HRQOL is an important patient-centered outcome, in that it provides an objective indicator of the patients' functional status and overall sense of well-being. HRQOL has been postulated as a method to populations are "at-risk" for poor outcomes, such as recidivism, future healthcare utilization, and higher healthcare costs[23, 24]. The time required for completion and need follow-up assessment, represent important barriers for administration of HRQOL instruments in the ED setting, which is typified by brief, episodic encounters. Moreover, ED illnesses are short-term and diverse, while many HRQOL assessments are disease specific. These challenges have resulted in a lack of validated instruments for the ED, and a dearth of ED-based HRQOL investigations. We believe our investigation is the first to assess a validated HRQOL instrument for a characteristic, heterogeneous pediatric ED illness, in the ED setting. Our results illustrate the PedsQL™ can overcome many of the barriers to ED assessment of HRQOL.
The results of our study demonstrate that the PedsQL™ is a practical and feasible for evaluation of short-term pediatric ED febrile illnesses. The brevity and ease of administration of the PedsQL™ allowed for enrollment and follow-up rates that resemble those of typical prospective studies conducted in the ED. Furthoermore, the missing item response rate in our study was quite, and was representative of other feasibility assessments of the PedsQL™.
The PedsQL™ demonstrated excellent construct validity for ED febrile illnesses: HRQOL scores were significantly lower at FU for children who remained febrile, functionally impaired, or relapsed to healthcare, compared with those who were asymptomatic or had not relapsed. Analysis of the subscales of the PedsQL™ demonstrated that impaired physical function of the child was particularly related to poor outcomes. This is sensible: physical impairments can certainly result from a febrile condition, and are visible to parents, leading them to return for further healthcare evaluation. Not surprisingly, school functioning domain was substantially affected, a valid finding: ill-children would be expected to have difficulty maintaining the level of concentration required to perform well in this setting. In addition to total and subscale analyses, increased days of fever, child functional impairment, and family unit functioning, were also significantly correlated with lower HRQOL scores. Moreover, HRQOL scores at FU decreased significantly with increasing numbers of reported poor outcomes, demonstrating a cumulative, dose-response effect. These encouraging findings support the construct validity of the PedsQL™ for short-term febrile illnesses in the ED setting.
The PedsQL™ also proved to be responsive to changes over a relatively brief time frame. Significantly smaller changes in HRQOL scores, from initial ED evaluation to FU, were exhibited for children that remained febrile, functionally impaired, or relapsed to healthcare. This statistically significant responsiveness was also present within the majority of measured domains of the PedsQL™. Responsiveness was greatest in the analysis or relapse to healthcare, again, consistent with the objectives of a HRQOL instrument; children with even worse perceived health would logically seek additional physician visits. Similar to our validity assessment, a dose-response relationship was also demonstrated between the change in PedsQL™ scores and increasing numbers of poor outcomes, consistent with statistical responsiveness to change in HRQOL. The responsiveness of the PedsQL™ in our study was also corroborated by the statistical measure of effect size, which persisted in the total and most of the subscale analyses.
Our evaluation generated results similar to those of prior studies of the PedsQL™, enhancing the validity of our findings. Population studies of the PedsQL™ have demonstrated that mean total scores for chronically ill and healthy populations are 73.1 ± 16.5 and 82.3 ± 15.6, respectively. The mean total PedsQL™ score for our study population at enrollment, which occurred during the acute febrile illness, was similar to the mean for ill children with conditions frequently evaluated in the ED, including mild persistent asthma  and migraine headaches. Similarly, the mean total score at FU, after resolution of the illness, was consistent with the population means for healthy children. Additionally, the mean change in PedsQL™ total score in our study population was nearly twice the calculated minimally clinically important change of 4.5 points.
Few previous studies have evaluated HRQOL for short-term ED illnesses, such as fever. In 2004, Gorelick et al. evaluated HRQOL following acute asthma exacerbations treated in the ED, using the Integrated Therapeutics Groups Child Asthma Short Form (ITG-CASF), a 10-item, asthma-specific HRQOL instrument. The ITG-CASF was initially validated for use in chronic asthma; nevertheless, the authors found this instrument to be valid and responsive for acute asthma, using constructs similar to those in our study. This study was limited in that a disease-specific HRQOL instrument was used. In contrast, the PedsQL™ is a generic instrument, with the ability to assess HRQOL across a wide spectrum of conditions. This flexibility particularly suits the ED, where a variety of acute, short-term illnesses are evaluated. Shoham et al. evaluated HRQOL for another acute condition, community-acquired pneumonia, using an recurrent ENT infections HRQOL instrument. Using constructs similar to our study, and a short-time frame (21 days), significantly lower HRQOL scores were found for patients with community-acquired pneumonia, compared with controls. However, only 34.2% of subjects were enrolled on presentation to the ED, and the authors did not perform statistical analysis for validation or responsiveness of the HRQOL instrument. We were able to demonstrate responsiveness of the PedsQL™ over a shorter time frame, thereby strengthening the association between our constructs and HRQOL. Moreover, we were able to corroborate the validity and responsiveness of this tool using statistical methods.
In summary, the PedsQL™ exhibits feasibility, and statistically significant validity and responsiveness for a common, diverse ED illness. Our findings support potential utility of the PedsQL™ as an effective HRQOL measure for the pediatric ED setting. We feel our study of serves as an important starting point in assessment of HRQOL in the ED setting, and for short-term illnesses such as fever. As our ability to evaluate HRQOL in the ED becomes more advanced, investigators and clinicians will be able to use HRQOL and other patient-centered outcomes to assess their management decisions, including therapeutic interventions and discharge dispositions, to better benefit children and their families.
Our study does have several limitations. Despite multiple telephone attempts, 63 (39%) subjects were lost to follow-up, potentially introducing selection bias. However, demographic and study characteristics of subjects lost to follow-up were similar to those completing the study, and initial PedsQL™ scores did not differ, suggesting that lost subjects did not suffer from greater morbidity. The lack of follow-up also resulted in small numbers of subjects with "poor outcomes", our primary outcome measures, limiting the magnitude of our results. In our study, missing item responses were more likely to occur in the school functioning scale of the PedsQL™, introducing difficulty in statistical assessment of validity and responsiveness for this domain. This likely resulted because not all children required completion of all 5 scale items, since not all children were enrolled in daycare or school. Future ED studies of the PedsQL™ will need to focus on missing time responses to allow for a more complete assessment of the instrument. constructs and follow-up HRQOL scores were assessed by parental self-report, subjecting our results to observer and recall bias. To eliminate recall bias, in-person follow-up by a trained health professional would be necessary, which is neither feasible nor practical; furthermore, caregiver assessment of the child's health often is the impetus for caregiver behaviors; therefore, our results may actually represent a more clinically realistic situation. PedsQL™ assessments were only collected via the parent-proxy version. Ideally, validation should be accomplished using both the parent-proxy and child versions. We attempted to administer the child version in this study; however, < 50% of subjects were ≥ 5 years of age (the minimum age for the child report); this sample was too small to permit statistical analyses. Although there are Spanish versions of the PedsQL™, we only evaluated English-speaking patients, due to lack of translator availability.