Study protocol

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

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

For all author emails, please log on.

BMC Pulmonary Medicine 2013, 13:41 doi:10.1186/1471-2466-13-41

Published: 4 July 2013

Abstract (provisional)

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).

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 Number: NTR2643

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.