Pediatric Annals

ALLERGIC RHINITIS AND ASTHMA 

Quality-of-Life Outcomes Measures of Asthma and Allergic Rhinitis

D Melissa Graham, MD; Michael S Blais, MD

Abstract

Asthma substantially influences patients' lives. In 1995, asthma was estimated to affect 14 million people in the United States and its prevalence is expected to increase worldwide.1'2 The highest incidence is in the pediatric population, where it affects approximately 7% of children. The goals of asthma treatment have broadened beyond managing traditional clinical markers of disease. We should now include a focus on the benefits of treatment and satisfaction with care in terms that are most meaningful to patients: how does asthma interfere with quality of life and how do treatments improve this?

Allergic rhinitis affects approximately 20% to 25% of the population.3 Because individuals with allergic rhinitis rarely, if ever, are hospitalized or require surgery or other sophisticated interventions, and because their day-to-day survival is not threatened, the condition is not considered to have a major impact on them. However, along with the bothersome nasal symptoms of itching, sneezing, and rhinorrhea, allergic rhinitis can lead to serious morbidity in children such as sinusitis, otitis media, and nasal polyps. It can also be associated with the development of asthma.

With dramatic changes in the health care system due to managed care, it has become necessary to provide evidence that changes in our patients' current and future health are attributable to the care they receive. This is the field of outcomes research.4 The purpose of outcomes research is determining what works and what does not work for patients. This information is important for patients, but physicians, public and private purchasers of health care, and managed care organizations need these data to make the best possible decisions in choosing appropriate medical treatment and resource allocation.5 A major focus of outcomes research is the evaluation of the impact of the disease and its treatment on patients' quality of life.6 This article discusses tools used to measure quality-of-life outcomes in children with asthma and allergic rhinitis.

IMPORTANCE OF QUALITY-OF-LIFE MEASUREMENTS

Physicians assess the outcome of medical management of allergic rhinitis by documenting improvement in clinical parameters such as nasal itching, sneezing, rhinorrhea, nasal blockage, and ocular symptoms. Asthma is assessed similarly by a decrease in symptom frequency, improvement in pulmonary function measurements, and decreased resource use. The latter includes the number of unscheduled physician visits, emergency department visits, and hospitalizations.

The patients' evaluation of the effects of medical treatment on their quality of life has recently become important in judging overall effectiveness of care for allergic rhinitis and asthma. The concept of quality of life encompasses the value we place on different aspects of life such as health, standard of living, family and friends, environment, and freedom. What then is meant by health-related quality of life! The World Health Organization defines health as a "state of complete physical, psychological and social wellbeing and not merely the absence of disease."7 This also defines health-related quality of life. Currently, four domains of function are used to evaluate health-related quality of life8: (1) physical status and functional abilities, (2) psychological status and well-being, (3) social and role interactions, and (4) the patient's perception of his or her health. A comprehensive health-related quality-of-Iife analysis addresses all four domains.

DIFFERENT TYPES OF HEALTH-RELATED QUALITYOF-LIFE INSTRUMENTS

Generally, two major types of instruments are used in clinical trials and practice: generic and specific.9 Generic surveys are broad-based, reproducible measurements that can assess quality of life over different disease states and conditions, treatment interventions, and population states. The use of a generic instrument allows broad comparisons of health-related quality of life for different disease states, such as allergic rhinitis, asthma, hypertension, and diabetes. Generic instruments can also serve as health profiles. The…

Asthma substantially influences patients' lives. In 1995, asthma was estimated to affect 14 million people in the United States and its prevalence is expected to increase worldwide.1'2 The highest incidence is in the pediatric population, where it affects approximately 7% of children. The goals of asthma treatment have broadened beyond managing traditional clinical markers of disease. We should now include a focus on the benefits of treatment and satisfaction with care in terms that are most meaningful to patients: how does asthma interfere with quality of life and how do treatments improve this?

