ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial

P Ravaud, R-M Flipo, I Boutron, C Roy, A Mahmoudi, B Giraudeau, T Pham, P Ravaud, R-M Flipo, I Boutron, C Roy, A Mahmoudi, B Giraudeau, T Pham

Abstract

Objective: To evaluate the impact of standardised consultations on patients with osteoarthritis of the knee.

Design: Open pragmatic cluster randomised controlled trial.

Setting: Primary care in France.

Participants: 198 primary care rheumatologists, each of whom had to include two consecutive patients who met the American College of Rheumatology criteria for osteoarthritis of the knee.

Interventions: Standardised consultation was provided during three goal oriented visits (education on osteoarthritis and treatment management; information on physical exercises; information on weight loss) or usual care.

Main outcome measures: Change in body weight and in time spent on physical exercises (Baecke index) at four months.

Results: 336 patients were included (154 allocated to standardised consultation and 182 to usual care). Nine patients were excluded because of lack of baseline data (standardised consultation, n=8; usual care, n=1). At four months, taking into account the clustering effect, the decrease in weight was greater in the standardised consultation group than in the usual care group (mean -1.11 (SD 2.49) kg v -0.37 (2.39) kg; P=0.007). The physical activity score was higher for the standardised consultation group than for the usual care group (mean 0.20 (0.65) v 0.04 (0.78); P=0.013). The standardised consultation and usual care groups did not differ in secondary outcomes, except for global assessment of disease activity (0-10 numeric scale: mean -1.66 (2.26) v -0.90 (2.48); P=0.003) and pain level (0-10 numeric scale: mean -1.65 (2.32) v -1.18 (2.58); P=0.04).

Conclusions: A structured consultation programme for patients with osteoarthritis of the knee resulted in short term improvement in weight loss and time spent on physical activity.

Trial registration: Clinical trials NCT00462319.

Conflict of interest statement

Competing interests: None declared.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787550/bin/ravp585406.f1.jpg
Flow diagram of participants in the trial

