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. 2012 Jul 11;2012(7):CD007672. doi: 10.1002/14651858.CD007672.pub2

McWhinney 1994.

Methods RCT; Unit of allocation: Patient; Stratified by: N/A
Participants Patients having symptomatic cancer which had metastasised or spread to surrounding tissues, expected to survive for two months, and being cared for at home by an eligible care giver.
Setting / country: A home care service and about 200 general practitioners, most of whom provided home care: London, Ontario / Canada
Type of cancer: Any type
Phase of care: Palliative care
Sample size at randomisation: 146
Interventions Palliative care home support team: the team was based in on a 14‐bed palliative care unit, and consisted of 2 experienced palliative care nurses, one physician, and a part time social worker. Because of the range of home care services available already, the team was planned to be a consulting and support service for family physicians and home care nurses. Within 3 days of referral by a family doctor or nurse (with family doctor's agreement) one of the team nurses carried out a full assessment of the patient in his/her home. The nurse's assessment and recommendations were discussed with the team physician, then sent to the family physician with copies to the visiting nurse and home care case manager. A consultation by the team physician was available on request. All new and active cases discussed at the weekly team meeting.
Involvement of the team following initial assessment depended on the wishes of the patient and family and on negotiation with the family physician and home care nurse. There was either no further contact with the patient or caregivers, progress monitored through telephone calls, or periodic visits made to the home. Patients were given a number to call one of the team nurse if their home nurse or family physician could not be reached. Patients received the intervention immediately after enrolment.
Control: Waiting list: patients received the same intervention as the intervention group one month after enrolment. Emergency consultation by the team physician was made available for patients in the waiting list group if requested by the family physician.
Outcomes Patient: Pain, symptom ‐ nausea
Notes Length of follow‐up: 18 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The project coordinator assessed eligibility and conducted randomisation using a computer generated table of random numbers. A research assistant, who was blind to the assignment, visited the home to give more details of the study; obtain written consent;and explain the questionnaires, including the Melzack three day nausea and pain diary, and leave them with the patient and care giver. The assistant visited again after three days to collect the questionnaires then notified the coordinator that baseline data collection was completed. Data collection was repeated at one and two months, one month being the main comparison point."
Allocation concealment (selection bias) Low risk See quote above.
Blinding (performance bias and detection bias) 
 All outcomes High risk Quote: "A research assistant, who was blind to the assignment, visited the home to give more details of the study, obtain written consent, and explain the questionnaires to complete. Data collection was repeated at one and two months." 
 
 Measures were collected through self‐report questionnaires, and the patients were not blinded, so the assessors could not have been blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "Of the 146 randomised, 53 were lost to follow up before one month, 36 because of early death and 14 because of failure to complete the one month questionnaires. Only 74 care givers completed the questionnaires."
Comment: No results were presented.
Selective reporting (reporting bias) High risk No results were presented.
Other bias High risk Quote: "Admission of patients in the control group to the palliative care unit exposed them to a standard of palliative care equivalent to that offered by the palliative care home support team."
Baseline outcomes similar? Unclear risk Comment: No results were presented because of an important attrition due to death among participants.
Baseline characteristics similar? Unclear risk Comment: No results were presented because of an important attrition due to death among participants.
Protected against contamination? High risk Quote: "Admission of patients in the control group to the palliative care unit exposed them to a standard of palliative care equivalent to that offered by the palliative care home support team."
Comment: The same care providers were in charge of emergency care for control group participants and for intervention group participants. Some possibilities of contamination therefore existed.