Validity of the International Consultation on Incontinence Questionnaire-Pediatric Lower Urinary Tract Symptoms: A Screening Questionnaire for Children

Validity of the International Consultation on Incontinence Questionnaire-Pediatric Lower Urinary Tract Symptoms: A Screening Questionnaire for Children

Voiding Dysfunction Validity of the International Consultation on Incontinence Questionnaire-Pediatric Lower Urinary Tract Symptoms: A Screening Ques...

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Voiding Dysfunction

Validity of the International Consultation on Incontinence Questionnaire-Pediatric Lower Urinary Tract Symptoms: A Screening Questionnaire for Children Mario De Gennaro, Mauro Niero, Maria Luisa Capitanucci,* Alexander von Gontard, Mark Woodward, Andrea Tubaro and Paul Abrams From the Urodynamic Unit, Department of Nephrology and Urology, Children’s Hospital Bambino Gesù (MDG, MLC) and Department of Urology, Sant’Andrea Hospital (AT), Rome and Department of Methodology, University of Verona (MN), Verona, Italy, Department of Pediatric Neuropsychiatry, Saarland University Hospital (AvG), Homburg, Germany, and Department of Paediatric Surgery, Bristol Children’s Hospital (MW) and Department of Urology, Southmead Hospital (PA), Bristol, United Kingdom

Abbreviations and Acronyms BD ⫽ bladder diary CRF ⫽ case report form FLW ⫽ uroflowmetry ICI ⫽ International Consultation on Incontinence ICIQ ⫽ ICI Questionnaire ICIQ-CLUTS ⫽ ICIQ-Pediatric LUTS LUTS ⫽ lower urinary tract symptoms PCA ⫽ principal component analysis PVR ⫽ post-void residual urine SRCC ⫽ Spearman’s ␳ correlation coefficient Study received institutional review board approval. Supplementary material for this article can be obtained at www.ospedalebambinogesu.it/ Portale2008/Default.aspx?Iddoc⫽730. * Correspondence: Urodynamics Unit, Department of Nephrology and Urology, Children’s Hospital Bambino Gesù, Piazza Sant’Onofrio, 4, 00165Rome, Italy (telephone: ⫹390668592643; FAX: ⫹390668592518; e-mail: [email protected]).

Purpose: Lower urinary tract symptoms are common in pediatric patients. To our knowledge no validated instruments properly designed to screen lower urinary tract symptoms in the pediatric population have been published to date. In the International Consultation on Incontinence Questionnaire Committee the psychometric properties of a screening questionnaire for pediatric lower urinary tract symptoms were assessed. Materials and Methods: The 12-item International Consultation on Incontinence Questionnaire-Pediatric Lower Urinary Tract Symptoms was developed in child and parent self-administered versions, and produced in English, Italian and German using a standard cross-cultural adaptation process. The questionnaire was self-administered to children 5 to 18 years old and their parents presenting for lower urinary tract symptoms (cases) or to pediatric/urological clinics for other reasons (controls). A case report form included history, urinalysis, bladder diary, flowmetry/post-void residual urine volume and clinician judgment on whether each child did or did not have lower urinary tract symptoms. Questionnaire psychometric properties were evaluated and data were stratified into 3 age groups, including 5 to 9, 10 to 13 and 14 to 18 years. Results: A total of 345 questionnaires were completed, of which 147 were negative and 198 were positive for lower urinary tract symptoms. A mean of 1.67% and 2.10% of items were missing in the child and parent versions, respectively. Reliability (Cronbach’s ␣) was unacceptable in only the 5 to 9-year-old group. The high ICC of 0.847 suggested fair child/parent equivalence. Sensitivity and specificity were 89% and 76% in the child version, and 91% and 73.5% in the parent version, respectively. Conclusions: The questionnaire is an acceptable, reliable tool with high sensitivity and specificity to screen for lower urinary tract symptoms in pediatric practice. Problems related to literacy suggest use of the child versions for patients older than 9 years. In research this questionnaire could be used to recalibrate the prevalence of lower urinary tract symptoms in children. Key Words: urinary tract, urination disorders, questionnaires, child, parents

