Kane 1984.
Methods | RCT; Unit of allocation: Patient | |
Participants | Patients admitted to the hospital with a terminal prognosis of two weeks to six months and informed of this prognosis. Setting / country: Veterans Administration Wadsworth Medical Center, West Los Angeles, a university‐affiliated teaching hospital / USA Type of cancer: Any type Phase of care: Palliative care Sample size at randomisation: 246 (or 247?) |
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Interventions | Hospice care: The hospice included: (a) an 11‐bed inpatient unit team staffed by 2 physicians, 19 nurses, a social worker, a chaplain, and about 30 volunteers, which sought to spend more time with the patients and their family to help them cope more effectively with impending death, (b) a home care program serving about 25 patients at any given time and (c) a consultation service for patients awaiting admission to the hospice inpatient unit or needing emergency hospital care when no hospice inpatients bed were available. The last modality (consultation) was used when all the beds in the hospice unit were assigned, because all hospice patients receiving home care were guaranteed admission on demand. Although patients on the consultation service were regarded as hospice patients, they remained in the care of a family physician and hospice staff provided limited help and advice for the patient and his familial caregiver during this time. Control: Conventional care usually located in the intermediate care unit (chronic care ward) but may also be in the surgery, ENT, or haematology/oncology wards of the hospital. |
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Outcomes | Patient: Pain, symptoms, depression, anxiety, satisfaction, survival, functional status Informal carer: Anxiety, satisfaction Process: Place of death, use of institution services (hospital and nursing home), surgical procedures, radiation, chemotherapy |
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Notes | Length of follow‐up: Until death or the maximum number of interviews completed (N = 6) (min. 1.5; max. 4.5 months) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "After informed consent was received from patients and their FCGs, patients were randomly assigned to receive hospice or conventional care; the sampling proportion was deliberately weighted to favour hospice care." Quote from email message from the author: "I do not remember." |
Allocation concealment (selection bias) | Unclear risk | See quote first item |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote from ref #2: "Interviews to assess the reliability of the various scales... were with the four interviewers conducting the data collection." Comment: Data were collected by means of interviews performed by 4 interviewers, but no other details are presented. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quotes: "Of the 263 patients eligible for the study, only 17 (6%) declined to participate. Another 10 patients withdrew after enrolment." "The survival curves for the hospice and control groups were essentially the same." Comment: The proportion of participants who withdrew in each group was not specified, and neither were reasons of withdrawal. However, because the authors used survival analysis, they took into account individuals lost to follow‐up. |
Selective reporting (reporting bias) | High risk | Results from the functional status described in Methods was not reported in Results or elsewhere. |
Other bias | Low risk | No evidence of any other bias. |
Baseline outcomes similar? | Low risk | Quote: "Repeated‐measures analyses of covariance, with baseline score as a covariate, were performed for symptoms, affect, satisfaction, activities of daily living, and involvement‐with‐care measures to determine whether there were differences between hospice and control subjects." |
Baseline characteristics similar? | Low risk | Quote from ref #1: "t‐tests on baseline data revealed no significant differences between hospice and control subjects on any measures." Comment: Baseline characteristics presented in Table 1 are similar in the 2 experimental groups. |
Protected against contamination? | Unclear risk | Experimental and control group patients were located in separated units of the same hospital, but it is unclear whether there was some link between professionals in these units. |