title: An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial.
abstract: BACKGROUND
  Breathlessness is a common and distressing symptom, which increases in many diseases as they progress and is difficult to manage. We assessed the effectiveness of early palliative care integrated with respiratory services for patients with advanced disease and refractory breathlessness.
  
  
  METHODS
  In this single-blind randomised trial, we enrolled consecutive adults with refractory breathlessness and advanced disease from three large teaching hospitals and via general practitioners in South London. We randomly allocated (1:1) patients to receive either a breathlessness support service or usual care. Randomisation was computer generated centrally by the independent Clinical Trials Unit in a 1:1 ratio, by minimisation to balance four potential confounders: cancer versus non-cancer, breathlessness severity, presence of an informal caregiver, and ethnicity. The breathlessness support service was a short-term, single point of access service integrating palliative care, respiratory medicine, physiotherapy, and occupational therapy. Research interviewers were masked as to which patients were in the treatment group. Our primary outcome was patient-reported breathlessness mastery, a quality of life domain in the Chronic Respiratory Disease Questionnaire, at 6 weeks. All analyses were by intention to treat. Survival was a safety endpoint. This trial is registered with ClinicalTrials.gov, number NCT01165034.
  
  
  RESULTS
  Between Oct 22, 2010 and Sept 28, 2012, 105 consenting patients were randomly assigned (53 to breathlessness support service and 52 to usual care). 83 of 105 (78%) patients completed the assessment at week 6. Mastery in the breathlessness support service group improved compared with the control (mean difference 0·58, 95% CI 0·01-1·15, p=0·048; effect size 0·44). Sensitivity analysis found similar results. Survival rate from randomisation to 6 months was better in the breathlessness support service group than in the control group (50 of 53 [94%] vs 39 of 52 [75%]) and in overall survival (generalised Wilcoxon 3·90, p=0·048). Survival differences were significant for patients with chronic obstructive pulmonary disease and interstitial lung disease but not cancer.
  
  
  CONCLUSIONS
  The breathlessness support service improved breathlessness mastery. Our findings provide robust evidence to support the early integration of palliative care for patients with diseases other than cancer and breathlessness as well as those with cancer. The improvement in survival requires further investigation.
  
  
  BACKGROUND
  UK National Institute for Health Research (NIHR) and Cicely Saunders International.
authors.affiliation: Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, King's College London, Denmark Hill, London, UK. Electronic address: irene.higginson@kcl.ac.uk.
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
authors.affiliation: Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, King's College London, Denmark Hill, London, UK; Department of Palliative Medicine, Munich University Hospital, Munich, Germany.
authors.forename: Claudia
authors.initials: C
authors.lastname: Bausewein
authors.affiliation: Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, King's College London, Denmark Hill, London, UK.
authors.forename: Charles C
authors.initials: CC
authors.lastname: Reilly
authors.affiliation: Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, King's College London, Denmark Hill, London, UK.
authors.forename: Wei
authors.initials: W
authors.lastname: Gao
authors.affiliation: Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, King's College London, Denmark Hill, London, UK; University of Amsterdam, Centre for Social Science and Global Health, Amsterdam, Netherlands.
authors.forename: Marjolein
authors.initials: M
authors.lastname: Gysels
authors.affiliation: Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, King's College London, Denmark Hill, London, UK.
authors.forename: Mendwas
authors.initials: M
authors.lastname: Dzingina
authors.affiliation: Institute of Psychiatry, King's College London, Denmark Hill, London, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.affiliation: Palliative Care Department, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: Sara
authors.initials: S
authors.lastname: Booth
authors.affiliation: Department of Respiratory Medicine, King's College London, Denmark Hill, London, UK.
authors.forename: Caroline J
authors.initials: CJ
authors.lastname: Jolley
authors.affiliation: Department of Respiratory Medicine, King's College London, Denmark Hill, London, UK.
authors.forename: John
authors.initials: J
authors.lastname: Moxham
mesh_terms: D000328:Adult; D002908:Chronic Disease; D004417:Dyspnea / Q000628:therapy*; D006333:Heart Failure / Q000150:complications; D006801:Humans; D017563:Lung Diseases, Interstitial / Q000150:complications; D016472:Motor Neuron Disease / Q000150:complications; D010166:Palliative Care / Q000379:methods*; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications; D011788:Quality of Life; D012138:Respiratory Therapy / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome