263 OPERAM: cluster randomised controlled trial - SI Table SI1.7. Patient-reported outcomes, considering only interviews within the prespecified time window. Control Intervention Outcome Follow-up (month) 1 N Mean (SD) N Mean (SD) Adjusted difference (95% CI) 2 P value QoL/EQ-VAS 3 2 625 64.6 (20.3) 614 65.7 (19.6) 0.56 (-1.50 to 2.63) 0.59 6 657 65.6 (19.0) 631 67.0 (17.4) 0.98 (-1.06 to 3.02) 0.35 12 648 64.8 (19.4) 568 67.0 (18.0) 2.26 (0.18 to 4.34) 0.03 Pain/discomfort score (EQ-5D) 4 2 643 1.13 (1.19) 631 1.07 (1.11) -0.05 (-0.17 to 0.07) 0.45 6 670 1.19 (1.19) 644 1.05 (1.15) -0.11 (-0.23 to 0.01) 0.08 12 666 1.15 (1.21) 582 1.02 (1.11) -0.12 (-0.25 to -0.00) 0.048 ADL 5 2 631 86.9 (20.5) 627 88.6 (19.4) 0.94 (-1.29 to 3.17) 0.41 6 660 88.0 (18.8) 638 89.4 (18.6) 0.73 (-1.49 to 2.96) 0.52 12 658 87.0 (20.2) 575 88.6 (18.9) 1.60 (-0.64 to 3.83) 0.16 ©MMAS-8 6 2 599 6.54 (0.804) 593 6.56 (0.788) 0.02 (-0.07 to 0.11) 0.67 12 653 6.58 (0.811) 576 6.61 (0.746) 0.04 (-0.05 to 0.12) 0.41 1 Time windows: ±14 days at the 2-month interview; ±30 days at the 6-month interview; ±30 days at the 12-month interview. 2 Adjusted difference: Adjusted for the baseline value of the outcome. Positive values indicate higher values in the intervention group. 3 QoL/EQ-VAS: Quality of life as measured by the visual analogue scale that is the second part of the 5-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-VAS). Values ranged from 0 to 100. Higher values indicate higher quality of life. 4 Pain/discomfort score (EQ5D): Pain/discomfort as measured in the 5-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-VAS). Values ranged from 0 to 4. Higher values indicate higher level of pain or discomfort. 5 ADL: Basic Activities of Daily Living, as measured by the Barthel Index. Values ranged from 0 to 100. Higher values indicate higher functional independence. 6 ©MMAS-8: Drug compliance, measured by Medication Adherence Questionnaire (©MMAS8) developed by Morisky [1–3]. Values ranged from 0 to 8. Higher scores indicate higher levels of adherence. Abbreviations: CI, confidence interval; N, number; OR, odds ratio; SD, standard deviation 3
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