Development and validation of the Riley Bladder Quality of Life Questionnaire (RIBQQ) for children with lower urinary...

Existing health-related quality of life (HRQOL) questionnaires used for children with lower urinary tract dysfunction (LUTD) do not exclusively focus on what matters to children and have limited sensitivity to LUTD symptoms. We aimed to develop and validate a child-centered LUTD-specific HRQOL questionnaire.

We drafted an 18-question pilot questionnaire using a comprehensive question generation/refinement process with children with LUTD, parents, and providers. It was administered to children 8-17 years old attending LUTD clinics and age-matched controls (2023-2024). Final questions were determined by clinical relevance, high factor loadings and psychometrics. At baseline and at 3 months, children also completed the 13-question symptom questionnaire (VQ, Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire), 20-question Pediatric Incontinence Questionnaire (PinQ, LUTD-specific symptoms/HRQOL) and 10-question Kidscreen-10 questionnaire (child-centered generic HRQOL). Non-parametric tests, factor analysis and linear regression were used.

Median age of 172 children was 12 years old (44 % males), similar to 32 controls (p ≥ 0.12). Face and content validity of the 10-question Riley Bladder Quality of Life Questionnaire (RIBQQ) were established by children, parents, and experts. Internal consistency and 1 week test-retest reliability were high (Cronbach's alpha = 0.85, ICC = 0.80). Correlations were moderate with VQ (r = -0.45), strong with PinQ (r = -0.81) and weak with Kidscreen-10 (r = 0.29). Individuals would appreciate RIBQQ differences of ≥ 10/100 points. RIBQQ scores were lower among children with LUTD than controls (medians: 50 vs. 100, p < 0.0001) and correlated with LUTD severity (very mild: 66, mild: 57.5, moderate: 37.5, p < 0.0001). For 89 children providing 3-month follow-up data (20 implemented therapies), VQ improved by a median 1 point (p = 0.01) and RIBQQ by 2.5 (p = 0.03), without significant changes in PinQ or Kidscreen-10 (p ≥ 0.22). At 3 months, after adjusting for sex, age, and enuresis, RIBQQ scores increased for children with symptom improvement (+0.88 points/1-point VQ decrease, p = 0.02) and lower baseline RIBQQ scores (+0.33 points/1-point lower baseline RIBQQ, p < 0.001). RIBQQ score changes did not vary with sex, age, enuresis, or baseline VQ scores (p ≥ 0.15).

This new child-reported LUTD-specific HRQOL questionnaire outperformed existing questionnaires, correlated with symptom severity, and detected HRQOL changes as symptoms changed. Children were more likely to report HRQOL improvement after the symptoms that made them feel bad improved. External validation is forthcoming. Being a real-life observational validation study, it was underpowered to evaluate treatment effectiveness.

RIBQQ is a short, valid HRQOL questionnaire for children with LUTD and may be the preferred method of assessing clinical change.