Interpretation of rhinoconjunctivitis quality of life questionnaire data.
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Conjunctivitis↗
Biomedical subjects
E F Juniper
Publications and source records attributed to E F Juniper.
Quality of life as an outcome measure in nursing research. "May you have a long and healthy life".
Quality of life has emerged as an important concept and outcome in health and health care. Policy-makers, researchers, clinicians, and the public at large consider perceived quality of life to be an important dimension of the health of a population or an individual. The nature of nursing is such that many of its anticipated outcomes relate to improvement in the quality of life of individuals and populations. There continues to be debate about the actual definition of quality of life, and a concept that is difficult to define will naturally pose challenges to measurement. This has not impeded the proliferation of quality-of-life instruments, since the concept is recognized as an increasingly important clinical and research outcome. Progress has been made in clarifying and operationalizing the concept. We propose a conceptual viewpoint that separates what quality of life is from what contributes to quality of life. This will assist nurse researchers planning to use quality of life as an outcome in evaluating nursing interventions. In clinical or research situations, for the purposes of measurement, an operational definition of quality of life stems from a definition of health. From this is drawn a definition of health-related quality of life (HRQL). For the purpose of outcome measurement, the operational definition relates to the domains important to the study population and the particular health intervention under study. Issues that arise in the measurement of HRQL are also presented.
Humans↗
[The quality-of-life questionnaire with asthma patients: the Spanish version of the Asthma Quality of Life Questionnaire].
This paper describes the translation to Castilian and adaptation of a quality of life measurement instrument: the Asthma Quality of Life Questionnaire (AQLQ). The AQLQ, developed by Juniper et al, contains 32 items, 5 of which relate to habitual activities that the patient can choose from among a list of 26 possibilities. Answers are given on a scale of 7 points. To adapt this instrument for use in Spain, we subjected it to a process of translation/back translation by bilingual informants. The translated and original versions of each item, activity and answer option were evaluated as being totally equivalent (A), fairly equivalent but with some questionable wording (B), or of questionable equivalence (C). The naturalness and correctness of the Spanish version were also evaluated on a scale of 1 to 10. Three (9%) items and 1 (4%) activity were considered to be of questionable equivalence (C) and 12 (37%) items and 1 activity (4%) were considered to be of type B equivalence. The questionable aspects of types B and C equivalence were discussed in 2 meetings, along with expressions that were equivalent but unnatural or grammatically incorrect; the first meeting involved researchers and translators and the second was held with a group of 6 asthmatics. Consensus was finally obtained for each item and activity included in the second draft. That draft was then administered to another group of 7 patients in order to check comprehension and equivalence, after which a definitive version was produced by the researchers.(ABSTRACT TRUNCATED AT 250 WORDS)
Asthma↗
Quality of life in asthma clinical trials: comparison of salmeterol and salbutamol.
Most clinical trials in asthma have focused on outcomes that are primarily of importance to the clinician. Very few have assessed whether patients feel better and can function better in day-to-day activities. The aim of this study was to compare the effects of salmeterol (50 micrograms twice daily), salbutamol (200 micrograms four times a day), and placebo on asthma-specific quality of life and to relate the findings to conventional clinical asthma outcomes. The study was a 12-wk multicenter, double blind, randomized, placebo-controlled crossover trial with each trial medication taken for 4 wk. The subjects were 140 adults with mild to moderate asthma enrolled from 14 respiratory clinics across Canada. Outcome measures were: (1) the Asthma Quality of Life Questionnaire and spirometry at the end of each treatment period; and (2) daily asthma symptoms, morning and evening peak expiratory flow rates (PEFRs), and rescue salbutamol use during the last 14 d of each treatment period. Asthma-specific quality of life, both overall and for the individual domains (activity limitation, symptoms, emotional function, and exposure to environmental stimuli) was better with salmeterol than with placebo (p < 0.0001), and better with salmeterol than with salbutamol (p < 0.001). In both comparisons, differences were not only statistically significant, but most were also clinically important. There were moderate correlations between change in quality of life and change in clinical outcomes.(ABSTRACT TRUNCATED AT 250 WORDS)
Adolescent↗
Quality-of-life considerations in the treatment of asthma.
