Pisani 2006.

Study characteristics
Methods	Design: RCT Unit: cluster (202 health centres)
Participants	Location/setting: National Capital Region of Manila, Philippines Sample size: 151,168 women Dropouts/withdrawals: N/A Sex: females were included. Mean age: mean age of the compliers was 44.8 years and mean age of those who refused to be examined was 44.7 years. Inclusion criteria: women resident in 12 municipalities of the National Capital Region of Manila, Philippines and were included in the electoral rolls. Exclusion criteria: women who didn't live in the study area. Recruited nurses and midwives were trained in CBE using silicone breast models. Training was repeated for those who missed or over‐reported by 20% the lumps in the silicone models.
Interventions	Intervention group: (n = 151,168) 5 annual CBEs were performed in the National Capital Region of Manila, Philippines by the trained nurses/midwives with block randomisation amongst 202 clinics based on size of catchment population. First round of examinations took place in 24 months between January 1996 and December 1997, women were interviewed and CBE was implemented on 92% of participants. They were also instructed with BSE technique and given a leaflet in the local language explaining the importance of BSE. Registered cases of breast cancer were followed up until 2001 to assess their vital status. Control group: received no active intervention but were exposed to general health education campaigns carried out by municipal authorities and voluntary bodies. 138,392 women (92%), consented to receive the intervention over a period of 24 months between January 1996 and December 1997 with a 3‐year follow‐up of confirmed breast cancer cases.
Outcomes	Primary outcomes: number and cumulative incidence of breast cancers in the cohort of interviewed women. Secondary outcomes: diagnostic follow‐up for those with breast cancer. Timing of outcome assessment: outcomes were assessed after intervention was implemented. Because only one screening round was carried out, sensitivity, specificity and predictive value were calculated using as gold standard the incident cases identified by the registries in 2 years from screening examination, including those diagnosed at the time of testing.
Notes	Study start date: 1995 Study end date: 2001 Conflicts of interest: author conflicts not declared. Outcome data are only presented by arm of intervention and data for the control arm is not provided. The intervention was discontinued after the first round of screening due to non‐compliance of follow up by the participating women.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "These were randomly assigned to intervention or control arm by block randomization." Comment: insufficient information pertaining to the method of sequence generation to permit judgement.
Allocation concealment (selection bias)	Unclear risk	Comment: insufficient information to permit judgement.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: probably not done. Each participant and health worker were aware of the arm to which the participant were allocated.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: probably not done. Each participant and health worker were aware of the arm to which the participant were allocated.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: amongst the women detected positive for lump after first round, 35% completed diagnostic follow‐up, whereas 42.4% actively refused further investigation even with home visits, and 22.5% were not traced.
Selective reporting (reporting bias)	High risk	Comment: some outcomes like mortality and down staging were not reported as study was aborted.
Other bias	High risk	Comment: due to a very low compliance with clinical follow‐up, the intervention ceased after completion of the first round of examinations.