Designs for evidence: public and private faces of cardiac surgery research

This paper offers a critical reflection on changes in cardiac surgical research based on empirical work on the development of implantable circulatory support devices over appropriately 20 years to the present. Trials of surgery and implantable devices have received relatively little attention from social science, but offer important comparisons with the pharmacological and organisational trials examined in the literature and in our own previous work. Drawing on journal commentary, trial reports, and policy documents, we focus on the emergence of more adaptive trial designs and the use of registries in the assessment of devices. These very different developments can be viewed as social experiments, shaping new relationships between physicians, manufacturers and regulators (or private and public actors) as well as more or less formal statements about what should count as evidence in the device field. Yet while such agreements increasingly included a public account of the ongoing and improvisational quality of surgical innovation around devices (allowing for patient populations, endpoints or devices themselves to be modified in a single study), they also obscured or bracketed other adaptations which remained informal and private (including changing methods of implantation and the space allowed for surgeons’ developing skills and preferences), which we describe with reference to ethnographic data on our case. We conclude with a reflection on the contemporary reach and meaning of the RCT as the dominant mode of knowledge production in medicine.