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An epistemology of patient safety research: a framework for study design and interpretation. Part 4. One size does not fit all
  1. C Brown1,
  2. T Hofer2,
  3. A Johal1,
  4. R Thomson3,4,
  5. J Nicholl5,
  6. B D Franklin6,
  7. R J Lilford1
  1. 1
    Department of Public Health and Epidemiology, University of Birmingham, Birmingham, UK
  2. 2
    University of Michigan Medical School, Ann Arbor, Michigan, USA
  3. 3
    National Patient Safety Agency, London, UK
  4. 4
    Newcastle upon Tyne Medical School, Newcastle upon Tyne, UK
  5. 5
    University of Sheffield, Sheffield, UK
  6. 6
    London School of Pharmacy, London, UK
  1. 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 final article in the series on the epistemology of patient safety research, and considers the selection of study design and end points during the planning of an evaluation. The key message of this series is that “one size does not fit all”: the nature of the evaluation will depend on logistical and pragmatic constraints, a priori assessment of the probability of benefits and harms, the plausible scale of these effects and the target audience for the results. This paper also discusses the advantages of mixed method designs. The strength of any conclusions can be increased if different end points concur and the authors therefore advocate assessment of the effect of the intervention on different end points across the generic causal chain linking structure, process and outcome. The use of both qualitative and quantitative methods is also advocated to help explain findings, generate theory and help contextualise results. We show how a bayesian framework can be used to synthesise evidence from a number of different sources and why this approach may be particularly appropriate for the evaluation of patient safety interventions.

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Footnotes

  • See Editorial, p 154

  • Competing interests: None.

  • Authors’ contributions: RL conceived the Network and formulated the first draft of the report and the current paper with assistance from AJ. CB contributed to subsequent drafts of the report and this paper. BDF, TH, RT and JN contributed to the Research Network and provided comments on drafts of the report and papers in their areas of expertise.

  • This work forms part of the output of a Cross-Council Research Network in Patient Safety Research funded by the Medical Research Council (Reference G0300370). More details of the Research Network can be found at: http://www.pcpoh.bham.ac.uk/publichealth/psrp/MRC.htm

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