The impact of COVID-19 on clinical research: the PIPPRA and MEDRA experience

Abstract

Background: Coronavirus disease 2019 (COVID-19) has had a significant impact on clinical research. This paper aims to provide an insight into how the COVID-19 pandemic, associated public health restrictions and international guidance on the conduct of clinical research impacted two clinical rheumatology research trials - the Physiotherapist-led Intervention to Promote Physical Activity in Rheumatoid Arthritis (PIPPRA) and the MEDiterranean diet in Rheumatoid Arthritis (MEDRA) projects. Methods: The March 2019 public health restrictions imposed to mitigate the risk of COVID-19 occurred at a time when PIPPRA was in the process of delivering assessment and intervention on a face-to-face basis (n=48) and MEDRA had commenced recruitment. Participants in PIPPRA and MEDRA had a diagnosis of rheumatoid arthritis, with some being immunosuppressed and thus at a higher risk for COVID-19. The decision-making processes of both trials is outlined to demonstrate the required amendments to continue in the context of the COVID-19 pandemic. Results: Amendments to PIPPRA and MEDRA trial protocols were agreed and received ethical and funder approval. Both trials switched from a face-to-face delivery to a telehealth using online platforms. The PIPPRA study was paused for five months (April-August 2020), resulting in n=33 (60%) deviations from assessment protocol. MEDRA switched from face-to-face to online recruitment with 20% (n=35/44) deviation in recruitment. Of the n=18 participants who consented to participating in a face-to-face trial, just n=2 (11%) opted to engage with telehealth delivery of the intervention. MEDRA assessment and intervention deviations were 100% as no sessions were completed as planned in 2020. Conclusions: The COVID-19 pandemic has severely impacted the PIPPRA and MEDRA clinical trials. Moving face-to-face clinical research to telehealth delivery may not be the panacea it is purported to be. Our experiences may be of benefit to researchers, clinicians, and funders in seeking to continue clinical research during a global pandemic.

Effects of a Telehealth-Delivered Mediterranean Diet Intervention in Adults with Rheumatoid Arthritis (MEDRA): A Randomised Controlled Trial

“…The MEDRA study was an open-label, telehealth-delivered, randomised controlled trial with two parallel intervention arms. In response to the pandemic and following the Irish government's announcement of a national lockdown, we sought to use telehealth methods to deliver the proposed intervention [28]. The study was designed in accordance with and adheres to the Consolidated Standards of Reporting Trials (CONSORT) statement [29].…”

Clinical research stakeholders’ experiences of clinical research during COVID-19: a qualitative study

“…COVID-19 has had a significant impact on healthcare and clinical research, causing significant disruption to the delivery of health services and suspension of clinical research activities [ 1 ]. Clinical research stakeholders (CRS) were doubly impacted, tasked with navigating challenges across clinical and academic settings.…”

“…Impact on clinical research varied based on the stage of projects, ranging from recruitment disruptions, pausing data collection pausing and cessation [ 2 ]. Long-term effects continue to be felt across the clinical research landscape with ongoing patient concerns of COVID-19 exposure creating reluctance for clinical research participants [ 1 , 2 ].…”

A randomised controlled trial of a Mediterranean Dietary Intervention for Adults with Rheumatoid Arthritis (MEDRA): Study protocol

“…The telehealth approach for delivering dietary interventions is a safe, convenient and potentially a more inclusive way to capture diverse perspectives compared to face-to-face appointments with participants which is an essential consideration given the recent Covid-19 public health pandemic [ 26 , 27 ]. A systematic review including 23 studies demonstrated that telemedicine could offer a cost-effective and widely accepted approach to deliver consultations remotely in rheumatology [ 28 ].…”