Browsing Palliative Care Clinical Studies Collaborative (PaCCSC) by Author "Currow, David Christopher"
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ItemAdverse 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 PickarBackground: 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. ItemAnti-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 ChristopherIntroduction: 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. ItemA collateral benefit of research in palliative care(Mary Ann Liebert, Inc., 2011-09-12) Lobb, Elizabeth A; Swetenham, Kate; Agar, Meera Ruth; Currow, David ChristopherA 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. ItemCreating 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 MareeThis 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. ItemCurrent 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 ChristopherConstipation 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. ItemDefining refractory pain in cancer for clinicians and researchers(Mary Ann Liebert, Inc., 2012-01-23) Currow, David Christopher; Spruyt, Odette; Hardy, JanetManaging 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. ItemEnd-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 ChristopherResearch 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. ItemThe 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 ChristopherBreathlessness 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. ItemEvolution of palliative care in Australia 1973-2013(Cancer Council Australia, 2013-03) Currow, David Christopher; Phillips, JaneIn parallel with the rapid development of oncology in Australia, palliative and supportive care has evolved rapidly. The sponsorship for such development was largely generated by oncology services in response to unmet needs that were encountered daily. Development of state, territory and national strategies has mirrored the professional development in service delivery, education (of existing practitioners and tomorrow’s clinicians) and research. More recently, national programs are delivering better outcomes for palliative care patients and their families, world-leading clinical research, improved access to essential medications in the community and the ability to access quality evidence to inform practice and policy. These initiatives provide a valuable foundation for continuing to improve access to high quality clinical care wherever people live. ItemHow should we conduct and interpret phase III clinical trials in palliative care?(Elsevier, 2010-01) Abernethy, Amy Pickar; Clark, Katherine; Currow, David ChristopherThe 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. ItemInformed consent in palliative care clinical trials: challenging but possible(Mary Ann Liebert, Inc., 2013-04-30) Agar, Meera Ruth; Ko, Danielle N; Sheehan, Caitlin; Chapman, Michael; Currow, David ChristopherObtaining informed consent is a key protection that should be afforded universally to people using health services and the basis around which any participation in clinical trials is built. Randomized controlled effectiveness studies are necessary to answer key questions in hospice and palliative care, in order to help systematically improve the quality of care. In order to be properly generalizable, such trials need to have broad inclusion criteria to reflect the population most likely to be affected by the condition. The inclusion of patients who are seriously ill, and therefore potentially vulnerable, requires careful exploration of ethical and legal principles that underpin informed consent. Specific challenges in obtaining informed consent for randomised clinical trials (RCTs) in clinically unstable populations such as hospice and palliative care include higher rates of people with impaired cognitive capacity as well as interventional studies in clinical situations which may present as a sudden change in condition. None of these challenges is unique to hospice and palliative care research, but the combination and frequency with which they are encountered require systematic and considered solutions. This article outlines five different ethically valid consent approaches and discusses their applicability to hospice and palliative care research trials. These include: consent by the patient (at the time of enrolment, in advance of the study, or delayed until after the study has commenced); a proxy (or legally authorised representative); or a consent waiver. Increased use of the less traditional modes of informed consent may lead to greater participation rates in hospice and palliative care trials, thereby improving the evidence base more rapidly in part by better reflecting the population served and hence improving generalizability. ItemAn 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 PickarBackground: 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. ItemLetter to the Editor re "Four essential drugs needed for quality care of the dying: a Delphi-study based international expert consensus opinion"(Mary Ann Liebert, Inc., 2013-06-21) Clark, Katherine; Sheehan, Caitlin; Currow, David ChristopherHigh-quality patient care can be defined as an approach that minimizes harm whilst aligning with people's expectations. Dying people and their relatives have articulated that they expect health care providers to manage physical and psychological symptoms well, with expectations even higher when such care is delivered by specialist services. Despite excellent intentions, palliative care clinicians and researchers have done little to improve