Talcott 2011.
| Study characteristics | ||
| Methods | Parallel randomised trial Study conducted between September 1994 and January 1999. |
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| Participants | Setting: USA Participants: recruited from outpatients with postchemotherapy febrile neutropenia and assessed as low risk if there was no indication for hospitalisation other than fever and neutropenia (such as systemic hypotension, altered mental status, respiratory failure, or inadequate oral fluid intake during 24‐hour observation; and had adequately controlled cancer) Age 20 to 81 years, median 47 years Number recruited: hospital at home: 47; inpatient: 66 |
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| Interventions | Admission avoidance hospital at home, patients recruited from outpatient clinic. Provided by commercial home care provider who agreed to provide protocol care for patients without out‐of‐pocket charges; daily visits by a home care nurse who followed a protocol/standard checklist and contacted the primary care physician if there were abnormal findings. Daily blood tests. 24‐hour care available. Hospital specialist examined the patient 2 to 4 days following discharge and then at least weekly. Home IV available. Control group received care in oncology units in general hospitals. |
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| Outcomes | Major medical complications, readmission to hospital, quality of life | |
| Notes | Folllow‐up time for each episode was the resolution of fever, neutropenia, and any complications arising during the episode. Quality of life data were collected at the time of consent to join the study and as soon as possible after resolution of the episode. Funding: National Cancer Institute (USA) Conflicts of interest: authors indicated no potential conflicts of interest. Ethical approval: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated blocks of random numbers stratified by colony‐stimulating factors, institution, and whether random assignment occurred on weekends, holidays, or after hours |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Baseline outcome measurements (selection bias) | Low risk | Baseline outcome measurements done prior to intervention for clinical characteristics and quality of life; no relevant differences found |
| Baseline characteristics (selection bias) | Low risk | Baseline characteristics of the study and control groups are reported and are similar for all main characteristics |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Any medical event requiring urgent diagnostic or therapeutic intervention. Predefined complications included systemic hypotension (systolic blood pressure > 90 mmHg), respiratory failure (partial pressure of oxygen < 60 torr adjusted for hyperventilation) |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Low risk | Predefined medical complications using blinded review |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Low risk for mortality and cost |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost to follow‐up, 5 withdrawn/excluded (3 withdrew consent, 2 excluded as neutropenia had resolved at recruitment) |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to allocate low or high risk |