title: Putting health status guided COPD management to the test: protocol of the MARCH study.
abstract: BACKGROUND
  Chronic Obstructive Pulmonary Disease (COPD) is a disease state characterized by airflow limitation that is not fully reversible and usually progressive. Current guidelines, among which the Dutch, have so far based their management strategy mainly on lung function impairment as measured by FEV1, while it is well known that FEV1 has a poor correlation with almost all features of COPD that matter to patients. Based on this discrepancy the GOLD 2011 update included symptoms and impact in their treatment algorithm proposal. Health status measures capture both symptoms and impact and could therefore be used as a standardized way to capture the information a doctor could otherwise only collect by careful history taking and recording. We hypothesize that a treatment algorithm that is based on a simple validated 10 item health status questionnaire, the Clinical COPD Questionnaire (CCQ), improves health status (as measured by SGRQ) and classical COPD outcomes like exacerbation frequency, patient satisfaction and health care utilization compared to usual care based on guidelines.
  
  
  METHODS
  This hypothesis will be tested in a randomized controlled trial (RCT) following 330 patients for two years. During this period general practitioners will receive treatment advices every four months that are based on the patient's health status (in half of the patients, intervention group) or on lung function (the remaining half of the patients, usual care group).
  
  
  CONCLUSIONS
  During the design process, the selection of outcomes and the development of the treatment algorithm were challenging. This is discussed in detail in the manuscript to facilitate researchers in designing future studies in this changing field of implementation research.
  
  
  BACKGROUND
  Netherlands Trial Register, NTR2643.
authors.affiliation: Department of General Practice, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. j.w.h.kocks@umcg.nl
authors.forename: Janwillem
authors.initials: J
authors.lastname: Kocks
authors.forename: Corina
authors.initials: C
authors.lastname: de Jong
authors.forename: Marjolein Y
authors.initials: MY
authors.lastname: Berger
authors.forename: Huib A M
authors.initials: HA
authors.lastname: Kerstjens
authors.forename: Thys
authors.initials: T
authors.lastname: van der Molen
mesh_terms: D000328:Adult; D000465:Algorithms; D002985:Clinical Protocols / Q000592:standards*; D019468:Disease Management; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000502:physiology; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology* / Q000628:therapy*; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires