ABSTRACT
Introduction: Mobility training is a complex intervention and recovery post-stroke is multidimensional. AVERT DOSE is the first trial to use an adaptive trial design in stroke rehabilitation and aims to define optimal early intervention regimens for people with mild to moderate ischaemic stroke. Seven Irish sites are participating. Method(s): AVERT DOSE (ACTRN:12619000557134) is a randomised trial that will recruit >2,500 patients internationally. Randomisation is to two groups according to stroke severity. Patients are then randomised to one of four mobility training regimens in each strata and the intervention is delivered for up to 14-days. Primary Outcome: Identification of the intervention regimen that results in higher proportion of favourable outcome at 3-months post-stroke. Seven Irish sites are participating. Result(s): In Ireland, 3 sites are recruiting (SJH, OLOLH, and MMUH) with 4 finalising contracts. Thirteen patients have been recruited to date in Ireland and 265 internationally. Trial set-up has proven complex and variable across Irish sites, with time to ethics approval ranging from 10-37-months. Given the COVID-19 pandemic and international nature of the trial, online training and meetings were necessitated for all Irish sites. Close communication, teamwork and shared responsibilities have supported this process. Flexibility was required with some blinded followup assessments using telehealth. Conclusion(s): Undertaking rehabilitation research requires a dynamic, problem-solving approach, particularly during a pandemic. Irish sites have embraced this opportunity to answer an important stroke research question. In Ireland, shared learning in trial governance should improve future rehabilitation trial readiness. Trial recruitment is expected to gain pace as more Irish and international sites are approved.
ABSTRACT
Background: Many patients with rheumatic disease require immunosuppressive medication putting them at high risk of COVID-19 infection. Reduced staffing in rheumatology due to redeployment to COVID-19 work, limited out patient capacity and patient vulnerability have had a major impact on our ability to review our patients to assess their condition and treatment (by face-to-face, video or telephone consultations). Novel strategies are essential to safely and effectively treat patients with rheumatic disease whilst minimising their risk of exposure to COVID-19 infection. Objectives: The objective was to develop a digital solution to help deliver safe, efficient and effective care for patients with rheumatic diseases. The aim was to produce a system that allowed us to integrate data recorded directly by patients with information held in our electronic health records to provide a virtual review of care. Methods: An online questionnaire was used to collect clinical information, including validated disease activity measures, to conduct a remote assessment in 175 patients awaiting follow-up appointments. This assessment was integrated within our electronic health records (EHR). The questionnaire contained measures of disease activity (DAS28 or BASDAI);patient reported outcomes;patient preferences regarding the urgency and type of appointment;any recent problems or changes in medication. This information was imported into a database for clinician review, together with previous clinical records and results of relevant investigations, to inform clinical decisions and to decide on the safest and most appropriate timing for follow-up. Report letters were sent to the patient and their primary care providers. Results: Of the 175 patients (149 with RA and 26 with AS), 108 patients (89/149 [60%] with RA [mean age=64;female=65%] and 19/26 [73%] with AS [mean age=45;female=54%]) submitted responses over a 6-week period based on which clinical decisions were made. The mean questionnaire completion time was 19 minutes for RA responders and 16 minutes for AS responders. Non responders (67/175 [mean age=61;female=63%]) remained on our list of patients awaiting follow-up arrangements to be made. Sixty-nine responders (64%) had stable disease therefore did not require any changes to their treatment and were offered an appointment within the next 6 months, of whom 12 (11%) requested face-to-face follow-up. Of the remaining 39 -with less stable disease -requiring more rapid follow-up assessment, 22 patients (56%) required a face-to-face consultation to consider treatment change. So far 9 of these patients have had follow-up, of whom 6 necessitated treatment escalation (Methotrexate increase n=2;anti-inflammatory increase n=2;intramuscular steroid n=1;anti-TNF escalation n=1). Thirty-nine patients (36%) provided feedback on the process of completing the questionnaire, 85% of whom used a mobile phone and the remainder used a computer or tablet. The majority (70%) found it “extremely easy” or 'somewhat“extremely difficult” 0%. Conclusion: We have created and tested a system of remote clinical management for patients with RA and AS. Amongst the 108 responders, just 31% required a face-to-face appointment, with treatment changes made accordingly. With a backlog of 3,800 awaiting allocation to follow-up appointments, remote clinical management will allow us to safely and efficiently prioritise patients requiring urgent follow-up for treatment optimisation. We will integrate this system into our standard care pathway beyond the COVID-19 pandemic to streamline our service, deliver effective care and provide evidence to support the use of costly biologic drugs.1 We plan to investigate the barriers for non-responders.