Patient safety: Safety culture and patient safety ethics

Marlene Dyrløv Madsen

    Research output: Book/ReportPh.D. thesisResearch

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    Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally and internationally. This subject raises numerous challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of research is safety culture; through empirical and theoretical studies to comprehend the phenomenon, address the problems, and suggest possible solutions for improving patient safety through the promotion of safety culture and ethics. I seek to illuminate the issues of patient safety from several perspectives; the organizational healthcare system, in particular the healthcare workers perspectives and experiences, and those of patients who experience the physical effect of poor patient safety. The dissertation consists of nine papers and an appendix. Paper 1 describes the results of doctors and nurses attitudes towards reporting and the handling of adverse events. Paper 2 is a study and “review” of the international literature of assessment of safety culture in healthcare. Paper 3 summarizes results of an intervention study introducing a reporting system and using a questionnaire survey of safety culture within three Danish hospitals to measure the effects. Paper 4 reports key results from the study in paper 3, demonstrating significant, consistent and sometimes large differences in terms of safety culture factors across the units participating in the survey. Paper 5 is the results of a study of the relation between safety culture, occupational health and patient safety using a safety culture questionnaire survey and interviews with staff and management in four hospital departments. The appendix contains the Patient Safety Culture Questionnaire tool that I have developed, tested and revised for use in the Danish hospital setting based on the research projects on safety culture described in papers 3, 4 and 5. Paper 6 concerns the attitudes and responses to adverse events from the patient’s point of view, using a questionnaire survey, and comparing these to staffs responses to the same questions. Significant differences were found between those “actions” patients considered important following adverse events and those healthcare staff thought patients considered important. Papers 7, 8 and 9 address ethical issues through a philosophical lens, to demonstrate that patient safety is more than putting the right “systems” in place and that culture should not be understood independently of ethics. Paper 7 investigates the nature of apology and its internal logic in the context of healthcare. This is followed by paper 8, in which I suggest some overall recommendations for different acknowledging actions to patients following medical harm; from acknowledging harm to expressing regret and making an apology. In paper 9 I argue for the need of an Ethics of Patient Safety to overcome some of the obstacles that other strategies for improving patient safety have not yet overcome, and that such an ethics, in general, can help support improvement programs to advance safety culture and patient safety. Finally, I bring the most important findings and conclusions of the papers forth and suggest future research perspectives based on the findings in this Ph.D. dissertation.
    Original languageEnglish
    Place of PublicationRoskilde, Denmark
    PublisherRisø National Laboratory
    Number of pages324
    ISBN (Print)87-550-3520-5
    Publication statusPublished - 2006


    • Risø-PhD-25(EN)
    • Risø-PhD-25
    • Risø-PhD-0025

    Cite this

    Madsen, M. D. (2006). Patient safety: Safety culture and patient safety ethics. Risø National Laboratory. Risø-PhD, No. 25(EN)