Sinonasal symptoms are notably widespread,

Transcription

1 Quality of life for children with persistent sinonasal symptoms DAVID J. KAY, MD, and RICHARD M. ROSENFELD, MD, MPH, Brooklyn, New York OBJECTIVE: The goal was to validate the SN-5 survey as a measure of longitudinal change in healthrelated quality of life (HRQoL) for children with persistent sinonasal symptoms. DESIGN AND SETTING: We conducted a before and after study of 85 children aged 2 to 12 years in a metropolitan pediatric otolaryngology practice. Caregivers completed the SN-5 survey at entry and at least 4 weeks later. The survey included 5 symptom-cluster items covering the domains of sinus infection, nasal obstruction, allergy symptoms, emotional distress, and activity limitations. RESULTS: Good test-retest reliability (R 0.70) was obtained for the overall SN-5 score and the individual survey items (R > 0.58). The mean baseline SN-5 score was 3.8 (SD, 1.0) of a maximum of 7.0, with higher scores indicating poorer HRQoL. All SN-5 items had adequate correlation (R > 0.36) with external constructs. The mean change in SN-5 score after routine clinical care was 0.88 (SD, 1.19) with an effect size of 0.74 indicating good responsiveness to longitudinal change. The change scores correlated appropriately with changes in related external constructs (R > 0.42). CONCLUSIONS: The SN-5 is a valid, reliable, and responsive measure of HRQoL for children with persistent sinonasal symptoms, suitable for use in outcomes studies and routine clinical care. (Otolaryngol Head Neck Surg 2003;128:17-26.) From the Department of Otolaryngology, State University of New York Downstate Medical Center and The Long Island College Hospital. Presented at the Annual Meeting of the American Academy of Otolaryngology, Denver, CO, September 9-12, Sponsored by an Outcomes Research Small Project Grant from the American Academy of Otolaryngology Head and Neck Surgery. Reprint requests: David J. Kay, MD, Department of Pediatric Otolaryngology, Children s Hospital of Pittsburgh, 3705 Fifth Ave, Pittsburgh, PA ; , davidkay@ pol.net. Copyright 2003 by the American Academy of Otolaryngology Head and Neck Surgery Foundation, Inc /2003/$ doi: /mhn Sinonasal symptoms are notably widespread, with rhinosinusitis being one of the most common infections in the United States. According to a recent evidence report from the Agency for Healthcare Research and Quality, Americans spend $200 million on prescriptions and over $2 billion for over-the-counter medications to treat rhinosinusitis. 1 Children have a 7.6% prevalence of chronic sinusitis and a 6.6% prevalence of allergic rhinitis, compared with 1.9% for chronic diseases of the tonsils or adenoids. True sinusitis in young children seen by primary pediatricians in the winter months comprises 4.2% of all visits and 17.3% of those with cold or cough symptoms. 2 The net result is considerable loss of school time and accumulation of medical expenses, affecting the children themselves, their parents, and society as a whole. Despite the high prevalence of pediatric sinonasal symptoms, there are currently no validated outcome measures to quantify the impact of medical or surgical interventions on child health status. Quality of life is a subjective outcome that reflects the patient s perception of their health status. 3 Health-related quality of life (HRQoL) excludes other widely valued aspect of life, such as income, freedom, and quality of the environment. In the context of sinonasal symptoms, quality of life describes the net consequences of associated illness on a child s physical, social, and emotional well-being. Physical symptoms may be caused by sinusitis, allergic rhinitis, or nasal obstruction (typical from enlarged adenoids), which often coexist in children and have cumulative effects. An appropriate measure of pediatric sinonasal HRQoL should sample all these related domains. An ideal HRQoL survey for sinonasal symptoms should be easy to administer and able to quantify changes within children as trivial, small, moderate, or large. The survey should yield stable results when readministered to patients with stable disease (test-retest reliability) and have adequate 17

