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Elizabeth F Juniper - One of the best experts on this subject based on the ideXlab platform.
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from the authors the Asthma Control Questionnaire for children still more questions than answers
European Respiratory Journal, 2011Co-Authors: Elizabeth F Juniper, Kevin Gruffyddjones, Sabbi Ward, Klas SvenssonAbstract:From the authors: L. van den Bemt and co-workers raise an important issue concerning the use of both self- and interviewer-administered versions for the validation of the Asthma Control Questionnaire (ACQ) in children and one we considered carefully when designing the study. We wanted to ensure that the ACQ could be used in clinical practice (individual children followed over time), paediatric research (6–16 yrs) and adult research (≥12 yrs). Therefore, two separate Questionnaires was not an option. The development of the ACQ had ensured that it contained the questions that are important for assessing Asthma Control in children 6–16 yrs of age (content validity) but we knew the self-administered adult version could not be completed unaided by younger children. We considered validating an interviewer version for all ages (6–16 yrs) but realised this would be less practical for older children and also for adult clinical trials that enrol patients ≥12 yrs of age. The decision to develop …
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Asthma Control Questionnaire in children validation measurement properties interpretation
European Respiratory Journal, 2010Co-Authors: Elizabeth F Juniper, Kevin Gruffyddjones, Sabbi Ward, Klas SvenssonAbstract:The Asthma Control Questionnaire (ACQ) has been validated in adults to measure the primary goal of management (minimisation of symptoms, activity limitations, short-acting β2-agonist use and airway narrowing). The present study evaluated the validity, measurement properties and interpretability of the ACQ in children aged 6–16 yrs. 35 children attended clinic on three occasions (0, 1 and 4 weeks) and completed the ACQ, Mini Paediatric Asthma Quality of Life Questionnaire and the Royal College of Physicians’ “Three Questions”. Parents completed the Paediatric Asthma Caregiver’s Quality of Life Questionnaire. Between visits, children completed the Asthma Control Diary and measured peak expiratory flow. At weeks 1 and 4, clinicians and parents completed Global Rating of Change Questionnaires. All patients completed the study. 19 children were stable between two assessments and provided evidence of good test–retest reliability (intraclass correlation coefficient 0.79). The ACQ was responsive to change in Asthma Control (p = 0.026) and the mean±sd Minimal Important Difference was 0.52±0.45. Both cross-sectional and longitudinal correlations between the ACQ and the other outcomes were close to predicted and provided evidence that the ACQ measures Asthma Control in children. The ACQ has strong measurement properties and is valid for use in children aged 6–16 yrs. In children aged 6–10 yrs, it must be administered by a trained interviewer.
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identifying well Controlled and not well Controlled Asthma using the Asthma Control Questionnaire
Respiratory Medicine, 2006Co-Authors: Elizabeth F Juniper, Jean Bousquet, Linda Abetz, Eric D BatemanAbstract:Summary The 7-item Asthma Control Questionnaire (ACQ) has been validated to measure the goals of Asthma management as defined by international guidelines (minimisation of day- and night-time symptoms, activity limitation, β 2 -agonist use and bronchoconstriction). Responses are given on a 7-point scale and the overall score is the mean of the responses (0=totally Controlled, 6=severely unControlled). The aim of this analysis was to determine the cut-point on the ACQ that best differentiates between ‘well-Controlled' and ‘not well-Controlled' for (a) clinical practice (low risk of missing ‘not well-Controlled') and (b) clinical trials (low risk of including ‘well-Controlled'). All 1323 patients who provided data sets at week 12 in the Gaining Optimal Asthma Control (GOAL) clinical trial were included in the analysis. The gold standard for ‘well-Controlled' was a composite based on the GINA/NIH guidelines and derived from data collected in the clinical trial diaries and clinic records. The analysis showed that the crossover point between ‘well-Controlled' and ‘not well-Controlled' is close to 1.00 on the ACQ. However, to be confident that a patient has well-Controlled Asthma, the optimal cut-point is 0.75 (negative predictive value=0.85). To be confident that the patient has inadequately Controlled Asthma, the optimal cut-point is 1.50 (positive predictive value=0.88). In conclusion, knowledge of these cut-points will enhance practising clinicians ability to identify patients whose Asthma requires additional treatment, enable investigators to enroll poorly Controlled patients into studies and for both clinicians and investigators to evaluate whether treatment goals are being achieved.
