Quality of life in sickle cell disease
Research type
Research Study
Full title
Quality of life in sickle cell disease: validation of health-related quality of life questionnaires for use in the UK.
IRAS ID
161076
Contact name
Kathleen Mulligan
Contact email
Sponsor organisation
City University London
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Sickle cell disease (SCD) is an inherited structural haemoglobin disorder, which is now the most common serious inherited disorder in England. SCD can have a significant impact on morbidity and mortality; episodes of pain can be very severe, last several days to weeks, and progress to life-threatening complications such as the acute chest crisis and multi-organ failure.
An important clinical outcome is patients’ health-related quality of life (HRQoL).
To date, HRQoL has been assessed in adults with SCD using generic measures such as the SF-36. However, both disease-specific and generic measures of HRQoL are important. Generic measures are required to enable comparison with other diseases as well as with the general population. Disease specific measures are required as they are likely to be more sensitive than generic measures to small but clinically significant changes as well as being more relevant to the disease being studied. A SCD-specific measure of HRQoL has been developed in the US – the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) – but there is currently no disease-specific HRQoL measure for adults with SCD that has been validated for use in the UK.This study will test the validity of the ASCQ-Me for use in the UK. Construct validity will be tested by comparing the ASCQ-Me with other validated scales that measure similar domains. We will require 150 participants to complete the measures at both time-points. If we estimate a dropout rate of 25% between the first and second time-point, we would need to recruit 200 participants into the study.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
14/NW/1522
Date of REC Opinion
19 Dec 2014
REC opinion
Favourable Opinion