2 18 KAY and ROSENFELD January 2003 internal consistency. A more elusive concept of survey design is validity or the ability of the survey to actually measure what it purports to measure. Validity is generally assessed by comparing the survey results and item responses with external constructs that tap similar domains. Some relationship should exist with a general HRQoL instrument, but existing research with adult rhinosinusitis suggests only a modest static relationship and a trivial dynamic relationship. 14 In this prospective outcomes study, caregivers of eligible children completed 3 sets of surveys over a 5- to 8-week period during routine clinical care. The 3 time points consisted of the initial clinical visit, a survey that was returned by mail about 1 week later (test-retest reliability), and a follow-up evaluation at least 4 weeks later (evaluation of clinical change). Our goal was to validate the SN-5 survey by demonstrating adequate test-retest reliability, internal consistency, construct validity, and responsiveness to clinically meaningful longitudinal change within children. To accomplish these goals, the SN-5 responses were compared with several external constructs, including general- and disease-specific HRQoL measures and with direct and indirect measures of clinical change. METHODS This study was conducted at a pediatric otolaryngology practice in a private not-for-profit hospital in Brooklyn, New York, between November 2000 and February Specific inclusion criteria were (1) ages 2 through 12 years, inclusive; (2) one or more of the following sinonasal symptoms: nasal discharge, nasal congestion, nasal obstruction, postnasal drip, daytime cough, or foul breath (fetor oris); (3) active symptoms at the time of initial evaluation; (4) persistent symptoms for 1 month or longer; and (5) caregiver (proxy respondent) able to read and understand English. Specific exclusion criteria were (1) inability of caregiver to read and understand English, (2) primary diagnosis of obstructive sleep apnea syndrome caused by tonsillar hyperplasia, and (3) mental retardation, cognitive impairment, or developmental delay. Institutional review board approval was obtained before the commencement of the study. Table 1. Sample question for sinus infection domain Sinus infection: Nasal discharge, bad breath, daytime cough, postnasal drip, headache, facial pain, or head banging. How often has this been a problem for your child during the past 4 weeks? Score [ ] None of the time 1 [ ] Hardly any time at all 2 [ ] A small part of the time 3 [ ] Some of the time 4 [ ] A good part of the time 5 [ ] Most of the time 6 [ ] All of the time 7 The original instrument designed for this study was the SN-6 survey, which was later reduced to the SN-5 after an item regarding medication use was eliminated to improve psychometric validity. The self-administered survey was completed by the child s parent using 7-point ordinal response scales for each item. Content was based on a literature review and unstructured interviews of children with sinonasal symptoms and their parents. Domains included sinus infection, nasal obstruction, allergy symptoms, medication use, emotional distress, and activity limitations. A direct measure of global HRQoL was obtained using a 10-point visual analog scale at the bottom of the form. The SN-6 design was modeled after the OM-6, which has been used successfully in several outcome studies since its initial development. 4,5 In contrast to the OM-6, however, the SN-6 did not include a question about caregiver concerns, because of the controversy over whether parent issues should be kept distinct from questions about child health status. Each domain was represented by a single item listing several ways in which sinonasal symptoms might affect that domain. For example, the sinus infection domain (Table 1) included the symptom cluster of nasal discharge, bad breath, daytime cough, post-nasal drip, headache, and facial pain or head-banging. This approach permits rapid sampling of multiple domains and is a validated means of assessing generic and disease-specific health outcomes. 4,6 For each survey item caregivers described how often during the past 4 weeks their child exhibited

