Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation

Background: The APEKS-cUTI study demonstrated the non-inferiority of cefiderocol to imipenem−cilastatin in the primary endpoint of the composite of clinical and microbiological outcome in patients with complicated urinary tract infections (cUTIs). We piloted a structured patient interview (SPI) to e...

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Autores principales:	Simon Portsmouth, Roger Echols, Kiichiro Toyoizumi, Glenn Tillotson, Tsutae Den Nagata
Formato:	article
Lenguaje:	EN
Publicado:	SAGE Publishing 2021
Materias:	Infectious and parasitic diseases RC109-216
Acceso en línea:	https://doaj.org/article/d3f3b4385cc24a1e89e68c28a8f0a782
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spelling	oai:doaj.org-article:d3f3b4385cc24a1e89e68c28a8f0a7822021-11-30T23:35:43ZStructured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation2049-937X10.1177/20499361211058257https://doaj.org/article/d3f3b4385cc24a1e89e68c28a8f0a7822021-11-01T00:00:00Zhttps://doi.org/10.1177/20499361211058257https://doaj.org/toc/2049-937XBackground: The APEKS-cUTI study demonstrated the non-inferiority of cefiderocol to imipenem−cilastatin in the primary endpoint of the composite of clinical and microbiological outcome in patients with complicated urinary tract infections (cUTIs). We piloted a structured patient interview (SPI) to evaluate clinical outcomes based on patient-reported symptoms while conducting this pivotal randomized, double-blind, phase-2 study. The objectives were to assess the value of the SPI, using its performance relative to physician assessment, and also to strengthen the value of patient-reported measures in conducting clinical trials for cUTI treatment. Methods: In addition to the protocol-defined clinical and microbiological outcomes, patients randomized in the APEKS-cUTI study were interviewed by the investigator or qualified study personnel at screening/baseline, early assessment (EA), end of treatment (EOT), test of cure (TOC), and follow-up (FUP). The 14-element questionnaire graded cUTI symptoms as absent or present, and if present, as mild, moderate, or severe. Changes in post-baseline symptoms based on patients’ responses were rated by the interviewer. The overall clinical outcome was evaluated based on the responses provided by patients at each time point. Results: Among the 371 patients in the modified intention-to-treat population, the rate of SPI completion in each treatment arm exceeded 90% at each time point. SPI-assessed clinical cure rates were 89.7% in the cefiderocol arm and 84.9% in the imipenem–cilastatin arm. There was substantial agreement between SPI evaluation and investigator global assessment of clinical outcome at TOC and FUP, with lower agreement at EA and EOT. Conclusion: This analysis suggests that patient-reported symptoms can be effectively captured in hospitalized patients with cUTI in a clinical trial setting. Development of a validated patient-reported outcome for use in such a setting is warranted. Registration: NCT02321800 (registered on 22 December 2014).Simon PortsmouthRoger EcholsKiichiro ToyoizumiGlenn TillotsonTsutae Den NagataSAGE PublishingarticleInfectious and parasitic diseasesRC109-216ENTherapeutic Advances in Infectious Disease, Vol 8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Infectious and parasitic diseases RC109-216
spellingShingle	Infectious and parasitic diseases RC109-216 Simon Portsmouth Roger Echols Kiichiro Toyoizumi Glenn Tillotson Tsutae Den Nagata Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation
description	Background: The APEKS-cUTI study demonstrated the non-inferiority of cefiderocol to imipenem−cilastatin in the primary endpoint of the composite of clinical and microbiological outcome in patients with complicated urinary tract infections (cUTIs). We piloted a structured patient interview (SPI) to evaluate clinical outcomes based on patient-reported symptoms while conducting this pivotal randomized, double-blind, phase-2 study. The objectives were to assess the value of the SPI, using its performance relative to physician assessment, and also to strengthen the value of patient-reported measures in conducting clinical trials for cUTI treatment. Methods: In addition to the protocol-defined clinical and microbiological outcomes, patients randomized in the APEKS-cUTI study were interviewed by the investigator or qualified study personnel at screening/baseline, early assessment (EA), end of treatment (EOT), test of cure (TOC), and follow-up (FUP). The 14-element questionnaire graded cUTI symptoms as absent or present, and if present, as mild, moderate, or severe. Changes in post-baseline symptoms based on patients’ responses were rated by the interviewer. The overall clinical outcome was evaluated based on the responses provided by patients at each time point. Results: Among the 371 patients in the modified intention-to-treat population, the rate of SPI completion in each treatment arm exceeded 90% at each time point. SPI-assessed clinical cure rates were 89.7% in the cefiderocol arm and 84.9% in the imipenem–cilastatin arm. There was substantial agreement between SPI evaluation and investigator global assessment of clinical outcome at TOC and FUP, with lower agreement at EA and EOT. Conclusion: This analysis suggests that patient-reported symptoms can be effectively captured in hospitalized patients with cUTI in a clinical trial setting. Development of a validated patient-reported outcome for use in such a setting is warranted. Registration: NCT02321800 (registered on 22 December 2014).
format	article
author	Simon Portsmouth Roger Echols Kiichiro Toyoizumi Glenn Tillotson Tsutae Den Nagata
author_facet	Simon Portsmouth Roger Echols Kiichiro Toyoizumi Glenn Tillotson Tsutae Den Nagata
author_sort	Simon Portsmouth
title	Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation
title_short	Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation
title_full	Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation
title_fullStr	Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation
title_full_unstemmed	Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation
title_sort	structured patient interview to assess clinical outcomes in complicated urinary tract infections in the apeks-cuti study: pilot investigation
publisher	SAGE Publishing
publishDate	2021
url	https://doaj.org/article/d3f3b4385cc24a1e89e68c28a8f0a782
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Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation

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