Stevens 2006.
Methods | Randomised, cross‐over study, 6 months subsequent phases of either home of hospital chemotherapy | |
Participants | 2 to 16 year age group 29 children with acute lymphoblastic leukaemia (ALL) in the year prior to enrolment in study 15 allocated to home and then hospital chemotherapy and 14 vice versa Total 23 children received allocated treatment 6 children discontinued intervention or relapsed | |
Interventions | Comparison of home‐based with hospital‐based chemotherapy At home, chemotherapy administered by a trained nurse | |
Outcomes | Child's quality of life (QOL)
Effects on parental caregivers
Adverse effects
Costs Data assessed at baseline, 3 months (postphase 1), 6 months (postphase 1), 3 months (postphase 2) and 6 months (postphase 2) |
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Notes | Cross‐over study with no time gap between cross‐over of two study arms | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: " Using a table of random numbers, eligible children were randomly assigned by the study site manager to either the hospital (standard care) or home (treatment) chemotherapy group for phase 1 (6 months)." |
Allocation concealment (selection bias) | Unclear risk | Comment: the allocation concealment is not mentioned. |
Blinding (performance bias and detection bias) All outcomes | High risk | Comment: The study method implies that blinding of neither participants nor clinicians was possible. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | As above |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Not mentioned whether data were analysed by independent clinicians blinded to the outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcome data were reported for all participants. |
Selective reporting (reporting bias) | Low risk | Comment: outcome data were presented for all outcomes reported as measured. |
Other bias | Low risk | Comment: none were identified. |