Black 1994.
Methods | RCT | |
Participants | People with non‐melanoma skin cancer (USA) CVD risk: low Control: randomised 67, analysed 58 Intervention: randomised 66, analysed 57 Mean years in trial: 1.9 % male: control 67%, intervention 54% Age: mean control 52.3 (sd 13.2), intervention 50.6 (sd 9.7) | |
Interventions | Reduced fat vs. usual diet Control aims: no dietary advice Intervention aims: total fat 20%E, protein 15%E, CHO 65%E Control methods: no dietary change, 4 monthly clinic visits Intervention methods: 8 weekly classes, with behavioural techniques, plus 4 monthly clinic visits Total fat intake ("during study" months 4‐24): low fat 20.7 (sd 5.5), cont 37.8 (sd 4.1)%E Saturated fat intake ("during study, months 4‐24): low fat 6.6 (sd 1.8), cont 12.8 (sd 2.0)%E Style: diet advice Setting: community |
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Outcomes | Stated trial outcomes: incidence of actinic keratosis and non‐melanoma skin cancer
Data available on total mortality? yes
Cardiovascular mortality? yes
Events available for combined cardiovascular events: cardiovascular deaths Secondary outcomes: cancer deaths (none) Tertiary outcomes: none (weight data provided, but no variance info) |
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Notes | At 2 years control ‐1.5kg n=50?, intervention ‐1kg n=51? | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "list of randomly generated numbers" |
Allocation concealment (selection bias) | Unclear risk | Randomisation method not clearly described |
Blinding (performance bias and detection bias) All outcomes | High risk | Physician blinding: adequate Participant blinding: inadequate |
Incomplete outcome data (attrition bias) All outcomes | Low risk | For mortality. Unclear for other outcomes |
Selective reporting (reporting bias) | Low risk | Not relevant for primary and secondary outcomes as all trialists asked for data |
Other bias | Low risk | |
Free of systematic difference in care? | High risk | Minor, all have 4 monthly clinic visits, the intervention group had 8 behavioural technique classes that the control group did not have |
Free of dietary differences other than fat? | Low risk | See Control and Intervention Aims in Interventions section of the Table of Characteristics of Included Studies |