3 Volume 128 Number 1 KAY and ROSENFELD 19 specific symptom clusters using the following response scale: (1) none of the time, (2) hardly any time at all, (3) a small part of the time, (4) some of the time, (5) a good part of the time, (6) most of the time, and (7) all of the time. A 7-point ordinal scale has been shown to possess adequate evaluative properties. 7 Frequency was assessed rather than severity because a quality of life study for adult sinusitis showed increased item reliability for the former. 8 The 4-week recall period was long enough to avoid acute fluctuations in quality of life status but short enough to avoid problems with recall bias, as demonstrated in other valid pediatric quality of life surveys. 4,9 An overall survey score was derived from the mean of all 6 items (range, 1.0 to 7.0). Higher scores reflected poorer diseasespecific HRQoL. The visual analog scale did not contribute to the survey score. Test-retest reliability of the SN-6 was assessed with the Spearman rank correlation coefficient by comparing responses on the initial survey with mail response survey returned within 1 week of the initial visit. Surveys were only used for testretest if the caregiver indicated no change or almost the same on the change assessment form, a 5-item form is used as a direct assessment of clinical change as perceived by the child s caregiver, which has been previously validated as a comparative measure of longitudinal change. 7 Coefficients were calculated for individual survey items and for the survey summary score. Internal consistency of the SN-6 was determined using Cronbach s. Construct validity of the SN-6 was assessed by comparing item responses with external constructs using Spearman rank correlation, with correlations 0.30 considered adequate. 10 Correlation coefficients of 0.30 to 0.50 are consistent with other pediatric disease specific HRQoL surveys 4,9 and represent our a priori expected level of correlation. The external constructs included (1) the PedsQL 4.0 survey, (2) the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and (3) a physician information form. The PedsQL 4.0 is a valid and reliable 23-item measure of general HRQoL in children aged 2 to 18 years, which samples the domains of physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school/daycare functioning (3 items) over a 4-week intake period. 11 The RQLQ is a valid and reliable 28-item measure of diseasespecific HRQoL for children with allergic rhinoconjunctivitis. 12 Only the domains for nasal and eye symptoms (8 questions) were used. For consistency with the SN-6, the RQLQ intake period was increased from 7 days to 4 weeks. The physician information form included demographic information (child age, gender, ethnicity; proxy respondent age, education, and relation to child), sinonasal symptoms (onset, frequency, and duration of symptoms; degree of nasal airway obstruction), sinonasal medication history, and information on initial clinical management decisions. Change scores were calculated as the difference between survey scores at the follow-up and initial visits. Follow-up surveys were completed at least 4 weeks after the initial visit. Validity of the change score was assessed by correlation with the (1) change in disease-specific HRQoL on the visual analog faces scale, (2) change in general HRQoL on the PedsQL (readministered at this time), and (3) direct caregiver estimate of change. The direct caregiver estimate of change was calculated using a 7-point ordinal response scale, which produced a rating from 3 to 3 in integer increments. 7 Improvement was coded as a positive value, and worsening was coded as a negative value. Trivial, small, moderate, and large change had values of 0, 1, 2, and 3, respectively. Responsiveness of the SN-6 to clinical change was determined by seeing if change scores at the 4 levels of direct caregiver-reported change (trivial, small, moderate, and large) behaved similar to other validated surveys. First, the mean SN-6 change score and 95% CI for the 4 change levels were compared with other surveys, 4,7 which have shown consistent results when a 7-point response scale is used: change score [lt]0.50 is trivial change, 0.50 to 0.99 is small change, 1.00 to 1.49 is moderate change, and 1.50 is large change. Second, the effect size and 95% CI were calculated for change levels using the standardized response mean (SRM) by dividing the mean SN-6 change score by its standard deviation. Based on published data, we expected children with small change to have an SRM of about 0.20, moderate change to have an SRM of 0.50, and large change to have an SRM of at least ,14

