Background This study follows structured frameworks to assess the internal and external validity of a decision-analytic model-based cost-effectiveness of approaches to implement a risk-stratified national breast screening programme (risk-NBSP) in the United Kingdom (UK).
Methods A pre-defined set of steps were used to conduct the process of validation of a published decision-analytic model-based cost-effectiveness analysis of a risk-NBSP (UK healthcare perspective; lifetime horizon; costs (£; 2019). Internal validation was assessed in terms of: descriptive validity; technical validity; face validity. External validation was assessed in terms of: operational validation; convergent validity (or corroboration); predictive validity.
Results The results outline the findings of each step of internal and external validation. The positive aspects of the model in meeting internal validation requirements are shown. The limitations of MANC-RISK-SCREEN are described.
Conclusion Following a transparent and structured validation process, MANC-RISK-SCREEN has been shown to have good internal validity and satisfactory external validity. We suggest that MANC-RISK-SCREEN provides a robust decision-analytic model to assess the cost-effectiveness of risk-NBSP from the UK perspective.
Key points for decision makers There are emerging suggested adaptations to national screening programmes, such as the introduction of risk-stratification to the national breast screening programme (risk-NBSP) in the United Kingdom (UK)
There is a key role for the use of decision-analytic model-based analysis of healthcare interventions, such as a risk-NBSP, that are difficult to evaluate in trials due to the large number of participants required and very long follow up period required.
This study follows structured frameworks to assess the internal and external validity of a decision-analytic model-based cost-effectiveness of a potential risk-NBSP. The decision-analytic model is shown to perform to a satisfactory level, with possible limitations described clearly, to inform resource allocation decisions from the perspective of the UK healthcare system.