PREdictors of COVID19 OUtcomeS (PRECIOUS)

BACKGROUND: COVID-19 has impacted >767 million people worldwide. Addressing the long-term impacts, areas of rehabilitation need within the COVID-19 population and establishing costs of care are a priority. AIM: Create an international, multidisciplinary COVID-19 database, synthesising long-term outcomes, predictors and costs. OBJECTIVES: Describe: 'Ä¢ long-term outcomes and predictors, by International Classification of Functioning, Disability and Health (ICF) domains 'Ä¢ financial costs of COVID-19 'Ä¢ findings to patients, public, health professionals and researchers METHODS DESIGN: Systematic identification and recruitment of COVID-19 datasets, creating an international multidisciplinary database to support individual participant data (IPD) meta-analysis. Patients & Public Involvement (PPI) and health professionals will inform methodological decisions & dissemination. STAGE 1: A systematic search of electronic databases, trial registries, grey literature, forward & backward citation tracking, with no language restrictions, for COVID-19 cohort studies and randomised controlled trials, from any setting, where assessments are recorded >=1 month of symptom onset. Investigators will be invited to contribute IPD. Data will be securely stored, cleaned & mapped to ICF domains. STAGE 2: Demographic, socioeconomic, clinical, treatment, resource use data (in natural units), and long-term outcomes will be extracted. Our existing algorithm will support data standardisation within ICF domains. Planned IPD meta-analyses will consider the effects of demographic, socio-economic, comorbidity, clinical & treatment variables on (A) long-term outcomes using a one-step regression approach; and (B) resource use (individual, healthcare & community costs). Data permitting, a prediction algorithm will be developed for clinical use. FEASIBILITY: >8000 IPD (14 studies; 10 countries) secured and is expected to increase. OUTCOMES, IMPACT & DISSEMINATION will describe the COVID-19 population in whom evidence is based, highlight gaps, applicability of findings & direct future research; map expected long-term impacts; provide information for people with COVID-19, families, GPs, clinicians, researchers & policy makers; inform resource allocation, prognosis and avenues for early intervention; develop a prediction algorithm for clinical use; quantify the cost of COVID-19, direct resources and support to areas of need. A legacy dataset will facilitate future analyses. Outputs will be delivered via a website, peer-reviewed papers, engagement with health professionals via existing networks, people with COVID-19 & their families via PPI led activities & social media. DURATION: 2 years ETHICS: University ethics approval is pending for anonymised data analysis. IRAS registration has been requested. Data sharing will be subject to local approvals. Data contribution, preparation and analysis will adhere to a data management plan. COSTS: An international IPD database will permit efficient analyses. Costs support experienced IPD meta-analysis rehabilitation researchers, statisticians, health economists, clinical researchers in long-term conditions, rehabilitation (OT, Physio, SLT, Audiology), respiratory medicine, infectious diseases and PPI partners. Our shared legacy database will reduce research waste.