Preliminary validation of a Urinary Symptom Questionnaire for individuals with Neuropathic Bladder using Intermittent Catheterization (USQNB-IC): A patient-centered patient reported outcome

Abstract

BackgroundWe developed a Urinary Symptom Questionnaire for individuals with neurogenic bladder due to spinal cord injury (SCI) and spina bifida (SB) who manage their bladders with intermittent catheterization, the USQNB-IC. This project followed an approach to patient-centered patient reported outcomes development that we created and published in 2017, specifically to ensure the primacy of the patient’s perspective and experience.ParticipantsTwo sets of responses were collected from individuals with neurogenic bladder due to either SCI (n = 336) and SB (patients, n = 179; and caregivers of patients with NB, n = 66), and three sets of “controls”, individuals with neurogenic bladder who do not have a history of UTIs (n = 49) individuals with chronic mobility impairments (neither SCI nor SB) and without neurogenic bladder (n = 46), and those with no mobility impairment, no neurogenic bladder, and no history of UTIs (n = 64).MethodData were collected from all respondents to estimate these psychometric or measurement domains characterizing a health related PRO: Reliability (minimization of measurement error; internal consistency or interrelatedness of the items; and maximization of variability that is due to “true” difference between levels of the symptoms across patients), and validity (content, reflection of the construct to be measured; face, recognizability of the contents as representing the construct to be measured; structural, the extent to which the instrument captures recognizable dimensions of the construct to be measured; and criterion, association with a gold standard).ResultsEvidence from these five groups of respondents suggest the instrument has face, content, criterion, convergent, and divergent validity, as well as reliability. The items were all more descriptive of our patient (focus) groups and were only weakly endorsed by the control groups.ConclusionsThe instrument is unique in its emphasis on, and origination from, the lived experiences of patients with neurogenic bladder who use intermittent catheterization; this preliminary psychometric evidence suggests the instrument could be useful for research and in the clinic. These results justify further development of the instrument, including formal exploration of the scoring and estimation of responsivity of these items to clinical interventions as well as patient-directed self care.

Clinical Profiles and Symptom Burden Estimates to Support Decision‐Making Using the Urinary Symptom Questionnaire for People with Neurogenic Bladder (USQNB) using Intermittent Catheters

“…The instrument for which these scoring methods were studied was developed to satisfy psychometric criteria for both reliability and validity 9 ; the items were included based on appeal to clinical practice guidelines, clinical opinion, and patient input 12 . However, although our focus has been on maintaining the primacy of the patient's perspective, the burden estimation and profile approaches discussed here render that perspective interpretable and actionable by the practitioner, the investigator, and the patient alike.…”

“…The USQNB‐IC is a valid and reliable measure of urinary symptoms among people with NB who use IC 9 and decision‐making tool that can be used by patients for self‐management and monitoring, clinicians for clinical decision‐making, and clinical investigators in research studies. We optimized scoring for decision‐making by clinicians and patients, while also supporting research in the domain 19 .…”

“…Once the USQNB‐IC was developed, 9,12 we convened an expert panel of two urologists and one hospitalist to assess our work‐grouping symptoms into sets that were exchangeable within group and diverse across groups. These experts also evaluated the resulting profiles, to ensure a consensus representing current clinical practice.…”

“…We have developed a new set of patient‐centered PROs to monitor and guide decision‐making in response to urinary signs and symptoms among people with neurogenic bladder (NB). These instruments, the Urinary Symptom Questionnaires for Neurogenic Bladder (USQNB), are developed specifically according to bladder management, yielding one for intermittent catheterization (USQNB‐IC) 9 ; two others have been completed for indwelling catheters and for voiders 10,11 . These instruments were developed following a model that prioritizes the patient experience, while integrating the clinical and research perspectives 12 .…”

Intravesical Lactobacillus rhamnosus GG is safe and well tolerated in adults and children with neurogenic lower urinary tract dysfunction: first-in-human trial

“…To overcome the variability associated with ‘UTI’ as an outcome, our team developed a set of Urinary Symptom Questionnaires for people with neurogenic bladder (USQNBs) to advance care, self-management, and evidence. The first of these, the USQNB-IC, is for people with NLUTD and who use an intermittent catheter (IC), 17,18 while two other USQNBs are in development (indwelling catheter and void versions). Each instrument has been developed following a model that prioritizes the patient experience, while integrating the clinical and research perspectives.…”