Ricauda 2008.
| Study characteristics | ||
| Methods | Parallel randomised trial Study conducted between April 2004 and April 2005. |
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| Participants | Setting: Italy Patients requiring acute hospitalisation for acute exacerbation of COPD; care supervision at home; telephone connection; living in the catchment area; family or social support Age (SD): T: 80.1 (3.2), C: 79.2 (3.1) Number recruited: hospital at home: 52; inpatient: 52 |
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| Interventions | Physician‐led admission avoidance hospital outreach service; GHHS of a regional hospital. The home care programme emphasised patient and caregiver education about the disease, advice about smoking cessation, nutrition, management of activities of daily living and energy conservation, understanding and use of drugs, health maintenance, and early recognition of triggers of exacerbation that require medical intervention. In the first days after admission to GHHS, physicians and nurses visited each patient at home daily, then daily visits by the nurse and visits by the doctor every 2 to 3 days or less. Blood tests, electrocardiogram, spirometry, pulse oximetry, oxygen, IV fluids, antimicrobials and other medications, blood transfusions, surgical treatment for pressure ulcers were available. Control group: inpatient hospital care |
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| Outcomes | Mortality, readmission, health status, satisfaction, residential care, length of stay, resource use and cost, caregiver outcomes | |
| Notes | Follow‐up: 6 months Funding: S. Giovanni Battista Hospital of Torino Conflict of interest: public funds of S. Giovanni Battista Hospital of Torino were used in this study. The editor‐in‐chief has reviewed the conflict of interest checklists provided by the authors and determined that none of the authors have any financial or any other kind of personal conflicts with this manuscript. Ethical approval: ethical approval was obtained from the hospital ethics committee. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
| Allocation concealment (selection bias) | Low risk | The project manager randomly allocated participants using a numbered set of sealed envelopes |
| Baseline outcome measurements (selection bias) | Low risk | Baseline outcome measurements done prior to intervention for health status; no relevant differences found |
| Baseline characteristics (selection bias) | Low risk | Baseline characteristics of the study and control groups are reported and are similar |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Data collected by independent postgraduate physicians who were not involved in the care of patients or the research team |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Outcomes assessed by a postgraduate doctor not involved with delivery of health care, and blinded to the study allocation |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Outcomes assessed by a postgraduate doctor not involved with delivery of health care, and blinded to the study allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | Standard set of outcomes reported |