Palliative Care Clinical Studies Collaborative (PaCCSC) - Collected Works
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ItemPalliative care clinical trials: how nurses are contributing to ethical, integrated and evidence based care of palliative care patients participating in clinical trials(Max Allen Healthcare, 2011)The aim of this paper is to describe the emerging role of the palliative care clinical trials nurse in an era of evidence based practice and increasing clinical trial activity in palliative care settings across Australia. An overview of the current clinical trials work is provided with a focus on three aspects of clinical trials nursing practice which have significant implications for patients: (1) the consent process; (2) integration of clinical trials into multidisciplinary care, and (3) promotion of evidence based practice in palliative care settings. Clinical trials roles provide palliative care nurses with an opportunity to contribute to clinical research, help expand palliative care’s evidence base as well as develop their own research capabilities.
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ItemOnce-daily opioids for chronic dyspnea: a dose increment and pharmacovigilance study(Elsevier, 2011-04-04)Context Randomised controlled trials (RCTs) can answer questions of efficacy, but rarely generate a complete safety profile. Long term pharmacovigilance studies complement RCTs. Objectives Level I evidence supports short term efficacy of opioids in reducing refractory dyspnoea. This study aims to determine: the minimum effective daily dose of sustained release morphine to reduce refractory breathlessness; and whether net clinical benefits are sustained safely. Methods In a phase II dose increment study, 10mg sustained release morphine was administered daily, and increased by 10mg daily each week to a maximum of 30mg daily. The participant was withdrawn if there were unacceptable side-effects or no response to maximum dose. If participants had a 10% improvement in dyspnoea over their own baseline, they joined a long-term phase IV effectiveness/safety study at that dose. Complying with STROBE guidelines for reporting observational studies, response and side-effects are described, with demographic and clinical characteristics of responders. Results Eighty five participants (65 males, mean age 74, 59% with chronic obstructive pulmonary disease (COPD) provided >30 patient-years of data. Fifty three participants derived ≥10% benefit (35.4% improvement over baseline) giving a response rate of 62% (number needed to treat of 1.6); for 70%, this dose was 10mg/24hours. Benefit was maintained at three months for 28 (33%) people. Breathlessness was reduced significantly (p<0.001) but constipation increased (p<0.001) despite aperients. There were no severe adverse events including no respiratory depression nor hospitalisations. Conclusion Ten mg of sustained release oral morphine daily is safe in this population, and effective for most people.
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ItemThe evidence base for oxygen for chronic refractory breathlessness: issues, gaps, and a future work plan(Elsevier, 2012-09-26)Breathlessness or “shortness of breath”, medically termed dyspnoea, remains a devastating problem for many people and those who care for them. As a treatment intervention, administration of opioids to relieve breathlessness is an area where progress has been made with the development of an evidence base. As evidence in support of opioids has accumulated, so has our collective understanding about trial methodology, research collaboration and infrastructure that is crucial to generate reliable research results for palliative care clinical settings. Analysis of achievements to date and what it takes to accomplish these studies provides important insights into knowledge gaps needing further research as well as practical insight into design of pharmacological and non-pharmacological intervention trials in breathlessness and palliative care. This paper presents current understanding of opioids for treating breathlessness, what is still unknown as priorities for future research and highlights methodological issues for consideration in planned studies.