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concordance between supervised and postal administration of the mini Asthma quality of life Questionnaire miniaqlq and Asthma Control Questionnaire acq was very high
Journal of Clinical Epidemiology, 2005Co-Authors: Hilary Pinnock, Elizabeth F Juniper, Aziz SheikhAbstract:Abstract Background and Objective There is increasing international interest in using patient-based outcome measures to evaluate interventions. We compared responses to postal administration of Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and Asthma Control Questionnaire (ACQ) with the gold standard of supervised self-completion. Study Design and Setting Validation study involving 96 adults, recruited from U.K. general practice, sent the postal Questionnaires with an instruction sheet 1 week before supervised self-completion. Responses for those whose quality of life ( n = 56) or Asthma Control ( n = 61) had ‘not changed’ between postal and supervised completions were compared using paired-sample t -tests, Pearson's correlation coefficient ( r ), and intraclass correlation coefficient (ICC). Results For the MiniAQLQ, overall mean scores were similar in both groups: Postal = 5.14 (SD = 1.42) vs. Supervised = 5.17 (SD = 1.39), with mean difference of −0.03 (95% CI = −0.14, 0.08; P = .59), with a high degree of correlation ( r = .96, P P P = .74), with good correlation ( r = .94, P P Conclusions Correlation and concordance between supervised and postal administration of the MiniAQLQ and ACQ are very high. Users may confidently choose the mode of administration most appropriate to their needs.
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measurement properties and interpretation of three shortened versions of the Asthma Control Questionnaire
Respiratory Medicine, 2005Co-Authors: Elizabeth F Juniper, Klas Svensson, Annchristin Mork, Elisabeth StahlAbstract:The Asthma Control Questionnaire (ACQ) measures the adequacy of Asthma treatment as identified by international guidelines. It consists of seven items (5 x symptoms, rescue bronchodilator use and FEV1% of predicted normal). A validation study suggested that in clinical studies measurement of FEV1 and bronchodilator use may not be needed but this has never formally been tested in a clinical trial. The aims of this analysis were (1) to examine the measurement properties of three shortened versions of the ACQ (symptoms alone, symptoms plus FEV1 and symptoms plus short-acting beta2-agonist) and (2) to determine whether using the shortened versions would alter the results of a clinical trial. In the randomised trial, 552 adults completed the ACQ at baseline and after 13 and 26 weeks of treatment. The analysis showed that the measurement properties of all four versions of the ACQ are very similar. Agreement between the original ACQ and the reduced versions was high (intraclass correlation coefficients: 0.94-0.99). Mean differences between the ACQ and the shortened versions were less than 0.04 (on the 7-point scale). Clinical trial results using the four versions were almost identical with the mean treatment difference ranging from -0.09 (P=0.17), to -0.13 (P=0.07). For interpretability, the minimal important difference for all four versions was close to 0.5. In conclusion, these three shortened versions of the ACQ can be used in large clinical trials without loss of validity or change in interpretation.
Parameswaran Nair - One of the best experts on this subject based on the ideXlab platform.
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weight adjusted intravenous reslizumab in severe Asthma with inadequate response to fixed dose subcutaneous mepolizumab
American Journal of Respiratory and Critical Care Medicine, 2018Co-Authors: Manali Mukherjee, Nicola Lavigne, Fernando Aleman Paramo, Gayatri Nair, Melanie Kjarsgaard, Katherine Radford, Brittany M Salter, Roma Sehmi, Parameswaran NairAbstract:Rationale: Clinical benefits of fixed-dose 100-mg subcutaneous (SC) mepolizumab in prednisone-dependent patients are modest when sputum eosinophilia is not adequately Controlled.Objectives: This study compared treatment response of weight-adjusted intravenous (IV) reslizumab in patients previously treated with 100-mg SC mepolizumab.Methods: Ten prednisone-dependent patients with Asthma (sputum eosinophils >3% and blood eosinophils >300 cells/μl), who had previously received mepolizumab (100 mg SC dosed every 4 wk [Q4W]) for at least 1 year, received two infusions of placebo (Q4W) followed by four infusions of 3.0 mg/kg reslizumab Q4W in a single-blind, placebo-Controlled sequential trial. Primary outcomes were reduction of eosinophils in sputum and blood. Additional outcomes included FEV1, Asthma Control Questionnaire, eosinophil peroxidase, IL-5, sputum and blood innate lymphoid cells group 2, eosinophil progenitor cells, and autoimmune responses.Measurements and Main Results: IV reslizumab attenuated sp...
