Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg)

This observational study will be conducted in two phases:

Phase 1 - the development of a post-COVID-19 patient reported quality of life measure Phase 2
- the longitudinal completion of the quality of life tool by post-COVID-19 patients each
month for 12 months All participants will complete an online informed consent form and a
demographic questionnaire at the start of their involvement with the study Phase 1 The study
will recruit a minimum of 30 participants and a maximum of 60 participants, 10-20 across
three groups: those who were not hospitalised; those who were hospitalised but not in
intensive care units; and those who were hospitalised and in intensive care units.
Investigators will take the first 10-20 participants who match in each group. If contact is
received from participants but their group is already full they will be asked if they are
still be happy to participate in phase 2 and an offer to contact them when that commences
will be made.

Firstly, a novel method (Jandhyala Method) will be used to elicit post-COVID-19 patients'
preferences for a post-COVID-19 quality of life tool. Participants will do this by completing
an Awareness Round survey, this means using free-text responses to ask participants about the
areas of their lives impacted by COVID-19 and those areas they see as most important to their
quality of life. The research team will collate and code these free text responses then
create a comprehensive list of all of those deemed important to participants who will then be
sent a Consensus Round survey to ask how far they agree or disagree with the inclusion of
those items in a quality of life tool. Researchers will then collate this information, group
it into relevant domains and develop a weighting tool to be sent to participants to ask them
to rate the relevant importance of the different areas to be included, which will be used to
create weighted domain and item scores to be used in a final quality of life tool. We expect
for the Awareness round surveys to be completed within a one month time period and then two
weeks will be allocated for the research team to analyse and finalise the Consensus round
survey; the Consensus round survey will then be open for two weeks, with prompting to
participants after one week if not completed. The research team will then have a further two
weeks to complete the weighting tool and participants will be given a further two weeks to
complete this. At this stage the research team will have a further two weeks to finalise the
Post-COVID-19 quality of life tool and then phase 2 will begin.

In summary:

1. Awareness round online survey (hosted on Survey Monkey) - asking for areas of life which
the participants feel have been impacted by COVID-19, including details and examples of
those impacts

a. The research team will collate and code these responses and generate a list of
statements based on the information provided by participants

2. Consensus round online survey (hosted on Survey Monkey) - the list of statements will be
sent to participants and they will be asked to rate how far they agree or disagree with
the inclusion of these areas in a post-COVID-19 quality of life tool

a. The research team will collate this information, group it into relevant domains and
develop a weighting tool

3. Weighting tool (online Microsoft excel template) - participants will be asked to weight
the individual items and domains for the finalised post-COVID-19 quality of life tool
using an online excel spreadsheet template a. The research team will use this
information to develop the finalised post-COVID-19 quality of life measure to be
completed by participants and to develop the system to score this tool Phase 2 At this
stage the recruitment will be re-opened for additional participants, including those
with a clinical diagnosis regardless of test status, aiming for a minimum of 100 and a
maximum of 5000 at this stage, though this will be subject to review. Recruitment will
remain open for time 1 surveys for one year, with a another year following this to gain
the full 12 months of data from participants, again subject to review. The finalised
post-COVID-19 quality of life measure will be hosted on a secure online system (Castor
EDC tm) and participants will be allocated an ID number. They will be asked to complete
this measure at monthly intervals for a period of 12 months. The research team will
analyse the changes over time within and between groups. Statistical methods for this
will be finalised when the measure has been completed at the end of Phase 1 by our
biostatistician.