Abstract
Background The effectiveness of the Munich Breathlessness Service (MBS), integrating palliative care, respiratory medicine and physiotherapy, was tested in the BreathEase trial in patients with chronic breathlessness in advanced disease and their carers.
Methods BreathEase was a single-blinded randomised controlled fast-track trial. The MBS was attended for 5–6 weeks; the control group started the MBS after 8 weeks of standard care. Randomisation was stratified by cancer and the presence of a carer. Primary outcomes were patients’ mastery of breathlessness (Chronic Respiratory Disease Questionnaire (CRQ) Mastery), quality of life (CRQ QoL), symptom burden (Integrated Palliative care Outcome Scale (IPOS)) and carer burden (Zarit Burden Interview (ZBI)). Intention-to-treat (ITT) analyses were conducted with hierarchical testing. Effectiveness was investigated by linear regression on change scores, adjusting for baseline scores and stratification variables. Missing values were handled with multiple imputation.
Results 92 patients were randomised to the intervention group and 91 patients were randomised to the control group. Before the follow-up assessment after 8 weeks (T1), 17 and five patients dropped out from the intervention and control groups, respectively. Significant improvements in CRQ Mastery of 0.367 (95% CI 0.065–0.669) and CRQ QoL of 0.226 (95% CI 0.012–0.440) score units at T1 in favour of the intervention group were seen in the ITT analyses (n=183), but not in IPOS. Exploratory testing showed nonsignificant improvements in ZBI.
Conclusions These findings demonstrate positive effects of the MBS in reducing burden caused by chronic breathlessness in advanced illness across a wide range of patients. Further evaluation in subgroups of patients and with a longitudinal perspective is needed.
Abstract
The effectiveness of the Munich Breathlessness Service (MBS) was tested in a single-blinded randomised controlled fast-track trial. Significant improvements were shown in mastery of breathlessness and quality of life in patients with advanced illness. https://bit.ly/3nT8jfT
Footnotes
This article has supplementary material available from erj.ersjournals.com
This study is registered at ClinicalTrials.gov with identifier number NCT02622412. We first submitted the record to ClinicalTrials.gov on 31 October 2015, 7 months after the first patient had been enrolled. At that time, we had recruited 32 patients (17% of the total). The submission was posted on 4 December 2015. The delay in registration was caused by the heavy workload at the beginning of the trial. We had obtained approval from the ethics committee on 8 January 2015. In July 2015, we dropped an inclusion criterion (requiring modified Medical Research Council dyspnoea scale grade ≥2 for inclusion of patients) in an amendment to the study protocol. At that time, we had become aware that we had not intended to exclude patients with an intermittent burden of breathlessness. No further changes to inclusion and exclusion criteria were made throughout the study. All individual patient data that underlie the results reported in this article after anonymisation can be made available to researchers who provide a methodologically sound proposal; they will need to sign a data access agreement. To gain access, proposals should be directed to the corresponding author.
Author contributions: All authors made substantial contributions to the conception or design of the study and/or to the acquisition, analysis or interpretation of data; all authors were involved in either drafting the manuscript or revising it critically for important intellectual content; all authors approve of the final version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Conflict of interest: M. Schunk reports grants from BMBF (German Federal Ministry of Education and Research), during the conduct of the study.
Conflict of interest: L. Le has nothing to disclose.
Conflict of interest: Z. Syunyaeva has nothing to disclose.
Conflict of interest: B. Haberland has nothing to disclose.
Conflict of interest: S. Tänzler has nothing to disclose.
Conflict of interest: U. Mansmann has nothing to disclose.
Conflict of interest: L. Schwarzkopf has nothing to disclose.
Conflict of interest: H. Seidl has nothing to disclose.
Conflict of interest: S. Streitwieser has nothing to disclose.
Conflict of interest: M. Hofmann has nothing to disclose.
Conflict of interest: T. Müller has nothing to disclose.
Conflict of interest: T. Weiß has nothing to disclose.
Conflict of interest: P. Morawietz has nothing to disclose.
Conflict of interest: E.A. Rehfuess has nothing to disclose.
Conflict of interest: R.M. Huber reports grants from BMBF (German Federal Ministry of Education and Research), during the conduct of the study.
Conflict of interest: U. Berger reports grants from BMBF (German Federal Ministry of Education and Research), during the conduct of the study.
Conflict of interest: C. Bausewein reports grants from BMBF (German Federal Ministry of Education and Research), during the conduct of the study.
Support statement: BMBF (German Federal Ministry of Education and Research) funded this study (reference 01GY1331). Funding information for this article has been deposited with the Crossref Funder Registry.
- Received June 3, 2020.
- Accepted January 12, 2021.
- Copyright ©The authors 2021. For reproduction rights and permissions contact permissions{at}ersnet.org
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