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reslizumab for poorly Controlled eosinophilic Asthma a randomized placebo Controlled study
American Journal of Respiratory and Critical Care Medicine, 2011Co-Authors: Mario Castro, Jeffrey H Wilkins, Timothy Henkel, Sameer K. Mathur, James B Young, Louis-philippe Boulet, Frederick E. Hargreave, Parameswaran NairAbstract:Rationale: Eosinophilic Asthma is a phenotype of Asthma characterized by the persistence of eosinophils in the airways. IL-5 is involved in the activation and survival of eosinophils.Objectives: To evaluate the effect of the antibody to IL-5, reslizumab, in patients with eosinophilic Asthma that is poorly Controlled with high-dose inhaled corticosteroid.Methods: Patients were randomly assigned to receive infusions of reslizumab at 3.0 mg/kg (n = 53) or placebo (n = 53) at baseline and at Weeks 4, 8, and 12, with stratification by baseline Asthma Control Questionnaire (ACQ) score less than or equal to 2 or greater than 2. The primary efficacy measure was the difference between the reslizumab and placebo groups in the change in ACQ score from baseline to end of therapy (Week 15 or early withdrawal).Measurements and Main Results: Mean changes from baseline to end of therapy in ACQ score were –0.7 in the reslizumab group and –0.3 in the placebo group (P = 0.054) and in FEV1 were 0.18 and –0.08 L, respectively...
Eric D Bateman - One of the best experts on this subject based on the ideXlab platform.
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Erratum: International ERS/ATS guidelines on definition, evaluation and treatment of severe Asthma (European Respiratory Journal (2014) 43 (343–373) DOI: 10.1183/09031936.00202013)
European Respiratory Journal, 2020Co-Authors: Kian Fan Chung, Mario Castro, Sally E Wenzel, Eric D Bateman, Jan Brozek, Andrew Bush, Peter J. Sterk, Ian M. Adcock, Eugene R. BleeckerAbstract:This article from the February 2014 issue of the European Respiratory Journal was originally published with errors in the criteria used to define severe Asthma on page 350 and in table 3. At both aforementioned points in the article, the “poor symptom Control” criterion for severe Asthma should have been defined as: Asthma Control Questionnaire (ACQ) consistently 1.5 or Asthma Control Test (ACT) 1.5 or ACT 3 days each) in the previous year.
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A randomized study of BI 671800, a CRTH2 antagonist, as add-on therapy in poorly Controlled Asthma.
Allergy and Asthma Proceedings, 2017Co-Authors: David Miller, Eric D Bateman, Chester C. Wood, Craig Laforce, Jon Blatchford, James Hilbert, Abhya Gupta, Andrew FowlerAbstract:BACKGROUND: Asthma is characterized by a complex interaction of inflammatory mediators. The prostaglandin D2 receptor, chemoattractant receptor-homologous molecule on Th2 cells (CRTH2), plays a pivotal role in the pathogenesis of allergic airway inflammation. OBJECTIVE: To ealuate the efficacy, safety, and pharmacokinetics of BI 671800, a CRTH2 antagonist, when added to inhaled corticosteroid therapy in adult patients with symptomatic Asthma. METHODS: In this phase IIa, 12-week, randomized, double-blind, three-period, four-treatment, incomplete block crossover trial, BI 671800 was administered either as a single 400-mg dose in the morning (A.M.) or evening (P.M.), or 200 mg twice daily (A.M. and P.M.) versus placebo, together with fluticasone propionate (44 μg, two inhalations twice daily). The primary end point was the change from baseline in trough forced expiratory volume in 1 second percentage predicted after 4 weeks. The secondary end point was the change in Asthma Control Questionnaire score from baseline. RESULTS: A total of 108 patients were randomized and treated. After 4 weeks, the adjusted mean (± SE) treatment differences for the primary end point versus placebo were 0.08 ± 0.62%, 0.28 ± 0.61%, and 0.67 ± 0.63% for BI 671800 at 200 mg twice daily, 400 mg A.M., and 400 mg P.M., respectively (not statistically significant). No statistically significant or clinically meaningful differences in the Asthma Control Questionnaire score were observed versus placebo. Each treatment was well tolerated. CONCLUSION: BI 671800 at a dose of 400 mg administered for 4 weeks with fluticasone propionate did not provide clinical improvement in patients with Asthma; reasons for this are unclear, but it may be due to insufficient inhibition of the CRTH2 receptor at the doses used.
