Tramarin 1992.
| Study characteristics | ||
| Methods |
Design: RCT (patient) Methodological quality: 2.5/6a (EPOC RCT/CCT checklist) |
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| Participants |
Country and regions: Italy, Vicenza health district and surroundings, metropolitan and rural areas Recruitment (1990, 1 month): from infectious diseases department at San Bortolo General Hospital;
Number of patients (allocated): 42 (10 intervention and 32 control; 7 randomised controls and 25 non‐randomised who did not meet ≥ 1criteria above) Diseases: AIDS (42) Patient characteristics: median age 28.0 and 31.3 years intervention (stage 2 and 3, respectively), 30.6 and 32.5 years control (stage 2 and 3, respectively); 21% female Deaths at end of study: 22 (5 intervention and 17 control) Withdrawals/other drop‐outs: 1 intervention (care refusal) and 2 controls (attending other AIDS clinics) |
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| Interventions | Home palliative care vs. usual care "Home‐care Assistance" Type: intermediate palliative care Service base: infectious diseases department at San Bortolo Hospital, with 15 beds, outpatient clinic and hospice offering HC Team: multidisciplinary team of 4 trained nurses, 1 psychologist, 10 volunteers, social workers (where available), 2 infectious disease specialists; family doctor seen as part of team Responsibility: consultant doctor; "personnel (medical and paramedical) employed in the referral infectious disease department are responsible for home care"; "other caregivers (family doctors, volunteers, social care agencies) should participate under supervision of consultant doctors of the referral department" Description: integrated package of HC "based on the principles of palliative care"; aimed to improve quality of life whenever possible through symptom control; aligned with National Health AIDS Plan guidelines, aiming to limit use of inappropriate inpatient services by substituting with more suitable palliative care; chemotherapy, parenteral nutrition, blood transfusion and fluids administered if needed at home using a tunnelled catheter Duration: "average" 74.1 days Control: usual care, mainly HB treatment and care |
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| Outcomes | Quality of life (QWB) Assessment points: weekly from enrolment to death or up to 6 months Analysis: forwards from enrolment |
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| Resource use/costs | Inpatient (number of hospital admissions, hospital inpatient days, hospital length of stay) Outpatient clinics (number of day admissions) Home palliative care (length of stay, staff hours, nurse and specialist visits) Time horizon: from study entry to death or up to 6 months (multiplied by 2 to produce estimates per person‐year) Costs: inpatient, outpatient, HC and total costs per person‐year Currency: 1990 ITL (converted to 1990 USD using healthcare‐specific purchasing power parities) Cost‐effectiveness: cost‐utility ratio (expressed as cost per well‐week) |
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| Notes |
Power considerations: none stated Risk of selection bias as 25/32 controls were not randomised Death at home and time spent at home reported for intervention group only (4/9 home deaths; 74.1 days/patient spent at home) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Concealment of allocation (RCT / CCT) | High risk | 17 patients were randomised to intervention (10) and control (7); process not stated; remaining 25 controls not randomly allocated |
| Follow‐up (RCT / CCT) | Low risk | 39/42 (93%) |
| Blinding (RCT / CCT) | Unclear risk | Not stated |
| Baseline measurement (RCT / CCT) | Unclear risk | 25/32 controls failed to meet ≥ 1 of the following criteria – adequate economic and family support, living within 10 km from hospital, willingness to accept HC and stage 2/3 (as opposed to 1); however, comparisons were made only with stage 2/3 patients with no significant differences in age, baseline quality of life scores and risk behaviour categories |
| Reliability of outcome measurement (RCT / CCT) | Unclear risk | Unclear if self report or proxy‐report; "individual QWB scores were calculated each week by a trained caregiver using a standard checklist" |
| Protection against contamination (RCT / CCT) | High risk | Patients randomised |