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Biomedical subjects

E F Juniper

Publications and source records attributed to E F Juniper.

At least 37 records · Page 2Linked to original sources

Asthma quality of life during 1 year of treatment with budesonide with or without formoterol.

The Formoterol and Corticosteroids Establishing Therapy (FACET) study has provided the first opportunity to examine the long-term effects of inhaled steroids and long-acting beta2-agonists on asthma-specific quality of life. The objectives of the present study were to: evaluate the effects of long-term (1 yr) formoterol and increasing doses of budesonide on asthma quality of life; 2) to determine whether initial improvements in quality of life are sustained when improvements in clinical indices persist; and 3) to evaluate the long-term relationship between changes in clinical indices and changes in quality of life. Of the 852 asthmatic adults enrolled, 470 from five countries participated in this quality of life evaluation. After a 4-week run-in on 1,600 microg budesonide, patients were randomized to either 200 microg (Bud200) or 800 microg budesonide (Bud800) in combination with either 24 microg formoterol (F) or placebo daily for 1 yr. The Asthma Quality of Life Questionnaire (AQLQ) was completed and conventional clinical indices measured at enrolment and randomization and on seven occasions during the following 12 months. During the run-in, there was an improvement in AQLQ score (changes (delta) in overall score approximately 0.50; p<0.0001). After randomization, there was a further improvement in the Bud800+F group (delta=0.21; p=0.028). One month post-randomization, improvements in all groups stabilized and were sustained throughout the 12 months in a pattern very similar to that observed for the conventional clinical indices. The correlation of individual patient changes in clinical indices and changes in AQLQ score during the 12-month randomized period were weak to moderate (maximum r=0.51). Improvements in quality of life, which were greatest in the 800 microg budesonide plus 24 microg formoterol group, were sustained throughout the 12 months in a similar manner to the clinical indices. Long-term changes in conventional clinical indices cannot be used to predict the effect of treatment on individual patient experience.

Adrenergic beta-Agonists↗

Validation of a standardized version of the Asthma Quality of Life Questionnaire.

BACKGROUND: In the original 32-item Asthma Quality of Life Questionnaire (AQLQ), five activity questions are selected by patients themselves. However, for long-term studies and large clinical trials, generic activities may be more appropriate. METHODS: For the standardized version of the AQLQ, the AQLQ(S), we formulated five generic activities (strenuous exercise, moderate exercise, work-related activities, social activities, and sleep) to replace the five patient-specific activities in the AQLQ. In a 9-week observational study, we compared the AQLQ with the AQLQ(S) and examined their measurement properties. Forty symptomatic adult asthma patients completed the AQLQ(S), the AQLQ, the Medical Outcomes Survey Short Form 36, the Asthma Control Questionnaire, and spirometry at baseline, 1, 5, and 9 weeks. RESULTS: Activity domain scores (mean +/- SD) were lower with the AQLQ (5.7 +/- 0.9) than with the AQLQ(S) (5.9 +/- 0.8; p = 0.0003) and correlation between the two was moderate (r = 0.77). However, for overall scores, there was minimal difference (AQLQ, 5.4 +/- 0.8; AQLQ(S), 5.5 +/- 0.8; r = 0.99). Reliability (AQLQ intraclass correlation coefficient, 0.95; AQLQ(S) intraclass correlation coefficient, 0.96) and responsiveness (AQLQ, p < 0.0001; AQLQ(S), p < 0.0001) were similar for the two instruments. Construct validity (correlation with other measures of health status and clinical asthma) was also similar for the two instruments. CONCLUSIONS: The AQLQ(S) has strong measurement properties and is valid for measuring health-related quality of life in asthma. The choice of instrument should depend on the task at hand.

Activities of Daily Living↗

Health-related quality of life in moderate asthma: 400 microg hydrofluoroalkane beclomethasone dipropionate vs 800 microg chlorofluorocarbon beclomethasone dipropionate. The Study Group.