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magnitude of effect of Asthma treatments on Asthma quality of life Questionnaire and Asthma Control Questionnaire scores systematic review and network meta analysis
The Journal of Allergy and Clinical Immunology, 2015Co-Authors: Eric D Bateman, Dirk Esser, Costel Chirila, Maria Fernandez, Andy Fowler, Petra Moronizentgraf, Mark J FitzgeraldAbstract:Background The Asthma Quality of Life Questionnaire (AQLQ) and the Asthma Control Questionnaire (ACQ) are widely used in Asthma research; however, in studies of newer Asthma treatments, mean improvements in these measures compared with placebo arms do not exceed the minimal important difference (MID), particularly when a new treatment is added to current treatment. Objective We performed a systematic review and network meta-analysis to examine the magnitude of AQLQ and ACQ responses achieved with commonly used Asthma drugs and factors influencing these end points in clinical trials. Methods A systematic literature search was conducted to identify blinded randomized Controlled trials reporting AQLQ or ACQ results. Mixed treatment comparisons, combined with meta-regression, were then performed. Results Of the 64 randomized Controlled trials (42,527 patients) identified, 54 included the AQLQ and 11 included the ACQ as end points. The presence of a run-in period, the nature of treatment during the run-in period, concurrent treatment during the treatment period, and instrument version significantly influenced the change in AQLQ score from baseline and whether it exceeded the MID. When compared with placebo, only inhaled corticosteroids (ICSs), with or without a long-acting β-agonist, achieved the MID. The ACQ results were comparable with those of the AQLQ: no differences from placebo exceeded the MID, and ICS-based treatments provided the greatest improvements. Conclusion The established within-patient MID for the ACQ and AQLQ is not achievable as a group-wise efficacy threshold between treatment arms in clinical studies in which Controllers are added to ICS treatment. Thus in addition to reporting mean changes of the instruments, other measurement criteria should be considered, including responder analyses.
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identifying well Controlled and not well Controlled Asthma using the Asthma Control Questionnaire
Respiratory Medicine, 2006Co-Authors: Elizabeth F Juniper, Jean Bousquet, Linda Abetz, Eric D BatemanAbstract:Summary The 7-item Asthma Control Questionnaire (ACQ) has been validated to measure the goals of Asthma management as defined by international guidelines (minimisation of day- and night-time symptoms, activity limitation, β 2 -agonist use and bronchoconstriction). Responses are given on a 7-point scale and the overall score is the mean of the responses (0=totally Controlled, 6=severely unControlled). The aim of this analysis was to determine the cut-point on the ACQ that best differentiates between ‘well-Controlled' and ‘not well-Controlled' for (a) clinical practice (low risk of missing ‘not well-Controlled') and (b) clinical trials (low risk of including ‘well-Controlled'). All 1323 patients who provided data sets at week 12 in the Gaining Optimal Asthma Control (GOAL) clinical trial were included in the analysis. The gold standard for ‘well-Controlled' was a composite based on the GINA/NIH guidelines and derived from data collected in the clinical trial diaries and clinic records. The analysis showed that the crossover point between ‘well-Controlled' and ‘not well-Controlled' is close to 1.00 on the ACQ. However, to be confident that a patient has well-Controlled Asthma, the optimal cut-point is 0.75 (negative predictive value=0.85). To be confident that the patient has inadequately Controlled Asthma, the optimal cut-point is 1.50 (positive predictive value=0.88). In conclusion, knowledge of these cut-points will enhance practising clinicians ability to identify patients whose Asthma requires additional treatment, enable investigators to enroll poorly Controlled patients into studies and for both clinicians and investigators to evaluate whether treatment goals are being achieved.
William W Busse - One of the best experts on this subject based on the ideXlab platform.
