Outcome (number of data pointsMEDIC number of data pointswritten advice)* | Improvement in MEDIC group (95% CI) | Improvement in written advice group (95% CI) | Between-group (MEDIC vs written advice) difference (model 1)† (95% CI) | Between-group (MEDIC vs written advice) difference (model 2)‡ (95% CI) |
Primary outcome | ||||
Mean change in KOOS4 from baseline to 5 years (267, 264) | 22.8 (16.9 to 28.8) | 19.1 (10.8 to 27.3) | 5.3 (−1.5 to 12.1) | 5.3 (−1.5 to 12.1) |
Secondary outcomes | ||||
KOOS Pain (270, 264) | 20.5 (13.1 to 27.8) | 22.2 (13.1 to 31.2) | 0.6 (−7.2 to 8.5) | 0.6 (−7.2 to 8.4) |
KOOS Symptoms (270, 264) | 20.3 (13.7 to 27.0) | 16.9 (8.4 to 25.4) | 4.7 (−3.0 to 12.3) | 4.7 (−3.0 to 12.4) |
KOOS ADL (270, 264) | 21.4 (14.8 to 27.9) | 17.1 (8.3 to 25.8) | 6.8 (−1.2 to 14.8) | 6.8 (−1.2 to 14.8) |
KOOS Sport/Recreation (267, 257) | 16.5 (8.3 to 24.7) | 22.8 (11.2 to 34.4) | −5.3 (−15.2 to 4.5) | −5.3 (−15.1 to 4.5) |
KOOS Quality of life (267, 264) | 25.7 (18.2 to 33.2) | 20.2 (11.1 to 29.2) | 6.6 (−1.4 to 14.7) | 6.6 (−1.4 to 14.7) |
Mean change in EQ-5D | ||||
EQ-5D index (269, 264) | 0.138 (0.074 to 0.203) | 0.138 (0.060 to 0.215) | 0.025 (−0.043 to 0.092) | 0.025 (−0.043 to 0.092) |
EQ VAS (267, 265) | 6.0 (0.1 to 11.8) | 10.2 (1.7 to 18.6) | −2.1 (−10.7 to 6.6) | −2.1 (−10.7 to 6.6) |
MEDIC treatment: patient education, supervised exercise, weigth loss, insoles, and pain medication KOOS4: the mean score of four out of five of the Knee injury and Osteoarthrits Outcome Score subscales covering pain, symptoms, function in daily living (ADL) and quality of life, with scores ranging from 0 to 100 (worst to best scale); Sport/Rec: function in sport and recreation. VAS: visual analogue scale.
*n refers to the number of data points out of 300 in each group (50 at baseline, 3, 6, 12, 24 months and 5 years).
†Estimates are from a linear mixed model adjusting for patient, follow-up, treatment arm and interaction between follow-up and treatment arm.
‡Estimates are from a linear mixed model adjusting for patient, follow-up, treatment, site and interaction between follow-up and treatment arm. A positive between-group difference indicates a difference in favour of the MEDIC group and a negative between-group difference indicates a difference in favour of the written advice group.
KOOS, Knee injury and Osteoarthritis Outcome Score;