Validation of a patient‐administered questionnaire to measure the severity and bothersomeness of lower urinary tract symptoms in uncomplicated urinary tract infection (UTI): the UTI Symptom Assessment questionnaire

Abstract

OBJECTIVE To develop and validate a self‐administered questionnaire to assess the ‘severity’ and ‘bothersomeness’ of the most frequently reported signs and symptoms of uncomplicated urinary tract infection (uUTI). SUBJECTS AND METHODS The UTI Symptoms Assessment questionnaire (UTISA) is a 14‐item instrument asking about the severity and bothersomeness of seven key uUTI symptoms. It was developed after comprehensive literature and data review and administration in draft form to a sample of 30 women with uUTI. The final questionnaire was completed by 276 women with uUTI who participated in a noncomparative clinical trial of ciprofloxacin. The women completed the questionnaire in electronic format at baseline (before the first dose of ciprofloxacin once‐daily), at 3‐h and 8‐h intervals until all UTI symptoms were resolved, and at the test‐of‐cure visit. Baseline scores on the King's Health Questionnaire (KHQ) were used to assess convergent and divergent validity; responses to the Global Rating of Change (GRC) were used to assess both responsiveness and the ‘minimally important difference’. Discriminant validity and responsiveness were assessed by comparing UTISA scores with a clinical evaluation of UTI symptoms performed by the investigator at baseline and at the test‐of‐cure visit. RESULTS The UTISA was found to comprise three four‐item domains named ‘urination regularity’, ‘problems with urination’, and ‘pain associated with UTI’. Two questions asking about haematuria loaded on a fourth factor. The three domains were homogeneous (with high inter‐item correlations) and internally consistent. Convergent validity was shown by high correlations between similar UTISA and KHQ domains (all rs > 0.40), and divergent validity by small correlations between unlike domains (all rs < 0.15). In general, the UTISA domains showed excellent discriminant validity, with scores on selected domains discriminating between women with different clinical evaluations. The responsiveness of the UTISA was also excellent, with high correlations between changes in domain scores and the clinical evaluation and GRC items. Symptom improvement was highest in the first 3 h, leading to greater responsiveness and minimally important difference during this period. However, the UTISA could detect even small subsequent changes. CONCLUSION The three‐domain UTISA has excellent psychometric properties and it is likely to prove an excellent tool for assessing uUTI outcome from a patient's perspective, both in research and clinical settings.

Toward A Simple Diagnostic Index for Acute Uncomplicated Urinary Tract Infections

“…5 The symptoms are bothersome and have a negative impact on quality of life. [6][7][8][9] Although empiric antibiotic treatment of all women with urinary symptoms has been reported to be cost-effective,…”

“…5 The symptoms are bothersome and have a negative impact on quality of life. [6][7][8][9] Although empiric antibiotic treatment of all women with urinary symptoms has been reported to be cost-effective, 10,11 bacterial resistance is rising, [12][13][14][15] and an accurate diagnosis of UTI is needed to facilitate a well-targeted use of antibiotics.Various medical history questions and urine investigations can be used for UTI diagnosis, of which nitrite, blood, and leukocyte esterase urine …”

The Clinical Urine Culture: Enhanced Techniques Improve Detection of Clinically Relevant Microorganisms

“…Scores for each symptom range from 0 to 3; a 0 corresponds to no symptom present, whereas a 3 indicates highest severity or bother. The seven symptoms can be clustered into four symptom domains: urination regularity (frequency and urgency), problems with urination (incomplete bladder emptying and pain or burning), pain associated with the UTI (abdominal or pelvic pain and lower back pain), and blood in the urine (16).…”

“…At baseline, urinary symptoms were characterized using a self-completed, validated UTI symptom assessment (UTISA) questionnaire, completed by both cohorts (16). Participants were dichotomized based on their yes/no response to the question "Do you feel you have a UTI?"…”

New Self-Reporting Questionnaire to Assess Urinary Tract Infections and Differential Diagnosis: Acute Cystitis Symptom Score

“…Diaries, questionnaires and symptom scores used in these studies were mainly adapted from other tools. Only a few studies developed a questionnaire to evaluate the impact on activity impairment and severity [15,16]. However, currently no specific and validated questionnaire is available for diagnostics, for differential diagnosis or for assessing severity, quality of life and treatment efficacy [4,15,16,17].…”