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Anti–IL-5 treatments in patients with severe Asthma by blood eosinophil thresholds: Indirect treatment comparison
The Journal of Allergy and Clinical Immunology, 2018Co-Authors: William W Busse, Frank C Albers, Geoffrey L. Chupp, Daniel J. Bratton, S. Doyle, Hiroyuki Nagase, Qin Shen, Necdet B GunsoyAbstract:Background Three anti–IL-5 pathway–directed therapies are approved for use in patients with severe eosinophilic Asthma (SEA); however, no head-to-head comparison data are available. Objective We sought to compare the efficacy of licensed doses of mepolizumab, benralizumab, and reslizumab in patients with SEA, according to baseline blood eosinophil counts. Methods This indirect treatment comparison (ITC) used data from a Cochrane review and independent searches. Eligible studies were randomized Controlled trials in patients aged 12 years or greater with SEA. End points included annualized rate of clinically significant exacerbations and change from baseline in Asthma Control Questionnaire score and FEV1. An ITC was performed in patients with Asthma Control Questionnaire scores of 1.5 or greater and stratified by baseline blood eosinophil count. Results Eleven studies were included. All treatments significantly reduced the rate of clinically significant exacerbations and improved Asthma Control versus placebo in all blood eosinophil count subgroups. Mepolizumab reduced clinically significant exacerbations by 34% to 45% versus benralizumab across subgroups (rate ratio ≥400 cells/μL: 0.55 [95% CI, 0.35-0.87]; ≥300 cells/μL: 0.61 [95% CI, 0.37-0.99]; and ≥150 cells/μL: 0.66 [95% CI, 0.49-0.89]; all P Conclusions This ITC of the licensed doses suggests that mepolizumab was associated with significantly greater improvements in clinically significant exacerbations and Asthma Control compared with reslizumab or benralizumab in patients with similar blood eosinophil counts.
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Anti-IL-5 treatments in patients with severe Asthma by blood eosinophil thresholds: Indirect treatment comparison.
The Journal of Allergy and Clinical Immunology, 2018Co-Authors: William W Busse, Frank C Albers, Geoffrey L. Chupp, Daniel J. Bratton, S. Doyle, Hiroyuki Nagase, Qin Shen, Necdet B GunsoyAbstract:Background Three anti–IL-5 pathway–directed therapies are approved for use in patients with severe eosinophilic Asthma (SEA); however, no head-to-head comparison data are available. Objective We sought to compare the efficacy of licensed doses of mepolizumab, benralizumab, and reslizumab in patients with SEA, according to baseline blood eosinophil counts. Methods This indirect treatment comparison (ITC) used data from a Cochrane review and independent searches. Eligible studies were randomized Controlled trials in patients aged 12 years or greater with SEA. End points included annualized rate of clinically significant exacerbations and change from baseline in Asthma Control Questionnaire score and FEV1. An ITC was performed in patients with Asthma Control Questionnaire scores of 1.5 or greater and stratified by baseline blood eosinophil count. Results Eleven studies were included. All treatments significantly reduced the rate of clinically significant exacerbations and improved Asthma Control versus placebo in all blood eosinophil count subgroups. Mepolizumab reduced clinically significant exacerbations by 34% to 45% versus benralizumab across subgroups (rate ratio ≥400 cells/μL: 0.55 [95% CI, 0.35-0.87]; ≥300 cells/μL: 0.61 [95% CI, 0.37-0.99]; and ≥150 cells/μL: 0.66 [95% CI, 0.49-0.89]; all P Conclusions This ITC of the licensed doses suggests that mepolizumab was associated with significantly greater improvements in clinically significant exacerbations and Asthma Control compared with reslizumab or benralizumab in patients with similar blood eosinophil counts.
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A randomized multicenter study evaluating Xolair persistence of response after long-term therapy.
