1. Qualitative development of a new patient reported outcome measure for underactive bladder
A. Uren1, N. Cotterill1, C. Harding2, C. Hillary3, C. Chapple3, M. Klaver4, D. Bongaerts4, Z. Hakimi4, P. Abrams1
1Bristol Urological Institute, UK; 2Freeman Hospital, Newcastle; 3Royal Hallamshire Hospital, Sheffield; 4Astellas Pharma Europe B.V., Leiden, The Netherlands.
BACKGROUND
Detrusor underactivity (DU) is a common but poorly understood lower urinary tract dysfunction diagnosed during a urodynamic assessment. Underactive bladder (UAB) is currently proposed as a term to describe the symptoms and signs associated with DU :
The lack of an existing patient reported outcome measure (PROM), validated in the target population and complying with current regulatory standards, supports the development of a novel PROM for the assessment of the symptoms, signs and impact of underactive bladder.
This is the qualitative development of a PROM, the ICIQ-UAB, which is being developed in-line with current FDA guidelines for use in research and clinical practice.
“A symptom complex suggestive of detrusor underactivity and is usually characterised by prolonged urination time with or without a sensation of incomplete bladder emptying, usually with hesitancy, reduced sensation on filling, and a slow stream.”
Chapple et al. 2015
METHODS
In-depth concept elicitation (CE) interviews were conducted with patients in whom a primary DU diagnosis was given at urodynamics.
Interviews continued until no new concepts were mentioned during further interviews (data saturation achieved).
Following detailed qualitative analysis of the transcripts, a draft PROM was developed in which each item corresponded to a symptom, sign or behaviour reported by patients. Each item was worded with idiomatic language used by the patient population.
Cognitive debriefing interviews were scheduled and iterative revisions of the PROM made, until items were interpreted by patients as intended and no further changes were deemed necessary.
RESULTS
Concept elicitation interviews were conducted in Bristol and cognitive debriefing interviews were held in Bristol, Sheffield or Newcastle hospitals, UK. All interviews were performed with patients diagnosed with DU, with or without coexisting urological conditions (table 1).
More than 30 lower urinary tract symptoms, signs or behaviours were identified, having a broad impact on quality of life.
The first version of the PROM contained 37 items which was refined to 31 items (see figure 1 and 2) based on feedback from the cognitive debriefing interviews.
Table 1. Sample population characteristics.
Examples of quotes from patients from the CE interviews:
Sample Characteristic
Concept elicitation interviews
Cognitive debriefing interviews
Total sample (n) 44
37*
DU (only) (n) 19 14
DU + co-existing urological conditions (n) 25 22
Males (n)
29 (66%)
28 (76%)
Mean age and range (years)
64 (27-88)
66 (26-88)
Ethnicity
White British (100%)
Education background
Varied
Intermittent self-catheterisation (n)
23 (52%) current or historical
11 (30%) current
PVR >30ml (n)
34 (77%)
Figure 1. Items included in draft PROM.
*Includes one practice interview with a patient with a diagnosis
of bladder outlet obstruction.
Figure 2. An example of an item in the draft PROM following the cognitive debriefing interviews.
CONCLUSIONS
Concept elicitation and cognitive debriefing interviews have been carried out in a large group of patients with DU.
The result is a novel and comprehensive version of the PROM for the evaluation of UAB symptoms and its impact on quality of life.
Further concept exploration in Japan and the US, and assessment of its psychometric properties will refine items for inclusion in the final PROM.
Reference
Chapple, C.R., Osman, N. I., Birder, L. et al. (2015). The Underactive Bladder: A New Clinical Concept? Eur Urol 68(3):
Sponsored by Astellas Pharma Europe B.V.