Geoff Mitchell

Designing and conducting randomized controlled trials in palliative care: A summary of discussions from the 2010 clinical research forum of the Australian Palliative Care Clinical Studies Collaborative

Rigorous clinical research in palliative care is challenging but achievable. Trial participants are likely to have deteriorating performance status, co-morbidities and progressive disease. It is difficult to recruit patients, and attrition unrelated to the intervention being trialled is high. The aim of this paper is to highlight practical considerations from a forum held to discuss these issues by active palliative care clinical researchers. To date, the Australian Palliative Care Clinical Studies Collaborative (PaCCSC) has randomized more than 500 participants across 12 sites in 8 Phase III studies. Insights from the 2010 clinical research forum of the PaCCSC are reported. All active Australian researchers in palliative care were invited to present their current research and address three specific questions: (1) What has worked well? (2) What didn’t work well? and (3) How should the research be done differently next time? Fourteen studies were presented, including six double-blind, randomized, controlled, multi-site trials run by the PaCCSC. Key recommendations are reported, including guidance on design; methodologies; and strategies for maximizing recruitment and retention. These recommendations will help to inform future trial design and conduct in palliative care.

Integration, Coordination and Multidisciplinary Care: What can These Approaches Offer to Australian Primary Health Care?

Australias population is ageing and the consequential burden of chronic disease increasingly challenges the health system. This has raised interest in, and awareness of, approaches built on multidisciplinary teams and integrated and coordinated care in managing the complex care needs of patient groups such as the chronically ill or frail aged. A systematic investigation of the literature relating to these approaches provided the opportunity to explore the meaning of these terms and their potential application and relevance to the Australian primary health care setting. Five systematic reviews of a sentinel condition and an exemplar approach to coordinated and multidisciplinary care were completed. Common learnings from the individual reviews were identified. The literature suggests that approaches encouraging a coordinated and multidisciplinary plan of care for individual patients and/or particular populations may improve a variety of outcomes. There are many methodological considerations in conducting reviews of complex interventions and in assessing their applicability to the Australian health system.

A driving cessation program to identify and improve transport and lifestyle issues of older retired and retiring drivers

BACKGROUND This study explored the transport and lifestyle issues of older retired and retiring drivers participating in the University of Queensland Driver Retirement Initiative (UQDRIVE), a group program to promote adjustment to driving cessation for retired and retiring older drivers. METHODS A mixed method research design explored the impact of UQDRIVE on the transport and lifestyle issues of 55 participants who were of mean age 77.9 years and predominantly female (n = 40). The participants included retired (n = 32) and retiring (n = 23) drivers. Transport and lifestyle issues were identified using the Canadian Occupational Performance Measure and rated pre- and post-intervention. RESULTS Paired t-tests demonstrated a statistically significant improvement in performance (t = 10.5, p < 0.001) and satisfaction (t = 9.9, p < 0.001) scores of individual issues. Qualitative content analysis identified three categories of issues including: protecting my lifestyle; a better understanding of transport options; and being prepared and feeling okay. CONCLUSIONS Participation in UQDRIVE had a positive and significant effect on the issues of the participants. The results highlight that although all participants stated issues related predominantly to practical concerns, there were trends in the issues identified by the drivers and retired drivers that were consistent with their current phase of the driving cessation process.

The potential for a structured approach to palliative and end of life care in the community in Australia

The demand for palliative care (PC) in Australia is expected to increase as the population ages and the number of people with chronic and life-limiting conditions rises. With limited specialist PC resources available in the community, general practitioners (GPs) will increasingly provide and co-ordinate palliative and end-of-life (EOL) care. The majority of the last year of life of people with a life-limiting illness is spent in the community, hence, GPs are well placed to identify and care for people who may benefit from a palliative approach to care. Currently, many people at EOL access PC care in a reactive, ad-hoc, fashion that is dependent on the knowledge, skills and interest of relevant health professionals. National standards and policy documents provide guidance for quality care at the EOL for all Australians. However, no mechanism has been proposed to ensure that such standards are routinely operationalised within the community. The Gold Standards Framework (GSF) is a potential base on which an EOL framework for community care in Australia may be built. The GSF is an evidenced-based organisational system for providing best practice EOL care in general practice and residential aged care. It facilitates the identification of people for whom a palliative approach may be appropriate and provides a structure for the identification of needs, pro-active care planning and ongoing monitoring of progress. Where the GSF has been implemented in the United Kingdom, significantly improved care processes have been reported. While there are numerous barriers to the uptake of an unmodified GSF in Australia, it may provide the framework on which a structured model of PC in general practice is developed. We will examine the potential for such a structured approach to EOL care in the community and general practice in Australia.

