Abstract
Purpose
The Acute Cystitis Symptom Score (ACSS) was developed as a self-reporting questionnaire for diagnosing and monitoring acute uncomplicated cystitis (AC) in female patients. The study aims at the translation of the ACSS into Turkish from the original Uzbek including its linguistic, cognitive and clinical validation.
Materials and Methods
After forward and backward translation of the ACSS from Uzbek to Turkish and vice versa, the cognitive assessment of the Turkish ACSS was performed on 12 female subjects to achieve the final study version.
Results
The clinical validation was performed on a total of 120 female respondents including 64 Patients with AC and 56 controls without AC. For clinical diagnosis of AC, the predefined summary score of the typical symptoms of >6 showed high values (95% confidence interval) for sensitivity (0.88 [0.77–0.94]), specificity (0.98 [0.91–1.00]), and diagnostic accuracy (0.93 [0.86–0.97]). All patients were followed up between five to nine days after the baseline visit. Forty-four (68.75%) patients used antimicrobial treatment, whereas the rest (31.25%) preferred non-antimicrobial treatment. The severity scores of the typical symptoms and the quality of life were reduced significantly at follow-up. Using different (favored) thresholds for successful and non-successful treatment a clinical success rate between 54.7% and 64.1% (60.9%) was achieved.
Conclusions
After translation from the original Uzbek and cognitive assessment, the Turkish ACSS showed similar good results for clinical diagnosis and patient-reported outcome as in other languages validated so far and could therefore now be used for clinical studies as well as in everyday practice.
Keywords: Acute Cystitis Symptom Score, Diagnosis, Patient-reported outcome measure, Uncomplicated urinary tract infection, Urinary tract infections
INTRODUCTION
In the latest update of the European Association of Urology (EAU) guidelines, cystitis in not pregnant women without anatomical and functional abnormalities of the urinary system and relevant comorbidities is defined as acute uncomplicated cystitis (AC) [1]. Since typical clinical symptoms usually allow the accurate diagnosis of AC, it is essential to improve the clinical diagnostic and patient-reported outcome criteria.
The Acute Cystitis Symptom Score (ACSS) was developed on three important principles: i) determination of the severity of AC symptoms; ii) assessment of the decrease in daily activity and quality of life (QoL) due to symptoms; iii) differentiation of AC from other pathologies presenting with similar symptoms [2]. Developed initially in Uzbek and now available in many other languages, the ACSS, a patient self-reporting questionnaire, may serve as a diagnostic tool to determine the severity of AC- and AC-like symptoms and to monitor female patients with AC during follow-up [2].
The current study aimed to perform linguistic and clinical validation of the Turkish version of the ACSS to use it as a diagnostic tool for AC as well as a patient-reported outcome measures (PROMs) in the Turkish-speaking female population.
1. Main points
1) According to guidelines and clinical practice the diagnosis and outcome of AC are usually stated according to clinical symptoms and history.
2) The ACSS, now translated and validated in many languages, was developed to improve clinical diagnosis and PROM in patients with AC.
3) The ACSS now translated from original Uzbek into Turkish, cognitively assessed and clinically validated, has shown as good results as in other languages validated to date and therefore can be used for clinical studies as well as in everyday practice in the Turkish-speaking population.
4) The current study has also revealed no correlation between the level of pyuria at baseline with the severity of symptoms at baseline or clinical outcome.
MATERIALS AND METHODS
1. Study design
This study was initiated by the Urology and Gynecology/Obstetrics departments of the Trakya University Hospital as a prospective, non-interventional, comparative clinical study in Türkiye.
2. Ethical approval
The research was performed following the Declaration of Helsinki (2013) and its later amendments or comparable ethical standards. Approval of the study protocol was provided by the local ethical committee of the Trakya University School of Medicine (ethical approval date: 08.04.2019, no. TÜTF-BAEK2019/127).
3. Study tool
The ACSS is a self-reporting symptom questionnaire to assess the severity of symptoms and monitor qualitative and quantitative changes in symptoms during symptomatic episodes of lower urinary tract infections in women. The structure, validity, and development process of the ACSS were previously described elsewhere [2].
The process of translation, linguistic and cognitive validation of the Turkish version of the ACSS consisted of two steps:
1) Forward translation of the ACSS from the source Uzbek version by two independent professional translators with Turkish as their mother language with further correction by two native Turkish-speaking medical professionals (urologists).
2) Backward translation of the draft Turkish version merged from two forward-translated versions, corrected by the medical professionals to the Uzbek language by the qualified translator with Uzbek as the mother language to exclude any discrepancies.
3) Reconciliation and correction of the backward translated version of the ACSS by the member of the ACSS Steering Committee (SC).