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ItemPlanning phase III multi-site clinical trials in palliative care: the role of consecutive cohort audits to identify potential participant populations(Springer-Verlag, 2010)Goals of Work: Multiple sites enable more successful completion of adequately powered phase III studies in palliative care. Audits of the frequency and distribution of the symptoms of interest can better inform research planning by determining realistic recruitment goals for each site. The proposed studies are to improve the evidence-base for registration and subsidy applications for frequently encountered symptoms where current pharmacological interventions are being used ‘off-licence’. Methods: Six services participated in a standardized, retrospective, consecutive cohort audit of five symptoms of their inpatient populations to inform the design of double blind randomised controlled phase III studies to which each site would recruit simultaneously. The audit covered all deaths in a three month period for people who were referred to a specialist palliative care service who had at least one inpatient admission between referral and death regardless of when the person was referred to the service. The audits were based around inclusion and exclusion criteria for the proposed studies. Main Results: Of the 468 people whose medical records were reviewed, potential study participant rates varied by symptom having accounted for general and specific inclusion and exclusion criteria: pain 17.7%; delirium 5.8%; anorexia 5.1%; bowel obstruction 2.8% and cholestatic itch 0%. For those people with a symptom of interest, it was noted at the beginning of the inpatient admission more than half the time. Of all inpatients, fewer then one third would be eligible to participate in at least one study. Conclusions: These data provide a baseline estimate of potential people to approach about clinical trials in supportive care but do not account for clinician ‘gate-keeping’, lack of interest in participating nor withdrawal from the study once initiated. The data are retrospective and therefore limited by clinical documentation. The audit directly informed an increase in the number of participating sites.
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ItemPromoting the consumer voice in palliative care: exploring the possibility of using consumer impact statements(John Wiley and Sons Ltd, 2013-08-19)Background: It can be difficult to engage consumers in health decision making. This is particularly so in the area of palliative care, where consumers are very unwell and are unlikely to become involved in long term programs that promote consumer input. This paper explores the possibility of using ‘Consumer Impact Statements’ to facilitate the inclusion of the viewpoint of people at the end of life in the process of policy and decision making, particularly in the area of subsidy of pharmaceuticals used in palliative care. Search Strategy: A broad search was conducted to find information about the use of impact statements in any health field. The health literature and grey literature were searched to explore the use of Consumer Impact Statements to date. Results: No papers were found describing the use of Consumer Impact Statements in the palliative care setting. Health impact assessment is used in the areas of environmental health and community health. Impact statements are less commonly used in other areas of health, especially policy development, and no formal description of a Consumer Impact Statement was found. Discussion: There is considerable scope for developing the use of Consumer Impact Statements to promote the consumer viewpoint in health decision making, because it will allow people who are otherwise unlikely to contribute to the public debate to have their views heard by decision makers. Conclusion: The use of Consumer Impact Statements is particularly suited to palliative care, given that consumers are often otherwise unable to contribute to the public debate.
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ItemOff-label prescribing in palliative care – a cross-sectional national survey of Palliative Medicine doctors(SAGE Publications, 2012-11-05)Background: Regulatory bodies including the European Medicines Agency register medications (formulation, route of administration) for specific clinical indications. Once registered, prescription is at clinicians’ discretion. Off-label use is beyond the registered use. While off-label prescribing may, at times, be appropriate, efficacy and toxicity data are often lacking. Aim: The aim of this study was to document off-label use policies (including disclosure and consent) in Australian palliative care units and current practices by palliative care clinicians. Design: A national, cross-sectional survey was conducted online following an invitation letter. The survey asked clinicians their most frequent off-label medication/indication dyads and unit policies. Dyads were classified into unregistered, off-label and on-label, and for the latter, whether medications were nationally subsidised. Setting/participants: All Australian palliative medicine Fellows and advanced trainees. Results: Overall, 105 clinicians responded (53% response rate). The majority did not have policies on off-label medications, and documented consent rarely. In all, 236 medication/indication dyads for 36 medications were noted: 45 dyads (19%) were for two unregistered medications, 118 dyads (50%) were for 26 off-label medications and 73 dyads (31%) were for 12 on-label medications. Conclusions: Off-label prescribing with its clinical, legal and ethical implications is common yet poorly recognised by clinicians. A distinction needs to be made between where quality evidence exists but registration has not been updated by the pharmaceutical sponsor and the evidence has not been generated. Further research is required to quantify any iatrogenic harm from off-label prescribing in palliative care.
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