Meeting pragmatism halfway: making a pragmatic clinical trial protocol

Pragmatic clinical trials (PCTs) are today an increasingly prominent means of measuring the ‘effectiveness’ of healthcare interventions in ‘real world’ clinical settings, in order to produce evidence on which to base regulatory and clinical decision‐making. Although several sociological studies have...

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Bibliographic Details
Published in:Sociology of health & illness 2015-11, Vol.37 (8), p.1285-1298
Main Author: Rushforth, Alexander
Format: Article
Language:English
Subjects:
Careers
Clinical Protocols
Clinical trials
Decision making
Evidence-Based Medicine
Health
Health care services
health technology/technology assessment
Humans
Law
Medical research
Mothers
National Health Programs
National Health Service (NHS)
Pragmatic Clinical Trials as Topic - methods
Pragmatism
Qualitative Research
Randomized Controlled Trials as Topic
Recruitment
Research design
Socialized medicine
Sociology
Sociology, Medical
United Kingdom
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Summary:Pragmatic clinical trials (PCTs) are today an increasingly prominent means of measuring the ‘effectiveness’ of healthcare interventions in ‘real world’ clinical settings, in order to produce evidence on which to base regulatory and clinical decision‐making. Although several sociological studies have shown persuasively how PCTs are co‐constructed within particular healthcare systems in which they are based, they have tended to focus on relatively later stages in careers of trials. The paper contributes to literature by considering how the ‘real world’ of the UK National Health Service (NHS) is incorporated into the design of a research protocol. Drawing on a meeting held just prior to patient recruitment for a PCT in maternal health, the paper analyses a trial collective's efforts to purify the messy domain of NHS clinical care into the orderly confines of the protocol (Law 2004), which meant satisfying demands for both scientific and social robustness (c.f. Nowotny et al. 2001). The findings show how efforts to inscribe robustness into the PCT protocol were themselves mediated through epistemic and regulatory conventions surrounding protocols as devices in healthcare research. Finally it is argued that meetings constitute an important epistemic instrument through which to settle various emerging tensions in PCT protocol design.
ISSN:0141-9889
1467-9566
DOI:10.1111/1467-9566.12311