The Journal of Allergy and Clinical Immunology, 2016Co-Authors: Dennis K. Ledford, William W Busse, Benjamin Trzaskoma, Theodore A. Omachi, Karin Rosén, Bradley E. Chipps, Allan T. Luskin, Paul G. SolariAbstract:Background Few data are available to assist clinicians with decisions regarding long-term use of Asthma therapies, including omalizumab. Objective We sought to evaluate the benefit and persistence of response in subjects continuing or withdrawing from long-term omalizumab treatment. Methods Evaluating the Xolair Persistency Of Response After Long-Term Therapy (XPORT) was a randomized, double-blind, placebo-Controlled withdrawal study that included subjects with moderate-to-severe persistent Asthma receiving long-term omalizumab. Subjects were randomized by using a hierarchical dynamic randomization scheme to continue their same dose of omalizumab or withdraw to placebo and were then followed every 4 weeks for 1 year. The primary outcome was any protocol-defined severe Asthma exacerbation. The secondary outcome was time to first protocol-defined severe Asthma exacerbation. Exploratory outcomes included changes in Asthma Control Questionnaire and Asthma Control Test scores. Results Significantly more subjects in the omalizumab group (67%) had no protocol-defined exacerbation than in the placebo group (47.7%); an absolute difference of 19.3% (95% CI, 5.0%, 33.6%) represents a 40.1% relative difference. Time to first protocol-defined exacerbation analysis revealed a significantly different between-group exacerbation pattern that was consistent with the primary analysis. Subjects continuing omalizumab had significantly better Asthma Control (mean [SD] change from baseline to week 52: Asthma Control Test score, −1.16 [4.14] vs placebo, −2.88 [5.38], P = .0188; Asthma Control Questionnaire score, 0.22 [0.66] vs placebo, 0.63 [1.13], P = .0039). Discontinuation of omalizumab was associated with an increase in free IgE levels and an increase in basophil expression of the high-affinity IgE receptor. No safety concerns were noted. Conclusion Continuation of omalizumab after long-term treatment results in continued benefit, as evidenced by improved symptom Control and reduced exacerbation risk.
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randomized double blind placebo Controlled study of brodalumab a human anti il 17 receptor monoclonal antibody in moderate to severe Asthma
American Journal of Respiratory and Critical Care Medicine, 2013Co-Authors: William W Busse, Yun Chon, Edward Kerwin, Stephen T Holgate, Jingyuan FengAbstract:Rationale: IL-17 signaling has been implicated in development and persistence of Asthma. Cytokine-targeted strategies blocking IL-17 receptor signaling may be beneficial in Asthma treatment.Objectives: To determine efficacy and safety of brodalumab, a human anti–IL-17 receptor A monoclonal antibody, in subjects with inadequately Controlled moderate to severe Asthma taking regular inhaled corticosteroids.Methods: Three hundred two subjects were randomized to brodalumab (140, 210, or 280 mg) or placebo. Primary endpoint was change in Asthma Control Questionnaire (ACQ) score from baseline to Week 12. Secondary endpoints included FEV1, symptom scores, and symptom-free days. Prespecified subgroup analyses were conducted to identify potential responsive subpopulations. Analyses included randomized subjects receiving one or more doses of investigational product using last-observation-carried-forward imputation.Measurements and Main Results: Demographics and baseline characteristics were generally balanced among ...
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Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in Asthmatic patients
The Journal of Allergy and Clinical Immunology, 2012Co-Authors: William W Busse, Eli O Meltzer, Sally E Wenzel, Yun Chon, Edward Kerwin, Nan Zhang, Alison L. BudelskyAbstract:BACKGROUND: The D-prostanoid receptor and the chemoattractant receptor homologous molecule expressed on T(H)2 cells (CRTH2) are implicated in Asthma pathogenesis. AMG 853 is a potent, selective, orally bioavailable, small-molecule dual antagonist of human D-prostanoid and CRTH2. OBJECTIVE: We sought to determine the efficacy and safety of AMG 853 compared with placebo in patients with inadequately Controlled Asthma. METHODS: Adults with moderate-to-severe Asthma were randomized to placebo; 5, 25, or 100 mg of oral AMG 853 twice daily; or 200 mg of AMG 853 once daily for 12 weeks. All patients continued their inhaled corticosteroids. Long-acting β-agonists were not allowed during the treatment period. Allowed concomitant medications included short-acting β-agonists and a systemic corticosteroid burst for Asthma exacerbation. The primary end point was change in total Asthma Control Questionnaire score from baseline to week 12. Secondary and exploratory end points included FEV(1), symptom scores, rescue short-acting β-agonist use, and exacerbations. RESULTS: Among treated patients, no effect over placebo (n = 79) was observed in mean changes in Asthma Control Questionnaire scores at 12 weeks (placebo, -0.492; range for AMG 853 groups [n = 317], -0.444 to -0.555). No significant differences between the active and placebo groups were observed for secondary end points. The most commonly reported adverse events were Asthma, upper respiratory tract infection, and headache; 9 patients experienced serious adverse events, all of which were deemed unrelated to study treatment by the investigator. CONCLUSION: AMG 853 as an add-on to inhaled corticosteroid therapy demonstrated no associated risks but was not effective at improving Asthma symptoms or lung function in patients with inadequately Controlled moderate-to-severe Asthma.