4) After the required adaptation based on comments of the SC, the consensus Turkish version of the ACSS was used for the cognitive assessment, which included female subjects of different ages and different educational levels. This process also included medical professionals answering frequently asked questions, such as differentiating between flank and back pain, vaginal and urethral discharge or the premenstrual syndrome, and clarifying details of the process to study subjects. Results of the cognitive assessment and comments from the study subjects were discussed with the SC and after the concluding adaptations, the study version of the Turkish ACSS was finalized.
4. Study participants and respondents
According to the study protocol, the local study decision-making supervisor (M.Ç.) and two medical investigators (S.A. and E.A.) were defined to assign the respondents into either of the two groups (female patients with AC and controls without AC) and further analyze their cognitive ability to understand and respond.
After obtaining signed written informed consent, native Turkish-speaking female patients ≥18 years old and with symptoms suggestive of AC presenting to Clinics of Urology or Gynecology/Obstetrics and healthy females presenting to the Clinic of Gynecology for routine periodical control between January 2019 and January 2020 were included into this prospective, non-interventional study. The remaining respondents (patients and controls) were requested to fill in part A of the ACSS at the Baseline visit and patients also part B at the follow-up visit within 1–2 weeks to determine the patient-reported outcome. Subjects with conditions that might affect bacterial virulence or host response (e.g., immunodeficiency, abnormalities of the urogenital system), and those who had received antimicrobial or immunosuppressive agents four weeks preceding the study, as well as respondents who did not show up for follow-up visit, were excluded from further analysis.
The first investigator (S.A.) only had access to the respondent’s medical records, including lab results, and was blinded to the ACSS responses, i.e., he was asked to make his diagnosis “classically” according to local standards and international guidelines, such as the EAU guidelines [1], by which the diagnosis of uncomplicated cystitis can be made with high probability based on a focused history of lower urinary tract symptoms (LUTS; dysuria, frequency, and urgency) and the absence of vaginal discharge. Urinalysis, such as leukocyturia etc., and urine culture were performed up to the treating physician. In contrast, the second investigator (E.A.) had access only to the ACSS responses, being blind to the respondent’s medical records, and thus expressed his suspicion about the presence or absence of AC based only on the respondent’s subjectively reflected symptomatology. Their conclusions were then reviewed by the decision-making supervisor (M.Ç.) by comparing all documents. All revealed diagnostic discrepancies were discussed with the investigators to reach a final decision, and the study respondents were then assigned as Controls or Patients.
The appropriate therapy for the Patients was prescribed according to the standards and regulations approved by the local authorities.
5. Statistical analysis
The R-Studio with the installed R version 4.1.0 (2021-05-08) with built-in and additional packages was used for the processing, statistical analysis, and graphical representation of the data obtained in the present study [3,4,5,6].
The normality of distributions was tested numerically and graphically, using the Shapiro test and Q-Q plots, respectively [7]. The homogeneity of processed variables was verified using Levene’s test [8].
Descriptive statistics of the quantitative data were represented in total numbers and proportions and by the central tendency (the median) and variability dispersion (interquartile range, IQR).
For the comparative analysis of the independent samples, we used a two-sided independent sample t-test (with the Welch correction for inequality of variances) for the continuous variables, a chi-squared test for categorical variables, and a two-sided Wilcoxon–Mann–Whitney test for interval variables [9,10,11]. Pearson product-moment correlation coefficient was used to assess the strengths of associations [12].
The psychometric reliability of the Turkish version of the ACSS was assessed using internal consistency values represented by Cronbach’s alpha and split-half reliability for each domain separately [13].
Diagnostic values of the domains and items of the ACSS were assessed by calculating sensitivity, specificity, the likelihood ratios of the positive and negative test results, the diagnostic accuracy of the test, diagnostic odds ratio (DOR), Youden index, etc., including the area under the receiver operating characteristic curve (AUC). Generalized linear models of linear regression were chosen to assess the prognostic values. Statistical significance was set at the p-value less than 0.05.
RESULTS
1. Linguistic validation and cognitive assessment
1) Pilot test of the Turkish ACSS
The cognitive assessment of the consensus version of the Turkish ACSS was performed on 12 female subjects with an average (mean±standard deviation) age of 24.6±12.4 years, having different education levels (one with an elementary grade, one with a high school grade, nine with college grade, and one postgraduate). All 12 participants of the pilot test reported that the ACSS items and suggested answers were clear and sufficient given that the questionnaire could not be answered in more than one way.
After a discussion of all comments, the members of SC agreed on the final study version of the Turkish ACSS (Supplementary Fig. 1), which was used for the clinical validation study.
