An Official American Thoracic Society/European Respiratory Society Statement: Asthma Control and Exacerbations Standardising Endpoints for Clinical Asthma Trials and Clinical Practice

被引：1562

作者：

Reddel, Helen K. ^{[1
]}

Taylor, D. Robin ^{[21
]}

Bateman, Eric D. ^{[2
]}

Boulet, Louis-Philippe ^{[3
]}

Boushey, Homer A. ^{[4
]}

Busse, William W.

Casale, Thomas B. ^{[5
]}

Chanez, Pascal ^{[6
]}

Enright, Paul L. ^{[7
]}

Gibson, Peter G. ^{[8
,9
]}

de Jongste, Johan C. ^{[10
]}

Kerstjens, Huib A. M. ^{[11
]}

Lazarus, Stephen C. ^{[4
]}

Levy, Mark L. ^{[12
]}

O'Byrne, Paul M. ^{[13
]}

Partridge, Martyn R. ^{[14
]}

Pavord, Ian D. ^{[15
]}

Sears, Malcolm R. ^{[13
]}

Sterk, Peter J. ^{[16
]}

Stoloff, Stuart W. ^{[17
]}

Sullivan, Sean D. ^{[20
]}

Szefler, Stanley J. ^{[18
,19
]}

Thomas, Mike D. ^{[22
]}

Wenzel, Sally E. ^{[23
]}

机构：

[1] Woolcock Inst Med Res, Camperdown, NSW, Australia

[2] Univ Cape Town, Lung Inst, ZA-7925 Cape Town, South Africa

[3] Hop Laval, Inst Cardiol & Pneumol, Quebec City, PQ, Canada

[4] Univ Calif San Francisco, San Francisco, CA 94143 USA

[5] Creighton Univ, Omaha, NE 68178 USA

[6] Univ Mediterranee, Marseille, France

[7] Univ Arizona, Tucson, AZ USA

[8] Univ Newcastle, Ctr Asthma & Resp Dis, Callaghan, NSW 2308, Australia

[9] Univ Newcastle, Hunter Med Res Inst, Callaghan, NSW 2308, Australia

[10] Sophia Childrens Univ Hosp, Rotterdam, Netherlands

[11] Univ Groningen, Univ Med Ctr Groningen, NL-9713 AV Groningen, Netherlands

[12] Univ Edinburgh, Edinburgh, Midlothian, Scotland

[13] McMaster Univ, Firestone Inst Resp Hlth, Hamilton, ON, Canada

[14] Univ London Imperial Coll Sci Technol & Med, London, England

[15] Univ Leicester, Leicester, Leics, England

[16] Univ Amsterdam, Amsterdam, Netherlands

[17] Univ Nevada, Sch Med, Reno, NV 89557 USA

[18] Natl Jewish Med & Res Ctr, Denver, CO USA

[19] Univ Colorado, Hlth Sci Ctr, Denver, CO USA

[20] Univ Washington, Seattle, WA 98195 USA

[21] Univ Otago, Dunedin Sch Med, Dunedin, New Zealand

[22] Univ Aberdeen, Aberdeen, Scotland

[23] Univ Pittsburgh, Pittsburgh, PA USA

来源：

AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE | 2009年 / 180卷 / 01期

关键词：

asthma control; asthma exacerbations; asthma severity; clinical trials; outcome assessment (health care); predictive value of tests; EXHALED NITRIC-OXIDE; QUALITY-OF-LIFE; PEAK EXPIRATORY FLOW; EOSINOPHIL CATIONIC PROTEIN; RANDOMIZED CONTROLLED-TRIAL; OBSTRUCTIVE PULMONARY-DISEASE; INHALED FLUTICASONE PROPIONATE; HEALTH-CARE UTILIZATION; METHACHOLINE AIRWAY RESPONSIVENESS; FORCED OSCILLATION TECHNIQUE;

D O I：

10.1164/rccm.200801-060ST

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

Background. The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways. Purpose: The Task Force was established to provide recommendations about standardization of outcomes relating to asthma control, severity, and exacerbations in clinical trials and clinical practice, for adults and children aged 6 years or older. Methods: A narrative literature review was conducted to evaluate the measurement properties and strengths/weaknesses of outcome measures relevant to asthma control and exacerbations. The review focused on diary variables, physiologic measurements, composite scores, biomarkers, quality of life questionnaires, and indirect measures. Results: The Task Force developed new definitions for asthma control, severity, and exacerbations, based on current treatment principles and clinical and research relevance. In view of current knowledge about the multiple domains of asthma and asthma control, no single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Recommendations are provided for the assessment of asthma control in clinical trials and clinical practice, both at baseline and in the assessment of treatment response. Conclusions: The Task Force recommendations provide a basis for a multicomponent assessment of asthma by clinicians, researchers, and other relevant groups in the design, conduct, and evaluation of clinical trials, and in clinical practice.

引用

页码：59 / 99

页数：41

共 424 条

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