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. 2012 May 16;2012(5):CD002137. doi: 10.1002/14651858.CD002137.pub3

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
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)
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