Cost-effectiveness of a multifaceted podiatry intervention for the prevention of falls in older people: The 3 REFORM trial findings 4

Background: Falls are a major cause of morbidity among older people. Multifaceted interventions may be 47 effective in preventing falls and related fractures. Objective: To evaluate the cost-effectiveness alongside the REFORM (REducing Falls with Orthoses and a 50 Multifaceted podiatry intervention) trial. 51 52 Methods: REFORM was a pragmatic multicentre cohort randomised controlled trial in England and Ireland; 53 1010 participants (>65 years) were randomised to receive either a podiatry intervention (n= 493), including foot 54 and ankle strengthening exercises, foot orthoses, new footwear if required, and a falls prevention leaflet, or 55 usual podiatry treatment plus a falls prevention leaflet (n=517). Primary outcome: incidence of falls per 56 participant in the 12 months following randomisation. Secondary outcomes: proportion of fallers and quality of 57 life (EQ-5D-3L) which was converted into quality-adjusted life years (QALYs) for each participant. Differences 58 in mean costs and QALYs at 12 months were used to assess the cost-effectiveness of the intervention relative to 59 usual care. Cost-effectiveness analyses were conducted in accordance with National Institute for Health and 60 Clinical Excellence reference case standards, using a regression based approach with costs expressed in GBP 61 (2015 price). The base case analysis used an intention to treat approach on the imputed data set using multiple 62 imputation (MI). Results: There was a small, non-statistically significant reduction in the incidence rate of falls in the 65 intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). Participants allocated to 66 the intervention group accumulated on average marginally higher QALYs than usual care participants (mean 67 difference 0.0129, 95% CI -0.0050 to 0.0314). The intervention costs on average £252 more per participant 68 compared to usual care (95% CI -£69 to £589). Incremental cost-effectiveness ratios ranged between £19,494 69 and £20,593 per QALY gained, below the conventional NHS cost-effectiveness thresholds of £20,000 to 70 £30,000