OBJECTIVE: To compare the effect of hydrofluoroalkane-134a (HFA) beclomethasone dipropionate (BDP; 400 microg/d) with that of chlorofluorocarbon (CFC) BDP (800 microg/d) on asthma health-related quality of life in a 12-week, parallel-group, multicenter study. BACKGROUND: HFA-BDP is a new CFC-free preparation of BDP, which was developed as a result of CFCs being phased out from metered dose inhalers. METHODS: Following 7 to 12 days of prednisone, 30 mg/d, 347 adults with moderate asthma were randomized to receive either 400 microg/d HFA-BDP, 800 microg/d CFC-BDP, or HFA placebo for 12 weeks (all other oral and inhaled steroids were withdrawn). Patients completed the Asthma Quality of Life Questionnaire (AQLQ), and clinical asthma status was measured at the end of a run-in period, at randomization (after oral steroid treatment), and at the end of the study treatment. RESULTS: Sixty-one patients withdrew, 43 due to worsening asthma (33 placebo; 5 HFA-BDP; 5 CFC-BDP). There was a deterioration in the AQLQ score (- 0.81) in the placebo group, and the difference between this and the stability observed in both the HFA-BDP group (+ 0.13) and the CFC-BDP group (- 0.03) was statistically significant (p </= 0.003). The difference between the two active treatments was not significant (p = 0.290). The calculated number of patients who needed to be treated in order to see a benefit in one patient (with the placebo as the standard treatment) was 2.4 for HFA-BDP and 3.0 for CFC-BDP. Only weak to moderate correlations were observed between changes in AQLQ scores and between asthma clinical status measures. CONCLUSION: HFA-BDP (400 microg/d) was as effective as CFC-BDP (800 microg/d) in sustaining improvements in asthma quality of life following withdrawal of 7 to 12 days of prednisone treatment in moderate asthma.

Administration, Inhalation↗

Measuring quality of life in children with rhinoconjunctivitis.

OBJECTIVE: The objective of this study was to develop, pretest, and validate a questionnaire to measure quality of life in children with seasonal allergic rhinoconjunctivitis (SAR). METHODS (DEVELOPMENT STUDY): Thirty-four children with SAR were enrolled from summer camps, notices in the media, and an allergy clinic (Southern Ontario). After generating a pool of 48 potentially important quality of life items, the children identified the ones that they experienced with their SAR and scored each for bother (1 = a little bothered to 4 = extremely bothered). Items identified most frequently and with the highest bother score were included in the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). The PRQLQ was pretested for ease completion and accuracy of understanding. RESULTS (DEVELOPMENT STUDY): The PRQLQ has 23 items in five domains (nose symptoms, eye symptoms, practical problems, other symptoms, and activities). Responses are given on a seven-point scale, and children are asked to score their experiences during the previous 7 days. METHODS (VALIDATION STUDY): Seventy-five children with symptomatic SAR were enrolled from notices in the media and a pediatric allergy clinic (Austin, Tex.). A single cohort design was used, with children assessed at 0, 1, and 3 weeks. The PRQLQ was administered to the children by a trained interviewer at 1 and 3 weeks. A conventional nasal symptom daily diary was completed for 1 week before each of these clinic visits. Global ratings were completed at the final visit. RESULTS (VALIDATION STUDY): In patients who were stable between clinic visits, the PRQLQ demonstrated good reliability (intraclass correlation coefficient = 0.93). The questionnaire was very responsive to change (p < 0.001) and was able to differentiate between patients who were in a stable clinical state and those whose clinical state changed between visits (p = 0.005). Correlations between the PRQLQ and diary scores were close to predicted and supported both the cross-sectional and longitudinal validity of the PRQLQ. CONCLUSIONS: The PRQLQ measures the quality of life impairments important to children with SAR. Children provide reliable and accurate responses, the measurement properties are strong, and the questionnaire can be used with confidence in clinical trials, clinical practice, and surveys.

Child↗

Rhinitis management: the patient's perspective.

Seasonal allergic rhinitis causes considerable impairment of health-related quality of life (HQRL). Generic quality-of-life questionnaires enable a comparison to be made between patients with different illnesses, but they often have insufficient depth to measure specific problems that are important to an individual with a particular condition. In order to overcome these shortcomings, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was developed. Eighty-nine patients, with a wide range of rhinoconjunctivitis severity, scored a list of 91 problems for importance. The highest-scoring problems were the practical problems: continually having to blow the nose, rub the nose and eyes, and carry tissues. Patients were also bothered by sleep impairments and systemic problems such as tiredness, poor concentration and thirst. Questionnaires have also been developed for adolescents (12-17 years of age)--finding similar results to those for adults--and children (6-12 years of age), who were troubled by their symptoms but did not have the emotional dysfunction experienced by adults and adolescents. All three questionnaires have strong measurement properties and have high reliability and good responsiveness, validity and interpretability. Quality-of-life questionnaires can be used in clinical studies to help elucidate which treatments are preferred by patients and the efficacy of treatment regimens. Disease-specific quality-of-life questionnaires can also be used during routine assessments and may reveal problems not spontaneously volunteered by patients, particularly children. Results can also be compared at each clinic visit to determine whether each intervention has been beneficial.

