Grande 1999.
Study characteristics | ||
Methods | Randomised trial, UK. 12 participants excluded from the analysis as alive at the end of the study. | |
Participants | Requiring terminal care: intervention group: 186 (87% with a diagnosis of cancer); control group: 43 (86% with a diagnosis of cancer); 241 participants randomised, 12 had not died by end of study and were excluded from analysis, data were collected from 229 participants. Living alone: intervention group: 21%; control group: 17% Mean age: intervention group: 72 (SD 11); control group: 73 (SD 14) Number of women: 92/186 (50%); 23/43 (54%) Survival from referral for both groups: median 11 days |
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Interventions | Intervention group: referred from primary or secondary care 6 qualified nurses, 2 nursing aides, a co‐ordinator (RGN level), agency staff providing 24‐hour care if required for a maximum of 2 weeks, most had Marie Curie experience. Intervention participants could also access standard care. Control group: standard care: hospital care or hospice care, with input from the GP and district nurses, Marie Curie nursing, Macmillan nursing, social services and private nursing. |
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Outcomes | Symptoms and support, GP visits, place of death and admission to hospital Follow‐up: 2 weeks |
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Notes | Funding: Elizabeth Clark Charitable Trust and the NHS R&D Primary/Secondary Care Interface Programme Conflict of interest: not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: 4:1 randomisation ratio (intervention:control) to ensure sufficient admissions to hospital at home. Random numbers from a random number table were used. |
Allocation concealment (selection bias) | Low risk | Comment: allocation for each referral was assigned by the researcher using a random number table and concealed in sequentially numbered, opaque, sealed envelopes. |
Baseline characteristics | Low risk | Comment: demographic data similar. |
Baseline outcome measurements | Low risk | Comment: not reported as place of death and mortality at follow‐up. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: low‐risk place of death and mortality data obtained from the Office of National Statistics. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: response rates: 144/198 (73%) caregivers, 225/228 (99%) district nurses, 194/228 (85%) primary care physicians. |
Selective reporting (reporting bias) | Low risk | Comment: all stated outcomes reported. |
Protection against contamination | Low risk | Comment: Figure 1 reported in Grande 2000 indicated that none of the participants allocated to the control received the intervention. |