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LOWER urinary tract symptoms are common and distressing problems in children, leading to a significant im-

pact on quality of life.1–3 Due to literacy issues, cross-informant variance and broad differences in the LUTS

0022-5347/10/1844-1662/0 THE JOURNAL OF UROLOGY® © 2010 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION

Vol. 184, 1662-1667, October 2010 Printed in U.S.A. DOI:10.1016/j.juro.2010.03.075

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VALIDITY OF PEDIATRIC LOWER URINARY TRACT SYMPTOM QUESTIONNAIRE

spectrum validated questionnaires available in adults are not suitable in children. Scoring and quality of life questionnaires specific to children with LUTS and urinary incontinence have been validated.4 –9 However, to our knowledge no validated instruments have been published that are properly designed to screen LUTS in the pediatric population. Beyond epidemiological insights specifically developing such a tool would help separate children who do not have any problems with LUTS from those who may need to visit a physician specializing in LUTS treatment. This may help pediatric practices draw attention to and treat LUTS, and perhaps improve overall treatment efficacy. These considerations are particularly important in children, in whom simple measures such as lifestyle advice and behavioral therapy may prevent or treat initial LUTS, decreasing the need for pharmacological therapy or more complex, costly treatments. The ICIQ Committee developed a screening questionnaire for pediatric LUTS, named ICIQ-CLUTS, simultaneously in English, Italian and German with the involvement of 3 European pediatric centers in Rome, Italy, Bristol, United Kingdom, and Saarland, Germany.

PATIENTS AND METHODS ICIQ-CLUTS is a self-administered, 12-item screening questionnaire for pediatric LUTS. Two versions of the questionnaire were produced, including 1 for children and 1 for parents. Items 1 and 2 asked about age and gender, 9 specific items investigated LUTS and 1 asked about weekly defecation frequency. ICIQ-CLUTS design was derived from a combination of literature review,1,2 expert opinion and patient testing. The early version underwent preliminary testing in 32 patient/caregiver pairs. Cultural adaptation to the 3 national contexts was done by first producing an English version of the 2 patient/caregiver questionnaires and subsequently applying a standard systematic procedure for each country, including 2 independent translations from English into the target version and back translation from the target language into English to compare the results with the original version.10 This was followed by cognitive interviewing, in which questionnaires were administered for understanding in 6 sets of patient-parents in each participating country. ICIQ-CLUTS child and parent versions were self-administered in subjects recruited in consecutive order from those presenting for LUTS (cases) or attending urological/ pediatric outpatient clinics for reasons other than urological ones (controls). Postoperative urological controls, patients with uncontrolled insulin dependent diabetes and patients with anatomical abnormalities or neurological disorders were excluded from analysis. ICIQ-CLUTS was administered before physician or nurse visits. Children and parents completed the questionnaires independently and with no help from practitioners. An identification number was assigned to the child

