Qualitative interviews to confirm the content validity of PRO for MVA

• Research type

  Research Study

• Full title

  Qualitative interviews to confirm the content validity of a Patient-Reported Outcome (PRO) measure for use in Microvascular Angina (MVA)

• IRAS ID

  242242

• Contact name

  Chloe Tolley

• Contact email

  chloe.tolley@adelphivalues.com

• Sponsor organisation

  Sanofi

• Clinicaltrials.gov Identifier

  37642, CPMS ID

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Coronary microvascular angina (MVA) can be defined as angina pectoris (chest pain or discomfort), caused by spasms or other abnormalities within the walls of the small blood vessels that may reduce or limit blood flow to the heart muscle.
  Patients with MVA can be separated in two different populations;
  Population A: patients with stable MVA, defined as symptoms of stable angina pectoris with evidence of myocardial ischemia in the absence of obstructive coronary artery disease
  Population B: patients with a history of coronary artery disease and persisting symptoms of angina despite an anatomically successful revascularization and no further indication for revascularization
  Definitions of the two MVA populations of interest are supported by the European Society of Cardiology (ESC) guidelines (2013) and clinical research (Suzuki, 2015). Whilst patients in population B have a history of Coronary Artery Disease (CAD), patients in population A have no history of CAD.
  Sanofi plan to include a patient-reported outcome (PRO) measure in their upcoming clinical trials to better assess symptoms and impacts of MVA. It is important for any PROs that are implemented in a clinical trial to assess product efficacy to be developed and validated in line with best practice guidelines.
  The objective of the current study is to assess the content validity of a newly developed PRO measure. In total, 12 adult patients from the above-mentioned MVA populations will participate in qualitative cognitive debriefing interviews
  in the UK. These interviews will aim to evaluate the relevance of the questions in the PRO measure and to also evaluate patients' ability to understand and consistently interpret the measure wording, instructions, response options and recall period as intended. In addition to these 12 interviews in the UK, 36 other interviews will be conducted in Germany and the USA.

• REC name

  North East - York Research Ethics Committee

• REC reference

  18/NE/0206

• Date of REC Opinion

  11 Jun 2018

• REC opinion

  Favourable Opinion