Evidence map›Paper›PMID 27044249›Full record

Trial reportTrials2016

The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial.

Morag C Farquhar, A Toby Prevost, Paul McCrone, Barbara Brafman-Price, Allison Bentley, Irene J Higginson, Chris J Todd, Sara Booth

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00678405 (Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.), which is not on this map. Cited by 59 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 13 pooled it
–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.

NCT00678405 phase3unknown statusnot on this map

Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.

TypeinterventionalSponsorCambridge University Hospitals NHS Foundation TrustRan2008 to 2010Enrolled120ConditionsDyspneaArmsBreathlessness Intervention Service, Best supportive care (Standard Care)
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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  3. Multicomponent services for symptoms in serious respiratory illness: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2024
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  4. Non-pharmacological interventions targeting mobility among people with advanced cancer: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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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

8 authors.

Morag C FarquharPrimary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Institute of Public Health, Robinson Way, Cambridge, CB2 0SR, UK. mcf22@medschl.cam.ac.uk.
A Toby PrevostImperial Clinical Trials Unit, School of Public Health, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
Paul McCroneInstitute of Psychiatry, King's College London, De Crespigny Park, London, SE5 8AF, UK.
Barbara Brafman-PriceFormerly of Palliative Care Service, Cambridge University Hospitals' NHS Foundation Trust, Addenbrooke's Hospital, Hills Rd, Cambridge, CB2 0QQ, UK.
Allison BentleyFormerly of Palliative Care Service, Cambridge University Hospitals' NHS Foundation Trust, Addenbrooke's Hospital, Hills Rd, Cambridge, CB2 0QQ, UK.
Irene J HigginsonDepartment of Palliative Care, Policy & Rehabilitation, King's College London, Cicely Saunders Institute, Denmark Hill, London, SE5 9PJ, UK.
Chris J ToddSchool of Nursing, Midwifery and Social Work, Jean McFarlane Building, University of Manchester, Oxford Rd, Manchester, M13 9PL, UK.
Sara BoothFormerly of Palliative Care Service, Cambridge University Hospitals' NHS Foundation Trust, Addenbrooke's Hospital, Hills Rd, Cambridge, CB2 0QQ, UK.

Funding

Department of Health PB-PG-0107-11134Department of Health PB-PG-0808-17311Marie Curie MCCC-RP-15-A18859
6 · The paper itself

Abstract

backgroundBreathlessness is the most common and intrusive symptom of advanced non-malignant respiratory and cardiac conditions. The Breathlessness Intervention Service (BIS) is a multi-disciplinary complex intervention, theoretically underpinned by a palliative care approach, utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease in managing their breathlessness. Having published the effectiveness and cost effectiveness of BIS for patients with advanced cancer and their carers, we sought to establish its effectiveness, and cost effectiveness, in advanced non-malignant conditions.

methodsThis was a single-centre Phase III fast-track single-blind mixed method RCT of BIS versus standard care for breathless patients with non-malignant conditions and their carers. Randomisation was to one of two groups (randomly permuted blocks). Eighty-seven patients referred to BIS were randomised (intervention arm n = 44; control arm n = 43 received BIS after four-week wait); 79 (91 %) completed to key outcome measurement. The primary outcome measure was 0-10 numeric rating scale for patient distress due to breathlessness at four weeks. Secondary outcome measures were Chronic Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Client Service Receipt Inventory, EQ-5D and topic-guided interviews.

resultsQualitative analyses showed the positive impact of BIS on patients with non-malignant conditions and their carers; quantitative analyses showed a non-significant greater reduction in the primary outcome ('distress due to breathlessness'), when compared to standard care, of -0.24 (95 % CI: -1.30, 0.82). BIS resulted in extra mean costs of £799, reducing to £100 when outliers were excluded; neither difference was statistically significant. The quantitative findings contrasted with those previously reported for patients with cancer and their carers, which showed BIS to be both clinically and cost effective. For patients with non-malignant conditions there was a notable trend of improvement over both trial arms to the key measurement point; participants may have experienced a therapeutic effect from the research interviews, diluting the intervention's impact.

conclusionsBIS had a statistically non-significant effect for patients with non-malignant conditions, and slightly increased service costs, but had a qualitatively positive impact consistent with findings for advanced cancer. Trials of palliative care interventions should consider multiple, mixed method, primary outcomes and ensure that protocols limit potential contaminating therapeutic effects in study designs.

trial registrationCurrent Controlled Trials ISRCTN04119516 (December 2008); ClinicalTrials.gov NCT00678405 (May 2008).

Indexed as

Health Care CostsRespirationAgedAged, 80 and overCaregiversCombined Modality TherapyCost-Benefit AnalysisDyspneaEnglandFemaleHumansLungMaleMiddle AgedPalliative CarePatient Care TeamAdvanced diseaseBreathlessnessChronic obstructive pulmonary diseaseComplex interventionMixed methodsNon-malignant diseasePalliative careRandomised controlled trial

Identifiers

PMID27044249
PMCPMC4820876

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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.