Allergic rhinitis affects approximately 20% to 25% of the population.3 Because individuals with allergic rhinitis rarely, if ever, are hospitalized or require surgery or other sophisticated interventions, and because their day-to-day survival is not threatened, the condition is not considered to have a major impact on them. However, along with the bothersome nasal symptoms of itching, sneezing, and rhinorrhea, allergic rhinitis can lead to serious morbidity in children such as sinusitis, otitis media, and nasal polyps. It can also be associated with the development of asthma.

With dramatic changes in the health care system due to managed care, it has become necessary to provide evidence that changes in our patients' current and future health are attributable to the care they receive. This is the field of outcomes research.4 The purpose of outcomes research is determining what works and what does not work for patients. This information is important for patients, but physicians, public and private purchasers of health care, and managed care organizations need these data to make the best possible decisions in choosing appropriate medical treatment and resource allocation.5 A major focus of outcomes research is the evaluation of the impact of the disease and its treatment on patients' quality of life.6 This article discusses tools used to measure quality-of-life outcomes in children with asthma and allergic rhinitis.

IMPORTANCE OF QUALITY-OF-LIFE MEASUREMENTS

Physicians assess the outcome of medical management of allergic rhinitis by documenting improvement in clinical parameters such as nasal itching, sneezing, rhinorrhea, nasal blockage, and ocular symptoms. Asthma is assessed similarly by a decrease in symptom frequency, improvement in pulmonary function measurements, and decreased resource use. The latter includes the number of unscheduled physician visits, emergency department visits, and hospitalizations.

The patients' evaluation of the effects of medical treatment on their quality of life has recently become important in judging overall effectiveness of care for allergic rhinitis and asthma. The concept of quality of life encompasses the value we place on different aspects of life such as health, standard of living, family and friends, environment, and freedom. What then is meant by health-related quality of life! The World Health Organization defines health as a "state of complete physical, psychological and social wellbeing and not merely the absence of disease."7 This also defines health-related quality of life. Currently, four domains of function are used to evaluate health-related quality of life8: (1) physical status and functional abilities, (2) psychological status and well-being, (3) social and role interactions, and (4) the patient's perception of his or her health. A comprehensive health-related quality-of-Iife analysis addresses all four domains.

DIFFERENT TYPES OF HEALTH-RELATED QUALITYOF-LIFE INSTRUMENTS

Generally, two major types of instruments are used in clinical trials and practice: generic and specific.9 Generic surveys are broad-based, reproducible measurements that can assess quality of life over different disease states and conditions, treatment interventions, and population states. The use of a generic instrument allows broad comparisons of health-related quality of life for different disease states, such as allergic rhinitis, asthma, hypertension, and diabetes. Generic instruments can also serve as health profiles. The major disadvantages of generic instruments are that they may contain items not relevant to the disease and they may not be sensitive for detecting change within a particular disease.

Examples of generic instruments include the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36),10 the Medical Outcomes Study 12-Item Short Form Health Survey (SF12),11 and the Child Health Questionnaire (CHQ).12 The SF-36 uses 36 questions to assess physical and mental components through 9 health concepts (vitality, bodily pain, physical and social functioning, role limitations due to physical and emotional problems, mental health, general perception of health, and change in health).10 The SF-36 is scored on a 100-point scale, with 100 being perfect health. This questionnaire is useful for children older than 15 years. It has been reliable and valid in studies of disease and general population groups, and can estimate the health burden of different treatments.1315 Because the SF-36 is widely used, it permits a broad range of comparisons for interpretation of results.

