Out of the frying pan? Streamlining the ethics review process of multisite qualitative research projects.

This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.

Anatomy of an incident disclosure: the importance of dialogue.

BACKGROUND: Disclosure of health care incidents to patients and family members, as an ethical imperative, is becoming increasingly prevalent. The experiences of a woman whose husband died forms the basis for a case study of how she and her family and friends were able to renegotiate clinicians' understandings of what had gone wrong and influence their views of what needed to be done in response. METHODS: The case was constructed in late 2010 using the replicated single-case approach, which involved repeated checking and correcting details of an interview with the patient's wife. Her husband, diagnosed with multiple myeloma in 2006, was hospitalized in January 2009 following a hip replacement. While in the hospital, he received a vasopressin overdose. He died in February 2009. THE DISCLOSURE PROCESS: The basis of the disclosure was the drug error, yet the patient's wife informed the caller (the head of the ICU), "You've got a greater problem than a drug error... you've got a massive, big communication problem here." The disclosure process, which unfolded in a series of phone calls and meetings, enabled the patient's wife and her family not only to ask questions but to put forward their knowledge, views, and concerns, and it moved from "disclosing an incident" (the vasopressin overdose) to addressing repeated communication failures and inappropriate behaviors. As a result, the disclosure process became a genuine dialogue that informed the clinicians as much as the family. CONCLUSIONS: This case study expands our understanding of what is possible as part of disclosure communication. Patients and family members can and should play a critical role in quality improvement and patient safety, given their knowledge and questions about the trajectory of care and their passion for ensuring that similar incidents do not recur to harm others.

What do patients and relatives know about problems and failures in care?

OBJECTIVE: To understand what patients and family members know about problems and failures in healthcare. DESIGN: Qualitative, semistructured open-ended interviews were conducted with 39 patients and 80 family members about their experiences of incidents in tertiary healthcare. Nineteen interviews involved more than one respondent, yielding 100 interviews in total. Participants were recruited through advertisements in the national broadsheet and tabloid print media (43%), with the help of the health services where the incidents occurred (28%), through invitations sent out by two internet marketing companies (27%) and by consumer organisations (2%). SETTING: Interviews were conducted in the homes of the respondents or over the phone. One participant emailed her responses to the questionnaire. RESULTS: Analysis of the interview data revealed: (1) considerable knowledge on the part of patients and relatives about health service risks, problems and incidents; (2) the insight of interviewees into care improvement opportunities; and (3) challenges faced by patients and relatives when trying to negotiate their knowledge and insights with health service staff. CONCLUSION: Patients (and family members) need access to structured processes ensuring dialogue with health service personnel about perceived risks, problems and incidents. Such dialogue would reveal patients' and family members' questions and knowledge about improvement opportunities, and minimise the risk that their questions and knowledge are ignored.

What prevents incident disclosure, and what can be done to promote it?

BACKGROUND: Adverse-event incident disclosure is gaining international attention as being central to incident management, practice improvement, and public engagement, but those charged with its execution are experiencing barriers. Findings have emerged from two large studies: an evaluation of the 2006-2008 Australian Open Disclosure Pilot, and a 2009-2010 study of patients' and relatives' views on actual disclosures. Clinicians and patients interviewed in depth suggest that open disclosure communication has been prevented by a range of uncertainties, fears, and doubts. METHODS: Across Australia, 147 clinical staff were interviewed (mostly over the phone), and 142 patients and relatives were interviewed in their homes or over the phone. Interviews were recorded, transcribed, and analysed by three independent investigators. Transcription analyses yielded thematic domains, each with a range of ancillary issues. RESULTS: Analysis of interview transcripts revealed several important barriers to disclosure: uncertainty among clinicians about what patients and family members regard as requiring disclosure; clinicians' assumption that those harmed are intent on blaming individuals and not interested in or capable of understanding the full complexity of clinical failures; concerns on the part of clinicians about how to interact with (angry or distressed) patients and family members; uncertainties about how to guide colleagues through disclosure; and doubts surrounding how to manage disclosure in the context of suspected litigation risk, qualified-privilege constraints, and risk-averse approaches adopted by insurers. CONCLUSIONS: Disclosure practices appear to be inhibited by a wide range of barriers, only some of which have been previously reported. Strategies to overcome them are put forward for frontline clinicians, managerial staff, patient advocates, and policy agencies.

Patients' and family members' views on how clinicians enact and how they should enact incident disclosure: the "100 patient stories" qualitative study.

OBJECTIVES: To investigate patients' and family members' perceptions and experiences of disclosure of healthcare incidents and to derive principles of effective disclosure. DESIGN: Retrospective qualitative study based on 100 semi-structured, in depth interviews with patients and family members. SETTING: Nationwide multisite survey across Australia. PARTICIPANTS: 39 patients and 80 family members who were involved in high severity healthcare incidents (leading to death, permanent disability, or long term harm) and incident disclosure. Recruitment was via national newspapers (43%), health services where the incidents occurred (28%), two internet marketing companies (27%), and consumer organisations (2%). MAIN OUTCOME MEASURES: Participants' recurrent experiences and concerns expressed in interviews. RESULTS: Most patients and family members felt that the health service incident disclosure rarely met their needs and expectations. They expected better preparation for incident disclosure, more shared dialogue about what went wrong, more follow-up support, input into when the time was ripe for closure, and more information about subsequent improvement in process. This analysis provided the basis for the formulation of a set of principles of effective incident disclosure. CONCLUSIONS: Despite growing prominence of open disclosure, discussion about healthcare incidents still falls short of patient and family member expectations. Healthcare organisations and providers should strengthen their efforts to meet patients' (and family members') needs and expectations.

Lessons learned from measuring safety culture: an Australian case study.

BACKGROUND: adverse events in maternity care are relatively common but often avoidable. International patient safety strategies advocate measuring safety culture as a strategy to improve patient safety. Evidence suggests it is necessary to fully understand the safety culture of an organisation to make improvements to patient safety. AIM: this paper reports a case study examining the safety culture in one maternity service in Australia and considers the benefits of using surveys and interviews to understand safety culture as an approach to identify possible strategies to improve patient safety in this setting. SETTING: the study took place in one maternity service in two public hospitals in NSW, Australia. Concurrently, both hospitals were undergoing an organisational restructure which was part of a major health reform agenda. The priorities of the reform included improving the quality of care and patient safety; and, creating a more efficient health system by reducing administration inefficiencies and duplication. DESIGN: a descriptive case study using three approaches: FINDINGS: the safety culture was identified to warrant improvement across all six safety culture domains. There was reduced infrastructure and capacity to support incident management activities required to improve safety, which was influenced by instability from the organisational restructure. There was a perceived lack of leadership at all levels to drive safety and quality and improving the safety culture was neither a key priority nor was it valued by the organisation. CONCLUSION: the safety culture was complex as was undertaking this study. We were unable to achieve a desired 60% response rate highlighting the limitations of using safety culture surveys in isolation as a strategy to improve safety culture. Qualitative interviews provided greater insight into the factors influencing the safety culture. The findings of this study provide evidence of the benefits of including qualitative methods with quantitative surveys when examining safety culture. Undertaking research in this way requires local engagement, commitment and capacity from the study site. The absence of these factors is likely to limit the practicality of this approach in the clinical setting. SIGNIFICANCE: the use of safety culture surveys as the only method of assessing safety culture is of limited value in identifying strategies to potentially improve the safety culture.