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and parent versions before the visit. At the visit clinicians recorded medical and voiding history, and physical examination information on a CRF numbered with the corresponding questionnaire identification number. Before discharge home a BD (2 days and 3 nights) was explained and given to patients and parents. During visit 2 BDs were collected, and all case and control children underwent urinalysis and FLW with ultrasound evaluation for PVR. Data on BDs, urinalysis and FLW/PVR were reported on the corresponding CRF. Final clinician judgment on whether the case was LUTS positive or negative based on CRF data (medical and voiding history, physical examination, BD, urinalysis and FLW/PVR) was made by a clinician different from those who first visited subjects or at least by the same investigator but at different times. Subjective clinician judgments of the type of lower urinary tract dysfunction (overactive bladder, dysfunctional voiding, mixed, or monosymptomatic or nonmonosymptomatic nocturnal enuresis) in each subject were added to the CRF. Evaluation of ICIQ-CLUTS psychometric properties was organized around 3 methodological objectives, including assessing diagnostic accuracy, testing validity, acceptability and reliability, and highlighting the performance of the patient and caregiver versions with special regard to age groups, including 5 to 9 (children), 10 to 13 (prepubertal patients) and 14 to 18 years (postpubertal patients). Since the main issue was to evaluate sensitivity and specificity, the term accuracy refers to comparison of outcomes of the children and parent ICIQ-CLUTS test versions with those of a reference standard (final clinician judgment) applied to cases suspicious for and controls not suspicious for LUTS, the condition of interest.11–13 Sensitivity and specificity were calculated, and ROC curves were used to identify appropriate cutoff points.14 Related statistics were positive and negative likelihood ratios, and area under the ROC curve, which evaluates questionnaire discriminant ability. To evaluate construct validity, we applied PCA15 with the quartimax solution for rotation.16 We used multiple regression stepwise analysis by Pratt’s importance index17 to evaluate whether eliminating some items was convenient and determine items that were the best predictors of LUTS. ICIQ-CLUTS acceptability was evaluated as a percent of missing items. Reliability was defined as internal consistency among items according to dedicated statistics, including Cronbach’s ␣ index. Cronbach’s ␣ is acceptable at ⱖ0.7.18 We analyzed the correlation between child and parent answers with ICC (2-way mixed model and 95% CI)19 and SRCC.20 ICC describes the correlation and the agreement between the measures under scrutiny. SRCC provides insight about behaviors and feelings perceived by patients and caregivers. We used SPSS® 17.0 and Microsoft® Excel® for calculations.

RESULTS We recruited 345 patients, including 209 who were 5 to 9, 65 who were 10 to 14 and 71 who were 14 to 18 years old. Child and parent versions were collected

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from 267 respondents. Only the caregiver or the child version was completed in 75 and 3 cases in the 5 to 9 and 14 to 18-year groups, respectively. Of the 134 questionnaires completed by children 5 to 9 years old 123 were answered by those 7 to 9 years old and the remaining 11 were answered by children younger than 7 years. Thus, analysis of ICIQCLUTS validity in younger children can be reasonably referred to the age range of 7 to 9 years. Final clinician judgment identified 147 children without and 198 with LUTS. According to International Children’s Continence Society guidelines2 23 children had overactive bladder, 55 had dysfunctional voiding, 14 had mixed dysfunction, 33 had monosymptomatic enuresis and 73 had nonmonosymptomatic enuresis. A mean of 1.67% and 2.10% items was missing in the child and parent versions, respectively. The percent of missing items was higher in children 5 to 9 years old (2.69%) and in the parents (3.24%) of 14 to 18-year-old children. In the same age groups relevant items missed by children and parents were items 6 (7.69%), 8 (4.81%) and 12 (4.81%), and 6 (5.88%), 9 (8.82%) and 12 (4.81%), respectively. PCA was applied to the child and caregiver versions to assess possible differences in internal conceptual structure. Analysis showed a 3-factor solution in the child and parent versions (variance explained 52.390% and 53.085%, respectively). Factor loadings of first component results were similar while other components showed minor differences. Table 1 lists the variance explained by each item. Items showed similar patterns across the child and parent versions. In each version items that were the best predictors of LUTS were those on incontinence (items 4 and 5), urgency (item 7), voiding postponement (item 8) and incomplete emptying (item 11) (table 1). Table 1. Multiple stepwise regression of best LUTS predictors using total scale with dependent variables and individual dependent items % Variance by Item* Items

Children

Parents

3 4 5 6 7 8 9 10 11 12

0.068 0.133 0.115 0.059 0.140 0.107 0.096 0.087 0.122 0.072 1.000

0.070 0.158 0.166 0.050 0.139 0.111 0.056 0.122 0.108 0.021 1.000

* Considering total variance explained as 1 (Pratt’s importance values, items ␤ coefficient ⫻ zero order correlation coefficient).

