Confirmatory structural validation and refinement of the Recurrent Urinary Tract Infection Symptom Scale.

Objectives: To confirm the structural validity of the Recurrent Urinary Tract Infection Symptom Scale (RUTISS), determining whether a bifactor model appropriately fits the questionnaire's structure and identifying areas for refinement. Used in conjunction with established clinical testing methods, this patient-reported outcome measure addresses the urgent need to validate the patient perspective. Patients and methods: A clinically and demographically diverse sample of 389 people experiencing recurrent UTI across 37 countries (96.9% female biological sex, aged 18-87 years) completed the RUTISS online. A bifactor graded response model was fitted to the data, identifying potential items for deletion if they indicated significant differential item functioning (DIF) based on sociodemographic characteristics, contributed to local item dependence or demonstrated poor fit or discrimination capability. Results: The final RUTISS comprised a 3-item symptom frequency section, a 1-item global rating of change scale and an 11-item general 'rUTI symptom and pain severity' subscale with four sub-factor domains measuring 'urinary symptoms', 'urinary presentation', 'UTI pain and discomfort' and 'bodily sensations'. The bifactor model fit indices were excellent (root mean square error of approximation [RMSEA] = 0.041, comparative fit index [CFI] = 0.995, standardised root mean square residual [SRMSR] = 0.047), and the mean-square fit statistics indicated that all items were productive for measurement (mean square fit indices [MNSQ] = 0.64 - 1.29). Eighty-one per cent of the common model variance was accounted for by the general factor and sub-factors collectively, and all factor loadings were greater than 0.30 and communalities greater than 0.60. Items indicated high discrimination capability (slope parameters > 1.35). Conclusion: The 15-item RUTISS is a patient-generated, psychometrically robust questionnaire that dynamically assesses the patient experience of recurrent UTI symptoms and pain. This brief tool offers the unique opportunity to enhance patient-centred care by supporting shared decision-making and patient monitoring.

Evaluating the quality of life impact of recurrent urinary tract infection: Validation and refinement of the Recurrent UTI Impact Questionnaire (RUTIIQ).

BACKGROUND AND AIMS: Recurrent urinary tract infection (rUTI) has significant negative consequences for a wide variety of quality of life (QoL) domains. Without adequate validation and assessment of the unique insights of people living with rUTI, clinical results cannot be fully understood. The Recurrent UTI Impact Questionnaire (RUTIIQ), a novel patient-reported outcome measure of rUTI psychosocial impact, has been robustly developed with extensive patient and clinician input to facilitate enhanced rUTI management and research. This study aimed to confirm the structural validity of the RUTIIQ, assessing its strength and bifactor model fit. METHODS: A sample of 389 adults experiencing rUTI (96.9% female, aged 18-87 years) completed an online cross-sectional survey comprising a demographic questionnaire and the RUTIIQ. A bifactor graded response model was fitted to the data, optimizing the questionnaire structure based on item fit, discrimination capability, local dependence, and differential item functioning. RESULTS: The final RUTIIQ demonstrated excellent bifactor model fit (RMSEA = 0.054, CFI = 0.99, SRMSR = 0.052), and mean-square fit indices indicated that all included items were productive for measurement (MNSQ = 0.52-1.41). The final questionnaire comprised an 18-item general "rUTI QoL impact" factor, and five subfactor domains measuring "personal wellbeing" (three items), "social wellbeing" (four items), "work and activity interference" (four items), "patient satisfaction" (four items), and "sexual wellbeing" (three items). Together, the general factor and five subfactors explained 81.6% of the common model variance. All factor loadings were greater than 0.30 and communalities greater than 0.60, indicating good model fit and structural validity. CONCLUSIONS: The 18-item RUTIIQ is a robust, patient-tested questionnaire with excellent psychometric properties, which capably assesses the patient experience of rUTI-related impact to QoL and healthcare satisfaction. Facilitating standardized patient monitoring and improved shared decision-making, the RUTIIQ delivers the unique opportunity to improve patient-centered care.

The Recurrent Urinary Tract Infection Symptom Scale: Development and validation of a patient-reported outcome measure.

