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Challenges in evaluating an arthritis self-management program for people with hip and knee osteoarthritis in real-world clinical settings |
Ackerman IN, Buchbinder R, Osborne RH |
The Journal of Rheumatology 2012 May;39(5):1047-1055 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To evaluate the influence of a 6-week Arthritis Self-Management Program (ASMP) on health-related quality of life (HRQOL) and self-management skills in clinical settings. METHODS: Individuals with hip or knee osteoarthritis referred to orthopedic surgeons or rheumatologists at 6 hospitals in Victoria, Australia, were recruited. In a randomized controlled trial, participants received the Stanford ASMP and self-help book (intervention) or book only (control). Assessments included the Assessment of Quality of Life instrument (AQoL; range -0.04 to 1.00) and Health Education Impact Questionnaire (heiQ; range 1 to 6) at baseline and up to 12 months. The primary outcome was HRQOL at 12 months (assessed using the AQoL). RESULTS: Recruitment was concluded early due to persistent challenges including infrequent referrals and patient inability or disinterest in participating. Of 1125 individuals screened, only 120 were randomized (control, n = 62; intervention, n = 58). Seven ASMP were conducted while 18 scheduled ASMP were cancelled. Forty-four of 58 intervention group participants received the intervention as allocated (76%); all control group participants were sent the book (100%). Ninety-four participants (78%) completed 12-month assessments (control, 90%; intervention, 66%). There was no difference in HRQOL at 12 months (adjusted mean difference -0.02, 95% CI -0.09 to 0.05). At 6 weeks, the intervention group reported higher heiQ skill and technique acquisition scores (adjusted mean difference 0.29, 95% CI 0.04 to 0.55); however, this dissipated by 3 months. CONCLUSION: Significant challenges hampered this evaluation of the ASMP. The observed lack of enthusiasm from potential referrers and patients raises doubts about the practicality of this intervention in real-world settings. (ANZCTR Clinical Trials Registry number ACTRN12606000174583).
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