Tjard Schermer - One of the best experts on this subject based on the ideXlab platform.
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Comparison between an online self-administered and an interviewer-administered version of the Asthma Control Questionnaire: a cross-sectional validation study.
Primary Care Respiratory Journal, 2013Co-Authors: Persijn J Honkoop, Tjard Schermer, Rik Loijmans, Evelien H. Termeer, Jiska B. Snoeck-stroband, Gerben Ter Riet, Jacob K SontAbstract:BACKGROUND: Online self-management programmes for Asthma have recently become available. International guidelines suggest that the Asthma Control Questionnaire (ACQ) can be used in these programmes. In order to assess the current level of Control and guide therapy, the same cut-off values are being used as in conventional Asthma management. However, results might differ between different types of administration of the ACQ. AIMS: To assess the agreement between an online self-administered version of the ACQ and an interviewer-administered version at a routine visit. METHODS: Cross-sectional data from primary care Asthma patients in the Asthma Control Cost Utility Randomized Trial Evaluation (ACCURATE) trial aged 18-50 years and prescribed inhaled steroids were analysed. We selected patients who self-administered an ACQ online and subsequently had an ACQ completed by a nurse practitioner within 7 days at a trial-related Control visit. ACQ scores were calculated and agreement assessed by paired t-tests, Pearson's correlation coefficient and a Bland-Altman plot. RESULTS: A total of 351 patients were eligible (68% female, mean age 40 years). The time interval between the two versions was 3.2 days. There was a significant difference of 0.14 (95% CI 0.09 to 0.20; p
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comparison between an online self administered and an interviewer administered version of the Asthma Control Questionnaire a cross sectional validation study
Primary Care Respiratory Journal, 2013Co-Authors: Persijn J Honkoop, Tjard Schermer, Jiska B Snoeckstroband, Rik Loijmans, Evelien H. Termeer, Gerben Ter Riet, Jacob K SontAbstract:BACKGROUND: Online self-management programmes for Asthma have recently become available. International guidelines suggest that the Asthma Control Questionnaire (ACQ) can be used in these programmes. In order to assess the current level of Control and guide therapy, the same cut-off values are being used as in conventional Asthma management. However, results might differ between different types of administration of the ACQ. AIMS: To assess the agreement between an online self-administered version of the ACQ and an interviewer-administered version at a routine visit. METHODS: Cross-sectional data from primary care Asthma patients in the Asthma Control Cost Utility Randomized Trial Evaluation (ACCURATE) trial aged 18-50 years and prescribed inhaled steroids were analysed. We selected patients who self-administered an ACQ online and subsequently had an ACQ completed by a nurse practitioner within 7 days at a trial-related Control visit. ACQ scores were calculated and agreement assessed by paired t-tests, Pearson's correlation coefficient and a Bland-Altman plot. RESULTS: A total of 351 patients were eligible (68% female, mean age 40 years). The time interval between the two versions was 3.2 days. There was a significant difference of 0.14 (95% CI 0.09 to 0.20; p<0.001) between the results of the online self-administered ACQ (mean 1.04+/-0.04) and the interviewer-administered ACQ results (0.90+/-0.04). The Pearson correlation coefficient was 0.79. The limits of agreement (-0.86, 1.14) exceeded the predefined minimal clinically important difference between results (+/-0.5). The Bland-Altman plot therefore showed insufficient agreement. CONCLUSIONS: Assessment of Asthma Control by the ACQ is influenced by the type of administration. Our results suggest that better Control of Asthma is perceived when interacting with a caregiver than by online self-assessment.
