CoV-Sym
Research type
Research Study
Full title
The development of the CoV-Sym questionnaire: a psychometrically validated patient reported outcome measure for use in COVID-19 intervention trials
IRAS ID
288269
Contact name
Dan Wootton
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
0 years, 8 months, 30 days
Research summary
When doctors perform a clinical trial, the tools they use to decide which treatment works best are called ‘outcome measures’. The clinical trial regulators insist pneumonia trials include a ‘patient related outcome measure’ (PROM) such as a questionnaire capturing how a treatment affects patients symptoms from their own perspective.
Since the pattern of COVID-19 symptoms are different to ‘normal pneumonia’, pre-existing pneumonia PROMS may not be valid. Therefore, we need to validate a new PROM (questionnaire) for use in COVID-19 trials.
We aim to do this by adapting an existing pneumonia quesitonnaire, the CAP-Sym questionnaire, and conducting a mixed methods study to create a new, validated tool, to measure patients symptoms during COVID-19.
This study has three phases:
Phase 1:
We will interview patients recovering from COVID-19 to ask which symptoms they feel are important to be included in our questionnaire. As a preliminary step, we have reviewed the literature and consulted local experts to create a long list of COVID-19 symptoms for PROM inclusion.Phase 2:
From the output of phase 1, we will create a draft questionnaire, and interview another group of patients to check if the way we have written the questions makes sense to them.Phase 3: Finally, we will follow 50 patients with acute COVID and complete the questionnaire at multiple time points during their illness. We will check that when a patient’s symptoms are changing rapidly, such as when treatment is started, the questionnaire captures that change. When a patient’s symptoms are stable day-to-day, we will check that the answers recorded by the questionnaire don’t vary.
The resulting questionnaire will enable patient’s symptoms to be objectively measured in future COVID-19 trials to assess the effectiveness of potential treatments.
Summary of Results
it does not make sense to put something in the PIS which is not for participants, but for the study doctors, this should be covered elsewhere.REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0051
Date of REC Opinion
22 Mar 2021
REC opinion
Further Information Favourable Opinion