McCorkle 2000.
Methods | RCT; Unit of allocation: Patient | |
Participants | Post‐surgical cancer patients aged 60 or older diagnosed with a solid tumour and given a survival prognosis of 6 months or greater after the surgery. Setting / country: Comprehensive Cancer Center in south eastern Pennsylvania / USA Type of cancer: Any type Phase of care: Discharge, surveillance, palliative care Sample size at randomisation: 375 |
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Interventions | Specialised home care provided by advanced practice nurses (APNs): The APN telephoned the patients within 24 h after discharge to schedule a meeting. The intervention consisted in standard assessment and management of post‐surgical guidelines, doses of instructional content, and schedules of contacts. It lasted 4 weeks and consisted of three home visits and five telephone contacts provided by APNs. Both the patients and their family caregivers received comprehensive clinical assessments, monitoring, and teaching, including skills training. The APNs followed specific guidelines to assess and monitor the physical, emotional, and functional status of patients, provide direct care when needed, assist in obtaining services or other resources from the community, and provide teaching, counselling, and support during the period of recovery. Nurses also functioned as a liaison to healthcare settings and providers, as well as to patients and families, in the provision of technical and psychological support. If complications arose, the APNs consulted with physicians and intervened immediately. APNs were available on a 24‐hour basis using a paging system. Control: Standard postoperative care in the hospital and routine follow‐up in outpatient clinics upon discharge. |
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Outcomes | Patient: Survival | |
Notes | Length of follow‐up: 44 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: " Once Wave 1 data were obtained, subjects were randomised using the sealed opaque envelope technique" |
Allocation concealment (selection bias) | Unclear risk | See quote first item. |
Blinding (performance bias and detection bias) Functional status | Unclear risk | Functional status was "reported by the patient and rated by the interviewer". No details on blinding of the interviewer. |
Blinding (performance bias and detection bias) Psychological status | High risk | Symptom distress and depressive symptom were self‐reported. Since the patients were not blinded than the assessor could not be blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Reduction in sample size was caused primarily by death." Comment: Survival being an end‐point, it should not be addressed as missing data. However, the other causes of attrition should have been reported in each group since they could have bias the results. |
Selective reporting (reporting bias) | Low risk | All outcomes described in Methods are reported in Results. |
Other bias | Low risk | No evidence of any other bias. |
Baseline outcomes similar? | Low risk | Comment: The three psychosocial measures were similar in the experimental groups at baseline (Table 2). |
Baseline characteristics similar? | Low risk | Quotes: "Despite randomisation, there were differences between the two groups on stage at diagnosis, with the intervention group having more late stage patients (38%) compared with the control group (26%)." "Since the two groups differed on stage of disease post‐randomisation, stratified log‐rank test was used to compare them." |
Protected against contamination? | Unclear risk | Comment: Patients were the unit of randomisation. There is no information on the setting through which the APN nurses in charge of patients in the intervention group operated. If they operated through the same outpatient clinics than nurses in charge of control group patients, then there would be a risk of contamination. |