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.

Patient perceptions of carrying their own health information: approaches towards responsibility and playing an active role in their own health - implications for a patient-held health file.

OBJECTIVE: To elicit patients' views on whether they could contribute to improvements in their care by carrying their own health information to clinician encounters; and to consider the implications for the development of a patient-held health file (PHF). BACKGROUND: Increasing rates of chronic disease lead to health care being delivered by multiple care providers often at distributed geographic locations. As a way of increasing the availability of patient information to care providers our project will trial a PHF. Patients carry these files to doctors' appointments where clinicians record data for other doctors or the patient. Increasing the availability of patient information is anticipated to enhance the safety and quality of care delivery and improve health outcomes. STUDY DESIGN: Qualitative semi-structured interviews were conducted with 10 patients. Participants were evenly distributed in terms of gender, aged 60 years or greater and visited at least two specialists and one general practitioner. FINDINGS: In this exploratory study, patients who were currently active in decision making about their own health already recorded some health information. They were receptive to carrying their information and thought they should take some responsibility for their health. Patients who were more passive in making decisions about their health did not perceive a need to carry their own information and felt that their doctors communicated adequately. CONCLUSION: Patient-held health files provide an opportunity for patients to access their health information. Such files have the potential to improve health outcomes for patients who adopt both active and passive roles in relation to their own health and engaging with their health information.

The National Open Disclosure Pilot: evaluation of a policy implementation initiative.

OBJECTIVE: To determine which aspects of open disclosure "work" for patients and health care staff, based on an evaluation of the National Open Disclosure Pilot. DESIGN, SETTING AND PARTICIPANTS: Qualitative analysis of semi-structured and open-ended interviews conducted between March and October 2007 with 131 clinical staff and 23 patients and family members who had participated in one or more open disclosure meetings. 21 of 40 pilot hospital sites, in New South Wales, South Australia, Victoria and Queensland, were included in the evaluation. Participating health care staff comprised 49 doctors, 20 nurses, and 62 managerial and support staff. In-depth qualitative data analysis involved mapping of discursive themes and subthemes across the interview transcripts. RESULTS: Interviewees broadly supported open disclosure; they expressed uncertainty about its deployment and consequences, and made detailed suggestions of ways to optimise the experience, including careful pre-planning, participation by senior medical staff, and attentiveness to consumers' experience of the adverse event. CONCLUSION: Despite some uncertainties, the national evaluation indicates strong support for open disclosure from both health care staff and consumers, as well as a need to resource this new practice.