Cohort Profile: Post-Hospitalisation COVID-19 (PHOSP-COVID) study

Résumé fourni par la source

The Post-Hospitalisation COVID-19 (PHOSP-COVID) study is a national UK multicentre cohort study of patients who were hospitalized for COVID-19 and subsequently discharged. PHOSP-COVID was established to investigate the medium- and long-term sequelae of severe COVID-19 requiring hospitalization, understand the underlying mechanisms of these sequelae, evaluate the medium- and long-term effects of COVID-19 treatments and to serve as a platform to enable future studies, including clinical trials. Data collected covered a wide range of physical measures, biological samples and patient-reported outcome measures (PROMs). Participants could join the cohort either in Tier 1 only with remote data collection using hospital records, a PROMs app and postal saliva sample for DNA; or in Tier 2 in which they were invited to attend two specific research visits for further data collection and biological research sampling. These research visits occurred at 5 (range 2–7) months and 12 (range 10–14) months post-discharge. Participants could also participate in specific nested studies (Tier 3) at selected sites. All participants were asked to consent to further follow-up for 25 years via linkage to their electronic healthcare records and to be re-contacted for further research. In total, 7935 participants were recruited from 83 UK sites: 5238 to Tier 1 and 2697 to Tier 2, between August 2020 and March 2022. Cohort data are held in a Trusted Research Environment and samples stored in a central biobank. Data and samples can be accessed upon request and subject to approvals from https://www.phosp.org/data-sample-request/. To date, there have been >750 million reported cases of COVID-19 globally since the pandemic began in early 2020.1 In the UK, there have been >1 million patients hospitalized and 180 000 deaths due to COVID-19.2 Previous viral epidemics and conditions causing acute respiratory distress syndrome caused long-lasting health impacts on the affected survivors.3,4 At the time of conception of the Post-Hospitalisation COVID-19 (PHOSP-COVID) cohort in March 2020, the longer-term pulmonary and multisystem effects of COVID-19 and impact on health status were unknown.5 We identified a need to establish a cohort of hospitalized COVID-19 survivors to collect detailed information about the medium- and long-term effects of COVID-19 on physical and mental health, lifestyle and occupation status. Although the majority of individuals with COVID-19 were not hospitalized, we expected that the consequences of COVID-19 might be most pronounced after severe illness. Furthermore, the pressures on health systems during the pandemic needed to be taken into consideration when establishing a new clinical cohort. Therefore, we designed the PHOSP-COVID study to align with clinical follow-up reviews of hospitalized patients, where possible. PHOSP-COVID was designed to take a patient-centred, holistic approach to understanding the medium- and long-term effects of COVID-19, recognizing the need to consider physical and mental health, social support and lifestyle. There were three main aims of PHOSP-COVID: To determine the medium- and long-term health (and health economic) sequelae of COVID-19 in post-hospitalization survivors; to define demographic, clinical and molecular biomarkers of susceptibility, including to severity of the acute illness and development, progression and resolution of sequelae. To understand the impact of inpatient and post-discharge, pharmacological and non-pharmacological interventions on long-term sequelae of COVID-19. To build the foundation for in-depth studies of emergent conditions and worsening of pre-morbid disease to inform precision medicine in at-risk groups by directing new clinical trials and care for current and future patients with long COVID. Individuals who were discharged from hospital between 1 February 2020 and 31 March 2021 were invited to participate in the PHOSP-COVID study if they were: aged ≥18 years, admitted to a participating UK hospital with confirmed or clinically suspected COVID-19 and able to provide informed consent either personally or via a consultee or an appropriate representative. Exclusion criteria included: admission due to a diagnosis of a different pathogen with no indication or likelihood of co-infection with COVID-19, attendance at emergency department only, declined to provide informed consent or life-limiting illness with life expectancy of <6 months such as disseminated malignancy. During the recruitment period (August 2020 to March 2022), eligible patients were invited to participate in the study by research teams based at the participating sites ≤1 year after discharge. A total of 83 sites from England, Northern Ireland, Scotland and Wales participated following the study advertisement in social media and research networks. Different methods were used to obtain consent including: face-to-face, telephone, postal and eConsent. Participants could join as Tier 1 participants only with remote data collection or could join as Tier 2 participants in which they were invited to attend two research visits for further data collection and biological research sampling (Figure 1). Consort diagram of the Post-Hospitalisation COVID-19 (PHOSP-COVID) study. aThe wide range window for the first research visit (2–7 months) was deliberately chosen to accommodate the variation in planned clinical follow-up appointments across the different participating sites and to allow the research visit to coincide with the planned clinical follow-up appointments Participants in either Tier 1 or Tier 2 could additionally join Tier 3 sub-studies in which they were either recalled for additional research procedures or undertook additional research procedures during their Tier 2 research visits. For example, a subset of 141 participants had an extended blood draw to enable additional sampling and advanced cellular studies6 and another subset of 531 participants completed up to three whole-body magnetic resonance imaging (MRI) scans to examine the effect of COVID-19 on multiple body organs (Capturing MultiORgan Effects of COVID-19, C-MORE sub-study).7,8 A total of 7935 participants were recruited into the PHOSP-COVID cohort—5238 participants to Tier 1 and 2697 to Tier 2—between 10 August 2020 and 31 March 2022. The participants’ demographics, comorbidities and admission characteristics are detailed in Table 1 and Supplementary Table S1 (available as Supplementary data at IJE online). Over 1000 participants to date have also been included in Tier 3 studies. Participant demographics, comorbidities and admission characteristics of the Post-Hospitalisation COVID-19 (PHOSP-COVID) cohort Data are n (%) unless indicated. Percentages are calculated by category after exclusion of missing data for that variable. Mean (SD). Median [IQR]. WHO classes are: 3–4 = no continuous supplemental oxygen needed; 5 = continuous supplemental oxygen only; 6 = continuous or bi-level positive airway pressure ventilation or high-flow nasal oxygen; and 7–9 = invasive mechanical ventilation or other organ support. See Supplementary Table SM1 (available as Supplementary data at IJE online) for further descriptions of variables. IQR, interquartile range; SARS-CoV-2 PCR, severe acute respiratory syndrome coronavirus 2 polymerase chain reaction; WHO, World Health Organization. Participant demographics, comorbidities and admission characteristics of the Post-Hospitalisation COVID-19 (PHOSP-COVID) cohort Data are n (%) unless indicated. Percentages are calculated by category after exclusion of missing data for that variable. Mean (SD). Median [IQR]. WHO classes are: 3–4 = no continuous supplemental oxygen needed; 5 = continuous supplemental oxygen only; 6 = continuous or bi-level positive airway pressure ventilation or high-flow nasal oxygen; and 7–9 = invasive mechanical ventilation or other organ support. See Supplementary Table SM1 (available as Supplementary data at IJE online) for furt

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