2. Clinical validation
1) Demographic data and baseline characteristics
The questionnaire data from a total of 120 female respondents with a median age of 36.5 (15–65) were considered satisfactory for further analysis. Of those, 64 with AC were diagnosed as Patients, and 56 as Controls (Table 1). Clinical diagnosis and treatment of AC were determined according to national and international guidelines. Table 1 demonstrates the relative homogeneity of both groups in all parameters, except the health status and anamnesis related to AC-relevant symptomatic.
Table 1. Some demographic characteristics of study subjects.
| Parameter | Total | Controls | Patients | p-valuea | |
|---|---|---|---|---|---|
| Number of subjects | 120 (100.0) | 56 (46.7) | 64 (53.3) | - | |
| Age (y) | 36.5 (28.0–47.0) | 37.5 (28.8–48.0) | 36.0 (27.8–45.2) | 0.433 | |
| Sexually active | 100 (83.3) | 48 (85.7) | 52 (81.3) | 0.682 | |
| Antimicrobial therapy in preceding 3 mo | 22 (18.3) | 5 (8.9) | 17 (26.6) | 0.024* | |
| Number of acute episodes within the last year | 0.0 (0.0–1.0) | 0.0 (0.0–0.0) | 0.0 (0.0–2.0) | <0.001* | |
| Number of acute episodes within the last 6 mo | 0.0 (0.0–1.0) | 0.0 (0.0–0.0) | 0.0 (0.0–2.0) | <0.001* | |
| Employment | |||||
| Full-time | 26 (21.7) | 13 (23.2) | 13 (20.3) | 0.871 | |
| Part-time | 1 (0.8) | 0 (0.0) | 1 (1.6) | - | |
| Studying | 9 (7.5) | 5 (8.9) | 4 (6.2) | 0.835 | |
| Not working/unemployed | 84 (70.0) | 38 (67.9) | 46 (71.9) | 0.780 | |
| “Typical” symptoms, presenting at the time of admission | |||||
| Frequent urination | 73 (60.8) | 14 (25.0) | 59 (92.2) | <0.001* | |
| Urgent urination | 67 (55.8) | 9 (16.1) | 58 (90.6) | <0.001* | |
| Painful urination | 67 (55.8) | 7 (12.5) | 60 (93.8) | <0.001* | |
| Feeling of uncomplete bladder emptying | 54 (45.0) | 3 (5.4) | 51 (79.7) | <0.001* | |
| Suprapubic pain | 60 (50.0) | 7 (12.5) | 53 (82.8) | <0.001* | |
| Visible blood in urine | 10 (8.3) | 2 (3.6) | 8 (12.5) | 0.151 | |
| “Differential” symptoms, presenting at the time of admission | |||||
| Flank pain | 59 (49.2) | 16 (28.6) | 43 (67.2) | <0.001* | |
| Vaginal discharge | 46 (38.3) | 12 (21.4) | 34 (53.1) | 0.001* | |
| Urethral discharge | 39 (32.5) | 10 (17.9) | 29 (45.3) | 0.003* | |
| Feeling fever | 19 (15.8) | 3 (5.4) | 16 (25.0) | 0.007* | |
| Additional conditions according to the ACSS “Additional” domain | |||||
| Menstruation | 25 (20.8) | 8 (14.3) | 17 (26.6) | 0.154 | |
| Premenstrual syndrome | 22 (18.3) | 2 (3.6) | 20 (31.3) | <0.001* | |
| Symptoms of menopause | 20 (16.7) | 6 (10.7) | 14 (21.9) | 0.164 | |
| Pregnancy | 30 (25.0) | 18 (32.1) | 12 (18.8) | 0.139 | |
| Known sugar diabetes | 17 (14.2) | 9 (16.1) | 8 (12.5) | 0.766 | |
Values are presented as number (%) or median (interquartile range).
a:Parameters are compared between the groups using a two-sided independent sample t-test with the Welch correction in cases of inequality of variances for continuous variables and the chi-squared test for categorical variables.
*Statistically significant p<0.05.
2) Psychometric characteristics, reliability, and validity of the Turkish ACSS
The most optimal ratio of the reliability and validity values belonged to the summary score of the “Typical” domain, followed by the total scores of cumulative “Typical” and “QoL” domains, and then the “QoL” domain itself and “Differential” domains in descending order (Table 2, Fig. 1).
Table 2. Coefficients of reliability of the ACSS domains.
| Domain | Cronbach’s alpha (95% CI) | Split-half reliability (95% CI) |
|---|---|---|
| “Typical” domain | 0.82 (0.78–0.86) | 0.82 (0.77–0.86) |
| “Differential” domain | 0.54 (0.42–0.66) | 0.56 (0.52–0.60) |
| “QoL” domain | 0.92 (0.89–0.94) | 0.82 (0.80–0.84) |
| Cumulative “Typical”&“QoL” domains | 0.89 (0.87–0.92) | 0.90 (0.79–0.93) |
ACSS, Acute Cystitis Symptom Score; CI, confidence interval; QoL, quality of life.
