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Research in the time of COVID-19: Recruitment to a clinical trial comparing models of NIV implementation in people with MND
Sleep advances : a journal of the Sleep Research Society ; 2(Suppl 1):A64-A64, 2021.
Article in English | EuropePMC | ID: covidwho-2326257
ABSTRACT
Introduction A pilot randomised controlled trial (RCT) examining the feasibility of a new model of non-invasive ventilation (NIV) implementation was due to commence in early 2020. Based on previous research, it was anticipated that 100% of people with motor neurone disease (MND) would be eligible, 60% would consent to participate and 20 people would be randomised in five months. The aim of this report is to describe the impact of COVID-19 pandemic contingencies on trial recruitment. Methods Report of project progress, participant screening and recruitment. Results First reports of COVID-19 coincided with study commencement and changed usual healthcare delivery. Lockdowns meant telehealth substituted for face-to-face assessment, respiratory function testing was limited and/or patients were reluctant to seek medical treatment. This modified pathway impacted evaluation of diagnosis, timing of need for NIV and procedural safety, with patients then referred specifically for a single-day hospital NIV implementation to enable face-to-face multidisciplinary assessment to aid decisions. Of 81 potential participants screened in an 8-month period, 64% were ineligible for the RCT. Despite this shift in eligibility rate, 16 people with MND have been recruited as of May 2021. Conclusion The current climate has amplified the significance of this research trial;people with MND have had reduced access to face-to-face services globally and clinicians have had to quickly adapt to a changing landscape of telemedicine and remote monitoring of patients. This trial's screening data suggest that COVID-19 hasn't stopped people with MND being implemented on NIV, but it has altered assessment pathways.
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Collection: Databases of international organizations Database: EuropePMC Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Sleep advances : a journal of the Sleep Research Society Year: 2021 Document Type: Article

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Collection: Databases of international organizations Database: EuropePMC Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Sleep advances : a journal of the Sleep Research Society Year: 2021 Document Type: Article