Search

Abstract Background Patients, their family members and caregivers have firsthand experiences of living with or supporting someone living with a disease or medical condition. This knowledge by experience cannot be replaced by the knowledge acquired by clinicians, researchers, or other professionals through study and/or work. The Therapies for Long COVID in non-hospitalised individuals (TLC) research project was funded in the UK by the National Institute for Health and Care Research (NIHR) and UK Research and Innovation to investigate the impact of long COVID on affected individuals. This article focuses on the implementation of PPIE for the TLC project. It provides details on the methodological approach that was adopted, the evaluation and reporting of the PPIE for the project and some previously unreported challenges we faced. Main body A PPIE Lead was appointed to coordinate PPIE for the project and facilitate communication and relationship building with the patient partners. Our overarching approach was collaborative with patient partners actively involved in the various work packages of the project.. This was achieved by recruiting PPIE members from (1) direct contacts, (2) long COVID support groups (3) a local general practitioner (GP) surgery. Although we were unable to hold face-to-face meetings due to the social restrictions during the COVID-19 pandemic, we offered patients the choice of using virtual platforms like Zoom, telephone calls, and emails for communication. We adopted a 4-tiered model for the PPIE group with each tier providing different opportunities for contributing to the project. This model helped the PPIE Lead to effectively co-ordinate PPIE activities for the project as well as provide all patient partners the opportunity to contribute to the project whilst managing their condition. PPIE for the TLC project was co-evaluated with patient partners. Conclusions Despite the challenges we encountered with the pandemic, the TLC project provided a valuable opportunity for patients to shape the design, conduct and dissemination of the research findings. The information provided in this article may be useful to other researchers and patients when planning PPIE for future health research. The implementation of PPIE in healthcare research could help ensure that the outcomes of research are those valued by and relevant to the needs of patients and other end users.

Abstract Post COVID-19 condition or long COVID is highly prevalent and often debilitating, with key symptoms including fatigue, breathlessness, and brain fog. There is currently a lack of evidence-based treatments for this highly complex syndrome. There is a need for clinical trial platforms to rapidly evaluate nonpharmacological treatments to support affected individuals with symptom management. We co-produced a mixed methods feasibility study to evaluate a multi-arm digital decentralised clinical trial (DCT) platform to assess non-pharmacological interventions for Long COVID, using pacing interventions as an exemplar. The study demonstrated that the platform was able to successfully e-consent participants, randomise them into one of four intervention arms, capture baseline data, and capture outcomes relevant to a health economic evaluation. The study also highlighted several challenges, including difficulties with recruitment, imposter participants, and high attrition rates. We highlight how these challenges can potentially be mitigated to make a fully powered DCT more feasible.

Introduction Individuals with COVID-19 frequently experience symptoms and impaired quality of life beyond 4–12 weeks, commonly referred to as Long COVID. Whether Long COVID is one or several distinct syndromes is unknown. Establishing the evidence base for appropriate therapies is needed. We aim to evaluate the symptom burden and underlying pathophysiology of Long COVID syndromes in non-hospitalised individuals and evaluate potential therapies.Methods and analysis A cohort of 4000 non-hospitalised individuals with a past COVID-19 diagnosis and 1000 matched controls will be selected from anonymised primary care records from the Clinical Practice Research Datalink, and invited by their general practitioners to participate on a digital platform (Atom5). Individuals will report symptoms, quality of life, work capability and patient-reported outcome measures. Data will be collected monthly for 1 year.Statistical clustering methods will be used to identify distinct Long COVID-19 symptom clusters. Individuals from the four most prevalent clusters and two control groups will be invited to participate in the BioWear substudy which will further phenotype Long COVID symptom clusters by measurement of immunological parameters and actigraphy.We will review existing evidence on interventions for postviral syndromes and Long COVID to map and prioritise interventions for each newly characterised Long COVID syndrome. Recommendations will be made using the cumulative evidence in an expert consensus workshop. A virtual supportive intervention will be coproduced with patients and health service providers for future evaluation.Individuals with lived experience of Long COVID will be involved throughout this programme through a patient and public involvement group.Ethics and dissemination Ethical approval was obtained from the Solihull Research Ethics Committee, West Midlands (21/WM/0203). Research findings will be presented at international conferences, in peer-reviewed journals, to Long COVID patient support groups and to policymakers.Trial registration number 1567490.