Validation of the American English Acute Cystitis Symptom Score

Jakhongir F Alidjanov, Kurt G Naber, Adrian Pilatz, Florian M Wagenlehner, Jakhongir F Alidjanov, Kurt G Naber, Adrian Pilatz, Florian M Wagenlehner

Abstract

The diagnosis of acute uncomplicated cystitis (UC) is usually based on clinical symptoms. The study aims to develop and validate the American-English Acute Cystitis Symptom Score (ACSS), a self-reporting questionnaire for diagnosis and patient-reported outcome in women with acute uncomplicated cystitis (UC). After certified translation into American-English and cognitive assessment, the clinical validation of the ACSS was performed embedded in a US phase-II trial. 167 female patients with typical symptoms of UC were included in the study following US Food and Drug Administration (FDA) guidance. At Day 1 (diagnosis), the mean (SD) sum score of the six ACSS typical symptoms reached 10.60 (2.51). Of 100 patients followed-up last time on Day 5 or 6 (End-of-treatment, EoT), 91 patients showed clinical success according to the favored ACSS criteria (sum score of typical symptoms 0.98 (1.94)). There was no correlation between the severity of symptoms on Day 1 or between clinical success rate at EoT and level of bacteriuria on Day 1. The American-English ACSS showed high predictive ability and responsiveness and excellent levels of reliability and validity. It can now be recommended as the new master version in clinical and epidemiological studies, in clinical practice, or for self-diagnosis of women with symptoms of UC.

Keywords: ACSS; acute cystitis symptom score; cystitis; diagnosis; female patients; patient-reported outcome; urinary tract infection.

Conflict of interest statement

Kurt G. Naber, Prof. Florian M. Wagenlehner, Adrian Pilatz, and Jakhongir Alidjanov are authors and copyright holders of the ACSS questionnaire. Jakhongir Alidjanov declares a personal conflict of interest with Elsevier publishing company due to his personal disagreement with the policy of the company.

Figures

Figure 1
Figure 1
American English Acute Cystitis Symptom Score (ACSS)—Questionnaire.
Figure 2
Figure 2
Boxplots (IQR, range, mean ± SD) of the number present and sumscore of the six ACSS typical symptoms in the US group versus the three categories of bacteriuria at Day 1.
Figure 3
Figure 3
Boxplots (IQR, range, mean ± SD, error of mean) of the sumscore of the six ACSS typical symptoms in the US group on Day 1–6.
Figure 4
Figure 4
Receiver operating characteristic (ROC) curves and diagnostic odds ratios for the ACSS typical symptoms in 100 patients of the US group comparing the results obtained at Day 1 (diagnostics) and Day 5/6 (end of treatment).

