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* HealthAct, Boston, Massachusetts
Department of Urology, Stanford University School of Medicine, Stanford, California
Harvard Medical School and Department of Urology, Children’s Hospital, Boston, Massachusetts
|| Department of Urology, Division of Pediatric Urology, University of Iowa, Iowa City, Iowa
¶ Division of Nephrology, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
# Department of Urology, Louisiana State University Health Sciences Center/Children’s Hospital, New Orleans, Louisiana
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ABSTRACT |
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 TOP ABSTRACT METHODSFINDINGSDISCUSSIONCONCLUSIONSTHE BUSINESS OF AMERICA...REFERENCES |
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Methods. The questionnaire consisted of items that measure the impact on the child and his/her parent, the child’s coping ability and commitment to treatment, previous treatment success, family frustration and overall cohesion, and parental attitudes about enuresis and its treatment. Questionnaires (n = 208) were completed by parents during the child’s scheduled office visit for enuresis at 5 specialty clinics across the United States. Traditional criteria were used to assess reliability and validity of the questionnaire, including analysis of variance.
Results. Success rates provide evidence that many of the items in the child scale (79%) and all items in the parent scale (100%) met stringent criteria. 
values were .62 and .77, respectively. Statistically significant differences were observed for the scales across responses on all but 1 global item, the majority of parental attitude items, whether the child urinated at bedtime, and the number of pads used. These findings suggest that the child’s coping ability and commitment and the family’s overall cohesion and frustration with the problem influence parental perceptions about the impact of enuresis on the child and the family.
Conclusions. Findings about the performance of the new measure were satisfactory and suggest that, after further refinement, it should prove as a useful tool for clinicians treating enuresis in children.
Key Words: quality of life • outcomes • pediatric enuresis • measurement
Abbreviations: PEMQOL, Pediatric Enuresis Module to assess quality of life
Enuresis1 is estimated to affect 5 to 7 million US children 
6 years of age.2 Yearly, the spontaneous rate of resolution for nocturnal enuresis is 
15%.3,4 There are few population-based studies to date concerning the natural resolution of diurnal or polysymptomatic nocturnal enuresis. Thus, for the vast majority of children, the presence of diurnal and nocturnal enuresis is a source of shame and embarrassment. It profoundly affects the child’s life socially, emotionally, and behaviorally and also impacts the everyday life of his/her family.5–14 In fact, as noted by Morison et al,10 many adolescents report a "perceived helplessness" and lack of hope or optimism about their future because they feel they have no control over the problem. Work by Hagglof et al14 noted that impairment to self-esteem is significantly worse for patients with enuresis versus their peers, and research by Theunis et al4 suggests that there is correlation between self-esteem and the number of treatment failures. Children who have experienced more treatment failures report lower self-esteem. Finally, using standardized tests, Chang et al5 observed that children with enuresis have lower social competence and school performance than their gender-matched controls and that parents demonstrate more parenting stress than their peers. These findings are noteworthy and provide empirical evidence of the underlying complexities that may confound the diagnostic process as well as the development and implementation of an effective treatment plan.
The recommended evaluation of enuresis requires an extensive voiding history to aid in diagnosing the problem and developing a comprehensive treatment plan.15 The history should include previous treatments and the parent’s perceptions concerning these treatment options and their effectiveness. Although many forms of enuresis pose no significant health risk, there are significant social stressors. As a routine part of the assessment of the severity of the problem, it is recommended that practitioners evaluate the emotional well being of the child at the start of treatment and throughout the entire course of therapy.15 Many of the therapies require a high degree of motivation for the child and family. Assessing the impact of enuresis and its severity on the child and family may also guide the physician when considering various treatment options.
A questionnaire that is brief and scientifically sound yet comprehensive in scope would be a useful asset and provide the practitioner with an objective method for assessing the everyday impact of enuresis on the child and family. It could be used over the course of the child’s treatment (during regularly scheduled visits) to monitor the ongoing impact of care. Instruments have been developed to assess the impact of enuresis on the everyday well being of adult patients.16,17 However, these measures are inappropriate for children and adolescents, because they specifically target stress/urge incontinence or ask about daily issues applicable to adults such as housework, employment, and sexual functioning.
