Research in the time of COVID-19: Recruitment to a clinical trial comparing models of NIV implementation in people with MND

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.

Post COVID condition phenotypes-Role in clinical practice?

Introduction/Aim: Post COVID conditions are highly heterogenous and pose significant challenges to healthcare systems. The aim of this study was to identify and characterise symptom clusters at 6-months following COVID illness. Method(s): Symptom burden was assessed in a COVID respiratory clinic 6-months following diagnosis. K-mean cluster analysis was utilised to identify clusters and validated assessment tools for dyspnoea [MMRC], mood [PHQ-4], fatigue [FSS] and pain [WPI]were used to characterise clusters. Result(s): 58 patients (median age 59 years, 31 males) attended 6-month follow up. Cluster 4 represented patients experiencing high symptom burden with high fatigue, pain, depression and anxiety scores. A high proportion of Cluster 2 reported no symptoms but had high dyspnoea scores. Results for PHQ-4, FSS and WPI are presented as means (95%confidence interval) Cluster (n) Symptoms MMRC >1 (n%) PHQ-4 FSS WPI 1(8) anosmia, headache, fatigue, memory, concentration 3(5.1) 1(1,2) 31(17,45) 5(-1,10) 2(42) Isolated Dyspnoea 15(25.9) 1(1,2) 22(18,26) 1(0,1) 3(3) fatigue, nasal congestion, chest pain 3(5.1) 5(-10,21) 36(-26,98) 7(-11,24) 4(4) high symptom burden 4(6.9) 7(0,13) 51(36,66) 12(2,21) Conclusion(s): This exploratory analysis identified 4 possible post COVID condition phenotypes with unique symptom profiles. Larger scale phenotyping may facilitate a streamlined and customised approach to managing this evolving chronic and highly heterogenous clinical condition.

Clinical and respiratory function outcomes 6-months following diagnosis of COVID-19

Introduction/Aim: As health systems emerge through successive waves of COVID-19, focus shifts to the management of Post-COVID-19 conditions. The aim of this prospective observational study was to characterise and evaluate the respiratory sequelae affecting patients 6-months post-diagnosis of COVID-19. SIGNFICANT MODELLING PREDICTORS Outcome Predictors MMRC>= 1 Disease severity Moderate: OR 16.5 +/- 1.02 (SE) p = 0.006 Impaired DLCO (%predicted) Disease severity B=-1.51+/-0.67 (SE) p = 0.010 Impaired TLC (%predicted) D-Dimer B= -0.305 +/- 0.001 (SE), p = 0.05 TLC below LLN Diabetes B=-1.28 +/- 0.32 (SE), p = 0.044 Methods: Patients were evaluated for symptom burden and lung function at 6-months post-diagnosis of COVID-19 in an outpatient setting. Result(s): Fifty-eight (45 inpatients and 13 outpatients;median age 59 years, 28 females) patients attended 6-month clinic appointment. Whilst nearly half (28,48.3%) were asymptomatic at 6-months, 24 (41.3%) patients reported a modified medical research council dyspnoea scale (MMRC) >= 1 and 21 (36.2%) patient-reported fatigue (n= 21, 36.2%). Reduced TLC (n= 11/50, 22.0%) and DLCO (n = 12/51, 23.5%) were common at 6-months. Results of predictive modelling analyses are described in adjacent table. Conclusion(s): Patients presenting with increased disease severity are at risk of persistent dyspnoea and impaired diffusion capacity, 6-months following acute COVID-19 illness. Research guided management of this growing at risk cohort, while paramount, poses a formidable challenge to stretched healthcare systems.