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 trialBMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b421 (Published 23 February 2009) Cite this as: BMJ 2009;338:b421
- P Ravaud, professor of epidemiology1,
- R-M Flipo, professor of rheumatology 2,
- I Boutron, assistant professor of epidemiology1,
- C Roy, statistician1,
- A Mahmoudi, general practitioner3,
- B Giraudeau, assistant professor of statistics4,
- T Pham, assistant professor of rheumatology5
- 1INSERM, U738, Paris; Université Paris 7 Denis Diderot, UFR de Médecine, Paris; AP-HP, Hôpital Bichat, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France
- 2Service de Rhumatologie, Centre Hospitalier et Universitaire, Lille, France
- 3Almirall, SAS, Paris
- 4INSERM CIC 202, France; Université François Rabelais Tours, France; CHRU de Tours, France; INSERM U717, Paris
- 5Service de Rhumatologie, Hôpital de la Conception, Marseille, France
- Correspondence to: P Ravaud, INSERM U738, Dpt d’Epidémiologie, Biostatistique et Recherche Clinique, Groupe Hospitalier Bichat-Claude Bernard, 46 rue Henri Huchard, 75877 PARIS Cedex 18
- Accepted 11 November 2008
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.
Contributors: PR was involved in creating and developing the intervention, designing and supervising the trial, analysing and interpreting the results, and preparing the manuscript. R-MF and TP assisted in the trial design and conduct and reviewed the manuscript. BG advised on the statistical design of the trial and on analysis and interpretation of data and reviewed the manuscript. CR did the statistical analysis. IB participated in interpreting the results and preparing the manuscript. AM supervised the conduct of the trial. PR is the guarantor.
Funding: This trial was funded by Almirall SAS, Paris, France. The researchers were independent from funders. The sponsor was not involved in the design of the trial; collection, analysis, or interpretation of data; the writing of the report; or the decision to submit the manuscript. The sponsor was responsible for supervising the conduct of the trial.
Competing interests: None declared.
Ethical approval: Hospital Bichat (Paris) medical research ethics committee; informed consent was obtained from all rheumatologists and patients.
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