How the context of reception affects the meaning of RCT evidence

Abstract

This article takes as a case study a set of disagreements in the early 2000s about randomised controlled trial (RCT) evidence for a newly developed drug in the field of intensive care medicine. The interpretation of RCT findings – and in particular, the application of these findings to clinical practice – were contested among research-active intensive care doctors, despite their shared professional and epistemic values. I examine the arguments about scientific interpretation and application to clinical practice advanced by two readily identifiable groups. The analysis documents how four particular aspects of scientific knowledge were perceived and portrayed differently by the two groups, and notes how each group was associated with different kinds of routine work practices and external networks. My argument is that these differences give rise to distinctive hermeneutic frames and orientations towards the scientific results and disparities in their consequential judgements regarding the legitimate use of the newly developed drug, and I introduce the concept situationally specific habitus to make the link between context and hermeneutic frames and orientations. The analysis has implications for furthering our understanding of how the clinical meaning attributed to scientific evidence is affected by the context of reception of results, even where epistemic and professional values are shared.

Exploring valuation practices in diagnosis‐as‐category: The rising dominance of clinical practice in the categorisation of Sepsis, 1991–2016

“…Our awareness of this case of disease categorisation originated from the first author's continual research on intensive care, including three extensive projects (an organisational ethnography, an evaluation of an organisational innovation and an interview-based study). While reflecting on the findings from the third study in particular (Carmel, 2023), we were intrigued that the categorisation of sepsis had changed several times over a 25-year period. The present project was then undertaken from January to June 2022 to identify and examine the forces driving these changes.…”

“…(Interview, May 2011; see also Carmel, 2023) In other words, while the balance of efficacy and safety had in principle favoured efficacy in the pivotal trial (Bernard et al, 2001), the marketing of the proposed mechanism of action continually reminded practitioners of the risks, which were reiterated in articles and blogs (e.g., Eichacker & Natanson, 2007;Hopley & van Schalkwyk, 2006;MacKenzie, 2005).…”

“…For example, the EMEA referred to severe sepsis as resulting from a ‘generalised inflammatory and procoagulant response to infection’ (2004, p. 1) and members of the FDA panel later referred to the drug’s trial as testing ‘the hypothesis that part of the pathophysiology of sepsis is caused by unrestricted or inappropriate coagulation in the microcirculation’ (Warren et al., 2002). This condensed version of the pathophysiology of severe sepsis formed the basis of ensuing scientific controversy about the balance between efficacy and safety for rhAPC (Carmel, 2023).…”