Development and validation of a questionnaire to assess clinical characteristics and outcomes of patients with Carbapenem-Resistant Urinary Tract Infections.

Abstract Background and aim: Urinary tract infections (UTIs) caused by carbapenem-resistant (CR) bacteria cause poor outcomes in infected patients. An interviewer administered questionnaire to collect data on clinical characteristics and outcomes is needed to assess the clinical outcome and to improve patient care. Present study developed and validated a questionnaire to assess clinical characteristics and outcomes during hospital stay and after discharge over three months, among patients with CR-UTI. Method A four-phase methodology was followed. (1) item generation by literature search, (2) content validation by an expert panel review (n = 3), (3) face validation by conducting a pilot study (n = 20), (4) construct validity and reliability analysis with the participation of 123 patients confirmed with CR-UTIs. Results Questionnaire with 14 items were generated by the end of phase 1. Content validation indicated a strong item content validity index for relevance. Several revisions were done to improve clarity. Exploratory factor analysis using principal component analysis showed that items loaded > 0.04 on a single item explained total variance of 71.67%. The Kaiser-Mayer-Olkin value was acceptable (0.34), with significant Bartlett’s sphericity test (p < 0.05). The Cronbach’s alpha value indicated sufficient reliability (0.53) for a newly developed questionnaire. At the end of four phases, 21-item questionnaire was generated. Conclusion The questionnaire validated for clinical characteristics and outcome assessment of CR-UTI patients was with excellent psychometric properties. To the best of our knowledge, this is the first attempt to develop and validate a standardized questionnaire, to enhance patient care through monitoring of clinical characteristics and outcome assessment of patients diagnosed with CR-UTIs.