The CHQ PF-50 and the shorter CHQ PF-28 child general health measures are useful in pediatric patients younger than 15 years.16 Both are parent-completed forms that measure 12 concepts (child's physical functioning, role /social functioning-physical, general health, bodily pain, family activities, role /social functioning-emotional/behavioral, parental time impact, parental emotional impact, self-esteem, mental health, general behavior, and family cohesion), and both yield 2 summary health measures (physical summary and psychosocial summary).16

Specific instruments usually focus on one particular interest, such as a disease state, a particular patient population, or certain functions or problems. This type of instrument allows the researcher to evaluate important aspects of health-related quality of life relevant solely to the condition studied. This method has responsiveness to change in a particular aspect of the patient's health-related quality of life. For example, these instruments are useful in directly comparing efficacy among different therapeutic regimens.9

Juniper and Guyatt have developed several disease-specific questionnaires that are particularly useful for rhinoconjunctivitis, rhinitis, adolescent and pediatric rhinoconjunctivitis, and pediatric asthma and for those who care for children with asthma. The Rhinitis Quality of Life Questionnaire is self-administered with two major parts.17 First, the patient scores 3 activities from a list of 29, which are limited by nose and eye symptoms, from "not troubled" to "extremely troubled." A second section of 25 questions scores other domains of allergic rhinitis (Table 1) on a 6-point scale, with a lower score indicating better quality of life. Studies have shown that a change of 0.5 or more can represent a statistically significant change in quality of life.18 Age can affect what is important to a patient's health-related quality of life. In developing the Adolescent Rhinoconjunctivitis Quality of Life Questionnaire, Juniper and Guyatt questioned patients from 12 to 17 years old with allergic rhinitis and found that sleep was not a major problem, but ability to concentrate, especially in school work, was an important quality-oflife parameter.19

Table

TABLE 1Domains of the Juniper and Guyatt Rhinoconjunctlvltls Quality of Ufe Questionnaire*

TABLE 1

Domains of the Juniper and Guyatt Rhinoconjunctlvltls Quality of Ufe Questionnaire*

Juniper and Guyatt have also developed two instruments for pediatric asthma: the Pediatric Asthma Quality of Life Questionnaire, completed by children, and the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). These assess how asthma limits normal daily activities and how it may incite fear and anxieties in the caregiver.20,21 To evaluate the PACQLQ, a 9-week single cohort study was conducted with assessments at 1, 5, and 9 weeks. Participants were primary caregivers of 52 children (7-17 years old) with symptomatic asthma. Caregivers completed the PACQLQ, the Impacton-Family Scale, and the Global Rating of Change Questionnaire. Patients completed the Pediatric Asthma Quality of Life Questionnaire and an asthma control questionnaire. Spirometry was performed and the use of beta-agonists was recorded. The PACQLQ was able to differentiate caregivers with quality-of-life changes (P < .001) and from caregivers whose quality of life remained stable (P < .0001).

Recently, the three major national allergy and clinical immunology organizations contracted with QualityMetrics to develop the Asthma Outcomes Monitoring System (AOMS) and the Rhinitis Outcomes Monitoring System (ROMS). The systems are composed of several questionnaires that physicians can use to observe clinical, economic, and humanistic outcomes in their patients with asthma and allergic rhinitis. Generic and disease-specific measures were used in both to evaluate how functional health and well-being are affected by asthma and allergic rhinitis.

The AOMS and the ROMS use the generic and asthma-specific or rhinitis-specific functional health and well-being scales that had already been validated for asthma and rhinitis. For adolescents and adults, generic measures included the SF-36 scale and summary measures. For children, the generic measures used included the CHQ PF-50 and CHQ PF-28 scales and summary measures. New specific quality-of-life questionnaires for pediatric rhinitis (Table 2) and pediatric asthma (Table 3), plus one for each disease in adults, were also produced and validated. For children, a 10-item, asthma-specific scale was developed for the AOMS that yields an overall measure of asthma-specific quality of life, incorporating role-social limitations, fatigue, impact of medications, and impact of asthma on the parent or the family. The pediatric quality-of-life questionnaires are completed by the caregiver of the child and scored on a 10-point scale from "none of the time" to "all of the time."