Table 2. Two-way mixed effect model ICC of total child and parent ICIQ-CLUTS scores by age group Age (yrs)

No. Children

ICC (95% CI)

5–9 10–13 14–18

102 125 32

0.836 (0.757–0.8890) 0.803 (90.719–0.861) 0.930 (0.857–0.966)

Overall

259

0.848 (0.806–0.881)

Overall ICIQ-CLUTS reliability was ␣ ⫽ 0.719 and 0.690 for the child and parent versions, respectively. Each was around the threshold of acceptability of ␣ ⫽ 0.7. When repeating calculations by age group, ␣ was less than 0.7 in children 5 to 9 and 14 to 18 years old (0.674 and 0.645, respectively), and in parents of children 5 to 9 years old (0.649). ICC was greater than 0.8 across all possible comparisons of the child and parent versions, and throughout all age groups (table 2). Table 3 lists SRCC values. The correlation between child and parent answers was high for items 4, 5 and 10 on incontinence, and in the 14 to 18-year age group (r ⫽ ⬎0.6). The figure shows the ROC curve with scores on the child and parent versions plotted against the standard reference. For each score level the figure shows sensitivity and specificity, and their distribution. A score of 14 on the child and 13 on the parent version were identified as cutoff points discriminating children with LUTS from healthy children. At the cutoffs overall sensitivity and specificity were 89% and 76% for the child version, and 91% and 73.5%, respectively, for the parent version. Area under the ROC curve was 0.890 for the patient and 0.900 for the parent version (table 4). In the 5 to 9 and 10 to 14-year age groups AUC was less than that calculated in the overall sample but not less than 86%.

DISCUSSION The lack of validated instruments properly designed to screen for LUTS in the pediatric population may Table 3. SRCC of child and parent answers by age group Items

5–9 Yr SRCC

10–13 Yr SRCC

14–18 Yr SRCC

Total SRCC

3 4 5 6 7 8 9 10 11 12

0.266 0.875 0.612 0.404 0.400 0.484 0.362 0.587 0.534 0.407

0.391 0.870 0.684 0.448 0.385 0.481 0.555 0.648 0.362 0.546

0.363 0.999 1.000 0.737 0.654 0.646 0.397 0.806 0.711 0.630

0.363 0.999 1.000 0.737 0.654 0.646 0.397 0.806 0.711 0.630

VALIDITY OF PEDIATRIC LOWER URINARY TRACT SYMPTOM QUESTIONNAIRE

1,0 ,8

Sensitivity

,5 ,3 0,0 0,0

,3

,5

,8

1,0

1 - Specificity Child (red curve) and parent (blue curve) score ROC curves. Diagonal line represents reference standard.

have a negative impact on understanding the prevalence of these problems, the overlap of LUTS with other diseases and the association of LUTS with comorbid conditions. The clinical implications of these findings may improve treatment in children with LUTS. Considering these issues, the ICIQ Committee promoted the development of a validated screening questionnaire for pediatric LUTS, that is ICIQ-CLUTS. To decrease interviewer bias and simplify administration ICIQ-CLUTS was designed as a self-administered, multi-response, 12-item questionnaire. The number of items was kept as few as possible, including all conceptually relevant issues for LUTS diagnosis, to decrease issues with questionnaire management. ICIQ-LUTS was planned as a 1-score instrument for easy handling and score calculation. Problems related to literacy and reliability of judgment were minimized by producing 2 ICIQCLUTS versions, including 1 for children 5 to 18 years old and another for parents. The upper limit of age was chosen to overlap age 18 years while the lower limit was selected because LUTS start to be considered in children older than 5 years.1,2 Since a screening tool should be appropriate for use in different countries and cultures, ICIQ-CLUTS was developed in English, Italian and German through a standard cross-cultural adaptation process. The standard reference (final clinician judgment) that is the pillar of the overall research design was constructed based on ICI1 and International Children’s Continence Society2,3 recommendations, which