There is a growing body of evidence showing that the conventional clinical indices of asthma severity (airway calibre, symptoms, airway responsiveness, etc.) correlate only weakly with how patients are actually feeling and how they are able to function in their daily lives because of their asthma. When assessing and treating asthma, it is certainly important to evaluate the airways. However, it is equally important to evaluate the impact of the condition on the patients themselves. There are now a number of health-related quality-of-life instruments, with strong measurement properties, that may be used in both clinical studies and practice. They provide scientifically sound and valid information about patients' experience that complements conventional clinical measures.
Adult↗
Sodium cromoglycate eye drops: regular versus "as needed" use in the treatment of seasonal allergic conjunctivitis.
OBJECTIVE: The objective of this study was to compare the efficacy and side effects of sodium cromoglycate eye drops (Opticrom 2%) used regularly versus as needed in the treatment of seasonal (ragweed) allergic conjunctivitis. METHODS: A randomized, unblinded, parallel group comparison was performed during the 6 weeks of the ragweed pollen season. Sixty-two adults with ragweed pollen-induced conjunctivitis were recruited for the study from previous ragweed studies and notices in the local media. Two drops of sodium cromoglycate were placed in each eye either four times daily (regular treatment group) or when needed, up to four times daily (prn group), from 1 week before and throughout the ragweed pollen season. Uncontrolled eye symptoms were treated with terfenadine 60 mg as needed, up to 120 mg daily. Subjects kept daily diaries for symptoms and medication requirements throughout the 6 weeks of treatment. The Rhinoconjunctivitis Quality of Life Questionnaire was administered and adverse experiences were reported after 1, 3, and 6 weeks of treatment. RESULTS: Diary eye symptoms were similar in the two treatment groups, but quality of life was better in the regular treatment group. There was a trend for the prn group to require more terfenadine for uncontrolled eye symptoms. CONCLUSIONS: There may be some additional therapeutic benefit from using sodium cromoglycate eye drops regularly throughout the ragweed pollen season.
Adolescent↗
Assessment of quality of life in adolescents with allergic rhinoconjunctivitis: development and testing of a questionnaire for clinical trials.
BACKGROUND: The objectives of the study were to evaluate impairment in quality of life in 12- to 17-year-old patients with seasonal allergic rhinoconjunctivitis and to develop and test a questionnaire suitable for evaluating change in quality of life during clinical trials. METHODS: Patients were asked to identify physical and emotional impairments associated with allergic rhinoconjunctivitis. The resultant questionnaire was tested for responsiveness and validity in a clinical trial in which fluticasone nasal spray and loratadine were compared for treatment of ragweed pollen-induced rhinoconjunctivitis. Eighty-three patients, 12 to 17 years of age, with grass- or ragweed-induced hayfever participated in the instrument development phase. They were recruited for the study from an allergy clinic and local schools and recreational organizations. Two hundred forty patients with ragweed hayfever participated in the clinical trial and provided quality of life data. RESULTS: The survey showed that in addition to local symptoms, patients experienced impairment of quality of life because of systemic symptoms, activity limitations, and emotional and practical problems. The resultant questionnaire has 25 items in six domains. In the clinical trial responsiveness was demonstrated by the questionnaire's ability to detect change over time and differences between treatments. Construct validity was demonstrated by moderate to strong relationships between changes in diary symptom scores and quality of life. CONCLUSIONS: The items identified by 12- to 17-year-old patients were not identical to those previously identified by adults. This suggests that impairment of quality of life may not be the same in the two groups and that it is appropriate to have a questionnaire specifically designed for adolescent rhinoconjunctivitis clinical trials.
Activities of Daily Living↗
Determining a minimal important change in a disease-specific Quality of Life Questionnaire.