Fig. 1. Receiver operating characteristic-curves and corresponding area under the curve (AUC) for the items of the “Typical” domain and summary scores of the selected Acute Cystitis Symptom Score (ACSS) domains of the Turkish ACSS. CI, confidence interval.
Among individual items, the best balance between sensitivity and specificity belonged to painful urination (AUC 0.95), followed by urgency (AUC 0.91) and frequency (AUC 0.87) (Fig. 1).
The diagnostic values of the predefined cut-off point by the summary “Typical” score of 6 have also resulted in high values of sensitivity (95% confidence interval) of 0.88 (0.77–0.94), specificity of 0.98 (0.91–1.00), DOR of 392 (47.45–3,238.47) with a diagnostic accuracy of 0.93 (0.86–0.97) and Youden index of 0.86 (0.67–0.94) (Table 3).
Table 3. Different diagnostic values of the recommended cut-off value by the summary score of ≥6 of the “Typical” domain of the Turkish version of the ACSS.
| Parameter | Value (95% CI) |
|---|---|
| Sensitivity | 0.88 (0.77–0.94) |
| Specificity | 0.98 (0.91–1.00) |
| Diagnostic accuracy | 0.93 (0.86–0.97) |
| Diagnostic odds ratio | 392 (47.45–3,238.47) |
| Youden index | 0.86 (0.67–0.94) |
| Positive predictive value | 0.98 (0.91–1.00) |
| Negative predictive value | 0.88 (0.77–0.94) |
| The likelihood ratio of a positive test | 49.87 (7.13–348.77) |
| The likelihood ratio of a negative test | 0.13 (0.07–0.24) |
| The proportion of false positive result | 0.02 (0.00–0.09) |
| The proportion of false negative result | 0.12 (0.06–0.23) |
ACSS, Acute Cystitis Symptom Score; CI, confidence interval.
3) The severity of symptoms: Patients vs. Controls
The distribution of total scores by ACSS areas did not correspond to normal (Supplementary Fig. 2).
At the baseline, the summary scores of all ACSS domains (except “Additional”) were significantly higher in the group of Patients compared to Controls, as well as the average severity of individual symptoms reflected in the ACSS items, except for “visible blood in urine” of the “Typical” domain (Table 4, Fig. 2).
Table 4. Comparison of scores of items and summary scores of the selected ACSS domains between Patients and Controls.
| Parameter (scores) | Subjects of the study | p-valuea | ||
|---|---|---|---|---|
| Controls (n=56) | Patients (n=64) | |||
| “Typical” domain | Frequency | 0.0 (0.0–0.2) | 2.0 (1.0–2.0) | <0.001 |
| Urgency | 0.0 (0.0–0.0) | 2.0 (1.0–2.0) | <0.001 | |
| Painful urination (dysuria) | 0.0 (0.0–0.0) | 2.0 (1.0–3.0) | <0.001 | |
| Incomplete bladder emptying | 0.0 (0.0–0.0) | 1.0 (1.0–2.0) | <0.001 | |
| Suprapubic pain | 0.0 (0.0–0.0) | 1.0 (1.0–2.0) | <0.001 | |
| Visible blood in the urine | 0.0 (0.0–0.0) | 0.0 (0.0–0.0) | 0.076 | |
| A summary score of the “Typical” domain | 0.0 (0.0–2.0) | 7.0 (6.0–10.0) | <0.001 | |
| “Differential” domain | Flank pain | 0.0 (0.0–1.0) | 1.0 (0.0–2.0) | <0.001 |
| Vaginal discharge | 0.0 (0.0–0.0) | 1.0 (0.0–1.0) | <0.001 | |
| Urethral discharge | 0.0 (0.0–0.0) | 0.0 (0.0–1.0) | 0.002 | |
| Feeling fever | 0.0 (0.0–0.0) | 0.0 (0.0–0.2) | <0.001 | |
| A summary score of the “Differential” domain | 0.0 (0.0–2.0) | 2.0 (1.0–4.0) | <0.001 | |
| “QoL” domain | General discomfort | 0.0 (0.0–1.0) | 2.0 (1.0–2.0) | <0.001 |
| Everyday activities/work | 0.0 (0.0–1.0) | 2.0 (1.0–2.0) | <0.001 | |
| Social activities | 0.0 (0.0–1.0) | 2.0 (1.0–2.0) | <0.001 | |
| A summary score of the “QoL” domain | 0.0 (0.0–3.0) | 5.0 (3.0–6.0) | <0.001 | |
| A summary score of cumulative “Typical”&“QoL” domains | 1.0 (0.0–4.0) | 12.0 (10.0–16.0) | <0.001 | |
Values are presented as median (interquartile range).
