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An epistemology of patient safety research: a framework for study design and interpretation. Part 1. Conceptualising and developing interventions

¹ Department of Public Health and Epidemiology, University of Birmingham, Birmingham, UK
² University of Michigan Medical School, Ann Arbor, Michigan, USA
³ National Patient Safety Agency, London, UK
⁴ Newcastle upon Tyne Medical School, Newcastle upon Tyne, UK
⁵ University of Sheffield, Sheffield, UK
⁶ London School of Pharmacy, London, UK

Correspondence to:
Dr C Brown, Research Methodology Programme, Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK; c.a.brown{at}bham.ac.uk

ABSTRACT
This is the first of a four-part series of articles examining the epistemology of patient safety research. Parts 2 and 3 will describe different study designs and methods of measuring outcomes in the evaluation of patient safety interventions, before Part 4 suggests that "one size does not fit all". Part 1 sets the scene by defining patient safety research as a challenging form of service delivery and organisational research that has to deal (although not exclusively) with some very rare events. It then considers two inter-related ideas: a causal chain that can be used to identify where in an organisation’s structure and/or processes an intervention may impact; and the need for preimplementation evaluation of proposed interventions. Finally, the paper outlines the authors’ pragmatist ontological stance to patient safety research, which sets the philosophical basis for the remaining three articles.

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