An evidence-base for the implementation of hospital-based palliative care programs in routine cancer practice: A systematic review.

BACKGROUND: Despite global support, there remain gaps in the integration of early palliative care into cancer care. The methods of implementation whereby evidence of benefits of palliative care is translated into practice deserve attention. AIM: To identify implementation frameworks utilised in integrated palliative care in hospital-based oncology services and to describe the associated enablers and barriers to service integration. DESIGN: Systematic review with a narrative synthesis including qualitative, mixed methods, pre-post and quasi experimental designs following the guidance by the Centre for Reviews and Dissemination (PROSPERO registration CRD42021252092). DATA SOURCES: Six databases searched in 2021: EMBASE, EMCARE, APA PsycINFO, CINAHL, Cochrane Library and Ovid MEDLINE searched in 2023. Included were qualitative or quantitative studies, in English language, involving adults >18 years, and implementing hospital-based palliative care into cancer care. Critical appraisal tools were used to assess the quality and rigour. RESULTS: Seven of the 16 studies explicitly cited the use of frameworks including those based on RE-AIM, Medical Research Council evaluation of complex interventions and WHO constructs of health service evaluation. Enablers included an existing supportive culture, clear introduction to the programme across services, adequate funding, human resources and identification of advocates. Barriers included a lack of communication with the patients, caregivers, physicians and palliative care team about programme goals, stigma around the term 'palliative', a lack of robust training, or awareness of guidelines and undefined staff roles. CONCLUSIONS: Implementation science frameworks provide a method to underpin programme development and evaluation as palliative care is integrated within the oncology setting.

Care plus study: a multi-site implementation of early palliative care in routine practice to improve health outcomes and reduce hospital admissions for people with advanced cancer: a study protocol.

BACKGROUND: Current international consensus is that 'early' referral to palliative care services improves cancer patient and family carer outcomes. In practice, however, these referrals are not routine. An approach which directly addresses identified barriers to early integration of palliative care is required. This protocol details a trial of a standardized model of early palliative care (Care Plus) introduced at key defined, disease-specific times or transition points in the illness for people with cancer. Introduced as a 'whole of system' practice change for identified advanced cancers, the key outcomes of interest are population health service use change. The aims of the study are to examine the effect of Care Plus implementation on (1) acute hospitalisation days in the last 3 months of life; (2) timeliness of access to palliative care; (3) quality and (4) costs of end of life care; and (5) the acceptability of services for people with advanced cancer. METHODS: Multi-site stepped wedge implementation trial testing usual care (control) versus Care Plus (practice change). The design stipulates 'control' periods when usual care is observed, and the process of implementing Care Plus which includes phases of planning, engagement, practice change and evaluation. During the practice change phase, all patients with targeted advanced cancers reaching the transition point will, by default, receive Care Plus. Health service utilization and unit costs before and after implementation will be collated from hospital records, and state and national health service administrative datasets. Qualitative data from patients, consumers and clinicians before and after practice change will be gathered through interviews and focus groups. DISCUSSION: The study outcomes will detail the impact and acceptability of the standardized integration of palliative care as a practice change, including recommendations for ongoing sustainability and broader implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN 12619001703190 . Registered 04 December 2019.

Acceptability and barriers to implementation of N-of-1 tests in Ethiopia - a qualitative study.

BACKGROUND: Locally produced generic drugs offer a cost-effective alternative to imported drugs to treat patients in Ethiopia. However, due to a lack of bioequivalence testing, additional assurance tests are needed to build trust in cheaper, locally made drugs. By testing bioequivalence of local drugs to gold standard, N-of-1 tests have the potential to promote patient centred quality use of medicines. METHOD: We sought to assess the acceptability of, and explore barriers to, conducting N-of-1 tests to evaluate local medicines in a resource limited clinical setting. We conducted a descriptive qualitative study, analysing four focus group discussions and five key informant interviews. Participants were senior drug regulatory authority members, institutional review board members, physicians and patients. All interviews were audio taped and transcribed verbatim. Patient interviews were conducted in Amharic and translated to English prior to analysis. Data analysis used an inductive, thematic process. RESULTS: Five major themes were identified; (1) Appropriateness of N-of-1 tests to determine the therapeutic equivalence of local drugs, (2) N-of-1 therapeutic equivalence tests: clinical care or research? (3) Ethical and regulatory requirements (IRB), (4) Potential barriers to implementing N-of-1 tests and (5) Possible solutions to identified challenges. The study demonstrated considerable support for using N-of-1 tests for clinical equivalence studies between local and imported medicines, but important impediments were very likely to impact the feasibility of conducting N-of-1 tests in Ethiopia. Key informants from the regulatory authority did not support additional tests of local drugs. There were also mixed opinions regarding ethical requirements for conducting N-of-1 tests. The Institutional Review Board (IRB) members believed that IRB approval was sufficient to conduct N-of-1 tests, however, the regulatory authority members considered that N-of-1 tests constituted a clinical trial, and required approval at the regulatory level. CONCLUSION: This study showed that there were key uncertainties that could impact the feasiblity of using N-of-1 testing local drugs in Ethiopia. Therefore, a number of protocol amendments to address contextual threats and regulatory challenges, would be needed before progressing to conducting these tests.

