Irene J Higginson1, Claudia Bausewein2, Charles C Reilly3, Wei Gao3, Marjolein Gysels4, Mendwas Dzingina3, Paul McCrone5, Sara Booth6, Caroline J Jolley7, John Moxham7. 1. 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. 2. 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. 3. Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, King's College London, Denmark Hill, London, UK. 4. 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. 5. Institute of Psychiatry, King's College London, Denmark Hill, London, UK. 6. Palliative Care Department, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. 7. Department of Respiratory Medicine, King's College London, Denmark Hill, London, UK.
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. FINDINGS: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. INTERPRETATION: 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. FUNDING: UK National Institute for Health Research (NIHR) and Cicely Saunders International.
RCT Entities:
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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: UK National Institute for Health Research (NIHR) and Cicely Saunders International.
Authors: Michael Hoerger; Laura M Perry; Brittany D Korotkin; Leah E Walsh; Adina S Kazan; James L Rogers; Wasef Atiya; Sonia Malhotra; James I Gerhart Journal: J Palliat Med Date: 2019-01-07 Impact factor: 2.947
Authors: Amy S Kelley; Kenneth E Covinsky; Rebecca J Gorges; Karen McKendrick; Evan Bollens-Lund; R Sean Morrison; Christine S Ritchie Journal: Health Serv Res Date: 2016-03-18 Impact factor: 3.402