Measuring asthma control. Clinic questionnaire or daily diary?

Daily symptom, peak expiratory flow rate (PEFR), and medication diaries are often used in clinical trials of treatments for asthma on the assumption that they provide a better estimate of clinical status than does a questionnaire completed in the clinic. We conducted a study with the aim of comparing the measurement properties of the clinic-completed Asthma Control Questionnaire with those of the Asthma Control Diary. The diary is composed of questions and response options almost identical to those of the questionnaire, but uses PEFR instead of FEV(1) as the measure of airway caliber. In an observational study, 50 adults with symptomatic asthma attended a McMaster University asthma clinic at 0, 1, 5, and 9 wk to complete the Asthma Control Questionnaire and other measures of asthma status. For 1 wk before each follow-up visit, patients completed the Asthma Control Diary every morning and evening. Concordance between the questionnaire and diary was high (intraclass correlation coefficient [ICC] = 0.87). Both reliability (ICC: questionnaire = 0.90; diary = 0.86) and responsiveness (responsiveness index: questionnaire = 1.06; diary = 0.90; p = 0.005) were better with the questionnaire than with the diary. Correlations between the two instruments and other measures of clinical asthma status were similar and close to a priori predictions. Both the Asthma Control Questionnaire and the Asthma Control Diary are valid instruments for measuring asthma control, but the questionnaire has slightly better discriminative and evaluative measurement properties than does the diary.

Development and validation of the mini Rhinoconjunctivitis Quality of Life Questionnaire.

BACKGROUND: The 28-item Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) has strong measurement properties but for large clinical trials, surveys and practice monitoring, where high efficiency is important, a shorter questionnaire is needed. OBJECTIVE: To develop and validate an abbreviated version of the RQLQ. METHODS: Using five RQLQ databases, items with high item-item correlations were combined and then the highest scoring items were selected for the MiniRQLQ (14 questions). There are five domains: activity limitations (standardized), practical problems and nose symptoms, eye symptoms and other symptoms. The MiniRQLQ, which is self-administered, was tested in a 5-week observational study in 100 adults with symptomatic rhinoconjunctivitis. Patients completed the MiniRQLQ, the RQLQ, and other measures of health status at baseline, 1 and 5 weeks. RESULTS: In patients whose rhinoconjunctivitis was stable between clinic visits, reliability (reproducibility and ability to discriminate between patients of different impairment) was very acceptable for the MiniRQLQ (ICC = 0.93) but not quite as good as for the RQLQ (ICC = 0.97). Responsiveness to change in clinical status was better with the MiniRQLQ than the RQLQ (P = 0. 044). Construct validity (correlation with other indices of health status) was strong for both the MiniRQLQ and the RQLQ. Concordance between the two instruments was high (ICC = 0.87). CONCLUSIONS: The MiniRQLQ has strong measurement properties and measures the same construct as the original RQLQ. The choice of questionnaire should depend on the task at hand.

Development and validation of a questionnaire to measure asthma control.

International guidelines on asthma management indicate that the primary goal of treatment should be optimum asthma control. The aim of this study was to develop and validate the Asthma Control Questionnaire (ACQ). The authors generated a list of all symptoms used to assess control and sent it to 100 asthma clinicians who were members of guidelines committees (18 countries). They scored each symptom for its importance in evaluating asthma control. From the 91 responses, the five highest scoring symptoms were selected for the ACQ. In addition, there is one question on beta2-agonist use and another on airway calibre (total questions=7). The ACQ was tested in a 9-week observational study of 50 adults with symptomatic asthma. The ACQ and other measures of asthma health status were assessed at baseline, 1, 5 and 9 weeks. In patients whose asthma was stable between clinic visits, reliability of the ACQ was high (intraclass correlation coefficient (ICC)=0.90). The questionnaire was very responsive to change in asthma control (p<0.0001). Cross-sectional and longitudinal validity were supported by correlations between the ACQ and other measures of asthma health status being close to a priori predictions. In conclusion, the Asthma Control Questionnaire has strong evaluative and discriminative properties and can be used with confidence to measure asthma control.

Development and validation of the Mini Asthma Quality of Life Questionnaire.

The 32-item Asthma Quality of Life Questionnaire (AQLQ) has shown good responsiveness, reliability and construct validity; properties that are essential for use in clinical trials, clinical practice and surveys. However, to meet the needs of large clinical trials and long-term monitoring, where efficiency may take precedent over precision of measurement, the 15-item self-administered MiniAQLQ has been developed. The MiniAQLQ was tested in a 9-week observational study of 40 adults with symptomatic asthma. Patients completed the MiniAQLQ, the AQLQ, the Short Form (SF)-36, the Asthma Control Questionnaire and spirometry at baseline, 1, 5 and 9 weeks. In patients whose asthma was stable between clinic visits, reliability was very acceptable for the MiniAQLQ (intraclass correlation coefficient (ICC)=0.83), but not quite as good as for the AQLQ (ICC=0.95). Similarly, responsiveness in the MiniAQLQ (p=0.0007) was good but not quite so good as for the AQLQ (p<0.0001). Construct validity (correlation with other indices of health status) was strong for both the MiniAQLQ and the AQLQ. Criterion validity showed that there was no bias between the instruments (p=0.61) and the correlation between them was high (r=0.90). The Mini Asthma Quality of Life Questionnaire has good measurement properties but they are not quite as strong as those of the original Asthma Quality of Life Questionnaire. The choice of questionnaire should depend on the task at hand.

Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire.

BACKGROUND: In the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), the 3 activity questions are selected by the patients themselves. For greater efficiency, a version with standardized activities is required. OBJECTIVE: Our purpose was to develop and validate a standardized version of the RQLQ, the RQLQ(S). METHODS: With use of 5 RQLQ databases, we identified the activities most frequently selected by patients and formulated 3 generic questions that would encompass the majority of these activities. The RQLQ(S) was tested in a 5-week observational study in 100 adults with symptomatic rhinoconjunctivitis. Patients completed the RQLQ(S), the RQLQ, and other measures of health status at baseline and 1 and 5 weeks. RESULTS: The activity domain of the RQLQ(S) consistently gave lower scores than did the activity domain of the RQLQ (P <.001). However, this made very little difference to the overall scores (RQLQ[S] = 2.36 +/- 1.23, RQLQ = 2.43 +/- 1.23), and overall concordance was high (intraclass correlation coefficient = 0.996). In patients whose rhinoconjunctivitis was stable between clinic visits, reliability (reproducibility and ability to discriminate between patients of different impairment) was high for both instruments and almost identical (intraclass correlation coefficient = 0.97). Responsiveness to change was also very similar and good (P <.001). Construct validity (correlation with other index values of health status) was strong for both the RQLQ(S) and the RQLQ. CONCLUSIONS: The RQLQ(S) has strong measurement properties and measures the same construct as the original RQLQ. The choice of questionnaire should depend on the task at hand.

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.

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.

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.

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.

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.

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.

[The quality-of-life questionnaire with asthma patients: the Spanish version of the Asthma Quality of Life Questionnaire]. / Cuestinario de calidad de vida en pacientes con asma: la versión española del 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)

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.

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.

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.

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.

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.

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.