STUDIES IN PEDIATRIC AND ADOLESCENT ASTHMA AND RHINITIS WITH GENERIC HEALTH-RELATED QUALITY-OF-LIFE INSTRUMENTS

In 1994, Bousquet et al. used a generic instrument, the French version of the SF-36, to evaluate health-related quality of life in allergic rhinitis.22 This cross-sectional study involved 111 patients with documented perennial allergic rhinitis due to dust mites, pet dander, or both, and 116 healthy control subjects. Most patients with rhinitis had symptom scores ranging from moderately severe to severe for runny nose, itchy nose, sneezing, and stuffy nose. There was significant impairment in all of the following domains of health-related quality of life compared with control subjects: physical and social functioning, role limitations secondary to physical problems and emotional problems, mental health, energy or fatigue, pain, and general health perception.

Table

TABLE 2Rhinitis Outcomes Monitoring System: Pediatric Quality of Life Survey

TABLE 2

Rhinitis Outcomes Monitoring System: Pediatric Quality of Life Survey

In the pilot study of the AOMS in pediatrics, the CHQ PF-50 was given to 233 children with asthma prior to enrollment. When results were compared with values for children without asthma, those with asthma had significantly poorer quality of life than did non-sufferers for many of the domains (Fig. 1). There was also a relationship betwen the severity of the child's asthma (as defined by the 1997 National Heart, Lung, and Blood Institute Asthma Guidelines) and the degree of quality-of-life impairment (Fig. 2)23

STUDIES IN PEDIATRIC AND ADOLESCENT ASTHMA AND RHINITIS WITH SPECIFIC HEALTH-RELATED QUALITY-OF-LIFE INSTRUMENTS

The advantage of approaching these conditions from a quality-of-life perspective is that one can see how they impact the family. At the University of Tennessee Pediatric Allergy Clinic, 44 children were evaluated by their parents to assess the relationship between the parents' general perception of the child's rhinitis and specific clinical symptoms, measured by the ROMS pediatric qualityof-life questionnaire. Children rated by their parents as having mild and moderate rhinitis had the lowest scores on the quality-of-life question: "Have you worried about your child's present or future health because of allergies or rhinitis?'' Parents whose children's asthma was rated as severe or very severe had the same concerns of "worried about your child's present and future health" and low scores on the item: "Has your child had trouble sleeping because of allergies or rhinitis?'' The caregivers were also questioned about the child's symptoms, and the investigators examined which questions of the ROMS qualityof-life questionnaire gave the lowest score for each symptom. The most frequently listed symptoms were sneezing, stuffy, blocked nose, and postnasal drip. It did not matter which was the worst symptom because in all cases the lowest score was seen in the question dealing with "worried about your child's present and future health."24 This study demonstrates the caregiver's perception that the child's allergic rhinitis is a serious concern and leads to apprehension and uneasiness about total impact of the disease on the child's health.

Table

TABLE 3Asthma Outcomes Monitoring System: Pediatric Quality of Life Survey*

TABLE 3

Asthma Outcomes Monitoring System: Pediatric Quality of Life Survey*

Figure 1. Child Health Questionnaire PF-50 profile: baseline scores for Asthma Outcomes Monitoring System (AOMS) children with adjusted U.S. norm. *Significant difference between AOMS and adjusted U.S. norm. PF = physical functioning; RP = role limitations-physical problems; GH = general health; BP = bodily pain; FA = family activities; REB = role limitations-emotional behavior problems; PE = parental emotion; PT = parental time; SE = self-esteem; MH = mental health; BE = general behavior; FC = family cohesion; PHS = physical health scale; PSS = psychosocial scale. (Reprinted with permission from Graham DM, Blaiss MS, Bayliss MS, Ware JE. Impact of changes in asthma severity on health-related quality of life in pediatric and adult asthma patients: result from the AOMS. Allergy Asthma Proc. In press.)