Significant event audit as a means of defining the value of general practice to a health system: A proposal

This paper illustrates, by means of a case study, the value of significant event audit in defining the strengths general practice can bring to a health system. Systematic undervaluing of the general practitioners skills of early diagnosis, gatekeeping, patient advocacy, and whole patient care led to serious adverse health consequences for a patient in Austria. A health system that does not value the key role of the general practitioner can expose individual patients to severe adverse health consequences. The development of a national significant event register to assist in the formulation of more appropriate national health policies is proposed.

Views and perceptions about locally manufactured medicines in Ethiopia: a qualitative study of physicians, patients and regulatory authorities

BackgroundBecause of their cost, the use of locally produced, bioequivalent, generic drugs is universally recommended. In Ethiopia. while the government is committed to raising the market share and use of locally produced drugs, the process is hampered by the lack of a bioequivalence testing centre to strengthen the regulatory environment and deliver quality-assured local medicines. The purpose of this study is to assess the views and perceptions of key regulatory stakeholders, physicians and patients about locally produced generic medicines.MethodsA descriptive qualitative study, using focus group discussions and key informant interviews, was conducted. Five key informant interviews (two senior regulatory authority members and 3 institutional review board members) as well as 4 focus group discussions (2 with physicians and 2 with patients) were held. Data were analysed using an inductive, thematic process.ResultsFour major themes emerged: awareness of lack of bioequivalence profiles associated with local medicines, perceptions about the quality and effectiveness of local medicines, quality and efficacy of imported medicines from developing countries and quality and efficacy of cheaper medicines. All institutional review board members were aware of bioequivalence issues. However, many physicians lacked detailed knowledge about bioequivalence, its clinical relevance and the lack of bioequivalence data for local medicines. All institutional review board members, physicians and male patients, but not female patients, were concerned about the quality and effectiveness of local medicines. Female patients were more confident about the locally produced drugs. In addition, some physicians and patients were not confident about the quality and effectiveness of cheaper drugs and drugs imported from developing countries. Government officials believed that local drugs are reliable.ConclusionThe success of promoting the use of inexpensive local medicines and changing the perception of the community depends not only on increasing the domestic market share held by local companies, but also on the capacity of the regulatory environment and companies to produce quality assured medicines and to overcome misconceptions. Among other initiatives, establishing an accredited bioequivalence centre in the country needs to be addressed urgently.

Needs based utilisation of palliative care services in Australia: Overview of a program of work 2003-2009

number: 1 Presentation type: Invited Lecture Session: Education / An Introduction to Grantsmanship: The art of preparing grants How to set up a research group Stein Kaasa, St. Olav’s Hospital, Trondheim, Norway, Ola Dale, Department of Circulation and Medical Imaging, Trondheim, Norway Palliative care is defined as an active, total care of patients. Comprehensive palliative care provides relief from pain and other distressing symptoms, integrates the psychological and spiritual care and offers a support system to help the family. In establishing a research group, one need to decide if one want to focus on one specific area of palliative care, or include several of the elements. The skills, knowledge and resources available ‘on site’ should guide the research strategy. Furthermore, it might be wise to adopt the palliative care research strategy to the overall strategy of the university and the hospital, and even consider national research strategies. In the period of establishment, one may also look for possible national and/or international collaboration, which may strengthen the team in the planning process of the research, in conducting and analysing research, as well as being a partner when applying for funding. Abstract number: 2 Presentation type: Invited Lecture Session: Education / Mixed methods approachnumber: 2 Presentation type: Invited Lecture Session: Education / Mixed methods approach