Adolescent↗

First-line treatment of seasonal (ragweed) rhinoconjunctivitis. A randomized management trial comparing a nasal steroid spray and a nonsedating antihistamine.

OBJECTIVE: To determine whether better health-related quality of life (HRQL) is achieved by initiating treatment of seasonal (ragweed) rhinoconjunctivitis (hay fever) with a nasal steroid (fluticasone) backed up by a nonsedating antihistamine (terfenadine) or whether it is better to start with the antihistamine and add the nasal steroid when necessary. DESIGN: Randomized, nonblind, parallel-group management study during the 6 weeks of the ragweed pollen season in 1995. PATIENTS: Sixty-one adults with ragweed pollen hay fever recruited from patients who had participated in previous clinical studies and from those who responded to notices in the local media. SETTING: Southern Ontario. INTERVENTIONS: Nasal steroid group: 200 micrograms of fluticasone nasal spray when needed (up to 400 micrograms/d) starting about 1 week before the ragweed pollen season and continued throughout, with 1 to 2 tablets of terfenadine daily (maximum 120 mg/d) if needed. Antihistamine group: 1 60-mg tablet of terfenadine when needed (maximum 120 mg/d) starting about 1 week before the ragweed pollen season and continued throughout, with 200-400 micrograms/d of fluticasone nasal spray (maximum 400 micrograms/d) if needed. OUTCOME MEASURES: HRQL before, at the height of and toward the end of the ragweed pollen season; HRQL was measured using the Rhinoconjunctivitis Quality of Life Questionnáire. RESULTS: Overall, HRQL tended to be better in the group of patients whose first-line treatment was with fluticasone (p = 0.052), but the difference between the 2 groups was small and not clinically important. Just over half (52% [16/31]) of the patients in the fluticasone group did not need additional help with terfenadine, whereas only 13% (4/30) of those in the terfenadine group did not need additional help with fluticasone (p = 0.002). CONCLUSIONS: There is little difference in the therapeutic benefit between the 2 approaches for the treatment of ragweed pollen hay fever. Therefore, the approach to treatment should be based on patient preference, convenience and cost. Regardless of the treatment, at least 50% of patients will need to take both types of medication in combination to control symptoms adequately.

Administration, Inhalation↗

Measuring health-related quality of life in rhinitis.

Patients with rhinitis are bothered both by the nasal symptoms themselves and by associated symptoms such as headache and fatigue. The combination can produce quite severe impairment of day-to-day physical, emotional, occupational, and social functioning and can cause emotional distress. This breadth of impairment of health-related quality of life in patients with rhinitis is often not recognized and is sometimes trivialized by some health care professionals. One of the aims of treating patients with rhinitis must be to ensure that all individual patient problems are recognized and treated appropriately. Several studies now show that correlations between conventional nasal symptom-severity diaries and health-related quality of life are only weak to moderate. Therefore, to get an overall picture of a patient's health status, it is essential to measure quality of life. Genetic health-status questionnaires are able to compare burden of illness across different medical conditions, but they are often not responsive enough to small but clinically important changes in patients' quality of life. As a result, we have seen the emergence of disease-specific instruments for rhinitis that have strong measurement properties and that are much more sensitive to these changes. Most clinical trials in rhinitis now include a measure of health-related quality of life as a primary outcome, and many clinicians are incorporating quality of life into routine clinical assessments.

Clinical Trials as Topic↗

Clinical impact versus factor analysis for quality of life questionnaire construction.

OBJECTIVE: We have compared two philosophically different methods for selecting items for a disease-specific quality of life questionnaire. The impact method selects items that are most frequently perceived as important by patients whereas the psychometric method (factor analysis) selects items primarily according to their relationships with one another. PATIENTS: 150 adults with symptomatic asthma and a wide range of disease severity were enrolled from asthma clinics and notices in the local media. STUDY DESIGN: From a list of 152 items that are potentially troublesome to patients with asthma, the patients identified those items they had experienced in the previous year and scored the importance of each on a five-point scale. For the impact method, items that were identified most frequently and that scored the highest were included in the final instrument. For the psychometric method, factor analysis was performed after highly skewed items had been removed. Items with high factor loading were included in the final instrument. RESULTS: The impact method resulted in a 32-item instrument and psychometric analysis in one with 36 items. Twenty items were common to both instruments. The psychometric approach discarded the highest impact emotional function and environmental items and included in their place lower impact items mainly associated with fatigue. CONCLUSIONS: Although some items were the same for both methods, there were also some important differences. Different approaches to item reduction led to appreciably different instruments.