References

    1. Colgan R., Williams M. Diagnosis and treatment of acute uncomplicated cystitis. Am. Fam. Physician. 2011;84:771–776.
    1. Desforges J.F., Stamm W.E., Hooton T.M. Management of urinary tract infections in adults. N. Engl. J. Med. 1993;329:1328–1334. doi: 10.1056/NEJM199310283291808.
    1. Barry H.C., Ebell M.H., Hickner J. Evaluation of suspected urinary tract infection in ambulatory women: A cost-utility analysis of office-based strategies. J. Fam. Pr. 1997;44:49–60. doi: 10.1097/00005392-199804000-00141.
    1. Colgan R., Keating K., Dougouih M. Survey of symptom burden in women with uncomplicated urinary tract infections. Clin. Drug Investig. 2004;24:55–60. doi: 10.2165/00044011-200424010-00007.
    1. Clayson D., Wild D., Doll H., Keating K., Gondek K. 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. BJU Int. 2005;96:350–359. doi: 10.1111/j.1464-410X.2005.05630.x.
    1. Wild D., Clayson D.J., Keating K.N., Gondek K. Validation of a patient-administered questionnaire to measure the activity impairment experienced by women with uncomplicated urinary tract infection: The Activity Impairment Assessment (AIA) Health Qual. Life Outcomes. 2005;3:42. doi: 10.1186/1477-7525-3-42.
    1. Alidjanov J.F., Naber K.G., Abdufattaev U.A., Pilatz A., Wagenlehner F.M. Reliability of Symptom-Based Diagnosis of Uncomplicated Cystitis. Urol. Int. 2018;102:83–95. doi: 10.1159/000493509.
    1. Alidjanov J.F., Abdufattaev U.A., Makhsudov S.A., Pilatz A., Akilov F.A., Naber K.G., Wagenlehner F.M. New self-reporting questionnaire to assess urinary tract infections and differential diagnosis: Acute cystitis symptom score. Urol Int. 2014;92:230–236. doi: 10.1159/000356177.
    1. Alidjanov J.F., Naber K.G., Pilatz A., Radzhabov A., Zamuddinov M., Magyar A., Tenke P., Wagenlehner F.M. Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women. World J. Urol. 2020;38:63–72. doi: 10.1007/s00345-019-02761-3.
    1. Alidjanov J.F., Naber K.G., Pilatz A., Radzhabov A., Zamuddinov M., Magyar A., Tenke P., Wagenlehner F.M. Additional assessment of Acute Cystitis Symptom Score questionnaire for patient-reported outcome measure in female patients with acute uncomplicated cystitis: Part II. World J. Urol. 2020;38:1977–1988. doi: 10.1007/s00345-019-02948-8.
    1. Food Drug Administration Center for Drugs Evaluation Research . Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment: Guidance for Industry. U.S. Food and Drug Administration; Silver Spring; Maryland, MD, USA: 2019. p. 20.
    1. European Medicines Agency Committee for Human Medicinal Products . Draft Guideline. European Medicines Agency Committee for Human Medicinal Products; Amsterdam, The Netherlands: 2018. Evaluation of medicinal products indicated for treatment of bacterial infections; p. 20.
    1. Alidjanov J.F., Naber K.G., Pilatz A., Hurley M., Mohoney C.M., Barnes B.D., Werchan P., Wagenlehner F. The American English Acute Cystitis Symptom Score—Linguistic Validation; Proceedings of the 33rd Annual Congress of the European Association of Urology; Copenhagen, Denmark. 16–20 March 2018; Copenhagen, Denmark: European Association of Urology; 2018.
    1. Alidjanov J.F., Abdufattaev U.A., Makhmudov D., Mirkhamidov D., Khadzhikhanov F.A., Azgamov A.V., Pilatz A., Naber K., Wagenlehner F.M., Akilov F.A. Development and clinical testing of the Russian version of the Acute Cystitis Symptom Score—ACSS. Urologiia. 2014;6:14–22.
    1. Alidjanov J.F., Pilatz A., Abdufattaev U.A., Wiltink J., Weidner W., Naber K.G., Wagenlehner F. German validation of the Acute Cystitis Symptom Score. Urologe A. 2015;54:1269–1276. doi: 10.1007/s00120-015-3873-5.
    1. Alidjanov J.F. Preliminary Clinical Validation of the UK English Version of the Acute Cystitis Symptom Score in UK English-speaking female population of Newcastle, Great Britain. JOJ Urol. Nephrol. 2017;1:555561.
    1. Di Vico T., Morganti R., Cai T., Naber K.G., Wagenlehner F.M., Pilatz A., Alidjanov J.F., Morelli G., Bartoletti R. Acute Cystitis Symptom Score (ACSS): Clinical Validation of the Italian Version. Antibiotics. 2020;9:104. doi: 10.3390/antibiotics9030104.
    1. Magyar A., Alidjanov J.F., Pilatz A., Nagy K., Arthanareeswaran V.K.A., Póth S., Bécsi A., Wagenlehner F.M., Naber K.G., Tenke P., et al. The role of the Acute Cystitis Symptom Score questionnaire for research and antimicrobial stewardship. Validation of the Hungarian version. Central Eur. J. Urol. 2017;71:134–141.
    1. Heytens S., De Sutter A., Coorevits L., Cools P., Boelens J., Van Simaey L., Christiaens T., Vaneechoutte M., Claeys G. Women with symptoms of a urinary tract infection but a negative urine culture: PCR-based quantification of Escherichia coli suggests infection in most cases. Clin. Microbiol. Infect. 2017;23:647–652. doi: 10.1016/j.cmi.2017.04.004.
    1. Hooton T.M., Roberts P.L., Cox M.E., Stapleton A.E. Voided midstream urine culture and acute cystitis in premenopausal women. N. Engl. J. Med. 2013;369:1883–1891. doi: 10.1056/NEJMoa1302186.
    1. Stamm W.E., Counts G.W., Running K.R., Fihn S., Turck M., Holmes K.K. Diagnosis of coliform infection in acutely dysuric women. N. Engl. J. Med. 1982;307:463–468. doi: 10.1056/NEJM198208193070802.
    1. Alidjanov J.F., Naber K.G., Abdufattaev U.A., Pilatz A., Wagenlehner F.M. Reevaluation of the Acute Cystitis Symptom Score, a Self-Reporting Questionnaire. Part II. Patient-Reported Outcome Assessment. Antibioics. 2018;7:43. doi: 10.3390/antibiotics7020043.
    1. Alidjanov J.F., Naber K.G., Abdufattaev U.A., Pilatz A., Wagenlehner F.M.E. Reevaluation of the Acute Cystitis Symptom Score, a Self-Reporting Questionnaire. Part I Development, Diagnosis and Differential Diagnosis. Antibiotics. 2018;7:43. doi: 10.3390/antibiotics7020043.
    1. Acquadro C. Linguistic Validation Manual for Patient-Reported Outcomes (PRO) Instruments. Mapi Research Institute; Lyon, France: 2004.
    1. Acquadro C., Conway K., Giroudet C., Mear I. Linguistic Validation Manual for Health Outcome Assessments. Mapi Institute; Lyon, France: 2012.
    1. Acquadro C., Jambon B.D.E., Marquis P. Language and translation issues. In: Spilker B., editor. Quality of Life and Pharmacoeconomics in Clinical Trials. Lippincott Williams & Wilkins; Philadelphia, PA, USA: 1996. pp. 575–586.
    1. R Core Team . R: A Language and Environment for Statistical Computing. R Core Team; Vienna, Austria: 2017.
    1. Robin X.A., Turck N., Hainard A., Tiberti N., Lisacek F., Sanchez J.-C., Müller M. pROC: An open-source package for R and S+ to analyze and compare ROC curves. BMC Bioinform. 2011;12:77. doi: 10.1186/1471-2105-12-77.
    1. Stevenson M., Nunes T., Heuer C., Marshall J., Sanchez J., Thornton R., Reiczigel J., Robison-Cox J., Sebastiani P., Solymos P., et al. epiR: Tools for the Analysis of Epidemiological Data. [(accessed on 18 December 2020)];2017 Available online: .
    1. Wickham H. Tidyverse: Easily Install and Load the ‘Tidyverse’. [(accessed on 18 December 2020)];2017 Available online: .

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