Palliative Care Clinical Studies Collaborative (PaCCSC)

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https://hdl.handle.net/2328/26917

The Palliative Care Clinical Studies Collaborative was established to build the evidence base for palliative medications that can improve practice, and to expend clinical trials research capacity in the area of palliative care.

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Quality use of medicines for palliative care
(Cancer Council Australia, 2007-03) Hardy, Janet
Many of the drugs commonly used in palliative care are not listed on the Pharmaceutical Benefits Scheme in Australia and are therefore not freely available to patients outside the acute hospital system. In an attempt to address the inequity faced by patients being cared for in the community or hospices, the Palliative Care Medicines Working Group was established by the Australian Government. This has resulted in a separate palliative section within the Schedule of Pharmaceutical Benefits Scheme which allows for authority prescribing of a number of medications that may be required by a palliative care patient. This paper discusses the medications currently on this listing, the processes by which they were selected and the ongoing efforts to broaden access to required medications.
Promoting patient centred palliative care through case conferencing
(Royal Australian College of General Practitioners, 2007-11) Shelby-James, Tania Maree; Currow, David Christopher; Phillips, Paddy Andrew; Williams, Helena; Abernethy, Amy Pickar
BACKGROUND What are the characteristics of case conferences between general practitioners and specialised palliative care services (SPCS)? METHODS Study participants were adults (N=461) with pain in the preceding 3 months who were referred to a SPCS and their GPs (N=230). Patients were randomised to case conferences or routine care by SPCS. RESULTS One hundred and sixty-seven conferences were held; 46 patients withdrew and 142 died before the conference could be conducted. Medicare payment was requested for 72 (43%) conferences. Median time from randomisation to case conference was 52 days (SD: 55), and from case conference to death/end of study was 79 days (SD: 166). Twenty-five percent of conferences had over three health professionals participant; patients and/or their caregivers participated in 91%. Average conference duration was 39 minutes (SD: 13). Mean conference length did not increase when more health professionals were present (3 vs. >3, 39 [SD: 14] vs. 42 [SD 11] minutes, p=0.274), nor when patients/caregivers were present (present vs. absent, 39 [SD: 13] vs. 44 [SD: 14] minutes, p=0.159). DISCUSSION Case conferencing involving SPCS, the GP, other health professionals and the patient can be an efficient part of routine care.
Creating a research culture in a palliative care service environment: A qualitative study of the evolution of staff attitudes to research during a large longitudinal controlled trial (ISRCTN81117481)
(Centre de Recherche Institut Universitaire de Gériatrie de Montreal, 2008) Fazekas, Belinda Susan; Currow, David Christopher; Grbich, Carol Frances; Abernethy, Amy Pickar; Shelby-James, Tania Maree
This study investigated the impact of a three-year randomized control trial of different models of service provision on palliative care staff associated with the hospice where the trial was being conducted. Eleven open access de-identified qualitative focus groups were held over a period of three years: three months into the trial, one year after its inception, and at the end of the trial. Four staff groups were involved: inpatient hospice nurses, palliative care outreach nurses, medical palliative specialists, and administrative staff and social workers. Initially the impact of the trial produced high levels of staff stress which largely diminished over time, to be replaced by enthusiasm for the changes achieved and sadness that post trial the perceived benefits gained would be lost. When attempting to change a clinical culture to incorporate research, and in particular where increased staff workload is involved, highly interactive levels of communication and valuing of staff input are required to minimize the stress and burden of this imposition.
Measuring impacts of value to patients is crucial when evaluating palliative care
(Elsevier, 2009-06) McCaffrey, Nicola; Currow, David Christopher; Eckermann, Simon Douglas
The inclusion of preparation for death and managing affairs in the end-of-life instrument designed by Borreani et al.1 to elicit preferences about dying is commendable. Of note, few quality-of-life (QOL) measurement tools contain or adequately assess this patient-valued domain. Given the importance that patients place on these issues, it is possible that evaluations of palliative health care interventions, including comparative effectiveness and cost-effectiveness analyses, could easily misinterpret the net benefit of such interventions without inclusion of this domain as an outcome measure. Better assessment methods that incorporate preparation for death and managing affairs are needed.
Planning phase III multi-site clinical trials in palliative care: the role of consecutive cohort audits to identify potential participant populations
(Springer-Verlag, 2010) Currow, David Christopher; Shelby-James, Tania Maree; Agar, Meera Ruth; Plummer, John Lewis; Rowett, Debra Sharon; Glare, Paul; Spruyt, Odette; Hardy, Janet
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.