Adolescent↗

Quality of life in adults and children with asthma and rhinitis.

Many clinicians now recognize the importance of incorporating an assessment of health-related quality of life (HRQL) into their clinical studies and practice. Conventional clinical measures provide valuable information about the status of the affected organ system, but they rarely capture the functional impairments (physical, emotional, and social) that are important to the patients in their everyday lives. In order to obtain a complete picture of a patient's health status, both the conventional clinical indices and the patient's HRQL must be measured. Both adults and children with asthma and rhinitis are distressed by the symptoms, and they are limited in their day-to-day activities such as sports, work or school work, and participation in other activities with friends. In addition, both adults and children experience emotional strain as a result of both conditions. Disease-specific HRQL questionnaires have been developed and validated for both adults and children with asthma and rhinitis. These questionnaires have good measurement properties and validity and can be used in both clinical trials and clinical practice to assess the impact of the condition on a patient's life. Since one of the aims of treatment is to ensure that patients benefit from it, an essential component of clinical assessment should be an evaluation of HRQL.

Adult↗

Minimum skills required by children to complete health-related quality of life instruments for asthma: comparison of measurement properties.

To gain a complete picture of a child's health-status, measurement of health-related quality of life (HRQL) is necessary. Since parents do not accurately perceive children's HRQL, information must be obtained from the children themselves. The aim of this study was to determine the minimum age and reading skills required by children to complete competently the Paediatric Asthma Quality of Life Questionnaire (PAQLQ), the Health Utilities Index (HUI), the Feeling Thermometer and the Standard Gamble, and to evaluate the validity of each for measuring HRQL in children with asthma. Fifty two children (age 7-17 yrs) with symptomatic asthma participated in a 9 week single cohort study with HRQL and clinical asthma control assessed every 4 weeks. All children provided very reliable data for the PAQLQ and the HUI but they needed > or = grade 6 reading skills to complete the Standard Gamble and > or = grade 2 skills for the Feeling Thermometer. In those children who were able to provide reliable data, the PAQLQ had the best discriminative and evaluative measurement properties, followed closely by the Feeling Thermometer. Measurement properties in the Standard Gamble were weaker and although the HUI was very reliable it was not actually measuring asthma-specific HRQL. The Paediatric Asthma Quality of Life Questionnaire may be used with confidence in clinical studies and practice to provide a profile of children's day-to-day experiences. In those children with adequate skills to complete the test reliably, the Feeling Thermometer provides a good estimate of the value that children place on their asthma health status.

Adolescent↗

Children and adult perceptions of childhood asthma.

OBJECTIVE: To explore children's and parents' assessment of children's asthma. DESIGN: Prospective 2-month cohort study in which children and parents were reviewed at baseline and 1-month intervals. SETTING: Mid-sized, English-speaking, industrial community serving an urban and regional rural population. PATIENTS OR PARTICIPANTS: Fifty-two children, 7 to 17 years old, with a wide range of asthma severity, and their parents. INTERVENTIONS: We offered patients with inadequately controlled asthma additional inhaled steroid. MAIN OUTCOME MEASURES: Children and parents provided global ratings of change in childhood symptoms and children completed spirometry and the Paediatric Asthma Quality of Life Questionnaire at clinic visits. Patients recorded peak flow rates, symptoms, and medication use in a daily diary. The diary symptom report, medication use, and spirometry were combined to form an asthma control score. RESULTS: In children younger than 11, children's global rating of change in symptoms correlated strongly with changes in quality of life (0.54 to .67) but not with measures of airway caliber or asthma control, while parents' global ratings did not correlate with children's quality of life but showed moderate correlations with airway caliber (0.29 to .48) and asthma control (0.50). In children over the age of 11, correlations with all clinical variables were higher for their own than their parents' global ratings. CONCLUSIONS: In children under 11, clinicians can gain complementary information from questioning children and parents. For children over 11, parents can provide little if any information beyond that obtained through questioning the child.

Adolescent↗

Measurement characteristics of two asthma symptom diary scales for use in clinical trials.