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suggest voiding history, physical examination, BD, FLW/PVR and urinalysis as diagnostic tools. ICIQ-CLUTS performance as a screening tool is supported by a satisfying level of sensitivity and specificity. Areas under the ROC curve indicated excellent ability to discriminate between children with and without LUTS. A crucial query was whether the planned 1-score scale solution was the most suitable solution. According to PCA, ICIQ-CLUTS has a multicomponent structure, which usually suggests that subscales/ subscores could be more convenient from the psychometric viewpoint. Nevertheless, the reliability (Cronbach’s ␣) of all possible subscales was always lower than that of the 1-scale/1-score solution, as foreseen by the original study design that was used throughout this study. Likewise, since regression analysis showed that some items explained a small portion of the score variance (table 1), one could wonder whether a better functioning scale would be obtained by deleting some items. Nevertheless, in all possible alternative combinations except item 12 reliability was not higher than that of the total ICIQ-CLUTS 1-score solution. Another central study query was whether the child and parent version are equivalent. The 2 versions showed more agreement than expected. ICC revealed that general agreement was high. Also, it was impressive to see the similarity of the factor structure of the 2 versions as well as the order of the items and the variance which was practically the same for the first 6 items in table 1. However, there are some limitations about selfadministration in younger children and interpretation of responses from parents of older children. The percent of missing values and item-by-item correlation between the patient and caregiver versions may be useful for deeper insight. The worst percent of missing items and reliability were in children 5 to 9

Table 4. ROC curve discriminant capability for patient/caregiver questionnaire by age group Age (yrs) 5–9: Children Parents 10–13: Children Parents 14–18: Children Parents Overall: Children Parents

Mean ⫾ SE Area

Asymptotic Significance (95% CI)

0.873 ⫾ 0.038 0.862 ⫾ 0.042

0.000 (0.798–0.947) 0.000 (0.780–0.945)

0.872 ⫾ 0.032 0.896 ⫾ 0.029

0.000 (0.810–0.934) 0.000 (0.839–0.952)

0.950 ⫾ 0.037 0.941 ⫾ 0.040

0.000 (0.877–1.023) 0.000 (0.863–1.019)

0.890 ⫾ 0.020 0.900 ⫾ 0.020

0.000 (0.850–0.930) 0.000 (0.862–0.939)

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years old and in parents of children 14 to 18 years old, underlining that acceptability is critical. Problems related to literacy may be reasonably advocated to explain the lower acceptability and reliability of questionnaires completed by younger children. Further studies are required to identify the lower age limits at which younger children can provide reliable, valid responses to ICIQ-CLUTS. Interview administration of ICIQ-CLUTS may also be psychometrically tested in children in age categories unable to complete a self-administered questionnaire. In older children symptom duration may explain the higher rate of missing items. Poor awareness of the voiding habits of adolescent children may be hypothesized to explain the higher percent of missing items and the lower Cronbach’s ␣ reported by parents of older patients. However, this speculation seems to disagree with the high degree of correlation between patients and caregivers in several items in the 14 to 18year age group (table 4). Since a remarkable number of items was missed by parents of older children, we hypothesize that parents elected not to answer doubtful items. Thus, the remaining answered items may be focused on visible symptoms and behaviors. This would explain the high level of correlation between questionnaire versions in older children. Answers of children 5 to 14 years old showed high correlations with those of their parents on items investigating a striking symptom, such as incontinence. Correlation was poor for symptoms that could not be consciously hidden or unrecognized in everyday life, such as pain or burning during micturition, daytime frequency, urgency, postponed voiding, abdominal straining to void, the sense of inadequate emptying and weekly defecation frequency. Differences between child and parent answers on daytime

