Abstract
PurposeRecurrent urinary tract infection (rUTI) is a highly prevalent condition associated with significant poor quality of life outcomes. A patient-reported outcome measure (PROM) of rUTI-associated psychosocial impact is urgently required to supplement clinical evaluation and validate the challenges experienced by patients. This study therefore developed and validated the Recurrent UTI Impact Questionnaire (RUTIIQ).MethodsA rigorous four-stage methodology was followed: (I) concept elicitation through a qualitative survey of the experiences of people with rUTI (N = 1983); (II) Delphi expert screening of the RUTIIQ with expert rUTI clinicians (N = 15); (III) one-to-one cognitive interviews with people experiencing rUTI (N = 28) to evaluate the comprehensiveness and comprehensibility of the RUTIIQ, and (IV) full pilot testing of the RUTIIQ with people experiencing rUTI (N = 240) to perform final item reduction and psychometric analysis.ResultsExploratory factor analysis demonstrated a five-factor structure comprising: ‘patient satisfaction’, ‘work and activity interference’, ‘social wellbeing’, ‘personal wellbeing’, and ‘sexual wellbeing’, collectively accounting for 73.8% of the total variance in pilot scores. Results from expert clinicians and patients indicated strong item content validity (I-CVI > .75). The internal consistency and test–retest reliability of the RUTIIQ subscales were excellent (Cronbach’s α = .81–.96, ICC = .66–.91), and construct validity was strong (Spearman’s ρ > .69).ConclusionThe RUTIIQ is a 30-item questionnaire with excellent psychometric properties, assessing the patient-reported psychosocial impact of living with rUTI symptoms and pain. This new instrument delivers the unique opportunity to enhance patient-centred care through standardised observation and monitoring of rUTI patient outcomes.Trial registrationThis study was pre-registered with ClinicalTrials.gov (identifier: NCT05086900).
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