Speaking up about safety concerns: multi-setting qualitative study of patients views and experiencesVikki A Entwistle, Dorothy McCaughan, Ian S Watt, Yvonne Birks, Jill Hall, Maggie Peat, Brian Williams, John Wright for the PIPS (Patient Involvement in Patient Safety) groupVikki A Entwistle, Professor of Values in Healthcare, Social Dimensions of Health Institute, University of Dundee, 11 Airlie Place, Dundee, DD1 4HJDorothy McCaughan, Research Fellow, Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington Campus, York, YO10 5DD Ian S Watt, Professor of Primary and Community Care, Hull York Medical School, Department of Health Sciences, Seebohm Rowntree Building, Heslington Campus, York, YO10 5DDYvonne Birks, Senior Research Fellow, Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington Campus, York, YO10 5DD Jill Hall, Research Fellow, Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington Campus, York, YO10 5DD Maggie Peat, Senior Research Nurse, Harrogate and District Foundation NHS Trust, Harrogate District Hospital, Lancaster Park Road, HG2 7SX Brian Williams, Director, Social Dimensions of Health Institute, University of Dundee, 11 Airlie Place, Dundee, DD1 4HJJohn Wright, Director, Bradford Institute for Health Research, Bradford Royal Infirmary, BD9 6RJ. Contacts for corresponding author: v.entwistlecpse.dundee.ac.uk; tel. 01382 388661 or (01224 749720 home, not for publication).Word count for main text: 2970 Key words: patient safety; patient participation; professional-patient relationsThe PIPS group comprises the authors of this paper plus Simon Gilbodya, Su Goldera, Peter Mansellb and Trevor Sheldona. (a. University of York; b. Formerly with National Patient Safety Agency)AbstractObjectives: To explore patients and family members experiences of and views about speaking up about safety concerns at the point of care.Design: Qualitative study using 71 individual interviews and 12 focus group discussions. Participants and settings: People with recent experience of one of five conditions or interventions associated with different safety problems (childhood asthma, diabetes, breast cancer, elective joint replacement, severe and enduring mental health problems) and people who had lodged concerns with healthcare providers were recruited from both NHS services (primary and secondary care) and patient support organisations.Findings: Participants had identified various safety concerns in the course of their healthcare and had sometimes spoken up about these as they occurred. Their inclination and ability to speak up were apparently variously shaped by their assessments of: the gravity of the threat of harm; the relative importance of their concern given other patients needs and staff workloads and priorities; their confidence about their grounds for concern; roles and responsibilities; and the likely consequences of speaking up. These assessments were pervasively influenced by the way healthcare staff behaved and related to them. People who had spoken up about concerns reported diverse responses from health professionals. Some responses averted harm or provided welcome reassurance, but others exacerbated anxieties and possibly contributed to patient harm. ConclusionThe potential for patients to contribute to their safety by speaking up about their concerns depends heavily on the quality of patient-professional interactions and relationships. Abstract: 239Key words: patient safety; patient participation; professional-patient relationsSpeaking up about safety concerns: multi-setting qualitative study of patients views and experiencesRecent initiatives to improve patient safety have focused on reporting and learning from safety problems, improving the design of healthcare technologies and systems, communication among health professionals, and safety cultures within healthcare organisations.1,2 The possibility that patients We use the term patients to include patients, their family members and others who care for them but are not employed to do so as members of health service staff. might contribute to their own and others safety was noted early in the patient safety movement: To Err is Human2 suggested they could serve as last (failsafe) checks in their care. Several authors have since discussed other ways that patients might be involved in safety improvement.3-5 The most widespread approach to engaging patients as contributors to their own safety involves the production and dissemination of advice that encourages patients, for example, to ask clinicians if they have washed their hands, and to speak up if something doesnt seem right about their care.6-8 There have been no rigorous studies of the outcomes of this approach,6,9 but theoretical critiques suggest some of the proposed behaviours would be impractical and i