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Background  Attempts to achieve digital transformation across the health service have stimulated increasingly large-scale and more complex change programmes. These encompass a growing range of functions in multiple locations across the system and may take place over extended timeframes. This calls for new approaches to evaluate these programmes.    Main body  Drawing on over a decade of conducting formative and summative evaluations of health information technologies, we here build on previous work detailing evaluation challenges and ways to tackle these. Important considerations include changing organisational, economic, political, vendor and markets necessitating tracing of evolving networks, relationships, and processes; exploring mechanisms of spread; and studying selected settings in depth to understand local tensions and priorities.    Conclusions  Decision-makers need to recognise that formative evaluations, if built on solid theoretical and methodological foundations, can help to mitigate risks and help to ensure that programmes have maximum chances of success.

Theoretical and methodological considerations in evaluating large-scale health information technology change programmes