4 20 KAY and ROSENFELD January 2003 Table 2. Distribution of baseline sinonasal survey responses (N 80) Item response, n (%) Item Sinus infection 4 (5) 3 (4) 6 (8) 17 (21) 24 (30) 21 (26) 5 (6) Nasal obstruction 2 (2) 2 (2) 4 (5) 14 (18) 20 (25) 27 (34) 11 (14) Medication use 13 (16) 3 (4) 10 (13) 16 (20) 19 (24) 9 (11) 10 (13) Allergy symptoms 20 (25) 14 (18) 10 (13) 16 (20) 15 (19) 4 (5) 1 (1) Emotional distress 13 (16) 14 (18) 12 (15) 17 (21) 15 (19) 5 (6) 4 (5) Activity limitations 29 (36) 14 (18) 12 (15) 11 (14) 13 (16) 1 (1) 0 Responses are graded on an ordinal scale, with 1 indicating none of the time and 7 indicating all of the time. Data entry was performed using a microcomputer and verified for 100% accuracy. All statistical analyses were performed using True Epistat software 15 except for Cronbach s, which was calculated using SAS 8.0 software. 16 Spearman rank correlation was used to compare numerical data. A 2-sided level of.05 was used for all hypothesis tests, and 95% confidence intervals were calculated for primary results when applicable. A sample size of 85 subjects was needed to detect a population correlation as small as 0.20 and to estimate test-retest reliability within Fig 1. Distribution of SN-6 mean survey scores. RESULTS Eighty children aged 2.1 to 12.2 years (mean, 4.9; SD, 2.7) were enrolled from November 2001 through February There were 52 boys (65%) and 28 girls (35%), with an ethnicity of 81% white, 10% black, 3% Hispanic, and 2% other. Proxy respondents were aged 20.9 to 49.3 years (mean, 35.3; SD, 6.7) and were either the child s mother (90%) or father (10%). Nearly all proxies had a high school (49%) or college (47%) education, and some had postgraduate training (3%). The median duration of sinonasal symptoms at study entry was 4 months (range, 0 to 48 months), with a median time since first symptom onset of 18 months (range, 1 to 72 months). Children with recurrent symptoms (39%) had a median of 3 episodes in the past 6 months (range, 1 to 12) and 6 in the past 12 months (range, 2 to 24). During the 28 days before study entry children had 5.3 mean days of antibiotics (range, 0 to 23), 5.6 mean days of nasal sprays (range, 0 to 28), and 15.0 mean days of sinusitis or upper respiratory infection (URI) symptoms (range, 0 to 28). Most children had sinusitis based on history (50%) or imaging studies (19%) but less had allergic rhinitis (26%) or asthma (24%). Antibiotics offered no benefit for 30% of children, mild benefit for 15%, moderate benefit for 28%, and large benefit for 27%. The degree of nasal airway obstruction was 0% to 25% for 20% of children, 26% to 50% for 9%, 50% to 75% for 11%, 76% to 100% for 24%, and unknown for 36%. Nasal endoscopy was used most to assess the nasal airway (45%), followed by imaging studies (27%) or mirror examination at surgery (26%). Initial management included watchful waiting (32%), medical therapy (42%), adenoidectomy (22%), and endoscopic sinus surgery (5%). Baseline sinonasal survey results are shown in Table 2 and Figure 1. Symptoms of sinus infection or nasal obstruction were present at least a good part of the time for more than 50% of children. Conversely, over one third indicated that sinonasal symptoms caused emotional distress or activity limitations either none of the time or hardly any time at all. A broad distribution of responses was observed for all questions, but the sinus and nasal items were skewed toward higher values (as expected). In order of decreasing mean response

5 Volume 128 Number 1 KAY and ROSENFELD 21 Table 3. Survey results (n 80) and test-retest reliability (n 48) Item response Retest reliability* Item Median Mean (SD) R P value Sinus infection (1.5) Nasal obstruction (1.4) Medication use (1.9) Allergy symptoms (1.7) Emotional distress (1.7) Activity limitations (1.5) Survey score (0.9) Global faces scale (2.1) *Includes retest surveys completed by same respondent within 7 days of first survey for children with a trivial or minimal change in sinonasal symptoms. Arithmetic mean of all six survey items. (Table 3), the items were nasal obstruction, sinus infection, medication use, emotional distress, allergy symptoms, and activity limitations. The retest survey was returned by 71 of 80 proxies (89%) within 1 to 20 days after the baseline survey (mean, 5.7 days; SD, 3.8). Test-retest reliability was determined using 48 surveys that were (1) returned within 7 days, (2) completed by the same proxy respondent, (3) had complete data, and (4) indicated only a trivial or minimal change in