Objectives: This study aimed to develop and validate a tailored patient-reported outcome measure (PROM) evaluating the patient experience of recurrent urinary tract infection (rUTI) symptom severity. This measure was designed to supplement clinical testing methods, allowing full assessment of the patient experience of rUTI symptom burden, while enhancing patient-centred UTI management and monitoring. Subjects and Methods: The Recurrent Urinary Tract Infection Symptom Scale (RUTISS) was developed and validated using a three-stage methodology, in accordance with gold-standard recommendations. Firstly, a two-round Delphi study was conducted to gain insights from 15 international expert clinicians working in rUTI, developing an initial pool of novel questionnaire items, assessing content validity and making item refinements. Next, two phases of one-to-one semi-structured cognitive interviews were conducted with a diverse sample of 28 people experiencing rUTI to assess questionnaire comprehensiveness and comprehensibility, making refinements after each phase. Finally, a comprehensive pilot of the RUTISS was conducted with 240 people experiencing rUTI across 24 countries, providing data for psychometric testing and item reduction. Results: Exploratory factor analysis indicated a four-factor structure comprising: 'urinary pain and discomfort', 'urinary urgency', 'bodily sensations' and 'urinary presentation', together accounting for 75.4% of the total variance in data. Qualitative feedback from expert clinicians and patients indicated strong content validity for items, which was supported by high content validity indices in the Delphi study (I-CVI > 0.75). Internal consistency and test-retest reliability of the RUTISS subscales were excellent (Cronbach's α = 0.87-0.94 and ICC = 0.73-0.82, respectively), and construct validity was strong (Spearman's ρ = 0.60-0.82). Conclusion: The RUTISS is a 28-item questionnaire with excellent reliability and validity, which dynamically assesses patient-reported rUTI symptoms and pain. This new PROM offers a unique opportunity to critically inform and strategically enhance the quality of rUTI management, patient-clinician interactions, and shared-decision making by monitoring key patient-reported outcomes.

Development and psychometric validation of a patient-reported outcome measure of recurrent urinary tract infection impact: the Recurrent UTI Impact Questionnaire.

PURPOSE: Recurrent 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). METHODS: A 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. RESULTS: Exploratory 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). CONCLUSION: The 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 REGISTRATION: This study was pre-registered with ClinicalTrials.gov (identifier: NCT05086900).

Preclinical safety assessment of a recombinant plague vaccine (rF1V).

A recombinant vaccine (rF1V) is being developed to protect adults 18 to 55 years of age from fatal pneumonic plague caused by aerosolized Yersinia pestis. A comprehensive series of studies was conducted to evaluate the general toxicity and local reactogenicity of the rF1V vaccine prior to first use in humans. Toxicity was evaluated in CD-1 mice vaccinated with control material and three dosage concentrations of rF1V with or without Alhydrogel(®) by intramuscular (IM) injection on Study Days 1, 29, 57 and 71 in a volume of 0.1 mL. Total immunizing protein given in each dose was 0, 20 or 60 µg/animal. Local reactogenicity was evaluated in mice at the dosages given and in New Zealand white (NZW) rabbits using the same injection volume and formulations (40, 80, 160 and 320 µg/mL total antigen and 0.3% (w/v) Alhydrogel(®)) intended for human use (0.5 mL). The rF1V vaccine produced no apparent systemic toxicity and only transient edema and erythema at the injection site. Together these results indicated a favorable safety profile for rF1V and supported its use in a Phase 1 clinical trial.

ACASI Gender-of-Interviewer Voice Effects on Reports to Questions about Sensitive Behaviors Among Young Adults.

Although previous research indicates that audio computer-assisted self-interviewing (ACASI) yields higher reports of threatening behaviors than interviewer-administered interviews, very few studies have examined the potential effect of the gender of the ACASI voice on survey reports. Because the voice in ACASI necessarily has a gender, it is important to understand whether using a voice that is perceived as male or female might further enhance the validity associated with ACASI. This study examines gender-of-voice effects for a set of questions about sensitive behaviors administered via ACASI to a sample of young adults at high risk for engaging in the behaviors. Results showed higher levels of engagement in the behaviors and more consistent reporting among males when responding to a female voice, indicating that males were potentially more accurate when reporting to the female voice. Reports by females were not influenced by the voice's gender. Our analysis adds to research on gender-of-voice effects in surveys, with important findings on measuring sensitive behaviors among young adults.

Telemetric analysis to detect febrile responses in mice following vaccination with a live-attenuated virus vaccine.

Non-human primates (NHP) are considered to be the most appropriate model for predicting how humans will respond to many infectious diseases. Due to ethical and monetary concerns associated with the use of NHP, rodent models that are as predictive of responses likely to be seen in human vaccine recipients are warranted. Using implanted telemetry devices, body temperature and activity were monitored in inbred and outbred mouse strains following administration of the live-attenuated vaccine for Venezuelan equine encephalitis virus (VEEV), V3526. Following analysis of individual mouse data, only outbred mouse strains showed changes in diurnal temperature and activity profiles following vaccination. Similar changes were observed following VEEV challenge of vaccinated outbred mice. From these studies, we conclude, outbred mouse strains implanted with telemeters are a sensitive model for predicting responses in humans following vaccination.