Effect of second timed appointments for non-attenders of breast cancer screening in England: a randomised controlled trial.

BACKGROUND: In England, participation in breast cancer screening has been decreasing in the past 10 years, approaching the national minimum standard of 70%. Interventions aimed at improving participation need to be investigated and put into practice to stop this downward trend. We assessed the effect on participation of sending invitations for breast screening with a timed appointment to women who did not attend their first offered appointment within the NHS Breast Screening Programme (NHSBSP). METHODS: In this open, randomised controlled trial, women in six centres in the NHSBSP in England who were invited for routine breast cancer screening were randomly assigned (1:1) to receive an invitation to a second appointment with fixed date and time (intervention) or an invitation letter with a telephone number to call to book their new screening appointment (control) in the event of non-attendance at the first offered appointment. Randomisation was by SX number, a sequential unique identifier of each woman within the NHSBSP, and at the beginning of the study a coin toss decided whether women with odd or even SX numbers would be allocated to the intervention group. Women aged 50-70 years who did not attend their first offered appointment were eligible for the analysis. The primary endpoint was participation (ie, attendance at breast cancer screening) within 90 days of the date of the first offered appointment; we used Poisson regression to compare the proportion of women who participated in screening in the study groups. All analyses were by intention to treat. This trial is registered with Barts Health, number 009304QM. FINDINGS: We obtained 33 146 records of women invited for breast cancer screening at the six centres between June 2, 2014, and Sept 30, 2015, who did not attend their first offered appointment. 26 054 women were eligible for this analysis (12 807 in the intervention group and 13 247 in the control group). Participation within 90 days of the first offered appointment was significantly higher in the intervention group (2861 [22%] of 12 807) than in the control group (1632 [12%] of 13 247); relative risk of participation 1·81 (95% CI 1·70-1·93; p<0·0001). INTERPRETATION: These findings show that a policy of second appointments with fixed date and time for non-attenders of breast screening is effective in improving participation. This strategy can be easily implemented by the screening sites and, if combined with simple interventions, could further increase participation and ensure an upward shift in the participation trend nationally. Whether the policy should vary by time since last attended screen will have to be considered. FUNDING: National Health Service Cancer Screening Programmes and Department of Health Policy Research Programme.

The appraisal of public health interventions: the use of theory.

BACKGROUND: Public health decision-making is hampered by inappropriate adherence to underpowered randomized controlled trials (RCTs) which give inconclusive results and lead to decision-makers being loath to recommend interventions with strong theoretical and observational support. METHODS: We outline situations in which robust decisions about health interventions can be made without trial evidence. We present a new approach in which theory, causal models and past observations are given proper regard in the decision-making process. RESULTS: Using our approach, we provide examples where the use of causal theories and observations in areas, such as salt reduction, smoking cessation and gardening to improve mental health, is sufficient for deciding that such interventions are effective for improving health without needing the support of underpowered RCTs. Particularly where RCT evidence is inconclusive, our approach may provide similar aggregate health outcomes for society for vastly lower cost. CONCLUSIONS: When knowledge and theoretical understanding are unable sufficiently to reduce doubt about the direction of effect from an intervention, decisions should be made using evidence-based medicine approaches. There are, however, many cases where the combination of robust theory, causal understanding and observation are able to provide sufficient evidence of the direction of effect from an intervention that current practice should be altered.