Pilot assessment of the measurement properties of the UAB PRO V1.0
Research type
Research Study
Full title
Pilot assessment of the measurement properties of the Underactive Bladder (UAB) PRO instrument in patients with detrusor underactivity(DU) v1.0
IRAS ID
178674
Contact name
Paul Abrams
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
The objective of this research is to conduct a pilot observational assessment to provide a preliminary evaluation of the psychometric properties, recall period and scoring rules of the UAB PRO instrument in subjects with DU. The evaluation of the UAB PRO instrument will be conducted using a pen and paper version of the instrument and six additional PRO instruments used for validation purpose. The UAB PRO instrument includes items assessing the symptoms and impacts of UAB using a 1 week recall period. To test the recall period adequacy of the UAB PRO symptom items only, subjects will also complete a 24 hour recall period version of these items. The assessment period will start on day 1 and end on day 10. Fifty subjects will be recruited from United Kingdom, The Netherlands and Germany and will be required to meet inclusion/exclusion criteria described within the protocol. No investigational drugs or devices will be administered or evaluated. The data will be collected and entered into a database. Analyses will be performed using SAS 9.4, separately for the two UAB PROs (with 1 week recall and a 24 hour recall period). Subjects’ socio-demographic and medical characteristics collected in the CRF and DHIF will be summarized descriptively. Descriptive statistics will be used to understand the item distributions and whether any ceiling or floor effects are present. Parametric statistical analyses will be conducted to assess the reliability, validity and further redundancy of the UAB PRO instrument. Agreement between the responses for the 1 week recall and 24 hour recall period will be examined. The estimated overall duration of this pilot study is six months from the time of recruitment initiation. Subject recruitment will begin only after local site research ethic committee’s approval of the protocol and supporting pilot assessment documents are obtained.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1113
Date of REC Opinion
26 Jun 2015
REC opinion
Further Information Favourable Opinion