baseline sinonasal symptoms on the change assessment form. Test-retest reliability for individual items was fair to good (Table 3), with Spearman rank correlations ranging from 0.58 to The overall survey score and the global faces scale had good test-retest reliability (correlations 0.70). Cronbach s was 0.56 but improved to 0.62 when the medication use item was dropped. Although 0.62 is only fair (0.70 or higher is good), we did not expect high homogeneity because each survey item is a self-contained domain (not one of several items within a single domain). Medication use was also the only item with an unacceptable item-total correlation of 0.09 (0.20 or higher is acceptable), compared with correlations of 0.29 to 0.48 for remaining items. The medication use item was deleted from the survey, which was renamed the SN-5 (Fig 2). The mean baseline SN-5 score was 3.8 (1.0, SD), ranging from 1.0 to 6.0. Test-retest reliability for the SN-5 score was 0.71 (P ). All SN-5 items and the survey score had adequate correlation (0.30 or higher) with one or more external constructs (Table 4). The lack of correlation between the nasal obstruction item and the clinician rating of obstruction severity most likely stemmed from a discrepancy between subjective and objective perceptions. In contrast, the caregiver rating of nasal obstruction had good correlation with a related (but differently worded) question on the RQLQ survey. The medication use question had fair-good correlation with antibiotic (0.45, P 0.001) and nasal spray (0.46, P 0.001) used over the past month but was not included in the SN-5 for reasons noted above. Sensitivity of the SN-5 to longitudinal change was assessed for 71 children whose proxies completed follow-up surveys after a median of 36 days (range, 18 to 148); the interval was at least 29 days for 75% of children and 50 days or longer for 25%. The SN-5 had excellent sensitivity to change compared with other outcome measures (Table 5). Change scores for the SN-5 showed large changes relative to baseline and had a large effect size ( 0.70). As expected, the sinus infection and nasal obstruction items were most sensitive to change (Table 6), but all items had at least a small effect size ( 0.20). Effect sizes were also higher for children receiving active therapy (Table 7). Validity of the SN-5 as a measure of clinical change was demonstrated by fair-good Spearman rank correlation with change in external constructs including the direct proxy change estimate (0.47, P ), global faces scale change score ( 0.43, P ), and PedsQL survey change score ( 0.42, P ). Change scores for the sinus infection and

6 22 KAY and ROSENFELD January 2003 Fig 2. The SN-5 Sinus and Nasal Quality of Life Survey. nasal obstruction items also had fair-good correlation with the direct proxy change estimate (Table 6). Appropriate responsiveness to clinical change was suggested by change scores that increased relative to the direct proxy change estimate (Table 8), although there was significant overlap for the small and moderate improvement categories. DISCUSSION The SN-5 is a valid measure of change in health status for children with persistent sinonasal symptoms. The survey has adequate test-test reliability, is internally consistent, and correlates with related external constructs. When the SN-5 is administered to the same individuals over time, the changes in scores correlate with indirect estimates of global change in HRQoL, with direct estimates of clinical change reported by the caregiver, and show appropriate sensistivity to change in the effect size magnitudes. Moreover, the change scores can be used to readily describe the magnitude of change in sinonasal HRQoL over time as trivial, small, moderate, or large. Validation of the SN-5 survey provides clinicians and researchers with a simple and useful evaluative tool, which is urgently needed given the high prevalence of pediatric sinonasal symp-

7 Volume 128 Number 1 KAY and ROSENFELD 23 Table 4. Sinonasal survey construct validity Survey item External construct for comparison R P value Sinus infection RQLQ Runny Nose item URI or cold symptoms in past 4 weeks PedsQL 4.0 Physical Functioning domain Antibiotic use for sinonasal disease in past 4 weeks Nasal obstruction RQLQ Stuffy/Blocked Nose item Degree of obstruction estimated by clinician Allergy symptoms RQLQ Nasal and Eye domain Emotional distress PedsQL 4.0 Emotional Functioning domain PedsQL 4.0 Social Functioning domain Activity limitations PedsQL 4.0 School Functioning or Daycare domain PedsQL 4.0 Social Functioning domain Survey score* Global faces scale PedsQL 4.0 overall survey score RQLQ, Rhinoconjunctivitis Quality of Life Questionnaire; URI, upper respiratory infection. *Arithmetic mean of the five items in the final SN-5 survey (excludes Medication Use). Correlation is negative because higher scores on the construct reflect higher quality of life. Table 5. Sensitivity to longitudinal change of SN-5 versus other outcome measures Outcome measure Baseline, mean (SD) Change score, mean (SD)* Change from baseline, % (range) Effect size SN-5 score 3.8 (1.0) 0.9 (1.2) 23.2 ( 52.6 to 73.7) 0.74 PedsQL score 81.7 (14.3) 2.6 (10.8) 3.2 ( 3.5 to 4.7) 0.24 Global faces scale 6.0 (2.1) 0.4 (2.0) 6.3 ( 100 to 67) 0.19 *Baseline score minus follow-up score; positive values indicate improvement for the SN-5 and negative scores indicate improvement for the other measures. Mean change score divided by its standard deviation. Table 6. Change scores for SN-5 survey items and overall score (n 74) Change score Correlation with direct change* SN-5 item Mean (SD) Effect size R P value Sinus infection 1.19 (1.93) Nasal obstruction 1.28 (1.92) Allergy symptoms 0.80 (1.74) Emotional distress 0.64 (1.97) Activity limitations 0.52 (1.19) Overall SN-5 score 0.88 (1.19) *Spearman rank correlation for change score versus degree of direct change reported by the child s proxy respondent. Mean change score divided by its standard deviation. toms and their associated interventions. This is especially true for studies of pediatric rhinosinusitis, which rely on appropriate patient-based outcome measures for validity. For example, a meta-analysis of pediatric functional endoscopic sinus surgery (FESS) compared surgical outcomes as positive versus not positive, without quantification. 18 In another recent study of adenoidectomy versus FESS for pediatric rhinosinusitis the outcome measure was a nonvalidated symptom survey. 19 Similarly, Chan and colleagues 20 could not create a practice guideline for pediatric sinusitis because symptom improvements could not be quantified, leading to disagreements among expert panel members.

8 24 KAY and ROSENFELD January 2003 Table 7. Comparison of SN-5 change scores by initial management Initial management (n) Mean (SD) Change score Effect size* Watchful waiting (24) 0.68 (1.20) 0.57 Medication (29) 0.85 (1.17) 0.73 Adenoidectomy (16) 0.95 (1.19) 0.80 Endoscopic sinus surgery (4) 2.10 (1.15) 1.83 *Mean change score divided by its standard deviation; values of 0.2 indicate a small effect, and 0.8 or higher, a large effect. A useful evaluative survey must be able to measure clinically meaningful change after an intervention. Change in health status can be measured directly by asking people how much better or worse they feel after an intervention or indirectly by assessing health status before and after an intervention and studying the difference. 10 Clinicians often use the direct approach by asking How much has your child s quality of life changed? Although this is a time-honored approach, retrospective estimates of initial state correlate more with present health status than with actual baseline findings. Indirect measurement of change is preferred over retrospective direct estimates, 3,13 particularly if the anticipated changes are small. 21 Additional problems arise when satisfaction measures are used as outcome surrogates (eg, Would you recommend this treatment to others, or Would you have this treatment again? ) because a positive response bias rarely yields rates less than 80%. Indirect change in health status is measured with change scores, obtained by subtracting postintervention survey responses from the baseline survey scores after an appropriate time interval. A positive change score indicates a clinical improvement and a negative score indicates a deterioration. The magnitude of the change score reflects the degree of change experienced by a given individual. When using a 7-point response scale, change scores of 0.5 generally indicate a small change; 1.0, a moderate change; and 1.5, a large change. 