229 OPERAM: cluster randomised controlled trial Primary outcome The number of patients with a first confirmed drug-related hospital admission was 211 (21.9%) in the intervention group, and 234 (22.4%) in the control group (Table 4, Figure SI1.2). Table SI1.2 lists the medication classes implicated in drug-related hospital admissions. In the intention-to-treat analysis, applying censoring for death at time of death, the HR for drug-related hospital admission was 0.95 (95%CI=0.77 to 1.17). In the per-protocol analysis, HR was 0.91 (95%CI=0.69 to 1.19, Table SI1.3, Figure SI1.3), with similar results in sensitivity analyses of competing risk of death, adjusting for baseline characteristics, and assessing varying intervention effect across time (Tables SI1.4-1.6). In post-hoc analyses, HR for first preventable drugrelated hospital admission (41% of first confirmed drug-related hospital admissions) was 0.89 (95%CI=0.63 to 1.25), and HR was 0.88 (95%CI=0.65 to 1.19) for first drugrelated hospital admission in patients with ≥1 STOPP recommendation implemented after 2 months (N=398 in the intervention group, N=875 in the control group still in the trial after 2 months). The intervention effect on drug-related hospital admissions did not differ in pre-specified subgroup analyses, except for trial site (Louvain HR 0.50, 95%CI=0.30 to 0.85, p for interaction=0.05) and dementia diagnosis (p for interaction=0.04) (Figure SI1.4). Secondary outcomes The event rates for falls were 0.49 and 0.59 per person-year in the intervention and control groups respectively, with a HR for first fall was 0.96 (95%CI=0.79 to 1.15) among intervention patients. The HR for death was 0.90 (95%CI=0.71 to 1.13, Table 4, Figure SI1.5). Pain, activities of daily living status, drug adherence and drug-related outcomes did not differ significantly between groups, except for quality of life at 12 months which was better in the intervention group (between-group adjusted mean difference: 2.29 [95%CI=0.31 to 4.26], Table 5). Results were similar in per-protocol analyses, as well as in sensitivity analyses of competing risk of death, adjusting for baseline characteristics, time-varying intervention effect, and exclusion of interviews outside pre-specified time windows (Tables SI1.3-1.7). Subgroup analyses of all-cause mortality showed potential benefits for men, patients aged ≥ 80 years, and those randomized in Louvain (p values for interaction = 0.004, 0.01 and 0.02, respectively; Figure SI1.6). The ICCs for the main outcomes were in the expected range (Table SI1.8). 3
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