This study was carried out to determine whether the minimal important difference, in evaluative quality of life instruments which use a 7-point scale, is similar across individual domains and for both improvement and deterioration. Thirty nine adults with asthma were studied, using an 8 week cohort with assessments at 0, 4 and 8 weeks. The outcomes were the Asthma Quality of Life Questionnaire and global rating of change. For overall asthma-specific quality of life and for all individual domains (activities, emotions, symptoms), the minimal important difference of quality of life score per item was very close to 0.5 (range: 0.42-0.58); differences of approximately 1.0 represented a moderate change (range: 0.77-1.51); differences greater than 1.5 represented large changes. Changes for improvement and deterioration were very similar. The changes in quality of life score that represent a minimal important difference are very similar to those observed for other evaluative instruments. The observation that the minimal important difference is consistent across domains and for both improvement and deterioration will facilitate interpretation of results of studies examining quality of life.
Adult↗
[Airway response. Standardized provocation tests in adults: pharmacological, physical and sensitizing stimuli. Work Group on Standardization of Respiratory Function Tests. European Community for Coal and Steel. Official position of the European Respiratory Society].
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Adult↗
Quality of life issues in women with vertebral fractures due to osteoporosis.
OBJECTIVE: To learn about the physical, emotional, and social limitations experienced by postmenopausal women who have back pain due to vertebral fractures resulting from osteoporosis. METHODS: We conducted a cross-sectional survey of female patients with persistent pain due to vertebral fractures. RESULTS: Respondents had a mean (+/- SD) bone density of 0.87 +/- 0.13 gm/cm2 and a mean (+/- SD) of 2.84 +/- 2.18 fractures. Disability was identified in pain, movement, activities of daily living, and emotion. There was a poor correlation between quality of life and findings on radiography or densitometry. CONCLUSION: To evaluate the effects of osteoporosis on a patient's functional status, direct questioning is required.
Aged↗
Aqueous beclomethasone dipropionate in the treatment of ragweed pollen-induced rhinitis: further exploration of "as needed" use.
BACKGROUND: The objective of this study was to compare regular and "as required" (prn) use of aqueous beclomethasone dipropionate nasal spray (Beconase AQ nasal spray) in the treatment of ragweed pollen-induced rhinitis and to examine possible predictors of unsatisfactory symptom control in the group of patients who used it on a prn basis. METHODS: Sixty adults with ragweed pollen-induced rhinitis, who had participated in previous hay fever studies or who responded to media notices, were enrolled in the study. The study design was a randomized, unblinded, parallel group comparison between regular use (400 micrograms daily) and prn use of Beconase AQ spray during the 6 weeks of the ragweed pollen season. Patients recorded daily symptoms and medication use in diaries. The Rhinoconjunctivitis Quality of Life Questionnaire was administered, and patient satisfaction with symptom control was assessed at clinic visits. RESULTS: Symptoms and quality of life tended to be better in the regular group, but differences were not statistically significant. Twenty-seven percent of patients in the prn group reported unsatisfactory control of symptoms; they experienced significantly worse symptoms and quality of life than the remainder of the prn group and used significantly more Beconase. No obvious predictors of unsatisfactory control were identified. Patients who achieved satisfactory control in the prn group had symptom and quality of life scores that were very similar to those of the regular group. CONCLUSIONS: Most patients can use Beconase AQ as needed successfully for the treatment of hay fever, but there may be an apparently unpredictable minority who do not achieve satisfactory symptom control or quality of life with this approach and who require regular treatment.
Adolescent↗
Measuring quality of life in asthma.
The aim of this study was to evaluate the measurement properties of an Asthma Quality of Life Questionnaire. The study design was an 8-wk unblinded single cohort with assessments at 0, 4, and 8 wk. Thirty-nine adults with symptomatic asthma and a wide range of airway responsiveness and medication requirements were enrolled from previous studies and through notices in the local media. Those with inadequately controlled asthma were offered an inhaled steroid (budesonide). Asthma Quality of Life Questionnaire, spirometry, a clinical asthma control questionnaire, medication requirements, airway responsiveness to methacholine, the Sickness Impact Profile, and the Rand questionnaire were recorded at each visit. Patients kept daily diaries of peak flow rates and medications. The Asthma Quality of Life Questionnaire was able to detect changes in patients who responded to treatment or who had natural fluctuations in their asthma (p < 0.001) and to differentiate these patients from those who remained stable (p < 0.001). The Questionnaire was reproducible in patients who were stable (intraclass correlation coefficient = 0.92). There were significant longitudinal and cross-sectional correlations between asthma quality of life and other measures of both clinical asthma and generic quality of life. We conclude that the Asthma Quality of Life Questionnaire has good measurement properties and that it is valid as both an evaluative and a discriminative instrument. It measures the component of asthma most important to patients, and it should be considered for inclusion in all asthma studies.
