The conceptualization and development of a patient-reported neurogenic bladder symptom score

Abstract

Background

There is no single patient-reported instrument that was developed specifically to assess symptoms and bladder-related consequences for neurogenic bladder dysfunction. The purpose of this study was to identify and consolidate items for a novel measurement tool for this population.

Methods

Item generation was based on a literature review of existing instruments, open-ended semistructured interviews with patients, and expert opinion. Judgment-based item reduction was performed by a multidisciplinary expert group. The proposed questionnaire was sent to external experts for review.

Results

Eight neurogenic quality of life measures and 29 urinary symptom-specific instruments were identified. From these, 266 relevant items were extracted and used in the creation of the new neurogenic symptom score. Qualitative interviews with 16 adult patients with neurogenic bladder dysfunction as a result of spinal cord injury, multiple sclerosis, or spina bifida were completed. Dominant themes included urinary incontinence, urinary tract infections, urgency, and bladder spasms. Using the literature review and interview data, 25 proposed items were reviewed by 12 external experts, and the questions evaluated based on importance on a scale of 1 (not important) to 5 (very important). Retained question domains had high mean importance ratings of 3.1 to 4.3 and good agreement with answer hierarchy.

Conclusion

The proposed neurogenic bladder symptom score is a novel patient-reported outcome measure. Further work is underway to perform a data-based item reduction and to assess the validity and reliability of this instrument.

Keywords:

• urinary bladder
• neurogenic
• questionnaires
• quality of life
• outcome assessment
• health status indicators
• lower urinary tract symptoms

Supplementary materials

Table S1 Proposed items for the neurogenic bladder symptom score

Acknowledgments

This investigator-driven research was supported by the CUA Astellas Research Grant Program funded by Astellas Pharma Canada, Inc., and jointly established by Astellas Pharma Canada, Inc., and the Canadian Urological Association. All authors contributed substantially to this work. BW is the primary author and was responsible for study design and data analysis. BW, SAM, PP, and KS made up the expert committee and were responsible for item generation and review as well as manuscript content. WM was responsible for patient interviews, data collection, and the literature review.

Disclosure

BW has received speaker fees from Astellas, Pfizer, and Allergan. SAM, PP, KS and WM report no conflicts of interest in this work.