RT Journal Article SR Electronic T1 Economic evaluation of robot-assisted training versus an enhanced upper limb therapy programme or usual care for patients with moderate or severe upper limb functional limitation due to stroke: results from the RATULS randomised controlled trial JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e042081 DO 10.1136/bmjopen-2020-042081 VO 11 IS 5 A1 Fernandez-Garcia, Cristina A1 Ternent, Laura A1 Homer, Tara Marie A1 Rodgers, Helen A1 Bosomworth, Helen A1 Shaw, Lisa A1 Aird, Lydia A1 Andole, Sreeman A1 Cohen, David A1 Dawson, Jesse A1 Finch, Tracy A1 Ford, Gary A1 Francis, Richard A1 Hogg, Steven A1 Hughes, Niall A1 Krebs, H I A1 Price, Christopher A1 Turner, Duncan A1 Van Wijck, Frederike A1 Wilkes, Scott A1 Wilson, Nina A1 Vale, Luke YR 2021 UL http://bmjopen.bmj.com/content/11/5/e042081.abstract AB Objective To determine whether robot-assisted training is cost-effective compared with an enhanced upper limb therapy (EULT) programme or usual care.Design Economic evaluation within a randomised controlled trial.Setting Four National Health Service (NHS) centres in the UK: Queen’s Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust; Northwick Park Hospital, London Northwest Healthcare NHS Trust; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde; and North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust.Participants 770 participants aged 18 years or older with moderate or severe upper limb functional limitation from first-ever stroke.Interventions Participants randomised to one of three programmes provided over a 12-week period: robot-assisted training plus usual care; the EULT programme plus usual care or usual care.Main economic outcome measures Mean healthcare resource use; costs to the NHS and personal social services in 2018 pounds; utility scores based on EQ-5D-5L responses and quality-adjusted life years (QALYs). Cost-effectiveness reported as incremental cost per QALY and cost-effectiveness acceptability curves.Results At 6 months, on average usual care was the least costly option (£3785) followed by EULT (£4451) with robot-assisted training being the most costly (£5387). The mean difference in total costs between the usual care and robot-assisted training groups (£1601) was statistically significant (p<0.001). Mean QALYs were highest for the EULT group (0.23) but no evidence of a difference (p=0.995) was observed between the robot-assisted training (0.21) and usual care groups (0.21). The incremental cost per QALY at 6 months for participants randomised to EULT compared with usual care was £74 100. Cost-effectiveness acceptability curves showed that robot-assisted training was unlikely to be cost-effective and that EULT had a 19% chance of being cost-effective at the £20 000 willingness to pay (WTP) threshold. Usual care was most likely to be cost-effective at all the WTP values considered in the analysis.Conclusions The cost-effectiveness analysis suggested that neither robot-assisted training nor EULT, as delivered in this trial, were likely to be cost-effective at any of the cost per QALY thresholds considered.Trial registration number ISRCTN69371850.Data are available upon reasonable request. De-identified participant data will be made available to scientific researchers upon approval of their study protocol and analysis plan, by a committee of the RATULS team. Proposals should be directed to the corresponding author. A data sharing agreement will need to be signed by data requestors.