Addington‐Hall 1992.
Methods | Cluster‐RCT; Unit of allocation: General practice; Stratified by: Number of GP partners in the practice, postal district | |
Participants | Cancer patients expected to live for less than a year Setting / country: Inner London health district / UK Type of cancer: Any type Phase of care: Palliative care Sample size at randomisation: 554 |
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Interventions | Community‐based nurse coordinator: The coordinators' role was to ensure that patients received appropriate and well coordinated services, tailored to their individual needs and circumstances. They introduced themselves to patients as nurses who provided a link between the hospital, the general practitioner, and community services. They acted as "brokers" of services and their role was to assess need for services from agencies in the NHS, local authority, and voluntary sector; to offer advice on how to obtain these services and to contact the agencies themselves if necessary; to ensure that services were provided and well coordinated; and to stay in regular contact to monitor the changing needs of the patient and family for services. Patients were encouraged to contact the coordinators if they needed help or advice. The coordinators did not themselves provide practical nursing care, specialist palliative care advice, or counselling; instead they liaised with district nurses and hospice or Macmillan nurses, as appropriate, when patients required this type of support. Control: Routinely available services. |
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Outcomes | Patient: Symptoms, QoL, anxiety and depression (distress), satisfaction with social support, survival Informal carer: Anxiety and depression Process: Use of services, medication use, sources of help |
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Notes | Length of follow‐up: Until death (min. 0.5; max. 27) months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from reference #1: "general practices in the district were randomly allocated to the coordination or the control group, stratified by number of partners and postal district." |
Allocation concealment (selection bias) | Unclear risk | See quote above. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote from reference #1: "Independent interviewers, who were not informed which group the patients were in, interviewed patients at home on entry to the trial (baseline interview) and at intervals ranging from two weeks to six months until death or the end of the trial (follow up interviews)." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote from reference #1: "Information from the interview nearest death (or nearest the end of the study, for patients alive at this point) and from the interview after bereavement were used to measure the effects of the coordinating service on patients and families." Comment: There was a low retention rate in the 2 groups (coordination = 33%; control = 42%). Missing outcomes were not perfectly balanced in the 2 groups, with more deaths in the coordination group (147) compared to the control (98). Potentially inappropriate application of simple imputation: last observation carried forward. |
Selective reporting (reporting bias) | Low risk | All relevant outcomes in the methods section are reported in the results section. |
Other bias | Low risk | Quotes from reference #1: "By September 1987 it was apparent that too few patients were entering the coordination group to keep the nurse coordinators fully employed. Thirteen randomly selected control group practices were therefore transferred to the coordination group. This change in randomisation has been allowed for in the analysis." Comment: The selection of patients to be switched from one group to the other was apparently performed at random. |
Baseline outcomes similar? | Low risk | Quote from reference #1: "Scores at the baseline interview were controlled for with the Mantel‐Haenszel test for categorical data and regression analysis for interval data." Comment: No results at baseline are presented, but the authors mention that there was some imbalance. An appropriate analysis was performed to adjust outcomes for baseline imbalance. |
Baseline characteristics similar? | Low risk | See Table 1. Comment: No characteristics are presented but differences appear to be non‐significant. |
Protected against contamination? | Low risk | Quote from reference #1: "To prevent the contamination that could occur if patients of the same general practice had been allocated to different groups, general practices in the district were randomly allocated to the coordination or the control group, stratified by number of partners and postal district." Comment: Allocation was performed by practice. |