frequency may be explained by the high variability of voiding frequency in the same subject on different days. In the child and parent versions the items that best predicted LUTS were those on incontinence, urgency, postponed voiding and incomplete emptying. The child version differed from the parent version, in that the former also identified items about symptoms suspected of urinary tract infection, abdominal straining to void and weekly defecation frequency as good LUTS predictors. Since items that best predicted LUTS were strictly related to symptoms due to overactive bladder (urgency) and dysfunctional voiding (voiding postponement and incomplete emptying), ICIQCLUTS could be used to identify the most common pediatric lower urinary tract dysfunctions. However, further discussion and research are needed to address such matters.

CONCLUSIONS ICIQ-CLUTS is a good diagnostic tool to screen for LUTS in general pediatric practice. Problems related to literacy make the child version unreliable in patients younger than 9 years. In all other cases findings show discrepancies between information provided by caregivers and patients. This reinforces the need for an integrated view by collecting the child and the parent versions, when possible. For research ICIQ-CLUTS may be helpful to recalibrate data on the prevalence of LUTS in children.

ACKOWLEDGMENTS Drs. R. J. Nijman, J. Wande Walle and P. Mastroiacovo provided initial study design, and Dr. Nadia Oprandi provided data collection.

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functional voiding, urinary tract infection and vesicoureteral reflux. The International Reflux Study in Children. J Urol 1992; 148: 1699. 5. Farhat W, Bagli DJ, Capolicchio G et al: The dysfunctional voiding scoring system: quantitative standardization of dysfunctional voiding symptoms in children. J Urol 2000; 164: 1011. 6. Sureshkumar P, Craig JC, Roy LP et al: A reproducible pediatric daytime urinary incontinence questionnaire. J Urol 2001; 165: 569.

tative evaluation of incontinence symptoms in pediatric population. J Urol 2005; 173: 969. 9. Afshar K, Mirbagheri A, Scott H et al: Development of a symptom score for dysfunctional elimination syndrome. J Urol 2009; 182: 1939. 10. Acquadro C, Conway K, Giroudet C et al: Linguistic Validation Manual for Patient-Reported Outcomes (PRO) Instruments. Lyon: MAPI Research Institute 2004.

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18. Apolone G: Defining and measuring quality of life in medicine. JAMA 1998; 279: 431. 19. Shrout PE and Fleiss JL: Intraclass correlations: Uses in assessing rater reliability. Psychol Bull 1979; 86: 420. 20. Diehr P, Chen L, Patrick D et al: Reliability, effect size, and responsiveness of health status measures in the design of randomized and cluster-randomized trials. Contemp Clin Trials 2005; 26: 45.

EDITORIAL COMMENT These authors created and assessed a scoring system that would be beneficial in children with LUTS and the parents of those children. Parents of children with LUTS may experience frustration and loss of confidence in parenting skills, and quit performing the parental role. Such a reaction would only complicate compliance with the offered treatment options. While many stressors in children and their families are similar across cultures, emotional behavior and family responses are culturally based. In future studies using the scoring questionnaire the authors must elaborate more on the different results of the scoring system among different cultures and countries. On another note, from a cultural and linguistic perspective it may be mandatory to know who performed the translation for this study. It is not clear who did the translation to the different languages and what criteria were used to accurately translate

the questions. It would be beneficial to have more information on the method and knowledge of medical disease, and the peculiarity of LUTS as an entity in children. Were health care providers such as nurses and/or psychologists involved in the process of developing or translating the scoring system? Several scoring systems have been previously described and used. However, it may be important for the pediatric urology community and health care providers who deliver care to this patient population to adopt the current questionnaire after it is finetuned so that we can systematically study LUTS and design/tailor the appropriate treatment modalities in these children and their parents. Walid A. Farhat Division of Urology The Hospital for Sick Children Toronto, Ontario Canada