4,7 Scores of the SN-5 behaved similarly (Table 8), but there was poor discrimination between the small and moderate change categories. As the SN-5 is used in future studies, additional data will reveal whether this overlap refects an inherent limition of the SN-5 or a result of the limited sample size (and statistical power) in this initial investigation. Dividing the mean change score by its standard deviation yields the SRM, a measure of effect size and sensitivity to change. 13,14 Effect size provides a signal-to-noise ratio, in which the signal is the magnitude of change and the noise is the standard deviation (eg, random fluctuations unrelated to the intervention). The effect size (0.74) for the SN-5 survey score suggested excellent sensitivity to longitudinal change (Table 5) and was much larger than effect sizes for a general pediatric HRQoL measure (0.24) and a direct global caregiver rating of change (0.19). Further, the SN-5 effect size had an appropriate relationship to initial management (Table 7). The data in Table 7 are not presented to support effectiveness of the listed strategies but rather to show that effect sizes vary accordingly. The limited sample size and failure to adjust for confounding factors preclude any effectiveness conclusions. Pediatric sinonasal symptoms are multifactorial, comprising a spectrum of disorders including rhinosinusitis, upper respiratory infection (URI), allergic rhinitis, and adenoid infection or hyperplasia. A single generic measure of sinonasal symptoms offers significant advantages over multiple disease-specific measures, because the various diseases often coexist cannot be distinguished clinically. Consequently, the focus of this investigation was on sinonasal symptoms per se, not on individual disease entities. Adult sinonasal symptoms are more readily classified as pure sinusitis, which has facilitated the development of several validated outcome measures. 8,22,23 Conversely, there are no valid measures of generic sinonasal symptoms for children, and existing disease-specific measures are limited to allergic rhinitis, 12 acute sinusitis, 24 and a nonvalidated rhinosinusitis survey. 25 A pediatric HRQoL survey must address the problem of age-related developmental change, which affects child perceptions of cognition, selfcare, and quality of life. 26,27 One solution is to design different surveys for each age group. This is essential for discriminative surveys which stratify HRQoL among different children, such as the generic PedsQL survey, 11 but may cause confusion in busy clinical settings. Another solution is

9 Volume 128 Number 1 KAY and ROSENFELD 25 Table 8. SN-5 change scores versus direct caregiver estimate of clinical change Outcome reported by proxy at follow-up (n) Mean (95% CI) SN-5 change score* Range Worsening (8) 0.40 ( 0.90 to 0.10) 1.4 to 0.6 No change or trivial change (17) 0.55 ( 0.06 to 1.16) 2.0 to 2.8 Small improvement (18) 1.06 (0.57 to 1.55) 2.0 to 2.8 Moderate improvement (17) 1.04 (0.59 to 1.49) 0.6 to 2.6 Large improvement (10) 1.96 (1.30 to 2.62) 0.2 to 2.8 CI, Confidence interval. *Baseline score minus follow-up score; positive values indicate improvement. to use broad global questions that are not age specific. 4,6 This approach is excellent for evaluative surveys, such as the SN-5, which measure HRQoL changes within individuals, because respondents presumably consider the same issues on successive surveys. This approach is less valid for discriminative surveys, because varying interpretations of global questions by different respondents may not be compatible. An additional problem encountered in designing a pediatric HRQoL survey is that proxy respondents must be used, because children often do not volunteer or state their symptoms even on direct questioning. Parents are good surrogates for some domains, such as physical suffering and observable symptoms like activity limitations, that is, those with directly observable behavioral consequences. 28 Although parents are not good surrogates for complex psychosocial issues, these domains are not relevant to our current study. Although parents are the most knowledgeable source of information about their children, their judgments are based on their own interpretations. 26 However, even if they do not perfectly correlate with their children s judgments, they remain valid in their own right as part of the total HRQoL picture. 