Adolescent↗
Comparison of powder and aerosolized budesonide in perennial rhinitis: validation of rhinitis quality of life questionnaire.
The aims of the study were to compare the efficacy and side effects of intranasal budesonide as a dry powder and as a freon propelled pressurized aerosol in the treatment of perennial rhinitis and to validate a perennial rhinitis quality of life questionnaire. The design was a single-blind, randomized, parallel group comparison of two active treatments over a 6-week period. Sixty adults with symptomatic perennial rhinitis, stratified for atopy, received 400 micrograms intranasal budesonide administered daily either as one inhalation/nostril/day of pure drug powder or two puffs/nostril/day of drug delivered by a freon propelled aerosol. Subjects kept daily symptom diaries and, at each clinic visit, rhinitis quality of life and adverse experiences were recorded. Fifty-eight subjects completed the study. During the 6 weeks, there were significant improvements in symptoms and quality of life in both treatment groups. The improvements tended to be slightly greater in the aerosol group but the differences did not reach significance. Most frequently reported adverse experiences were headache and nosebleed, which were equally distributed in the two groups. We conclude that budesonide taken 400 micrograms daily for 6 weeks was associated with improvements in perennial rhinitis with little evidence of any difference in efficacy or side effects between the powder and aerosol. The questionnaire is a valid instrument for assessing quality of life in perennial rhinitis clinical trials.
Adult↗
Airway responsiveness. Standardized challenge testing with pharmacological, physical and sensitizing stimuli in adults. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society.
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Adult↗
Aqueous beclomethasone dipropionate nasal spray in the treatment of seasonal (ragweed) rhinitis.
OBJECTIVES: To determine whether the provision of appropriate medication and comprehensive information before the ragweed pollen season enables patients to manage their hay fever successfully, achieving satisfactory symptom control and quality of life, to examine patient characteristics that may predict successful symptom management and to learn which factors patients consider when making treatment choices. DESIGN: Single-group prospective cohort management study. SUBJECTS: Ninety adults sensitive to ragweed pollen recruited from those who had participated in previous clinical studies and from those who responded to advertisements in the local media. INTERVENTION: Aqueous beclomethasone dipropionate nasal spray and comprehensive information about optimal therapy (starting before the ragweed pollen season and continued throughout at a dose of 400 micrograms/d) and how it may be used less intensively with an as-required regimen. MAIN OUTCOME MEASURES: Symptom control, patient satisfaction, quality of life and medication use. RESULTS: More than 80% of the patients reported very good symptom control and were very satisfied. In all, 62% chose to use less than the optimal daily dose. Patients who had less than optimal symptom control used significantly less of the nasal spray than those with very good control either because they wanted to keep medication use to a minimum or because they were unable to remember to take their medication. The only significant predictor of inadequate control was an acknowledged inability to remember to take medication. Symptoms and trust in the practitioner were the primary factors perceived by the patients to determine their treatment choices. CONCLUSION: When provided with aqueous beclomethasone dipropionate nasal spray and comprehensive information on the drug and dosing, most patients are successful in managing their hay fever.
Administration, Intranasal↗
Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials.
