261 OPERAM: cluster randomised controlled trial - SI Table SI1.4. Time-to-event analysis taking into account competing risks (regression on sub-hazards). Events (%) Outcome Control Intervention HR (95% CI) 1 P value First drug-related hospital admission 234 (22.4%) 211 (21.9%) 0.96 (0.79 to 1.18) 0.71 Death by cancer 55 (5.3%) 43 (4.5%) 0.76 (0.47 to 1.23) 0.27 First hospitalization 516 (49.4%) 447 (46.4%) 0.89 (0.77 to 1.03) 0.12 First fall 263 (25.2%) 237 (24.6%) 0.96 (0.81 to 1.16) 0.70 First preventable drugrelated hospital admission 2 100 (9.6%) 84 (8.7%) 0.91 (0.65 to 1.27) 0.58 1 HR<1 indicates fewer events in the intervention group; 2 Post hoc analysis. For the first drug-related hospital admission, first hospitalization and first fall, the analysis takes into account the competing risk of death. For death by cancer, the analysis takes into account the competing risk of other type of death. For first preventable drug-related hospital admission, the competing risk of other types of drug-related hospital admission were taken into account. Drug-related hospital admissionwas considered preventablewhen deemed by the adjudication committee as potentially related to a drug overuse, underuse or misuse (i.e. drug with an indication, but error in prescribing, dispensing, administering or monitoring the medication). Abbreviations: CI, confidence interval; HR, hazard ratio. Table SI1.5. Analysis adjusted for baseline characteristics. Outcome Control Intervention HR (95%CI) 1 P value N Events (%) N Events (%) First drug-related hospital admission 1,045 234 (22.4%) 963 211 (21.9%) 0.94 (0.76 to 1.16) 0.57 Death 1,045 203 (19.4%) 963 172 (17.9%) 0.89 (0.71 to 1.12) 0.33 N 2 Mean (SD) N 2 Mean (SD) Adjusted difference (95% CI) 3 Number of long-term medications 2 months after enrolment 4 893 11.0 (4.27) 833 11.2 (4.54) -0.21 (-0.53 to 0.10) 0.18 Number of long-term medications 12 months after enrolment 4 767 10.7 (4.57) 726 10.7 (4.54) -0.39 (-0.73 to -0.04) 0.03 1 HR<1 indicates fewer events in the intervention group; 2 Numbers of participants differ from those for clinical outcomes, as they were based on available data at months 2, 6, and 12 for medication-related outcomes, and non-available data at 12 months were mainly due to death (N of deaths until month 2, 6, 12: 167, 280, 385). 3 Adjusted difference: Adjusted for the baseline value of the outcome. Positive values indicate higher values in the intervention group. 3 Long-term medications are defined as use of a drug for >30 days. Analysis further adjusted for baseline characteristics (i.e., site, departments of clusters, sex, non-independently living, age, number of medications at baseline, number of comorbidities at baseline, dementia). Abbreviations: CI, confidence interval; HR, hazard ratio; N, number; SD, standard deviation. 3
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