In 2001, after the current study was underway, 2 articles18,19 about pediatric enuresis questionnaires were published. Neither of these instruments, however, measured the impact or emotional or social burden of enuresis, which is the principal focus of our work and is suggested in the literature as worthy of study.4–15
Our objective was to develop and evaluate a clinically useful questionnaire that could be used as an essential component in the continuous monitoring of nocturnal and/or diurnal enuresis in children and adolescents. We recognized that treatment will vary depending on when the child wets and that, in the published literature, enuresis subtypes are rarely examined concurrently. Our reason for creating a single questionnaire was quite practical. The literature and clinical experience suggested that the emotional and social well being of the child and family are impacted negatively irrespective of when the child wets. What may differ, but is relatively unexplored, is the degree of this impact. Thus, using a single questionnaire in concert with brief questions about previous history and other clinical data such as when the child wets would be less burdensome to the doctors’ staff and parents. It would simplify the assessment process for the practitioner while simultaneously providing researchers with further insight about the relative burden of enuresis on the child and family.
Questionnaire development is an iterative process. The psychometric findings presented in this article were based on a full-length prototype and represent work in progress as we further evaluate the performance of the instrument in the clinical setting and develop a shorter, more practical version.
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METHODS |
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5 years of age. As an initial step, development of a parent self-administered questionnaire seemed the most practical. It allowed for the broadest age range to be captured and eliminated the need for trained interviewers. The impact on families as well as children/adolescents could be assessed simultaneously. Fourth, given the busy pace of most clinics, we felt it would be more informative and practical to have a single measure that assessed the impact of either nocturnal and/or diurnal enuresis, as opposed to separate forms for each enuresis subtype. As expressed earlier, differences in impact could be assessed and compared across the respective subgroups without adding additional burden to office staff or families. It would also allow clinicians to assess patients who present with both daytime and nighttime enuresis without having to track the use of multiple forms. In addition to reviewing the current literature, interviews, ranging from 60 to 90 minutes in length, were held with a panel of practicing pediatric urologists in children’s hospitals distributed throughout the country to help develop the content and construction of items in the questionnaire. Topics that emerged from the literature review were covered during the interviews and included 1) areas of concern as reported by parents and children, 2) parent/child interactions/communication styles, 3) patient’s and families’ attitudes, 4) how the problem is identified and discussed by parents and their children, 5) how the family impacts the child’s attitude toward the problem and its treatment, 6) ways in which the problem affects the everyday life of the child/adolescent and his/her family, 7) factors that most influence adherence to treatment, 8) barriers to treatment, 9) how prior failures with treatment influence perceptions, 10) ways the child/family exhibit coping abilities, and 11) areas or parameters most useful to clinicians to help monitor the impact of the care provided.
Description of the Module
A sample of the developmental full-length version of the Pediatric Enuresis Module to assess quality of life (PEMQOL) is provided in Table 1. The questionnaire was designed to be self-completed by the parent with an estimated 7th-grade reading level based on the Flesch-Kincaid method found in Microsoft Word 2000. It consisted of several sections. Part 1 included questions about the impact of enuresis on the child and parent, parental attitudes about enuresis and its treatment, coping, commitment to treatment, and frustration with previous experience. Part 2 included 10 standard clinical history items (eg, number of leaks, number of pads used, age of onset, and number/speciality of physicians seen) and 6 demographic questions. Part 1, which forms the core of the questionnaire, is described in more detail below.
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The Child Impact scale consisted of 14 items. Ten items were specific to enuresis and its impact on the child’s life during the past 4 weeks (eg, "my child seldom goes to overnight events due to wetting" and "my child doesn’t play sports or go to gym because of wetting"). The remaining 4 items were more general (eg, "my child works to his/her potential"). The parent was asked to indicate the degree to which the statements/items reflect how life has been for his/her child during the past 4 weeks. The continuum of responses ranged from "a lot" to "not at all."
The Family Impact scale consisted of 17 items. The parent was asked to indicate how strongly each statement/item reflected the situation for them personally, at home, and with their family. The continuum of possible responses ranged from "a lot" to "not at all." All items were tailored to assess impact of enuresis on family relationships and activities (eg, "relatives and family members are patient and tolerant about the problem" or "we are embarrassed to have people in our home").