ACSS, Acute Cystitis Symptom Score; CI, confidence interval; QoL, quality of life.
a:Parameters are compared between the groups using a two-sided Wilcoxon test.
Fig. 2. Scores of the items of the “Typical” domain (A) and summary scores of the selected ACSS domains (B) of the Turkish Acute Cystitis Symptom Score (ACSS) between Patients and Controls.
All patients were followed up between five to nine days after the baseline visit according to their treatment and symptoms. Forty-four (68.75%) Patients used antimicrobial treatment, whereas the rest (31.25%) preferred a non-antimicrobial treatment like oral hydration, intimal hygiene, etc.
4) Effect of treatment
The average scores of the individual items and summary scores of the ACSS domains in the group of Patients differed significantly between baseline and follow-up visits (Fig. 3).
Fig. 3. Scores of the items of the “Typical” domain (A) and summary scores of the selected ACSS domains (B) of the Turkish Acute Cystitis Symptom Score (ACSS) in the group of Patients before and after the therapy.
The results of the assessment of the treatment success according to predefined “thresholds” are shown in Table 5. According to the preferred threshold (B), the clinical success rate was 60.9% [4].
Table 5. Proportions of the patients with the assessment of the treatment efficacy at follow-up (n=64) according to different predefined thresholds.
| Successful treatment outcome | Success | Non-success |
|---|---|---|
| A) Score of ACSS domain “dynamics” <1 | 35 (54.7) | 29 (45.3) |
| B) Summary score of typical domain ≤5 scores, no item >1 and “visible blood in urine” =0 | 39 (60.9) | 25 (39.1) |
| C) Summary score of typical domain <5 scores, no item >1 and no item of QoL >1 and “visible blood in urine” =0 | 33 (51.6) | 31 (48.4) |
| D) Summary score of 4 FDA symptoms ≤4, no item >1 and “visible blood in urine” =0 | 41 (64.1) | 23 (35.9) |
| E) Summary score of 3 EMA symptoms ≤3, no item >1 and “visible blood in urine” =0 | 41 (64.1) | 23 (35.9) |
The values are presented as number (%).
ACSS, Acute Cystitis Symptom Score; QoL, quality of life; FDA, Food and Drug Administration; EMA, European Medicines Agency.
The summary scores of the ACSS domains representing symptom severity before and after treatment did not differ significantly from the results of the leucocyte-esterase test presented at the baseline visit (Supplementary Fig. 3A). We also found no significant relationship between the symptom severity and the levels of leucocyturia at the follow-up visit (Supplementary Fig. 3B, C).
DISCUSSION
Our study has verified the applicability of the Turkish ACCS, as well as the studies in other languages. Given the cut-off value 6 for the summary score of the “typical” symptoms, sensitivity and specificity in the diagnosis of AC in patients were 88% and 98%, respectively, and similar to the findings of the original versions of the ACCS (Uzbek and Russian) [2,14]. The original version of the ACCS (Uzbek and Russian) has been tested and clinically verified in a study on 286 patients and satisfactory results have been obtained including the sub-groups of the questionnaire in terms of reliability, differential and psychometric characteristics [2]. Other clinical validation studies have also indicated that the translated versions of the ACCS can be applied as reliably as the original version [14,15].
Actual guidelines suggest that the presence of the symptoms of dysuria, frequency and urgency, without the presence of vaginal discharge are sufficient for the diagnosis of AC [1]. Questionnaires inquiring about similar LUTS, although not specific to AC, have been developed and are frequently utilized [16,17]. However, these questionnaires may be unsatisfactory for the differential diagnosis of asymptomatic bacteriuria not requiring treatment. Our study has indicated that the psychometric and diagnostic values of the Turkish ACSS, even in sub-groups are substantially high, as indicated in prior studies using the translated versions of the ACCS [15,18,19,20]. Having received clear and comprehensible responses from patients of all educational levels supports the utility of the Turkish version of the ACCS in daily practice.
