6 research outputs found
Recommended from our members
Confirmatory structural validation and refinement of the Recurrent Urinary Tract Infection Symptom Scale
AbstractObjectivesTo 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 patientâreported outcome measure addresses the urgent need to validate the patient perspective.Patients and methodsA clinically and demographically diverse sample of 389 people experiencing recurrent UTI across 37 countries (96.9% female biological sex, aged 18â87 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.ResultsThe final RUTISS comprised a 3âitem symptom frequency section, a 1âitem global rating of change scale and an 11âitem general ârUTI symptom and pain severityâ subscale with four subâfactor domains measuring âurinary symptomsâ, âurinary presentationâ, âUTI pain and discomfortâ and âbodily sensationsâ. 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 meanâsquare fit statistics indicated that all items were productive for measurement (mean square fit indices [MNSQ] = 0.64 â 1.29). Eightyâone per cent of the common model variance was accounted for by the general factor and subâfactors 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).ConclusionThe 15âitem RUTISS is a patientâgenerated, psychometrically robust questionnaire that dynamically assesses the patient experience of recurrent UTI symptoms and pain. This brief tool offers the unique opportunity to enhance patientâcentred care by supporting shared decisionâmaking and patient monitoring
Recommended from our members
Psychosocial burden and healthcare disillusionment in recurrent UTI: a large-scale international survey of patient perspectives
ObjectivesRecurrent 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.MethodsQualitative 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.ResultsTwo 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.ConclusionsThe findings demonstrated that ambiguity in the diagnosis of rUTI and inconsistencies in the subsequent treatment pathway are exacerbated by poor patientâclinician 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
Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19
IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19.
Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19.
DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 nonâcritically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022).
INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (nâ=â257), ARB (nâ=â248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; nâ=â10), or no RAS inhibitor (control; nâ=â264) for up to 10 days.
MAIN OUTCOMES AND MEASURES The primary outcome was organ supportâfree days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes.
RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ supportâfree days among critically ill patients was 10 (â1 to 16) in the ACE inhibitor group (nâ=â231), 8 (â1 to 17) in the ARB group (nâ=â217), and 12 (0 to 17) in the control group (nâ=â231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ supportâfree days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively).
CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570
Recommended from our members
The Recurrent Urinary Tract Infection Symptom Scale: Development and validation of a patientâreported outcome measure
Abstract Objectives This study aimed to develop and validate a tailored patientâreported 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 patientâcentred UTI management and monitoring. Subjects and Methods The Recurrent Urinary Tract Infection Symptom Scale (RUTISS) was developed and validated using a threeâstage methodology, in accordance with goldâstandard recommendations. Firstly, a twoâround 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 oneâtoâone semiâstructured 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 fourâfactor structure comprising: âurinary pain and discomfortâ, âurinary urgencyâ, âbodily sensationsâ and âurinary presentationâ, 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 (IâCVIâ>â0.75). Internal consistency and testâretest reliability of the RUTISS subscales were excellent (Cronbach's αâ=â0.87â0.94 and ICCâ=â0.73â0.82, respectively), and construct validity was strong (Spearman's Ïâ=â0.60â0.82). Conclusion The RUTISS is a 28âitem questionnaire with excellent reliability and validity, which dynamically assesses patientâreported rUTI symptoms and pain. This new PROM offers a unique opportunity to critically inform and strategically enhance the quality of rUTI management, patientâclinician interactions, and sharedâdecision making by monitoring key patientâreported outcomes
Recommended from our members
Development and psychometric validation of a patient-reported outcome measure of recurrent urinary tract infection impact: the Recurrent UTI Impact Questionnaire.
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). A rigorous four-stage methodology was followed: (I) concept elicitation through a qualitative survey of the experiences of people with rUTI (Nâ=â1983); (II) Delphi expert screening of the RUTIIQ with expert rUTI clinicians (Nâ=â15); (III) one-to-one cognitive interviews with people experiencing rUTI (Nâ=â28) to evaluate the comprehensiveness and comprehensibility of the RUTIIQ, and (IV) full pilot testing of the RUTIIQ with people experiencing rUTI (Nâ=â240) to perform final item reduction and psychometric analysis. 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-CVIâ>â.75). The internal consistency and test-retest reliability of the RUTIIQ subscales were excellent (Cronbach's αâ=â.81-.96, ICCâ=â.66-.91), and construct validity was strong (Spearman's Ïâ>â.69). 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. This study was pre-registered with ClinicalTrials.gov (identifier: NCT05086900). [Abstract copyright: © 2023. The Author(s).
Recommended from our members
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 18â87 years) completed an online cross-sectional survey comprising a demographic questionnaire and the RUTIIQ. A bifactor graded response model was fitted to the data, optimising 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 = .054, CFI = .99, SRMSR = .052), and mean-square fit indices indicated that all included items were productive for measurement (MNSQ = .52 â 1.41). The final questionnaire comprised an 18-item general ârUTI QoL impactâ factor, and five sub-factor domains measuring âpersonal wellbeingâ (3 items), âsocial wellbeingâ (4 items), âwork and activity interferenceâ (4 items), âpatient satisfactionâ (4 items), and âsexual wellbeingâ (3 items). Together, the general factor and five sub-factors explained 81.6% of the common model variance. All factor loadings were greater than .30 and communalities greater than .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 standardised patient monitoring and improved shared decision-making, the RUTIIQ delivers the unique opportunity to improve patient-centred care