Other areas assessed included 1) coping ability, 2) commitment to treatment, 3) degree of frustration, 4) parental attitudes toward the problem, 5) frequency of success with previous treatments, and 6) cohesion within the family, which has been shown to be an important predictor of adherence to medical treatment for adolescents.28
To assess attitudinal perceptions, parents were asked to rate how strongly they agree or disagree with 7 general statements about enuresis. Four statements focused on medical health (eg, "wetting is a significant health issue" or "medication will be more helpful in solving the problem than behavior modification"), and 3 statements were more behaviorally focused (eg, "my child could control his/her wetting if he/she tried harder" or "my child will outgrow the problem"). A 5-level response option ranging from "strongly agree" to "strongly disagree" was used.
Sampling Methods
The 5 study sites represented all regions in the United States, treated both children and adolescents at their respective specialty clinics, and were actively involved in ongoing research in the area of enuresis. The project, to recruit patients to complete the questionnaire during regularly scheduled visits, was submitted independently at each study site. Approval and/or exemption was received from each institution’s human subjects review committee. Data were collected between June 2001 and June 2002.
A cross-sectional study design was used. Eligible patients had to be 5 years of age and presenting for a scheduled clinical appointment for wetting. Those with underlying pathologies (ie, patients with known neurogenic or anatomic urologic diseases such as posterior urethral valves, bladder exstrophy, and spina bifida) were excluded from the project. English-speaking parents of nighttime and/or daytime wetting patients were invited to complete the questionnaire. (The questionnaire has not been translated yet.) All questionnaires were completed on site during the office visit. Type of treatment was open ended.
No patient identifiers were used. Patients were categorized by the participating physician as "new" to the clinic or as an "established" patient. Each investigator was asked to recruit 20 patients per "status" (new/established). It is not uncommon for patients to start, stop, and restart treatment several times. Therefore, an established patient was defined by clinical consensus a priori as someone who was actively involved in ongoing treatment with his or her respective physician for at least 4 consecutive months.
During the initial 2 weeks and periodically throughout the data-collection period, participating physicians were asked to provide feedback about parent responses to the questionnaire and to identify problem items or concerns and issues that were not captured on the form but were perceived as being important. Families were also encouraged to make notations and comments on the forms themselves. All comments were read and transcribed verbatim into the study data set. Relevant enhancements will be made to the questionnaire before the initiation of the next stage of development.
Sample Demographics
A total of 208 questionnaires were received. Table 2 presents sample characteristics. Percentages are based on the number of actual responses for each item. A slight majority (61%; n = 116) was classified by the participating physician as new to their care.
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A slight majority reported that their child wet at night only (54%; n = 108) versus those for whom both daytime and nighttime wetting were indicated (40%; n = 79). Isolated daytime wetting was indicated in 7% of the sample (n = 13). Sixty-nine percent (n = 130) of the parents reported that this was not their child’s first visit to a doctor for wetting. A wide range of responses (<1 to 10 years) were observed for the item "years with the problem." A relatively even distribution was observed for those reporting <1 year, 1 year, or 2 years (19%, 20%, and 20%, respectively). However, 40% indicated that their child had received treatment for "3 years or more." The latter group was distributed evenly across status as reported by the physician. Fifty-four percent were reported as new to the practice, whereas 46% of the sample was classified as established patients.
A relatively normal distribution was observed across all ages for the total sample. When we looked at enuresis subtype in our sample, we observed that age was skewed slightly toward the younger ages (6–12 years) for those whose parents reported both diurnal and nocturnal enuresis.
Table 3 profiles voiding history and other clinical information for the study sample. The number of treatments tried ranged from none (19%; n = 34) to 4 (13%; n = 23), with 29% (n = 53) having tried only 1 treatment. For 39% of the sample (n = 75), parents reported that their child was not on treatment during the 4 weeks preceding the office visit. Treatments were varied, with 19% (n = 37) of parents reporting the use of medication only and 25% (n = 49) reporting the combination of 2 treatment types. A wide range of responses were observed for "number of times urinates during a 24-hour period" (0–25), with 56% (n = 95) reporting 6 episodes. For 58% of the sample (n = 73), 1 urine leaks were reported, and 51% of the sample (n = 76) indicated wetting the bed "one time" at bedtime. Relatively few parents in our sample (10%; n = 18) reported that their child needed 2 pads per 24-hour period. Almost half of the sample (63%; n = 132) indicated that their child had seen 2 physicians for problems with wetting.
