DevPROMsHaem

• Research type

  Research Study

• Full title

  Development and Validation of Musculoskeletal Patient Reported Outcome Measures in Haemophilia

• IRAS ID

  207835

• Contact name

  Simon P Frostick

• Contact email

  s.p.frostick@liv.ac.uk

• Duration of Study in the UK

  2 years, 1 months, 30 days

• Research summary

  Joint diseases are common conditions affecting all age groups. Patient reported outcome measures (questionnaires) are currently used to accurately assess health status in these patients, but do come with many limitations. They are important to both patients and clinicians as they can be used to assess change with therapeutic intervention and research purposes among other things.
  Development of a PROM consists of a various stages depicted in the diagram below.
  Item generation=>Item reduction=>Feasibility study=>Pilot study=>Validation study

  This research will look into developing a better questionnaire to assess the function in an overall manner in those with a diagnosis of haemophilia. This is because this population have a tendency of bleeding into their joints, which results in severe joint damage. Thus the main outcome of this research is to develop and validate a new patient reported outcome to assess joint function in haemophiliacs.
  
  Patients recruited for developing, piloting and validating the questionnaire will be done on National Health Service (NHS) patients in outpatient clinics. This will occur across two trusts, the Royal Liverpool and Broadgreen University Hospitals NHS trust (RLBUHTs) and Guy's and St Thomas' NHS Foundation Trust (GSST).

  The study comprises of
  (1) A qualitative study: This involves the developing the questionnaire. It will consist of two stages, item generation and item reduction both of which will utilise interviews. Item generation will involve the participation of patients, carers and health care professionals while the item reduction will consist of an expert panel made up of patients and health care professionals.
  (2) A pilot study: This involves a feasibility study, which will text the qualitative properties of the questionnaire, which will utilise short interviews. While the second stage consists of assessing the measurement properties of the novel questionnaire on a small cohort. This study only requires the participation of patients.
  (3) A validation study: This will assess the measurement properties of the novel qusetionnaire on a larger cohort. This study will also utilise age and sex matched controls.

  This over all study will last over two years.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  16/NW/0532

• Date of REC Opinion

  19 Aug 2016

• REC opinion

  Further Information Favourable Opinion