, Milano, Italy

Volume :

Issue :

Pages :

136-41

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 01 December 2009

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Bibliography

Dieppe PA. Recommended methodology for assessing the progression of osteoarthritis of the hip and knee joints. Osteoarthritis Cartilage 1995; 3: 73-7.
Buckland-Wright JC. Radiographic imaging of osteoarthritis. In Reginster J-Y, Pelletier J-P, Martel-Pelletier JM, Henrotin Y, Eds. Osteoarthritis: Clinical and experimental aspects. Berlin: Springer-Verlag, 1999: 246-68.
Altman R, Brandt K, Hochberg M, Moskowitz R. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Osteoarthritis Cartilage 1996; 4: 217-43.
Lequesne M, Brandt K, Bellamy N, Moskowitz R, Menkes CJ, Pelletier J-P. Guidelines for testing slow acting drugs in osteoarthritis. J Rheumatol 1994; 21 (Suppl 41): 65-73.
Vignon E, Conrozier T, Piperno M, Richard S, Carrillon Y, Fantino O. Radiographic assessment of hip and knee osteoarthritis. Recommendations: recommended guidelines. Osteoarthritis Cartilage 1999; 7: 434-6.
Dougados M, Devogelaer JP, Annefeldt M, et al. Recommendations for the registration of drugs used in the treatment of osteoarthritis. Ann Rheum Dis 1996; 55: 552-7.
Lequesne M. Quantitative measurement of joint space during progression of osteoarthritis: chondrometry. In Kuettner KE, Goldberg V, Eds. Osteoarthritis disorders. Rosemont: American Academy of Orthopaedic Surgery, 1995: 424-44.
Reginster JY, Deroisy R, Rovati LC, et al. Long-term effects of glucosamine sulfate on ostearthritis progression: a randomised, placebo-controlled clinical trial. Lancet 2001; 357: 251-6.
Altman R, Asch E, Bloch D, et al. Development of criteria for the classification and reporting of osteoarthritis. Arthritis Rheum 1986; 29: 1039-49.
Altman RD, Hochberg GM, Murpy WA, Wolfe F, Lequesne M. Atlas of individual radiographic features in osteoarthritis. Osteoarthritis Cartilage 1995; 3 (Suppl A): 3-70.
Jonsson K, Buckwalter K, Helvier M, Niklason L, Martel W. Precision of hyaline cartilage thickness measurements. Acta Radiol 1992; 33: 234-9.
Hirsch PR, Riegelman RK. Statistical operations. Cambridge: Blackwell Science, 1995: 20-7.
Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care 1990; 28: 632-42.
Liang MH. Evaluating measurement responsiveness. J Rheumatol 1995; 22: 1191-2.
Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care 1989; 27 (Suppl 3): 178-89.
Pocock SJ. The size of a clinical trial. In Pocock SJ, Ed. Clinical trials: a practical approach. Chichester: Wiley & Sons Ltd, 1983: 123-41.
Rovati LC. Radiographic assessment. Introduction: existing methodology. Osteoarthritis Cartilage 1999; 7: 427-9.
Buckland-Wright JC. Radiographic assessment of osteoarthritis: comparison between existing methodologies. Osteoarthritis Cartilage 1999; 7: 430-3.
Ravaud P, Chastang C, Auleley G-R, et al. Assessment of joint space width in patient with osteoarthritis of the knee: a comparison of four measuring instruments. J Rheumatol 1996; 23: 1749-55.
Committee for Proprietary Medicinal Products. Points to consider on clinical investigation of medicinal products used in the treatment of osteoarthritis. The European Agency for the Evaluation of Medicinal Products; July 1998 (CPMP/EWP/784/97).
Dacre JE, Huskisson EC. The automatic assessment of knee radiographs in osteoarthritis using digital image analysis. Br J Rheumatol 1989; 28: 506-10.
Buckland-Wright JC, Macfarlane DG, Williams SA, Ward RJ. Accuracy and precision of joint space width measurements in standard and macroradiographs of osteoarthritic knees. Ann Rheum Dis 1995; 54: 872-80.
Hammad TA. Structure modification in knee osteoarthritis: methodology and outcome parameters. Osteoarthritis Cartilage 2001; 9: 488-98.
Buckland-Wright JC, Wolfe F, Ward RJ, Flowers N, Hayne C. Substantial superiority of semiflexed (MTP) views in knee osteoarthritis: a comparative radiographic study, without fluoroscopy, of standing extended, semiflexed (MTP), and Schuss views. J Rheumatol 1999; 26: 2664-74.
Piperno M, Hellio Le Graverand M-P, Conrozier T, Bochu M, Mathieu P, Vignon E. Quantitative evaluation of joint space width in femorotibial osteoarthritis: comparison of three radiographic views. Osteoarthritis Cartilage 1998; 6: 252-9.
Lynch JA, Buckland-Wright JC, Macfarlane DG. Precision of joint space width measurement in knee osteoarthritis from digital image analysis of high definition macroradiographs. Osteoarthritis Cartilage 1993; 1: 209-18.
Buckland-Wright JC, Macfarlane DG, Lynch JA, Jasani MK, Bradshaw CR. Joint space width measures cartilage thickness in osteoarthritis of the knee: high resolution plain film and double contrast macroradiographic investigation. Ann Rheum Dis; 54: 263-8.
Conrozier T, Tron AM, Mathieu P, Vignon E. Quantitative assessment of radiographic normal and osteoarthritic hip joint space. Osteoarthritis Cartilage 1995; 3 (Suppl A): 81-7.