Summary Background Loss of arm function is a common problem after stroke. Robot-assisted training might improve arm function and activities of daily living. We compared the clinical effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice and with usual care. Methods RATULS was a pragmatic, multicentre, randomised controlled trial done at four UK centres. Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their first stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care. Robot-assisted training and EULT were provided for 45 min, three times per week for 12 weeks. Randomisation was internet-based using permuted block sequences. Treatment allocation was masked from outcome assessors but not from participants or therapists. The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN69371850. Findings Between April 14, 2014, and April 30, 2018, 770 participants were enrolled and randomly assigned to either robot-assisted training (n=257), EULT (n=259), or usual care (n=254). The primary outcome of ARAT success was achieved by 103 (44%) of 232 patients in the robot-assisted training group, 118 (50%) of 234 in the EULT group, and 85 (42%) of 203 in the usual care group. Compared with usual care, robot-assisted training (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70–1·96]) and EULT (aOR 1·51 [0·90–2·51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0·78 [0·48–1·27]). More participants in the robot-assisted training group (39 [15%] of 257) and EULT group (33 [13%] of 259) had serious adverse events than in the usual care group (20 [8%] of 254), but none were attributable to the intervention. Interpretation Robot-assisted training and EULT did not improve upper limb function after stroke compared with usual care for patients with moderate or severe upper limb functional limitation. These results do not support the use of robot-assisted training as provided in this trial in routine clinical practice. Funding National Institute for Health Research Health Technology Assessment Programme.
While an increasing number of healthcare providers are purchasing surgical robots because of anticipated improvements in patient outcomes, their implementation into practice is highly variable. In robotic surgery, the surgeon is physically separated from the patient and the rest of the team with the potential to impact communication and decision making in the operating theatre and subsequently patient safety. Drawing on the approach of realist evaluation, in this article we review reports of the experience of surgical teams that have introduced robotic surgery to identify how and in what contexts robotic surgery is successfully integrated into practice and how and in what contexts it affects communication and decision making. Our analysis indicates that, while robotic surgery might bring about a number of benefits, it also creates new challenges. Robotic surgery is associated with increased operation duration, which has implications for patient safety, but strategies to reduce it can be effective with appropriate support from hospital administration and nursing management. The separation of the surgeon from the team can compromise communication but may be overcome through use of standardised communication. While surgeon situation awareness may be affected by the separation, the ergonomic benefits of robotic surgery may reduce stress and tiredness and enhance surgeon decision making. Our review adds to the existing literature by revealing strategies to support the introduction of robotic surgery and contextual factors that need to be in place for these to be effective.
Health Services and Delivery ResearchISSN 2050-4349 (Print) ISSN 2050-4357 (Online) This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: journals.library@nihr.ac.ukThe full HS&DR archive is freely available to view online at www.journalslibrary.nihr.ac.uk/hsdr. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Health Services and Delivery Research journalReports are published in Health Services and Delivery Research (HS&DR) if (1) they have resulted from work for the HS&DR programme or programmes which preceded the HS&DR programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. HS&DR programmeThe Health Services and Delivery Research (HS&DR) programme, part of the National Institute for Health Research (NIHR), was established to fund a broad range of research. It combines the strengths and contributions of two previous NIHR research programmes: the Health Services Research (HSR) programme and the Service Delivery and Organisation (SDO) programme, which were merged in January 2012.The HS&DR programme aims to produce rigorous and relevant evidence on the quality, access and organisation of health services including costs and outcomes, as well as research on implementation. The programme will enhance the strategic focus on research that matters to the NHS and is keen to support ambitious evaluative research to improve health services.For more information about the HS&DR programme please visit the website: http://www.nets.nihr.ac.uk/programmes/hsdr This reportThe research reported in this issue of the journal was funded by the HS&DR programme or one of its preceding programmes as project number 12/5005/04. The contractual start date was in September 2013. The final report began editorial review in September 2016 and was accepted for publication in February 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HS&DR editors and production house have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department...
Fig. 1. A dashboard with four dynamically generated QualCards (left) including one for the Mortality metric (a); and an expansion of the Mortality QualCard with categorical (b), quantitative (c) and temporal (d) subsidiary views, which are customisable via a popover (e).
ObjectiveTo capture stakeholders’ theories concerning how and in what contexts robot-assisted surgery becomes integrated into routine practice.DesignA literature review provided tentative theories that were revised through a realist interview study. Literature-based theories were presented to the interviewees, who were asked to describe to what extent and in what ways those theories reflected their experience. Analysis focused on identifying mechanisms through which robot-assisted surgery becomes integrated into practice and contexts in which those mechanisms are triggered.SettingNine hospitals in England where robot-assisted surgery is used for colorectal operations.ParticipantsForty-four theatre staff with experience of robot-assisted colorectal surgery, including surgeons, surgical trainees, theatre nurses, operating department practitioners and anaesthetists.ResultsInterviewees emphasised the importance of support from hospital management, team leaders and surgical colleagues. Training together as a team was seen as beneficial, increasing trust in each other’s knowledge and supporting team bonding, in turn leading to improved teamwork. When first introducing robot-assisted surgery, it is beneficial to have a handpicked dedicated robotic team who are able to quickly gain experience and confidence. A suitably sized operating theatre can reduce operation duration and the risk of de-sterilisation. Motivation among team members to persist with robot-assisted surgery can be achieved without involvement in the initial decision to purchase a robot, but training that enables team members to feel confident as they take on the new tasks is essential.ConclusionsWe captured accounts of how robot-assisted surgery has been introduced into a range of hospitals. Using a realist approach, we were also able to capture perceptions of the factors that support and constrain the integration of robot-assisted surgery into routine practice. We have translated these into recommendations that can inform future implementations of robot-assisted surgery.
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