Prescription of inappropriate antibiotics and the development of antibiotic resistance among bacteria is a serious issue, both in Türkiye and worldwide. Urine culture studies are not frequently ordered in the outpatient setting in Türkiye, where instead empiric antibiotic therapies remain the first choice. EAU guidelines also support concentrating on the symptoms and risk factors for the diagnosis of AC [1]. Studies supporting the use of non-antimicrobial agents in AC depending on the severity of symptoms have led to the need for a new diagnostic tool to guide clinicians in rational prescribing of antimicrobial and non-antimicrobial therapy by improving the reliability and quickness of diagnosis in AC [21]. Demonstrating the clinical applicability of the Turkish version of the ACSS, we feel that it can serve as a reliable diagnostic tool that allows the patients to self-assess their current condition and helps to compare different treatment options, such as antimicrobial versus non-antimicrobial ones. As an additional benefit may be mentioned the reduced frequency of unnecessary personal contact in places having no direct access to a qualified urologist or during times of increased contamination risk such as the COVID-19 pandemic [22].
The guidelines of the EAU state that urine analysis in patients with typical AC symptoms can only be minimally useful and this step may even be skipped [23]. We did not find a significant correlation between the severity of symptoms and the level of leucocyturia in our analysis, both at the initial and during the follow-up analyses. Similarly, no difference was noted between pre-treatment and post-treatment severity of symptoms and leucocyte-esterase test results. The lack of significant association between levels of bacteriuria and severity of symptoms at baseline as well as for clinical outcome as found in other studies correlates with our results concerning the amount of bacteriuria [24,25].
Physical examination and laboratory tests are the mainstays for diagnosis. However, self-evaluation of the patient’s level of complaints and QoL before and after treatment is seen as an objective method [26]. Internationally validated scoring systems such as the IPSS (International Prostate Symptom Score) and the Bristol Female Lower Urinary Tract Symptoms Questionnaire by which the patients evaluate and report their symptoms have already become firmly in the clinical practice around the world [17,27]. However, no other questionnaire evaluates subgroups such as “Typical Symptoms” and “Quality of Life” together, whereas the ACSS allows this. In our study, the scores of these subgroups, both separately and together, decreased significantly after treatment between the groups of Control and Patients. In addition, the ACSS is so far the only questionnaire that allows diagnosing AC with such accuracy at the baseline visit and also can be used as a PROM at the follow-up visits.
The limitations of our study can be summarized as the relatively small number of patients, and to be performed in a single centre. However, our results are in agreement with those found with the ACSS translated and validated in other languages as well [2,14,15,18,19,20,24,25].
CONCLUSIONS
The validated Turkish version of the ACSS is a valid and reliable diagnostic self-reporting tool and PROM in Turkish-speaking female patients suggestive of AC and could be used for clinical studies. It is also easily applicable in daily practice. The study also showed in addition that the amount of leucocyturia does not correlate with the severity of symptoms and does not play a role in forecasting the therapeutic efficacy.
ACKNOWLEDGMENTS
The Acute Cystitis Symptom Score (ACSS) is copyrighted by the Certificate of Deposit of Intellectual Property in Fundamental Library of the Academy of Sciences of the Republic of Uzbekistan, Tashkent (Registration no. 2463; 26 August 2015) and the Certificate of the International Online Copyright Office, European Depository, Berlin, Germany (Nr. EU-01-000764; 21 October 2015). The rightsholders are Jakhongir Fatikhovich Alidjanov (Uzbekistan), Ozoda Takhirovna Alidjanova (Uzbekistan), Adrian Martin Erich Pilatz (Germany), Kurt Guenther Naber (Germany), and Florian Martin Erich Wagenlehner (Germany). The e-USQOLAT is copyrighted by the Authorship Certificate of the International Online Copyright Office, European Depository, Berlin, Germany (Nr. EC-01-001179; 18 May 2017) 19. Translations of the ACSS in other languages are available on the website: http://www.acss.world/downloads.html. The authors thank all the participants of the study for their contribution. They also express special gratefulness to the professional translators for their contribution and support.
Footnotes
CONFLICTS OF INTEREST: Jakhongir Alidjanov, Adrian Piatz, Florian M. Wagenlehner, and Kurt G. Naber are copyright holders of the Acute Cystitis Symptom Score. The other authors have nothing to disclose.
FUNDING: None.
- Research conception and design: Mete Çek and Kurt G. Naber.
- Data acquisition: Jakhongir Alidjanov, Ersan Arda, and Sinan Ates.
- Statistical analysis: Jakhongir Alidjanov and Adrian Piatz.
- Data analysis and interpretation: Ersan Arda, Sinan Ates, and Florian M. Wagenlehner.
- Drafting of the manuscript: Ersan Arda and Sinan Ates.
- Critical revision of the manuscript: Mete Çek, Kurt G. Naber, Adrian Piatz, and Ersan Arda.
- Obtaining funding: Jakhongir Alidjanov, Florian M. Wagenlehner, and Kurt G. Naber.
- Administrative, technical, or material support: Mete Çek, Kurt G. Naber, and Sinan Ates.
- Supervision: Kurt G. Naber, Florian M. Wagenlehner, Jakhongir Alidjanov, and Adrian Piatz.