Is care really shared? A systematic review of collaborative care (shared care) interventions for adult cancer patients with depression.

BACKGROUND: Collaborative care involves active engagement of primary care and hospital physicians in shared care of patients beyond usual discharge summaries. This enhances community-based care and reduces dependence on specialists and hospitals. The model, successfully implemented in chronic care management, may have utility for treatment of depression in cancer. The aim of this systematic review was to identify components, delivery and roles and responsibilities within collaborative interventions for depression in the context of cancer. METHODS: Medline, PsycINFO, CINAHL, Embase, Cochrane Library and Central Register for Controlled Trials databases were searched to identify studies of randomised controlled trials comparing a treatment intervention that met the definition of collaborative model of depression care with usual care or other control condition. Studies of adult cancer patients with major depression or a non-bipolar depressive disorder published in English between 2005 and January 2018 were included. Cochrane checklist for risk of bias was completed (Study Prospero registration: CRD42018086515). RESULTS: Of 8 studies identified, none adhered to the definition of 'collaborative care'. Interventions delivered were multi-disciplinary, with care co-ordinated by nurses (n = 5) or social workers (n = 2) under the direction of psychiatrists (n = 7). Care was primarily delivered in cancer centres (n = 5). Care co-ordinators advised primary care physicians (GPs) of medication changes (n = 3) but few studies (n = 2) actively involved GPs in medication prescribing and management. CONCLUSIONS: This review highlighted joint participation of GPs and specialist care physicians in collaborative care depression management is promoted but not achieved in cancer care. Current models reflect hospital-based multi-disciplinary models of care. PROTOCOL REGISTRATION: The protocol for this systematic review has been registered with PROSPERO. The registration number is CRD42018086515.

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

BACKGROUND: Because 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. METHODS: A 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. RESULTS: Four 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. CONCLUSION: The 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.

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.

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.

Can spirituality be taught to health care professionals?

Although people with life-limiting conditions report a desire to have spiritual concerns addressed, there is evidence that these issues are often avoided by health care professionals in palliative care. This study reports on the longitudinal outcomes of four workshops purpose-designed to improve the spiritual knowledge and confidence of 120 palliative care staff in Australia. Findings revealed significant increases in Spirituality, Spiritual Care, Personalised Care, and Confidence in this field immediately following the workshops. Improvements in Spiritual Care and Confidence were maintained 3 month later, with Confidence continuing to grow. These findings suggest that attendance at a custom-designed workshop can significantly improve knowledge and confidence to provide spiritual care.

Cancer survivorship care and general practice: A qualitative study of roles of general practice team members in Australia.

Primary care providers, including general practice teams (GPTs), are well positioned within the community to integrate cancer survivorship care into ongoing health management. However, roles of GPT members in delivery of cancer survivorship care have not been explored. The purpose of this study is to explore these roles from the perspectives of General Practitioners (GPs), Practice Nurses (PNs) and Practice Managers (PMs). An interpretive qualitative study using semi-structured in-depth telephone interviews with ten GPs, nine PNs and five PMs was conducted. Interviews were recorded, transcribed and analysed using grounded theory methods. Perspectives of roles in delivery of cancer survivorship care were highly variable. Variation was evident among perceptions of needs of cancer survivors, individual team members' scopes of practice, and individual professional knowledge and skills. A lack of clarity in roles and responsibilities of GPT members was thought to contribute to a lack of consistency in survivorship care. Reducing variations in perceptions of survivorship care in the primary care setting should be a priority. Such efforts may include development of practical guidance to support GPT members to clarify scopes of practice within the team. In addition to accessible comprehensive education programs, other innovative, tailored individualised education approaches may be helpful. System-level support in clarifying and supporting the roles of the primary care team is needed to facilitate a survivorship delivery system at general practice level where those within GPT can ensure that individual patients' needs are met in a timely and effective manner.