Figure 1. Child Health Questionnaire PF-50 profile: baseline scores for Asthma Outcomes Monitoring System (AOMS) children with adjusted U.S. norm. *Significant difference between AOMS and adjusted U.S. norm. PF = physical functioning; RP = role limitations-physical problems; GH = general health; BP = bodily pain; FA = family activities; REB = role limitations-emotional behavior problems; PE = parental emotion; PT = parental time; SE = self-esteem; MH = mental health; BE = general behavior; FC = family cohesion; PHS = physical health scale; PSS = psychosocial scale. (Reprinted with permission from Graham DM, Blaiss MS, Bayliss MS, Ware JE. Impact of changes in asthma severity on health-related quality of life in pediatric and adult asthma patients: result from the AOMS. Allergy Asthma Proc. In press.)

Figure 2. Child Health Questionnaire PF-50 profile: baseline scores for children with asthma by severity level versus U.S. norm. PF = physical functioning; RP = role limitations-physical problems; CH = general health; BP = bodily pain; FA = family activities; REB = role limitations-emotional behavior problems; PE = parental emotion; PT = parental time; SE = self-esteem; MH = mental health; BE = general behavior. (Reprinted with permission from Bayliss MS, Ware JE Jr, Espindle DM. Asthma Outcomes Monitoring System: Baseline Psychometric Report. Lincoln, Rl: QualityMetric; 1998.)

Figure 2. Child Health Questionnaire PF-50 profile: baseline scores for children with asthma by severity level versus U.S. norm. PF = physical functioning; RP = role limitations-physical problems; CH = general health; BP = bodily pain; FA = family activities; REB = role limitations-emotional behavior problems; PE = parental emotion; PT = parental time; SE = self-esteem; MH = mental health; BE = general behavior. (Reprinted with permission from Bayliss MS, Ware JE Jr, Espindle DM. Asthma Outcomes Monitoring System: Baseline Psychometric Report. Lincoln, Rl: QualityMetric; 1998.)

Figure 3. Health-related quality-of-life changes associated with a change in asthma severity in children. Asthma severity defined using National Heart, Lung, and Blood Institute and National Asthma Education and Prevention Program severity staging. Summary scales, standardized units. ** = P< .01; *** = P < .001 . (Reprinted with permission from Graham DM, Blaiss MS, Bayliss MS, Ware JE. Impact of changes in asthma severity on health-related quality of life in pediatric and adult asthma patients: result from the AOMS. Allergy Asthma Proc. In press.)

Figure 3. Health-related quality-of-life changes associated with a change in asthma severity in children. Asthma severity defined using National Heart, Lung, and Blood Institute and National Asthma Education and Prevention Program severity staging. Summary scales, standardized units. ** = P< .01; *** = P < .001 . (Reprinted with permission from Graham DM, Blaiss MS, Bayliss MS, Ware JE. Impact of changes in asthma severity on health-related quality of life in pediatric and adult asthma patients: result from the AOMS. Allergy Asthma Proc. In press.)

Figure 4. Health-related quality-of-life changes associated with a change in asthma severity in children. Asthma severity defined using National Heart, Lung, and Blood Institute and National Asthma Education and Prevention Program severity staging. Child Health Questionnaire PF-28+ scales, standardized units. ** = P< .01; ***=p< .001 . PF = physical functioning; RP = role limitations-physical problems; CH = general health; BP = bodily pain; REB = role limitations-emotional behavior problems; SE = self-esteem; MH = mental health; BE = general behavior; PT = parental time; PE = parental emotion; FA = family activities; FC = family cohesion. (Reprinted with permission from Graham DM, Blaiss MS, Bayliss MS, Ware JE. Impact of changes in asthma severity on health-related quality of life in pediatric and adult asthma patients: result from the AOMS. Allergy Asthma Proc. In press.)