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the Asthma Control Questionnaire for children still more questions than answers
European Respiratory Journal, 2011Co-Authors: E A J M Van Den Bemt, S Van Bragt, Tjard SchermerAbstract:To the Editors: Optimising Control is the main goal in paediatric Asthma management and reliable instruments that can help physicians to evaluate Asthma Control in an easy way are valuable. The article by Juniper et al. [1] provides some initial insights on the use of the Asthma Control Questionnaire (ACQ), an instrument that was originally developed for adult Asthma, to assess Asthma Control in children. The process of developing and validating such a Questionnaire is a delicate one. In 2009 Juniper [2] published a critical editorial about the consequences of even small modifications to original Questionnaires and how this could …
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tracing unControlled Asthma in family practice using a mailed Asthma Control Questionnaire
Annals of Family Medicine, 2008Co-Authors: Lotte Van Den Nieuwenhof, Tjard Schermer, Marianne Heins, Joke Grootens, Petra Eysink, B J A M Bottema, Chris Van Weel, Patrick J E BindelsAbstract:PURPOSE A substantial proportion of adult patients with Asthma have inadequately Controlled symptoms despite the availability of effective treatment. The Asthma Control Questionnaire (ACQ) can be used to discriminate between Asthma patients with well- and suboptimally Controlled Asthma symptoms. The objective of this study was to investigate whether a postal mailing of the ACQ can be used to identify Asthma patients with suboptimal symptom Control in family practice. METHODS In this observational study, we sent 434 Asthma patients from 6 Dutch family practices an ACQ by mail to measure Control of their Asthma symptoms. Both respondents and nonrespondents were characterized by information gathered from their medical records. Patients with an ACQ sum score (total score) of greater than 3 were considered to have suboptimally Controlled Asthma symptoms. RESULTS The response rate was 77%. Respondents were more likely than non-respondents to be female and to use Asthma medication. The mean ACQ sum score of the respondents was 5.2. Of this group, 53.4% (95% confidence interval, 48.0%–58.8%) had suboptimally Controlled Asthma symptoms. Of the 168 respondents who had not visited their family physician in the 2 years before the study, 42.9% (95% confidence interval, 35.4%–50.4%) had inadequate Asthma symptom Control. CONCLUSIONS Our results show that a postal mailing of the ACQ is an effective approach for tracing Asthma patients who need medical attention. It also traces patients who would otherwise not have consulted their family physician. The ACQ seems to be a useful starting point for health care professionals in family practice to improve the level of Asthma symptom Control in their patient population.
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can the Asthma Control Questionnaire be used to differentiate between patients with Controlled and unControlled Asthma symptoms a pilot study
Family Practice, 2006Co-Authors: Lotte Van Den Nieuwenhof, Tjard Schermer, Petra Eysink, Chris Van Weel, Patrick J E Bindels, Eric Halet, B J A M BottemaAbstract:BACKGROUND: A substantial number of adult patients with Asthma are inadequately Controlled despite the availability of effective Asthma treatment. Patients and physicians seem to overestimate the level of Asthma Control. OBJECTIVE: The current study explores whether valid differentiation is possible between Asthma patients with Controlled and unControlled Asthma symptoms, on the basis of the Asthma Control Questionnaire (ACQ). METHODS: In this multi-centre, cross-sectional study, patients were classified according to Global Initiative for Asthma criteria into levels of Asthma symptom Control based on a diary card registration. We defined Step 1 ('well Controlled' Asthma symptoms), Step 2 ('moderately Controlled'), Step 3 ('poorly Controlled') and Step 4 ('very poorly Controlled'). These Control steps were related with the sum score of the ACQ. RESULTS: From 108 Asthma patients complete data were obtained. The Step 1 subgroup comprised 17 patients; Step 2, 12 patients; Step 3, 22 patients; and Step 4, 57 patients. Receiver Operating Characteristic curve analysis showed that the optimal ACQ sum score cut-off value to differentiate between Step 1 and Steps 2, 3 and 4 was three points (sensitivity: 84%, specificity: 76%). For Steps 1 and 2 versus Steps 3 and 4, this was four points (sensitivity: 77%, specificity: 59%). For Steps 1, 2 and 3 versus Step 4, this was six points (sensitivity: 70%, specificity: 74%). CONCLUSION: Our results show that discrimination between Asthma patients with Controlled and unControlled Asthma symptoms, based on the ACQ, is possible with a reasonable margin of test inaccuracy. Thus, the ACQ may be an important tool for health care professionals who aim to optimize the level of Asthma Control in their patient population.
