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

  dwootton@liverpool.ac.uk

• 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.

• 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