How should we conduct and interpret phase III clinical trials in palliative care?
(Elsevier, 2010-01) Abernethy, Amy Pickar; Clark, Katherine; Currow, David Christopher
The article by Wildiers et al.1 raises some challenges in terms of ethical approaches to phase III end-of-life studies and their interpretation. Although the authors should be commended for undertaking a large, multisite, randomized, controlled trial in palliative care, there are fundamental questions that do need to be addressed before the first steps can be taken to adopt the study's findings into practice.
Current approaches to diagnosing and managing constipation in advanced cancer and palliative care
(Mary Ann Liebert, Inc., 2010-04-12) Clark, Katherine; Urban, Kat; Currow, David Christopher
Constipation is common in advanced cancer. Despite this, clinicians' understanding of the underlying changes affecting the colon and the rest of the gastrointestinal tract are limited. Two case histories are used to illustrate the problems encountered when the current approaches to diagnosing and managing altered bowel habits are unsuccessful. An alternative paradigm in which to consider the problems of constipation encountered by some people with advanced cancer is proposed.
Anti-cholinergic load, health care utilization, and survival in people with advanced cancer: a pilot study
(Mary Ann Liebert, Inc., 2010-07-02) Agar, Meera Ruth; To, Timothy H M; Plummer, John Lewis; Abernethy, Amy Pickar; Currow, David Christopher
Introduction: Anti-cholinergic medications have been associated with increased risks of cognitive impairment, premature mortality and increased risk of hospitalisation. Anti-cholinergic load associated with medication increases as death approaches in those with advanced cancer, yet little is known about associated adverse outcomes in this setting. Methods: A substudy of 112 participants in a randomised control trial who had cancer and an Australia modified Karnofsky Performance Scale (AKPS) score (AKPS) of 60 or above, explored survival and health service utilisation; with anti-cholinergic load calculated using the Clinician Rated Anti-cholinergic Scale (modified version) longitudinally to death. A standardised starting point for prospectively calculating survival was an AKPS of 60 or above. Results: Baseline entry to the sub-study was a mean 62 ± 81 days (median 37, range 1–588) days before death (survival), with mean of 4.8 (median 3, SD 4.18, range 1 – 24) study assessments in this time period. Participants spent 22% of time as an inpatient. There was no significant association between anti-cholinergic score and time spent as an inpatient (adjusted for survival time) (p = 0.94); or survival time. Discussion: No association between anti-cholinergic load and survival or time spent as an inpatient was seen. Future studies need to include cognitively impaired populations where the risks of symptomatic deterioration may be more substantial.
A strategy to advance the evidence base in palliative medicine: formation of a palliative care research cooperative group
(Mary Ann Liebert, Inc., 2010-11-24) Abernethy, Amy Pickar; Aziz, Noreen M; Basch, Ethan; Bull, Janet; Cleeland, Charles S; Currow, David Christopher; Fairclough, Diane; Hanson, Laura; Hauser, Joshua; Ko, Danielle N; Lloyd, Linda; Morrison, R Sean; Otis-Green, Shirley; Pantilat, Steve; Portenoy, Russell K; Ritchie, Christine; Rocker, Graeme; Wheeler, Jane L; Zafar, S Yousuf; Kutner, Jean S
Background: Palliative medicine has made rapid progress in establishing its scientific and clinical legitimacy, yet the evidence base to support clinical practice remains deficient in both the quantity and quality of published studies. Historically, the conduct of research in palliative care populations has been impeded by multiple barriers including health care system fragmentation, small number and size of potential sites for recruitment, vulnerability of the population, perceptions of inappropriateness, ethical concerns, and gate-keeping. Methods: A group of experienced investigators with backgrounds in palliative care research convened to consider developing a research cooperative group as a mechanism for generating high-quality evidence on prioritized, clinically relevant topics in palliative care. Results: The resulting Palliative Care Research Cooperative (PCRC) agreed on a set of core principles: active, interdisciplinary membership; commitment to shared research purposes; heterogeneity of participating sites; development of research capacity in participating sites; standardization of methodologies, such as consenting and data collection/management; agile response to research requests from government, industry, and investigators; focus on translation; education and training of future palliative care researchers; actionable results that can inform clinical practice and policy. Consensus was achieved on a first collaborative study, a randomized clinical trial of statin discontinuation versus continuation in patients with a prognosis of less than 6 months who are taking statins for primary or secondary prevention. This article describes the formation of the PCRC, highlighting processes and decisions taken to optimize the cooperative group's success.