Facilitating needs based cancer care for people with a chronic disease: Evaluation of an intervention using a multi-centre interrupted time series design.

BACKGROUND: Palliative care should be provided according to the individual needs of the patient, caregiver and family, so that the type and level of care provided, as well as the setting in which it is delivered, are dependent on the complexity and severity of individual needs, rather than prognosis or diagnosis [1]. This paper presents a study designed to assess the feasibility and efficacy of an intervention to assist in the allocation of palliative care resources according to need, within the context of a population of people with advanced cancer. METHODS/DESIGN: People with advanced cancer and their caregivers completed bi-monthly telephone interviews over a period of up to 18 months to assess unmet needs, anxiety and depression, quality of life, satisfaction with care and service utilisation. The intervention, introduced after at least two baseline phone interviews, involved a) training medical, nursing and allied health professionals at each recruitment site on the use of the Palliative Care Needs Assessment Guidelines and the Needs Assessment Tool: Progressive Disease - Cancer (NAT: PD-C); b) health professionals completing the NAT: PD-C with participating patients approximately monthly for the rest of the study period. Changes in outcomes will be compared pre-and post-intervention. DISCUSSION: The study will determine whether the routine, systematic and regular use of the Guidelines and NAT: PD-C in a range of clinical settings is a feasible and effective strategy for facilitating the timely provision of needs based care. TRIALS REGISTRATION: ISRCTN21699701.

Contemporary Educational Interventions for General Practitioners (GPs) in Primary Care Settings in Australia: A Systematic Literature Review.

Background: The primary purpose of educational interventions is to optimize the clinical management of patients. General practitioners (GPs) play a major role in the detection and management of diseases. This systematic literature review will describe the type and outcomes of educational interventions designed for general practitioners (GPs) in the Australian context. Methods: PubMed, CINHAL, and Scopus databases were systematically searched for studies on educational interventions conducted for GPs in Australia during 1st January 2008 to 11th June 2018. Data collected on the methodology of the interventions, GPs satisfaction regarding the educational intervention, changes in knowledge, confidence, skills and clinical behavior of the GPs. We also assessed whether the acquired clinical competencies had an impact on organizational change and on patient health. Results: Thirteen publications were included in this review. The methods with which educational interventions were developed and implemented varied substantially and rigorous evaluation was generally lacking particularly in detailing the outcomes. The reported GP response rate varied between 2 and 96% across studies, depending upon the method of recruitment, the type of intervention and the study setting (rural vs. urban). The most effective recruitment strategy was a combination of initial contact coupled with a visit to GP practices. Nine of the studies reviewed reported improvement in at least one outcome measure: gaining knowledge, improving skills or change in clinical behavior which was translated into clinical practice. In the 3 pre- and post-intervention analysis studies, 90-100% of the participating GPs reported improvement in their knowledge and attitudes. Conclusion: Education interventions for GPs in Australia had low response (recruitment) and retention (GPs that participated in follow-ups) rates, even when financial benefits or CPD points were used as incentives. Higher GP response rates were achieved through multiple recruitment strategies. Multifaceted interventions were more likely to achieve the primary outcome by improving knowledge, skills or changing practice, but the effect was often modest. Inconsistent results were reported in studies involving the use of multiple contact methods within an intervention and conducting online interventions.

Tracking patients with advanced kidney disease in the last 12 months of life.

BACKGROUND: There is increasing recognition of the clinical need for timely and coordinated supportive and palliative care for those with terminal organ failure. OBJECTIVE: To describe symptoms, quality of life and supportive care needs in the anticipated 12-month period prior to death in adults with chronic kidney disease (CKD) stages 4 or 5. METHOD: An observational, prospective, longitudinal design was used to follow 19 patients. The measures used were the Chronic Kidney Disease-Symptom Burden Index (CKD-SBI), the Australian Karnofsky Performance Scale (AKPS), the Functional Assessment of Chronic illness Therapy Palliative-14 (FACIT PAL-14), the Assessment of Quality of Life 6 Dimensions (AQoL-6D) and the Sheffield Profile for Assessment and Referral for Care (SPARC). Data were collected at study entry and three monthly until death or study end. RESULTS: Patients' median age was 78 years (range 42-90), most were male (63%), 10 were receiving dialysis and seven died during the study. The most prevalent symptoms reported differed from those that were most troublesome. The median AKPS score did not change over time (60). Quality of life remained steady over time [FACIT-PAL median range: 43.5-46; AQoL-6D means range: 0.66 (SD 0.19) to 0.75 (SD 0.2)]. Supportive care needs were few. CONCLUSION: We found a substantial symptom burden and slow functional decline in this group of patients. Regular assessment of both symptoms and QOL is warranted particularly if clinical experience indicates that the person is likely to be in their last year of life. Integrated supportive care programmes could assist with easing symptom burden during this time.

