Evidence map›Paper›PMID 34671668›Full record

ArticleERJ open research2021

BreathEase: rationale, design and recruitment of a randomised trial and embedded mixed-methods study of a multiprofessional breathlessness service in early palliative care.

Michaela Schunk, Ursula Berger, Lien Le, Eva Rehfuess, Larissa Schwarzkopf, Sabine Streitwieser, Thomas Müller, Miriam Hofmann, Rolf Holle, Rudolf Maria Huber and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in ERJ open research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02622412 (Randomised Controlled Trial Testing the Effectiveness of a New Multi-professional Breathlessness sErvice for Patients With Any Advanced diSease Against Usual Care), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02622412 nacompletednot on this map

Randomised Controlled Trial Testing the Effectiveness of a New Multi-professional Breathlessness sErvice for Patients With Any Advanced diSease Against Usual Care (BreathEase)

TypeinterventionalSponsorLudwig-Maximilians - University of MunichRan2015 to 2019Enrolled183ConditionsBreathlessness, COPD, Cancer, Chronic Heart FailureArmsMulti-professional breathlessness service (MBS), Delayed MBS Intervention
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Michaela SchunkDept of Palliative Medicine, LMU Hospital, LMU Munich, Munich, Germany.ORCID https://orcid.org/0000-0002-1200-1903
Ursula BergerPettenkofer School of Public Health, Munich, Germany.
Lien LeFaculty of Medicine, Institute for Medical Information Processing, Biometry and Epidemiology, LMU Munich, Munich, Germany.
Eva RehfuessPettenkofer School of Public Health, Munich, Germany.
Larissa SchwarzkopfHealth Economics and Health Care Management (IGM), Helmholtz Zentrum München GmbH, German Research Center for Environmental Health, Munich, Germany.ORCID https://orcid.org/0000-0002-9402-7700
Sabine StreitwieserDept of Palliative Medicine, LMU Hospital, LMU Munich, Munich, Germany.
Thomas MüllerFaculty of Medicine, Institute for Medical Information Processing, Biometry and Epidemiology, LMU Munich, Munich, Germany.
Miriam HofmannFaculty of Medicine, Institute for Medical Information Processing, Biometry and Epidemiology, LMU Munich, Munich, Germany.ORCID https://orcid.org/0000-0002-2757-3402
Rolf HollePettenkofer School of Public Health, Munich, Germany.
Rudolf Maria HuberDept of Medicine V, LMU Hospital, LMU Munich, Munich, Germany.ORCID https://orcid.org/0000-0001-7041-6368
Ulrich MansmannPettenkofer School of Public Health, Munich, Germany.
Claudia BauseweinDept of Palliative Medicine, LMU Hospital, LMU Munich, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Munich Breathlessness Service 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 (BreathEase; NCT02622412) with embedded qualitative interviews and postal survey. The aim of this article is to describe the intervention model and study design, analyse recruitment to the trial and compare sample characteristics with other studies in the field.

methodsAnalysis of recruitment pathways and enrolment, sociodemographic and clinical characteristics of participants and carers.

resultsOut of 439 people screened, 253 (58%) were offered enrolment and 183 (42%) participated. n=97 (70%) carers participated. 186 (42%) people 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 nine carers.

conclusionThe 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.

Identifiers

PMID34671668
PMCPMC8521025

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.