Palliative 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) Hosie, Annmarie; Fazekas, Belinda Susan; Shelby-James, Tania Maree; Mills, Elaine; Byfieldt, Naomi; Margitanovic, Vera; Hunt, Jane; Phillips, Jane
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.
Adverse events in hospice and palliative care: a pilot study to determine feasibility of collection and baseline rates
(Mary Ann Liebert, Inc., 2011-01-19) Currow, David Christopher; Agar, Meera Ruth; To, Timothy H M; Rowett, Debra Sharon; Greene, Aine; Abernethy, Amy Pickar
Background: Continuous quality improvement is fundamental in all health care, including hospice and palliative care. Identifying and systematically reducing symptomatic adverse events is limited in hospice and palliative care because these events are mostly attributed to disease progression. Objectives: The aim of this study was to assess the feasibility of symptomatic adverse events in hospice and palliative care and assessing their incidence. Methods: A retrospective, consecutive cohort of notes from a specialist palliative care inpatient service was surveyed by a clinical nurse consultant for symptomatic adverse events: falls, confusion, decreased consciousness, hypo- and hyperglycaemia, urinary retention, and hypotension. Demographic and clinical factors were explored for people at higher risk. Results: Data were available on the most recent admissions of 65 people, generating >900 inpatient days. Fifty people (78%) had events precipitating admission, of whom 31 (62%) had at least one further event during admission. Eleven of 15 people who were admitted without an event experienced at least one during their admissions. Only 4 did not have an adverse event. During their stay, there were 0.13 (standard deviation [SD] = 0.19) events per patient per day. No drug-drug or drug-host events were noted. No clinical or demographic factors predicted groups at higher risk. Conclusions: This pilot highlights the feasibility of collecting, and ubiquity of, symptomatic adverse events, and forms a baseline against which future interventions to decrease the frequency or intensity can be measured. Given the frailty of hospice and palliative patients, any adverse event is likely to accelerate irreversibly their systemic decline.
Once-daily opioids for chronic dyspnea: a dose increment and pharmacovigilance study
(Elsevier, 2011-04-04) Currow, David Christopher; McDonald, Christine; Oaten, Sheila; Kenny, Bernadette; Allcroft, Peter; Frith, Peter Anthony; Briffa, Michael; Johnson, Miriam J; Abernethy, Amy Pickar
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.
A collateral benefit of research in palliative care
(Mary Ann Liebert, Inc., 2011-09-12) Lobb, Elizabeth A; Swetenham, Kate; Agar, Meera Ruth; Currow, David Christopher
A collateral benefit of being in a research-active clinical unit is that there is evidence that better care is delivered. The most dramatic data to date demonstrate that in cardiology, research- active cardiology departments in community and university hospitals deliver better survival than those units that do not enroll people in clinical trials.
Progressing an evidence-base beyond case series
(Mary Ann Liebert, Inc., 2011-12-06) Hardy, Janet; Agar, Meera Ruth; Currow, David Christopher
High-quality randomized trials in hospice and palliative care are achievable to provide quality evidence to guide our practice especially if several sites work together to conduct the trial. Palliative medicine is a specialty that is contributing more and more to the care of patients with life limiting disease. It is time we based this practice on highquality evidence and that can only come with high-quality research.
Defining refractory pain in cancer for clinicians and researchers
(Mary Ann Liebert, Inc., 2012-01-23) Currow, David Christopher; Spruyt, Odette; Hardy, Janet
Managing pain in people with cancer remains a challenge, especially in those referred to as having refractory pain. But what is refractory or intractable pain? Until there is a standard definition there is the risk that: a) clinically, new medications are continuously added, each with diminishing returns in reducing pain, and each with an increasing likelihood of toxicity as the only noticeable change; and b) in research, there will be differing baselines for the operational definition of refractory, making it difficult to adopt the findings into practice, or to compare clinical trials in any systematic way.