systematically the evidence base for prescribing when people are actually dying. Few data exist to inform clinicians' understanding of how people's actual experiences align with their articulated wishes. Symptoms are managed based on relatives' and staff's assumptions of the experience of the dying person, with a “good death” often being seen as quiet and calm. Achieving this often requires sedation, for which the dying person will very rarely have given consent. This requires consideration, especially when evidence suggests people facing death will forgo symptom control to remain as alert and interactive for as long as possible. We ignore patients' wishes at our peril if we are to be truly patient centered. ItemThe longitudinal pattern of response when morphine is used to treat chronic refractory dyspnea(Mary Ann Liebert, Inc., 2013-07-22) Currow, David Christopher; Quinn, Stephen; Greene, Aine; Bull, Janet; Johnson, Miriam J; Abernethy, Amy PickarBackground: While evidence supports using sustained release morphine for chronic refractory breathlessness, little is known about the longitudinal pattern of breathlessness intensity as people achieve symptomatic benefit. The aim of this study is to describe this pattern. Methods: This secondary analysis used breathlessness intensity scores (100mm visual analogue scale (VAS)) from a prospective, dose increment study of once daily (morning) sustained release morphine for chronic refractory breathlessness. Participants who achieved < 10% improvement over their own baseline at one week (10 mg) were titrated to 20mg and if no response, another week later to 30mg for one week. Time was standardized at the first day of the week in which participants responded generating twice daily data one week either side of symptomatic benefit. Analysis used random effect mixed modeling. Results: Of the 83 participants, 17/52 responders required > 10 mg: 13 participants (20 mg) and 4 (30 mg), contributing 634 VAS observations. In the week leading to a response, average VAS scores worsened by 0.3mm/ day ( p = 0.16); the average improvement in the first 24 hours of response was 10.9mm (7.0 to 14.7; p < 0.0001), with continued improvement of 2.2 mm/day ( p < 0.001) for six more days. Conclusion: When treating chronic refractory breathlessness with once daily sustained release morphine, titrate to effect, since inadequate dose may generate no response; and following an initial response, further dose increases should not occur for at least one week. Whether further benefit would be derived beyond day six on the dose to which people respond, and what net effect a further dose increase would have are questions yet to be answered. ItemMeasuring impacts of value to patients is crucial when evaluating palliative care(Elsevier, 2009-06) McCaffrey, Nicola; Currow, David Christopher; Eckermann, Simon DouglasThe 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. ItemOff-label prescribing in palliative care – a cross-sectional national survey of Palliative Medicine doctors(SAGE Publications, 2012-11-05) To, Timothy H M; Agar, Meera Ruth; Shelby-James, Tania Maree; Abernethy, Amy Pickar; Doogue, Matthew; Rowett, Debra Sharon; Ko, Danielle N; Currow, David ChristopherBackground: 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. ItemOnce-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 PickarContext 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. ItemPharmacovigilance 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 SharonBackground: 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. ItemA pilot study to assess the feasibility of measuring the prevalence of slow colon transit or evacuation disorder in palliative care(Mary Ann Liebert, Inc., 2013-04-27) Clark, Katherine; Currow, David ChristopherContext: Constipation is prevalent in palliative care. Whilst numerous factors contribute to this problem, opioid analgesia remains the most quoted aetiology. However, in gastroenterology, constipation is classified as a problem of prolonged transit times of colonic contents, impaired function of the structures of defecation or both. Little work in palliative care has used these assessments. Aims: The report aims to describe the feasibility of assessing the colon transit times and pelvic floor structures of constipated palliative care patients and to report the results of a pilot study of 10 people who underwent these investigations. Methods: Colon transit times were measured with a combination of orally administered radio-opaque markers and a single plain radiograph of the abdomen at day 5. Anal manometry plus rectal balloon expulsion was used to assess the pelvic floor. The results of the investigations were used to allocate people to one of four constipation subcategories: 1). slow colonic transit; 2) evacuation disorders; 3) mixed disorder or 4) normal transit. Results: Two people had slow transit only, 2 people had evacuation disorders only and 5 had both. Only person had neither problem. The investigations were well tolerated and took a small amount of people's time. Conclusion: These pilot data strongly support the feasibility of undertaking comprehensive assessments of the colon and pelvic floor in palliative care patients with the results, although preliminary, highlighting the complexity of the problem of constipation. The results of this work underpin the need to progress to a much larger study. ItemPlanning 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, JanetGoals 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.