References

    1. Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum 1998;41:778-99.
    1. Conaghan PG, Dickson J, Grant RL. Care and management of osteoarthritis in adults: summary of NICE guidance. BMJ 2008;336:502-3.
    1. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum 2000;43:1905-15.
    1. Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, et al. EULAR recommendations 2003: an evidence based approach to the management of knee osteoarthritis: report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis 2003;62:1145-55.
    1. Denoeud L, Mazieres B, Payen-Champenois C, Ravaud P. First line treatment of knee osteoarthritis in outpatients in France: adherence to the EULAR 2000 recommendations and factors influencing adherence. Ann Rheum Dis 2005;64:70-4.
    1. Felson DT, Zhang Y, Anthony JM, Naimark A, Anderson JJ. Weight loss reduces the risk for symptomatic knee osteoarthritis in women: the Framingham study. Ann Intern Med 1992;116:535-9.
    1. Serdula MK, Mokdad AH, Williamson DF, Galuska DA, Mendlein JM, Heath GW. Prevalence of attempting weight loss and strategies for controlling weight. JAMA 1999;282:1353-8.
    1. Galuska DA, Will JC, Serdula MK, Ford ES. Are health care professionals advising obese patients to lose weight? JAMA 1999;282:1576-8.
    1. Fontaine KR, Haaz S, Bartlett SJ. Are overweight and obese adults with arthritis being advised to lose weight? J Clin Rheumatol 2007;13:12-5.
    1. Mechanic D, McAlpine DD, Rosenthal M. Are patients’ office visits with physicians getting shorter? N Engl J Med 2001;344:198-204.
    1. Dugdale DC, Epstein R, Pantilat SZ. Time and the patient-physician relationship. J Gen Intern Med 1999;14(suppl 1):S34-40.
    1. Gross DA, Zyzanski SJ, Borawski EA, Cebul RD, Stange KC. Patient satisfaction with time spent with their physician. J Fam Pract 1998;47:133-7.
    1. Ravaud P, Boutron I. Primer: assessing the efficacy and safety of nonpharmacologic treatments for chronic rheumatic diseases. Nat Clin Pract Rheumatol 2006;2:313-9.
    1. Ravaud P, Keita H, Porcher R, Durand-Stocco C, Desmonts JM, Mantz J. Randomized clinical trial to assess the effect of an educational programme designed to improve nurses’ assessment and recording of postoperative pain. Br J Surg 2004;91:692-8.
    1. Ravaud P, Giraudeau B, Logeart I, Larguier JS, Rolland D, Treves R, et al. Management of osteoarthritis (OA) with an unsupervised home based exercise programme and/or patient administered assessment tools: a cluster randomised controlled trial with a 2×2 factorial design. Ann Rheum Dis 2004;63:703-8.
    1. Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and statistics in medicine. Stat Med 2007;26:2-19.
    1. Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health 2004;94:416-22.
    1. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702-8.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295-309.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med 2008;148:W60-6.
    1. Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, et al. Development of criteria for the classification and reporting of osteoarthritis: classification of osteoarthritis of the knee. Arthritis Rheum 1986;29:1039-49.
    1. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ 2000;321:694-6.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008;337:a1655.
    1. Munjanja SP, Lindmark G, Nystrom L. Randomised controlled trial of a reduced-visits programme of antenatal care in Harare, Zimbabwe. Lancet 1996;348:364-9.
    1. Serdula MK, Khan LK, Dietz WH. Weight loss counseling revisited. JAMA 2003;289:1747-50.
    1. Pols MA, Peeters PH, Bueno-De-Mesquita HB, Ocke MC, Wentink CA, Kemper HC, et al. Validity and repeatability of a modified Baecke questionnaire on physical activity. Int J Epidemiol 1995;24:381-8.
    1. Florindo AA, Latorre Mdo R, Jaime PC, Tanaka T, Zerbini CA. [Methodology to evaluation the habitual physical activity in men aged 50 years or more]. Rev Saude Publica 2004;38:307-14.
    1. Florindo AA, Latorre Mdo R, Santos EC, Negrao CE, Azevedo LF, Segurado AA. Validity and reliability of the Baecke questionnaire for the evaluation of habitual physical activity among people living with HIV/AIDS. Cad Saude Publica 2006;22:535-41.
    1. Hurst NP, Ruta DA, Kind P. Comparison of the MOS short form-12 (SF12) health status questionnaire with the SF36 in patients with rheumatoid arthritis. Br J Rheumatol 1998;37:862-9.
    1. Guittet L, Giraudeau B, Ravaud P. A priori postulated and real power in cluster randomized trials: mind the gap. BMC Med Res Methodol 2005;5:25.
    1. Kurth T, Walker AM, Glynn RJ, Chan KA, Gaziano JM, Berger K, et al. Results of multivariable logistic regression, propensity matching, propensity adjustment, and propensity-based weighting under conditions of nonuniform effect. Am J Epidemiol 2006;163:262-70.
    1. Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull 1979;86:420-8.
    1. Felson DT, Lawrence RC, Hochberg MC, McAlindon T, Dieppe PA, Minor MA, et al. Osteoarthritis: new insights. Part 2: treatment approaches. Ann Intern Med 2000;133:726-37.
    1. Fransen M, McConnell S, Bell M. Therapeutic exercise for people with osteoarthritis of the hip or knee: a systematic review. J Rheumatol 2002;29:1737-45.
    1. Fransen M, McConnell S, Bell M. Exercise for osteoarthritis of the hip or knee. Cochrane Database Syst Rev 2003;(3):CD004286.
    1. Brosseau L, MacLeay L, Robinson V, Wells G, Tugwell P. Intensity of exercise for the treatment of osteoarthritis. Cochrane Database Syst Rev 2003;(2):CD004259.
    1. Deyle GD, Henderson NE, Matekel RL, Ryder MG, Garber MB, Allison SC. Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med 2000;132:173-81.
    1. Kreuter MW, Chheda SG, Bull FC. How does physician advice influence patient behavior? Evidence for a priming effect. Arch Fam Med 2000;9:426-33.
    1. Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet 2002;359:614-8.
    1. Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ 2003;327:785-9.
    1. Boutron I, Tubach F, Giraudeau B, Ravaud P. Blinding was judged more difficult to achieve and maintain in non-pharmacological than pharmacological trials. J Clin Epidemiol. 2004;57:543-550.
    1. Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum 2005;52:2026-32.
    1. Felson DT, Lawrence RC, Dieppe PA, Hirsch R, Helmick CG, Jordan JM, et al. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med 2000;133:635-46.

Source: PubMed

3
Subskrybuj