Brown 2002.
Methods | Randomised individual, multisite (4 sites) trial, 12 months | |
Participants | UK, 4 hospital clinics (61 participants), breast cancer, women, mean age 65.34 years | |
Interventions | INT (n = 30): participant to contact BCN by telephone if any problems/ as needed. Given written information on signs and symptoms of recurrence. Safety net – yearly mammogram. CONT (n = 31): consultant‐led (schedule NR), availability of emergency appointments unclear. |
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Outcomes | Health‐related quality of life: 6 and 12 months (EORTC QLQ‐C30) Disease‐specific health‐related quality of life: 6 and 12 months (EORTC QLQ‐BR23) Psychological morbidity: 6 and 12 months (HADS) Satisfaction: 6 and 12 months (bespoke tool) Contact with health professional: 12 months (medical records) |
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Notes | Source of funding and conflicts of interest NR. Contacted authors for more information, no further data provided. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number list generated by staff. |
Allocation concealment (selection bias) | Unclear risk | Details NR. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blinded; all outcomes self‐reported. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unclear if BCN blinded; all outcomes self‐reported. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 20% in CONT and 10% in INT lost to 'difficulties in recording' for satisfaction. Unsure of numbers for EORTC outcome. |
Selective reporting (reporting bias) | Low risk | All outcomes reported for all time points. |
Other bias | High risk | Some participants not recommended to study due to staff opinion about suitability which was not fully explained; 'presentation bias' as all women who agreed to be part of the study may have felt more positively or may have been more knowledgeable about the PIAS anyway, especially as many women refused participation because they wanted to remain on routine follow‐up. |