ERS statement: a core outcome set for clinical trials evaluating the management of COPD exacerbations

被引：42

作者：

Mathioudakis, Alexander G. ^{[1
,2
]}

Abroug, Fekri ^{[3
]}

Agusti, Alvar ^{[4
,5
,6
]}

Ananth, Sachin ^{[7
]}

Bakke, Per ^{[8
]}

Bartziokas, Konstantinos ^{[9
]}

Beghe, Bianca ^{[10
]}

Bikov, Andras ^{[1
,2
]}

Bradbury, Thomas ^{[11
]}

Brusselle, Guy ^{[12
,13
,14
]}

Cadus, Cordula ^{[15
,16
]}

Coleman, Courtney ^{[17
]}

Contoli, Marco ^{[18
]}

Corlateanu, Alexandru ^{[19
]}

Corlateanu, Olga ^{[20
]}

Criner, Gerard J. ^{[21
]}

Csoma, Balazs ^{[22
]}

Emelyanov, Alexander ^{[23
]}

Faner, Rosa ^{[4
,5
]}

Romero, Gustavo Fernandez ^{[21
]}

Hammouda, Zeineb ^{[4
,5
]}

Horvath, Peter ^{[22
]}

Garcia, Arturo Huerta ^{[4
,5
,24
]}

Jacobs, Michael ^{[21
]}

Jenkins, Christine ^{[11
]}

Joos, Guy ^{[14
]}

Kharevich, Olga ^{[25
]}

Kostikas, Konstantinos ^{[9
]}

Lapteva, Elena ^{[25
]}

Lazar, Zsofia ^{[22
]}

Leuppi, Joerg D. ^{[15
,16
]}

Liddle, Carol ^{[17
]}

Linnell, John ^{[17
]}

Lopez-Giraldo, Alejandra ^{[4
,5
,6
]}

McDonald, Vanessa M. ^{[26
,27
,28
]}

Nielsen, Rune ^{[8
,29
]}

Papi, Alberto ^{[18
]}

Saraiva, Isabel ^{[17
]}

Sergeeva, Galina ^{[23
]}

Sioutkou, Agni ^{[11
]}

Sivapalan, Pradeesh ^{[30
,31
]}

Stovold, Elizabeth ^{[32
]}

Wang, Hao ^{[33
]}

Wen, Fuqiang ^{[33
]}

Yorke, Janelle ^{[34
,35
]}

Williamson, Paula R. ^{[36
]}

Vestbo, Jorgen ^{[1
,2
]}

Jensen, Jens-Ulrik ^{[30
,37
]}

机构：

[1] Univ Manchester, Manchester Acad Hlth Sci Ctr, Sch Biol Sci, Div Infect Immun & Resp Med, Manchester, Lancs, England

[2] Manchester Univ NHS Fdn Trust, Wythenshawe Hosp, North West Lung Ctr, Manchester, Lancs, England

[3] Hosp Fattouma Bourguiba, Monastir, Tunisia

[4] Univ Barcelona, Hosp Clin, Resp Inst, Barcelona, Spain

[5] Univ Barcelona, Catedra Salud Resp, Barcelona, Spain

[6] Natl Spanish Network Resp Res CIBERES, Inst Invest Biomed August Pi i Sunyer IDIBAPS, Barcelona, Spain

[7] West Hertfordshire Hosp NHS Trust, Watford, England

[8] Univ Bergen, Dept Clin Sci, Bergen, Norway

[9] Univ Ioannina, Resp Med Dept, Sch Med, Ioannina, Greece

[10] Univ Modena & Reggio Emilia, Dept Med, Sect Resp Dis, Modena, Italy

[11] Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia

[12] Erasmus MC, Dept Epidemiol, Rotterdam, Netherlands

[13] Erasmus MC, Dept Resp Med, Rotterdam, Netherlands

[14] Ghent Univ Hosp, Dept Resp Med, Ghent, Belgium

[15] Cantonal Hosp Basell & Liestal, Univ Dept Med, Basel, Switzerland

[16] Univ Basel, Fac Med, Basel, Switzerland

[17] European Lung Fdn, Sheffield, S Yorkshire, England

[18] Univ Ferrara, Res Ctr Asthma & COPD, Dept Med Sci, Ferrara, Italy

[19] State Univ Med & Pharm Nicolae Testemitanu, Dept Resp Med, Kishinev, Moldova

[20] State Univ Med & Pharm Nicolae Testemitanu, Dept Internal Med, Kishinev, Moldova

[21] Temple Univ, Lewis Katz Sch Med, Dept Thorac Med & Surg, Philadelphia, PA 19122 USA

[22] Semmelweis Univ, Dept Pulmonol, Budapest, Hungary

[23] North Western Med Univ St Petersburg, Dept Resp Med & Allergy, St Petersburg, Russia

[24] Clin Sagrada Familia, Resp Intens Care Div, Barcelona, Spain

[25] Belarusian Med Acad Postgrad Educ, Dept Pulmonol & TB, Minsk, BELARUS

[26] Hunter New England Local Hlth Dist, Dept Resp & Sleep Med, John Hunter Hosp, Med & Intervent Serv, New Lambton Hts, Australia

[27] Univ Newcastle, Prior Res Ctr Hlth Lungs, Callaghan, NSW, Australia

[28] Univ Newcastle, Sch Nursing & Midwifery, Callaghan, NSW, Australia

[29] Haukeland Hosp, Dept Thorac Med, Bergen, Norway

[30] Herlev Gentofte Hosp, Dept Internal Med, Sect Resp Med, Hellerup, Denmark

[31] Zealand Univ Hosp, Dept Internal Med, Roskilde, Denmark

[32] St Georges Univ London, Cochrane Airways Grp, Populat Hlth Res Inst, London, England

[33] Sichuan Univ, West China Hosp, Dept Resp & Crit Care Med, West China Sch Med, Chengdu, Peoples R China

[34] Univ Manchester, Fac Biol Med & Hlth, Sch Hlth Sci, Manchester, Lancs, England

[35] Christie NHS Fdn Trust, Christie Patient Ctr Res, Manchester, Lancs, England

[36] Univ Liverpool, Liverpool Hlth Partners, Dept Hlth Data Sci, MRC NIHR Trials Methodol Res Partnership, Liverpool, Merseyside, England

[37] Univ Copenhagen, Fac Hlth Sci, Inst Clin Med, Copenhagen, Denmark

来源：

EUROPEAN RESPIRATORY JOURNAL | 2022年 / 59卷 / 05期

基金：

英国医学研究理事会;

关键词：

OBSTRUCTIVE PULMONARY-DISEASE; MEASUREMENT INSTRUMENTS; TIME-COURSE; IMPACT; CARE; QUALITY; LIFE; QUESTIONNAIRE; VALIDATION; CHECKLIST;

D O I：

10.1183/13993003.02006-2021

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritised for inclusion in the core outcome set through a two-round Delphi survey completed by 1063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in five continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to 1) finalise the core outcome set and 2) prioritise a single measurement instrument to be used for evaluating each of the prioritised outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for at all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, the need tor a higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimise some of the selected measurement instruments. The panel did not consider the prioritised set of outcomes and associated measurement instruments to be burdensome for patients and health professionals to use.

引用

页数：19

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