Evidence map›Paper›PMID 25578330›Full record

Trial reportBMC pulmonary medicine2015

The Prospective Non-Interventional DACCORD Study in the National COPD Registry in Germany: design and methods.

Peter Kardos, Claus Vogelmeier, Roland Buhl, Carl-Peter Criée, Heinrich Worth

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pulmonary medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Trial
  2. The Diagnosis and Treatment of COPD and Its Comorbidities.Deutsches Arzteblatt international · 2023
    Review
  3. Article
  4. Article
  5. Observational
  6. Article
  7. Dual bronchodilation vs triple therapy in the "real-life" COPD DACCORD study.International journal of chronic obstructive pulmonary disease · 2018
    Observational
  8. The COPDnet integrated care model.International journal of chronic obstructive pulmonary disease · 2018
    Article
  9. "Real-life" inhaled corticosteroid withdrawal in COPD: a subgroup analysis of DACCORD.International journal of chronic obstructive pulmonary disease · 2017
    Article
  10. A year in the life of German patients with COPD: the DACCORD observational study.International journal of chronic obstructive pulmonary disease · 2016
    Observational
  11. Observational
  12. Review
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

5 authors.

Peter KardosGroup Practice and Centre for Allergy, Respiratory and Sleep Medicine, Red Cross Maingau Hospital, Scheffelstrasse 33, 60318, Frankfurt am Main, Germany. kardos@lungenpraxis-maingau.de.
Claus VogelmeierDepartment of Respiratory Diseases, University of Marburg, 35043, Marburg, Germany. claus.vogelmeier@med.uni-marburg.de.
Roland BuhlPulmonary Department, Mainz University Hospital, 55131, Mainz, Germany. buhl@3-med.klinik.uni-mainz.de.
Carl-Peter CriéeDepartment of Sleep and Respiratory Medicine, Evangelical Hospital Goettingen-Weende, 37120, Bovenden, Germany. criee@ekweende.de.
Heinrich WorthDepartment of Pulmonology and Cardiology, Hospital Fuerth, University Erlangen-Nuernberg, 90766, Fuerth, Germany. heinrich.worth@t-online.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA variety of large randomized controlled trials (RCT's) evaluating pharmacotherapy in chronic obstructive pulmonary disease (COPD) patients does exist. One of the drugs that has been tested is the new long-acting anticholinergic glycopyrronium bromide.

methodsAs the generalizability of results from RCT's is questionable we designed a longitudinal, prospective non-interventional study (DACCORD) of two years duration plus two years extension with at least 6000 participants in approximately 500 primary and secondary care practices in Germany (within the new established COPD National Prospective Registry), to assess patient reported outcomes (PRO's), lung function, adherence and drug safety. To circumvent the hurdle of inappropriate COPD diagnosis in a non-interventional trial, patients have to fulfill the inclusion criteria of the COPD disease management program (DMP) of the German statutory health insurances. Patient management should follow the German national COPD guidelines, which are based on Global Initiative for Chronic Obstructive Lung Disease 2007 (GOLD) report. Labels of prescribed drugs should also be taken into account. Patients received treatment as part of their standard care: at the discretion of the investigator patients were included in one of two arms. A: standard care with glycopyrronium containing regimen, and arm B: standard care without glycopyrronium. DISCUSSION: For 2016 we expect important results regarding longitudinal development of PRO's including exacerbations, lung function, adherence and side effects. We also investigate applicability of the new GOLD staging system in usual care. Data on diagnostic and treatment modalities in current German primary and secondary care, as well as pharmaco-economic data will be generated.

trial registration1. German Register for non-interventional studies: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb . 2. EMA EnCePP http://www.encepp.eu/ .

Indexed as

OutpatientsRegistriesAdrenergic beta-2 Receptor AgonistsAdultBronchodilator AgentsFemaleFollow-Up StudiesGermanyGlycopyrrolateHumansMaleProspective StudiesPulmonary Disease, Chronic ObstructiveTreatment OutcomeAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsGlycopyrrolate

Identifiers

PMID25578330
PMCPMC4417326

What OpenQuestion holds

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Registered trials

None linked

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 OpenQuestion graph.