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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.

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.

Objectives: Recurrent UTI (rUTI) is a debilitating health condition that is associated with persistent mental, physical, and social burdens. People living with rUTI face inconsistencies in diagnostic testing and fragmented treatment pathways alongside their symptoms, which are likely to add considerably to their illness-related burdens. This study aimed to characterize the factors negatively impacting this population using the qualitative perspectives of people living with the condition. Methods: Qualitative data were collected via free-text responses using an online survey hosted by an rUTI patient advocacy website. Female participants with self-reported rUTI (n = 1,983) described the factors that were most salient to their experience of living with the condition. Data were analyzed using a coding reliability approach to thematic analysis. Results: Two overarching themes were identified: (1) the patient burden of rUTI, which describes the multifaceted biopsychosocial impact of the illness, and (2) healthcare disillusionment, which describes patient dissatisfaction with healthcare received, both in terms of the treatments offered and communication with healthcare professionals. The patient burden of rUTI encompassed four subordinate themes: facing ongoing uncertainty; symptom salience; sex is not simple anymore; and perceived UTI stigma. Healthcare disillusionment included three subordinate themes: discomfort with frequent antibiotic use; fragmented treatment pathways; and devalued patient perspectives. Conclusions: The findings demonstrated that ambiguity in the diagnosis of rUTI and inconsistencies in the subsequent treatment pathway are exacerbated by poor patient–clinician communication. The extent of the female-specific burden of rUTI symptoms confirmed the harmful effects of illness-related stigma. This novel qualitative reporting of rUTI symptom burden and life impact highlights the urgent need for increased patient-centered care for those living with rUTI. More effective rUTI management could have a major impact on treatment outcomes and patient-reported psychosocial wellbeing.

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.

Background and AimsRecurrent 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.MethodsA 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.ResultsThe 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.ConclusionsThe 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.

Background: Recurrent urinary tract infection (rUTI) is associated with significant symptom and quality of life burden. Given the unique challenges in diagnostics and management, healthcare disillusionment and stigmatisation which distinguish rUTI from other urological conditions, specific identification of the key illness processes experienced by this patient population is required. This study aimed to identify the unique illness processes and perceptions that contribute to quality of life in rUTI, through perceived health status, psychological wellbeing, and coping. Methods: An international sample of adults living with rUTI (N = 389, 96.9% female) completed a cross-sectional survey comprising the following standardised questionnaires: the EuroQoL EQ-5D-5L, Patient Health Questionnaire 9 (PHQ-9), Generalised Anxiety Disorder 7 (GAD-7), Connor-Davidson Resilience Scale–10 (CD-RISC-10), Pain Catastrophising Scale (PCS). Sociodemographic characteristics were also assessed. Structural equation modelling was conducted to identify the underlying constructs which contributed to psychological wellbeing in rUTI, establishing the ‘rUTI Illness Process Model’. Results: The positive relationship between ‘perceived health status’ and ‘psychological wellbeing’ was partially mediated by ‘rUTI coping’, after controlling for the impact of household income and age (p 

Background Clinical trial recruitment faces significant challenges, with 55% of trials terminated due to low enrolment and more than 80% failing to reach targets on time. While digital recruitment strategies show promise, standardised implementation frameworks using digital health informatics approaches remain underdeveloped. Referral partnerships combined with multi-platform analytics offer potential solutions but lack systematic implementation methodologies. Objective To demonstrate a structured methodology for implementing and measuring multi-channel digital recruitment campaigns for clinical trials using integrated analytics platforms and referral partnerships. Methods A six-month multi-channel digital recruitment campaign was implemented across seven channels to support two ongoing Phase III clinical trials (EAGLE studies, NCT04020341, NCT04187144), from May to October 2022. The campaign was integrated with an analytics platform to track performance across mass emails, website announcements, browser notifications, Instagram posts and three email automations. The implementation utilised both direct and indirect funnel architectures, with real-time performance optimisation. Results The integrated analytics framework successfully tracked 4829 clicks across seven channels, achieving an overall click-through rate (CTR) of 2.79%, substantially exceeding clinical trial banner advertisement benchmarks (0.1–0.3%) and healthcare industry Facebook advertisement standards (0.83%). Website announcements generated the highest volume (52.54% of total clicks), followed by mass emails (28.00%). Conclusions This study provides a replicable informatics framework for implementing analytics-driven digital recruitment campaigns for clinical trials. The methodology demonstrates how clinical trial recruiters can integrate analytics platforms and referral partners to optimise outreach and achieve performance substantially above industry benchmarks.