An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice
(Mary Ann Liebert, Inc., 2012-02-21) Currow, David Christopher; Rowett, Debra Sharon; Doogue, Matthew; To, Timothy H M; Abernethy, Amy Pickar
Background: Medication registration currently requires evidence of safety and efficacy from adequately powered phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting) provide data on more widespread and longer term use. Historically, voluntary reporting systems for pharmacovigilance have had low reporting rates, relying on ad hoc reporting and retrospective chart reviews, or prospective registries have often been limited to specific drugs or clinical conditions. Furthermore, these data are often irrelevant in hospice and palliative care due to the timeliness of which such data become available and the unique characteristics of our population and prescribing: compounding comorbidities, progressive organ failure, accumulation of symptom-specific medications, tendency to attribute toxicity to disease progression, use of old, off-patent medications, and incorporation of evolving evidence. There is a need for prospective, systematic pharmacovigilance in hospice and palliative care. Method: Here we describe an international, Web-based, 128-bit secure initiative to collect pharmacovigilance data documenting net clinical benefit and safety of common medications. The intention is for a diverse and large group of clinical units to record data prospectively on a small deidentified consecutive cohort of patients started on the medication of interest. A new medication would be studied every 3 months. Three key time points (different for each medication) will be assessed for each patient, collecting easily codefiable data at baseline, a point at which clinical benefit should be experienced, and a point at which short- to medium-term toxicities may occur. Toxicities can additionally be recorded at any time they occur. Data collection will take a maximum of 10 minutes per patient. Conclusion: The intention is to create an efficient, relevant system to improve hospice and palliative care with maximally generalizable results.
Pharmacovigilance in hospice/palliative care: rapid report of net clinical effect of metoclopramide
((C) Mary Ann Liebert, Inc., 2012-07-20) Currow, David Christopher; Vella-Brincat, Jane; Fazekas, Belinda Susan; Clark, Katherine; Doogue, Matthew; Rowett, Debra Sharon
Background: Understanding the performance of prescribed medications in day-to-day practice is important to minimize harm, maximize clinical benefits, and, eventually, better target the people who are most likely to benefit, especially in hospice/palliative care where there may be limited time to optimize prescribing. Metoclopramide, a benzamide prokinetic antiemetic, is widely used for a number of indications including nausea, vomiting, hiccups, and reflux. It has recently had a new ‘‘black box’’ warning issued by the Food and Drug Administration in relation to tardive dyskinesia to limit use to 12 weeks. Methods: A consecutive cohort of patients from 12 participating centers in two countries who were having metoclopramide initiated had data collected at three time points—baseline, 2 days (clinical benefit), and day 7 (clinical harm). Additionally, harms could be recorded at any time. Results: Of the 53 people included in the cohort, 23 (43%) reported benefit at 48 hours, but only 18 (34%) of these people were still using it one week after commencing it. For the other 5, the medication was ceased due to harms. The most frequent harms were akathisia (n = 4), headache (n = 4), and abdominal pain (n = 4). Nine people (17%) had no clinical benefit and experienced harms. Conclusion: Overall, one in three people gained net clinical benefit at one week. Limiting effects include sideeffects that need to be sought actively in clinical care.
End-of-life research: do we need to build proxy consent into all clinical trial protocols studying the terminal phase?
(Mary Ann Liebert, Inc., 2012-09-04) Sheehan, Caitlin; Agar, Meera Ruth; Currow, David Christopher
Research into symptoms that occur at the end of life is paramount for ensuring we provide the best possible care for patients in the terminal phase, yet obtaining informed consent from the study participant is not possible at the time these symptoms occur. Importantly, these questions cannot be answered in any clinical population and defining the net clinical effect of medications used, for example, for noisy respiratory secretions is crucial if the quality of care is to be further improved.
The evidence base for oxygen for chronic refractory breathlessness: issues, gaps, and a future work plan
(Elsevier, 2012-09-26) Johnson, Miriam J; Abernethy, Amy Pickar; Currow, David Christopher
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.
The role of ondansetron in the management of cholestatic or uremic pruritis - a systematic review
(2012-11) To, Timothy H M; Clark, Katherine; Lam, Lawrence; Shelby-James, Tania Maree; Currow, David Christopher
Pruritus associated with hepatic or renal failure can be a troublesome symptom, refractory to treatment, associated with significant physical and emotional distress, and reduction in quality of life for patients already burdened with chronic disease. Serotonin has been implicated as a possible pathological mediator, and therefore 5HT3 antagonists have been suggested as a possible therapeutic intervention. Objectives This review of the literature systematically explores the role of ondansetron in the management of cholestatic or uraemic pruritus. Methods Electronic databases were systematically searched for randomized controlled trials (RCTs) examining the role of ondansetron in cholestatic or uraemic pruritus between 1966 and 2008. Results Five RCTs were included in this systematic review: three for cholestatic pruritus, and two for uraemic pruritus. All trials examined ondansetron versus placebo, however with differing treatment protocols. Overall, three studies showed no benefit to ondansetron over placebo, however two studies in cholestatic pruritus showed small reductions in pruritus with questionable clinical significance. Conclusion Ondansetron was demonstrated to have negligible effect on cholestatic or uraemic pruritus on the basis of a limited number of studies.

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