Evidence map›Paper›PMID 40623795›Full record

ArticleBMJ open respiratory research2025

Real-world effectiveness study of guideline-directed COPD STANDARDized management in patients with chronic obstructive pulmonary disease: a cluster randomised trial design.

Fen Dong, Rui Su, Yu Ren, Ke Huang, Wei Li, Lulu Yang, Xuexin Li, Xiao Hu, Tao Ye, Dong Jin and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open respiratory research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04664491 (Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04664491 narecruitingnot on this map

Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial

TypeinterventionalSponsorChina-Japan Friendship HospitalRan2023 to 2027Enrolled3,456ConditionsChronic Obstructive Pulmonary DiseaseArmsStandardized COPD management, Routine COPD management
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Fen DongDepartment of Clinical Research and Data management, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.ORCID http://orcid.org/0000-0003-4761-0239
Rui SuDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; National Clinical Research Center for Respiratory Diseases, National Center for Respiratory Medicine, Beijing, China.ORCID http://orcid.org/0009-0009-4796-6690
Yu RenDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; National Clinical Research Center for Respiratory Diseases, National Center for Respiratory Medicine, Beijing, China.ORCID http://orcid.org/0009-0009-2482-0808
Ke HuangDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, Beijing, China.ORCID http://orcid.org/0000-0001-8933-387X
Wei LiDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, Beijing, China.ORCID http://orcid.org/0000-0001-9003-3508
Lulu YangFangzhuang Community Health Service Center, Capital Medical University, Beijing, Beijing, China.ORCID http://orcid.org/0000-0001-6569-2886
Xuexin LiDepartment of Emergency, China-Japan Friendship Hospital, Beijing, China.ORCID http://orcid.org/0009-0000-4124-5037
Xiao HuGlaxoSmithKline, Shanghai, China.ORCID http://orcid.org/0009-0000-1600-1495
Tao YeGlaxoSmithKline, Shanghai, China.ORCID http://orcid.org/0009-0002-1089-6528
Dong JinGlaxoSmithKline, Shanghai, China.ORCID http://orcid.org/0009-0004-8608-1434
Ting YangDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, Beijing, China zryyyangting@126.com paul.w.jones@btinternet.com.ORCID http://orcid.org/0000-0002-7027-5179
Paul W JonesCity St George's, University of London, London, UK zryyyangting@126.com paul.w.jones@btinternet.com.ORCID http://orcid.org/0000-0001-6087-9182
Chen WangDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, Beijing, China.ORCID http://orcid.org/0000-0001-7857-5435

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic obstructive pulmonary disease (COPD) affects the ageing population worldwide. Exacerbations worsen health status and increase health resource use. Existing guidelines recommend disease management, but they are not fully implemented in a clinical setting. Evidence regarding best practice and real-world effectiveness is limited. METHODS AND ANALYSIS: A nationwide multicentre clinical effectiveness trial is being performed between 2023 and 2027, involving 99 secondary hospitals in urban and rural areas in China. It is an open-label, adjudicator and assessor-blinded, parallel group, cluster randomised pragmatic trial. Hospitals are randomly allocated to standardised management (SM) or usual care. A total number of 3456 stable patients with COPD who are symptomatic (individuals in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group B) or have exacerbation risk (individuals with one moderate exacerbation history in Group A and individuals in Group E) using GOLD 2023 ABE classification will be enrolled. In the SM group, an integrated intervention comprising five components will be delivered using a physician and nurse model. These are: (1) long-term inhaled maintenance therapy, (2) periodic inhaler technique assessment and symptom monitoring, (3) annual pulmonary function testing, (4) COPD education session and (5) health behaviour adoption (smoking cessation, vaccination, pulmonary rehabilitation). In the control group, patients will receive routine care. The primary goal is to assess the real-world effectiveness of guideline-directed disease management on exacerbation prevention, with moderate-to-severe exacerbation as the primary outcome and hospital admission, mortality, health status and COPD self-management as secondary outcomes. It is the first pragmatic trial undertaken of this form in a developing country. It is anticipated that it will provide a feasible and effective COPD management model that can inform guidelines and be rolled out into secondary and primary care, with modification, to ensure standardised COPD care nationwide. TRIAL REGISTRATION NUMBER: NCT04664491.

Indexed as

Pulmonary Disease, Chronic ObstructiveChinaDisease ProgressionHumansMalePractice Guidelines as TopicPragmatic Clinical Trials as TopicCOPD ExacerbationsPulmonary Disease, Chronic Obstructive

Identifiers

PMID40623795
PMCPMC12232468

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.