COVID-19 Long term protocol & survey

ISARIC Global COVID-19 follow-up working group.

A working group of international clinicians from different specialties and external experts, developed a study protocol and a patient survey for periodical follow up of patients with confirmed COVID-19 post discharge.

The aim is standardise data collection to facilitate timely, robust analysis to assess frequency and risk factors for long term health and psychosocial consequences of COVID-19.

Healthcare sites are welcome to join this collaborative effort forwarding the evidence into COVID-19 and how it affects different populations worldwide.

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The Tier 1 follow up form uses a range of validated standardised tools. It is designed to enable wide dissemination with minimal resources, by enabling patient self-assessment via paper forms, post, or online link or for telephone or in-clinic follow up.

There are two Tier 1 follow up surveys:

• The Tier 1 initial survey: used the first follow up appointment, it captures data on psychological, psychosocial health, occupational status and socieconomic data, plus pre-COVID-19 baseline data.
• The Tier 1 Ongoing survey: documents the same data but without the baseline data. 

The study is designed to follow up patients included in the ISARIC/WHO clinical characterisation study, with a confirmed COVID-19 diagnosis post-discharge at serial intervals. These patients have acute-phase data and pre-existing risk factors, documented in the ISARIC Core- or Rapid Case report forms (CRFs). This data will be linked with the follow up data for the analysis. New sites are welcome to join this open-access collaborative study at any time. There are options to transfer data from other studies, or the Rapid CRF can be completed retrospectively from medical records, contact us on the email below to discuss.

For sites already following up patients using other forms, contact us to discuss options for merging the data already collected.

ISARIC can support translations of the survey and the patient -facing online link.

To join this collaborative effort, register on the REDCap database or for further information contact: ncov@isaric.org

To join the ISARIC Global Follow up working group contact the study co-lead on: louise.sigfrid@ndm.ox.ac.uk

For existing COVID-19 Core or Rapid CRF users – the follow up form can be found at the end of the acute, Core and Rapid forms.

Summary

• This is an international prospective, observational multi-site study. It will enrol patients following a diagnosis of COVID-19.
• Tier 1 is developed to be used for following up patients post-discharge at serial intervals (3 to 6 months) depending on needs and resources.
• The Tier 1 follow up survey can be used for data collection alone or in combination with sampling and diagnostics methods, depending on need and resources.
• The Tier 1 follow up survey can also be used to identify subsets of patients experiencing specific symptomatology to invite for further specialist in-clinic follow up combined with sampling and diagnostics ( Tier 2).