- Approval of the final manuscript: Sinan Ates, Ersan Arda, and Mete Çek.
SUPPLEMENTARY MATERIALS
Supplementary materials can be found via https://doi.org/10.4111/icu.20230010.
The Turkish Acute Cystitis Symptom Score (ACSS) questionnaire. Part A. First visit (diagnostics). Part B. Follow-up visits (patient-reported outcome) – http://www.acss.world/downloads.html (see attachment).
Q-Q plots for testing the normality of distributions of the summary scores of the selected domains of the Turkish Acute Cystitis Symptom Score. QoL, quality of life.
Strength of associations (Pearson’s ρ) between levels of leukocyturia and summary scores of Acute Cystitis Symptom Score (ACSS) domains at Baseline (A), levels of leukocyturia at Baseline and summary scores of ACSS domains at follow-up visit (B), and levels of leukocyturia and summary scores of ACSS domains at follow-up visit (C). During the follow-up visit, there were only 53 patients with leukocyturia measured and no patient had a large (3+) amount of leukocyturia. The colour fields correspond to the following values; Negative ≤10 white blood cell (WBC)/µL, Small (1+)=approximately 25 WBC/µL, Moderate (2+)=approximately 75 WBC/µL, and Large (3+)=approximately ≥500 leucocytes/µL. The blue-green line represents the trend line of logistic regression, and the grey area around represents the standard error. QoL, quality of life.
References
- 1.Bonkat G, Bartoletti R, Bruyère F, Cai T, Geerlings SE, Köves B, et al. EAU guidelines on urological infections. Arnhem: European Association of Urology; 2022. pp. 1–84. [Google Scholar]
- 2.Alidjanov JF, Abdufattaev UA, Makhsudov SA, Pilatz A, Akilov FA, Naber KG, et al. 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. Erratum in: Urol Int 2016;96:369. [DOI] [PubMed] [Google Scholar]
- 3.R Development Core Team. R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing; 2017. [Google Scholar]
- 4.Wickham H. tidyverse: Easily Install and Load the 'Tidyverse' [Internet] City of publication: publisher; 2017. Nov 14, [cited 2023 Feb 15]. Available from: http://cran.nexr.com/web/packages/tidyverse/index.html . [Google Scholar]
- 5.Revelle W. psych: Procedures for Psychological, Psychometric, and Personality Research [Internet] Evanston, IL: publisher; 2020. [cited 2023 Feb 15]. Available from: https://cran.r-project.org/web/packages/psych/index.html . [Google Scholar]
- 6.Robin X, Turck N, Hainard A, Tiberti N, Lisacek F, Sanchez JC, et al. pROC: an open-source package for R and S+ to analyze and compare ROC curves. BMC Bioinformatics. 2011;12:77. doi: 10.1186/1471-2105-12-77. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Shapiro SS, Wilk MB. An analysis of variance test for normality (complete samples) Biometrika. 1965;52:591–611. [Google Scholar]
- 8.Levene H. In: Contributions to probability and statistics: essays in honor of Harold Hotelling. Olkin I, Ghurye SG, Hoeffding W, Madow WG, Mann HB, editors. Stanford: Stanford University Press; 1960. Robust tests for equality of variances; pp. 278–292. [Google Scholar]
- 9.Student The probable error of a mean. Biometrika. 1908;6:1–25. [Google Scholar]
- 10.Pearson K. X. On the criterion that a given system of deviations from the probable in the case of a correlated system of variables is such that it can be reasonably supposed to have arisen from random sampling. Lond Edinb Dublin Philos Mag J Sci. 1900;50:157–175. [Google Scholar]
- 11.Wilcoxon F. Individual comparisons by ranking methods. Biom Bull. 1945;1:80–83. [Google Scholar]
- 12.Pearson K. VII. Note on regression and inheritance in the case of two parents. Proc R Soc Lond. 1895;58:240–242. [Google Scholar]
- 13.Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16:297–334. [Google Scholar]
- 14.Alidjanov JF, Abdufattaev UA, Makhmudov D, Mirkhamidov D, Khadzhikhanov FA, Azgamov AV, et al. [Development and clinical testing of the Russian version of the Acute Cystitis Symptom Score - ACSS] Urologiia. 2014;(6):14–22. Russian. [PubMed] [Google Scholar]
- 15.Alidjanov JF, Pilatz A, Abdufattaev UA, Wiltink J, Weidner W, Naber KG, et al. [German validation of the Acute Cystitis Symptom Score] Urologe A. 2015;54:1269–1276. doi: 10.1007/s00120-015-3873-5. German. [DOI] [PubMed] [Google Scholar]