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coefficient,32 between .5033 and .70.34 All computations were performed by using the Revised Multitrait/Multi-item Analysis Program for DOS.29 (Note that item-scaling analysis is not appropriate for single items.34) In addition to traditional item-scaling criteria, differences in scores for the 2 scales were examined based on 1) responses to the 6 global questions, 2) responses to the 7 attitude statements, 3) clinical status as reported by the practitioner, 4) whether this was a first visit as reported by parent, 5) nighttime versus day/night enuresis, 6) number of programs tried, 7) number of times child urinates per 24-hour period, 8) number of times child leaks urine during a 24-hour period, 9) number of times child urinates at bedtime during a 24-hour period, 10) number of pads used per 24-hour period, 11) treatment type, and 13) gender.
As reported previously, a wide of range of responses was observed for some of the voiding history items (number of pads used) and clinical variables (number of treatments tried). Therefore, for purposes of data analysis, responses were grouped as indicated in Table 3. Age was also grouped as indicated in Table 2. For the "success with treatment during the past 4 weeks" item, those who indicated "too soon to tell" or "not on any program" were omitted from the analysis. Thus, differences in scale scores are examined across the 3 levels of success ("extremely," "somewhat," and "not very").
Analysis of variance was used to assess whether differences across the different data cuts were statistically significant. Posthoc tests were examined to further inform our understanding about observed differences. Because of the volume of data produced, findings from these tests are detailed in the text only. Mean scale scores for the various subgroups used in the posthoc tests are provided in Appendices A–C.
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FINDINGS |
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0.43 were observed for 5 items in the Child Impact scale. The median correlation observed for this scale (not shown) was 0.26. A negative correlation was observed for 1 item ("my child hasn’t let problems with wetting interfere with making friends or doing his/her usual things": –0.03), and substantially low correlations were observed for 2 additional items ("my child seems bothered and upset by wetting": 0 .09; "my child is at an age when he/she should accept more responsibility for the problem but does not": 0.19). Correlations for the remaining 6 items were slightly lower than the minimum standard for new scales (0.30)27 and ranged from 0.20 to 0.29.
High correlations 0.44 were observed for 9 items in the Parent Impact scale. The median correlation was 0.44. Extremely low correlations were observed for 2 items ("I know my child doesn’t wet on purpose": 0.14; "our family talks openly about my child’s problem": 0.19). Correlations for the remaining 6 items ranged from 0.21 to 0.36, with 50% of these items exceeding the acceptable minimum standard for new scales.
Findings for tests of "item discriminant validity" are presented in column 2 of Table 4. For ease of interpretation, the data are summarized in the final column of the table entitled "% Scaling Success." A perfect scaling success rate (100%) was observed for the Family Impact scale. This means that correlations for all 17 items in this scale met/exceeded the standard for discriminant validity. The success rate for the Child Impact scale was less but still noteworthy (79%).
There were no floor or ceiling effects observed for either scale (not shown in table), suggesting that scores were relatively well distributed across the response options for the 31 items that comprise the 2 core scales. Reliability estimates were 0.62 for the Child Impact scale and 0.77 for the Family Impact scale and are presented in the final column of Table 4.
Table 5 summarizes analysis of variance findings across the exploratory data cuts (global, attitude, and clinical items). Corresponding mean scale scores for all the subgroups are detailed in Appendices A–C.
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Posthoc tests for these items (data not shown) revealed that the differences were noteworthy within the response levels and not just at the extreme ends of the respective response continuums. For example, we observed significant differences for those who indicated that their child had "poor" coping abilities versus those who reported that their child had "fair" abilities (P = .004). We also observed differences in impact on the child for those reporting "excellent" coping abilities versus those reporting their child to have "very good" coping abilities (P = .000).