BACKGROUND: In the past only physiological and clinical outcomes have been used to assess the effect of asthma interventions and the effect of the intervention on the lives of the patients has not been determined. The objective of this study was to assess health related impairment of quality of life in adult asthmatic patients and to develop a questionnaire for measuring quality of life in clinical trials in asthma. METHODS: Impairment of quality of life in adults with asthma was evaluated from structured interviews in which patients were asked to identify the parts of their daily lives affected by asthma. On the basis of these results, an asthma quality of life questionnaire was developed in an interviewer and self administered form and tested for comprehension and acceptability. A total of 150 adults with asthma and with a wide range of airway hyperresponsiveness were enrolled from previous clinical trials, local asthma clinics, and notices in the media. RESULTS: Areas of quality of life impairment included symptoms classically associated with asthma, responses to environmental stimuli, the need to avoid these stimuli, limitation of activities, and emotional dysfunction. Areas of impairment were similar across strata of airway hyperresponsiveness, age, and treatment requirements and between sexes, thus allowing a single questionnaire suitable for all adults with asthma to be developed. The questionnaire contains 32 items and takes 5-10 minutes to administer; in the pretesting it was shown to be acceptable to a wide range of patients. CONCLUSIONS: The questionnaire includes areas of quality of life impairment that are important to adult asthmatic patients. It has been designed to be responsive to within subject change and therefore may be used as a measure of outcome in clinical trials in asthma.
Adolescent↗
Reduction of budesonide after a year of increased use: a randomized controlled trial to evaluate whether improvements in airway responsiveness and clinical asthma are maintained.
We have demonstrated recently that 1 year of regular inhaled budesonide use can produce substantial improvements in airway responsiveness accompanied by significant improvements in clinical asthma severity. The present study was designed to evaluate whether these improvements are maintained when the dose of budesonide is reduced. At the end of the original study, 28 subjects with asthma, who had been in the active-treatment arm of the study were randomized either to continue taking the dose of budesonide taken in the original study or to have the dose reduced. Airway responsiveness to methacholine, bronchodilator requirements, symptoms, and spirometry were assessed after 6 weeks and 3 months. During the 3 months, no subject experienced an asthma exacerbation, and there was no evidence of change in airway responsiveness in subjects who had their steroids reduced (provocative concentration causing a 20% drop in FEV1; initial, 2.03 mg/ml; final, 1.91 mg/ml), and this change was not different from change in subjects maintained with a higher dose (initial, 3.02 mg/ml; final, 3.12 mg/ml) (p = 0.39). Similarly, there was no evidence of any change in bronchodilator requirements (p = 0.89). However, after 3 months of reduced steroid use, there was a small decline in spirometry (FEV1 percent predicted: initial, 84.4%; final, 81.5%), and this change was significantly different from change in subjects in whom steroids were not reduced (initial, 90.2%; final, 90.2%) (p = 0.002). At 3 months, symptoms (predominantly sputum production) were also beginning to redevelop in the reduced budesonide group (p = 0.056).(ABSTRACT TRUNCATED AT 250 WORDS)
Asthma↗
Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis.
The objective of this study was to develop and test a health-related quality of life questionnaire for clinical trials in rhinoconjunctivitis. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was developed by asking patients to identify areas of their lives affected by rhinoconjunctivitis. The resultant RQLQ was tested for reproducibility, responsiveness and validity in a randomized, double-blind trial of regular versus 'as required' aqueous beclomethasone dipropionate (BDP) nasal spray in ragweed pollen-induced rhinoconjunctivitis. Eighty-five patients from previous rhinoconjunctivitis studies participated in the developmental survey. Sixty ragweed-sensitive patients, from previous trials and media notices, were enrolled in the clinical trial. Aqueous BDP (800 micrograms) nasal spray was administered regularly or 'as required' throughout the ragweed pollen season. The survey revealed that, in addition to local symptoms of rhinoconjunctivitis, patients experienced impairment of quality of life through systemic symptoms, sleep disturbance, practical problems, activity limitations and emotional problems. The RQLQ includes 28 questions related to these dimensions. Repeated administration of the RQLQ demonstrated good reproducibility. During the clinical trial, the RQLQ proved responsive in its ability to distinguish between regular and 'as required' medication use. Validity was shown by moderate to strong relations between changes in symptom diary scores and changes in RQLQ scores. In conclusion the RQLQ is likely to prove useful as a measure of health-related quality of life in clinical trials in both rhinoconjunctivitis and rhinitis.
Clinical Trials as Topic↗