Nimako 2015.
Methods | RCT ‐ with intervention group (IG), usual care control group (UCG), and attention control group (ACG) | |
Participants | Patients of all ages with a diagnosis of a thoracic cancer who had recently completed treatment. Country: UK Age: IG: mean 64.6 years; ACG: mean 64.7 years; UCG: 62.9 years Sex: IG: 44% female; ACG: 45% female; UCG: 46% female Inclusion criteria
Exclusion criteria
N randomised: N = 138; IG: n = 45; ACG: n = 47; UCG: n = 46 N in analysis Baseline measures: N = 138; IG: n = 45; ACG: n = 47; UCG: n = 46 6 weeks' measures: N = 131; IG: n = 42; ACG: n = 45; UCG: n = 44 |
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Interventions |
Content of screen:HRQoL: tool = EORTC QLQ‐C30: 5 functional scales, 9 symptom scales, and 2 General Health and QoL items, no total score can be computed Interventionist: No interventionist for screening act, self‐completion of screening tool Intervention procedure:Solitary SI
Conditions for implementation:
Comparative condition: Usual care group Length of follow‐up: 6 weeks |
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Outcomes |
Primary outcomes
Secondary outcomes
Outcome time points: baseline and 6 weeks after baseline |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Electronic randomisation is mentioned, however exact method of sequence generation is unclear |
Allocation concealment (selection bias) | Unclear risk | Not mentioned who allocated the participants to the 3 conditions and how this was done, unclear if allocation was concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and doctors were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | QoL assessments: completed on paper and over the phone, unclear if the telephone assessor was blinded QoL issues identification and management: outcome assessment by the principal investigator based on the record chart completed by the unblinded doctor and the GP letter |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data appear to be complete, dropout from baseline to 6 weeks' postbaseline +/− 7% |
Selective reporting (reporting bias) | High risk | Only data on the Global Health question of the EORTC QLQ‐C30 was used/reported for control group while whole questionnaire was administered by participants in the control group |
Other bias | Low risk | / |