Boyes 2006.
Methods | RCT; Unit of allocation: Patient | |
Participants | People diagnosed with cancer attending the oncology outpatient clinic and confirmed to receive active treatment. Setting / country: Medical oncology outpatient clinic at one major public cancer treatment centre in the state of New South Wales / Australia Type of cancer: Any type Phase of care: Treatment Sample size at randomisation: 80 |
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Interventions | Routine assessment and real‐time feedback: Patients' psychosocial well‐being was repeatedly collected over the course of treatment using a touch screen computer survey. Each time an intervention group patient completed the survey, the computer software immediately scored his/her answers and printed a feedback report, which was placed in the patient's file for consideration during his/her consultation with the oncologist. The feedback report listed the physical symptoms the patient reported as debilitating, a graphical representation of anxiety and depression scores, and the supportive care needs items that the patient reported. Suggested strategies for managing each identified issue were also included. The feedback report and recommended management strategies were developed in consultation with the treatment team including representatives from medical oncology, social work, occupational therapy, nursing, nutrition and dietetics and pastoral care. Control: Participants allocated to the control group underwent a usual consultation and their survey results were not made available to their oncologist. |
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Outcomes | Patient: Anxiety and depression (distress), perceived needs, symptoms. | |
Notes | Length of follow‐up: During 3 visits at outpatient clinic months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "When first completing the computer survey, participants were alternately allocated, by the computer, to either the intervention or the control group." Comment: This is a quasi‐randomised allocation method. |
Allocation concealment (selection bias) | High risk | Comment: Allocation could not have been completely concealed since one could predict the different groups from alternation. |
Blinding (performance bias and detection bias) All outcomes | High risk | Comment: Self‐report questionnaire were used and patients were not blinded to group allocation, so blinding of assessors was not possible. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "There was no significant difference in the dropout rate between the two groups (60% of both groups completed the third follow‐up)." "Importantly, the rate of attrition was similar in both groups, as were the reasons for attrition. Therefore, it is unlikely that missing data due to attrition had any impact on the results." |
Selective reporting (reporting bias) | Low risk | All outcomes in the methods section are reported in the results section. |
Other bias | Low risk | No evidence of other bias. |
Baseline outcomes similar? | Low risk | Quotes: "Trends in the mean level of anxiety and depression were compared between the control and intervention groups using random effects models. Trends in the proportion of patients with a moderate or high level of need were compared between the control and intervention groups using generalised estimating equations" Comment: There were some differences in depression and in one of the need domain at baseline but no statistical tests were presented to compare these scores. Statistical analysis, however, took into account baseline value to detect trend in outcome during follow‐up. |
Baseline characteristics similar? | High risk | Quote: "Table 1 summarizes the demographic, disease and treatment characteristics of participants at baseline. Patient characteristics were well balanced between the two groups although the intervention group had a significantly larger proportion of older patients (60 to 79 years) and patients diagnosed more than 1 year prior to the study." Comment: These potential confounding variables were not taken into account in analysis. |
Protected against contamination? | High risk | Quote from discussion: "In addition to the limitations of sample size and eligibility criteria, there was the potential for contamination between the intervention and control groups as all medical oncologists saw patients in both groups. We believe that the impact of this is likely to be minimal as there is considerable evidence that medical oncologists have poor awareness of the issues faced by their patients (Newell et al. 1998; Fallowfield et al. 2001)." Allocation was not by practice or professional, and the same professionals were in contact with control and experimental groups patients. |