Figure 4. Health-related quality-of-life changes associated with a change in asthma severity in children. Asthma severity defined using National Heart, Lung, and Blood Institute and National Asthma Education and Prevention Program severity staging. Child Health Questionnaire PF-28+ scales, standardized units. ** = P< .01; ***=p< .001 . PF = physical functioning; RP = role limitations-physical problems; CH = general health; BP = bodily pain; REB = role limitations-emotional behavior problems; SE = self-esteem; MH = mental health; BE = general behavior; PT = parental time; PE = parental emotion; FA = family activities; FC = family cohesion. (Reprinted with permission from Graham DM, Blaiss MS, Bayliss MS, Ware JE. Impact of changes in asthma severity on health-related quality of life in pediatric and adult asthma patients: result from the AOMS. Allergy Asthma Proc. In press.)

Asthma also takes it toll. During the pilot study of the AOMS, analyses were performed to compare the generic and the asthma-specific scores for patients whose asthma severity improved, stayed the same, or worsened during 1 year. The purpose of this study was to determine the impact of changes in asthma severity (defined using National Heart, Lung, and Blood Institute and National Asthma Education and Prevention Program severity staging) on patient-assessed health-related quality of life. This was a 1-year observational study involving 15 allergy practices in the United States, representative of the practice type, geographic, and reimbursement characteristics of the Joint Council of Allergy, Asthma, and Immunology membership. Two hundred thirtythree pediatric patients with asthma were enrolled. The study concluded that the generic and the asthma-specific scales are sensitive to changes in disease severity (Figs. 3 and 4).

CONCLUSION

The incorporation of quality-of-life measurements in clinical practice will continue to increase in health care. Documentation of improvement in quality of life will be as common as documentation of traditional clinical indices. It is understandable that the chronic and serious condition of asthma could adversely affect a patient's quality of life. However, allergic rhinitis has a significant impact on quality of life as well. Because allergic rhinitis is not associated with hospitalizations or mortality, it has not been perceived as having a major impact on the child or adolescent. Nothing could be further from the truth. Along with the constant bothersome nasal symptoms of itching, sneezing, and rhinorrhea, allergic rhinitis can lead to serious morbidity in children by contributing to the development of asthma, sinusitis, otitis media, and nasal polyps. Patients not only suffer because of these physical symptoms, but also have significant psychological and social distress, which affects their ability to function optimally at work and play. Monitoring quality-oflife indices can help improve the quality of care we provide for both of these common disorders.

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19. Juniper EF, Guyatt GH, Dolovich J. Assessment of quality of life in adolescents with allergic rhinoconjunctivitis: development and testing of a questionnaire for clinical trials. J Allergy Clin Immunol. 1994;93:413-23.

20. Juniper EF, Guyatt GH, Feeny DH, Feme PJ, Griffith LE, Townsend M. Measuring quality of life in children with asthma. Qual Life Res. 1996;5:35-46.

21. Juniper EF, Guyatt GH, Feeny DH, Feme PJ, Griffith LE, Townsend M. Measuring quality of life in the parents of children with asthma. Qual Life Res. 1996;5:27-34.

22. Bousquet J, Bullinger M, Fayol C, Marquis P, Valentin B, Burtin B. Assessment of quality of life in patients with perennial allergic rhinitis with the French version of the SF36 Health Status Questionnaire. J Allergy Clin Immunol. 1994;94:182-188.

23. Bayliss MS, Espindle DM, Ware JE. Asthma Outcomes Monitoring System Final Report: Development, Validation and Analysis of Pilot Study. Lincoln, RI: QualityMetric; 1998.

24. Graham DM, Blaiss MS, Bayliss MS. Rhinitis Outcomes Monitoring System pediatric quality of life (QOL) questionnaire: correlation of parents' perception of their child's QOL with clinical symptoms. Presented at the American College of Allergy, Asthma and Immunology Annual Meeting; November 1999; Chicago, IL. Abstract.

TABLE 1

Domains of the Juniper and Guyatt Rhinoconjunctlvltls Quality of Ufe Questionnaire*

TABLE 2

Rhinitis Outcomes Monitoring System: Pediatric Quality of Life Survey

TABLE 3

Asthma Outcomes Monitoring System: Pediatric Quality of Life Survey*

10.3928/0090-4481-20000701-12

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