Echevarria 2018.
Study characteristics | ||
Methods | Parallel randomised trial Study conducted between June 2014 and January 2016. |
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Participants | Setting: UK Patients aged >= 35 years, admitted to hospital with COPD exacerbation and low mortality risk. Those with life expectancy < 1 year due to illness other than COPD, long‐term ventilation, and coexistent secondary diagnosis necessitating admission were excluded. Number recruited: hospital at home: 62; usual care: 58 (analysed: hospital at home: 60; usual care: 58) Mean age (SD): T: 71 (9.6), C: 68.7 (10.5) Female: T: 32/60 (53%), C: 30/58 (52%) Approximately 1/5 of participants also had ischaemic heart disease and depression. |
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Interventions | The intervention consisted of once‐ or twice‐daily visits from a respiratory specialist nurse, under remote supervision from a respiratory consultant. An emergency contact number allowed patients to contact the team 24/7. Patients were monitored daily, and blood sampling was taken as required. Other available services included oral and IV therapies, acute controlled oxygen therapy, physiotherapy, psychology, occupational therapy, and formal social care. Comparison: usual hospital care |
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Outcomes | Main outcomes: health and social care costs over 90 days (non‐inferiority analysis) Other outcomes: survival; all‐cause and respiratory readmission rates; bed days over a) acute period of care, and b) postdischarge to 90 days; caregiver and patient preference; COPD exacerbations; unplanned health resource use; HADS score; quality of life; caregiver burden; perceptions of health care of patients and their caregivers and health professionals regarding the use of the clinical score for group allocation |
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Notes | Follow‐up: 90 days Trial registry: ISRCTN29082260 Funding: National Institute for Health Research (NIHR, UK) Conflicts of interest: "SCB reports grants from NIHR: Research for Patient Benefit Programme, during the conduct of the study; HTA funding, grants from Philips Respironics and Pfizer Open Air, personal fees from Pfizer and AstraZeneca, outside the submitted work. JG reports grants from NIHR Research for Patient Benefit, during the conduct of the study. CE, GJG, TH, AJS and JS have no competing interests to declare." Ethical approval: local ethics committee |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Allocation to HAH or UC was based on 1:1 randomisation, performed by minimisation undertaken by an external, independent agency (sealedenvelope. com)” |
Allocation concealment (selection bias) | Low risk | Quote: “The researchers were blind to the method of allocation for individual patients. For the primary cost analysis, the health economist was blinded to group allocation” |
Baseline outcome measurements (selection bias) | Low risk | Comment: similar proportion of ECOPD treatment prior to admissions, Hospital Anxiety and Depression score, COPD assessment tool, and utility scores (EQ‐5D‐5L) |
Baseline characteristics (selection bias) | Low risk | Quote: “Groups were well matched with respect to minimisation indices” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “For the primary cost analysis, the health economist was blinded to group allocation.” |
Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Comment: subjective outcome was 'stated preference for HAH care day 14' (subjective to patient, did not require subjective judgement by researcher) Quote: “Patients in both arms maintained a diary of all health and social care visits and attendances, and were phoned every 2 weeks to prompt completion and collect data.” |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: “For the primary cost analysis, the health economist was blinded to group allocation.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: sensitivity analysis carried out for missing data |
Selective reporting (reporting bias) | Low risk | Comment: outcomes are consistent between trial registry and published results. |