Across the attitude items, statistically significant differences in Child Impact scores were observed for 4 attitude items: "wetting is a behavioral issue" (P = .019); "there is a neurologic basis for wetting" (P = .05); "my child will outgrow the problem" (P = .05); and "I’m concerned that my child has a serious medical issue" (P = .000). Again, posthoc tests revealed that differences were notable within the different response options and not just at the extreme ends of the continuum. For example, posthoc tests for "wetting is a behavioral issue" indicated that differences were noteworthy for those who endorsed "agree" versus those selecting "disagree" (P = .029) or "strongly disagree" (P = .001) and those responding "neither agree/disagree" versus "strongly disagree" (P = .048).
Differences in Child Impact scores were notable for 2 of the clinical questions: 1) whether the child urinated at bedtime (P = .029); and 2) the number of pads used (P = .011). Interestingly, posthoc tests indicate that differences were most notable only for those children whose parents reported 1 micturition versus 2 episodes (P = .009). There was also a marked difference for those using 2 pads versus no pads used (P = .004) and versus use of a single pad (P = .005).
As might be expected, a higher (better) scale score was observed on the Child Impact scale for established patients (68.48) versus those whom the physician reported as new to their care (63.98; P = .013). A higher and statistically significant difference (P = .039) was also observed on the Child Impact scale for girls (67.53) versus boys (63.99).
Notable findings were also observed for the Parent Impact scale. Significant differences were observed for all 6 of the global items (P values ranged from .021 to .000). Differences were significant for 5 of the 7 attitude statements (P ranged from .026 to .001), and posthoc tests revealed that the differences occurred within all response levels and not just at the extremes.
Noteworthy differences were observed for 2 of the clinical questions: 1) whether the child urinated at bedtime (P = .002); and 2) the number of pads used (P = .011). Posthoc tests showed that the difference was most pronounced for those who wet the bed 2 times versus once or not at all (P = .001 and P = .006, respectively).
There was also a marked difference (data not shown) for those using 2 pads versus no pads used (P = .003) and versus use of a single pad (P = .012).
Finally, a higher and statistically significant score was observed for parents responding "no" versus "yes" (P = .018) to the question concerning "first visit."
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DISCUSSION |
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Others have reported that boys are twice as likely to wet at night than girls,35 yet earlier work suggests that this may not be the case.36 However, for daytime wetting, a higher rate has been reported for girls (13%) as opposed to boys (8%), and the rate was higher for girls if they had a urinary tract infection.37 A second investigation observed daytime wetting in 21% of girls in a 6-month period but only more than once a week in 3%.38
In our sample, we observed more females than males (56% and 44%, respectively; P = .08). Yet, if examined by enuresis subtype, we observed a higher prevalence among boys than girls for nocturnal enuresis (57% [n = 60] vs 43% [n = 46]; P = .174). More girls than boys were observed for those with both nocturnal and diurnal wetting (69% [n = 54] vs 31% [n = 24]; P = .001). The isolated day-wetting subgroup was also weighted toward girls, but the sample sizes were extremely small for both groups (girls: 80% [n = 8] vs 20% [n = 2]; P = .058). Of note in the present study is the observation of significantly higher scores for females on the Child Impact scale, suggesting that the effects of enuresis (as perceived by parents) may be more negative for boys than girls. Further work is needed to verify this finding.
Our patient population consisted of children/adolescents seeking care at specialty clinics (as opposed to the primary care practitioner’s office), and we observed very few children whose parents reported daytime problems only. It is important to note, however, that the occurrence of nocturnal and diurnal wetting among US children is difficult to estimate, because few population-based studies are available. A 1990 review indicated that 80% of children with enuresis were reported as having nocturnal enuresis, and 20% were reported to wet during the day only.39 A 1993 publication, using an opportunity sampling of 1192 children, reported nocturnal and diurnal wetting in 18% and 10% of the sample, respectively.37 Because this is a referral sample, it is likely that our findings are skewed toward children for whom enuresis and/or treatment is more problematic. Thus, our findings may not be generalizable to the general population of children with wetting issues.
Published findings indicate that enuresis is inherited genetically.3,6,40–42 We did not ask parents whether they had problems with wetting as children. Inclusion of this question in the subsequent iteration of the module may be appropriate, because a parent’s previous experience may influence attitudes and perceptions about the impact of the problem. However, in the present study, we were interested in whether having other children in the family with enuresis would increase the negative impact of enuresis on families.
We observed a high percentage of parents (73%) who indicated that no other siblings had trouble with wetting. A larger sample of those with siblings is needed to fully investigate whether there is a relationship between the number of children in the household who wet and overall impact.
Despite the aforementioned limitations of our sample, there are several findings worth noting. Overall responses on the global items support underlying assumptions about the complexity of treating this condition. They suggest that a comprehensive understanding of external factors such as coping, commitment, and frustration is needed to understand the degree to which the child and the family are impacted by wetting problems.
The variation observed with regard to parental attitudes about enuresis were compelling and suggest that additional work is needed to educate families about common misconceptions surrounding enuresis.
Differences were observed for the Child Impact scale with regard to the number of times the child wets at night and for the Parent Impact scale. This finding is not altogether surprising. Oftentimes the child is aware that they have had an accident, and the parent is usually fully awakened by the pressing need to change the child’s linens at the time that accident occurs. Interestingly, parents reported a marked difference with regard to (no pads) versus (number of pads), but only if the number used was 2. Finally, the negative impact of enuresis was more pronounced for families whose child has not yet received treatment for wetting.
Overall, preliminary findings for tests of item-scaling assumptions were encouraging. First, we did not observe any missing data, which suggested that the respondents understood the questions and response choices. Second, all possible response options were endorsed, as evidenced by the lack of floor and ceiling effects. Third, coefficients were acceptable for both scales, although a higher coefficient was observed for the Family Impact scale. Eliminating some of the items with very low correlations in the Child Impact scale will most likely result in an increase in its overall internal consistency. However, as has been recommended,27 findings need to be assessed in >1 sample to make a definitive determination as to which are the most optimal items to retain and which are potential candidates for elimination. Other methods, such as stepwise regression, have also proven advantageous in deriving short-form alternatives.23,43
It will be important to conduct additional scaling tests across larger samples of different age groupings, gender, treatment status (type and duration), enuresis subtype (diurnal, nocturnal, and both), and settings (general primary care as well as subspecialty clinics).
Significant differences in scores were observed across the global items and attitude items but less so for the clinical variables (eg, number of pads used). However, the lack of differences in this regard has been observed across other common conditions such as asthma.44 These finding underscore the importance of a comprehensive health-management program that provides for ongoing assessment of the impact of a condition on the health and well being of children and their families in concert with more traditional clinical indicators to monitor care. For some conditions a reduction in symptoms may not result in improvements where it matters most: at home, at school, and with others.21
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CONCLUSIONS |
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THE BUSINESS OF AMERICA IS BUSINESS |
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Recaldo A. Pharmastem wins judgment in umbilical cord patent case. Wall Street Journal. November 3, 2003
Submitted by Student
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ACKNOWLEDGMENTS |
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Ms Landgraf thanks Linda Shortliffe, MD, Uri Alon, MD, Craig Peters, MD, Bartley G. Cilento, Jr, MD, Tim Hunt, PhD, and Steve Hass, PhD for insightful comments and suggestions on the initial draft of the questionnaire; and Jeff C. Smith for help with analysis and tables.
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FOOTNOTES |
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Reprint requests to (J.M.L.) HealthAct, 205 Newbury St, 4th Fl, Boston, MA 02116. E-mail: jml{at}healthact.com
An abstract of this work was initially presented at the XIIth Annual Meeting of the European Society for Pediatric Urology, April 26–29 2001, Aarhus, Denmark.
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This article has been cited by other articles:
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  H. Kojima Breastfeeding During Infancy and Bed-wetting During Childhood Pediatrics, October 1, 2006; 118(4): 1803a - 1804. [Full Text] [PDF]
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Y. Shoham, R. Dagan, N. Givon-Lavi, Z. Liss, T. Shagan, O. Zamir, and D. Greenberg Community-Acquired Pneumonia in Children: Quantifying the Burden on Patients and Their Families Including Decrease in Quality of Life Pediatrics, May 1, 2005; 115(5): 1213 - 1219. [Abstract] [Full Text] [PDF]
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