Until the chemist opens - palliation from the doctor's bag.

BACKGROUND: People with a life limiting illness may have unpredictable exacerbations of their symptoms requiring after hours care by general practitioners using medications that are readily accessible. All doctors are provided with injectable 'doctor's bag' emergency drugs for use in such a crisis. OBJECTIVE: This article aims to: identify which medications from the doctor's bag can be used in the palliative care crises that are most frequently encountered, present the best possible evidence for these indications, and to provide GPs caring for palliative care patients after hours with management strategies so, whenever appropriate, they can continue to be managed at home. DISCUSSION: The clinical context, including disease trajectory and patient and caregivers' wishes, must be assessed in palliative care crises. Having excluded reversible problems, symptoms can be treated using doctor's bag medications. Attention must be given to route of administration, duration of effect, and appropriate doses for effective palliation.

Killing George with kindness--is there such a thing as too much palliative care?

Early referral and anticipatory planning are central tenets of good palliative care. Each case, however, needs to be considered on its merits. Too many supports put in place at the wrong time may have adverse consequences for some patients. A clear understanding of the patient's understanding of their illness and prognosis, and appreciation of their mental state at each stage, are important in determining how much palliative care is enough.

Lung cancer.

BACKGROUND: Lung cancer is a preventable disease that has a poor prognosis in most patients. It has a high association with tobacco smoking. Diagnosis involves looking for new symptoms and signs, or changes in existing ones, with a heightened index of suspicion in patients who have ever smoked. OBJECTIVE: This article outlines the role of the general practitioner in the diagnosis, treatment and palliative care of the patient with lung cancer. DISCUSSION: The risk of developing lung cancer increases with increasing cigarette smoking and decreases when smoking is ceased. The development or change in a 'usual' cough should alert the GP to a diagnosis of lung cancer. Any referral to a respiratory specialist must be preceded by informing the patient of the nature of the possible disease, and ensuring that the patient has a realistic understanding of the limited chance of cure. Palliation is required by most patients with the GP playing an important role. Promotion of smoking cessation is the only real strategy available to doctors to reduce morbidity from this disease.

Chemotherapy and radiotherapy. When to call it quits.

BACKGROUND: Patients diagnosed with cancer are often treated with chemotherapy and radiotherapy with curative intent. The transition from curative to palliative intent involves re-evaluation of treatment, and has to take into account the attitudes, beliefs and life aims of the patient. OBJECTIVE: To discuss the difficulties in determining when to cease chemotherapy and radiotherapy in patients with advanced cancer. DISCUSSION: The concept of treatment evaluation using a 'burden versus benefit' paradigm is discussed. Treatment aims must be in concordance with those of the patient, which are often couched in functional terms or linked to future significant life events. Chemotherapy and radiotherapy can offer patients in the palliative phase of cancer illness, benefits in terms of relief of symptoms and meaningful prolongation of life, and should be considered in appropriate circumstances.

Assessing the impact of nano- and micro-scale zerovalent iron particles on soil microbial activities: particle reactivity interferes with assay conditions and interpretation of genuine microbial effects.

The effects of nano-scale and micro-scale zerovalent iron (nZVI and mZVI) particles on general (dehydrogenase and hydrolase) and specific (ammonia oxidation potential, AOP) activities mediated by the microbial community in an uncontaminated soil were examined. nZVI (diameter 12.5 nm; 10 mg g⁻¹ soil) apparently inhibited AOP and nZVI and mZVI apparently stimulated dehydrogenase activity but had minimal influence on hydrolase activity. Sterile experiments revealed that the apparent inhibition of AOP could not be interpreted as such due to the confounding action of the particles, whereas, the nZVI-enhanced dehydrogenase activity could represent the genuine response of a stimulated microbial population or an artifact of ZVI reactivity. Overall, there was no evidence for negative effects of nZVI or mZVI on the processes studied. When examining the impact of redox active particles such as ZVI on microbial oxidation-reduction reactions, potential confounding effects of the test particles on assay conditions should be considered.