Objective: To evaluate the responsiveness of the Recurrent Urinary Tract Infection Symptom Scale (RUTISS) to antibiotic treatment and determine the minimal clinically important difference (MCID). Methods: Female adults with recurrent UTI (N = 108, mean age = 53.6 years) completed a repeated-measures, longitudinal, 40-day naturalistic follow-up study. For participants initiating and completing antibiotic treatment within this period, RUTISS scores were evaluated at baseline (2 days pre-treatment), day 1 of treatment, day 3, and at follow-up (7 days post-treatment). Responsiveness was assessed using effect sizes pre-and post-treatment (rank-biserial correlation), Spearman's rank correlations with anchor measures (Patient Global Impression of Change, PGIC, and UTI Symptom Assessment, UTISA), and receiver operating characteristic analysis. The MCID was triangulated via anchor-and distribution-based methods. Results: The RUTISS total score demonstrated excellent responsiveness between all timepoints and was strongest between baseline and day 3 (rank-biserial r = 0.52), with strong correlations with the PGIC (Spearman's rho = 0.73) and UTISA (Spearman's rho = 0.63). Receiver operating characteristic analysis indicated excellent discrimination for detecting even minimal improvement (AUC = 0.82). The recommended MCID was 6.5 points, exceeding the standard error of measurement. All subscales demonstrated good to excellent responsiveness. Conclusion: The RUTISS demonstrates excellent responsiveness to antibiotic treatment providing a validated MCID, enabling precise interpretation of treatment effects. As the first fully validated PROM for recurrent UTI, the RUTISS addresses a critical unmet need to assess patient symptom reporting. By providing a responsive and interpretable patient-centered endpoint, the RUTISS enables adequately powered clinical trials and evidence-based symptom monitoring, directly supporting improved patient care and intervention development.

Recurrent urinary tract infection (rUTI) is common, debilitating, and associated with substantial negative impact on quality of life. Despite this, rUTI healthcare is often experienced as fragmented, dismissive, and poorly aligned with patient needs. Applying behavioural science theory to systematically identify modifiable intervention targets offers a promising but unexplored approach to improving rUTI care. To explore patient experiences of rUTI healthcare in the United Kingdom, identify barriers to and facilitators of quality care, and generate theory-informed targets for behaviour-change intervention and service improvement. Qualitative interview study using reflexive thematic analysis, followed by deductive mapping of themes to the Theoretical Domains Framework (TDF), Behaviour Change Technique Taxonomy (BCTT), and Behaviour Change Intervention Ontology (BCIO). Semi-structured one-to-one interviews with 26 adults living with rUTI in the United Kingdom, with the interview schedule informed by the TDF. Four barrier themes revealed systematic challenges: 'Struggling with the System,' 'Unheard Voices,' 'Shouldering Blame' and 'Forced to Become an Expert.' Together, these captured how diagnostic limitations, fragmented services, clinical dismissal, and individualised blame compel people living with rUTI into self-advocacy experienced as exhausting. Four facilitator themes demonstrated that quality care is achievable: 'Feeling Validated,' 'Partners in the Puzzle,' 'Continuity and Connection' and 'Expanding the Toolkit.' All 14 TDF domains were implicated, most frequently 'social influences,' 'beliefs about consequences,' 'environmental context and resources' and 'knowledge,' indicating improvement requires both system restructuring and interpersonal skill development. Mapping to the BCTT and BCIO identified specific intervention techniques targeting these domains. People living with rUTI face structural and relational challenges in healthcare that compound illness burden. When individuals feel believed, involved, and supported, rUTI healthcare experiences are transformed. By integrating reflexive thematic analysis with behavioural theory, this study demonstrates that improving rUTI care requires attention to both system-level factors such as diagnostic flexibility, service continuity, and treatment options, alongside relational factors, particularly validation and shared decision-making. These findings provide a theoretically grounded foundation for intervention development, with broader relevance for chronic conditions characterised by diagnostic uncertainty.

Background: Urinary tract infections (UTIs) are among the most prevalent bacterial infections. With many patients turning to the Internet as a health resource, this study seeks to understand public engagement with online resources concerning recurrent UTIs (rUTIs), assess their reliability, and identify common questions/concerns about rUTIs. Methods: Social media analysis tool BuzzSumo was used to calculate online engagement (likes, shares, comments, views) with information on rUTIs. The reliability of highly engaged articles was evaluated using the DISCERN questionnaire. Highly engaged categories were entered as keywords in Google Trends to quantify search interest. To categorize patient-specific concerns, a database containing anonymously collected patient questions about rUTIs was created. Results: BuzzSumo revealed four search categories: general information, treatment, causes, and herbal remedies. DISCERN scores indicated moderate reliability overall; however, the "herbal remedies" category demonstrated poor reliability despite high engagement. Google Trends analysis highlighted "causes" and "treatment" searches as highest in relative interest. The 10 most popular categories of concern were antibiotics, microbiome, vaccines, prevention, pelvic pain, sex, testing, symptoms, diet/lifestyle, and hormones. Conclusions: People living with rUTIs demonstrate key concerns and often seek information online, yet articles with high engagement often contain unreliable information. Healthcare professionals may consider counteracting misinformation by providing evidence-based information online about rUTIs.