TY - JOUR T1 - BreathEase: rationale, design and recruitment of a randomised trial and embedded mixed methods study of a multi-professional breathlessness service in early palliative care JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00228-2020 SP - 00228-2020 AU - Michaela Schunk AU - Ursula Berger AU - Lien Le AU - Eva Rehfuess AU - Larissa Schwarzkopf AU - Sabine Streitwieser AU - Thomas Müller AU - Miriam Hofmann AU - Rolf Holle AU - Rudolf Maria Huber AU - Ulrich Mansmann AU - Claudia Bausewein Y1 - 2021/01/01 UR - http://openres.ersjournals.com/content/early/2021/07/22/23120541.00228-2020.abstract N2 - Background The Munich Breathlessness Service (MBS) has adapted novel support services to the German context, to reduce burden in patients and carers from breathlessness in advanced disease. It has been evaluated in a pragmatic fast track randomised controlled trial (RCT) (BreathEase, NCT02622412) with embedded qualitative interviews and postal survey. The aim of this paper is to describe the intervention model and study design, analyse recruitment to the trial and compare sample characteristics with other studies in the field.Methods Analysis of recruitment pathways and enrolment, sociodemographic and clinical characteristics of participants and carers.Results Of 439 people screened, 253 (58%) were offered enrolment and 183 (42%) participated. n=97 (70%) carers participated. 186 people (42%) did not qualify for inclusion, mostly because breathlessness could not be attributed to an underlying disease. All participants were self-referring, 60% through media sources. Eligibility and willingness to participate were associated to social networks and illness-related activities as recruitment routes. Mean age of participants was 71 years (51% women), with COPD (63%), chronic heart failure (8%), interstitial lung disease (9%), pulmonary hypertension (6%) and cancer (7%) as underlying conditions. Postal survey response rate was 89%. Qualitative interviews were conducted with 16 patients and 9 carers.Conclusion The BreathEase study has a larger and more heterogeneous sample compared to other trials. The self-referral-based and prolonged recruitment drawing on media sources approximates real-world conditions of early palliative care. Integrating qualitative and quantitative components will allow a better understanding and interpretation of the results of the main effectiveness study.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: Dr. Schunk has nothing to disclose.Conflict of interest: Dr. Berger reports grants from Federal Ministry of Education and Research (Germany), during the conduct of the study.Conflict of interest: Dr. Le has nothing to disclose.Conflict of interest: Dr. Rehfuess has nothing to disclose.Conflict of interest: Dr. Schwarzkopf has nothing to disclose.Conflict of interest: Dr. Streitwieser has nothing to disclose.Conflict of interest: Dr. Müller reports grants from BMBF - Federal Ministery of Science and Research, during the conduct of the study.Conflict of interest: M. Hofmann has nothing to disclose.Conflict of interest: Dr. Holle reports grants from Federal Ministry of Research, during the conduct of the study.Conflict of interest: Dr. Huber reports grants from German Ministry of Education and Research (BMBF), during the conduct of the study.Conflict of interest: Dr. Mansmann reports grants from BMBF - Federal Ministery of Science and Research, during the conduct of the study.Conflict of interest: Dr. Bausewein reports grants from the German Federal Ministry of Education and Research during the conduct of the study. ER -