239 OPERAM: cluster randomised controlled trial Discussion Principal findings In this cluster-RCT, evaluating the effect of a structured pharmacotherapy optimization intervention, five out of six multimorbid older patients experienced inappropriate prescribing. On average, 2.75 STOPP/START recommendations per patient were provided in the intervention group, and 62% of intervention patients had ≥1 recommendation implemented at 2 months, mostly discontinuation of drug overuse. Reduction of potentially inappropriate medication led to no detriment to patient outcomes, but drug-related hospital admissions were not significantly reduced during a 12-month follow-up, compared to usual care, despite providing evidence-based recommendations to hospital physicians, patients and their GPs. Comparison with other evidence Few RCTs have assessed the impact of reducing inappropriate prescribing on clinical outcomes. A previous Cochrane review of pharmacotherapy optimization interventions in older people identified nine RCTs reporting hospital admissions as outcomes, seven of which found no significant difference between intervention and control groups [7]. However, the primary endpoint of these studies was often non-clinical and measurement methods varied considerably across these studies. The review judged the risk of bias for this outcome as very high, due to risk of contamination between groups, insufficient blinding, selective reporting, lack of adjudication of clinical outcomes, short follow-up and/or small sample size. In addition, only four of these RCTs were conducted in hospitalized patients. Hospitalizations and emergency department visits were reduced in one small RCT (N=110) whose setting however differed substantially from ours in that it included only patients undergoing first-time transfer to a long-term care facility, was singleblinded (primary outcome assessors blinded), and the intervention was performed by a pharmacist transition coordinator [26]. Another RCT of 368 hospitalized patients aged ≥80 years (with and without polypharmacy) compared medication review performed by ward-based pharmacists to usual care, and found an 80% (95%CI 59-90%) subsequent reduction in drug-related hospital readmissions [16]. However, outcomes were not independently adjudicated, and generalizability of the results was limited due to the single centre design. Other RCTs had additional limitations such as short follow-up, single-centre design, and insufficient power to identify a difference in hospital admissions [7]. More recently, the SENATOR RCT of 1,537 hospitalized multimorbid older patients with polypharmacy compared software-guided medication optimization advice provided to attending physicians versus standard care, and found no between3
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