27 The SN-5 survey can facilitate outcomes research for children with sinonasal symptoms. As a measure of HRQoL change, the SN-5 can quantify the degree of change perceived by caregivers following any intervention for pediatric sinonasal symptoms. This subjective, patient-based information is an adjunct to, not a substitute for, objective change in utilization of health care services and pharmacologic therapies. For pediatric sinonasal symptoms, however, which are rarely serious or life threatening, validated measures of subjective change in disease-specific child quality of life are especially important. The SN-5 fills a void by offering clinicians, researchers, and administrators a simple, valid, and reliable tool for evaluating HRQoL changes in children with persistent sinonasal symptoms. We thank Ari J. Goldsmith and Nira A. Goldstein for contributing study patients. REFERENCES 1. Lau J, Zucker D, et al. Diagnosis and treatment of acute bacterial rhinosinusitis. Evidence Report/Technology Assessment No. 9 (Contract to the New England Medical Center). Rockville, MD: Agency for Health Care Policy and Research; March Aitken M, Taylor JA. Prevalence of clinical sinusitis in young children followed up by primary care pediatricians. Arch Pediatr Adolesc Med 1998;152: Guyatt GH, Feeny DH, Patrick DL. Measuring healthrelated quality of life. Ann Intern Med 1993;118: Rosenfeld RM, Goldsmith AJ, Tetlus L, et al. Quality of life for children with otitis media. Arch Otolaryngol Head Neck Surg 1997;123: Rosenfeld RM, Bhaya MH, Bower CM, et al. Impact of tympanostomy tubes on child quality of life. Arch Otolaryngol Head Neck Surg 2000;126: Hadorn DC, Ubersax J. Large-scale health outcomes evaluation: how should quality of life be measured? Part I---calibration of a brief questionnaire and a search for preference groups. J Clin Epidemiol 1995; 48: Juniper EF, Guyatt GH, Willan A, et al. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994;47: Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope 1995;105: Franco RA Jr, Rosenfeld RM, Rao M: Quality of life for children with obstructive sleep apnea. Otolaryngol Head Neck Surg 2000;123: Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use. Oxford: Oxford Medical Publications; 1995.

10 26 KAY and ROSENFELD January Varni JW, Seid M, Rose CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care 1999;37: Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy 1991;21: Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care 1992;28: Gliklich RE, Hilinski JM. Longitudinal sensitivity of generic and specific health measures in chronic sinusitis. Qual Life Res 1995;4: Gustafson TL. True Epistat reference manual, 5th ed. Richardson, TX: Epistat Services; Version 8.0 software. Cary, NC: SAS Institute Inc. 17. Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use. Oxford: Oxford Medical Publications; Hebert RL, Bent JP. Meta-analysis of outcomes of pediatric functional endoscopic sinus surgery. Laryngoscope 1998; 108: Ramadan HH. Adenoidectomy vs endoscopic sinus surgery for the treatment of pediatric sinusitis. Arch Otolaryngol Head Neck Surg 1999;125: Chan KH, Winslow CP, Levin MJ, et al. Clinical practice guidelines for the management of chronic sinusitis in children. Otolaryngol Head Neck Surg 1999;120: Fischer D, Stewart AL, Bloch DA, et al. Capturing the patient s view of change as a clinical outcome measure. JAMA 1999;282: Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg 1997;123: Jones ML, Piccirillo JF, Haiduk A, et al. Functional endoscopic sinus surgery: do ratings of appropriateness predict patient outcomes? Am J Rhinol 1998;12: Garbutt JM, Gellman EF, Littenberg B. The development of an instrument to assess acute sinus disease in children. Qual Life Res 1999;8: Rosenfeld RM. Pilot study of outcomes in pediatric rhinosinusitis. Arch Otolaryngol Head Neck Surg 1995;121: Rosenbaum PL, Saigal S. Measuring health-related quality of life in pediatric populations: conceptual issues. In: Spilker B, editor. Quality of life and pharmacoeconomics in clinical trials. 2nd ed. Philadelphia: Lippincott-Raven; p Eiser C. Children s quality of life measures. Arch Dis Child 1997;77: Landgraf JM, Abetz LN. Measuring health outcomes in pediatric populations: issues in psychometrics and application. In: Spilker B, editor. Quality of life and pharmacoeconomics in clinical trials. 2nd ed. Philadelphia: Lippincott-Raven; p American Academy of Otolaryngology Head and Neck Surgery Annual Meetings 2003 Orlando, Florida September New York, New York September Los Angeles, California September 25-28