Hanks 2002.
Methods | RCT; Unit of allocation: Patient; Stratified by: Hospital site, and within each hospital setting, by cancer and non‐cancer patients | |
Participants | Inpatients newly referred to the Palliative Care Team. Setting / country: Teaching hospital trust (United Bristol Healthcare Trust) in England / UK Type of cancer: Any type Phase of care: Palliative care Sample size at randomisation: 261 |
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Interventions | Full‐palliative care team (PCT): the multidisciplinary specialist PCT was the usual service and comprised 2 clinical academic consultants, one specialist registrar, and 3 clinical nurse specialists (2.5 full‐time equivalent). The PCT has close link with a clinical psychologist, a local hospice and community‐based palliative care services and access to social workers, rehabilitation staff and the chaplaincy in the hospital. Initial assessment of patients was undertaken by a specialist doctor or specialist nurse, either alone or together, and detailed advice about any problems identified was written in the patients case notes and communicated to the patients medical and nursing team personally or by telephone. Appropriate follow‐up was then instituted which usually involved both telephone and in‐person consultations with the patient, their family and the medical and nursing staff caring for the patient by one of the specialist nurses or the registrar. All patients were reviewed at least weekly by one of the consultants. For patients who were discharged from hospital, the PCT also provided liaison with community based health professionals and outpatient follow‐up in the Palliative Care clinic if appropriate. Control: Telephone‐PCT, limited telephone advice: A more limited form of intervention was devised as a control. This involved no direct contact between the PCT and the patient or their family. Instead, within one working day of referral, a telephone consultation took place between a senior medical member of the PCT and the referring doctor and also between a PCT nurse specialist and a member of the ward nursing staff directly involved with the patient. A second telephone consultation could be made if necessary but thereafter no further follow‐up or advice was given. Such a telephone advisory service commonly forms a part of the operational policy of specialist palliative care teams. |
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Outcomes | Patient: Emotional bother, QoL, satisfaction, mood Informal carer: Satisfaction, anxiety and depression (distress) Process: Length of hospital stay and rates of readmission, use of hospital resources, use of primary care services |
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Notes | Length of follow‐up: Until death (min. 0.25; max. 1) months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The randomisation schedule was prepared by generating random numbers on a computer (within Microsoft Access) in permuted blocks of three to ensure equality of randomisation between the strata." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomisation details were recorded on adhesive labels placed in opaque non‐resealable envelopes. Randomisation was undertaken by a non‐clinical administrator with no involvement in patient recruitment or assessment." |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The researchers who undertook the assessments were blind to the group allocation." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "The randomised groups were compared on an intention‐to‐treat basis, including the use of confidence intervals. All analyses therefore included individuals in the group to which they were randomised, regardless of whether they subsequently switched groups." Comment: Proportions of missing data in the control (43%) and in the intervention groups (33%) were similar. Reason for attrition was death in all cases. No imputation was used. |
Selective reporting (reporting bias) | Low risk | All outcomes in the methods section are reported in the results section. |
Other bias | High risk | Quote: "However, there was a highly significant difference in the number of patients who switched intervention groups, in favour of the ‘full‐PCT’. It seems clear from these data that patients in both groups were being well managed. This poses the question as to whether either or both interventions contributed to this good management." |
Baseline outcomes similar? | Low risk | Quote: "The prevalence of the most bothersome symptom volunteered by patients at the baseline assessment was also similar in the two allocated groups (Table 5)." + table 4 "The primary analyses involved regression models comparing the allocated groups in respect of outcomes at follow‐up, adjusting for baseline scores as covariates." |
Baseline characteristics similar? | Low risk | Quote: "The allocated groups were similar in baseline characteristics except in gender distribution (Table 4)." Comment: The small difference in gender between group is unlikely to have biased study results, since there are no indication that gender would affect outcome measurements. |
Protected against contamination? | High risk | Patients were the units of allocation and the intervention was delivered by the same team (Palliative care team). |