Work Package 6: Guidance

Evidence based European guidance

Lead partner: Universitätsklinik Köln (KOELN)

The main aim of the BETTER-B project is to test the effectiveness of mirtazapine for the relief of chronic breathlessness in patients with COPD or ILD. In addition to these research aspects, it will intend to disseminate the results of the trial in order to inform the clinical practice and to improve the patient’s care at the end of life.

The Work Package 6 achieves this aim attending at following objectives:

1. To identify and summarize the current evidence on the pharmacological management of chronic breathlessness in advanced disease with opioids, benzodiazepine and antidepressants.   

2. To develop a comprehensive scientific review based on the identified evidence and the consensus of a multidisciplinary and international panel of experts (health professional and patients’ representatives). 

3. To disseminate the evidence among respiratory and palliative care specialists at an international level.

4. To make guidance recommendations for policy makers to advance the clinical management of breathlessness.

The steps 1-3 will be carried out under the methodological supervision of the European Respiratory Society (ERS) and will result in the development of an official ERS statement according to requirements of the ERS. ERS statements are international, widely used document and it might serve as a common basis for the formulation of future guidelines by national medical societies. The statement will incorporate the findings of the trial. Further dissemination chances are a monograph in the Palliative Care Formulary (PCF) and international conferences.

The development of recommendations will follow standard methods according to AGREE and the RIGHT statement. The recommendations will be circulated to BETTER-B consortium and presented to an all assembly meeting. Consensus on recommendations of the clinical guidance will be reached using a Delphi process based on the Guidance on Conducting and Reporting Delphi Studies (CREDES) in palliative care.

This Work Package is led by Dr Simon and Dr Pralong at the University Hospital of Cologne, Center for Palliative Medicine, who have extensive expertise in evidence based medicine and guidance development and have contributed to reviews and empirical research on breathlessness.