- 16.Coyne KS, Sexton CC, Kopp Z, Chapple CR, Kaplan SA, Aiyer LP, et al. Assessing patients' descriptions of lower urinary tract symptoms (LUTS) and perspectives on treatment outcomes: results of qualitative research. Int J Clin Pract. 2010;64:1260–1278. doi: 10.1111/j.1742-1241.2010.02450.x. [DOI] [PubMed] [Google Scholar]
- 17.Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996;77:805–812. doi: 10.1046/j.1464-410x.1996.00186.x. [DOI] [PubMed] [Google Scholar]
- 18.Alidjanov JF, Naber KG, Pilatz A, Wagenlehner FM. Validation of the American English Acute Cystitis Symptom Score. Antibiotics (Basel) 2020;9:929. doi: 10.3390/antibiotics9120929. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Bruyère F, Piraux A, Bohbot JM, Begue C, Vallée M, Alidjanov J, et al. Linguistic validation and cognitive assessment of the French version of the Acute Cystitis Symptom Score questionnaire. Prog Urol. 2022;32:73–76. doi: 10.1016/j.purol.2021.12.001. [DOI] [PubMed] [Google Scholar]
- 20.Di Vico T, Morganti R, Cai T, Naber KG, Wagenlehner FME, Pilatz A, et al. Acute Cystitis Symptom Score (ACSS): clinical validation of the Italian version. Antibiotics (Basel) 2020;9:104. doi: 10.3390/antibiotics9030104. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Kranz J, Schmidt S, Lebert C, Schneidewind L, Mandraka F, Kunze M, et al. The 2017 update of the German clinical guideline on epidemiology, diagnostics, therapy, prevention, and management of uncomplicated urinary tract infections in adult patients. Part II: therapy and prevention. Urol Int. 2018;100:271–278. doi: 10.1159/000487645. [DOI] [PubMed] [Google Scholar]
- 22.World Health Organization. Advice for the public: coronavirus disease (COVID-19) [Internet] Geneva: World Health Organization; 2020. [cited 2023 Feb 15]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public . [Google Scholar]
- 23.Bent S, Nallamothu BK, Simel DL, Fihn SD, Saint S. Does this woman have an acute uncomplicated urinary tract infection? JAMA. 2002;287:2701–2710. doi: 10.1001/jama.287.20.2701. [DOI] [PubMed] [Google Scholar]
- 24.Alidjanov JF, Overesch A, Abramov-Sommariva D, Hoeller M, Steindl H, Wagenlehner FM, et al. Acute Cystitis Symptom Score questionnaire for measuring patient-reported outcomes in women with acute uncomplicated cystitis: clinical validation as part of a phase III trial comparing antibiotic and nonantibiotic therapy. Investig Clin Urol. 2020;61:498–507. doi: 10.4111/icu.20200060. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Stamatiou K, Samara E, Alidjanov JF, Pilatz AME, Naber KG, Wagenlehner FME. Clinical validation of the Greek version of the Acute Cystitis Symptom Score (ACSS)-part II. Antibiotics (Basel) 2021;10:1253. doi: 10.3390/antibiotics10101253. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.Staquet M, Berzon R, Osoba D, Machin D. Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res. 1996;5:496–502. doi: 10.1007/BF00540022. [DOI] [PubMed] [Google Scholar]
- 27.Barry MJ, Fowler FJ, Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, et al. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992;148:1549–1557. doi: 10.1016/s0022-5347(17)36966-5. discussion 1564. [DOI] [PubMed] [Google Scholar]
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Supplementary Materials
The Turkish Acute Cystitis Symptom Score (ACSS) questionnaire. Part A. First visit (diagnostics). Part B. Follow-up visits (patient-reported outcome) – http://www.acss.world/downloads.html (see attachment).
Q-Q plots for testing the normality of distributions of the summary scores of the selected domains of the Turkish Acute Cystitis Symptom Score. QoL, quality of life.
Strength of associations (Pearson’s ρ) between levels of leukocyturia and summary scores of Acute Cystitis Symptom Score (ACSS) domains at Baseline (A), levels of leukocyturia at Baseline and summary scores of ACSS domains at follow-up visit (B), and levels of leukocyturia and summary scores of ACSS domains at follow-up visit (C). During the follow-up visit, there were only 53 patients with leukocyturia measured and no patient had a large (3+) amount of leukocyturia. The colour fields correspond to the following values; Negative ≤10 white blood cell (WBC)/µL, Small (1+)=approximately 25 WBC/µL, Moderate (2+)=approximately 75 WBC/µL, and Large (3+)=approximately ≥500 leucocytes/µL. The blue-green line represents the trend line of logistic regression, and the grey area around represents the standard error. QoL, quality of life.