title: The Prospective Non-Interventional DACCORD Study in the National COPD Registry in Germany: design and methods.
abstract: BACKGROUND
  A 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.
  
  
  METHODS
  As 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  1. German Register for non-interventional studies: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb . 2. EMA EnCePP http://www.encepp.eu/ .
authors.affiliation: Group Practice and Centre for Allergy, Respiratory and Sleep Medicine, Red Cross Maingau Hospital, Scheffelstrasse 33, 60318, Frankfurt am Main, Germany. kardos@lungenpraxis-maingau.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Kardos
authors.affiliation: Department of Respiratory Diseases, University of Marburg, 35043, Marburg, Germany. claus.vogelmeier@med.uni-marburg.de.
authors.forename: Claus
authors.initials: C
authors.lastname: Vogelmeier
authors.affiliation: Pulmonary Department, Mainz University Hospital, 55131, Mainz, Germany. buhl@3-med.klinik.uni-mainz.de.
authors.forename: Roland
authors.initials: R
authors.lastname: Buhl
authors.affiliation: Department of Sleep and Respiratory Medicine, Evangelical Hospital Goettingen-Weende, 37120, Bovenden, Germany. criee@ekweende.de.
authors.forename: Carl-Peter
authors.initials: CP
authors.lastname: Criée
authors.affiliation: Department of Pulmonology and Cardiology, Hospital Fuerth, University Erlangen-Nuernberg, 90766, Fuerth, Germany. heinrich.worth@t-online.de.
authors.forename: Heinrich
authors.initials: H
authors.lastname: Worth
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use*; D000328:Adult; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006024:Glycopyrrolate / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010045:Outpatients; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy / Q000503:physiopathology*; D012042:Registries; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D006024:Glycopyrrolate