The measurement characteristics of two asthma symptom diary scales developed for use as health outcome measures in clinical trials of asthma therapy were investigated. A daytime diary scale was designed to capture the frequency and inconvenience of daytime asthma symptoms and their effects on activities, and a nocturnal asthma symptom diary scale was designed to capture awakenings with asthma symptoms. The internal consistency, reliability, validity and responsiveness of both asthma diary scales were assessed in 346 adult asthma patients in two placebo-controlled clinical trials of an investigational asthma therapy, a leukotriene biosynthesis inhibitor. The daytime symptom scale showed sufficient internal consistency (0.90-0.92), and the daytime and nocturnal symptom scales showed sufficient test retest reliability (0.69-0.87). Construct validity was demonstrated by generally moderate-to-strong correlations for changes in the diary scales with changes in other measures of asthma status, such as forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), and puffs of beta-agonist inhaler. Both scales demonstrated significant responsiveness to change in asthma due to therapy in one of the clinical trials. Based on these results, the daytime and nocturnal asthma symptom diary scales show measurement characteristics appropriate for use as asthma outcome measures in clinical trials of asthma therapy.

Adult↗

How important is quality of life in pediatric asthma?

Many pediatricians now recognize the importance of incorporating an assessment of health-related quality of life (HRQL) into their clinical studies. Conventional clinical measures provide valuable information about the status of the affected organ system but they rarely capture the functional impairments (physical, emotional, and social) that are important to the patients in their everyday lives. To obtain a complete picture of a child's health status, both the conventional clinical indices and the child's HRQL have to be measured. Parents do not perceive accurately their children's HRQL, hence it is necessary to obtain the information directly from each child. Children with asthma are distressed by the symptoms (shortness of breath, wheezing, and cough), and they are limited in their day-to-day activities (sports, school, work, and playing with pets). In addition, children are often upset and frightened by asthma attacks, and express anger (younger children) and frustration (older children) because they have asthma. They frequently feel different from their friends and get frustrated that they cannot participate in activities. Disease-specific quality of life questionnairs for children with asthma have been developed. These questionnaires have good measurement properties and validity, and can be used both in clinical trials and in clinical practice to assess the impact of asthma on a child's life. Because one of the aims of treatment is to ensure that the children benefit from treatment, an essential component of clinical assessment of these children should be the evaluation of health-related quality of life.

Activities of Daily Living↗

Measuring quality of life in the parents of children with asthma.

Parents and primary caregivers of children with asthma are limited in normal daily activities and experience anxieties and fears due to the child's illness. We have developed the Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) to measure these impairments. The objective of this study was to evaluate the measurement properties of the PACQLQ. A 9-week single cohort study was conducted with assessments at 1, 5 and 9 weeks. Participants in the study were primary caregivers of 52 children (age 7-17 years) with symptomatic asthma, recruited from notices in the local media and paediatric asthma clinics. Caregivers completed the PACQLQ, Impact-on-Family Scale and Global Rating of Change Questionnaires. Patients completed the Paediatric Asthma Quality of Life Questionnaire and an asthma control questionnaire. Spirometry and beta-agonist use were recorded. The PACQLQ was able to detect quality of life changes in those caregivers who changed (p < 0.001) and to differentiate these from the caregivers whose quality of life remained stable (p < 0.0001). The PACQLQ is reproducible in subjects who are stable (ICC = 0.84), and showed acceptable levels of longitudinal and cross-sectional correlations with the child's asthma status and health-related quality of life and with other measures of caregiver health-related quality of life. The PACQLQ functions well as both an evaluative and a discriminative instrument.

Adolescent↗

Measuring quality of life in children with asthma.

The Paediatric Asthma Quality of Life Questionnaire contains 23 items that children with asthma have identified as troublesome in their daily lives. The aim was to evaluate the measurement properties of the questionnaire. The study design consisted of a 9 week single cohort study with assessments at 1, 5 and 9 weeks. Patients participating in the study were fifty-two children, 7-17 years of age, with a wide range of asthma severity. At each clinic visit, a trained interviewer administered the Paediatric Asthma Quality of Life Questionnaire, the Feeling Thermometer, a clinical asthma control questionnaire and measured spirometry. For 1 week before each clinic visit, patients recorded morning peak flow rates, medication use and symptoms in a diary. The Paediatric Asthma Quality of Life Questionnaire was able to detect quality of life changes in those patients who altered their health status either as a result of treatment or natural fluctuations in their asthma (p < 0.001) and to differentiate these patients from those who remained stable (p < 0.0001). It was reproducible in patients who were stable (ICC = 0.95), which also indicates the instrument's strength to discriminate between subjects of different impairment levels. The questionnaire showed good levels of both longitudinal and cross-sectional correlations with the conventional asthma indices and with general quality of life. The results were consistent across individual domains and different age strata. The Paediatric Asthma Quality of Life Questionnaire has good measurement properties and is valid both as an evaluative and a discriminative instrument. It captures aspects of asthma most important to the patient and adds additional information to conventional clinical outcomes.

Adolescent↗