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BMC Pulmonary Medicine
Published in: BMC Pulmonary Medicine 1/2013

Open Access 01-12-2013 | Study protocol

Putting health status guided COPD management to the test: protocol of the MARCH study

Authors: Janwillem Kocks, Corina de Jong, Marjolein Y Berger, Huib AM Kerstjens, Thys van der Molen

Published in: BMC Pulmonary Medicine | Issue 1/2013

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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/Design

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).

Discussion

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.

Trial registration

Netherlands Trial Register, NTR2643
Appendix
Available only for authorised users
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Metadata
Title
Putting health status guided COPD management to the test: protocol of the MARCH study
Authors
Janwillem Kocks
Corina de Jong
Marjolein Y Berger
Huib AM Kerstjens
Thys van der Molen
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Pulmonary Medicine / Issue 1/2013
Electronic ISSN: 1471-2466
DOI
https://doi.org/10.1186/1471-2466-13-41

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